UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG
`
`Petitioner,
`
`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.
`
`PATENT OWNER BOSTON SCIENTIFIC SCIMED, INC.’S
`SECOND SET OF OBJECTIONS TO
`PETITIONER EDWARDS LIFESCIENCES CORP.’S EXHIBITS
`
`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
`
`Petitioner,
`
`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.
`
`PATENT OWNER BOSTON SCIENTIFIC SCIMED, INC.’S
`SECOND SET OF OBJECTIONS TO
`PETITIONER EDWARDS LIFESCIENCES CORP.’S EXHIBITS
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of and acting
`
`in a representative capacity for Boston Scientific Scimed, Inc. (“Patent Owner”),
`
`hereby submits the following objections to Edwards Lifesciences Corp.’s
`
`(“Petitioner”) Exhibits 1035-42, 1045-66, 1068, 1070-76, and any reference to
`
`and/or reliance on the foregoing. Patent Owner’s objections below apply the
`
`Federal Rules of Evidence (“F.R.E.”) as required by 37 C.F.R. § 42.62.
`
`I.
`
`OBJECTIONS TO EXHIBITS 1035-42 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1035 (Supplemental Declaration of Nigel. P.
`
`Buller, M.D.), Exhibit 1036 (Approved Judgment, Edwards Lifesciences, Inc. v.
`
`Boston Scientific Scimed, Inc., HC-2015-004574 dated March 3, 2017), Exhibit
`
`1037 (Judgment, CoreValve Inc. v. Edwards Lifesciences AG et al., HC 07 C01243
`
`dated January 9, 2009), Exhibit 1038 (Approved Judgment, Edwards Lifesciences
`
`AG v. Cook Biotech Inc., HC08 C 00934 dated June 12, 2009), Exhibit 1039
`
`(Memorandum, Edwards Lifesciences AG et al. v. CoreValve, Inc. et al., C.A. No.
`
`08-91 (GMS) dated February 1, 2011), Exhibit 1040 (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), Exhibit 1041 (Vossoughi et al. (Eds.), Stent Graft
`
`Update, Medical and Engineering Publishers Inc. (2000)), Exhibit 1042 (Dolmatch
`
`-1-
`
`
`
`et al. (Eds.), Stent-Grafts Current Clinical Practice, Thieme (2000)), and any
`
`reference to and/or reliance thereon.
`
`Grounds for objection: 37 C.F.R. § 42.23 (“Oppositions and Replies”); 37
`
`C.F.R. § 42.123 (“Filing of Supplemental Information”).
`
`Exhibits 1035-42 were served on April 26, 2017 as supplemental evidence in
`
`response to Patent Owner’s first set of objections (see Paper 9). Accordingly,
`
`Exhibits 1035-42 are to be filed with Petitioner’s opposition to Patent Owner’s
`
`motion to exclude, if filed. See Generico, LLC v. Dr. Falk Pharma GMBH,
`
`IPR2016-00297, Paper 15 at 2-3 (P.T.A.B. July 15, 2016). Exhibits 1035-42, since
`
`they were filed with Petitioner’s Reply, constitute improperly filed supplemental
`
`information in violation of 37 C.F.R. § 42.123 and new evidence in violation of 37
`
`C.F.R. § 42.23. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
`
`48,767 (U.S. Patent & Trademark Office Aug. 14, 2012).
`
`II. OBJECTIONS TO EXHIBIT 1035 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1035 (Supplemental Declaration of Nigel. P.
`
`Buller, M.D.) and any reference to and/or reliance thereon.
`
`Grounds for objection: F.R.E. 401 (“Test for Relevant Evidence”); F.R.E.
`
`402 (“General Admissibility of Relevant Evidence”); F.R.E. 403 (“Excluding
`
`Relevant Evidence for Prejudice, Confusion, Waste of Time, or Other Reasons”).
`
`-2-
`
`
`
`Exhibit 1035, Dr. Buller’s supplemental declaration in response to Patent
`
`Owner’s first set of objections (see Paper 9), fails to address Patent Owner’s
`
`objections and, therefore, is insufficient to cure the deficiencies of Dr. Buller’s first
`
`declaration (see Ex. 1007). Accordingly, it is not relevant to any ground on which
`
`this IPR was instituted and, if admitted, its minimal probative value would be
`
`substantially outweighed by the unfair prejudice it would cause, the confusing and
`
`misleading nature of the materials, the undue delay upon these proceedings, and
`
`the waste of time that would ensue, in violation of F.R.E. 401-403.
`
`III. OBJECTIONS TO EXHIBITS 1036-40 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`Evidence objected to: Exhibit 1036 (Approved Judgment, Edwards
`
`Lifesciences, Inc. v. Boston Scientific Scimed, Inc., HC-2015-004574 dated March
`
`3, 2017), Exhibit 1037 (Judgment, CoreValve Inc. v. Edwards Lifesciences AG et
`
`al., HC 07 C01243 dated January 9, 2009), Exhibit 1038 (Approved Judgment,
`
`Edwards Lifesciences AG v. Cook Biotech Inc., HC08 C 00934 dated June 12,
`
`2009), Exhibit 1039 (Memorandum, Edwards Lifesciences AG et al. v. CoreValve,
`
`Inc. et al., C.A. No. 08-91 (GMS) dated February 1, 2011), Exhibit 1040
`
`(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), and any
`
`reference to and/or reliance thereon.
`
`-3-
`
`
`
`Grounds for objection: F.R.E. 401 (“Test for Relevant Evidence”); F.R.E.
`
`402 (“General Admissibility of Relevant Evidence”); F.R.E. 403 (“Excluding
`
`Relevant Evidence for Prejudice, Confusion, Waste of Time, or Other Reasons”);
`
`F.R.E. 801 (“Definitions That Apply to This Article; Exclusions From Hearsay”);
`
`F.R.E. 802 (“The Rule Against Hearsay”).
`
`A.
`
`Exhibits 1036-40 are Irrelevant
`
`Exhibits 1036-40 are not relevant to Dr. Buller’s qualifications as an expert
`
`in this proceeding and, if admitted, their minimal probative value would be
`
`substantially outweighed by the unfair prejudice they would cause, the confusing
`
`and misleading nature of the materials, the undue delay upon these proceedings,
`
`and the waste of time that would ensue, in violation of F.R.E. 401-403.
`
`B.
`
`Exhibits 1036-40 are Hearsay
`
`Exhibits 1036-40 are out-of-court statements offered into evidence by
`
`Petitioner to prove the truth of the matters asserted in Exhibits 1036-40. Petitioner
`
`has not identified any hearsay exception that applies to Exhibits 1036-40.
`
`Accordingly, Exhibits 1036-40 are in violation of F.R.E. 801-802.
`
`IV. OBJECTIONS TO EXHIBITS 1041-42, 1052-54, 1059-60, 1070, AND
`1072 AND ANY REFERENCE TO AND/OR RELIANCE THERON
`
`Evidence objected to: Exhibit 1041 (Vossoughi et al. (Eds.), Stent Graft
`
`Update, Medical and Engineering Publishers Inc. (2000)), Exhibit 1042 (Dolmatch
`
`et al. (Eds.), Stent-Grafts Current Clinical Practice, Thieme (2000)), Exhibit 1052
`
`-4-
`
`
`
`(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)), Exhibit 1053 (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)), Exhibit 1054
`
`(Zaman et al., Incidence and Predictors of Permanent Pacemaker Implantation
`
`Following Treatment with the Repositionable LotusTM Transcatheter Aortic Valve,
`
`Catheterization and Cardiovascular Interventions (2016)), Exhibit 1059 (WO
`
`2005/102015 to Bergheim et al.), Exhibit 1060 (Jayalath, R.W. et al., “Aortic
`
`Calcification,” Eur. J. Vasc. Endovasc. Surg., Vol. 30, 476-488 (2005)), Exhibit
`
`1070 (Roy, David et al., “Transcatheter Aortic Valve Implantation for Pure Severe
`
`Native Aortic Valve Regurgitation,” JACC, Vol. 16(15), 1577-84 (2013), Exhibit
`
`1072 (H.B. Riberio et al., Balloon-Expandable Prostheses for Transcatheter Aortic
`
`Valve Replacement, 56 Progress in Cardiovascular Diseases 583 (2014)), and any
`
`reference to and/or reliance thereon.
`
`Grounds for objection: F.R.E. 801 (“Definitions That Apply to This Article;
`
`Exclusions From Hearsay”); F.R.E. 802 (“The Rule Against Hearsay”).
`
`Exhibits 1041-42, 1052-54, 1059-60, 1070, and 1072 are out-of-court
`
`statements offered into evidence by Petitioner to prove the truth of the matters
`
`asserted in Exhibits 1041-42, 1052-54, 1059-60, 1070, and 1072. Petitioner has
`
`-5-
`
`
`
`not identified any hearsay exception that applies to Exhibits 1041-42, 1052-54,
`
`1059-60, 1070, and 1072. Accordingly, Exhibits 1041-42, 1052-54, 1059-60,
`
`1070, and 1072 are in violation of F.R.E. 801-802.
`
`V.
`
`OBJECTIONS TO EXHIBIT 1045 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1045 (Reply Declaration of Nigel P. Buller,
`
`M.D.) and any reference to and/or reliance thereon.
`
`Grounds for objection: F.R.E. 403 (“Excluding Relevant Evidence for
`
`Prejudice, Confusion, Waste of Time, or Other Reasons”); F.R.E. 601
`
`(“Competency to Testify in General”); F.R.E. 602 (“Need for Personal
`
`Knowledge”); F.R.E. 701 (“Opinion Testimony by Lay Witnesses”); F.R.E. 702
`
`(“Testimony by Expert Witnesses”); F.R.E. 703 (“Bases of an Expert’s Opinion
`
`Testimony”); F.R.E. 704 (“Opinion on an Ultimate Issue”); F.R.E. 705
`
`(“Disclosing the Facts or Data Underlying an Expert’s Opinion”); 37 C.F.R.
`
`§ 42.65 (“Expert Testimony; Tests and Data”).
`
`A.
`
`Dr. Buller is Not a Qualified Expert
`
`There has been no showing that Dr. Buller is qualified to provide expert
`
`testimony on any technical matter relevant to transcatheter aortic heart valves,
`
`including engineering devices for sealing spaces formed by native valve leaflets,
`
`fluid dynamics associated with paravalvular leakage of transcatheter aortic heart
`
`valves, transcatheter aortic heart valve migration and foreshortening, and the
`
`-6-
`
`
`
`calcification of the aorta (see, e.g., Ex. 1045 Sections III-VI), rendering his
`
`testimony on these matters improper and inadmissible pursuant to at least
`
`F.R.E. 702-705 and 37 C.F.R. § 42.65. There has further been no showing that
`
`Dr. Buller is qualified to provide expert testimony on whether the claims of U.S.
`
`Patent No. 8,992,608 (the “‘608 patent”) are valid, whether a person of ordinary
`
`skill would have been motivated to combine prior art references to disclose the
`
`inventions claimed in the ‘608 patent, and whether the Sapien 3 infringes the ‘608
`
`patent (see, e.g., id. Sections II-VI), rendering his testimony on these matters
`
`improper and inadmissible pursuant to at least F.R.E. 702-705 and 37 C.F.R.
`
`§ 42.65. There has further been no showing that Dr. Buller is qualified to provide
`
`expert testimony on claim construction or the application of claim terms from the
`
`‘608 patent (see, e.g., id. Section II), rendering his testimony on these matters
`
`improper and inadmissible pursuant to at least F.R.E. 702-705 and 37 C.F.R.
`
`§ 42.65. Further, Dr. Buller has not demonstrated that he possesses first-hand
`
`knowledge, experience, or perceptions regarding the testimony identified above,
`
`rendering any lay testimony or lay opinions on these matters improper and
`
`inadmissible pursuant to at least F.R.E. 601-602 and 701.
`
`Accordingly, Dr. Buller’s testimony regarding the matters identified above,
`
`and any reference thereto and/or reliance thereon in Petitioner’s submissions,
`
`-7-
`
`
`
`would be misleading and unfairly prejudicial to Patent Owner, in violation of
`
`F.R.E. 403.
`
`B.
`
`Dr. Buller’s Testimony is Not Based on Sufficient Facts, Data, or
`Scientific Evidence and is Not the Product of Reliable
`Methodology
`
`Dr. Buller’s testimony regarding the validity of the ‘608 patent claims and a
`
`person of ordinary skill’s motivation to combine prior art references to disclose the
`
`inventions claimed in the ‘608 patent, including how prior art devices could be
`
`combined, why prior art devices would be combined, and the function of combined
`
`prior art devices; the Sapien 3’s infringement of the ‘608 patent; Petitioner’s
`
`prototypes; the concepts of migration and foreshortening; and nature of the aorta
`
`(see, e.g., id. Sections II-VI (In particular, ¶¶ 10-11, 13, 16, 19, 24, 29-30, 34, 36-
`
`39, 42-47)), is not based on sufficient facts, data, or scientific evidence. Further,
`
`Dr. Buller’s testimony is premised on flawed methodology as it fails to address
`
`Patent Owner’s evidence of secondary considerations of nonobviousness.
`
`Accordingly, Dr. Buller’s testimony on these matters is improper and inadmissible
`
`pursuant to at least F.R.E. 702 and 37 C.F.R. § 42.65.
`
`VI. OBJECTIONS TO EXHIBIT 1046 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1046 (Declaration of Larry Lee Wood) and
`
`any reference to and/or reliance thereon.
`
`-8-
`
`
`
`Grounds for objection: F.R.E. 403 (“Excluding Relevant Evidence for
`
`Prejudice, Confusion, Waste of Time, or Other Reasons”); F.R.E. 601
`
`(“Competency to Testify in General”); F.R.E. 602 (“Need for Personal
`
`Knowledge”); F.R.E. 701 (“Opinion Testimony by Lay Witnesses”); F.R.E. 702
`
`(“Testimony by Expert Witnesses”); F.R.E. 703 (“Bases of an Expert’s Opinion
`
`Testimony”); F.R.E. 704 (“Opinion on an Ultimate Issue”); F.R.E. 705
`
`(“Disclosing the Facts or Data Underlying an Expert’s Opinion”); 37 C.F.R.
`
`§ 42.65 (“Expert Testimony; Tests and Data”).
`
`A. Mr. Wood is Not a Qualified Expert
`By his own admission (see Ex. 1046 ¶ 8 n.2), Mr. Wood allegedly possesses
`
`specialized knowledge only in the field of commercializing and marketing
`
`Petitioner’s transcatheter heart valve devices. There has been no showing that Mr.
`
`Wood is qualified to provide expert testimony on any matter other than
`
`commercializing and marketing Petitioner’s transcatheter heart valves, including
`
`whether the claims of the ‘608 patent are valid and infringed by the Sapien 3 (see,
`
`e.g., id. ¶ 15), technical aspects of patent law such as secondary considerations of
`
`nonobviousness (see, e.g., id. ¶ 16), survival rate of patients suffering from aortic
`
`valve stenosis (see, e.g., id. ¶ 20), statistics (see, e.g., id. ¶ 29), solutions that
`
`reduced PVL and their effectiveness (see, e.g., id. ¶¶ 29-31), clinical outcomes of
`
`products unrelated to this proceeding (see, e.g., id. ¶ 32), comparisons between
`
`-9-
`
`
`
`products (see, e.g., id. ¶ 33), factors attributing to commercial success (see, e.g., id.
`
`¶¶ 39-41), improvements in mortality, stroke, and vascular complications seen with
`
`Sapien 3 (see, e.g., id. ¶ 42), or the expansion of the TAVR market (see, e.g., id.
`
`¶ 45), rendering his testimony on these matters improper and inadmissible pursuant
`
`to at least F.R.E. 702-705 and 37 C.F.R. § 42.65. Further, Mr. Wood has not
`
`demonstrated that he possesses first-hand knowledge, experience, or perceptions
`
`regarding the testimony identified above, rendering any lay testimony or lay
`
`opinions on these matters improper and inadmissible pursuant to at least F.R.E.
`
`601-602 and 701.
`
`Accordingly, Mr. Wood’s testimony regarding the matters identified above,
`
`and any reference thereto and/or reliance thereon in Petitioner’s submissions,
`
`would be misleading and unfairly prejudicial to Patent Owner, in violation of
`
`F.R.E. 403.
`
`B. Mr. Wood’s Testimony is Not Based on Sufficient Facts, Data, or
`Scientific Evidence
`
`Mr. Wood’s testimony regarding secondary considerations of
`
`nonobviousness, including failure of others, long-felt need, copying, industry
`
`praise, unexpected results, and commercial success (see, e.g., id. Section III (In
`
`particular, ¶¶ 15-16, 20, 28-33, 36, 39-42, 45), is not based on sufficient facts, data,
`
`or scientific evidence, rendering his testimony on these matters improper and
`
`inadmissible pursuant to at least F.R.E. 702 and 37 C.F.R. § 42.65.
`
`-10-
`
`
`
`C. Mr. Wood’s Testimony is Not Based on First-Hand Knowledge,
`Experience, or Perceptions
`
`Mr. Wood’s testimony regarding secondary considerations of
`
`nonobviousness, including the survival rate of patients suffering from aortic valve
`
`stenosis (see, e.g., id. ¶ 20), statistics (see, e.g., id. ¶ 28), solutions that reduced
`
`PVL and their effectiveness (see, e.g., id. ¶¶ 29-31), clinical outcomes of products
`
`unrelated to this proceeding (see, e.g., id. ¶ 32), comparisons between products
`
`(see, e.g., id. ¶ 33), factors attributing to commercial success (see, e.g., id. ¶¶ 39-
`
`41), improvements in mortality, stroke, and vascular complications seen with
`
`Sapien 3 (see, e.g., id. ¶ 42), and the expansion of the TAVR market (see, e.g., id.
`
`¶ 45), is not based on his first-hand knowledge, experience, or perceptions,
`
`rendering his testimony on these matters improper and inadmissible pursuant to at
`
`least F.R.E. 601-602 and 701.
`
`VII. OBJECTIONS TO EXHIBITS 1048, 1056-57, 1068, 1071, AND 1073-75,
`AND ANY REFERENCE TO AND/OR RELIANCE THEREON
`Evidence objected to: Exhibit 1048 (Shuren, Life-Saving, Smart Regulation
`
`on Behalf of Patients with Aortic Stenosis, FDA Voice (June 16, 2014)), Exhibit
`
`1056 (Medtronic CoreValveTM EvolutTM R System First TAVI to Receive CE
`
`Mark for Intermediate Risk Aortic Stenosis Patients, Medtronic Press Release
`
`(August 1, 2016)), Exhibit 1057 (Medtronic Expands TAVR Access to More
`
`Patients With Symptomatic, Severe Aortic Stenosis Upon Intermediate Risk FDA
`
`-11-
`
`
`
`Approval, Medtronic Press Release (July 10, 2017)), Exhibit 1068 (Lotus Valve
`
`FDA Recall Notice), Exhibit 1071 (J.A. Southard, M.D., TAVR: It’s a Career, Not
`
`Just a Procedure! (May 5, 2012) available at www.ucdmc.ucdavis.edu/internal
`
`medicine/cardio/pdf/Symposium%202012/TAVR%20Talk.pdf), Exhibit 1073
`
`(“Centera: Novel Transcatheter Heart Valve Shows Promise in Aortic Stenosis,”
`
`EuroPCR Meeting News (May 26, 2017)), Exhibit 1074 (Edwards Lifesciences
`
`Press Release: “Edwards’ Novel Self-Expanding Transcatheter Heart Valve
`
`Demonstrates Excellent Early Patient Outcomes” (May 17, 2017)), Exhibit 1075
`
`(“Edwards’ Self-Expanding Transcatheter Heart Valve Demonstrates Excellent
`
`Early Patient Outcomes,” DAIC (May 24, 2017)), and any reference to and/or
`
`reliance thereon.
`
`Grounds for objection: F.R.E. 801 (“Definitions That Apply to This Article;
`
`Exclusions From Hearsay”); F.R.E. 802 (“The Rule Against Hearsay”); F.R.E. 901
`
`(“Authenticating or Identifying Evidence”).
`
`A.
`
`Exhibits 1048, 1056-57, 1068, 1071, and 1073-75 are
`Unauthenticated
`
`Petitioner has not provided any evidence sufficient to authenticate Exhibits
`
`1048, 1056-57, 1068, 1071, and 1073-75, in violation of F.R.E. 901.
`
`Moreover, Exhibits 1048, 1056-57, 1068, 1071, and 1073-75 appear to be
`
`printouts of webpages. Petitioner has not proffered testimony of a witness with
`
`personal knowledge of the information on the websites to authenticate Exhibits
`
`-12-
`
`
`
`1048, 1056-57, 1068, 1071, and 1073-75, in violation of F.R.E. 901. See Neste Oil
`
`Oyj v. REG Synthetic Fuels, LLC, IPR2013-00578, Paper 53 at 4 (P.T.A.B.
`
`Mar. 12, 2015) (“When offering a printout of a webpage into evidence to prove the
`
`website’s contents, the proponent of the evidence must authenticate the
`
`information from the website itself, not merely the printout.”).
`
`B.
`
`Exhibits 1048, 1056-57, 1068, 1071, and 1073-75 are Hearsay
`
`Exhibits 1048, 1056-57, 1068, 1071, and 1073-75 are out-of-court
`
`statements offered into evidence by Petitioner to prove the truth of the matters
`
`asserted in Exhibits 1048, 1056-57, 1068, 1071, and 1073-75. Petitioner has not
`
`identified any hearsay exception that applies to Exhibits 1048, 1056-57, 1068,
`
`1071, and 1073-75. Accordingly, Exhibits 1048, 1056-57, 1068, 1071, and 1073-
`
`75 are in violation of F.R.E. 801-802.
`
`VIII. OBJECTIONS TO EXHIBITS 1049-50, 1055, 1061-63, AND 1065-66,
`AND ANY REFERENCE TO AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1049 (Edwards Endovascular HVT – Patriot
`
`Technical Design Review Proof of Concept & Selection of 1st Generation Valve
`
`dated June 11, 2003), Exhibit 1050 (Rowe, Stanton, “History of Sapien and the
`
`Future of THV” [EDWARDS 02433143-211]), Exhibit 1055 (August 18, 2016
`
`Letter from B. Zuckerman to J. Mazzarella re: P130009/S057), Exhibit 1061
`
`(Compilation of Pictures of PVT Prototype Designs), Exhibit 1062 (Engineering
`
`Drawings, S3 External Skirt), Exhibit 1063 (Engineering Drawings, S3 Internal
`
`-13-
`
`
`
`Skirt), Exhibit 1065 (U.S. Patent App. No. 13/290,369 Prosecution History,
`
`Examiner’s Answering Brief to Appeal (Mar. 12, 2015)), Exhibit 1066 (U.S.
`
`Patent App. No. 13/290,369 Prosecution History, PTAB Appeal Decision (June 2,
`
`2017)), and any reference to and/or reliance thereon.
`
`Grounds for objection: F.R.E. 801 (“Definitions That Apply to This Article;
`
`Exclusions From Hearsay”); F.R.E. 802 (“The Rule Against Hearsay”); F.R.E. 901
`
`(“Authenticating or Identifying Evidence”).
`
`A.
`
`Exhibits 1049-50, 1055, 1061-63, and 1065-66 are Unauthenticated
`
`Petitioner has not provided any evidence sufficient to authenticate Exhibits
`
`1049-50, 1055, 1061-63, and 1065-66, in violation of F.R.E. 901.
`
`B.
`
`Exhibits 1049-50, 1055, 1061-63, and 1065-66 are Hearsay
`
`Exhibits 1049-50, 1055, 1061-63, and 1065-66 are out-of-court statements
`
`offered into evidence by Petitioner to prove the truth of the matters asserted in
`
`Exhibits 1049-50, 1055, 1061-63, and 1065-66. Petitioner has not identified any
`
`hearsay exception that applies to Exhibits 1049-50, 1055, 1061-63, and 1065-66.
`
`Accordingly, Exhibits 1049-50, 1055, 1061-63, and 1065-66 are in violation of
`
`F.R.E. 801-802.
`
`IX. OBJECTIONS TO EXHIBITS 1051 AND 1058, AND ANY
`REFERENCE TO AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1051 (Boston Scientific’s 2016 Annual
`
`Report), Exhibit 1058 (Boston Scientific Receives CE Mark for LotusTM Valve
`
`-14-
`
`
`
`System, Boston Scientific Press Release (October 28, 2013)), and any reference to
`
`and/or reliance thereon.
`
`Grounds for objection: F.R.E. 901 (“Authenticating or Identifying
`
`Evidence”).
`
`A.
`
`Exhibits 1051 and 1058 are Unauthenticated
`
`Petitioner has not provided any evidence to authenticate Exhibits 1051 and
`
`1058, in violation of F.R.E. 901.
`
`Moreover, Exhibits 1051 and 1058 appear to be printouts of webpages.
`
`Petitioner has not proffered testimony of a witness with personal knowledge of the
`
`information on the websites to authenticate Exhibits 1051 and 1058, in violation of
`
`F.R.E. 901. See Neste Oil Oyj, IPR2013-00578, Paper 53 at 4 (“When offering a
`
`printout of a webpage into evidence to prove the website’s contents, the proponent
`
`of the evidence must authenticate the information from the website itself, not
`
`merely the printout.”).
`
`X.
`
`OBJECTIONS TO EXHIBIT 1064 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1064 (Brecker Deposition Exhibit 1, Excerpts
`
`from Textbook of Interventional Cardiology, 2d Ed. (1994)) and any reference to
`
`and/or reliance thereon.
`
`Grounds for objection: F.R.E. 106 (“Remainder of or Related Writings or
`
`Recorded Statements”); F.R.E. 403 (“Excluding Relevant Evidence for Prejudice,
`
`-15-
`
`
`
`Confusion, Waste of Time, or Other Reasons”); F.R.E. 801 (“Definitions That
`
`Apply to This Article; Exclusions From Hearsay”); F.R.E. 802 (“The Rule Against
`
`Hearsay”).
`
`A.
`
`Exhibit 1064 is Incomplete
`
`Exhibit 1064 appears to be an excerpt from a book. Any reference to and/or
`
`reliance on Exhibit 1064 in any Petitioner submission in this proceeding is
`
`incomplete, misleading, and unfairly prejudicial, in violation of F.R.E. 106
`
`and 403.
`
`B.
`
`Exhibit 1064 is Hearsay
`
`Exhibit 1064 is an out-of-court statement offered into evidence by Petitioner
`
`to prove the truth of the matters asserted therein. Petitioner has not identified any
`
`hearsay exception that applies to Exhibit 1064. Accordingly, Exhibit 1064 is in
`
`violation of F.R.E. 801-802.
`
`XI. OBJECTIONS TO EXHIBITS 1041-42, 1047-58, 1060, AND 1071-76
`AND ANY REFERENCE TO AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1041 (Vossoughi et al. (Eds.), Stent Graft
`
`Update, Medical and Engineering Publishers Inc. (2000)), Exhibit 1042 (Dolmatch
`
`et al. (Eds.), Stent-Grafts Current Clinical Practice, Thieme (2000)), Exhibit 1047
`
`(Curriculum Vitae of Larry Lee Wood), Exhibit 1048 (Shuren, Life-Saving, Smart
`
`Regulation on Behalf of Patients with Aortic Stenosis, FDA Voice (June 16,
`
`2014)), Exhibit 1049 (Edwards Endovascular HVT – Patriot Technical Design
`
`-16-
`
`
`
`Review Proof of Concept & Selection of 1st Generation Valve dated June 11,
`
`2003), Exhibit 1050 (Rowe, Stanton, “History of Sapien and the Future of THV”
`
`[EDWARDS 02433143-211]), Exhibit 1051 (Boston Scientific’s 2016 Annual
`
`Report), Exhibit 1052 (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)), Exhibit 1053
`
`(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)), Exhibit 1054 (Zaman et al., Incidence and Predictors of Permanent
`
`Pacemaker Implantation Following Treatment with the Repositionable Lotus™
`
`Transcatheter Aortic Valve, Catheterization and Cardiovascular Interventions
`
`(2016)), Exhibit 1055 (August 18, 2016 Letter from B. Zuckerman to J. Mazzarella
`
`re: P130009/S057), Exhibit 1056 (Medtronic CoreValve™ Evolut™ R System
`
`First TAVI to Receive CE Mark for Intermediate Risk Aortic Stenosis Patients,
`
`Medtronic Press Release (August 1, 2016)), Exhibit 1057 (Medtronic Expands
`
`TAVR Access to More Patients With Symptomatic, Severe Aortic Stenosis Upon
`
`Intermediate Risk FDA Approval, Medtronic Press Release (July 10, 2017)),
`
`Exhibit 1058 (Boston Scientific Receives CE Mark for Lotus™ Valve System,
`
`Boston Scientific Press Release (October 28, 2013)), Exhibit 1060 (Jayalath, R.W.
`
`et al., “Aortic Calcification,” Eur. J. Vasc. Endovasc. Surg., Vol. 30, 476-488
`
`-17-
`
`
`
`(2005)), Exhibit 1071 (J.A. Southard, M.D., TAVR: It’s a Career, Not Just a
`
`Procedure! (May 5, 2012) available at www.ucdmc.ucdavis.edu/internal
`
`medicine/cardio/pdf/Symposium%202012/TAVR%20Talk.pdf), Exhibit 1072
`
`(H.B. Riberio et al., Balloon-Expandable Prostheses for Transcatheter Aortic Valve
`
`Replacement, 56 Progress in Cardiovascular Diseases 583 (2014)), Exhibit 1073
`
`(“Centera: Novel Transcatheter Heart Valve Shows Promise in Aortic Stenosis,”
`
`EuroPCR Meeting News (May 26, 2017)), Exhibit 1074 (Edwards Lifesciences
`
`Press Release: “Edwards’ Novel Self-Expanding Transcatheter Heart Valve
`
`Demonstrates Excellent Early Patient Outcomes” (May 17, 2017)), Exhibit 1075
`
`(“Edwards’ Self-Expanding Transcatheter Heart Valve Demonstrates Excellent
`
`Early Patient Outcomes,” DAIC (May 24, 2017)), Exhibit 1076 (Declaration of
`
`Gregory S. Cordrey), and any reference to and/or reliance thereon.
`
`Grounds for objection: 37 C.F.R. § 42.6(a)(3) (“Filing of Documents,
`
`Including Exhibits; Service”).
`
`Exhibits 1041-42, 1047-58, 1060, and 1071-76 are not cited in the Reply.
`
`Accordingly, any attempt by Petitioner to rely on these exhibits by citing its
`
`expert’s declaration constitutes improper incorporation by reference, in violation of
`
`37 C.F.R. § 42.6(a)(3).
`
`-18-
`
`
`
`XII. OBJECTIONS TO EXHIBIT 1076 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1076 (Declaration of Gregory S. Cordrey) and
`
`any reference to and/or reliance thereon.
`
`Grounds for objection: 37 C.F.R. § 42.64(b)(2) (“Objection; Motion to
`
`Exclude”).
`
`Paragraphs 3-6 of Exhibit 1076 are properly characterized as supplemental
`
`evidence in response to Patent Owner’s first set of objections (see Paper 9) that,
`
`because it was filed with Petitioner’s Reply, is in violation of 37 C.F.R.
`
`§ 42.64(b)(2).
`
`Dated: September 29, 2017
`
`Respectfully submitted,
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`Wallace Wu, Ph.D. (Reg. No. 45,380)
`ARNOLD & PORTER 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.
`
`-19-
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER
`BOSTON SCIENTIFIC SCIMED, INC.’S SECOND SET OF OBJECTIONS TO
`PETITIONER EDWARDS LIFESCIENCES CORP.’S EXHIBITS was served on
`September 29, 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 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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