UNITED STATES PATENT AND TRADEMARK OFFICE
`
`––––––––––––––
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`––––––––––––––
`
`
`GENOME & COMPANY,
`Petitioner,
`
`v.
`
`THE UNIVERSITY OF CHICAGO,
`Patent Owner.
`
`––––––––––––––
`
`PGR2019-00002
`Patent 9,855,302 B2
`
`––––––––––––––
`
`PATENT OWNER’S REPLY IN SUPPORT OF
`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 REPLY IN SUPPORT OF
`MOTION TO EXCLUDE EVIDENCE
`UNDER 37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`
`Patent Owner’s Reply in Support of
`Motion to Exclude Evidence
`
`PGR2019-00002
`Patent 9,855,302 B2
`
`
`
`I.
`II.
`
`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
`
`B.
`
`C.
`
`
`
`i
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`
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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
`
`INTRODUCTION
`Patent Owner maintains all motions to exclude and comments further
`
`on only selected motions.
`
`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
`
`Petitioner’s transmitted hearsay is not “reckless” (Opp. 2), because it is based
`
`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
`
`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.
`
`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
`
`Owner discussed extensively in its motion but which Petitioner ignores in its
`
`opposition.
`
`B.
`
`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
`
`evidence of what how one of ordinary skill would have understood it (Opp. 6)
`
`mischaracterizes the Petition. Petitioner relied on O’Mahony at pages 31 and
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`1
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`PGR2019-00002
`Patent 9,855,302 B2
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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:
`
`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].
`
`Pet. 31; and
`
`Additional research showed while a strains had anti-tumor
`activity and immunostimulatory (see Ex. 1005, 1007), other
`strains were anti-inflammatory (Ex. 1017).
`
`Id. at 44.
`
`Whether O’Mahony’s data is true of the facts Petitioner ascribes to it
`
`depends utterly on whether and how O’Mahony’s experiments were carried
`
`out. It therefore requires the testimony of a person having first-hand
`
`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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`2
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`PGR2019-00002
`Patent 9,855,302 B2
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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
`
`be excluded.
`
`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
`
`exhibits was published before the June 1, 2015 priority date. Petitioner instead
`
`relies on Yeda Research as blanket authority to rely on post-dated publications
`
`as evidence of the state of the art. But Yeda Research was a narrow decision
`
`on distinguishable facts.
`
`In Yeda Research, the challenged patent claimed a dosing regimen.
`
`Yeda Research v. Mylan Pharm. Inc., 906 F.3d 1031, 1035–36
`
`(Fed. Cir. 2018). A post-dated reference (“Khan 2009”) was deemed
`
`admissible because it reported on a dosing regimen study that was designed
`
`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
`
`evidence of how the POSITA thought about dosing regimens at that time.
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`Id. at 1041.
`
`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
`
`3
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`PGR2019-00002
`Patent 9,855,302 B2
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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.
`
`With particular reference to Exhibit 1028, Petitioner offers no support
`
`for the assertion that “[i]f the effectiveness of CPIs remained in doubt as of
`
`2017, then Exhibit 1028 is surely relevant regarding the expectations of a
`
`POSITA as of the filing date of the ‘302 patent.” Opp. 9–10. Petitioner’s
`
`argument assumes without justification that doubt can only lessen, not
`
`increase, with time.
`
`With particular reference to Exhibit 1032, Petitioner does not explain
`
`how the discrepancy between the March 12, 2015 date at the beginning of the
`
`article and the 2018 copyright date at the end can be resolved in favor of the
`
`former. The conflicting dates create an ambiguity that is best handled by
`
`discarding the evidence.
`
`With particular reference to Exhibit 1033, Petitioner does not explain
`
`how to determine which parts of the reference formed part of the original
`
`publication and which were not added to it when it was revised after the
`
`priority date. Thus every part of the document is suspect.
`
`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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`4
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`PGR2019-00002
`Patent 9,855,302 B2
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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
`Motion to Exclude Evidence
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`statutes that have created the patent system, possess something — call it what
`
`you will — which sets them apart from the workers of ordinary skill, and one
`
`should not go about determining obviousness under § 103 by inquiring into
`
`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
`
`Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985) (emphasis in original).
`
`III. CONCLUSION
`For these reasons, Patent Owner’s motion to exclude evidence should
`
`be granted.
`
`Dated: January 10, 2020
`
`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
`
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`5
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`PGR2019-00002
`Patent 9,855,302 B2
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`
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`Patent Owner’s Reply in Support of
`Motion to Exclude Evidence
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I certify that on the date listed below, a
`
`copy of this paper and every exhibit (if any) filed with this paper was served
`
`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)
`
`
`
`Dated: January 10, 2020
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`
`
`
`
`
`
` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
`
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`ii
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