Opinion
Civil Action No. 96-5541 (MLC).
June 17, 2004
MEMORANDUM OPINION
I. Introduction
This patent case was tried to a jury on plaintiff's claim of infringement and defendant's claims of invalidity on grounds of obviousness and prior invention. During trial, both parties made timely Rule 50 motions, which this Court deferred until post-verdict pursuant to Federal Rule of Civil Procedure ("Rule") 50(b). The verdict was in favor of plaintiff. Defendant timely renewed its motion for judgment as a matter of law, and moved alternatively for a new trial under Rule 59(a).
Adjudication of these motions has required a thorough analysis by the Court of the lengthy pretrial record and the voluminous trial record, applying the established standards for post-trial motions. Based upon that analysis, we will set aside the verdict and enter judgment in favor of defendant on all issues. Alternatively, the motion for new trial will also be granted.
II. The Claim in Suit and the Accused Device
Plaintiff Princeton Biochemicals, Inc. ("plaintiff" or "Princeton") is the owner of U.S. Patent No. 5,045,172 (`the `172 patent) entitled Capillary Electrophoresis Apparatus. The `172 patent is directed to an apparatus for use in the process of capillary electrophoresis whereby proteins and other molecules are separated and detected within fluid samples as a result of application of an electrical charge in a capillary tube.
Electrophoresis, also known as electrophoretic separation, is a phenomenon in which electrically charged particles move at different rates in a conductive buffer medium or fluid, enabling efficient detection of biological components. Capillary electrophoresis, also called zone electrophoresis, is one of several known systems for practicing electrophoretic separation.
The Background section of the `172 patent states in part as follows:
Capillary electrophoresis has been shown to be a technique for obtaining high separation efficiency. . . . In general, this technique utilizes a fused silica (quartz) capillary with an inside diameter ranging from about 25 microns to about 200 microns, and a length ranging from about 10 centimeters to about 100 centimeters.
. . . .
In the prior art, it is generally known that a material, containing mixtures of substances to be analyzed, can be passed along a capillary tube and through a detector under the influence of an applied voltage. The applied voltage charges the substances and the charges on the substances determine their spacing and their speed of passage along the capillary tube.
(`172 patent, col. 1, ll. 50-58 and col. 2, Il. 32-38.)
Plaintiff is the owner/assignee of the `172 patent, which issued on September 3, 1991 and will expire on September 2, 2008. The named inventor, Dr. Norberto Guzman, is the founder, sole employee, and controlling shareholder of the plaintiff corporation. He holds his Ph.D. in biochemistry from Rutgers University and has been continuously employed as a scientist in industry since obtaining that degree, first at Hoffman LaRoche and then at Johnson Johnson.
Defendant Beckman Coulter, Inc. (formerly known as Beckman Instruments, Inc.) ("defendant" or "Beckman") makes and sells the accused devices, known as the P/ACE 2000 and 5000 Series capillary electrophoresis instruments. Both series contain structures that are identical for purposes of this action, and the parties refer to them generally as the "P/ACE" device or devices. It is stipulated that the accused devices have been marketed since at least 1993, and that the sales have exceeded $50,000,000.
The `172 patent contains 40 claims, but only claim 32 is in issue in this action. Plaintiff seeks damages for alleged infringement of claim 32 under 35 U.S.C. § ("Section") 271(a). Defendant denies infringement and counterclaims for a declaration of invalidity on grounds of obviousness under Section 103, and prior invention under Section 102(g). This trial addressed issues of liability and invalidity only, with damages issues bifurcated to a later trial. (9-25-00 Order at 53; 3-27-97 Mem. Order.)
We will cite chiefly to the trial transcripts and trial exhibits in this opinion. All trial exhibits bear designations "PX" or "DX," which we cite as P- and D-for convenience. Additional portions of the litigation file are identified when cited. Docketed filings in this Court are identified by docket entry date and page, for example, "9-25-00 Order at 5."
The trial testimony is contained in 17 volumes of transcripts, totaling approximately 2,000 pages. In quoting testimony we have corrected obvious clerical errors, but none affecting the meaning of the text. We have also inserted bracketed material where needed for comprehension, and deleted conversational material. The transcripts are cited by volume number and page rather than by date, for example, "Tr. 2 at 6-8," according to the following table:
Vol. No. Date Vol. No. Date
1 9-5-01 a.m. 10 9-13-01 a.m. 2 9-6-01 a.m. 11 9-13-01 p.m. 3 9-6-01 p.m. 12 9-14-01 a.m. 4 9-7-01 a.m. 13 9-14-01 p.m. 5 9-7-01 p.m. 14 9-17-01 a.m. 6 9-10-01 a.m. 15 9-17-01 p.m. 7 9-10-01 p.m. 16 9-18-01 a.m. 8 9-12-01 a.m. 17 9-18-01 p.m. 9 9-12-01 p.m.
The parties also submitted briefs in support of and opposition to defendant's post-trial motions, which we will refer to by the following abbreviations: Def. Inf. Br., Def. Obv. Br., Def. Pl. Br., Pl. Br., Def. Inf. Rep. Br., Def. Obv. Rep. Br., and Def. Pl Rep. Br.
Claim 32 is an independent claim containing eight elements:
Pre. Capillary electrophoresis apparatus comprising
(1) a capillary tube of the type which can be electrically charged,
(2) said capillary tube having first and second ends,
(3) first means at said first end of said capillary tube providing a source of buffer solution and a source of a sample substance to be analyzed,
(4) second means coupled to said apparatus for applying electrical potential across said capillary tube whereby a sample flows through said capillary tube and past said detector,
(5) said first means includes a rotatable table carrying a plurality of sample cups and
(6) a holder for holding an end of said capillary tube in operative relation with one of the said cups, said cups containing either buffer solution or a sample to be analyzed, and
(7) said capillary tube is in the form of a coil of glass tubing
(8) secured to a support member.
The words "secured to a support member" are not present in claim 32 in the final printed version of the `172 patent. (See P-l, col. 23, l. 47.) The parties stipulated at trial that this was a printing error only, and those words (element 8) are part of claim 32 as issued. (Tr. 12 at 120-22.)
(P-1, col. 23, Il. 30-47 (paragraphing added by stipulation, P-72).)
The Federal Circuit has set some of the parameters of the dispute in its opinion reversing an earlier grant of summary judgment of noninfringement, Princeton Biochemicals, Inc. v. Beckman Instruments, Inc., Federal Circuit No. 98-1525, decided August 19, 1999 ("Fed. Cir. Op."). See discussion infra, Section IV.
III. Patent Prosecution History
The prosecution history resulting in the issuance of the `172 patent containing claim 32 began with the filing of a patent application ("original application") on November 25, 1987. That original application was abandoned in May, 1989, in favor of a continuation-in-part ("CIP") application that had been filed on November 14, 1988.
An overview of the file history is that elements 1 through 6 of issued claim 32 stem from claim 1 as it appeared in both the original application and in the CIP application; elements 7 stems from CIP application claim 39; and element 8 stems from CIP application claim 40. (See Fed. Cir. Op. at 3; 9-25-00 Order at 6.) We next summarize the portions of both application files directed to the issuance of claim 32.
The original application contained 28 claims, including claim 1 in the form quoted in the margin. (D-2 at 29-50.) All original claims were rejected as obvious under Section 103, in a first office action on June 2, 1988. (Id. at 84-87.) That office action rejected claims 1 to 28 as unpatentable over "Jorgenson in view of Stevenson and Arlinger." (Id. at 85.) An amendment containing changes not here relevant resulted in a final rejection on October 31, 1988, again rejecting claims 1 to 28 as obvious. (Id. at 92-96.) A telephone interview and two more amendments, filed on January 6, 1989 and March 2, 1989, did not overcome the prior rejection. (Id. at 97-102 and 105-08.) The application terminated with a Notice of Abandonment on May 31, 1989. (Id. at 109.)
Claim 1 in the original application, filed on November 25, 1987, stated as follows:
1. Capillary electrophoresis apparatus comprising
a capillary tube of the type which can be electrically charged, said capillary tube having first and second ends,
a detector adjacent to said capillary tube,
first means at said first end of said capillary tube providing a source of buffer solution and a source of a sample substance to be analyzed,
second means coupled to said apparatus for applying electrical potential across said capillary tube whereby a sample flows through said capillary tube and past said detector, and
said first means includes a rotatable table carrying a plurality of sample cups and a holder for holding an end of said capillary in operative relation with one of the said cups, said cups containing either buffer solution or a sample to be analyzed.
(D-2 at 28.)
Exhibits D-2 and D-3 are the file histories of the original patent application and the CIP application, respectively. At trial, they were also admitted into evidence as plaintiff's exhibits P-2 and P-3. (Tr. 3 at 6-7.) For purposes of this opinion, we will refer solely to D-2 and D-3.
The Jorgenson reference (P-93) is an article by James W. Jorgenson entitled "Capillary Zone Electrophoresis," in a book edited by Jorgenson entitled New Directions in Electrophoretic Methods (1987) ("Jorgenson article"). (See P-1 at 1.) There is also an article by Rose and Jorgenson cited in the `172 file history entitled "Characterization and Automation of Sample Introduction Methods for Capillary Zone Electrophoresis," in Analytical Chemistry, vol. 60, no. 7, Apr. 1, 1988 at 642-48 ("Rose/Jorgenson article"). (See P-1 at 1.) This latter article is discussed infra, n. 28.
The Stevenson reference (D-4) is U.S. Patent No. 3,918,913 ("Stevenson"). (See P-1 at 1.)
The Arlinger reference (P-96) is U.S. Patent No. 3,948,753 ("Arlinger"). (See P-1 at 1.)
The CIP application had meanwhile been filed on November 14, 1988, approximately one year after the filing of the original application. (D-3 at 5.) That application contained a total of 49 claims. Claim 1 of the CIP application was identical to claim 1 of the original application insofar as relevant to this case. (See Fed. Cir. Op. at 9.) Claim 39 of the CIP application was "[t]he apparatus defined in claim 1 wherein said capillary tube is in the form of a coil of glass tubing." (D-3 at 60.) Claim 40 of that application was "[t]he apparatus defined in claim 39 wherein said coil of glass tubing is secured to a support member." (Id.)
The first office action in response to the CIP application was a rejection of many of the claims including claims 1 and 39. (Id. at 69.) As before, claim 1 was rejected on the grounds of obviousness due to "Jorgenson in view of Stevenson et al and Arlinger." (Id. at 70.) Claim 39 was rejected for obviousness reasons as well, with that claim found "unpatentable over Jorgenson in view of Stevenson et al and Arlinger as applied to claims 1-28 and 48 above, and further in view of Akiyama." (Id. at 72.) The examiner objected to, but did not reject, claim 40, on the ground that it depended upon rejected claims. But the examiner stated that claim 40 "would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims." (Id. at 73.) Here it may be noted that the examiner did not object to claim 40 on grounds of obviousness.
The Akiyama reference (D-5) is U.S. Patent No. 3,941,678 ("Akiyama") (See P-1 at 1.)
The applicant responded to the first office action on the CIP application by filing an amended application making a series of changes. (Id. at 75-88.) Those changes included moving most of the text of former claim 1 into claim 39, thus combining claim 1 with the coiled glass capillary element of former claim 39. That amended claim 39 thus read:
39. (Amended) Capillary electrophoresis apparatus comprising a capillary tube of the type which can be electrically charged, said capillary tube having first and second ends,
first means at said first end of said capillary tube providing a source of buffer solution and a source of a sample substance to be analyzed,
second means coupled to said apparatus for applying electrical potential across said capillary tube whereby a sample flows through said capillary tube and past said detector,
said first means includes a rotatable table carrying a plurality of sample cups and a holder for holding an end of said capillary tube in operative relation with one of the said cups, said cups containing either buffer solution or a sample to be analyzed, and
said capillary tube is in the form of a coil of glass tubing.
(Id. at 88.)
The Patent Office issued a final rejection of the CIP application on September 5, 1990. (Id. at 96.) That notice allowed certain claims but continued to reject amended claim 39 and several other claims, and continued to object to claim 40. (Id.) This time the examiner cited the Jorgenson, Stevenson, and Akiyama references in rejecting as obvious certain claims, including amended claim 39. (Id. at 98.) The objection to claim 40 remained the same, the examiner again indicating that he would allow claim 40 if it were combined with the elements of claims 1 and 39. (Id. at 99-100.) The applicant adopted the examiner's suggestion in its October 11, 1990 amendment, combining the language of CIP claims 1, 39 and 40 into amended claim 39. (Id. at 103.) Thus, for the first time in the prosecution history, element 8, consisting of the words "secured to a support member," were added at the end of the language of combined claims 1 and 39.
The second amended CIP application received a Notice of Allowability on October 26, 1990, and the `172 patent was issued on September 3, 1991. (Id. at 107; P-1 at 1.) In the process, amended claim 39 was renumbered to be claim 32. (D-3 at 88.) The result of this prosecution history is that claim 32, as issued, contains elements 1 through 6 of original application claim 1 (which were carried forward unamended into CIP application claim 1), combined with elements 7 and 8 stemming from CIP claims 39 and 40. (See Fed. Cir. Op. at 9-10.)
A more detailed review of the file history pertaining to claim 32 is in Section VII, infra.
IV. Litigation History
Plaintiff commenced this action against defendant on November 21, 1996, alleging that defendant's P/ACE devices infringe the `172 patent. Defendant denied infringement and counterclaimed for a declaration of invalidity. There was no injunctive phase. A bifurcation order was entered providing that adjudication of issues of willful infringement and damages would follow adjudication of liability and invalidity issues, and discovery ensued. (3-27-97 Mem. Order.)
Defendant moved for summary judgment of noninfringement, and plaintiff cross-moved for partial summary judgment of infringement. This Court held a Markman hearing directed to construing only the "holder limitation" of element 6 of claim 32, as requested by defendant in its motion. (10-27-97 Tr., filed 12-5-97.) We issued an opinion granting defendant summary judgment of noninfringement on grounds of both literal infringement and doctrine of equivalents. (6-25-98 Memo. Order.) Plaintiff appealed only the literal infringement ruling. (Fed. Cir. Op. at 5, n. 2.) The Federal Circuit reversed, holding that this Court had erred in its claim construction of that limitation and therefore its infringement analysis of the accused device could not stand (Id. at 11-12.)
The Federal Circuit appeal concerned only the construction of the "holder" limitation of element 6 of claim 32, namely the words "a holder for holding an end of said capillary tube in operative relation with one of the said cups." (Id. at 2.) That Court described the dispute as follows:
The P/ACE devices consist of an apparatus in which a vertically moving table and sample cup is "in operative relation" with a stationary capillary. The parties disputed whether the claim covers only the embodiment where the holder and the capillary tube move vertically toward a stationary sample cup and table, or also the alternative embodiment in which the sample cup and table move vertically toward a stationary holder and capillary tube as in the accused devices.
Plaintiff has argued that this and other language in the Federal Circuit Opinion constitutes a ruling that the accused device does in fact contain a "holder" within the meaning of element 6. (Tr. 6 at 14-19.) We rejected that notion because the same opinion ruled that the issue of infringement based on the "holder" limitation was not decided by the Circuit on appeal. (Id.) See n. 12 infra and accompanying text.
(Id. at 3 (emphasis added).)
This Court had construed the language "in operative relation" to require vertical movement of the structure that holds the capillary toward sample cups, and not to encompass the opposite action, vertical movement of the sample cups or the table holding the sample cups toward a stationary structure holding the capillary. (Id. at 3-4.) Based upon that claim construction, we had concluded that the accused device did not infringe claim 32 for two reasons, stating that "[t]he capillary in the alleged infringing device is stationary; it does not move vertically. Moreover, the alleged infringing device has no holder for the capillary at all." (Id. at 4-5, quoting 6-25-98 Mem. Order at 18.)
The appeals court opinion relied upon its reading of both the claim language and the written description. (Fed. Cir. Op. at 6-7.) It also pointed out that a close reading of the prosecution history reveals that although there were some narrowing amendments submitted during the course of the original application, those amendments did not result in the issuance of claim 32. (Id. at 8-9.) Finally, it made reference to the prior art, specifically Jorgenson and Stevenson, stating that "the prior art discloses embodiments in which capillary tubes, individual sample cups, and rotatable sample tables are raised and lowered." (Id. at 11.) For those reasons, the Court held that "the proper interpretation of the holder limitation is that "in operative relation" encompasses both vertical movement of the holder as well as vertical movement of the sample cups and table." (Id. at 3-4.)
The final point addressed in the Federal Circuit opinion was plaintiff's contention that having reversed the district court's claim interpretation, that court should grant plaintiff's motion for summary judgment of infringement as to the holder limitation. The Court declined to so rule, stating that the issue was not before it in that appeal.
This was the Circuit ruling on this point, in its entirety:
Finally, Princeton urges that if we are to reverse the district court's claim interpretation, as we have done, we should also grant summary judgment of literal infringement as the P/ACE devices contain a "holder" in the form of either the cartridge which houses the coiled capillary tube itself or the plugs which seal the capillary tube ends to the cartridge wall at the inlet and outlet openings. Beckman asserts that this is inappropriate as the district court dismissed Princeton's motion for summary judgment of infringement as moot and thus is not before us on appeal. We agree with Beckman. In this case, the proper disposition is for us to remand the case to the district court to determine the issue of literal infringement in light of the correct claim interpretation. Although the district court determined that "the alleged infringing device has no holder for the capillary at all," Slip op. at 18, this finding was based on an incorrect claim interpretation and thus cannot stand
(Fed. Cir. Op. at 11-12.)
Discovery and motion practice continued upon remand Plaintiff moved to amend the complaint to include in its infringement claim a later series of defendant's instruments, called the P/ACE MDQ series. That motion was denied by the Magistrate Judge and not appealed to the District Judge. (3-6-00 Order.) Defendant moved again for summary judgment, this time seeking a declaration of invalidity on grounds of obviousness. We issued an opinion denying that summary judgment motion, ruling that plaintiff's opposition papers had sufficed to establish the existence of factual issues. (12-29-00 Mem. Order.)
Following entry of the Pretrial Order, the parties engaged in extensive in limine motion practice. (See generally docket entries 74-112.) The resolution of those motions included two evidentiary hearings, one on a document authenticity issue and the other a Daubert hearing on one of defendant's expert witnesses. (4-4-01 H'g Tr., docket entry 107; 5-22-01 H'g Tr., docket entry 109.) Certain evidentiary rulings were made in the course of the in limine motions, and others were made during the ensuing trial. Also during the trial, this Court conducted (out of the presence of the jury) a Daubert hearing regarding the scope of Dr. Guzman's proposed expert testimony, and a Markman hearing to construe claim 32 in its entirety. (Tr. 4 at 104-48; Tr. 5 at 3-60; Tr. 6 at 3-57.) To the extent that the evidentiary and claim construction rulings made during the pretrial and trial proceedings are pertinent to this opinion, they are addressed in the discussion sections infra.
The jury trial was conducted in nine days of trial sessions. (See n. 2 supra.) Plaintiff presented Dr. Guzman as both fact and expert witness, and also a fact witness named Dr. Olsen. (Tr. 3 at 9-55; Tr. 4 at 44-80; Tr. 5 at 59-101; Tr. 7 at 4-76; Tr. 8 at 14-230; Tr. 9 at 15-57; Tr. 10 at 3-195; Tr. 11 at 3-23.) Defendant presented fact witnesses named Dr. Osborne and Messrs. Burolla and Harbaugh, and expert witnesses named Dr. Jorgenson and Mr. Jester, (Tr. 11 at 57-84; Tr. 12 at 3-204; Tr. 13 at 3-102; Tr. 14 at 11-108.) Each side used deposition excerpts of party witnesses as testimonial evidence. Plaintiff used portions of Dr. Osborne's deposition (Tr. 11 at 25-53), and defendant used portions of Dr. Guzman's depositions. (Tr. 14 at 3-5; Tr. 16 at 45; Defendant's Submission of Citations to Deposition Videoclips Presented During Trial, dated 9-18-01, docket entry 171.) Stipulations were also made part of the record at various points in the trial. (See, e.g., Tr. 9 at 59-61; Tr. 14 at 109.)
Both parties moved for judgment as a matter of law before the case was submitted to the jury, and we reserved judgment until appropriate motions could be filed post-verdict. (Tr. 16 at 45-46.) During deliberations the jury asked one question, which was discussed at length with counsel and was responded to as shown in the record. (Id. at 15-38; docket entry 168.) The verdict sheet, reproduced in the margin, was answered by the jury in favor of plaintiff on all issues.
The verdict sheet asked and was answered as follows:
1. Do you find that Princeton has proven by a preponderance of the evidence that Beckman's P/ACE devices infringe Claim 32 of the patent?
Yes X No ____
2. Do you find that Beckman has proven by clear and convincing evidence that Claim 32 of the patent is invalid because the subject matter of that claim would have been obvious in view of the prior art?
Yes ____ No X
3. Do you find that Beckman has proven by clear and convincing evidence that Claim 32 of the patent is invalid because the invention described in that claim was made by Beckman before it was made by Princeton?
Yes ____ No X
(Docket entry 169.)
V. Claim Construction at Trial
Certain basic legal principles guided our approach to claim construction for the trial. Patent claims must be interpreted to determine the scope of the invention and the meaning of the words used in the claim. Construction of a patent claim is a matter of law exclusively for the court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). Claims are construed the same way for purposes of validity and infringement. Id., 52 F.3d at 1025 n. 7. In general, words in a claim must be given their ordinary and customary meaning. Elekta Instrument S.A. v. O.U.R. Scientific Int'l, Inc., 214 F.3d 1302, 1307 (Fed. Cir. 2000); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). To interpret an asserted claim, the court should look first to the intrinsic evidence, which is the patent itself, including the claims, the specification and the prosecution history. Id.
The parties during trial provided the Court with undisputed recommended claim construction language for a few of the limitations of claim 32. They did agree, based upon the outcome of the prior appeal, that the phrase "in operative relation" in element 6 means "that the end of the capillary can move toward the cups or the cups can move upward toward the end of the capillary." They also agreed that most of the words in claim 32 could have their ordinary English meaning. They further agreed that the entirety of element 4, which is a "means plus function" limitation, would properly be construed to mean "a high voltage power supply which causes sample components to migrate through the capillary."
The rest of the claim construction process was the subject of much debate, both in briefing materials and in oral argument. The result of the Court's rulings on those issues is reflected in the claim construction set forth in the jury charge. Here we will highlight only the most contentious of those rulings.
The oral arguments of the parties concerning the claim construction to be used at trial are found in the trial transcripts. (See Tr. 6 at 3-54; Tr. 16 at 43-44.) Those were supported in a series of issue briefs submitted during trial ("claim construction trial briefs"). Those briefs, maintained only in chambers under the local rules of this Court at the time, have been filed on the docket under a separate filing order, for convenience on appeal. (Docket entry 170.)
The construction of claim 32 provided in the jury charge stated in full as follows:
We have something called claim construction in a patent case. To decide the questions of infringement and invalidity, you must first understand what the claims of the patent cover, that is what they prevent anyone else from making or selling. You must use the same claim meaning for both your decision on infringement and your decision on invalidity. In this case it is my duty under the law to define any words or phrases in Claim 32 whose meaning is not plainly apparent. Therefore I must provide you with the definitions of those words or phrases. They are as follows.
If you look at Element 3, the phrase "first means at said first end of said capillary tube providing a source of buffer solution and a source of sample substance to be analyzed," that phrase is defined as a rotatable table carrying a plurality of sample cups and a holder for holding an end of the capillary tube in operative relation with one of the sample cups. That's how I am defining for you Element 3 there.
Then we have Element 4, the phrase, "second means coupled to said apparatus for applying electrical potential across said capillary tube whereby a sample flows through said capillary tube and past said detector," that phrase I am defining for you as a high voltage power supply which causes sample components to migrate through the capillary.
Lastly, down in Element 6, the phrase, "in operative relation" means that the end of the capillary can move toward the cups or the cups can move upward toward the end of the capillary.
You should give all of the remaining words in Claim 32 their ordinary meaning consistent with these instructions, ordinary English word meaning.
(Tr. 15 at 33-34.)
The parties sharply disagreed on the meaning of the "means plus function" language of element 3. Defendant argued that the proper construction of that limitation, under Section 112 ¶ 6, would refer to the function of introducing the fluid into the capillary tube. Based on this premise, defendant contended that since the only structure identified in the patent specification for introducing both a buffer solution and a sample substance into the capillary was a suction, vacuum or peristaltic pump manually connected to the capillary using a tube connector for the application of mild suction, element 3 should be limited to that structure or its structural equivalent. Plaintiff argued for an interpretation that a capillary loading feature is not part of claim 32, and that the stated function of element 3 is simply to provide a source of buffer and sample solutions. Plaintiff urged that under that view, a proper construction of element 3 under Section 112 ¶ 6 would refer only to the structures for performing that function explicitly identified in elements 5 and 6, namely the rotatable table and holder limitations of elements 5 and 6.
A ruling favorable to defendant on this point would enable it to argue that element 3 is not infringed by the accused P/ACE device, which normally uses a pressure injection system to introduce the fluid into the capillary rather than a suction pump. (See, e.g. Tr. 12 at 7-10 and 26-27.) Details concerning the capillary injection capabilities of the P/ACE device, and the development of those features in the design phase, are found throughout the trial evidence. (See, e.g., id.; Tr. 14 at 41-47.) Despite our ruling on the claim construction of element 3, the details concerning the capillary injection system of the P/ACE device remain relevant to an understanding of the accused device itself, on the issue of infringement. (See Section IXinfra.)
This Court ultimately construed element 3 consistent with the view advanced by plaintiff. (Tr. 6 at 19-54; see also n. 14supra.) We thus explicitly included the rotatable table and holder limitations of elements 5 and 6 in the construction of element 3. Although the parties preserved each of their claim construction objections on the record, defendant does not revisit any claim construction issues in the present motion.
See n. 15 supra, quoting claim construction in jury charge.
VI. Motion Standards under Rules 50 and 59
A. Motion for Judgment as a Matter of Law
Rule 50(a)(1) states:
If during a trial by jury a party has been fully heard on an issue and there is no legally sufficient evidentiary basis for a reasonable jury to find for that party on that issue, the court may determine the issue against that party and may grant a motion for judgment as a matter of law against that party with respect to a claim or defense that cannot under the controlling law be maintained or defeated without a favorable finding on that issue.
A motion for judgment as a matter of law must be made before the submission of the case to the jury. Id. at (a)(2). The Court, however, may reserve ruling on the motion for JMOL, and submit the action to the jury "subject to the court's later deciding the legal questions raised by the motion." Id. at (b). That was the procedure followed by the Court and the parties in this case. (Tr. 16 at 45-46.)
Rule 50 provides one of many procedural safeguards insuring litigants and the system against an improper outcome in a civil case. Connell v. Sears, Roebuck Co., 722 F.2d 1542, 1546 (Fed. Cir. 1983). A motion for judgment as a matter of law should be granted "only if, viewing all the evidence in favor of the nonmoving party, no reasonable jury could find liability on a particular point." Duquesne Light Co. v. Westinghouse Elec. Corp., 66 F.3d 604, 613 (3d Cir. 1995). Conversely, judgment as a matter of law is required when "a party has been fully heard on an issue and there is no legally sufficient evidentiary basis for a reasonable jury to find" for the nonmoving party. Rule 50(a);see Goodman v. Pa. Tpk. Comm'n, 293 F.3d 655, 665 (3d Cir. 2002); Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558, 1563 (Fed. Cir. 1996).
On a motion for judgment as a matter of law, the court's task is to determine "whether there is substantial evidence to support" the jury's verdict. Dawn Equip. Co. v. Ky. Farms, Inc., 140 F.3d 1009, 1014 (Fed. Cir. 1998); see also Glenn Distribs. Corp. v. Carlisle Plastics, Inc., 297 F.3d 294, 299 (3d Cir. 2002). Substantial evidence "is such relevant evidence from the record taken as a whole as a reasonable mind might accept as adequate to support the finding under review."Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987); see also Sibia Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1354 (Fed. Cir. 2000). To make that legal analysis, a "court must: (1) consider all of the evidence; (2) in a light most favorable to the non-moving party; (3) drawing all reasonable inferences favorable to that party; (4) without determining credibility of witnesses; and (5) without substituting its choice for that of the jury's in deciding between conflicting elements of the evidence."Verdegaal Bros., 814 F.2d at 631; see also Sibia, 225 F.3d at 1354-55; Lightning Lube, Inc. v. Witco Corp., 5 F.3d 1153, 1166 (3d Cir. 1993).
The court must view the trial record as a whole, Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150-51 (2000), and must consider evidence that "both justifies and detracts from the decision of the fact-finder." Sibia, 225 F.3d at 1354-55. In considering evidence that detracts from the jury verdict, the court must accept as true the evidence that is "uncontradicted and unimpeached, at least to the extent that that evidence comes from disinterested witnesses." Reeves, 530 U.S. at 151 (resolving circuit conflict concerning evidence on a Rule 50 motion). "The question is not whether there is literally no evidence supporting the party against whom the motion is directed but whether there is evidence upon which the jury could properly find for that party." Walter v. Holiday Inns, Inc., 985 F.2d 1232, 1238 (3d Cir. 1993) (citation omitted). See Goodman, 293 F.3d at 665 (observing that "a scintilla of evidence will not enable the non-movant to survive a Rule 50 motion").
B. Motion for New Trial
Rule 59(a) states:
A new trial may be granted to all or any of the parties on all or part of the issues (1) in an action in which there has been a trial by jury, for any of the reasons for which new trials have heretofore been granted in actions at law in the courts of the United States.
The decision to grant or deny a new trial is within the Court's "sound discretion," and "unlike the standard for determining judgment as a matter of law, the court need not view the evidence in the light most favorable to the verdict winner." Eaton Corp. v. Parker Hannifin Corp., 292 F. Supp.2d 555, 566 (D. Del. 2003) (citing Allied Chem. Co. v. Daiflon, Inc., 449 U.S. 33, 36 (1980)).
New trials may be granted where "the verdict is contrary to the great weight of the evidence." Roebuck v. Drexel Univ., 852 F.2d 715, 735 (3d Cir. 1988). A new trial may be granted on this basis, however, "only when the record shows that the jury's verdict resulted in a miscarriage of justice or where the verdict, on the record, cries out to be overturned or shocks the conscience." Klein v. Hollings, 992 F.2d 1285, 1290 (3d Cir. 1993) (citation omitted). Discovery abuses by the nonmovant that prejudice the movant may also be grounds for a new trial.Seaboldt v. Pa. R.R. Co., 290 F.2d 296, 299-300 (3d Cir. 1961).
VII. Defendant's Claim of Obviousness
A. Legal Principles
A patent shall be presumed valid, and each claim shall be presumed valid independently of the validity of other claims. 35 U.S.C. § 282. The party asserting the invalidity of a patent has the burden of establishing the invalidity of a patent or any claim thereof, which is satisfied only by clear and convincing evidence. Id.; Bausch Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443, 446 (Fed. Cir. 1986). Clear and convincing evidence is evidence that proves in the mind of the trier of fact an abiding conviction that the truth of the factual contentions is highly probable. Intel Corp. v. U.S. Int'l Trade Comm'n, 946 F.2d 821, 830 (Fed. Cir. 1991).
Defendant claims that claim 32 of the `172 patent is invalid on grounds of obviousness and prior invention. If it is invalid on either ground, the patent cannot support an infringement claim by the patent owner. This section will discuss the issues pertaining to obviousness.
An invention cannot be patented if "the difference between the new thing and what was known before is not considered sufficiently great to warrant a patent." Graham v. John Deere Co., 383 U.S. 1, 17 (1966) (quoting H.R. 1923, 82d Cong., 2d Sess., at 7 (1952)). The standard for determining obviousness is found at Section 103. It states in relevant part:
A patent may not be obtained if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.35 U.S.C. § 103.
"It is black letter law that the ultimate question of obviousness is a question of law." Richardson-Vicks v. Upjohn Co., 122 F.3d 1476, 1478 (Fed. Cir. 1997). To determine whether a claimed invention would have been obvious, a court must consider: (1) the scope and content of the prior art; (2) the differences, if any, between the prior art and the claims at issue; (3) the level of ordinary skill in the art; and (4) any objective evidence of nonobviousness ("the Graham factors").Graham v. John Deere Co., 383 U.S. at 17. See also Bausch Lomb, 796 F.2d at 447. The law presumes that all the prior art references are directly in front of the hypothetical person of ordinary skill. In re Winslow, 365 F.2d 1017, 1020 (C.C.P.A. 1966); see Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985).
An obviousness inquiry is not directed to the so-called point of novelty for a patent claim. The issue turns on whether the claimed subject matter, as a whole, would have been obvious to a person of ordinary skill at the time the invention was made.Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1566 (Fed. Cir. 1987); Union Carbide Corp. v. Am. Can Co., 724 F.2d 1567, 1575 (Fed. Cir. 1984). The correct legal standard requires also that the collective teachings of the prior art be viewed "as a whole" through the eyes of one skilled in the art. See, e.g., In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991).
The "prior art" is the collection of everything in a particular art or science that pre-dates the patent-in-suit. In re Yale, 347 F.2d 995, 1000 (C.C.P.A. 1965). The prior art also encompasses the general knowledge of those of ordinary skill in that art. Para-Ordnance Mfg., Inc. v. SGS Imps. Int'l, Inc., 73 F.3d 1085, 1090 (Fed. Cir. 1995). In this case it was undisputed that the measuring date for the prior art included at least all patents, publications and devices that were published or offered for sale before November 14, 1987, which was one year before the filing date of the CIP application. 35 U.S.C. § 102(b). (Tr. 15 at 38-39.)
A claimed invention would have been obvious if "there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the [claimed] combination." In re Beattie, 974 F.2d 1309, 1311 (Fed. Cir. 1992). A suggestion or motivation to modify prior art teachings may be derived from the prior art itself, from the knowledge of one of ordinary skill in the art, or from the nature of the problem to be solved. Sibia, 225 F.3d at 1356. Indeed, the suggestion to make the claimed invention may be based upon "the common knowledge and common sense of the person of ordinary skill in the art without any specific hint or suggestion in a particular reference." In re Bozek, 416 F.2d 1385, 1390 (C.C.P.A. 1969). That motivation cannot come from the claimed invention itself; thus it cannot be based on hindsight. See, e.g., In re Dembiczak, 175 F.3d 994, 999 (Fed. Cir. 1999); In re Rouffet, 149 F.3d 1350, 1358 (Fed. Cir. 1998); In re Geiger, 815 F.2d 686, 688 (Fed. Cir. 1987).
The threshold question for the court with respect to obviousness, on a motion for judgment as a matter of law, is "whether the factual findings of the jury, expressed or implied in the verdict, are supported by substantial evidence in the record." Richardson-Vicks, Inc., 122 F.3d at 1478. After determining which, if any, factual findings may be supported by substantial evidence, the court must apply its judgment to the ultimate legal question of whether claim 32 would have been obvious. Id.
B. Review of the Evidence
The jury in this case was instructed to use the date of November 14, 1987 (one year before the filing date of the CIP application) as the undisputed date on which to identify prior art relevant to the `172 patent. (Tr. 15 at 38-39.) See 35 U.S.C. § 102(b). All other underlying facts pertinent to theGraham factors were submitted to the jury for its determination, with accompanying jury instructions. (Tr. 15 at 38-39.) We will identify the findings of fact necessarily implicit in the jury's finding of nonobviousness after the following summary of the evidence.
To the degree that the evidence summarized in this section also bears upon the issues of infringement and invalidity due to prior invention, we will refer back and amplify it as necessary in the discussion portions on those issues, Sections VIII and IX,infra.
As previously stated, plaintiff's case was presented chiefly through the testimony of its principal, Dr. Guzman. Plaintiff also called a fact witness, Dr. Olsen, whose testimony related only to the issue of prior invention. Defendant called five witnesses at trial, described below. Each party cross-examined each other's witnesses to elicit certain undisputed facts and to challenge other asserted facts. Each party also presented deposition excerpts of the other as trial evidence pursuant to Rule 32(a)(2). Throughout the trial, during the examination of both plaintiff's and defendant's witnesses, trial exhibits were under discussion as identified in the record. (See n. 2 supra.)
Due to the volume of the trial record, we have of necessity selected the segments to summarize and discuss in this opinion. The summary of evidence set forth in this section and in Sections VIII and IX infra is based upon the Rule 50 standards reviewed in Section VI.A supra.
1. Defendant's Evidence on Obviousness
Defendant presented fact testimony from Dr. Osborne and Messrs. Burolla and Harbaugh (current and former Beckman employees). There was expert testimony from an independent patent attorney, Mr. Jester, limited to an explanation of the `172 file history and Patent Office procedure. (See 11-4-01 Tr.; 6-28-01 Order.) Finally, defendant offered expert opinion testimony from Dr. Jorgenson (not affiliated with Beckman), himself one of those cited for prior art in the prosecution history. (See n. 6supra and accompanying test.) Defendant also elicited certain points relevant to obviousness from plaintiff's witness, Dr. Guzman. (See Section VII.B.3 infra.)
a. Dr. Osborne
James C. Osborne is vice-president of technology for Beckman. He holds degrees of B.S. in chemistry, M.S. in physical chemistry, and Ph.D. in biochemistry. He has worked at Beckman since September, 1985. (Tr. 11 at 57-58.) A summary of his testimony is as follows.
Beckman makes and sells diagnostic tests and analytical instruments for use in academic research labs, biotech research companies, and medical laboratories. Its products include systems for separation and analysis of compounds and for drug development. Examples include the "ultra-centrifuge" equipment used by Dr. Salk to isolate the polio vaccine, systems used in the sequencing of the human genome, and automated robots used in processing samples in large labs such as pharmaceutical companies. (Id. at 58-60.)
Beckman has long been the leading manufacturer of ultra-centrifuges. A centrifuge separates samples by spinning a rotor at a very high RPM, causing the samples to separate at different rates. As of the mid-1980's it also had an HPLC (high pressure liquid chromatography) product line. When Osborne arrived at Beckman in 1985 as manager of centrifuge applications and research, Beckman felt its business was sample separation. It was looking at other ways to separate compounds, and capillary electrophoresis was viewed as a natural extension of its product lines. Essentially, capillary electrophoresis devices use only a small volume of sample, and separate compounds in the capillary. (Id. at 60-62.)
The status of capillary electrophoresis product development research at Beckman as of September, 1985 was that Beckman had, since 1984, an existing exclusive research contract for capillary electrophoresis with the laboratory of Dr. Richard Zare on the campus of Stanford University at Palo Alto, California. Dr. Zare holds an endowed professorship in chemistry at Stanford University and is a worldwide celebrated scientist in laser manipulation of molecules and capillary electrophoresis. The purpose of the contract was to have the high-risk capillary electrophoresis done in a senior scientist's lab outside the company, and if that research demonstrated feasibility, Beckman would move the research in-house and address making a product out of it. (Id. at 62-65.)
Dr. Zare had developed in his lab a capillary electrophoresis system consisting of components arranged on an "optical bench," like a lab table. As of September, 1985, Dr. Zare's system had a detector and a gas laser aimed at a block through a series of mirrors and lenses. There was a long capillary inserted through the block. At each end of the capillary would be an inlet or outlet reservoir or cup. The end of the capillary was manually inserted into the lid (septum) of the cup during the run. The system also included electrodes going into the cups, and a high voltage power supply. Beckman's response, according to Dr. Osborne, was:
We were excited about his device because he was able to show the separation in a reasonable amount of time. He was showing that you could use the high voltage in a fairly safe way. But there were some drawbacks of his work. One was that he did not have temperature control. The second was that he was manipulating the ends of the capillary. And these capillaries are very fragile and they break. And when they break or become fractured, it affects the separation. The third thing we found out with Dr. Zare's device is that when the capillary swayed during the run, it affected the separation. So we wanted to address in our program temperature control, and we were convinced that we did not want to manipulate the tips of the capillary. And we did not want the capillary moving during the separation.
(Id. at 65-67.)
Dr. Osborne and other scientists at Beckman observed the structure and operation of that system at Dr. Zare's lab. Next, Beckman set up a small replica in its own lab, just to show that it could reproduce Dr. Zare's work in-house. Dr. Osborne's responsibility focused on the science of the project, and at that point it was ready to turn over to the engineering department. The engineering team would be responsible to design a capillary electrophoresis product, in collaboration with the scientists and the applications area. The project was dubbed the OTEP project, and chief engineer Victor Burolla was assigned as team leader. (Id. at 67-68.)
The OTEP project was initially funded at approximately $250,000, beginning in about April, 1986. (Id. at 68.) Dr. Osborne testified that Beckman also had as a resource its own vast experience in designing and making analytical instrumentation, including auto-sampling (i.e., rotatable tables), temperature control, optical design, and computer control providing "walk-away automation." (Id. at 69-70.) He cited Beckman's existing HPLC product line and the 6300 amino acid separation product line in terms of auto-sampling, and the latter product as having a coiled capillary since the late 1960's. (Id. at 70-71.)
Dr. Osborne was one of the supervisors who received periodic reports on the progress of the OTEP project. He identified the Beckman file materials entered into evidence as the regularly maintained business records pertaining to the OTEP project, and gave an overview of its chronology and results. He confirmed that the OTEP project led to commercialization in the form of the P/ACE device. (Id. at 70-84.) That testimony led to the detailed description of the project provided in the ensuing trial testimony by Mr. Burolla, the project leader. Dr. Osborne added that the field of capillary electrophoresis research was very active during the 1984 through 1986 time frame, led by Dr. Zare, Dr. Jorgenson, a researcher named Everaerts, and a few others whose names he recalled from that period. (Id. at 84.)
The accused P/ACE device was described in some detail by Dr. Osborne. Since that part of his testimony pertains to the infringement issue, it is summarized infra, Section IX. Relevant to the topic of obviousness, however, he listed the several of types of electrophoresis that the P/ACE device can perform, describing them as follows:
• Isotachophoresis — The components in the sample are separated by additives to the buffer and then the separated bands move at the same speed through the capillary.
• Capillary gel electrophoresis — Gel is inserted into the capillary and the components are separated based on their interaction with the gel. This is distinguished from "gel slab electrophoresis," which is electrophoresis, but without a capillary.
• Isoelectric focusing — The components in the sample are separated based on their isoelectric point.
• Open tube capillary electrophoresis — [Explaining that] there are a great variety of different buffers that can be used in open tube capillary electrophoresis.
(Tr. 12 at 3-5.) Dr. Osborne stated that the latter mode is also called "capillary zone electrophoresis," which is the mode in the P/ACE device that plaintiff contends infringes claim 32. (Id. at 23-24.) He further explained that in each of the above modes, the P/ACE device permits the operator to decide whether the inside wall of the capillary will be charged or neutral, stating that in the first three modes the capillary wall should be uncharged. (Tr. 11 at 5.) He confirmed that there is a separate portion of the P/ACE device Operating Manual for the latter mode, and that the name of the entire device gets its last two letters, CE, from the words capillary electrophoresis. (Tr. 12 at 22-24.)
b. Mr. Harbaugh
Jon Harbaugh is a former Beckman employee, having worked there from 1969 until he retired in 1993 and became a college professor in business administration. He holds degrees of B.S. and M.S. in chemistry, and an M.B.A. in business. (Tr. 12 at 34-35.) He worked as an applications research chemist at Beckman for his first five years, then moved into marketing management positions. (Id. at 36-39.)
Mr. Harbaugh testified that during his research years, 1969 to 1974, he used instruments called gas chromatographs and amino acid analyzers. Both are separation devices. The gas chromatograph is used to separate, identify and quantify volatile components of a mixture. The amino acid analyzer uses a form of liquid chromatography to separate, identify and quantify amino acids in protein and peptide samples. (Id.)
He stated that during the approximately 30 years from the mid 1960's to the mid 1990's, Beckman made and sold an amino acid analyzer product. He described that device as having been equipped with a rotatable table driven by a small electric motor, into which up to 48 samples could be placed for automated operation. Those samples would then be injected into the system in sequence and analyzed by the system. It also had a requirement for maintaining the capillary tube at a certain temperature, which was accomplished by winding the capillary around a mandrel and securing it, then immersing the capillary/mandrel assembly into a temperature-controlled hot water bath. (Id.)
Mr. Harbaugh was director of molecular structure research and development at Beckman in 1984, when it first began funding the capillary electrophoresis research in Dr. Zare's lab at Stanford. He stated that he made the initial recommendation to fund that work. He also personally observed Dr. Zare and his graduate students in the project, and was permitted to operate the equipment that they developed there. (Id. at 39-42.)
Beckman records show that as of April 10, 1986, Mr. Harbaugh recommended that it launch a product development effort based on Zare's work, and that by April 24, 1986, Beckman had received from Dr. Zare the "protocol" for constructing Zare's lab device in-house as a starting point for that effort. (Id. at 43-51.) Mr. Harbaugh stated that he based that recommendation in part on the following awareness:
[T]he capillary tube is not nearly as fragile as I had expected. You can take it and actually wind it around your hand So that . . . what was [a] one meter long, fairly ungainly piece of equipment, is now going to be something that the engineers will be able to package and make it a very user friendly kind of device.
(Id. at 43.)
c. Mr. Burolla
Victor Burolla is a former Beckman employee. He holds degrees of B.S. in chemical engineering and M.S. in engineering. Prior to joining Beckman in September 1985, he had worked for approximately 14 years in the military and in a laboratory company. (Tr. 14 at 11-12.) In September, 1986, he was assigned as project leader of the OTEP development project, in the engineering department of the division that designed and made centrifuges and other molecular structure products. He explained that the original name of the project, OTEP, meant open tube electrophoresis; later the project was also called HVEC or HiVEC, meaning high voltage electro chromatography. (Id. at 12-15 and 61.) His testimony relevant to obviousness may be summarized as follows.
The role of the engineering department in Burolla's division at Beckman was to create engineering designs and the necessary supporting documentation, with reference to industry standards, and convey their results to the manufacturing group to make a commercial product. (Id. at 13-14.) As of September, 1986, the OTEP project was managed by Burolla and consisted of a small group including an engineer technician and a computer software engineer. (Id. at 31-33.) The team reported to upper management, and it could draw upon internal and external resources by following authorized procedures. (Id. at 15-18, 24, 45-46.) Its charter was to determine the feasibility of turning capillary electrophoresis technology into a commercial product for Beckman. (Id. at 15.)
Burolla himself had absolutely no experience in capillary electrophoresis when he was assigned to the OTEP project. (Id.) He began with an awareness that capillary electrophoresis technology itself had existed since 1930, and that Beckman had been working with Dr. Zare for several years. But Beckman itself had not to date offered a product that could do open tube capillary electrophoresis, nor did it have an existing product that it could modify for that purpose, so in that sense it was a new commercial technology for Beckman. (Id. at 18-24, 73-74.)
The plan of action for the OTEP project was established in a Project Authorization document prepared by Burolla and approved by the company on or about October 1, 1986. (D-109, D-111.) The first step was to verify that a replica of the Zare apparatus, which had no autosampler and was not automated, would function in Beckman's lab as it did at Stanford. That meant that the replica apparatus would have to produce the same chemical separations, using the same instructions, as those obtained in Dr. Zare's lab. The next step was to design a first prototype having certain features and capabilities. Those included that the first prototype would be fully automated and computer-controlled; it would allow sample injection using either high voltage electricity or air pressure; and it would perform data collection. It was also anticipated that their device could be compact in size. The target date to design and build the first functioning prototype was the first week of January, 1987, but the desired date was the first week of December, 1986, (Id.; Tr. 14 at 15-26, 89-90.)
As he embarked upon the OTEP project, Mr. Burolla first read published articles by a number of researchers, Dr. Jorgenson and his graduate students (including Lukacs and Green) primary among them. (Id. at 27-29.) He prepared a memo summarizing some of the data and knowledge set forth in those articles, for the use of the team. (Id.; D-103.) That memo noted that researchers at the time were seeking the best reproducibility of results and were looking at factors that could affect that, including the electric current in the capillary. (Id. at 29.) Another issue for researchers was resolution, meaning that the resulting electropherograms should have sharp, tall peaks to distinguish the components being sampled. It was known that temperature control was required to obtain good resolution, so any device must include components to control and measure the temperature. (Id. at 29-31, 33-34.)
Burolla's literature review did not list the references to Chilla, Macko, Everaerts or an LKB device discussed infra in this section. (Tr. 14 at 91-92.)
The first Beckman capillary electrophoresis prototype was called OTEP I. (Id. at 38.) Mr. Burolla testified that it was completed ahead of schedule on the day before Thanksgiving, November 26, 1986, and it successfully produced its first electropherogram the following week, on December 2, 1986. (Id. at 23, 45-48.) Beckman documented that OTEP I was delivered from the engineering department to the research and applications group on December 15, 1986. (D-100 at 1.) The following month, on January 28, 1987, it was deactivated and refurbished into OTEP II. (Tr. 14 at 88, 97-98; D-112 at 2.)
The documentation for the OTEP I and OTEP II phase was maintained by Mr. Burolla as team leader during the project. It was received in evidence without objection as the regularly maintained business records of Beckman. (See, e.g., Tr. 11 at 75-77; Tr. 14 at 16, 23-24, 26-27, 31-32, 48-50, 54-55, 57-58, 61-66, 96-97.) Those documents included task allocations and timetables, hardware and software specifications, sequentially numbered engineering specifications, purchase requisitions, periodic team progress reports and management reports, and electropherograms. (Id.) Of those, the only documents noted on the record to be undated were some of the sequentially numbered engineering drawings, surrounded by others in the series that were dated. (Id. at 51-52, 92-93.)
During the OTEP II phase there was also an engineering log maintained, to record the progress of development of the capillary cartridge. (Id. at 48-49.) Finally, the OTEP II device itself was shown in photographic slides and prints from the slides. Those slides were date-stamped in March, 1987. (Id. at 65-69; D-122.)
Plaintiff has suggested, in the context of the prior inventorship issue, that if Beckman had the claim 32 invention in the OTEP I design, it abandoned that design in January, 1987 when OTEP I was deactivated. Beckman replies that the design of OTEP II built upon the work done to create OTEP I. We need not reach an issue of abandonment in the present motion, because Beckman relies on OTEP II and its undisputed invention date of February 1, 1987, for purposes of its motion on prior inventorship. See Section VIII infra.
Mr. Burolla described the features of the OTEP I device, summarizing the relevant documentation in evidence, see n. 21supra. (Tr. 14 at 33-45, 50-54.) He also drew a rough sketch of OTEP I at trial and used it as a visual aid to explain his testimony to the jury. (Id.; D-310.) He described OTEP I as a capillary electrophoresis device equipped with a rotatable table with openings for a number of vials. "We could load up five different samples, for example, program the device, walk away from it, and sometime later we could get results from five different separations. . . ." (Tr. 14 at 35.) "It gave us an electropherogram as a result. But basically what it did was it applied an electric potential to a capillary where the ends of the capillary were immersed in a solution that was electrically conductive. We could also automate the process of injecting sample into the capillary either by pressure or voltage." (Id. at 37.) His description of the components that surrounded the capillary in OTEP I was as follows:
Q [Referring to D-310, trial sketch.] If you could describe how it works?
A Sure. These are the fundamental elements of it. I'll start from one end and work my way through. We would have a sample table which is basically a rotating disk, the box with holes in it. Each hole would hold a vial . . ., just a plastic vial that would hold liquid. And underneath the vial there'd be a pneumatic cylinder that would push the vial up and down so that we didn't have to move the capillary. We could just lift the vial up and down and get into the capillary.
Immediately above that there was an acrylic block that held both the electrode, the end of the capillary and a — actually there's one part missing [in the sketch] — there is also a feed to a cylinder to provide pressure. So that when this vial came up in contact with this acrylic block, there was an O ring in here that we could — if we pressurized the space inside this block, then we'd be pressurizing that entire air space and forcing liquid up into the capillary. . . . And at the top here, the capillary was sealed against this block. So was the electrode. So was this pressure tube.
The capillary went from there to this aluminum bath that I described earlier, this aluminum box that held water. It was coiled inside, came out this end, went to another aluminum block that . . . we'll call the detector. It had some fiber optics that would bring in a laser signal and export a laser signal to the [detector]. . . .
Then the capillary would go from there to a block, an acrylic block, that was identical to the one at this [inlet] end and fed in the same way and it also contained an electrode and a pressure fitting. And there was another vial at this end also moved up and down by a pneumatic cylinder. I think that's about it.
The reference to an aluminum bath, also referred to as a temperature chamber, is to the following Burolla testimony about the OTEP I device:
Q You mentioned water surrounding the column. How did the water surround the column?
THE COURT: When you say column, you're talking about the capillary tube?
A Yes. We created basically a metal box that we could thread the capillary into and out of, and put a lid on this box. And it had an inlet and outlet where we pumped water of a known temperature into and out of it. So that the capillary inside this box was completely immersed in this water solution.
Q How was the capillary configured inside the metal box?
A We tried to cram as much capillary as we could inside there. So what we did was we took a plastic cylinder and cut grooves in it — we actually cut a tread in it, but it's the effect of cutting grooves — and we wound the capillary around that cylinder in those grooves, and made sure it exited the box at the two locations through fittings that would prevent it from leaking around the capillary.
Q You're now referring to the prototype that was built in phase one of OTEP by November 26th?
A. Yes.
(Tr. 14 at 36-37.)
Q Can you tell us what the capillary was made of?
A The capillary's made of fused [silica] which is basically very pure glass. . . .
Q And the sample table, did it provide both the buffer and sample?
A It could provide anything that we needed to provide it.
Q Describe how the fluids got into the capillary.
A Basically we would just pressurize the air space in these acrylic holders and then — it's sort of like the reverse of a straw, you use a straw to suck liquid up into your mouth. If you pressurize the air space above, you're forcing liquid into the capillary and it goes to the other side. So we'd either pressurize this end or this end, not both, and liquid would flow through it.
Q You were able to lift a vial up out of the table up against that acrylic holder?
A We have [an] acrylic holder, right. This was an acrylic block so that we could see . . . what's going on inside. . . . But we had cylinders down here [below the vials], pneumatic cylinders that we would pressurize and would force this vial and provide actually significant force against this acrylic holder so that we had an O ring that would seal it. And so we could pressurize this to 20, 30, . . . 40 PSI to get the liquid moving through there [the capillary] pretty quickly.
(Id. at 39-43.)
Q [Referring to engineering drawing D-125, page 19.] Use your pointer and describe the features of the temperature chamber.
A. . . . [I]f you look [at] this side view — this is as if you were looking at the side and you had sliced this box . . . right about in the middle — what would you see?
The hatched area in general indicates solid material. The non-hatched area indicates open space. So this would be the space filled with water and holding the capillary and the cylinder that the capillary was wound around.
In addition to that, you need to have the capillary go into and out of this box. That's shown by this threaded hole and this threaded hole. We had a special fitting that we insert here and that we thread the capillary through it and then tighten that fitting around the capillary.
In addition to that, you'd have to have some fittings for the water to enter and exit. That's what this is.
We observe that Mr. Burolla's description of the OTEP I device encompasses all of the elements of claim 32 of the patent in suit, and Beckman does not dispute that for purposes of this case. This point is discussed infra in this section and in Section IX.
OTEP I met the design criteria of being completely computer-controlled and had several other advantages, according to Mr. Burolla. Those included the fact that the capillary was coiled and secured and temperature-controlled; fluid could be injected into the capillary by air pressure rather than voltage; and the flexible but fragile glass capillary remained stationary above a vertically moving vial. One of the disadvantages of OTEP I was that the capillary was threaded through a series of blocks or boxes, with fittings tightened around the capillary at each capillary hole, and was prone to breakage. The replacement process was then very tedious. (Id. at 23, 37-38, 42-44, 52-53, 60-62.)
Phase Two of the project was development of the OTEP II prototype. Mr. Burolla stated that the disadvantage referred to above was overcome in the design of the OTEP II prototype. (Id. at 60-61.) His discussion of the relevant components of OTEP II and the commercial P/ACE device pertains primarily to the infringement issue, and is set forth in Section IX infra.
Mr. Burolla stated that OTEP II was completed in January, 1987. (Id. at 61, 69.) Beckman documented, and Burolla testified, that on February 1, 1987, the operational OTEP II was delivered from the engineering department to the research and applications group for further commercial development. (Id. at 61-62, 97-98; D-100 at 1; D-112 at 2.)
The documentary evidence pertaining to OTEP II is described supra n. 21.
The project was called HiVEC by April, 1987. Mr. Burolla remained with it for the further steps that led to the commercial release of the first P/ACE models in 1989. (Tr. 14 at 70-71.) He confirmed that the P/ACE device resulted from the OTEP project. (Id. at 14-15.) The Beckman 1990 Annual Report referred to the P/ACE launch, stating that it took just three months to completely automate the capillary electrophoresis process. Mr. Burolla testified that this was a reference to the period from September to December, 1986, during which the design, assembly and testing of OTEP 1 was accomplished by his project team. (Id. at 73-74; P-67.)
The 1990 Beckman Annual Report also contains the following statements: "According to Senior Engineer Vic Burolla, . . . capillary electrophoresis is a fundamentally different way to separate samples; as with any new technology, there is a lot to be learned. . . . We were starting from ground zero on this one." (P-67 at 7.) Mr. Burolla testified he did not believe that the "ground zero" language was his wording, but what he meant by that was "there was not any experience within Beckman in capillary electrophoresis that we could draw on." (Tr. 14 at 73-74.) On cross-examination he agreed that capillary electrophoresis was a fundamentally different way to separate samples in view of what Beckman had done in the past. (Id. at 95-96.)
d. Mr. Jester
Michael H. Jester is a registered patent attorney with 25 years of patent practice experience. The evidence showed no affiliation of Mr. Jester with defendant other than his retention to serve as an expert witness in this case. (Tr. 12 at 54-57, 157-158.) The Court ruled prior to trial that his expert testimony would be limited to providing the jury with a review of the `172 patent file history and an explanation of relevant patent laws and Patent Office procedures. (4-4-01 H'g Tr.; 6-28-01 Order.) His testimony described the filings and the dialogue between the applicant and the Patent Office that resulted in the issuance of claim 32, summarized supra, Section III. (Tr. 12 at 55-167.) Here we set forth that dialogue in the file history, as described during the testimony of Mr. Jester. (D-2; D-3.)
It will be recalled that claim 1 of the original application was identical to claim 1 of the CIP application, in all respects pertinent to this case. (See Fed. Cir. Op. at 9.) Claim 1 in each of those application is the source of elements 1 through 6 of claim 32 as issued. (Id. at 3; compare text, n. 4 supra, with P-72.) Claims 39 and 40 made their first appearance in the CIP application, and are the source of elements 7 and 8, respectively, of claim 32 as issued. (See Fed. Cir. Op. at 3; P-72.)
The applicant filed a List of Prior Art form with the original application. (D-2 at 68.) There the applicant listed U.S. patents including Akiyama and Arlinger. (Id.; see nn. 8 9 supra.) In its first office action rejecting that application, the Patent Office filed a Notice of References Cited. (D-2 at 90.) That notice listed Arlinger, but added the Stevenson patent, the Jorgenson article, and the Rose/Jorgenson article. (Id.; see nn. 6 7 supra.)
The examiner rejected claim 1 in the original application as obvious. (See Section III supra.) The examiner never changed that position as to the language of claim 1, throughout the prosecution of both the original application and the CIP application. (D-2 at 93-96; D-3 at 69-72.) The examiner's statement accompanying the original rejection of claim 1 is quoted here as follows:
There were two examiners who participated in the `172 application process at various times. (See Tr. 12 at 87-88, 129-130.) We will refer to them in the singular for purposes of this opinion.
Claims 1 to 28 are rejected under 35 U.S.C. § 103 as being unpatentable over Jorgenson in view of Stevenson and Arlinger.
Jorgenson discloses an electrophoretic apparatus. Jorgenson also discloses using the electromigration technique to introduce sample into capillary. Specifically on page 185, Jorgenson recites "The buffer reservoir at the high voltage end is replaced with a reservoir containing sample. High voltage is applied for a specific amount of time (usually a few seconds) and then turned off. The brief application of voltage migrates a narrow band of sample into the capillary. Now the sample reservoir is removed, and the buffer reservoir is replaced. High voltage is again applied, and the electrophoresis run begins."
Applicant's apparatus is considered to be an obvious automation of the manual process described by Jorgenson. For example, Stevenson et al discloses a sample introduction system of a liquid chromatographic system (liquid chromatography and capillary electrophoresis are closely related techniques). This sample introduction system contains all of the critical elements recited in the claims: a rotating turnable, a vertically moving sample probe, etc. Hence, it would be obvious to one skilled in the art to automatic apparatus and process of Jorgenson using notoriously well-known automating elements. It has been well-established that the obvious automation of a known manual process is not patentable. See In re Vener and Bowser, 120 USPQ 192 and In re Rundell, 9 USPQ 220.
Arlinger teaches that it is sometimes desirable to recover the sample after the electrophoretic separation is completed. Arlinger discloses an electrophoretic apparatus with sample recovery means. It would be obvious to one skilled in the art to provide the apparatus with sample recovery means. It would be obvious to one skilled in the art to provide the apparatus and process of Jorgenson with sample recovery means employing automation elements similar to the sample introduction means. Any automation elements not specifically recited in Stevenson et al or differences between the claimed automation element and those of Stevenson et al would be obvious, i.e. dictated by the apparatus and the manual process of Jorgenson. Moreover, some of the claimed automation recited appear to be optional. For example, . . .
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The article of Rose and Jorgenson shows a sample introduction system which is identical to the applicant's in all essential structure. Although this article cannot be used as a reference to reject claims because of the requirements of 35 U.S.C. § 102, the examiner believes this reference supports the examiner's rejection of the claims under 35 U.S.C. § 103.
In quoting the above text we have corrected obvious clerical errors by observing the retyped versions of most of the above text in later rejections. (See D-2 at 94-96; D-3 at 70-72.) Here we also note the last paragraph of the quoted text, which cites and comments upon the Rose/Jorgenson article while stating that it cannot be used as a prior art reference. That comment apparently refers to the fact that the Rose/Jorgenson article is dated April 1, 1988, which is later than November 14, 1987, the one-year cutoff date prior to the filing date of the CIP application. (D-2 at 90.) See 35 U.S.C. § 102.
It will also be recalled that in response to the first rejection of the original application, including claim 1, the applicant filed a minor amendment not here relevant and presented argument of nonobviousness, all of which the Patent Office rejected. (See Section III supra.) That argument from the applicant asserted in pertinent part as follows:
Even though Jorgenson and Arlinger show electrophoresis apparatus and Stevenson shows a rotary apertured table holding sample cups, these references do not provide such teaching as to anticipate the claimed apparatus. The claimed apparatus is considerably more complex than apparatus in the prior art and is in commercial form.
(D-2 at 92.)
The examiner rejected those arguments in the following statement:
Applicant's arguments . . . have been fully considered but they are not deemed to be persuasive.
The applicant fails to specifically point out how the language of claims patentably distinguishes them from the reference. In particular, the applicant fails to show how the amendments avoid such references. Statements such as "The claimed apparatus is considerably more complex than apparatus in the prior art and is in commercial form" . . . are considered to be mere allegations of patentability.
(Id. at 96 (emphasis in original).)
The CIP application, which contained independent claim 1 and dependent claims 39 and 40 as relevant to this case, was initially met with rejection of claims 1 and 39 as obvious. (See Section III supra; D-3 at 69.) As before, the examiner cited Jorgenson, Stevenson and Arlinger against numerous claims including claim 1, with the same explanation as during the original application. (Id. at 70-72; see n. 28 supra and accompanying text.) The basis for rejection of claim 39 was stated as follows:
Claims 29, 34, 35, 39 and 47 are rejected under 35 U.S.C. § 103 as being unpatentable over Jorgenson in view of Stevenson et al and Arlinger as applied to claims 1-28 and 48 above, and further in view of Akiyama.
Akiyama teaches that the two features recited in the above claims are known in the art. Akiyama discloses a capillary electrophoresis apparatus in which the capillary is coiled. Akiyama also discloses means for supplying inert gas to the sample chambers. It would be obvious to one skill [sic] in the art that these features are desirable for any capillary electrophoresis apparatus, manual or automated.
(D-3 at 72.) As for claim 40, the examiner stated:
Claims 31 to 33, 36, 40 to 43, and 49 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
(Id. at 73.)
The applicant responded to the first office action on the CIP application by combining the language of claims 1 and 39 and arguing:
Claim 39 is in independent form and includes the elements of claim 1. This claim calls for the capillary tubing being in the form of a coil of glass tubing and should be allowable like claim 40.
(Id. at 90.)
The examiner rejected amended claim 39, stating as follows:
Claims 39 and 50 are rejected under 35 U.S.C. § 103 as being unpatentable over Jorgenson in view of Stevenson et al and Akiyama [sic]. See rejection of claim 39 in previous Office action for details. Applicant's arguments . . . have been fully considered but they are not deemed to be persuasive.
(Id. at 98.)
Ultimately, the applicant did combine the language of claims 1, 39 and 40 into amended claim 39, as the examiner had suggested. (Id. at 101-04.) The `172 patent was then granted, with amended claim 39 renumbered as claim 32. (Id. at 101-04; Tr. 12 at 106-09.) The face sheet of the `172 patent lists all of the references considered by the examiner during the prosecution history of the entire patent, as follows: Flower et al., Stevenson, Akiyama, Arlinger, Jorgenson and Rose/Jorgenson. (P-1 at 1; Tr. 12 at 111-20.)
The Flower reference is U.S. Patent No. 3,793,180. Neither party has directed the attention of the Court to it as a possible prior art reference relating to claim 32. (Tr. 12 at 111-20, 128-58, 162-67.)
Mr. Jester testified that in his view, the Arlinger patent was not particularly relevant to claim 32 as issued. (Tr. 12 at 84, 130-34, 137-42.)) The Arlinger patent is entitled Apparatus for Isotachophoretical Separation. (Id. at 146-48; P-96.) Mr. Jester pointed out that when the examiner characterized Arlinger in earlier rejections of various claims including claim 1, the examiner described Arlinger as pertaining to a sample recovery means. He stated that he did not see any words in claim 32 talking about sample recovery, but acknowledged that claim 32 does provide for the capillary to have "first and second ends." (Tr. 12 at 158-59, 165-67.) He agreed that when claim 39 was amended in the CIP application process to include the language of claim I, the examiner's rejection of amended claim 39 as obvious no longer cited Arlinger. He did not venture to surmise what that omission meant in the mind of the examiner. (Id. at 162-65.) This portion of the evidence is discussed infra, nn. 34 51.
Mr. Jester stated his conclusion from reviewing the patent prosecution as follows:
After reviewing these file wrappers in great detail, it is my opinion that after repeated obviousness rejections, Dr. Guzman was only able to get Claim 32 allowed by limiting that claim to a coiled capillary tube secured to a support member. Unless he put "secured to a support member," that claim would not have been allowed.
(Id. at 127.) He agreed, however, that the scope of claim 32 contains not just the words of element 8, but all the words in the claim. (Id. at 153-55.)
e. Dr. Jorgenson
James W. Jorgenson is chairman of the Chemistry Department at the University of North Carolina. He earned his Ph.D. in chemistry at Indiana University in 1979, and began his teaching and research career at U.N.C. that same year. His career has focused upon the subject of chemical separation, with particular emphasis on capillary electrophoresis. He is co-editor of a 1987 text published by the American Chemical Society entitled "New Directions in Electrophoretic Methods," and is the author or co-author of numerous published works based upon his research in capillary electrophoresis, including the Jorgenson and Rose/Jorgenson references cited in the `172 patent history. (See n. 6 supra; Tr. 12 at 168-73.) In the course of his work he has studied, but never performed, other chemical separation techniques such as isotachophoresis, isoelectric focusing, and gas chromatography. (Id. at 175-76; Tr. 13 at 64-65.) His professional activities have included supervising graduate level research in his university lab, and conducting numerous peer scientific symposia on capillary electrophoresis. (Tr. 12 at 169, 175-76.) He is also the named inventor in several patents. (Tr. 13 at 46-47.)
Dr. Jorgenson has no affiliation with Beckman other than serving as an expert witness in this case, and he has never testified as an expert prior to this case. (Tr. 12 at 175-76; Tr. 13 at 47.) The Court accepted him as an expert witness in the area of chemical separation, particularly capillary electrophoresis. (Tr. 12 at 176-77.)
He was asked what he was doing in his university laboratory regarding capillary electrophoresis during the period 1979 to 1988, and responded as follows:
Basically essentially getting the field started. We got curious — I had done a little bit of work with the technique called paper electrophoresis in my graduate research at Indiana and was struck by how primitive that technique was — very useful, but kind of primitive — and so I set out to see if I couldn't develop a form of electrophoresis that would be more instrumental in nature, more automated, would generate data that could be fed directly into computers, for instance. And that led to a whole line of research in this area that's come to be called capillary electrophoresis.
(Id. at 168-69.) He was actively running capillary electrophoresis samples himself during the early 1980's, working with a graduate student named Krynn Lukacs. Since that time he has supervised thousands of capillary electrophoresis tests in directing research performed by his graduate students. (Id.)
Dr. Jorgenson's testimony began with a basic description of electrophoresis and some of its recognized techniques. He stated that electrophoresis is any separation done in a fluid medium, where the separation is caused by application of an electric field. The substances then move at different rates and separate from each other. The basis purpose of electrophoresis is to separate different substances, determining the identity and quantity of the substances in the sample. (Id. at 177-79.)
He explained that there are many ways of setting up an electrophoresis experiment. Those techniques all share the common property that they use an electric field to cause the separation process. He stated that among the numerous varieties of electrophoretic techniques are zone electrophoresis, isotachophoresis, and isoelectric focusing. They vary in the types of buffers (ionic solutions) used, and how they are used. (Id. at 178-79.) His overview of those techniques is quoted in the margin. He also stated that various containers or media can be used in electrophoretic techniques. Those modes include paper, gel slab, and capillary — the latter two being the most common formats in current use. (Id. at 179-82.) He confirmed that the technique called zone electrophoresis is done in a capillary. (Tr. 13 at 32-33.) Describing a capillary, as distinguished from larger sizes of chemical separation tubes or columns, he put an approximate internal diameter of one millimeter or smaller. (Tr. 12 at 191.) He added that isotachophoresis is a subset of capillary electrophoresis if it is practiced in a capillary. (Tr. 13 at 64.)
Dr. Jorgenson stated:
In isotachophoresis, for instance, you sandwich your sample between a very fast moving ion and an extremely slow moving ion. And that's the way that game is played. In isoelectric focusing, you do this electrophoretic separation in the presence of a PH ingredient, going from very acidic PH to very basic PH.So by setting up the initial experiment in different ways you can get different kinds of separations to occur. And one of the simplest actually is zone electrophoresis. It's just done in the presence — you just put your sample, sandwich it between two identical buffers, apply a field, do a separation. That's the one that I've spent most of my time working on.
(Tr. 12 at 178-79.)
The topic of Dr. Jorgenson's testimony next turned to a review of the prior art listed in the `172 patent history. He stated that in his opinion, the examiner was correct in concluding that elements 1 through 6 of claim 32 were obvious in light of his own cited 1987 article and the 1975 Stevenson patent. He said it would not be unusual for one skilled in the art to combine teachings from references in chemical separation techniques such as capillary electrophoresis (Jorgenson) and liquid chromatography (Stevenson). (Id. at 183-84.)
His testimony on this point included the following:
Q Is there anything unusual in your mind about combining an auto sampler of the Stevenson reference with the technology discussed on capillary zone electrophoresis in your 1987 book?
. . .
A No. I mean — Stevenson was one example of an auto-sampler in use, a carousel type of auto-sampler that Stevenson happened to apply to liquid chromatography. But other samplers of a variety of types — including a carousel of samples — were in widespread use by 1980 in all forms of chemical analysis, whether it be gas chromatography, liquid chromatography, atomic absorption spectroscopy, you name it.
Everyone, if you had an established technique, if possible, people wanted to add onto the instrument the capability for an operator to bring up a whole host of samples, load them in a carousel, or a tray of some kind, and let them all be run automatically unattended, while you could be off doing some other work. It's a great labor saver.
So to make a combination with capillary electrophoresis I thought was very obvious. We were working on the same thing starting in 1985, actually ourselves.
Q So it doesn't look unusual to you that these two references were combined to show the obviousness of the first six elements of Claim 32, does it?
A Right.
Q And the fact that the Stevenson reference was specifically dealing with liquid chromatography chemical separation, in no way changes your view about combining Stevenson with your own article?
A No, I mean anyone working in the analytical field, in the separations field, is apt to be using or certainly be aware of these different separation methods.
(Tr. 12 at 183-84.)
Dr. Jorgenson also agreed that the examiner correctly combined the Jorgenson, Stevenson and Akiyama references to reject elements 1 through 7 of claim 32 as obvious. (Id. at 186-87.) The 1976 Akiyama patent described a capillary electrophoresis device where the capillary was shown coiled inside a chamber. (D-5; Tr. 12 at 186-87.) Dr. Jorgenson confirmed that it was known, since long before 1976, to coil capillaries in chemical separation techniques. He recalled that by the early 1960's people were using coiled capillaries in gas chromatography, where the columns they used reached to as long as 150 feet, "and you are certainly going to coil those up because you don't want that kind of thing running all around your lab." (Id. at 185-86.) He added that between the late 1960's and mid-1970's, coiled tubes were used in electrophoretic techniques including capillary electrophoresis, isotachophoresis, and isoelectric focusing. He said, "any time you would have a long electrophoresis tube of some kind, then you'd be natural to want to use a coil." (Id. at 186.)
The stated opinion of Dr. Jorgenson was that at the relevant time it also would have been obvious to make the entire device of claim 32, including limitation 8, wherein the coiled electrophoresis capillary was "secured to a support member." (Id. at 188-89, Tr. 13 at 39-43.) He said, "you don't want a coil floating around without some kind of support. It wouldn't be a good idea, so it would be very natural to do that." (Tr. 12 at 189.) He based this conclusion upon public information not considered by the examiner, and upon his own stated familiarity with what was known by persons of ordinary skill in the art, as described below.
It was Dr. Jorgenson's testimony that at the relevant time there was prior art specifically showing electrophoresis capillaries, and larger electrophoresis tubes, secured in place in a variety of ways. (Id. at 188-89.) He discussed examples of that teaching in the published prior art. Those examples were materials by Everaerts, LKB, Lukacs and Stover in the capillary electrophoresis format, and Chilla and Macko in an electrophoretic technique using larger plastic tubing. It was undisputed that each publication appeared prior to the obviousness date of November 14, 1987. (See, e.g., Tr. 14 at 4-6.) Those sources, and Dr. Jorgenson's accompanying testimony, may be summarized as follows.
"Everaerts" is an article by F.M. Everaerts et al. entitled "Some `Theoretical and Practical Aspects of Isotachophoretical Analysis," published in the Annals of the New York Academy of Sciences in 1973. (D-29.) It expressly compares isotachophoresis (called a closed capillary tube system) with zone electrophoresis. (Id. at B 07388.) The authors describe their apparatus for isotachophoresis in pertinent part as follows:
Basically the analytical electrophoretical equipment (figure 3) consists of a thin-walled narrow-hole tube, made of P'TFE (Teflon), glass, or a common plastic material. The experimentally determined optimum diameter is 0.4-0.6 mm (i.d.) [interior diameter] and 0.65-0.85 (o.d.). This diameter is defined by the electrolyte chosen, the electric driving current used, the temperature of the environment of the capillary tube, the possible addition of a polymer to the electrolyte for stabilizing the zones, etc. . . . [T]he length of the capillary tube is determined by the pair of ions most difficult to separate. Although 10 cm is adequate for the separation of proteins, a length of 50-100 cm is needed for the separation of weak acids without the use of counterflow equipment. . . . The capillary is wound around an aluminum block in the form of a helix and pressed into a groove made in the block. A heat-sink component is used for good thermal contact.
(Id. at B 07388-07389 (emphasis added).)
This is the schematic of the coiled capillary shown in the Everaerts article:
(Id. at B 07389.)
Dr. Jorgenson pointed out that in the Everaerts apparatus, the capillary was wound around an aluminum block. He observed that "clearly they're winding the capillary onto a mandrel or spool or what have you." (Tr. 12 at 193-94.)
"LKB" refers to an isotachophoresis device called LKB Tachophor, which was made by a Swedish company named LKB and was sold as a commercial instrument. It is described in LKB public seminar notes in 1978 entitled "Isotachophoresis" ("the LKB document"). (D-30.) The LKB document shows a coiled capillary secured inside a cartridge called a "capillary plate." (Id.) The Tachophor capillary plate is described in pertinent part as follows:
Other brochures for the LKB device are in evidence as exhibits D-32 and D-33. (Tr. 12 at 196-98.)
Each capillary plate contains a Teflon capillary tube surrounded by the thermostatting fluid, kerosene. Four different plates are available, containing capillaries of lengths 230, 430, 610 or 800 mm.
(Id. at B 07944 (emphasis added).) This is the schematic of the coiled capillary shown in the LKB Tachophor document:
(Id. at B 07943.)
Dr. Jorgenson explained that the capillary cartridge in the LKB device was designed to be removable, so that pre-assembled cartridges containing various lengths of capillary could be installed. (Tr. 12 at 194-96, 198.) He showed that the coiled capillary inside an LKB cartridge was anchored and held in place inside the cartridge at various points by tabs. (Id. at 194.) He recalled that he saw the LKB devices at trade shows in the United States in the early 1980's. (Id. at 195.)
There was a connection between the LKB company and the named inventor of the Arlinger patent cited in the `172 patent history. (See n. 30 supra and accompanying text.) Dr. Jorgenson stated that Mr. Arlinger, whom Dr. Jorgenson met several times, was an employee of LKB. However, Dr. Jorgenson testified that the technology described in the Arlinger patent was not used in the LKB Tachophor device, and indeed that Arlinger patent was not in any way related to LKB Tachophor. (Tr. 12 at 196-97.)
"Stover" is an article by F.S. Stover et al. of the Monsanto corporate research laboratories published in 1987 in the Journal of Chromatography. The topic, as described in its title, is "Simple System for Total Automation of Isotachophoresis Using an LKB 2127 Tachophor." (D-36.) It describes "the total automation of isotachophoresis (ITP)" using "minor modifications to an LKB Tachophor." Those modifications included adding computer systems for data acquisition and analysis and instrument control, as well as an automatic sampling system that could be obtained commercially. (Id. at B 07856, 07861.) It concluded:
Demonstration of totally automated ITP has been accomplished using the above system for several 8-12 [hour] periods of unattended operation. This development raises the overall capabilities of ITP to the level of other modern analytical instruments.
(Id. at B 07862.)
Again it will be recalled that the LKB Tachophor featured an electrophoresis capillary coiled and held in place inside a capillary cartridge. Dr. Jorgenson testified that the Stover article demonstrates that by 1987 there was a publication showing specifically that the LKB commercial isotachophoresis device had been automated to "act like other modern analytical instruments — like modern HPLC columns, like modern gas chromatography instruments — which were already routinely coupled to autosamplers." (Tr. 12 at 202-04; Tr. 13 at 3.)
"Lukacs" is a Ph.D. thesis published in 1983 by Dr. Jorgenson's graduate student Krynn Lukacs, who worked under his supervision at the University of North Carolina ("Lukacs thesis"). (D-86.) It describes their experiments in capillary zone electrophoresis at that time, stating in part as follows:
Straight lengths of tubing were used almost exclusively. Occasionally, very long columns (2 meters or more) were coiled, but this resulted in the coils being electrostatically attracted to each other when voltage was applied. Insulation between the loops solved that problem.
(Id. at B 08358.)
Dr. Jorgenson testified that the Lukacs thesis describes work during the early 1980's in which he personally participated with student Lukacs. (Tr. 13 at 22.) Part of the work was to use capillaries of various lengths, to investigate the effect of capillary length on the capillary electrophoresis separation process. (Id. at 19-20.) Some of those capillaries would be as long as three meters, equivalent to ten feet, which was longer than a laboratory bench. For that reason, "we used a coiled capillary to conserve some space." (Id. at 20.) Dr. Jorgenson testified that once the capillary was coiled, there arose a need to separate the coils due to electrical attraction during operation:
She [Lukacs] had a very simple setup of a beaker, a second beaker, a high-voltage power supply — . . . 20,30,000 volts — to an electrode at one end, ground potential applied through an electrode to the other end, a detector. . . . And again, this was two, three meters of capillary tubing. So to conserve space, we simply arranged it as a coil right out on the desktop. And when we first turned it on, it turns out that the coils almost violently attract to each other when you turn the electricity on because as you go from 30,000 volts down to zero volts, each point of the capillary is at a progressively lower and lower potential. And since they're at different potentials, they're attracted to each other. So . . . what she did is she put an insulated [sic] in between there. I believe we tried at first something akin to wax paper called parafilm. And I believe later on it was a little more effective to use some plastic plates. But it was just to try and separate them from each other so they weren't quite so violently attracted to each other. And then she was able to complete her experiments on the effect of capillary length on separation process.
(Id. at 20-21.)
The notion of automating a capillary electrophoresis device was also addressed in an article published in 1983, co-authored by Jorgenson and Lukacs ("Jorgenson/Lukacs article"). (D-85.) Dr. Jorgenson confirmed that in that article, the authors made the following suggestion:
Capillaries also seem well-suited for automation. Our present electromigration injection technique is relatively straightforward and should be simple to automate. . . . Automated versions would be useful in routine analyses such as separation of serum proteins in a clinical laboratory. Capillary systems offer higher resolution, greater speed and better accuracy than conventional methods.
(D-85; Tr. 13 at 34.)
Automation of sample introduction in a capillary electrophoresis device was described in a September, 1987, article published in the International Journal on Chromatography, Electrophoresis and Related Methods. The article was by authors Susumu Honda et al., and entitled "Evaluation of an Automatic Siphonic Sampler for Capillary Zone Electrophoresis" ("Honda article"). (D-77.) The Honda article stated in pertinent part:
Capillary zone electrophoresis (CZE) is a recently developed method for the separation of ions, based on a combination of the effects of electrophoresis and electroosmosis in a capillary tube. It was introduced by Mikkers et al., and developed by Jorgenson and Lukacs. Its applicability is very wide. . . . However, all these studies on CZE were performed by manual sample introduction, because no automatic apparatus was commercially available. This has hampered the popularization of CZE.
The most difficult problem in sample introduction in CZE is that an extremely small volume . . . of a sample solution has to be introduced into a capillary tube which is strictly insulated so as to withstand high voltages. . . .
As compared to the above techniques, the one based on siphoning is important. Since it can be performed manually, many studies on CZE were done by this technique, though on a qualitative basis. We propose here an automatic sampler for both qualitative and quantitative studies, based on this principle.
(Id. at B 08569-08570 (footnotes omitted).)
Dr. Jorgenson confirmed that the Honda article described a capillary electrophoresis device with an auto-sampler consisting of a rotating carousel of samples and buffers. (Tr. 13 at 7-8.)
Dr. Jorgenson also described the siphonic method of capillary injection used in the Honda apparatus. (Tr. 13 at 7-8.) This led to a more general description of the problem of sample introduction into electrophoresis capillaries. (Id. at 8-10.) The topic of capillary injection appears again in Section IXinfra.
Returning to the subject of coiled electrophoresis tubes secured to support members, Dr. Jorgenson also testified about such structures used in isoelectric focusing. Although those tubes were larger than capillary size and were made of plastic, they were coiled and secured to support members as illustrated in works by authors Macko and Chilla.
"Macko" is a 1970 article co-authored by V. Macko and H. Stegemann entitled "Free Electrofocusing in a Coil of Polyethylene Tubing ("the Macko article"). (D-24.) The Macko article states in pertinent part:
Electrofocusing or isoelectric fractionation has been used in density gradients and in polyacrylamide gels for separation of proteins. Recently an apparatus for electrofocusing in free solution was described. . . .
Electrofocusing in our arrangement takes place in a coil of polyethylene tubing as shown in Figure 1. Polyetheylene tubing, (100 cm long, 4 mm i.d. [interior diameter], 1 mm was thickness) is marked every 2.5 cm and coiled around a copper tube of 20 mm diameter. The coiling is aided by double-face tape. . . . The coiled tubing is held in place by a piece of wire screen fastened at the ends with strings.
(Id. at B 07661 (footnotes omitted; emphasis added).)
This is the schematic of the coiled tubing shown in the Macko article:
(Id.)
"Chilla" is an article by R. Chilla et al. published in 1973 in the Archives of Biochemistry and Biophysics ("the Chilla article"). (D-25.) It builds on the Macko work in isoelectric focusing, stating:
Isoelectric focusing of the purified enzyme was performed in a 1-m polyethylene tube using a modification of the apparatus described by Macko and Stegemann. . . . The tube (4 mm i.d. and 6 mm o.d.) was marked every 2.5 cm and fixed in close turns around the metal pipe shown in Fig. 1.
(Id. at B 07334 (footnotes omitted; emphasis added).)
This is the schematic of the coiled tubing shown in the Chilla article:
(Id.)
Dr. Jorgenson confirmed that both Macko and Chilla were doing isoelectric focusing in a plastic tube that was wider than capillary size. (Tr. 12 at 191.) He described the purpose of the coiled tubing structure in each of those articles as follows:
What they have here [referring to Macko], they were doing one of these forms of electrophoresis called isoelectrofocusing in a plastic tube. And they had quite a length of this plastic tube, and they wanted to be able to cool it, thermostat it if possible, in a fluid medium. Because of the great length, they wanted to wrap it around in a coil, around a form. They wanted good heat transfer, so they wrapped it around a copper rod, and then they secured it in place. So it wouldn't just unwrap itself, they held it in place with a metal screen.
. . .
[T]he authors of this article [referring to Chilla] admit — it's a takeoff on the Macko et al article. And what they've added to this, they wrapped around a plastic tube and they've added a sort of convenience feature, of securing it not with a metal gauze, but with little tabs that can slide along here that each end of the tube has to go through, so they can anchor it down in that manner. You anchor it at one end through one of these little sliding eyelets, wrap your tubing on, and then anchor the other end through an eyelet, and that allows you to have variable lengths that are usually held in place.
(Id. at 191-93)
The usefulness of small-diameter tubes in electrophoretic techniques was recognized in publications of the 1976-1983 time frame, as described by Dr. Jorgenson. He first addressed a book entitled "Isotachophoresis," published in the Journal of Chromatography Library in 1976. (D-35; Tr. 12 at 198-202.) That text describes capillaries as "glass narrow-bore tubes," giving internal diameters from .45 mm to .1 mm. (D-35 at 395.) It states reasons why narrow capillaries are desirable in isotachophoresis, including decreasing amounts of ionic species to be separated, less temperature differences between successive zones in the tube, and decreased time of analysis. It also observes that "the sharpness of the zones increase[s] by decreasing the diameter of the narrow-bore tube, partly owing to the small differences in temperature between the zones." (Id. at 395; Tr. 12 at 198-202.) A similar concept was expressed in the 1983 Jorgenson/Lukacs article, which was cited in Dr. Guzman's 1986 thesis. (Compare D-85 with P-11 at 67.) That article, discussing capillary zone electrophoresis, states that "[e]fficient heat transfer from small diameter capillaries permits use of unusually high voltages, resulting in both high resolution and rapid analysis." (D-85 at B 08317; Tr. 13 at 32-36.)
This book, co-authored by F.M. Everaerts, contains background on the history and principles of electrophoretic techniques. (See D-35 at 1-24.) It states that the four main types of electrophoresis are zone electrophoresis, isotachophoresis, isoelectric focusing, and moving-boundary electrophoresis. (Id. at 7.)
Dr. Jorgenson concluded that in his expert opinion, all of the elements of claim 32 would have been obvious to one of ordinary skill in the art by no later than 1983. (Tr. 13 at 43.) On that issue be testified as follows:
Q What is your opinion with regard to the obviousness of Claim 32 in view of these references [referring to Everacrts, LKB, Macko and Chilla]?
A I would say that coiling a tube or a capillary in an electrophoresis apparatus around any kind of a form or support — inside of a cartridge, you name it — is pretty well covered. And even if it weren't for these, I would say the idea is just dead obvious.
Q It's dead obvious even if you didn't have any of these references, isn't it? Is that what you're saying?
A To me it is. I mean we were working — we coiled capillaries. We didn't run out and patent them.
Q Why not?
A Because I thought it was dead obvious. That's what you do when you have a long length of something. You coil it up.
Q How about some of the other concepts in Claim 32? What about getting a patent combining all of these eight elements put together?
A Well to me, the whole thing is obvious, every last piece. And then the combination is obvious. As I said, when you would go to a trade meeting at the time in the early 1980's, every analytical instrument was being attached to an auto-sampler. Often these were carousels of samples. And you name it. In the field of analytical chemistry, if it was possible, people were attaching those things to auto-samplers. It's just an absolutely obvious and natural thing to do.
Q Suppose I were to say to you, "Dr. Jorgenson, I can't find a single article that explains all eight elements as written by Dr. Guzman's attorney in Claim 32. How can you say it's obvious?" What would you tell me?
A I would just say that the combination is obvious. Every one of the individual ideas is obvious. And the combination is absolutely obvious. Everybody in all of the related fields in all of the related technologies is doing those kinds of things.
. . . .
Q In view of everything you've seen in this trial, including Mr. Jester's testimony, the references you've seen, do you believe that there is anything worthwhile in Claim 32?
A What I think is that it's all very obvious. The entire package taken together is obvious.
. . . .
Q Would it have been obvious to those with skill in the art or ordinary skill in the art, the capillary electrophoresis art?
A By 1983, that combination would be obvious.
Q Why did you pick 1983?
A I picked 1983 because the basic capillary electrophoresis instrument had been described, a simple instrument by that time. And some of the boundaries of what would provide good or bad results were defined by that time. Auto-samplers had existed in widespread use long before that time. Coiling capillaries and electrophoresis tubes — electrophoresis capillaries — had been done long before that time.
(Id. at 39-43.)
2. Plaintiff's Evidence on Obviousness
Plaintiff presented fact testimony from Dr. Guzman on what he thought he invented in claim 32 of the `172 patent. Dr. Guzman was not offered to present expert opinion testimony on the issue of obviousness. (See Tr. 3 at 40-42; Tr. 8 at 204-06.) Plaintiff also cross-examined Dr. Jorgenson, defendant's expert witness on obviousness. (Tr. 13 at 44-102.) Plaintiff presented no expert testimony at trial in opposition to defendant's claim of obviousness. (Tr. 14 at 108-09.)
Plaintiff's cross-examination of defendant's other witnesses did not relate to the issue of obviousness, with one exception. Mr. Burolla, who led the team that developed defendant's accused device, acknowledged on cross-examination that his review of selected literature when he began that project did include works by Jorgenson but did not include the Everaerts, LKB, Macko or Chilla references adduced by defendant at trial. (Tr. 14 at 91-92.) Also, on cross Mr. Burolla was called upon to explain his quoted statements in the 1990 Beckman Annual Report. (See n. 26 supra and accompanying text.)
a. Dr. Guzman
Norberto A. Guzman is the sole named inventor of the `172 patent. (P-1; Tr. 3 at 39-40.) He obtained degrees of B.S. in clinical biochemistry in 1971, M.S. in cell and molecular biochemistry in 1975, and Ph.D. in biochemistry in 1986. (Id. at 11-15.) The Ph.D. program was at Rutgers University and Rutgers Medical School. (Id. at 15.) He was subsequently employed for five years as a senior scientist in protein biology by Hoffman LaRoche at its facility in New Jersey. (Id. at 9-10, 20-21.) He has been continuously employed as a clinical biochemist at Johnson Johnson in New Jersey since 1992, currently holding the position of research fellow. His entire professional life has been in the field of clinical biochemistry. (Id. at 9-10, 21-22.)
He testified that his Ph.D. was awarded in a joint program between Rutgers University and Rutgers Medical School (now named University of Medicine and Dentistry of New Jersey). (Tr. 3 at 13-14; P-12.)
Dr. Guzman was accepted by the Court to provide expert testimony on topics relating to plaintiff's claim of infringement in this case. (See Tr. 3 at 40-42; Tr. 8 at 204-06.) Those topics are addressed in Section IX infra. Also, certain facts in his professional history are relevant to defendant's claim of invalidity due to prior invention. Those facts are addressed in detail in Section VIII infra.
He testified that he became interested in capillary electrophoresis in the early 1980's, while he was participating in the Rutgers Ph.D. program and earning his way partly by working as a laboratory clinician at various hospitals. (Id. at 22-27.) He formed the plaintiff corporation, Princeton Biochemicals, Inc., in 1985. (Id. at 26-27.) He stated that he worked in his company basically full time during the two years between 1985 and 1987, until he went to work for Hoffman LaRoche. (Id.) He described his work during those two years as follows: "All of the work I did was analyzing different constituents of biological fluid using capillary electrophoresis. So it was a full-time job for me to develop the variety of different prototypes to improve the technology to see the best separation that I could." (Id.) He is the president and majority shareholder of the plaintiff corporation. (Id. at 46-47; Tr. 10 at 44-45, 50.) Plaintiff is the assignee of the `172 patent. (Tr. 3 at 46.)
English is not Dr. Guzman's first language, and the trial record reflects transcription difficulties relating to his pronunciation and usage. The trial transcript was prepared by a certified transcription service using the tape recording of the trial, pursuant to standard procedure in this Court.
When we quote the testimony of any witness in this opinion, we have taken the liberty of correcting obvious transcription errors, and deleting irrelevant conversational features and redundancy. We have not made any corrections where the meaning of the text is unclear or correction would vary the content. Also, for simplicity in quoting text, we have replaced an unqualified affirmative answer with "[Yes.]." The parties are invited to participate with the Court in resolving any disputes concerning the official trial transcript if that becomes necessary.
He testified that the present structure of plaintiff is as follows:
Q Are you presently employed by Princeton Biochemicals?
A I'm the president of the corporation.
Q Does the corporation have any other employees?
A One person.
Q [W]ho is that person?
A It is a silent partner.
(Tr. 3 at 46-47; see also Tr. 10 at 44-45, 50.) Dr. Guzman stated that he is the 60% owner of the shares of the plaintiff corporation, and the silent partner owns the rest. (Tr. 5 at 31.)
Dr. Guzman stated that he is the named inventor of the patent in issue in this case, and several others that have been issued in other countries arising out of his capillary electrophoresis work. (Id. at 39.) He is also the named inventor of an unrelated patent issued to Johnson Johnson in 2000. (Tr. 10 at 62.) He is an adjunct member of the Rutgers University committee overseeing graduate students doing theses in capillary electrophoresis, and is a visiting professor for the same function at the University of Buenos Aires in Argentina and the University of Barcelona in Spain. He is on the editorial board of a publication named Journal of Liquid Chromatography, has published papers in peer-reviewed journals on capillary electrophoresis and other topics in medical science, and is the editor of two books, including one on capillary electrophoresis. (Tr. 3 at 29-32.) He has also presented hundreds of seminars relating to capillary electrophoresis around the world, and founded a Latin American symposium on capillary electrophoresis that he attends every year. (Id. at 32-34.)
Dr. Guzman also testified that he is the editor-in-chief of a publication named the Journal of Capillary Electrophoresis, launched in 1994. (Tr. 3 at 29-31.) On cross-examination he acknowledged that it had not published any new issues in approximately two years preceding trial, although he said that three issues were in press (the same three issues to which he had testified at deposition more than a year earlier). (Tr. 10 at 51-54.)
He described the invention in claim 32 of the `172 patent in his own words, in two places in the trial transcript, as follows:
I have a small box that has the two containers basically — two different beakers which connect the capillary from one side to another. And it has a high-voltage power supply. So the capillary, you can see, has a first end and a second end which is the inlet and the outlet. But it's also in a support system that is coil the capillary [sic] for a number of reasons. The capillary coil will make the instrument more compact. That was one of the main reasons why I started doing this. The first instrument that I did, I had no idea that I could coil the capillary. So it was a very long instrument. So now we have a small little instrument that could be portable in the luggage for traveling. And it has a detectable optical system. Everything can be detached. So it's like a mobile unit. . . .
These descriptions of the claim 32 invention by Dr. Guzman are referred to later in this section.
(Id. at 54-55.)
Basically I built or manufactured a capillary electrophoresis device containing certain elements and some of those elements — at the heart of the instrumentation itself, has a fused silica capillary. . . .
And one of those elements was a capillary tube, which is basically a transport tube that is able to separate certain constituents of various different samples. And this particular capillary has an inlet and an outlet. And there's a rotatory table or a sampler of a way of a source, of providing a source for the sample and source of the buffer. In order to have some motion of these elements in the capillary, within the capillary, we need something called a high voltage power supply that provided potential of moving this across the capillary. And once after a certain period of time we needed a detector which is going to provide the signal of passing through that particular detector and also give some quantification of the quantity of the material that we're analyzing.
The capillary was kind of embedded into something called an — in a cartridge cassette. And the two ends of the capillary were in operative relationship with some of the vials in the rotatory table. And there was a support member, which is the cartridge cassette, there's a support in this particular device. Those are in the sample's way general scope of what I call invention. The critical part of this is that all of these elements in combination were able to function what we call the claim 32.
(Tr. 8 at 14-15.)
b. Plaintiff's Cross-examination of Dr. Jorgenson
Plaintiff established on cross-examination of Dr. Jorgenson that not one of the prior art references identified at trial teaches all of the limitations of claim 32. (Tr. 13 at 58-59.) Plaintiff also highlighted the following differences between some of those references and claim 32:
• Stevenson (D-4) relates to liquid chromatography, which is a different separation method than capillary electrophoresis. (Id. at 79-80.)
• Akiyama (D-5) relates to a capillary electrophoresis device identified in Mr. Jester's testimony about the `172 patent file history. (Id. at 80-83.)
• Everaerts (D-29) relates to an isotachophoresis device that did not have a rotatable table, sample cups or holder as in claim 32, and it refers to a plastic rather than a glass capillary tube. It also describes leading and trailing electrolytes and a sample undergoing analysis, which are not part of the language of claim 32. (Id. at 71-72.)
• LKB (D-30) relates to an isotachophoresis device that did not have a rotatable table. It includes a cooling function using kerosene, unlike the language of claim 32, which does not mention temperature control. (Id. at 74-76.)
• Honda (D-77) relates to a capillary electrophoresis device that did have a rotatable table, but the capillary was not coiled. It describes a siphoning method of sample injection, unlike the language of claim 32, which does not mention any sample injection method. (Id. at 88-91.)
• Macko (D-24) relates to an isoelectric focusing device that did not have a rotatable table and used low voltage. It describes a coiled tube made of plastic that is wider than capillary size. Its separation technique involves freezing and cutting the coiled tubing to complete the analysis, and requires approximately 60 hours. In contrast, claim 32 has a glass capillary, a rotatable table, and a high voltage power supply. Also, capillary electrophoresis does not destroy the capillary and takes only 5 to 30 minutes. (Id. at 61-66.)
• Chilla (D-25) relates to a modification of the Macko device that also did isoelectric focusing using similar equipment, technique, and timing as Macko. (Id. at 66-70.)
This portion of the Jorgenson cross-examination appears to be a reference to the examiner's citation of Akiyama against element 7 but not against element 8 in the `172 file history. (Tr. 12 at 103-104.) Dr. Jorgenson testified on direct examination that the Akiyama reference does not show any obvious support member for its coiled capillary. (Tr. 12 at 187-188.)
The Everaerts reference actually describes a coiled and supported capillary made of either Teflon, glass, or a common plastic material, with a narrow interior dimension of .04-.06 mm. (D-29 at B 07388.)
Plaintiff's counsel pointed out during cross-examination of Dr. Jorgenson that his expert report and deposition testimony did not refer to certain prior art references in evidence at trial. (Tr. 13 at 53.) Cross-examination also showed that at deposition Dr. Jorgenson stated that he was "not prepared to say right now" what combination of prior art references he would need to get all of the limitations of claim 32. (Id. at 77-79.)
Plaintiff also elicited from Dr. Jorgenson that the word "automation" is not found in claim 32, nor does claim 32 describe any motors. However, on this point Dr. Jorgenson stated, "I believe that what's meant by automation is the ability to have multiple samples on a carousel. That's what is the automation in this patent. So, in fact, although the word automation does not appear there, claim 32 is containing a key part of the proposed automation." (Id. at 83-84.)
It was emphasized on cross-examination that although Dr. Jorgenson testified that he has studied isotachophoresis and isoelectric focusing, he has never actually run any chemical separations using those techniques. (Id. at 64-65;see Tr. 12 at 175-76.)
Dr. Jorgenson was also shown five of his own patents in the same Patent Office class as the `172 patent (204/299), which were all approved by the same primary examiner who approved the `172 patent. He acknowledged that he had not cited any of the references discussed during this trial in any of those five patent applications. However, the subject matter of those patents was not described in the record. (Tr. 13 at 91-102.)
3. Defendant's Cross-examination of Dr. Guzman on Obviousness
Dr. Guzman did not testify as an expert on the issue of obviousness. (See Tr. 3 at 40-42; Tr. 8 at 204-06; Tr. 14 at 108-09.) Thus, he provided no testimony on the knowledge of one of ordinary skill in the art at the relevant time. However, he did state in his direct examination what he considered was the invention in claim 32, as quoted above. (See n. 43 supra and accompanying text.) Dr. Guzman stated the following in cross-examination on that topic:
Q You're not contending that you invented capillary electrophoresis?
The entire cross-examination, and redirect examination, of Dr. Guzman on this specific topic is contained in Volume 10 of the trial transcript at pages 63-94, 124-126, and 175. The excerpts quoted here are an accurate summary of the entire line of questioning.
A Absolutely not.
Q There were instruments performing capillary electrophoresis predating you by many years?
A Many years before. That's correct.
Q To do capillary electrophoresis, you have to have a capillary tube, right? [Yes.]
Q And you have to have electrical charging? [Yes.]
Q So you didn't invent anything with regard to limitation number 1?
A No.
(Tr. 10 at 63-64.)
Q Now, if there's a capillary electrophoresis device, wouldn't it always have to have first and second ends? [Yes.]
Q So you didn't invent the idea of having a capillary tube with a first and second end?
A Not at all.
Q So we just have a first and second ends, and you take no credit for inventing anything that I've shown on the board so far, that is the preamble, limitation 1 and limitation 2, right?
A Absolutely, yes.
(Id. at 64-65.)
Q Limitation 3, a first means at the first end of the capillary tube providing a source of buffer solution and a source of a sample substance to be analyzed. Did you see capillary electrophoresis not performed with buffer or sample?
A No.
. . . .
Q So you have to have a capillary and a first and second ends — and a source of buffer and a source of sample, right? [Yes.]
Q So you take no credit whatsoever for inventing anything that I've shown so far up to limitation 3?
A Not at all.
(Id. at 65-66.)
Q [L]et's look at limitation 4. Second means coupled to said apparatus for applying electrical potential across said capillary tube whereby a sample flows through said capillary tube and past said detector, see that? [Yes.]
Q Wouldn't every single capillary electrophoresis device have to perform what's shown as the second means?
A I agree with you.
Q You have to have a voltage supply?
A Absolutely.
Q And the flow has to go past the detector? [Yes.]
Q And you have to look through the detector to see the separation? [Yes.]
Q So isn't it clear that you could not have invented anything through this claim up to limitation 4?
A Absolutely, yes, I agree with you.
(Id. at 64-65.)
Q There seems to be a lot of discussion about the rotatable table carrying a plurality of sample cups, you see that? [Yes.]
Q You're well aware of the fact that you didn't invent limitation 5?
A No.
Q That's an old technique in chemical separation?
A Yes. There are different names for the rotatable table, the trays, the autosamplers, and the fraction collectors are also called. So it was in the literature prior to that as —
Q Well known, right?
A Well known.
. . . .
Q So when I see it in the literature and it says autosampler, that's what they're referring to, rotatable tables?
A Yes. It's a general terminology, mean how can you supply that into the buffer and once again, it's not just round, it can be in different shapes.
Q But it's well known well before . . . you began your research in capillary electrophoresis, to have rotatable tables for carrying plurality of sample cups so that any automated equipment would be able to test and diagnose multiple samples?
A That is correct.
Q That's the purpose of automated devices with rotatable tables, isn't it?
A Yes, and exactly they providing the plurality of samples, vials.
Q So is it safe to say as we dissect this claim, you invented nothing up through limitation 5?
A That is correct.
(Id. at 67-69.)
Q Limitation 6: A holder for holding an end of said capillary tube in operative relation with one of said cups, said cups containing either buffer solution or sample to be analyzed. Now we know the cups have to contain buffer or sample because you already said that earlier, right? [Yes.]
Q I think everybody realizes that said cups containing either buffer solution or a sample to be analyzed, that can't lend any inventiveness or patentability to the claim, isn't that right?
A No.
. . . .
Q So do you believe you were the inventor of the holder for holding the end of the capillary?
A No, because the holder is a very general terminology. So there are many different holders and so I'm not inventor of those holders.
Q So you're not inventor of anything in Limitation 6, right?
A No.
. . . .
Q So we can now agree that you could not have invented anything from the preamble all the way through Limitation 6, right?
A That is correct.
(Id. at 69-71.)
Q At the time you filed for this Claim 32, you thought you were the first ever to coil the capillary in a capillary electrophoresis device?
A Capillary electrophoresis device, yes.
Q Since that time, do you still believe that you were the first one to invent the idea of coiling the tubing in a capillary electrophoresis device?
A I [had] never seen literature prior to that date.
Q You didn't look at the literature that's been submitted in this case?
A Right, after `89.
. . . .
Q I'm referring to literature that existed before you ever filed your second application in November of 1988. Have you seen literature in this case, which shows that you in fact were not the first to publish, think of, build, use, test, a coil of glass tubing in a capillary electrophoresis device, yes or no?
A [If] you're comparing conventional and traditional electrophoresis versus modern capillary electrophoresis, the answer is yes. If you are comparing the back of — what happens in the past if you — and something like that, of course they existed, but those — are different kind of electrophoresis.
. . . .
Q Where is "modern" in your claim 32?
A There's no modern, but that's — everybody knows today that capillary electrophoresis is a different way of doing things from the past.
Q I'm not asking you what people know today. When you filed this claim in 1988, did you ever have the word "modern" anywhere in it?
A No.
. . . .
Q Before the break, we were talking about limitation 7. Have you reviewed the exhibits which are on each of the parties' exhibit books? . . . [Yes.]
Q Did you see any references discussing coiling the capillary in a capillary electrophoresis device?
A I saw reference coiling a capillary in traditional and conventional capillary.
Q So what year did it go from traditional to — what did you call it — modern?
A Modern capillary electrophoresis.
Q And when did that transition occur in the field of chemical separation in your view?
A I would say 1981 was probably the most classical year, to define modern capillary electrophoresis with some of the first papers from Dr. Jorgenson.
Q So by 1981 your view of modern capillary electrophoresis was now well known due to the papers written by Dr. Jorgenson, who is sitting in the front of the courtroom? [Yes.]
. . . .
Q Have you read papers by Dr. Jorgenson and a student of his named Lukacs? [Yes.]
. . . .
Q Did you ever read a thesis dated 1983, by Krynn DeArman Lukacs, at the University of North Carolina at Chapel Hill?
A Never.
Q You never saw it?
A No, I never saw that.
Q You never saw it even though it's been in defendant's exhibit book, and designated as an exhibit since the pretrial order in September of 2000?
A Yes, I don't think I have the whole copy.
Q I'm going to give you a whole copy. . . . Let's go back to [claim 32], before we have the lunch break, and I'll come back. [Regarding] limitation 7, is it your testimony that at the time you filed your application in November of 1988, you thought that you were the first to ever coil the capillary in a "modern" capillary electrophoresis device?
A Yes, I never saw it before, yes.
Q As you sit here today, do you still believe that you were the first ever to coil the capillary in a modern capillary electrophoresis device?
A Well, it was —
Q Yes or no?
A I will say yes.
Q Do you know, are you guessing, speculating, just picking and choosing, or do you have any knowledge whatsoever as to when those of skill in the art, like Dr. Jorgenson in his lab, began coiling capillaries?
A I never saw those references — that you're referring to.
. . . .
Q So you know that there were coils in gas chromatography?
A Oh, I admitted that the capillary coil has been coiled for many many years. What I'm saying in — capillary electrophoresis I mean — there are two different things. So, capillary coil existed before in isotachophoresis and gas chromatography, and many other forms of electrophoresis. But like I said, to my knowledge in this particular thing, in combination with the rest of the claim, this is the first time.
Q You refer to other forms of capillary electrophoresis. Isotachophoresis — is that one form?
A No, I have conventional and traditional electrophoresis, yes.
Q Is it your testimony that isotachophoresis is not a form of electrophoresis?
A It is.
. . . .
Q You do concede that coiled capillaries have been used for years before you?
A Yes.
Q And before you began doing any work in capillary electrophoresis you recognize that coiled capillaries were used in isotachophoresis? [Yes.]
Q And were used in gas chromatography? [Yes.]
Q And were used in other chemical separation techniques?
A Yes, quite possible.
(Id. at 74-85.)
Q Let's go to the last limitation and we'll save limitation 7 for after the lunch break. This one — secured to a support member. Is it your testimony that securing to a support member was your idea?
A No.
. . . .
Q In Claim 32, what is being secured to the support member?
A This is the support itself.
Q I'll ask the question again, what is being secured to the support member?
A The capillary is secured to the cartridge cassette.
Q Is the cartridge cassette anywhere in this claim?
A No.
Q So cartridge cassette, let's get that out of the way. We're just talking support members, right?
A Well it could be any support members, it's a general term.
Q In your view, looking at claim 32, what is secured to the support member?
A I did explain that before to you, secured is the coiled capillary that is secured to a support member. The coiled glass tubing.
. . . .
Q Is it your testimony that the "coil of glass tubing" is secured to the support member?
A [It] is the capillary tubing, [in] the form of a coil of a glass tube, [that] is secured to a support member.
. . . .
Q Other than what we're going to cover after lunch, you concede you did not invent securing capillary tubes or any portion thereof to support members?
A No.
Q That's old, right?
A You mean . . . limitation 8, is that right?
Q Yes.
A Yes, sir. I didn't.
Q You did not invent — okay. Limitation 8 doesn't add.
A Right.
(Id. at 89-94.)
Q [After lunch recess, and referring to D-86, Lukacs 1983 thesis, at B 08358.] Do you see that in 1983, it was public information that you could coil the capillary in capillary electrophoresis devices?
A I can see that.
Q Particularly I'd like to read in the sentence, where it says, "Occasionally, very long columns (two meters or more) were coiled, but this resulted in the coils being electrostatically attracted to one another when voltage was applied." See that? [Yes.]
Q The thesis continues and shows how they resolved the problem of the coiled segments touching each other by electricity, see that? [Yes.]
Q Then it talks about putting insulation between each of the loops or rings, or coils, of the capillary, right?
A Yes, . . . they don't say that they solved all the problems, they say they solved that problem.
Q But you do concede now that coils were known in the art, particularly as published by the students of Dr. Jorgenson?
A No, what I didn't see there in that paragraph, is . . . all the elements in combination together.
Q I was just discussing limitation 7, just to show to you that limitation 7 was not a contribution made by you to the field of capillary electrophoresis. Isn't that correct?
A I can see that now.
(Id. at 124-26.)
Dr. Guzman was also cross-examined on a topic relating to objective indicia of nonobviousness (commercial success of the patented invention), in the following exchange:
Q You said your company was created for the purpose of selling capillary electrophoresis instrumentation, do you remember that?
A For the design and manufacture of capillary electrophoresis.
Q Do you remember testifying out of the presence of the jury that the purpose of you creating this company was to sell capillary electrophoresis instrumentation?
A There was probably another word that I used. But I also said design and manufacture.
Q Did you ever sell a single capillary electrophoresis device ever?
A Commercially, no, but I manufacture it internally, yes.
Q I'm just asking about selling to someone else that may actually use this. Did you ever sell a single one?
A No.
(Id. at 46-47.)
C. Conclusion on Issue of Obviousness
We find that on the issue of obviousness pursuant to Section 103, the underlying historical facts are not in dispute. We further find that the only reasonable factual conclusion supported by the trial record is that all of the elements of claim 32, in combination, were obvious to a person of ordinary skill in the art of capillary electrophoresis apparatus as of the relevant date of November 14, 1987. Accordingly, we hold as a matter of law that defendant has met its burden of proving, by clear and convincing evidence, that claim 32 of the `172 patent is invalid as obvious.
The following discussion is structured under the four Graham factors: (1) the level of ordinary skill in the art; (2) the scope and content of the prior art; (3) the differences, if any, between the prior art and the claims at issue; and (4) any objective evidence of nonobviousness. Graham, 383 U.S. at 17. This analysis incorporates by reference all of the trial evidence pertaining to the issue of obviousness. That evidence is cited and summarized supra, Section VII.B. We will highlight that evidence as we apply the legal standards under Section 103. The general legal standards are set forth supra Section VII.A, and discussed here.
The "Conclusion" subsections of this opinion generally do not contain citations to the evidence except after quoted language. The trial record citations are set forth in the "Review of the Evidence" portion of each section.
1. Level of Ordinary Skill in the Art
"There are six factors a court should consider in determining the level of ordinary skill in the art: (1) the educational level of the inventor; (2) the type of problems encountered in the art; (3) the prior art solutions; (4) the rapidity of innovation; (5) the sophistication of the technology at issue; and (6) the educational level of active workers in the field." Ajinomoto Co. v. Archer-Daniels-Midland Co., No. 95-218, 1998 WL 151411, at *40 (D. Del. Mar. 13, 1998) (citing Bausch Lomb, 796 F.2d at 449-50). Neither of the parties made any issue of the level of ordinary skill in this case at trial.
The evidence showed that the chemical separations field, and specifically the field of electrophoresis, was an active research area with numerous published materials during the early and mid-1980's. The publications in the field of electrophoresis techniques were by Ph.D. level researchers and their Ph.D. candidate postgraduate students. Dr. Guzman was a Ph.D. candidate in biochemistry when he developed the designs leading to his `172 patent application. Beckman developed its P/ACE device based on research by a leading academic chemist (Dr. Zare), initial research authorization by a manager with an M.S. in chemistry (Mr. Harbaugh), project approval for commercialization by a vice president with a Ph.D. in biochemistry (Dr. Osborne), and research and development work by a team comprised of an M.S. level chemical engineer (Mr. Burolla) and other technical engineers, computer specialists, and precision instrument makers.
We find that the level of ordinary skill in the art would require at least an M.S. or its equivalent in biochemistry or chemical engineering, with some practical knowledge of electrophoresis instrumentation and its operation.
2. Scope and Content of Prior Art
a. Scope
A reference is within the scope of prior art if it is within the field of the inventor's endeavor. Bausch Lomb, 796 F.2d at 449. If it is not, a reference is included in the scope of prior art if it "is reasonably pertinent to the particular problem with which the inventor was involved." Id. "A reference is reasonably pertinent if, even though it may be in a different field of endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor's attention in considering his problem." In re GPAC Inc., 57 F.3d 1573, 1578 (Fed. Cir. 1995) (quotations and citations omitted). If a reference disclosure relates to the same problem as that addressed by the claimed invention, "that fact supports use of that reference in an obviousness rejection." In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992).
The title of the `172 patent is "Capillary Electrophoresis Apparatus." Certainly the scope of relevant prior art includes all references in the field of capillary electrophoresis. However, the inquiry does not end there.
We note that defendant's witness Mr. Jester testified that the title of the `172 patent is actually a printing error, and should have read "Automated Capillary Electrophoresis Apparatus." (Tr. 12 at 120.) Plaintiff did not stipulate to such a fact. (Id. at 156.) We need not rule on the point since it does not appear to affect the outcome of the case.
The `172 file history itself demonstrates that the scope of relevant prior art may include other electrophoretic techniques, and even other chemical separation techniques not limited to electrophoresis, if such art was reasonably pertinent to the particular problem with which the inventor was involved. The examiner in this case consistently rejected elements 1 through 6 of claim 32 as obvious, citing references ranging from capillary electrophoresis (Jorgenson) to liquid chromatography (Stevenson), stating "liquid chromatography and capillary electrophoresis are closely related techniques." (D-2 at 86.) The examiner expressly found that it would be obvious to one skilled in the art to combine the capillary electrophoresis apparatus of Jorgenson with automating elements found, for example, in Stevenson. (Id.) The examiner's citation of the Arlinger patent at various points of the `172 file history also shows that references in isotachophoresis may be prior art relevant to a capillary zone electrophoresis device. Both the examiner and the applicant referred to the Arlinger device as an "electrophoretic apparatus." (Id. at 86, 92.)
The Arlinger patent was cited numerous times by the examiner in rejecting various claims in both the original and the CIP application for the `172 patent. For example, Arlinger was cited against claims 1 through 28, 29, 30, 34, 35, 39, 47 and 48 in the examiner's initial rejection of the CIP application. (See D-3 at 70-72.) The examiner characterized the Arlinger patent as an electrophoretic apparatus disclosing a sample recovery means. (See, e.g., id. at 71.) Mr. Jester saw no apparent reason why Arlinger was not named among the references ultimately cited against only amended claims 39 and 50. (See n. 30 supra and accompanying text.) We can discern no evidence relevant to obviousness from this aspect of the file history, except for the examiner's citation of Arlinger, which disclosed an isotachophoresis device, as a reference against many claims in the `172 patent application for a capillary zone electrophoresis device.
The evidence revealed that the scope of peer publications in the chemical separations field during the relevant period would typically address many of these related techniques. Examples include the following:
• The Honda article entitled "Evaluation of an Automatic Siphonic Sampler for Capillary Zone Electrophoresis" appeared in a publication named the International Journal on Chromatography, Electrophoresis and Related Methods. (D-77.)
• The book edited by Everaerts entitled "Isotachophoresis" appeared in a publication named the Journal of Chromatography. (D-35.) It states that the four main types of electrophoresis are zone electrophoresis, isotachophoresis, isoelectric focusing, and moving-boundary electrophoresis.
• The Stover article describing automation of the LKB Tachophor device was published in the same Journal of Chromatography. (D-36.)
• The Everaerts article entitled "Some Theoretical and Practical Aspects of Isotachophoretical Analysis" expressly compares isotachophoresis (called a closed capillary tube system) with zone capillary electrophoresis. (D-29.)
• The Jorgenson reference on capillary electrophoresis cited by the examiner in the `172 file history is a chapter in a book entitled New Directions in Electrophoretic Methods. (P-93.)
• Dr. Jorgenson testified that it was not unusual to combine teaching from techniques such as capillary electrophoresis and liquid chromatography, as the `172 examiner did, because "anyone working in the analytical field, in the separations field, is apt to be using or certainly be aware of these different separation methods." (Tr. 12 at 183-84.)
We find that based upon this unrebutted evidence, the scope of analogous prior art must include prior art references in any electrophoretic method, as well as liquid chromatography, if the content of the reference is reasonably pertinent to the particular problems with which the inventor of claim 32 was involved. This scope would potentially include all of the prior art references in evidence at trial.
b. Content
The next inquiry considers what problems the inventor of claim 32 was involved in solving, and whether the content of the identified prior art references is reasonably pertinent to those problems. Bausch Lomb, 796 F.2d at 449.
Claim 32 is one of 40 claims in the `172 patent as issued. Like many of the other claims in that patent, claim 32 has numerous limitations. The parties have by stipulation divided claim 32 into eight listed elements. (P-72.) Within those eight elements are various limitations, depending upon how one would subdivide the claim language. It is understood that the obviousness inquiry is not directed to the so-called point of novelty of claim 32. Rather, the inquiry focuses upon the claimed subject matter as a whole. The content of the collective teachings of the prior art must also be viewed as a whole, through the eyes of one of ordinary skill in the art. See Section VII.A. supra.
Defendant argued at the summary judgment stage that plaintiff acquiesced in the examiner's rejection of elements 1 through 7 as obvious, and that by accepting the added limitation of element 8, plaintiff allowed the subject matter of claim 32 to reduce to that single point of novelty. We left that issue open for further factual development at trial. (See 12-29-00 Mem. and Order, nn. 1 and 4.) Based upon the full trial record we reach the conclusion that the entirety of claim 32 was obvious, in light of the entirety of the relevant prior art. Therefore it is not necessary to reach the issue of acquiescence, although both parties have preserved their positions on this issue for appeal. (See Tr. 12 at 125-126, 149-150, 155-156.)
The patent examiner in this case reviewed certain prior art references pertinent to elements 1 through 7 of claim 32, and rejected the combination of all those elements as obvious. The Patent Office's final rejection of elements 1 through 7 relied upon "Jorgenson in view of Stevenson et al and Akiyana [sic]." (D-3 at 98.) Plaintiff could not, and did not, rebut those conclusions or the underlying references at trial. The relevant content of those references, cited by the examiner, may be summarized as follows:
• Jorgenson describes the basic structure and operation of Jorgenson's capillary electrophoresis system at the time. (P-93.) Jorgenson does not have a coiled and supported capillary nor a rotatable table.
• Stevenson describes a rotatable table carrying a plurality of sample cups in a liquid chromatography device. (D-4.) Stevenson is not a capillary electrophoresis device, so it lacks several other features of claim 32.
• Akiyama describes a capillary electrophoresis device containing elements 1 through 7 of claim 32, excluding the rotatable table. It features a coiled capillary tube made of "an insulating material such as Teflon," with an internal diameter of, "for example, .05 mm." (D-5, col. 3, l. 41-45.) It does not show a support member for the coiled portion of the capillary.
The Honda article in evidence confirms that the prior art specifically in capillary electrophoresis did show an automated device with a rotatable table carrying a plurality of sample cups, corresponding to elements 1 through 6 of claim 32. (D-77.) Honda does not describe a coiled capillary secured to a support member.
It is well established that the source of a suggestion or motivation to modify prior art teachings can be the content of the public prior art, the knowledge of one of ordinary skill in the art, or the nature of the problem to be solved. Sibia, 225 F.3d at 1356. The question of what is relevant content in the prior art for the coiled capillary "secured to a support member," element 8, therefore may depend upon the needs the inventor would have been addressing at the time of adding that feature to his capillary electrophoresis device. Here we have the testimony of the inventor himself, identifying the needs he was addressing in adding that feature:
So the capillary, you can see, has a first end and a second end which is the inlet and the outlet. But it's also in a support system that is coil the capillary [sic] for a number of reasons. The capillary coil will make the instrument more compact. That was one of the main reasons why I started doing this. The first instrument that I did, I had no idea that I could coil the capillary. So it was a very long instrument. So now we have a small little instrument that could be portable in the luggage for traveling.
(Tr. 3 at 54-55; see also Tr. 8 at 14-15.)
The two needs apparently identified in that statement are: (1) to make the capillary electrophoresis apparatus more compact, and (2) to immobilize the coiled capillary. It will be recalled that Beckman identified those same two needs among its objectives for the OTEP automated capillary electrophoresis product development.
In the real world, an additional need can be addressed while coiling and supporting an electrophoretic tube of any sort, whether capillary size or larger. The trial record contains many references to (1) a coiled and supported electrophoretic tube being combined with other features to achieve temperature control inside the coiled portion of the tubing, and (2) temperature control inside the tubing being important in all types of electrophoresis, whether or not a coiled capillary is used. However, because temperature control is not expressly addressed in the language of claim 32 of the `172 patent, we do not address that aspect in this section. We do address it in the following section, because it becomes relevant to the chronology of Dr. Guzman's inventorship based upon the patent prosecution history and the testimony of plaintiff's witnesses.
The examiner, as we know, found that coiling the capillary in an automated capillary electrophoresis device, regardless of the reason, was obvious. However, as a practical matter, the "secured to a support member" element (8) cannot be divorced from the "coil of glass tubing" element (7), because the coiled tubing is secured to the support member according to the claim language. Therefore, the prior art must be analyzed for content addressing either or both of those needs.
Searching the trial evidence, we find the following references pertinent to those specific needs:
• The Lukacs thesis stated that during capillary electrophoresis work in Dr. Jorgenson's laboratory, very long coils were coiled. This resulted in the problem that the coils were electrostatically attracted to each other when voltage was applied. (D-86.)
• Beckman witness Dr. Osborne testified that even in Dr. Zare's apparatus without coiling, the capillary swayed during the electrophoresis run, which affected the separation results, so "we did not want the capillary to move during the separation." (Tr. 11 at 67.)
• Dr. Jorgenson identified the coiled electrophoresis tubes used in prior art references Everaerts, LKB Tachophor, Macko and Chilla, discussed below. He stated that those were prior art specifically showing coiled electrophoresis tubes, including capillary tubes, secured in place in a variety of ways.
• Dr. Jorgenson testified that from the late 1960's forward, those of ordinary skill were using coiled tubes to conserve space, in electrophoretic techniques including capillary electrophoresis, isotachophoresis and isoelectric focusing. He said, "any time you would have a long electrophoresis tube of some kind, then you'd be natural to want to use a coil." (Tr. 12 at 186.)
• Dr. Jorgenson further testified that at the relevant time it was known by persons of ordinary skill in the art that it was obvious to secure a coiled electrophoresis tube to a support member, for the reason that "you don't want a coil floating around without some kind of support." (Id. at 189.)
3. Difference between Prior Art and the Claimed Invention
Dr. Jorgenson, in the course of his testimony, discussed the five prior art references in evidence that specifically used coiled electrophoretic tubes secured to a support member. Those were Everaerts, LKB Tachophor and Stover using the isotachophoresis technique, and Macko and Chilla using the isoelectric focusing technique. For each of those references he pointed out the coiled portion of the tube and the structures that supported it. Briefly, to recap:
• Everaerts describes an isotachophoresis device with an electrophoresis capillary (0.4 to 0.6 mm) made of Teflon, glass or plastic, wound around an aluminum block and pressed into a groove made in the block. (D-29.)
• The LKB Tachophor reference describes an isotachophoresis device with an electrophoresis capillary described as made of Teflon, coiled around a spool or mandrel inside a cartridge, and anchored in place at various points by tabs. (D-30.)
• Stover describes a "simple system for total automation" of isotachophoresis using an LKB Tachophor. (D-36.) It would use the LKB Tachophor cartridge containing the coiled and secured capillary tube.
• Macko describes an isoelectric focusing device using polyethylene tubing (4 mm) coiled around a copper tube aided by double-face tape, and held in place by a piece of wire screen fastened at the ends with strings. (D-24.)
• Chilla describes an isoelectric focusing device based on the Macko design, using the same size and type of polyethylene tubing but fixed in close turns around a metal pipe and secured at each end through eyelets using sliding tabs. (D-25.)
Dr. Jorgenson admitted that no single prior art reference had been found showing all eight elements of claim 32 in combination. However, his testimony established that each of those five references showed that it was public information that lengths of electrophoretic tubing were being accommodated by coiling, and that the coiled tubing was being secured in place, within electrophoresis devices at the relevant time. Dr. Jorgenson also pointed out contemporaneous publications from his lab and another authoritative source that stated the desirability of small-diameter capillaries in electrophoresis generally, thus providing the suggestion or motivation to reduce the diameter of the tube to capillary size. Indeed, Dr. Guzman paraphrased that information in his thesis. Nor is there anything special about a glass capillary over a Teflon or plastic capillary as an electrophoretic medium, as demonstrated by Everacrts and LKB.
It will also be recalled that the Akiyama patent in capillary electrophoresis stated that its capillary was made of Teflon, and that patent was cited against element 7 by the examiner.
Those five references are found in the same field of technology as claim 32, namely electrophoresis, and they each relate to the same problems addressed in elements 7 and 8 of claim 32. Considered in light of the surrounding evidence presented through Dr. Jorgenson, those references provide the suggestion that an inventor using a glass capillary in an apparatus for capillary zone electrophoresis could successfully solve the dual problems of accommodating length and immobilizing the capillary by coiling it and securing it to some kind of support member. We find that the only reasonable conclusion from this evidence is that those five references are reasonably pertinent to the particular problems addressed in elements 7 and 8 of claim 32. Therefore, they must be included within the scope of analogous prior art, along with references pertaining to the other elements of claim 32 such as Jorgenson, Stevenson and Akiyama.
Dr. Guzman admitted that he does not consider himself the inventor of any of the eight elements of claim 32; only the combination. However, he did not offer expert testimony from the standpoint of one of ordinary skill in the art. That hypothetical person is presumed by law to have (1) all of the prior art references before him or her and (2) the knowledge and common sense of one of ordinary skill in the art. Only Dr. Jorgenson presented testimony under that standard.
Mr. Burolla did not purport to know all that the hypothetical person of ordinary skill in the art would know. However, his practical experience in leading the Beckman design team is relevant to the issue of the obviousness of claim 32. He had no prior experience in electrophoresis when assigned to Beckman's OTEP project. He learned how to make a basic capillary electrophoresis device by studying Dr. Zare's work and some of the pertinent literature, not including the above-cited five references. He was aware of the need to have a compact machine and to immobilize the capillary. His team designed its very first prototype to be a capillary electrophoresis device containing each of the elements of claim 32, including elements 7 and 8, even without knowledge of those five references. It is also relevant that as described by Mr. Harbaugh, Beckman sold a chemical separation instrument called an amino acid analyzer since the mid-1960's that featured a capillary tube wound around and secured to a mandrel.
Dr. Jorgenson testified that at the relevant time, (1) the published prior art references made all elements of claim 32 obvious, and (2) even in the absence of such references;
[T]he combination is obvious. Every one of the individual ideas is obvious. And the combination is absolutely obvious. Everybody in all of the related fields in all of the related technologies is doing those kinds of things. . . . The entire package taken together is obvious.
(Tr. 13 at 41.)
We have considered the unrebutted opinion testimony of Dr. Jorgenson on obviousness and all of the evidence on this issue presented by both parties at trial. We find that defendant has presented clear and convincing evidence establishing that claim 32 of the `172 patent was obvious to one of ordinary skill in the art as of the benchmark date of November 14, 1987. The jury verdict to the contrary is not sustained by the evidence.
4. Any Objective Evidence of Nonobviousness
The consideration of objective evidence of nonobviousness, such as commercial success and long-felt need, is "a necessary part of the obviousness determination." WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999); see also In re Rouffet, 149 F.3d 1350, 1355 (Fed. Cir. 1998). Such evidence may also rebut a prima facie case of obviousness. Id. Commercial success of a patented invention is relevant to obviousness, but only if the success of a product is related to the merits of the patented claim. Sibia, 225 F.3d at 1358-59 (attempted reliance on commercial success failed when there was no evidence of a nexus between the alleged success and the claimed invention); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996).
There is no objective evidence of nonobviousness in the trial record. It was undisputed that the accused Beckman P/ACE devices were the first commercial instruments capable of performing capillary zone electrophoresis, and that gross sales have exceeded $50 million. However, even assuming arguendo that the P/ACE device infringes claim 32 of the `172 patent, plaintiff made no showing that its commercial success was attributable to the features of claim 32 rather than the myriad other factors that could account for that success.
Claim 32, for example, does not address temperature control, removable capillary cartridge, sample injection, automation motors, or computer hardware and software for inputting, collecting and analyzing data. All of these features are among the attributes of the Beckman product. (See Section IXinfra.) Also, the P/ACE devices are equipped to perform several varieties of electrophoresis, not limited to capillary zone electrophoresis, including isotachophoresis and isoelectric focusing. (See Section VII.B.1.a supra.) Finally, it is undisputed that plaintiff itself solely controls the rights to the `172 patent, and it has never marketed or sold one single device. For these reasons, we find that plaintiff has presented no objective evidence tending to rebut defendant's showing that claim 32 was obvious.
An independent invention of the patented claim that is contemporaneous with the patentee's invention also constitutes some objective evidence of obviousness. See Monarch Knitting Mach. Corp. v. Sulver Morat GMBH, 139 F.3d 877, 883 (Fed. Cir. 1998); Matsushita Elec. Indus. Co. v. Cinram Int'l, Inc., 299 F. Supp.2d 348, 363 (D. Del. 2004). Defendant has shown that its product development effort produced a working prototype within the same 12-month period that plaintiff claims to have made its invention. (See nn. 26 56 supra and accompanying text.) Plaintiff does not contend that defendant had any knowledge of Dr. Guzman or his work at that time. (Tr. 10 at 132.)
5. Review of Jury Verdict on Obviousness
The jury found that defendant had not proven by clear and convincing evidence that claim 32 was obvious. (See n. 13supra.) The jury instructions on this issue were consistent with the law as set forth in this opinion. (See Tr. 2 at 72; Tr. 15 at 24-44.) All factual issues pertinent to obviousness were submitted to the jury, subject to the parties' Rule 50 motions upon which this Court reserved decision.
In order to reach the verdict rendered, the jury would have had to make underlying factual findings that the prior art reference in evidence were not analogous, or that those references did not supply the required suggestion or motivation to make all elements of claim 32. The jury would also have had to reject Dr. Jorgenson's unrebutted expert testimony that even without those publicly-available references, all elements of claim 32 were obvious to those of ordinary skill in the art.
The jury could also have reached its verdict by incorrectly holding defendant to a burden of proving anticipation rather than obviousness, i.e., by requiring that one single prior art reference should contain all of the elements of claim 32. (See 35 U.S.C. § 102(a); Tr. 13 at 58-59.) This would be a failure to adhere to the jury instructions, and at a minimum require a new trial.
This Court now concludes under Rule 50, viewing the trial evidence as a whole in the light most favorable to the plaintiff, that no reasonable fact-finder could make factual findings supporting the verdict in favor of plaintiff on the issue of obviousness. We therefore hold as a matter of law that claim 32 of the `172 patent is invalid as obvious, pursuant to Section 103. In the alternative, we will exercise the discretion of the Court and grant defendant's motion for new trial under Rule 59(a), holding that this verdict is so contrary to the great weight of the evidence that to allow it to stand would result in a miscarriage of justice.
VIII. Defendant's Claim of Prior Invention
A. Legal Principles
Defendant also asserts that claim 32 of the `172 patent is invalid on grounds of prior invention by Beckman. 35 U.S.C. § 102(g). Section 102(g) provides that a person is not entitled to a patent if "before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it."
An inventor can establish that she was the first to invent under § 102(g) by demonstrating either that she was the first to reduce the invention to practice or that she was the first to conceive of the invention and then, prior to the other party's conception, exercised reasonable diligence in reducing the invention to practice.Union Carbide Chems. Plastics Tech. Corp. v. Shell Oil Co., 308 F.3d 1167, 1189 (Fed. Cir. 2002). The issue of prior invention at trial focused upon who first reduced to practice a device containing each element of claim 32: plaintiff or defendant. "To prove actual reduction to practice, an inventor must establish that he actually prepared the composition and knew it would work." Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 592 (Fed. Cir. 1997) (quotations and citations omitted).
Plaintiff has preserved for appeal its argument that the prior invention inquiry in this case should focus on conception, rather than reduction to practice. This Court determined that the latter standard applies here, and so instructed the jury. (See Tr. 15 at 43-44; Tr. 16 at 6-16, 43-44; Pl. Br. at 22, n. 20.)
When the inventor seeking to establish his or her own prior invention is also a party to the litigation, that inventor's own testimony, alone, is insufficient to establish actual reduction to practice. Rather, such interested testimony must be accompanied by evidence corroborating its veracity. Sandt Tech., Ltd. v. Resco Metal Plastics Corp., 264 F.3d 1344, 1350 (Fed. Cir. 2001) ("It is well-established in our case law that a party claiming his own prior inventorship must proffer evidence corroborating his testimony."). "This rule addresses the concern that a party claiming inventorship might be tempted to describe his actions in an unjustifiably self-serving manner in order to obtain a patent or to maintain an existing patent." Id. (quoting Singh v. Brake, 222 F.3d 1362, 1367 (Fed. Cir. 2000)); see also Kridl v. McCormick, 105 F.3d 1446, 1450 (Fed. Cir. 1997) ("The tribunal must also bear in mind the purpose of corroboration, which is to prevent fraud, by providing independent confirmation of the inventor's testimony."). Only evidence "independent of information received from the inventor" can legally corroborate an inventor's invention date. See, e.g., Hahn v. Wong, 892 F.2d 1028, 1032-33 (Fed. Cir. 1989).
A "rule of reason" test governs whether an inventor's testimony of prior inventorship has been sufficiently corroborated.Sandt, 264 F.3d at 1350. The court has the obligation under the rule of reason analysis to insure proper corroboration. See Finnigan Corp. v. Int'l Trade Comm'n, 180 F.3d 1354, 1369 n. 11 (Fed. Cir. 1999). In applying the rule of reason test, the court must examine all pertinent evidence in order to determine for itself whether the "inventor's story" is credible. "Each corroboration case must be decided on its own facts with a view to deciding whether the evidence as a whole is persuasive."Berges v. Gottstein, 618 F.2d 771, 776 (Fed. Cir. 1980).
Documentary or physical evidence that is made contemporaneously with the inventive process provides the most reliable source of corroboration. Sandt, 264 F.3d at 1350-51 (citing Woodland Trust v. Flowertree Nursery, Inc., 148 F.3d 1368, 1373 (Fed. Cir. 1998)). Such evidence guards against "the risk of litigation-inspired fabrication or exaggeration." Sandt, 264 F.3d at 1351.
Oral testimony of someone other than the inventor may also corroborate an inventor's testimony. Id. However, the Federal Circuit has cautioned that "post-invention oral testimony is more suspect, as there is more of a risk that the witness may have a litigation-inspired motive to corroborate the inventor's testimony, and that the testimony may be inaccurate." Id. (citing Woodland Trust, 148 F.3d at 1373). See also Sandt, 264 F.3d at 1351 (testimony from witnesses often reflects "their proneness to recollect things as the party calling them would have them recollect them") (citing Barbed Wire Patent Case, 143 U.S. 275, 284 (1892)).
The only issues at trial with regard to prior invention were the parties' respective dates of reduction to practice. The question of when a party reduced an invention to practice is a legal question. See, e.g., Sliptrack Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256, 1262 (Fed. Cir. 2002). That a jury has answered a legal question does not relieve the court "of the judicial duty to insure that the law is correctly applied."Senmed, Inc. v. Richard-Allan Med. Indus., 888 F.2d 815, 818 (Fed. Cir. 1989), disapproved of on other grounds by Cardinal Chem. Co. v. Morton Int'l, Inc., 508 U.S. 83 (1993); see also Newell Co., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 761-66 (Fed. Cir. 1988). Accordingly, a court will grant judgment as a matter of law to defendant on the issue of prior invention if (1) defendant has established that it reduced to practice before plaintiff did, "by evidence that the jury would not be at liberty to disbelieve"; and (2) "the only reasonable conclusion is in [defendant's] favor." Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1065 (Fed. Cir. 1998) (stating standard for judgment as a matter of law with respect to invalidity generally).
B. Review of the Evidence
Defendant selects the date of February 1, 1987 as the completion date of its claim 32 invention, for purposes of this post-trial motion. (Def. Pl Br. at 7.) Plaintiff does not dispute that date. (See Pl. Br. at 22, 27.)
Plaintiff asserts, and defendant denies, that the accused P/ACE device contains all eight elements of claim 32. For purposes of this section dealing with the prior invention counterclaim, we will assume arguendo that plaintiff can establish infringement. The issue of infringement is addressedinfra, Section IX.
The dispute concerns the date of plaintiff's reduction to practice. Plaintiff asserts that Dr. Guzman had a fully functioning capillary electrophoresis device, containing all elements of claim 32, no later than April of 1986. (Pl. Br. at 23.) Defendant contends that plaintiff's evidence is legally insufficient to create a material issue of fact as to whether claim 32 was reduced to practice by Dr. Guzman before February 1, 1987.
Defendant presented uncontroverted evidence to establish its own date of invention as of February 1, 1987. We have summarized that evidence in the preceding section, describing the chronology of the P/ACE development process. (See Section VII.B.1supra.)
The parties each offered evidence concerning Dr. Guzman's invention date. Defendant presented evidence drawn from the `172 patent file history and from the testimony of several witnesses including the inventor, Dr. Guzman, in support of its contention that Dr. Guzman could not show a date of invention earlier than February 1, 1987. Plaintiff presented the trial testimony of Dr. Guzman, along with physical and documentary evidence, to support his asserted earlier invention date. Plaintiff also presented a corroboration witness named Dr. Bjorn Olsen, who was a former colleague of Dr. Guzman.
1. Defendant's Evidence on its Prior Invention
Defendant established its invention date to be no later than February 1, 1987, as noted above. The balance of the evidence of both parties on prior inventorship was devoted to the question of Dr. Guzman's invention date for claim 32. Defendant presented the following evidence relevant to its contention that Dr. Guzman could not establish a date of reduction to practice earlier than February 1, 1987.
Dr. Guzman signed the inventorship declaration for the original `172 patent application on November 17, 1987. (D-2 at 62.) It included the inventor's acknowledgment of the duty to disclose material information. (Id.) Mr. Jester testified that when an apparatus is the subject of a patent application, the duty to disclose material information encompasses the duty to disclose the best mode to build the apparatus, including all features and advantages known to the inventor at the time the patent application was filed. (Tr. 12 at 61-63.) He stated that the penalty for violating the best mode requirement would generally be to render the patent invalid. (Id. at 64.) Dr. Guzman acknowledged at trial that same sanction for failure to disclose the best mode. (Tr. 3 at 50-51.)
The original application for the `172 patent was filed on November 25, 1987, more than nine months after February 1, 1987. That application contained no claim language, specifications, or drawings disclosing a coiled capillary secured to a support member (elements 7 and 8 of claim 32 as issued). Those features were wholly absent from the prosecution of the original application for the `172 patent. (D-2; Tr. 12 at 77-91.)
An overview drawing of the capillary electrophoresis device claimed in the original application was depicted in Figure 1 of that application, and remains Figure 1 of the `172 patent as issued. That drawing is as follows:
(D-2 at 52; P-1, Sheet 1.)
The CIP application was filed on November 14, 1988, more than 21 months after February 1, 1987. (D-3 at 4; Tr. 12 at 92.) There, for the first time in the patent prosecution, elements 7 and 8 were disclosed to the Patent Office. Element 7 was disclosed in added claim 39, and element 8 was disclosed in added claim 40. (D-3 at 60; Tr. 12 at 97-99.) Figures 16 and 17, each depicting elements 7 and 8, made their first appearance in the CIP application. (D-3 at 125; Tr. 12 at 95-97.) Those Figures were accompanied by the new specification language quoted in the margin, referring to a coiled capillary contained in a cassette/cartridge assembly.
The pertinent specification language corresponding to Figures 16 and 17 in the CIP application, which is repeated verbatim in the `172 patent specification, states:
The apparatus of the invention may also use a modified capillary which, as shown in Fig. 16, comprises a capillary cartridge 711. The cartridge includes a capillary cassette which comprises a coiled capillary tube 713 embedded in a body of metal, glass, plastic or the like. In coiled form, the capillary tube may be of any suitable length and it may contain various chemistries. The capillary cassette is held in a housing 721 made up of two plates of metal, glass, plastic or the like coupled by screws or the like. A temperature control fluid, which can be heated or cooled, can be circulated through the housing by way of inlet and outlet tubes 723 and 725. It is noted that the capillary cassette can be easily removed from the housing 721 and replaced by another cassette of different size or other characteristics.
The utility of the capillary assembly 711 as a readily replaceable cartridge which can provide capillaries of different lengths and chemistries will be clear to those skilled in the art. A mounting arrangement for the capillary assembly or cartridge 711 is illustrated in Fig. 17.
(D-3 at 31; P-1, col. 11, ll. 36-56.)
An overview drawing of the modified capillary electrophoresis device corresponding to the coiled capillary specification in the CIP application is Figure 17 in both the CIP application and the `172 patent. That drawing is as follows:
(D-3 at 125, Fig. 17; P-1, Sheet 11, Fig. 17.)
A closeup drawing of the capillary cartridge corresponding to the coiled capillary specification in the CIP application is Figure 16 in both the CIP application and the `172 patent. That drawing is as follows:
(D-3 at 125, Fig. 16; P-1, Sheet 11, Fig. 16.)
Dr. Guzman acknowledged at trial that CIP claims 39 and 40 disclosed an improved mode for accommodating capillary length, which was unquestionably superior to the two modes for that same purpose disclosed in the original patent application. (Tr. 10 at 145-48, 156-60.) It was thus undisputed that this better mode was not disclosed to the Patent Office on November 25, 1987, when the original application was filed, or at any time during the succeeding year until the CIP application was filed on November 14, 1988.
See Section VIII. C.4 infra.
Defendant at trial presented deposition testimony of Dr. Guzman in support of its contention regarding Dr. Guzman's date of inventorship of claim 32, as follows. Dr. Guzman testified at deposition that he first coiled a capillary in approximately September, 1986, but did not initially place the coiled capillary into a cassette. He stated at deposition that he first made a prototype equipped with a cartridge cassette in December, 1986. However, during discovery there were only two prototype electrophoresis devices produced by plaintiff: (1) an orange and black plastic device, and (2) a stainless steel device. Dr. Guzman testified at deposition that he made that orange and black plastic prototype around the middle of 1987, and he made that stainless steel prototype in late 1987 and into 1988. He further testified at deposition that the first time be ever showed anyone a prototype device that had a cartridge cassette was when he showed that stainless steel prototype to a Merck representative named Dr. Majors in late 1987 or early 1988.
Deposition testimony of an officer of a party is admissible as evidence at trial when offered by the adverse party. See Fed.R.Civ.P. 32(a)(2). Defendant displayed videotaped deposition excerpts of Dr. Guzman at trial, pursuant to this rule. (Tr. 14 at 6-8; Tr. 16 at 45.) Those deposition excerpts were also filed in printed form in Defendant's Submission of Citations to Deposition Videoclips Presented During Trial. (Docket entry 171.) Plaintiff's counsel incorrectly suggested that such evidence is "hearsay" during closing arguments, and the Court was obliged to provide the jury with a corrective instruction. (Tr. 15 at 122, 124.)
Deposition text:
Q [W]e were talking about your coiled capillary . . . when you first coiled it, . . . was it always inside a cartridge?
A The intent — yes, without a cartridge cassette. No, was without.
Q When did you first coil the capillary?
A It could have been sometime in maybe September of 1986.
(Guzman 3-26-97 dep. at 134.)
Deposition text:
Q When do you recall placing the coil inside a cassette?
A In December of `86.
Q December of `86?
A Yes.
Q How do you recall first putting the coil in the cassette in December of `86?
A With electropherograms like I showed to you, it was done sometime during the Christmastime of 1986.
(Guzman 3-26-97 dep. at 134.)
Those two prototypes, produced by plaintiff during pretrial discovery, were marked for identification at trial as follows. The orange and black prototype produced in discovery was marked P-20A at trial. The stainless steel prototype produced in discovery was marked P-20 at trial. This Court made evidentiary rulings and provided jury instructions pertaining to those two exhibits in the course of the trial, as described infra.
Deposition text:
Q When did you construct the actual prototype that's plastic in the library [of the law firm]?
A It could have been . . . in the middle of `87, 1987, that is correct.
(Guzman 3-27-97 dep. at 263.)
Deposition text:
Q When did you make the stainless steel prototype?
A That was make — started probably late in `87, part of `88. That was one of the prototype that was show[n] to Dr. Ronald Majors.
(Guzman 3-27-97 dep. at 261.)
Deposition text:
Q Do you recall meeting Mr. Weinberger [of an unidentified corporation] in the spring of 1987?
A Yes. I think so.
Q Do you recall showing Mr. Weinberger your prototype?
A There was an early prototype at the time, but not with the cartridge cassette. It was one of the very elementary prototype.
Q When did you first make a prototype with the cartridge cassette?
A In December of 1986.
Q But you didn't show that prototype —
A No.
Q — to Mr. Weinberger?
A Not to him or to anybody in that corporation.
Q When did you first show somebody a prototype with a cartridge cassette?
A Was probably late `87, early `88.
Q And to whom did you show it?
A Dr. Ronald Majors from I think E.M. Science, the people from Merck at Germany.
(Guzman 3-27-97 dep. at 215-16; see also text quoted supra, n. 68.)
2. Plaintiff's Evidence on its Prior Inventorship
Plaintiff presented evidence at trial in support of its contentions on the issue of the timing of Dr. Guzman's invention. That evidence, including direct and cross-examination of witnesses and voir dire on various exhibits, occupies a substantial portion of the trial transcripts. We have organized this subsection in three parts: first, a summary of Dr. Guzman's narrative of events; second, a description of the corroborative exhibits presented through Dr. Guzman's trial testimony; and third, a summary of the testimony of plaintiff's corroboration witness, Dr. Olsen.
a. Dr. Guzman's Narrative of Events
The undisputed benchmark dates in the history of Dr. Guzman, in relation to the chronology of the claim 32 invention, are as follows:
1975 He received M.S. degree at Medical College of Georgia; then moved to New Jersey and enrolled in Ph.D. program at Rutgers. (Tr. 3 at 13-15.)
1985 He formed the plaintiff corporation, Princeton Biochemicals, Inc. (Id. at 26.)
May, 1986 His thesis was approved and he was awarded the Ph.D. (P-11; P-12.)
July, 1987 He commenced working for Hoffman-LaRoche ("Hoffman"). (Tr. 3 at 20-21; Tr. 8 at 32; Tr. 10 at 143.)
11-17-87 He signed inventorship declaration for original `172 patent application. (D-2 at 62.)
11-25-87 Filing date of original `172 application. (Id. at 3; P-1.)
11-14-88 Filing date of CIP application. (D-3 at 4; P-1.)
Dr. Guzman's trial testimony describing the process and timing of the claim 32 invention may be summarized as follows. Some of plaintiff's physical and documentary corroborative evidence is referred to in this part, and all of that category of evidence is described in detail in the following part.
In this subsection we merely summarize the trial testimony of Dr. Guzman on the issue of prior inventorship. Defendant disputes the truth of the key facts in this testimony. We address that issue in the conclusion subsection, infra.
Guzman's thesis concerned a type of enzyme used in collagen, comparing it in chick embryo and human placenta. He was interested in differentiating those two enzymes. (Tr. 3 at 13-18; P-11.) In the course of his thesis work, he used separation techniques including HPLC, slab gel electrophoresis, and capillary electrophoresis. (Tr. 8 at 20-21; Tr. 10 at 134-138; Tr. 11 at 12-13, 16; Tr. 13 at 32-36; P-11 at 67, 108, 172-174.)
He started his invention efforts that eventually led to the `172 patent in approximately 1980, while enrolled in the Ph.D. program. (Tr. 8 at 15-16.) He described his invention process in general as follows:
The first part of my time was a very frustrating time. It was a trial and error and 1 develop improvement from the very simple element to offer this particular capillary electrophoresis system all the way to improve. So I make sketches. I did significant amount of prototypes. And then finally I tested. I ran samples so I knew that the final proto was a functional operationable machine and for use in electropherogram.
(Id. at 15.)
He founded the plaintiff corporation in 1985, while still enrolled in the Ph.D. program. (Tr. 3 at 26, 48.) He then worked for his corporation "full time basically," from 1985 until he started at Hoffman in July, 1987. (Id.; Tr. 10 at 143.) "So I worked in PBI during those years. . . . [I]t was a full-time job for me to develop the variety of different prototypes to improve the technology to see the best separation that I could." (Tr. 3 at 27.)
His prototype devices began as a simple arrangement of a straight capillary between two beakers. (Tr. 8 at 115-17.) Gradually he added and modified components, creating successive prototypes based on preceding models. (Id. at 85-87, 115-17.) He would re-use components from earlier models wherever possible, to save money. (Id. at 124-26, 145-46; Tr. 10 at 153-55.)
One of the problems he encountered in his design efforts was how to accommodate varying lengths of capillary. He wanted a prototype that was compact and could fit into luggage for travel. (Tr. 8 at 115-16, 140; Tr. 10 at 153-55.) His first two approaches to that problem were a bellows/accordion type arrangement, and a modular arrangement similar to table leaves. (Tr. 10 at 145, 155-60; P-1, Figs. 1, 15.) Eventually he thought of the idea of coiling the capillary and securing it to a support member. (Tr. 8 at 14-15, 89-91, 142-43; Tr. 10 at 9-11, 145.) That was a better mode for accommodating capillary length than his earlier methods. (Tr. 10 at 145-48, 156-60.)
There were six members on Guzman's thesis committee at Rutgers. The committee was chaired by Dr. Darwin Prockop, the department head. (Tr. 3 at 18-19.) Another committee member was Dr. Olsen. (Id.) By April of 1985, Guzman had been in the Ph.D. program for almost ten years but had not finished his thesis. (Tr. 8 at 20.) The committee sent him a letter dated April 30, 1985, advising that if he did not finish it within the next two months his Ph.D. degree would be in jeopardy. (P-10.) The committee later extended the thesis deadline to April 30, 1986. (Tr. 8 at 113-115.)
As the deadline for his thesis approached, Guzman wanted to include in his thesis an electropherogram that he had made in his capillary electrophoresis experiments. (Id. at 20-21, 149-53; Tr. 10 at 141-43.) He would need the approval of the committee for this, and Dr. Olsen agreed to meet with him. (Id. at 153.) Dr. Olsen knew nothing about capillary electrophoresis. (Id. at 92.)
That meeting took place at the dining room table in the home of Dr. Olsen on April 22, 1986 ("Olsen meeting"). (Id. at 17-19, 25-28, 80-82.) Dr. Guzman brought to the Olsen meeting some instrumentation and an electropherogram. (Id. at 82, 85, 117-19, 140-43, 149-53; Tr. 10 at 23, 177.) The instrumentation consisted of a plastic prototype capillary electrophoresis device, and a separate plastic cassette for a capillary to be coiled into grooves in the cassette. (Tr. 8 at 140-43, 146-49; Tr. 10 at 9-11.)
The prototype that Guzman took to the Olsen meeting was not complete. It was missing several necessary components and was not operational at that meeting. (Tr. 8 at 25-27, 89-93, 142-43.) The instrumentation that he brought to the Olsen meeting, although incomplete, did contain all of the elements of claim 32. (Tr. 8 at 142-43; Tr. 10 at 9-11.) During that meeting, Dr. Guzman also drew sketches and used them in his explanation to Dr. Olsen. (P-6; P-8; see, e.g., Tr. 8 at 17-22, 80-84, 92.) Dr. Guzman had used that some prototype, fully assembled and operational, to make the electropherogram that he brought to the Olsen meeting. (Id. at 148-53.) That electropherogram was then incorporated into his thesis. (Id. at 153.)
The thesis was approved in May, 1986. (Tr. 3 at 15-16; P-11.) He received his Ph.D. as of May 22, 1986. (P-12.) The thesis contains a capillary electrophoresis electropherogram, with some descriptive text. (P-11 at 67, 85, 108-09, 172-73.) It makes no reference to a coiled capillary apparatus. (Tr. 8 at 156; Tr. 10 at 134-38.)
When Dr. Guzman had formed the plaintiff corporation in 1985, the attorney who handled the incorporation suggested that he consult with the law firm that eventually became his patent counsel. (Tr. 3 at 48-49.) The attorneys named in the original `172 application were Messrs. Wilson and Green, and attorney Green prosecuted the patent to its approval. (D-2 at 4; D-3 at 4, 136.) Dr. Guzman signed the retainer agreement with Mr. Green's firm in March, 1987. (Tr. 10 at 132.) However, he consulted with Mr. Green initially in 1985 and several times in 1986. (Id. at 132-34.) He kept all reference to a coiled capillary device out of his May, 1986, thesis based on free advice from that attorney. (Tr. 8 at 156-57; Tr. 10 at 132-38.)
The next step in his inventorship took place as soon as he obtained his Ph.D. in May, 1986. He commenced developing the first of four metallic prototype devices. (Tr. 8 at 165, 168-70, 180.) Before making any metallic prototypes, he had created approximately 31 plastic prototype devices. (Tr. 8 at 119-26.) The version he displayed at the Olsen meeting was approximately version 28 or 29 of those approximately 31 plastic prototypes. (Id. at 123-24.) Later, in approximately 1989, after making several of his metallic prototypes, he made one more plastic prototype and sent it to a professor in Argentina in 2000. (Tr. 8 at 174-77; Tr. 10 at 60-61.) He was constantly evolving capillary electrophoresis devices from 1980 through at least 1989. (Tr. 3 at 15; Tr. 8 at 145-46; Tr. 10 at 54-63.)
As he commenced developing his first metallic prototype in May, 1986, he also started to develop a cartridge housing to surround the coiled capillary cassette. Within the cartridge housing, fluid could be circulated around the coiled capillary for temperature control. (Tr. 8 at 159-61.) He had a working metallic prototype, equipped with such a cartridge and all the other elements of claim 32, as of December, 1986. (Id. at 165-74, 180-87.) He knew it worked because he made electropherogram on it. (Id. at 181.) One of those electropherogram is an original document bearing his handwritten notations including the date of December 27, 1986. (Id. at 191-93; P-13.) A photocopy of that same document differs from the original. (Id. at 201-02; Tr. 10 at 28-40, 167-68; P-14.) He made electropherograms using every one of the prototypes that he completed. (Tr. 10 at 15-16.)
Dr. Guzman described development of the capillary cartridge cassette as follows:
Q [Did] you design any other capillaries or cartridges, or cartridge cassettes, in 1986?
A Yes, I was doing several cartridge cassettes.
Q Describe the next iteration of cassette [after the P-17 cassette].
A The next concept was not only to be able to coil the capillary, those grooves that I show, but also be able to cool the system, with some kind of a cooling device. In fact the first time I did this device, was in my home, so I used to use hot water, and cold water and a combination of those to maintain a certain temperature with a simple hose. So I developed a few prototypes for my so-called cassette cartridge device.
Q This is a cartridge cassette you're now describing? [Yes.]
Q What was the the cartridge made out of?
A It was also plastic, it was a heavy plastic, but . . . it required more sophistication so I went to some professional company to do that.
Q Are you describing the cartridge now, or the cassette? My question I think was directed to the cassette.
A Well the cassette was a simple issue, I have many cassette done prior to my thesis. What I didn't have then was the cartridge, which is another sandwich after the cassette.
Q And so the cartridge was used to hold the cassette? [Yes.]
Q And in turn the cartridge was used to hold the capillary? [Yes.]
(Tr. 8 at 158-59.)
The differences between the various original documents and corresponding photocopies produced by plaintiff are addressed in the next subsection, infra.
Guzman's employment at Hoffman commenced in July, 1987. (Id. at 143.) When Hoffman became aware that he was working with attorneys to file patent applications, it demanded documentation that he had made his inventions prior to July, 1987. (Tr. 8 at 31-33.) In response to that demand, he provided Hoffman with documentation that included two original handwritten pencil sketches dated April 22, 1986. (Id. at 31-33, 80-82, 99-107.) One of those sketches is a schematic of a capillary electrophoresis device including a "cartridge cassette coiled capillary" with an inlet and outlet for liquid to be circulated from a "liquid cooler-heater unit." (P-8.) He made photocopies of those two sketches in approximately late 1988, before he delivered the originals to Hoffman. (Tr. 8 at 33, 37, 99.) He received the originals back from Hoffman in 1991. (Id. at 37-39; Tr. 10 at 143-44.) There are differences between those originals and the photocopies. (See discussion infra.)
When he retained his patent counsel in March, 1987, he provided the attorney with full information about his claim 32 invention, including the coiled and secured capillary. (Tr. 10 at 132-34, 145-48.) The information he provided his attorney included six prototypes with cartridges and cassettes. (Id. at 145-48.) However, the original application for the `172 patent, filed in November, 1987, contained no disclosure of a coiled capillary secured to a support member. He was aware that the original patent application contained no such disclosure when he signed the inventorship declaration on November 17, 1987. (Id.)
b. Plaintiff's Corroboration Exhibits
This subsection will summarize in detail the trial testimony of Dr. Guzman directed to plaintiff's corroboration exhibits. We have grouped those exhibits, for purposes of this narrative, into the following three categories based upon his trial testimony: (1) "the May, 1986, materials," (2) "the December, 1986, materials," and (3) other corroboration materials.
The following summary, which describes Dr. Guzman's trial testimony addressing the corroboration exhibits for his claimed date of invention, cites both his direct and cross-examination on those points.
i. "The May, 1986, materials"
Plaintiff offered the following physical and documentary exhibits in support of Dr. Guzman's trial testimony concerning the status of his invention efforts as of May, 1986:
• An orange and black plastic capillary electrophoresis chassis containing certain components. (P-20A.)
• A plastic coiled capillary cassette. (P-17.)
• Dr. Guzman's thesis dated May, 1986. (P-11.)
• The original of a handwritten pencil sketch dated April 22, 1986, showing various components including a coiled capillary, with related photocopy. (P-8; P-9.)
• The original of another handwritten pencil sketch dated April 22, 1986, showing various components, with related photocopy. (P-6; P-7.)
Each of those materials was admitted into evidence at trial, with the exception of P-20A. Exhibit P-20A was the subject of extensive trial testimony, both on voir dire and during the direct and cross-examination of Dr. Guzman. However, the physical exhibit itself ultimately was not admitted into evidence, and the jury was instructed accordingly as described below. We will now describe Dr. Guzman's trial testimony about each of the exhibits in this group.
Exhibit P-20A
Plaintiff produced one plastic prototype capillary electrophoresis device in this case. That same plastic prototype was produced during discovery and at trial. (Tr. 8 at 175.) It bore exhibit number P-20A for identification at trial. (Id. at 117.)
The physical exhibit displayed at trial consisted of a plastic chassis in several modules, constructed out of plastic in a black and orange color scheme. (Id. at 140-42; Tr. 10 at 156-57.) As presented at trial, the P-20A chassis did not include certain components including the following:
• a capillary
• a complete holder for holding an end of a capillary
• a coiled capillary
• a support member for a coiled capillary
• a detector.
(Tr. 8 at 123-126.)
The color scheme of black and orange for P-20A was chosen by Dr. Guzman as a reference to the school colors of Princeton University, because he had named his company Princeton Biochemicals. He called his black and orange prototype "the Princeton Tiger." (Tr. 8 at 140-42; see also Tr. 10 at 41-43.) The trial transcript refers to exhibit P-20A alternately by that nickname. (See, e.g. Tr. 8 at 148, 174.)
He testified that as he made each successive prototype, he would typically transfer components to the next generation prototype, to reduce expense. (Id. at 124-26, 143-46; Tr. 10 at 155.) At the conclusion of voir dire on the admissibility of P-20A at trial, this Court sustained defendant's objection to admitting it into evidence in its current condition. (Tr. 8 at 139-40.) However, we instructed the jury that it could consider Dr. Guzman's testimony concerning P-20A as the device had existed in the past. (Id. at 142-43.)
Dr. Guzman's deposition testimony on the question of when he made P-20A is quoted supra, n. 67. His trial testimony regarding P-20A may be summarized as follows.
Exhibit P-20A was one of the more advanced versions of the various prototypes that he made, beginning from a very simple concept with two beakers in 1982. (Tr. 8 at 117-18.) His process of making P-20A was as follows:
Q How did you make the prototype of 20A?
A By buying components and going to different show machines and doing the sketches and — putting together with the help of different plastic people, or electronic people.
(Id. at 119.)
His inventive steps evolved as he built a series of prototype capillary electrophoresis devices during the period 1982 through at least 1989. (Id. at 117, 145-46; Tr. 10 at 24-27, 61-63.) He made approximately 31 plastic prototypes and four metallic prototypes during that period. (Tr. 8 at 119-20.) Exhibit P-20A represented approximately number 28 or 29 in the evolution of the 31 plastic prototypes. All but one of the plastic prototypes, including P-20A, were made before he made his four metallic prototypes. (Id. at 174-80; Tr. 10 at 11-13.) However, as of 1989 he was still refining his various prototypes, including P-20A and the later metallic versions, to add automation. (Id. at 24-26, 61-63, 161-62.)
Trial text:
Q What version are we looking at, one or 31? Pretend we're at Baskin and Robbins, and we've got 31 flavors, and they're numbered one to 31. Which version do we have here, in P-20A?
A I don't know. It could have been 28, 29, but one of the very latest versions.
(Tr. 8 at 124.)
Dr. Guzman produced three partial capillary electrophoresis prototypes in this case. None was complete and operational during this litigation. Two were produced in discovery: trial exhibits P-20A (plastic) and P-20 (metallic). During the trial this Court conducted a Rule 104 hearing out of the presence of the jury, and Dr. Guzman revealed that he had another metallic prototype at home in his attic that had not been produced. (Tr. 5 at 16-17.) This Court directed plaintiff to produce that prototype, and it was admitted into evidence as P-133, discussed infra.
Dr. Guzman showed the P-20A plastic prototype to Dr. Olsen during the Olsen meeting on April 22, 1986. (Tr. 8 at 117-19, 122-24, 140-43; Tr. 10 at 24-25.) At that meeting, the P-20A plastic prototype possessed all the elements of claim 32, including a coiled capillary secured to a support member. (Tr. 8 at 124-26, 142-43; Tr. 10 at 9-11, 163.) That prototype was not operational at the Olsen meeting because it lacked several necessary components. (Tr. 8 at 25-27, 89-93, 142-43.) However, Dr. Guzman had operated the P-20A plastic prototype to produce the electropherogram that he showed Dr. Olsen at that meeting. (Id. at 148-53; Tr. 10 at 23-24.)
Exhibit P-17
Trial exhibit P-17 is a physical object consisting of two flat pieces of clear plastic held together by four screws. One of the two plastic pieces has grooves cut into its internal surface in a coil-like pattern. There are broken pieces of capillary inside the grooves, held in place by patches of tape. (Tr. 8 at 146-47.) It appears as follows:
(Photo of P-17.)
Here we summarize Dr. Guzman's trial testimony on exhibit P-17.
He calls this assembly a cassette ("cassette"). See n. 84infra. The grooves inside the cassette are there "to guide the capillary to go around." (Tr. 8 at 147.) He made P-17 as follows:
[T]his is a very simple thing to do. You go to a place, they cut it . . . and . . . you can do [these] grooves, and then . . . they put . . . the screws here.
(Id.)
Dr. Guzman showed P-17 to Dr. Olsen during the Olsen meeting on April 22, 1986. (Id. at 148.) The electropherogram that Dr. Guzman brought to the Olsen meeting had been made by him using the P-20A plastic prototype device, equipped with the P-17 coiled capillary cassette. That cassette had been attached to the P-20A device adjacent to the detector during operation of the device. (Id. at 122-23, 146-49.)
Exhibit P-11
Trial exhibit P-11 is Dr. Guzman's thesis, bearing the approval date "May, 1986." (P-11 at Bates no. 341.) Figure 19 of the thesis is a comparison of three electropherograms, shown as follows:
(Id. at 173.) The text accompanying Figure 19 states in its entirety:
FIGURE 19. High-resolution electrophoresis of purified prolyl 4-hydroxylase from chick embryo and human placenta. Capillary free zone electrophoresis was performed using native conditions as described in the text. Approximately 1 to 5 ul of protein was applied to the column. Optical density at 280 nm measured. A: Chick embryo prolyl 4-hydroxylase. B: Human placenta prolyl 4-hydroxylase.
C. Mixture of both enzymes.
(Id. at 172.) The thesis also states the following, in a section bearing the heading MATERIALS AND METHODS:
Capillary free zone electrophoresis (high performance or high resolution electrophoresis) was performed with a homemade system consisting of a capillary column, two buffer reservoirs, an in-column detector, and a power supply. Fused silica capillaries (I.D. 50 and 75u) were purchased from Scientific Glass Engineering, Austin, TX. The electrophoresis power supply (high voltage) was obtained from Spellman High Voltage Electronics Corp., Plainview, N.Y.
(Id. at 85.) The thesis also refers to capillary electrophoresis in another section, quoted in full in the margin.
The further text of the thesis on the subject of capillary electrophoresis states as follows:
Capillary Zone Electrophoresis of Prolyl 4-Hydroxylase
Buffer-filled open-tubular capillaries are an alternative to gels as a medium in which to conduct zone electrophoresis. Using fused silica capillaries with typical dimensions of 50 or 75 micron inside diameter and 50 to 100 cm length, it has been possible to apply potentials from 1,000 to as high as 30,000 volts to drive separations (Jorgenson and Lukacs, 1983; Green et al., 1985.) Such high voltages can be applied due to the efficient heat dissipation of small diameter capillaries. The advantages of very high voltages (and very low current) for driving electrophoresis are increased resolution and speed of analysis.
During the course of this thesis, capillary zone electrophoresis was used as an alternative method to compare charge differences between the avian and mammalian prolyl 4-hydroxylase. Fifty and 75 micron inside diameter and 60 cm length untreated fused silica capillaries were used. A variety of buffers were used during the performance of these experiments, but the one which gave the most consistent results was 0.050 M sodium borate, pH 8.2 at room temperature (Hjerten and Zhu, 1985). The detection system used was ultraviolet absorbance, usually 214 and 229 mm, on-column. For this purpose a UA-5 detector (ISCO, Lincoln, NE) was used, containing a Type-9 optical unit system with Hg and Zn lamps (214, 254, and 280 nm filters) or Type-6 optical unit system with Hg and Cd lamps (229, 254, and 280 nm filters). About 1-5 ug per 1-5 ul of protein sample was injected into the column by applying a short-term, high-voltage pulse. Routinely, 5,000 volts for about 4-7 see were used for the initial injection and then a potential gradient of about 300 volts per cm, 30 microamps, were kept during the rest of the experiment.
Several considerations were always kept in mind during the use of capillary zone electrophoresis as a powerful separation technique. Of major concern was the fact that proteins tend to adsorb onto the capillary wall, and in so doing, tend to migrate as broadened zones. Although it has been suggested (Green et al., 1985) that the phenomenon of adsorption of proteins to capillary walls can be minimized by a number of different capillary surface treatments, during the course of this thesis only one "blocking" substance was used. Commercially available untreated fused capillaries were treated with a solution of 0.2% (w/v) methylcellulose before use (Hjerten and Zhu, 1985). Methylcellulose suppresses electroendosmosis and minimizes adsorption of solutes, in general, on the capillary walls. Without the methylcellulose treatment of the capillaries (blocking of active groups), the resolution of the protein bands was not accomplished.
(P-11 at 108-11.)
Here we quote Dr. Guzman's trial testimony on direct examination concerning the relationship between his thesis, P-11, and the elements of the claim 32 invention:
Q What is it in the thesis that was derived from the use of PX-17 on the Princeton Tiger?
A That was the [result] of separation, which is called electropherograms, of the two different enzymes, one derived from chicken embryos, and one derived from human placenta.
Q So are you telling us that you performed a separation using the Princeton Tiger and the cassette of PX-17? [Yes.]
Q And you did that before May of 1986? [Yes.]
Q And we know that, because it's in the thesis right? [Yes.]
Q Explain exactly what it is in the thesis [P-11] that confirms the testimony you just offered.
A Well, is the electropherogram — I believe it's Page 173, and —
Q What is on Page 173, which would be of interest to these jurors?
A It's basically what I call electropherogram, that I —
THE COURT: Your question was would he please explain how the drawing there demonstrates that it was made using the Princeton Tiger which has loosely been referred to as such here — an apparatus made of plastic with some black and orange — which included this cassette, P-17, that he's holding.
A I made it to prove to my advisor Dr. Darwin Prokap that this particular piece of information in my thesis, was very important. He was a very conservative person and he rejected the fact that it was put in the thesis something he didn't understand So after a lot of discussion we settled that someone in the Committee has to see and understand the electropherograms, and be able to see if there was any instrument at all in which I make such a thing.
Well, this was the final product, and you can notice that there is [an] A . . . for one particular enzyme, which I presume was chicken embryos, then there is a B, that it was the next enzyme was human placenta hydroxylase and there are minor differences because they were very similar in physical chemical characteristic. But when you mix them, you notice that there are two species, without any question.
And this is what I used the other day that were this same — my thesis, because even though without this I could have still received my Ph.D. degree, was the most scientific evidence to prove when compared to all the tradition of — they — that I did in the past.
So final when Dr. Olsen noticed that this was an important issue, he convinced my boss that it should be in the thesis, and the final was accepted by the rest of the Committee.
Q What do the two peaks [in] panel C demonstrate?
A This [is] the combination of the two enzymes simultaneous, which mix and you add it into the system. If there was no separation it would be a single peak.
Q So the two peaks demonstrate that the Princeton Tiger [and] PX-17 had performed the intended separation?
A Absolutely, it was complete operational instrument.
Q Again directing your attention to the thesis, PX-11, does the thesis make any reference to a coiled capillary as represented by PX-17?
A No.
Q Why not?
A There was two explanation to that. First of all I mentioned to you that I never ever applied for a patent before, so even though that my final agreement with my attorney was in 1987, in 1985 when I filed the corporation, there was a lady Ms. Lydia Kuhn, who was the attorney that opened the corporation, and she mentioned to me that her husband Mr. Kuhn was another attorney, — for the firm of Mr. Wilson that eventually introduced me to Mr. Green, so when I did that for the first time in 1985, the attorney advised me that I have to be very careful to disclosure, anything that was in the invention, because I was —
THE COURT: To not disclose?
THE WITNESS: Not to disclose to the public what I was doing.
Q Go ahead.
A My invention and the reason is because I was planning to apply for a European patent, that eventually was issued, I have a European patent and this was called PCT, Patent Corporate Treaties. And the moment you disclosure this to the people you no longer have a patent in Europe.
Q What did you say? The moment you disclose what?
A Your invention to the public, you have no possibility of having a European patent. Was a different in the United States, I think from the moment you showed to someone your invention, you have one year to apply to the patent office. So that was basically the main reason of keeping most of this information away from the public.
Q You thought if you described the coiled capillary in your thesis, you would lose your opportunity to obtain a patent in Europe? [Yes.]
(Tr. 8 at 149-57.)
Q I think [defense counsel on cross examination] was asking you questions about whether or not there was any discussion in your thesis about the capillary cartridge. [Yes.]
Q And we've previously established that Page 173 was the electropherogram of your thesis? [Yes.]
Q And that electropherogram was produced on the Princeton Tiger, if I have it right?
A That is correct.
Q And in that configuration the Princeton Tiger had the coiled capillary?
A That is correct.
(Tr. 10 at 177.)
On cross examination regarding his thesis, Dr. Guzman again acknowledged that nothing in the thesis disclosed any capillary electrophoresis instrumentation featuring a coiled capillary:
Q Did you or did you not testify on your direct examination that you consulted with an attorney to keep information out of your thesis?
A That is correct. That was in `86.
Q So in `86 you were consulting an attorney?
A That is correct, I didn't pay, and we didn't have a signed agreement.
Q So you kept information outside of your thesis, based on free advice from an attorney?
A That is correct.
. . . .
Q Is there any reference here, whatsoever, to any of the components on the Princeton Tiger, which you tried to get admitted as P-20A?
A My attorney told me not to put the components that I'm going to patent, so no.
. . . .
Q This was a homemade device, wasn't it?
A This is all was homemade device.
Q Right, and that's what you referred to it as, right? [Yes.]
Q Didn't you also refer to it in your thesis as a homemade in-column device, didn't you?
A I don't know if I see that.
Q Does "in-column" suggest that it was not coiled?
A Not necessarily.
Q Is there anything in your thesis that explains how you got the data on Figure 19 that uses a coiled capillary?
A I explained every detail, how I did it, and all the conditions, and I said this is the best buffer that I used, I also used the — the sample, I injected into the column. The time that I injected, amount of voltage that I injected. The 30 microamps, there's a lot of detail here, what I did. I also —
Q In all those details, is there anything explaining a coiled capillary?
A I'm still looking for that. And — then —
Q Rather than keep talking, could you please find to me any reference where you believe your thesis indicates that there's a coiled capillary?
A I was — tell you — under the advice of an attorney I was told not to put the details in the thesis.
Q [So] you don't need to look; you know it's not in there?
A Right.
. . . .
Q The reference to Page 85 of the thesis. The first full paragraph on the left column, where it begins "capillary free zone electrophoresis." Did I correctly characterize your thesis here where it calls [it] a homemade system? [Yes.]
Q What device are you referring to when you say a homemade system?
A That's the only device that I have at the time, was the — the plastic device.
Q The Princeton Tiger? [Yes.]
Q When you say "capillary column" and when you say "in-column detector," you are purposely leaving out any mention of the coil, correct?
A That's correct, sir.
(Id. at 133-39.)
The subject of controlling capillary temperature also came up during Dr. Guzman's trial testimony regarding his thesis. He referred to the statement in his thesis concerning room temperature, quoted supra, n. 76. He testified that in performing his capillary electrophoresis separations for the thesis, he controlled the temperature of the capillary at room temperature by using water at 25 degrees centigrade, the equivalent of room temperature. That segment of his trial testimony is quoted here in the margin. Series of sketches, Exhibits P-6 through P-9
Dr. Guzman testified at trial that that he controlled capillary temperature in performing the capillary electrophoresis for his thesis in May, 1986. That testimony was as follows:
Q Is there anything else in this thesis in any way, suggests how you were able to obtain the data which formed Figure 19?
A Well there's a sentence. . . .
. . . .
A See it said [quoting P-11 at 108], "during the course of this thesis, capillary electrophoresis was used as an alternative method to compare charge differences between the avian and mammalian prolyl 4-hydroxylase." So the Thesis Committee, especially Dr. Olsen, saw the instrument, and under the next page, the only thing I'm telling you is some of the components that I used here for the instrumentation which is Page 109. So basically it said that several buffers were used but the one which gave the most consistent results was with 50 — buffer — 8.2, at room temperature. . . .
Q Room temperature, is that what you said? [Yes.]
Q So you didn't control the temperature of the capillary?
A Oh, no I was — it was with water. I was telling you I was cooling the whole thing and it was measured at 25 — centigrade. So that's what I called room temperature. . . .
(Tr. 10 at 135-36.)
Trial exhibit P-6 is a one-page sketch in pencil that has obviously been altered. Exhibit P-7 is a photocopy of P-6, but it differs from P-6 in certain respects. There is a second set of similar documents marked P-8 and P-9, consisting of another altered pencil sketch and its related but different photocopy.
Each of the four documents bears the date of April 22, 1986, but the handwriting of the dates has been altered in the originals. Also, the handwriting of the dates does not match when comparing the originals and the photocopies, and the P-6 original has an added notation not present on its photocopy, P-7.
Plaintiff produced copies of the originals, P-6 and P-8, in an early stage of discovery in this case. Defense counsel observed that there appeared to be obvious erasures and superimposed handwriting on the produced copies of the originals, and questioned Dr. Guzman about those alterations during a deposition. Thereafter, plaintiff produced the related photocopies, P-7 and P-9. This Court held a pretrial hearing on defendant's motion to exclude the whole series from evidence, resulting in the motion being withdrawn. (5-22-01 H'g Tr.; docket entries 108-13.) All four documents were admitted into evidence at trial, without objection.
Any authenticity issue regarding exhibits P-6 through P-9 was for the jury, pursuant to Federal Rules of Evidence 1003 and 1008. Defendant did not raise any other objections to admissibility of the series, and the Court agreed that they were admissible because they are alleged prior statements by Dr. Guzman. See Fed.R.Ev. 801(c)(1)(B) (prior consistent statements by a witness, offered to rebut an express or implied charge against the declarant of recent fabrication, are not hearsay).
Dr. Guzman's trial testimony concerning this series of documents may be summarized as follows.
When Dr. Guzman met with Dr. Olsen at the Olsen residence in April, 1986, Guzman made sketches and used them to explain certain concepts to him. (Tr. 8 at 17-19.) Dr. Guzman later went to work for Hoffman, in July, 1987. (Tr. 3 at 20-21.) At that time he was working with his patent counsel to file patent applications on his own behalf. Hoffman learned of his patenting activities, and in 1988 it demanded documentation to establish that the inventions he was seeking to patent had not been created during his employment at Hoffman. He had saved in his attic a few documents, including two sketches. He delivered the originals of those two sketches to Hoffman for its inspection in or about late 1988. Before conveying the originals to Hoffman, he made and retained a photocopy of each sketch. He received the two originals back from Hoffman in 1991. He put the originals back in his attic without noticing any changes. (Tr. 8 at 31-38, 99, 104-07.)
When he began working with plaintiff's litigation counsel to file this action, he gave that counsel the two originals, P-6 and P-8, copies of which were initially produced in discovery. (Id. at 35-36.) He does not recall when he gave plaintiff's counsel the two related photocopies, P-7 and P-9. (Id. at 69-73.) He himself made no alternations to the originals since they were created in April, 1986, nor did he alter the photocopies. (Id. at 79-80, 111-13.)
Looking at the originals, P-6 and P-8, he agrees that someone has written over the dates in pencil, and that the underlying original handwritten dates are not legible. (Id. at 44-45.) The overwritten portions of the originals, including the dates, are not in his handwriting. (Id. at 30, 97-99, 100-04.) There is also a notation on one of the originals, P-6, that is not in his handwriting. (Id. at 36.) [We will refer to both the overwritten and the added notations in the originals as "the added writing."] He does not know when or how the added writing was placed on the originals. He can only surmise that it was placed there by persons within Hoffman during the period from late 1988 until 1991, when the originals were in the possession of Hoffman. (Id. at 37-39, 97-99, 104-07.)
Looking at the photocopies, P-7 and P-9, he believes that those photocopies accurately depict what the originals looked like in late 1988, when he gave the originals to Hoffman for inspection. (Id. at 39, 99-100.)
He created those two sketches at the home of Dr. Olsen during the Olsen meeting on April 22, 1986. He used the sketches at that meeting to explain to Dr. Olsen certain concepts concerning capillary electrophoresis in general, and specifically his instrument. (Id. at 20-21, 27, 82-83, 85-89.) They are conceptual sketches only, and are not accurate drawings of the instrumentation that Dr. Guzman brought with him to the Olsen meeting. (Id. at 25-26, 126-34.)
There is a legend on the bottom of each document in this series that states: "Shown to Dr. Bjorn Olsen (Thesis Committee) April 1986." Leaving aside the fact that the "April 1986" date is overwritten in the originals (P-6 and P-8), it is apparent from observing P-6 and P-7 that the letter "n" in the word "shown" has been wedged into the line as an afterthought. Dr. Guzman was questioned on voir dire as to whether he wrote that legend on April 22, 1986, rather than on some other date, and he could not swear to that, stating only it was "possible." (Tr. 8 at 25-28.) But he asserted that the sketch portions of both documents, except for the added writing contents, were all placed by him on P-6 and P-8 during the Olsen meeting. (Id. at 17-19, 21-22, 82-84.)
P-6 is a sketch of three boxes with various features. The first box is marked "external high voltage power supply," the second is marked "recorder," and the third is marked "motor controller." The "recorder" box is shown printing out a document resembling an electropherogram. (P-6.) Those units were not on the prototype device that Dr. Guzman brought to the Olsen meeting, and he made this sketch to show Dr. Olsen "what are the elements that I needed to make this device functional and operational." (Id. at 25-26.)
P-8 is a sketch of a capillary electrophoresis chassis with various fcatures, reproduced here in its entirety:
(P-8.)
Dr. Guzman's testimony about what is depicted in P-8 changed between direct and voir dire examination, as follows:
Q [Describe P-8.]
A This is actually the drawing that I was making to Dr. Olsen to explain about what is what I invented, and how my electropherogram that eventually appeared in my thesis was made. So I tried to do as much as I could, once again, this is a sketch of what I call the capillary electrophoresis apparatus that I used at the time.
(Tr. 8 at 82 (direct testimony).)
Q Let's take a look at some of the dates here [P-8]. Is it your testimony that you had a device like this at the time of April 22d 1986?
A Yes. Plastic device, let's make a difference.
Q So it was plastic, but it looked like this? [Yes.]
Q And everything is in the right location?
A Everything is in the right location? You have to remember that what 1 brought to Dr. Olsen is not what is there, what I brought to Dr. Olsen is what I wanted to explain, how the whole mechanism of capillary electrophoresis worked.
Q And you used this to explain to Dr. Olsen how capillary electrophoresis works?
A In base of some of the things that I brought to his home, yes [sic].
See further development of this topic, n. 81 infra and accompanying text.
(Id. at 89-90 (voir dire on P-8).)
Q You're not suggesting that P-20A, that orange and black thing, you're not suggesting that's in the drawing of P-8, are you?
A Not at all.
Q They're two separate things, what's in the drawing?
A This — absolutely.
(Id. at 119-20 (voir dire on P-20A).)
Q Do you have any documents whatsoever, that show any of the versions of P-20A as it existed at any time, with any date, . . . yes or no?
A I have a — sketch, of what I presented to Dr. Olsen, of what I think is going to be the next generation of 20A, or 29 version.
Q But we established, I thought, that P-8 . . . that's not a picture of P-20A?
A That's not a picture of 20A, but it contained all the components of 20A.
Q It shows all the components?. . . . Show me in P-8, where it shows this component?
A The components are — the package, the whole thing.
. . . [Further voir dire examination.]
Q Now, explain to me how this . . . P-8 is an accurate depiction of Exhibit 20A?
A It's not an accurate depiction. What I'm trying to say that — I explained to Dr. Olsen this first, that I have a system, was two boxes, was one cover — with one ground — and capillary — some meters and — so on and so forth. Once I finished that I said look, this is the one instrument and component, in fact it's in the reverse order. Right here it's in the reverse order, the components.
Dr. Guzman acknowledged in the above-quoted testimony that his P-8 sketch shows the cartridge containing the coiled capillary in the wrong location. (Tr. 8 at 131.) The sketch depicts the cartridge on the outlet side of the detector. (P-8.) Dr. Guzman agreed that this is incorrect because the length of capillary relates to the time necessary for the sample to undergo chemical separation between the inlet point and the detector window, and the temperature control must occur on the inlet side of the detector, so there would be no reason to coil and cool the capillary on the outlet side of the detector. (Tr. 8 at 89-97.) Defendant's expert witness on capillary electrophoresis, Dr. Jorgenson, stated in reference to P-8 that if one of his graduate students had made such a sketch, "I would point out the problems and say go back to the drawing board." (Tr. 13 at 38.)
. . . .
Q [W]as there any reason why you were unable to draw P-8 with any degree of accuracy of P-20A?
A Because this was not a drawing of that, I explained the principles first. The principle capillary electrophoresis, how it was going to be in operation. What do I need.
Q So this is a future device, P-8?
A Yes.
Q So P-8 is not P-20A? Can we establish that?
A P-8 is a model of what I call P-20A, I mean you have to remember there are two different things here, this is a schematic, how the work capillary electrophoresis and then I bring to the table, and say look this is a physical evidence which I did in my thesis.
Q I didn't ask you about the thesis. I just want to ask you one more time, do you concede that P-8 is not a drawing of P-20A?
A Is not an accurate drawing.
Q Did you intend [P-8] to be an accurate drawing of P-20A?
A That's what I have in the next instrumentation.
Q Pointing to the left side of the courtroom, it's in the next instrumentation. Is it your testimony that P-8 is a depiction of your next instrument?
A Once again, this is the general principles.
Q Is it your testimony that P-8 is simply to show the general principles and it's not intended to be an accurate depiction of any device whatsoever?
A That is correct. Not a device of this.
Q Now that's consistent with Dr. Olsen — just shows principle, right?
A Right.
(Id. at 126-34 (continued voir dire on P-20A).)
Each of "the May, 1986, materials" described above, as well as the exhibits described in the following two subsections, are discussed in Section VIII.C infra.
ii. "The December, 1986, materials"
Plaintiff offered the following physical and documentary exhibits in support of Dr. Guzman's trial testimony concerning the status of his invention efforts as of December, 1986:
• A metallic capillary electrophoresis chassis containing certain components. (P-20.)
• A plastic coiled capillary cassette cartridge. (P-18.)
• The original of an electropherogram containing handwritten pencil notations including the date "12/27/86." (P-13.)
• An invoice from Genito company dated May 15, 1986. (P-27.)
Exhibit P-13 also has a related photocopy, exhibit P-14 moved into evidence by defendant, described in this subsection.
Each of those exhibits was admitted into evidence. We will now describe Dr. Guzman's trial testimony about each of the exhibits in this group.
Exhibit P-20
Plaintiff produced two metallic capillary electrophoresis prototype devices in this action. Exhibit P-20 was the metallic prototype produced both in discovery and at trial. Exhibit P-133, described below, was produced at the direction of the Court during trial. See n. 75 supra.
The condition of P-20 at trial was incomplete. It had certain features such as a rotatable table, a removable coiled capillary cartridge (described below), a high voltage power supply, and an incomplete holder for the end of the capillary. It lacked two sets of components, one containing all the electronics for the various motors, and the other being the electronic part of the detector. It was not rigged with a capillary. (Tr. 8 at 183-88.)
Defendant renewed a prior objection to P-20, toward the close of Dr. Guzman's testimony on that exhibit, after it had been admitted into evidence. The objection was based on Dr. Guzman's testimony that P-20 was not a complete apparatus at trial; he said it was modified after December, 1986, to add automation; and it appeared that at least one necessary component, the high voltage power supply, had been installed after December, 1986, based on its manufacturer code. (Tr. 8 at 183-188; Tr. 10 at 61-63, 161-63.) We allowed the exhibit to remain in evidence because at that point it had already been admitted and fully discussed in the testimony. (Id. at 162.) Therefore, exhibit P-20 remains in evidence at this writing, subject to defendant's objection.
Dr. Guzman's deposition testimony on the question of when he made P-20 is quoted supra, n. 68. His trial testimony regarding P-20 may be summarized as follows.
Exhibit P-20 is the first of his four metallic prototype capillary electrophoresis devices. He made P-20 between May and December, 1986. (Tr. 8 at 165, 170-74, 180, 183; Tr. 10 at 24-26.) Dr. Guzman designed P-20, and "made the components with the contractor," and assembled it at home. (Tr. 8 at 169.)
He continued to refine each of his prototypes, including P-20, into at least 1989. (Tr. 10 at 24-26, 61-63, 161-62.) However, as of December, 1986, the P-20 prototype possessed all of the elements of claim 32, and it functioned to produce electropherograms. (Tr. 8 at 173-74, 180-83, 197-99; Tr. 10 at 23-26.)
Exhibit P-18
Trial exhibit P-18 is a physical object consisting mainly of two pieces of clear plastic held together with four screws, which form a housing around the coiled capillary cassette, P-17. It appears as follows:
(Photo of P-18.)
Here we summarize Dr. Guzman's trial testimony on exhibit P-18.
He calls the P-18 assembly a cartridge cassette ("cartridge"). (Tr. 8 at 159.) He designed P-18, but it was made by a company named Genito, and then he assembled the components. (Id. at 159-61.)
We note that the trial transcript contains numerous references to both P-17 and P-18 as a coiled capillary cassette or a cartridge or some combination of those terms. However, the physical exhibit P-17 is distinct from P-18. Basically, P-18 is a two-part housing into which P-17 may be inserted. Neither counsel nor the witnesses used a consistent nomenclature distinguishing P-17 and P-18 in the trial record. For purposes of this opinion, we maintain the distinction between the two exhibits by referring to P-17 as a "cassette," and P-18 as a "cartridge." However, the quoted portions of the trial record use those terms indiscriminately in referring to P-17 and P-18.
He made P-18 between May and about September, 1986. (Id. at 161, 164.) It was one of two prototypes of a cartridge cassette that he made. (Id.) P-18 is configured as follows:
A [Y]ou can see that — inside of this there is the cassette, which I just show it to you before that. . . . So this — extra sandwich, two more pieces, in front of the piece that you saw before, it has a function to be attached to the detector, and there is some system here that you screw. But also it has two inlet and outlet some holes that go all around here. And that was to put fluid into the system. So it can circulate and be able to have some kind of cooling into the system, or heating whatever was necessary. So you see four holes, and very professional made, that was made by this company called Genito, and — and then some screws to be able — and there was also a gasket that is not here to avoid the liquid to go out of the system. That's basically it.
THE COURT: This is water?
A At that time I used water, it was attached to a cooling device, eventually. It started with a hose to my just regular faucet in my home, and then eventually I bought a commercially available system, or I used one of those so it would circulate the water in one direction to another. Down here, and goes there, and in both sides, there are four holes there.
(Id. at 160-61.)
A. . . . Now, in this area, you can see two protruberants and these are placed into the detector. So the capillary go inside of the detector and then you will see in the next there is a screw that we can attach this into the detector itself.
(Id. at 167.)
Dr. Guzman made P-18 to be used on his first metallic prototype, P-20, (Id. at 163.) He operated the metallic prototype device, P-20, with the P-18 cartridge attached, to produce electropherograms beginning in October, 1986, and finishing in December, 1986. (Id. at 165-68, 180-88.)
Dr. Guzman's testimony at a pretrial Rule 104 hearing was in conflict with his trial testimony regarding when he first made and used a cartridge such as P-18. He testified at the pretrial hearing that he had made P-18 by April, 1986, and that he displayed P-18 to Dr. Olsen as one of the components of the device he brought to the Olsen meeting on April 22, 1986. (5-22-01 H'g Tr. at 124-25, docket entry 109.)
Exhibits P-13 and P-14
Trial exhibit P-13 is an original electropherogram containing handwritten notations in pencil. Exhibit P-14 is a photocopy of P-13 that differs from the original.
Dr. Guzman testified that P-13 is the first electropherogram that he made using his first metallic prototype device, exhibit P-20. He made that electropherogram on December 27, 1986. (Id. at 191-93; Tr. 10 at 23-24, 28-30, 167-68.) That date is written in pencil, in his handwriting, in the lower left corner of P-13. (Tr. 8 at 191-93.) All of the handwritten notations on P-13 are in his handwriting, but possibly not with the same pencil. (Tr. 10 at 29-30.) The fact that he could make this electropherogram showed him that P-20 was working for its intended function as of that date. (Tr. 8 at 197-99; Tr. 10 at 167-68.)
Exhibit P-14, also produced by plaintiff in this case, is a photocopy of P-13 that differs from the original in certain respects, including the following:
• The date of December 27, 1986, in the lower left corner of P-13 is not present on P-14, although both P-13 and P-14 bear that date on the upper right corner. (Id. at 38-39, 167-68.)
• The phrase "(Temperature ~ 25°C through cartridge cassette)" is written at the end of the list of test conditions on the lower right of the original, P-13, but is absent from the photocopy, P-14. (Id. at 39-40.)
Dr. Guzman testified that to the best of his memory, he wrote all of the handwritten information on P-13 on the day of December 27, 1986, including the date and the reference to a cartridge cassette, although he added that his memory on that point was not certain. (Id. at 30-36.) He stated that he did not make the photocopy, P-14, and did not know any reason for the differences between the original and the photocopy. (Id. at 38-40.)
Exhibit P-27
Trial exhibit P-27 is an invoice to plaintiff from Genito company, dated May 15, 1986. The total cost of the order is $45.00 plus tax. The quantity ordered is "J." The description states, "lot of plastic pes. — machined as per instr."
The name "Genito" is misspelled "Geneto" in the trial transcripts. (See, e.g. Tr. 10 at 188.) The correct spelling has been used here.
Dr. Guzman's trial testimony relating to the Genito company, and P-27 in particular, may be summarized as follows.
He obtained plastic parts to build his various prototypes and components from various companies, including sources named Bio Plastic, Cadillac and Genito. He purchased many plastic parts, dating back to at least 1985. Sometimes he paid cash; sometimes he used a check. Usually when he paid cash he would not retain a receipt. (Id. at 165-67.)
Genito was the company that was fabricating some of the pieces Dr. Guzman used "for the cassette." (Id. at 188-89.) Genito also fabricated many other pieces, "especially the connection of the so-called cartridge cassette to the detectors." (Id.) The P-27 invoice, totaling $47.70, was for "the small little items that I bought and this is one of the so many items that I did with Genito." (Id. at 189.)
Genito machined the pieces that form the outer housing of the P-18 cartridge. Exhibit P-27 is the invoice for those specific pieces. Dr. Guzman used those pieces to fabricate the P-18 cartridge. (Id. at 190; Tr. 11 at 9-12.) That was "the first thing Genito ever did for me." (Id. at 10.)
The pieces that he purchased in the P-27 invoice were as follows:
Q Is it your testimony that the invoice . . . P-27, [reflects] the purchase of that device, Exhibit P-18?
A Yes. This is the first thing —
Q So you bought that for $47.70 —
A That is correct —
Q — is that your testimony?
A — at that time, in `80 something.
Q But all this document says is lot of plastic pieces machined as per instructions, $45.
A Yes because the one piece, another piece and then there was pieces that we have to insert to cool the system, which are located here, one, two, three and four, and there is another cylinder, six, seven. So there's quite a few pieces that they made —
Q All for $45?
A Yes. It's plastic.
(Id. at 11.)
Dr. Guzman acknowledged that invoice P-27 does not state anything about coiling a capillary. (Id. at 9-10.)
iii. Other corroboration materials
Plaintiff also offered the following physical and documentary exhibits on the issue of Dr. Guzman's asserted date of invention in April, 1986.
• A metallic capillary electrophoresis chassis containing certain components. (P-133.)
• Photocopy of a receipt from Bio Medical Equipment company dated June 8, 1985. (P-21.)
• Photocopy of an invoice from Spellman High Voltage Electronics Corporation dated July 11, 1985. (P-22.)
• Photocopy of a quotation from Isco, Inc. dated December 23, 1985. (P-23.)Exhibit P-133
Trial exhibit P-133 was the metallic prototype device produced by plaintiff during trial. See n. 75 supra. It was in Dr. Guzman's attic, along with other instrumentation. Dr. Guzman testified that he had forgotten about this prototype until he was being cross-examined during a Rule 104 hearing at trial. He estimated that it had been stored in the attic since some time in the early 1990's. (Tr. 10 at 16, 57-60.)
The condition of P-133 at trial was that it had certain components pointed out by Dr. Guzman in his testimony, including a rotatable a rotatable table, high voltage power supply, detector, and an incomplete holder for the end of the capillary. It was not rigged with a capillary. (Id. at 11-13, 17-21.)
Dr. Guzman's trial testimony regarding P-133 may be summarized as follows.
He designed and made the P-133 metallic prototype after he made his first metallic prototype, P-20. (Id. at 153.) He first began working to make P-133 "later in the `80's, probably 1988." (Id. at 15.) The P-133 device had two detectors rather than one, which made it longer than its predecessor. (Id. at 15-16.) He designed his various prototypes to have interchangeable parts when possible, to save cost. (Id. at 17-20.) He continued to refine each of his prototypes, including P-133, into at least 1989. (Id. at 14.)
The P-133 device did perform chemical separations. (Id. at 16.) He thinks P-133 first worked to produce an electropherogram sometime in 1988. (Id. at 23.) There was a time when he had a coiled capillary mounted on the P-133 device. (Id. at 15.)
Exhibit P-21
Trial exhibit P-21 is a photocopy of a receipt to Dr. Guzman from Bio Medical Equipment company dated June 8, 1985. The photocopy was admitted into evidence in the absence of an original. (Id. at 178-85.) There are four items described on P-21, as follows (1) "vertical slab gel unit," (2) "electrophoresis chamber," (3) "cylinder — electrophoresis chamber," and (4) ring assemblies.
Dr. Guzman's trial testimony acknowledged that the first item on P-21 related to slab gel electrophoresis, rather than capillary electrophoresis. (Id. at 187; Tr. 11 at 13.) He did not recall whether the second item related to his capillary electrophoresis work. (Tr. 10 at 187.) He testified that the third item, "cylinder," as well as the fourth item, "ring assemblies," did relate to his capillary electrophoresis work. (Id. at 185-87.) His testimony describing the latter item was as follows:
The next one is called ring assembly, which is the very last one, and that work [was] some rubber tubing that Mr. Silverman [company owner] used to cut for me to put [as] a gasket for the cartridge cassette when there was the liquid when we pressed the content so in order to avoid the liquid to get out of the system where — where there's — so there was some — he call it ring assembly, but that's what it was.
(Id. at 186-87.)
Dr. Guzman acknowledged that nothing stated on the P-21 receipt itself indicates that any of the listed items were for use in capillary electrophoresis, or in a particular device. (Tr. 11 at 13-14.)
Exhibit P-22
Trial exhibit P-22 is a photocopy of a two-page invoice to plaintiff from Spellman High Voltage Corp. dated July 11, 1985. The photocopy was admitted into evidence in the absence of an original. (Tr. 10 at 192-93.) Exhibit P-22 shows the purchase of power supply components with an instruction manual for $2,020.00 cash.
Dr. Guzman testified that the equipment purchased in P-22 was a large, heavy, external high voltage power supply that would not fit inside his capillary electrophoresis devices. (Tr. 11 at 14-15.) He stated that it was used in connection with his capillary electrophoresis work, but he could not relate it specifically to any of the prototypes described in the record. (Tr. 10 at 190-195.)
He said that the P-22 power supply unit, purchased in 1985, predated all of the prototype devices shown at trial. (Tr. 11 at 15-16.) Each of those prototypes, exhibits, P-20A, P-20 and P-133 133, has an internal high voltage unit. (Tr. 8 at 142; Tr. 10 at 11-15, 20-21, 162-63.)
Dr. Guzman also testified, on cross-examination, that he identified the P-22 Spellman external high voltage power unit in his thesis, when describing the capillary electrophoresis equipment used for the thesis. (Tr. 11 at 16; see P-11 at 85 (quoted supra, in text accompanying n. 76).)
Exhibit P-23
Trial exhibit P-23 is a photocopy of a one-page quotation to plaintiff from Isco, Inc. dated December 23, 1985. The photocopy was admitted into evidence in the absence of an original. (Tr. 11 at 3-5.) It lists an absorbance detector with built-in recorder and other components. The prices for the listed items are quoted but not totaled. (P-23.)
Dr. Guzman testified that he did purchase a detector from Isco, as described in P-23. He stated that it was made to be used in high performance liquid chromatography, but he purchased it to use in his capillary electrophoresis work and had it modified for that purpose. He then used it in the plastic prototype that he brought to the Olsen meeting, P-20A. It was that detector that he described in his thesis. (Tr. 11 at 4-8, 17-18.)
Guzman testimony pertaining to P-21, P-22 and P-23
Dr. Guzman testified that exhibits P-21, 22 and 23 are probative of his having made a capillary electrophoresis device in the time frame of those documents. He acknowledged that none of them shows anything about coiling a capillary. (Id. at 9-10.)
c. Plaintiff's Corroboration Witness
Dr. Bjorn Olsen was one of the members of the thesis committee for Dr. Guzman's Ph.D. degree that was awarded in May, 1986. He currently holds endowed professorships at Harvard Medical School and Harvard Dental School. As of April, 1986, he had left his position at Rutgers and commenced working at Harvard, but he remained on the thesis committee for graduate student Guzman. Also, his family and his residence were still in New Jersey so that the children could finish the school year. (Tr. 6 at 59-72, 77.) He was called as a fact witness in this case. His testimony may be summarized as follows.
He recalls that he did meet with Dr. Guzman in April, 1986. (Id. at 75-76.) At that time, Guzman was in danger of not receiving his Ph.D. because he had been in the program for ten years without finishing his thesis. (Id. at 76-77; Tr. 7 at 67-68.) He has no independent recollection of the exact date of the Olsen meeting. (Id. at 59-61.) During this litigation, plaintiff's counsel showed him the handwritten sketches dated April 22, 1986, P-6 and P-8. (Id. at 16-23, 68-69.) As to the timing of the meeting, he notes that April 22 is his birthday; Guzman was under a thesis deadline of Spring, 1986, at the time and the thesis was approved in May, 1986; and he recalls that the meeting with Guzman took place in his dining room while he went in and out of the room to join his family. (Tr. 6 at 77-79, 87-88; Tr. 7 at 6-7, 72-73.)
The April, 1986 meeting described in Dr. Olsen's trial testimony is referred to in this opinion as "the Olsen meeting." However, it should be noted that Dr. Olsen also testified that he met several times thereafter with Dr. Guzman and/or his counsel. Those meetings, as he recalled, were as follows: (1) Meetings with Dr. Guzman at Rutgers after he received his Ph.D. (Tr. 7 at 11.) (2) Meeting with Guzman and a lawyer in New York City in the late 1980's; Olsen does not recall the purpose of that meeting. (Id. at 57-58, 64-66.) (3) Approximately two meetings with Guzman "when he worked in Princeton," in or around 1989 or 1990. At that time Olsen actually saw Guzman perform capillary electrophoresis, but does not know whether that apparatus was one of Guzman's devices or from other sources. (Id. at 37-39, 49-50, 74-76.) (4) Meetings with Guzman and/or plaintiff's litigation counsel in this case, beginning in approximately 1996. (Id. at 16-35, 64-66.) He does not recall whether he ever met with lawyers regarding Dr. Guzman's patent application or any attempt by Dr. Guzman to obtain funding for his company. (Id. at 64-66.)
Dr. Olsen knew nothing about capillary electrophoresis before Dr. Guzman began to tell him about it during the time immediately prior to 1986. He had never seen a capillary electrophoresis device of any kind before that time. (Id. at 9-10)
During the period leading up to the Olsen meeting, Guzman had told Dr. Olsen about the type of device he was using to do capillary electrophoresis:
Q Did Dr. Guzman describe to you the type of device he was using to employ capillary electrophoresis?
A Yes. He was trying to build a prototype of a machine that could do this, this prototype evolved over time, so his goal was to be able to clearly show that hydroxylase from chicken embryos was different, has different properties, somehow by separation technique, from the same enzyme activity that he could isolate from — placenta. And as he was doing this, he improved on the machine, and components from one prototype went into the formation of the second version, or generation of a machine.
(Tr. 6 at 74-75.)
Dr. Guzman brought several items to the Olsen meeting, and drew sketches to show to Dr. Olsen during the meeting. (Id. at 78-82.) The items that Dr. Olsen recalls having seen at the meeting were:
• A device that was made of reddish-orange and clear plexiglas ("the Olsen meeting prototype").
• A two-part clear plexiglas unit with internal grooves into which could fit a coiled capillary, which he recognized as exhibit P-17.
Dr. Olsen could not state from his recollection whether the Olsen meeting prototype was the same device as P-20A. He stated that the device that he saw at the meeting could have been P-20A, or it could have been an earlier version. (Tr. 6 at 84-86; Tr. at 45-48, 54-57.)
• Electropherograms.
• Sketches made by Dr. Guzman at the meeting.
The Olsen meeting prototype "was not an operating machine" during the Olsen meeting (Id. at 82.) It was not equipped with a capillary or fully assembled, and Dr. Guzman did not demonstrate it in operation. (Id. at 82, 86.) Dr. Guzman did not bring a capillary to the meeting, as he recalls. "The purpose of his visit was not to demonstrate a running machine, because he had the results with him, he had the results that he wanted to include in this thesis." (Id. at 83.)
Dr. Olsen recalls that the instrumentation Guzman showed him at the meeting included the following:
Q Can you describe the device as best you can recall that you saw at that time?
A [W]hat was striking and what I remember distinctly, because it was typical of Norberto — something, but make it beautiful. And it had red — red orange color, plexiglas with clear plexiglas and — and it was a neat piece of plexiglas work.
And it had a couple of features that I thought was very, very important. He had been talking to me about capillary electrophoresis before, but there had — was a way of [coiling] the capillary tube, but very simple device actually, two plates of plexiglas, with a groove sort of — in one of them, and it could — the tube along these screws and it could put the whole thing like a little cartridge, into the machine and I thought that it was a major conceptual advance, actually because it would allow one to have longer capillaries in a smaller physical setup.
(Id. at 79.)
He saw the two-part cassette, P-17, or a unit like that, at the meeting:
Q Did you discuss the capillary and the cartridge as you're describing it, on April 22nd?
A He described it yes.
Q Did you see it at that time?
A Well I certainly saw it in — on the drawing. But I remember that the two plates of plexiglas, so I must have seen it.
Q Can you describe P-17?
A Well this is a — a square piece of plexiglas, which has — of two squares the same size, and one on top of the other. And on the one side of that two squares, was spiral sort of groove, that is carved into — with a drill or something, into the surface of the plexiglas. And when you put the two plates together you've got a tunnel that runs in this spiral like fashion, between the two plates, and the two plates are clamped together with the screws at the four corners.
Q Have you seen P-17 before? [Yes.]
Q When did you see it?
A This was the one I saw in April 1986.
(Id. at 79-81 (direct examination).)
Q You're also positive that Dr. Guzman, in fact, showed you a cartridge on the prototype, is that what you're —
A Right.
Q Yes. And he did so with Exhibit P-17?
A I believe so. I've seen this before.
Q So, do you believe you were one of the first people ever to see Dr. Guzman's prototype with the cartridge, like Exhibit P-17?
A Among the members of the Thesis Committee, I was perhaps the first or the second because I know that he tried to show these things and talk about this to Dr. Prokop. But Prokop wasn't interested. I was interested in listening to Norberto and I saw that this might be very useful.
Q And so you're positive, right, that he showed you this prototype with the cartridge.
A A prototype like that.
Q I understand
A It's a different thing.
(Tr. 7 at 48-49 (cross examination).)
He also recalls having seen a rotatable table at the meeting:
Q Do you recall anything else about the device you saw, on your dining room table, on April 22nd, of 1986?
A Well there were two things that I thought was — I remember otherwise I'm not sure I would have remembered this, one was — what was — this way of taking longer capillary and making it physically more compact. The second thing — to me that you would have almost like a round — collector you would have a plate — with holes in it, for tubes that could contain the different samples that we wanted to analyze, and putting that on a rotating machine, and then — present each tube in succession to one of a capillary, so that you can in principle, automate this machine.
And this was not an operating machine at the time, he didn't run it on my table. But clearly the concepts were there for having multiple samples, could load it, and then you could have a long — sort of long capillary in a small machine, I thought that was very important.
(Tr. 6 at 82.)
Dr. Olsen understood that an electropherogram was "the product of running this type of machine." (Id. at 83.) Guzman showed Dr. Olsen electropherograms during the meeting. (Id.) The electropherograms shown at the Olsen meeting were ultimately approved for inclusion in Dr. Guzman's thesis, P-11 at page 173, Figure 19, items A, B and C. (Tr. 7 at 7-8.)
Based on the discussion he had with Guzman during that meeting, Dr. Olsen understood that those electropherograms were generated on the prototype that he saw at the Olsen meeting. (Tr. 7 at 8-9.) "He showed me electropherograms, and obviously I assumed — but that's an assumption — that he had produced it with this machine. As far as I know he had no other machine, so." (Tr. 6 at 83.) In his opinion, Guzman was absolutely a trustworthy person. (Id. at 83-84.; Tr. 7 at 73-74.)
During the Olsen meeting, Guzman explained to Dr. Olsen where the capillary would run, not by running the machine but by making a sketch, "sort of explaining the principle of how this worked." (Tr. 6 at 86.) As Dr. Olsen recalled, the sketch that he saw was actually about the "what the potential would be." (Id. at 87.) That potential, as he recalled Dr. Guzman describing through a sketch, was as follows:
Q Why was it necessary for Dr. Guzman to prepare a sketch when you had the device in front of you?
A Well, he could then explain it on how it worked but what the potential would be. So again Norberto was an unusual student, because he was always thinking about the next step and next generation of things that it would do, or in the next few experiments. So he had all these ideas, about what it might do with this, and where to take it, and one of those things he explained together with this well cartridge, or whatever, of plexiglas with a spiralized capillary, was that of course you could run — put it in a — or you could have circling water around it, or some other fluid, could keep it cold, you could keep it hot, you could — do things with this, that — couldn't do. And — he says you could clear it — you could run it at a high voltage. And get rid of more heat that you would generate if you do the separation at high voltage, so you could decrease time for separation — one of the goals was to do — separations, a very clean separations — get beautiful peaks, in a very short period of time, and that it did.
(Id. at 87.)
Dr. Olsen was partially occupied with his family in another room while Dr. Guzman was making his sketches during the meeting, so Olsen did not observe all of the sketching process. (Id. at 87-88.) He has no recollection of seeing a sketch resembling P-6 at that meeting. That sketch does not show a coiled capillary or rotatable table. (Tr. 7 at 39-40, 69-72.) He does recall seeing "this kind of document," referring to P-8, at the Olsen meeting. (Tr. 6 at 96.) He remembers that at that meeting, he saw "a drawing like this explaining how these different components would work." (Id. at 97-98.) Dr. Olsen has no contemporaneous documents from that meeting in his current files. (Tr. 7 at 42-43.)
The sketch he recalls having seen during the meeting showed the following:
Q Do you recall what specific portions of the document [referring to the photocopy, P-9] Dr. Guzman prepared in your presence?
A I cannot . . . say that I remember every detail of this. But I do remember his exploration of the cartridge, what he calls cartridge here, that it could be heated or cooled, and he was drawing that. And then he indicated where he would have detector, to detect what was electrophoresis. And then he indicated that he had different samples in the sample compartment.
(Tr. 6 at 89.)
Q Describe for the jury what elements if any you do recall seeing on April 22, 1986?
A [W]hat I do remember is what I thought was important. And that is again that the way that multiple samples could be loaded in the machine, with the device flat, that the capillary was [coiled], so it could — you could have a long capillary, with significant separating power, in a small setup. And that perhaps in the future, one could then run the machine at high voltage, and cool the samples as it was running through the capillary.
Dr. Olsen could not be more specific about whether he had seen P-8 or a similar sketch at the Olsen meeting, or what other features the sketch that he saw contained at the time. (Tr. 6 at 88-91, 92-98; Tr. 7 at 3-5, 69-72.)
(Id. at 91.)
Looking just at the electropherogram readout shown in Dr. Guzman's thesis, Dr. Olsen can identify it as an optical density readout on a recorder, but cannot say whether it was made by electrophoresis or by other separation methods using a similar readout machine. (Tr. 7 at 53.) He knows the readout was made by capillary electrophoresis because at that time, "only that kind of instrumentation could produce that very sharp, separation study obtained." (Id. at 52.)
Dr. Olsen acknowledges that nothing in the thesis electropherogram or what he has read in the thesis, P-11, shows that the electropherogram was produced by a certain capillary electrophoresis machine, with or without a coiled capillary or coiled capillary cartridge. (Id. at 53-54.) He concludes:
Q From looking at the thesis, can you tell whether or not Dr. Guzman ever used a coiled capillary of any kind to perform any capillary electrophoresis to perform any chart or electropherogram in this thesis?
A No.
Q Is any cartridge mentioned? Any cartridge cassette in the thesis?
A Not in the legend. And I have not looked at the materials or methods.
Q But you can't tell from looking at the graph, or anything in that thesis as you sit here today, that shows anything whatsoever to do with a coil.
A No.
Q Anything to do with a cartridge cassette?
A No.
Q Anything to do with thermal couple cooling?
A No.
Q So, this data could have been obtained using a regular old system with two beakers and a straight capillary, as far as you know?
A Correct.
(Id. at 63-64.)
C. Conclusion on Issue of Prior Invention
This Court finds that the trial evidence established that defendant had a claim 32 invention reduced to practice by no later than February 1, 1987. Plaintiff does not dispute this fact. (Pl. Br. at 22, 27.) That date is more than 21 months prior to the filing date of the CIP application for the `172 patent, November 14, 1988. There, for the first time in the patent history, the applicant disclosed elements 7 and 8 of claim 32.
Plaintiff challenges defendant's claim of prior invention by asserting that Dr. Guzman actually had his claim 32 invention reduced to practice prior to February 1, 1987, despite his failure to disclose it to the Patent Office until November 14, 1988. The dispute on the issue of prior invention therefore concerns the date of Dr. Guzman's reduction to practice.
The question of when a party reduced an invention to practice is a legal question, and submitting it to the jury does not relieve a court of the duty to ensure that the law is correctly applied. The primary focus of that inquiry must be on the corroborating evidence of the prior invention date. See authorities cited supra, Section VII.A.
Only evidence "independent of information received from the inventor" can legally corroborate an inventor's asserted invention date. See, e.g., Hahn, 892 F.2d at 1032-33. The court applies a rule of reason analysis to ensure that the record contains proper corroboration. It must then determine for itself, on the basis of the independent corroboration evidence, whether the "inventor's story" is credible. See Finnigan Corp., 180 F.3d at 1369 n. 11.
1. No Independent Corroboration Evidence
This Court has searched the record in vain for any evidence, independent of Dr. Guzman's own statements, to support his trial testimony that he had a working claim 32 device prior to February 1, 1987. We will briefly review each of the physical and documentary exhibits offered by plaintiff on this issue, along with the testimony of corroboration witness Dr. Olsen.
We find that the testimony of the inventor, Dr. Guzman, is testimony of the plaintiff in this case for purposes of imposing the corroboration requirement. See n. 41 supra.
"The May, 1986, materials"
• P-20A is an orange and black plastic chassis with various components. It was excluded from evidence but was the subject of extensive trial testimony. As presented at trial, it had no capillary or any support member for a coiled capillary, and was missing other components needed to make it operational. There were no dates shown on P-20A, or any dated photographs or engineering drawings accompanying P-20A, to establish an assembly date prior to February 1, 1987. Dr. Olsen could not say whether the plastic prototype that he saw during the Olsen meeting, in April, 1986, was P-20A or some carlier prototype. Nor was the prototype that Dr. Olsen saw at that meeting complete or operational.
• P-17 is a "cassette" consisting of two flat pieces of clear plastic held together by four screws, with grooves cut into its internal surface to secure a coiled capillary. Dr. Olsen testified that he saw this unit, or a similar unit, during the Olsen meeting. However, the cassette was not assembled, with capillary, onto the plastic prototype device at that meeting. Nor was the prototype device operated during that meeting.
• P-6 is an altered original pencil sketch dated April 22, 1986. It depicts three components called external high voltage power supply, recorder and motor controller. Those components would be common to various types of instrumentation, not just a claim 32 instrument. (P-7 is a photocopy of P-6 that differs from the original.)
• P-8 is an altered original pencil sketch dated April 22, 1986. It depicts a capillary electrophoresis chassis with various components including a rotatable table and units called "cartridge-cassette coiled capillary" and "liquid cooler-heater." The cartridge shown in the sketch is inserted at the wrong location. See n. 81 supra. Dr. Olsen testified that be recalls seeing P-8, or a sketch resembling P-8, at the Olsen meeting, and he understood that sketch to depict "what the potential would be." (Tr. 6 at 87.) He did not report seeing any physical object at that meeting that would correspond to the temperature-controlled "cartridge-cassette" depicted in the P-8 sketch. He only testified that he saw the simple two-piece cassette unit, P-17. (P-9 is a photocopy of P-8 that differs from the original.)
• P-11 is Dr. Guzman's thesis, bearing approval date "May, 1986." Figure 19 of the thesis consists of three related electropherograms, with text attributing those readings to a "homemade system consisting of a capillary column, two buffer reservoirs, an in-column detector, and a power supply." (P-11 at 85.) The thesis does not disclose any coiled capillary secured to a support member. Nor does it disclose any component corresponding to the "holder" or "rotatable table" limitations of claim 32. Dr. Olsen testified that based only on the information contained in the thesis, the electropherogram data shown in Figure 19 could have been obtained using a regular old capillary electrophoresis system with two beakers and a straight capillary."The December, 1986, materials"
• P-20 is a metallic chassis with various components. As presented at trial, it had no capillary, and was missing other components needed to make it operational. There were no dates shown on P-20, or any dated photographs or engineering drawings accompanying P-20, to establish an assembly date prior to February 1, 1987.
• P-18 is a "cartridge cassette" consisting mainly of two pieces of clear plastic held together with four screws, which form a housing for a unit such as the P-17 cassette. It also has inlet and outlet holes for temperature control liquid, and two protruberants to be placed into the detector and screwed in place, to attach the cartridge to an electrophoresis device. There were no dates shown on P-18, or any dated photographs or engineering drawings accompanying P-18.
• P-13 is an altered original electropherogram containing handwritten pencil notations, including the date "December 27, 1987." At the bottom of the list of test conditions written in pencil, the following appears: "(Temperature ~ 25°C through cartridge cassette)."
• P-14 is a photocopy of P-13 that has one conspicuous difference from the original: the quoted language at the bottom of P-13 (being the only reference to a cartridge cassette on the document) is not present in the photocopy, P-14.
• P-27 is an invoice from Genito company dated May 15, 1986, totaling $47.70. The quantity ordered is 1. The description states, "lot of plastic pcs. — machined as per instr."
There was no corroboration testimony about any of the materials described in this group.
"Other corroboration materials"
• P-133 is a metallic chassis with various components. It was produced for the first time at trial, at the direction of the Court. Plaintiff does not contend that this prototype was made prior to February 1, 1987.
• P-21 is copy of a receipt from Bio Medical Equipment company dated June 8, 1985, listing four items: (1) "vertical slab gel unit," (2) "electrophoresis chamber," (3) "cylinder — electrophoresis chamber," and (4) ring assemblies.
• P-22 is a copy of an invoice from Spellman High Voltage Corp. dated July 11, 1985, showing purchase of an external power supply unit and related items for $2,020.00. Plaintiff does not contend that this power supply unit was used with any of the prototype devices shown at trial.
• P-23 is a copy of a quotation from Isco, Inc. dated December 23, 1985. It lists an absorbance detector with built-in recorder and other components. The prices for the listed items are quoted but not totaled.
There was no corroboration testimony about any of the materials described in this group.
Summary of corroboration evidence
Dr. Olsen, the sole corroboration witness, testified to a meeting in April, 1986, at which the inventor showed him an incomplete, non-operational plastic capillary electrophoresis prototype device, and a two-piece plastic "cassette" (such as P-17) that could hold a coiled capillary. Dr. Olsen did not see the device in operation, with or without a cassette attached, during the meeting. The sketch Dr. Olsen recalls seeing at that meeting did not depict the P-17 cassette. He understood that sketch to depict a "potential" future development of a temperature-controlled cartridge.
There is no corroboration witness for the time period between the Olsen meeting (April, 1986) and defendant's invention date (February 1, 1987). Neither the P-20 metallic prototype, nor the P-18 temperature-controlled "cartridge cassette," were the subject of any corroborating testimony on when they were made and when, if ever, they functioned.
The independent documents submitted as corroboration for plaintiff's claimed invention date contain no reference to any kind of coiled capillary assembly. The only documents that make such a reference are the handwritten pencil statements in P-8 (and its photocopy, P-9) and P-13 (but not its photocopy, P-14), attributed to Dr. Guzman.
We conclude that the trial record contains no evidence, independent of the statements of the inventor Dr. Guzman, to corroborate a finding that he had an operational capillary electrophoresis device containing each of the elements of claim 32, at any time before February 1, 1987.
2. Unreliability of Uncorroborated Inventor Testimony
This tribunal must keep in mind the purpose of corroboration, which is to prevent fraud, by providing independent confirmation of the inventor's testimony. Kridl, 105 F.3d at 1450. Having found no independent corroboration of the date of Dr. Guzman's reduction to practice of his claim 32 invention, the Court is not required to proceed to the next step and determine whether, in our view, the "inventor's story" is credible. Nevertheless, the numerous conflicts and discrepancies in the sworn testimony of Dr. Guzman in this case do lead us firmly to the conclusion that the prior inventorship story projected by Dr. Guzman at trial is unworthy of belief.
The most significant of the conflicts in Dr. Guzman's testimony was the abrupt change in his claimed dates of having made the two prototypes produced in discovery, the plastic P-20A and the metallic P-20. When asked in deposition when he constructed P-20A, he testified: "It could have been . . . in the middle of `87, 1987, that is correct." See n. 67 supra. Defense counsel was clearly surprised when, for the first time at trial, the inventor testified that P-20A was the exact prototype that he brought to the Olsen meeting in April, 1986, that it featured a coiled capillary, and that he had operated it (albeit not in the presence of Dr. Olsen) in that configuration by that time. (See Tr. 8 at 117-124, 140-142, 148-153; Tr. 10 at 23, 177.) Likewise at deposition Dr. Guzman testified that he constructed P-20 "start[ing] probably late in `87, part of `88." See n. 68supra. At trial he swore that P-20, and its P-18 coiled capillary cartridge, were operational by December, 1986. (Tr. 8 at 165-174, 180-187.)
Related surprise developments at trial included Dr. Guzman's testimony that he had made a later plastic prototype after making his metallic prototypes, and gave that plastic device to a professor in Argentina in 2000, during the pendency of this case. Also, the P-133 metallic device emerged from Dr. Guzman's attic only as the result of a lengthy Rule 104 hearing during the trial.
Equally serious is the conflict between Dr. Guzman's deposition and trial testimony in answer to the point-blank question of when he first placed a coiled capillary inside a cassette. That question was based, of course, on element 8 of claim 32, "secured to a support member." (P-72). "In December of `86," was his answer at deposition. See n. 65 supra. At trial, he pointed to the P-17 cassette and testified that he had that cassette, and used it to produce electropherograms on his plastic prototype device, prior to his April, 1986, meeting with Dr. Olsen. (But see n. 85 supra.) The obvious significance of his misleading answer to that deposition question was that defense counsel prepared for trial knowing that Dr. Guzman could produce no corroboration, in the form of documents or witnesses, covering the period between the Olsen meeting in April, 1986, and defendant's date of invention in February, 1987. See n. 69supra. So whatever Dr. Guzman claimed he had as of December, 1986, would be uncorroborated, unless Dr. Olsen could corroborate it form the April, 1986, meeting. As it turned out, Dr. Olsen at trial could not corroborate any actual operation of the Olsen meeting prototype (whatever generation prototype it was) with the P-17 cassette, to produce the electropherogram shown in Dr. Guzman's thesis. Dr. Guzman's testimony to that effect at trial was in conflict with his sworn deposition testimony.
The inventor's trial testimony itself is riddled with obvious inconsistencies, some of which are quoted at length above, including the following: Compare:
Q So are you telling us that you performed a separation using the Princeton Tiger and the cassette of PX-17?
A Yes.
Q And you did that before May of 1986?
A Yes.
Q And we know that, because it's in the thesis right?
A Yes.
Q Explain exactly what it is in the thesis that confirms the testimony you just offered.
A Well, is the electropherogram — I believe it's Page 173. . . .
(Tr. 8 at 149.)
With:
Q Is there anything in your thesis that explains how you got the data on Figure 19 that uses a coiled capillary?
A I explained every detail, how I did it, and all the conditions, and I said this is the best buffer that I used, I also used the — the sample, I injected into the column. The time that I injected, amount of voltage that I injected. The 30 microamps, there's a lot of detail here, what I did. I also —
Q In all those details, is there anything explaining a coiled capillary?
A I'm still looking for that. And — then —
Q Rather than keep talking, could you please find to me any reference where you believe your thesis indicates that there's a coiled capillary?
A I was — tell you — under the advice of an attorney I was told not to put the details in the thesis.
Q [So] you don't need to look; you know it's not in there?
A Right.
(Tr. 10 at 138.)
Compare:
Q [Describe P-8.]
A This is actually the drawing that I was making to Dr. Olsen to explain about what is what I invented, and how my electropherogram that eventually appeared in my thesis was made. So I tried to do as much as I could, once again, this is a sketch of what I call the capillary electrophoresis apparatus that I used at the time.
(Tr. 8 at 82.)
With:
Q Is it your testimony that P-8 is simply to show the general principles and it's not intended to be an accurate depiction of any device whatsoever?
A That is correct. Not a device of this.
(Id. at 134.)
Compare:
Q Is there anything else in this thesis in any way, suggests how you were able to obtain the data which formed Figure 19 [of the thesis]?
. . . .
A. . . . So the Thesis Committee, especially Dr. Olsen, saw the instrument, and under the next page, the only thing I'm telling you is some of the components that I used here for the instrumentation which is Page 109. So basically it said that several buffers were used but the one which gave the most consistent results was with 50 — buffer — 8.2, at room temperature. . . .
Q Room temperature, is that what you said?
A. Yes.
Q So you didn't control the temperature of the capillary?
A Oh, no I was — it was with water. I was telling you I was cooling the whole thing and it was measured at 25 — centigrade. So that's what I called room temperature. . . .
(Tr. 10 at 134-36; see n. 77 supra.)
With:
Q Describe the next iteration of cassette [after the P-17 cassette].
A The next concept was not only to be able to coil the capillary, those grooves that I show, but also be able to cool the system, with some kind of a cooling device. . . . So I developed a few prototypes for my so-called cassette cartridge device.
(Tr. 8 at 158; see n. 71 supra.)
Last but not least is the fact that the originals of all three of the purportedly contemporaneous handwritten documents produced by plaintiff are obviously altered. Dr. Guzman's explanation of how P-6 and P-8 may have come to be altered is plausible at best. However, there is no excuse for the augmentation of the original of P-13 to insert a reference to a "cartridge cassette" at some time after the photocopy, P-14, was made. Dr. Guzman had no explanation for that obvious tampering with the original, written in pencil in his own handwriting.
3. Review of Jury Verdict on Prior Invention
The jury found that defendant had not proven by clear and convincing evidence that claim 32 was invalid due to prior invention by defendant. (See n. 13 supra.) All factual issues pertinent to prior invention were submitted to the jury, subject to the parties' Rule 50 motions upon which this Court reserved decision. However, the Court was and is mindful that the question of when a party reduced an invention to practice is a legal question, and that the legal sufficiency of the evidence on the issue of prior invention must be determined by the Court.
It will be recalled that all of plaintiff's proffered corroboration materials were admitted into evidence at trial, with the exception of P-20A. The testimony of plaintiff's corroboration witness, Dr. Olsen, was also presented at trial. The admissibility of that evidence at trial does not relieve this Court of its obligation to make a determination, as a matter of law, as to whether such evidence provides independent corroboration of the inventor's claimed invention date.
Based upon the analysis set forth above, we hold that none of plaintiff's purported corroboration evidence provides any support, independent of the statements of the inventor, for a finding that Dr. Guzman had a claim 32 invention reduced to practice prior to defendant's undisputed invention date. We further conclude that in view of this failure of corroboration, the statements and testimony of the inventor are not competent to establish his own invention date. Finally, we conclude that the statements and testimony of Dr. Guzman in evidence, viewed as a whole, demonstrate on their face that the testimony of this inventor about his invention date is unreliable in the extreme. Accordingly, the jury verdict in favor of plaintiff on this issue cannot stand
It has been established by defendant, and this Court has found, that defendant's claim 32 invention date was February 1, 1987. That date is more than 21 months prior to November 14, 1988, which was plaintiff's patent application filing date for claim 32. Based upon this trial record, we therefore hold as a matter of law that claim 32 of the `172 patent is invalid due to prior invention by defendant, pursuant to Section 102(g).
4. Alternative Ground: Motion for New Trial
This Court is firmly of the view that it would be inappropriate to require another trial on the issue of prior invention in this case, rather than entering judgment for defendant as a matter of law. However, as a technical matter we hereby grant, in the alternative, defendant's motion for new trial on the issue of prior invention, to prevent manifest injustice under all the circumstances described above.
In the event of a remand requiring a new trial on this issue, we wish to call to the attention of the parties and the Court of Appeals an unsettled question of law that was not fully addressed during the trial phase in this case. The question was uncovered in our further research on the pending motions, and in our view would need to be resolved (by us or the appeals court) before we could retry the prior inventorship claims in this case. That question is as follows:
Where, as here, a patentee seeks to rely upon an asserted invention date prior to its patent application filing date to defeat a claim of prior inventorship by another party, what burden of proof is assigned to each party thus claiming a prior invention date?
The jury instructions in the trial of this case followed the usual course of assigning the burden of proof, by clear and convincing evidence, to the defendant to prove that it had an invention date prior to the patentee's date. (See Tr. 15 at 32, 43-44.) Our research, described below, leads us to believe that this was an inappropriate assignment of the burdens when each party is actually claiming an invention date prior to the presumptive invention date of the patent application filing.
Patents are presumed valid. 35 U.S.C. § 282. Accordingly, "a party asserting invalidity under § 102(g) must prove facts by clear and convincing evidence establishing a prior invention that was not abandoned, suppressed, or concealed." Apotex USA, Inc. v. Merck Co., 254 F.3d 1031, 1036 (Fed. Cir. 2001). If the party asserting prior invention satisfies this standard, a limited burden of production shifts to the patentee: "Because the patentee . . . has the benefit of the presumption of validity, that party should only be held to bear a burden of producing evidence indicating that the prior inventor may have suppressed or concealed the invention." Id. at 1037.
The patentee, however, must necessarily have an additional burden where, as in this case, it seeks to stave off a claim of prior invention by asserting a date of invention prior to the date it filed its patent application. Though neither the Court nor the parties have identified any Federal Circuit cases directly addressing this issue, review of lower court caselaw on this and related points suggests that a patentee asserting that it invented the subject matter of the patent in question prior to the date of its application must bear some burden of proving the date of its own prior invention.
Courts have found in various invalidity contexts that a patentee seeking to establish a date of invention prior to the application date must do so by clear and convincing evidence. InAmerican Standard Inc. v. Pfizer Inc., 722 F. Supp. 86 (D. Del. 1989), the court addressed the defendant's claim that a patent was invalid under Section 102(a)'s doctrine of anticipation.Id. at 108-09. The court observed that the issue turned on the date the patentee had invented the subject matter of the patent, and further stated: "In order to receive an effective date earlier than the filing date of the `123 Patent . . . a patentee has the burden of proving by clear and unequivocal evidence, that the invention was both conceived and reduced to practice before the application date." Id. at 109 (quotations and citations omitted). The court in All States Plastic Mfg. Co. v. Weckesser Co., 362 F. Supp. 94 (N.D. Ill. 1973), aff'd, 506 F.2d 465 (7th Cir. 1974), addressed the date of a patentee's invention in the Section 103 obviousness context. Id. at 97. The court observed: "The burden of carrying an invention back of the date of filing of the patent application thereon is heavy, and the evidence tending to establish such earlier date must be so clear and unequivocal as to leave no reasonable doubt." Id. In the Section 102(e) context, the court in Rohm Hass Co. v. Dawson Chemical Co., 557 F. Supp. 739 (S.D. Tex. 1983), rev'd on other grounds, 722 F.2d 1556 (Fed. Cir. 1983), observed:
Generally, the date of an invention is deemed to be the date of the filing of an application adequately disclosing the subject matter of the invention with the Patent Office. The date of a claimed invention can be established also by proving an actual reduction to practice of the invention, or by proving a conception of the invention coupled with diligence to achieve a reduction to practice. The burden of establishing the date of an invention or reduction to practice prior to the time of filing rests with the inventor. The burden of the inventor in this regard has been described as a heavy one when compared to the burden of an infringer to establish prior use.Id. at 802 (citations omitted). Finally, in the interference context, the Third Circuit stated in Standard Oil Co. (Ind.) v. Montedison, S.p.A., 664 F.2d 356 (3d Cir. 1981), that a party seeking to establish priority of invention may rely either "on the filing date of its [patent] application, which constitutes constructive reduction to practice, or by proof of actual reduction to practice on an earlier date." Id. at 362-63.
The district court in Diasonics, Inc. v. Acuson Corp., No. 91-3118, 1993 WL 248654 (N.D. Cal. June 24, 1993), confronted the same issue implicated in this case: the burden of proof on a patentee who seeks to avoid a finding of prior invention by relying on an invention date earlier than the filing date. Id. at *15-*17. The court concluded that the patentee could only rely on an earlier date if it could establish an invention on that date by clear and convincing evidence. The court's reasoning, with which we concur, was as follows:
As is apparent, the Court assigned the burden of proof on this issue to Diasonics. Diasonics vigorously disputed this assignment, arguing that the burden of proof should be on Acuson to show prior invention. Diasonics relied on the fundamental statement of patent law that a lawfully issued patent is presumed to be valid. In contrast, Acuson relies on the proposition in patent law that the date of invention is presumed to be the date of the patent application. There is no precedent directly on point for the Court's decision to assign the burden of proof to Diasonics on this issue.
The Court is convinced, however, that the only sensible resolution of these conflicting presumptions is that the inventor must bear the burden of proof when it is the inventor who seeks to establish a date of invention before the application date. Generally, burdens as assigned to the party who seeks to prove the truth of the fact asserted, and reality would seem to dictate such an assignment in patent priority of invention contests. If the burden is on Acuson to establish Diasonics' date of invention, Acuson's only incentive is to produce no evidence to meet this burden. The situation remains essentially the same if the burden of proof remains with Acuson and the burden of going forward with evidence is assigned to Diasonics. In the absence of precedent, the Court looks to common sense solutions and it is apparent to this Court that this assigns the burden of proof to Diasonics in this case.Id. at *15.
We find the reasoning of the Diasonics court compelling. We also find that the imposition of the burden of proof on the patentee in other invalidity contexts supports applying the burden here, too. Therefore, were we to conduct a new trial, to establish an invention date earlier than the filing date for purposes of defeating a claim of prior invention we would require plaintiff to prove (by some standard) "either (1) conception plus diligence or (2) conception plus reduction to practice," Id. at *16, as of plaintiff's asserted invention date.
The need for this legal standard to be determined before any retrial is especially highlighted in this case, where the inventor has admitted under oath at trial that he knowingly failed to disclose the best mode of practicing his invention when he certified his original patent application. (See Section VIII.B.1 supra.) In that connection, we note that in the event of a retrial of this case on the issue of prior inventorship, we anticipate a motion by defendant to reopen the pleadings and discovery to the extent necessary to conform the pleadings to the new revelations by Dr. Guzman at trial. See Fed.R.Civ.P. 15(b).
The attorney upon whose advice Dr. Guzman says he acted in withholding information in the original patent application is currently listed as a practicing attorney in this state. It appears that by presenting that testimony at trial, plaintiff has waived any attorney-client privilege that Dr. Guzman may have had during the prosecution of the `172 patent. The crime/fraud exception to the privilege may also apply. Therefore, the files and recollection of that attorney and any others with relevant knowledge on the subject of the patent prosecution will likely be subject to discovery by defendant prior to any retrial on this issue. Discovery may also be necessary to explore other areas opened up by Dr. Guzman's self-contradictory testimony on the issue of his invention date.
IX. Plaintiff's Claim of Infringement
A. Legal Principles
Infringement is governed by Section 271, which states in pertinent part:
[W]hoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States . . . during the term of the patent therefore, infringes the patent.35 U.S.C. § 271(a).
Infringement is a two-part analysis. First, the court must construe the patent claims. Second, the factfinder must determine whether the accused device reads on the claims as construed.Prima Tek II, L.L.C. v. Polypap, S.A.R.L., 318 F.3d 1143, 1148 (Fed. Cir. 2003); Hybritech Inc. v. Abbott Labs., 849 F.2d 1446, 1455 (Fed. Cir. 1988). Claims are construed the same way for purposes of validity and infringement. Markman, 52 F.3d at 996 n. 7 (Mayer, J., concurring).
Plaintiff claims literal infringement in this case. Specifically, plaintiff claims that defendant's P/ACE devices infringe claim 32 of the `172 patent. Defendant stipulates that all models of its P/ACE 2000 and 5000 series are identical for purposes of this analysis. (Final Pretrial Order at 7, docket entry 71.)
Defendant was granted summary judgment of noninfringement under the doctrine of equivalents early in the case. (Docket entry 28.) The Federal Circuit ruled that because that determination was not contested in the prior appeal, plaintiff was foreclosed from relying upon the doctrine of equivalents at trial. (Fed. Cir. Op. at 5, n. 2.)
"Literal infringement . . . requires that the accused device contain each of the claim elements and their recited limitations." Signtech USA, Ltd. v. Vutek, Inc., 174 F.3d 1352, 1358 (Fed. Cir. 1999). A patentee claiming infringement must prove that claim by a preponderance of the evidence. Carroll Touch, Inc. v. Electro Mech. Sys., Inc., 15 F.3d 1573, 1578 (Fed. Cir. 1993).
The jury found that plaintiff met its burden of proving by a preponderance of the evidence that the P/ACE devices infringe claim 32. (See n. 13 supra.) The Court should grant defendant judgment as a matter of law only if, viewing the evidence in the light most favorable to plaintiff, there is no legally sufficient evidentiary basis for a reasonable jury to have reached that verdict. Alternatively, a new trial may be granted only where the verdict is contrary to the great weight of the evidence. (See Section VII supra.)
B. Claim Construction
The only limitations of claim 32 at issue in defendant's post-trial motions are the "holder" language of element 6, and the "secured to a support member" language of element 8. (Def. Inf. Br. at 8-11; Pl. Br. at 5-10; Def. Inf. Rep. Br. at 1-5.) Here we again quote just those portions of claim 32, in context:
(6) a holder for holding an end of said capillary tube in operative relation with one of the said cups, . . ., and
(7) said capillary tube is in the form of a coil of glass tubing
(8) secured to a support member.
(P-72; P-1, col. 23, Il. 42-47; see n. 3 supra.)
This Court performed the claim construction step of the infringement analysis at trial. We instructed the jury to give the words of claim 32 their ordinary English word meaning, with certain stated exceptions. (See nn. 14 15 supra and accompanying text.) All of the words quoted above were subject to that "ordinary meaning" construction, except that the phrase "in operative relation" was construed to mean "that the end of the capillary can move toward the cups or the cups can move upward toward the end of the capillary." (see n. 15 supra.)
Here we note that the word "holder" is part of the phrase in element 6 that is quoted above. In the following discussion we will refer to the word "holder," read in the context of that phrase, as the "holder limitation," or the "element 6 holder."
The claim construction performed by this Court during trial construed the "means plus function" language of element 3 as incorporating by reference the "holder limitation" found in element 6. (See nn. 16 17 supra and accompanying text.) For convenience in this opinion, we will refer to the "holder limitation" as if it is found in element 6 only.
We likewise observe that the words "support member" are part of the entire clause constituting elements 7 and 8: "said capillary tube is in the form of a coil of glass tubing secured to a support member." We will refer to the words "secured to a support member," read in the context of that clause, as the "support member element," or "element 8."
We use the term "clause" to describe a portion of a sentence that contains a subject and a verb, and thus could stand as a separate sentence. We use the term "phrase" to describe a portion of a sentence that has a subject, but no verb. By those definitions, the word "holder" is part of a phrase in element 6; and the words "support member" are part of a clause that spans elements 7 and 8.
C. Review of the Evidence
Defendant did not dispute at trial that its accused device is a capillary electrophoresis apparatus containing the features described in elements 1 through 5 of claim 32. Those features include a capillary tube that can be electrically charged, having first and second ends, a high voltage power supply to cause the sample in the capillary to flow past a detector, and a rotatable table carrying a plurality of sample cups. Defendant also agreed that the cups in its device move upward toward the end of the capillary (element 6 "in operative relation" limitation), and that its device includes glass capillary tubing that may be in the form of a coil (element 7 "in the form of a coil of glass tubing" limitation).
The issue on infringement, based on the evidence at trial, reduces to this: Does the accused device have both an element 6 "holder," and a feature as claimed in element 8? Plaintiff has taken the position, both during the prior appeal and at trial, that the "holder" in the accused device is "either the cartridge which houses the coiled capillary tube itself or the plugs which seal the capillary tube ends to the cartridge wall at the inlet and outlet openings." (See, e.g., Fed. Cir. Op. at 11-12, quoted supra n. 12.) Plaintiff contends that the mandrel located inside the P/ACE cartridge satisfies element 8. (Tr. 9 at 32-34.)
Defendant argues that the configuration of its accused device does not feature any "holder" that can be distinguished from the support member that secures the coiled capillary. Therefore, defendant contends, its device does not have both a "holder for holding an end of the capillary tube in operative relation with one of [the] cups" (element 6), and (also element 6) a "support member" to which the capillary tube in the form of a coil of glass tubing is "secured" (element 8).
The parties do not dispute the physical features of the accused device, or the contents of the accompanying product literature. Actually, both parties rely heavily upon that body of evidence in support of their respective positions on the infringement issue. Here we will summarize that evidence. Next we will summarize the testimony presented by each party on the issue of infringement.
1. Description of Accused Device
This description of the accused device is derived from the text and drawings contained in defendant's P/ACE product documents, placed in evidence by plaintiff, including: P/ACE Operating Manual (P-49) and Beckman Capillary Replacement Procedure (P-50). Also admitted into evidence at trial was an actual P/ACE capillary electrophoresis instrument (D-88), with an accompanying P/ACE UV capillary cartridge (P-46).
The main component of the P/ACE capillary electrophoresis device is called a "UV capillary cartridge." (P-49, pg. 3-6, Fig. 3-4.) The parties do not dispute that the entire length of the capillary is contained within the P/ACE cartridge, except a portion at both the inlet end and the outlet end of the capillary that protrudes from the cartridge. The capillary is a continuous, unbroken tube from inlet end to outlet end.
In this section we refer to the cartridge in the accused device as the "P/ACE cartridge", or simply "cartridge" where the context makes it clear that the reference is to the P/ACE cartridge.
The detection point along the capillary is located inside the P/ACE cartridge. (P-49, pp. 3-7.) The location where the capillary can be coiled is also located inside the cartridge. (Id.) Looking at the capillary beginning at its inlet end, the location for coiling the capillary inside the cartridge is found before the contents inside the capillary flow past the detection window. After the capillary contents flow past the detection window, the contents exit the capillary through the outlet end of the capillary. (See P-50 at 7, 15.) Coolant fluid flows through the cartridge to maintain constant temperature around the capillary within the cartridge. (P-49, pg. 3-7.)
The P/ACE cartridge is manually inserted into the P/ACE instrument. (Id.) When the cartridge is in that position, the bottom of the cartridge is the exterior surface of the cartridge through which the inlet and outlet ends of the capillary protrude. The bottom of the cartridge contacts an interface mechanism. The two ends of the capillary, protruding through the bottom of the cartridge, each fit through a hole in the interface and extend downward, "protected within four plastic fingers." (Id., pg. 3-8.)
The P/ACE Operating Manual describes the functions of the interface mechanism as follows:
The interface mechanism performs several functions: it aids in coupling the capillary to two of the vials in the autosampler, creating a bridge between two electrolyte solutions; it houses the electrodes connected to the high-voltage power supply; it opens the flaps on each vial cap, allowing the capillary and electrode access to the fluid in the vial; and it provides a sealing mechanism for the openings surrounding the capillary ends and the inlet and exit openings for the coolant in the bottom of the capillary cartridge, preventing leakage.
(P-49, pg. 3-8.)
Each capillary end is immersed in a fluid vial during a run. (Id.) The vials are located on two concentric autosampler trays. (Id., pg. 3-2.) One tray is used to hold inlet vials; the other is used to hold outlet vials. "One vial in the larger tray and one vial in the smaller tray are always in position beneath the ends of the capillary located within the cartridge interface. . . . When these two vials are pneumatically raised from the autosampler, the ends of the capillary (and the electrodes) are immersed in the fluid in the vials." (Id.)
The configuration and parts of the P/ACE cartridge are described in detail in the product booklet entitled "Capillary Replacement Procedure," exhibit P-50. The following drawings, with accompanying text, are included in that booklet.
This is an overview of the P/ACE cartridge with its lid in place. The detection aperture is shown as the round opening near the lower right corner of the cartridge. The other five round features shown on the lid are occupied by Phillips-head screws.
(P-50 at 22.)
This is an overview of the P/ACE cartridge with its lid removed. This drawing labels the inlet and outlet ends of the capillary, and the mandrel location where the capillary is coiled. The detection location, although not labeled in this drawing, can be seen in the same position as in the above drawing.
(Id. at 7.)
The Capillary Replacement Procedure booklet sets forth a 5-step method for removing an existing capillary from the cartridge, followed by an 11-step method to install a new capillary. One can observe at close range the configuration inside the cartridge by reviewing those steps, as illustrated by the drawings. We can summarize and illustrate that configuration as follows.
The housing of the cartridge consists of a lid and a base. The lid contains the aperture for use with the detector optics. (P-49, pg. 3-7.) It also contains five screw holes, and its surface is molded in a certain shape. (See P-50 at 22, drawing shown above.) The base receives the rest of the cartridge components. We will describe those components from the floor of the base upward, moving generally from the inlet to the outlet side of the cartridge.
The base half of the cartridge body is referred to in P-50 as the "cartridge bottom." (See P-50 at 17.) However, we will refer to that structure as the "cartridge base" here for clarity, because we will be looking at the cartridge from an overview perspective with the lid removed during this description. In actual operation, the completely assembled cartridge is inserted into the capillary electrophoresis instrument in such a position that the external surface of the cartridge through which the capillary ends protrude becomes the "bottom" of the cartridge, as described supra.
The capillary enters the cartridge on the inlet side through the cartridge inlet hole. (Id. at 17.) There is a rubber plug inside the cartridge inlet hole. That part is shown as follows:
(Id. at 2; see also id. at 19, infra.)
There is an oblong sealant strip on the cartridge base immediately inside the inlet hole. That part is shown as follows:
(Id. at 2.)
The capillary lies flat as it crosses over the inlet sealant strip, then remains flat on the cartridge base as it travels between three pairs of small posts molded into the base. (Id. at 17, 18.) We will refer to the small posts in the cartridge as "guideposts." An inlet clamp is positioned over the capillary between the second and third pair of those guideposts, and screwed into place. The locations of the scalant strip, guideposts and clamp on the inlet side of the cartridge are shown as follows:
(Id. at 18.)
The next location in the cartridge base is the mandrel location. There, a large post is molded into a well in the base. (Id. at 17.) We will refer to that post as the "mandrel base post." The mandrel base post has a keyed opening to receive a protruding guide on the bottom of the mandrel. In this manner the mandrel and the mandrel base post are keyed to ensure proper positioning, allowing the mandrel to seat completely, as shown:
(Id. at 17.)
The capillary enters the mandrel area along the inner side of a post molded into the mandrel, called a mandrel post. (Id. at 14.) A short length of tubing called "capillary retainer tubing" is positioned over the capillary on that mandrel post, as shown:
(Id. at 12.)
The capillary retainer tubing is shown here:
(Id. at 2.)
The mandrel itself is grooved. (Id. at 14.) The capillary is next wound around the mandrel the prescribed number of turns depending on the total length of capillary, as follows:
(Id. at 13.)
The capillary leaves the mandrel at the outlet end of the mandrel, on the inner side of another mandrel post covered by another capillary retainer tube. (Id. at 12.) Next, the capillary travels along the cartridge base in the direction of the aperture plate. (Id. at 17.) Another pair of guideposts stands just before the capillary reaches the detection aperture area. The capillary passes between those guideposts and over another sealant strip, then arrives at the aperture area.
(Id. at 10.)
The aperture area consists of two semi-circular posts surrounding just that area. Within those aperture posts, on the floor of the cartridge base, is an oblong "aperture plate" positioned perpendicular to the path of the capillary, with an "aperture plate groove" running across the center of the aperture plate in the direction of travel of the capillary. The capillary travels across the aperture plate centered into the aperture plate groove, and the capillary window is centered on that groove. Then a large clamp, also known as the outlet clamp, is positioned over the capillary and screwed in place, so that small grooves in the underside of the clamp are holding the capillary in place over the aperture plate. (Id. at 2, 16.) The aperture area is shown below.
The next portion of capillary, beyond the outlet clamp, travels over another scalant strip, between two more sets of guideposts, and over one more sealant strip. (Id. at 10.) It then travels out of the cartridge through the cartridge outlet hole. The aperture area and the adjacent outlet area are shown here:
(Id. at 16.)
The cartridge outlet hole is equipped with the same type of rubber plug found in the cartridge inlet hole, shown as follows:
(Id. at 19.)
The capillary ends protruding from both the inlet and outlet sides of the cartridge are trimmed to equal length using a cleaving stone and alignment guide plate. (Id. at 20.) The cartridge is completed by installing a large and small gasket on the base at specified locations, and attaching the cartridge lid to the base with five screws. (Id. at 21.)
The base of the cartridge also has holes for coolant fluid to circulate in and out of the cartridge during use. Those coolant openings are located in the base of the cartridge between the capillary inlet and outlet holes. (P-49, pg. 3-7.)
2. Plaintiff's Evidence on Infringement
Plaintiff presented Dr. Guzman as an expert to provide his opinion testimony comparing the elements of claim 32 with the accused device. (Tr. 8 at 204-06.) Plaintiff also presented deposition testimony of defendant's employee Dr. Osborne in support of its infringement claim. (Tr. 11 at 25-53.) The areas of that evidence pertaining specifically to the disputed elements of claim 32 (elements 6 and 8) are summarized in this subsection.
Plaintiff's counsel also cross-examined defendant's witnesses Osborne and Burolla at trial. That testimony is included with the direct testimony of those witnesses in the next subsection. Likewise, defendant's cross-examination of Dr. Guzman on the disputed infringement points is included in this subsection.
a. Dr. Guzman
Dr. Guzman testified that in his opinion the accused device has all elements of claim 32, including an element 6 holder and a feature corresponding to element 8. (Tr. 9 at 15, 32-35.) The following is a representative sampling of his testimony directed to those two elements:
Q Limitation 6, do you have any evidence from PX-49 [the P/ACE Operating Manual] with respect to that element?
A Yes. Here we have — the holder is there. The whole cartridge cassette.
We have found it necessary to quote Dr. Guzman's testimony at length in this subsection rather than try to summarize it, so that his exact words may be shown. In this subsection, as before, we continue to correct obvious transcription errors and delete irrelevant material that does not affect the meaning of the quoted text. (See n. 40 supra.) We also include necessary explanatory references in brackets. We note that some of the testimony quoted in this subsection has transcription errors in key testimony. Where that occurs, we have reviewed the trial recording and have substituted the erroneous text with the corrected text in brackets. Again, the parties are invited to participate with the Court in resolving any disputes concerning the official trial transcript if that becomes necessary. (Id.)
Q For instance, take a look at Page 3-3 of PX-49.
A The figure 3-2?
Q Yes. Do you find evidence relating to Limitation 6 on that page?
A Yes. I think I mentioned — we have an auto-sampler with two vials, which are always positioned beneath the cartridge interface. So these two vials have to be in such a way that they will be — every one of the ends of the capillary, which is the inlet and the outlet submerged in the liquid.
Q During operation of a PACE instrument, the ends of the capillary are stationary, correct? [Yes.]
Q They don't move at all, right? [Yes.]
Q So what happens? How do they cooperate or relate to, the sample cups which you've described in connection with the rotatable table?
A Well if they are in a stated position, there has to be something that holds two ends of the capillary. If not, the capillary will drop. And they have to be in a relationship with the two cups that we have beneath the inlet and the outlet. So the capillary itself has to be holded in one way or another.
Q [C]an you describe the movement of the cups as it relates to the stationary capillary tube?
A There are two tables, the inner and — table — sample and the outer. So they move in a position drive either by the computer until you find two individual holes which contain the two vials. And they will be pneumatically pushed up in such a —
Q What's pushed up?
A The two vials. And so they will be in a relationship in a coordination with each one of the two ends of the capillary.
Q In other words, the rotatable table positions the cups in the right place —
A Positions the cups in the right place until they find which one of the two cups are related to the separation or the additional buffers or sample.
Q So one of the cups is under the inlet end and one of the cups is under the outlet end of the capillary, right? [Yes.]
Q Then there's a device in the machine that pneumatically pushes the cups up —
A That is correct. And then —
Q — so the cup is in operative relation with the end of the capillary, correct?
A Is in operative relation with the end of the capillary. And in any particular time when you only need two vials to be in this operative relationship.
(Tr. 9 at 16-19.)
Q Turn to Page 3-5 of PX-49. And do you see any information on that page that relates to Limitation 6?
A Yes, this one sentence here say, "When the vials are in position pressing keys to manually raise or lower the vials or running a process —" — I presume through the computer — "cause pneumatic cylinder to raise the vial holders so that the ends of the capillary are immersed in fluid."
Q So that passage there on Page 3-5 confirms what we just talked about?
A Yes.
(Id. at 19-20.)
Q Turn the page to 3-6 [of P-49]. And is there any evidence on Page 3-6 that relates to the presence of Limitation 6 in the PACE instrumentation?
A Yes. Here is a sentence that say, "The ends of the capillary protrude through two sealed openings in the bottom of the housing."
Q How does that relate to the holder limitation of Element 6?
A Well here "protrude through two scaled openings," there are some blue plug in the cartridge cassette that would be also holding the capillaries and one of the end of the capillary — and an end of the capillary.
Q What is the holding structure utilized by PACE for the purposes of Limitation 6?
A Well my opinion is the whole cartridge as a whole, with some of the components within, and the plug in which the capillary will protrude and pass through those little blue plugs.
THE COURT: So repeat that. The whole cartridge?
. . . .
Q Do you have the question, Dr. Guzman?
A Yes. The holder in the PACE device is the whole cartridge with some of the components that keep the capillary in a holding position, including the two blue plugs which the capillary protrude at that particular end.
(Id. at 20-22.)
Q Turn to Page 3-8 [of P-49], specifically Figure 3-6, and tell us if you have anything to say about Limitation 6.
A Well here in Figure 3-6, the cartridge interface, both ends —
. . . .
Q I believe you were reading from the caption which appears in connection with Figure 3-6? [Yes.] Okay. Please do so — so you have a complete thought on the record.
A The cartridge interface, both ends of the capillary extend through the interface and are immersed in fluid vials during a run.
Q So the ends of the capillary tube are in operative relation with the cups, correct?
A That is correct.
(Id. at 22-23.)
Q Page 17 [of P/ACE Capillary Replacement Procedure booklet, P-50] is the view with the pair of hands inserting the mandrel into the cartridge, correct? [Yes.]
Q In fact, Page 17 tells us quite a lot with respect to Claim 32? [Yes.]
Q It shows the capillary tube?
A Yes. This is the capillary in a coil position in the mandrel, so —
Q It also shows the first and second ends of the capillary protruding through the wall of the housing?
A Yes — that was the prior claim that we just focused on — in the coil.
Q No, I understand — we're focusing on [element] seven, but I'm broadening my question — to extend to certain of the other limitations. And page 18 shows us some of the same information again, doesn't it?
A The same information but now they have some of the components within the cartridge cassette, the clamps, for instance, that they will screw to the capillary to make it in a secure position there as a holder.
Q So the word clamp appears in two places on Page 18? [Yes.]
Q The drawings on Page 18 also illustrate where those blue plugs would be placed that you described earlier?
A That is correct. . . .
(Id. at 25-26.)
Q That brings us to the last limitation of the claim, Number 8. And the question becomes whether the PACE instruments have the coiled capillary secured to a support member. Where do you find evidence of that?
A In . . . [P-50]. . . . On Page 13 is — a mandrel.
Q Now we're back to the little boy with the capillary. The word mandrel doesn't appear in connection with the illustration, but of course it does appear in the right heading of the table? [Yes.]
Q So is it your understanding that the mandrel described in PX-50 satisfies Limitation 8 of Claim 32?
A Support member, yes.
Q [Refer to P-50, page 14 the language under the second heading which includes the word note.] The last entry on the page, although it's really only in the middle of the page.
A There are two "note." One is at the end.
Q I want to direct you to the second "note" [P-50, page 14]. What does that say?
A . . . "If the capillary is loose, carefully pull the end of the capillary until it is tight around the mandrel."
Q That's an instruction in the Beckman document to secure the capillary to the support member?
A That is correct.
(Id. at 32-34.)
Q [Compare the claim language to the actual device, referring to P/ACE instrument (P-88) and P/ACE cartridge (P-46).]
A . . . This is the end of a capillary. It's not a tip of a capillary, just the end because the capillary could be as long as one meter in length. And in going operation because as you can see here, the only time that this can function is when one of the two vials, one at the inlet and one at the outlet, are in operative relationship. So that will satisfy Limitation number 6, which is the holder for holding an end of the capillary. And then again, I'm not sure if I can open this or not, but the holder is the overall cartridge with some of the components that you saw internally, to be the clamps, but also there is a blue plug there which may have more than one function, but here also holds the capillary. . . . So that is what we have for Limitation 6. Once again I repeat, the overall cartridge with a component inside and the blue plug which will hold an end of the capillary.
. . . .
Q [W]ould you relate the schematic, which appears on Page 17 of PX-50, to the cartridge cassette that you have in your hand [P-46]? Would you explain to the jury how we would get to here if we were to take that apart?
A Basically, if we have a capillary in the air, it's going to basically drop to the floor. We have to have some system to hold it. So here we have (inaudible) which is holding it and also have the blue plugs at the end of the system there of the two capillary which protrude through that aperture —
. . . .
Q [Remove the lid of the P-46 cartridge and continue with this answer.]
A Here you have the inside part of the cartridge. And this is the mandrel here. But I cannot get it out of mandrel because of the support here with a little clamp. But if you remove the clamp, you can see. So the first of that is to maintain in a steady position. If not, this will go out. Then there is a second plug in this position here which is also holding the capillary in a very steady position because this is the area in which the window has been removed. . . . So it's very fragile, this area. And this you see, it break. The one with the (inaudible) — you can bring it around and nothing happens. So then we have some new putty as the children play with. It's like little rubber. And that basically helps that the liquid will be maintained in this area. And finally we have —
THE COURT: You mean a cooling liquid?
THE WITNESS: Yes, the cooling liquid.
A And finally we have those blue plugs that maintain the capillary in a position that is going to be very straight. And this will be, like I mentioned to you before — there will be a cup here, another here, so it will be in operative relation to that.
. . . .
THE WITNESS: [Element] Number 8 was secured to a support member. And this is the support member, the mandrel. And here is something really interesting. There are some little sleeves there — one at every end. And this maintain it in a very steady position. If I do this and you remove this, it separates. It no longer will be — so there are many different ways of considering something that is holding the capillary. But this whole thing, the mandrel, is the support member, is to secure the capillary.
(Id. at 35-45.)
Q The white cylinder that we've called 303D [part of Guzman metallic prototype P-20], that's a holder of the type described in Limitation 6 of Claim 32? [Yes.]
A Where is the holder placed in relation to the end of the capillary, not only in PX-20 but in terms of the language of the patent?
A Well the holder has to be in relation, in operative relationship with the cups. So when this goes up, this move, another one come, goes down. And so there is an end. It's not a tip of the capillary — a certain —
Q What's not a tip?
A Well I'm not holding the tip of the capillary here. If I hold it here, it would never work.
THE COURT: Here meaning what?
THE WITNESS: The tip of the —
Q At the very end, in other words?
A At the very tip, yes, that's what I call the tip, the very end of the capillary. So — but an end of the capillary is all this portion that goes after that.
Q In other words, the end of the capillary is that portion of the capillary which extends beyond the holder, is that what you —
A That is correct.
Q And it extends beyond the holder so it can be immersed into the sample cup or the buffer cup, correct? [Yes.]
Q The holder is not at the very tip of the capillary?
A No. The holder is here. I'm holding it here. Okay. You can see that. I can adjust it also different dimension depending on the tube.
Q Look at PX-46 [the P/ACE cartridge], and explain what you just said in connection with the holder and the end of the capillary? I'm just asking [you] to explain the spatial relationship between the holder and the end of the capillary tube.
A This is basically the same. In order to be in operative relationship you can see that you need a distance from — this called a holder which in this case is the blue plug which is holding that, but you need a space, a certain distance and length of capillary.
Q How much of the capillary stands beyond the holder in connection with PX-46?
A It will vary from instrument to instrument. But in this particular case, it's probably an inch and a half, two inches.
(Tr. 10 at 7-9.)
Q What touches the end of the capillary, that is the portion beyond the blue plug, in the Pace device?
A I give you two answer, in the air, nothing touches the capillary. In the tube, the liquid touches the capillary. When — immersed in the tube, it touch the liquid.
Q It touches the liquid, okay.
A Is that correct?
Q Yes, it has to touch the liquid to work. Doesn't it? [Yes.]
Q Doesn't every capillary electrophoresis device have to touch the liquid in order for the liquid to get into the capillary?
A Yes.
(Id. at 128.)
Q You stated that in the Pace device [P-46], that it is your position that the end is held in that device, in order to read your Claim onto it? Is that your position?
A By the blue plug.
Q No, how about the portion which you have defined as the end, which is the portion beyond the blue plug?
A Yes.
Q That's held, in your opinion, right?
A Yes.
(Id. at 128-29.)
Q On Friday you held a screwdriver, remember that? And I read it into the record, when you were holding a screwdriver and you held it in your hand, like this, and you said, this is holding the end of the screwdriver, correct?
A An end.
Q An end, yes.
A Yes, I didn't say the end.
. . . .
Q [S]uppose I did this. Am I holding two ends in operative relation if they're both — the vials? Let the record reflect I'm holding a tape measure, I have the 40 inch mark, and I've got approximately 40 inches on each side, dangling in a U. Am I holding the ends in operative relation?
A Doesn't say in the Claim.
(Id. at 129-32.)
Q That limitation, Number 6, does not describe a holder system, does it?
A No.
Q It describes a holder and uses the word holder? [Yes.]
Q In unqualified fashion, correct?
A Yes.
(Id. at 169.)
Q Does Limitation 6 of Claim 32 require the holder to be in the absolute tip of the capillary?
A No.
(Id. at 177.)
Dr. Guzman also compared the claim language of claim 32 to the features of his own metallic prototype, exhibit P-20, and one or more versions of his cartridge cassette. (Tr. 9 at 47-52; Tr. 10 at 3-8.) Extensive cross and redirect examination ensued, pertaining to the specification language and drawings of the `172 patent. (Id. at 94-122, 169-75; Tr. 11 at 18-23.) Throughout that testimony, Dr. Guzman identified distinctly separate structures as corresponding to the element 6 holder and the element 8 support member of his claim 32 invention. (See also Tr. 8 at 89-91.)
b. Deposition Testimony of Dr. Osborne
Plaintiff introduced deposition testimony of Dr. Osborne, vice-president of chemistry development for Beckman, as part of plaintiff's evidence on the issue of infringement. (Tr. 11 at 25-54.) Representative portions of that testimony pertinent to disputed elements 6 and 8 are as follows:
Q [T]he ends of the capillary tube are always in operative relation to an inlet cup and an outlet cup?
A During operation, that's correct.
(Id. at 33.)
Q Do all of the cartridges presently sold by Beckman have a mandrel? [Yes.]
Q If the cartridge is equipped with a capillary tube, is the capillary tube coiled around the mandrel?
A It depends upon the length of the capillary tube that's in there. If it is required to be coiled around the mandrel to fit the system, yes.
(Id. at 36-37.)
Q [P-51, page 8] has additional instructions for securing the tube to the mandrel? [Yes.]
Q It says that after the capillary has been coiled around the mandrel the appropriate number of times, the capillary should be held firmly so that it is tight around the mandrel? [Yes.]
Q In fact, the document includes an additional instruction that if the capillary is loose, it should be tightened so it is secured to the mandrel?
A Yes. You said secured to the mandrel. The capillary is to be pulled until it is tight around the mandrel.
Q That's what the document says?
A Yes.
(Id. at 43.)
Q [Ref. to P-49, page 3-6, top heading.] That refers specifically to the UV capillary cartridge? [Yes.]
Q Thereafter, it describes the cartridge and indicates that the ends of the capillary protrude through two sealed openings in the bottom of the housing?
A Yes.
(Id. at 46.)
Q When the machine is in operation, namely any one of the P/ACE 2000 instruments, is the cartridge cassette moving?
A No. We do not want the cartridge cassette to move in any of our systems.
Q Nor do you want the tube to be moving?
A No. We do not want the capillary to be moving either.
Q The capillary is intended to be in proximity to the inlet and the outlet cups?
A The inlet and the outlet cups are designed to be under the inlet and outlet capillary tips.
. . . .
Q The way I understand, the way the instrument works is that in order to get the end of the capillary tube to cooperate with the cup, the cup is lifted by a pneumatic piston from the auto-sampler table, right?
A That's correct. We do not move the capillary or the cartridge. We move the inlet and outlet reservoirs.
Q So you bring the cups to the end of the tube, is what you're saying?
A We position the cups under the ends of the tubes and then the pneumatic system lifts them to the capillary.
(Id. at 48-49.)
Q What holds the end of the capillary tube above the cup when the electrophoresis analysis is being conducted?
A I didn't quite understand that. The cup is positioned under the inlet and outlet tubes during separation.
Q Right, And what I'm asking you is what is holding the inlet and outlet ends of the tube in relation to the cups during the separation analysis?
A The pneumatic piston — that raises the buffer reservoirs.
Q The pneumatic piston is raising the cup, right? [Yes.]
Q But the pneumatic piston doesn't hold the capillary tube, right?
A We don't hold the capillary tube.
Q Then how does it stay stationary during the operation of the instrument?
A That's why we have a cartridge.
Q And what you are telling me then is it's the ends of the capillary tube are protruding through the openings in the cartridge as reflected by Figure 3-4, correct? [Yes.]
Q In fact, the ends of the capillary tube are protruding through two sealed openings, correct?
A Yes.
Q Those two sealed openings are mounted on the cartridge housing as reflected by Figure 3-4, right?
A Yes.
(Id. at 49-51.)
Q [Ref. to P-49, page 3-7, first sentence.] It says that within the cartridge, the capillary tube is wound around a mandrel a number of times depending on its length? [Yes.]
Q The capillary tube is coiled around the mandrel?
A Yes.
(Id. at 51-52.)
3. Defendant's Evidence on Infringement
It will be recalled that Dr. Osborne was the senior executive at Beckman in charge of the P/ACE development project, and Mr. Burolla was the team leader on the project. (See Section VIIsupra.) Defendant presented their trial testimony on the issue of infringement. (Tr. 11 at 57-84; Tr. 12 at 3-33; Tr. 14 at 11-108.) The areas of that evidence pertaining specifically to the disputed elements of claim 32 (elements 6 and 8) are summarized in this subsection.
a. Mr. Burolla
Mr. Burolla's testimony concerning the development of Beckman's first capillary electrophoresis prototype, called OTEP I, is described supra, Section VII. His further testimony, directed to the OTEP II prototype and the P/ACE commercial product, may be summarized as follows.
One of the disadvantages of OTEP I was that the capillary was threaded through a series of blocks or boxes, with fittings tightened around the capillary at each capillary hole, and was prone to breakage. (Tr. 14 at 23, 37-38, 42-44, 52-53, 60-62.) That disadvantage was overcome in the design of the OTEP II prototype by introducing two differences:
Q Describe how the OTEP II prototype differed from OTEP I.
A Basically there were, well, at least two differences. OTEP II used a capillary cartridge instead of the scheme that I showed earlier about threading the capillary through several boxes. In addition to that, the acrylic holders that I described on either end were changed so that the capillary did not have to be threaded through any fitting. The capillary simply passed through that block. When the cartridge was placed on top of those holders it had an O-ring. So the O-ring created the necessary gas seal and the capillary didn't have to be touched, it just simply passed through the block.
Q Why was OTEP II designed to avoid threading the capillary down into a block?
A Because I got tired of replacing capillaries that I broke, and it was a very tedious process. It could take as long as a half an hour, primarily because when you're threading the capillary you also, prior to threading the capillary you have to burn off the protective coating of the capillary in the detection area, and that made the capillary there very, very delicate. It's this coating, this plastic coating, that allows you to wrap it around things and become very flexible. So if you have to do that before you thread it through everything there — it greatly increases the chance that you're going to break it in the process of threading it through everything. With the capillary cartridge we avoided that.
(Id. at 60-61.)
Mr. Burolla was involved in developing the P/ACE commercial product, which resulted from further steps in the development process after OTEP II. (Id. at 70-71.) As such, he is familiar with the features of that product, including the P/ACE capillary cartridge.
The main difference between the OTEP I design and the P/ACE instrument is the way the capillary is introduced into the vial on the sample table. "In the P/ACE instrument, there's no disturbance of the capillary from the cartridge into the vial." (Id. at 84.) In contrast, the capillary in OTEP I had to go through an acrylic block near the inlet and outlet end, "that had the ferrule in it that we had to tighten to hold the capillary in place." (Id.)
Q [Contrast OTEP I and the P/ACE device.]
A . . . So the difference between OTEP I and P/ACE would be that the capillary, as it exists in the [P/ACE] cartridge, simply hangs down from the cartridge, and there is no attachment of the capillary to anything on the instrument prior to going into the vial.
Q And there's no structure for it?
A There's no structure, no.
Q Holding it?
A Basically there are holes in the interface block that the capillary goes through, and that's it.
(Id. at 85-86.)
The P/ACE cartridge includes the blue plugs from which the capillary protrudes from the cartridge on the inlet and outlet sides of the cartridge. (Id. at 78.) The function of those plugs is to prevent gas pressure from escaping during pressure injection of the capillary. The blue plugs do not hold the capillary. (Id. at 78-79.)
The pressure injection feature of the P/ACE device is described in Dr. Osborne's testimony summarized infra.
When the blue plugs are pushed out of their normal position in the capillary inlet and outlet openings of the cartridge, Mr. Burolla observes no change in the alignment of the capillary protruding from the cartridge as a result of removing the plugs from their normal position. (Id. at 77-78.) He acknowledges that in that demonstration position, the blue plugs pushed down on the exposed portion of capillary remain "in frictional contact" with the capillary. (Id. at 102-04.) He further agrees that to prevent escape of gas during pressure injection, the blue plugs as installed in the cartridge must have a tight fit with the capillary and the cartridge body. (Id.)
Q [I]t is your testimony that the cartridge of the P/ACE 2000 instrument holds the capillary, correct?
A Yes.
(Id. at 106.)
b. Dr. Osborne
Dr. Osborne's testimony concerning the development process for the P/ACE device is summarized supra, Section VII. Excerpts of his trial testimony describing the P/ACE device, as relevant to disputed elements 6 and 8, are as follows:
Q [Using a demonstrative, describe certain components of the P/ACE device.]
A This is a diagram of some of the components that we have in the P/ACE device. The cartridge is here. You see the capillary ends below the cartridge. The cartridge is inserted into this cartridge interface. You see four holes in that interface. Two holes are for the capillaries and the other two holes are an inlet and outlet for the cooling liquid that we use to cool the capillary. . . .
Q [E]xplain how the cartridge is inserted into the machine and what happens.
A We place the cartridge into the machine. The capillaries go into these two outer holes. We then latch it in place. You program the computer to turn these autosampler wheels to the vials that you want to interrogate. And then a pneumatic piston raises those [pneumatic] tubes up so that the ends of the capillary are inside the inlet and outlet tube.
Q You mentioned the cartridge interface, could you describe . . . what the function of that is?
A That interface has the electrode connections in it. It has the fluid for cooling the capillary inlet and outlet. And these devices are running sometimes at 30 kilovolts and so you really want to make sure that you don't get arcing and things like that. That's why we actually latch that cartridge in place with this latch on top.
Q [E]xplain how the buffer and then the capillary fluid gets into the capillary in the P/ACE system.
A Here's the coil and the cartridge. And . . . if you have a capillary that is 27 centimeters, you would not put it around that mandrel. It would just go straight over to the side. If it's 37 or higher centimeters, then you would coil it the appropriate amount of times around that mandrel. The cartridge bottom sits on the interface that we saw before.
Q Now could you show what of the interface is shown in this graphic, if at all?
A In this graphic, there are shown two holes that the capillary fits through the interface. So the capillaries extend through the interface into the inlet and outlet vials when the pneumatic piston has raised them up.
Q Does this graphic show the entire interface structure or is it cut away?
A This is a cut away. It's not the entire interface structure. It's just the part of it that the cartridge sits on. This particular diagram does not show the cooling fluid inlet and outlet either. In order for capillary electrophoresis to work, the capillaries on the inlet and outlet have to be in the buffer. And there is a cap on each of our inlet and outlet vials and you can see it diagramed here. And if the fluid in the inlet and outlet vials is higher than the cap, then it'll leak out and you'll get arcing. And so the operational ends of the capillary is really that part of the capillary that extends below these caps. So we have the — when the pneumatic pistons lift the tubes up, we now have the capillary operative ends in the buffer. This is a diagram of our positive pressure injection system. The caps on these vials actually make a seal on the bottom of the interface. We then pump gas in, and on the cartridge there's a seal so that we can maintain that positive pressure and we actually pressurize the buffer all the way through to the other side. Now you can also inject the sample and you would just have the pressure on for a smaller amount of time.
. . . .
Q Looking at those structures on the left [in the demonstrative], it's identified as gas sealing plug. Can you explain . . . what their function is?
A You want to maintain a positive pressure, and if you didn't have a gas sealing plug in the cartridge then you would not be able to reproducibly use positive pressure to get the buffer in or inject the sample.
Q Are these plugs the so-called blue plugs that we've been hearing about?
A Yes.
Q So the function of the blue plugs is to do what?
A It's [to] enable the positive pressure gas injection. Those blue plugs really don't have anything to do with the capillary electrophoresis run itself.
Q And what if one were to move the blue plugs, what effect if any does that have?
A You would not be able to have the positive pressure injection, but you would still be able to perform capillary electrophoresis. You would have to inject the sample and the buffer in a different way.
Q So if you remove the blue plugs entirely, what if any effect does that have on the capillary ends as you've been describing it?
A It would have no effect on that.
Q To sum up, what structure, if any, does the P/ACE system have for holding the ends of the capillary?
A As I said in my deposition, we don't hold the ends of the capillary.
Q [E]xplain one more time why that's the case?
A We found with Dr. Zare's device that if you manipulate the ends of the capillary, they're very fragile, they break, they'll split. There's a polyamide coating and if it cracks you can get arcing across the capillary ends. And so in the design that Vic Burolla and his team came up with, we did not want the capillary to move. If you remember Dr. Zare's device, the capillary moved. And so that's why we wrap it tightly around this mandrel. And we did not want to have the ends held by any other device.
(Tr. 12 at 6-11.)
Q [Refer to P-46, disassembled cartridge.] [T]hat's the part used on the P/ACE instruments, right?
A Once it's assembled, yes.
Q And it shows a mandrel sort of structured to the coiled capillary, right?
A Yes, it does.
Q And then there are the blue plugs that you identified in your testimony?
A Yes.
Q And that there's a portion or an end of the capillary protruding from the plugs, is that right?
A Yes.
(Id. at 32-33.)
Q In the actual P/ACE device as you described it . . ., what holds the ends of the capillary in operative relation . . . during the operation of a P/ACE device?
A We don't hold the ends of the capillary tubes.
Q Well, you hold the capillary with the cartridge cassette, do you not?
A The capillary is tightly wound or tightly supported by the cartridge, yes.
Q Right. And the ends of the capillary tube protrude through the cartridge housing?
A They protrude through the cartridge house, yes.
(Id. at 29-30.)
C. Conclusion on Issue of Infringement
There is no dispute in this case as to the configuration of the P/ACE cartridge, or the way that it is inserted and functions within the P/ACE capillary electrophoresis device. What is at issue is the nomenclature to be assigned to that apparatus, and thus whether the apparatus fits the language of elements 6 and 8 of claim 32.
Plaintiff points to the mandrel in the P/ACE cartridge as the element 8 feature. Plaintiff's position on what constitutes the element 6 feature is difficult to discern. Dr. Guzman in his trial testimony variously identified the clement 6 "holder for holding an end of said capillary tube in operative relation with one of the said cups" as the entire cartridge, or the cartridge and the interface into which it is inserted, or the cartridge with some of its components including the clamps and blue plugs, or the blue plugs alone.
Defendant's witnesses Burolla and Osborne agreed that the capillary itself can be coiled inside the cartridge, and that the coiled capillary is both wound around the mandrel within the cartridge and "tightly supported by the cartridge," to quote Dr. Osborne. (Tr. 12 at 29-30.) However, they would not agree that "an end" of the capillary is "held." Rather, those witnesses pointed to the fact that the portions of each capillary that protrude from the cartridge do not touch anything until they are immersed in the fluid in the vials.
The jury found in favor of plaintiff on the issue of infringement, as on the other issues submitted for its determination at trial. In our view, a reasonable jury could agree with plaintiff that the "end" portion of the capillary that protrudes from the cartridge is "held" in operative relation to the liquid in the cups by the cartridge, even though no structure touches the portion of the capillary that protrudes from the cartridge. The screwdriver analogy is helpful here: a screwdriver has a handle and a shank, with a point at the tip of the shank that must contact a screw for the screwdriver to function. Even though the handle does not touch the portion of the shank that extends out from the handle, the handle nevertheless serves as a "holder for holding an end" of the shank "in operative relation" with the screw. So too the P/ACE cartridge can be viewed as a "holder" that holds the ungrasped portion of capillary that extends down beyond the cartridge and into the vials in operation.
The problem with that concept, however, is that when the cartridge as a whole is deemed to be the element 6 "holder," then it becomes impossible to distinguish that "holder" from the element 8 "support member" for the coiled capillary. We reject as a matter of law that any reasonable reading of claim 32 could permit elements 6 and 8 to be the same structure. They are clearly separated by the conjunction "and" in element 6. Dr. Guzman acknowledged that his claim 32 invention contemplates that elements 6 and 8 refer to separate items.
Looking at the actual configuration of the P/ACE cartridge, the capillary is in fact tightly secured so that it cannot move at any location in its continuous travel through the cartridge. It is not just "secured to a support member" at the location where it may be coiled. It is secured to the cartridge housing throughout its travel through the cartridge by all the features put there for that purpose, including the capillary inlet holes (with or without their blue rubber plugs); the cartridge base itself with its numerous sealant strips and guideposts; the screwed-in capillary clamps in the inlet and aperture/outlet areas; the grooved mandrel keyed into the mandrel base post and the retaining tubes on the mandrel posts; the grooved aperture plate; and the gasket-sealed lid that completes the cartridge assembly.
We must also reject as a matter of law the notion that given the configuration of the P/ACE cartridge, the mandrel alone can qualify as the element 8 "support member" to which the coiled capillary is "secured." The relevant clause of claim 32, containing both elements 7 and 8, reads, "said capillary tube is in the form of a coil of glass tubing secured to a support member." It does not read "the coiled portion of said capillary tubing is secured to a support member." Comparing the literal claim language of element 8 to the P/ACE cartridge, the only reasonable factual conclusion is that the capillary inside the cartridge, which may be coiled at a certain location within the cartridge to accommodate varying lengths, is "secured" at every point in its travel through that cartridge, not just at the mandrel, and that the complete cartridge is the "support member" for the coiled capillary.
The patent file history reveals that during prosecution of the CIP application, when claims 1 and 39 had been combined into an amended claim 39 ending with the words "said capillary tube is in the form of a coil of glass tubing," the applicant added a new proposed dependent claim 50 that read as follows:
50. The apparatus defined in claim 39 wherein said capillary tube includes a portion in the form of a coil of glass tubing.
(D-3 at 88.) Claim 50 was rejected as both indefinite and obvious. (Id. at 96-98.) The applicant cancelled claim 50, in the same Amendment After Final Rejection that combined former claims 1, 39 and 40 into claim 32 as issued. (Id. at 101-04.)
We conclude that a reasonable jury could not find that the mandrel inside the P/ACE cartridge constitutes the element 8 "support member" for the coiled capillary, while also finding that all other parts of the cartridge constitute the element 6 "holder" for holding an end of the capillary. Nor could a finder of fact reasonably conclude that the "holder" limitation is satisfied in the accused device by the "blue plugs" alone, or some other assortment of cartridge parts except the mandrel. Similarly, no reasonable jury could find that the entire P/ACE cartridge embodies both the "holder" requirement of element 6and the "support member" requirement of element 8, although in actual operation the P/ACE cartridge does perform both of those functions. The inescapable fact is that the P/ACE cartridge is a unitary design. Call the P/ACE cartridge what you will, but it is not two structures, as required by claim 32.
This Court holds that claim 32 demands that elements 6 and 8 be two distinguishable structures, and no such distinguishable structures exist in the configuration of the accused device. For these reasons, we will enter judgment as a matter of law denying plaintiff's claim that the accused device infringes claim 32 of the patent. Alternatively, we conclude that the substantial weight of the evidence does not support the verdict on infringement, and the motion for a new trial on this claim should be granted.
X. Conclusion
Plaintiff Princeton Biochemicals, Inc., the owner of U.S. Patent No. 5,045,172, sues defendant Beckman Coulter, Inc., claiming infringement of claim 32 of the patent. Defendant denies infringement, and counterclaims for declaratory judgment of invalidity on grounds of obviousness and prior invention. The case was tried to a jury on issues of liability and invalidity only, resulting in a verdict for plaintiff on all three claims.
Defendant filed timely motions for judgment as a matter of law and, alternatively, for a new trial. For the reasons stated herein, the motion for judgment as a matter of law is granted. Accordingly, final judgment will be entered in favor of defendant, declaring claim 32 of the patent invalid on grounds of both obviousness and prior invention, and plaintiff's claim of infringement will be dismissed with prejudice. Alternatively, the motion for new trial is also granted.
A post-trial motion seeking to intervene in this action was filed by Rutgers University. Defendant joined in that motion, and sought to stay trial on any damages phase until the claim by Rutgers to ownership of the `172 patent was adjudicated. We have granted the motion to intervene, in a separate Memorandum Opinion and Order. (Docket entries 172 173.) Based upon the disposition of defendant's motions for judgment as a matter of law and for new trial set forth herein, we will dismiss the motion for stay as moot.
An appropriate Order and Judgment accompanies this Memorandum Opinion.
This matter being opened to the Court on motions for judgment as a matter of law and related relief following jury trial on issues of liability and infringement only; and the Court having considered the moving papers and oral argument of the parties; and good cause appearing, for the reasons set forth in the accompanying Memorandum Opinion,
IT IS on this 17th day of June, 2004, ORDERED as follows:
(1) Defendant's motion for judgment as a matter of law, docketed as a motion for summary judgment (docket entry 143-1) is hereby GRANTED;
(2) Defendant's alternative motion for new trial (docket entry 143-2) is hereby GRANTED;
(3) Defendant's motion to stay trial on a damages phase (docket entry 152-2) is hereby DISMISSED AS MOOT; andIT IS further ORDERED AND ADJUDGED as follows:
(4) DECLARATORY JUDGMENT is hereby GRANTED in favor of defendant-counterclaimant, and this Court hereby declares claim 32 of U.S. Patent No. 5,045,172 invalid due to obviousness pursuant to 35 U.S.C. § 103;
(5) DECLARATORY JUDGMENT is hereby GRANTED in favor of defendant-counterclaimant, and this Court hereby declares claim 32 of U.S. Patent No. 5,045,172 invalid due to prior invention by defendant, pursuant to 35 U.S.C. § 102(g); and
(6) A JUDGMENT OF NO CAUSE OF ACTION is hereby ENTERED on plaintiff's claim of infringement by defendant of claim 32 of U.S. Patent No. 5,045,172; and accordingly,
(7) The Complaint herein (docket entry 1) is hereby DISMISSED WITH PREJUDICE.