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