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 B2
`_______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`PATENT OWNER’S RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`STATEMENT OF PRECISE RELIEF REQUESTED .......................................1
`I.
`INTRODUCTION ...............................................................................................2
`II.
`III. BACKGROUND .................................................................................................6
`A. TAVR...................................................................................................................6
`B. The ‘608 Patent....................................................................................................8
`C. Petitioner’s Earlier-Generation TAVR Devices................................................11
`D. Petitioner’s Infringing SAPIEN 3 TAVR Device .............................................12
`E. The Petition........................................................................................................15
`IV.
`THE OPINIONS OF PETITIONER’S EXPERT ARE ENTITLED TO LITTLE
`OR NO WEIGHT.........................................................................................................15
`V.
`CLAIM CONSTRUCTION ..............................................................................20
`VI. CLAIMS 1-4 ARE NOT UNPATENTABLE...................................................20
`A. There Was No Motivation To Combine Spenser With Elliot, Thornton, Or
`Cook..........................................................................................................................21
`1.There Was No Motivation To Combine Spenser With Elliot ...........................22
`a) Spenser And Elliot Address Different Problems........................................22
`b) The Teachings Of Spenser Are Inconsistent With The Seal Of Elliot.......27
`2.There Was No Motivation To Combine Spenser With Thornton .....................32
`a) Spenser And Thornton Address Different Problems..................................32
`b) The Teachings Of Spenser Are Inconsistent With The Seal Of Thornton.34
`3.There Was No Motivation To Combine Spenser With Cook ...........................35
`a) Spenser And Cook Address Different Problems ........................................35
`b) The Teachings Of Spenser Are Inconsistent With The Seal Of Cook .......37
`B. None Of Petitioner’s Combinations Discloses Every Element Of Claims 1-4.38
`
`-i-
`
`

`

`1.Spenser In View Of Elliot Does Not Disclose Every Element Of Claims 1-4 .39
`2.Spenser In View Of Thornton Does Not Disclose Every Element Of Claims
`1-4 ......................................................................................................................42
`3.Spenser In View Of Cook Does Not Disclose Every Element Of Claims 1-4 .44
`C. Objective Indicia Of Non-Obviousness Establish That Claims 1-4 Are Not
`Invalid Under 35 U.S.C. § 103(a)......................................................................47
`1.There Is A Strong Nexus Between Petitioner’s Use Of The Invention And
`The Objective Indicia Of Non-Obviousness .....................................................50
`2.Objective Indicia Of Non-Obviousness.............................................................58
`a) Others, Including The Petitioner, Tried And Failed To Solve The
`Problem Of PVL................................................................................................58
`b) There Was A Long-Felt Need For A Solution To The Problem Of
`Paravalvular Leakage.................................................................................63
`c) Petitioner Copied The Invention.................................................................64
`d) The Industry Has Praised The Invention ....................................................66
`e) The Invention Yielded Unexpected Results ...............................................69
`f) The Invention Has Enjoyed Commercial Success......................................70
`3.Petitioner’s Expert Failed To Consider The Objective Indicia Of
`Nonobviousness.................................................................................................72
`VII. CONCLUSION..................................................................................................75
`
`-ii-
`
`

`

`TABLE OF AUTHORITIES
`
`CASES
`Apple Inc. v. Samsung Elec. Co., Ltd.,
`839 F.3d 1034 (Fed. Cir. 2016) ..............................................................48, 64, 69
`
`Page(s)
`
`Bio-Rad Labs., Inc. v. GE Healthcare Bio-sciences AB,
`IPR2015-01826 (Feb. 6, 2015) ...........................................................................18
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) ..........................................................................26
`
`CFMT, Inc. v. YieldUp Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) ..........................................................................38
`
`CaptionCall, L.L.C. v. Ultratec, Inc.,
`IPR2015-00636 (Sept. 7, 2016)..........................................................................18
`
`Costco Wholesale Corp., v. Robert Bosch LLC,
`IPR2016-00035 (April 25, 2016)........................................................................22
`
`Crocs, Inc. v. ITC,
`598 F.3d 1294 (Fed. Cir. 2010) ..........................................................................66
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) ..........................................................................30
`
`DePuy Synthes Sales, Inc. v. Acantha LLC,
`IPR2016-00334 (June 6, 2016)...........................................................................31
`
`Gnosis S.P.A. v. South Alabama Med. Sci. Found.,
`IPR2013-00116 (June 20, 2014).........................................................................57
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966)..........................................................................................21, 48
`
`Heidelberger Druckmaschinen AG v. Hantscho Commercial Prod., Inc.,
`21 F.3d 1068 (Fed. Cir. 1994) ............................................................................63
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) ..............................................................48, 62, 64
`
`-iii-
`
`

`

`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................................21
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ..........................................................................48
`
`In re Nuvasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) ....................................................................22, 26
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) ..............................................................................38
`
`Innopharma Licensing, Inc. v. Senju Pharm. Co.,
`IPR2015-00902 (July 28, 2016) .........................................................................49
`
`Intouch Techs., Inc. v. VGo Commc’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) ....................................................................72, 73
`
`Intri-plex Tech., Inc. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309 (March 23, 2014)................................................................48, 66
`
`Keurig Green Mountain, Inc. v. Touch Coffee & Beverages, LLC,
`IPR2016-01394 (Jan. 4, 2017)...........................................................................30
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) ..................................................26, 69, 70, 72, 73
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)............................................................................................21
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ........................................................23, 48, 49, 71
`
`Micro Motion, Inc. v. Invensys Sys., Inc.,
`IPR2014-01409 (Feb. 18, 2015) .........................................................................24
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) ....................................................................23, 63
`
`Nike, Inc. v. Adidas AG,
`812 F.3d 1326 (Fed. Cir. 2016) ..........................................................................48
`
`-iv-
`
`

`

`Oil States Energy Services, LLC v. Greene’s Energy Group, LLC,
`2017 WL 2507340 (U.S. June 12, 2017)..............................................................1
`
`Owens Corning v. Fast Felt Corp.,
`IPR2015-00650 (Aug. 11, 2016) ........................................................................18
`
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`IPR2016-00165 (April 21, 2016)........................................................................27
`
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. Appx. 755 (Fed. Cir. 2015) .....................................................................30
`
`Rambus Inc. v. Rea,
`731 F.3d 1248 (Fed. Cir. 2013) ..............................................................48, 69, 72
`
`Seabery North America, Inc. v. Lincoln Global, Inc.,
`IPR2016-00749 (Sept. 21, 2016)........................................................................22
`
`Shaw Indus. Grp., Inc. v. Automated Creel Sys. Inc.,
`IPR2013-00132 (July 24, 2014) .........................................................................31
`
`St. Jude Med., Inc. v. Access Closure, Inc.,
`729 F.3d 1369 (Fed. Cir. 2013) ..........................................................................38
`
`TCL Corp. v. Telefonaktiebolaget LM Ericsson,
`IPR2015-01674 (Feb. 13, 2017) .........................................................................17
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ..................................... 48, 57, 64, 66, 69, 70, 72
`
`Windsurfing Int’l, Inc. v. AMF, Inc.,
`782 F.2d 995 (Fed. Cir. 1986) ............................................................................66
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ..........................................................................66
`
`STATUTES
`
`35 U.S.C. § 102(b) ...................................................................................................15
`
`35 U.S.C. § 103........................................................................................................20
`
`35 U.S.C. § 103(a) ...................................................................................3, 15, 38, 47
`
`-v-
`
`

`

`OTHER AUTHORITIES
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.65(a).................................................................................................18
`37 CPR. § 42.65(a) ............................................................................................... ..18
`
`37 C.F.R. § 42.100(b) ..............................................................................................20
`37 CPR. § 42.100(b) ............................................................................................ ..20
`
`-vi-
`
`_Vi_
`
`

`

`PATENT OWNER’S 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
`
`-vii-
`
`

`

`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
`
`-viii-
`
`

`

`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)
`
`-ix-
`
`

`

`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
`
`-x-
`
`

`

`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
`
`-xi-
`
`

`

`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/
`
`-xii-
`
`

`

`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)
`
`-xiii-
`
`

`

`Exhibit No.
`
`2091
`
`Description
`Email chain dated Aug. 8, 2011 (EDWARDS 02186713)
`
`-xiv-
`
`

`

`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`On October 12, 2016, Edwards Lifesciences Corporation (“Petitioner”)
`
`submitted a Petition for Inter Partes Review (the “Petition”) of U.S. Patent
`
`No. 8,992,608 (the “‘608 patent”). On March 29, 2017, the Board instituted inter
`
`partes review of claims 1-4 of the ‘608 patent on three of the eleven grounds
`
`asserted in the Petition. Boston Scientific Scimed, Inc. (“Patent Owner”)
`
`respectfully submits this Response to the Petition showing that Petitioner has not
`
`carried its burden of proving by a preponderance of the evidence that claims 1-4
`
`are unpatentable.1
`
`Patent Owner submits herewith the declarations of Stephen J.D. Brecker,
`
`M.D., a practicing interventional cardiologist with extensive experience in
`
`transcatheter aortic valve replacement (“TAVR”) procedures, and Andrew
`
`J. Manganaro, M.D., a practicing vascular surgeon with extensive experience in
`
`implanting surgical valves and stent grafts to treat aortic aneurysms.
`
`1 Patent Owner reserves the right to argue that, in the event that Federal Circuit
`
`precedent is overturned and the Supreme Court determines that the PTAB lacks the
`
`authority to invalidate patents in Oil States Energy Services, LLC v. Greene’s
`
`Energy Group, LLC, 2017 WL 2507340 (U.S. June 12, 2017), the decision in Oil
`
`States applies to the present proceeding.
`
`-1-
`
`

`

`II.
`
`INTRODUCTION
`
`Petitioner’s attempt to invalidate claims on what it has itself described as a
`
`major advancement—from a clinical and commercial perspective—in the relevant
`
`technology, using references that do not even recognize the problem addressed by
`
`the invention, should be rejected. Claims 1-4 of the ‘608 patent address
`
`paravalvular leakage (“PVL”)—a problem uniquely associated with TAVR, a
`
`treatment for aortic valve disease (sometimes called transcatheter aortic valve
`
`implantation, or “TAVI”). In TAVR procedures, the diseased native valve leaflets
`
`are not removed but are merely pushed aside by an expandable stent or anchor;
`
`once deployed, a prosthetic replacement valve inside the anchor takes over the
`
`function of the aortic valve. The ‘608 patent, which is entitled to a priority date no
`
`later than June 2004, identified the problem of PVL—leakage of blood around the
`
`outside of the anchor when the valve is closed, through spaces formed by the
`
`diseased, often calcified, native valve leaflets—and disclosed a solution to that
`
`problem. Specifically, the patent claims a fabric seal around the outside of the
`
`anchor which, when the device is deployed, comprises flaps extending into the
`
`spaces formed by the native leaflets and pockets that fill with blood in response to
`
`backflow pressure.
`
`As the Board concluded in its Institution Decision, WO 03/047468
`
`(“Spenser”) (Ex. 1004) does not disclose every element of claims 1-4 of the ‘608
`
`-2-
`
`

`

`patent. Spenser, which makes no mention of PVL, teaches a cuff of valve material
`
`around the exterior of the stent to provide stability. As the Board noted, “Spenser
`
`describes as an ‘important feature’ the constant length of the support beams 23
`
`such that ‘there is no need for slack material.’” (Paper 7 at 8.) Thus, as the
`
`Petition expressly acknowledges, Spenser fails to disclose a fabric seal that “in the
`
`deployed state ... comprises flaps that extend into spaces formed by native valve
`
`leaflets” or “pockets ... adapted to fill with blood in response to backflow
`
`pressure,” as required by claims 1-4 of the ‘608 patent.
`
`None of the three prior art combinations on which the Board has instituted
`
`review—Spenser in view of U.S. Patent Application Pub. No. 2003/0236567 A1
`
`(“Elliot”) (Ex. 1005), Spenser in view of U.S. Patent No. 6,015,431 (“Thornton”)
`
`(Ex. 1019), or Spenser in view of U.S. Patent Application Pub. No. 2004/0082989
`
`(“Cook”) (Ex. 1006)—renders claims 1-4 of the ‘608 patent obvious under 35
`
`U.S.C. § 103(a). Even assuming that a person of ordinary skill in the art
`
`(“POSITA”) making the valve disclosed in Spenser would have recognized the
`
`problem of PVL, the POSITA would have had no motivation to combine Spenser
`
`with Elliot, Thornton, or Cook. Elliot, Thornton, and Cook, which do not disclose
`
`valves at all, address an entirely different problem—in the context of stent grafts to
`
`treat aneurysms, preventing leaks between the grafts and healthy aortic tissue, not
`
`to fill gaps formed by diseased and calcified native leaflets. Moreover, Spenser
`
`-3-
`
`

`

`teaches (i) a cuff made of the valve material to “enhance the stability” of the valve
`
`(ii) the avoidance of “slack” in the valve material, and (iii) preventing migration of
`
`the valve assembly. Combining Spenser with Elliot, Thornton, or Cook to turn the
`
`cuff into a loosely fitting fabric seal around the exterior of the valve assembly
`
`would have undermined these principal objectives of Spenser.
`
`In any event, the cited prior art does not describe a fabric seal comprising
`
`“flaps that extend into spaces formed by native valve leaflets” as required by
`
`claims 1-4 of the ‘608 patent. As the Board noted in its Institution Decision, and
`
`as Spenser’s inventors have acknowledged, Spenser does not teach a seal to
`
`prevent PVL. Elliot, Thornton, and Cook do not even address valves, much less
`
`PVL. Moreover, there is no suggestion that modifying the cuff of Spenser with the
`
`mostly conical seals disclosed in Elliot, Thornton, and Cook would result in flaps
`
`that would extend into spaces formed by the native valve leaflets.
`
`There is also an unusually strong nexus between Petitioner’s use of the
`
`invention of the ‘608 patent and the objective indicia of non-obviousness. The first
`
`two generations of Petitioner’s TAVR devices, launched in 2007 and 2010, lacked
`
`the claimed fabric seal; rigorous clinical studies documented the incidence of
`
`significant PVL associated with those devices, as well as the correlation between
`
`PVL and increased mortality. Petitioner itself spent years trying to develop a PVL
`
`solution for its second-generation TAVR device but failed. From 2004 until 2014,
`
`-4-
`
`

`

`practitioners identified PVL as the “Achilles heel” of TAVR—a weakness that
`
`could limit wider adoption of the therapy.
`
`Petitioner itself, as well as clinicians, touted the reduction in PVL resulting
`
`from the addition of a fabric skirt to Petitioner’s third-generation TAVR device,
`
`the “SAPIEN 3,” which was launched in 2014. These reductions in PVL and
`
`associated mortality rates led regulators to expand the indications for the device to
`
`new patient populations, dramatically increasing Petitioner’s commercial
`
`opportunities. Thus, several of the objective indicia of non-obviousness—
`
`including failure of others, long-felt need, copying, industry praise, unexpected
`
`results, and commercial success—establish that the invention of the ‘608 patent
`
`was not obvious in 2004. The Federal Circuit has been critical of experts who, like
`
`Petitioner’s expert here, failed to consider these objective indicia before
`
`concluding that the claims were obvious. At bottom, Petitioner’s suggestion that it
`
`omitted an “obvious” solution to PVL from the first two generations of its TAVR
`
`device—thereby deliberately exposing tens of thousands of patients to the risk of
`
`premature death—is simply not credible. The Board should make the far more
`
`plausible finding that the invention of claims 1-4 of the ‘608 patent was not
`
`obvious.
`
`-5-
`
`

`

`III. BACKGROUND
`
`TAVR
`A.
`The ‘608 patent, which claims a priority date no later than June 16, 20042,
`
`relates to endovascular replacement of diseased heart valves, particularly the aortic
`
`valve—i.e., TAVR. (Ex. 1001 col. 1:15-16, col. 1:29-31, col. 2:19-22,
`
`col. 8:31-38, FIGS. 5-7; Ex. 2001 at 1.) TAVR is a treatment for aortic valve
`
`disease, in which the leaflets of the valve become too calcified or otherwise
`
`diseased to function normally; if untreated, this condition leads to death in
`
`approximately 50% of symptomatic patients within two years of diagnosis.
`
`(Ex. 2001 at 4; see Ex. 2072.) Before the advent of TAVR, the standard treatment
`
`for aortic valve disease was surgical valve replacement, which involved opening
`
`the patient’s chest, stopping the heart, placing the patient on a bypass machine,
`
`excising the diseased native valve leaflets, and suturing a valve prosthesis in place
`
`of the diseased valve. (Ex. 2079 ¶¶ 20-24; Ex. 1007 ¶ 37; see Ex. 2069; Ex. 2073;
`
`Ex. 2074; Ex. 2075.) This surgery is traumatic and entails a relatively long,
`
`difficult recovery period; some patients may be too sick to survive the surgery and
`
`are, therefore, ineligible for valve replacement s