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Medinol Ltd. v. Guidant Corp.

September 30, 2004

MEDINOL LTD., PLAINTIFF,
v.
GUIDANT CORP. AND ADVANCED CARDIOVASCULAR SYSTEMS, INC., DEFENDANTS.



The opinion of the court was delivered by: Shira A. Scheindlin, U.S.D.J.

OPINION AND ORDER

Medinol Ltd. ("Medinol") alleges that Guidant Corp. ("Guidant") and its subsidiary Advanced Cardiovascular Systems, Inc. ("ACS") (collectively "defendants") infringed (and continue to infringe) certain of Medinol's patents directed to balloon-expandable stents. Specifically, Medinol contends that the asserted claims of United States Patent Nos. (1) 5,733,303 ("'303 Patent"); (2) 5,843,120 ("'120 Patent"); (3) 5,972,018 ("'018 Patent"); (4) 6,443,982 ("'982 Patent"); and (5) 6,461,381 ("'381 Patent") (collectively "patents-in-suit")*fn1 are infringed by defendants' manufacture, use, offer for sale, sale, and/or importation of the MULTI LINK PENTA® and MULTI LINK ZETA' systems.*fn2 Although the parties have agreed on definitions for seven terms contained in the asserted claims, twelve terms are in dispute. A Markman Hearing was held on September 2, 2004.*fn3 The Court's construction of the disputed terms follows.

I. BACKGROUND

My previous opinion in this case described the underlying facts and procedural history, which I will not repeat here, except to summarize those points that are relevant to the instant dispute over claim terms.*fn4

A. The Parties

Medinol, which designs and manufactures coronary stents, maintains its principal place of business in Tel Aviv, Israel.*fn5 Guidant, an Indiana-based company, develops, markets, and sells cardiovascular medical products. ACS has its principal place of business in California.*fn6

B. History of Stent Development

Balloon-expandable stents were developed to improve the success rate of percutaneous transluminal coronary angioplasty ("PTCA" or "balloon angioplasty").*fn7 PTCA is a procedure during which the narrowed, diseased arteries are dilated to restore blood flow. This is accomplished by inserting and maneuvering into place a catheter to which a deflated balloon is attached. Once properly positioned, the balloon is inflated, compressing the fatty deposits, or plaque, against the artery wall. The catheter and balloon are then removed from the artery.

Despite the benefits associated with PTCA, approximately thirty-five percent of patients experienced renarrowing of the arteries, a problem that stents are designed to address.*fn8 Stents are, in essence, miniature scaffolding devices that prop open constricted arteries. They are delivered into the vessels on a balloon via a catheter. When the balloon is "at the area of blockage, it is inflated, [causing] the stent to expand and press against the vessel wall, thereby opening the artery. The balloon is then deflated and removed...."*fn9 In light of the foregoing, it is desirable for stents to possess the following characteristics: (1) flexibility, which permits the stent to negotiate the curves of the artery; (2) strength or rigidity; and (3) uniform coverage, i.e., relatively few gaps so that portions of the vessel do not press between the struts into the lumen.*fn10

1. Early Stent Designs: Slotted Tube and Coil

The "first generation" stents were of two varieties: slotted tube and coil. Developed by Julio Palmaz in the 1980s,*fn11 the slotted tube stents had a "plurality of slots... disposed substantially parallel to the longitudinal axis of the tubular member" that, when expanded, had a honeycomb appearance.*fn12 Because the Palmaz stent was very rigid, it provided significant radial strength, but lacked flexibility.*fn13 By contrast, the coil stent was designed by Cesare Gianturco and comprised "wire formed into a serpentine configuration including a series of straight sections and a plurality of bends."*fn14 As such, it was highly flexible but lacked rigidity and hence strength.

2. Articulated Stents

The next generation of stents addressed some of the weaknesses of the early devices. Specifically, the Palmaz-Schatz stent, based on the slotted cell design,*fn15 dealt with the inflexibility of its predecessor through the incorporation of a one-millimeter straight flexible connector joining two seven-millimeter tubular members.*fn16 This yielded a device that was more maneuverable, although the tubular members were still inflexible. Moreover, the straight connector that created an articulation point and allowed the stent to bend also caused a large gap to form in middle of the device.*fn17 Johnson & Johnson attempted to remedy this problem by inserting not one, but six, helical connectors between the rigid members. Nonetheless, the stent still lacked flexibility and presented new hazards, e.g., upon expansion, the helical connectors caused the rigid portions to twist, risking damage to the vessel.*fn18

3. Guidant's Multi-Link Stent

Guidant's Multi-Link stent, based on U.S. Patent 5,421,955 ("Lau '955 Patent") was among the next generation of stents, for which the primary innovation was the ability to be uniformly flexible at any point along the stent.*fn19 The Lau '955 Patent disclosed an invention comprising serpentine rings with straight connectors.*fn20 The rings may be connected in two ways: out of phase (connecting adjacent crowns of rings that face each other) and in phase (crowns pointing in one direction).*fn21 The in-phase arrangement was commercialized as the Multi-Link stent. Although the straight connectors are inflexible, serving to "provide increased stability and... prevent warping of the stent upon expansion," the rings themselves permit flexibility.*fn22 Consequently, the rings could become deformed, resulting in large, irregular gaps, thereby compromising vessel wall support. Medinol dubbed this as an "open cell"*fn23 design, as opposed to a "closed cell" design, which is associated with stents that have flexible links permitting the "cells on the outside of the curve to elongate uniformly and the cells on the inside of the curve to shorten uniformly."*fn24

C. Medinol's Patents

Medinol is the assignee of the '303, '018, '120, '381, and '982 Patents, a family of flexible, expandable stents developed by Henry Marshall Israel and Gregory Pinchasik. Medinol asserts thirty-three claims from the patents-in-suit: 13, 16, 18, 27, and 28 of the '120 Patent; 1, 2-15, and 17 of the '982 Patent; claim 28 of the '303 Patent; claim 51 of the '018 Patent; and claims 56-58, 61, 63, 65-66, and 68-70 of the '381 Patent.*fn25

The patents-in-suit all share the same drawings and essentially the same specification, and are continuations of Application Serial No. 282,181 (filed on July 28, 1994) and continuations-in-part of Application Serial No. 213,272 (filed on March 17, 1994), issued as U.S. Patent No. 5,449,373 ("Pinchasik '373 Patent").*fn26 The specification of the patents-in-suit describes the stent design as comprising: (1) claims that describe stents in terms of two types of intertwined meander patterns and (2) claims that describe stents in terms of the structural elements of its flexible cells.*fn27 The "key to the flexibility of the stents" based on Medinol's patents, is the "capacity for loops in the flexible links (or in the second meander patterns) to elongate differentially when the stent goes around a curve."*fn28 The pattern for the stent is further explained in terms of three embodiments, represented pictorially in eight figures (Figures 1-5 [first preferred embodiment], 6 [second embodiment], and 7-8 [third embodiment]).

D. Cordis Litigation

In December 1999, Medinol and its licensee, Scimed Life Systems, Inc., filed a patent infringement action in the district of Delaware, alleging that Cordis Corp., Johnson & Johnson, and Johnson & Johnson Interventional Systems, Inc. had infringed certain claims of Medinol's '303, '120, and '018 patents.*fn29 During those proceedings, the district court construed various claim terms, including: "stent"; "cell"; "member having a longitudinal component"; "loop"; "first loop" and "second loop"; "disposed between"; "disposed generally opposite"; "flexible compensating member or flexible link"; "area of inflection"; "uniform cellular structure"; "meander," "first meanders," and "second meanders"; "said loops adapted so that said stent prior to expansion is substantially uniformly flexible along its longitudinal axis"; "stent which is substantially uniformly flexible with respect to its longitudinal axis by the flexibility of its cells with respect to said axis"; "apices"; and "plurality of flexible links."*fn30

II. APPLICABLE LAW

A. Principles of Claim Construction

Determination of infringement in a patent case involves two steps: (1) construction of the terms of the asserted claims ("claim construction") and (2) a determination of whether the accused device infringes the claims, as construed.*fn31 Claim construction is a question of law,*fn32 the purpose of which is to determine what is covered by the claims of a patent. In other words, "'[t]he construction of claims is simply a way of elaborating the normally terse claim language in order to understand and explain, but not to change, the scope of the claims.'"*fn33 Claim disputes often turn on the meaning of a phrase, a word, or a single functional or structural aspect of the patented device.

Courts confronted with the task of construing patent claims are guided by well settled principles of interpretation. Of primary importance is the "intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history."*fn34 Additionally, courts may, as a discretionary matter, receive extrinsic evidence, such as expert testimony, to understand the technical aspects of a patent.*fn35 However, extrinsic evidence cannot be used to "arrive at a claim construction that is clearly at odds with the construction mandated by the intrinsic evidence."*fn36

Courts first consider the "words of the claims themselves... to define the scope of the patented invention."*fn37 A claim term is presumed to possess its ordinary and customary meaning, in view of both the temporal and technological context in which it arose. That is, the critical inquiry for purposes of claim construction relates to how "artisans of ordinary skill in the relevant art at the time of invention" understood the claim terms.*fn38 In ascertaining the "ordinary and customary meaning" of particular words, the Federal Circuit has counseled that "dictionaries, encyclopedias and treatises [publicly available at the time the patent is issued] are particularly useful resources" as they are objective "reflections of common understanding not influenced by expert testimony or events subsequent to the fixing of the intrinsic record by the grant of the patent, not colored by the motives of the parties, and not inspired by litigation."*fn39 Nonetheless, courts must exercise caution in relying on non-scientific dictionaries when confronted with technical terms.*fn40

The presumption favoring the general usage of particular terms can be rebutted by evidence in the intrinsic record. For instance, "a patentee may choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history."*fn41 Accordingly, courts also review the patent specification, which is perhaps the "single best guide to the meaning of a disputed term"*fn42 and demonstrates whether the patentee "used terms in a manner inconsistent with their ordinary meaning."*fn43 The specification contains a "written description of the invention which must be clear and complete enough to enable those of ordinary skill in the art to make and use it."*fn44 The presumption of ordinary meaning is overcome by the specification where the patentee "has set forth a definition for the term different from its... customary meaning or where the patentee has disavowed or disclaimed scope of coverage, by using words or expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope."*fn45

Courts also examine the prosecution history of the patent to assess whether the patentee made express representations regarding the scope and meaning of the claims to obtain the patent.*fn46 The prosecution history includes the record of all proceedings relating to the patent that took place before the Patent and Trademark Office ("PTO"), including "any express representations made by the applicant regarding the scope of the claims," and possibly an examination of the prior art.*fn47

"As in the case of the specification, the patent applicant's consistent usage of a term in prosecuting the patent may enlighten the meaning of that term."*fn48 In particular, under the doctrine of prosecution disclaimer, the prosecution history "'limits the interpretation of claim terms so as to exclude any interpretation that was disclaimed during prosecution.'"*fn49 Indeed, it is a "fundamental precept" in claim construction jurisprudence that patentees cannot "recaptur[e] through claim interpretation specific meanings disclaimed during prosecution."*fn50 This "promotes the public notice function of the intrinsic evidence and protects the public's reliance on definitive statements made during prosecution."*fn51 Although prosecution disclaimer does not attach where the "alleged disavowal of claim scope is ambiguous,"*fn52 an unequivocal disavowal of a particular meaning advanced by the patentee to overcome the prior art and obtain the patent narrows the "ordinary meaning of the claim congruent with the scope of surrender."*fn5 ...


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