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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`GENOME & COMPANY,
`Petitioner,
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`v.
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`THE UNIVERSITY OF CHICAGO,
`Patent Owner.
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`––––––––––––––
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`PGR2019-00002
`Patent 9,855,302 B2
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`––––––––––––––
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`UNDER 37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`
`––––––––––––––
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`––––––––––––––
`
`
`GENOME & COMPANY,
`Petitioner,
`
`v.
`
`THE UNIVERSITY OF CHICAGO,
`Patent Owner.
`
`––––––––––––––
`
`PGR2019-00002
`Patent 9,855,302 B2
`
`––––––––––––––
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`UNDER 37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`
`Patent Owner’s Motion to Exclude Evidence
`
`
`PGR2019-00002
`Patent 9,855,302 B2
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`
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`I.
`II.
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`B.
`C.
`D.
`E.
`F.
`G.
`H.
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`TABLE OF CONTENTS
`INTRODUCTION .................................................................................... 1
`ARGUMENT ............................................................................................ 1
`A.
`Exhibit 1002 (First Declaration of Dr. Braun): exclusion of
`paragraphs 41–89, 93–126, 129–136, and 138–206 ...................1
`Exhibit 1017 (O’Mahony): lacking first-hand knowledge .........5
`Exhibit 1023: lacking authentication and relevance ...................6
`Exhibit 1028: lacking authentication and relevance ...................7
`Exhibit 1032: lacking authentication and relevance ...................8
`Exhibit 1033: lacking relevance ..................................................9
`Exhibit 1041 (Fares): lacking relevance .....................................9
`Exhibit 1043 (Reply Declaration of Dr. Braun) ....................... 10
`1.
`Exclusion of paragraphs 41, 43, 44, 57–66, 72–85,
`and 87–98 as hearsay duplicated from the Reply .......... 10
`Exclusion of paragraphs 1–9, 14, 20–22, 57–58, 63–
`64, 72, 77–78, 81, 84, 87, 93–94, and 99 as irrelevant
`because they are not cited in the Reply ......................... 11
`Exclusion of paragraphs 23–30, 31–42, 45–51, and
`67–71 as impermissible incorporations-by-reference ... 11
`Exhibit 1044 (Sánchez): lacking relevance .............................. 12
`I.
`Exhibit 1057 (Weber): lacking relevance ................................ 13
`J.
`Exhibit 1059 (Schultz Declaration): lacking relevance ........... 13
`K.
`Ex. 2005 as relied upon in the Reply: lacking relevance ......... 13
`L.
`III. CONCLUSION ...................................................................................... 14
`
`
`2.
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`3.
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`i
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`Patent 9,855,302 B2
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`I.
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`Patent Owner’s Motion to Exclude Evidence
`
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`INTRODUCTION
`Patent Owner moves to exclude Petitioner’s Exhibits 1002 (selected
`
`paragraphs), 1017, 1023, 1028, 1032, 1033, 1041, 1043 (selected paragraphs),
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`1044, 1057, and 1059. Patent Owner also moves to exclude Exhibit 2005 for
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`the manner in which Petitioner relies on it in its Reply. The grounds for the
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`motion were filed and served in Patent Owner’s Objections to Evidence
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`(Papers 10 and 25).
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`II. ARGUMENT
`A. Exhibit 1002 (First Declaration of Dr. Braun): exclusion of
`paragraphs 41–89, 93–126, 129–136, and 138–206
`Patent Owner moves to exclude selected paragraphs of Exhibit 1002
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`(Dr. Braun’s first declaration) under FRE 802 as inadmissible hearsay and (ii)
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`FRE 702 and 703 for not meeting the standard for an expert to rely on hearsay.
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`Paper 10, 1–5 (stating objections). The following paragraphs of Exhibit 1002
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`mirror the Petition nearly verbatim at the pages indicated:
`
`Exhibit 1002
`
`¶¶ 41–631
`
`Duplicated Petition pages
`6–12 (Sections V.A and B)
`
`
`1 Paragraphs 43, 46, 50, 51, 53, 54, 56, and 58 of Dr. Braun’s Declaration
`include direct quotes to long passages of U.S. Patent No. 9,855,302 (Ex. 1001)
`that are not included in the Petition; otherwise, the Declaration paragraphs and
`the Petition pages are nearly verbatim.
`
`1
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`Exhibit 1002
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`¶¶ 64–892
`¶¶ 93–126
`¶¶ 129–136, 138–1663
`¶¶ 167–174
`¶¶ 175–176
`¶¶ 177–178
`¶ 179 (at least with respect to
`claims 1, 10, 11, and 18 in the
`claim chart)
`¶¶ 180–188
`¶¶ 189–190
`¶¶ 191–192
`¶¶ 193–194
`¶ 195 (at least with respect to
`claims 1, 5, and 6 in the claim
`chart)
`¶¶ 196–206
`¶¶ 207–208
`¶¶ 209–210
`¶ 211 (at least with respect to
`claims 1, 2, 3, and 7 in the claim
`chart)
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`Patent Owner’s Motion to Exclude Evidence
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`
`Duplicated Petition pages
`13–21 (Section V.C)
`21–34 (Section VI)
`36–48 (Section VII)
`50–52 (Section VIII.A)
`57–58 (Section VIII.B)
`58–59 (Section VIII.C)
`52–59 (claim chart for claims 1, 10,
`11, and 18)
`
`59–62 (Section VIII.D)
`67 (Section VIII.E)
`68 (Section VIII.F)
`68–69 (Section VIII.G)
`63–68 (claim chart for claims 1, 5,
`and 6)
`
`69–73 (Section VIII.H)
`79 (Section VIII.I)
`79–80 (Section VIII.J)
`73–78 (claim chart for claims 1, 2, 3,
`and 7)
`
`
`2 The Petition does not contain the text of the Declaration’s paragraphs 68, 72,
`76, much of which is directly quoting long passages of the prosecution history.
`3 The only substantive difference between Exhibit 1002 and the Petition in
`these paragraphs is this single clause that appears in ¶ 155 of Exhibit 1002 but
`not in the Petition, in the paragraph spanning pages 44–45: “Because of the
`highly unpredictable nature of cancer treatment in general, combined with the
`highly unpredictable nature of immune checkpoint inhibitors and different
`species of Bifidobacterium, . . . .”
`
`2
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`Patent Owner’s Motion to Exclude Evidence
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`Although an expert may rely on hearsay in certain circumstances, “[a]n
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`expert who simply repeats the hearsay of the client who retained him, without
`
`any independent investigation or analysis, does not assist the trier of fact in
`
`understanding matters
`
`that require specialized knowledge”—in such
`
`circumstances, the expert’s testimony does not qualify for an exception.
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`Arista Records LLC v. Usenet.com, Inc., 608 F. Supp. 2d 409, 424–29
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`(S.D.N.Y. 2009) (excluding portions of an expert’s testimony under FRE 702
`
`where the expert did not investigate facts himself and merely restated the
`
`views of the party hiring him). In other words, an expert relying on hearsay
`
`may not “simply transmit that hearsay” to the factfinder and instead “must
`
`form his own opinions by applying his extensive experience and reliable
`
`methodology to the inadmissible materials,” as “simply repeating hearsay
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`evidence without applying any expertise whatsoever . . . allows [a party] to
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`circumvent the rules prohibiting hearsay.” United States v. Mejia, 545 F.3d
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`179, 197–98 (2nd Cir. 2008) (internal quotation marks and citations omitted).
`
`Large tracts of Dr. Braun’s declaration, as detailed in the table above,
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`simply reproduce the Petition verbatim or near verbatim. This word-for-
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`copying suggests that Dr. Braun’s testimony was provided to him by
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`Petitioner, a suggestion reinforced by Dr. Braun’s admission on redirect
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`3
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`examination that Petitioner’s counsel prepared the first draft of his
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`Patent Owner’s Motion to Exclude Evidence
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`declaration. Ex. 2033, 90:25–91:14. Dr. Braun further testified that he
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`“discussed” the elements of his declaration with Petitioner’s counsel (id. at
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`90:25–91:5), and that he reviewed and revised subsequent drafts (id. at 91:11–
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`14), and that he reviewed all the exhibits attached to his declaration (id. at
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`91:21–23), all of which indicates collaboration between Dr. Braun and
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`Petitioner’s counsel, rather than the “independent investigation or analysis”
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`required by law. See Arista, 608 F. Supp. 2d at 429.
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`Petitioner did not include with its Petition evidence that Dr. Braun’s
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`testimony was the result of independent investigation or analysis. Patent
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`Owner timely described the precise nature of its objection to Dr. Braun’s
`
`testimony (Paper 10, 1–5), but Petitioner did not respond with supplemental
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`evidence to cure this objection.
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`Patent Owner also moves to exclude the above-listed paragraphs of
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`Exhibit 1002 to the extent they are relied upon as expert witness testimony
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`because they do not satisfy the requirements of FRE 702. For example, given
`
`that Dr. Braun’s statements are verbatim recitations of the Petition’s
`
`arguments, these statements are attorney argument and do not provide
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`“scientific, technical, or other specialized knowledge [that] will help the trier
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`4
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`of fact to understand the evidence or to determine a fact in issue” as required
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`Patent Owner’s Motion to Exclude Evidence
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`by FRE 702(a), and they are not “the product of reliable principles and
`
`methods” as required by FRE 702(c). Thus, Dr. Braun’s testimony is
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`inadmissible under FRE 702.
`
`Exhibit 1017 (O’Mahony): lacking first-hand knowledge
`B.
`Patent Owner moves to exclude Exhibit 1017 as inadmissible under 37
`
`C.F.R. § 42.61(c), to the extent Petitioner relies on Ex. 1017 as evidence of
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`the truth of the data reported therein or of Petitioner’s assertions that
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`“O’Mahony
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`taught Bifidobacterium
`
`strains may be
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`significantly
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`immunomodulatory
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`following oral consumption
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`in humans and
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`Bifidobacterium strains could be used in the prophylaxis and/or treatment of
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`gastrointestinal cancer(s)” (Pet. 13), “while Bifidobacterium longum strain
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`1714 exhibited imm[u]nosuppressive properties, Bifidobacterium longum
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`strain UCC356624 exhibited immunostimulatory properties. Ex. [1]017. at
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`[0103-0109]”
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`(Pet. 16), “O’Mahony did
`
`teach
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`immunostimulatory
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`Bifidobacterium
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`longum strains” (Pet. 16), “Bifidobacterium
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`longum
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`subspecies infantis strain UCC356624 was immunostimulatory whereas
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`Bifidobacterium longum strain 1714 was imm[u]nosuppressive or anti-
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`inflammatory. Bifidobacterium longum strain UCC356624 had ‘quite a
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`5
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`different pattern’ for immunostimulatory cytokines IL-12, IFNγ and IL-6
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`Patent Owner’s Motion to Exclude Evidence
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`than Bifidobacterium longum strain 1714” (Pet. 31), and “Additional
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`research showed . . . other strains were anti-inflammatory” (Pet. 44).
`
`Petitioner is relying on O’Mahony as evidence of the truth of its data,
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`not merely of what it describes, because Petitioner argues that one of ordinary
`
`skill in the art would have known from O’Mahony that certain things were
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`true. For example, Petitioner concludes its discussion of O’Mahony at Pet. 31
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`with the following: “As shown above, different species of Bifidobacteria, and
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`even different strains of the same species of Bifidobacteria, affect the immune
`
`system in different and unpredictable ways, e.g., some are immunostimulatory
`
`whereas others are immunosuppressive. Ex. 1002 at ¶ 117.” Pet. 32.
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`Petitioner is presenting these conclusions as truth, not merely as disclosure
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`from O’Mahony. Rule 42.61(c) requires the filing of a declaration from a
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`person having first-hand knowledge of how the data was generated. Petitioner
`
`has not filed such a declaration. Petitioner therefore may not rely on
`
`O’Mahony in the manner it has.
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`C. Exhibit 1023: lacking authentication and relevance
`Patent Owner moves to exclude Exhibit 1023 as inadmissible under
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`FRE 901 for lacking authentication. Exhibit 1023 purports to be a copy of a
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`6
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`printout of a webpage of the National Cancer Institute. However, Petitioner
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`Patent Owner’s Motion to Exclude Evidence
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`provides no evidence that Exhibit 1023 is a true and correct printout of the
`
`website. For example, Petitioner has not provided the testimony of any
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`witness with personal knowledge of the website. See Nestle Oil OYJ v. Reg
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`Synthetic Fuels, LLC, IPR2013-00578, Paper 53 at 3–4 (P.T.A.B. March 12,
`
`2015).
`
`Patent Owner moves to exclude Exhibit 1023 as inadmissible under
`
`FRE 402 because it is not relevant. Petitioner provides no evidence of the
`
`date the content as it appears in the printout was publicly available. The
`
`webpage that is presently located at the URL https://www.cancer.gov/about-
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`cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet
`
`indicates the website was “Updated” on “March 18, 2019,” which is after the
`
`effective filing date in this case.
`
`D. Exhibit 1028: lacking authentication and relevance
`Patent Owner moves to exclude Exhibit 1028 as inadmissible under
`
`FRE 901 because it lacks authentication. Exhibit 1028 includes no indication
`
`that it was ever published or of a date on which it became available as a printed
`
`publication.
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`Patent Owner moves to exclude Exhibit 1028 as inadmissible under
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`7
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`FRE 401 and 402 because Petitioner has not shown that it qualifies as prior
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`Patent Owner’s Motion to Exclude Evidence
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`art. The first page of Exhibit 1028 indicates a “Received” date in 2017,
`
`indicating that the document did not predate the effective filing date in this
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`case.
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`Exhibit 1032: lacking authentication and relevance
`E.
`Patent Owner moves to exclude Exhibit 1032 as inadmissible under
`
`FRE 901 because it lacks authentication. Exhibit 1032 purports to be a copy
`
`of a printout of a webpage. However, Petitioner provides no evidence that
`
`Exhibit 1032 is a true and correct printout of the website. For example,
`
`Petitioner has not provided the testimony of any witness with personal
`
`knowledge of the website. See Nestle Oil, IPR2013-00578, Paper 53 at 3–4.
`
`Patent Owner also moves to exclude Exhibit 1032 as inadmissible
`
`under FRE 401 and 402 because it is not relevant. Although the printout
`
`includes the date “Mar. 12, 2015,” Petitioner provides no evidence that the
`
`content as it appears in the printout was publicly available as of that date. In
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`addition, the printout also includes the date “31 August 2018” (Ex. 1032 at 6)
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`and a copyright date of 2018 (Ex. 1032 at 8), indicating that the document did
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`not predate the effective filing date in this case.
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`8
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`Patent Owner’s Motion to Exclude Evidence
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`Exhibit 1033: lacking relevance
`F.
`Patent Owner moves to exclude Exhibit 1033 as inadmissible under
`
`FRE 401 and 402 for lack of relevance. Exhibit 1033 includes the following
`
`text on its front page: “This article was published on November 19, 2014, and
`
`last updated on November 12, 2015, at NEJM.org.” The date “November 12,
`
`2015” is after the effective filing date in the case. Petitioner has not provided
`
`evidence establishing that Exhibit 1033 qualifies as prior art.
`
`G. Exhibit 1041 (Fares): lacking relevance
`Patent Owner moves to exclude Exhibit 1041 as inadmissible under
`
`FRE 401 and 402 for lack of relevance.4 Exhibit 1041 recites “published at
`
`ascopubs.org on May 17, 2019” (Ex. 1041 at 1, left-hand margin) and includes
`
`the year “2019” in its footer. Thus, Exhibit 1041 indicates that it was not
`
`available until 2019, which is after the effective filing date in this case.
`
`Exhibit 1041 also lacks relevance because Petitioner does not cite this Exhibit
`
`in its Reply. Patent Owner objected to the introduction of this exhibit during
`
`Dr. Mani’s deposition. Ex. 1042, 37:18–38:13.
`
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`4 Petitioner also used Exhibit number 1041 for the supplemental evidence it
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`served on Patent Owner on May 13, 2019.
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`Patent Owner’s Motion to Exclude Evidence
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`H. Exhibit 1043 (Reply Declaration of Dr. Braun)
`1. Exclusion of paragraphs 41, 43, 44, 57–66, 72–85, and
`87–98 as hearsay duplicated from the Reply
`Patent Owner moves to exclude paragraphs 41, 43, 44, 57–66, 72–85,
`
`and 87–98 of Exhibit 1043 as inadmissible under FRE 802 to the extent they
`
`are relied upon as evidence of the truth of the matters asserted therein, because
`
`they are hearsay under FRE 802 and do not meet the standard for an expert to
`
`rely on hearsay under FRE 702 and 703. For example, at least the following
`
`paragraphs of Exhibit 1043 mirror the Reply nearly verbatim:
`
`Exhibit 1043
`¶¶ 41, 43–44
`¶¶ 57–63
`¶¶ 64–66
`¶¶ 72–77
`¶¶ 78–83
`¶¶ 84–85, 87–89
`¶¶ 90–92
`¶¶ 93–98
`
`Duplicated from Reply pages
`10–11
`12–13 (Section II.B.2)
`13–15 (Section II.B.3)
`15–17 (Section II.B.4)
`18–19, 21 (Section III.A)
`21–24 (Section III.B)
`24–25 (Section III.B.1)
`25–27 (Section III.C)
`
`As discussed above for Exhibit 1002, testimony duplicated from a
`
`party’s argument amounts to nothing more than party-supplied hearsay.
`
`Petitioner has offered no evidence that Dr. Braun’s testimony was the result
`
`of an independent investigation or analysis. Arista, 608 F. Supp. 2d at 429.
`
`Patent Owner also moves to exclude the above-listed paragraphs as
`
`inadmissible expert witness testimony under FRE 702. For example,
`
`10
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`Patent 9,855,302 B2
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`Dr. Braun’s statements that are verbatim recitations of the Reply’s arguments
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`Patent Owner’s Motion to Exclude Evidence
`
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`are attorney argument and do not provide “scientific, technical, or other
`
`specialized knowledge [that] will help the trier of fact to understand the
`
`evidence or to determine a fact in issue” as required by FRE 702(a), and they
`
`are not “the product of reliable principles and methods” as required by FRE
`
`702(c). Thus, Dr. Braun’s reply declaration testimony is inadmissible under
`
`FRE 702.
`
`2. Exclusion of paragraphs 1–9, 14, 20–22, 57–58, 63–64,
`72, 77–78, 81, 84, 87, 93–94, and 99 as irrelevant
`because they are not cited in the Reply
`Patent Owner moves to exclude paragraphs 1–9, 14, 20–22, 57–58, 63–
`
`64, 72, 77–78, 81, 84, 87, 93–94, and 99 of Exhibit 1043 as inadmissible under
`
`FRE 401 and 402 because they lack relevance to this proceeding, as the Reply
`
`does not refer to or cite these paragraphs.
`
`3. Exclusion of paragraphs 23–30, 31–42, 45–51, and 67–
`71 as impermissible incorporations-by-reference
`Patent Owner moves to exclude paragraphs 23–30, 31–42, 45–51, and
`
`67–71 as impermissible incorporations-by-reference under 37 C.F.R. ¶
`
`42.6(a)(3). These paragraphs are inadmissible because, as cited in the Reply,
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`they constitute an improper circumvention of the word count limit:
`
`paragraphs 23–30 (465 words), which are cited together in the Reply at 9, note
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`11
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`6; paragraphs 31–42 (750 words), which are cited together in the Reply at 10,
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`Patent Owner’s Motion to Exclude Evidence
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`note 7; paragraphs 45–51 (442 words), which are cited together in the Reply
`
`at 11; and paragraphs 67–71 (317 words), which are cited together in the
`
`Reply at 15. These paragraphs are incorporations-by-reference in violation of
`
`Rule 42.6(a)(3) because they are cited with little or no explanation in the
`
`Reply. See Cisco Systems, Inc. v. C-Cation Techs., LLC, Case IPR2014-00454
`
`(PTAB Aug. 29, 2014) (Paper 12, 7–10) (informative) (“we will not consider
`
`arguments that are not made in the Petition, but are instead incorporated by
`
`reference to the cited paragraphs [of the expert declaration]”). The passages
`
`thus incorporated total 1,974 words, which, when combined with the Reply
`
`certified word count of 5,457 (Reply 29) causes the Reply to exceed the word
`
`limit of 5,600 words (37 C.F.R. § 42.24(c)(1)) by 1,831 words, or 33% of the
`
`allowed limit.
`
`Exhibit 1044 (Sánchez): lacking relevance
`I.
`Patent Owner moves to exclude Exhibit 1044 as inadmissible under
`
`FRE 401 and 402 for lack of relevance. Exhibit 1044 recites “Volume 2015”
`
`in its first-page header and “Copyright © 2015” on the first page. Petitioner
`
`has not provided any evidence showing that Exhibit 1044 was available as a
`
`printed publication sufficiently early in 2015 to predate the effective filing
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`12
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`date of June 1, 2015 in this case.
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`Patent Owner’s Motion to Exclude Evidence
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`Exhibit 1057 (Weber): lacking relevance
`J.
`Patent Owner moves to exclude Exhibit 1057 as inadmissible under
`
`FRE 401 and 402 for lack of relevance, as Petitioner has not provided any
`
`evidence that Exhibit 1057 was available as a printed publication before the
`
`effective filing date. Exhibit 1057 includes no publication date. The exhibit
`
`recites “CID 2015:61 (1 August)” in its footer, “1 August” in its first-page
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`header, and “2015” and “© The Author 2015” at the end. To the extent a
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`publication date of August 1, 2015 is inferable from these recitations, it is after
`
`the effective filing date of June 1, 2015 in this case.
`
`K. Exhibit 1059 (Schultz Declaration): lacking relevance
`Patent Owner moves to exclude Exhibit 1059 as inadmissible under
`
`FRE 401 and 402 for lack of relevance. Petitioner does not cite this Exhibit
`
`in its Reply.
`
`Exhibit 2005 as relied upon in the Reply: lacking relevance
`L.
`Patent Owner moves to exclude Exhibit 2005, as relied upon in the
`
`Reply at 9–10, as inadmissible under FRE 401 and 402 for lack of relevance.
`
`Petitioner cites Exhibit 2005 as relevant to what a person of ordinary skill in
`
`the art would have concluded (Reply at 10, note 7) but has not presented
`
`evidence that Exhibit 2005 predates the effective filing date. Exhibit 2005
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`13
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`includes a “DEC 08 2015” date stamp on its cover page, the date “27
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`Patent Owner’s Motion to Exclude Evidence
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`NOVEMBER 2015” on its Contents page and footer, and the text “Published
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`online 5 November 2015” on page 1084—all of these dates are after the
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`effective filing date.
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`III. CONCLUSION
`For these reasons, Patent Owner moves to exclude the above-listed
`
`evidence.
`
`Dated: December 24, 2019
`
`Respectfully submitted,
`
` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
`Covington & Burling LLP
`One CityCenter
`850 Tenth Street, NW
`Washington, DC 20001
`Phone: (202) 662-5339
`Fax: (202) 778-5339
`
`Jennifer L. Robbins, Reg. No. 61,163
`Covington & Burling LLP
`The New York Times Building
`620 Eighth Ave
`New York, NY 10018
`Phone: (212) 841-1180
`Fax: (646) 441-9180
`
`Counsel for Patent Owner
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`14
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`Patent Owner’s Motion to Exclude Evidence
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I certify that on the date listed below, a
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`copy of this paper and every exhibit (if any) filed with this paper was served
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`on the Petitioner by electronic mail to the following counsel of record for
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`Petitioner:
`
`John A. Bauer (john.bauer@nelsonmullins.com)
`Kongsik Kim (kongsik.kim@nelsonmullins.com)
`Jane Remillard (jane.remillard@nelsonmullins.com)
`Amy Mandragouras (amy.mandragouras@nelsonmullins.com)
`
`
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`Dated: December 24, 2019
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`
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`
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`
`
` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
`
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`ii
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