IPR2016-00649
`U.S. Patent No. 8,664,231
`
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________
`FRONTIER THERAPEUTICS, LLC
`Petitioner
`v.
`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH
`Patent Owner
`___________________________________
`
`Inter Partes Review Case No. IPR2016-00649
`Patent Number 8,664,231
`
`Before the Honorable TONI R. SCHEINER, ERICA A. FRANKLIN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`
`
`
`
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE SUBMITTED WITH
`PETITIONER’S INTER PARTES REVIEW PETITION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of and acting
`
`in a representative capacity for Patent Owner Medac Gesellschaft Für Klinische
`
`Spezialpräparate MBH (“Patent Owner”), hereby submit the following objections
`
`to Petitioner Frontier Therapeutic LLC’s (“Petitioner”) Exhibits as indicated
`
`below, and any reference thereto/reliance thereon, without limitation. Patent
`
`Owner’s objections below apply the Federal Rules of Evidence (“F.R.E.”) as
`
`required by 37 C.F.R § 42.62.
`
`
`
`These objections address evidentiary deficiencies in the material served by
`
`- 1 -
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`
`U.S. Patent No. 8,664,231
`
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________
`FRONTIER THERAPEUTICS, LLC
`Petitioner
`v.
`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH
`Patent Owner
`___________________________________
`
`Inter Partes Review Case No. IPR2016-00649
`Patent Number 8,664,231
`
`Before the Honorable TONI R. SCHEINER, ERICA A. FRANKLIN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`
`
`
`
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE SUBMITTED WITH
`PETITIONER’S INTER PARTES REVIEW PETITION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of and acting
`
`in a representative capacity for Patent Owner Medac Gesellschaft Für Klinische
`
`Spezialpräparate MBH (“Patent Owner”), hereby submit the following objections
`
`to Petitioner Frontier Therapeutic LLC’s (“Petitioner”) Exhibits as indicated
`
`below, and any reference thereto/reliance thereon, without limitation. Patent
`
`Owner’s objections below apply the Federal Rules of Evidence (“F.R.E.”) as
`
`required by 37 C.F.R § 42.62.
`
`
`
`These objections address evidentiary deficiencies in the material served by
`
`- 1 -
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`Petitioner with the Petition on February 22, 2016.
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`The following objections apply to the Exhibits indicated below as they are
`
`actually presented by Petitioner, in the context of Petitioner’s February 22, 2016
`
`Petition (Paper 1, “Petition”) and not in the context of any other substantive
`
`argument on the merits of the instituted grounds in this proceeding. Patent Owner
`
`expressly objects to any other purported use of these Exhibits, including as
`
`substantive evidence in this proceeding, which would be untimely and improper
`
`under the applicable rules, and Patent Owner expressly asserts, reserves, and does
`
`not waive any other objections that would be applicable in such a context.
`
`I. Objections to Exhibit 1004 And Any Reference to/Reliance Thereon
`Grounds for objection: F.R.E. 106 (Incomplete Document); F.R.E. 1002
`
`(“Requirement of the Original”); F.R.E. 1003 (“Admissibility of Duplicates”); and
`
`F.R.E. 801, 802 (Impermissible Hearsay).
`
`Patent Owner objects to the use of Exhibit 1004 under F.R.E. 106, 1002, and
`
`1003 because Petitioner fails to provide the complete document. Exhibit 1004
`
`appears to be missing at least page 648.
`
`Patent Owner objects to Exhibit 1004 as impermissible hearsay under F.R.E.
`
`801 and 802 to the extent to which the out of court statements therein, or the out of
`
`court statements referenced therein, are offered for the truth of the matters asserted
`
`and constitute impermissible hearsay for which Petitioner has not demonstrated
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`- 2 -
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`Attorney Docket No.
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`IPR2016-00649
`110670-0010-651
`
`U.S. Patent No. 8,664,231
`
`any exception or exclusion to the rule against hearsay (F.R.E. 801, 802).
`
`II. Objections to Exhibits 1005, 1007-1010, 1018-1030 And Any Reference
`to/Reliance Thereon
`
`Grounds for objection: F.R.E. 901 (“Authenticating or Identifying
`
`Evidence”); F.R.E. 902 (“Evidence That is Self-Authenticating”); F.R.E. 1002
`
`(“Requirement of the Original”); F.R.E. 1003 (“Admissibility of Duplicates”); and
`
`37 C.F.R. § 42.61 (“Admissibility”).
`
`Patent Owner objects to the use of Exhibits 1005, 1007-1010, 1018-1030
`
`under F.R.E. 901, 1002, 1003, and 37 C.F.R. § 42.61 because Petitioner fails to
`
`provide the authentication required for these documents, and has not established
`
`that the Exhibits are self-authenticating under F.R.E. 902.
`
`III. Objections to Exhibits 1006, 1011, 1014, 1015, And Any Reference
`to/Reliance Thereon
`
`Grounds for objection: F.R.E. 901 (“Authenticating or Identifying
`
`Evidence”); F.R.E. 1002 (“Requirement of the Original”); F.R.E. 1003
`
`(“Admissibility of Duplicates”); F.R.E. 801, 802 (Impermissible Hearsay); and 37
`
`C.F.R. § 42.61 (“Admissibility”).
`
`Patent Owner objects to the use of Exhibits 1006, 1011, 1014, and 1015
`
`under F.R.E. 901, 1002, 1003, and 37 C.F.R. § 42.61 because Petitioner fails to
`
`provide the authentication required for these documents, and the has not
`
`established that the Exhibits are self-authenticating under F.R.E. 902.
`
`- 3 -
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`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`Patent Owner further objects to Exhibits 1006, 1011, 1014, and 1015 as
`
`impermissible hearsay under F.R.E. 801 and 802 to the extent to which the out of
`
`court statements therein, or the out of court statements referenced therein, are
`
`offered for the truth of the matters asserted and constitute impermissible hearsay
`
`for which Petitioner has not demonstrated any exception or exclusion to the rule
`
`against hearsay (F.R.E. 801, 802).
`
`IV. Objections to Exhibits 1012 and 1013 And Any Reference to/Reliance
`Thereon
`
`Grounds for objection: F.R.E. 801 and 802 (Impermissible Hearsay).
`
`Further, Drs. Gershwin and Gammon purport to make use of statements
`
`contained within the exhibits they cite for the truth of the matter contained therein,
`
`but they have not demonstrated that any hearsay exception applies, which violates
`
`FRE 801, 802. (See, e.g., Ex. 1012 ¶¶ 71, 75, 78) and Ex. 1013 ¶¶ 41, 42, 48, 51,
`
`55, 62).
`
`V. Objections to Exhibit 1017 And Any Reference to/Reliance Thereon
`Grounds for objection: F.R.E. 106 (Incomplete document) F.R.E. 1002
`
`(“Requirement of the Original”); and F.R.E. 1003 (“Admissibility of Duplicates”).
`
`Patent Owner objects to the use of Exhibit 1017 under F.R.E. 106, 1002, and
`
`1003 because Petitioner fails to provide the complete document.
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`- 4 -
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`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`
`Dated: September 15, 2016
`
`
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`
`
`Respectfully submitted,
`
`ROPES & GRAY LLP
`
`
`
`
`
`
`
`
`
`By /James F. Haley, Jr./
`
`James F. Haley, Jr., Lead Counsel
`Registration No. 27,794
`james.haley@ropesgray.com
`T: 212-596-9034
`J. Steven Baughman, Backup Counsel
`Registration No. 47,414
`steven.baughman@ropesgray.com
`T: 202-508-4606
`
`
`ROPES & GRAY LLP
`1211 Avenue of the Americas
`New York, New York 10036-8704
`
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`- 5 -
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`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that copies of the following documents
`
`have been served in their entirety by filing these documents through the Patent
`
`Review Processing System as well as providing courtesy copies via e-mail to the
`
`following attorneys of record for the Petitioners listed below:
`
`1.
`
`Patent Owner’s Objections To Evidence Submitted With Petitioner’s Inter
`
`Partes Review Petition.
`
`
`
`
`
`Lead Counsel:
`Dr. Gregory Gonsalves
`Reg. No. 43,639
`2216 Beacon Lane
`Falls Church, VA 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
`
`Back-up Counsel:
`Christopher Casieri
`McNeely, Hare & War LLP 12
`Roszel Road,
`Suite C104
`Princeton, NJ 08540 Phone: 609
`731 3668 chris@miplaw.com
`
`Dated:
`
`September 15, 2016
`
` /BRIAN M. GUMMOW/_____
`
`ROPES & GRAY LLP
`
`
`
`
`
`1
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