UNITED STATES PATENT AND TRADEMARK OFFICE
`-------------------------
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`EDWARDS LIFESCIENCES CORP., et al.
`Petitioner
`v.
`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
`
`Case IPR2017-00060
`Patent 8,992,608
`
`apks.com
`Arnold & Porter Kaye Scholer LLP
`All Rights Reserved.
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2101
`
`
`-------------------------
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`EDWARDS LIFESCIENCES CORP., et al.
`Petitioner
`v.
`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
`
`Case IPR2017-00060
`Patent 8,992,608
`
`apks.com
`Arnold & Porter Kaye Scholer LLP
`All Rights Reserved.
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2101
`
`
`
`(Exhibit 2014 (Sapien).)
`
`(Exhibit 2017 (Sapien XT).)
`
`(Exhibit 2001 (Sapien 3).)
`
`Privileged & Confidential
`
`2
`
`
`
`Dr. Nigel Buller
`
`(Exhibit 2028 at 20:21-24.)
`
`(Exhibit 2028 at 21:6-9.)
`
`Dr. Stephen Brecker
`• Over 25 years of medical
`experience as a practicing
`interventional cardiologist
`• Chief of Cardiology at St.
`George’s University Hospitals
`• Performed over 1,100 TAVR
`procedures
`• Proctored over 600 TAVR
`procedures
`
`(Exhibit 2080 ¶¶ 2-12.)
`
`Dr. Andrew Manganaro
`• Over 25 years of medical
`experience in cardiac, vascular,
`and endovascular surgery
`• Performed hundreds of SAVR
`procedures
`
`(Exhibit 2079 ¶¶ 5-13.)
`
`3
`
`(Exhibit 2028 at 37:14-17.)
`Privileged & Confidential
`
`
`
`Dr. Nigel Buller
`
`….
`(Exhibit 2028 at 49:12-16.)
`
`Dr. Andrew Manganaro
`• Performed hundreds of aortic
`aneurysm repairs (both through
`surgical and endovascular
`means), including AAA, thoracic
`aortic aneurysms, and
`thoracoabdominal aneurysms
`(Exhibit 2079 ¶¶ 5-13.)
`
`(Exhibit 2094 at 11:6-18.)
`Privileged & Confidential
`
`4
`
`
`
`“S&N’s own invalidity expert even admitted that
`he did not consider the objective indicia of
`nonobviousness in reaching his conclusions
`regarding the invalidity of the patents.”
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342, 1368 (Fed. Cir. 2012) (reversing
`trial court’s finding of obviousness)
`
`“There was, moreover, no effort by [obviousness
`expert] Dr. Yanco to guard against this hindsight
`bias by appropriately considering all objective
`evidence of nonobviousness.”
`InTouch Techs., Inc. v. VGO Comm’s, 751 F.3d
`1327, 1352 (Fed. Cir. 2014) (reversing trial
`court’s findings of invalidity)
`Privileged & Confidential
`
`5
`
`
`
`Buller Deposition (Ex. 2028) at 153:12-154:11:
`
`Q. When you were forming your opinions in this proceeding, did
`you ask from Edwards or its counsel for any information about
`Edwards’ own attempts to solve the problem of PVL prior to
`the Sapien 3?
`
`* * *
`THE WITNESS: No, because of the date that I am considering is as of
`2004, there wasn’t even Sapien….
`
`So in your view, events occurring after the June 2004 date in this
`Q.
`case are irrelevant?
`
`A. Well, I’m not a lawyer. I don’t know if they are relevant, but I
`have not considered them….
`
`Privileged & Confidential
`
`6
`
`
`
`Buller Second Deposition (Ex. 2094) at 52:1-5:
`
`Q. And you didn’t consider any secondary considerations in your
`reply declaration other than copying; is that right?
`
`A. That’s correct.
`
`“once Patent Owner presented its evidence and
`arguments, in the Response, Dr. Karger
`submitted a rebuttal declaration addressing
`Patent Owner’s evidence.”
`Activision Blizzard, Inc. v. Acceleration
`Bay, LLC., IPR2015-01953, Paper 107, at 36,
`n.15 (PTAB Mar. 23, 2017)
`
`Privileged & Confidential
`
`7
`
`
`
`(Exhibit 2070.)
`
`(Exhibit 2071.)
`Privileged & Confidential
`
`(Exhibit 2081.)
`
`8
`
`
`
`(Exhibit 2001 at 4.)
`Privileged & Confidential
`
`9
`
`
`
`‘608 PATENT
`
`(Exhibit 1001 at 12:19-27, FIG. 13.)
`Privileged & Confidential
`
`10
`
`
`
`Privileged & Confidential
`
`(Exhibit 1004 at 22, FIG 1.)
`
`11
`
`
`
`Spenser does not address PVL:
`
`(Exhibit 2030 at 2:27-28.)
`
`Privileged & Confidential
`
`12
`
`
`
`Elliot, Thornton, and Cook
`do not address PVL:
`
`Elliot: “stent-graft used to treat
`an aortic aneurysm (e.g., abdominal
`aortic aneurysm (‘AAA’))”
`(Exhibit 1005 ¶ [0009].)
`
`Thornton: “adapted for
`delivery to an intravascular region of
`an aneurysm and provides a conduit
`through that region while protecting
`the aneurysm from the intraluminal
`pressure”
`(Exhibit 1019 at 3:58-62.)
`Cook: “graft prosthesis,
`particularly one used to exclude an
`abdominal aortic aneurysm (AAA)”
`(Exhibit 1006 ¶ [0003].)
`
`Privileged & Confidential
`
`13
`
`
`
`Elliot, Thornton, and Cook address a
`different problem than the ‘608 patent:
`
`Elliot: “healthy
`portions of the aorta”
`
`Cook: “healthy
`Thornton: “vascular wall at
`aortic wall tissue”
`a location adjacent to aneurysm
`Privileged & Confidential
`(Exhibits 1005 ¶ [0003], FIG. 1 (prior art); 1019 at 9:43-10:12, FIG. 3; 1006 ¶ [0030], FIG. 3.)
`
`14
`
`
`
`AAA Landing Zone
`
`(Exhibit 2079 ¶¶ 67-72.)
`
`Privileged & Confidential
`
`15
`
`
`
`Aortic Annulus
`
`Privileged & Confidential
`
`(Exhibit 2079 ¶¶ 67-72.)
`
`16
`
`
`
`Dr. Manganaro’s Conclusion
`
`(Exhibit 2079 ¶¶ 67-72.)
`
`Privileged & Confidential
`
`17
`
`
`
`Dr. Buller:
`
`(Exhibit 2094 at 44:12-24.)
`Privileged & Confidential
`
`18
`
`
`
`Dr. Buller:
`
`….
`
`(Exhibit 2094 at 38:10-39:4.)
`
`Privileged & Confidential
`
`19
`
`
`
`Dr. Buller:
`
`(Exhibit 2094 at 41:23-42:11.)
`Privileged & Confidential
`
`20
`
`
`
`Spenser’s cuff “enhance[s] the stability”
`of the valve:
`
`(Exhibit 1004 at 22-23.)
`
`Privileged & Confidential
`
`21
`
`
`
`Spenser discourages “migration”:
`
`(Exhibit 1004 at 30-31, 36-37.)
`
`Privileged & Confidential
`
`22
`
`
`
`Combinations could lead to
`increased migration:
`
`Privileged & Confidential
`
`(Exhibit 2080 ¶ 79.)
`
`23
`
`
`
`“flaps that extend into spaces formed by native valve leaflets”
`
`No flaps:
`
`Elliot
`
`Thornton
`
`Cook
`
`(Exhibits 1005 FIG. 5b; 1019 FIG. 1; 1006 FIG. 1.)
`Privileged & Confidential
`
`24
`
`
`
`“flaps that extend into spaces formed by native valve leaflets”
`
`Crushed when in deployed state:
`
`Elliot
`
`Thornton
`
`Cook
`
`(Exhibits 1005 FIG. 5a; 1019 FIG. 3; 1006 FIG. 3.)
`Privileged & Confidential
`
`25
`
`
`
`“flaps that extend into spaces formed by native valve leaflets”
`
`Flaps:
`
`‘608 Patent FIG. 33
`
`Privileged & Confidential
`
`(Exhibit 1001 FIG. 33.)
`
`26
`
`
`
`“flaps that extend into spaces formed by native valve leaflets”
`
`AAA landing zone according to
`Dr. Manganaro:
`
`Privileged & Confidential
`
`(Exhibit 2079 ¶ 47.)
`
`27
`
`
`
`“flaps that extend into spaces formed by native valve leaflets”
`
`Aortic annulus according to
`Dr. Manganaro:
`
`(Exhibit 2079 ¶ 49.)
`
`Privileged & Confidential
`
`28
`
`
`
`“flaps that extend into spaces formed by native valve leaflets”
`
`Elliot
`
`Thornton
`
`Cook
`
`(Exhibits 1005 FIG. 5a; 1019 FIG. 3; 1006 FIG. 3.)
`Privileged & Confidential
`
`29
`
`
`
`OBJECTIVE INDICIA OF
`
`OBJECTIVE INDICIA OF
`NONOBVIOUSNESS
`
`NONOBVIOUSNESS
`
`
`
`30
`
`
`
`LEGAL STANDARD
`
`“Evidence of secondary considerations plays a
`critical role in the obviousness analysis because
`it serves as objective indicia of nonobviousness
`and ‘may often be the most probative and cogent
`evidence in the record. It may often establish
`that an invention appearing to have been
`obvious in light of prior art was not.’... In fact,
`we have expressly stated that ‘when secondary
`considerations are present … it is error not to
`consider them.’”
`
`Nike, Inc. v. Adidas AG, 812 F.3d 1326, 1339 (Fed.
`Cir. 2016) (emphasis in original) (quoting In re
`Kao, 639 F.3d 1057, 1067 (Fed. Cir. 2011))
`Privileged & Confidential
`
`31
`
`
`
`“The purpose of evidence of failure of others is to show
`indirectly the presence of a significant defect in the prior art....
`[A competitor’s] failure accomplishes that purpose, confirming
`that a therapeutically effective [solution] was lacking in the
`prior art and that skilled artisans struggled to attain it. Such a
`scenario is classic evidence of nonobviousness.”
`In re Cyclobenzaprine Hydrochoride Extended Release
`Patent Litig., 676 F.3d 1063, 1082 (Fed. Cir. 2012)
`
`“Indeed, the litigation argument that an innovation is really
`quite ordinary carries diminished weight when offered by
`those who had tried and failed to solve the same problem, and
`then promptly adopted the solution that they are now
`denigrating.”
`Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1379-80 (Fed. Cir.
`2012) (quoting Heidelberger Druckmaschinen AG v. Hantscho
`Commercial Prod., Inc., 21 F.3d 1068, 1072 (Fed. Cir. 1994)).
`Privileged & Confidential
`
`32
`
`
`
`(Exhibit 2039 at 1.)
`
`Privileged & Confidential
`
`33
`
`
`
`Buller Deposition (Ex. 2028) at 140:12-23:
`Q. Now, in 2004, persons of ordinary skill in the art knew that
`moderate to severe paravalvular leakage was bad for patient mortality.
`That level of leakage was known to have an adverse effect on mortality at
`the time; is that right?
`
`* * *
`THE WITNESS: Well, yes, but again, you’ve got to, in these very early
`patients – absolutely. I mean the answer is yes, the simple answer….
`
`Wood Deposition (Ex. 2096) at 16:14-19:
`
`34
`
`
`
`(Exhibit 2040 at 36-38.)
`
`Privileged & Confidential
`
`35
`
`
`
`(Exhibit 2043 at 24.)
`
`Privileged & Confidential
`
`36
`
`
`
`(Exhibit 2042 at 11.)
`
`Privileged & Confidential
`
`37
`
`
`
`Privileged & Confidential
`
`(Exhibit 2044 at 12.)
`
`38
`
`
`
`Privileged & Confidential
`
`(Exhibit 2051 at 38.)
`
`39
`
`
`
`Kodali, et al.
`
`* * *
`
`(Exhibit 2019 at 5.)
`
`Privileged & Confidential
`
`40
`
`
`
`(Exhibit 2056 at 58.)
`
`Privileged & Confidential
`
`41
`
`
`
`Privileged & Confidential
`
`(Exhibit 2031 at 36.)
`
`42
`
`
`
`Privileged & Confidential
`
`(Exhibit 2090 at 5.)
`
`43
`
`
`
`Wood Deposition (Ex. 2096) at 48:18-25:
`
`Wood Deposition (Ex. 2096) at 41:6-9:
`
`Wood Deposition (Ex. 2096) at 42:17-22:
`
`44
`
`
`
`(Exhibit 2038.)
`
`Privileged & Confidential
`
`45
`
`
`
`Arai, et al.
`
`(Exhibit 2024 at 3.)
`
`Privileged & Confidential
`
`46
`
`
`
`Privileged & Confidential
`
`(Exhibit 2052 at 26.)
`
`47
`
`
`
`Privileged & Confidential
`
`(Exhibit 2099 at 26.)
`
`48
`
`
`
`NEXUS
`
`Distal end of valve leaflets attached to fabric seal
`
`(Exhibit 1001 at 22:35-40.)
`
`Expandable anchor (30)
`
`The fabric seal (380) extends from distal
`end of replacement valve back proximally
`
`A distal end of replacement valve (20)
`leaflets is attached to the fabric seal here
`Privileged & Confidential
`
`49
`
`
`
`NEXUS
`
`Distal end of valve leaflets attached to fabric seal
`
`Expandable anchor
`
`The fabric seal
`extends from distal
`end of replacement
`valve back
`proximally
`
`A distal end of
`replacement valve
`leaflets is attached to
`the fabric seal here
`
`Sutures
`
`(Exhibit 2034 at 6.)
`
`Privileged & Confidential
`
`50
`
`
`
`NEXUS
`
`Distal end of valve leaflets attached to fabric seal
`Buller Second Deposition (Ex. 2094) at 68:19-69:17:
`
`51
`
`
`
`NEXUS
`
`Distal end of valve leaflets attached to fabric seal
`July 9, 2014 amendment (Ex. 1002 at 361):
`
`“neither Leonhardt nor De Paulis, whether considered independently
`or in combination, teaches, suggests, or otherwise renders obvious a
`‘when the expandable anchor is in the collapsed delivery configuration,
`the fabric seal extends from the distal end of the replacement valve and
`back proximally over the expandable anchor, the fabric seal being
`adapted to prevent blood from flowing between the fabric seal and
`heart tissue,’ as is claimed.”
`
`Privileged & Confidential
`
`(Exhibits 1027 FIG. 4; 1021 FIG. 2.)
`
`52
`
`
`
`NEXUS
`
`Commissure support element attached to anchor (1)
`
`(Exhibits 2080 App’x B Claim 1.2 (citing 2077 at 11); 2046 at 28.)
`
`Privileged & Confidential
`
`53
`
`
`
`NEXUS
`
`Commissure support element attached to anchor (2)
`
`Privileged & Confidential
`
`(Exhibit 2077 at 11.)
`
`54
`
`
`
`NEXUS
`
`Commissure support element attached to anchor (2)
`Buller Second Deposition (Ex. 2094) at 71:12-21:
`
`Webster’s II New Riverside University Dictionary (1988):
`
`Privileged & Confidential
`
`55
`
`
`
`BACKGROUND
`
`BACKGROUND
`
`
`
`56
`
`
`
`SAVR
`
`(Exhibits 2073, 2074, and 2075.)
`
`Privileged & Confidential
`
`57
`
`
`
`TAVR
`
`Privileged & Confidential
`
`(Exhibit 2001 at 10.)
`
`58
`
`
`
`PVL
`
`Privileged & Confidential
`
`(Exhibit 2080 at ¶ 38.)
`
`59
`
`
`
`PVL
`
`(Exhibit 2004 at 397.)
`
`Privileged & Confidential
`
`60
`
`
`
`PVL
`
`(Exhibit 2004 at 397-99.)
`
`Privileged & Confidential
`
`61
`
`
`
`‘608 PATENT
`
`(Exhibit 1001 at 1.)
`
`Privileged & Confidential
`
`62
`
`
`
`‘608 PATENT
`
`(Exhibit 1001 at 14:21-29, FIGS. 33 and 34.)
`Privileged & Confidential
`
`63
`
`
`
`EXPERTS
`
`EXPERTS
`
`ARNOLD Er PORTER
`I KAYE SCHOLER
`
`64
`
`
`
`NO MOTIVATION TO COMBINE
`
`NO MOTIVATION TO COMBINE
`
`
`
`65
`
`
`
`NO MOTIVATION TO COMBINE
`
`Spenser discourages “slack”:
`
`(Exhibit 1004 at 23.)
`
`Privileged & Confidential
`
`66
`
`
`
`NO MOTIVATION TO COMBINE
`
`Combinations would result in slack:
`
`Privileged & Confidential
`
`(Exhibit 2080 ¶ 76.)
`
`67
`
`
`
`NO MOTIVATION TO COMBINE
`
`Combinations could destabilize device:
`
`Privileged & Confidential
`
`(Exhibit 2080 ¶ 75.)
`
`68
`
`
`
`NO MOTIVATION TO COMBINE
`
`Dr. Buller regarding migration:
`
`Privileged & Confidential
`
`(Exhibit 2028 at 66:12-67:2.)
`
`69
`
`
`
`MISSING ELEMENT
`
`MISSING ELEMENT
`
`
`
`70
`
`
`
`“flaps that extend into spaces formed by native valve leaflets”
`
`Extends into spaces when in deployed state:
`
`‘608 Patent FIG. 34
`
`Privileged & Confidential
`
`(Exhibit 1001 FIG. 33.)
`
`71
`
`
`
`BERGHEIM
`
`Bergheim’s seal does not include
`excess material:
`
`(Exhibit 1059 FIG. 5.)
`
`(Exhibit 2094 at 22:10-18.)
`
`Privileged & Confidential
`
`72
`
`
`
`LEGAL STANDARD
`
`The objective indicia may “serve to guard against slipping
`into use of hindsight, and to resist the temptation to read
`into the prior art the teachings of the invention at issue.”
`Apple Inc. v. Samsung Elec. Co., Ltd., 839 F.3d 1034, 1052 (Fed. Cir.
`2016) (quoting Graham v. John Deere Co., 383 U.S. 1, 36 (2007))
`
`“The objective indicia of non-obviousness play an
`important role as a guard against the statutorily proscribed
`hindsight reasoning in the obviousness analysis.”
`WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir. 2016))
`
`“[The] fact finder[] must withhold judgment on an
`obviousness challenge until it considers all relevant evidence,
`including that relating to the objective considerations.”
`In re Cyclobenzaprine Hydrochloride Extended-Release
`Capsule Patent Litig., 676 F.3d 1063, 1079 (Fed. Cir. 2012)
`Privileged & Confidential
`
`73
`
`
`
`LONG-FELT NEED
`
`LONG-FELT NEED
`
`
`
`74
`
`
`
`LONG-FELT NEED
`
`“Evidence of a long felt but unresolved need
`tends to show non-obviousness because it is
`reasonable to infer the need would not have
`persisted had the solution been obvious.”
`WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1332
`(Fed. Cir. 2016)
`
`“[E]vidence of a longfelt need for an extended
`release formulation and the failure of others to
`formulate one strongly support a conclusion of
`nonobviousness.”
`In re Cyclobenzaprine Hydrochloride Extended-Release
`Capsule Patent Litig., 676 F.3d 1063, 1080 (Fed. Cir. 2012)
`Privileged & Confidential
`
`75
`
`
`
`LONG-FELT NEED
`
`Buller Second Deposition (Ex. 2094) at 35:1-5:
`
`Q. The problem that the '608 2 patent is trying to solve with the fabric
`seal was to prevent paravalvular 4 regurgitation, correct?
`
`A. Yes.
`
`Privileged & Confidential
`
`76
`
`
`
`LONG-FELT NEED
`
`(Exhibit 1008 at 5.)
`
`Privileged & Confidential
`
`77
`
`
`
`LONG-FELT NEED
`
`(Exhibit 2041 at 6, 7.)
`
`Privileged & Confidential
`
`78
`
`
`
`LONG-FELT NEED
`
`(Exhibit 2042 at 11.)
`
`Privileged & Confidential
`
`79
`
`
`
`LONG-FELT NEED
`
`Privileged & Confidential
`
`(Exhibit 2055 at 5.)
`
`80
`
`
`
`LONG-FELT NEED
`
`Wood Deposition (Ex. 2096) at 16:12-25:
`
`Privileged & Confidential
`
`81
`
`
`
`LONG-FELT NEED
`
`Walther, et al.
`
`(Exhibit 2053 at 6.)
`
`Privileged & Confidential
`
`82
`
`
`
`LONG-FELT NEED
`
`Vahanian, et al.
`
`* * *
`
`* * *
`
`(Exhibit 2054 at 3.)
`
`Privileged & Confidential
`
`83
`
`
`
`LONG-FELT NEED
`
`Azadani, et al.
`
`* * *
`
`(Exhibit 2048 at 3.)
`
`Privileged & Confidential
`
`84
`
`
`
`LONG-FELT NEED
`
`Genereux, et al.
`
`* * *
`
`(Exhibit 2049 at
`3.)
`
`Privileged & Confidential
`
`85
`
`
`
`LONG-FELT NEED
`
`Lerakis, et al.
`
`* * *
`
`* * *
`
`(Exhibit 2004 at 1, 9.)
`
`Privileged & Confidential
`
`86
`
`
`
`LONG-FELT NEED
`
`Oversizing Not A Complete Solution
`Wood Deposition (Ex. 2096) at 23:4-10:
`
`Yang (Ex. 2059) at 8:
`
`Privileged & Confidential
`
`87
`
`
`
`LONG-FELT NEED
`
`Oversizing Not A Complete Solution
`
`(Exhibit 2059 at 9.)
`
`Privileged & Confidential
`
`88
`
`
`
`LONG-FELT NEED
`
`Proper Valve Sizing Not A Complete Solution
`
`Wood Deposition (Ex. 2096) at 18:9-15:
`
`Wood Deposition (Ex. 2096) at 30:13-15:
`
`Privileged & Confidential
`
`89
`
`
`
`LONG-FELT NEED
`
`(Exhibit 2057 at 13.)
`
`ential
`
`90
`
`
`
`FAILURE OF OTHERS
`
`FAILURE OF OTHERS
`
`
`
`91
`
`
`
`FAILURE OF OTHERS
`
`“The purpose of evidence of failure of others is to show
`indirectly the presence of a significant defect in the prior art....
`[A competitor’s] failure accomplishes that purpose, confirming
`that a therapeutically effective [solution] was lacking in the
`prior art and that skilled artisans struggled to attain it. Such a
`scenario is classic evidence of nonobviousness.”
`In re Cyclobenzaprine Hydrochoride Extended Release
`Patent Litig., 676 F.3d 1063, 1082 (Fed. Cir. 2012)
`
`“Indeed, the litigation argument that an innovation is really
`quite ordinary carries diminished weight when offered by
`those who had tried and failed to solve the same problem, and
`then promptly adopted the solution that they are now
`denigrating.”
`Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1379-80 (Fed. Cir.
`2012) (quoting Heidelberger Druckmaschinen AG v. Hantscho
`Commercial Prod., Inc., 21 F.3d 1068, 1072 (Fed. Cir. 1994)).
`Privileged & Confidential
`
`92
`
`
`
`FAILURE OF OTHERS
`
`(Exhibit 2040 at 36-38.)
`
`Privileged & Confidential
`
`93
`
`
`
`FAILURE OF OTHERS
`
`(Exhibit 2043 at 23.)
`
`Privileged & Confidential
`
`94
`
`
`
`FAILURE OF OTHERS
`
`(Exhibit 2042 at 12.)
`
`Privileged & Confidential
`
`95
`
`
`
`FAILURE OF OTHERS
`
`(Exhibit 2046 at 4, 10.)
`
`Privileged & Confidential
`
`96
`
`
`
`FAILURE OF OTHERS
`
`Crimped Profile Does Not Explain Petitioner’s Failure
`
`‘608 patent (Ex. 1001) at 22:30-35, Figs. 32, 33:
`
`undeployed state
`
`deployed state
`
`Privileged & Confidential
`
`97
`
`
`
`FAILURE OF OTHERS
`
`Crimped Profile Does Not Explain Petitioner’s Failure
`Wood Deposition (Ex. 2096) at 18:9-15:
`
`Privileged & Confidential
`
`(Exhibit 2031 at 39.)
`
`98
`
`
`
`FAILURE OF OTHERS
`
`Crimped Profile Does Not Explain Petitioner’s Failure
`
`Privileged & Confidential
`
`(Exhibit 2057 at 14.)
`
`99
`
`
`
`COPYING
`
`COPYING
`
`ARNOLD Er PORTER
`I KAYE SCHOLER
`
`100
`100
`
`
`
`COPYING
`
`“[C]opying the claimed invention, rather than
`one with public domain, is indicative of non-
`obviousness.”
`WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1336 (Fed. Cir.
`2016) (quoting Windsurfing Int’l, Inc. v. AMF, Inc., 782
`F.2d 995, 1000 (Fed. Cir. 1986))
`
`“A party may prove copying by showing that an
`accused copier had access to the patented
`product combined with substantial similarity to
`the patented product.”
`Intri-plex Techs., Inc. v. Saint-Gobain Performance
`Plastics Rencol, Ltd., IPR2014-00309, Paper 83 at 40
`(citing Wyers v. Master Lock Co., 616 F.3d 1231, 1246
`(Fed. Cir. 2010)).
`Privileged & Confidential
`
`101
`
`
`
`COPYING
`
`(Exhibit 2056 at 56.)
`(Exhibit 2056 at 56.)
`
`COPYING
`
`I KAYE SCHOLER
`
`ARNOLD Er PORTER
`
`102
`
`
`
`COPYING
`
`Buller Second Deposition (Ex. 2094) at 25:20-28:24:
`
`Q. The SAPIEN TAVR device, what is that?
`A. That is the first commercial product of Edwards that was launched
`worldwide for sale to treat patients with -- by TAVR procedures.
`Q. And that device did not have any outer skirt, correct?
`A. Correct. That device did not have an outer skirt.
`
`* * *
`Q. And the SAPIEN XT also did not have a skirt or a cuff around the
`outside of the device, correct?
`A. Correct.
`
`* * *
`Q. … Before the SAPIEN 3, Edwards 21 had never commercialized the
`TAVR device that had an outer skirt around the cuff, correct?
`A.
`I believe that is true.
`
`Privileged & Confidential
`
`103
`
`
`
`INDUSTRY PRAISE
`
`INDUSTRY PRAISE
`
`
`
`104
`
`
`
`INDUSTRY PRAISE
`
`“Industry participants ... are not likely to
`praise an obvious advance over the known art.
`Thus, if there is evidence of industry praise of
`the claimed invention in the record, it weighs
`in favor of the non-obviousness of the claimed
`invention.”
`
`Apple, Inc. v. Samsung Elecs. Co., 839
`F.3d 1034, 1053 (Fed. Cir. 2016)
`
`Privileged & Confidential
`
`105
`
`
`
`INDUSTRY PRAISE
`
`Yang, et al.
`
`(Exhibit 2059 at 3.)
`
`Privileged & Confidential
`
`106
`
`
`
`INDUSTRY PRAISE
`
`Hastings, et al.
`
`(Exhibit 2018 at 2, 3.)
`
`Privileged & Confidential
`
`107
`
`
`
`INDUSTRY PRAISE
`
`Nijhoff, et al.
`
`(Exhibit 2062 at 2.)
`
`Privileged & Confidential
`
`108
`
`
`
`UNEXPECTED RESULTS
`
`UNEXPECTED RESULTS
`
`
`
`109
`
`
`
`UNEXPECTED RESULTS
`
`(Exhibit 2063 at 4.)
`
`Privileged & Confidential
`
`110
`
`
`
`COMMERCIAL SUCCESS
`
`COMMERCIAL SUCCESS
`
`
`
`111
`
`
`
`COMMERCIAL SUCCESS
`
`“When a product attains a high degree of
`commercial success, there is a basis for
`inferring that attempts to a solution have been
`made and failed.... Demonstrating that an
`invention has commercial value, that it is
`commercially successful, weighs in favor of its
`nonobviousness”
`
`WBIP, LLC v. Kohler Co., 829 F.3d 1317,
`1337 (Fed. Cir. 2016)
`
`Privileged & Confidential
`
`112
`
`
`
`COMMERCIAL SUCCESS
`
`First Quarter 2015 Earnings Call Transcript (Ex. 2025 at 2):
`“[O]ur competitive position in Europe strengthened during the first
`quarter, driven by the introduction of SAPIEN 3 last year. Clinician
`feedback on this platform has been very positive and sales of this product
`in the quarter represented more than 90% of our THV sales in Europe.”
`
`Fourth Quarter 2015 Earnings Call Transcript (Ex. 2026 at 2):
`“In Transcatheter Heart Valves, full-year global sales were $1.2 billion,
`up 38% over the prior year on an underlying basis. We exceeded our
`original estimate of 15% to 25% provided a year ago, primarily due to the
`early approval of SAPIEN 3 in the U.S….”
`
`Second Quarter 2016 Earnings Call Transcript (Ex. 2068 at 3):
`“[W]e are increasing our 2016 sales guidance by $100 million to between
`$1.5 and $1.7 billion. We now expect our underlying sales growth to
`exceed 30%.”
`
`Privileged & Confidential
`
`113
`
`
`
`NEXUS
`
`NEXUS
`
`ARNOLDEPORTER
`I KAYE SCHOLER
`
`114
`114
`
`
`
`NEXUS
`
`Wood Declaration (Ex. 1046) at ¶ 40:
`
`Wood Deposition (Ex. 2096) at 49:13-18:
`
`Privileged & Confidential
`
`115
`
`
`
`NEXUS
`
`Distal end of valve leaflets attached to fabric seal
`“[T]he district court read into the term a requirement
`that the … sequences … should be directly joined with no
`intervening nucleotides.
`We hold, however, that this interpretation of the
`term ‘joined’ is not the broadest, reasonable
`interpretation…. To be joined or connected does not
`necessitate a direct joining or connection.”
`Genentech v. Chiron Corp., 112 F.3d 495,
`501 (Fed. Cir. 1997) (italics in original)
`
`Webster’s II New Riverside University Dictionary (1988):
`
`Privileged & Confidential
`
`116
`
`
`
`MOTION TO EXCLUDE
`
`MOTION TO EXCLUDE
`
`
`
`117
`
`
`
`MOTION TO EXCLUDE
`
`Buller Deposition (Ex. 2028) at 154:17-155:3:
`
`Q. Are you aware of any praise in the industry directed at the
`Sapien 3’s solution to paravalvular leakage?
`
`* * *
`THE WITNESS: Yes, I think people like the device. I’ve seen
`what can be called praise for it. They like the device. It has
`produced good results. Some results are published. None of that
`was in existence back in 2004. So I did not consider that as
`part of my analysis for this declaration.
`
`Privileged & Confidential
`
`118
`
`
`
`MOTION TO EXCLUDE
`
`Buller Deposition (Ex. 2028) at 170:5-13:
`
`Q. Did you undertake any effort to determine whether Edwards’
`Sapien 3 product was an embodiment of Claims 1 through 4 of the
`'608 patent in the course of your analysis in your declaration?
`
`A. No. I’ve already said – I thought I answered very clearly – I
`did not consider Sapien 3 at all for any purpose for my
`declaration.
`
`Privileged & Confidential
`
`119
`
`
`
`MOTION TO EXCLUDE
`
`Buller Deposition (Ex. 2028) at 143:15-144:3:
`
`Q. Do you believe the Sapien 3 is a commercially successful
`product?
`
`A. Yes.
`
`Q. Did you consider that commercial success in
`rendering your opinions in this case?
`
`A. No.
`
`Q. Do you think the commercial success of the Sapien has any
`relevance to the issues in this IPR?
`
`A. Not to my knowledge. I’m not a lawyer. It is not part of my
`analysis. I don’t see that it has any relevance.
`
`Privileged & Confidential
`
`120
`
`
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