Opinion
No. C 01-03671 CRB
September 18, 2002
MEMORANDUM AND ORDER
This patent infringement action involves three method patents, the `268, `128, and `086, owned by plaintiff The Board of Trustees Of The Leland Stanford Junior University ("Stanford"). The patents-in-suit claim a method for identifying an HIV-infected patient that has developed resistance to his current drug regimen and is therefore likely to suffer immunological decline. The inventors filed the application for the `128 on August 15, 1994 and the `086 is an amendment to the `128. Nevertheless, Stanford claims the effective filing date of these patents is November 14, 1992 — the date the inventors filed their application for the parent application, the `327.
Defendant Visible Genetics moves for partial summary judgment on the issue of the effective filing date of the `128 and the `086, and in particular, for an order that the filing date is August 15, 1994. If the priority date is August 14, 1994, Visible Genetics will subsequently argue that the patents are invalid as anticipated or obvious in light of the prior art.
BACKGROUND
The parent application, the `327, was filed on May 14, 1992. The method set forth in the application involved detection of a mutation at codon 215. The Patent and Trademark Office ("PTO") issued a final rejection on March 3, 1995.
While the `327 was pending the inventors filed a continuation-in-part ("CIP") application on August 15, 1994. The CIP involved a method of detecting mutations at codons 215 and/or 74. After various rejections and responses, the PTO issued the notice of allowance on October 24, 1996 and the CIP, known as the '128, issued on May 20, 1997.
On January 15, 1997, while the CIP was still pending, the inventors filed a continuation application and preliminary amendment to the `128 application. The application and amendment sought to delete from claim 1 of the `128 the limitation that the patient "is being treated with an antiretroviral agent." This patent, known as the `086, issued on January 5, 1999. The primary distinction between the `128 and the `086 is that the `128 is limited to HIV-patients currently undergoing treatment while the `086 applies to those patients who are not receiving any antiretroviral treatment
For purposes of this motion the parties do not dispute that the priority date for the `086 is whatever the date is for the `128. They disagree, however, on the priority date for the `128. Visible Genetics now seeks a ailing that the priority date of the `128 and `086 is August 15, 1994 — the date the `128 application was filed. Stanford seeks the benefit of the priority date of the `327 parent application, November 14, 1992, and contends that the matter is in dispute and not susceptible to summary adjudication.
SUMMARY JUDGMENT STANDARD
Summary judgment is proper when "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). An issue is "genuine" only if there is a sufficient evidentiary basis on which a reasonable fact finder could find for the nonmoving party, and a dispute is "material" only if it could affect the outcome of the suit under governing law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248-49 (1986). In considering a motion for summary judgment, "[t]he evidence must be reviewed in a light most favorable to the non-movant, and all reasonable inferences must be drawn in the non-movant's favor." J M Corp. v. Harley-Davidson, Inc., 269 F.3d 1360, 1365 (Fed. Cir. 2001). A principal purpose of the summary judgment procedure "is to isolate and dispose of factually unsupported claims." Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). "Where the record taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no `genuine issue for trial.'"Matsushita Elec. Ind. Co. v. Zenith Radio, 475 U.S. 574, 587 (1986).
As Visible Genetics is challenging the validity of the `128 and `086, it will have the burden at trial of proving by clear and convincing evidence that the `128 and `086 are not entitled to the priority date of the parent application. See WMS Gaming Inc. v. International Game Tech., 184 F.3d 1339, 1355 (Fed. Cir. 1999). Where the moving party will have the burden of proof on an issue at trial, it must affirmatively demonstrate that no reasonable trier of fact could find other than for the moving party. See Celotex Corp. v. Cattrett, 477 U.S. 317, 323 (1986). Thus, on this motion for summary judgment, Visible Genetics, as the moving party, has the burden of showing that a reasonable jury would have to find for Visible Genetics; that is, that the jury would have to find Visible Genetics had proved by clear and convincing evidence that the `128 and `086 are not entitled to the priority date. See Verdegaal Bros., Inc. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987)("Thus, the precise question to be resolved in this case is whether [the moving party's] evidence is so clear and convincing that reasonable jurors could only conclude that the claims in issue were invalid.").
MICHAEL KOZAL DECLARATION
At oral argument Stanford sought to file in support of its opposition a declaration of one of the inventors, Michael J. Kozal. As Stanford offered no explanation for its late filing, and the Court is not aware of any reason why Stanford could not have filed the declaration in compliance with the Local Rules, the Court will not consider the declaration in connection with Visible Genetics's motion.
DISCUSSION
35 U.S.C. § 120 governs the filing date of a patent based on a parent application:
An application for patent for an invention disclosed in the manner provided by the first paragraph of section 112 of this title in an application previously filed in the United States, or as provided by section 363 of this title, which is filed by an inventor or inventors named in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application.
"Thus, a patent application will receive the benefit of a parent application's earlier filing date if (1) the applications are submitted by the same inventor or inventors; (2) the applications were co-pending, meaning that the second application was filed while the first application was still pending; (3) the later application contains a specific reference to the prior application, and (4) the prior application disclosed the invention in the manner required by 35 U.S.C. § 112."Pfizer Inc. v. Perrigo Co., 933 F. Supp. 377, 380 (S.D.N.Y. 1996).
It is undisputed that the first three requirements are met here: (1) the `086 and `128 were filed by the same inventor(s) as the `327; (2) the `128 was filed before the termination of the `327 proceedings; and (3) the `128 and `086 applications contain a specific reference to the `327 application. The issue on this motion is the fourth requirement whether the application for the `327 disclosed the inventions claimed in the `128 and the `086 "in the manner provided by the first paragraph of section 112." See In Re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995) ("It is elementary patent law that a patent application is entitled to the benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.").
The first paragraph of section 112 contains three requirements: enablement, best mode, and written description Visible Genetics argues that the `327 application does not satisfy section 112's requirements of enablement and a written description with respect to a method detecting a mutation at codon 74, or codons 74 and 215.
A. The written description requirement
35 U.S.C. § 112, first paragraph, requires a "`written description of the invention' which is separate and distinct from the enablement requirement. The purpose of the `written description' requirement is broader than to merely explain how to `make and use'; the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the `written description' inquiry, whatever is now claimed." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (emphasis added); see also Augustine Medical, Inc. v. Gaymar Industries, Inc., 181 F.3d 1291, 1302 (Fed. Cir. 1999) ("A decision on the proper priority date — the parent application date or the CIP application date — for subject matter claimed in a CIP application depends on when that subject matter first appeared in the patent disclosures. To decide this question, a court must examine whether the `disclosure of the application relied upon reasonably convey[s] to the artisan that the inventor had possession at that time of the later claimed subject matter.`") (citations omitted).
"Whether the written description requirement has been met is a question of fact." Wang Laboratories, Inc. v. Toshiba Corp., 993 F.2d 858, 865 (Fed. Cir. 1993).
1. The `327 written description
The `128 and `086 both claim a method of evaluating the effectiveness of antiretroviral therapy of an HIV-infected patient comprising detecting mutations at codon 215 or 74, or codons 215 and 74, "in which the presence of the mutations correlates positively with future immunologic decline." Thus, the invention involves detecting mutations at codon 74. The question is whether the `327 application provides a sufficient "written description" of such invention such that one of ordinary skill in the art would know that the inventor possessed such an invention.
The only description of a method detecting a mutation at codon 74 in the `327 application is as follows:
In preferred embodiments of the invention the antiretroviral agent is AZT. Resistance to certain antiretroviral agents, including AZT, is associated with a mutation at codon 215. Resistance to other antiretroviral agents, such as ddI, is associated with a mutation at codon 74. The present invention provides for analogous techniques in which the effectiveness of antiretroviral therapy is monitored by determining whether plasma HIV RNA or PBMC contain a mutation at codon 74 of HIV RT, in which a mutation at that locus may augur immunologic decline and may warrant a modification of antiretroviral therapy.
O'Keefe Decl. Exh. C (`327 Application) at p. 16. In the `128 application, the inventors changed this paragraph: instead of stating that the mutation at codon 74 "may augur" immunologic decline and "may warrant" modification of therapy, the `128 application states that a mutation at codon 74 "augurs" immunologic decline and "warrants" modification of therapy. O'Keefe Del. Exh. K at p. 20.
2. The parties' arguments
Visible Genetics emphasizes that in the claimed invention the mutation at codon 74 correlates positively with immunologic decline whereas in the `327 application the mutation at codon 74 may, but not necessarily will, correlate positively with immunologic decline. Therefore, argues Visible Genetics, one of ordinary skill in the art reading the `327 application would not have understood that the inventors possessed the invention later claimed in the `128, namely, detecting mutations at codon 74. The fact that the inventors deleted the "may" language in the `128 application is further evidence that what was disclosed in the `327 is not what is claimed in the `128. Visible Genetics also argues that the `327 does not describe the mutation at codon 74 correlating positively with immunlogic decline within the next six to twelve months, as is required by claim 1 of the `128, and also not describe the effect of mutations at codons 215 and 74 together.
As additional support defendant cites to the deposition testimony of one of the inventors, Dr. Kozol. Dr. Kozol states that in May 1992, he had not done any work on the correlation between a mutation at codon 74 and immunologic decline and so, when he was at a conference in May 1992, he did not express any opinion on that subject. O'Keefe Decl. Tab. U ("I wouldn't have answered [a question about codon 74] because I wouldn't have any data to support anything that I would say.") Since he had not done any research, argues Visible Genetics, he had not yet "invented" the positive correlation between a mutation at codon 74 and immunologic decline.
Stanford first responds that Visible Genetics has not satisfied its summary judgment burden because Visible Genetics has not offered any evidence that one of ordinary skill in the art would not have understood from the `327 application that the inventors possessed the invention later claimed in the `128 and `086, in other words, Stanford contends that Visible Genetics has to offer expert testimony. The Court disagrees. Visible Genetics is arguing that based on the plain language of the `327 application it is clear that one of ordinary skill in the art would not have understood that the inventor was also disclosing an invention as to codon 74. If the `327 application was wholly silent as to codon 74, for example, no expert testimony would be necessary to establish that the application does not sufficiently describe an invention involving codon 74. See TurboCare Div. of Demag Delaval Turbomachinery Corp. v. General Elec. Co., 264 F.3d 1111, 1119 (Fed. Cir. 2001) (concluding based solely on language of specification that no reasonable jury could find written description requirement was satisfied). While the `327 is not silent as to codon 74, its reference is so fleeting and limited that Visible Genetics can credibly argue, based on the `327 application alone, that the written description does not convey to one skilled in the art that the inventors possess the invention claimed in the `128 and `086.
Moreover, the inventor's own testimony that as of May 1992 he did not have any data on the effects of a mutation at codon 74 confirms that the `327 application did not disclose any such invention. Thus, Visible Genetics has come forward with evidence that would permit a jury to find by clear and convincing evidence that the `128 and `086 patents are not entitled to the priority date of the parent application because the `327 application does not satisfy the written description requirement of section 112.
The burden is on Stanford, then, to come forward with evidence sufficient to create a genuine dispute as to whether the `327 application satisfies the written description requirement Stanford points to the PTO's finding that the `128 and `086 are in fact entitled to the priority date of the `327.
3. The prosecution history
When the inventors filed the `128 CIP they specifically claimed the filing date of the `327. O'Keefe Decl., Exh. K at 1 ("Priority of application serial no. 07/833,327 filed on May 14, 1992 in United States is claimed under 35 U.S.C. § 119."). By Office Action dated September 14, 1995, the PTO rejected the `128 CIP. With regard to the specification, the PTO stated:
Applicant is advised that the only reference to codon 74 mutations in the parent case, 07/883,327, on page 16, lines 13 and 21 does not identify the mutation at codon 74 of the HIV RT which is altered, therefore not supporting any specific sequences tied to this mutation. Further, the references in the parent to codon 74 are both non-initialed, non-dated alterations of the original specification.
O'Keefe Decl. Exh. M at 3. The PTO was referring to the fact that the one reference to codon 74 in the `327 application appeared to be written in by hand.
The inventors responded to the PTO's concerns in writing on February 13, 1996. The inventors explained that it is irrelevant that the `327 application does not identify the particular mutation at codon 74 that is altered and therefore the particular DNA sequence to be performed because the claims of the `128 do not recite any particular sequence; in other words, the sequence is not part of the invention. The inventors also affirmatively represented that the handwritten "74" on the `327 application was in the original application at the time it was filed. The inventors concluded that the `327 "application clearly and adequately discloses the codon 74 mutation for priority purposes." O'Keefe Del. Exh. N at 5-6.
The PTO responded in an Office Action Summary of April 30, 1996. The PTO again rejected the claims. It also stated. "Since the inventor's declaration was filed after the filing of the application, for purposes of priority, the current application will be given priority back to the parent case, /07/883/327, for the non-initialed, non-dated alterations." O'Keefe Del. Exh. O at 2. Thus, it appears the PTO Examiner concluded that all requirements had been met for the purpose of giving the `128 application the priority of its parent application
Since the PTO concluded that priority is appropriate, the Court cannot conclude that no reasonable trier of fact could reach the same conclusion. The PTO examiner is presumably one of ordinary skill in the relevant art. The PTO examiner specifically questioned the appropriateness of the earlier priority date and, alter considering the inventors' response, concluded that the earlier priority date is warranted. This evidence creates a genuine dispute as to whether the `327 application satisfies the written disclosure requirement, it is evidence that at least one person skilled in the art concluded that it did satisfy the requirement.
Visible Genetics responds that the Court should give no deference, or even consideration, to the PTO Examiner's determination. It notes that the Manual of Patent Examining Procedure ("MPEP") section 201.08 provides that the Examiner need not determine the appropriateness of priority in the ordinary case:
Unless the filing date of the earlier nonprovisional application is actually needed, for example, in the case of an interference or to overcome a reference, there is no need for the Office to make a determination as to whether the requirement of 35 U.S.C. § 120, that the earlier nonprovisional application discloses the invention of the second application in the manner provided by the first paragraph of 35 U.S.C. § 112, is met and whether a substantial portion of all of the earlier nonprovisional application is repeated in the second application in a continuation-in-part situation. Accordingly, an alleged continuation-in-part application should be permitted to claim the benefit of the filing date of an earlier nonprovisronal application if the alleged continuation-in-part application complies with the following formal requirements of 35 U.S.C. § 120:
(A) The first application and the alleged continuation-in-part application were filed with at least one common inventor;
(B) The alleged continuation-in-part application was "filed before the patenting or abandonment of or termination of proceedings on the first application or an application similarly entitled to the benefit of the filing date of the first application, and
(C) The alleged continuation-in-part application "contains or is amended to contain a specific reference to the earlier filed application."
(Emphasis added.) Based on this procedure, Visible Genetics argues that there was no need for the Examiner to determine the filing date; the Examiner must only have meant that the inventors could claim the earlier priority date because requirements (A), (B), and (C) above had been met.
The Court agrees that the Examiner's comments are somewhat cryptic. They can, however, reasonably be read as an actual determination that priority is warranted. If the Examiner was merely determining whether the requirements of (A), (B), and (C) had been met there would have been no need to inquire as to the handwritten 74 notation, the three requirements are met regardless of the status of the 74. Moreover, the Examiner stated that the current application (the `128) "will be given priority back to the parent case." O'Keefe Decl. Exh. O at 2. The Examiner did not merely note that the inventors could claim priority; rather, the Examiner said that the application would be given priority.
Visible Genetics's next argument is that no deference to the PTO should be given where new evidence and argument not presented to the PTO are presented. See Carnegie Mellon University v. Hoffman-LaRoche, 148 F. Supp.2d 1004, 1011 (N.D. Cal. 2001). The only new argument or evidence is the inventor testimony. That testimony, however, does not answer whether the application satisfies the written disclosure requirement. Moreover, the issue here is not one of deference; rather, the issue is whether Visible Genetics has shown that every reasonable juror would have to find that it has shown by clear and convincing evidence that the `128 is not entitled to the priority of the `327. The question is close. In light of the Examiner's conclusion that priority is appropriate, and given that all reasonable inferences must be drawn in favor of the non-moving party' the Court cannot conclude that Visible Genetics has met its heavy burden.
C. Enablement
To meet the enablement requirement of section 112 the applicant must include in the specification information sufficient to enable a person skilled in the relevant art, using the knowledge available and the disclosure in the patent document, to make and use the invention without undue experimentation. Visible Genetics also contends that Dr. Kozal's deposition testimony proves that one skilled in the art would not have been armed with enough information to have practiced the invention and that the information in the `327 is insufficient.
Visible Genetics has not met its summary judgment burden. It offers no analysis and instead simply asserts that the `327 did not enable. Such an assertion is not clear and convincing evidence. Moreover, as is explained above, the PTO Examiner determined that priority was warranted. That is some evidence that the `327 satisfies the enablement requirement. This issue is genuinely in dispute.
CONCLUSION
For the foregoing reasons, Visible Genetics's motion for partial summary judgment is DENIED.
IT IS SO ORDERED.