Edwards Lifesciences LLC v. Cook Inc.

• Decision Date: 22 September 2009
• Docket Number: No. 2009-1006.,2009-1006.
• Citation: 582 F.3d 1322
• Parties: EDWARDS LIFESCIENCES LLC and Endogad Research Pty Limited, Plaintiffs-Appellants, v. COOK INCORPORATED, Defendant-Appellee, and W.L. Gore & Associates, Inc., Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

582 F.3d 1322

EDWARDS LIFESCIENCES LLC and Endogad Research Pty Limited, Plaintiffs-Appellants, v. COOK INCORPORATED, Defendant-Appellee, and W.L. Gore & Associates, Inc., Defendant-Appellee.

No. 2009-1006.

United States Court of Appeals, Federal Circuit.

September 22, 2009.

Hugh A. Abrams, Sidley Austin LLP, of Chicago, IL, argued for plaintiffs-appellants. With him on the brief were Constantine L. Trela, Jr., David T. Pritikin and Lisa A. Schneider.

Richard A. Kaplan, Brinks Hofer Gilson & Lione, of Chicago, IL, argued for defendant-appellee Cook Incorporated. With him on the brief were Bradley G. Lane, Jeffry M. Nichols and Julie L. Leichtman.

Harry C. Marcus, Locke Lord Bissell & Liddell LLP, of New York, NY, argued for defendant-appellee W.L. Gore & Associates, Inc. With him on the brief was Matthew K. Blackburn, of San Francisco, CA.

Before LOURIE, RADER, and MOORE, Circuit Judges.

LOURIE, Circuit Judge.

Edwards Lifesciences LLC and Endogad Research PTY Limited (collectively, "Edwards") appeal from the judgment of the United States District Court for the Northern District of California granting summary judgment of noninfringement of several claims of U.S. Patents 6,582,458 ("the '458 patent"); 6,613,073 ("the '073 patent"); 6,685,736 ("the '736 patent"); and 6,689,158 ("the '158 patent"). See Edwards Lifesciences LLC v. Cook, No. C 03-03817 JSW, 2007 WL 2128333, 2007 U.S. Dist. Lexis 55634 (N.D.Cal. July 23, 2007) ("Claim Construction Order"); Edwards Lifesciences LLC v. Cook, No. C 03-03817 JSW, 2008 WL 744825, 2008 U.S. Dist. Lexis 21248 (N.D.Cal. Mar. 18, 2008) ("Order Granting Cook Summary Judgment"); Edwards Lifesciences LLC v. Cook, No. C 03-03817 JSW, 2008 WL 4279666, 2008 U.S. Dist. Lexis 70130 (N.D.Cal. Sept. 15, 2008) ("Order Granting Gore Summary Judgment"). Because the court correctly construed certain claim terms and correctly determined that Cook Incorporated's and W.L. Gore & Associates, Inc.'s (collectively, "Appellees'") devices did not infringe under those constructions, we affirm.

BACKGROUND

Edwards owns the four patents in suit, which are related and share a common specification.¹ The patents relate to intraluminal grafts for treating aneurisms and occlusive diseases of the blood vessels without open surgery. See '458 patent col.1 ll.11-20. An aneurism is a weakness in a blood vessel, such as the aorta, that can cause enlargement or dilation of the vessel. If an aneurism is not repaired, the vessel can rupture, resulting in serious injury or death. To avoid the adverse consequences of open surgery, the medical profession has developed techniques for repairing aneurisms endovascularly, or intraluminally, allowing surgeons to make a small incision and guide a specially made device through the arteries to the aneurism. In endovascular aneurism repair, a graft reinforced with a metal framework, also called a stent-graft, is compressed onto a delivery catheter, which is guided through the artery to the aneurism site. Once at the site, the graft is expanded into position against the walls of the blood vessel. Stents, and therefore stent-grafts, are generally classified into two types, self-expanding and balloon expandable. A self-expanding stent or stent-graft is inserted into a blood vessel inside a catheter. Upon release from the catheter, it automatically expands to the size of the vessel. See id. at col.1 ll.20-31. A balloon expandable stent or stent-graft, on the other hand, is guided through a catheter on an inflatable balloon until it extends from the catheter into the vessel. See id. at col.1 ll.54-63. At that point, the balloon is inflated, expanding the stent or stent-graft to the size of the vessel, and then the balloon is deflated and removed. See id.

The specification describes one method of treating an aneurism using two overlapping grafts, whereby the degree of overlap can be adjusted to change the overall length of the graft. '458 patent col.4 ll.4-17. The specification also describes a "trouser graft," which has a bifurcation at its downstream end, and a supplemental graft that overlaps with one of the legs of the trouser graft. Id. at col.4 ll.18-31.

In August 2003, Edwards sued Cook for infringement of claims 1-3, 6, 8, 9, 11, 12, 15, and 17-20 of the '458 patent; claims 1-3, 6, 8, 9, 12, and 14-19 of the '073 patent; claims 1-4, 6, 9, 10, 12, 14-20, and 22-25 of the '736 patent; and claims 1, 15, 17, and 18-23 of the '158 patent. Edwards sued Gore for infringement of claims 1-3, 7, 8, 11, 12, and 16-20 of the '458 patent; claims 1-3, 7-9, 13-15, and 17-19 of the '073 patent; claims 1-3, 7-9, 12-15, and 22-25 of the '736 patent; and claims 1, 2, 4-6, 8, 11-14, and 17-22 of the '158 patent. Claim 1 of the '458 patent is representative of the asserted claims:

1. A prosthesis comprising:

(i) a bifurcated base structure which defines a common flow lumen and a pair of connector legs which define divergent flow lumens from the common flow lumen; and

(ii) a graft which is adapted to be anchored within one of the flow lumens of said bifurcated base structure to form a continuous extension of that lumen.

'458 patent col.6 ll.12-19. All of the asserted independent claims recite two of the following structures (in addition to any recitations in the preambles): a "graft" ('458 patent claim 1), a "graft body" ('073 patent claim 1; '736 patent claims 1, 20, 22), a "graft structure" ('158 patent claims 1, 15, 17, 23), a "bifurcated base structure" ('458 patent claim 1), and a "bifurcated base graft structure" ('158 patent claims 1, 15, 17, 23). Further, in all of the asserted independent claims, those two structures are "anchored" ('458 patent claim 1; '158 patent claim 1), "attached" ('158 patent claims 15, 17, 23), "attachable" ('736 patent claims 1, 20, 22), or "dockable" ('073 patent claim 1) to each other while they are inside the vessel.²

In July 2007, the district court construed certain limitations of the asserted claims. The court construed the claim term "graft" to mean "an intraluminal device that is used in unitary fashion to substitute, repair, or replace a missing or defective part of a vessel." Claim Construction Order, 2007 WL 2128333, at *8, 2007 U.S. Dist. Lexis 55634, at *26. The court reasoned that the graft had to be intraluminal because the specification used the term "graft" as shorthand for "intraluminal graft" and referred to an "intraluminal graft" as "the invention." Id. at *7, 2007 U.S. Dist. Lexis 55634, at * 19-22. The court further reasoned that the claimed "graft" could not encompass a traditional surgically implanted vascular graft because all of the disclosed embodiments contained wires, which the parties agreed are a feature of intraluminal grafts. Id. at *8, 2007 U.S. Dist. Lexis 55634, at *22-26. According to the court, the claimed "graft" could not include a traditional vascular graft also because the claims required that the "graft" components be used together in a unitary fashion, preventing the device from being comprised, in part, of a device that had already been implanted. Id.

The court construed the term "graft body" to mean "an artificial device formed of plastic or fabric for use inside of a vessel." Claim Construction Order, 2007 WL 2128333, at *12, 2007 U.S. Dist. Lexis 55634, at *37. The court reasoned that the graft body did not include malleable wires because, throughout the specification, the inventors distinguished between the material of the graft body and the wires. Id. at *13, 2007 U.S. Dist. Lexis, at *35-37.

The court construed the terms "bifurcated base structure" and "bifurcated base graft structure" to mean "an intraluminal graft that has one opening at its upstream end and two openings at its downstream end and which includes at least one malleable wire." Claim Construction Order, 2007 WL 2128333, at *11, 2007 U.S. Dist. Lexis 55634, at *33. As with the term "graft," the court reasoned that the specification demonstrates that the structure must be intraluminal because it describes only embodiments that are placed into a vessel. Id. at *11, 2007 U.S. Dist. Lexis 55634, at *28-29. The court also found that at least one wire was required because something more than a graft was required to give meaning to the word "base." Id. at *18, 2007 U.S. Dist. Lexis 55634, at *31-32. Further, although Edwards asserted that claim differentiation should prevent the terms from necessarily including wires because dependent claims later added wires, according to the court, claim differentiation did not apply where, as here, the dependent claim adds other features as well as wires. Id. at *11, 2007 U.S. Dist. Lexis 55634, at *29-31. Finally, the court reasoned that the specification disclaims grafts with self-expanding wires, so the wires must not be self-expanding but, instead, must be "malleable." Id. at *13, 2007 U.S. Dist. Lexis 55634, at *32-33.

Edwards accused four of Cook's products of infringing the patents in suit: the Zenith AAA Endovascular Graft, the Zenith Flex AAA Endovascular Graft, the Zenith Fenestrated AAA Endovascular Graft, and the Zenith TX2 Thoracic TAA Endovascular Graft. Order Granting Cook Summary Judgment, 2008 WL 744825, at *2, 2008 U.S. Dist. Lexis 21248, at *5. All four accused Cook devices include a fabric sleeve reinforced with wires both inside and outside the sleeve. Id. *3, 2008 U.S. Dist. Lexis 21248, at *5-6. The Cook devices are compressed and constrained in a sheath until positioned in a patient's vessel, when the sheath is withdrawn. Id. at *6. As the pressure of the sheath is removed from the accused device, the wires expand to fit within the vessel. Id. A balloon may then be used to mold the device to more smoothly conform to the vessel walls. Id. at *2, 2008 U.S. Dist. Lexis 21248, at *7. Edwards also accused two of Gore's products of infringing the patents in suit, the Gore Excluder Bifurcated Endoprosthesis and the Gore TAG Thoracic Endoprosthesis. Order Granting Gore Summary...