Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Official citation and/or docket number and footnotes (if any) for this case available with purchase.

Learn more about what you receive with purchase of this case.


United States District Court, S.D. New York

December 27, 2005.

MEDINOL LTD., Plaintiff and Counter-Defendant,

The opinion of the court was delivered by: SHIRA SCHEINDLIN, District Judge



  Medinol Ltd. ("Medinol") brings this action for damages and declaratory and permanent injunctive relief relating to the alleged infringement by Guidant Corp. and its subsidiary Advanced Cardiovascular Systems, Inc. ("ACS") (collectively "Guidant") of certain of Medinol's patents.*fn1 This Opinion resolves Guidant's motion for summary judgment on the issue of invalidity, which asserts that all claims of the patents-in-suit are obvious as a matter of law.*fn2 For the following reasons, Guidant's motion for summary judgment on invalidity is denied.


  Two previous Opinions have been issued in this case. One granted in part and denied in part Guidant's motion for summary judgment based on collateral estoppel.*fn3 The other construed several terms necessary to evaluate the claims in this case.*fn4 Familiarity with both Opinions is assumed.

  A. The Parties

  Medinol, which has its principal place of business in Tel Aviv, Israel, designs and manufactures coronary stents.*fn5 The company was founded by, among others, Dr. Jacob ("Kobi") Richter, who currently serves as Medinol's Chairman of the Board and Chief Technical Officer.*fn6 Guidant develops, markets, and sells cardiovascular medical products and has its principal place of business in Indiana. ACS has its principal place of business in California.*fn7

  B. The Technology

  The devices at issue in this litigation are directed toward opening diseased coronary arteries*fn8 and maintaining blood flow to and from the heart.*fn9 In the 1970's, the preferred treatment for coronary artery disease was "balloon angioplasty," also known as "percutaneous transluminal coronary angioplasty", or PTCA.*fn10 This procedure involves first inserting a balloon into the diseased artery via a catheter, then inflating the balloon to push open the artery.*fn11 The goal is for the artery to stay open once the balloon is removed. However, in about thirty-five percent of such procedures, the effects were temporary and the artery eventually re-closed, or "recoiled."*fn12

  Stents provide a more permanent solution. A stent is a "medical device much like [] miniature scaffolding that physically holds open a diseased artery into which [it is] inserted."*fn13 Stents are used to treat diseased arteries in the heart (i.e. coronary arteries), as well as "peripheral arteries" located in other areas of the body.*fn14 Stents are introduced into the blood vessel on a balloon catheter, in a procedure during which the catheter is maneuvered into the blocked artery, where the balloon is inflated, causing the stent to expand against the vessel wall. Once the balloon has been deflated and removed, the stent remains in place indefinitely, holding the blood vessel open and thereby improving blood flow.*fn15

  The modern stent originated in the 1980s. In April 1988, a patent was issued to Julio Palmaz (Palmaz '762 Patent) for an "expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft," i.e., a "stent," which Johnson & Johnson commercialized in 1991. The Palmaz '762 Patent described the first stent to "include a plurality of closed cells" that, upon expansion, "transformed [from slot-shaped cells] into diamond-shaped cells, resulting in an expanded stent with a honeycomb appearance."*fn16

  At approximately the same time, Palmaz patented another stent (Palmaz '417 Patent) "combining slot-shaped cells with flexible connectors to increase longitudinal flexibility."*fn17 Other designs used "coil connectors" to impart great flexibility, but at the expense of radial strength once the stent is expanded or deployed.*fn18 In 1995, Richard Schatz developed a new variation of the Palmaz stent, involving "straight flexible connectors between tube sections" (Palmaz/Schatz '984 Patent).*fn19

  C. Prior Stent Designs

  Three prior stent designs are particularly important to resolution of this motion. First, in the early 1990s, Guidant developed a stent design based on connecting single serpentine rings with flexible straight connectors, for which it obtained the Lau '955 Patent.*fn20 Second, in 1994, a team of engineers filed, and then abandoned, a patent application for a "hybrid stent" that attempted to combine flexibility and radial strength ("the Burmeister Application").*fn21 Third, in 1999, the Fischell '370 Patent was issued, disclosing a stent using rings that become circular when fully expanded, connected with either straight or "undulating" (looped) longitudinals.*fn22

  1. Lau

  The Lau '955 Patent asserts that "[w]hat has been needed and heretofore unavailable is a stent which has a high degree of flexibility so that it can be advanced through tortuous passageways and can be readily expanded and yet have the mechanical strength to hold open the body lumen into which it is expanded. The present invention satisfies this need."*fn23 Lau's invention was 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."*fn24

  The Lau '955 Patent discloses an invention comprising serpentine rings, connected with straight "connectors," or links between rings.*fn25 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).*fn26 The out-of-phase design, shown in Lau Figure 11, contains only a single connector between each pair of rings.*fn27

  While the straight connectors are designed to be inflexible, serving to "provide increased stability and . . . prevent warping of the stent upon expansion," the rings themselves permit flexibility.*fn28 Moreover, Lau teaches that "[t]he number and location of elements interconnecting adjacent cylindrical elements can be varied in order to develop the desired longitudinal flexibility in the stent structure both in the unexpanded as well as the expanded condition."*fn29 2. Burmeister

  Beginning in 1994, Scimed engineers, including Burmeister, Euteneuer and Brown, sought to develop a hybrid stent that would partially self-expand, and then fully expand with a balloon.*fn30 A patent application to this effect, including several drawings, was filed with the U.S. Patent and Trademark Office ("PTO") on May 19, 1994. The application asserts that:

[t]he devices of this invention are generally cylindrical or tubular in overall shape and of such a configuration as to allow radial expansion for enlargement. Furthermore, the devices are comprised of at least one component which exhibits a resiliency or spring-like tendency to self-expand the device and at least one other component which is deformable so as to allow an external force, such as a balloon positioned within the body of the device, to further expand it to a final desired size.*fn31
  Most relevant to this motion are Figures 14a and 14b of the Burmeister Application, created by Euteneuer and Brown.*fn32 Figure 14a discloses the Burmeister design in its unexpanded state, while Figure 14b reflects the expanded, or deployed, state. The team of engineers who produced the Burmeister design experimented with several different designs.*fn33 The Burmeister design embodied in Figures 14a and 14b never entered the market; it was abandoned soon after the first stainless-steel prototypes were produced.*fn34

  3. Fischell

  The Fischell Patent describes itself as "an expandable stent that can be used in an artery or any other vessel of the human body which, when expanded, forms a multiplicity of generally circular rings whose closed structure optimizes hoop strength so as to minimize elastic recoil of the vessel into which the stent is inserted."*fn35 "Although the optimum design for maximizing hoop strength is a closed circular structure, no prior art stent has been described which has a small diameter when percutaneously inserted into a vessel and which expands into the form of multiplicity of closed circular structures (i.e., rings) expanded outward against the vessel wall."*fn36

  Fischell recites four objects, only two of which are relevant to this motion. First, "an object of this invention is to provide a stent having a maximum hoop strength by the employment of closed, generally circular structures which are in fact rings."*fn37 Second, "[s]till another object of this invention is that the fully deployed rings are spaced apart by means of longitudinals which are either straight or undulating wires that are placed to be generally parallel to the longitudinal axis of the vessel into which the stent is deployed."*fn38 Notably, Dr. Timothy Fischell, an inventor of the '370 patent, has testified that one of his goals was "to make a stent that would be very flexible."*fn39

  D. The Patents-in-Suit

  According to Richter, prior art stents on the market in the last half of 1993 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.*fn40
  The leading strong but inflexible stents were the Palmaz and Palmaz-Schatz. On the other end of the spectrum, coiled wire stents were very flexible, but at the expense of radial strength once deployed.*fn41 Richter has stated that "the idea [that] brewed in my mind . . . [was] that flexibility was needed when you are trying to track it through the curviness of the artery, [b]ut once you get it to the position you don't need [flexibility.]."*fn42

  On September 12, 1995, U.S. Patent No. 5,449,373 was issued to Gregory Pinchasik et al. and assigned to Medinol. The application for this patent was filed on March 17, 1994.*fn43 A series of stents, described as continuations or continuations-in-part of this patent, were invented by Henry Israel and Gregory Pinchasik, and assigned to Medinol.*fn44 These patents — the '303, '018, '120, '381, and '982 — describe a family of flexible, expandable stents.*fn45 Specifically, Medinol's patents:

share the same drawings, and essentially the same specification, and are described as continuations of a series of applications beginning with Application Serial No. 282,181 . . . filed on July 28, 1994, and continuations-in-part of Application Serial No. 213,272 . . . which was filed on March 17, 1994, and issued as [the Pinchasik '373 Patent]. The Medinol patents generally describe and illustrate stent designs that achieve the objectives and flexibility during delivery, compensation for foreshortening, continuous uniform scaffolding, and resistance to radial deformation and collapse upon expansion.*fn46
  Although Medinol originally alleged infringement of all five patents, "it has since dropped any claims relating to the '303 and '018 patents."*fn47 The remaining claims*fn48 can be divided into roughly two groups: the "meander" claims and the "flexible cell" claims. The "meander" claims, comprised of the asserted claims of the '120 and '982 Patents, generally describe stent structures comprised of 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.*fn49 I have construed "first meander" to mean "a periodic sinusoidal pattern about a center line."*fn50 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."*fn51

  A "flexible cell," as used in the claims of the '381 Patent, 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."*fn52

  Medinol introduced the NIR stent in 1996, based on the teachings of at least some of the patents-in-suit, although the record is unclear on this point.*fn53 Between 1996 and 2000, Medinol sold over two million NIR stents.*fn54 The NIR stent garnered notice from the industry as well. For example, Johnson & Johnson attempted to acquire the rights to the NIR stent in 1995, offering Medinol up to $335 million for the rights.*fn55 The President of Johnson & Johnson asserted that the NIR stent "uniquely combines (1) flexibility (a serious disadvantage in the Palmaz/Palmaz-Schatz slotted tube design) and (2) radial strength (better than our current design)."*fn56

  E. The Cordis Litigation

  In December 1999, Medinol and its licensee, Scimed Life Systems, Inc. ("Scimed"), filed a patent infringement action in 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.*fn57 After a two-week jury trial, the jury returned various verdicts of infringement, noninfringement and invalidity.*fn58 Of most relevance to the present motion is that the Cordis jury found that all of the asserted claims were invalid for obviousness and failure to comply with the written description requirement, except for claim 13 of the '120 Patent.*fn59 Claim 13 is the only remaining claim common to the Cordis litigation and this case.*fn60

  The district court denied in part and granted in part Medinol and Scimed's motion for judgment as a matter of law ("JMOL") and for a new trial under Rule 59(a). Specifically, the court denied plaintiffs' motion as to infringement, and also rejected plaintiffs' argument that the asserted claims of the '303 and '018 patents are not invalid for obviousness, finding that "defendants presented substantial evidence to support a reasonable jury's conclusion that claims 12, 35, 47 and 60 would have been obvious to one of ordinary skill in the art in July 1994, the time the inventions described in those claims were made."*fn61 In particular, the court rejected plaintiffs' argument that they were entitled to a new trial based on an inconsistent jury verdict on obviousness:

Claim 13 of the '120 patent has an additional limitation, i.e., that the stent must have "at least one of the loops of each of the first meanders disposed between each consecutive second meander to which the first meander is connected" over claim 60 of the '018 patent. This supports the jury's verdict that claim 13 is not invalid for obviousness whereas claim 60 is invalid.*fn62
  Medinol and Scimed then unsuccessfully appealed the denial of their post-trial motions to the Federal Circuit, which held that "there was substantial evidence in the record to support the conclusion that the asserted claims of the '303 and '018 patents were obvious over the prior art at the time they were filed with the PTO."*fn63

  In response to plaintiffs' argument that "even if each of the elements of the asserted claims was in the prior art, the record does not demonstrate that there was a motivation to combine" them, the Federal Circuit referred to the Burmeister Application as substantial evidence that "a person of ordinary skill in the art did, in fact, combine the elements of the stent design claimed by the '303 and '018 patents prior to July 28, 1994."*fn64


The jury had before it expert testimony that a person of ordinary skill in the art, on July 28, 1994, would inspect the drawings of the Burmeister application and conclude it disclosed a stent design that combined the claimed elements of the balloon expandable stent design taught by the patents-in-suit. This was legally sufficient evidence from which the jury could have found a motivation to combine in the knowledge of one of ordinary skill in the art, a finding of fact we must presume the jury to have made given that it returned a verdict on the validity issue in favor of Cordis.*fn65

  A. Governing Law/Standard for Summary Judgment

  As a general principle, Federal Circuit precedent governs issues of patent law, while the law of the regional circuit applies to nonpatent issues.*fn66 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."*fn67 "An issue of fact is genuine `if the evidence is such that a jury could return a verdict for the nonmoving party.'"*fn68 A fact is material when "it `might affect the outcome of the suit under the governing law.'"*fn69 The movant has the burden of demonstrating that no genuine issue of material fact exists.*fn70

  In turn, to defeat a motion for summary judgment, the non-moving party must raise a genuine issue of material fact. To do so, it must do more than show that there is a "`metaphysical doubt as to the material facts,'"*fn71 and it "`may not rely on conclusory allegations or unsubstantiated speculation.'"*fn72 In determining whether a genuine issue of material fact exists, the court must construe the evidence in the light most favorable to the non-moving party and draw all justifiable inferences in that party's favor.*fn73

  B. Standard of Review

  A patent enjoys a presumption of validity.*fn74 A party seeking to destroy this presumption must do so with clear and convincing evidence of invalidity.*fn75 Clear and convincing evidence exists when the movant "place[s] in the mind of the ultimate fact finder an abiding conviction that the truth of its factual contentions are `highly probable.'"*fn76

  C. Obviousness As an initial matter, "[t]he grant of summary judgment of invalidity for obviousness must be done on a claim by claim basis."*fn77 A claimed invention is unpatentable if the differences between it and the prior art "are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art."*fn78 The ultimate determination of obviousness is a legal conclusion based on the following underlying factual inquiries: (1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of non-obviousness.*fn79 Additionally, "[a] showing of obviousness requires a motivation or suggestion to combine or modify prior art references, coupled with a reasonable expectation of success."*fn80

  1. Scope and Content of Prior Art

  The scope of the prior art has been defined as that "`reasonably pertinent to the particular problem with which the inventor was involved.'"*fn81 "To ascertain the scope of the prior art, a court examines the field of the inventor's endeavor, and the problem with which the inventor was involved, at the time the invention was made."*fn82 Content in this context includes material established by the novelty subsections of section 102 of Title 35, United States Code, including, inter alia: 1) printed publications or patents from anywhere in the world published or issued before the date of invention; 2) a United States patent application subsequently issued, and filed before the date of invention; and 3) another's invention that was made in this country and not abandoned, suppressed, or concealed before the invention date of the invention in question.*fn83

  2. Level of Ordinary Skill in the Art

  "[A] person having ordinary skill in the art" for the purpose of section 103 refers to a hypothetical person reasonably skilled in the applicable art.*fn84 However, this hypothetical person is incapable of thinking outside of the conventional wisdom in the art, as it stood at the time of the claimed invention.*fn85

  "In determining [the level of ordinary skill in the art], the court may consider various factors including [the] type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field."*fn86 Every one of these factors need not be present in every case, and one or more factors may predominate.*fn87 The skill level to be considered is the level at the time the invention was made.*fn88

  3. Differences Between Claimed Invention and Prior Art

  When assessing differences between the prior art and the claimed invention, section 103 requires consideration of the invention as a whole.*fn89 After all, inventions are often merely new combinations of existing principles or features.*fn90 Absent the "as a whole" requirement:

[a]n obviousness assessment might successfully break an invention into its component parts, then find a prior art reference corresponding to each component. This line of reasoning would import hindsight into the obviousness determination by using the invention as a roadmap to find its prior art components. This improper method would discount the value of combining various existing features or principles in a new way to achieve a new result — often the essence of invention.*fn91
  Accordingly, when obviousness is based on the teachings of multiple prior art references, the party claiming invalidity must establish a "motivation to combine" the references.*fn92 This means that there was some "suggestion, teaching, or motivation" that would have led a person of ordinary skill in the art to combine the relevant prior art teachings in the manner claimed.*fn93 That party must also show that such a combination would have had a reasonable chance of success.*fn94

  Accordingly, "[w]hen determining the patentability of a claimed invention which combines two known elements, `the question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination.'"*fn95 The source of the teaching, suggestion, or motivation may be "the nature of the problem," "the teachings of the pertinent references," or "the ordinary knowledge of those skilled in the art."*fn96 "Each individual reference must be considered for everything it teaches by way of technology and is not limited to the particular invention it is describing and attempting to protect."*fn97 A court must also determine whether the prior art references in question "teach away" from, or discourage, the claimed design.*fn98

  "Broad conclusory statements regarding the teaching of multiple references, standing alone, are not `evidence' [of motivation to combine]."*fn99 Additionally, to examine obviousness at the time the invention was made "requires the oft-difficult but critical step of casting the mind back to the time of invention, to consider the thinking of one of ordinary skill in the art, guided only by the prior art references and the then-accepted wisdom in the field . . ." in order to "guard[] against entry into the tempting but forbidden zone of hindsight."*fn100 This means, among other things, that a court must avoid the temptation to "`use hindsight reconstruction to pick and choose among isolated disclosures in the prior art to deprecate the claimed invention,'"*fn101 and must also avoid "[d]efining the problem in terms of its solution."*fn102

  4. Objective Evidence of Non-Obviousness/Secondary Considerations

  The Supreme Court has noted that inquiry into one of several "secondary considerations . . . may have relevancy . . . as indicia of obviousness or nonobviousness."*fn103 These considerations include "commercial success, long felt but unsolved needs, [and] failure of others [to address the problems claimed to be addressed by the patent-in-suit]."*fn104 Such evidence has long been valued as "a helping hand to the judiciary which . . . is most ill-fitted to discharge the technological duties cast upon it by patent legislation."*fn105 Secondary considerations also "serve to guard against slipping into use of hindsight."*fn106

  Although this factor is referred to in seemingly dismissive fashion as "secondary considerations," the Federal Circuit has made clear that such evidence is not of secondary importance:

  [E]vidence of secondary considerations may often be the most probative and cogent evidence in the record. It may often establish that an invention appearing to have been obvious in light of the prior art was not. It is to be considered as part of all the evidence, not just when the decisionmaker remains in doubt after reviewing the art.*fn107 Accordingly, a district court must at least consider such evidence before granting summary judgment on obviousness grounds.*fn108 Nonetheless, a patent can still be found to be obvious on summary judgment even if secondary considerations favor the patentee.*fn109

  For secondary evidence to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.*fn110 "A prima facie case of nexus is generally made out when the patentee shows both that there is commercial success, and that the thing (product or method) that is commercially successful is the invention disclosed and claimed in the patent."*fn111 "[I]f the marketed product embodies the claimed features, and is coextensive with them, then a nexus is presumed and the burden shifts to the party asserting obviousness to present evidence to rebut the presumed nexus."*fn112 To the extent that the patentee demonstrates the required nexus, its objective evidence of nonobviousness will be accorded more or less weight.*fn113


  A. Effect of Cordis Verdict on Validity

  Medinol argues that because the Cordis jury found claim 13 of the '120 patent not invalid, I cannot find the same claim, and "the other meander claims that have similar limitations," invalid on summary judgment.*fn114 Medinol is wrong for two reasons. First, Guidant correctly states that "as there is no such thing as a `validity' verdict, different verdicts — one finding a claim not invalid, the other one finding the same claim invalid — are not necessarily inconsistent."*fn115 "[P]atents cannot be held `valid' under all circumstances. Rather, a court merely decides in a particular case that the one attacking validity has not overcome the statutory presumption of validity."*fn116 Second, as Guidant was not a party to the Cordis litigation, and as it claims to have new evidence of invalidity,*fn117 it would be inappropriate to summarily foreclose its arguments as to the "meander" claims, including claim 13 of the '120 Patent.*fn118

  B. Analysis of Graham Factors

  1. Scope and Content of Prior Art

  For purposes of this motion, Guidant relies on only two prior art references: the Lau '955 Patent and the Fischell '370 Patent.*fn119 The general content of this prior art was discussed above.*fn120 Medinol disputes that the Fischell '370 Patent, as opposed to the earlier Fischell application that became the Fischell '312 Patent, is prior art to the patents-in-suit.*fn121 However, the Fischell '370 Patent is a continuation of the application that became the '312 Patent.*fn122 That application was filed on February 25, 1994, but the '312 Patent was not issued until July 1, 1997, two months after the filing of the application that became the '370 Patent. For these reasons, the Fischell '370 Patent claims priority to the application that became the '312 Patent.*fn123 Moreover, my earlier Opinion in this case noted that the parties agree that the Fischell '370 Patent is prior art to the patents-in-suit.*fn124 Thus, the Fischell '370 Patent is prior art for purposes of this motion.*fn125

  2. Level of Ordinary Skill in the Art In Medinol I, I held that "one of ordinary skill in the art is assumed to be an engineer working with a physician or a `stent design team,' who are presumed to know all of the relevant prior art."*fn126 The parties broadly agree that this definition should apply now.*fn127

  The only area of disagreement concerns Guidant's assertion that "the stent design field was becoming increasingly crowded in 1994, serving to expand the knowledge base of a person of skill in the art at this time."*fn128 But Guidant provides no support for this assertion, aside from listing a handful of stent design patents granted before 1994.*fn129 Even if true, this assertion is not of value, because it provides no method for determining whether the knowledge base of a hypothetical person was in fact expanding.*fn130 Thus, I will adhere to the definition of ordinary skill in the art established in my earlier Opinion and agreed to by the parties.

  3. Differences Between the Claimed Invention and the Prior Art

  a. Presence of Claim Limitations in Lau and/or Fischell

  Much of Guidant's opening brief is devoted to demonstrating that each limitation of the patents-in-suit is disclosed by Lau and/or Fischell.*fn131 However, Guidant also concedes that many of the limitations of the patents-in-suit are present in the prior art only if one combines certain disclosures of Lau and Fischell in a certain way.*fn132 At the same time, Medinol does not seriously dispute that one could find every claim of the patents-in-suit in Lau, Fischell, or a certain combination of the two references.*fn133 For this reason, analysis of this factor will necessarily turn on whether a motivation to combine the prior art existed.*fn134 Thus, I will only briefly summarize the similarities and differences between Lau, Fischell and the patents-in-suit, before turning to whether there was a motivation to combine Lau and Fischell in the manner Guidant claims.

  The presence of some limitations of the patents-in-suit in the prior art cannot be reasonably disputed. For example, Lau discloses first meanders as construed by the Court, and as required by all asserted claims of the '120 and '981 Patents.*fn135 These first meanders include "loops,"*fn136 and "circumferential members,"*fn137 within the meaning of this Court's construction of those terms. Lau also discloses claim 13 of the '120 patent's limitation of "an expandable stent formed of an elongated cylindrical unitary tube."*fn138 I have already held that Lau Figure 5 discloses "a plurality of enclosed spaces" within the meaning of several of Medinol's claims.*fn139 Finally, Lau discloses U- or C-shaped structures.*fn140

  I have construed the term "second meander" to mean "a periodic pattern about a center line oriented in a direction different from the axis of the first meanders."*fn141 A plurality of second meanders, required by all the asserted claims of the '120 and '981 Patents, is disclosed by Lau Figure 5.*fn142 However, Guidant strains to find second meanders in the Fischell Patent, because this Court's construction requires that a second meander be accompanied by a first meander. And despite Guidant's contention, Fischell does not disclose first meanders, because Fischell teaches the desirability of circular rings, rather than the undulating rings of Lau.*fn143

  Moreover, Lau Figure 11, on which Guidant heavily relies as the starting point for its asserted combination of Lau and Fischell, does not have a plurality of second meanders, as the rings of Lau Figure 11 only have one connector.*fn144 To obtain such a plurality of second meanders in Lau Figure 11, Guidant must add connectors to Lau's drawing.*fn145 Guidant similarly depends on a hypothetical combination of Lau and Fischell to find in the prior art several other claims of the patents-in-suit entailing a plurality of second meanders, because the second meanders disclosed in Lau Figure 5 do not otherwise correspond to the limitations of the patents-in-suit.*fn146 The parties also dispute whether flexible cells, of the type required by the '381 Patent, appear in the prior art.*fn147 Again, Guidant relies on its hypothetical combination of Lau and Fischell to find many, if not all, of the required elements of the asserted claims of the '381 Patent in the prior art.*fn148 Medinol argues that Guidant cannot use its hypothetical stent to prove the obviousness of the '381 claims because it "has not provided — and cannot provide — any evidence regarding how flexible or `longitudinally stiff' Guidant's fictional stent is."*fn149 b. Motivation to Combine

  In any event, even if every element of the patents-in-suit were present in Lau and/or Fischell, this would not end the inquiry. Guidant must still show a motivation to combine these elements of Lau and Fischell, with a reasonable expectation of success, to arrive at the designs disclosed by the patents-in-suit. Drawing all reasonable inferences in Medinol's favor — as I must — I conclude that Guidant cannot show the absence of genuine issues of material fact.*fn150

  Guidant's evidence regarding motivation to combine falls into two categories. First, Guidant asserts that a combination of Lau's out-of-phase serpentine rings, as pictured in Figure 11, and the undulating connectors disclosed by Figure 8 of Fischell, would produce a stent exhibiting every limitation of the claims at issue in this case.*fn151 Second, Guidant asserts that "there is evidence that persons skilled in the art of stent design in July 1994 — [the Burmeister engineers] — actually did combine the concepts disclosed in Lau (sinusoidal rings) and Fischell (undulating connectors) in their efforts to design a stent."*fn152

  As an initial matter, Guidant asserts that "the Lau and Fischell patents are directed to the same problem — creating a flexible stent."*fn153 But this statement of the problem is pitched at an improper level of generality. As Medinol notes, the problem of creating a flexible stent as such was solved by the prior creation of the coil stent.*fn154 In fact, Lau and Fischell are directed to somewhat different problems in the stent art. Specifically, while Lau attempts to achieve a balance between deliverability (i.e. flexibility) and radial support once deployed, the primary concern of Fischell is to achieve sufficient "hoop strength," for radial support.

  To be sure, Fischell also teaches that longitudinal predeployment flexibility can be addressed through the use of undulating longitudinals.*fn155 But Guidant does not adequately explain why a stent designer of ordinary skill, seeking to address the same problems sought to be addressed by the patents-in-suit, would adapt the undulating longitudinals of Fischell Figure 8 to the straight connectors of Lau, but at the same time disregard Fischell's teachings 1) favoring the use of longitudinals running the length of the stent, as opposed to connectors between each pair of rings;*fn156 and 2) prescribing the use of circular hoops as opposed to Lau's meandering rings.

  Nor does Guidant adequately explain why Lau Figure 11 would be selected as a starting point to combine Lau and Fischell, as opposed to the in-phase design of Lau Figure 5, which Lau teaches would minimize or prevent foreshortening (a concern addressed by the patents-in-suit).*fn157 Similarly, while Guidant correctly notes Lau's teaching that adding connectors between rings addresses one goal of the patents-in-suit, improved "scaffolding," preventing harmful gaps between rings, Medinol has raised a serious question as to whether adding connectors for that purpose to Lau Figure 11, as Guidant proposes, is consistent with Lau's goals and teachings.*fn158 Guidant attempts to bridge these gaps in its theory by noting that Lau is not explicitly limited to the use of straight, as opposed to longitudinal connectors;*fn159 and that the term "longitudinal" in Fischell is not explicitly limited to structures that run the length of the stent and connect all the rings.*fn160 However, neither of these interpretations flow naturally from the teachings of either patent, and to the extent that the parties offer equally plausible interpretations of the prior art, factual disputes must be resolved in Medinol's favor at the summary judgment stage.*fn161

  The Burmeister Application is offered by Guidant as real-world evidence of motivation to combine.*fn162 Although Medinol attacks the probative value of this reference on several grounds, two of its arguments can quickly be set aside. First, it is of no consequence whether the Burmeister reference is prior art, because Guidant does not offer it for that purpose. Rather it is offered as evidence of a person of ordinary skill's contemporaneous motivation to combine prior art.*fn163

  Second, at the time of the invention, the Burmeister inventors did not possess extraordinary skill in the art. Although it is true that both Brown and Euteneuer, who drew Figures 14a and 14b, ultimately became accomplished inventors in the field of interventional cardiology, neither had significant experience in the field in 1994.*fn164 Accordingly, the Burmeister Application is relevant to whether a person of ordinary skill would be motivated to combine Lau and Fischell.*fn165 Even so, the Burmeister Application cannot be dispositive here because it does not establish that the claimed combination of prior art carried a reasonable expectation of success. Indeed, Medinol asserts that the design based on Figures 14a and 14b was a failure, as "the design was inflexible, had protrusions into the lumen on expansion, and could leave significant gaps on the outside of a bend."*fn166 It may be true, as Guidant contends, that the design was not a failure as such because it was merely experimental, never intended for development into a marketable product.*fn167 However, the fact that the design was apparently unsuccessful undercuts its probative value,*fn168 at least at this stage of the proceedings.*fn169

  4. Secondary Evidence

  Medinol has submitted several types of objective evidence of non-obviousness. First, it asserts that the NIR stent met with commercial success, with 2.2 million units sold between 1996-2000.*fn170 The term "NIR" stent as used by Medinol apparently means both the "original" NIR stent, and a later product called the "NIR Conformer" which incorporated modifications to the end rings of the stent in order to "achieve better conformability, higher radial strength at the end, [and] better trackability."*fn171

  Second, Medinol asserts that there was a long-felt need in the industry for stents exhibiting the characteristics taught by the patents-in-suit.*fn172 Third, Medinol asserts that many in the industry, including Guidant, failed to overcome known problems in the prior art stents.*fn173 Fourth, Medinol notes praise of the stent designs based on the Medinol patents by others in the industry, including Johnson & Johnson, which attempted to buy Medinol's NIR design, despite already owning the rights to the Fischell '370 Patent.*fn174

  Guidant first disputes that Medinol has shown the required nexus between the patents-in-suit and the NIR stents.*fn175 Guidant asserts that Medinol has failed to put forward prima facie evidence to support a nexus, and also notes that one of Medinol's own experts, Dr. Snyder, testified that he has never analyzed the claims of Medinol's patents in connection with the NIR stent under this Court's claim construction.*fn176

  But Guidant itself states that "[t]he original NIR stent is the commercial embodiment of Medinol's patents."*fn177 Medinol, for its own strategic purposes, disputes this apparent admission, asserting in response that "[t]he NIR stent is a commercial embodiment of some claims of some Medinol patents" no longer at issue in this case.*fn178 Aside from Guidant's admission, there are few clear indications from the record that the original NIR stent does in fact practice the teachings of the patents-in-suit.*fn179

  Regarding the NIR Conformer, Medinol asserts that "the NIR Conformer stent as a whole is an embodiment of the Patents-in-Suit," relying on testimony of Richter to that effect.*fn180 However, Guidant points to the same testimony to make the contrary assertion.*fn181 Although Medinol's interpretation of Richter's testimony seems more plausible,*fn182 the record as a whole is unclear as to whether the NIR Conformer in fact practices the teachings of the patents-in-suit, creating a disputed issue of material fact that, on this point, cuts against Medinol as it has the initial burden to show a nexus.*fn183 Accordingly, as the nexus between either of the NIR stents and the patents-in-suit established by this record is uncertain, the weight afforded Medinol's secondary evidence concerning the original NIR stent is significantly reduced.*fn184 Aside from the nexus issue, the remainder of Guidant's response to Medinol's secondary evidence underscores that there are disputed issues of material fact regarding this factor. For example, Guidant responds to Medinol's evidence of long-felt need for the invention by providing its own contrary evidence, asserting that a pre-commercial version of Guidant's Multi-Link stent (the "Bronco") negated any long-felt need that might have been addressed by Medinol's patents.*fn185

  Guidant also disputes whether Medinol's NIR stents were in fact commercially successful, based on the fact that sales fell sharply three years after introduction.*fn186 Similarly, Guidant's evidence of problems identified with the NIR stent, offered in response to Medinol's evidence concerning praise for the invention in the industry, merely creates a disputed issue of fact concerning whether the patents-in-suit in fact met with general praise in the industry.*fn187 For these reasons, consideration of this Graham factor militates slightly against granting summary judgment.


  There are no disputed issues of material fact concerning two of the Graham factors: scope and content of the prior art and level of ordinary skill in the art. However, as set forth above, disputed issues of material fact exist regarding the last two Graham factors: differences between the prior art and the claimed invention, and secondary considerations.

  In particular, on the decisive issue of whether one of ordinary skill in the art in 1994 would have been motivated to combine the Lau and Fischell references to create the claimed invention, both parties offer reasonable interpretations of the teachings of the prior art. Therefore, because I must draw reasonable inferences from the evidence in Medinol's favor at this stage, Guidant's motion for summary judgment of invalidity is denied.*fn188 The Clerk of the Court is directed to close the pending motion [number 66 on the docket sheet].



© 1992-2006 VersusLaw Inc.

Buy This Entire Record For $7.95

Official citation and/or docket number and footnotes (if any) for this case available with purchase.

Learn more about what you receive with purchase of this case.