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MEDINOL LTD. v. GUIDANT CORP.

December 27, 2005.

MEDINOL LTD., Plaintiff and Counter-Defendant,
v.
GUIDANT CORP. and ADVANCED CARDIOVASCULAR SYSTEMS, INC., Defendants and Counter-Plaintiffs.



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

OPINION AND ORDER

I. INTRODUCTION

  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.

  II. BACKGROUND

  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 ...

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