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`Paper No. ___
`Filed: July 31, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`MYLAN TECHNOLOGIES INC.,
`Petitioner,
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner.
`
`_____________________________
`
`Case IPR2017-00200
`Patent No. 8,603,514
`
`_____________________________
`
`PETITIONER MYLAN TECHNOLOGIES INC.’S
`NOTICE OF OBJECTION TO EVIDENCE
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`Case IPR2017-00200
`Patent 8,603,514
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`TABLE OF CONTENTS
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`I.
`
`INTRODUCTION ........................................................................................ 1
`
`II.
`
`OBJECTIONS .............................................................................................. 1
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`1.
`
`2.
`
`3.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
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`6.
`
`Objections to paragraphs 15, 85 of Ex. 2007 and Patent
`Owner’s reliance thereon .......................................................... 1
`
`Objections to Ex. 2009 and Patent Owner’s reliance
`thereon ...................................................................................... 2
`
`Objections to Ex. 2010 and Patent Owner’s reliance
`thereon ...................................................................................... 4
`
`Objections to Ex. 2013 and Patent Owner’s reliance
`thereon ...................................................................................... 5
`
`Objections to Ex. 2018 and Patent Owner’s reliance
`thereon ...................................................................................... 6
`
`Objections to Ex. 2019 and Patent Owner’s reliance
`thereon ...................................................................................... 7
`
`Objections to Exs. 2020-2024 and Patent Owner’s
`reliance thereon ......................................................................... 8
`
`Objections to Exs. 2026 and Patent Owner’s reliance
`thereon ...................................................................................... 9
`
`Objections to Exs. 2027, 2028, 2031 and Patent Owner’s
`reliance thereon ....................................................................... 10
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`III. CONCLUSION .......................................................................................... 11
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`-i-
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`Patent 8,603,514
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`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Mylan Technologies Inc. (“Petitioner”)
`
`submits the following objections to Monosol RX LLC’s (“Patent Owner”)’s
`
`Exhibits 2007, 2009-2010, 2013, 2018-2024, 2026-2028, and 2031, as listed inn
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`Patent Owner’s Exhibit List filed on July 24, 2017, and any reference to or reliance
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`on the foregoing Exhibits in Patent Owner’s Response (“Response”) or future
`
`filings by Patent Owner. As required by 37 C.F.R. § 42.62, Petitioner’s objections
`
`below apply the Federal Rules of Evidence (“F.R.E.”).
`
`II. OBJECTIONS
`1. Objections to paragraphs 15, 85 of Ex. 2007 and Patent
`Owner’s reliance thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); 37 C.F.R. §42.53
`
`(form for testimony).
`
`Patent Owner describes Ex. 2007 as Declaration of Dr. Robert Langer.
`
`Patent Owner describes Ex. 2013 (cited in paragraphs 15 and 85 of Ex. 2007) as a
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`trial transcript in “C.A. No. 1:14-cv-01451-RGA.” Patent Owner does not cite Ex.
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`2013 in its Response. Dr. Langer relies in paragraphs 15 and 85 on Ex. 2013 to
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`incorporate by reference his own hearsay statements and the hearsay statements of
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`other declarants who Patent Owner has not agreed to submit for deposition in this
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`proceeding and who have not been subjected to cross-examination in this
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`proceeding in violation of the Board’s rule regarding the taking of testimony. 37
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`C.F.R. §42.53. Patent Owner relies on such statements for the truth of the matter
`
`asserted, and such statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805.
`
`Moreover, Patent Owner provides insufficient basis for the statements as lay or
`
`expert testimony. F.R.E. 602, 701, 702. Moreover, the trial transcript and opinion
`
`are not from a case in which Petitioner was a party, and the probative value of such
`
`assertions is thus outweighed by the likelihood of unfair prejudice to Petitioner.
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`F.R.E. 401, 402, 403.
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`2. Objections to Ex. 2009 and Patent Owner’s 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
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
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`(Authenticity); 37 C.F.R. §42.53 (form for testimony)
`
`Patent Owner describes Ex. 2009 as a “Master’s Thesis” with an asserted
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`completion date in 2007, years after the earliest claimed priority date of the
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`invention of the patent at issue. Ex. 2009 does not purport on its face to have been
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`published at any point in time. Because the asserted submission date is later than
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`the alleged date of invention for the patent at issue, the fact that the content of any
`
`of these exhibits was published on the asserted date, even if established by Patent
`
`Owner, is irrelevant to whether the claimed subject matter was obvious at the
`
`alleged time of the invention. F.R.E. 401, 402. Further, even if relevant, Ex. 2009
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`which were created years after the alleged date of invention, is so attenuated to the
`
`question of whether the claimed invention was obvious at the alleged time of the
`
`invention, that it is unduly prejudicial, misleading, and a waste of time. F.R.E.
`
`403.
`
`To the extent that Patent Owner relies on any statements in any of Ex. 2009
`
`for the truth of the matter asserted, such statements are inadmissible hearsay.
`
`F.R.E. 801, 802, 803, 805. Moreover, Patent Owner provides no foundation for the
`
`statements with lay testimony or expert testimony for any particular declarant.
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`F.R.E. 602, 701, 702. Patent Owner also fails to provide any evidence
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`authenticating Ex. 2009 or statements made therein (F.R.E. 901) and has failed to
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`make the alleged declarant of statements within Ex. 2009 available for deposition
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`in this IPR proceeding. 37 C.F.R. §42.53 (form for testimony).
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`3. Objections to Ex. 2010 and Patent Owner’s 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
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay).
`
`Patent Owner describes Ex. 2010 as a 2013 publication by “Morales et al.”
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`Because the asserted publication date is later than the alleged date of invention for
`
`the patent at issue, the fact that the content of Ex. 2010 was published on the
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`asserted date, even if established by Patent Owner, is irrelevant to whether the
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`claimed subject matter was obvious at the alleged time of the invention. F.R.E.
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`401, 402. Further, even if relevant, Ex. 2010, which was created years after the
`
`alleged date of invention, is so attenuated to the question of whether the claimed
`
`invention was obvious at the alleged time of the invention that EX2010 is unduly
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`prejudicial, misleading, and a waste of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in Ex. 2010 for the
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`truth of the matter asserted, such statements are inadmissible hearsay. F.R.E. 801,
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`802, 803, 805. Moreover, Patent Owner provides no foundation for the statements
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`as either lay testimony or expert testimony of any particular declarant. F.R.E. 602,
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`701, 702.
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`1. Objections to Ex. 2013 and Patent Owner’s 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
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); 37 C.F.R. §42.53
`
`(form for testimony).
`
`Patent Owner describes Ex. 2013 as a trial transcript in “C.A. No. 1:14-cv-
`
`01451-RGA.” Patent Owner does not cite Ex. 2013 in its Response. Dr. Langer
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`relies on Ex. 2013 to incorporate by reference his own hearsay statements and the
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`hearsay statements of other declarants who Patent Owner has not agreed to submit
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`for deposition in this proceeding and who have not been subjected to cross-
`
`examination in this proceeding in violation of the Board’s rule regarding the taking
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`of testimony. 37 C.F.R. §42.53. Patent Owner relies on such statements for the
`
`truth of the matter asserted, and such statements are inadmissible hearsay. F.R.E.
`
`801, 802, 803, 805. Moreover, Patent Owner provides insufficient basis for the
`
`statements as lay or expert testimony. F.R.E. 602, 701, 702. Moreover, the trial
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`transcript and opinion are not from a case in which Petitioner was a party, and the
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`probative value of such assertions is thus outweighed by the likelihood of unfair
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`prejudice to Petitioner. F.R.E. 401, 402, 403.
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`2. Objections to Ex. 2018 and Patent Owner’s 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
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay).
`
`Patent Owner describes Ex. 2018 as a 2006 publication by “De Muth” that
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`was purportedly published years after the earliest claimed priority date of the
`
`invention of the patent at issue. Because the asserted publication date is years later
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`than the alleged date of invention for the patent at issue, the fact that the content of
`
`this exhibit was published on the asserted date, even if established by Patent
`
`Owner, is irrelevant to whether the claimed subject matter was obvious at the
`
`alleged time of the invention. F.R.E. 401, 402. Further, even if relevant, Ex. 2018,
`
`which was created years after the alleged date of invention, is so attenuated to the
`
`question of whether the claimed invention was obvious at the alleged time of the
`
`invention, 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. 2018 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay. F.R.E. 801,
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`802, 803, 805. Moreover, Patent Owner provides no foundation for the statements
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`as either lay testimony or expert testimony of any particular declarant. F.R.E. 602,
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`701, 702.
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`3. Objections to Ex. 2019 and Patent Owner’s reliance thereon
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`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`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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`(Authenticity); 37 C.F.R. §42.53 (form for testimony)
`
`Patent Owner describes Ex. 2019 as “Ch.33 at p. 578” of a 1988 book,
`
`though Ex. 2019 lacks any bibliographic materials identifying the source or date of
`
`the Exhibit. Ex. 2019 lacks indicia sufficient to authenticate it or provide a
`
`foundation for it. (F.R.E. 602, 901.) Ex. 2019 does not purport on its face to have
`
`been published at any point in time. Because Patent Owner has not provided
`
`necessary foundation to establish its publication claim, Ex. 2019 is irrelevant to
`
`whether the claimed subject matter was obvious at the alleged time of the
`
`invention. F.R.E. 401, 402. Further, even if relevant, Ex. 2013 is so attenuated to
`
`the question of whether the claimed invention was obvious at the alleged time of
`
`the invention, that it is unduly prejudicial, misleading, and a waste of time. F.R.E.
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`403.
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`To the extent that Patent Owner relies on any statements in any of Ex. 2009
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`for the truth of the matter asserted, such statements are inadmissible hearsay.
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`F.R.E. 801, 802, 803, 805. Moreover, Patent Owner provides no foundation for the
`
`statements with lay testimony or expert testimony for any particular declarant.
`
`F.R.E. 602, 701, 702. Patent Owner also has failed to make the alleged declarant
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`of statements within Ex. 2009 available for deposition in this IPR proceeding. 37
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`C.F.R. §42.53 (form for testimony).
`
`4. Objections to Exs. 2020-2024 and Patent Owner’s reliance
`thereon
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`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay).
`
`Patent Owner describes Exs. 2020-2024 as various documents with asserted
`
`publication dates after the earliest claimed priority date of the invention of the
`
`patent at issue. Because the asserted publication dates are later than the alleged
`
`date of invention for the patent at issue, the fact that the content of any of these
`
`exhibits was published on the asserted date, even if established by Patent Owner, is
`
`irrelevant to whether the claimed subject matter was obvious at the alleged time of
`
`the invention. F.R.E. 401, 402. Further, even if relevant, each of Exs. 2020-2024,
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`which were created the alleged date of invention, is so attenuated to the question of
`
`whether the claimed invention was obvious at the alleged time of the invention,
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`that each of these exhibits is unduly prejudicial, misleading, and a waste of time.
`
`F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in any of Exs.
`
`2020-2024 for the truth of the matter asserted, such statements are inadmissible
`
`hearsay. F.R.E. 801, 802, 803, 805. Moreover, Patent Owner provides no
`
`foundation for the statements as either lay testimony or expert testimony of any
`
`particular declarant. F.R.E. 602, 701, 702.
`
`5. Objections to Exs. 2026 and Patent Owner’s reliance thereon
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`Grounds for Objection: F.R.E. 401, 403 (Relevance); F.R.E. 602
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`(Foundation); F.R.E. 701, 702 (Expert Foundation and Opinions); F.R.E. 801, 802,
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`803, 805 (Inadmissible Hearsay); F.R.E. 901 (Authentication).
`
`Patent Owner describes Exs. 2026 as “Sigma-Aldrich Product Information
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`Sheet re Caffeine (Anhydrous).” Ex. 2026 does not purport on its face to have
`
`been published at any point in time. Ex. 2026 is irrelevant and any probative value
`
`is outweighed by the risk of being unduly prejudicial, misleading, and a waste of
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`time. F.R.E. 401, 403.
`
`To the extent that Patent Owner relies on any statements in Ex. 2026 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay. F.R.E. 801,
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`802, 803, 805. Moreover, Patent Owner provides no foundation for the statements
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`with lay testimony or expert testimony for any particular declarant. F.R.E. 602,
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`701, 702. Patent Owner also fails to provide any evidence authenticating Ex. 2009
`
`or statements made therein (F.R.E. 901).
`
`6. Objections to Exs. 2027, 2028, 2031 and Patent Owner’s
`reliance thereon
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`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`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).
`
`Patent Owner describes Exs. 2027, 2028, and 2031 as various documents
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`with asserted creation dates after the earliest claimed priority date of the invention
`
`of the patent at issue. Because the asserted creation dates are later than the alleged
`
`date of invention for the patent at issue, the fact that the content of any of these
`
`exhibits 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
`
`the invention. F.R.E. 401, 402. Further, even if relevant, each of Exs. 2027, 2028,
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`and 2031, which were created after the alleged date of invention, is so attenuated to
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`the question of whether the claimed invention was obvious at the alleged time of
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`the invention, that each of these exhibits is unduly prejudicial, misleading, and a
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`waste of time. F.R.E. 403.
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`To the extent that Patent Owner relies on any statements in any of Exs.
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`2027, 2028, and 2031 for the truth of the matter asserted, such statements are
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`inadmissible hearsay. F.R.E. 801, 802, 803, 805. Moreover, Patent Owner
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`provides no foundation for the statements as either lay testimony or expert
`
`testimony of any particular 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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`Response on July 24, 2017. These objections are made within 5 business days of
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`service pursuant to 37 C.F.R. § 42.64.
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`Dated: July 31, 2017
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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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
`
`foregoing Petitioner Mylan Technologies Inc.’s Notice of Objections to Evidence,
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`on this 31st day of July, 2017, on the Patent Owner at the correspondence address
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`of the Patent Owner as follows:
`
`Harold Fox
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington, DC 20036-1795
`Email: hfox@steptoe.com
`Email: 514MIPR@steptoe.com
`
`
`John L. Abramic
`STEPTOE & JOHNSON LLP
`115 South LaSalle Street, Suite 3100
`Chicago, IL 60603
`Email: jabramic@steptoe.com
`
`
`
`
`
`
`Charanjit Brahma
`TROUTMAN SANDERS
`580 California Street, Suite 1100
`San Francisco, CA 94104
`Email:
`charanjit.brahma@troutmansanders.com
`
`Dustin B. Weeks
`TROUTMAN SANDERS
`600 Peachtree Street, NE, Suite 5200
`Atlanta, GA 30308
`Email:
`dustin.weeks@troutmansanders.com
`
`Dated: July 31, 2017
`
`
`
`
`
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
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`-12-
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