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 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
`
`
`_______________
`
`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 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
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`Description
`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)
`Declaration of Marc A. Cohn in Support of Motion for Pro Hac
`Vice Admission (May 9, 2017)
`Declaration of Matthew M. Wolf in Support of Motion for Pro Hac
`Vice Admission (May 9, 2017)
`Declaration of Edward Han in Support of Motion for Pro Hac Vice
`Admission (May 9, 2017)
`Proposed Stipulated Protective Order (June 20, 2017)
`
`Comparison to Default Protective Order (June 20, 2017)
`
`Exhibit No.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`-1-
`
`
`
`Exhibit No.
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`Description
`Edwards SAPIEN Transcatheter Heart Valve (THV) - P100041,
`U.S. Food & Drug Admin. (Sept. 6, 2013), https://wayback.archive-
`it.org/7993/20161023015438/http:/www.fda.gov/MedicalDevices/
`ProductsandMedicalProcedures/DeviceApprovalsandClearances/
`Recently-ApprovedDevices/ucm280840.htm
`Press Release: Edwards Lifesciences Receives CE Mark for
`Edwards SAPIEN Transcatheter Heart Valve, Edwards Lifesciences
`(Sept. 5, 2007)
`Press Release: Edwards Lifesciences Announces First Human
`Implants With 18 French Transcatheter Valve System, Edwards
`Lifesciences (May 14, 2009)
`SAPIEN XT Valve Product Overview, Edwards Lifesciences,
`http://www.edwards.com/devices/heart-valves/sapien-xt-valve (last
`visited June 21, 2017)
`Ramin S. Hastings & Isaac George, The Sapien 3 Valve, Cardiac
`Interventions Today, Mar./Apr. 2016
`Susheel Kodali et al., Paravalvular Regurgitation after
`Transcatheter Aortic Valve Replacement with the Edwards Sapien
`Valve in the PARTNER trial: characterizing patients and impact on
`outcomes, Eur. Heart J. (2014)
`Press Release: Edwards Lifesciences Receives FDA Approval for
`First Catheter-Based Aortic Heart Valve in the U.S., Edwards
`Lifesciences (Nov. 2, 2011)
`Press Release: Edwards Lifesciences Launching Sapien XT Valve
`In The U.S., Edwards Lifesciences (June 16, 2014)
`TAVR By Edwards: Our Latest Valve, Edwards Lifesciences,
`https://tavrbyedwards.com/our-latest-heart-valve-sapien-3 (last
`visited Nov. 14, 2016)
`Press Release: Edwards Receives European Approval for Advanced
`SAPIEN 3 Valve, Edwards Lifesciences (Jan. 27, 2014)
`Takahide Arai et al., Comparison of Edwards SAPIEN 3 versus
`SAPIEN XT in transfemoral transcatheter aortic valve implantation:
`Difference of valve selection in the real world, J. Cardiology (2016)
`Edwards Lifesciences (EW) Michael A. Mussallem on Q1 2015
`Results - Earnings Call Transcript
`Edwards Lifesciences (EW) Michael A. Mussallem on Q4 2015
`Results - Earnings Call Transcript
`
`-2-
`
`
`
`Exhibit No.
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`Description
`Press Release: Edwards SAPIEN 3 Transcatheter Heart Valve
`Receives Expanded Indication From FDA, Edwards Lifesciences
`(Aug. 18, 2016)
`Deposition Transcript of Nigel P. Buller, M.D., dated June 15, 2017
`
`Transcript of Proceedings, Cordis Corp. v. Boston Scientific Corp.,
`No. 10-39-SLR, Dkt. 275 (D. Del. May 11, 2012)
`U.S. Patent No. 7,276,078 to Spenser et al.
`
`Slide Deck titled “SAPIEN 3 26mm CDR Nov 2010”
`(EDWARDS 01933840-939)
`Boston Scientific Corp. v. Edwards Lifesciences Corp., No. 16-275-
`SLR-SRF, Dkt. 186 (D. Del. June 1, 2017)
`Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards
`Lifesciences, http://www.edwards.com/devices/Heart-Valves/
`Transcatheter-Sapien-3 (last visited June 21, 2017)
`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)
`Photograph of Sapien 3 Valve (BSC-EDW0059565)
`
`Permanent PVL Locking Stitch to Skirt, Element ID 220
`(EDWARDS 01026527-35)
`Press Release: FDA approves SAPIEN 3 THV artificial heart valve,
`FDA (June 17, 2015)
`TAVItalk Designing the Future of TAVI - A Technology-Focused
`Edition: The SAPIEN 3 Valve, Edwards Lifesciences, Summer
`2014
`Document titled “Meeting with Physicians: PHV sizing and
`paravalvular Leak” dated May 23, 2003 (EDWARDS00743914-18)
`Patent application (EDWARDS 01032820-88)
`
`Document titled “Summary of Stanley’s and Larry’s visit July 27-
`29, 2004” (EDWARDS 01033971-90)
`
`-3-
`
`
`
`Exhibit No.
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`Description
`Document titled “Visit Summary Stu, Keith, Jan, Mark K., Larry,
`Stanley & Laksen,” dated May 24, 2006 (EDWARDS 01033782-
`825)
`Document titled “Summary of Management Quarterly Visit July
`12-14, 2005” (EDWARDS 01033844-86)
`Slide Deck titled “THV2 Design Commitment Review,” dated May
`13, 2007 (EDWARDS00260617-58)
`Slide Deck titled “PHV2,” dated March 2006 (EDWARDS
`02438701-26)
`Slide Deck titled “Limited Clinical Feasibility (FIM) Design
`Review SAPIEN 3 with the NovaFlex 4 Delivery System (DS) and
`Accessories” (EDWARDS 0174788-849)
`Document titled “FACT SHEET: Cribier-Edwards Percutaneous
`Aortic Heart Valve,” Edwards Lifesciences
`Ali N. Azadani et al., Energy Loss Due to Paravalvular Leak With
`Transcatheter Aortic Valve Implantation, 88 Annals Thoracic
`Surgery 1857 (2009)
`Philippe Généreux et al., Paravalvular Leak After Transcatheter
`Aortic Valve Replacement, 61 J. Am. C. Cardiology 1125 (2013)
`Ignacio Cruz-González et al., Paravalvular Leak Closure After
`Transcatheter Aortic Valve Implantation Simultaneously Using
`Amplatzer Vascular Plug III and IV Devices, 68 Revista Española
`Cardiologia 1035 (2015)
`Martin B. Leon slide deck titled “A Randomized Evaluation of the
`SAPIEN XT Transcatheter Valve System in Patients with Aortic
`Stenosis Who Are Not Candidates for Surgery: PARTNER II,
`Inoperable Cohort,” dated March 10, 2013, available at
`http://www.acc.org/~/media/Clinical/PDF-Files/Approved-
`PDFs/2011/04/04/07/06/PARTNER-2-ACC13-Presentation-
`Slides.pdf
`Vinod H. Thourani slide deck titled “SAPIEN 3 Transcatheter
`Aortic Valve Replacement Compared with Surgery in Intermediate-
`Risk Patients: A Propensity Score Analysis,” dated April 3, 2016,
`available at https://www.acc.org/~/media/Clinical/PDF-Files/
`Approved-PDFs/2016/03/29/08/33/SUN%201145am%20ACC16
`%20Slides%20PARTNER%20II%20Sapien%203.ppt
`
`-4-
`
`
`
`Exhibit No.
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`Description
`Thomas Walther et al., Transapical Minimally Invasive Aortic
`Valve Implantation Multicenter Experience, 116 Circulation I-240
`(2017)
`Alec Vahanian et al., Transcatheter valve implantation for patients
`with aortic stenosis: a position statement from the European
`Association of Cardio-Thoracic Surgery (EACTS) and the
`European Society of Cardiology (ESC), in collaboration with the
`European Association of Percutaneous Cardiovascular Interventions
`(EAPCI), 34 Eur. J. Cardio-thoracic Surgery 1 (2008)
`Slide Deck titled “Edwards LifeSciences: Transcatheter Aortic
`Valve Implantation Product Attribute Study Report,” dated July
`2011 (EDWARDS 02186714-69)
`Slide Deck titled “THV Competitive Deep Dive,” dated November
`2008 (EDWARDS 02079411-527)
`Slide Deck titled “SAPIEN 3 - US Team Download,” dated Nov.
`21, 2014 (EDWARDS 01809151-282)
`Dave Fornell, Transcatheter Repair of Paravalvular Leak,
`Diagnostic & Interventional Cardiology, Feb. 8, 2016,
`http://www.dicardiology.com/article/transcatheter(cid:173)repair(cid:173)
`paravalvular(cid:173)leak
`Tae-Hyun Yang et al., Incidence and Severity of Paravalvular
`Aortic Regurgitation With Multidetector Computed Tomography
`Nominal Area Oversizing or Undersizing After Transcatheter Heart
`Valve Replacement With the Sapien 3, 8 JACC: Cardiovascular
`Interventions 462 (2015)
`Robert P. Gooley, Comparison of Self-Expanding and
`Mechanically Expanded Transcatheter Aortic Valve Prostheses, 8
`JACC: Cardiovascular Interventions 962 (2015)
`B. Gonska et al., Comparison of the new balloon-expandable
`Edwards Sapien 3 valve with the self-expanding Medtronic
`corevalve for transfemoral aortic valve implantation in 200 patients,
`EuroIntervention, May 15, 2015, https://www.pcronline.com/
`eurointervention/AbstractsEuroPCR2015/abstracts-europcr-
`2015/POS291/comparison-of-the-new-balloon-expandable-
`edwards-sapien-3-valve-with-the-self-expanding-medtronic-
`corevalve-for-transfemoral-aortic-valve-implantation-in-200-
`patients.html
`
`-5-
`
`
`
`Exhibit No.
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`2071
`
`2072
`
`2073
`
`2074
`
`2075
`
`Description
`Freek Nijhoff et al., Transcatheter Aortic Valve Implantation With
`the New Balloon-Expandable Sapien 3 Versus Sapien XT Valve
`System, Circulation: Cardiovascular Interventions, June 1, 2015,
`http://circinterventions.ahajournals.org/content/circcvint/8/6/
`e002408.full.pdf
`Document titled “Journey to S3,” dated May 8, 2016 (EDWARDS
`02399064-68)
`Press Release: Edwards Lifesciences Reports Fourth Quarter
`Results, Edwards Lifesciences (Feb. 1, 2017)
`Press Release: Edwards Receives FDA Approval for SAPIEN 3
`Transcatheter Heart Valve, Edwards Lifesciences (June 17, 2015)
`Press Release: Edwards Sapien 3 Transcatheter Heart Valve
`Receives Expanded Indication In Europe, Edwards Lifesciences
`(Sept. 19, 2016)
`Edwards Lifesciences’ (EW) CEO Michael Mussallem on Q4 2014
`Results - Earnings Call Transcript
`Edwards Lifesciences (EW) Michael A. Mussallem on Q2 2016
`Results - Earnings Call Transcript
`Aortic Valve, Wikipedia,
`https://en.wikipedia.org/wiki/Aortic_valve
`What is Severe Aortic Stenosis?, Medtronic,
`http://www.corevalve.com/us/what-severe-aortic-
`stenosis/index.htm
`Image No. 848 Gross pathology of rheumatic heart disease: aortic
`stenosis, CDC Public Health Image Library (PHIL),
`https://phil.cdc.gov/phil/details.asp?pid=848
`Matthew J. Czarny & Jon R. Resar, Diagnosis and Management of
`Valvular Aortic Stenosis, Clinical Medicine Insights: Cardiology
`2014:8(S1), 15-24
`Image of Hancock II Ultra valve, Medtronic,
`http://www.medtronic.com/content/dam/medtronic-com-m/mdt/
`cardsurg/images/hancock_ii_ultra_b.jpg
`Carpentier-Edwards PERIMOUNT Aortic Heart Valve, Edwards
`Lifesciences, http://www.edwards.com/eu/products/heartvalves/
`pages/perimountaortic.aspx
`Aortic Heart Valve with Conform-X Sewing Ring, CryoLife, Inc.,
`http://www.cryolife.com/products/on-x-heart-valves/
`
`-6-
`
`
`
`Exhibit No.
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`2089
`
`2090
`
`Description
`Aorta scheme image, Wikimedia Commons,
`https://commons.wikimedia.org/wiki/File:Aorta_scheme.jpg
`Slide Deck titled “Designing the Future of TAVR” (EDWARDS
`01820001-48)
`Photograph of the Sapien 3 Valve (BSC-EDW0059563)
`
`Declaration of Dr. Andrew J. Manganaro in Support of Patent
`Owner’s Response (June 23, 2017)
`Declaration of Steven J. D. Brecker in Support of Patent Owner’s
`Response (June 23, 2017)
`Image of Heart Valve, WikiDoc,
`http://www.wikidoc.org/index.php/File:1687.jpg
`Sapien 3 Placement Video, Edwards Lifesciences, retrieved from
`http://www.edwards.com/devices/Heart-Valves/Transcatheter-
`Sapien-3
`Sapien 3 Transfemoral Animation, Edwards Lifesciences, retrieved
`from http://www.edwards.com/devices/Heart-Valves/Transcatheter-
`Sapien-3
`Sapien 3 Transformational Design Animations, Edwards
`Lifesciences, retrieved from
`http://www.edwards.com/devices/Heart-Valves/Transcatheter-
`Sapien-3
`Document titled “SAPIEN 3, PVL Skirt Meeting,” dated September
`16, 2011 (EDWARDS 01934680-84)
`Slide Deck titled “SAPIEN 3 Product Deep Dive” (EDWARDS
`01956628-77)
`Orange Gasket Video (EDWARDS01029569)
`
`Document titled “SAPIEN 3, PVL Skirt Meeting,” dated September
`16, 2011 (EDWARDS 01756438)
`Email chain dated March 20, 2013 (EDWARDS 02405909-10)
`
`Slide Deck titled “THV Sales Meeting,” dated Jan. 9, 2014
`(EDWARDS 01807655-707)
`
`-7-
`
`
`
`Exhibit No.
`
`2091
`
`2092
`
`2093
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`Description
`Email chain dated Aug. 8, 2011 (EDWARDS 02186713)
`
`Proposed Stipulated Protective Order (July 28, 2017)
`
`Comparison to Default Protective Order (July 28, 2017)
`
`Deposition Transcript of Nigel P. Buller, M.D., dated October 17,
`2017
`Drawing, Exhibit A to Dr. Buller Deposition, October 17, 2017
`
`Deposition Transcript of Larry Wood, dated October 19, 2017
`
`Kodali et al., Two-Year Outcomes After Transcatheter or Surgical
`Aortic-Valve Replacement, N. Engl. J. Med., vol. 366 (2012)
`Deposition Transcript of Larry Wood, dated June 13, 2017
`
`Document titled “Global THV - Q2 2016 Update” dated July 12,
`2016 (EDWARDS 02146627-95)
`
`Dated: November 3, 2017
`
`Respectfully submitted,
`/s Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`Wallace Wu (Reg. No. 45,380)
`ARNOLD & PORTER KAYE
`SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax: (213) 243-4199
`
`Attorneys for Patent Owner Boston
`Scientific Scimed, Inc.
`
`-8-
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of PATENT OWNER’S UPDATED
`EXHIBIT LIST and Exhibits 2094-2099 were served on November 3, 2017, to the
`following Counsel for Petitioner via e-mail:
`
`Gregory S. Cordrey (Reg. No. 44,089)
`Jeffer Mangels Butler & Mitchell, LLP
`3 Park Plaza, Suite 1100
`Irvine, CA 926214
`Email: gcordrey@jmbm.com
`Telephone: 949-623-7200
`Facsimile: 949-623-7201
`
`Brian Egan (Reg. No. 54,866)
`Morris, Nichols, Arsht & Tunnell, LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`Email: began@MNAT.com
`Telephone: 302-351-9454
`Facsimile: 302-498-6216
`
`Catherine Nyarardy (Reg. No. 42,042)
`Paul, Weiss, Rifkind, Wharton &
`Garrison, LLP
`1285 Avenue of the Americas
`New York, NY 10019
`Email: cnyarardy@paulweiss.com
`Telephone: 212-373-3532
`Facsimile: 212-492-0532
`
`Attorneys for Petitioners Edwards Lifesciences Corporation, Edwards Lifesciences
`LLC, and Edwards Lifesciences AG
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`ARNOLD & PORTER KAYE
`SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax: (213) 243-4199
`
`- i -
`
`
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