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Medinol Ltd. v. Guidant Corp.

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK


February 10, 2006

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

I. INTRODUCTION

Medinol Ltd. ("Medinol") brings this action for damages and injunctive relief relating to the alleged infringement by Guidant Corp. and its subsidiary Advanced Cardiovascular Systems, Inc. (collectively, "Guidant") of certain of Medinol's patents.*fn1 Medinol moves for summary judgment based on literal infringement of two of the three patents-in-suit, the '120 Patent and the '381 Patent. Guidant responds with its own motion for summary judgment, asserting that the accused products infringe none of the patents-in-suit, either literally or under the doctrine of equivalents. For the following reasons, Medinol's motion is granted with respect to the '381 Patent and denied with respect to the '120 Patent; and Guidant's motion is granted except with respect to the '381 Patent. In short, Guidant's accused products literally infringe Medinol's '381 Patent.*fn2

II. BACKGROUND

Medinol, based in Tel Aviv, Israel, designs and manufactures coronary stents.*fn3 The company was founded by, among others, Dr. Jacob ("Kobi") Richter, Medinol's Chairman of the Board and Chief Technical Officer.*fn4 Guidant develops, markets, and sells cardiovascular medical products and has its principal place of business in Indiana. ACS is based in California.*fn5

The general background of the stent technology at issue here has been adequately covered by my prior Opinions in this case.*fn6 Familiarity with these Opinions is assumed.

A. The Patents-in-Suit

According to Richter, stents on the market in the early 1990's all possessed advantages and offsetting disadvantages, because they:

were of two extreme kinds . . . , [o]ne was very flexible . . . but because it was very flexible, also when it was extended it was not stable. The loops could be drawn away from each other, and it would not support very well the lesion, the narrowing in the vessel. So, it could go anywhere you want [within the body], but would not support. The other type had a rigid enough, stable enough structure such that when deployed, it would support pretty well, but it was very inflexible, rigid. So you could not push it through the curves of the arterial system to the position you are trying to treat. That was suboptimal.*fn7

On September 12, 1995, U.S. Patent No. 5,449,373 was issued to Gregory Pinchasik et al. and assigned to Medinol ("'373 Patent"). The application for this patent was filed on March 17, 1994.*fn8 A series of stents, described as continuations or continuations-in-part of this patent, were invented by Henry Israel and Pinchasik, and assigned to Medinol. These patents -- the '303, '018, '120, '381, and '982*fn9 -- describe a family of flexible, expandable stents that "achieve the objectives and flexibility during delivery, compensation for foreshortening, continuous uniform scaffolding, and resistance to radial deformation and collapse upon expansion."*fn10 Preferred embodiments of the patents-in-suit, taken from the '381 Patent, are shown below:*fn11

[OMITTED]

Although Medinol originally alleged infringement of claims from all five of these patents, it has now dropped its infringement allegations pertaining to the '303 and '018 Patents.*fn12 The remaining claims can be divided into two groups: the "meander" claims and the "flexible cell" claims. The "meander" claims, comprised of the asserted claims of the '120 and '982 Patents, describe stent structures formed by two types of meander patterns intertwined with one another.

These patterns are referred to as "first meanders," which extend in a circumferential direction; and "second meanders," which extend in a longitudinal direction.*fn13 I have construed "first meander" to mean "a periodic sinusoidal pattern about a center line."*fn14 I construed a "second meander" to mean "periodic pattern[s] about a center line oriented in a direction different from the axis of the first meanders."*fn15

The "flexible cell" claims refer to the asserted claims of the '381 Patent. A "flexible cell," as used in these claims, has been construed as "[a]n arrangement of structural elements that defines an enclosed space. The cells must be substantially flexible prior to expansion of the stent and substantially rigid after expansion of the stent."*fn16

B. The Asserted Claims of the Patents-in-Suit

1. The '120 Patent

The United States Patent and Trademark Office ("PTO") issued the '120 Patent, entitled "Flexible-Expandable Stent," on December 1, 1998. Five of the claims are asserted here --13, 16, 18, 27, and 28, which, in seriatim, state:

13. An expandable stent formed of an elongated cylindrical unitary tube suitable for insertion into a lumen or blood vessel in which it may be expanded, comprising: a plurality of first meanders extending in a first direction on the cylinder of the tube and a plurality of second meanders extending in a second direction, on the cylinder of the tube, wherein the first and second meanders are formed with loops and are interconnected such that at least one of the loops of each of the first meanders is disposed between each consecutive second meander to which the first meander is connected, and at least one of the loops of each of the second meanders is disposed between each consecutive first meander to which it is connected; the first and second meanders defining a plurality of enclosed spaces.

16. A stent according to claim 13, wherein the first and second meanders are connected together such that the loops thereof cooperate so that upon bending of the stents the loops change shape to compensate for the difference in length between the inside and outside curves.

18. A stent according to claim 13, wherein the stent can bend in any direction and in more than one direction at any time.

27. A stent according to claim 21 wherein said second meander patterns intersect with said first meander patterns so as to leave at least one loop of said first meander patterns between each pair of adjacent second meander patterns.

28. A stent according to claim 21 wherein said second meander patterns intersect with said first meander patterns at common members which are shared by said first and said second meander patterns.*fn17

2. The '982 Patent

On September 3, 2002, the PTO issued the '982 Patent. Claims 1, 2-15, and 17 are asserted here and read as follows:

1. An expandable stent for supporting a vessel, wherein in the expanded and deployed state, the stent consists of:

(a) first meander patterns having loops, the first meander patterns being longitudinally spaced from each other and having axes extending in a first direction; and

(b) second meander patterns having loops, the second meander patterns having axes extending in a second direction, different than the first direction,

(c) wherein the first and second meander patterns are interconnected to form a tubular structure;

(d) wherein the first meander patterns are connected to the second meander patterns so as to leave at least one loop of each of the second meander patterns in the space between each pair of adjacent first meander patterns; and

(e) wherein the second meander patterns are connected to the first meander patterns so as to leave no more than two loops of each of the first meander patterns between each pair of adjacent second meander patterns.

2. The stent according to claim 1, wherein the shape and placement of the loops provides radial strength to the expanded stent to hold the vessel open.

Id. col. 8, ll. 6-21.

3. The stent according to claim 2, wherein the first direction extends in a circumferential direction.

4. The stent according to claim 3, wherein the second direction extends in a longitudinal direction.

5. The stent according to claim 2, wherein the second direction extends in a longitudinal direction.

6. The stent according to claim 1, wherein the stent defines a plurality of enclosed spaces, with each longitudinal end of each of the enclosed spaces being formed by one or more loops of the first meander pattern.

7. The stent according to claim 6, wherein the enclosed spaces are substantially the same size.

8. The stent according to claim 7, wherein the first direction extends in a circumferential direction.

9. The stent according to claim 8, wherein the second direction extends in a longitudinal direction.

10. The stent according to claim 7, wherein the second direction extends in a longitudinal direction.

11. The stent according to claim 6, wherein the first direction extends in a circumferential direction.

12. The stent according to claim 11, wherein the second direction extends in a longitudinal direction.

13. The stent according to claim 6, wherein the second direction extends in a longitudinal direction.

14. The stent according to claim 1, wherein the first direction extends in a circumferential direction.

15. The stent according to claim 14, wherein the second direction extends in a longitudinal direction.

17. The stent according to claim 1 wherein the second direction extends in a longitudinal direction.*fn18

e. The '381 Patent

The '381 Patent was issued on October 8, 2002. Claims 56-58, 61,

63, 65-66, and 68-70, asserted in this action, recite:

56. A balloon expandable stent for implantation into a lumen to support the lumen, said stent both in the unexpanded state and in the balloon-expanded state including: a plurality of flexible cells adjacent to one another both circumferentially and longitudinally each of said flexible cells comprising:

a) a first flexible link including an arc, the first flexible link having a first longitudinal end and a second longitudinal end;

b) a second flexible link including an arc, the second flexible link having a first longitudinal end and a second longitudinal end;

c) a first circumferential member disposed between said first longitudinal end of said first flexible link and said first longitudinal end of said second flexible link and;

d) a second circumferential member disposed between said second longitudinal end of said first flexible link and said second longitudinal end of said second flexible link,

e) at least one of said first circumferential member and said second circumferential member in each of said cells having a portion with a substantial longitudinal component that is also a portion with a substantial longitudinal component of a first circumferential member or a second circumferential member in a longitudinally adjacent cell, wherein in the expanded state the first and second circumferential members have a substantial longitudinal component to provide coverage of the lumen.

57. A stent according to claim 56, wherein in the unexpanded state, a radial plane perpendicular to a longitudinal axis can pass through the flexible links of the flexible cells and not pass through the circumferential members.

58. A stent according to claim 56 wherein each of said first and second flexible links has ends generally aligned with respect to each other along a longitudinal axis of the stent.

61. A stent according to claim 56, wherein the first members of circumferentially adjacent cells are connected in a closed circumferential structure which contains at least five loops and the second members of circumferentially adjacent cells are connected in a closed circumferential structure which contains at least five loops.

63. A stent according to claim 56 wherein said plurality of flexible cells provide substantially all the support for said stent.

65. A balloon expandable stent for implantation into a lumen to support the lumen, said stent both in the unexpanded state and in the balloon-expanded state including: a plurality of flexible cells adjacent to one another both circumferentially and longitudinally each of said flexible adjacent cells comprising:

a) a first flexible link including an arc, the first flexible link having a first longitudinal end and a second longitudinal end;

b) a second flexible link including an arc, the second flexible link having a first longitudinal end and a second longitudinal end;

c) a first circumferential member disposed between said first longitudinal end of said first flexible link and said first longitudinal end of said second flexible link and;

d) a second circumferential member disposed between said second longitudinal end of said first flexible link and said second longitudinal end of said second flexible link,

e) at least one of said first circumferential member and said second circumferential member in each of said cells having a portion with a substantial longitudinal component that is also a portion with a substantial longitudinal component of a first circumferential member or a second circumferential member in a longitudinally adjacent cell,

f) wherein said plurality of connected flexible cells imparts radial strength to said stent and coverage of the surface of said lumen in an amount sufficient to support said lumen when said stent is expanded by a balloon from a delivery diameter to a deployment diameter.

66. A stent according to claim 65, wherein in the unexpanded state, a radial plane perpendicular to a longitudinal axis can pass through the flexible links of the flexible cells and not pass through the circumferential members.

68. A stent according to claim 65, wherein the first members of circumferentially adjacent cells are connected in a closed circumferential structure which contains at least five loops and the second members of circumferentially adjacent cells are connected in a closed circumferential structure which contains at least five loops.

69. A stent according to claim 65 wherein each of said first and second flexible links has ends generally aligned with respect to each other along a longitudinal axis of the stent.

70. A stent according to claim 65 wherein said plurality of flexible cells provide substantially all the support for said stent.*fn19

C. The Accused Products

The accused products are new iterations of Guidant's original Multi-Link stent design, which Guidant asserts was the "first uniformly flexible stent to employ rings and links."*fn20 The progenitor of the first Multi-Link stent, as well as succeeding stents in this line such as the accused products, was U.S. Patent No. 5,421,955 to Lilip Lau (June 6, 1995) ("Lau Patent"), which teaches different ways of connecting circumferential rings and connectors to form a stent.*fn21 The Lau Patent, which I have discussed in a previous Opinion,*fn22 can be summarized as "an expandable stent which is relatively flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in an expanded condition to maintain the patency of a body lumen such as an artery when implanted therein."*fn23 Guidant adopted Lau's teachings in commercializing the first Multi-Link stent in 1997.*fn24 However, Guidant asserts that it later moved beyond Lau's serpentine rings "to incorporate features that would provide better flexibility both before and after expansion."*fn25 Each year after the introduction of the original Multi-Link, Guidant introduced a new stent system, including the Multi-Link Duet in 1998, the Multi-Link Tristar in 1999, and the Multi-Link Tetra in 2000.*fn26 Prior to the release of the accused products, the Multi-Link stents utilized straight, as opposed to looped, connectors.*fn27 The switch to looped connectors was the modification that prompted Medinol to accuse Guidant of infringement.*fn28

The Penta was introduced in 2001.*fn29 According to Guidant, "the Penta employs circumferential rings with a unique complex pattern that provides superior flexibility (both before and after expansion), radial strength, radiopacity (the ability to see the stent by angiogram during delivery for precise placement), scaffolding, and conformability."*fn30 The Penta's circumferential rings are connected by five-turn links, which Guidant refers to as an "Access-Link."*fn31 "One part of the [circumferential] ring is widened to accommodate the embedded five-turn link . . . in addition, the links at the right end of the stent are not curved, but straight."*fn32

The Zeta system was introduced in 2002. The only difference between the Penta and Zeta is in the delivery platform, and the parties agree that for present purposes the Penta and Zeta can be analyzed interchangeably.*fn33

Finally, the Multi-Link Vision was introduced in 2003. This stent also employs circumferential rings with "a complex pattern, occasionally connected by a substantially straight link with a single turn."*fn34 This stent links its circumferential rings with a long connector, straight except for a single U-shaped loop.*fn35 Guidant refers to the curved portion of this connector as a "Flexalink."*fn36 Guidant asserts that a "hallmark" of the Multi-Link family of stents is that they are flexible both before and after expansion.*fn37 According to Guidant, post-deployment flexibility is just as important as pre-deployment flexibility, because a stent that does not sufficiently conform to the blood vessel where it is deployed runs the risk of straightening that vessel.*fn38

Guidant asserts that Medinol only belatedly recognized the importance of post-deployment flexibility, prompting it to upgrade its original NIR stent to a newer NIRFLEX design.*fn39

III. LEGAL STANDARD

A. Standard of Review

Federal Circuit precedent governs issues of patent law, while the law of the regional circuit applies to nonpatent issues.*fn40 Summary judgment is appropriate if the record "show[s] that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law."*fn41 In determining whether a genuine issue of material fact exists, the court construes the evidence in the light most favorable to the non-moving party and draws justifiable inferences in that party's favor.*fn42

B. Infringement

Patent infringement refers to "the unauthorized making, using, selling, offering to sell, or importing into the United States of any patented invention during the term of the patent."*fn43 "Infringement analysis is a two-step process: '[f]irst, the court determines the scope and meaning of the patent claims asserted . . . [and second,] the properly construed claims are compared to the allegedly infringing device.'"*fn44 The patentee must prove infringement by a preponderance of the evidence.*fn45 To prove infringement, the patentee must show that the accused device meets each claim limitation of the patents-in-suit, either literally or under the doctrine of equivalents.*fn46 The doctrine of equivalents enables a patent owner to prove infringement, despite a lack of literal infringement, if the differences between the claimed product and the product accused of infringement are insubstantial.*fn47 Under either theory, infringement is found only when the accused product contains all the limitations of the patent-in-suit.*fn48

C. Claim Construction

"When, as here, the parties do not dispute any relevant facts regarding the accused product but disagree over [claim interpretation], the question of literal infringement collapses to one of claim construction and is thus amenable to summary judgment."*fn49 "It is a 'bedrock principle' of patent law that 'the claims of a patent define the invention to which the patentee is entitled the right to exclude.'"*fn50 Claim construction is a question of law, the purpose of which is to determine what is covered by the asserted claims of a patent.*fn51 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."'*fn52

When construing patent claims, courts are directed to give primary importance to the "intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history."*fn53 However, a court may also, as a discretionary matter, receive extrinsic evidence, such as expert testimony, to understand the technical aspects of a patent.*fn54

Claim terms "are generally given their ordinary and customary meaning."*fn55 This refers to "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention."*fn56 Courts should first consider the "words of the claims themselves . . . to define the scope of the patented invention."*fn57 The Federal Circuit has noted that in some cases claim construction "involves little more than the application of the widely accepted meaning of commonly understood words" and "in such circumstances, general purpose dictionaries may be helpful."*fn58 In addition, "the context of the surrounding words of the claim also must be considered in determining the ordinary and customary meaning" of a term.*fn59 A second source of intrinsic evidence is the patent specification, which 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."*fn60

"In light of the statutory directive that the inventor provide a 'full' and 'exact' description of the claimed invention, the specification necessarily informs the proper construction of the claims."*fn61 Indeed, the patent specification is perhaps the "single best guide to the meaning of a disputed term"*fn62 and may demonstrate whether the patentee "used terms in a manner inconsistent with their ordinary meaning."*fn63

Courts also examine the prosecution history of the patent, which includes the record of all proceedings relating to the patent that took place before the PTO, "any express representations made by the applicant regarding the scope of the claims," and in some cases an examination of the prior art.*fn64 Courts use this information to assess whether the patentee made express representations regarding the scope and meaning of the claims to obtain the patent.*fn65

Generally, the prosecution history can inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether she narrowed the scope of her claims in the course of prosecution.*fn66 By scrutinizing the prosecution history during claim construction, courts must "ensure[] that claims are not construed one way in order to obtain their allowance and in a different way against accused infringers."*fn67

D. Doctrine of Equivalents -- Prosecution History Estoppel

"Equivalence is shown by evidence that the accused device contains an element that is not substantially different from any claim element that is literally lacking, or that the claimed limitation and the accused component perform substantially the same function in substantially the same way to achieve substantially the same result."*fn68 Equivalency is a question of fact, and as with any summary judgment motion, all reasonable inferences must be drawn in favor of the non-movant.*fn69

Prosecution history estoppel is a "legal limitation on the doctrine of equivalents."*fn70 This doctrine limits the availability of the doctrine of equivalents to the extent that an applicant: (1) makes a narrowing amendment for purposes of patentability (amendment-based estoppel); or (2) clearly and unmistakably surrenders subject matter by arguments made to the PTO (argument-based estoppel).*fn71 With regard to argument-based estoppel, the only form of estoppel at issue in this case, an objective test is applied, inquiring "whether a competitor would reasonably believe [from the applicant's arguments to the PTO] that the applicant had surrendered the relevant subject matter."*fn72

IV. DISCUSSION

A. Claim Construction Disputes

Although I have already construed a dozen terms necessary to the infringement analysis,*fn73 the parties now dispute the proper interpretation of several phrases used in my claim construction Opinion. The parties agree that my resolution of these additional claim construction disputes will determine the outcome of the pending motions, at least with regard to literal infringement.*fn74

1. "Sinusoidal"

I previously held that "first meander" means "a periodic sinusoidal pattern about a center line."*fn75 In including the term "sinusoidal," I relied on the written description of the patents-in-suit, which "clearly provides that the first meander is sinusoidal about a center line."*fn76 After the close of expert discovery, the parties disputed the meaning of "sinusoidal."*fn77

As an initial matter, "sinusoidal" in the context of the patents-in-suit must mean something different than the plain meaning of the term, which according to the relevant dictionary is "of, relating to, shaped like, or varying according to a sine curve or sine wave."*fn78 This conclusion is mandated because the first meanders pictured in Figure 2 of the patents-in-suit (identified explicitly as a "vertical sinusoid") are not sine waves at all, but are squared off at the top of each repeating pattern.*fn79 Thus, the plain meaning of "sinusoidal" would impermissibly exclude a preferred embodiment from the claim construction.*fn80

Accordingly, both parties agree that sinusoidal must have a different meaning.*fn81 Medinol contends that "a person of ordinary skill in the art would understand 'sinusoidal,' in the context of the Patents-in-Suit, to refer [to] alternating turns."*fn82 Guidant argues for a narrower meaning, hewing as closely as possible to the dictionary definition quoted above and contending that "sinusoidal" in the context of the patents-in-suit means a pattern exhibiting "(1) constant amplitude, (2) equal distances from one curve [of the meander pattern] to the next, and (3) a single repeating pattern of one up-or-down curve."*fn83 To arrive at this definition, Guidant determined "which characteristics of a sine wave are consistent with the disclosure in Medinol's patents," and then constructed its three-part test.*fn84 Not surprisingly, the accused products fall within Medinol's proposed definition for sinusoidal.

The intrinsic evidence regarding the meaning of sinusoidal is sparse, as the word "sinusoid" is used only once in the patents-in-suit, in the written description of Figure 2. Indeed, Medinol's expert derived his definition of sinusoidal from a review of the Figures included in the patents-in-suit.*fn85

Accordingly, the text of the claims, specification and written description is inconclusive.

The only item of prosecution history bearing on the proper construction of "sinusoidal" is a representation made by Medinol that:

The text [of the related '303 Patent] defines a "meander pattern" as a periodic pattern . . . According to the American Heritage Dictionary of the English Language (1975), the term "meander" means "circuitous windings or sinuosities (of a stream or path) or a circuitous journey or excursion; a ramble' . . . . Thus, when the specification mentions . . . that the term "meander pattern" is a periodic pattern, it means that a meander pattern is a periodic pattern about a center line.*fn86

Guidant asserts that this statement is a concession by Medinol that a first meander must be shaped like a sinusoid, which in turn should be defined as a pattern exhibiting characteristics of a sine wave consistent with the disclosures of the patents-in-suit. But Guidant places far more weight on this statement than it can bear. In fact, this statement supports Medinol's position, because it indicates the patentee's understanding that "sinuosity" in this context means something more expansive than simply a pattern resembling a sine wave. In particular, this definition of meander reveals that Medinol took it to mean "circuitous windings or sinuosities," indicating that the definition is not limited to sinuosities.*fn87 The statement further explains that a meander can "ramble" which is far from a mathematical sinusoidal structure.*fn88

More generally, while Guidant's definition is elegant and better grounded in the dictionary definition of "sinusoidal,"*fn89 it does not account for the fact that Medinol's patents are not limited, by the prosecution history or any other intrinsic evidence, to rings exhibiting the particular characteristics of sine waves selected by Guidant.*fn90 Moreover, Guidant's proposed definition for "sinusoidal" would render superfluous the terms "periodic pattern" and "about a center line" in the Court's construction of first meanders. Any ring structure meeting Guidant's three criteria would necessarily be a periodic pattern about a center line. At the same time, Guidant is incorrect when it argues that Medinol's definition of sinusoidal fails to take account of the difference between the construction of "first meander" and "second meander."*fn91 It is entirely possible for there to be a "periodic pattern about a center line" that does not also have "alternating turns."*fn92 For example, the second meanders disclosed in Figure 5 of the Lau Patent,*fn93 exhibit a repeating pattern, but also include straight elements (the straight connectors of Lau), and therefore those second meanders do not consist of alternating turns.

I note, however, that Medinol's contention that Guidant's definition of sinusoidal would exclude a preferred embodiment of the patents-in-suit is meritless. Medinol relies on an alleged small deviation in the distance between loops in Figure 2 of the '120 Patent to argue that the patents-in-suit do not display "equal distances from one curve to the next," as required by Guidant's proposed definition of sinusoidal.*fn94 This reliance is misplaced. There is no indication in the specification of the patents-in-suit that the alleged variations in Figure 2 result from any intent that the loops of the design be spaced unevenly.*fn95 Indeed, Figure 5A of the patents-in-suit, illustrating a close-up diagram of the same first meander pattern, clearly discloses that the distances between each loop in the pattern are meant to be equal.*fn96

Given the intrinsic evidence, there is no real need to examine the extrinsic evidence cited by the parties.*fn97 Nonetheless, I note that Medinol's extrinsic evidence in support of its definition misses the mark. Medinol points to usage of the terms "sinusoidal" or "sinusoid-like" by Guidant in relation to other products, as well as in third-party patents, that Medinol asserts is consistent with Medinol's definition of the term. Because this evidence post-dates 1994, the relevant date for purposes of determining the meaning of sinusoidal, it is irrelevant for the purpose of claim construction.*fn98 In sum, Medinol's proposed definition is more consistent with the prosecution history and my previous Opinion. Accordingly, "sinusoidal" is defined as a "series of alternating turns with no intervening material." 2. "About a Center Line" The parties also disagree as to the definition of "about a center line," another term used by the Court in construing "meander." Guidant asserts that "about a center line" means there must be the same amount of stent elements on either side of the line. By contrast, Medinol argues that "'[a]bout a center line' means that the meander is oriented in a straight line, with repeating elements on either side of the straight line being the same distance from the line on each cycle."*fn99 But Medinol's definition cannot be correct because it is simply a long-winded way of saying "periodic."*fn100 Medinol's expert essentially admitted this at his deposition.*fn101 For this reason alone, Medinol's proffered definition must be rejected.

At claim construction, Guidant argued for the inclusion of the words "uniformly distributed" in the definition of first meander, "arguing that the ordinary meaning of 'center line' is a 'real or imaginary line that is equidistant from the surface or sides of something.'"*fn102 I rejected that argument, but held that:

"the phrase 'about a center line' requires that the meander pattern be uniformly distributed about the line. But the meaning of 'uniformly distributed' is adequately captured by the words 'center line.' To use both 'uniformly distributed' and 'center line' would be needlessly redundant."*fn103

Thus, the phrase "uniformly distributed" is already incorporated into the definition of both first and second meander. Moreover, at claim construction I declined to adopt Medinol's suggestion, repeated here, that meander patterns merely be "oriented about a center line."*fn104

Medinol argues that Guidant's definition would exclude two preferred embodiments of the patents-in-suit, namely Figures 2 and 7. Medinol is wrong as to both. While Medinol points to a center line in Figure 2 that appears to place unequal amounts of stent material on either side of the line, there is no indication in the written description that this was intentional. A court cannot rely on what could simply be a poor drawing.*fn105

Moreover, Guidant correctly notes that accepting Medinol's argument regarding Figure 2 would mean that Figure 2 does not meet Medinol's own definition of center line, which requires that "'repeating elements on either side of the line [be] the same distance from that line.'"*fn106

Regarding Figure 7, Medinol contends that "[u]nder Guidant's definition, a longitudinal structure extending over an odd number of cells in a Figure 7-like stent can never be a "meander," because there will always be more loops on one side of the line."*fn107 But Medinol ignores the fact that Figure 7 is not intended to depict an entire stent, so the fact that there are an unequal number of loops on either side of Figure 7's center line is of no consequence.*fn108 Even if Figure 7's pattern were used throughout an entire stent, Guidant's definition can be refined to require that the elements of the stent be uniformly distributed on each periodic cycle.

Finally, Medinol asserts that its definition of "about a center line" is established by a PTO examiner's drawing, during prosecution, of a center line on a putative second meander pattern of the Burmeister application, a prior art stent design.*fn109 But it is unclear why a drawing made years before my claim construction in this case should override the plain meaning of the patents-in-suit and the intrinsic evidence before this Court.

For these reasons, I conclude that "about a center line" means that the stent elements must be uniformly distributed about a center line on each periodic cycle. This is consistent with the plain meaning of "center line."*fn110

3. "Loop"

I have construed "loop" to mean "a C- or U-shaped structure."*fn111 The presence of such a loop is required by all asserted claims. Guidant argued in a letter preceding its motion that the Penta does not infringe these claims because its Access-Link is actually a five-turn "S-shaped" structure.*fn112

However, Guidant does not make this argument in its motion.*fn113 In any case, Guidant's argument is at odds with the clear language of my claim construction and the asserted claims themselves. First, Medinol is correct that the phrase "C- or U-shaped structure" does not by its terms exclude C-or U-shapes that happen to be part of an S-shape.*fn114 Second, the claims themselves only require that there be at least one loop between consecutive first meanders, clearly contemplating that there may be instances where there is more than one loop between first meanders of a stent based on the patents-in-suit. For these reasons, the Penta's Access-Links constitute "loops" for the purpose of these motions.*fn115

4. "Rigid"

I construed the term "flexible cell" (relevant to the asserted claims of the '381 Patent) to mean "[a]n arrangement of structural elements that defines an enclosed space. The cells must be substantially flexible prior to expansion of the stent and substantially rigid after expansion of the stent."*fn116 The term "rigid" can refer to two different attributes of a stent, and the parties disagree about which attribute is necessary under my claim construction.*fn117 Medinol contends that "rigid" refers to radial support -- that is, the capacity of the stent to support the vessel wall after deployment.Guidant contends, however, that both "rigid" and "flexible" refer to longitudinal flexibility, and so "rigid" in this context means the opposite of "flexible." As the accused products, unlike the patents-in-suit, are designed to maintain longitudinal flexibility even after expansion and deployment (so as to avoid straightening blood vessels), Guidant asserts that its interpretation of "rigid" compels the conclusion that the accused products do not have "flexible cells," and thus do not infringe the '381 Patent.

The term "rigidity" is used twice in the text of the patents-in-suit. Most notably, the specification discloses that:

It will be appreciated that the two orthogonal meander patterns 11 and 12 and the compensation they provide to each other provides flexibility to the unexpanded stent of FIG. 1. However, when the stent is expanded, the changes in each of loops 14 and 16 provide rigidity to the resultant stent and thus, enable the stent to maintain a blood vessel at a desired inner diameter.*fn118

Both parties point to this passage as support for their interpretation of my construction of rigid.*fn119 But the only sensible reading of this passage, given the usage of "thus," is that "rigidity" is intended to relate to the ability of the stent to hold open the vessel. In other words, the specification clearly connects the concept of "rigidity" to the stent's purpose of maintaining proper scaffolding of the artery once deployed.

To be sure, the patents-in-suit use "rigid" in a different sense when describing the prior art Palmaz and Schatz stent designs, which the patents-in-suit describe as follows: "[s]ince [their] tubular grafts are relatively rigid, the flexible connectors are needed so that the stents can bend when being fed through a curved blood vessel."*fn120 However, the limited point made by this quotation, which does not contradict the specification's description of the invention, is that some prior art designs tended to be inflexible prior to expansion. The Palmaz designs, in particular, were well-known in the stent art to be relatively inflexible before expansion, which was one of the concerns the patents-in-suit sought to address in the first place.*fn121

The prosecution history relied upon by Guidant does not support its position. Guidant asserts that "Medinol overcame a rejection to the prior art Pinchasik '373 Patent arguing that the 'present invention' -- unlike the 'rigid' prior art articulated stent design -- was 'uniformly flexible' prior to expansion. . . . By contrasting flexible and rigid as essentially opposing qualities, Medinol made it quite clear its use of the term rigid meant the opposite of flexible."*fn122 However, the prosecution history cited by Guidant merely shows that Medinol distinguished the patents-in-suit from the '373 Patent's pre-deployment rigidity.*fn123 The '373 Patent, unlike the patents-in-suit, is an "articulated" stent design that can be bent pre-deployment only at certain intervals where connectors hold together "rigid" lengths of stent.*fn124 In fact, the statements from the prosecution history cited by Guidant all relate to pre-deployment flexibility.*fn125

Finally, Medinol's position is consistent with the stated goal of the patents-in-suit. As I have already noted, the chronic problem with early stent designs, which the patents-in-suit sought to address, is that there was an unfortunate trade-off between pre-deployment flexibility and post-deployment radial strength.*fn126 A stent could be flexible yet do a poor job of holding open a vessel once deployed, or it could be strong once deployed yet hard to maneuver through a blood vessel. The whole purpose of the patents-in-suit was to be flexible pre-deployment yet radially strong post-deployment. Thus, whether a stent based on the patents-in-suit is flexible or inflexible after deployment is largely beside the point.*fn127 Accordingly, Guidant's interpretation of "substantially flexible prior to expansion of the stent and substantially rigid after expansion of the stent" would, in effect, construe the patents-in-suit as teaching an attribute (post-deployment inflexibility) unrelated to their stated purpose.*fn128

Because the intrinsic evidence establishes the proper definition of "rigid" in this context, there is no need to turn to extrinsic evidence to construe "rigid."*fn129 In any case, the extrinsic evidence presented by the parties is largely irrelevant. Both parties collect various statements made by Medinol and Guidant employees, retained experts and third-party patents purporting to establish that their opponent has conceded the proper construction of "rigid."*fn130 These collected statements prove nothing. As already demonstrated, "rigid" in the context of stent technology can be used in two senses -- pre-deployment, it means the opposite of "flexible," and post-deployment (at least as used by the patents-in-suit), rigid refers to the ability of the stent to hold open a blood vessel.*fn131 The various uses of "rigid," "rigidity," or "radial rigidity" cited by the parties cannot be divorced from the contexts in which those statements were made, and thus they shed no particular light on the proper meaning of "rigid" as used in the patents-in-suit.*fn132

In sum, based on the intrinsic evidence Medinol's interpretation of "flexible cell" is correct.*fn133 Accordingly,"rigid" as used in my construction of "flexible cell" means "able to hold open the blood vessel at the desired inner diameter."

B. Literal Infringement

Now that the Court has completed its final claim construction, the next question is whether the accused products literally infringe Medinol's patents.*fn134

1. Meander Claims - '120 Patent

The rings and links of the accused products comprise a "periodic pattern," but as already described the stent elements are not uniformly distributed about a center line on each periodic cycle.*fn135 For this reason, the accused products do not include either first or second meanders as defined by this Court's claim construction. Indeed, Medinol concedes this, at least with regard to the putative second meanders of the accused products.*fn136 Because every asserted claim of the '120 Patent requires a first and second meander, Guidant is entitled to summary judgment as to literal infringement of that patent.

2. Flexible Cell Claims - '381 Patent*fn137

By its own admission, Guidant's opposition to a finding of literal infringement of the "flexible cell" claims of the '381 Patent is mostly premised on its interpretation of my claim construction of "flexible cell," which I have now rejected.*fn138 Specifically, Guidant asserts that the accused products do not have flexible cells purely because of its argument that "substantially rigid after expansion" refers to post-expansion inflexibility, a feature distinguishing the accused products from the teachings of the patents-in-suit.*fn139 But as I discussed above, the intrinsic evidence establishes that "substantially rigid after expansion" refers to the ability of the stent to hold open the blood vessel in which it is deployed, and Guidant does not dispute that the accused products qualify as "substantially rigid after expansion" under that definition.*fn140

Guidant raises two additional issues with regard to literal infringement of the '381 Patent, relating to a total of four claims.*fn141 Guidant contends that the accused products do not meet the limitations of claims 57 and 66 of the '381 Patent, which require, inter alia, that "in the unexpanded state, a radial plane perpendicular to a longitudinal axis can pass through the flexible links of the flexible cells and not pass through the circumferential members."*fn142 Specifically, Guidant contends that: (1) "the alleged radial plane does not pass through the five-turn "Access-Link" of the Penta stent," or the "Flexalink" of the Vision stent"; and (2) the diagrams relied on by Medinol to demonstrate that this limitation is met are not depictions of the accused products in their unexpanded state.*fn143

Guidant is wrong on both counts. First, a flexible link is defined as "a structural element connecting adjacent cells that is flexible and aligned with respect to the stent's longitudinal axis." Therefore, to the extent that Guidant argues that the radial plane must pass through the five-turn loops of the Access-Link, or the loop of the Flexalink, it is mistaken. The entire connector of the accused products qualifies as a flexible link, not just the looped portion.

Second, Medinol relies on Guidant's own depictions of the Penta and Vision stents to demonstrate that the "radial plane" limitation of claims 57 and 66 is met by the accused products.*fn144 Although disputed by Guidant, Medinol's reliance on these depictions supports its assertion of literal infringement. While these depictions (Gonell Ex. 3) are not explicitly labeled as pre-expansion depictions of the accused products, other documents produced by Guidant and cited by Medinol, clearly labeled as depictions of post-expansion stents, reveal that Exhibit 3 does in fact depict the pre-expansion stents.*fn145

Guidant also misreads claims 58 and 69 of the '381 Patent, which require that ends of a flexible link be "generally aligned with . . . each other along a longitudinal axis of the stent." The accused products clearly meet this limitation, and Guidant's misinterpretation of these claims to require that the ends of adjoining links be aligned with each other along the longitudinal axis*fn146 would (among other problems) exclude the preferred embodiment depicted in Figure 8, as Medinol demonstrates.*fn147

The Court's construction of the '381 Patent leads to the inexorable conclusion that the accused products literally infringe that patent. Thus, Medinol's motion for summary judgment as to the '381 Patent is granted.

C. Doctrine of Equivalents

Although Medinol asserts that the accused products infringe the patents-in-suit under the doctrine of equivalents, its present motion is confined to literal infringement of the '120 and '381 Patents. However, as part of its noninfringement cross-motion, Guidant asserts that substantial differences between the accused products and the patents-in-suit preclude a finding of infringement under the doctrine of equivalents.*fn148

Because I have found the '381 Patent to be literally infringed, I only consider the doctrine of equivalents with respect to the "meander" claims of the '120 and '982 Patents.*fn149 Guidant first argues that Medinol's doctrine of equivalents claims are barred by argument-based estoppel. During prosecution, Medinol explained to the PTO that "when the specification mentions . . . that the term 'meander pattern' is a periodic pattern, it meant that a meander pattern is a periodic pattern about a center line."*fn150 Thus, according to Guidant, "Medinol cannot now claim that the patterns found in the Penta and Vision stents that are not periodic about a center line are equivalent to simply a periodic pattern."*fn151

In response, Medinol argues that its statement to the PTO was made to clarify certain claims, rather than to distinguish the Lau and Palmaz patents.*fn152

The relevant inquiry, however, founded in the public notice function of patent law, is not focused on the patentee's intent, but on "whether a competitor would reasonably believe that the applicant has surrendered the relevant subject matter."*fn153 In clarifying its claims, Medinol made an unequivocal statement that it did not seek to patent a meander pattern that was not "about a center line."

Accordingly, estoppel must apply, and the accused products do not utilize patterns equivalent to Medinol's meander patterns, because the stent material of the accused products is not uniformly distributed about a center line. Thus, Guidant is entitled to a summary judgment of noninfringement as to the '120 and '982 Patents.*fn154

V. CONCLUSION

For the foregoing reasons, a summary judgment of infringement is granted in favor of Medinol as to the '381 Patent and denied as to the '120 Patent; and Guidant's cross-motion for a summary judgment of noninfringement is granted as to the '120 and '982 Patents, but not as to the '381 Patent. The Clerk of the Court is directed to close the pending motions [numbers 69 and 83 on the docket sheet]. A conference is scheduled for Monday, March 6 at 5:00 P.M. in Courtroom 15C. At this conference, the parties should be prepared to discuss when and how to proceed on Guidant's counterclaim for a declaratory judgment of patent invalidity.

SO ORDERED:

Shira A. Scheindlin U.S.D.J.


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