throbber

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`
`HOLOGIC, INC.
`
`and BECTON, DICKINSON AND COMPANY,
`
`Petitioners,
`
`v.
`
`ENZO LIFE SCIENCES, INC.,
`
`Patent Owner
`
`____________
`
`Case No. IPR2016-00820
`
`U.S. Patent No. 7,064,197
`
`____________
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`

`

`Table of Contents
`
`I. Requested Relief and Timely Objections ........................................................... 1
`
`II. The RTP Exhibits, And The Portions of Dr. Buck’s And Mr. Weiner’s
`Declarations Relying On Them, Are Inadmissible Evidence .................................... 1
`
`A. Summary of the RTP Exhibits ...................................................................... 2
`
`Paragraphs 3-10, 12, 14, 16, and 17 of the Weiner Declaration Should Be
`B.
`Excluded ................................................................................................................. 4
`
`1. Mr. Weiner Lacks Personal Knowledge For His Testimony ..................... 4
`
`2.
`
`The Weiner Declaration Is Inadmissible Hearsay. .................................... 6
`
`C. The RTP Exhibits Have Not Been Authenticated And Are Inadmissible
`Hearsay ................................................................................................................... 7
`
`1.
`
`2.
`
`The RTP Exhibits Are Unauthenticated and Inadmissible ........................ 7
`
`The RTP Exhibits Are Hearsay With No Legitimate Exception ............... 9
`
`D. Portions of Dr. Buck’s Declaration Should Be Excluded For Lack Of
`Personal Knowledge, Hearsay, And Failure To Explain Conclusions .................11
`
`1. Buck Lacks Personal Knowledge And Presents Inadmissible Hearsay ..11
`
`3. Dr. Buck’s Assertions Regarding the RTP Exhibits Are Improper Expert
`Testimony Under FRE 702 and 703 .................................................................12
`
`III. Conclusion ......................................................................................................15
`
`
`
`
`
`

`

`IPR2016-00820
`U.S. Patent 7,064,197
`
`I.
`
`
`Requested Relief and Timely Objections
`
`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c), Petitioners Hologic, Inc. and
`
`Becton, Dickinson and Company move to exclude the following:
`
`• Exhibits 2035 and 2037-2041 under Federal Rules of Evidence (“FRE”) 901
`
`for lack of authentication and under FRE 802 as improper hearsay;
`
`• Paragraphs 3-10, 12, 14, 16, and 17 of Exhibit 2043 (Mr. Weiner’s
`
`Declaration) under FRE 602 for lack of personal knowledge and under FRE
`
`802 as improper hearsay; and
`
`• Paragraphs 146 and 165-181 of Exhibit 2042 (Dr. Buck’s Declaration) under
`
`FRE 602 for lack of personal knowledge, under FRE 802 as improper
`
`hearsay, and under FRE 702 and 703 as improper expert testimony.
`
`Petitioners timely objected to these exhibits on those bases. Paper 24, at 2-4.
`
`II.
`
`
`The RTP Exhibits, And The Portions of Dr. Buck’s And Mr. Weiner’s
`Declarations Relying On Them, Are Inadmissible Evidence
`
`Enzo introduced Exhibits 2035, 2037, 2038, 2039, 2040, and 2041—
`
`purported to be copies of laboratory notebooks and other documents—as evidence
`
`of the conception and reduction to practice of the invention of the ’197 patent, in
`
`an effort to prove an invention date prior to October 1982 (collectively “the RTP
`
`Exhibits”). Paper 20, 40-41. These out of court statements in the RTP Exhibits
`
`have no indicia of reliability, and Petitioners have had no chance to cross-examine
`
`anyone with personal knowledge of the experiments and dates recorded in these
`
`
`
`1
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`

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`IPR2016-00820
`U.S. Patent 7,064,197
`documents. Also, most of the pages of the RTP Exhibits are unsigned, undated,
`
`unwitnessed, and/or illegible. Enzo chose not to present any inventor or other
`
`competent testimony to suggest that those documents are what Enzo says they are
`
`or that they satisfy any hearsay exception. For the reasons stated below, the RTP
`
`Exhibits and the related testimony from Patent Owner’s declarants, Dr. Gregory
`
`Buck and Mr. Barry Weiner (Exhibits 2042, 2043), should be excluded as
`
`inadmissible evidence. Each RTP Exhibit is summarized in turn before addressing
`
`evidentiary issues.
`
`A. Summary of the RTP Exhibits
`
`Exhibit 2035. Enzo alleges that Exhibit 2035 is a document signed by co-
`
`inventors Barbara Thalenfeld and Kenneth Johnston, demonstrating “[conception]
`
`on approximately February 22, 1982 and that the first written record and
`
`experiment demonstrating the invention occurred on May 26, 1982.” Paper 20, at
`
`41. The exhibit is neither dated nor witnessed. Ex. 2035, at 5.
`
`Exhibit 2037. Dr. Buck and Mr. Weiner describe Exhibit 2037 as inventor
`
`Dollie Kirtikar’s notebook. See Ex. 2042, ¶¶ 167, 169, 170, 172, 174, 175; Ex.
`
`2043, ¶¶ 10-11. This 306-page exhibit contains copies of removable sheets in a
`
`binder, which are in non-chronological order and are often undated and/or
`
`
`
`2
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`IPR2016-00820
`U.S. Patent 7,064,197
`unsigned. None of the pages are witnessed by a testifying declarant.1 Ex. 1036,
`
`140:10-144:3.
`
`Exhibits 2038 and 2039. Enzo alleges that Exhibits 2038 and 2039 are
`
`inventor Barbara Thalenfeld’s laboratory notebook. E.g., Ex. 2043, ¶¶ 12, 14.
`
`Exhibit 2038 is non-chronological, unsigned, and unwitnessed, while Exhibit 2039
`
`is neither signed nor witnessed. Both exhibits contain additional documents either
`
`“folded or stapled to the handwritten pages.” Ex. 2043, ¶¶ 13, 15.
`
`Exhibit 2040. Enzo asserts that Exhibit 2040 was prepared by inventors
`
`Barbara Thalenfeld and Kenneth Johnston and describes June 1982 experiments.
`
`Ex. 2042, ¶¶ 167-168; Ex. 2043, ¶ 16. It is not witnessed.
`
`Exhibit 2041. Enzo describes Exhibit 2041 as a photocopy of photocopies
`
`of Dr. Thalenfeld’s notebook, and the pages were “signed or initialed … after the
`
`copy was made.” Ex. 2043, ¶ 17 (emphasis added). Thus, the inventors did not sign
`
`the original notebook, and it is not witnessed.
`
`
`
`
`1 Mr. Weiner alleged that certain pages were witnessed by a non-inventor, Dr.
`
`Norman Kelker. Ex. 1036, 64:1-16, 66:1-13, 68:11-24. Dr. Kelker consulted with
`
`Mr. Weiner prior to his deposition (id., 10:4-7, 11:5-14:22), but Enzo chose not to
`
`present his testimony.
`
`
`
`3
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`IPR2016-00820
`U.S. Patent 7,064,197
`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
`
`Exhibits and to corroborate the experiments and dates reported in those documents.
`
`Paper 20, 40-41. Mr. Weiner, however, testified that he did not have a scientific
`
`background and he did not work in the lab with the inventors:
`
`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.
`
`Ex. 1036, 40:12-21; Ex. 1036, 24:6-10. Indeed, any knowledge he has regarding
`
`the claimed invention can be imputed to information received directly or indirectly
`
`from the inventors. Id., 19:13-21:23. Mr. Weiner has no personal knowledge of
`
`when the inventors’ allegedly reduced the claimed invention to practice:
`
`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?
`A. During that period in time, I was aware of
`developments that were ongoing within the
`4
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`IPR2016-00820
`U.S. Patent 7,064,197
`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.
`
`When asked to verify when the claimed subject matter was reduced to
`
`practice, Mr. Weiner identified the relevant time frame as 1980 to 1984, even
`
`though Enzo has alleged in its Response that the invention was reduced to practice
`
`“no later than August of 1982” (Paper 20, 39-41):
`
`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
`hybridization of nucleic acids on a non-porous solid
`support?
`
`
`
`5
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`IPR2016-00820
`U.S. Patent 7,064,197
`
`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.
`
`Ex. 1036, 138:16-139:21.
`
`As demonstrated, Mr. Weiner has no personal knowledge that the alleged
`
`reduction to practice activities occurred before 1984. Therefore, his testimony on
`
`when the claimed subject matter was reduced to practice is inadmissible under
`
`FRE 602.
`
`2. The Weiner Declaration Is Inadmissible Hearsay.
`Mr. Weiner’s testimony about the inventors’ experiments by certain dates is
`
`based on the purported inventor records, i.e., Exhibits 2035, and 2037-2041, and
`
`discussions with the inventors and laboratory supervisors who reported to him. See
`
`Ex. 1036, 19:13-21:23, 24:6-25, 37:7-38:2. As discussed below, the RTP Exhibits
`
`are inadmissible hearsay under FRE 801 and do not fall under any hearsay
`
`exception, including FRE 803, 804, and 807.
`
`Enzo is also trying to use Mr. Weiner’s recitation of inventors’ or lab
`
`supervisors’ statements, which were made outside this proceeding, to prove the
`
`
`
`6
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`

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`IPR2016-00820
`U.S. Patent 7,064,197
`truth of the matters asserted—this is hearsay. FRE 801. Some of these statements
`
`are attributed to particular individuals, such as Dr. Kelker, who reported scientific
`
`activities to Mr. Weiner. See Ex. 1036, 9:20-10:7, 31:18-32:12, 37:7-38:2. Enzo
`
`chose not to present testimony from Dr. Kelker—who still works with Enzo (Ex.
`
`1036, 11:8-12) or other individuals with first-hand knowledge of the scientific
`
`activities at Enzo during the relevant time period. Enzo cannot use Mr. Weiner
`
`now as a conduit to introduce otherwise inadmissible hearsay from the lab
`
`notebooks or discussions with inventors and laboratory supervisors.
`
`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
`
`evidence, the proponent must produce evidence sufficient to support a finding that
`
`the item is what the proponent claims it is.” FRE 901(a) (emphasis added). Thus,
`
`one starts with the proponent’s description of what the document is purported to be
`
`to determine whether a document is admissible under FRE 901. One may also
`
`consider circumstantial evidence such as “[t]he appearance, contents, substance,
`
`internal patterns, or other distinctive characteristics of the [document], taken
`
`together with all the circumstances.” FRE 901(b)(4). Here, under the
`
`circumstances, the RTP Exhibits are missing crucial indicia of authenticity, and as
`
`such, Enzo has failed to produce sufficient evidence to establish authenticity.
`
`
`
`7
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`IPR2016-00820
`U.S. Patent 7,064,197
`For instance, Mr. Weiner stated that signing, dating, and witnessing were
`
`part of Enzo’s notebook policy. Ex. 1036 at 50:11-57:4, 118:21-119:2. None of the
`
`RTP Exhibits, however, are consistently signed, dated, or witnessed, and at least
`
`Exhibits 2037, 2038, and 2039, were not maintained in a chronological fashion.
`
`Exhibit 2035 is undated and not witnessed. Exhibit 2037 is often undated and
`
`unsigned, and not witnessed by a testifying declarant. Exhibits 2038 and 2039 are
`
`neither signed nor witnessed; and only a copy of Exhibit 2041, which was never
`
`witnessed, was signed by the inventors.
`
`Such conditions create significant suspicion regarding the substance and
`
`dates on which the experiments or recording of the experiments occurred—
`
`findings which are critical to Enzo’s proffering the exhibits as contemporaneous
`
`records of the invention date of the ’197 patent. See, e.g., Linear Tech. Corp. v.
`
`Micrel, Inc., 275 F.3d 1040, 1055-56 (Fed. Cir. 2001) (excluding, as
`
`unauthenticated, proffered letters, “which are dated before the critical date [but] are
`
`not signed, are not on company letterhead,” and bear no other indicia of
`
`reliability).
`
`Mr. Weiner fails to address these shortcomings of the documents with
`
`respect to signatures, dates, and witnessing. While he recognized some of the
`
`handwriting, he testified that he did not have the scientific background to
`
`understand the details of the experiments, and in any case did not review the
`
`
`
`8
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`

`

`IPR2016-00820
`U.S. Patent 7,064,197
`notebooks at the time to assure they were being properly maintained. Ex. 1036,
`
`53:24-57:4; 40:12-21; id., 24:6-10.
`
`Because these Exhibits are missing critical indicia of reliability and
`
`authenticity, they cannot qualify as ancient documents under FRE 901(8), i.e.,
`
`where the document “is in a condition that creates no suspicion about its
`
`authenticity; was in a place where, if authentic, it would likely be; and is at least 20
`
`years old when offered.” FRE 901(8) (emphasis added); see also Mathin v. Kerry,
`
`782 F.3d 804, 812 (7th Cir. 2015) (“The requirement that the document be free of
`
`suspicion to be authenticated as an ancient document relates …to whether the
`
`document is what it purports to be.”). Here, the RTP Exhibits lack the details
`
`expected in reliable notebook-keeping practice, including Enzo’s own notebook
`
`policy (see Ex. 1036 at 50:11-57:4, 118:21-119:2). See id., finding affidavits did
`
`not qualify as ancient documents because they lacked any details that might be
`
`expected in a document created after the event in question.
`
`Finally, the RTP Exhibits cannot be self-authenticated under FRE 902, as
`
`they do not fall within any of the express categories covered by the rule.
`
`2. The RTP Exhibits Are Hearsay With No Legitimate Exception
`Enzo relies on the RTP Exhibits as written assertions offered to prove the
`
`truth of the matter asserted. This is inadmissible hearsay under FRE 801. Further,
`
`the RTP Exhibits do not fall within any of the hearsay exceptions, including FRE
`
`
`
`9
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`

`

`IPR2016-00820
`U.S. Patent 7,064,197
`803(6), 803(16), 804, and 807. The exhibits do not qualify for, e.g., the business
`
`records exception (FRE 803(6)), because none of the RTP Exhibits are
`
`consistently signed, dated, or witnessed according to Enzo’s notebook policy, as
`
`stated by Mr. Weiner (see Ex. 1036, 50:11-57:4; 118:21-119:2). Moreover, at least
`
`Exhibits 2037, 2038, and 2039 were not maintained in a chronological fashion.
`
`Therefore, the records were not kept according to Enzo’s notebook policy.
`
`Furthermore, the PTAB does not consider that laboratory notebooks and
`
`experimental data are records of “regularly conducted” business activity, and such
`
`documents do not qualify for the business records exception under FRE 803(6).
`
`Corning Inc. v. DSM IP Assets B.V., IPR2013-00043, Paper 97, at 5-7 (P.T.A.B.
`
`May 1, 2014) (“Conducting specific and unique scientific experimental work is not
`
`‘a regularly conducted activity.’ Rather, conducting specific scientific experiments,
`
`such as those conducted by [Patent Owner], involves unique events not normally
`
`repeated on a ‘regular’ basis.”).
`
`The absence of these indicia of reliability in each RTP Exhibit also prevents
`
`each from qualifying under other hearsay exceptions. As noted above, the RTP
`
`Exhibits do not qualify as ancient documents under FRE 901(8), and therefore are
`
`not admissible under FRE 803(16). The RTP Exhibits similarly cannot satisfy the
`
`requirements for admission under the exceptions for unavailable declarant under
`
`FRE 804 or under FRE 807.
`
`
`
`10
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`

`

`IPR2016-00820
`U.S. Patent 7,064,197
`For the reasons stated above, the RTP Exhibits are neither authenticated nor
`
`admissible hearsay, and must be excluded on those bases.
`
`D. Portions of Dr. Buck’s Declaration Should Be Excluded For Lack Of
`Personal Knowledge, Hearsay, And Failure To Explain Conclusions
`1. Buck Lacks Personal Knowledge And Presents Inadmissible
`Hearsay.
`
`Paragraphs 146 and 165-181 of Dr. Buck’s Declaration (Exhibit 2042)
`
`contend that the RTP Exhibits show conception and reduction to practice by
`
`certain dates. Dr. Buck, however, cannot independently confirm the inventors’
`
`activity in 1982, because he “was not in the lab in 1982 with the inventors” and
`
`“had nothing to do with Enzo at that period of time,” confirming that he “would
`
`not have any independent knowledge of that.” Ex. 1035, 39:11-14. In fact, Dr.
`
`Buck agreed that his testimony as to the dates of the experiments was based solely
`
`upon the RTP Exhibits and Mr. Weiner’s Declaration. Ex. 1035, 39:15-20.
`
`Thus, Dr. Buck lacks personal knowledge under FRE 602 about what the
`
`inventors were doing in 1982, and his testimony about what they did at that time is
`
`hearsay or hearsay within hearsay under FRE 802 and 805. Ex. 2042, ¶¶ 146, 165-
`
`178, 180, 181 (Dr. Buck’s testimony about the inventors’ alleged activity by, or on,
`
`certain dates).
`
`Just like Mr. Weiner’s testimony, Dr. Buck’s testimony about the inventors’
`
`activities by certain dates is based on the purported records of the inventors, which
`
`
`
`11
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`

`

`IPR2016-00820
`U.S. Patent 7,064,197
`are statements outside of this proceeding. Enzo chose not to present testimony of
`
`anyone having personal knowledge about when the inventors performed any work.
`
`Enzo cannot improperly use Dr. Buck “as a conduit for introducing hearsay under
`
`the guise that the testifying expert used the hearsay as the basis of his testimony.”
`
`See Marvel Characters, Inc. v. Kirby, 726 F.3d 119, 136 (2d Cir. 2013).
`
`3. Dr. Buck’s Assertions Regarding the RTP Exhibits Are
`Improper Expert Testimony Under FRE 702 and 703
`
`Dr. Buck’s testimony concerning the dates is not proper expert testimony
`
`under FRE 702 and 703; it is factual testimony about the dates on the documents.
`
`Also, although a properly qualified expert may opine as to what the contents of the
`
`RTP Exhibits would have meant, Dr. Buck does not provide the factual bases for
`
`his conclusions about the meaning of those documents as required by FRE 702.
`
`For example, Dr. Buck concludes that Ex. 2035 shows that “the first written
`
`record and experiment demonstrating the invention occurred” on May 26, 1982.
`
`Ex. 2042, ¶ 166. Dr. Buck cites no facts supporting that conclusion. Page 2 of
`
`Exhibit 2035 simply includes that date written next to those quoted words, but
`
`presents no actual written record. Moreover, Exhibit 2035 does not describe ’197
`
`claim limitations, e.g., a non-porous solid support, amines, epoxides, or hydroxyls.
`
`Dr. Buck also contends that notebooks of two of the inventors confirm that
`
`the inventions worked for their intended purpose. Ex. 2042, ¶ 166. But Dr. Buck’s
`
`subsequent testimony fails to explain the facts upon which that conclusion is based.
`
`
`
`12
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`IPR2016-00820
`U.S. Patent 7,064,197
`All of the challenged claims require that “at least one single-stranded nucleic acid
`
`is fixed or immobilized in hybridizable form to said non-porous solid support via
`
`said one or more amine(s), hydroxyl(s) or epoxide(s).” Addressing those
`
`limitations, Dr. Buck contends that the purported inventor documents show actual
`
`hybridization experiments with single-stranded nucleic acids fixed through an
`
`amine or hydroxyl. Id., ¶ 177, right col. of table, at pp. 94-98. However, he fails to
`
`explain how the documents support that conclusion.
`
`Dr. Buck first cites Exhibit 2041, at page 3, as showing “an experiment that
`
`showed that the fixed single-stranded DNA actually hybridized when contacted
`
`with complementary strands of DNA.” Id., ¶¶ 167, 168, 172, 173, 177 (p. 95, rt.
`
`col.). Dr. Buck failed to explain how that page shows successful hybridization
`
`work. And during his deposition, when discussing this purported work in Exhibit
`
`2041, Dr. Buck stated that “[t]hey show results and I assume this is what they’re
`
`referring to is that the hybridization works. So unfortunately, you can’t read the
`
`results here. I can’t read the results.” Ex. 1035, 81:5-17. Page 3 of Ex. 2041,
`
`however, does not indicate that “hybridization works.” Rather page 3 appears to
`
`show a protocol under the heading “Can we hybridize on microElisaplates [sic].”
`
`Dr. Buck thus fails to explain how he reached his conclusion that page 3 of Exhibit
`
`2041 shows actual hybridization.
`
`Dr. Buck then cites Exhibit 2041, at page 10, as showing “actual
`
`
`
`13
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`IPR2016-00820
`U.S. Patent 7,064,197
`hybridization experiments on non-porous supports,” but fails to explain why. Ex.
`
`2042, ¶ 177 (pp. 95-96, rt. col.). The portion of page 10 reproduced on page 96 of
`
`his declaration appears to be another protocol, rather than results.
`
`Dr. Buck then cites Exhibit 2040, at page 3, as showing “that an array of
`
`single-stranded DNA could be bound to a plastic plate via amines using PLL or
`
`DDDA coatings and then hybridized to other DNA strands.” Ex.2042, ¶ 177, p. 97,
`
`under the reproduced portion of p. 3 of Ex. 2040. Exhibit 2040, however, is not a
`
`laboratory record providing actual data or specific conditions for hybridization
`
`experiments. Moreover, the work described at Exhibit 2040, page 3, states that the
`
`hybridization work was performed with DNA “bound to polystyrene plates as
`
`described in section two [of Ex. 2040].” Ex. 1035, 73:15-74:23. Section two
`
`appears on page 2 of Exhibit 2040, and it discusses binding of DNA to uncoated
`
`polystyrene plates. Ex. 2040, 2; Ex. 1035, 73:11-14. Dr. Buck never asserted that
`
`binding to uncoated polystyrene plates was via an amine, hydroxyl, or epoxide.
`
`Rather, despite evidence to the contrary, Dr. Buck assumed that the hybridization
`
`work described on page 3 of Exhibit 2040 involved PLL-coated plates, which
`
`would have involved binding DNA via an amine. Ex. 1035, 79:25-92:3. Dr. Buck
`
`similarly admitted during his deposition that none of the hybridization discussion
`
`in Exhibit 2041 expressly stated that the experiments involved PLL-coated plates,
`
`rather than uncoated plates. Id. Thus, Dr. Buck fails to explain why Exhibits 2040
`
`
`
`14
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`IPR2016-00820
`U.S. Patent 7,064,197
`and 2041 show reduction to practice of this limitation of all claims.
`
`Finally, Dr. Buck cites Exhibits 2037, at pages 168-171, and Exhibit 2002 at
`
`page 3 (pdf page 4), as showing hybridization experiments. Ex. 2042, ¶¶ 167, 174,
`
`175, 177 (pp. 97-98, rt. col.). Page 171 of Exhibit 2037 appears to be a protocol
`
`without results. And Exhibit 2002, at page 3, states that the inventors “discovered
`
`that nucleic acids could be fixed to non-porous solid supports and remain available
`
`for hybridization”—presenting no actual results. Thus, Dr. Buck provides no
`
`explanation how Exhibits 2037 and 2002 show actual hybridization results.
`
`Thus, Dr. Buck’s testimony that the RTP Exhibits show actual hybridization
`
`of nucleic acids that are bound via an amine, hydroxyl, or epoxide, is improper
`
`under FRE 702 and 703, because he fails to provide factual bases for that
`
`conclusion. Dr. Buck fails to explain the factual bases for several of his other
`
`conclusions about the RTP Exhibits, but space constraints prevent Petitioners from
`
`addressing them all here.
`
` Conclusion
`III.
`For the foregoing reasons, the Exhibits 2035 and 2037-2041, and certain
`
`portions of Exhibits 2042 and 2043, should be excluded from this proceeding.
`
`Date: April 24, 2017
`
`
`Respectfully submitted,
`
`
`
`
`/M. Paul Barker/
`M. Paul Barker, Reg. No. 32,013
`Lead Counsel for Hologic, Inc.
`
`
`
`15
`
`

`

`IPR2016-00820
`U.S. Patent 7,064,197
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that the foregoing PETITIONERS’ MOTION TO
`
`EXCLUDE was served on April 24, 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.
`
`Date: April 24, 2017 Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Kristin M. Creed/
`Kristin M. Creed
`Case Manager
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT &
`DUNNER, L.L.P.
`
`
`
`
`
`

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