`IPR2017-00060
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS LIFESCIENCES
`LLC, AND EDWARDS LIFESCIENCES AG
`Petitioners
`
`v .
`
`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
`_______________
`
`Case IPR2017-00060_
`Patent 8,992,608
`_______________
`
`
`PETITIONERS’ OBJECTIONS UNDER 37 C.F.R. § 42.64(b)(1)
`TO EVIDENCE SUBMITTED WITH PATENT OWNER RESPONSE
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`IPR2017-00060
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioners Edwards Lifesciences
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`Corporation, et al. (Petitioners) hereby serve these objections to evidence
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`submitted by Patent Owner Boston Scientific Scimed, Inc. (“Patent Owner”) with
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`Patent Owner’s Preliminary Response in the above noted case. This notice is
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`being timely filed within 10 business days of institution of the Trial, which
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`occurred on March 29, 2017.
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`1.
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`Exhibit 2001
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`Petitioners object to the admissibility of Exhibit 2001 under FRE 401/402,
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`403, and 901. Specifically:
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` FRE 401/402, Lack of Relevance: The exhibit was purportedly
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`published in 2016, long after the priority date of U.S. Patent 8,992,608
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`(“patent-at-issue”). Additionally, Exhibit 2001 is a brochure regarding
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`Petitioners’ product, which is not at issue in or relevant to this IPR. For
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`these reasons, it is not relevant to the issues in the Trial.
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` FRE 403, Prejudicial, Confusing, Misleading: The exhibit was
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`purportedly published after the priority date of the patent-at-issue.
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`Additionally, Exhibit 2001 is a brochure regarding Petitioners’ product,
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`which is not at issue in or relevant to this IPR. Therefore, it is likely to
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`cause confusion regarding the state of the art at the time of the alleged
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`invention and also is misleading and potentially prejudicial.
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`
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`2
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` FRE 901, Lack of Authenticity: Patent Owner has not provided any
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`evidence sufficient to authenticate this exhibit. Therefore, the exhibit is
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`IPR2017-00060
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`inadmissible under FRE 901.
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`2.
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`Exhibit 2002
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`Petitioners object to the admissibility of Exhibit 2002 under FRE 401/402,
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`403, 801/802 and 901. Specifically:
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` FRE 401/402, Lack of Relevance: The exhibit was purportedly
`
`published on August 18, 2016, long after the priority date of the patent-
`
`at-issue. Additionally, Exhibit 2002 is a news release regarding
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`Petitioners’ product, which is not at issue in or relevant to this IPR. For
`
`these reasons, it is not relevant to the issues in the Trial.
`
` FRE 403, Prejudicial, Confusing, Misleading: The exhibit was
`
`purportedly published after the priority date of the patent-at-issue.
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`Additionally, Exhibit 2002 is a news release regarding Petitioners’
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`product, which is not at issue in or relevant to this IPR, and is cited only
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`for the proposition that open heart surgery is traumatic. Therefore, it is
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`likely to cause confusion regarding the state of the art at the time of the
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`alleged invention and also is misleading and potentially prejudicial.
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` FRE 801/802, Hearsay: The exhibit and publications cited therein are
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`inadmissible hearsay because Patent Owner offers it to prove the truth of
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`3
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`IPR2017-00060
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`the matter asserted, and this exhibit does not fall within any hearsay
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`exception.
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` FRE 901, Lack of Authenticity: Patent Owner has not provided
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`evidence sufficient to authenticate this exhibit. “When offering a
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`printout of a webpage into evidence to prove the website’s contents, the
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`proponent of the evidence must authenticate the information from the
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`website itself, not merely the printout.” Neste Oil Oyj v. REG Synthetic
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`Fuels, LLC, IPR2013-00578, Paper 53 at 4 (P.T.A.B. March 12, 2015).
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`Patent Owner has not proferred testimony of a witness with personal
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`knowledge of the website to authenticate the exhibit. Therefore, the
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`exhibit is inadmissible under FRE 901.
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`3.
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`Exhibit 2003
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`Petitioners object to the admissibility of Exhibit 2003 under FRE 401/402,
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`403, and 901. Specifically:
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` FRE 401/402, Lack of Relevance: The exhibit was purportedly
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`published on April 3, 2016, long after the priority date of the patent-at-
`
`issue. Additionally, Exhibit 2003 is a clinical study regarding
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`Petitioners’ product, which is not at issue in or relevant to this IPR. For
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`these reasons , it is not relevant to the issues in the Trial.
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`4
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`IPR2017-00060
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` FRE 403, Prejudicial, Confusing, Misleading: The exhibit was
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`purportedly published after the priority date of the patent-at-issue.
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`Additionally, Exhibit 2003 is a clinical study regarding Petitioners’
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`product, which is not at issue in or relevant to this IPR, and is cited only
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`as background regarding the transcatheter aortic valve replacement
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`procedure. Therefore, it is likely to cause confusion regarding the state
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`of the art at the time of the alleged invention and also is misleading and
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`potentially prejudicial.
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` FRE 901, Lack of Authenticity: Patent Owner has not provided any
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`evidence sufficient to authenticate this exhibit.
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`4.
`
`Exhibit 2004
`
`Petitioners object to the admissibility of Exhibit 2004 under FRE 401/402,
`
`403, 801/802 and 901. Specifically:
`
` FRE 401/402, Lack of Relevance: The exhibit was purportedly
`
`published in 2013, long after the priority date of the patent-at-issue. As
`
`such, it is not relevant to the issues in the Trial.
`
` FRE 403, Prejudicial, Confusing, Misleading: The exhibit was
`
`purportedly published after the priority date of the patent-at-issue.
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`Therefore, it is likely to cause confusion regarding the state of the art at
`
`
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`5
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`IPR2017-00060
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`the time of the alleged invention and also is prejudicial and misleading
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`for this reason.
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` FRE 801/802, Hearsay: The exhibit and publications cited therein are
`
`inadmissible hearsay because Patent Owner offers it to prove the truth of
`
`the matter asserted, and this exhibit does not fall within any hearsay
`
`exception.
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`5.
`
`Exhibit 2005
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`Petitioners object to the admissibility of Exhibit 2005 under FRE 401/402,
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`403, 801/802 and 901. Specifically:
`
` FRE 401/402, Lack of Relevance: The exhibit was purportedly
`
`published after the purported priority date of the patent-at-issue. As
`
`such, it is not relevant to the issues in the Trial.
`
` FRE 403, Prejudicial, Confusing, Misleading: The exhibit was
`
`purportedly published after the purported priority date of the patent-at-
`
`issue. Therefore, it is likely to cause confusion regarding the state of the
`
`art at the time of the alleged invention and also is prejudicial and
`
`misleading for this reason.
`
` FRE 801/802, Hearsay: The exhibit and publications cited therein are
`
`inadmissible hearsay because Patent Owner offers it to prove the truth of
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`
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`6
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`
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`the matter asserted, and this exhibit does not fall within any hearsay
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`IPR2017-00060
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`exception.
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`6.
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`Exhibit 2006
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`Petitioners object to the admissibility of Exhibit 2006 under FRE 401/402,
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`403, 801/802 and 901. Specifically:
`
` FRE 401/402, Lack of Relevance: The exhibit does not address any
`
`prior art upon which the Trial was instituted. As such, it is not relevant
`
`to the issues in the Trial.
`
` FRE 403, Prejudicial, Confusing, Misleading: The exhibit does not
`
`address any prior art upon which the Trial was instituted. Therefore, it is
`
`likely to cause confusion regarding the state of the art at the time of the
`
`alleged invention and also is prejudicial and misleading for this reason.
`
` FRE 801/802, Hearsay: The exhibit and publications cited therein are
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`inadmissible hearsay because Patent Owner offers it to prove the truth of
`
`the matter asserted, and this exhibit does not fall within any hearsay
`
`exception.
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`7.
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`Exhibit 2007
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`Petitioners object to the admissibility of Exhibit 2007 under FRE 401/402,
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`403, and 801/802. Specifically:
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`7
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`IPR2017-00060
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` FRE 401/402, Lack of Relevance: The exhibit pertains to an unrelated
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`proceeding that did not involve the patent-at-issue or the prior art upon
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`which Trial was instituted. As such, it is not relevant to the issues in the
`
`Trial.
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` FRE 403, Prejudicial, Confusing, Misleading: The exhibit pertains to
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`an unrelated proceeding that did not involve the patent-at-issue or the
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`prior art upon which Trial was instituted. Therefore, its use in this Trial
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`is prejudicial, will cause confusion, and is misleading.
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` FRE 801/802, Hearsay: The exhibit and publications cited therein are
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`inadmissible hearsay because Patent Owner offers it to prove the truth of
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`the matter asserted, and this exhibit does not fall within any hearsay
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`exception.
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`8.
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`Exhibit 2008
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`Petitioners object to the admissibility of Exhibit 2008 under FRE 401/402,
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`403, and 801/802. Specifically:
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` FRE 401/402, Lack of Relevance: The exhibit pertains to an unrelated
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`proceeding that did not involve the patent-at-issue or the prior art upon
`
`which Trial was instituted. As such, it is not relevant to the issues in the
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`Trial.
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`8
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`IPR2017-00060
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` FRE 403, Prejudicial, Confusing, Misleading: The exhibit pertains to
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`an unrelated proceeding that did not involve the patent-at-issue or the
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`prior art upon which Trial was instituted. Therefore, its use in this Trial
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`is prejudicial, will cause confusion, and is misleading.
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` FRE 801/802, Hearsay: The exhibit and publications cited therein are
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`inadmissible hearsay because Patent Owner offers it to prove the truth of
`
`the matter asserted, and this exhibit does not fall within any hearsay
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`exception.
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`Dated: April 12, 2017
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`Respectfully submitted,
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`
`/s/ Gregory S. Cordrey
`
`
`
`Gregory S. Cordrey (Reg. No. 44,089)
`Lead Counsel for Petitioners
`Jeffer Mangels Butler & Mitchell LLP
`3 Park Plaza, Suite 1100
`Irvine, CA 92614
`Tel: (949) 623-7236
`Fax: (888) 712-3345
`gxc@jmbm.com
`
`
`Brian Egan (Reg. No. 54,866)
`Back Up Counsel for Petitioners
`Morris, Nichols, Arsht & Tunnell
`LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`Tel: 302-351-9454
`began@MNAT.com
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`9
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`IPR2017-00060
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`Catherine Nyarady (Reg. No. 42,042)
`Back Up Counsel for Petitioners
`Paul, Weiss, Rifkind, Wharton &
`Garrison LLP
`1285 Avenue of the Americas
`New York, NY 10019
`Tel: 212-373-3532
`cnyarady@paulweiss.com
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`10
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`IPR2017-00060
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on April 12,
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`2017, a complete and entire copy of PETITIONERS’ OBJECTIONS UNDER
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`37 C.F.R. § 42.64(b)(1) TO EVIDENCE SUBMITTED WITH PATENT
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`OWNER RESPONSE has been served in its entirety by e-mail on the following
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`addresses of record for Patent Owner:
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`jennifer.sklenar@apks.com
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`wallace.wu@apks.com
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`
`
` /s/ Gregory S. Cordrey
`Gregory S. Cordrey
`Attorney for Petitioners
`Registration No. 44,089
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`11
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