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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`___________
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`HOLOGIC, INC.
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`and BECTON, DICKINSON AND COMPANY,
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`Petitioners,
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`v.
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`ENZO LIFE SCIENCES, INC.,
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`Patent Owner
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`____________
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`Case No. IPR2016-00822
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`U.S. Patent No. 7,064,197
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`____________
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`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
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`IPR2016-00822
`U.S. Patent 7,064,197
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`Table of Contents
`I. Requested Relief and Timely Objections ........................................................... 1
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`II. The RTP Exhibits, And The Portions of Dr. Buck’s And Mr. Weiner’s
`Declarations Relying On Them, Are Inadmissible .................................................... 1
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`A. Summary of the RTP Exhibits ...................................................................... 2
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`Paragraphs 3-10, 12, 14, 16, and 17 of the Weiner Declaration Should Be
`B.
`Excluded. ................................................................................................................ 4
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`1. Mr. Weiner Lacks Personal Knowledge For His Testimony. .................... 4
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`2. The Weiner Declaration Is Inadmissible Hearsay ..................................... 6
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`C. The RTP Exhibits Have Not Been Authenticated And Are Inadmissible
`Hearsay ................................................................................................................... 7
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`1. The RTP Exhibits Are Unauthenticated and Inadmissible ........................ 7
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`2. The RTP Exhibits Are Hearsay With No Legitimate Exception ............... 9
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`D. Portions of Dr. Buck’s Declaration Should Be Excluded For Lack Of
`Personal Knowledge, Hearsay, And Failure To Explain Conclusions .................11
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`1. Dr. Buck Lacks Personal Knowledge And Presents Inadmissible
`Hearsay…………………………………………………………………...…..11
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`2. Dr. Buck’s Assertions Regarding the RTP Exhibits Are Improper Expert
`Testimony Under FRE 702 and 703 .................................................................12
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`III. Conclusion ......................................................................................................15
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`IPR2016-00822
`U.S. Patent 7,064,197
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`Requested Relief and Timely Objections
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`I.
`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c), Petitioners Hologic, Inc. and
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`Becton, Dickinson and Company move to exclude the following:
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`• Exhibits 2135 and 2137-2141 under Federal Rules of Evidence (“FRE”) 901
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`for lack of authentication and under FRE 802 as improper hearsay;
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`• Paragraphs 3-10, 12, 14, 16, and 17 of Exhibit 2143 (Mr. Weiner’s
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`Declaration) under FRE 602 for lack of personal knowledge and under FRE
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`802 as improper hearsay; and
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`• Paragraphs 161 and 180-197 of Exhibit 2142 (Dr. Buck’s Declaration) under
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`FRE 602 for lack of personal knowledge, under FRE 802 as improper
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`hearsay, and under FRE 702 and 703 as improper expert testimony.
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`Petitioners timely objected to these exhibits on the indicated bases. Paper 23, at
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`2-4.
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`II. The RTP Exhibits, And The Portions of Dr. Buck’s And Mr.
`Weiner’s Declarations Relying On Them, Are Inadmissible
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`Enzo introduced Exhibits 2135, 2137, 2138, 2139, 2140, and 2141—
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`purported to be copies of laboratory notebooks and other documents—as evidence
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`of the conception and reduction to practice of the invention of the ’197 patent, in
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`an effort to prove an invention date prior to October 1982 (collectively “the RTP
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`Exhibits”). Paper 19, 44-45. These out of court statements in the RTP Exhibits
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`have no indicia of reliability, and Petitioners have had no chance to cross-examine
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`IPR2016-00822
`U.S. Patent 7,064,197
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`anyone with personal knowledge of the experiments and dates recorded in these
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`documents. Also, most of the pages of the RTP Exhibits are unsigned, undated,
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`unwitnessed, and/or illegible. Enzo chose not to present any inventor or other
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`competent testimony to suggest that these documents are what Enzo says they are
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`or that they satisfy any hearsay exception. For the reasons stated below, the RTP
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`Exhibits and the related testimony from Patent Owner’s declarants, Dr. Gregory
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`Buck and Mr. Barry Weiner (Exhibits 2142, 2143), should be excluded as
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`inadmissible evidence. Each RTP Exhibit is summarized in turn before addressing
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`evidentiary issues.
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`A. Summary of the RTP Exhibits
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`Exhibit 2135. Enzo alleges that Exhibit 2135 is a document signed by co-
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`inventors Barbara Thalenfeld and Kenneth Johnston, demonstrating “[conception]
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`on approximately February 22, 1982 and that the first written record and
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`experiment demonstrating the invention occurred on May 26, 1982.” Paper 19, at
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`44. The exhibit is neither dated nor witnessed. Ex. 2135, at 5.
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`Exhibit 2137. Dr. Buck and Mr. Weiner describe Exhibit 2137 as inventor
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`Dollie Kirtikar’s notebook. See Ex. 2142, ¶¶ 183, 185, 186, 190, 191; Ex. 2143, ¶¶
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`10-11. This 306-page exhibit contains copies of removable sheets in a binder,
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`which are in non-chronological order and are often undated and/or unsigned. None
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`2
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`of the pages are witnessed by a testifying declarant.1 Ex. 1036, 140:10-144:3.
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`Exhibits 2138 and 2139. Enzo alleges that Exhibits 2138 and 2139 are
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`inventor Barbara Thalenfeld’s laboratory notebook. E.g., Ex. 2143, ¶¶ 12, 14.
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`Exhibit 2138 is non-chronological, unsigned, and unwitnessed, while Exhibit 2139
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`is neither signed nor witnessed. Both exhibits contain additional documents either
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`“folded or stapled to the handwritten pages.” Ex. 2143, ¶¶ 13, 15.
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`Exhibit 2140. Enzo asserts that Exhibit 2140 was prepared by inventors
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`Barbara Thalenfeld and Kenneth Johnston and describes June 1982 experiments.
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`Ex. 2142, ¶¶ 183, 189; Ex. 2143, ¶ 16. It is not witnessed.
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`Exhibit 2141. Enzo describes Exhibit 2141 as a photocopy of photocopies
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`of Dr. Thalenfeld’s notebook, and the pages were “signed or initialed … after the
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`copy was made.” Ex. 2143, ¶ 17 (emphasis added). Thus, the inventors did not sign
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`the original notebook, and it is not witnessed.
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`1 Mr. Weiner alleged that certain pages were witnessed by a non-inventor, Dr.
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`Norman Kelker. Ex. 1036, 64:1-16, 66:1-13, 68:11-24. Mr. Weiner consulted with
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`Dr. Kelker prior to his deposition (id., 10:4-7, 11:5-14:22), but Enzo chose not to
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`present his testimony.
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`B. Paragraphs 3-10, 12, 14, 16, and 17 of the Weiner Declaration Should
`Be Excluded.
`1. Mr. Weiner Lacks Personal Knowledge For His Testimony.
`Enzo offers Mr. Weiner’s testimony in an attempt to authenticate the RTP
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`Exhibits and to corroborate the experiments and dates reported in those documents.
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`Paper 19, 44-45. Mr. Weiner, however, testified that he did not have a scientific
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`background and he did not work in the lab with the inventors:
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`Q. Were you aware of the specific steps and conditions of
`the experiments that the inventors were doing?
`A. I am not a scientist, as I've testified today. I do not
`review scientific methods, because I could not
`contribute to that benefit. And so my activity does not
`involve the actual scientific experimentation.
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`Ex. 1036, 40:12-21; see also Ex. 1036, 24:6-10. Indeed, any knowledge he has
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`regarding the claimed invention can be imputed to information received directly or
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`indirectly from the inventors. Id., 19:13-21:23. Mr. Weiner has no personal
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`knowledge of when the inventors’ allegedly reduced the claimed invention to
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`practice:
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`Q. Independent of the lab notebooks that you looked at
`before preparing your declarations, do you have any
`personal knowledge of when in 1982 did the inventors of
`the '197 patent accomplish the [im]mobilization of
`nucleic acids on a non-porous solid support?
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`A. During that period in time, I was aware of
`developments that were ongoing within the
`laboratory. I cannot say that I was aware of the
`specific date that the experiment was deemed to say
`success [sic], I think this was an iterative process,
`multiple times of review and examination internally.
`…
`See Ex. 1036, 136:11-137:6.
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`When asked to verify when the claimed subject matter was reduced to
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`practice, Mr. Weiner identified the relevant time frame as 1980 to 1984, even
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`though Enzo alleged in its Response that the invention was reduced to practice “no
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`later than August of 1982” (Paper 19, 44-45):
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`Q. But sitting here today, independent of the lab
`notebooks, you cannot verify for me a time frame during
`which the immobilization of nucleic acids on a non-
`porous solid support was done, correct?
`A. No, that's not correct. I mean, during this period,
`as I stated, this work was in process.
`Q. Can you state that period again?
`A. From the period of the early '80s, '80 through '84,
`we did work in the area. This particular work was the
`earlier part of our activity and clearly fell within that
`time frame.
`Q. And can you verify for me the time period during
`which the inventors of the '197 patent accomplished
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`hybridization of nucleic acids on a non-porous solid
`support?
`A. That time –
`Q. Independent of the lab notebooks, please verify.
`A. I can't recall 30 years ago the specific date of an
`event. This is a major project that this company
`worked on and embodied in its intellectual property.
`It happened during that period. I certainly can't
`recall a date 30 years ago when an experiment may
`have been discovered.
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`Ex. 1036, 138:16-139:21.
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`As demonstrated, Mr. Weiner has no personal knowledge that the alleged
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`reduction to practice activities occurred before 1984. Therefore, his testimony on
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`when the claimed subject matter was reduced to practice is inadmissible under
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`FRE 602.
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`2. The Weiner Declaration Is Inadmissible Hearsay.
`Mr. Weiner’s testimony about the inventors’ experiments by certain dates is
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`based on the purported inventor records, i.e., Exhibits 2135, and 2137-2141, and
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`discussions with the inventors and laboratory supervisors who reported to him. See
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`Ex. 1036, 19:13-21:23, 24:6-25, 37:7-38:2. As discussed below, the RTP Exhibits
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`are inadmissible hearsay under FRE 801, and do not fall under any hearsay
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`exception, including FRE 803, 804, and 807.
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`Enzo is also trying to use Mr. Weiner’s recitation of inventors’ or lab
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`supervisors’ statements, which were made outside this proceeding, to prove the
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`truth of the matters asserted—this is hearsay. FRE 801. Some of these statements
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`are attributed to particular individuals, such as Dr. Kelker, who reported scientific
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`activities to Mr. Weiner. See Ex. 1036, 9:20-10:7, 31:18-32:12, 37:7-38:2. Enzo
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`chose not to present testimony from Dr. Kelker—who still works with Enzo (Ex.
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`1036, 11:8-12) — or other individuals with first-hand knowledge of the scientific
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`activities at Enzo. Enzo cannot use Mr. Weiner now as a conduit to introduce
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`otherwise inadmissible hearsay from lab notebooks or discussions with inventors
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`and laboratory supervisors.
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`C. The RTP Exhibits Have Not Been Authenticated And Are
`Inadmissible Hearsay
`1. The RTP Exhibits Are Unauthenticated and Inadmissible.
`“To satisfy the requirement of authenticating or identifying an item of
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`evidence, the proponent must produce evidence sufficient to support a finding that
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`the item is what the proponent claims it is.” FRE 901(a) (emphasis added). Thus,
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`one starts with the proponent’s description of what the document is purported to be
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`to determine whether a document is admissible under FRE 901. One may also
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`consider circumstantial evidence such as “[t]he appearance, contents, substance,
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`internal patterns, or other distinctive characteristics of the [document], taken
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`together with all the circumstances.” FRE 901(b)(4). Here, under the
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`circumstances, the RTP Exhibits are missing crucial indicia of authenticity, and as
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`such, Enzo has failed to produce sufficient evidence to establish authenticity.
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`For instance, Mr. Weiner stated that signing, dating, and witnessing were
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`part of Enzo’s notebook policy. Ex. 1036 at 50:11-57:4, 118:21-119:2. None of the
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`RTP Exhibits, however, are consistently signed, dated, or witnessed, and at least
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`Exhibits 2137, 2138, and 2139, were not maintained in a chronological fashion.
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`Exhibit 2135 is undated and not witnessed. Exhibit 2137 is often undated and
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`unsigned, and not witnessed by a testifying declarant. Exhibits 2138 and 2139 are
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`neither signed nor witnessed; and only a copy of Exhibit 2141, which was never
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`witnessed, was signed by the inventors.
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`Such conditions create significant suspicion regarding the substance and
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`dates on which the experiments or recording of the experiment occurred—findings
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`which are critical to Enzo’s proffering the exhibits as contemporaneous records of
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`the invention date of the ’197 patent. See, e.g., Linear Tech. Corp. v. Micrel, Inc.,
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`275 F.3d 1040, 1055-56 (Fed. Cir. 2001) (excluding, as unauthenticated, proffered
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`letters, “which are dated before the critical date [but] are not signed, are not on
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`company letterhead,” and bear no other indicia of reliability).
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`Mr. Weiner fails to address these shortcomings of the documents with
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`respect to signatures, dates, and witnessing. While he claims to recognize some of
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`the handwriting, he testified that he did not have the scientific background to
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`understand the details of the experiments, and in any case did not review the
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`IPR2016-00822
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`notebooks at the time to assure they were being properly maintained. Ex. 1036 at
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`24:6-10; 53:24-57:4; 40:12-21.
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`Because these Exhibits are missing critical indicia of reliability and
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`authenticity, they cannot qualify as ancient documents under FRE 901(8), i.e.,
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`where the document “is in a condition that creates no suspicion about its
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`authenticity; was in a place where, if authentic, it would likely be; and is at least 20
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`years old when offered.” FRE 901(8) (emphasis added); see also Mathin v. Kerry,
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`782 F.3d 804 (7th Cir. 2015) (“The requirement that the document be free of
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`suspicion to be authenticated as an ancient document relates …to whether the
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`document is what it purports to be.”). Here, the RTP Exhibits lack the details
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`expected in reliable notebook-keeping practice, including Enzo’s own notebook
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`policy (Ex. 1036 at 50:11-57:4, 118:21-119:2). See id., finding affidavits did not
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`qualify as ancient documents because they lacked any details that might be
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`expected in a document created after the event in question.
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`Finally, the RTP Exhibits cannot be self-authenticated under FRE 902, as
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`they do not fall within any of the express categories covered by the rule.
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`2. The RTP Exhibits Are Hearsay With No Legitimate Exception
`Enzo relies on the RTP Exhibits as written assertions offered to prove the
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`truth of the matter asserted. This is inadmissible hearsay under FRE 801. The RTP
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`Exhibits also do not fall within any of the hearsay exceptions, including FRE
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`IPR2016-00822
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`803(6), 803(16), 804, and 807. The exhibits do not qualify, e.g., under the business
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`records exception (FRE 803(6)), because none of the RTP Exhibits are
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`consistently signed, dated, or witnessed, according to Enzo’s notebook policy, as
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`stated by Mr. Weiner (see Ex. 1036 at 50:11-57:4; 118:21-119:2). Further, at least
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`Exhibits 2137, 2138, and 2139 were not maintained in a chronological fashion.
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`Therefore, the records were not kept according to Enzo’s notebook policy.
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`Furthermore, the PTAB does not consider that laboratory notebooks and
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`experimental data are records of “regularly conducted” business activity, and such
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`documents do not qualify for the business records exception under FRE 803(6).
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`Corning Inc. v. DSM IP Assets B.V., IPR2013-00043, Paper 97, at 5-7 (P.T.A.B.
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`May 1, 2014) (“Conducting specific and unique scientific experimental work is not
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`‘a regularly conducted activity.’ Rather, conducting specific scientific experiments,
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`such as those conducted by [Patent Owner], involves unique events not normally
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`repeated on a ‘regular’ basis.”).
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`The absence of these indicia of reliability in each RTP Exhibit also prevents
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`each from qualifying under other hearsay exceptions. As noted above, the RTP
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`Exhibits do not qualify as ancient documents under FRE 901(8), and thus are not
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`admissible under the FRE 803(16) exception. The RTP Exhibits similarly cannot
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`satisfy the requirements for admission as exceptions for unavailable declarant
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`under FRE 804 or under FRE 807.
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`For the reasons stated above, the RTP Exhibits are neither authenticated nor
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`admissible hearsay, and must be excluded on those bases.
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`D. Portions of Dr. Buck’s Declaration Should Be Excluded For Lack Of
`Personal Knowledge, Hearsay, And Failure To Explain Conclusions
`1. Dr. Buck Lacks Personal Knowledge And Presents
`Inadmissible Hearsay
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`Paragraphs 161, 180-197 of Dr. Buck’s Declaration (Exhibit 2142) contend
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`that the RTP Exhibits show conception and reduction to practice by certain dates.
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`Dr. Buck, however, cannot independently confirm the inventors’ activities in 1982,
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`because he “was not in the lab in 1982 with the inventors” and “had nothing to do
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`with Enzo at that period of time,” confirming that he “would not have any
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`independent knowledge of that.” Ex. 1035, 39:11-14. In fact, Dr. Buck agreed that
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`his testimony as to the dates of the experiments was based solely upon the RTP
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`Exhibits and Mr. Weiner’s Declaration. Ex. 1035, 39:15-20.
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`Thus, Dr. Buck lacks personal knowledge under FRE 602 about what the
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`inventors were doing in 1982, and his testimony about what they did at that time is
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`hearsay or hearsay within hearsay under FRE 802 and 805. Ex. 2142, ¶¶ 161, 180-
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`194, 196, and 197 (Dr. Buck’s testimony about the inventors’ alleged activity by,
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`or on, certain dates).
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`Just like Mr. Weiner’s testimony, Dr. Buck’s testimony about the inventors’
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`activities by certain dates is based on the purported records of the inventors, which
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`are statements outside of this proceeding. Enzo chose not to present testimony of
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`anyone having personal knowledge about when the inventors performed any work.
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`Enzo cannot improperly use Dr. Buck “as a conduit for introducing hearsay under
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`the guise that the testifying expert used the hearsay as the basis of his testimony.”
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`See Marvel Characters, Inc. v. Kirby, 726 F.3d 119, 136 (2d Cir. 2013).
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`2. Dr. Buck’s Assertions Regarding the RTP Exhibits Are
`Improper Expert Testimony Under FRE 702 and 703
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`Dr. Buck’s testimony concerning the dates is not proper expert testimony
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`under FRE 702 and 703; it is factual testimony about the dates on the documents.
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`Also, although a properly qualified expert may opine as to what the contents of the
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`RTP Exhibits would have meant, Dr. Buck does not provide the factual bases for
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`his conclusions about the meaning of those documents as required by FRE 702.
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`For example, Dr. Buck concludes that Exhibit 2135 shows that “the first
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`experiment demonstrating the invention occurred on May 26, 1982.” Ex. 2142,
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`¶ 181. Dr. Buck cites no facts supporting that conclusion. Page 2 of Exhibit 2135
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`simply includes that date written next to those quoted words, but presents no actual
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`written record. Moreover, Exhibit 2135 does not describe ’197 claim limitations,
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`e.g., an array.
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`Dr. Buck also contends that notebooks of two of the inventors confirm that
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`the inventions worked for their intended purpose. Ex. 2142, ¶ 181. But Dr. Buck’s
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`subsequent testimony fails to explain the facts upon which that conclusion is based.
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`All of the challenged claims require an array comprising nucleic acids fixed in
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`hybridizable form. Addressing those limitations, Dr. Buck contends that the
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`purported inventor documents show actual hybridization experiments with single-
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`stranded nucleic acids. Id., ¶ 193, right col. of table, at pp. 98-104. But he fails to
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`explain how the documents support that conclusion.
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`Dr. Buck first cites Ex. 2141 at page 3, as showing an experiment that
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`showed that the fixed single-stranded DNA actually hybridized when contacted
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`with complementary strands of DNA. Id., ¶¶ 183, 184, 189, 193, pp. 99-100, rt.
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`col. Dr. Buck failed to explain how that page shows successful hybridization work.
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`During his deposition, when discussing this purported work in Ex. 2141, Dr. Buck
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`stated that “[t]hey show results and I assume this is what they’re referring to is that
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`the hybridization works. So unfortunately, you can’t read the results here. I can’t
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`read the results.” Ex. 1035, 81:5-17. Page 3 of Exhibit 2141, however, does not
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`indicate that “hybridization works,” but instead page 3 appears to show a protocol
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`under the heading “Can we hybridize on microElisaplates [sic].” Dr. Buck thus
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`fails to explain how he reached his conclusion that page 3 of Exhibit 2141 shows
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`actual hybridization.
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`Dr. Buck then cites Exhibit 2141, page 10, as showing actual hybridization
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`experiments on non-porous supports, but fails to explain why. Ex. 2142, ¶ 193, p.
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`100, rt. col. The portion of page 10 of the Exhibit 2141 reproduced on page 100 of
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`his declaration appears to be another protocol, rather than results.
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`Dr. Buck then cites Exhibit 2140 at page 3, as showing “that an array of
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`single-stranded DNA could be bound to a plastic plate via amines using PLL or
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`DDDA coatings and then hybridized to other DNA strands.” Ex. 2142, ¶ 193, page
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`101 under the reproduced portion of page 3 of Exhibit 2140. Ex. 2140, however, is
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`not a laboratory record providing actual data or specific conditions for
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`hybridization experiments. Moreover, Dr. Buck fails to explain why the work
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`described in Exhibit 2140 shows an array.
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`Dr. Buck also cites Exhibits 2137 at pp. 168-171, and Exhibit 2102 at page 3
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`(pdf page 4), as showing hybridization experiments. Ex. 2141, ¶¶ 183, 184, 190,
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`191, 193, pp. 101-102. Page 171 of Exhibit 2137 appears to be a protocol without
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`results. And Exhibit 2102, at page 3, states that the inventors “discovered that
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`nucleic acids could be fixed to non-porous solid supports and remain available for
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`hybridization”—presenting no actual results. Thus, Dr. Buck provides no
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`explanation how Exhibits 2137 and 2102 show actual hybridization results.
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`Dr. Buck further cites Exhibit 2138 (page 6) and Exhibit 2137 (pages 165
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`and 176) as showing arrays. Ex. 2141, ¶ 193, pp. 102-104. Dr. Buck fails to
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`explain how those pages show actual hybridization experiment results.
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`Thus, Dr. Buck’s testimony that the exhibits show actual hybridization of
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`nucleic acids in an array is improper under FRE 702 and 703, because he fails to
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`provide factual bases for that conclusion. Dr. Buck fails to explain the factual bases
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`for several of his other conclusions about the RTP Exhibits, but space constraints
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`prevent Petitioners from addressing them all here.
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`III. Conclusion
`For the foregoing reasons, the Exhibits 2135 and 2137-2141, and certain
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`portions of Exhibits 2142 and 2143 should be excluded from this proceeding.
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`Date: April 24, 2017
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`Respectfully submitted,
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`/M. Paul Barker/
`M. Paul Barker, Reg. No. 32,013
`Lead Counsel for Hologic, Inc.
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`Case No. IPR2016-00822
`U.S. Patent No. 7,064,197
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that the foregoing PETITIONERS’ MOTION TO
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`EXCLUDE was served on April 24, 2017, in its entirety via electronic mail to
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`Patent Owner’s and BD’s counsel at:
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`
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`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
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` For BD
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`Jamie T. Wisz
`jamie.wisz@wilmerhale.com
`Heather Petruzzi
`heather.petruzzi@wilmerhale.com
`Nancy Lynn Schroeder
`nancy.schroeder@wilmerhale.com
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`Patent Owner and BD have consented to electronic service.
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`Date: April 24, 2017 Respectfully submitted,
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`/Kristin M. Creed/
`Kristin M. Creed
`Case Manager
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT &
`DUNNER, L.L.P.
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