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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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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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`PGR2019-00002
`Patent 9,855,302 B2
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`PATENT OWNER’S REPLY IN SUPPORT OF
`MOTION TO EXCLUDE EVIDENCE
`UNDER 37 C.F.R. § 42.64(c)
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`Patent Owner’s Reply in Support of
`Motion to Exclude Evidence
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`PGR2019-00002
`Patent 9,855,302 B2
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`I.
`II.
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`TABLE OF CONTENTS
`INTRODUCTION .................................................................................... 1
`ARGUMENT ............................................................................................ 1
`A.
`Exhibits 1002 and 1043 (Declarations of Dr. Braun):
`exclusion of selected paragraphs as party-supplied hearsay .......1
`Exhibit 1017 (O’Mahony): exclusion of patent application
`data offered for the truth .............................................................1
`Exhibits 1023, 1028, 1032, 1033, 1041, 1044, 1057, and
`2005: exclusion for failure to show prior publication .................3
`III. CONCLUSION ........................................................................................ 5
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`B.
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`C.
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`PGR2019-00002
`Patent 9,855,302 B2
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`I.
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`Patent Owner’s Reply in Support of
`Motion to Exclude Evidence
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`INTRODUCTION
`Patent Owner maintains all motions to exclude and comments further
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`on only selected motions.
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`II. ARGUMENT
`A. Exhibits 1002 and 1043 (Declarations of Dr. Braun):
`exclusion of selected paragraphs as party-supplied hearsay
`Patent Owner’s suggestion that Dr. Braun’s testimony is largely
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`Petitioner’s transmitted hearsay is not “reckless” (Opp. 2), because it is based
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`on the undeniable near-identity of large swaths of Dr. Braun’s declaration to
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`Petitioner’s Petition and Reply, as well as on Dr. Braun’s freely-given
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`testimony that Petitioner’s counsel prepared the first draft. This evidence
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`indicates that Petitioner’s counsel prepared Dr. Braun’s declarations for him.
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`It refutes the alternative that Dr. Braun arrived at his testimony through the
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`“independent investigation or analysis” required of him, an issue Patent
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`Owner discussed extensively in its motion but which Petitioner ignores in its
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`opposition.
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`B.
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`Exhibit 1017 (O’Mahony): exclusion of patent application
`data offered for the truth
`Petitioner’s assertion that it offered O’Mahony’s data merely as
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`evidence of what how one of ordinary skill would have understood it (Opp. 6)
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`mischaracterizes the Petition. Petitioner relied on O’Mahony at pages 31 and
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`44, both times stating that O’Mahony “showed” certain facts to be true,
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`Patent Owner’s Reply in Support of
`Motion to Exclude Evidence
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`namely, that certain bacterial strains possess particular properties:
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`O’Mahony showed that Bifidobacterium longum subspecies
`infantis strain UCC356624 was immunostimulatory whereas
`Bifidobacterium longum strain 1714 was immnosuppressive
`or
`anti-inflammatory. Bifidobacterium
`strain
`longum
`UCC356624 had
`“quite
`a different pattern”
`for
`immunostimulatory cytokines IL-12, IFNγ and IL-6 than
`Bifidobacterium longum strain 1714. Consistent with those
`results, O’Mahony states that “the in vivo protection observed
`was strain specific”. See Ex. 1017 at [0103-0109], [0108].
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`Pet. 31; and
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`Additional research showed while a strains had anti-tumor
`activity and immunostimulatory (see Ex. 1005, 1007), other
`strains were anti-inflammatory (Ex. 1017).
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`Id. at 44.
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`Whether O’Mahony’s data is true of the facts Petitioner ascribes to it
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`depends utterly on whether and how O’Mahony’s experiments were carried
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`out. It therefore requires the testimony of a person having first-hand
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`knowledge of how the data was generated. See 37 CFR § 42.61(c). Thus the
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`manner in which Petitioner relies on O’Mahony’s data— that it “showed” the
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`truth of supposed scientific facts— triggers the requirement for a supporting
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`Patent Owner’s Reply in Support of
`Motion to Exclude Evidence
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`declaration. Petitioner has not provided the declaration, so O’Mahony should
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`be excluded.
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`C. Exhibits 1023, 1028, 1032, 1033, 1041, 1044, 1057, and 2005:
`exclusion for failure to show prior publication
`Petitioner does not dispute that it has failed to show that any of these
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`exhibits was published before the June 1, 2015 priority date. Petitioner instead
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`relies on Yeda Research as blanket authority to rely on post-dated publications
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`as evidence of the state of the art. But Yeda Research was a narrow decision
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`on distinguishable facts.
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`In Yeda Research, the challenged patent claimed a dosing regimen.
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`Yeda Research v. Mylan Pharm. Inc., 906 F.3d 1031, 1035–36
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`(Fed. Cir. 2018). A post-dated reference (“Khan 2009”) was deemed
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`admissible because it reported on a dosing regimen study that was designed
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`before the challenged patent’s filing date. Id. at 1037. The Court ruled that
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`the dosing regimens the authors designed for the Khan 2009 study were direct
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`evidence of how the POSITA thought about dosing regimens at that time.
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`Id. at 1041.
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`Here, Petitioner instead argues that it is reasonable to infer that the
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`POSITA’s state of mind as portrayed in the challenged references reflects the
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`POSITA’s state of mind from before the priority date. E.g., Opp. 8. But that
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`Patent Owner’s Reply in Support of
`Motion to Exclude Evidence
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`is no more than an inference which Petitioner supports with no evidence.
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`With particular reference to Exhibit 1028, Petitioner offers no support
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`for the assertion that “[i]f the effectiveness of CPIs remained in doubt as of
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`2017, then Exhibit 1028 is surely relevant regarding the expectations of a
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`POSITA as of the filing date of the ‘302 patent.” Opp. 9–10. Petitioner’s
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`argument assumes without justification that doubt can only lessen, not
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`increase, with time.
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`With particular reference to Exhibit 1032, Petitioner does not explain
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`how the discrepancy between the March 12, 2015 date at the beginning of the
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`article and the 2018 copyright date at the end can be resolved in favor of the
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`former. The conflicting dates create an ambiguity that is best handled by
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`discarding the evidence.
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`With particular reference to Exhibit 1033, Petitioner does not explain
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`how to determine which parts of the reference formed part of the original
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`publication and which were not added to it when it was revised after the
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`priority date. Thus every part of the document is suspect.
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`With particular reference to Exhibit 2005, what the ’302 patent’s
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`inventors made of Dong is irrelevant to the obviousness inquiry. “Inventors,
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`as a class, according to the concepts underlying the Constitution and the
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`Patent Owner’s Reply in Support of
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`statutes that have created the patent system, possess something — call it what
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`you will — which sets them apart from the workers of ordinary skill, and one
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`should not go about determining obviousness under § 103 by inquiring into
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`what patentees (i.e., inventors) would have known or would likely have done,
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`faced with the revelations of references.” Standard Oil Co. v. American
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`Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985) (emphasis in original).
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`III. CONCLUSION
`For these reasons, Patent Owner’s motion to exclude evidence should
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`be granted.
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`Dated: January 10, 2020
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`Respectfully submitted,
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` /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
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`Patent Owner’s Reply in Support of
`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:
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`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: January 10, 2020
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` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
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