Liebel-Flarsheim Co. v. Medrad Inc.

Full title: LIEBEL-FLARSHEIM CO., plaintiff, v. MEDRAD INC., Defendant

Court: United States District Court, S.D. Ohio, Western Division

Date published: Oct 17, 2001

Case C-1-98-858 (S.D. Ohio Oct. 17, 2001)

Opinion

Case C-1-98-858

October 17, 2001

ORDER

Sandra S. Beckwith, United States District Judge

This matter is before the Court on multiple motions for partial summary judgment. In this Order, the Court will address the motions filed under Doc. Nos. 57, 162, 164, 167, 168, and 169.

I. GENERAL BACKGROUND

The patents at issue in this case, United States Patent No. 5,456,669 ("the `669 patent"), United States Patent No. 5,658,261 ("the `261 patent"), United States Patent No. 5,662,612 ("the `612 patent"), and United States Patent No. 5,928,197 ("the `197 patent."), are part of a series of patents that relate to medical devices known as powered injectors which deliver contrast agents¹ from a syringe into a patient's bloodstream for certain medical diagnostic procedures. (Doc. No. 30, Exhs. 1-4). The specific patents at issue in this case involve two developments in the field of power injectors (1) the front-loadable power injector and (2) automatic control of the plunger driver during the injection process.

1 In a number of diagnostic procedures, such as angiography, computed tomography, ultrasound, and magnetic resonance imaging, the image obtained may be substantially enhanced through the use of a contrast agent, i.e., a pharmaceutical that is injected into the body of the patient.

A. Front-Loadable Power Injectors

When the original `110 application was filed, the powered injectors sold by both Plaintiff Liebel-Flarsheim Company ("L-F") and Defendant Medrad, Inc. ("Medrad") required that the syringe be inserted in the injector by a breech-load method. However, loading of the syringe by the breech-load method was cumbersome, timeconsuming, and inefficient, and this method presented a cleanliness problem and posed a safety hazard.

In the late 1980's, L-F began a brainstorming process that culminated in the invention of a front-loadable powered injector system that eliminated the disadvantages inherent in the breechloading power medical injectors and provided benefits in terms of use, speed, efficiency, sterility, and cleanliness.

On June 7, 1991, L-F filed its first patent application, Application Serial No. 07/712,110 ("the `110 application") on its CT injection system with a front-loadable syringe. (Doc. No. 57, Exh. 7). The `669 and `261 patents, entitled "Method of Front Loading an Injector and Injecting Fluid into Animals Therewith" and "Disposable Front Loadable Syringe," respectively, issued from a series of divisional applications originating with the `110 application.² (Doc. No. 30, Exhs. 1, 2).

2 The patent application for the `669 patent was filed on November 30, 1993, and issued on October 5 1995. The patent application for the `261 patent was filed on April 6, 1995, and issued on August 19, 1997. Because the `669 and `261 were divisional applications originating with the `110 application, they have an effective filing date of June 7, 1991, the filing date of the `110 applications. Furthermore, as divisional applications, the `669 and `261 patents have the same specifications and drawings.

At the time the `110 application was filed, all power injectors that used disposable plastic syringes had components known as pressure jackets, which are hollow cylindrical tubes attached to the front of the injector that surround the syringe. (Doc. No. 57, Exh. 8 — Goethel Depo., p. 465, Exh. 9 — Fago Depo., p. 103, Exh. 13, Dieterlen Depo., p. 141, Exh. 14 — Neer Depo, p. 135). During the development of its front-loadable injector system, L-F considered the idea of eliminating the pressure jacket. (Doc. No. 57, Exh. 9 — Fago Depo., p. 83, Exh. 13 — Dieterlen Depo., p. 63). After running several preliminary tests, L-F chose not to develop a jacketless injector system. (Doc. No. 57, Exh. 9 — Fago Depo., pp. 83-84, Exh. 13 — Dieterlen Depo., p. 63).

At a trade show in November of 1992, Medrad introduced the first pressure jacketless, front-loading CT injector system for disposable syringes. (Doc. No. 57, Exh. 11, ¶ 2). This system neither required nor used a pressure jacket. ( Id.). All of Medrad's injector systems that were or are front loaded did not and do not use or require a pressure jacket. ( Id. at ¶ 4). After Medrad introduced its jacketless injector, L-F amended the `669 and `261 patent applications, removing references to a pressure jacket in certain claims.³ (Doc. No. 57, Exhs. 22, 26).

3 The`669 patent was amended on September 12, 1994, and the `261 patent was amended on April 6, 1995.

B. Automatic Control of Plunger Drivers

On June 26, 1995 and August 28, 1997, L-F filed patent applications that issued as the `612 patent and the `197 patent, respectively, relating to the automatic control of plunger drives in powered medical injector systems.⁴ (Doc. 30, Exhs. 3, 4). At the time the patents were filed, the use of pre-filled disposable syringes was a recent advancement in the field of medical injector systems. These pre-filled syringes differed in capacity depending upon the medical procedure being performed.

4 The `612 patent issued on September 2, 1997 and the `197 patent issued on July 27, 1999. The `612 and `197 patents are continuations of a patent that was filed on November 27, 1993, but was subsequently abandoned. (Doc. No. 167, Exh. 4). Therefore, the `612 and `197 patents claim an effective filing date of November 24, 1993. Furthermore, as continuation applications, the `612 and `197 patents have the same specifications and drawings.

The `612 and `197 patents, both titled "Controlling Plunger Drives for Fluid Injections in Animals", disclose a powered medical injector that automates the injection of pre-filled syringes. (Doc. No. 30, Exhs. 3, 4). The injector claimed in the patents includes structure and control circuitry that detects physical indicia on a syringe that relates to physical properties of the syringe. Based on these physical properties, the control circuitry of the injector automatically controls the injection process.

L-F initiated this lawsuit on November 13, 1998, claiming that Medrad, through its manufacture, use, marketing, and/or sale of various injectors and syringes, infringed, contributorily infringed, and/or induced infringement of the `669, `261, `612 and `197 patents. (Doc. Nos. 1, 4, 5, 23, 30). Medrad denied L-F's claims and counterclaimed seeking a declaratory judgment that Medrad does not infringe the `669, `261, `612, and `197 patents, that such patents are invalid, that such patents are void and unenforceable due to L-F's inequitable conduct, and that L-F is precluded from asserting its claims by virtue of unclean hands, laches and/or equitable estoppel. (Doc. Nos. 24, 25, 39).

Numerous partial summary judgment motions have been filed in this matter, including a motion for claim construction. Accordingly, on July 23, 2001, this Court conducted a Markman hearing at which counsel for both parties presented evidence. The Court is now prepared to rule on the following motions for partial summary judgment:

1. plaintiff's Motion for Partial Summary Judgment of Claim Construction (Doc. 164).

2. Defendant's Motion for Partial Summary Judgment of Invalidity for Lack of Enablement of the Asserted Claims of the `669 and `261 Patents (Doc. 168).

3. Defendant's Motion for Partial Summary Judgment of Invalidity and Non-Infringement of the Asserted Claims of the `669 and `261 Patents (Doc. 57).

4. Defendant's Motion for Partial Summary Judgment of Non-Infringement of the `612 and `197 Patents Because Defendant Practices its Own Patent Which is Prior Art to the Asserted Patents (Doc. 162).

5. Defendant's Motion for Partial Summary Judgment of Non-Infringement and Invalidity of the Asserted Claims of the `612 and `197 Patents (Doc. 167).

6. Plaintiff's Motion for Partial Summary Judgment of Infringement on Counts I-IX of the Fourth Amended Complaint (Doc. 169).

II. SUMMARY JUDGMENT STANDARD

Summary judgment is proper "if 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). The party opposing a properly supported summary judgment motion "`may not rest upon the mere allegations or denials of his pleading, but must set forth specific facts showing that there is a genuine issue for trial.'" Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986) (quoting First Nat'l Bank of Arizona v. Cities Serv. Co., 391 U.S. 253 (1968)). The Court is not duty bound to search the entire record in an effort to establish a lack of material facts. Guarino v. Brookfield Township Trs., 980 F.2d 399, 404 (6th Cir. 1992); InterRoyal Corp. v. Sponseller, 889 F.2d 108, 111 (6th Cir. 1989), cert. denied, Superior Roll Forming Co. v. InterRoyal Corp., 494 U.S. 1091 (1990). Rather, the burden is on the non-moving party to "present affirmative evidence to defeat a properly supported motion for summary judgment . . .," Street v. J.C. Bradford Co., 886 F.2d 1472, 1479-80 (6th Cir. 1989), and to designate specific facts in dispute. Anderson, 477 U.S. at 250. The nonmoving party "must do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Electric Industries Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). The court construes the evidence presented in the light most favorable to the non-movant and draws all justifiable inferences in the non-movant's favor. United States v. Diebold Inc., 369 U.S. 654, 655 (1962).

The court's function is not to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial. Anderson, 477 U.S. at 249. The Court must assess "whether there is the need for trial — whether, in other words, there are any genuine factual issues that properly can be resolved only by a finder of fact because they may reasonably be resolved in favor of either party." Id. at 250. "If the evidence is merely colorable, . . ., or is not significantly probative, . . ., the court may grant judgment." Anderson, 477 U.S. at 249-50. (citations omitted). The Supreme Court has held that:

The mere existence of a scintilla of evidence in support of the plaintiff's position will be insufficient; there must be evidence on which the jury could reasonably find for the plaintiff. The judge's inquiry, therefore, unavoidably asks whether reasonable jurors could find by a preponderance of the evidence that the plaintiff is entitled to a verdict . . .

Id. at 252. The "`mere possibility'" of a factual dispute will not suffice. Mitchell v. Toledo Hospital, 964 F.2d 577, 582 (6th Cir. 1992) (quoting Gregg v. Allen-Bradley Co., 801 F.2d 859, 863 (6th Cir. 1986)).

Summary judgment is not appropriate simply because the weight of the evidence favors the moving party. Poller v. Columbia Broadcasting Systems, Inc., 368 U.S. 464, 472 (1962). The issue of material fact required "to entitle a party to proceed to trial is not required to be resolved conclusively in favor of the party asserting its existence; rather, all that is required is that sufficient evidence supporting the claimed factual dispute be shown to require a jury or judge to resolve the parties' differing versions of the truth at trial." Cities Serv. Co., 391 U.S. at 288-89.

Although summary judgment must be used with extreme caution since it operates to deny a litigant his day in court, Smith v. Hudson, 600 F.2d 60, 63 (6th Cir. 1979), (citations omitted), cert. dismissed, 444 U.S. 986 (1979), the United States Supreme Court has stated that the "[s]ummary judgment procedure is properly regarded not as a disfavored procedural shortcut, but rather as an integral part of the Federal Rules as a whole, which are designed to "secure the just, speedy and inexpensive determination of every action.'" Celotex Corp. v. Catrett, 477 U.S. 317, 327 (1986) (citations omitted)

III. PLAINTIFF'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF CLAIM CONSTRUCTION (DOC. 164)

In this motion, L-F moves the Court for construction of the following claim terms and claim language:

• "syringe receiving opening" or "opening"

• "high pressure"

• none of the asserted claims of the `669 patent and none of the asserted claims of the `261 patent requires that the injector include a pressure jacket

• "physical indicia"

• "motor" and "tracks the location of said motor"

(Doc. No. 164). Medrad has filed a memorandum in opposition (Doc. No. 172) to which L-F has filed a reply (Doc. No. 182).^{5 6}

5 The Court also reviewed Medrad's Motion to File a Sur-Reply (Doc. No. 191) and L-F's memorandum in opposition (Doc. No. 197). Additionally, the Court reviewed L-F's Motion to File a Post Claim Construction Hearing Memorandum (Doc. No. 223), Medrad's memorandum in opposition (Doc. No. 230), and L-F's reply (Doc. No. 236).

6 L-F and Medrad also presented arguments addressing the issue of interpretation of the claim terms in Medrad's Motion for Partial Summary Judgment of Invalidity and Non-infringement of the `669 and `261 Patents (Doc. No. 57), L-F's Response to that motion (Doc. No. 84), and Medrad's Reply (Doc. No. 99); in Medrad's Motion for Partial Summary Judgment of Non-infringement and Invalidity of the `612 and `197 Patents (Doc. No. 167), L-F's Response to that motion (Doc. No. 174), and Medrad's Reply (Doc. No. 184); in Medrad's Motion for Partial Summary Judgment of Invalidity for Lack of Enablement of the `669 and `261 Patents (Doc. No. 168); L-F's Response to that motion (Doc. No. 175), and Medrad's Reply (Doc. No. 187); in L-F's Motion for Partial Summary Judgment of Infringement (Doc. No. 169), Medrad's Response to that motion (Doc. No. 176), and L-F's Reply (Doc. No. 185). The Court reviewed the arguments presented in each of these documents when construing the claim terms.

A. Law on Claim Construction

When construing a patent claim, the court must first consider the intrinsic evidence, i.e., the claims, the specification, and the prosecution history. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996); Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996)). Extrinsic evidence may be considered if the intrinsic evidence does not resolve an ambiguity in a challenged claim. Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed. Cir. 1999). However, "the court may not use extrinsic evidence to arrive at a claim construction that is clearly at odds with the construction mandated by the intrinsic evidence." Karlin Technology Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971 (Fed. Cir. 1999). The court may receive extrinsic evidence to educate itself about the invention and the relevant technology. Id.

In claim construction, the court first considers the language of the claim. Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001); Johnson Worldwide Assocs., 175 F.3d at 989. The court should give claim terms their ordinary and customary meaning unless the specification or prosecution history provides a special, different meaning or definition. Kraft Foods, Inc. v. Int'l Trading Co., 203 F.3d 1362, 1366 (Fed. Cir. 2000); see Johnson Worldwide Assocs., 175 F.3d at 989. The court will ordinarily give general descriptive terms their full meaning and will not add modifiers to broad terms standing alone. Johnson Worldwide Assocs., 175 F.3d, at 989. The court "must presume that the terms in the claim mean what they say, and, unless otherwise compelled, give full effect to the ordinary and accustomed meaning of claim terms. Id. Where certain words have no specialized meaning to persons of skill in the art, "the ordinary meaning of those words to those skilled in the art controls . . ., unless the evidence indicates that the inventor used them differently." See Karlin Technology, 177 F.3d at 971; Toro Co. v. White Consolidated Industries, Inc., 199 F.3d 1295, 1299 (Fed. Cir. 1999) (quoting Hoechst Celanese Corp. v. B.P. Chemicals Ltd., 78 F.3d 1575, 1578 (Fed. Cir. 1996), cert. denied, 519 U.S. 911 (1996)).

In addition to interpreting a claim by the language used, the court also must read claims in view of the specification. Markman, 52 F.3d at 979 (citations omitted); see Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998) (stating that because a court must understand and interpret the inventor's words as they would be understood and interpreted by a person in that field of technology, the court must review the same resources as that skilled person would review, i.e., the patent specification and the prosecution history). The specification contains a written description of the invention that must enable a person of ordinary skill in the art to make and use the invention. Markman, 52 F.3d at 979. Furthermore, the description may define terms used in the claims. See id. The court reviews the specification to determine whether the patentee used terms in a manner inconsistent with their ordinary meaning. DeMarini Sports, Inc. v. Worth Inc., 239 F.3d 1314, 1323 (Fed. Cir. 2001).

Although claims are interpreted in light of the specification, this does not mean that everything stated in the specification must be read into all the claims. SRI Int'l v. Matsushita Electric Corp., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (quoting Raytheon Co. v. Roper Corp., 724 F.2d 951, 957 (Fed. Cir. 1983), cert. denied, 469 U.S. 835 (1984)). While the written description may help the court construe a claim term, the court may not read into the claim limitations, examples, or embodiments appearing only in the written description. Kraft Foods, 203 F.3d at 1366. "[I]nterpreting what is meant by a word in a claim `is not to be confused with adding an extraneous limitation appearing in the specification, which is improper.'" Intervet America, Inc. v. Kee-Vet Labs., Inc., 887 F.2d 1050, 1053 (Fed. Cir. 1989) (quoting E.I. Du Pont De Nemours Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir. 1988), cert. denied, 488 U.S. 986 (1988)). The claims measure the invention. SRI Int'l, 775 F.2d at 1121 (citations omitted).

However, "`[c]laims are not interpreted in a vacuum but are part of and are read in light of the specification.'" SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1341 (Fed. Cir. 2001) (quoting Slimfold Mfg. Co. v. Kinkead Industries, Inc., 810 F.2d 1113, 1116 (Fed. Cir. 1987)). "One purpose for reviewing the specification is to determine whether the patentee has limited the scope of the claims." Watts v. XL Systems, Inc., 232 F.3d 877, 882 (Fed. Cir. 2000). "Where the specification makes clear that the invention does not include a particular feature, that feature is deemed to be outside the reach of the claims of the patent, even though the language of the claims, read without reference to the specification, might be considered broad enough to encompass the feature in question." SciMed Life Systems, 242 F.3d at 1341.

In addition to the specification, a court considers the prosecution history to determine the true meaning of the language used in the patent claim. Markman, 52 F.3d at 980. However, the court may not use the prosecution history to "`enlarge, diminish, or vary' the limitations in the claims." Id. (quoting Goodyear Dental Vulcanite Co. v. Davis, 102 U.S. 222, 227 (1880)); see also, Intervet America, 887 F.2d at 1054. The court considers the prosecution history to determine whether or not the patentee made any express representations in obtaining the patent regarding the scope and meaning of the claims. DeMarini Sports, 239 F.3d at 1323.

With these principles in mind, the Court will proceed with the requested claim construction of the `669, `261, `612, and `197 patents.

B. "Syringe Receiving Opening" or "Opening"/Requirement of a Pressure Jacket

In this motion for partial summary judgment, L-F requests that the Court interpret the terms "syringe receiving opening" and "opening" as they appear in the asserted claims of the `669 and `261 patents.⁷ As the following analysis demonstrates, the construction of these terms is closely intertwined with L-F's contention that the injector referenced in the asserted claims of the `669 and `261 patents does not require a pressure jacket. The Court will, therefore, analyze these issues together.

7 The asserted claims are 10-11, 13, 16-19 of the `669 patent and 1, 8, 9, 11-13, 15-16, 18, 22, 27-28, 30-32, 34-37 of the `261 patent.

L-F proposes that the terms "syringe receiving opening" and "opening" refer to "an opening in an injector for receiving a syringe." (Doc. No. 164, p. 1). Medrad contends that the terms refer to the "open end of a pressure jacket." (Doc. No. 172, p. 16).

The difference in the parties' interpretations of these terms is significant. On the issue of non-infringement of the asserted claims, Medrad argues that the accused products do not infringe the `669 and `261 patents because both patent specifications describe an injector that requires a pressure jacket.⁸ (Doc. No. 57, p. 19). Medrad's accused injectors are jacketless. L-F, on the other hand, argues that the term "pressure jacket" does not appear in the asserted claims, and thus, the claims do not describe an injector that requires a pressure jacket. (Doc. No. 164, p. 23). In response, Medrad has argued that the asserted claims contain the terms "syringe receiving opening" or "opening," which, in order to preserve the validity of the patents, must be interpreted as the opening of a pressure jacket. (Doc. No. 57, p. 18). Therefore, according to Medrad, the claims describe a device that requires a pressure jacket. ( Id.).

8 It should be noted that the `669 and `261 patents do not claim the invention of a front-loadable injector. Rather, the `669 patent claims a method of front loading an injector and injecting fluid and the `261 patent claims a device of a frontloadable syringe. However, the claims of the `669 and `261 patents describe the injector with some specificity.

The Court begins its analysis where all claim construction begins — the language of the claim. See Interactive Gift Express, 256 F.3d at 1331. With respect to the asserted claims, "syringe receiving opening" and "opening" are described as follows:

• "a syringe receiving opening with a generally circular periphery therein adapted to receive a rearward end of a syringe having a generally circular rim"

• `669 patent, Claim 10

• "an opening at the front end of the injector dimensioned to receive the back end of a disposable syringe . . ."

• `669 patent, Claim 19

• "a circular syringe receiving opening therein bounded by a circular annular periphery . . ." `261 patent, Claim 11

• "a circular syringe receiving opening bounded by a circular annular periphery . . ."

`261 patent, Claim 30

(Doc. No. 30, Exhs. 1, 2). Clearly, this language describes a circular opening sized to accommodate the rear end of a syringe. Moreover, such a construction is supported by the ordinary dictionary definition of the terms. Webster's defines a "syringe" as "a device used to inject fluids into or withdraw them from the body or its cavities . . ." Webster's Third New International Dictionary at 2322 (1971). "Receive" is defined as "to take in: act as a receptacle or container for . . .", and "opening" is defined as "something that is open: as a (1): BREACH, APERTURE . . . (2): an open width: SPREAD, SPAN . . ." Id. at 1580, 1894. Thus, the dictionary definition of a "syringe receiving opening" is an open width able to take in a device used to inject fluids into or withdraw them from the body. The language of the claims requires that this "open width" be circular.

The real issue dividing the parties is not the characteristics of a "syringe receiving opening" or "opening" but rather the location of such an opening. L-F, by asking the Court to conclude that the asserted claims involve an injector that does not require a pressure jacket, is asking the Court to conclude that the "syringe receiving opening" may be located anywhere, including the front-end of a pressure jacket.⁹ Medrad argues, on the other hand, that the injector described in the asserted claims requires a pressure jacket; therefore, the "syringe receiving opening" must be located at the front-end of the required pressure jacket.

9 Based on the language of Claim 19 of the `669 patent ("an opening at the front end of the injector), it appears, at the very least, such an opening would be somewhere on the front of the injector.

The parties do not dispute that the asserted claims do not contain the term "pressure jacket". However, the absence of the term "pressure jacket" does not necessarily lead to the conclusion that the injector referred to in the asserted claims does not require a pressure jacket. While the claim language does not explicitly require a pressure jacket, neither does it explicitly describe a jacketless injector.¹⁰ Because the claim language is ambiguous with respect to the requirement of a pressure jacket, the Court must conduct a review of all the intrinsic evidence (the claim language, the specification, and the prosecution history) to determine whether the injector described in the asserted claims requires a pressure jacket. See Interactive Gift Express, 256 F.3d at 1331.

10 At the time the patent applications for the `669 and `261 patent were filed, injectors that used disposable syringes included pressure jackets. (Doc. No. 57, Exh. 8 — Goethel Depo., p. 465, Exh. 9 — Fago Depo., p. 103, Exh. 13, Dieterlen Depo. p. 141, Exh. 14 — Neer Depo, p. 135).

Even the most cursory reading of the specification of the `669 and `261 patents¹¹ reveals that the injector described in the specification includes a pressure jacket:

11 Ats explained in detail in footnote 2, the `669 and `261 patents have the same specification.

An animal fluid injector, replaceable syringe and method of replacement of the syringe in the injector are provided in which the syringe is loadable and unloadable into and from the injector through the open front end of a pressure jacket of the injector . . . `669 patent and `261 patent, Abstract

* * * It is an additional objective of the present invention to provide an injector wherein a used syringe can be removed and a new one inserted in the injector without retraction of the drive from the pressure jacket in most applications . It is a further objective of the invention to allow for the removal of the used syringe from the jacket without disconnection of the injector tube from the syringe nozzle. `669 patent, col. 2, lines 32-39 `261 patent, col. 2, lines 30-37

(Doc. No. 30, Exhs. 1, 2) (emphasis added). Not only does the specification contemplate an injector that includes a pressure jacket, a pressure jacket appears to be an essential component of the injector. According to the specification, the purpose of the pressure jacket is to reinforce the walls of the syringe used in the injector against pressures placed upon it by the injector:

The syringe 32 is disposable, and includes walls which will withstand only moderate or low pressure. The walls are usually outwardly deformable under operating pressures, particularly pressures of 300 psi or more. Such higher pressures are necessary to overcome pressure drops through the injection tubing at higher flow rates, which are often desirable. The jacket 31 is made of a stronger transparent material that will withstand the operating pressures. When the syringe 32 is contained in the jacket 31, it is surrounded by the jacket 31 and supported by the jacket 31 against expansion caused by the fluid pressure within as the syringe 32 expands against the jacket wall . `669 patent, col. 7, lines 15-26 `261 patent, col. 7, lines 10-21

* * *

The pressure jacket 31 has a generally cylindrical inner bore. . . The bore 33 is dimensioned so as to receive through the remote end 35 the disposable syringe 32 and to support the syringe against expansion from fluid pressure within such fluid pressure may range to more than a thousand psi . `669 patent, col. 7, lines 26-33 `261 patent, col. 7, lines 22-29

* * *

To provide this front end loadable feature, the syringes of the preferred and illustrated embodiments of the present invention are provided with a front wall that is pressure restraining, that is, of sufficient strength to support the front of the syringe against the expected pressures within the syringe, and that is securable to the front end of the pressure jacket so as to complete the pressure restraining enclosure of the syringe within the pressure jacket and hold the syringe in the jacket . `669 patent, col. 3, lines 1-9 `261 patent, col. 2, lines 65-67 to col. 3, lines 1-7

(Doc. No. 30, Exhs. 1, 2) (emphasis added). Furthermore, the pressure jacket is an integral component of the injector described in the specifications. Other features of the injector, including the syringe used in the injector, rely on the existence of a pressure jacket, and the specification does not describe how such features would work without the existence of a pressure jacket. (Doc. No. 30, Exh. 1, `669 patent: col. 2, lines 53-56; col. 3, lines 1-9; col. 7, lines 35-48; col. 8, lines 45-65; col. 9, lines 45-55; col. 10, lines 45-51). Quite simply, the specification fails to describe the components, design, or operation of an injector that does not include a pressure jacket.

In light of the specification, the fact that the asserted claims do not mention a pressure jacket simply does not support the conclusion that the asserted claims describe a jacketless injector. In SciMed Life Systems, 242 F.3d at 1341, the court concluded that:

[w]here the specification makes clear that the invention does not include a particular feature, that feature is deemed to be outside the reach of the claims of the patent, even though the language of the claims, read without reference to the specification, might be considered broad enough to encompass the feature in question.

In the present case, the opposite is true. The specification makes clear that the injector includes a pressure jacket. Accordingly, the Court concludes that the asserted claims do not cover a jacketless injector, even though the asserted claims might be considered broad enough to disclose a jacketless injector when read without reference to the specification. See also, Watts, 232 F.3d at 882-83 (claim that described pipe joints that could be "sealingly connected" limited to a misaligned taper angle connection method because specification discussed "the present invention" only in terms of the misaligned taper angle connection method); Wang Labs., Inc. v. America Online, Inc., 197 F.3d 1377, 1382 (Fed. Cir. 1999) (court limited a computer system claim term ("frame") to character-based systems noting that the "only system that is described and enabled in the [patent] specification uses a character-based protocol" and that "references to other known protocols [did] not describe them as included in the applicant's invention, and that the specification would not be so understood by a person skilled in the field of the invention.").

Although L-F does not appear to disagree with the conclusion that the specification describes an injector that includes a pressure jacket, it maintains that a pressure jacket is not a required element of the injector described in the asserted claims. (Doc. No. 164, pp. 18-19). L-F argues that the specification of the `669 and `261. patents merely discloses a preferred embodiment of a front-loadable injector that includes a pressure jacket. ( Id.). L-F points to the following excerpt, which appears immediately prior to the claims of the `669 and `261 patents:

[t]he invention has been described in the context of its preferred embodiments. It will be appreciated by those skilled in the art that variations and alternatives to the embodiments described may be employed without departing from the principles of the present invention. Accordingly, this patent is not intended to be limited except by the scope of the following claims: . . . `669 patent, col. 13, lines 52-58 `261 patent, col. 13, lines 54-60

(Doc. No. 30, Exhs. 1, 2). L-F correctly notes that a patent's claims are not limited to the preferred embodiment included in the specification, unless the language of the claims so limits them. See Karlin Technology, 177 F.3d at 973; see also SRI Int'l, 775 F.2d at 1122 (quoting Smith v. Snow, 294 U.S. 1, 11 (1935)). Because the asserted claims do not mention a pressure jacket, L-F argues that the limitation of a pressure jacket cannot be read into the asserted claims of the `669 and `261 patents. (Doc. No. 164 at 18-19)

However, as Medrad correctly argues, a review of the specification reveals that every embodiment disclosed in the asserted patents requires a pressure jacket. An injector that includes a pressure jacket is not a preferred embodiment of the injector. As the following excerpt demonstrates, the only injector contemplated by the specification is an injector with a pressure jacket:

According to the principles of the present invention , there is provided an angiographic injector having a front end loadable syringe that can be loaded into and removed from the injector pressure jacket through an opening that is provided in the front end of the pressure jacket. To provide this front end loadable feature, the syringes of the preferred and illustrated embodiments of the present invention are provided with a front wall that is pressure restraining . . . and that is securable to the front end of the pressure jacket . . . `669 patent, col. 2, lines 64-67 to col. 3, lines 1-4 `261 patent, col. 2, lines 61-67 to col. 3, line 1

(Doc. No. 30, Exhs. 1, 2) (emphasis added). Thus, a pressure jacket is a required element of the injector described in the asserted claims. See Modine Mfg. Co. v. United States Int'l Trade Comm'n, 75 F.3d 1545, 1551 (Fed. Cir. 1996), cert. denied, Showa Aluminum Corp. v. Modine Mfg., 518 U.S. 1005 (1996) ("[W]hen the preferred embodiment is described in the specification as the invention itself, the claims are not necessarily entitled to a scope broader than that embodiment."); Wang Labs, 197 F.3d at 1382-83 (scope of claims limited to the only embodiment described in the specification)

The prosecution history also supports the conclusion that the asserted claims of the `669 and `261 patents involve an injector that requires a pressure jacket. The original applications which led to the `669 and `261 patents were filed on November 30, 1993 and April 6, 1995, respectively. (Doc. No. 57, Exhs. 23, 25). In the applications, all the independent claims included a pressure jacket and no dependent claims provided for the removal or elimination of the pressure jacket.

On September 12, 1994, L-F amended certain claims of the application that resulted in the `669 patent. (Doc. No. 57, Exh. 22). L-F removed the references to the pressure jacket in those claims. ( Id.; Doc. No. 57, Exh. 2). Similarly, on April 6, 1995, L-F amended certain claims of the application that resulted in the `261 patent. (Doc. No. 57, Exh. 26). Again, L-F removed the references to the pressure jacket in those claims. ( Id.; Doc. No. 57, Exh. 3). The specifications for the `669 and `261 patents remained the same.

It is undisputed that L-F amended the claims after it learned of Medrad's invention of a jacketless injector. Regarding the amendment of claims in light of a competitor's product, the Federal Circuit has held that:

there is nothing improper, illegal or inequitable in filing a patent application for the purpose of obtaining a right to exclude a known competitor's product from the market; nor is it in any manner improper to amend or insert claims intended to cover a competitor's product the applicant's attorney has learned about during the prosecution of a patent application. Any such amendment or insertion must comply with all statutes and regulations, of course . . . .

Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 874 (Fed. Cir. 1988), cert. denied, 490 U.S. 1067 (1989) (citing State Indus., Inc. v. A.O. Smith Corp., 751 F.2d 1226, 1235 (Fed. Cir. 1985)). Thus, despite Medrad's argument to the contrary, L-F did nothing improper in amending the claims submitted in the original applications.

Although the fact that the original claims of the `669 and `261 patents were amended has no bearing on the Court's analysis, the substance of the original claims is relevant to its analysis. The original claims described an injector that required a pressure jacket. The specification was drafted for claims that disclosed an injector that required a pressure jacket, and this specification was not amended when the original claims were amended. It is unlikely that the specification, which was drafted for claims that included a pressure jacket, would describe an injector that does not require a pressure jacket, much less enable one skilled in the art to make and use such a device.

L-F argues that the prosecution history actually supports a conclusion that the injector described in the asserted claims does not require a pressure jacket. In an April 22, 1996, amendment to the `261 patent, L-F stated:

In the claims as amended herein, the locking structure is not necessarily at the front end of the syringe, nor is there necessarily a pressure jacket.

(Doc. No. 84, Exh. 4(b), MED 000189). Based on this excerpt alone, L-F argues that "[t]he Patent Office Examiner understood that the claims of the `261 patent were directed to the syringe/injector locking structure either at the front or the rear of the syringe and with or without a pressure jacket." (Doc. No. 164, p. 20). This Court cannot accept such an argument. When faced with a similar argument in DeMarini Sports, 239 F.3d at 1326, the court held that "[d]rawing inferences of the meaning of claim terms from an examiner's silence is not a proper basis on which to construe a patent claim . . ." As in DeMarini Sports, it is L-F, not the Examiner, who commented on the absence of a pressure jacket. The Examiner did not comment either way on the existence of a pressure jacket.

Finally, L-F proposes that the doctrine of claim differentiation prevents the Court from interpreting the asserted claims as requiring pressure jackets. (Doc. No. 164, pp. 16-18). The doctrine of claim differentiation is based "on the common sense notion that different words or phrases used in separate claims are presumed to indicate that the claims have different meanings and scope." Karlin Technology, 177 F.3d at 971-72. However, courts cannot use the doctrine of claim differentiation to "broaden claims beyond their correct scope, determined in light of the specification and the prosecution history and any relevant extrinsic evidence." Multiform Desiccants, 133 F.3d at 1480. The doctrine of claim construction "only creates a presumption that each claim in a patent has a different scope; it is `not a hard and fast rule of construction.'" Kraft Foods, 203 F.3d at 1368 (quoting Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998)); Karlin Technology, 177 F.3d at 972 (stating that the doctrine of claim differentiation is not a rigid rule).

According to L-F, the doctrine of claim differentiation precludes the Court from reading a pressure jacket requirement into claims 10 and 19 of the `669 Patent, as this requirement expressly appears in claim 14 which depends from claim 10.<sup>12</sup> (Doc. No. 164, p. 16-18). Likewise, L-F asserts that claim differentiation precludes the Court from reading a pressure jacket requirement into claims 1 and 18 of the `261 patent as this requirement expressly appears in dependent claims 2 and 19.¹³ ( Id.).

12 Claim 14 of the `669 patent provides as follows:
The method of claim 10 wherein:

the injector includes a hollow pressure jacket projecting therefrom having an open front end, the opening being located at the front end of the pressure jacket, the jacket having an internal cross-section dimensioned to surround and provide pressure restraining exterior support to the body of a syringe, inserted in the jacket through the opening, between at least the rearward end of the body to the rim;

the peripheral rim of the syringe is located at the forward end thereof;

the syringe inserting step includes the step of translating the syringe rearwardly and inserting thereby the body of the syringe, from the rearward end to the rim, into the jacket; and

the rotating step includes the step of locking the forward end of the syringe to the front end of the jacket.

13 Claim 2 of the `261 patent provides as follows:

The disposable replacement syringe of claim 1 for use with an injector having a pressure jacket extending forwardly therefrom, the jacket having a cylindrical bore therein, the opening of the injector being the hollow bore of the jacket, and wherein the internal sections are fixedly located on the inside of the jacket, wherein:

the radially extending mating sections of the locking structure comprise mating sections positioned in a plane perpendicular to the axis of the body of the syringe so as to align with the internal sections on the jacket when the syringe is inserted in the jacket and to lock the syringe to the jacket. Claim 19 of the `261 patent provides as follows:

The injector of claim 18 wherein:

the injector has a pressure jacket extending forwardly from the housing, the jacket having a cylindrical bore therein, the syringe receiving opening of the injector being in the bore of the jacket; and

the mating sections at the opening are fixedly located on the jacket, whereby the radially extending sections of the locking structure lock the syringe to the jacket.

(Doc. No. 30, Exhs. 1, 2).

L-F is applying the doctrine of claim differentiation in an attempt to broaden the asserted claims beyond their scope determined in light of the specification. See Multiform Desiccants, 133 F.3d at 1480. The specification does not contemplate a jacketless injector or instruct on the concept, design, or use of a jacketless injector. Thus, the Court cannot conclude simply because the term "pressure jacket" was explicitly used in dependent claims and not in the asserted claims, that the patents disclose a jacketless injector. As stated above, claim differentiation only creates a presumption that each claim has a different scope. "[C]laims that are written in different words may ultimately cover substantially the same subject matter." Multiform Sesiccants, 133 F.3d at 1480; see also, Tandon Corp. v. U.S. Int'l Trade Comm., 831 F.2d 1017, 1023 (Fed. Cir. 1987) ("[P]ractice has long recognized that `claims may be multiplied . . . to define the metes and bounds of the invention in a variety of different ways'.") (quoting Bourns, Inc. v. United States, 537 F.2d 486, 492 (Fed. Cir. 1976)).

Accordingly, the Court concludes that the terms "syringe receiving opening" and "opening" refer to a circular width of a size to accommodate the back end of a syringe. Furthermore, the Court concludes that the injector described in the asserted claims of the `669 and `261 patent requires a pressure jacket and that the syringe receiving opening/opening is located at the front of this pressure jacket.

C. "High Pressure"

Next, the Court must interpret the term "high pressure" as it is used in Claim 10 of the `669 patent, which claims "[a] method of loading a tubular replacement syringe into a high pressure power injector for injecting fluid into an animal." (Doc. No. 30, Exh. 1; `669 patent, col. 10, lines 17-18) (emphasis added). As the following analysis demonstrates, the term "high pressure" must be construed in its context as an adjective of the term "power injector." Therefore, the Court will construe the entire term "high pressure power injector."

The language of Claim 10 does not define the term "high pressure." However, when describing the syringe to be loaded into the injector, the claim does state that the syringe must be "capable of withstanding, . . . an operating pressure of at least 100 psi [pounds per square inch]." (Doc. No. 30, Exh. 1; `669 patent, col. 10, lines 32-34). Based on this language, L-F argues that the term "high pressure" means operating at pressures of at least 100 psi. (Doc. No. 164, p. 20).

While the claim language relied on by L-F may be relevant to the Court's overall analysis of the term "high pressure", it cannot, standing alone, define the term "high pressure." The claim language does not clearly delineate the pressure range to be attributed to the term "high pressure". As a result, the Court must interpret the claim language in light of the specification and prosecution history to ascertain the meaning of "high pressure."

When discussing injection pressures, the specification for the `669 patent states that:

For applications such as the injection of contrasting fluid for CT scanning, pressure may typically be in the range of from 25 to 300 psi, while in some angiographic injection applications the pressure may range to 1200 psi or higher. `669 patent, col. 12, line 24-27

(Doc. No. 30, Exh. 1). In other words, an injector operates at a pressure range of 25-300 psi for CT applications and operates at a pressure range up to 1200 psi or higher for angiographic applications. Thus, by determining which applications the injector in Claim 10 is capable of performing, the Court can infer the meaning of "high pressure power injector" as it is used in Claim 10.

The claim language does not indicate whether the injector disclosed in Claim 10 is capable of CT applications, angiographic applications, or both CT and angiographic applications. Thus, the Court must look to the specification and prosecution history for guidance on this issue. The specification for the `669 patent indicates that the injector described in the specification can be used for angiographic and/or CT applications:

FIG. 1 is a perspective view of an angiographic CT injector embodying principles of the present invention. `669 patent, col. 5, lines 21-22

* * *

Referring to FIG. 1, an angiographic injector 10 according to another preferred embodiment of the present invention is illustrated, configured for CT applications. `669 patent, col. 6, lines 12-14

(Doc. No. 30, Exh. 1). The question then becomes whether the injector described in Claim 10, like the injector described in the specification, is capable of both CT and angiographic application, only CT applications, or only angiographic applications.

The specification goes on to state that the fluid used in the injector "may be of relatively high pressure in the range, usually over 200 psi." (Doc. No. 30, Exh. 1; `669 patent, col. 12, lines 22-23). The implication of this statement is that pressures over 200 psi are considered high, therefore a "high pressure power injector", as in Claim 10, would be an injector that operates at pressures of 200 psi or higher, which would include both CT applications and angiographic applications

The conclusion that "high pressure power injector" refers to an injector that is capable of performing both CT and angiographic applications is also supported by the prosecution history of the `669 patent. L-F offered the following statements to the PTO Examiner during prosecution of the `669 patent:

Claim 95¹⁴ relates specifically to high pressure power injectors, as for example the injectors used in angiography, with CAT [¹⁵]equipment and the like . For such uses, applicants' front loading injector is totally new. The front loading feature is embodied in the simple operator motion of inserting the syringe into the injector by a rearward axial motion and twisting the syringe a fraction of a turn (as for example the quarter turn of the embodiment described in the specification).

14 Claim 95 issued as claim 10 of the `669 patent.

15 The terms CT and CAT are synonymous.

(Doc. No. 84, Exh. 3(B) at MED 002326). (emphasis added). At first glance, it is unclear whether "with CAT equipment and the like" is a phrase modifying the term angiography or whether it is part of a series of injector applications with "angiography" being the first in the series, with "with CAT equipment" being the second in the series, and with "the like" being the third in the series. However, a reading of the full prosecution history reveals that this statement, although grammatically incorrect, involves a series of injector applications.¹⁶ Therefore, Claim 95 related to "high pressure power injectors" such as those used in angiography and those used with CT equipment.

16 When discussing Claim 91 (issued as claim 1 of the `669 patent), L-F states that "claim 91 relates to the advantage of the present invention by which the efficiency of the use of a power injector, such as used in angiography and with CAT scanning equipment, is enhanced." When distinguishing this "present invention" from prior art devices, L-F states that "[t]he prior art devices provided for angiography and CAT scan uses do not have this capability." From these statements, the Court infers that "used. with CAT scanning equipment" is the equivalent of "CAT scan". (Doc. No. 84, Exhibit 3(B) at MED 002324-002325) (emphasis added)

It should be noted that the individual independent claims of the `669 patent refer to an injector as a "high pressure power injector", a "power injector", or simply an "injector."¹⁷ Nothing in the language of the various claims indicates whether the use of these different terms is intended to describe injectors capable of different applications. Medrad would argue that the use of these different terms indicates that the injector is intended to perform different applications. However, there is nothing in the specifications or prosecution history to support this conclusion. In fact, the prosecution history supports the opposite conclusion, that there is no difference in the terms. During patent prosecution, L-F stated the following to the PTO Examiner:

17 The independent claims of the `669 patent are 1, 6, 10, 19, 20, 22, 24, 31, and 36.

Applicants' invention relates to relatively high pressure power injectors . . . In order to focus more clearly on the particular features of the present invention and the advantages it provides, applicants have replaced the claims with seven independent claims, each relating to a particular unique problem and unique advantageous solution provided by the invention.

(Doc. No. 84, Exhibit 3(B) at MED 002324) (emphasis added). L-F then went on to discuss the seven independent claims referred to in this excerpt, which were apparently related to "high pressure power injectors." Those claims, 91, 93, 95, 100, 101, 103, and 105, issued as independent claims 1, 6, 10, 19, 20, 22, and 24 respectively. The issued claims refer to an injector as a "power injector" (claims 1, 19, 22), a "high power pressure injector" (claims 10, 20, 24), and an "injector" (claim 6) The inference to be drawn is that the terms "power injector", "high power pressure injector", and "injector" all refer to the same type of injector, i.e., a "high pressure power injector." This conclusion is consistent with the principle that "[c]laims that are written in different words may ultimately cover substantially the same subject matter." Multiform Desiccants, 133 F.3d at 1480

Accordingly, based on all the intrinsic evidence, the Court concludes that the "high power pressure injector" described in Claim 10 of the `669 patent is capable of performing angiographic as well as CT applications. As such, it operates at pressures ranging from 25 psi to in excess of 1200 psi.

D. "Physical Indicia"

L-F moves the Court to construe the term "physical indicia" as it is used in the asserted claims of "the `612 patent" and the `197 patent.¹⁸

18 The asserted claims of the `612 patent are 7, 8, 10, and 11 and the asserted claims of the `197 patent are 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 16, 17, 19, 20, 22, 23, 25, and 27.

Each of the asserted independent claims of the `612 patent and the `197 patent includes the term "physical indicia."¹⁹ These "physical indicia" relate to various properties of a syringe such as the capacity of a syringe, the distance of the plunger from the end of a syringe, the amount of fluid in a syringe, the end of travel position of an injector ram, the range of travel of an injector ram, and an offset value.

19 . . . a detector located proximate to a

syringe for detecting a physical indicia on said syringe related to the capacity of said syringe, and generating an electrical signal representative of said physical indicia, `612 patent, Claim 7,

detecting a physical indicia on a syringe said indicia being related to the capacity of said syringe, and generating an electrical signal representative of said physical indicia. . . `612 patent, Claim 10

. . . a syringe having . . . physical indicia related to the distance of the plunger from an end of said syringe `197 patent, Claim 1

. . . detecting a physical indicia on a syringe installed on said injector, said indicia being related to the distance of the plunger from an end of said syringe . . . `197 patent, Claim 4

a syringe having . . . physical indicia related to the amount of fluid in the syringe `197 patent, Claim 7

. . . detecting a physical indicia on a syringe installed on said injector, said indicia being related to amount of fluid in said syringe `197 patent, Claim 10

. . . a syringe having . . . physical indicia related to the end of travel position of an injector ram coupled to the plunger when the syringe is coupled to an injector . . . `197 patent, Claim 13

. . . detecting a physical indicia on a syringe installed on said injector, said indicia being related to the end of travel position of a ram moved by said motor when said syringe is mounted to the injector `197 patent, Claim 16

. . . a syringe having . . . physical indicia related to the range of travel of an injector ram coupled to the plunger when the syringe is coupled to an injector . . . `197 patent, Claim 19

. . . detecting a physical indicia on a syringe installed on said injector, said indicia being related to the range of travel of a ram moved by said motor when said syringe is mounted to the injector . . . `197 patent, Claim 22

. . . wherein the control circuit is operable obtain an offset value from physical indicia detected on the syringe `197 patent, Claim 25

. . . detecting a physical indicia on a syringe said indicia being related to the capacity of said syringe, to obtain an offset value, computing a value indicative of the location of said plunger within said syringe by applying the store offset value to the tracked location of said motor, and ceasing motion of said plunger when said computed value indicates that said plunger is at an end of said syringe. `197 patent, Claim 27

(Doc. No. 30, Exhs. 3, 4).

L-F urges this Court to give the term "physical indicia" its ordinary and customary meaning without looking beyond the claim language. Physical is defined as "of or relating to . . . material things as opposed to things mental, moral, spiritual, or imaginary." Webster's Third New International Dictionary at 1706 (1971). Indicia is defined as "a distinctive mark that indicates or that is felt to indicate the nature or quality or existence or reality of something." Id. at 1150. Thus, the term "physical indicia" means a tangible marking on a syringe that relates to a specific property of the syringe. L-F proposes that these specific properties include the capacity of a syringe, the distance of the plunger from the end of a syringe, the amount of fluid in a syringe, the end of travel position of an injector ram, the range of travel of an injector ram, and an offset value that is related to the capacity of a syringe. (Doc. No. 164, p. 24).

Medrad does not appear to disagree that the term "physical indicia" means a tangible marking on a syringe that relates to a specific property of the syringe. Rather, Medrad is arguing that "physical indicia", as used in the `612 and `197 patents, is limited only to indicia that indicate the length of an extender element used in a syringe.²⁰ (Doc. No. 172, pp. 29-30).

20 An extender is an element in a syringe that compensates for variations in the location of the plunger in pre-filled syringes to accommodate varying syringe volumes.

It should be noted that the language of the asserted claims does not limit the term "physical indicia" to the use of an extender element. Rather, the claim language unambiguously states that "physical indicia" are related to capacity of a syringe, the distance of the plunger from the end of a syringe, the amount of fluid in a syringe, the end of travel position of an injector ram, the range of travel of an injector ram, and an offset value. Supra, fn. 19. Therefore, unlike the ambiguous language construed in Section III(B) ("syringe receiving opening"/requirement of a pressure jacket), the claim language relating to the term "physical indicia` is clear and unambiguous. This distinction is significant because it affects the manner in which this Court will view the rest of the intrinsic evidence, i.e., the specification and the prosecution history. The Federal Circuit has recently held that:

If the claim language is clear on its face, then our consideration of the rest of the intrinsic evidence is restricted to determining if a deviation from the clear language of the claims is specified. A deviation may be necessary if "a patentee [has chosen] to be his own lexicographer and use terms in manner other than their ordinary meaning." Vitronics, 90 F.3d at 1582, 39 USPQ2d at 1576. A deviation may also be necessary if a patentee has "relinquished [a] potential claim construction in an amendment to the claim or in an argument to overcome or distinguish a reference." Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 979, 52 USPQ2d 1109, 1113 (Fed. Cir. 1999). If however the claim language is not clear on its face, then our consideration of the rest of the intrinsic evidence is directed to resolving, if possible, the lack of clarity.

Interactive Gift Express, 256 F.3d at 1331. Therefore, when construing the term "physical indicia", the Court will rely on the rest of the intrinsic evidence to determine only if a deviation from the clear language of the claim is specified rather than to resolve the meaning of the claim language, as it did in Section III(B).

Medrad bases its argument that "physical indicia" is limited to indicating the length of an extender on the following excerpts from the specifications of the `612 and `197 patents²¹:

21 As explained in detail in footnote 4, the `612 and `197 patents have the same specification.

The offset value . . . may be automatically computed by detecting physical indicia on the syringe or extender which indicate the length of the extender. `612 patent, Abstract

Alternatively, the offset value may be automatically computed by detecting physical indicia on the syringe or extender which indicate the length of the extender. `612 patent, col. 4, lines 2-3 `197 patent, col. 4, lines 1-2²²

22 Medrad also cites to unasserted Claim 3 of the `612 patents which states, in pertinent part, that the injector contains a detector used for "detecting the length of the extender which is attached to said plunger from physical indicia on the syringe or extender and generating an electrical signal representative of the detected length . . ." (Doc. 30, Exh. 3). In light of the law of claim differentiation discussed in section III (B), this claim language does not support Medrad's argument. Unlike the situation in section 111(B), L-F is not attempting to broaden the asserted claims beyond the scope of the claim language.

(Doc. No. 30, Exhs. 2, 3). Medrad argues that this language defines "physical indicia" as indicia related only to length of extender. Not surprisingly, L-F counters that this language is merely a preferred embodiment in which the physical indicia on the syringe indicates a specific property — the length of an extender.²³ (Doc. No. 182, p. 15). L-F argues that this embodiment does not preclude the use of physical indicia in relation to other properties of the syringe ( i.e., capacity, distance of the plunger from the end, amount of fluid, etc.).

23 Court notes that the language in question falls under the heading "Summary of the Invention" as opposed to the later heading of "Description of the preferred Embodiments."

Medrad also cites to the prosecution history of the `197 patent to support its interpretation. (Doc. No. 172, pp. 30-32). Claim 7 of the `197 patent includes the element "physical indicia related to the amount of fluid in the syringe," and claim 10 of the `197 patent includes the element of a "[physical] indicia being related to amount of fluid in said syringe." During the prosecution of the `197 patent, the PTO Examiner rejected L-F's proposed claims 7 and 10 due to failure to comply with the written description requirement of 35 U.S.C. § 112. In the Detailed Action, the PTO Examiner, in rejecting claims 22-45, explained that

The specification, as originally filed on 28 August 1997, does not adequately support the embodiments set forth in claims 22-27 wherein the syringe includes physical indicia related to the position of the plunger; claims 28-33 wherein the syringe includes physical indicia related to the amount of fluid in the syringe; claims 34-39 wherein the syringe includes physical indicia related to the end of travel position of a ram moved by the motor; and claims 40-45 wherein the syringe includes physical indicia related to the range of travel of a ram moved by the motor. The only recitation in the specification regarding the indicia on the syringe is on page 6, lines 23-26:

"Alternatively, the offset value may be automatically computed by detecting physical indicia on the syringe or extender which indicate the length of the extender.'

Thus there is inadequate disclosure of such indicia being related to plunger position, fluid quantity, end of travel position of the ram, and range of travel of the ram as now claimed. The disclosure only provides support for the indicia being related to the length of the extender.

(Doc. No. 172, Exh. 10, p. 2). The PTO Examiner rejected claims 22-45 based on failure to comply with 35 U.S.C. § 112, first paragraph. ( Id. at 3).

In response to the PTO Examiner, L-F argued that the other elements of "capacity of the syringe" and "amount of fluid in the syringe" were related to the length of the extender, and thus, those elements were supported in the specification through the references to the length of the extender:

With respect to claims 28-33, the Examiner submits that the specification does not support physical indicia on a syringe related to the amount of fluid in the syringe, and does not support computing the amount of fluid in the syringe.

In response, Applicant would note that a comparison of Fig. 1A to Fig. 1B clearly shows that the capacity of a syringe having an extender is less than the capacity of a syringe that does not have such an extender. Notably, the syringe shown in Fig. 1B is a "pre-filled" syringe, thus the syringe is filled to its capacity when it is installed on the injector. Since the capacity of the syringe is directly related to the length of the extender in the syringe, it follows that the amount of fluid in the syringe is directly related to the length of the extender. Accordingly, the indicia recited at page 6, which indicates the length of the extender, also thereby indicates the amount of fluid in the syringe. Indeed, at page 4, line 4 it is stated that the extender "reduc[es] the initial volume of the pre-filled syringe'. Accordingly, Applicant submits that the specification clearly describes a syringe having indicia related to the amount of fluid in the syringe.

( Id. at 12-13). L-F made similar arguments with respect to physical indicia relating to the distance of the plunger from the end of a syringe, the end of travel position of an injector ram, and the range of travel of an injector ram. ( Id. at 10-12, 13-16). The patent was subsequently issued by the PTO without any substantive amendment by L-F of the claims or specification. (Doc. No. 174, Exh. 4, Notice of Allowance on 4/1/99, p. 139).

The Court would agree with Medrad's argument that the term "physical indicia" is limited to indicia related to the length of the extender if the preceding excerpts from L-F's response to the PTO Examiner reflected the entirety of L-F's response. However, in the final paragraph of L-F's response, L-F stated that:

Applicant would further note that although the supporting specific embodiment of the invention found in the specification is disclosed in the context of compensating for the presence of a plunger extender attached to the plunger, the independent claims do not necessarily require a plunger extender, but rather are directed generally to using information from indicia on a syringe, to compensate for syringes having differing initial plunger positions, differing initial amounts of fluid, differing end-of-travel positions or ranges of travel for the ram.

( Id. at 16). Thus, L-F unequivocally stated to the PTO Examiner that the asserted claims of the `197 patent were not limited to indicia relating to the length of an extender.

In order to narrow unambiguous claim language based on the prosecution history, an accused infringer must "demonstrate that the patentee "defined" the claim as "excluding" a broader interpretation "with reasonable clarity and deliberateness.'" Pall Corporation v. PTI Technologies, Inc., 259 F.3d 1383, 1392-93 (Fed. Cir. 2001) (quoting Northern Telecom Ltd. v. Samsung Elecs. Co., 215 F.3d 1281, 1294-95 (Fed. Cir. 2000)). Based on the final paragraph of L-F's response, the Court cannot conclude that L-F limited the asserted claims to "physical indicia" only related to the length of an extender. L-F clearly viewed "physical indicia" as encompassing other syringe characteristics besides the length of the extender.

Thus, the Court construes the term "physical indicia" as a tangible mark on a syringe relating to various properties of the syringe. The properties may include the capacity of a syringe, the distance of the plunger from the end of a syringe, the amount of fluid in a syringe, the end of travel position of an injector ram, the range of travel of an injector ram, or an offset value.

Medrad argues that in the event the Court accepts L-F's construction of the term "physical indicia", the `612 and `197 patents are invalid pursuant to 35 U.S.C. § 112 for lack of enablement and failure to provide an adequate written description. (Doc. No. 172, pp. 32-33). This argument will be addressed in section VII(A).

E. "Motor" and "Tracks the Location of Said Motor" ²⁴

24 The Court reviewed L-F's Supplementation in Reply (Doc. No. 220) relating to this issue, Medrad's Motion to Strike L-F's Supplementation (Doc. No. 224), and L-F's memorandum in opposition (Doc. No. 235). These filings relate to extrinsic evidence not considered by the Court when construing the claim terms.

L-F requests that the Court interpret the terms "motor" and "tracks the location of said motor" as they are used in the `612 and `197 patents. Each of the asserted independent claims of the `612 and `197 patents recites that the injector has a motor which advances and retracts a plunger and that the device includes a control circuit which causes the motor to move and tracks the location of the motor while moving the motor.

L-F asserts that "motor" actually means the "drive mechanism" and "tracks the location of said motor" means "tracks the location of the drive mechanism." (Doc. No. 164, pp. 26-27). Medrad, relying strictly on dictionary definitions, argues that "motor" means a machine that imparts motion and that "tracks the location of said motor" means that the motor is moving to another location within the injector and that this movement is being tracked. (Doc. No. 172, pp. 33-34). The Court finds both L-F's and Medrad's arguments illogical and unpersuasive.

The terms "motor" and "tracks the location of said motor" are not defined by any of the asserted claims in the `612 and `197 patents. Therefore, the claims must be read in light of the specification to define the terms. See Interactive Gift Express, 256 F.3d at 1331.

The Court believes the following excerpt from the specification sufficiently defines the terms in question.

The motor 98 is coupled to a gear box which translates

rotary motion of the motor to linear translation of the plunger. . . The rotation of the motor is detected by optical encoder 166. . . Encoder 166 sends electrical pulses to circuit board 160, which relays them to Power PC 50, allowing CPU 52 on the Power PC to monitor movement of the motor. `612 patent, col. 10, lines 50-62 `197 patent, col. 10, lines 48-60

(Doc. No. 30, Exhs. 3, 4). In other words, the "motor" is a mechanism that rotates and this rotation causes gears in the gear box to move which ultimately results in the linear movement of the plunger. "Track the location of said motor" refers to the monitoring of the rotation of the motor.²⁵

25 In Plaintiff Liebel-Flarsheim Company's Opposition to Medrad's Motion for Partial Summary Judgment of Invalidity and Non-Infringement of the Asserted Claims of U.S. patent Nos. 5,662,612 and 5,928,197 (Doc. 174), L-F, in its argument regarding the construction of the terms "motor" and "tracks location of said motor", presented an argument identical to the Court's present analysis of these terms. It is unclear why L-F presented a completely different, and in the Court's opinion incorrect, argument in its summary judgment motion for claim construction.

L-F's proposed interpretation equates "motor" with the "drive mechanism of the plunger". However, the term "motor" is shown in the specifications and used in the claims as a distinct element. "Motor" is assigned reference number 98 and is depicted in Figure 5 of both patents, where the motor is different and distinct from the "gear box" (Ref. No. 164), the "optical encoder" (Ref. No. 166), the "plunger" (Ref. No. 12), the "linear pot" (Ref. No. 168), the "main circuit board" (No. 160), and other elements. (Doc. No. 30, Exhs. 3, 4). It appears that the "drive mechanism" includes parts in addition to the motor such as the gearbox, the ram, and all of the component parts that work to drive the plunger. Therefore, the motor cannot be the equivalent of the drive mechanism of the plunger.

Medrad's proposed interpretation, that the motor is moving from location to location, ignores the specification which clearly indicates that the motor is stationary. Furthermore, Medrad's proposed interpretation would exclude the preferred embodiment disclosed in the `612 and `197 patents, which describes a motor that is stationary. See Vitronics, 90 F.3d at 1583; Burke, Inc. v. Brundo Independent Living Aids, Inc., 183 F.3d 1334, 1341 (Fed. Cir. 1999).

In light of the clear and unambiguous language of the specification, the Court finds that its construction of the terms "motor" and "tracking the movement of the motor" is the more logical construction. Therefore, the Court construes the term "motor" as a stationary mechanism that rotates causing the movement of the gears in the gearbox and the term "tracking the movement of the motor" as the monitoring of the rotation of the motor.

IV. DEFENDANT'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF INVALIDITY FOR LACK OF ENABLEMENT OF THE ASSERTED CLAIMS OF THE `669 AND `261 PATENTS (DOC. 168)

Medrad filed this motion for partial summary judgment. (Doc. No. 168). L-F filed a Response (Doc. No. 175) to which Medrad filed a Reply (Doc. No. 187).

Based on the Court's construction that a pressure jacket is a required element of the asserted claims of the `669 and `261 patents (Section III(B)), the Court declares MOOT Defendant's Motion for Partial Summary Judgment of Invalidity for Lack of Enablement of the Asserted Claims of the `669 and `261 Patents (Doc. No. 168).

V. DEFENDANT'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF INVALIDITY AND NON-INFRINGEMENT OF THE ASSERTED CLAIMS OF THE `669 AND `261 PATENTS (DOC. 57)

Medrad filed this motion for partial summary judgment. (Doc. No. 57). L-F filed a Response (Doc. No. 84) to which Medrad filed a Reply (Doc. No. 99)^{26 27}

26 The Court also reviewed Medrad's Motion to File a Sur-Reply (Doc. No. 190) and L-F's memorandum in opposition (Doc. No. 196).

27 L-F also filed a motion to file a sur-reply (Doc. No. 104). Medrad filed a memorandum in opposition (Doc. No. 113) to which L-F filed a Reply (Doc. No. 120). L-F did not file a sur-reply but instead filed a supplemental memorandum in opposition (Doc. No. 195). Medrad filed a Response (Doc. No. 199) to which L-F filed a Reply (Doc. No. 203). These filings involve findings by the European Patent Office. This Court did not consider these findings when ruling on this matter.

A. Brief Background

Medrad seeks summary judgment arguing that if the asserted claims of the `669 and `261 patents are construed as not requiring a pressure jacket, the patents are invalid for failure to comply with the written description requirements of 35 U.S.C. § 112, ¶ 1. In the alternative, Medrad argues that if the asserted claims are construed as requiring a pressure jacket, it is entitled to summary judgment for non-infringement of the `669 and `261 patents because the accused products do not include a pressure jacket.

Based on the Court's construction that the asserted claims require a pressure jacket (Section 111(B)), the portion of Medrad's motion for summary judgement based on invalidity is MOOT. The Court now addresses Medrad's non-infringement portion of its motion.

B. Non-Infringement of the `669 and `261 Patents

Infringement is the unlicenced making, using, or selling of a patentee's claimed invention. 35 U.S.C.A. § 271(a). Literal infringement occurs when the accused product is precisely described in a patent claim. SRI Int'l, 775 F.2d at 1123. Under the doctrine of equivalents, infringement occurs when the accused product "performs substantially the same overall function or work, in substantially the same way, to obtain substantially the same overall result as the claimed invention." Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931, 934 (Fed. Cir. 1987) (en banc), cert. denied, 485 U.S. 961, 485 U.S. 1009 (1988).

To determine infringement, the court must apply a two-step analytic procedure. Wang Labs., 197 F.3d 1377, 1380-81 (Fed. Cir. 1999) (citations omitted); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1476 (Fed. Cir. 1998) (citation omitted). First, the court must construe the scope and meaning of the patent claims asserted, which are questions of law. Id. Then, the court must apply those claims to the allegedly infringing device or process, which is a question of fact. Id.

To establish literal infringement, every limitation set forth in a claim must be found in the accused product, exactly. Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed. Cir. 1999), cert. denied, 529 U.S. 1066 (2000) (quoting Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1211 (Fed. Cir. 1998)); Southwall Technologies, Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995), cert. denied, 514 U.S. 987 (1995). As a matter of law, there is no literal infringement if any claim limitation is absent from the accused device. Elkay Mfg. Co., 192 F.3d at 980.

Because "infringement is itself a fact issue, a district court must approach a motion for summary judgment of infringement or non-infringement with a care proportioned to the likelihood of its being inappropriate." SRI Int'l, 775 F.2d at 1116 (citing D.M.I., Inc. v. Deere Co., 755 F.2d 1570, 1573 (Fed. Cir. 1985)); Palumbo v. Don-Joy Co., 762 F.2d 969, 974 (Fed. Cir. 1985). "[A] trial often establishes facts and inferences not gleanable from papers submitted pre-trial." SRI Int'l, 775 F.2d at 1116.

In section III (B), this Court held that the injector described in the asserted claims of the `669 and `261 patents required a pressure jacket. It is undisputed that the accused injectors do not include a pressure jacket. Therefore, because a claim limitation, a pressure jacket, is absent from the accused products, there is no literal infringement of the `669 and `261 patents as a matter of law. Mas-Hamilton Group, 156 F.3d at 1211 (Fed. Cir. 1998) ("If even one limitation is missing or not met as claimed, there is no literal infringement.") (citations omitted).

Furthermore, it does not appear, nor has L-F argued, that the accused products include the equivalent of a pressure jacket. Therefore, there is no infringement under the doctrine of equivalents. See Mas-Hamilton Group, 156 F.3d at 1215-16 (explaining that when an accused device is missing the equivalent of a claim limitation there is no infringement under the doctrine of equivalents). See also, Anderson, 477 U.S. at 248 (The nonmoving party "`may not rest upon the mere allegations or denials of his pleading, but . . . must set forth specific facts showing that there is a genuine issue for trial.'" (citations omitted)).

Thus, the Court concludes that there is no genuine issue as to any material fact with respect to non-infringement of the `669 and `261 patents and that Medrad is entitled to judgment as a matter of law.

Thus, the Court GRANTS, with respect to non-infringement, Defendant's Motion for Partial Summary Judgment of Invalidity and Non-infringement of the Asserted Claims of the `669 and `261 Patents (Doc. 57) and declares the motion MOOT with respect to invalidity.

VI. DEFENDANT'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT OF THE `612 AND `197 PATENTS BECAUSE DEFENDANT PRACTICES ITS OWN PATENT WHICH IS PRIOR ART TO THE ASSERTED PATENTS (DOC. 162)

Medrad filed this motion for partial summary judgment. (Doc. No. 162). L-F filed a Response (Doc. No. 163) to which Medrad filed a Reply (Doc. No. 170).²⁸

28 The Court also reviewed L-F's Motion to File a Sur-Reply (Doc. No. 178), Medrad's memorandum in opposition (Doc. No. 180), and L-F's reply (Doc. No. 188).

A. Brief Background

Medrad seeks summary judgment on L-F's claims that Medrad infringed claims 7, 8, 10, and 11 of the `612 patent and claims 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 16, 17, 19, 20, 22, 23, 25, and 27 of the `197 patent.

The `612 patent issued on September 2, 1997 from an application filed June 26, 1995, and the `197 patent issued on July 27, 1999 from an application filed August 28, 1997. (Doc. No. 162, Exhs. 1, 2). The claims of the `197 and `612 patents recite specific uses of encoding information on a syringe which the patents refer to as "physical indicia."²⁹

29 Supra, fn. 19.

Prior to the filing of L-F's above-mentioned applications, Medrad, on August 17, 1992, filed an application which resulted in U.S. Patent No. 5, 383, 858 ("the `858 patent"). (Doc. No. 162, Exh. 3). The `858 patent, entitled "Front-Loading Medical Injector and Syringe For Use Therewith," was issued on January 24, 1995. Among other things, the `858 patent discloses a method and device for syringe encoding (collectively "syringe encoding").³⁰

30 The `858 patent provides as follows:

With further reference to FIG. 2, a system 67 for transmitting syringe information from the syringe 22 to an injector controller 68, illustrated in phantom lines in FIG. 1, while attaching the syringe to the injector housing front wall mounting assembly 23, also is provided. In this instance, the system 67 comprises an encoding device 70, such as a bar code having spaced bars 70b and located on the syringe 22, and a sensor 72 located on the injector 27, as for example, in a second one of the connector assembly retaining flanges 23f. Then, as the syringe 22 is rotated into its mounted position, the sensor 72 reads the encoding device 70 and forwards associated signals to the injector controller 68, which then interprets the signals and modifies the function of the injector apparatus 20 accordingly. Examples of the information which could be encoded on the encoding device 70 include dimensions of the syringe 22, content of the syringe in the case of a pre-filled syringe, manufacturing information such as lot numbers, dates and tool cavity number, recommended contrast media flow rates and pressures, and loading/injection sequences. As an alternative to the encoding device 70 being a bar code with spaced bars 70b, the encoding device also could include raised surfaces 70s corresponding to the spaced bars, which then would be read by a suitable injector sensor 72 in a similar manner, as the syringe 22 is mounted on the injector housing front wall 24. In addition to the encoding device 70, one may also use mechanically readable devices, e.g., a slot, hole, or projection on the syringe 22 or plunger 38 to register against a switch on the mounting assembly 23, or alternatively an optically readable device, e.g. characters, dots and other geometric shapes, that will send information concerning the type of syringe used to the intelligent circuits of the injector. `858 patent, col. 6, lines 31-65

(Doc. No. 162, Exh. 3).

B. Discussion

On summary judgment, Medrad argues that the accused products cannot, as a matter of law, infringe the `612 and `197 patents because Medrad practices its own prior art patent, the `858 patent. (Doc. No. 162, p. 10). Medrad contends that the accused products include the syringe encoding covered by the `858 patent. (Doc. No. 162, p. 2). Medrad argues further that because the `858 patent was issued in 1995, it constitutes prior art to the `612 and `197 patents, which were issued in 1997 and 1999, respectively. (Doc. No. 162, p. 3). Therefore, Medrad contends that it is practicing the prior art. If Medrad's conclusion is correct, the accused products cannot infringe the asserted patents literally or under the doctrine of equivalents. See Fiskars, Inc. v. Hunt Mfg. Co., 221 F.3d 1318, 1323 (Fed. Cir. 2000), cert. denied, 121 S.Ct. 1603 (2001) (it is an affirmative defense of an alleged infringer to establish that it is practicing the prior art).

To determine whether Medrad is practicing the prior art the Court must determine (1) whether the `858 patent is prior art to the `612 and `197 patents and (2) whether the accused products are covered by the `858 patent with respect to syringe encoding.

The parties appear to agree that the `858 patent is prior art to the `612 and `197 patents. Therefore, the next issue for the Court's consideration is whether the accused products are covered by the `858 patent, in particular with respect to the patent's syringe encoding disclosures. Medrad contends that the accused products include the syringe encoding disclosed by the `858 patent. In support of its contention, Medrad relies on the Second Declaration of Joseph B. Havrilla, the Senior Vice President of New Project Development for Medrad. (Doc. No. 162, Exh. 6). In his declaration, Havrilla states that:

3. Medrad's Envision CT™ and Medrad Vistron CT® injectors, and the syringes for use with these injectors, incorporate and practice inventions described in Medrad U.S. Patent No. 5,383,858 ("the `858 patent") filed August 17, 1992 and issued January 24, 1995.

4. In particular, Medrad's Envision CT™ and Medrad Vistron CT® injectors, and the syringes for use with these injectors, feature a syringe encoding apparatus and method as disclosed in column 6, lines 31-65 of the Medrad `858 patent. The same disclosure of syringe encoding appears in two other Medrad patents, U.S. Patent Nos. 5,997,502 ("the `502 patent") and 6,090,064 ("the `064 patent"), both of which have an August 17, 1992 effective filing date and both of which also explicitly claim syringe encoding. Medrad's Envision CT™ and Medrad Vistron CT® Injectors, in particular the syringe encoding aspects of these injectors, operate as disclosed in Medrad's `858 patent and as claimed in Medrad's `502 and `064 patents.

(Doc. No. 162, Exh. 6, ¶¶ 3, 4). Medrad also cites to statements made by two of L-F's own experts, Dennis A. Guenther and Arthur J. Helmicki, in support of its argument.³¹ With respect to the statements of Guenther and Helmicki, the Court concludes that they are not related to the issue of whether the accused products include the syringe encoding disclosed in the `858 patent. Therefore, the only credible evidence Medrad has presented that the accused products are covered by the `858 patent with respect to syringe encoding is the declaration of Havrilla.

31 Medrad cited to the January 31, 2001 Rebuttal Report of Dennis A. Guenther, Ph.D., P.E. Under Rule 26(a)(2)(B) of the Federal Rules of Civil Procedure in Civil Action C1-98-858, (Doc. 162, Exh. 8) and to the Report of Arthur J. Helmicki, Ph.D., Under Rule 26(a)(2)(B) of the Federal Rules of Civil Procedure, (Doc. 162, Exh 9 (page 1 of Exh. B and page 1 of Exh. C)).

L-F does not take a position on whether the accused products practice the prior art of the `858 patent with respect to syringe encoding. Rather, L-F argues that this issue is irrelevant because even if the accused products practice the prior art of the `858 patent, they also practice the subject matter of the claims of the `612 and `197 patents, which, L-F contends, are improvement patents of the `858 patent.³² (Doc. No. 163, pp. 8-10). As L-F accurately states, when a patentee claims an improvement over a prior invention, other parties may practice variations of that prior invention, as long as the variations are not the same as, or an equivalent of, the improvement claimed by the patentee. See Thomas Betts Corp. v. Litton Systems, Inc., 720 F.2d 1572, 1580 (Fed. Cir. 1983) (citing Sealed Air Corp. v. U.S. International Trade Comm'n, 645 F.2d 976, 984-85 (C.C.P.A. 1981).

32 Medrad has not disputed L-F's argument that the `612 and `197 patents are improvement patents of the `858 patent.

L-F argues that while the `858 patent discusses syringe encoding, it only refers to syringe encoding applications not claimed in the `612 and `197 patents. According to L-F, the syringe encoding disclosed in the `858 patent identifies:

• dimensions of the syringe

• content of the syringe in the case of a prefilled syringe

• manufacturing information such as lot numbers, dates and tool cavity number

• recommended contrast media flow rates and pressures loading/injections sequences

(Doc. No. 163, p. 6 (citing `858 patent, col. 6, lines 45-51)). On the other hand, L-F points out that the syringe encoding of the `612 and `197 identifies:

• capacity of the syringe

• distance of the plunger from an end of the syringe when the syringe is initially installed on the injector

• amount of fluid in the syringe

• end of travel position of an injector ram coupled to the plunger when the syringe is coupled to the an injector

• range of travel of an injector ram coupled to the plunger when the syringe is coupled to an injector

(Doc. No. 163, pp. 4-5 (citing Exh. 1, Helmicki Affidavit ¶ 7))³³ Further, according to L-F, the `858 patent fails to address the use of syringes that have "different end-of-travel positions, capacities, or different amounts of fluid or plunger-end-of-syringe distances." (Doc. No. 163, p. 7). Thus, L-F argues that the `858 patent "does not disclose the uses for indicia that are recited in the `612 and `197 patent claims." (Doc. No. 167, p 8). L-F argues that the accused products include syringe encoding that identifies the information contained in the `612 and `197 patents. (Doc. No. 167, p 10).

33 In its reply (Doc. No. 170), Medrad asks this Court to strike Helmicki's declaration as being not credible. The Court finds Medrad's argument on this issue unpersuasive and declines to strike Helmicki's declaration.

Medrad, relying on its claim construction argument that the term "physical indicia" is only related to the length of the extender, does not address L-F's argument that the accused products include syringe encoding that identifies other information besides the length of an extender. In section III(D), this Court rejected Medrad's proposed construction. Therefore, by relying exclusively on its proposed claim construction, which the Court had concluded is incorrect, Medrad has failed to present any factual evidence to dispute L-F's argument that the accused products include syringe encoding that identifies the information contained in the `612 and `197 patents.

However, the Court recognizes the difficulties faced by the parties due to the sequencing of motions in this matter. Therefore, the Court invites the parties to rebrief this argument in light of the Court's construction of the term "physical indicia". However, neither party should revisit the claim construction issue in any such briefings . Briefings should be confined to the issue of infringement in light of this Court's construction of the term "physical indicia" in section III(D). Defendant Medrad's revised motion is due on November 19, 2001, Plaintiff L-F's response is due on December 10, 2001, and Defendant Medrad's reply is due on December 31, 2001.

Accordingly, the Court RESERVES JUDGMENT on Medrad's Motion for Partial Summary Judgment of Non-infringement of the `612 and `197 Patents Because Defendant Practices its Own Patent Which Is Prior Art to the Asserted Patents (Doc. 162).

VII. DEFENDANT'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT AND INVALIDITY OF THE ASSERTED CLAIMS OF THE `612 AND `197 PATENTS (DOC. 167)

Defendant has filed a second motion for partial summary judgment of non-infringement and invalidity of the asserted claims of the `612 patent and the `197 patent. (Doc. No. 167). Defendant requested that the Court hear oral argument on this motion. Plaintiff has filed a Memorandum in Opposition (Doc. No. 174) to which Defendant has filed a Reply (Doc. No. 184).

In its motion for summary judgment, Medrad argues that the accused devices do not infringe the `612 and `197 patents because the accused devices lack at least two elements of the asserted claims, a moving motor and physical indicia indicating the length of an extender. Medrad also argues that the `612 and `197 patents are invalid because the specifications of both asserted patents fail to satisfy the written description and enablement requirements of 35 U.S.C. § 112. The Court will address Medrad's invalidity argument first.

A. Invalidity of the `612 and 197 Patents

Medrad contends that the `612 and `197 patents are invalid for failure to comply with the written description and enablement requirements provided in 35 U.S.C. § 112, ¶ 1. That paragraph provides, in pertinent part, as follows:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . . .

35 U.S.C. § 112, ¶ 1. This paragraph requires both a written description of the specific subject matter claimed and that the description enable one skilled in the art to make and use the claimed invention. Rohm and Haas Co. v. Mobil Oil Corp., 718 F. Supp. 274, 287 (D. Del. 1989), aff'd, 895 F.2d 1421 (Fed. Cir. 1990); see In re Wilder, 736 F.2d 1516, 1520 (Fed. Cir. 1984), cert. denied, Wilder v. Mossinghoff, 469 U.S. 1209 (1985) (citations omitted).

1. Written Description

The written description provision requires that the specification of the patent describe the inventions claimed in the patent. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1346 (Fed. Cir. 2000); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1479 (Fed. Cir. 1998). The written description must clearly allow those of ordinary skill in the art to recognize that the applicant invented what is claimed. In re Alton, 76 F.3d 1168, 1172 (Fed. Cir. 1996) (quoting In re Gosteli, 872 F.2d 1008, 1012, (Fed. Cir. 1989) (citation omitted)). "The adequate written description requirement . . . serves `to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him; how the specification accomplishes this is not material.'" In re Alton, 76 F.3d at 1172 (quoting In re Wertheim, 541 F.2d 257, 262 (C.C.P.A. 1976)).

A party arguing that a patent is invalid due to failure to comply with the written description requirement of § 112 carries a heavy burden. Every patent is presumed valid. National Recovery Technologies, Inc. v. Magnetic Separation Recovery Systems, Inc, 166 F.3d 1190, 1195 (Fed. Cir. 1999); Texas Instruments Inc. v. United States Int'l Trade Comm'n, 988 F.2d 1165, 1177 (Fed. Cir. 1993). This presumption of validity includes a presumption that the patent complies with 35 U.S.C. § 112. National Recovery Technologies, 166 F.3d at 1195. Thus, a party challenging the validity of a patent bears the burden of establishing invalidity by clear and convincing evidence. Texas Instruments Inc., 988 F.2d at 1177; ACS Hospital Systems, Inc. v. Montefiore Hospital, 732 F.2d 1572, 1575 (Fed. Cir. 1984) (stating that the burden of persuasion always remains on the party asserting invalidity); see also National Recovery Technologies, 166 F.3d at 1195 (quoting Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 941 (Fed. Cir. 1990), cert. denied, 498 U.S. 920 (1990)). Whether a specification complies with the written description requirement of § 112 is a question of fact. Suntiger, Inc. v. Scientific Research Funding Group, 189 F.3d 1327, 1334 (Fed. Cir. 1999); Gentry Gallery, 134 F.3d at 1479.

Medrad, relying on the conclusions of its experts, argues that the single phrase referring to "physical indicia" in the specifications of the `612 and `197 patents³⁴ fails to convey with reasonable clarity that the inventor had possession of the claimed subject matter as of the filing date of the applications for these patents.³⁵ ( See also, Doc. No. 167, Exh. 10).

34 The phrase referred to by Medrad is "physical indicia on the syringe or extender which indicate the length of the extender." (`669 patent, Abstract, col. 4, lines 1-3 and `197 patent, col. 3, lines 67-69).

35 his declaration, Robert Sturges states:

12. Based on lack of disclosure by L-F, the `612 patent would not teach or enable a typical or ordinary syringe or injector designer to construct or design a syringe with "physical indicia" other than, at best, "physical indicia" on the extender related to the length of the extender. The `612 patent contains no description or drawings that teach or even disclose "physical indicia" that are related to syringe capacity or other parameters.

(Doc. No. 167, Exh. 6, ¶ 12).
In his declaration, Rudy Kranys states:

23. I have also reviewed L-F's U.S. Patent No. 5,662,612 ("`612 patent") and L-F U.S. Patent No. 5,928,197 ("`197 patent"). Based on my review of `612 and `197 patents, the prosecution histories of the `612 and `197 patents, and the prosecution history of the related abandoned, parent U.S. Patent Application Serial No. 157,823, the L-F `612 and `197 patents only suggest to me, as one highly knowledgeable with respect to medical injectors, an injector and a pre-filled syringe system in which the injector has a detector to identify the length of the extender used with the syringe based on what is identified as "physical indicia" located on the syringe or extender that is used with the syringe.

(Doc. No. 167, Exh. 7, ¶ 23).

In response, L-F argues that the issue of sufficiency of the written description of the `612 and `197 patents was specifically dealt with by the PTO Examiner during prosecution of the `197 patent. As discussed in great detail in section III(D), the PTO Examiner initially rejected the `197 patent for failure to comply with the written description requirement. After L-F provided a response addressing the PTO Examiner's concerns, the patent was issued with no substantive amendment of the claims or specification. (Doc. No. 174, Exh. 4, Notice of Allowance on 4/1/99, p. 139). Additionally, L-F presents the affidavit of its own expert, Arthur Helmicki, who concludes that the specification of the `612 and `197 patents is sufficient.³⁶

36 In his affidavit, Helmicki states:

21. In his expert report in this matter, Medrad's expert Dr. Sturges, states that he expects ". . . to testify, based on a lack of L-F's disclosure, that the `612 patent would not teach or enable a typical or ordinary syringe or injector designer to construct or design a syringe with `physical indicia' other than at best `physical indicia' on the extender related to the extender position." I disagree. It is my belief that the typical or ordinary person charged with designing control systems for an injector, would be readily able to design and construct a syringe with physical indicia and a sensor for reading those indicia, without regard to whether the indicia are on an extender or relate to properties of an extender.

22. First, as quoted above from his report, Dr. Sturges accepts that the content of the `612 patent would enable a typical syringe/injector designer ". . . to construct or design a syringe with `physical indicia' on the extender related to the extender position." I agree with this statement. Moreover, I would submit that a designer of ordinary skill in the art, having taken this step, would clearly be able to realize this concept in other ways, to include "physical indicia" on the syringe, as is suggested in the `612 an `197 patents. Further, it is my opinion that a designer of ordinary skill in the art, armed with the contents of the `612 and `197 patents, would be able to carry out this activity in a straightforward manner.

23. Second, the point at issue here is the design of a device capable not only of automatically detecting "physical indicia" on the syringe but also using this information in order to achieve various automatic control objectives (e.g., remaining volume determination, end of travel shut-off, etc.) With regard to the use of information about a syringe (however obtained) in performing automatic control, I do not see how the `612 and `197 patents can be faulted for a lack of disclosure. The `612 and `197 patents contain a number of figures (Figures 3-5) together with supporting and detailed description in the specification of the operation of such a system from a block diagram standpoint. This description even includes details of the circuitry necessary for carrying out the design. Moreover, the specification provides a detailed set of flow diagrams (Figure 7) together with associated text description outlining the exact algorithms by which automatic control of the device should be operated. Finally, the `612 and `197 patents have associated with them a microfiche appendix containing the software code needed to run an injector performing automatic control. One could hardly ask for more disclosure. In fact, I would submit that someone of less than ordinary skill in the art, when presented with such a roadmap, would be able to duplicate a device with this functionality.

(Doc. No. 174, Exh. 5, ¶¶ 21-23)

Taking into account Medrad's burden on validity, establishing invalidity by clear and convincing evidence, compounded by the fact that the Court must approach summary judgment with extreme caution, the Court finds that, in light of the prosecution history of the `197 patent and the conclusion of L-F's expert, there are genuine issues of material fact that preclude summary judgment on the issue of invalidity based on failure to comply with the written description requirement of 35 U.S.C. § 112 ¶ 1.

2. Enablement

Medrad also contends that the asserted patents fail to satisfy the enablement requirement of 35 U.S.C. § 112, ¶ 1. The enablement requirement of § 112 demands "that the patent specification enable `those skilled in the art to make and use the full scope of the claimed invention without undue experimentation.'" National Recovery Technologies, 166 F.3d at 1195 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997), cert. denied, 522 U.S. 963 (1997)) (internal quotation marks and citations omitted). The scope of the claims must be equal to or less than the scope of the enablement, which is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation. National Recovery Technologies, 166 F.3d at 1196.

Whether a specification satisfies the enablement requirement of § 112 is a "`. . . conclusion of law and must be supported by facts proved by clear and convincing evidence . . .'" National Recovery Technologies, 166 F.3d at 1195 (quoting Northern Telecom, 908 F.2d at 941). "While enablement is ultimately a question of law . . ., it is based on underlying factual findings . . ." Bruning v. Hirose, 161 F.3d 681, 686 (Fed. Cir. 1998).

As with the written description requirement, a court, when reviewing for enablement, must keep in mind that every patent is presumed valid and the a party challenging its validity bears the burden of establishing invalidity by clear and convincing evidence. See National Recovery Technologies, 166 F.3d at 1195; Texas Instruments, 988 F.2d at 1177; ACS Hospital Systems, 732 F.2d at 1575.

The extent of experimentation required to enable a patent is a key question when analyzing a patent to determine if it meets the requirements of § 112. The Federal Circuit has established the following factors which a court may consider in determining whether a disclosure would require undue experimentation for enablement purposes:

(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.

Id. A court need not review all of the factors. Id. The facts of the case determine which factors are relevant. Id.

In support of its argument that the specification of the `612 and `197 patents does not meet the enablement requirement of § 112, Medrad relies on the conclusions of its experts, Robert Sturges and Rudy Kranys,³⁷ that the specification would not enable one skilled in the art of medical injectors to design or construct an injector system in which the injector uses physical indicia located on the syringe to determine properties of the syringe other than the length of an extender.

37 his declaration, Sturges states:

12. Based on lack of disclosure by L-F, the `612 patent would not teach or enable a typical or ordinary syringe or injector designer to construct or design a syringe with "physical indicia" other than, at best, "physical indicia" on the extender related to the length of the extender. The `612 patent contains no description or drawings that teach or even disclose "physical indicia" that are related to syringe capacity or other parameters.

* * *

16. Based on L-F's lack of disclosure, the `197 patent would not teach or enable a typical or ordinary syringe or injector designer to construct or design a syringe with "physical indicia" other than, at best, "physical indicia" on the extender related to the length of the extender.

(Doc. 167, Exh. 6, ¶¶ 12, 16)
In his declaration, Kranys states:

24. As one highly knowledgeable with respect to medical injectors, I find no teachings in the `612 and `197 patents that would have enabled me to construct an injector and prefilled or empty syringe system in which the injector uses a detector to detect "physical indicia' located on the syringe (used with the extender) or the extender (that is to be used with the syringe) to identify the length of the extender.

* * *

25. Additionally, I find no teachings in the `612 or `197 patents that would have enabled me to construct an injector and syringe system in which the injector uses a detector to detect "physical indicia" located on the syringe to identify the capacity of the syringe or any other parameter.

(Doc. No. 167, Exh. 7, ¶¶ 24, 25)

In its response, L-F fails to address Medrad's lack of enablement argument. Despite this failure, L-F has presented evidence in response to Medrad's written description argument that is relevant to Medrad's lack of enablement argument. As with the written description, the issue of enablement of the `612 and `197 patents was raised by the PTO Examiner during prosecution of the `197 patent. After L-F addressed the PTO Examiner's concerns, the patent was issued with no substantive amendment of the claims or specification. (Doc. No. 174, Exh. 4, Notice of Allowance on 4/1/99, p. 139). In addition, L-F's expert, Arthur Helmicki, addressed the issue of enablement in his affidavit and concluded that the specification of the `612 and `197 patent would enable one skilled in the art to create and design an injector system that detected "physical indicia" on a syringe that indicated various properties of the syringe. Supra, fn. 36.

As discussed above, the extent of experimentation required to enable a patent is a key issue to be considered by the court when making a determination regarding enablement. Medrad has utterly failed to present any evidence related to this issue. Rather, Medrad has simply presented the conclusory statements of its experts that the specification is not enabling without any factual support. This "evidence" is not sufficient to overcome Medrad's burden of proving lack of enablement by clear and convincing evidence.³⁸ In re Brandstadter, 484 F.2d 1395, 1405-06 (C.C.P.A. 1973) (experts' conclusory statements not sufficient for enablement when no factual support provided to support conclusions). Thus, the Court finds that summary judgment is inappropriate with respect to the issue of invalidity of the `612 and `197 patents based upon lack of enablement.

38 L-F's evidence on this issue is only slightly more persuasive than Medrad's evidence. However, Medrad, not L-F, has the burden of proof with respect to this issue.

B. Infringement

In section V(B) of this Order, the Court articulated the law on infringement. Rather than repeat verbatim that summary of the relevant law, the Court refers the parties to that section.

In its motion for summary judgment, Medrad argues that the accused products do not infringe the `612 and `197 patents because the accused products do not use an extender, and thus do not have physical indicia which indicate the length of the extender.

Medrad's argument is based on the assumption that the construction of the claim term "physical indicia" relates exclusively to the "length of the extender." As stated in section III(D), the Court does not adopt this construction of "physical indicia". Therefore, Medrad's argument in this summary judgment motion is irrelevant in light of the Court's construction of the claims.

The Court recognizes the difficulties faced by the parties due to the sequencing of motions in this matter. Therefore, the Court invites the parties to rebrief this argument in light of the Court's construction of the term "physical indicia". However, neither party should revisit the claim construction issue in any such briefings . Briefings should be confined to the issue of infringement in light of this Court's construction of the term "physical indicia" in section III(D). Defendant Medrad's revised motion is due on November 19, 2001, Plaintiff L-F's response is due on December 10, 2001, and Defendant Medrad's reply is due on December 31, 2001.

In its motion for summary judgment, Medrad also argues that the accused products do not infringe the `612 and `197 patents because the accused products do not have a "motor that moves" and the accused products do not "track the location of said motor."

Medrad's argument is based on its faulty construction of the term "motor" and "tracks location of said motor." As stated in section III(E), the Court does not adopt Medrad's construction of the terms "motor" and "tracks location of said motor." Therefore, Medrad's argument in this summary judgment motion is irrelevant in light of the Court's construction of the claims.

Again, the Court recognizes the difficulties faced by the parties due to the sequencing of motions in this matter. Therefore, the Court invites the parties to rebrief this argument in light of the Court's construction of the terms "motor" and "tracks location of said motor." However, neither party should revisit claim construction issues in any such briefings . Briefings should be confined to the issue of infringement in light of this Court's construction of the term "motor" and "tracks location of said motor" in section III(E). Defendant Medrad's revised motion is due on November 19, 2001, Plaintiff L-F's response is due on December 10, 2001, and Defendant Medrad's reply is due on December 31, 2001.

Thus, the Court DENIES, Defendant's Motion for Partial Summary Judgment of Non-infringement and Invalidity of the Asserted Claims of the `612 and `197 Patents (Doc. 167), with respect to invalidity. The Court RESERVES JUDGMENT on Medrad's motion with respect to infringement.

VIII. PLAINTIFF'S MOTION FOR PARTIAL SUMMARY JUDGMENT ON COUNTS I-IX OF THE FOURTH AMENDED COMPLAINT (DOC. 169)

Plaintiff filed this motion seeking summary judgment of infringement on specified claims disclosed in the `669 patent, the `261 patent, the `612 patent, and the `197 patent. (Doc. No. 169) Defendant filed a response (Doc. No. 176) to which Plaintiff filed a reply (Doc. No. 185).

Throughout this Order the Court has provided the majority of the factual background and the applicable law relevant to this dispositive motion. The Court will not repeat that information here but will reiterate any previous statements or provide any previously unmentioned information as is necessary.

A. The `669 and `261 Patents

Based upon the Court's ruling in section V, the Court declares MOOT Plaintiff's Motion for Partial Summary Judgment on Counts I-IX of the Fourth Amended Complaint (Doc. 169) with respect to Counts I and II.

B. The `612 and `197 Patents

Based upon the Court's ruling in section VII(B), the Court invites the parties to rebrief this issue in light of the Court's construction of the terms "physical indicia", "motor", and "tracks location of said motor" in Section III(E). Plaintiff L-F's revised motion is due on November 19, 2001, Defendant Medrad's response is due on December 10, 2001, and Plaintiff L-F's reply is due on December 31, 2001. Thus, the Court RESERVES JUDGMENT on L-F's motion with respect to Counts III and IV.

IX. CONCLUSION

In conclusion:

• Plaintiff's Motion for Partial Summary Judgment of Claim Construction (Doc. 164) is GRANTED insofar as the Court has construed the claims;

• Defendant's Motion for Partial Summary Judgment of Invalidity for Lack of Enablement of the Asserted Claims of the `669 and `261 Patents (Doc. 168) is MOOT;

• Defendant's Motion for Partial Summary Judgment of Invalidity and Non-Infringement of the Asserted Claims of the `669 and `261 Patents (Doc. 57) is MOOT IN PART AND GRANTED IN PART;

• Defendant's Motion for Partial Summary Judgment of Non-Infringement of the `612 and `197 Patents Because Defendant Practices its Own Patent Which is Prior Art to the Asserted Patents (Doc. 162) is NOT RULED ON because the Court RESERVES JUDGMENT pending further briefings;

• Defendant's Motion for Partial Summary Judgment of Non-Infringement and Invalidity of the Asserted Claims of the `612 and `197 Patents (Doc. 167) is DENIED IN PART and NOT RULED ON IN PART because the Court RESERVES JUDGMENT pending further briefings;

• Plaintiff's Motion for Partial Summary Judgment of Infringement on Counts I-IX of the Fourth Amended Complaint (Doc. 169) is MOOT IN PART and is NOT RULED ON IN PART because the Court RESERVES JUDGMENT pending further briefings.