UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`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
`FIRST SET OF OBJECTIONS TO
`PETITIONER EDWARDS LIFESCIENCES CORP.’S EXHIBITS
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`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
`FIRST SET OF OBJECTIONS TO
`PETITIONER EDWARDS LIFESCIENCES CORP.’S EXHIBITS
`
`
`
`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 Petitioner Edwards Lifesciences
`
`Corp.’s (“Petitioner”) Exhibits 1003, 1007-10, 1012-13, 1015-16, 1018, 1021-22,
`
`1026, 1028-29, 1031-32, 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 1003, 1008-10, 1018, 1021-22, 1026,
`1031-32, AND ANY REFERENCE TO AND/OR RELIANCE
`THEREON
`Evidence objected to: Exhibits 1003 (WO 98/29057 to Cribier et al.), 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)), 1009 (U.S. Patent App. Pub. No. 2001/0039450 to Pavcnik et al.), 1010
`
`(U.S. Patent App. Pub. No. 2004/0033364 to Spiridigliozzi et al.), 1018 (U.S.
`
`Patent No. 5,411,552 to Andersen et al.), 1021 (U.S. Patent No. 6,352,554 to De
`
`Paulis), 1022 (European Patent 2 749 254 B1 to Salahieh et al.), 1026 (Gore
`
`Excluder Instructions for Use (2002)), 1031(Boston Scientific’s August 24, 2016
`
`Response in Opposition Proceedings of EP 2 749 254 B1), 1032 (Boston
`
`-1-
`
`
`
`Scientific’s August 24, 2016 Reply in German Infringement Proceeding 4a O
`
`137/15), 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”).
`
`A.
`
`Exhibits 1003, 1008-10, 1018, 1021-22, 1026, and 1031-32 are
`Irrelevant
`
`Exhibits 1003, 1008-10, 1018, 1021-22, 1026, and 1031-32 are not relevant
`
`to any ground on which this IPR was instituted 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.
`
`II. OBJECTIONS TO EXHIBIT 1007 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1007 (Declaration of Dr. Nigel Buller) 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-
`
`
`
`37 C.F.R. § 42.61 (“Admissibility”); 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 Witness”); F.R.E. 702 (“Testimony by Expert Witness”); 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.
`
`Ground 1: 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
`
`and fluid dynamics associated with paravalvular leakage of transcatheter aortic
`
`heart valves (see, e.g., Ex. 1007 Sections IV.E and V-IX), 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 and whether a person of ordinary skill would have
`
`been motivated to combine prior art references to disclose the inventions claimed
`
`in the ‘608 patent (see, e.g., id. Sections V-IX), 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
`
`-3-
`
`
`
`provide expert testimony on claim construction or the application of claim terms
`
`from the ‘608 patent, (see, e.g., id. Sections VIII-IX), 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,
`
`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
`
`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 (see, e.g., id. Sections IV-IX (in particular, paragraphs 60-63,
`
`67-69, 87, 98, 100-106, 142-144, 148-150, 158-159, 163, 168-169, 174, 180-83,
`
`187, 191, and 194-96)), is not based on sufficient facts, data, or scientific evidence,
`
`-4-
`
`
`
`rendering his testimony on these matters improper and inadmissible pursuant to at
`
`least F.R.E. 702 and 37 C.F.R. § 42.65.
`
`C.
`
`Dr. Buller’s Testimony is Irrelevant
`
`Dr. Buller’s testimony in paragraphs 136-174 and 188-196 of his declaration
`
`are 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 testimony, the undue
`
`delay upon these proceedings, and the waste of time that would ensue, in violation
`
`of F.R.E. 401-403 and 37 C.F.R. § 42.61.
`
`Dr. Buller’s declaration references Exhibits 1003, 1008-10, 1018, 1021-22,
`
`1026, and 1031-32, which are not relevant to any ground on which this IPR was
`
`instituted. Dr. Buller’s testimony regarding these Exhibits is likewise irrelevant
`
`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
`
`testimony, the undue delay upon these proceedings, and the waste of time that
`
`would ensue, in violation of F.R.E. 401-403 and 37 C.F.R. § 42.61.
`
`III. OBJECTIONS TO EXHIBITS 1015-16 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`Evidence objected to: Exhibits 1015 (Excerpts from Vossoughi et al., Stent
`
`Graft Update (2000)), 1016 (Excerpts from Dolmatch et al., Stent Grafts: Current
`
`Clinical Practice (1999)), and any reference to and/or reliance thereon.
`
`-5-
`
`
`
`Grounds for objection: F.R.E. 106 (“Remainder of or Related Writings or
`
`Recorded Statements”); F.R.E. 403 (“Excluding Relevant Evidence for Prejudice,
`
`Confusion, Waste of Time, or Other Reasons”); F.R.E. 901 (“Authenticating or
`
`Identifying Evidence”).
`
`A.
`
`Exhibits 1015-16 are Incomplete
`
`Exhibits 1015-16 appear to be excerpts from books. Any reference to and/or
`
`reliance on Exhibits 1015-16 in any Patent Owner submission in this proceeding is
`
`incomplete, misleading, and unfairly prejudicial, in violation of F.R.E. 106
`
`and 403.
`
`B.
`
`Exhibits 1015-16 are Hearsay
`
`Exhibits 1015-16 are out-of-court statements offered into evidence by
`
`Petitioner to prove the truth of the matters asserted therein. (See, e.g., Petition at 7
`
`(Ex. 1015); Ex. 1007 ¶¶ 56 (Ex. 1016), 59 (Ex. 1015).) Petitioner has not
`
`identified any hearsay exception that applies to Exhibits 1015-16. Accordingly,
`
`Exhibits 1015-16 are in violation of F.R.E. 801-802.
`
`IV. OBJECTIONS TO EXHIBIT 1026 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1026 (Gore Excluder Instructions for Use
`
`(2002)) and any reference to and/or reliance thereon.
`
`-6-
`
`
`
`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.
`
`Exhibit 1026 is Unauthenticated
`
`Patent Owner has not provided any evidence to authenticate Exhibit 1026, in
`
`violation of F.R.E. 901.
`
`B.
`
`Exhibit 1026 is Hearsay
`
`Exhibit 1026 is an out-of-court statement offered into evidence by Petitioner
`
`to prove the truth of the matters asserted therein. (See, e.g., Petition at 62; Ex.
`
`1007 ¶ 163.) Petitioner has not identified any hearsay exception that applies to
`
`Exhibit 1026. Accordingly, Exhibit 1026 is in violation of F.R.E. 801-802.
`
`V.
`
`OBJECTIONS TO EXHIBIT 1028 AND ANY REFERENCE TO
`AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibit 1028 (Assignment Record for U.S. Patent
`
`App. Pub. No. 2003/0236567 to Elliot) 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”).
`
`-7-
`
`
`
`A.
`
`Exhibit 1028 is Unauthenticated
`
`Patent Owner has not provided any evidence to authenticate Exhibit 1028, in
`
`violation of F.R.E. 901.
`
`B.
`
`Exhibit 1028 is Hearsay
`
`Exhibit 1028 is an out-of-court statement offered into evidence by Petitioner
`
`to prove the truth of the matters asserted in Exhibit 1028. (See, e.g., Petition
`
`at 13 n.4.) Petitioner has not identified any hearsay exception that applies to
`
`Exhibit 1028. Accordingly, Exhibit 1028 is in violation of F.R.E. 801-802.
`
`VI. OBJECTIONS TO EXHIBITS 1012-13, 1016, 1029, AND ANY
`REFERENCE TO AND/OR RELIANCE THEREON
`
`Evidence objected to: Exhibits 1012 (Charles T. Dotter, “Transluminally-
`
`Placed Coilspring Endarterial Tube Grafts,” Investigate Radiology, 329-32
`
`(1969)), 1013 (Frank Ing, “Stents: What’s Available to the Pediatric Interventional
`
`Cardilogist?” Catheterization and Cardiovascular Interventions 57:274-386
`
`(2002)), 1016 (Excerpts from Dolmatch et al., Stent Grafts: Current Clinical
`
`Practice (1999)), 1029 (Lawrence et al., “Percutaneous Endovascular Graft:
`
`Experimental Evaluation,” Radiology, 163(2): 357-60 (May 1987)), 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
`
`-8-
`
`
`
`Reasons”); 37 C.F.R. § 42.6(a)(3) (“Filing of Documents, Including Exhibits;
`
`Service”); 37 C.F.R. § 42.22(a)(2) (“Content of Petitions and Motions”).
`
`A.
`
`Exhibit 1012-13, 1016, and 1029 are Irrelevant
`
`Exhibits 1012-13, 1016, and 1029 are not cited in the Petition. Accordingly,
`
`they are not relevant to any ground on which this IPR was instituted 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. Moreover, any attempt by Petitioner
`
`to rely on these exhibits by citing its expert’s declaration constitute improper
`
`incorporation by reference, in violation of 37 C.F.R. § 42.6(a)(3) and 37 C.F.R.
`
`§ 42.22(a)(2).
`
`Dated: April 12, 2017
`
`Respectfully submitted,
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`Wallace Wu, Ph.D. (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.
`
`-9-
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER
`BOSTON SCIENTIFIC SCIMED, INC.’S FIRST SET OF OBJECTIONS TO
`PETITIONER EDWARDS LIFESCIENCES CORP.’S EXHIBITS was served on
`April 12, 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 92614
`Email: gcordrey@jmbm.com
`
`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
`
`Catherine Nyarady (Reg. No. 42,042)
`Paul, Weiss, Rifkind, Wharton &
`Garrison LLP
`1285 Avenue of the Americas
`New York, NY 10019
`Email: cnyarady@paulweiss.com
`
`Attorneys for Petitioner Edwards Lifesciences Corp.
`
`/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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