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 IPR2017-0060
`Patent 8,992,608
`_______________
`
`DECLARATION OF GREGORY S. CORDREY
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`1
`
`Edwards Lifescience Corporation, et al. Exhibit 1076, p.1 of 10
`
`
`_______________
`
`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 IPR2017-0060
`Patent 8,992,608
`_______________
`
`DECLARATION OF GREGORY S. CORDREY
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`1
`
`Edwards Lifescience Corporation, et al. Exhibit 1076, p.1 of 10
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`
`
`
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`I, Gregory S. Cordrey, declare as follows:
`
`1.
`
`I am a partner at the law firm of Jeffer Mangels Butler & Mitchell,
`
`LLP, counsel to Petitioners Edwards Lifesciences Corporation, Edwards
`
`Lifesciences LLC and Edwards Lifesciences AG (collectively “Petitioners”) in the
`
`above-captioned matter.
`
`2.
`
`I have provided this declaration as evidence in support of Petitioners’
`
`Reply In Support of Inter Partes Review of U.S. Patent No. 8,922,608.
`
`3.
`
`Exhibit 1015 is a true and correct copy of excerpts from Vossoughi et
`
`al., Stent Graft Update (2000).
`
`4.
`
`Exhibit 1016 is a true and correct copy of excerpts from Dolmatch et
`
`al., Stent Grafts: Current Clinical Practice (1999).
`
`5.
`
`Exhibit 1026 is a true and correct copy of the Gore Excluder
`
`Instructions for Use (2002) available at the Federal Drug Administration website at
`
`https://www.fda.gov/ohrms/dockets/ac/02/briefing/3893b1_AAA.DEVICE.PMA.I
`
`FU.pre02.pdf.
`
`6.
`
`Exhibit 1028 is a true and correct copy of Assignment record for U.S.
`
`Patent App. Pub. No. 2003/0236567 to Elliot obtained from the USPTO online
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`records at http://portal.uspto.gov/pair/PAIRPrintServlet on July 23, 2016.
`
`7.
`
`Exhibit 1035 is a true and correct copy of the Supplemental
`
`Declaration of Niguel P. Buller, M.D.
`
`
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`Edwards Lifescience Corporation, et al. Exhibit 1076, p.2 of 10
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`
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`
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`8.
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`Exhibit 1036 is a true and correct copy of Approved Judgment,
`
`Edwards Lifesciences, Inc. v. Boston Scientific Scimed, Inc., HC-2015-004574
`
`dated March 3, 2017.
`
`9.
`
`Exhibit 1037 is a true and correct copy of Judgment, CoreValve Inc. v.
`
`Edwards Lifesciences AG et al., HC 07 C01243 dated January 9, 2009.
`
`10. Exhibit 1038 is a true and correct copy of Approved Judgment,
`
`Edwards Lifesciences AG v. Cook Biotech Inc., HC08 C 00934 dated June 12,
`
`2009.
`
`11. Exhibit 1039 is a true and correct copy of Memorandum, Edwards
`
`Lifesciences AG et al. v. CoreValve, Inc. et al., C.A. No. 08-91 (GMS) dated
`
`February 1, 2011.
`
`12. Exhibit 1040 is a true and correct copy of Plaintiffs’ Opening Brief
`
`in Support of Their Motion for Enhanced Damages Pursuant to 35 U.S.C. §
`
`284, Edwards Lifesciences LLC, et al. v. Medtronic CoreValve LLC, et al. C.A.
`
`12-023 (GMS) dated March 24, 2014.
`
`13. Exhibit 1041 is a true and correct copy of Vossoughi et al. (Eds.),
`
`Stent Graft Update, Medical and Engineering Publishers Inc. (2000).
`
`14. Exhibit 1042 is a true and correct copy of Dolmatch et al. (Eds.),
`
`Stent-Grafts Current Clinical Practice, Thieme (2000).
`
`
`
`Edwards Lifescience Corporation, et al. Exhibit 1076, p.3 of 10
`
`
`
`
`
`15. Exhibit 1043 is a true and correct copy of the Deposition
`
`Transcript of Stephen J.D. Brecker, M.D. (Sept. 1, 2017).
`
`16. Exhibit 1044 is a true and correct copy of the Deposition
`
`Transcript of Andrew J. Manganaro, M.D. (Sept. 15, 2017).
`
`17. Exhibit 1047 is a true and correct copy of the Curriculum Vitae of
`
`Larry Lee Wood.
`
`18. Exhibit 1048 is a true and correct copy of Shuren, Life-Saving,
`
`Smart Regulation on Behalf of Patients with Aortic Stenosis, FDA Voice (June
`
`16, 2014).
`
`19. Exhibit 1049 is a true and correct copy of Edwards Endovascular
`
`HVT – Patriot Technical Design Review Proof of Concept & Selection of 1st
`
`Generation Valve dated June 11, 2003.
`
`20. Exhibit 1050 is a true and correct copy of Presentation of Stanton
`
`Rowe, “History of Sapien and the Future of THV,” bearing Bates numbers
`
`[EDWARDS 02433143-211].
`
`21. Exhibit 1051 is a true and correct copy of Boston Scientific’s 2016
`
`Annual Report.
`
`22. Exhibit 1052 is a true and correct copy of Freeman et al., First-in-
`
`Man Transfemoral Transcatheter Aortic Valve Replacement with the 29 mm
`
`
`
`Edwards Lifescience Corporation, et al. Exhibit 1076, p.4 of 10
`
`
`
`
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`Edwards SAPIEN XT Valve, Catheterization and Cardiovascular Interventions,
`
`82:664-70 (2013).
`
`23. Exhibit 1053 is a true and correct copy of Wiegerinck et al., An
`
`Up-to-date Overview of the Most Recent Transcatheter Implantable Aortic
`
`Valve Prostheses, Expert Review of Medical Devices, 31-45 (2016).
`
`24. Exhibit 1054 is a true and correct copy of Zaman et al., Incidence
`
`and Predictors of Permanent Pacemaker Implantation Following Treatment
`
`with the Repositionable Lotus™ Transcatheter Aortic Valve, Catheterization
`
`and Cardiovascular Interventions (2016).
`
`25. Exhibit 1055 is a true and correct copy of August 18, 2016 Letter
`
`from B. Zuckerman to J. Mazzarella re: P130009/S057.
`
`26. Exhibit 1056 is a true and correct copy of Medtronic CoreValve™
`
`Evolut™ R System First TAVI to Receive CE Mark for Intermediate Risk
`
`Aortic Stenosis Patients, Medtronic Press Release (August 1, 2016).
`
`27. Exhibit 1057 is a true and correct copy of Medtronic Expands
`
`TAVR Access to More Patients With Symptomatic, Severe Aortic Stenosis
`
`Upon Intermediate Risk FDA Approval, Medtronic Press Release (July 10,
`
`2017).
`
`
`
`Edwards Lifescience Corporation, et al. Exhibit 1076, p.5 of 10
`
`
`
`
`
`28. Exhibit 1058 is a true and correct copy of Boston Scientific
`
`Receives CE Mark for Lotus™ Valve System, Boston Scientific Press Release
`
`(October 28, 2013).
`
`29. Exhibit 1059 is a true and correct copy of PCT Publication, WO
`
`2005/102015 A2 ("Bergheim").
`
`30. Exhibit 1060 is a true and correct copy of Jayalath, R.W. et al.,
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`“Aortic Calcification,” Eur. J. Vasc. Endovasc. Surg., Vol. 30, 476-488 (2005).
`
`31. Exhibit 1061 is a true and correct copy of a compilation of Exhibits
`
`32-43 to the May 26, 2017 Deposition of Assaf Bash, which are pictures of
`
`certain Percutaneous Valve Technologies physical prototypes of transcatheter
`
`heart valves.
`
`32. Exhibit 1062 is a true and correct copy of Edwards Lifesciences
`
`engineering drawings titled “PVL Skirt, laser cut THV3” bearing Bates
`
`numbers [EDWARDS 01026774-782].
`
`33. Exhibit 1063 is a true and correct copy of Edwards Lifesciences
`
`engineering drawings titled “CW Skirt, Laser Cut THV 3” bearing Bates
`
`numbers [EDWARDS 01026765-773].
`
`34. Exhibit 1064 is a true and correct copy of Exhibit 1 to the
`
`September 1, 2017 Deposition of Dr. Stephen J.D. Brecker, M.D., which is an
`
`
`
`Edwards Lifescience Corporation, et al. Exhibit 1076, p.6 of 10
`
`
`
`
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`excerpt of pages 1268-1276 from The Textbook of Interventional Cardiology,
`
`2d Ed. (1994), bearing Bates numbers [EDWARDS 00383578-589].
`
`35. Exhibit 1065 is a true and correct copy of Examiner’s March 12,
`
`2015 Answering Brief to Appeal from the Prosecution History of U.S. Patent
`
`App. No. 13/290,369.
`
`36. Exhibit 1066 is a true and correct copy of the Patent Trial and
`
`Appeal Board’s June 2, 2017 Appeal Decision from the Prosecution History of
`
`U.S. Patent App. No. 13/290,369.
`
`37. Exhibit 1067 is a true and correct copy of Declaration of Professor
`
`Stephen J.D. Brecker in Support of Boston Scientific’s Reply Claim
`
`Construction Brief (D.I. 109 in Boston Scientific Corp. v. Edwards Lifesciences
`
`Corp., C.A. No. 16-275 (SLR) (SRF) (D. Del.)).
`
`38. Exhibit 1068 is a true and correct copy of a November 19, 2014
`
`(updated January 13, 2015) FDA Recall Notice for the Lotus Transcatheter
`
`Aortic Valve Prosthesis.
`
`39. Exhibit 1069 is a true and correct copy of Edwards Lifesciences
`
`LLC’s and Edwards Lifesciences PVT, Inc.’s Reply Claim Construction Brief
`
`Regarding U.S. Patent Nos. 7,510,575, 9,168,133, and 9,339,383 (D.I. 106 in
`
`Boston Scientific Corp. v. Edwards Lifesciences Corp., C.A. No. 16-275 (SLR)
`
`(SRF) (D. Del.)).
`
`
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`Edwards Lifescience Corporation, et al. Exhibit 1076, p.7 of 10
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`
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`40. Exhibit 1070 is a true and correct copy of Roy, David et al.,
`
`“Transcatheter Aortic Valve Implantation for Pure Severe Native Aortic Valve
`
`Regurgitation,” JACC, Vol. 16(15), 1577-84 (2013).
`
`41. Exhibit 1071 is a true and correct copy of J.A. Southard, M.D.,
`
`TAVR: It’s a Career, Not Just a Procedure! (May 5, 2012), available at
`
`www.ucdmc.ucdavis.edu/internalmedicine/cardio/pdf/Symposium%202012/TA
`
`VR%20Talk.pdf.
`
`42. Exhibit 1072 is a true and correct copy of H.B. Riberio et al.,
`
`Balloon-Expandable Prostheses for Transcatheter Aortic Valve Replacement,
`
`56 Progress in Cardiovascular Diseases 583 (2014).
`
`43. Exhibit 1073 is a true and correct copy of “Centera: Novel
`
`Transcatheter Heart Valve Shows Promise in Aortic Stenosis,” EuroPCR
`
`Meeting News (May 26, 2017).
`
`44. Exhibit 1074 is a true and correct copy of Edwards Lifesciences
`
`Press Release: “Edwards’ Novel Self-Expanding Transcatheter Heart Valve
`
`Demonstrates Excellent Early Patient Outcomes” (May 17, 2017).
`
`45. Exhibit 1075 is a true and correct copy of “Edwards’ Self-
`
`Expanding Transcatheter Heart Valve Demonstrates Excellent Early Patient
`
`Outcomes,” DAIC (May 24, 2017).
`
`I declare under penalty of perjury that the foregoing is true and correct.
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`Edwards Lifescience Corporation, et al. Exhibit 1076, p.8 of 10
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`Dated: September 22, 2017
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`
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`By: /Gregory S. Cordrey/
`Gregory S. Cordrey
`
`
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`Edwards Lifescience Corporation, et al. Exhibit 1076, p.9 of 10
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on September
`
`22, 2017, a complete and entire copy of DECLARATION OF GREGORY S.
`
`CORDREY has been served in its entirety by e-mail on the following addresses of
`
`record for Patent Owner:
`
`jennifer.sklenar@apks.com
`
`wallace.wu@apks.com
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`
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`Date: September 22, 2017
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`
`
`
`
`
`
`/s/ Gregory S Cordrey
`Gregory S. Cordrey, Esq. (Reg. No. 44,089)
`Attorney for Petitioners
`
`
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`Edwards Lifescience Corporation, et al. Exhibit 1076, p.10 of 10
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`
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