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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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`COALITION FOR AFFORDABLE DRUGS VIII, LLC
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`Petitioner
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
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`Patent Owner
`
`
`Case IPR2015-01836
`U.S. Pat. No. 7,932,268
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
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`Pursuant to 37 C.F.R. § 42.64, Patent Owner objects to the admissibility of
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`the documents identified below submitted by Petitioner, Coalition for Affordable
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`Drugs VIII, LLC, during the preliminary proceedings, for the following reasons:
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`1.
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`Petitioner’s Exhibit 1002 (Declaration of Randall M. Zusman)
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`is objected to as unreliable under Federal Rule of Evidence 702 and Daubert
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`v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Dr. Zusman
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`does not possess the requisite credentials or expertise to render opinions in
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`this case. This Exhibit is further objected to as unreliable under Federal
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`Rules of Evidence 702/703 because its bases are not of the type reasonably
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`relied upon by experts in the field in forming an opinion. This Exhibit is
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`further objected to as unreliable under Federal Rules of Evidence 702/703 to
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`the extent that it relies on documents dated after the priority date of U.S.
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`Patent No. 7,932,268 (“the ’268 Patent”) for any prior art teaching.
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`2.
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`Petitioner’s Exhibit 1003 (Declaration of Michael Mayersohn)
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`is objected to as unreliable under Federal Rule of Evidence 702 and Daubert
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`v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Dr. Mayersohn
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`does not possess the requisite credentials or expertise to render opinions in
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`this case. This Exhibit is further objected to as unreliable under Federal
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`Rules of Evidence 702/703 because its bases are not of the type reasonably
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`relied upon by experts in the field in forming an opinion. This Exhibit is
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`further objected to as unreliable under Federal Rules of Evidence 702/703 to
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`the extent that it relies on documents dated after the priority date of the ’268
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`Patent for any prior art teaching.
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`3.
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`Petitioner’s Exhibit 1004 is objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding. This Exhibit is further objected to under Federal
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`Rules of Evidence 702/703 and Daubert v. Merrell Dow Pharmaceuticals,
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`Inc., 509 U.S. 579 (1993) to the extent it is offered as improper expert
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`testimony. The form of this Exhibit violates 37 C.F.R. § 42.63.
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`4.
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`Petitioner’s Exhibit 1005 is objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding. This Exhibit is further objected to under Federal
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`Rules of Evidence 702/703 and Daubert v. Merrell Dow Pharmaceuticals,
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`Inc., 509 U.S. 579 (1993) to the extent it is offered as improper expert
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`testimony. The form of this Exhibit violates 37 C.F.R. § 42.63.
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`5.
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`Petitioner’s Exhibit 1007 is objected to under Federal Rules of
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`Evidence 402/403 because it is cumulative over Exhibit 1001.
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`3
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`6.
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`Petitioner’s Exhibit 1013 is objected to under Federal Rules of
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`Evidence 402/403 to the extent that it is relied upon as prior art under 35
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`U.S.C. § 102. This Exhibit is further objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding.
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`7.
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`Petitioner’s Exhibit 1014 is objected to under Federal Rules of
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`Evidence 402/403 to the extent that it is relied upon as prior art under 35
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`U.S.C. § 102. This Exhibit is further objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding. This Exhibit is further objected to because it has not
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`been properly authenticated as required by Federal Rule of Evidence 901.
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`8.
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`Petitioner’s Exhibit 1023 is objected to under Federal Rules of
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`Evidence 402/403 to the extent that it is relied upon as prior art under 35
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`U.S.C. § 102. This Exhibit is further objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding. This Exhibit is further objected to because it has not
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`been properly authenticated as required by Federal Rule of Evidence 901.
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`9.
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`Petitioner’s Exhibit 1024 is objected to because it has not been
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`properly authenticated as required by Federal Rule of Evidence 901.
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`4
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`10. Petitioner’s Exhibit 1025 is objected to under Federal Rule of
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`Evidence 106 as incomplete. This Exhibit is further objected to under
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`Federal Rules of Evidence 402/403 because it is not relevant to any issue in
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`the above-captioned proceeding. This Exhibit is also objected to as hearsay
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`(subject to no exception) under Federal Rules of Evidence 801/802. This
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`Exhibit is further objected to because it has not been properly authenticated
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`as required by Federal Rule of Evidence 901.
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`11. Petitioner’s Exhibit 1026 is objected to under Federal Rule of
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`Evidence 106 as incomplete.
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`12. The form of Petitioner’s Exhibit 1028 violates 37 C.F.R. §
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`42.63.
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`13. The form of Petitioner’s Exhibit 1030 violates 37 C.F.R. §
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`42.63.
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`14. Petitioner’s Exhibit 1034 is objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding. This Exhibit is further objected to under Federal
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`Rules of Evidence 702/703 and Daubert v. Merrell Dow Pharmaceuticals,
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`Inc., 509 U.S. 579 (1993) to the extent it is offered as improper expert
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`testimony. This Exhibit is further objected to because it has not been
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`5
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`properly authenticated as required by Federal Rule of Evidence 901. The
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`form of this Exhibit violates 37 C.F.R. § 42.63.
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`15. Petitioner’s Exhibit 1035 is objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding. This Exhibit is further objected to because it has not
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`been properly authenticated as required by Federal Rule of Evidence 901.
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`16. Petitioner’s Exhibit 1036 is objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding. This Exhibit is further objected to because it has not
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`been properly authenticated as required by Federal Rule of Evidence 901.
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`17. Petitioner’s Exhibit 1037 is objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`captioned proceeding. This Exhibit is further objected to because it has not
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`been properly authenticated as required by Federal Rule of Evidence 901.
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`18. Petitioner’s Exhibit 1038 is objected to under Federal Rules of
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`Evidence 402/403 to the extent that it is relied upon as prior art under 35
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`U.S.C. § 102. This Exhibit is further objected to under Federal Rules of
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`Evidence 402/403 because it is not relevant to any issue in the above-
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`6
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`

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`captioned proceeding. This Exhibit is further objected to because it has not
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`been properly authenticated as required by Federal Rule of Evidence 901.
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`These objections have been timely made within ten business days from the
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`institution of trial in this case, as required by 37 C.F.R. § 42.64(b)(1).
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`
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`Date: March 21, 2016
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`Respectfully submitted,
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`/William G. James/
`William G. James
`Registration No. 55,931
`Goodwin Procter LLP
`901 New York Avenue NW
`Washington, DC 20001
`P: 202.346.4046
`F: 202.346.4444
`wjames@goodwinprocter.com
`
`Attorney For Patent Owner
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`7
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`

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`
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S OBJECTIONS TO EVIDENCE PURSUANT TO 37 C.F.R. §
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`42.64 was served electronically via e-mail on March 21, 2016 on the following:
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`
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`
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`/April E. Weisbruch/
`April E. Weisbruch
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`Dr. Gregory Gonsalves
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
`
`Christopher Casieri
`McNeely, Hare & War LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`(609) 731-3668
`chris@miplaw.com
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`
`
`Counsel for Petitioner Coalition
`for Affordable Drugs VIII, LLC
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`
`
`Dated:
`
`March 21, 2016

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