UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
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`HOLOGIC, INC.
`
`and BECTON, DICKINSON AND COMPANY,
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`Petitioners,
`
`v.
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`ENZO LIFE SCIENCES, INC.,
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`Patent Owner
`
`____________
`
`Case No. IPR2016-00822
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`U.S. Patent No. 7,064,197
`
`____________
`
`
`
`REPLY IN SUPPORT OF PETITIONERS’ MOTION TO EXCLUDE
`EVIDENCE
`
`
`
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`
`HOLOGIC, INC.
`
`and BECTON, DICKINSON AND COMPANY,
`
`Petitioners,
`
`v.
`
`ENZO LIFE SCIENCES, INC.,
`
`Patent Owner
`
`____________
`
`Case No. IPR2016-00822
`
`U.S. Patent No. 7,064,197
`
`____________
`
`
`
`REPLY IN SUPPORT OF PETITIONERS’ MOTION TO EXCLUDE
`EVIDENCE
`
`
`
`IPR2016-00822
`U.S. Patent 7,064,197
`Petitioners’ Motion to Exclude Evidence (“Mot.”) established that the RTP
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`Exhibits, and portions of Dr. Buck’s and Mr. Weiner’s Declarations concerning
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`those Exhibits, are not admissible under the Federal Rules of Evidence (“FRE”).
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`Enzo’s Opposition fails to affect that showing.
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`I. Mr. Weiner Lacks Personal Knowledge Of Reduction To Practice Dates
`In The RTP Exhibits, Which Are Otherwise Inadmissible Hearsay
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`Enzo argues that Mr. Weiner had personal knowledge of Enzo’s R&D
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`activities during the January to September 1982 time frame, during which he was
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`Vice President of Enzo Biochem. Enzo Opposition (“Opp.”), 2-4. Petitioners,
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`however, do not dispute that Mr. Weiner may have some personal knowledge of
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`Enzo’s R&D activities in 1982. Rather, Petitioners dispute Mr. Weiner’s personal
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`knowledge of the date when Enzo’s activities resulted in the claimed invention,
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`i.e., the date when the claimed invention was purportedly reduced to practice. His
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`knowledge of the general nature of Enzo’s R&D activities does not amount to
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`personal knowledge of when the claimed invention was reduced to practice.
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`At his deposition, Mr. Weiner answered that he was aware of Enzo’s R&D
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`activities, was a liaison between Enzo’s scientists and the business world, and had
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`contact with the inventors on a daily basis (see id.), even though he did not oversee
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`any R&D or work alongside the inventors (e.g., Ex. 1036, 20:12-21:3, 24:6-10,
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`35:24-38:9, 48:17-49:12, 51:21-52:16, 56:5-57:4, 69:14-23). But when he was
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`specifically asked whether he had any personal knowledge of when the claimed
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`
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`1
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`IPR2016-00822
`U.S. Patent 7,064,197
`subject matter was reduced to practice, independent of the RTP Exhibits, he stated
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`“I cannot say that I was aware of the specific date” or “recall 30 years ago the
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`specific date of an event.” E.g., Ex. 1036, 136:11-137:6, 138:16-139:21. In fact,
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`despite his alleged independent knowledge of Enzo’s R&D activities, Mr. Weiner
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`identified the relevant R&D period as 1980 to 1984—extending well beyond the
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`relevant October 1982 publication date of the VPK reference. Id., 138:16-139:5.
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`Unlike In re Hall where regular library practices were used to “approximate”
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`a public accessibility date from a proven library receipt date, here Mr. Weiner’s
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`testimony is not “competent evidence” to then “approximate” the date of invention
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`based on Enzo’s business practices. 781 F.2d 897, 899 (Fed. Cir. 1986). And Enzo
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`cannot rely upon Palo Alto Networks, where testimony about regular monthly
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`publication practices was admitted to prove a publication date. Palo Alto Networks,
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`Inc. v. Finjan, Inc., IPR2015-01974, Paper 49, at 19-20, 35-36 (P.T.A.B. March
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`16, 2017). By contrast, Mr. Weiner failed to show that Enzo followed any regular
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`business practice in maintaining the RTP Exhibits. E.g., Ex. 1036, 51:12-20, 53:6-
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`54:14. Indeed, Enzo effectively argues that it had no notebook maintenance
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`policy: “Enzo’s policy did not require that each notebook entry be signed and
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`witnessed or that notebooks be bound and consecutively dated.” Opp., 8.
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`Mr. Weiner’s testimony that the inventors’ experiments occurred by certain
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`dates is based on nothing more than the hearsay statements of the RTP Exhibits.
`
`
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`2
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`IPR2016-00822
`U.S. Patent 7,064,197
`Mr. Weiner’s purported knowledge of Enzo’s R&D activities does not give rise to
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`knowledge of the dates when such R&D activities resulted in reduction to practice
`
`of the claimed invention, and cannot be used to authenticate the RTP Exhibits.
`
`II. The RTP Exhibits Are Neither Authentic Nor Admissible Hearsay
`Petitioners’ Motion presented two separate grounds for excluding the RTP
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`Exhibits. Enzo’s opposition does nothing to overcome those grounds. First, the
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`RTP Exhibits cannot be authenticated because Enzo has not established they are
`
`what Enzo claims them to be—documents created by September 1982 showing
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`reduction to practice of the ’197 patent claims. See Opp., 7. Petitioners have shown
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`that Mr. Weiner lacks personal knowledge of when the RTP Exhibits were created,
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`and that the RTP Exhibits lack distinctive characteristics of reliable laboratory
`
`records, because they are not consistently dated, signed, or witnessed.
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`Enzo’s corroboration arguments also fail. See Opp., 9-10. Dr. Kirtikar’s
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`2003 declaration (Ex. 2002) was not submitted to prove an invention date (it
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`addressed a written description rejection). Also, Blicharz relates to the weight
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`given to corroborative evidence, which included testimony from a witness who
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`actually observed the experiments. Blicharz v. Hays, 496 F.2d 603, 605-606
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`(C.C.P.A. 1974). Blicharz does not support Enzo’s efforts to authenticate the
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`inconsistently dated, signed, and witnessed RTP Exhibits.
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`Second, the RTP Exhibits do not qualify as business records or other
`
`
`
`3
`
`
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`IPR2016-00822
`U.S. Patent 7,064,197
`exceptions to the hearsay rule. See Mot., 9-11. Enzo fails to demonstrate how the
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`RTP Exhibits meet the business record exception requirements: without consistent
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`dates, there is no way to confirm that the information was recorded “at or near the
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`time the experiments were performed,” and without a clear notebook policy (see
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`supra, p. 2), Enzo cannot demonstrate that there was a “regularly conducted
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`activity of the business.” Further, Corning Inc. is not as limited as Enzo suggests.
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`Corning Inc. v. DSM IP Assets B.V., IPR2013-00043, Paper 97, at 5 (“Federal
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`Circuit and Board precedent declines to invoke a Rule 803(6) exception to
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`laboratory notebook documents,” citing several cases refusing to admit scientific
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`research reports and tests under Rule 803(6)).
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`Moreover, the RTP Exhibits cannot qualify as authentic ancient documents
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`under either FRE 901(8) or 803(16), because the documents lack the details
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`expected in reliable notebook-keeping practice—consistent signing, dating, and
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`witnessing (i.e., proof of review)—creating suspicion about their authenticity.
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`III. Portions of Dr. Buck’s Testimony Must Be Excluded
`Enzo never disputes that Dr. Buck lacks personal knowledge of the dates
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`certain activities allegedly occurred. Instead, Enzo relies on Broadcom to argue
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`that Dr. Buck can use inadmissible facts in the RTP Exhibits to “analyz[e]
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`conception and reduction-to-practice questions.” Opp., 14. The Broadcom expert,
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`unlike Dr. Buck, gave “detailed testimony at trial explaining his basis for
`
`
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`4
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`IPR2016-00822
`U.S. Patent 7,064,197
`concluding that each [claim limitation] was present in the 1989 lab notebook.”
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`Broadcom Corp. v. Qualcomm Inc., 543 F.3d 683, 693 (Fed. Cir. 2008).
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`Dr. Buck went beyond addressing claim limitations when he testified that
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`inventor activities occurred by or on certain dates (Ex. 2142, ¶¶ 161, 180-194,
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`196, and 197), despite having no personal knowledge of when the inventors
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`performed any specific activity. Ex. 1035, 39:1-23. FRE 703 does not allow Enzo
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`to establish the truth of dates in the RTP Exhibits based on Dr. Buck’s reliance
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`thereon. See Marvel Characters, Inc. v. Kirby, 726 F.3d 119, 136 (2d Cir. 2013).
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`Finally, Enzo wrongly argues that Petitioners’ motion challenges the merits
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`of Dr. Buck’s opinions, which are allegedly based on “facts” in the RTP Exhibits.
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`Opp., 14-15. Here, the parties do not merely disagree on the meaning of a fact
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`while agreeing the fact itself is disclosed; rather, the RTP Exhibits lack any facts to
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`support Dr. Buck’s conclusions—indeed Dr. Buck at times agrees. See Mot., 12-
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`15. With no factual bases to support his opinions, Dr. Buck’s testimony is
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`improper expert testimony under FRE 702 and 703.
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`For the foregoing reasons and those in Petitioners’ Motion, the RTP Exhibits
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`and related portions of Exhibits 2142 and 2143 should be excluded.
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`Date: May 15, 2017
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`Respectfully submitted,
`
`/M. Paul Barker/
`M. Paul Barker, Reg. No. 32,013
`Lead Counsel for Hologic, Inc.
`
`
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`5
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`
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`IPR2016-00822
`U.S. Patent 7,064,197
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that the foregoing REPLY IN SUPPORT OF
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`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE was served on May 15,
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`2017, in its entirety via electronic mail to Patent Owner’s and BD’s counsel at:
`
`For Patent Owner
`EnzoIPRService@desmaraisllp.com
`Kevin K. McNish
`kmcnish@desmaraisllp.com
`Michael P. Stadnick
`mstadnick@desmaraisllp.com
`Justin P.D. Wilcox
`jwilcox@desmaraisllp.com
`Kerri-Ann Limbeek
`klimbeek@desmaraisllp.com
`
`For BD
`
`Jamie T. Wisz
`jamie.wisz@wilmerhale.com
`Heather Petruzzi
`heather.petruzzi@wilmerhale.com
`Nancy Lynn Schroeder
`nancy.schroeder@wilmerhale.com
`
`Patent Owner and BD have consented to electronic service.
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`Date: May 15, 2017
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`Respectfully submitted,
`
`/Kristin M. Creed/
`Kristin M. Creed
`Case Manager
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT &
`DUNNER, L.L.P.
`
`
`
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`
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