Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 1 of 19 PageID #: 863
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`ENDOHEART AG,
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`
`
`C.A. No. 14-1473 (LPS) (CJB)
`
`)))))))))
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`)
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`
`
`Plaintiff,
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`v.
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`EDWARDS LIFESCIENCES
`CORPORATION,
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`
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`Defendant.
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`
`
`DEFENDANT EDWARDS LIFESCIENCES CORPORATION’S
`OPENING CLAIM CONSTRUCTION BRIEF
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Jeremy A. Tigan (#5239)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`jtigan@mnat.com
`
`Attorneys for Defendant
`
`
`
`
`
`OF COUNSEL:
`
`Catherine Nyarady
`Christopher Terranova
`William O’Hare
`PAUL, WEISS, RIFKIND,
`WHARTON & GARRISON
`1285 Avenue of the Americas
`New York, NY 10019
`(212) 373-3000
`
`October 23, 2015
`
`ENDOHEART AG, EX. 2004 Page 1
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
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`

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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 2 of 19 PageID #: 864
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`TABLE OF CONTENTS
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`Page
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`TABLE OF AUTHORITIES ...................................................................................................... ii
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`I.
`
`II.
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`INTRODUCTION .............................................................................................. 1
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`BACKGROUND ................................................................................................ 2
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`III.
`
`ARGUMENT ...................................................................................................... 3
`
`A.
`
`B.
`
`The Law of Claim Construction ............................................................... 3
`
`Construction of the Claims of the ’530 Patent .......................................... 4
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`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`“elongated wire configured” (claim 1) / “elongated wire
`having a length along which the wire is configured”
`(claim 6) ...................................................................................... 4
`
`“configured to conform to a direction of blood flow”
`(claims 1 & 6) .............................................................................. 5
`
`a)
`
`b)
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`“configured” ..................................................................... 5
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`“to conform to a direction of blood flow” ......................... 6
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`(1)
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`(2)
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`Indefiniteness ........................................................ 6
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`Edwards’ Alternative Proposed Construction ........ 8
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`“installing” (claims 1 & 6) ..........................................................11
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`“access device having means for preventing bleeding
`through the access device” (claims 1 & 6) ...................................13
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`“the feeding directed by the blood flow” (claim 6) ......................14
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`IV.
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`CONCLUSION ..................................................................................................15
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`ENDOHEART AG, EX. 2004 Page 2
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 3 of 19 PageID #: 865
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`TABLE OF AUTHORITIES
`
`
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`Page(s)
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`CASES
`
`Dragon Intellectual Prop., LLC v. Apple, Inc.,
`No. CV 13-2058-RGA, 2015 WL 5298938 (D. Del. Sept. 9, 2015) .......................... 11, 13, 14
`
`Intellectual Ventures I LLC v. AT&T Mobility LLC,
`No. CV 12-193-LPS, 2015 WL 1393386 (D. Del. Mar. 24, 2015) ....................................... 11
`
`Interval Licensing LLC v. AOL, Inc.,
`766 F.3d 1364 (Fed. Cir. 2014) .............................................................................................. 6
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`134 S. Ct. 2120 (2014) .......................................................................................................... 6
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .................................................................................... 3, 8, 12
`
`Sarif Biomedical LLC v. Brainlab, Inc.,
`No. CV 13-846-LPS, 2015 WL 5072085 (D. Del. Aug. 26, 2015) ................................... 4, 14
`
`Tarkus Imaging, Inc. v. Adobe Sys., Inc.,
`No. CA 10-63-LPS, 2012 WL 1669598 (D. Del. May 11, 2012) ...................................... 4, 14
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)................................................................................................ 3
`
`Warner Chilcott Co. v. Teva Pharm. USA, Inc.,
`No. 08-CV-627-LPS, 2011 WL 7121450 (D. Del. Dec. 29, 2011) ....................................... 11
`
`
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`ENDOHEART AG, EX. 2004 Page 3
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 4 of 19 PageID #: 866
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`Defendant Edwards Lifesciences Corporation (“Edwards”) respectfully submits
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`this brief in support of its proposed constructions of the claim terms of U.S. Patent No. 8,182,530
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`(“the ’530 patent”).
`
`I.
`
`INTRODUCTION
`
`Claims 1 and 6 of the ’530 patent are directed to methods of implanting
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`transcatheter heart valves. Transcatheter heart valves allow doctors to replace a patient’s
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`defective heart valve—the aortic valve in this case—by mounting an artificial heart valve on a
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`stent and introducing it through a narrow catheter in the vascular system. This technology avoids
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`the need for open-heart surgical valve replacement in patients who cannot or will not undergo
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`such a highly invasive procedure.
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`Plaintiff Endoheart AG does not contend that the named inventor of the ’530
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`patent, Dr. Christoph Huber, invented the concept of transcatheter heart valve replacement. Nor
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`could it, because it is Edwards that pioneered the lifesaving transcatheter heart valve technology.
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`Rather, Endoheart claims that its ’530 patent covers the “transapical approach,” by which the
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`transcatheter heart valve is implanted directly into the heart through a chest and heart incision,
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`rather than through a patient’s vasculature. In the transapical approach, the transcatheter valve is
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`delivered to the diseased heart valve through a puncture made at the ventricular apex of the heart,
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`as opposed to, for example, a transfemoral approach (in which a valve is delivered through the
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`femoral artery). Endoheart has sued Edwards, alleging that Edwards induces infringement of
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`’530 patent claims 1 and 6 by selling its SAPIEN line of transcatheter heart valve products with
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`its Ascendra line of delivery systems. (See D.I. 1 at ¶ 11)
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`Edwards proposed six terms for construction. All remain disputed.
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`ENDOHEART AG, EX. 2004 Page 4
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 5 of 19 PageID #: 867
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`
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`II.
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`BACKGROUND
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`Defendant Edwards is the global leader in the science of heart valves. Over the
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`last 55 years, Edwards has invented and developed new ways to treat patients with heart valve
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`disease, including the transcatheter heart valve. Previously, patients with degenerating aortic
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`valves had to undergo open heart surgery to replace the valve, an invasive procedure with a long
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`and difficult recovery period. (Ex. 1 at 1:29–51.)1 Transcatheter heart valve technology—
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`technology for implanting prosthetic valves using a catheter—avoids the need for this extreme
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`procedure (id. at 1:10–25), allowing a prosthetic heart valve to be delivered percutaneously
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`(through the skin), or by a minimally invasive surgical procedure.
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`According to Endoheart, the ’530 patent claims an approach for performing
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`transcatheter heart valve replacement, the “transapical” approach, so named because access is
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`gained through the apex of the heart. Claims 1 and 6 are below (terms at issue are underlined):
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`1.
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`A method for implanting a heart valve comprising:
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`accessing a patient’s heart by piercing a myocardium with a
`cannulated needle having a sharp end;
`
`feeding through the cannulated needle an elongated wire
`configured to conform to a direction of blood flow, the
`feeding continuing such that the wire follows the blood
`flow until a length of the wire extends at least from a
`ventricular apex of the heart through an aortic valve of the
`heart;
`
`installing an access device in a wall of the heart, the access
`device having means for preventing bleeding through the
`access device;
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`inserting a valve delivery device through the access device;
`and
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`installing the heart valve.
`
`
`1 “Ex. __” refers to exhibits to the declaration of Christopher Terranova, filed herewith.
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`ENDOHEART AG, EX. 2004 Page 5
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`6.
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`A method of operating on a patient comprising:
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`accessing the patient’s heart by piercing a myocardium at a
`ventricular apex of the heart with a cannulated needle
`having a sharp end;
`
`feeding through the cannulated needle an elongated wire
`having a length along which the wire is configured to
`conform to a direction of blood flow, the feeding directed
`by the blood flow such that the wire follows the blood flow,
`the feeding continuing until the length extends at least from
`the ventricular apex to an aorta;
`
`installing an access device in a wall of the heart, the access
`device having means for preventing bleeding through the
`access device; and
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`performing a surgical procedure of implanting a heart
`valve.
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`III. ARGUMENT
`
`A.
`
`The Law of Claim Construction
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`The principles of claim construction are well known to this Court. In interpreting
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`claims, the Court should “look first to the intrinsic evidence of record, i.e., the patent itself,
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`including the claims, the specification and, if in evidence, the prosecution history.” Vitronics
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`Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Claim terms are generally
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`“given their ordinary and customary meaning” as viewed by persons of ordinary skill in the field
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`at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005)
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`(en banc); Vitronics, 90 F.3d at 1582. “In some cases, the ordinary meaning of claim language
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`as understood by a person of skill in the art may be readily apparent even to lay judges, and
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`claim construction in such cases involves little more than the application of the widely accepted
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`meaning of commonly understood words.” Phillips, 415 F.3d at 1314.
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`B.
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`Construction of the Claims of the ’530 Patent
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`1.
`
`“elongated wire configured” (claim 1) / “elongated wire
`having a length along which the wire is configured”
`(claim 6)
`
`“elongated wire configured” (claim 1)
`Endoheart’s Proposed Construction
`Edwards’ Proposed Construction
`A long and thin guidewire having a property or
`A guidewire having its entire length configured
`structure for achieving something
`
`
`
`“elongated wire having a length along which the wire is configured” (claim 6)
`Endoheart’s Proposed Construction
`Edwards’ Proposed Construction
`A long and thin guidewire having a length
`A guidewire having a portion of its length
`along which the guidewire has a property or
`configured
`structure for achieving something
`
`
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`The parties’ first set of disputes concerns the related terms “elongated wire
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`configured” and “elongated wire having a length along which the wire is configured,” which
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`appear, respectively, in claims 1 and 6. The parties agree that the wire in question is a guidewire,
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`but disagree as to the way in which the guidewire of claim 1 differs from the guidewire of
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`claim 6. And, as addressed below, infra Section III.B.2, the parties further dispute what it means
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`that the wire or a length thereof is “configured,” as well as the proper construction of the manner
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`of that configuration, “configured to conform to a direction of blood flow.”
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`Concerning the first of these questions, because “different claim terms are
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`presumed to have different meanings,” the guidewire of claim 1 is presumed to be different from
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`the guidewire of claim 6. Tarkus Imaging, Inc. v. Adobe Sys., Inc., No. CA 10-63-LPS, 2012
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`WL 1669598, at *5 (D. Del. May 11, 2012); see also Sarif Biomedical LLC v. Brainlab, Inc., No.
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`CV 13-846-LPS, 2015 WL 5072085, at *2 (D. Del. Aug. 26, 2015). The plain language of
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`claim 6 indicates that for that guidewire, it is “a length” that is configured; the term “a length” is
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`undefined and is used in its ordinary sense, namely, a portion of the total length of the guidewire.
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`The entire guidewire of claim 1, however, is “configured,” that is, configured not merely along a
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`length. To indicate the difference between the two wires, Edwards proposes that the guidewire
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`of claim 1 is a “guidewire having its entire length configured,” while the guidewire of claim 6 is
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`a “guidewire having a portion of its length configured.” Edwards’ proposed constructions are
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`thus consistent with the claim language and provide meaning to each separate phrase.
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`2.
`
`“configured to conform to a direction of blood flow”
`(claims 1 & 6)
`
`“configured to conform to a direction of blood flow” (claims 1 & 6)
`Endoheart’s Proposed Construction
`Edwards’ Proposed Construction
`Having a property or structure for adapting to
`Indefinite.
`the direction of blood flow
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`Alternatively, to the extent the Court
`determines the term requires construction:
`
`Adapted to be carried along with the antegrade
`flow of blood
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`
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`The parties’ next dispute overlaps with the first: what does it mean that the
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`guidewires of claims 1 and 6—either an “elongated wire configured” or an “elongated wire
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`having a length along which the wire is configured”—are “configured to conform to a direction
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`of blood flow”? That dispute can be further broken down into two issues: what does the word
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`“configured” mean, and what does it mean “to conform to a direction of blood flow”?
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`a)
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`“configured”
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`Edwards proposes that “configured” be afforded its plain and ordinary meaning,
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`namely, “adapted.” “Configured” is given no special meaning in the specification, and in the
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`bare handful of places in which it appears, it is used in this standard sense. For example, the
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`specification describes placing an “annular wire placement device” to assist in the procedures;
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`according to the specification, the “annular wire placement device is configured to track an
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`already placed guidewire.” (Ex. 1 at 5:6–11 (emphasis added).) Similarly, a “dissection repair
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`device . . . may include annularly enlargeable componentry configured to be inserted into the
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 9 of 19 PageID #: 871
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`
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`patient’s aorta.” (id. at 5:31–35 (emphasis added).) Each of these uses is most consistent with
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`“adapted,” which is the common understanding of the term, e.g., an airplane that is configured to
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`hold three seats per row instead of two, or a modular set of shelves that has been configured for
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`use in storing tall binders. And while no extrinsic evidence is necessary to support the
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`construction of “configured” to mean “adapted,” that evidence is consistent. (See, e.g., Ex. 2 at
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`428 (Configure: “To design or adapt to form a specific configuration or for some specific
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`purpose: The planes are being configured to hold more passengers in each row.” (emphasis in
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`original).)
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`b)
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`“to conform to a direction of blood flow”
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`Turning to the configuration in question—that the guidewire be configured “to
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`conform to a direction of blood flow”—Edwards submits that this claim limitation is indefinite,
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`as it fails to afford clear notice of what is claimed, resulting in a “zone of uncertainty” as to
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`whether the use of any particular guidewire will result in infringement. Nautilus, Inc. v. Biosig
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`Instruments, Inc., 134 S. Ct. 2120, 2129–30 (2014). Recognizing, however, that indefiniteness
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`determinations are sometimes deferred to a later stage of the case, although Edwards does not
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`believe that is necessary here, Edwards has briefed its alternative construction: that the guidewire
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`be “adapted to be carried along with the antegrade flow of blood.”
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`(1)
`
`Indefiniteness
`
`To satisfy the definiteness requirement, the “claims, when read in light of the
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`specification and the prosecution history, must provide objective boundaries for those of skill in
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`the art.” Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed. Cir. 2014). Because
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`one of ordinary skill in the art cannot reasonably determine which guidewires are “configured to
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`conform to a direction of blood flow,” this claim term is indefinite. See Nautilus, 134 S. Ct. at
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`2129–30.
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`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 10 of 19 PageID #: 872
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`
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`Neither the claims themselves nor the specification provides the necessary
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`guidance. Indeed, the specification fails even to identify the type of guidewires referred to in the
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`detailed description of the preferred embodiments, other than to say that one guidewire “may be
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`a relatively thin and flexible guidewire,” and that it may be a replaced with “a stiffer guidewire.”
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`(Ex. 1 at 9:10–14.) But guidewires come in many variations. As a contemporaneous (2003)
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`textbook on guidewires explains—in a section entitled “What Makes Guidewires Different from
`
`Each Other?”—“[b]asic construction affects handling characteristics and makes each guidewire
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`unique. Guidewires differ with respect to length, diameter, stiffness, coating, tip shape, and
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`special features.” (Ex. 3 at 34.) Some guidewires have flexible tips, or even shapeable tips that
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`can be adjusted. (Id. at 38.) Others have a floppy segment. (Id.) Yet others have a hydrophilic
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`coating to reduce friction. (Id.) General stiffness varies significantly, as reflected in the below
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`chart:
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`(Ex. 4 at 35.) The person of ordinary skill in the art would not know which of these guidewires,
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`if any, conforms to a direction of blood—not from the literature, and not from the specification
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`
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`of the ’530 patent.
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`Adding to the confusion, to the extent that the person of ordinary skill might
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`guess that the guidewire in question is on the less stiff side based on the brief mention in the
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`specification of the possibility of exchanging for a stiffer wire, that does not permit one to
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`identify with reasonable certainty which wires fall within the claim scope. As is discussed in
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`greater detail below in connection with Edwards’ proposed alternative construction, during the
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`prosecution, the Examiner rejected pending claims on the basis that the art disclosed using a
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`guidewire, and a “guide wire is known to be floppy and would be capable of conforming to
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`blood flow.” (Ex. 5 at EHT 631–32.) The applicant distinguished this art on the basis that his
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`guidewire was not the same. (Ex. 6 at EHT 655–656.) That is, it is a guidewire other than one
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`that is “floppy,” indicating that not simply any floppy guidewire is included within the
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`claim scope.
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`On this record, the person of ordinary skill, about to begin a transapical heart
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`valve replacement, would not know if the guidewire selected was one that would lead to
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`infringement. As a result, the claim term is indefinite.
`
`(2)
`
`Edwards’ Alternative Proposed Construction
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`Should this Court determine that the claim limitation is amenable to construction,
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`it should be construed in the manner that Edwards proposes, “adapted to be carried along with
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`the antegrade flow of blood,”2 both based on the plain meaning of the claim language and its
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`surrounding context, and because the prosecution history make clear that the guidewires of
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`claims 1 and 6 are different from an ordinary guidewire.
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`First, with respect to the claim language, “the context in which a term is used in
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`the asserted claim can be highly instructive.” Phillips, 415 F.3d at 1314. Here, that context
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`reveals an extensive focus on the need for a wire that can be carried along with the antegrade
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`2 The patent explicitly defines the term “antegrade” to “mean in the direction of blood flow”
`(Ex. 1 at 3:28–30), and Edwards therefore does not expect that Endoheart will disagree with
`the use of “antegrade flow of blood” as a part of the construction of this term. “Retrograde”
`is similarly defined as “opposite the direction of blood flow.” (Id.)
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 12 of 19 PageID #: 874
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`flow of blood, as the wire is not only configured in that fashion, but is also used in that fashion.
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`Claim 6, for example, requires that the feeding of the wire be “directed by the blood flow such
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`that the wire follows the blood flow.”3 Endoheart agrees that the guidewire in question is a
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`guidewire “configured to move with the blood flow.” (D.I. 1 at ¶ 12.B (emphasis added).)
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`Edwards’ proposed construction is consistent with this focus, and with the plain meaning of the
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`claim language.
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`Second, the prosecution history also makes clear that there is something unique
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`about the guidewire itself, and not simply that it is used in an antegrade direction. In a Request
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`for Continued Examination filed on June 3, 2011, and facing a rejection of then-claims 1 and 7
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`under § 103(a) based on Seguin et al. (Ex. 7, U.S. Pat. Pub. No. 2004/0093060 (“Seguin ’060”))
`
`in view of Lattouf (Ex. 8, U.S. Pat. Pub. No. 2003/0130571 (“Lattouf”)), the applicant amended
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`those claims to include, among other things, an “elongated wire having a length along which the
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`wire is configured to conform to a direction of blood flow” in claim 1 and an “elongated wire
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`configured to conform to a direction of blood flow” in claim 7. (Ex. 9 at EHT 620–621.)4 The
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`applicant failed, however, to persuade the examiner that the amended claims were patentable.
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`As the Examiner explained:
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`Applicant’s arguments filed 6/3/2011 have been fully
`considered but they are not persuasive.
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`“Applicant respectfully submits that neither Seguin ’060,
`nor Lattouf nor a combination of Seguin ’060 and Lattouf show or
`suggest feeding from a ventricular apex of the heart to an aorta, an
`elongate wire that is configured to conform to a direction of blood
`flow.” Examiner disagrees. Sequin ’060 discloses of extending the
`guide wire proximal and distal of the valve in order to deploy
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`3 The parties also dispute the proper meaning of this claim term, discussed below infra Section
`III.B.5.
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`4 Claim 1, as amended, issued as claim 6, while claim 7, as amended, issued as claim 1.
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 13 of 19 PageID #: 875
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`
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`blades 30 (Paragraph 74) on both sides of the valve or a distal filter
`(Paragraph 27). Lattouf also teaches of advancing a guide wire past
`the valve to accommodate tools to treat the valve. The aortic valve
`separates the left ventricle and the aorta, so that it would have been
`obvious to pass the guide wire into the aorta in order to
`accommodate tools to treat the valve. A guide wire is known to be
`floppy and would be capable of conforming to blood flow.
`
`(Ex. 5 at EHT 631–32 (emphasis added).)5
`
`In response, the applicant argued that his guidewire was different than the
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`guidewire used in Lattouf. Specifically, the applicant claimed that Lattouf did not teach a
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`guidewire configured to conform to a direction of blood flow (or a guidewire having a length
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`along which the wire is configured to conform to a direction of blood flow), arguing that, “[t]o
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`the contrary, Lattouf teaches guidewires that are configured for advancement against the
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`direction of blood flow.” (Ex. 6 at EHT 655–656 (emphasis added).) As discussed below, infra
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`Section III.B.5, the applicant also added additional limitations, at the suggestion of the examiner,
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`including the requirement in now-claim 6 that “the feeding [of the guidewire] is directed by the
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`blood flow.” (Id. at 656.) The claims then issued.
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`On this record, it is clear that whatever the configuration of the guidewire of
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`claims 1 and 6 may be—and, as explained above, Edwards believes that the configuration is in
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`fact indefinite—it is not simply a floppy wire that is being used in an antegrade direction.
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`Rather, it is a wire that has been configured differently than a wire that is used in a retrograde
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`direction, i.e., against the direction of blood flow. The wire of Lattouf that the applicant
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`distinguished was not configured in any special way; it is described in Lattouf simply as a “guide
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`wire.” (Ex. 8 at ¶¶ 10, 57.) And, as the Examiner noted previously, guidewires, including the
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`guidewire of Lattouf, are “known to be floppy.” (Ex. 5 at EHT 631–32.) Indeed, the
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`5 The Examiner repeated his observation that a “guide wire is known to be floppy and would
`be capable of conforming to blood flow” several additional times. (See Ex. 5 at 632–633.)
`
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`ENDOHEART AG, EX. 2004 Page 13
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 14 of 19 PageID #: 876
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`specification
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`itself refers to certain retrograde procedures—mitral and tricuspid valve
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`replacement—and makes no mention of any special guidewire configuration needed. (Ex. 1 at
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`3:59–67.) Rather, it is an allegedly inventive feature of the asserted claims, not explained in the
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`patent’s specification, that the guidewires used are “configured to conform to a direction of
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`blood flow.”
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`Having distinguished the guidewire of Lattouf—a wire “known to be floppy”—
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`Endoheart cannot now dispute that “configured to conform to a direction of blood flow” should
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`be construed to require more than any floppy guidewire, as “it is improper to construe claims as
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`covering prior art distinguished in prosecution.” Warner Chilcott Co. v. Teva Pharm. USA, Inc.,
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`No. 08-CV-627-LPS, 2011 WL 7121450, at *5 (D. Del. Dec. 29, 2011); see also, e.g.,
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`Intellectual Ventures I LLC v. AT&T Mobility LLC, No. CV 12-193-LPS, 2015 WL 1393386, at
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`*30 (D. Del. Mar. 24, 2015); Dragon Intellectual Prop., LLC v. Apple, Inc., No. CV 13-2058-
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`RGA, 2015 WL 5298938, at *4 (D. Del. Sept. 9, 2015).
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`3.
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`“installing” (claims 1 & 6)
`
`“installing” (claims 1 & 6)
`Endoheart’s Proposed Construction
`Edwards’ Proposed Construction
`Putting into place
`Anchoring in place
`
`
`The parties’ next dispute concerns the term “installing,” which appears in both
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`claim 1 and claim 6 in the claim limitation “installing an access device in a wall of the heart” and
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`in claim 1 in the claim limitation “installing the heart valve.” Edwards proposes that “installing”
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`be construed to have its plain meaning, namely, “anchoring in place.” That plain and ordinary
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`meaning is confirmed by the usage of the term in the claims and specification, as “installing” or
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`“installed” are used to connote that something has been implanted—anchored in place—and not
`
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`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 15 of 19 PageID #: 877
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`merely transiently placed, as Endoheart proposes. For example:
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` “Surgical methods in accordance with the present invention may also include
`resecting a diseased heart valve percutaneously, while installing the new heart
`valve transapically.” (Ex. 1 at 4:13–15.)
`
` “The implantation device may include a mechanism to pull the leaflets of a
`native valve downward while the new valve is installed within the native
`valve.” (Id. at 4:22–25.)
`
` “Using a delivery device like that described above (except making a retrograde
`approach in this case), the new valve is implanted directly over the diseased
`valve. Because the valve is being installed in a retrograde approach, the native
`leaflets will be pushed downward before being compressed against the aorta
`wall.” (Id. at 19:10–15.)
`
` “A method for implanting a heart valve comprising: . . . installing the heart
`valve.” (Id., claim 1.)
`
`The replacement heart valves discussed in these passages are unquestionably
`
`implanted, and not merely transiently placed—that is the very point of the procedure in question,
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`and claim 1 in fact refers to this process as a “method of implanting a heart valve.” Because
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`“claim terms are normally used consistently throughout the patent,” Phillips, 415 F.3d at 1314,
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`the term “installing” should therefore have the same meaning with respect to both heart valves
`
`and the access device, namely, anchoring in place. Indeed, the specification confirms that the
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`access device must be “anchored” and describes one way of anchoring (using distal and proximal
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`balloons) and states that the “[a]ccess device may be anchored in other suitable ways.” (Ex. 1 at
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`10:1–5.) In sum, there is no basis in the claims or specification to give the single term
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`“installing,” which is used and repeated in claim 1—with respect to both heart valves and the
`
`access device—two separate meanings.
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`ENDOHEART AG, EX. 2004 Page 15
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`Case 1:14-cv-01473-LPS Document 63 Filed 10/23/15 Page 16 of 19 PageID #: 878
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`4.
`
`“access device having means for preventing bleeding
`through the access device” (claims 1 & 6)
`
`“access device having means for preventing bleeding through the access device”
`(claims 1 & 6)
`Endoheart’s Proposed Construction
`Edwards’ Proposed Construction
`Catheter that includes a valve that is
`A device that provides an access port having
`mechanically operable as an iris diaphragm or
`means for preventing bleeding through the
`constructed of an elastic material with a small
`device
`central opening that is dilated by equipment
`
`inserted therethrough and always maintains a
`the “means for preventing bleeding” (1) may
`fluid-tight seal with the inserted equipment
`be mechanically operable as an iris diaphragm
`(like the aperture of a lens), (2) may be
`constructed of an elastic material with a small
`central opening that is dilated by whatever
`equipment is inserted therethrough, but always
`maintains a fluid-tight seal with the inserted
`equipment, (3) may compose any fluid-tight
`valve structure, or (4) may be equivalent to any
`of those disclosed structures
`
`
`The parties agree that the term “access device having means for preventing
`
`bleeding through the access device” is a means-plus-function element. As such, the term’s
`
`construction is limited to the structure disclosed in the pat