IPR2017-00060
`
`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
`____________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and ROBERT L.
`KINDER, Administrative Patent Judges.
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`1
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`

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`PETITIONERS’ UPDATED EXHIBIT LIST
`
`EXHIBIT 1001 U.S. Patent No. 8,992,608 to Haug et al.
`
`EXHIBIT 1002
`
`File History of U.S. Application No. 12/492,512
`
`EXHIBIT 1003 WO 98/29057 to Cribier et al.
`
`EXHIBIT 1004 WO 03/047468 to Spenser et al.
`
`EXHIBIT 1005 U.S. Patent App. Pub. No. 2003/0236567 to Elliot
`
`EXHIBIT 1006 U.S. Patent App. Pub. No. 2004/0082989 to Cook et al.
`
`EXHIBIT 1007 Declaration of Dr. Nigel Buller
`
`EXHIBIT 1008 Alain Cribier et al., “Early experience with percutaneous
`transcatheter implantation of heart valve prosthesis for the
`treatment of end-stage inoperable patients with calcific aortic
`stenosis,” J. Am. Coll. Cardiol., 43(4): 698-703 (2004).
`EXHIBIT 1009 U.S. Patent App. Pub. No. 2001/0039450 to Pavcnik et al.
`
`EXHIBIT 1010 U.S. Patent App. Pub. No. 2004/0033364 to Spiridigliozzi et al.
`
`EXHIBIT 1011 U.S. Patent No. 3,365,728 to Edwards
`
`EXHIBIT 1013
`
`EXHIBIT 1012 Charles T. Dotter, “Transluminally-Placed Coilspring
`Endarterial Tube Grafts,” Investigative Radiology, 329-32
`(1969).
`Frank Ing, “Stents: What’s Available to the Pediatric
`Interventional Cardiologist?” Catheterization and Cardiovascular
`Interventions 57:274-386 (2002).
`EXHIBIT 1014 U.S. Patent No. 6,206,911 to Milo
`
`EXHIBIT 1015
`
`Excerpts from Vossoughi et al., Stent Graft Update (2000)
`
`EXHIBIT 1016
`
`Excerpts from Dolmatch et al., Stent Grafts: Current Clinical
`Practice (1999)
`EXHIBIT 1017 Andersen et al., “Transluminal implantation of artificial heart
`valves. Description of a new expandable aortic valve and initial
`results with implantation by catheter technique in closed chest
`pigs,” European Heart Journal, 13:704-08 (1992).
`EXHIBIT 1018 U.S. Patent No. 5,411,552 to Andersen et al.
`
`EXHIBIT 1019 U.S. Patent No. 6,015,431 to Thornton et al.
`
`EXHIBIT 1020 U.S. Patent App. Pub. No. 2001/0021872 to Bailey et al.
`
`EXHIBIT 1021 U.S. Patent No. 6,352,554 to De Paulis
`
`

`

`EXHIBIT 1022
`
`European Patent 2 749 254 B1 to Salahieh et al.
`
`EXHIBIT 1023 American Heritage College Dictionary, 4th Ed. 2002 (definition
`of “flaps”)
`EXHIBIT 1024 Merriam-Webster’s Collegiate Dictionary, 10th ed. (2001)
`(definitions of “flaps” and “pleats”)
`EXHIBIT 1025 Charles S. Thompson et al., “Endoluminal stent grafting of the
`thoracic aorta: Initial experience with the Gore Excluder,”
`Journal of Vascular Surgery, 1163-70 (June 2002).
`EXHIBIT 1026 Gore Excluder Instructions for Use (2002)
`
`EXHIBIT 1027 U.S. Patent No. 5,957,949 to Leonhardt et al.
`
`EXHIBIT 1029
`
`EXHIBIT 1028 Assignment record for U.S. Patent App. Pub. No. 2003/0236567
`to Elliot
`Lawrence et al., “Percutaneous Endovascular Graft:
`Experimental Evaluation,” Radiology, 163(2): 357-60 (May
`1987).
`European Patent 2 926 766 B1 to Salahieh et al.
`
`Exhibit 1030
`
`Exhibit 1031
`
`Exhibit 1032
`
`Exhibit 1033
`
`Boston Scientific’s August 24, 2016 Response in Opposition
`Proceedings of EP 2 749 254 B1
`Boston Scientific’s August 24, 2016 Reply in German
`Infringement Proceeding 4a O 137/15
`U.S. Patent No. 5,855,601 to Bessler et al.
`
`Exhibit 1034
`
`U.S. Patent No. 5,476,506 to Lunn
`
`Exhibit 1035
`
`Supplemental Declaration of Nigel. P. Buller, M.D.
`
`Exhibit 1036
`
`Exhibit 1037
`
`Exhibit 1038
`
`Exhibit 1039
`
`Exhibit 1040
`
`Exhibit 1041
`
`Approved Judgment, Edwards Lifesciences, Inc. v. Boston
`Scientific Scimed, Inc., HC-2015-004574 dated March 3, 2017
`Judgment, CoreValve Inc. v. Edwards Lifesciences AG et al., HC
`07 C01243 dated January 9, 2009
`Approved Judgment, Edwards Lifesciences AG v. Cook Biotech
`Inc., HC08 C 00934 dated June 12, 2009
`Memorandum, Edwards Lifesciences AG et al. v. CoreValve,
`Inc. et al., C.A. No. 08-91 (GMS) dated February 1, 2011
`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
`Vossoughi et al. (Eds.), Stent Graft Update, Medical and
`Engineering Publishers Inc. (2000)
`
`

`

`Exhibit 1042
`
`Exhibit 1043
`
`Exhibit 1044
`
`Exhibit 1045
`
`Dolmatch et al. (Eds.), Stent-Grafts Current Clinical Practice,
`Thieme (2000)
`Deposition Transcript of Stephen J.D. Brecker, M.D. (Sept. 1,
`2017)
`Deposition Transcript of Andrew J. Manganaro, M.D. (Sept. 15,
`2017)
`Reply Declaration of Nigel P. Buller, M.D.
`
`Exhibit 1046
`
`Declaration of Larry Lee Wood
`
`Exhibit 1047
`
`Curriculum Vitae of Larry Lee Wood
`
`Exhibit 1048
`
`Exhibit 1049
`
`Exhibit 1049
`[Redacted]
`
`Exhibit 1050
`
`Exhibit 1050
`[Redacted]
`Exhibit 1051
`
`Exhibit 1052
`
`Exhibit 1053
`
`Exhibit 1054
`
`Exhibit 1055
`
`Exhibit 1056
`
`Shuren, Life-Saving, Smart Regulation on Behalf of Patients with
`Aortic Stenosis, FDA Voice (June 16, 2014)
`Edwards Endovascular HVT – Patriot Technical Design Review
`Proof of Concept & Selection of 1st Generation Valve dated June
`11, 2003
`[REDACTED] Edwards Endovascular HVT – Patriot Technical
`Design Review Proof of Concept & Selection of 1st Generation
`Valve dated June 11, 2003
`Rowe, Stanton, “History of Sapien and the Future of THV”
`[EDWARDS 02433143-211]
`[REDACTED] Rowe, Stanton, “History of Sapien and the
`Future of THV” [EDWARDS 02433143-211]
`Boston Scientific’s 2016 Annual Report
`
`Freeman et al., First-in-Man Transfemoral Transcatheter Aortic
`Valve Replacement with the 29 mm Edwards SAPIEN XT Valve,
`Catheterization and Cardiovascular Interventions, 82:664-70
`(2013)
`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)
`Zaman et al., Incidence and Predictors of Permanent Pacemaker
`Implantation Following Treatment with the Repositionable
`Lotus™ Transcatheter Aortic Valve, Catheterization and
`Cardiovascular Interventions (2016)
`August 18, 2016 Letter from B. Zuckerman to J. Mazzarella re:
`P130009/S057
`Medtronic CoreValve™ Evolut™ R System First TAVI to
`Receive CE Mark for Intermediate Risk Aortic Stenosis Patients,
`Medtronic Press Release (August 1, 2016)
`
`

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`Exhibit 1057
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`Exhibit 1058
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`Exhibit 1059
`
`Exhibit 1060
`
`Exhibit 1061
`
`Medtronic Expands TAVR Access to More Patients With
`Symptomatic, Severe Aortic Stenosis Upon Intermediate Risk
`FDA Approval, Medtronic Press Release (July 10, 2017)
`Boston Scientific Receives CE Mark for Lotus™ Valve System,
`Boston Scientific Press Release (October 28, 2013)
`WO 2005/102015 to Bergheim et al.
`
`Jayalath, R.W. et al., “Aortic Calcification,” Eur. J. Vasc.
`Endovasc. Surg., Vol. 30, 476-488 (2005)
`Compilation of Pictures of PVT Prototype Designs
`
`Exhibit 1062
`
`Engineering Drawings, S3 External Skirt
`
`Exhibit 1062
`[Redacted]
`Exhibit 1063
`
`Exhibit 1063
`[Redacted]
`Exhibit 1064
`
`Exhibit 1065
`
`Exhibit 1066
`
`Exhibit 1067
`
`Exhibit 1068
`
`Exhibit 1069
`
`Exhibit 1070
`
`Exhibit 1071
`
`[REDACTED] Engineering Drawings, S3 External Skirt
`
`Engineering Drawings, S3 Internal Skirt
`
`[REDACTED] Engineering Drawings, S3 Internal Skirt
`
`Brecker Deposition Exhibit 1, Excerpts from Textbook of
`Interventional Cardiology, 2d Ed. (1994)
`U.S. Patent App. No. 13/290,369 Prosecution History,
`Examiner’s Answering Brief to Appeal (Mar. 12, 2015)
`U.S. Patent App. No. 13/290,369 Prosecution History, PTAB
`Appeal Decision (June 2, 2017)
`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.))
`Lotus Valve FDA Recall Notice
`
`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.))
`Roy, David et al., “Transcatheter Aortic Valve Implantation for
`Pure Severe Native Aortic Valve Regurgitation,” JACC, Vol.
`16(15), 1577-84 (2013)
`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/Symposiu
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`

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`Exhibit 1072
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`Exhibit 1073
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`Exhibit 1074
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`Exhibit 1075
`
`Exhibit 1076
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`m%202012/TAVR%20Talk.pdf
`
`H.B. Riberio et al., Balloon-Expandable Prostheses for
`Transcatheter Aortic Valve Replacement, 56 Progress in
`Cardiovascular Diseases 583 (2014)
`“Centera: Novel Transcatheter Heart Valve Shows Promise in
`Aortic Stenosis,” EuroPCR Meeting News (May 26, 2017)
`Edwards Lifesciences Press Release: “Edwards’ Novel Self-
`Expanding Transcatheter Heart Valve Demonstrates Excellent
`Early Patient Outcomes” (May 17, 2017)
`
`“Edwards’ Self-Expanding Transcatheter Heart Valve
`Demonstrates Excellent Early Patient Outcomes,” DAIC (May
`24, 2017)
`Declaration of Gregory S. Cordrey
`
`Exhibit 1077
`
`Petitioners’ Demonstrative Exhibits
`
`Exhibit 1078
`
`[REDACTED] Petitioners’ Demonstrative Exhibits
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`

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`Exhibit 15311
`
`[REDACTED] Patent Owner’s Exhibit 2031 – Slide Deck titled
`“SAPIEN 3 26mm CDR Nov 2010” [EDWARDS 01933840-
`939]
`
`
`1
`On February 23, 2018, Petitioners filed on behalf of the parties a Joint
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`Revised Motion (Paper 61) to file the following confidential documents under seal:
`
`Exs. 1049, 1050, 1062-63, 2031, 2034, 2036, 2039, 2041-46, 2055-57, 2063, 2077,
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`2085-86, and 2088-91. Each of these Exhibits contains only Petitioners’
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`confidential information. With the Joint Motion, Petitioners filed redacted
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`versions of these Exhibits, which were originally sealed in their entirety. A
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`number of the corresponding confidential Exhibits were originally filed by PO, and
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`thus bear 2XXX exhibit numbers. The filing system, however, only allowed
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`Petitioners to file exhibits with 1XXX numbers, and would not permit Petitioners
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`to file exhibits with 2XXX numbers. Petitioners therefore filed redacted versions
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`of PO’s exhibits under 15XX exhibit numbers that correspond to the exhibit’s
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`actual 2XXX exhibit number. See Exs. 1531, 1534, 1536, 1539, 1541-46, 155-57,
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`1563, 1577, 1585-86, and 1588-91. For example, the redacted version of PO’s
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`exhibit 2031 was filed as Petitioners’ Exhibit 1531 and the description identifies it
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`as the redacted version of Exhibit 2031. Petitioners emailed the Board
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`concurrently with the Joint Motion to highlight this filing, and Petitioners
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`confirmed by telephone with the PTAB’s assistance line on February 26, 2018 that
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`the filing of an updated exhibit list will sufficiently clarify the docket on this issue.
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`Exhibit 1534
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`Exhibit 1536
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`Exhibit 1539
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`Exhibit 1541
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`Exhibit 1542
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`Exhibit 1543
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`Exhibit 1544
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`Exhibit 1545
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`Exhibit 1546
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`Exhibit 1555
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`Exhibit 1556
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`Exhibit 1557
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`Exhibit 1563
`
`[REDACTED] Patent Owner’s Exhibit 2034 – Slide Deck titled
`“Edwards SAPIEN 3 Transcatheter Heart Valve with the
`Edwards Commander System 23/26/29 mm Sizes Procedural
`Training Manual” [EDWARDS 01026580-751]
`[REDACTED] Patent Owner’s Exhibit 2036 – Permanent PVL
`Locking Stitch to Skirt, Element ID 220 [EDWARDS
`01026527-35]
`[REDACTED] Patent Owner’s Exhibit 2039 – Document titled
`“Meeting with Physicians: PHV sizing and paravalvular Leak”
`dated May 23, 2003 [EDWARDS 00743914-18]
`[REDACTED] Patent Owner’s Exhibit 2041 – Document titled
`“Summary of Stanley’s and Larry’s visit July 27-29, 2004”
`[EDWARDS 01033971-90]
`[REDACTED] Patent Owner’s Exhibit 2042 – Document titled
`“Visit Summary Stu, Keith, Jan, Mark K., Larry, Stanley &
`Laksen,” dated May 24, 2006 [EDWARDS 01033782-825]
`[REDACTED] Patent Owner’s Exhibit 2043 – Document titled
`“Summary of Management Quarterly Visit July 12-14, 2005”
`[EDWARDS 01033844-86]
`[REDACTED] Patent Owner’s Exhibit 2044 – Slide Deck titled
`“THV2 Design Commitment Review,” dated May 13, 2007
`[EDWARDS 00260617-58]
`[REDACTED] Patent Owner’s Exhibit 2045 – Slide Deck titled
`“PHV2,” dated March 2006 [EDWARDS 02438701-26]
`[REDACTED] Patent Owner’s Exhibit 2046 – Slide Deck titled
`“Limited Clinical Feasibility (FIM) Design Review SAPIEN 3
`with the NovaFlex 4 Delivery System (DS) and Accessories”
`[EDWARDS 0174788-849]
`[REDACTED] Patent Owner’s Exhibit 2055 – Slide Deck titled
`“Edwards Lifesciences: Transcatheter Aortic Valve Implantation
`Product Attribute Study Report,” dated July 2011 [EDWARDS
`02186714-69]
`[REDACTED] Patent Owner’s Exhibit 2056 – Slide Deck titled
`“THV Competitive Deep Dive,” dated November 2008
`[EDWARDS 02079411-527]
`[REDACTED] Patent Owner’s Exhibit 2057 – Slide Deck titled
`“SAPIEN 3 – US Team Download,” dated Nov. 21, 2014
`[EDWARDS 01809151-282]
`[REDACTED] Patent Owner’s Exhibit 2063 – Document titled
`
`

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`Exhibit 1577
`
`Exhibit 1585
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`Exhibit 1586
`
`Exhibit 1588
`
`Exhibit 1589
`
`Exhibit 1590
`
`Exhibit 1591
`
`“Journey to S3,” dated May 8, 2016 [EDWARDS 02399064-68]
`
`[REDACTED] Patent Owner’s Exhibit 2077 – Slide Deck titled
`“Designing the Future of TAVR” [EDWARDS 01820001-48]
`[REDACTED] Patent Owner’s Exhibit 2085 – Document titled
`“SAPIEN 3, PVL Skirt Meeting,” dated September 16, 2011
`[EDWARDS 01934680-84]
`[REDACTED] Patent Owner’s Exhibit 2086 – Slide Deck titled
`“SAPIEN 3 Product Deep Dive” [EDWARDS 01956628-77]
`[REDACTED] Patent Owner’s Exhibit 2088 – Document titled
`“SAPIEN 3, PVL Skirt Meeting,” dated September 16, 2011
`[EDWARDS 01756438]
`[REDACTED] Patent Owner’s Exhibit 2089 – Email chain dated
`March 20, 2013 [EDWARDS 02405909-10]
`[REDACTED] Patent Owner’s Exhibit 2090 – Slide Deck titled
`“THV Sales Meeting,” dated Jan. 9, 2014 [EDWARDS
`01807655-707]
`[REDACTED] Patent Owner’s Exhibit 2091 – Email chain dated
`Aug. 8, 2011 [EDWARDS 02186713]
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`Dated: February 26, 2018
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`Respectfully Submitted,
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`
`/s/Gregory S. Cordrey
` Gregory S. Cordrey, Esq. (Reg. No. 44,089)
` Brian P. Egan, Esq. (Reg. No. 54,866)
` Catherine Nyarady, Esq. (Reg. No. 42,042)
` Attorney for Petitioners
`Edwards Lifesciences Corporation,
`Edwards Lifesciences LLC, and
`Edwards Lifesciences AG
`
`
`
`

`

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`
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on February 26, 2018, a
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`CERTIFICATE OF SERVICE
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`complete and entire copy of PETITIONERS’ UPDATED EXHIBIT LIST has been
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`served in its entirety by e-mail on the following addresses of record for Patent
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`Owner:
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`jennifer.sklenar@apks.com
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`wallace.wu@apks.com
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`marc.cohn@apks.com
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`matthew.wolf@apks.com
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`edward.han@apks.com
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`
`
`/s/Gregory S. Cordrey
`Gregory S. Cordrey, Esq. (Reg. No. 44,089)
`Attorney for Petitioners
`Edwards Lifesciences Corporation,
`Edwards Lifesciences LLC, and
`Edwards Lifesciences AG
`
`