United States District Court, D. Delaware
W.L. GORE & ASSOCIATES, INC., Plaintiff,
C.R. BARD, INC. and BARD PERIPHERAL VASCULAR, INC., Defendants.
REPORT AND RECOMMENDATION
CHRISTOPHER J. BURKE, Magistrate Judge.
In this action filed by Plaintiff W.L. Gore & Associates, Inc. ("Gore" or "Plaintiff") against Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, "Bard" or "Defendants"), Gore alleges infringement of U.S. Patent Nos. 5, 735, 892 (the '892 Patent") and 5, 700, 285 (the '285 Patent") (the "Asserted Patents" or the "patents-in-suit"). Presently before the Court is the matter of claim construction. The Court recommends that the District Court adopt the constructions as set forth below.
A. The Parties
Gore is a Delaware corporation with its principal place of business in Newark, Delaware. (D.I. 64 at ¶ 2) It is the owner of the patents-in-suit. ( Id. at ¶¶ 14-15)
Defendant C.R. Bard, Inc. is a New Jersey corporation with its principal place of business in Murray Hill, New Jersey. (D.I. 189 at ¶ 3) Defendant Bard Peripheral Vascular, Inc. is an Arizona corporation with its principal place of business in Tempe, Arizona, and a wholly owned subsidiary of Defendant C.R. Bard, Inc. ( Id. at ¶¶ 4-5) Defendant Bard Peripheral Vascular, Inc. makes and sells the FLUENCY ® Plus Tracheobronchial Stent Graft ("Fluency") and the FLAIR ® Endovascular Stent Graft ("Flair"). ( Id. at ¶¶ 16-17)
B. The Asserted Patents
Gore asserts two related patents against Bard that share a common specification. Both of the Asserted Patents are entitled "Intraluminal Stent Graft." (D.I. 96, ex. A & V) The '892 Patent issued on April 7, 1998 from U.S. Appl. No. 109, 214, which was filed on August 18, 1993. ('892 Patent) The '285 Patent is a divisional of the '892 Patent and was issued on December 23, 1997. ('285 Patent) The Asserted Patents are two among a family of 14 patents claiming priority to the original application for the '892 Patent. (D.I. 99 at 5)
The Asserted Patents relate to intraluminal graft devices. The patents explain that conventional vascular grafts-typically, flexible tubes of woven or knitted polyethylene terephthalate or of porous polytetrafluoroethylene ("PTFE")-had long been used to repair damaged and diseased blood vessels and veins. ('892 Patent, col. 1:9-13) Implantation of these devices typically required invasive surgery that exposed much of the vessel to be repaired and caused major trauma to the patient. ( Id., col. 1:9-20) As an alternative, some physicians had begun to use intraluminal devices that combined conventional vascular grafts with stents. ( Id., col. 1:22-24) These devices were placed inside the damaged portion of the vessel using a less invasive "catheter type of delivery system." ( Id., col. 1:24-26, 37-38) However, the "relatively thick, bulky wall[s]" of these devices limited their use, making them difficult to "be contracted into a small cross-sectional area for insertion into a blood vessel." ( Id., col. 2:10-15) The present inventions were designed to overcome the limitations of the prior art, claiming thin-walled stent-graft devices "useful as an inner lining for blood vessels or other body conduits[, ]" and methods of making such devices. ( Id., col. 1:5-6)
C. Procedural History
On June 10, 2011, Gore commenced this action. (D.I. 1) Gore alleges that Bard's Fluency and Flair products infringe claims 32, 33, and 40 of the '892 Patent, as well as claim 15 (which incorporates the elements of claims 12 and 13) of the '285 Patent. (D.I. 191 at 1) On November 29, 2011, this case was referred to the Court by Chief Judge Leonard P. Stark to hear and resolve all pretrial matters, up to and including the resolution of case diapositive motions. (D.I. 20)
The parties filed simultaneous opening claim construction briefs on May 10, 2013, and simultaneous responsive briefs on June 7, 2013. (D.I. 99, 101, 111, 115) The Court held a Markman hearing on July 16, 2013. (D.I. 130, hereinafter "Tr.")
II. STANDARD OF REVIEW
It is well-understood that "[a] claim in a patent provides the metes and bounds of the right which the patent confers on the patentee to exclude others from making, using, or selling the protected invention." Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). The proper construction of claim terms is a question of law for the Court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The Court should generally give claim terms their "ordinary and customary meaning[, ]'" which is "the meaning that the term[s] would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (citations omitted). However, when determining the ordinary meaning of claim terms, the Court should not extract and isolate those terms from the context of the patent, but rather should endeavor to reflect their "meaning to the ordinary artisan after reading the entire patent." Id. at 1321.
To that end, the Court should look first and foremost to the language of the claims, because "[i]t 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." Id. at 1312 (internal quotation marks and citations omitted). For example, the context in which a term is used in a claim may be "highly instructive." Id. at 1314. In addition, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable" in discerning the meaning of particular claim term. Id. This is "[b]ecause claim terms are normally used consistently throughout the patent, [and so] the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. Moreover, "[d]ifferences among claims can also be a useful guide, " as when "the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15.
In addition to the words of the claims, the Court should look to other intrinsic evidence. For example, the Court should analyze the patent specification, which "may reveal a special definition given to a claim term... that differs from the meaning [that term] would otherwise possess." Id. at 1316. In that case, "the inventor's lexicography governs." Id. Even if the specification does not contain a special definition of the term-at-issue, it "is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Id. at 1315 (internal quotation marks and citation omitted). That said, however, the specification "is not a substitute for, nor can it be used to rewrite, the chosen claim language." SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). In addition to the specification, a court should also consider the patent's prosecution history, if it is in evidence, because it "can often inform the meaning of the claim language by demonstrating how the inventor understood the invention[.]" Phillips, 415 F.3d at 1317 (citations omitted).
Extrinsic evidence, "including expert and inventor testimony, dictionaries, and learned treatises[, ]" can also "shed useful light on the relevant art." Id. (internal quotation marks and citations omitted). Dictionaries (especially technical dictionaries) may be useful in this process because they typically provide "the accepted meanings of terms used in various fields of science and technology[.]" Id. at 1318. However, the United States Court of Appeals for the Federal Circuit has cautioned that "heavy reliance on [a] dictionary divorced from the intrinsic evidence risks transforming the meaning of the claim term to the artisan into the meaning of the term in the abstract, out of its particular context, which is the specification." Id. at 1321. Overall, while extrinsic evidence may be useful, it is "less significant than the intrinsic record in determining the legally operative meaning of claim language." Id. at 1317 (internal quotation marks and citations omitted); accord Markman, 52 F.3d at 981.
In utilizing these resources during claim construction, courts should keep in mind that "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
The parties set out six disputed terms or sets of terms for the Court's review. The Court takes up the disputes in the order in which they were argued.
A. Disputed Terms
1. Terms Relating to the Claimed Stent Structure
Asserted claims 32 and 40 of the '892 Patent and claim 12 of the '285 Patent (incorporated into asserted claim 15) claim a stent structure that is the subject of the parties' competing claim construction proposals. The use of the disputed terms in claim 32 of the '892 Patent ("claim 32") is representative:
32. A tubular intraluminal graft comprising:
a) a tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall of the stent;
b) a first tubular covering of porous expanded polytetrafluoroethylene affixed to the exterior surface of the tubular, diametrically adjustable stent; and
c) a second tubular covering of porous expanded polytetrafluoroethylene affixed to the luminal surface of the tubular, diametrically adjustable stent;
wherein the combined thickness of the first and second tubular coverings is less than about 0.10 mm thick exclusive of the stent.
('892 Patent, col. 11:25-39 (emphasis added))
Bard offers proposed constructions for the following terms relating to the claimed stent structure: (1) "tubular, diametrically adjustable stent"/"diametrically adjustable stent"; (2) "wall"; and (3) "multiplicity of openings." (D.I. 101 at 6-9) For its part, Gore asserts that no construction is necessary for any of these terms, as "[w]hen read as a whole, the meaning of this phrase is clear both on its face and in the context of the specification." (D.I. 99 at 11; see also D.I. 111 at 2) Alternatively, Gore proposes that for each of the disputed terms relating to the claimed stent structure, the Court adopt the constructions entered by the United States District Court for the Eastern District of Virginia in W.L. Gore & Assocs., Inc. v. Medtronic, Inc., 834 F.Supp.2d 465 (E.D. Va. 2011), aff'd, 530 F.App'x 939 (Fed. Cir. 2013), a case in which Gore asserted related U.S. Patent No. 5, 810, 870 (the '870 Patent") against Medtronic. (Tr. at 38-39, 79-81)
The Court will examine each of these terms separately, as, by and large, that is how they are addressed in the briefing. However, the Court agrees with Gore that the terms are related, as they each touch on the characteristics of the stent at issue that is described in the respective claims. (Tr. at 26-27, 39) That inter-relationship will be important in the Court's treatment of each of the terms below.
a. "tubular, diametrically adjustable stent"/"diametrically adjustable stent"
Bard proposes that these terms be construed to mean "structure designed for insertion in a lumen that is adjustable to contact the surface of the lumen." (D.I. 101 at 6; D.I. 115 at 4) Gore contends that no construction is necessary, or alternatively, that the definition for "stent" set out by the Medtronic Court be adopted: "[e]longated members [connected in such a way as to create a multiplicity of openings, and] forming a substantially cylindrical  structure." Medtronic, 834 F.Supp.2d at 473; Medtronic, 874 F.Supp.2d 526, 563 n.16 (E.D. Va. 2012). Bard asserts that its proposed construction is "broader" than Gore's view of the claimed stent, and in line with the patent's description of "all different types of stents[.]" (Tr. at 51-53, 63-64) The Court will address the appropriate construction by focusing on the two strands of argument that Bard puts forward in support of its proposal.
First, the Court addresses Bard's assertion that "[t]he patent is very clear that it covers all types of stents" and therefore the claimed stent should itself be defined very broadly as a "structure[.]" (Tr. at 64) In doing so, the Court looks first to the language of the claims, for it is well-settled that "[i]t is the claims that define the metes and bounds of the patentee's invention." Thorner v. Sony Computer Entm't Am. LLC, 669 F.3d 1362, 1367 (Fed. Cir. 2012). Focusing on the claim language is particularly crucial here, in order to honor the Federal Circuit's instruction that "[p]roper claim construction... demands interpretation of the entire claim in context, not a single element in isolation." Hockerson-Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed. Cir. 1999); see also Kyocera Wireless Corp. v. Int'l Trade Comm'n, 545 F.3d 1340, 1347 (Fed. Cir. 2008) (warning against "interpret[ing] claim terms in a vacuum, devoid of the context of the claim as a whole").
As Gore points out, an examination of claim 32 (and the other relevant claims) as a whole reveals "important information about the structure that's claimed" therein. (Tr. at 25-26; see also Tr. at 33 (Gore's counsel explaining that "for the claims at issue here, we have... specific requirements [for the claimed stent]")) These claims require a particular stent structure, one in which the stent at issue must be tubular and diametrically adjustable (and, for that matter, must have "an exterior surface, a luminal surface and a wall, and  a multiplicity of openings through the wall[.]"). ('892 Patent, col. 11:26-39; Tr. at 41 (Gore's counsel explaining that the claims disclose a "specific [stent] structure" as opposed to a "generic structure"); id. at 78) ...