UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG
`Petitioners
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
`_____________
`
`Case IPR2017-00060
`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.
`
`STATEMENT OF PRECISE RELIEF REQUESTED ...................................1
`
`INTRODUCTION ...........................................................................................1
`
`III. BACKGROUND .............................................................................................3
`
`A.
`
`B.
`
`TAVR ....................................................................................................3
`
`The ‘608 Patent .....................................................................................5
`
`IV. CLAIM CONSTRUCTION ............................................................................7
`
`V.
`
`VI.
`
`THE OPINIONS OF PETITIONERS’ EXPERT ARE ENTITLED
`TO LITTLE OR NO WEIGHT .......................................................................7
`
`PETITIONERS HAVE NOT MET THEIR BURDEN OF
`SHOWING THAT CLAIMS 1-4 ARE LIKELY INVALID........................10
`
`A.
`
`Petitioners Have Not Met Their Burden Of Showing That
`Claims 1-4 Are Likely Anticipated Under 35 U.S.C.
`§ 102(b) ...............................................................................................10
`
`1.
`
`Ground 1: Invalidity Under 35 U.S.C. § 102(b) Over
`Cribier .......................................................................................12
`
`a)
`
`b)
`
`Cribier Does Not Disclose A “Replacement
`Valve Commissure Support Element Attached
`to the Expandable Anchor” or “A Commissure
`Portion of a Replacement Valve Leaflet
`Attached to the Commissure Support Element”
`(Claim 1 – “Claim Element 1.2” and “Claim
`Element 1.3”)..................................................................12
`
`Cribier Does Not Disclose “Flaps That Extend
`Into Spaces Formed By Native Valve Leaflets”
`When The Fabric Seal Is In The Deployed State
`(Claim 1 – “Claim Element 1.6”)...................................16
`
`-i-
`
`

`

`c)
`
`d)
`
`Cribier Does Not Disclose A “Fabric Seal
`Being Adapted To Prevent Blood From
`Flowing Between The Fabric Seal And Heart
`Tissue” (Claim 1 – “Claim Element 1.9”)......................19
`
`Cribier Does Not Disclose “Pockets” Or
`Pockets “Adapted To Fill With Blood In
`Response To Backflow Blood Pressure”
`(Claims 2 and 3)..............................................................22
`
`2.
`
`Ground 11: Invalidity Under 35 U.S.C. § 102(b) Over
`Spenser......................................................................................22
`
`a)
`
`b)
`
`c)
`
`Spenser Does Not Disclose “Flaps That Extend
`Into Spaces Formed By Native Valve Leaflets”
`When The Fabric Seal Is In The Deployed State
`(Claim 1 – “Claim Element 1.6”)...................................23
`
`Spenser Does Not Disclose A “Fabric Seal
`Being Adapted To Prevent Blood From
`Flowing Between The Fabric Seal And Heart
`Tissue” (Claim 1 – “Claim Element 1.9”)......................26
`
`Spenser Does Not Disclose “Pockets” Or
`Pockets “Adapted To Fill With Blood In
`Response To Backflow Blood Pressure”
`(Claims 2 and 3)..............................................................28
`
`B.
`
`Petitioners Have Not Met Their Burden Of Showing That
`Claims 1-4 Are Likely Obvious Under 35 U.S.C. § 103(a)................28
`
`1.
`
`Governing Legal Authority.......................................................29
`
`a)
`
`b)
`
`The Obviousness Standard .............................................29
`
`Recognition Of A Previously-Unknown
`Problem Can Itself Be Evidence Of
`Nonobviousness..............................................................31
`
`2.
`
`Ground 2: Claims 1-4 Are Not Invalid Under 35
`U.S.C. § 103(a) Over Cribier In View Of
`Spiridigliozzi.............................................................................33
`
`-ii-
`
`

`

`a)
`
`b)
`
`There Was No Motivation To Combine Cribier
`And Spiridigliozzi...........................................................33
`
`The Combination Of Cribier And Spiridigliozzi
`Does Not Disclose All Of The Elements Of
`Claims 1-4.......................................................................36
`
`3.
`
`Ground 3: Invalidity Under 35 U.S.C. § 103(a) Over
`Cribier In View Of Elliot ..........................................................40
`
`a)
`
`b)
`
`There Was No Motivation To Combine Cribier
`And Elliot........................................................................40
`
`The Combination Of Cribier And Elliot Does
`Not Disclose All Of The Elements Of Claims 1-
`4 ......................................................................................42
`
`4.
`
`Ground 4: Invalidity Under 35 U.S.C. § 103(a) Over
`Cribier In View Of Thornton ....................................................44
`
`a)
`
`b)
`
`There Was No Motivation To Combine Cribier
`And Thornton..................................................................44
`
`The Combination Of Cribier And Thornton
`Does Not Disclose All Of The Elements Of
`Claims 1-4.......................................................................45
`
`5.
`
`Ground 5: Invalidity Under 35 U.S.C. § 103(a) Over
`Cribier In View Of Cook ..........................................................47
`
`a)
`
`b)
`
`There Was No Motivation To Combine Cribier
`And Cook........................................................................47
`
`The Combination Of Cribier And Cook Does
`Not Disclose All Of The Elements Of Claims 1-
`4 ......................................................................................48
`
`6.
`
`Ground 6: Invalidity Under 35 U.S.C. § 103(a) Over
`Cribier In View Of De Paulis....................................................49
`
`a)
`
`There Was No Motivation To Combine Cribier
`And De Paulis.................................................................49
`
`-iii-
`
`

`

`b)
`
`The Combination Of Cribier And De Paulis
`Does Not Disclose All Of The Elements Of
`Claims 1-4.......................................................................51
`
`7.
`
`8.
`
`9.
`
`Ground 7: Invalidity Under 35 U.S.C. § 103(a) Over
`Spenser In View Of Elliot.........................................................53
`
`Ground 8: Invalidity Under 35 U.S.C. § 103(a) Over
`Spenser In View Of Thornton...................................................56
`
`Ground 9: Claims 1-4 Are Not Invalid Under 35
`U.S.C. § 103(a) Over Spenser In View Of Cook......................57
`
`10. Ground 10: Invalidity Under 35 U.S.C. § 103(a) Over
`Spenser In View Of De Paulis ..................................................59
`
`VII. CONCLUSION..............................................................................................60
`
`-iv-
`
`

`

`TABLE OF AUTHORITIES
`
`CASES
`B roadcom C orp.v.Emu lex C orp.,
`732 F.3d 1325 (Fed. Cir. 2013) .....................................................................32
`
`Page(s)
`
`C FM T,Inc.v.YieldUpInt’lC orp.,
`349 F.3d 1333 (Fed. Cir. 2003) .....................................................................30
`
`C heese Sys.,Inc.v.Tetra P akC heese & P owderSys.,Inc.,
`725 F.3d 1341 (Fed. Cir. 2013) .....................................................................11
`
`C ont’lC an C o.USA ,Inc.v.M onsanto C o.,
`948 F.2d 1264 (Fed. Cir. 1991) .....................................................................11
`
`Garmin Int’l,Inc.v.C u ozzo Speed Techs.L L C ,
`Case No. IPR2012-00001..........................................................................8, 31
`
`Glaxo Inc.v.N ovopharm,
`52 F.3d 1043 (Fed. Cir. 1995) .......................................................................11
`
`Graham v.John D eere C o.,
`383 U.S. 1 (1966)...........................................................................................30
`
`InfoB ionic,Inc.v.B raemarM anu factu ring,L L C ,
`IPR2015-01704, Paper 11 (PTAB Feb. 16, 2016) ..........................................8
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) .......................................................................31
`
`Kinetic C oncepts,Inc.v.Smith& N ephew,Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .....................................................................32
`
`KSR Int’lC o.v.Teleflex Inc.,
`550 U.S. 398 (2007).................................................................................30, 31
`
`L eo P harm.P rods.,L td.v.Rea,
`726 F.3d 1346 (Fed. Cir. 2013) .....................................................................32
`
`-v-
`
`

`

`M edtronic Inc.v.Edwards L ifesciences C orp.,etal.,
`No. 12-0327 (C.D. Cal. Sept. 17, 2013) (Ex. 2007)........................................8
`
`M intz v.D ietz & W atson,Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .....................................................................32
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) .........................................................................30
`
`In re Robertson,
`169 F.3d 743 (Fed.Cir.1999) .........................................................................11
`
`Rohm and H aas C o.v.B rotechC orp.,
`127 F.3d 1089 (Fed. Cir. 1997) .......................................................................8
`
`St.Ju de M ed.,Inc.v.A ccess C losu re,Inc.,
`729 F.3d 1369 (Fed. Cir. 2013) .....................................................................30
`
`Therasense,Inc.v.B ecton,D ickinson & C o.,
`593 F.3d 1325 (Fed. Cir. 2010) ...............................................................11, 27
`
`Trintec Indu s.,Inc.v.Top-USA C orp.,
`295 F.3d 1292 (Fed. Cir. 2002) .........................................................10, 11, 27
`
`W .L .Gore & A ssocs.v.C .R.B ard,Inc.,
`Civ. A. No. 11-515-LPS-CJB, Dkt. 428 (D. Del. Nov. 9, 2015)
`(Ex. 2008) ........................................................................................................8
`
`STATUTES AND RULES
`
`37 C.F.R. § 42.6(a)(3)........................................................................................21, 27
`
`37 C.F.R. § 42.62(a)...................................................................................................8
`
`37 C.F.R. § 42.65(a)...................................................................................................8
`
`37 C.F.R. § 42.100(b) ................................................................................................7
`
`37 C.F.R. § 42.107(a).................................................................................................1
`
`35 U.S.C. § 102........................................................................................................10
`
`35 U.S.C. § 102(b) ............................................................................................passim
`
`-vi-
`
`

`

`35 U.S.C. § 103........................................................................................................29
`
`35 U.S.C. § 103(a) ............................................................................................passim
`
`OTHER AUTHORITIES
`
`U.S. Patent No. 6,015,431........................................................................................45
`
`U.S. Patent No. 6,352,554 B2..................................................................................50
`
`U.S. Patent No. 8,992,608.................................................................................passim
`
`-vii-
`
`

`

`PATENT OWNER’S EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`Sapien 3 Brochure, “Transcatheter Aortic Valve Replacement with
`the Edwards SAPIEN 3 Transcatheter Heart Valve”, 2016
`
`Press Release: FDA approves expanded indication for two
`transcatheter heart valves for patients at intermediate risk for death
`or complications associated with open-heart surgery, FDA
`8/18/2016
`
`Thourani, V. H., 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 Current Knowledge, Circulation, Jan. 22, 2013,
`p. 397-407
`
`Cribier et al., Mid-Term Experience of Percutaneous Heart Valves,
`JACC 47:1214:23 (2006)
`
`Bentall, H.H., De Bono, A.: A technique for complete replacement
`of the ascending aorta, Thorax, 23:338-39 (1968)
`
`Order re: Motions for Summary Judgment, Medtronic Inc. v.
`Edwards Lifesciences Corp., et al., No. 12-0327, Dkt. 414 (C.D.
`Cal. Sept. 17, 2013)
`
`Report and Recommendation at 11, n.6, W.L. Gore & Assocs. v.
`C.R. Bard, Inc., Civ. A. No. 11-515-LPS-CJB, Dkt. 428 (D. Del.
`Nov. 9, 2015)
`
`-viii-
`
`

`

`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`On October 12, 2016, Edwards Lifesciences Corporation, Edwards
`
`Lifesciences LLC, and Edwards Lifesciences AG (“Petitioners”) submitted a
`
`Petition for InterP artes Review (the “Petition”) challenging claims 1-4 of U.S.
`
`Patent No. 8,992,608 (the “‘608 patent”). Pursuant to 37 C.F.R. § 42.107(a),
`
`Boston Scientific Scimed, Inc. (“Patent Owner”) submits this Preliminary
`
`Response requesting that the Board deny the Petition because Petitioners have not
`
`demonstrated a reasonable likelihood of unpatentability of any challenged claim.
`
`II.
`
`INTRODUCTION
`
`The systems of claims 1-4 of the ‘608 patent address paravalvular leakage
`
`(“PVL”) ‒ a problem uniquely associated with transcatheter aortic valve
`
`replacement (“TAVR”), which is a treatment for aortic valve disease. In TAVR
`
`procedures, the diseased native valve leaflets are not removed but merely pushed
`
`aside by an expandable stent containing a prosthetic replacement valve. The ‘608
`
`patent identified the problem of PVL ‒ the leakage of blood around the outside of
`
`the stent through gaps formed by the diseased, often calcified, native valve
`
`leaflets ‒ and disclosed and claimed new systems to address that problem. Among
`
`other things, the systems include a fabric seal around the outside of an expandable
`
`anchor. In its deployed state, the fabric seal comprises flaps extending into the
`
`spaces formed by the native valve leaflets.
`
`-1-
`
`

`

`Petitioners’ principal prior art reference, WO 98/29057 (“Cribier”)
`
`(Ex. 1003), does not anticipate claims 1-4 of the ‘608 patent under 35 U.S.C.
`
`§ 102(b).1 In fact, Cribier denies that the problem of PVL even existed – it
`
`suggests that, if the prosthetic valve is properly positioned, then leakage around the
`
`valve would not occur. Cribier discloses a cover pulled taut against a collapsible
`
`frame to prevent blood from passing through the spaces in the frame ‒ not a seal to
`
`prevent blood from seeping around the exterior of the frame. The claim elements
`
`of the ‘608 patent that are not described in Cribier include: a fabric seal that “in the
`
`deployed state … comprises flaps that extend into spaces formed by native valve
`
`leaflets”; the “fabric seal being adapted to prevent blood from flowing between the
`
`fabric seal and heart tissue,” “pockets,” or pockets “adapted to fill with blood in
`
`response to backflow blood pressure.” Cribier also fails to disclose the claim
`
`elements relating to a “commissure support element.”
`
`Nor does Petitioners’ other allegedly anticipatory reference, WO 03/047468
`
`(“Spenser”) (Ex. 1004), disclose all of the elements of claims 1-4 of the ‘608
`
`patent. Spenser makes no mention of PVL and describes a cuff around the exterior
`
`1 Petitioners contend that the ‘608 patent has a June 2004 priority date. (Petition at
`
`1.) Patent Owner reserves the right to argue for an earlier priority date. However,
`
`for purposes of this preliminary response, the June 2004 priority date is immaterial.
`
`-2-
`
`

`

`of the stent to provide stability; it has no apparent sealing function. Spenser
`
`specifically discourages slack in the cuff material and thus fails to disclose a fabric
`
`seal that “in the deployed state … comprises flaps that extend into spaces formed
`
`by native valve leaflets,” the “fabric seal being adapted to prevent blood from
`
`flowing between the fabric seal and heart tissue,” “pockets,” or pockets “adapted to
`
`fill with blood in response to backflow blood pressure.”
`
`Petitioners’ other references are unrelated to valves or TAVR and do not
`
`address the problem of PVL. Petitioners have also failed to show that there would
`
`have been a rationale for one of skill in the art to combine those references to
`
`arrive at the invention of the ‘608 patent. In any event, none of the combinations
`
`proposed by Petitioners under 35 U.S.C. § 103(a) discloses all of the elements of
`
`claims 1-4 of the ‘608 patent ‒ particularly flaps extending into spaces formed by
`
`native valve leaflets.
`
`III. BACKGROUND
`
`A.
`
`TAVR
`
`The ‘608 patent relates to endovascular replacement of diseased heart
`
`valves, particularly the aortic valve ‒ i.e., TAVR. (Ex. 1001 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
`
`-3-
`
`

`

`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
`
`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. 1007 ¶ 37.)
`
`This surgery is traumatic and entails a relatively long, difficult recovery period;
`
`some patients may be too sick to survive the surgery. (Ex. 2002 [FDA Aug. 18,
`
`2016 Press Release]; Ex. 2001 [SAPIEN 3 Patient Brochure] 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 [Thourani, etal. publication] 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 had been with surgical replacements, but
`
`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.)
`
`-4-
`
`

`

`Almost 10 years after the advent of TAVR, clinicians began to understand
`
`that PVL was a major drawback of TAVR. The tendency of blood to leak around
`
`the 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 to the patient’s health post-procedure. (Ex. 2004 [Lerakis
`
`publication] at 397.) Moderate to severe PVL is associated with unsuccessful
`
`TAVR outcomes, including increased mortality within one year of the procedure.
`
`(Id.)
`
`B.
`
`The ‘608 Patent
`
`The ‘608 patent identified the significance of 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.
`
`-5-
`
`

`

`“diseased
`aortic valve”
`
`“native valve
`leaflets”
`
`“interface”
`
`“blood”
`
`(Ex. 1001 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.
`
`“fabric
`seal”
`
`“anchor”
`
`“fabric
`seal”
`
`(Ex. 1001 at 14:22-29 & FIGS. 33, 34.)
`
`-6-
`
`

`

`IV. CLAIM CONSTRUCTION
`
`Petitioners propose constructions for two terms ‒ “flaps” and “pockets.”
`
`(Petition at 40-45.) According to Petitioners, the person of ordinary skill would
`
`have understood the term “flaps” to mean “circumferentially oriented folds or
`
`unattached ends” and the term “pockets” to mean “open spaces or cavities formed
`
`by flaps of the fabric seal” in view of the specification, ‘608 prosecution history, a
`
`cited prior art reference and/or Patent Owner’s “commonly owned” European
`
`Patent. (Petition at 43-45.) Petitioners’ proposed constructions should be rejected
`
`as they are not the “broadest reasonable construction in light of the specification of
`
`the patent in which [they] appear[],” as required by 37 C.F.R. § 42.100(b).
`
`In any event, even under their proposed constructions, Petitioners cannot
`
`meet their burden of proving that claims 1-4 of the ‘608 patent are likely invalid as
`
`shown below. Accordingly, there is no need for the Board to engage in claim
`
`construction at this time. Patent Owner reserves the right to argue the construction
`
`of any and all terms of the ‘608 patent, as necessary, should the Board institute an
`
`interpartes review proceeding.
`
`V.
`
`THE OPINIONS OF PETITIONERS’EXPERT ARE
`ENTITLED TO LITTLE OR NO WEIGHT
`
`The declaration of Petitioners’ expert, Dr. Nigel P. Buller (“Buller”), is
`
`entitled to little or no weight because Buller repeatedly relies on unsupported,
`
`conclusory assertions, rather than credible evidence, in support of his opinions.
`
`-7-
`
`

`

`See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying
`
`facts or data on which the opinion is based is entitled to little or no weight.”)
`
`Nothing in the Federal Rules of Evidence, which are applicable in interpartes
`
`review proceedings (37 C.F.R. § 42.62(a)), or the Federal Circuit’s or this Board’s
`
`jurisprudence, requires a fact finder to credit unsupported assertions of an expert
`
`witness. See Rohm and H aas C o.v.B rotechC orp., 127 F.3d 1089, 1092 (Fed. Cir.
`
`1997); InfoB ionic,Inc.v.B raemarM anu factu ring,L L C , IPR2015-01704, Paper
`
`11, 6, 13 (denying institution) (PTAB Feb. 16, 2016) (“We do not find the
`
`testimony of Petitioner’s expert to be persuasive or helpful as it repeats the
`
`Petitioner’s arguments and offers little or no elaboration as to how one of ordinary
`
`skill in the art would understand the [term] … the cited expert testimony merely
`
`repeats the Petitioner’s conclusory argument, adding the phrase ‘[i]n my
`
`opinion’”).
`
`Other tribunals have criticized Buller for offering conclusory, unsupported
`
`opinions. See,e.g.,Order re: Motions for Summary Judgment at 47, M edtronic
`
`Inc.v.Edwards L ifesciences C orp.,etal., No. 12-0327 (C.D. Cal. Sept. 17, 2013)
`
`(Ex. 2007) (“The Court finds that Buller … does not explain in detail how each
`
`claim element is disclosed in the prior art reference, [and thus] a reasonable
`
`factfinder need not credit [Buller’s] testimony, and neither does the Court …”);
`
`Report and Recommendation at 11, n.6, W .L .Gore & A ssocs.v.C .R.B ard,Inc.,
`
`-8-
`
`

`

`Civ. A. No. 11-515-LPS-CJB, Dkt. 428 (D. Del. Nov. 9, 2015) (Ex. 2008)
`
`(“[Defendant’s] invalidity expert, Dr. Nigel Buller, states in conclusory fashion
`
`[what] the skilled artisan ‘would have understood’” but “does not offer any
`
`explanation as to how …”), at 26 (“Dr. Buller’s citation for the proposition … is to
`
`his own rebuttal report regarding non-infringement …”) (emphasis in original).
`
`Buller’s expert declaration here suffers from the same defects. For example,
`
`throughout his declaration, Buller repeatedly fails to offer credible evidence or
`
`support for his conclusions. See,e.g., Ex. 1007 ¶ 142 (concluding that “flaps” and
`
`“pockets” will form when the Cribier device is foreshortened, but citing only a
`
`foreign counterpart of the ‘608 patent that fails to relate foreshortening percentages
`
`to flaps and pockets). In multiple instances, Buller opines as to what a person of
`
`ordinary skill in the art would understand without providing explanation of or
`
`bases for that understanding. See id.¶ 103 (“in my opinion, the skilled person
`
`would appreciate that circumferentially oriented ‘flaps’ and ‘pockets’ could be
`
`achieved by extensive anchor foreshortening (e.g., 50% or more) when the fabric
`
`seal, made, for example, of Dacron, is secured at points along its length to the
`
`anchor”), ¶ 158 (opining that “[i]t would have been obvious to one of ordinary skill
`
`in the art to combine the teachings” but providing no support or citation). These
`
`assertions are particularly unreliable given the complete absence in Buller’s CV of
`
`-9-
`
`

`

`any experience implanting a TAVR heart valve (or any kind of heart valve). (See
`
`Ex. 1007 Exhibit A.)
`
`Moreover, a significant portion of Buller’s declaration does little more than
`
`parrot the Petition. E.g.,compare Petition at 51-52 withEx. 1007 ¶ 143; compare
`
`Petition at 59 withEx. 1007 ¶ 158; compare Petition at p. 75 withEx. 1007 ¶ 196.
`
`Throughout his declaration, Buller cites repeatedly to earlier sections of his own
`
`declaration for support, when those sections themselves lack any citation or
`
`support for such proposition. See,e.g.,Ex. 1007 ¶ 194, ¶ 145.
`
`For these reasons, Buller’s unsupported conclusory testimony should be
`
`accorded little or no weight.
`
`VI. PETITIONERS HAVE NOT MET THEIR BURDEN OF
`SHOWING THAT CLAIMS 1-4 ARE LIKELY INVALID
`
`A.
`
`Petitioners Have Not Met Their Burden Of Showing That
`Claims 1-4 Are Likely Anticipated Under 35 U.S.C. § 102(b)
`
`Petitioners argue through Ground 1 that claims 1-4 are invalid under 35
`
`U.S.C. § 102(b) in view of Cribier and through Ground 11 that claims 1-4 are
`
`invalid under 35 U.S.C. § 102(b) in view of Spenser. Petitioners have not carried
`
`their burden on either ground. Under 35 U.S.C. § 102, a single prior art reference
`
`“anticipates a patent claim [only] if it expressly or inherently describes each and
`
`every limitation set forth in the patent claim.” Trintec Indu s.,Inc.v.Top-U.S.A .
`
`C orp., 295 F.3d 1292, 1295 (Fed. Cir. 2002). Anticipation may not be found
`
`-10-
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`

`

`absent proof that the reference discloses “all of the elements of the claim within the
`
`four corners of the document . . . .” C heese Sys.,Inc.v.Tetra P akC heese &
`
`P owderSys.,Inc., 725 F.3d 1341, 1351 (Fed. Cir. 2013).
`
`If a limitation is not explicitly disclosed in an allegedly anticipating
`
`reference, it must be inherently disclosed ‒ i.e., it must always and necessarily be
`
`present; not merely possible or even probable. See Therasense,Inc.v.B ecton,
`
`D ickinson & C o., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010) (“Inherency, however,
`
`may not be established by probabilities or possibilities. The mere fact that a
`
`certain thing may result from a given set of circumstances is not sufficient.”
`
`(quoting C ont’lC an C o.USA ,Inc.v.M onsanto C o., 948 F.2d 1264, 1269 (Fed.
`
`Cir. 1991))); see Trintec Indu s.,Inc., 295 F.3d at 1295 (“Inherent anticipation
`
`requires that the missing descriptive material is ‘necessarily present,’ not merely
`
`probably or possibly present, in the prior art” (quoting In re Robertson, 169
`
`F.3d 743, 745 (Fed.Cir.1999))); Glaxo Inc.v.N ovopharm, 52 F.3d 1043, 1047-
`
`48 (Fed. Cir. 1995) (affirming rejection of invalidity defense where accused
`
`infringer maintained that the claimed compound was “inherently disclosed in [a
`
`prior art patent] because the practice of Example 32 [of the prior art patent] always
`
`yields [the claimed compound]” but “the district court found that the practice of
`
`Example 32 could yield [another compound]”) (emphasis added).
`
`-11-
`
`

`

`1.
`
`Ground 1: Invalidity Under 35 U.S.C. § 102(b) Over
`Cribier
`
`Petitioners have not established a reasonable likelihood of showing that
`
`Cribier (Ex. 1003), which was cited during prosecution (Ex. 1001 at 7), anticipates
`
`claims 1-4 of the ‘608 patent. Petitioners have not shown that Cribier describes
`
`many of the limitations in claims 1-4 of the ‘608 patent, including: “a replacement
`
`valve commissure support element attached to the expandable anchor”; “a
`
`commissure portion of a replacement valve leaflet attached to the commissure
`
`support element”; a fabric seal that “in the deployed state … comprises flaps that
`
`extend into spaces formed by native valve leaflets”; the “fabric seal being adapted
`
`to prevent blood from flowing between the fabric seal and heart tissue”; “pockets”;
`
`or, pockets “adapted to fill with blood in response to backflow blood pressure.”
`
`Cribier Does Not Disclose A “Replacement
`a)
`Valve Commissure Support Element Attached to the
`Expandable Anchor” or “A Commissure Portion of a
`Replacement Valve Leaflet Attached to the
`Commissure Support Element” (Claim 1 –“Claim
`Element 1.2” and “Claim Element 1.3” )
`Contrary to Petitioners’ assertions (see Petition at 48-49), Cribier fails to
`
`disclose either “a replacement valve commissure support element attached to the
`
`expandable anchor” or “a commissure portion of a replacement valve leaflet
`
`attached to the commissure support element” as required by claim 1 of the ‘608
`
`patent. (Ex. 1001 at 22:26-29.) The ‘608 patent discloses a commissure (24) along
`
`-12-
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`

`

`an edge of each replacement valve leaflet (26) – the commissure is where the valve
`
`leaflets come together. (Ex. 1001 at 5:60-63 & FIG. 3B.) The “commissures 24 of
`
`replacement valve leaflets 26 are coupled to and supported by posts 38,” while the
`
`posts are coupled to the anchor. (Id. at 5:40-44, 60-63.)
`
`Cribier does not disclose commissure portions of replacement valve leaflets
`
`‒ let alone a “commissure support element” ‒ because Cribier does not describe,
`
`depict or suggest any embodiment comprising valve leaflets. Every embodiment
`
`of Cribier involves a single hyperboloid “valvular structure 14 exhibiting a
`
`continuous surface.” (Ex. 1003 at 18:16-17; 6:5; see also 19:15-17.) Some
`
`examples of this continuous structure can be seen below:
`
`(Id. at FIGS. 4b, 10a, 11e; see also FIGS. 4-5, 9-11; col. 26:25-29:22.) Cribier
`
`teaches that “[t]he truncated shape forming a continuous surface … is more
`
`efficient for the systolo-diastolic movements of the valvular tissue during heart
`
`beats” and that “[a]nother advantage of this truncated continuous shape is that it is
`
`stronger and has less risk of being destroyed or distorted….” (Id. at 19:7-9, 20:17-
`
`19 (emphasis added).) Cribier lacks of description of a plurality of replacement
`
`-13-
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`

`

`valve leaflets, and, therefore, it lacks a description of “commissures” that would be
`
`between such leaflets. Thus, it does not describe “commissure support elements.”
`
`Petitioners assert that “Cribier discloses a replacement valve commissure
`
`support element attached to the expandable anchor in the form of guiding means,”
`
`one example of which are the “rectilinear struts 17” seen in Cribier’s Figure 4b.
`
`(Petition at 48; see id. at 21.) Petitioners do not provide any explanation of how
`
`these struts 17 could be considered commissure support elements. According to
`
`Cribier, these struts are not attached to commissures between replacement valve
`
`leaflets; rather, “[t]hey are formed from thicker zones of the tissue or from strips of
`
`stiffening material incorporated in the tissue; they can also be[ ] glued or soldered
`
`on the valvular tissue.” (Ex. 1003 at 18:26-28.)
`
`Moreover, even if the rectilinear struts were deemed “commissure support
`
`elements,” Cribier does not satisfy the requirement of “a replacement valve
`
`commissure support element attached to the expandable anchor” (Ex. 1001
`
`at 22:26-27) (emphasis added), as there is no suggestion in Cribier that the
`
`rectilinear struts are attached to the expandable frame at all. Petitioners fail to
`
`identify any portion of the valve that is attached to the frame other than the very
`
`bottom of the valve, which is not a commissure. (See Petition at 48.)
`
`Petitioners also misleadingly suggest that Cribier discloses “a commissure
`
`portion of a replacement valve leaflet atta