`Filed: December 22, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`MYLAN PHARMACEUTICALS INC.
`Petitioner,
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`v.
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`ALLERGAN, INC.
`Patent Owner.
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`_____________________________
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`Case IPR2016-01127 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,624,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132 (US 9,248,191 B2)
`_____________________________
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`PETITIONER MYLAN PHARMACEUTICALS INC.’S
`NOTICE OF OBJECTION TO EVIDENCE1
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`1 The word-for-word identical paper is filed in each proceeding identified in the
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`caption pursuant to the Board’s Scheduling Order (Paper 10).
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ........................................................................................ 1
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`II.
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`OBJECTIONS .............................................................................................. 1
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`1.
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`2.
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`3.
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`4.
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`Objections to Ex. 2001, and any Reference to/Reliance
`Thereon ..................................................................................... 1
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`Objections to Ex. 2003, and any Reference to/Reliance
`Thereon ..................................................................................... 2
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`Objections to Ex. 2006, and any Reference to/Reliance
`Thereon ..................................................................................... 3
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`Objections to Ex. 2008 and any Reference to/Reliance
`Thereon ..................................................................................... 5
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`III. CONCLUSION ............................................................................................ 6
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`I.
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`INTRODUCTION
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Mylan Pharmaceuticals Inc.
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`(“Petitioner”) submits the following objections to Allergan, Inc. (“Patent
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`Owner”)’s Exhibits 2001, 2003, 2006, and 2008 as listed on each List of Exhibits
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`filed by Patent Owner in each of Patent Owner’s Preliminary Responses
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`(“Preliminary Responses”) on September 9, 2016, and any reference to or reliance
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`on the foregoing Exhibits in the Preliminary Responses or future filings by Patent
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`Owner. As required by 37 C.F.R. § 42.62, Petitioner’s objections below apply the
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`Federal Rules of Evidence (“F.R.E.”).
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`II. OBJECTIONS
`1. Objections to Ex. 2001, and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
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`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
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`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
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`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
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`(Authenticating Evidence).
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`Patent Owner describes EX. 2001 as “NDA 21-023 Cyclosporine
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`Ophthalmic Emulsion 0.05%, Original NDA Filing, Vol. 1 (Feb. 24, 1999).”
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`However, EX. 2001 does not purport to have been published in 1999 or on any
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`particular date before the claimed priority date of the invention of the patent at
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`issue. To the extent that the publication date of EX. 2001 is later than the alleged
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`date of invention for the patent at issue, the fact that the content of EX. 2001 was
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`published on the asserted date, even if established by Patent Owner, is irrelevant to
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`whether the claimed subject matter was obvious at the alleged time of the
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`invention. F.R.E. 401, 402. Further, EX. 2001 is so attenuated to the question of
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`whether the claimed invention was obvious at the alleged time of the invention,
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`that it is unduly prejudicial, misleading, and a waste of time. F.R.E. 403.
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`To the extent that Patent Owner relies on EX. 2001 or on any statements in
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`EX. 2001 for the truth of the matter asserted, such statements are inadmissible
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`hearsay when offered by Patent Owner and also have not been authenticated.
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`F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides no foundation
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`for the statements as either lay testimony or expert testimony of any particular
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`declarant. F.R.E. 602, 701, 702.
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`2. Objections to Ex. 2003, and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
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`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
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`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
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`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
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`(Authenticating Evidence).
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`Patent Owner describes EX. 2003 as “Said et al., Investigative
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`Opthalmology & Visual Science, vol. 48, No. 11 (Nov. 2007): 5000-5006.”
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`However, EX. 2003 does not purport to have been published before the claimed
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`priority date of the invention of the patent at issue. To the extent that the
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`publication date of EX. 2003 is later than the alleged date of invention for the
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`patent at issue, the fact that the content of EX. 2003 was published on the asserted
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`date, even if established by Patent Owner, is irrelevant to whether the claimed
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`subject matter was obvious at the alleged time of the invention. F.R.E. 401, 402.
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`Further, EX. 2003, which appears to have been created years after the alleged date
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`of invention, is so attenuated to the question of whether the claimed invention was
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`obvious at the alleged time of the invention, that it is unduly prejudicial,
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`misleading, and a waste of time. F.R.E. 403.
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`To the extent that Patent Owner relies on any statements in EX. 2003 for the
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`truth of the matter asserted, such statements are inadmissible hearsay and also have
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`not been authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner
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`provides no foundation for the statements as either lay testimony or expert
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`testimony of any particular declarant. F.R.E. 602, 701, 702.
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`3. Objections to Ex. 2006, and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
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`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
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`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
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`(Authenticating Evidence).
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`Patent Owner describes EX. 2006 as “Dorland’s Illustrated Medical
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`Dictionary, definition of therapeutic.” However, EX. 2006 does not purport to
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`have been published before the claimed priority date of the invention of the patent
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`at issue. To the extent that the publication date of EX. 2006 is later than the
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`alleged date of invention for the patent at issue, the fact that the content of EX.
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`2006 was published on the asserted date, even if established by Patent Owner, is
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`irrelevant to whether the claimed subject matter was obvious at the alleged time of
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`the invention. F.R.E. 401, 402. Further, EX. 2006, which appears to have been
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`created years after the alleged date of invention, is so attenuated to the question of
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`whether the claimed invention was obvious at the alleged time of the invention,
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`that it is unduly prejudicial, misleading, and a waste of time. F.R.E. 403.
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`To the extent that Patent Owner relies on any statements in EX. 2006 for the
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`truth of the matter asserted, such statements are inadmissible hearsay and also have
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`not been authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner
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`provides no foundation for the statements as either lay testimony or expert
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`testimony of any particular declarant. F.R.E. 602, 701, 702.
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`4. Objections to Ex. 2008 and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
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`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
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`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
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`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
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`(Authenticating Evidence).
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`Patent Owner describes EX. 2008 as “RESTASIS® label.” However, EX.
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`2008 does not purport to have been published before the claimed priority date of
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`the invention of the patent at issue. To the extent that the publication date of EX.
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`2008 is later than the alleged date of invention for the patent at issue, the fact that
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`the content of EX. 2008 was published on the asserted date, even if established by
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`Patent Owner, is irrelevant to whether the claimed subject matter was obvious at
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`the alleged time of the invention. F.R.E. 401, 402. Further, EX. 2008, which
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`appears to have been created years after the alleged date of invention, is so
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`attenuated to the question of whether the claimed invention was obvious at the
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`alleged time of the invention, that it is unduly prejudicial, misleading, and a waste
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`of time. F.R.E. 403. Moreover, EX. 2008 lacks authentication. F.R.E. 901.
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`To the extent that Patent Owner relies on EX. 2008 or on any statements in
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`EX. 2008 for the truth of the matter asserted, such statements are inadmissible
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`hearsay when offered by Patent Owner and also have not been authenticated.
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides no foundation
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`for the statements as either lay testimony or expert testimony of any particular
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`declarant. F.R.E. 602, 701, 702.
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`III. CONCLUSION
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`The aforementioned exhibits were filed together with Patent Owner’s
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`Preliminary Response, prior to institution. Trial was instituted on December 8,
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`2016. These objections are made within 10 business days of institution pursuant to
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`Respectfully submitted,
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`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`37 C.F.R. § 42.64.
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`Dated: December 22, 2016
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`CERTIFICATE OF SERVICE
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`
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`This is to certify that I caused to be served a true and correct copy of the
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`foregoing Petitioner Mylan Pharmaceutical Inc.’s Notice of Objections to
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`Evidence, on this 22nd day of December, 2016, on the Patent Owner at the
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`correspondence address of the Patent Owner as follows:
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`Dorothy P. Whelan
`Michael J. Kane
`Fish & Richardson PC
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP1@fr.com
`Email: IPR13351-0008IP2@fr.com
`Email: IPR13351-0008IP3@fr.com
`Email: IPR13351-0008IP4@fr.com
`Email: IPR13351-0008IP5@fr.com
`Email: IPR13351-0008IP6@fr.com
`Email: PTABInbound@fr.com
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`Dated: December 22, 2016
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`Respectfully submitted,
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`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
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