`
`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`
`
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`HOLOGIC, INC., and BECTON, DICKINSON AND COMPANY,
`Petitioner
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`
`
`v.
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`
`
`ENZO LIFE SCIENCES, INC.,
`Patent Owner
`
`__________________
`
`
`
`Case IPR2016-00822
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`U.S. Patent No. 7,064,197
`TITLE: SYSTEM, ARRAY AND NON-POROUS SOLID SUPPORT
`COMPRISING FIXED OR IMMOBILIZED NUCLEIC ACIDS
`Issue Date: June 20, 2006
`
`__________________
`
`
`
`ENZO’S OPPOSITION TO PETITIONER’S
`MOTION TO EXCLUDE EVIDENCE
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`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 1
`THE BOARD SHOULD DENY PETITIONER’S MOTION TO
`EXCLUDE PORTIONS OF MR. WEINER’S DECLARATION .................. 2
`A. Mr. Weiner Has More Than Sufficient Personal Knowledge of
`Enzo’s R&D Activities Addressed In His Declaration
`Testimony. ............................................................................................. 2
`B. Mr. Weiner’s Declaration Contains No Inadmissible Hearsay. ............ 5
`III. THE BOARD SHOULD DENY PETITIONER’S MOTION TO
`EXCLUDE THE RTP EXHIBITS .................................................................. 6
`A.
`Enzo Provided Evidence Sufficient To Establish the
`Authenticity of the RTP Exhibits. ......................................................... 6
`The RTP Exhibits Are Admissible Under the FRE. ........................... 12
`B.
`IV. THE BOARD SHOULD DENY PETITIONER’S MOTION TO
`EXCLUDE PORTIONS OF DR. BUCK’S DECLARATION ..................... 13
`A.
`FRE 602, 802 and 805 Do Not Render Dr. Buck’s Expert
`Testimony Inadmissible. ..................................................................... 13
`Dr. Buck’s Testimony Is Admissible Under FRE 702 and 703. ......... 14
`B.
`CONCLUSION .............................................................................................. 15
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`I.
`II.
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`V.
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`U.S. Patent No. 7,064,197
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`TABLE OF AUTHORITIES
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`Pages
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`Cases
`Berges v. Gottstein,
`618 F.2d 771 (C.C.P.A. 1980) ......................................................................... 5
`Blicharz v. Hays,
`496 F.2d 603 (C.C.P.A. 1974) ......................................................................... 9
`Broadcom Corp. v. Qualcomm Inc.,
`543 F.3d 683 (Fed. Cir. 2008) ................................................................ 14, 15
`Cooper v. Goldfarb,
`154 F.3d 1321 (Fed. Cir. 1998) ....................................................................... 5
`Corning Inc. v. DSM IP Assets B.V.,
`IPR2013-00043, Paper 97 (P.T.A.B. May 1, 2014) ...................................... 13
`Flir Sys., Inc. v. Leak Surveys, Inc.,
`Case IPR2014-00411, Paper 113 (PTAB Sept. 3, 2015) ................................. 2
`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) ......................................................................... 5
`Knorr v. Pearson,
`671 F.2d 1368 (C.C.P.A. 1982) ....................................................................... 5
`Linear Tech. Corp. v. Micrel, Inc.,
`275 F.3d 1040 (Fed. Cir. 2001) ..................................................................... 10
`Mathin v. Kerry ,
`782 F.3d 804 (7th Cir. 2015) ......................................................................... 11
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`Case IPR2015-01974, Paper 49 (PTAB March 16, 2017) .............................. 5
`Threadgill v. Armstrong World Indus., Inc.,
`928 F.2d 1366 (3d Cir. 1991) ........................................................................ 11
`United States v. Kairys,
`782 F.2d 1374 (7th Cir.), cert. denied, 476 U.S. 1153 (1986) ...................... 11
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`Page(s)
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`United States v. Long,
`857 F.2d 436 (8th Cir.1988), cert. denied, 502 U.S. 828 (1991) .................... 7
`
`United States v. Natale,
`526 F.2d 1160 (2d Cir.1975), cert. denied, 425 U.S. 950 (1976) ................... 7
`
`Rules
`FRE 406 ..................................................................................................................... 5
`FRE 602 ..................................................................................................................... 3
`FRE 702 ................................................................................................................... 14
`FRE 801(c) ............................................................................................................... 14
`FRE 901(a) ................................................................................................................. 7
`FRE 901(b)(1) ............................................................................................................ 7
`FRE 901(b)(4) ............................................................................................................ 8
`Regulations
`37 C.F.R. § 42.20(c) ................................................................................................... 2
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`iii
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`I.
`INTRODUCTION
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`Petitioner’s motion to exclude Exhibits 2135, 2137-2141 (“the RTP
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`Exhibits”) and certain paragraphs of Exhibit 2143 (Declaration of Barry Weiner)
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`and of Exhibit 2142 (Declaration of Gregory Buck) should be denied because the
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`challenged evidence is admissible under the Federal Rules of Evidence (“FRE”).
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`The RTP Exhibits include laboratory notebooks and other business records
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`documenting the scientific activities that resulted in the inventions of the ’197
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`patent. Each RTP Exhibit is authenticated by (i) Mr. Weiner’s testimony, (ii)
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`multiple indicia of authenticity, and (iii) its qualification as an ancient document.
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`Each RTP Exhibit is admissible under at least two hearsay exceptions: (i) as a
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`business record; and (ii) as an ancient document. Petitioner’s arguments to the
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`contrary mischaracterize Enzo’s policies and misapply the FRE.
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`Mr. Weiner’s declaration includes testimony regarding certain of Enzo’s
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`research and development activities (“R&D activities”) in 1982 and corroborates
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`the authenticity of the RTP Exhibits that reflect those activities. Petitioner argues
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`that Mr. Weiner’s declaration testimony should be excluded because it is not based
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`on personal knowledge and constitutes inadmissible hearsay. But, Petitioner flatly
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`ignores Mr. Weiner’s unrefuted deposition testimony that his declaration testimony
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`is based solely on personal knowledge he gained at Enzo during 1982.
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`Petitioner’s request to exclude portions of the declaration of Enzo’s
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`technical expert—Dr. Buck—also lacks merit. Dr. Buck’s declaration provides
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`expert opinions admissible under FRE 702 and 703 regarding how a person of
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`ordinary skill in the art would have understood the contents of the RTP Exhibits.
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`Petitioner’s other arguments improperly address the merits of his opinions, not
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`their admissibility.
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`As the moving party, Petitioner has the burden of establishing that the
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`challenged evidence is inadmissible. 37 C.F.R. § 42.20(c); Flir Sys., Inc. v. Leak
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`Surveys, Inc., Case IPR2014-00411, Paper 113, at 5 (PTAB Sept. 3, 2015).
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`Petitioner’s motion should be denied because it has not met that burden.
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`II. THE BOARD SHOULD DENY PETITIONER’S MOTION TO
`EXCLUDE PORTIONS OF MR. WEINER’S DECLARATION
`A. Mr. Weiner Has More Than Sufficient Personal Knowledge of
`Enzo’s R&D Activities Addressed In His Declaration Testimony.
`Petitioner argues that because Mr. Weiner lacks sufficient personal
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`knowledge “that the alleged reduction to practice activities occurred before 1984,”
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`portions of his declaration are inadmissible under FRE 602. (Paper 41, 4-6.) In
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`particular, Petitioner challenges Mr. Weiner’s testimony that the Co-Inventors
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`conducted R&D activities related to nucleic acid hybridization and detection using
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`non-porous solid supports as reflected in the RTP Exhibits. (Ex. 2143 ¶ 4.) But
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`Mr. Weiner’s unrefuted testimony demonstrates that he was personally involved in
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`the management and supervision of those activities.
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`“A witness may testify to a matter only if evidence is introduced sufficient to
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`support a finding that the witness has personal knowledge of the matter. Evidence
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`to prove personal knowledge may consist of the witness’s own testimony.” FRE
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`602. Mr. Weiner has more than sufficient personal knowledge of the matters in the
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`challenged testimony—Enzo’s R&D activities between January and September of
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`1982 (the “Relevant Timeframe”) and certain documents reflecting those
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`activities—the RTP Exhibits. (Ex. 2143 ¶¶ 3-10, 12, 14, 16, 17.) For example, as
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`Enzo Biochem’s Vice President during the Relevant Timeframe, Mr. Weiner:
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` had personal knowledge about the regular practices and daily scientific
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`activities of the co-inventors (Ex. 1036, 24:11-21 (“I can say fairly
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`accurately that I had contact with every one of these inventors on a daily
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`basis.”); see also id., 36:15-37:6, 38:10-39:5, 43:13-44:11, 115:1-5 (“Q. So
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`during the 1982 time frame, you had discussions with the inventors of the
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`’197 patent regarding their scientific activities? A. Absolutely.”));
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` had personal knowledge about the developments resulting in the inventions
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`of the ’197 patent—a core R&D activity at Enzo (Ex. 1036, 116:20-117:4);
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` collaborated with Enzo’s scientists to communicate their nucleic acid
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`diagnostics research to the business world and oversaw bench-level
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`scientific policies, practices and developments (Ex. 1036, 20:12-21:23 (“it is
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`my role to translate this -- our science activity to . . . the business world . . . I
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`am party to the practices, the policies, the product and the potential of the
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`science.”); id., 33:15-35:12, 112:9-114:1); and
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` was responsible for maintaining Enzo’s core business records, including the
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`RTP Exhibits, at Enzo since their creation. (Ex. 1036, 75:8-77:23.)
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`To support its sweeping claim that Mr. Weiner has no personal knowledge
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`whether the disputed reduction to practice activities occurred before 1984,
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`Petitioner points to only two pages of Mr. Weiner’s deposition transcript. (Paper
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`41, 6.) But Petitioner ignores the rest of the transcript, which is replete with
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`examples of Mr. Weiner’s first-hand knowledge of the reduction to practice
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`activities in the Relevant Timeframe. For example, when asked about the May 26,
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`1982 date of the “[f]irst experiment demonstrating the invention” listed in Exhibit
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`2135, Mr. Weiner testified that “independently I completely am in concurrence
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`with the timing of these activities with these events.” (Ex. 1036, 135:7-23; see,
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`e.g., id., 47:3-12 (“Do you recollect that the technology that has been claimed in
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`the ’197 patent, that was done between January of 1982 to September of 1982 by
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`the co-inventors? A. Yes. During that period, this was a fundamental aspect of our
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`activity.”), id., 88:11-89:9 (“I was a participant in the scientific reviews that went
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`by. So, from my own personal knowledge, I can verify and attest that this work
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`was being done [between February and May of 1982].”).)
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`Petitioner also argues that Mr. Weiner lacks personal knowledge of his
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`testimony because “he did not have a scientific background and he did not work in
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`the lab with the inventors.” (Id., 4.) But Mr. Weiner need not have personal
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`knowledge of experimental details because his testimony is not directed to the
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`content of the RTP Exhibits.1 Nor does Petitioner’s argument find any support in
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`the law. Indeed, lay testimony that an event occurred—even from a witness that
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`did not personally observe that event—is admissible so long as the witness has
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`personal knowledge of a routine business practice, such as Enzo’s R&D activities,
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`indicating that the event occurred. In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986);
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`Palo Alto Networks, Inc. v. Finjan, Inc., Case IPR2015-01974, Paper 49, at 35-36
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`(PTAB March 16, 2017); FRE 406. Mr. Weiner testified that the Enzo R&D
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`activities reflected in the RTP Exhibits did in fact occur during the Relevant
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`Timeframe—matters of which he had personal knowledge. Thus, Petitioner’s FRE
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`602 arguments should be rejected.
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`B. Mr. Weiner’s Declaration Contains No Inadmissible Hearsay.
`Petitioner argues that Mr. Weiner’s declaration is inadmissible hearsay
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`because Mr. Weiner’s declaration purportedly describes the details of experiments
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`described in the RTP Exhibits. (Paper 41, 6-7 (“Mr. Weiner’s recitation of
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`1 Such “over-the-shoulder observer” testimony is not necessary to corroborate a
`reduction to practice. Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998)
`(“[C]ircumstantial evidence . . . can satisfy the corroboration requirement.”); Knorr
`v. Pearson, 671 F.2d 1368, 1374 (C.C.P.A. 1982); Berges v. Gottstein, 618 F.2d
`771, 774 (C.C.P.A. 1980) (“It is not required that one of the affiants shall have
`seen [the RTP] in the manner described in the unwitnessed Berges notebook.”).
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`inventors’ or lab supervisors’ statements”).) But Petitioner fails to identify any
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`portion of his declaration that contains such purportedly inadmissible testimony.
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`(Id.) Indeed, Mr. Weiner’s testimony does not recite the content of the laboratory
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`notebooks or any statement made by another individual. Moreover, Mr. Weiner
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`testified during his deposition that his recollection of Enzo’s R&D activities during
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`the Relevant Timeframe was independent of the RTP Exhibits and based instead
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`on his participation in those activities. (Ex. 1036, 117:11-17 (“Q. So independent
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`of . . . documents that you talk about in your declaration, you were aware that the
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`inventors were working on nucleic acid hybridization and detection using non-
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`porous solid supports, correct? A. Yes, I was.”), 125:6-24, 88:11-89:9.) Mr.
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`Weiner also testified that his declaration testimony is based on his own personal
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`knowledge and does not rely on any discussion with Dr. Kelker. (Ex. 1036, 33:5-
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`14.) Because Mr. Weiner’s declaration contains no statements made by another
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`individual, that testimony cannot be hearsay under FRE 801(c).
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`III. THE BOARD SHOULD DENY PETITIONER’S MOTION TO
`EXCLUDE THE RTP EXHIBITS
`A. Enzo Provided Evidence Sufficient To Establish the Authenticity
`of the RTP Exhibits.
`Petitioner argues that Enzo has not presented sufficient evidence of
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`authenticity for the RTP Exhibits under FRE 901. To “satisfy the requirement of
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`authenticating or identifying an item of evidence, the proponent must produce
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`evidence sufficient to support a finding that the item is what the proponent claims
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`it is.” FRE 901(a). “To meet this standard, the proponent need only demonstrate a
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`rational basis for its claim that the evidence is what the proponent asserts it to be.”
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`United States v. Long, 857 F.2d 436, 442 (8th Cir. 1988), cert. denied, 502 U.S.
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`828 (1991); United States v. Natale, 526 F.2d 1160, 1173 (2d Cir. 1975), cert.
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`denied, 425 U.S. 950 (1976). The record contains multiple types of evidence
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`recognized by FRE 901(b) as sufficient to authenticate the RTP Exhibits.
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`1. Testimony of a Witness With Knowledge. Mr. Weiner’s declaration
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`testimony confirms that the RTP Exhibits are what they are claimed to be—
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`inventor notebooks and other business records created in 1982 and maintained by
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`Enzo since that describe Enzo’s R&D activities that resulted in the inventions of
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`the ’197 patent. (Exhibit 2143 ¶¶ 8-10, 12, 14, 16, 17; see FRE 901(b)(1).) As
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`explained above, Mr. Weiner has more than sufficient personal knowledge of
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`Enzo’s R&D activities reflected in the RTP Exhibits.
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`2. Distinctive Characteristics and the Like. The appearance, contents,
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`substance, and internal patterns of the RTP Exhibits confirm that they are inventor
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`notebooks and other business records. FRE 901(b)(4). For example, Exhibits
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`2138 and 2139 are bound “Laboratory Notebook[s]” initialed and dated on their
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`covers, containing dated entries describing experimental procedures and results.
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`Exhibit 2137 is a binder labeled “T4 Experiments” containing dated entries
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`describing experiments with results and films. (See e.g., Ex. 2137, 168-170.)
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`Exhibit 2141, a collection of consecutively dated entries describing experiments,
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`contains lines and columns of the type found on laboratory notebook paper.
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`Finally, the RTP Exhibits’ appearance is consistent with their claimed age of 35
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`years.
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`Exhibits 2137-2139 and 2141 (the lab notebooks) describe experiments
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`performed in dated entries in accordance with Enzo’s policy of recording R&D
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`activities. (Ex. 1036, 118:21-119:2 (“Q. Sir, would you agree that the lab
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`notebooks themselves that you reviewed are proof that the inventors were
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`following Enzo’s policy about recording their scientific activities? A. Yes. The
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`data is recorded in a coherent and legible way and dated, yes.”).) Contrary to
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`Petitioner’s assertion (Paper 41, 8), Enzo’s policy did not require that each
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`notebook entry be signed and witnessed or that notebooks be bound and
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`consecutively dated. (Ex. 1036, 53:6-54:14, 94:22-96:1.) Nonetheless, each of the
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`lab notebooks contains signatures of the inventor who maintained it and some
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`contain entries with witness signatures. (Ex. 1036, 124:3-9, 64:1-16, 65:20-66:13
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`(identifying signatures of Dr. Kirtikar and Dr. Kelker in Ex. 2137); id., 90:11-18,
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`92:12-18 (identifying Dr. Thalenfeld’s initials on the cover of Ex. 2138 and her
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`signature on page 21); id., 98:22-99:5 (identifying Dr. Thalenfeld’s initials on the
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`cover of Ex. 2139); id. 104:3-8 (identifying the signatures of Dr. Thalenfeld and
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`Dr. Johnston on every page of Ex. 2141).)
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`In addition, certain experiments described in the lab notebooks are
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`corroborated by other Enzo records, including other RTP Exhibits, and the
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`examples in the ’197 patent itself. See Blicharz v. Hays, 496 F.2d 603, 606
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`(C.C.P.A. 1974) (finding “significant corroborative evidence” where a “Record of
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`Invention” and examples in the patent application were substantially identical to a
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`lab notebook’s description of an experiment). For example, Exhibit 2141 contains
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`a notebook entry dated May 26, 1982 describing an experiment for binding DNA
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`to plastic using polylysine for hybridization. (Ex. 2141, 1-3.) Similarly, the
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`Invention Record and Report contained in Exhibit 2135, which is signed by Dr.
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`Thalenfeld and Dr. Johnston, describes the invention using amine functionalized
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`polystyrene matrices to bind nucleic acids for hybridization and lists May 26, 1982
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`as the “[f]irst experiment demonstrating the invention.” The Exhibit 2140
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`invention summary, which is signed and dated on every page by Dr. Thalenfeld
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`and Dr. Johnston and stamped as received by Thomas Moran (Enzo’s patent
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`attorney at the time) on June 25, 1982, also describes experiments binding DNA to
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`amine functionalized polystyrene matrices for hybridization. The procedure
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`described in Example 6 of the ’197 patent mirrors the experiment descriptions in
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`Exhibits 2135, 2140, and 2141. In addition, the procedure for binding DNA to
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`glass using a silanization treatment described on page 155 of Exhibit 2137 matches
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`the procedure described in Example 1 of the ’197 patent. Finally, photocopies of
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`many of the notebook pages relied upon in Exhibit 2137 were attached as exhibits
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`to a declaration by Dr. Kirtikar submitted to and accepted by the Patent Office
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`during the prosecution of the ’197 patent. (Compare Ex. 2102, 12-46, with Ex.
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`2137, 154-172.) In that declaration, she testified that the experiments described in
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`those pages demonstrated that “nucleic acids could be fixed to non-porous solid
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`supports and remain available for hybridization and detection,” which is consistent
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`with Mr. Weiner’s recollection of the R&D activities in the Relevant Timeframe.
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`(Ex. 2102, 3.)
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` Petitioner’s reliance on Linear Tech. Corp. v. Micrel, Inc., 275 F.3d 1040,
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`1055-56 (Fed. Cir. 2001) is misplaced. (Paper 41, 8.) In Linear Tech., the Federal
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`Circuit held that the district court was within its discretion to exclude documents
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`proffered as letters that had been mailed to customers where no evidence showed
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`that the letters had been mailed. Here, however, Petitioner does not argue that any
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`of the alleged conditions create suspicion that the documents are not what Enzo
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`claims they are—laboratory notebooks and other business records reflecting
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`Enzo’s R&D activities. Petitioner’s arguments instead challenge the “substance
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`and dates on which experiments or recording of the experiment occurred” (Paper
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`41, 8), which “bear upon the weight to be accorded the evidence and do not affect
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`the threshold question of authenticity.” Threadgill v. Armstrong World Indus.,
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`Inc., 928 F.2d 1366, 1375–76 (3d Cir. 1991) (citing United States v. Kairys, 782
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`
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`F.2d 1374, 1379 (7th Cir.), cert. denied, 476 U.S. 1153 (1986)).
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`3. Nonexpert Opinion About Handwriting. Mr. Weiner also testified that
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`the RTP Exhibits were prepared by or belonged to certain of the named inventors
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`based on his familiarity with the inventors’ handwriting. (Ex. 1036, 86:14-24
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`(identifying Dr. Thalenfeld’s handwriting in Ex. 2135); id., 58:10-12 (identifying
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`Dr. Kirtikar’s handwriting in Ex. 2137); id., 91:17-92:2 (identifying Dr.
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`Thalenfeld’s handwriting in Ex. 2138); id., 99:17-20 (identifying Dr. Thalenfeld’s
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`handwriting in Ex. 2139); see FRE 902(b)(2).) Petitioner does not challenge the
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`sufficiency of that testimony to authenticate the RTP Exhibits.
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`4. Evidence About Ancient Documents. The RTP Exhibits qualify as
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`ancient documents under FRE 901(b)(8). Petitioner does not dispute that the
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`documents are at least 20 years and were found in a place, where, if authentic, they
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`would likely be—i.e. “within a locked, secured area where [Enzo] keeps all of its
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`critical documents and filings.” (Ex. 1036, 75:8-77:16.) And Petitioner’s reliance
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`on Mathin v. Kerry is misplaced. (Paper 41, 9.) In that case, the court found that
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`circumstances behind the discovery of disputed affidavits “created doubt as to the
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`legitimacy of the affidavits” and whether the affidavits were what they purported
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`to be. 782 F.3d 804, 812 (7th Cir. 2015). No such doubt exists here. The RTP
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`Exhibits were created as part of Enzo’s ordinary R&D activities, maintained at
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`Enzo’s facilities with other critical documents, and corroborated by Mr. Weiner’s
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`testimony. Thus, unlike the affidavit in Mathin, the RTP Exhibits are in a
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`condition that creates no suspicion as to whether they are what they purport to be.
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`B.
`The RTP Exhibits Are Admissible Under the FRE.
`Contrary to Petitioner’s arguments, the RTP Exhibits are admissible under at
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`least two hearsay exceptions. (Paper 41, 9-10.) First, each RTP Exhibit qualifies
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`as a business record under FRE 803(6). A qualified witness—Mr. Weiner—
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`testified that based on his knowledge of Enzo’s policies, the regular practices of
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`the co-inventors, and his own review of the records: (a) each of the RTP Exhibits
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`was made at or near the time the experiments were performed by someone with
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`knowledge of those activities (Ex. 2143 ¶¶ 5-6, 9, 10, 12, 14, 16, 17; Ex. 1036,
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`74:19-75:7, 118:21-120:3); (b) the RTP Exhibits were kept in the course of
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`regularly conducted activity of the business (Ex. 2143 ¶¶ 7-10, 12, 14, 16, 17; Ex.
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`1036, 100:23-102:12) under his oversight and responsibility for the maintenance of
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`Enzo business records (Ex. 2143 ¶¶ 5-7; Ex. 1036, 75:8-77:23); and (c) making
`
`laboratory notebooks, invention record and reports, and invention summaries was a
`
`regular practice of Enzo’s R&D activity (Ex. 2143 ¶¶ 5-7; Ex. 1036, 79:21-80:6,
`
`128:24-129:9, 102:13-23).
`
`Petitioner does not dispute that the RTP Exhibits meet each of the
`
`requirements of FRE 803(6), but rather incorrectly alleges that the notebooks were
`
`12
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`not kept according to Enzo’s supposed notebook policy. (Paper 41, 10.) As
`
`
`
`explained above, that argument mischaracterizes Enzo’s policy as well as the
`
`contents of the documents. In addition, Petitioner incorrectly relies on Corning
`
`Inc. v. DSM IP Assets B.V., IPR2013-00043, Paper 97, at 5-7 (P.T.A.B. May 1,
`
`2014) to argue that laboratory notebooks are not business records under FRE
`
`803(6). But Corning did not address laboratory notebooks of regularly conducted
`
`R&D activities like those in dispute here; it found that “specific and unique
`
`scientific experimental work” that “took place solely to address issues in the case”
`
`was not “a regularly conducted activity.” Id. (emphasis in original). At a
`
`minimum, RTP Exhibits (Exs. 2135, 2140), which are not notebooks, qualify as
`
`business records. For the reasons given above, all of the RTP Exhibits are also
`
`admissible as ancient documents under FRE 803(16).
`
`IV. THE BOARD SHOULD DENY PETITIONER’S MOTION TO
`EXCLUDE PORTIONS OF DR. BUCK’S DECLARATION
`A.
`FRE 602, 802 and 805 Do Not Render Dr. Buck’s Expert
`Testimony Inadmissible.
`Petitioner challenges the admissibility of certain portions of Enzo’s technical
`
`expert’s, Dr. Buck’s, opinions regarding reduction to practice based upon his
`
`analysis of the RTP Exhibits. Petitioner’s arguments regarding inadmissibility
`
`under FRE 602, 802, and 805 are not applicable to Dr. Buck’s expert testimony,
`
`which is admissible under FRE 702 and 703 as explained below. First, FRE 602
`
`13
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`explicitly excludes “a witness’s testimony under Rule 703” from the personal
`
`
`
`knowledge requirement. Second, Petitioner’s hearsay arguments lack merit
`
`because experts may rely on facts or data that are not otherwise admissible in
`
`forming their opinions if experts in the particular field would reasonably rely on
`
`those kinds of facts or data. FRE 703. Here, Dr. Buck reasonably relied upon
`
`laboratory notebooks and other records of scientific activity regularly maintained
`
`by the inventors by Enzo—the types of records relied upon by experts in analyzing
`
`conception and reduction-to-practice questions. See, e.g., Broadcom Corp. v.
`
`Qualcomm Inc., 543 F.3d 683, 693 (Fed. Cir. 2008). Thus, Petitioner has not met
`
`its burden to establish inadmissibility under FRE 602, 802, and 805.
`
`B. Dr. Buck’s Testimony Is Admissible Under FRE 702 and 703.
`Petitioner’s arguments that Dr. Buck’s testimony is “factual testimony about
`
`the dates on documents” and not “proper expert testimony” should likewise be
`
`rejected. Dr. Buck’s declaration testimony meets each of the elements of FRE 702:
`
`(1) he applied his specialized scientific knowledge in the field of nucleic acid
`
`detection and hybridization to help the trier of fact to determine a fact in issue—
`
`whether Enzo reduced-to-practice the inventions of the asserted claims of the ’197
`
`patent before October 1982; (2) he based his opinions sufficient facts and data—
`
`the information provided in the RTP Exhibits; (3) his testimony is the product of
`
`reliable principles and methods; and (4) he reliably applied the scientific principles
`
`14
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`to compare the contents of the RTP Exhibits to the claimed language in the ’197
`
`
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`patent in view of the understanding of a person of ordinary skill in the art in 1982.
`
`FRE 702. Significantly, Petitioner presented no rebuttal expert testimony
`
`challenging Dr. Buck’s opinions or any of the bases of those opinions.
`
`Petitioner’s arguments that Dr. Buck does not provide factual bases for his
`
`conclusions mischaracterize Dr. Buck’s testimony. Dr. Buck’s declaration
`
`describes the procedures and data in the RTP Exhibits as well as the scientific
`
`principles involved in those types of experiments. That expert testimony is proper
`
`to explain Dr. Buck’s conclusions that each element in the asserted claims was
`
`reduced to practice in the RTP Exhibits. See Broadcom, 543 F.3d at 693
`
`(affirming a finding of conception and reduction to practice based upon unrebutted
`
`expert testimony explaining his basis for concluding that each limitation of the
`
`accused claims was present in a lab notebook). Indeed, Petitioner’s arguments
`
`challenge the merits of Dr. Buck’s opinions about what the RTP Exhibits disclose,
`
`not their admissibility.
`
`V.
`
` CONCLUSION
`
`For those reasons, the Board should deny Petitioner’s Motion to Exclude.
`
`
`Dated: May 8, 2017
`
`Respectfully submitted,
`/Justin P.D. Wilcox/
`Justin P.D. Wilcox (pro hac vice)
`Counsel for Enzo Life Sciences, Inc.
`
`15
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`CERTIFICATE OF SERVICE
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on May 8,
`
`2017, a complete copy of the foregoing was served on counsel of record for the
`Petitioner by filing this document through PTAB E2E and by sending this
`document via electronic mail to the following addresses:
`
`For Petitioner Hologic:
`
`M. Paul Barker (Reg. No. 32,013)
`paul.barker@finnegan.com
`
`Arpita Bhattacharyya (Reg. No. 63,681)
`arpita.bhattacharyya@finnegan.com
`
`Thomas L. Irving (Reg. No. 28,619)
`tom.irving@finnegan.com
`
`For Petitioner BD:
`
`Jamie T. Wisz (Reg. No. 58,429)
`Jamie.Wisz@WilmerHale.com
`
`Heather Petruzzi (Reg. No. 71,720)
`Heather.Petruzzi@WilmerHale.com
`
`
`Respectfully submitted,
`
`/Justin P.D. Wilcox/
`Justin P.D. Wilcox (pro hac vice)
`jwilcox@desmaraisllp.com
`DESMARAIS LLP
`230 Park Avenue
`New York, NY 10169
`Telephone: 212-351-3400
`Facsimile: 212-351-3401
`
`Counsel for Patent Owner
`Enzo Life Sciences, Inc.
`
`
`
`
`
`Dated: May 8, 2017
`
`
`
`
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