UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP., EDWARDS LIFESCIENCES LLC, AND
`EDWARDS LIFESCIENCES AG,
`
`Petitioners,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-01293
`Patent 8,992,608
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP., EDWARDS LIFESCIENCES LLC, AND
`EDWARDS LIFESCIENCES AG,
`
`Petitioners,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-01293
`Patent 8,992,608
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`INTRODUCTION ...........................................................................................1
`
`BACKGROUND .............................................................................................4
`
`A.
`
`B.
`
`C.
`
`TAVR ....................................................................................................4
`
`The ‘608 Patent .....................................................................................6
`
`IPR2017-00060 ...................................................................................10
`
`III. CLAIM CONSTRUCTION ..........................................................................11
`
`A.
`
`B.
`
`The Intrinsic Evidence Establishes That “Flaps” And
`“Pockets” Are Distinct From “Sacs”...................................................11
`
`Petitioner Improperly Relies On Extrinsic Evidence Of
`Patent Owner’s Statements In The U.K. Trial ....................................15
`
`1.
`
`2.
`
`Petitioner Mischaracterizes Patent Owner’s
`Statements In The U.K. Trial....................................................16
`
`Petitioner’s Reliance On Foreign Argument Is
`Improper....................................................................................17
`
`IV.
`
`V.
`
`THE OPINIONS OF PETITIONER’S EXPERT ARE ENTITLED
`TO LITTLE OR NO WEIGHT .....................................................................19
`
`PETITIONER HAS NOT MET ITS BURDEN OF SHOWING
`THAT CLAIMS 1-9 ARE LIKELY INVALID............................................23
`
`A.
`
`B.
`
`Petitioner Has Not Met Its Burden Of Showing That
`Claims 1-4 Are Likely Anticipated Under 35 U.S.C. §
`102(b) ..................................................................................................23
`
`Petitioner Has Not Met Its Burden Of Showing That
`Claims 1-4 Are Likely Obvious Under 35 U.S.C. § 103 ....................30
`
`1.
`
`Petitioner’s Argument Is Based On Prior Art Directed
`To An Improper Claim Construction........................................30
`
`-i-
`
`
`
`2.
`
`3.
`
`4.
`
`Petitioner’s Proposed Combinations Do Not Disclose
`Every Element Of Claims 1-4...................................................33
`
`There Was No Motivation To Combine Seguin With
`Lazarus Or Lawrence-Brown....................................................38
`
`The Board Should Reject The Petition Under 35
`U.S.C. § 325(d) .........................................................................41
`
`VI. CONCLUSION ............................................................................................43
`
`-ii-
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`AIA Eng’g Ltd. v. Magotteaux Int'l S/A,
`657 F.3d 1264 (Fed. Cir. 2011) .....................................................................18
`
`Alcon Research Ltd. v. Barr Labs., Inc.,
`745 F.3d 1180 (Fed. Cir. 2014) .....................................................................24
`
`In re Alton,
`76 F.3d 1168 (Fed. Cir. 1996) .......................................................................25
`
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) ...............................................................24, 25
`
`Bio-Rad Labs., Inc. v. GE Healthcare Bio-sciences AB,
`IPR2015-01826, Paper 39 at 9 (Feb. 6, 2017)...............................................21
`
`BLD Services, LLC, v. LMK Techs.,
`IPR2014-00772 (Nov. 18, 2015)...................................................................15
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) .....................................................................40
`
`Captioncall, LLC v. Ultratec, Inc.,
`IPR2015-00636 (Sept. 7, 2016).....................................................................21
`
`CFMT, Inc. v. YieldUp Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) .....................................................................34
`
`Costco Wholesale Corp. v. Robert Bosch,
`IPR2016-00035 (PTAB Apr. 25, 2016) ........................................................39
`
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015) ...............................................................11, 12
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .....................................................................37
`
`-iii-
`
`
`
`In re Dulberg,
`472 F.2d 1394 (C.C.P.A. 1973).....................................................................18
`
`EnOcean GmbH v. Face Int’l Corp.,
`742 F.3d 955 (Fed. Cir. 2014) .......................................................................28
`
`In re Gardner,
`480 F.2d 879 (CCPA 1973)...........................................................................26
`
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001 (PTAB Jan. 9, 2013) ...........................................................34
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966)...........................................................................................33
`
`Heidelberger Druckmaschinen AG v. Hantscho Commercial Prods., Inc.,
`21 F.3d 1068 (Fed. Cir. 1994) .......................................................................17
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) .......................................................................39
`
`Keurig Green Mountain, Inc. v. Touch Coffee & Beverages, LLC,
`IPR2016-01394 (Jan. 4, 2017).......................................................................37
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .....................................................................40
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007).................................................................................33, 39
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) .....................................................................39
`
`Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co.,
`730 F.2d 1452 (Fed. Cir. 1984) .....................................................................18
`
`Micro Motion, Inc. v. Invensys Systems, Inc.,
`IPR2014-01409 (PTAB Feb. 18, 2015).........................................................40
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .....................................................................40
`
`-iv-
`
`
`
`In re: NuVasive Inc.,
`No. 2015-1841, slip op. (Fed. Cir. May 31, 2017)........................................14
`
`Owens Corning v. Fast Felt Corp.,
`PR2015-00650, Paper 32 at 24 (Aug. 11, 2016.............................................21
`
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`IPR2016-00165, Paper 7 at 17-18 (PTAB Apr. 21, 2016)............................40
`
`PPC Broadband, Inc. v. Corning Optical Comm’ns RF,
`LLC, 815 F.3d 747 (Fed. Cir. 2016)..............................................................14
`
`Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
`457 F.3d 1284 (Fed. Cir. 2006) .....................................................................18
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 ................................................................................................16
`
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. Appx. 755 (Fed. Cir. 2015) ................................................................37
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) ...................................................................33, 34
`
`Seabery North America, Inc. v. Lincoln Global, Inc.,
`IPR2016-00749, Paper 13 at 11-12 (PTAB Sept. 21, 2016).........................39
`
`Shaw Indus. Grp., Inc. v. Automated Creel Sys. Inc.,
`IPR2013-00132, Paper 42 at 27-28 (Jul. 24, 2014).......................................37
`
`St. Jude Med., Inc. v. Access Closure, Inc.,
`729 F.3d 1369 (Fed. Cir. 2013) .....................................................................33
`
`In re Suitco Surface, Inc.,
`603 F.3d 1255 (Fed. Cir. 2010) .....................................................................11
`
`Summit 6, LLC v. Samsung Telecommunications America, LLC,
`802 F.3d 1283 (Fed. Cir. 2015) .....................................................................15
`
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) .....................................................................11
`
`-v-
`
`
`
`STATUTES, RULES AND REGULATIONS
`
`35 U.S.C. § 102(b) ...................................................................................................22
`
`35 U.S.C. § 103........................................................................................3, 29, 31, 40
`
`35 U.S.C. § 112........................................................................................................23
`
`35 U.S.C. § 313..........................................................................................................1
`
`35 U.S.C. § 325(d) ..............................................................................................23,42
`
`37 C.F.R. § 42.100(b) ........................................................................................10, 11
`
`37 C.F.R. § 42.65(a).................................................................................................20
`
`OTHER AUTHORITIES
`
`U.S. Patent App. Pub. No. 2003/0236567 A1 ..........................................................9
`
`U.S. Patent App. Pub. No. 2004/0082989 .................................................................9
`
`U.S. Patent No. 6,015,431..........................................................................................9
`
`U.S. Patent No. 7,780,725........................................................................................25
`
`U.S. Patent No. 8,992,608 (“the ‘608 patent”) .................................................passim
`
`-vi-
`
`
`
`Exhibit No.
`2001
`2002
`2003
`
`2004
`
`2005
`
`2006
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`PATENT OWNER’S EXHIBIT LIST
`
`Description
`
`Sapien 3 Brochure
`FDA August 18, 2016 Press Release
`Thourani, et al., “Transcatheter aortic valve replacement versus
`surgical valve replacement in intermediate-risk patients: a
`propensity score analysis”, The Lancet, Apr. 3, 2016
`Lerakis, et al., “Paravalvular Aortic Leak After Transcatheter Aortic
`Valve Replacement”, AHA Journal vol. 127 p. 397-407
`Kodali, et. al., “Paravalvular Regurgitation after Transcatheter
`Aortic Valve Replacement with the Edwards Sapien Valve in the
`Partner Trial”, European Heart J., Oct. 1, 2014
`Transcript of deposition of Nigel P. Buller, M.D., June 15, 2017
`Medtronic Inc. v. Edwards Lifesciences, Case No., SACV 12-
`00327-JVS (MLGx), Dkt. 414, Order on Motions for Summary
`Judgment
`W.L. Gore & Assoc. v. C.R. Bard, 1:11-cv-00515-LPS, Dkt. 428,
`Report and Recommendations on motion for summary judgment.
`Takahide, et. al., “Comparison of Edwards SAPIEN 3 versus
`SAPIEN XT in transfemoral transcatheter aortic valve implantation:
`Difference of valve selection in the real world”, J. Cardiol. (2016)
`U.S. Pat. 7,780,725 (Aug. 24, 2010) Haug, et. al., Everting Heart
`Valve
`U.S. Pub. No. 2003-0109924 (Jun. 12, 2003) Cribier, Implanting a
`Valve Prosthesis in Body Channels
`U.S. Pub. No. 2003-0014104 (Jan. 16, 2003) Cribier, Valve
`Prosthesis for Implantation in Body Channels
`
`-i-
`
`
`
`I.
`
`INTRODUCTION
`
`Patent Owner respectfully submits this preliminary response under 35
`
`U.S.C. § 313 to the request of Edwards Lifesciences Corporation, Edwards
`
`Lifesciences LLC, and Edwards Lifesciences AG’s (collectively, “Petitioner”) for
`
`inter partes review (“IPR”) of claims 1-9 of U.S. Patent No. 8,992,608 (“the ‘608
`
`patent,” Ex. 1101). This preliminary response is timely filed within three months
`
`of the Board’s notice (Paper No. 6), mailed May 5, 2017, indicating that the
`
`petition was accorded a filing date. For the reasons set forth herein and in the
`
`accompanying exhibits, the Petition should be denied.
`
`Claims 1-9 of the ‘608 patent address paravalvular leakage (“PVL”)—a
`
`problem uniquely associated with transcatheter aortic valve replacement
`
`(“TAVR”), a treatment for aortic valve disease (sometimes called transcatheter
`
`aortic valve implantation, or “TAVI”). In TAVR procedures, the diseased native
`
`valve leaflets are not removed but are merely pushed aside by an expandable stent
`
`or anchor; once deployed, a prosthetic replacement valve inside the anchor takes
`
`over the function of the aortic valve. The ‘608 patent, which is entitled to a
`
`priority date no later than June 2004, identified the problem of PVL—leakage of
`
`blood around the outside of the anchor when the valve is closed, through spaces
`
`formed by the diseased, often calcified, native valve leaflets—and disclosed a
`
`solution to that problem. Specifically, the patent claims a fabric seal around the
`
`-1-
`
`
`
`outside of the anchor which, when the device is deployed, comprises flaps
`
`extending into the spaces formed by the native leaflets and pockets that fill with
`
`blood in response to backflow pressure.
`
`The Board should not institute trial because Petitioner’s validity challenges
`
`are contrary to law. Both of Petitioner’s grounds read the claim language out of
`
`context and divorced from the specification, requiring interpretations that are at
`
`odds with the teachings in the specification. First, Petitioners wrongly contend
`
`that the ‘608 patent is not entitled to the priority date of its grandparent application
`
`because the claims supposedly cover devices with only one “commissure support
`
`element” and one valve “commissure portion” while, according to Petitioner, the
`
`grandparent describes only a plurality of “commissure support element[s]” and
`
`valve “commissure portion[s].” Petitioner’s argument fails to recognize that a
`
`commissure support element with a valve attached thereto was well known in the
`
`art in 2004; the specification of the grandparent application properly focuses on
`
`improvements in the art—not aspects already known to those of skill in the art.
`
`Indeed, though not necessary to satisfy the written description requirement, prior
`
`art describing this feature was expressly referenced in the specification of the
`
`grandparent application. Because a person of skill in the art would have known in
`
`2004 how to make a TAVR valve with only one commissure support element and
`
`one commissure portion attached thereto, he or she would have drawn on this
`
`-2-
`
`
`
`knowledge to conclude that Patent Owner possessed the subject matter of the
`
`claims. Because the ‘608 patent is entitled to the priority date of its grandparent,
`
`the grandparent does not anticipate the ‘608 patent under § 102, and Petitioner
`
`cannot show a likelihood of invalidity under its first ground.
`
`Second, the Board should reject Petitioner’s improper attempt to construe the
`
`claims so as to encompass an unclaimed embodiment directed to “sacs in the form
`
`of peripheral inflatable chambers.” Petitioner’s proposed construction ignores the
`
`dispositive intrinsic evidence and relies instead on mischaracterizations of Patent
`
`Owner’s statements in a foreign tribunal. Moreover, Petitioner’s proposed
`
`combinations do not disclose every element of claims 1-4, including “commissure
`
`support elements” attached to the “expandable anchor” and to the “commissure
`
`portions of the replacement valve leaflets.” Finally, a person skilled in the art
`
`would not have been motivated to combine the prior art references on which it
`
`relies. Because claims 1-4 of the ‘608 patent were, therefore, not obvious under
`
`§ 103, Petitioner has failed to show a likelihood that those claims are invalid under
`
`its second ground.
`
`While Patent Owner reserves its right to advance additional arguments in the
`
`event that trial is instituted on any ground, for the reasons noted herein, the Board
`
`-3-
`
`
`
`should find that Petitioner has not met its burden of demonstrating a likelihood that
`
`the challenged claims are unpatentable.1
`
`II.
`
`BACKGROUND
`
`A.
`
`TAVR
`
`The ‘608 patent relates to endovascular replacement of diseased heart
`
`valves, particularly the aortic valve—i.e., TAVR. (Ex. 1101 at 1:15-16, 29-31;
`
`2:19-22; 8:31-38 & FIGS. 5-7.) TAVR is a treatment for aortic valve disease, in
`
`which the leaflets of the valve become too calcified to function normally; if left
`
`untreated, this condition leads to death in approximately 50% of symptomatic
`
`patients within two years of diagnosis. (Ex. 2001 at 4.) Before the advent of
`
`TAVR, the standard treatment for aortic valve disease was surgical valve
`
`1 Patent Owner also notes that in Oil States Energy Services, LLC v. Greene’s
`
`Energy Group, LLC, the Supreme Court is considering the constitutionality of
`
`proceedings such as PGR, in which a non-Article III tribunal may ultimately
`
`revoke a property right duly conferred by the U.S. Patent and Trademark Office.
`
`In the event that the Supreme Court overturns Federal Circuit precedent on this
`
`issue, Patent Owner respectfully reserves its right to argue that such decision is
`
`applicable to this proceeding and that the Board lacks authority to invalidate the
`
`‘608 patent.
`
`-4-
`
`
`
`replacement, which involved opening the patient’s chest, stopping the heart,
`
`placing the patient on a bypass machine, excising the diseased native valve leaflets,
`
`and suturing a valve prosthesis in place of the diseased valve. (Ex. 1107 ¶ 37.)
`
`This surgery is traumatic and entails a relatively long, difficult recovery period;
`
`some patients, due to advanced age or illness, may be ineligible for the procedure.
`
`(Ex. 2002; Ex. 2001 at 15 (“Based on their health, some patients may be
`
`considered high-risk or too sick for surgery”).)
`
`TAVR is a much less invasive procedure in which a replacement valve is
`
`delivered on a catheter through the vasculature via a small puncture in the groin or
`
`chest. (Ex. 2003 at 2.) The replacement valve is initially collapsed into a diameter
`
`small enough to traverse the patient’s vessels to the heart. (Ex. 2001 at 10.) When
`
`the replacement valve is positioned at the aortic valve, it is expanded to a larger,
`
`deployed diameter. (Id.) The diseased native valve leaflets are not removed, as
`
`they would be in surgical replacements, but are instead pushed aside by the
`
`expanded frame of the replacement valve and compressed between the frame and
`
`the wall of the aortic annulus. (Id.) The replacement valve leaflets inside the
`
`frame, which are typically made of animal tissue, take over the normal function of
`
`the valve. (Id.)
`
`After the first TAVR valves became available, clinicians began to recognize
`
`PVL as a major drawback of TAVR. The tendency of blood to leak around the
`
`-5-
`
`
`
`outside of the prosthetic frame during diastole—the phase of the cardiac cycle
`
`when the aortic valve must prevent blood from reentering the heart through the
`
`aorta—presented risks after TAVR procedures. (Ex. 2004 at 397.) Moderate to
`
`severe PVL is associated with unsuccessful TAVR outcomes, including increased
`
`mortality in the months or years after the procedure. (Id; Ex. 2005 at 1, 4-5.)
`
`B.
`
`The ‘608 Patent
`
`The ‘608 patent identified significant PVL as a risk of TAVR procedures.
`
`Specifically, the ‘608 patent recognized “a risk of paravalvular leakage or
`
`regurgitation around apparatus” caused by seepage of blood through gaps created
`
`by the irregular surface of the native valve leaflets:
`
`With reference now to FIG. 13, a risk of paravalvular leakage or
`regurgitation around the apparatus of the present invention is
`described. In FIG. 13, apparatus 10 has been implanted at the site of
`diseased aortic valve AV…. The surface of native valve leaflets L is
`irregular, and interface I between leaflets L and anchor 30 may
`comprise gaps where blood B may seep through. Such leakage poses
`a risk of blood clot formation or insufficient blood flow.
`
`-6-
`
`
`
`(Ex. 1101 at 12:19-27 & FIG. 13.)
`
`The ‘608 patent disclosed a solution for PVL, i.e., a “way to seal the
`
`replacement valve against leakage”:
`
`A fabric seal 380 extends from the distal end of valve 20 and back
`proximally over anchor 30 during delivery. When deployed, as shown
`in FIGS. 33 and 34, fabric seal 380 bunches up to create fabric flaps
`and pockets that extend into spaces formed by the native valve leaflets
`382, particularly when the pockets are filled with blood in response to
`backflow blood pressure. This arrangement creates a seal around the
`replacement valve.
`
`-7-
`
`
`
`(Ex. 1101 at 14:22-29 & FIGS. 33, 34.)
`
`In addition to the fabric seal that bunches up into flaps and pockets that
`
`extend into spaces formed by the native valve leaflets, the specification of the ‘608
`
`patent discloses two alternative seal embodiments: seals comprising sacs and seals
`
`comprising expandable foam. Seals comprising “[c]ompliant sacs,” as shown in
`
`FIGS. 15A-E, “may be disposed about the exterior of the anchor 30 to provide a
`
`more efficient seal along the irregular surface[.]” (Id.) Instead of “bunching up”
`
`as described in the “flaps and pockets” embodiments (see Ex. 1101 at 14:21-29),
`
`the “sacs” create a seal when filled with appropriate material,” such as “water,
`
`blood, foam or a hydrogel.” (See id. at 12:29-42.) Seals comprising “expandable
`
`foam,” as shown in FIGS. 30-31, begin with the foam in compressed form, which
`
`“dissolves in vivo to allow foam to expand” once deployed. (Id. at 14:12-20.)
`
`-8-
`
`
`
`(Id. at FIGS. 15A-C; FIGS. 30-31.)
`
`During prosecution, Patent Owner sought claims directed to all three seal
`
`embodiments. (See Ex. 1102 at 229-30.) However, on October 30, 2013, the
`
`Examiner issued a restriction requirement, noting that:
`
`The claim(s) is/are directed to the following disclosed patentably
`distinct species: Species A: a system for replacing a heart valve
`comprising a seal made from an expandable foam; Species B: a
`system for replacing a heart valve comprising a fabric seal with flaps
`to extend into the spaces of the native valve leaflets; and Species C: a
`system for replacing a heart valve having seals made of sacs disposed
`around the valve anchor. The species are independent or distinct
`because as disclosed the different species have mutually exclusive
`characteristics for each identified species.
`
`(Id. at 331.) The Examiner required Patent Owner to elect one of these species
`
`“for prosecution on the merits to which the claims shall be restricted….” (Id.)
`
`In response to the restriction requirement, Patent Owner elected Species B: a
`
`system for replacing a heart valve comprising a fabric seal with flaps to extend into
`
`the spaces of the native valve leaflets, without traverse, for examination on the
`
`-9-
`
`
`
`merits. (Id. at 337, 352.) The Patent Office subsequently acknowledged Patent
`
`Owner’s election and cancelled the claims directed towards Species A and C. (Id.
`
`at 352.) The ‘608 patent ultimately issued with claims exclusively directed to a
`
`fabric seal with flaps and pockets that extend into spaces formed by the native
`
`valve leaflets. (Id. at 442.)
`
`C.
`
`IPR2017-00060
`
`This is not Petitioner’s first attempt to invalidate claims of the ‘608 patent.
`
`On October 12, 2016, Petitioner filed a 75-page Petition for Inter Partes Review
`
`challenging claims 1-4 of the ‘608 patent on eleven grounds. IPR2017-00060
`
`(“’060 IPR”), Paper 1. On March 29, 2017, the Board instituted trial on three
`
`grounds2—while declining to institute review on the remaining eight grounds—and
`
`entered a scheduling order. (‘060 IPR, Papers 7 and 8.)
`
`On April 18, 2017, after the Board issued its institution decision in the ‘060
`
`IPR, Petitioner filed the instant petition (Paper 2 (the “Petition”)), asserting two
`
`new grounds of unpatentability based on four new references: (1) anticipation of
`
`2
`
`The Board instituted review on three obviousness grounds: WO 03/047468 A1
`
`(“Spenser”) in light of U.S. Patent App. Pub. No. 2003/0236567 A1 (“Elliot”);
`
`Spenser in light of U.S. Patent No. 6,015,431 (“Thornton”); and Spenser in light of
`
`U.S. Patent App. Pub. No. 2004/0082989 (“Cook”).
`
`-10-
`
`
`
`claims 1-9 by Haug (Ex. 1135); and (2) obviousness of claims 1-4 over Seguin
`
`(Exs. 1150, 1153) in view of Lazarus (Ex. 1147) and Lawrence-Brown (Ex. 1149.)
`
`Although Petitioner knew of or should have known of all of these references when
`
`it filed its Petition in the ‘060 IPR, it asserted no grounds of invalidity based on
`
`any of these references when it filed the ‘060 IPR.
`
`III. CLAIM CONSTRUCTION
`Petitioner’s proposed constructions are improper because, inter alia, they
`
`(1) ignore the context of the claim terms provided by the claims, the specification,
`
`and the prosecution history of the ‘608 patent and (2) are based on a
`
`mischaracterization of Patent Owner’s arguments in a foreign proceeding—
`
`extrinsic evidence that is misleading and that, in any event, should not be
`
`considered in claim construction.
`
`A.
`
`The Intrinsic Evidence Establishes That “Flaps” And
`“Pockets” Are Distinct From “Sacs”
`
`The Board should reject Petitioner’s attempt construe “flaps” and “pockets”
`
`so as to encompass “sacs.” For inter partes review, claim terms in an unexpired
`
`patent are given their broadest reasonable interpretation in light of the patent
`
`specification. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d
`
`1268, 1275–78 (Fed. Cir. 2015). Claim terms are given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the art in
`
`the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d
`
`-11-
`
`
`
`1249, 1257 (Fed. Cir. 2007). The construction must be read in light of the
`
`specification as it would be interpreted by one of ordinary skill in the art. See, e.g.,
`
`In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010).
`
`Notably absent from Petitioner’s claim construction argument is any
`
`discussion of what a person of skill in the art would understand the terms “flaps”
`
`and “pockets” to mean—not only in the context of the particular claims in which
`
`they appear, but in the context of the specification, as required by the BRI
`
`standard. 37 C.F.R. § 42.100(b); In re Cuozzo, 793 F.3d at 1275–78 (Fed. Cir.
`
`2015).
`
`First, the claims of the ‘608 patent are directed towards “flaps” and
`
`“pockets”; the claims do not mention “sacs.” Independent claim 1 of the ‘608
`
`patent recites, in pertinent part:
`
`a fabric seal at least partially disposed around an exterior portion of
`the expandable anchor when the anchor is in the expanded
`configuration …, wherein in the deployed state the fabric seal
`comprises flaps that extend into spaces formed by native valve
`leaflets….
`
`(Ex. 1101 col. 22:29-35.) Dependent claim 2 recites: “The system of claim 1,
`
`wherein, in the deployed state, the fabric seal defines a plurality of pockets.” (Id.
`
`col. 22:43-44.) Dependent claim 3 recites: “The system of claim 2, wherein the
`
`pockets are adapted to fill with blood in response to backflow blood pressure.” (Id.
`
`col. 22:45-46.) Dependent claim 4 adds a limitation as to the material from which
`
`-12-
`
`
`
`the expandable anchor is formed. (Id. col. 22:47-48.) Petitioner’s own expert, in
`
`describing the claims of the ‘608 patent, does not mention “sacs”: “As claimed,
`
`this structure is in the form of a fabric seal having ‘flaps’ and ‘pockets,’” which are
`
`shown “in figures 33 and 34[.]” (Ex. 1107 at ¶ 96.)
`
`Second, the specification makes clear that “flaps” and “pockets,” on the one
`
`hand, and “sacs,” on the other, represent distinct embodiments. A seal comprising
`
`“sacs” is described in a different portion of the specification than the seal
`
`comprising “flaps” and “pockets”; each of these passages references different
`
`figures. (Compare id. at 12:28-50 (referencing FIGS. 14-16) with id. at 14:21-29
`
`(referencing FIGS. 32-34).) Indeed, the specification expressly describes seals
`
`comprising “flaps” and “pockets” as an alternative embodiment to seals
`
`comprising “sacs”: “FIGS. 32-34 show another way to seal the replacement valve
`
`against leakage.” (Id. at 14:21-22 (emphasis added).) Moreover, as discussed in
`
`§ II.B supra, the specification clearly explains that “sacs” are formed from a
`
`mechanism distinct from that which forms “flaps” and “pockets”—“flaps” and
`
`“pockets” result from a fabric seal bunching up when the stent is foreshortened,
`
`whereas “sacs” expand when filled with material. (Compare Ex. 1101 at 12:29-42
`
`with id. at 14:22-29.) As even Petitioner observes, the ‘608 patent specification
`
`describes a “series of distinct THV [transcatheter heart valve] embodiments
`
`throughout the specification, including several mutually exclusive sealing
`
`-13-
`
`
`
`mechanisms”—including (1) “seals in the form of inflatable peripheral chambers
`
`referred to as ‘sacs,’” (2) a seal comprising “an expandable foam,” and (3) “a
`
`fabric seal that bunches up to form circumferential ‘flaps and pockets.’” (Petition
`
`at 30.)
`
`A patent specification may disclose more than any particular claim recites.
`
`PPC Broadband, Inc. v. Corning Optical Comm’ns RF, LLC, 815 F.3d 747, 755
`
`(Fed. Cir. 2016) (an applicant is not required to claim all that it discloses in an
`
`application); In re: NuVasive Inc., No. 2015-1841, slip op. at 12 (Fed. Cir. May 31,
`
`2017) (non-prec.) (a patent may describe “many matters that are manifestly not
`
`covered by the claims” where an applicant “has chosen not to claim all that the
`
`patent discloses”). Here, the specification clearly shows that the “sacs”
`
`embodiment is distinct from the “flaps” and “pockets” embodiment claimed by
`
`Patent Owner.
`
`Third, the prosecution history of the ‘608 patent further evidences that the
`
`“sacs” embodiment is distinct from the claimed “flaps” and “pockets”
`
`embodiment. As noted above, in response to the Examiner’s October 30, 2013
`
`restriction requirement, the Patent Owner unambiguously elected, without traverse,
`
`to proceed on claims directed towards “flaps” and “pockets”; the claims directed to
`
`the “sacs” embodiment were subsequently cancelled. (See supra § II.B; Ex. 1102
`
`-14-
`
`
`
`at 331-333, 337, 352.) Thus, the Patent Owner and the Examiner agreed that
`
`“sacs” were distinct from “flaps” and “pockets.”
`
`In sum, Petitioner’s construction is contrary to the plain language of the
`
`claims, the disclosures in the specification, and the prosecution history. (See
`
`Ex. 1102 at 331.)
`
`B.
`
`Petitioner Improperly Relies On Extrinsic Evidence Of
`Patent Owner’s Statements In The U.K. Trial
`
`While ignoring the intrinsic evidence, Petitioner relies on statements made
`
`during a proceeding in the United Kingdom in January 2017 (the “U.K. trial”)
`
`relating to two foreign patents—EP 2 749 254 (“EP 254,” Ex. 1122) and EP 2 926
`
`766 (“EP 766,” Ex. 1130). Although courts are permitted to consider extrinsic
`
`evidence in construing patent, such evidence is “generally of less significance than
`
`intrinsic record, and may not be used to contradict claim meaning that is
`
`unambiguous in light of intrinsic evidence.” Summit 6, LLC v. Samsung
`
`Telecomms. Am., LLC, 802 F.3d 1283, 1290 (Fed. Cir. 2015). Indeed, the Board
`
`has declined to give weight to extrinsic evidence in such circumstances and, in
`
`light of the overwhelming intrinsic evidence cited above, should similarly decline
`
`to do so here. See BLD Servs., LLC, v. LMK Techs., IPR2014-00772, Paper 39 at
`
`-15-
`
`
`
`21 n. 11 (Nov. 18, 2015).3 In addition, Petitioner’s construction of “flaps” and
`
`“pockets” should be rejected because (1) it is based on a mischaracterization of
`
`Patent Owner’s statements during the U.K. trial and (2) statements in foreign
`
`proceedings should not be used to construe claims.
`
`1.
`
`Petitioner Mischaracterizes Patent Owner’s
`Statements In The U.K. Trial
`
`Petitioner wrongly contends that (1) during the U.K. trial, Patent Owner took
`
`the position that “bunched-up fabric that forms flaps and pockets can read on a sac
`
`(and vice-versa),” and (2) the Board should construe “flaps” and “pockets” in light
`
`of this “new argument.” (Petition at 33-34, 37.) Petitioner’s argument rests on a
`
`gross mischaracterization of Patent Owner’s statements.
`
`In the U.K. trial, Patent Owner had asserted two patents, one claiming “flaps
`
`and pockets,” like the ‘608 patent, and another claiming “sacs”—a separate
`
`embodiment disclosed in the specification of the ‘608 patent, but not the basis of
`
`any claims at issue in either this or the ‘060 IPR. Although Patent Owner argued
`
`3
`
`Extrinsic evidence is similarly given minimal weight under the Phillips
`
`standard. Phillips v. AWH Corp., 415 F.3d 1303, 1318-19; 1324 (Fed. Cir. 2005)
`
`(“while extrinsic evidence can shed useful light on the relevant a
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