Trials@uspto.gov
`571-272-7822
`
`Paper 34
`Date: January 9, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GENOME & COMPANY
`Petitioner,
`v.
`THE UNIVERSITY OF CHICAGO
`Patent Owner.
`
`PGR2019-00002
`Patent 9,855,302 B2
`
`Before SHERIDAN K. SNEDDEN, SUSAN L.C. MITCHELL, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`SCHNEIDER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Patent Owner’s Request on Rehearing of Decision Granting
`Institution
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 34
`Date: January 9, 2020
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GENOME & COMPANY
`Petitioner,
`v.
`THE UNIVERSITY OF CHICAGO
`Patent Owner.
`
`PGR2019-00002
`Patent 9,855,302 B2
`
`Before SHERIDAN K. SNEDDEN, SUSAN L.C. MITCHELL, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`SCHNEIDER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Patent Owner’s Request on Rehearing of Decision Granting
`Institution
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`PGR2019-00002
`Patent 9,855,302 B2
`
`INTRODUCTION
`I.
`The University of Chicago (“Patent Owner”) filed a Request for
`Rehearing (Paper 11, “Reh’g Req.”) of our Decision on Institution of Post-
`Grant Review (“Decision”), holding that Petitioner has established a
`reasonable likelihood that it would prevail in showing that claims 1–29 of
`U.S. Patent No. 9,855,302 B2 (Ex. 1001, “the ’302 patent”) are
`unpatentable.
`Patent Owner requests rehearing arguing that we (1) improperly
`excused Petitioner from its burden of presenting evidence that the asserted
`experimentation was undue and not routine; (2) improperly shifted the
`burden to Patent Owner; (3) misapprehended Patent Owner’s argument that
`Petitioner had failed to show that Kohwi’s bacteria are immunostimulatory;
`(4) misapprehended Patent Owner’s argument that the record as a whole
`does not support Petitioner’s assertion that Kowhi’s bacteria are
`immunostimulatory; (5) misapprehended Patent Owner’s argument
`regarding Mohania. Reh’g Req. 1–14.
`For the reasons stated below, Patent Owner’s request is denied.
`II. STANDARD OF REVIEW
`The party requesting rehearing has the burden to show that the
`decision should be modified. Under 37 C.F.R. § 42.71(d), the request for
`rehearing must identify, specifically, all matters the party believes the Board
`misapprehended or overlooked, and the place where each matter was
`previously addressed in a motion, an opposition, or a reply. When rehearing
`a decision on a petition, we review the decision for an abuse of discretion.
`37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based
`on an erroneous interpretation of law, if a factual finding is not supported by
`
`2
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`PGR2019-00002
`Patent 9,855,302 B2
`substantial evidence, or if an unreasonable judgment is made in weighing
`relevant factors. In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir. 2000).
`III. ANALYSIS
`
`A. Enablement
`Patent Owner contends that we erred in finding that Petitioner had
`demonstrated that it was more likely than not that the challenged claims
`were not enabled. Reh’g. Req. 3. Patent Owner contends that we ignored
`Patent Owner’s argument that Petitioner had failed to present any evidence
`that the experimentation needed to practice the claimed invention would not
`involve repetition of known or commonly used techniques. Id. at 4–5.
`Patent Owner contends that the statements by Petitioner’s expert alone are
`insufficient to establish that the experimentation required was undue. Id.
`Patent Owner also contends that we improperly shifted the burden of
`proof to Patent Owner on the issue of enablement. Id. at 4–6. Patent Owner
`argues that by permitting Petitioner to show non-enablement without proof
`of undue experimentation, we have improperly forced Patent Owner to
`present evidence showing enablement. Id.
`We are not persuaded that we misapprehended or overlooked Patent
`Owner’s argument. As we noted in our Decision, the issue of whether undue
`experimentation is required to practice the claimed invention is evaluated
`using the factors outlined in In re Wands, a fact based inquiry. Dec. 8. Our
`conclusion for purposes of institution that undue experimentation would be
`required to practice the claimed invention was based, not only on
`Dr. Braun’s statement to that effect, but on the detailed analysis presented by
`Petitioner and Dr. Braun of all of the Wands factors as supported by the
`evidence of record. Dec. 14–15.
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`3
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`PGR2019-00002
`Patent 9,855,302 B2
`We considered Patent Owner’s argument that Petitioner had failed to
`show that the experimentation required was other than routine and found it
`unpersuasive at the institution stage of the proceeding. Id. Patent Owner’s
`argument was based on the premise that Dr. Braun’s opinion regarding non-
`enablement was based on the number of experiments and not whether the
`experiments were routine. Prelim. Resp. 2–4. This argument ignores the
`fact that our consideration of Dr. Braun’s opinion was based on an analysis
`of all of the Wands factors, a fact based inquiry that includes analyzing the
`minimal guidance presented in the Specification and the unpredictability of
`cancer treatments and unpredictable nature of CPIS, and not merely the
`number of experiments required. Id. at 15; Ex. 1002 ¶ 166; In re Morsa, 713
`F.3d 104, 109 (Fed. Cir. 2013) (“Enablement is a question of law based on
`underlying factual findings.”). Although we acknowledge Patent Owner’s
`argument in support of its position that the claimed subject matter is enabled,
`we remind Patent Owner that, for purposes of deciding whether to institute a
`post-grant review, we view a genuine issue of material fact in the light most
`favorable to the petitioner. 37 C.F.R. § 42.208(c). As Patent Owner offered
`attorney argument concerning enablement based on the current record, we
`resolved the parties’ dispute regarding enablement for which Petitioner
`offered Dr. Braun’s opinion as supported by evidence of record in favor of
`Petitioner.
`With respect to the issue of burden of proof, we begin by noting that
`the burden of establishing unpatentability remains with Petitioner and our
`decision to institute does not shift that burden. The standard we apply in
`deciding whether to institute post-grant review is whether “the information
`presented in the petition filed under section 321, if such information is not
`rebutted, would demonstrate that it is more likely than not that at least 1 of
`
`4
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`PGR2019-00002
`Patent 9,855,302 B2
`the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a).
`As discussed in our Decision, Petitioner has presented a detailed analysis of
`the Wands factors showing that the challenged claims are not enabled based
`on the evidence of record. Dec. 9–13. Patent Owner did not present
`additional evidence to rebut the information presented in the Petition, but
`chose to respond with an argument that Petitioner had not presented
`sufficient evidence to support a conclusion of non-enablement. Pet. 3–6. In
`our decision we addressed Patent Owner’s argument and found it to be
`unpersuasive in light of the information presented in the Petition. Dec. 14–
`15. Our Decision is consistent with the standard for instituting post-grant
`review set forth in the statute.
`Patent Owner contends that we should reconsider our decision to
`institute to avoid having Patent Owner address Petitioner’s legally
`insufficient enablement challenge. Reh’g. Req. 6–9. Patent Owner further
`contends that we should exercise our discretion and deny the Petition to help
`maintain the integrity of the patent system and promote fairness. Id. We
`have considered Patent Owner’s new arguments and are not persuaded.
`Those arguments were not previously raised in the Preliminary Response,
`and a request for rehearing is not the proper vehicle to set forth new
`argument.
`B. Obviousness based on Kohwi
`Patent Owner contends that we misapprehended its arguments with
`regards to the teachings of Kohwi. Reh’g. Req. 9–13. Patent Owner
`contends that we misapprehended Patent Owner’s argument that Petitioner
`failed to show that the bacteria used by Kohwi were immunostimulatory. Id.
`at 9. Patent Owner contends that we overlooked Patent Owner’s argument
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`5
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`PGR2019-00002
`Patent 9,855,302 B2
`that the statements in Kohwi regarding immunostimulatory effect are at most
`speculative and cannot be relied upon. Id.
`Patent Owner also contends that we misapprehended its argument at
`the evidence of record does not support Petitioner’s assertion that the
`bacteria used by Kohwi are immunostimulatory. Id. at 10. Patent Owner
`contends that we overlooked Patent Owner’s assertion that the teachings of
`O’Mahony are ambiguous at best and that Menard contradicts the assertion
`that B. adolescentis is immunostimulatory. Id. at 10–13.
`We have considered Patent Owner’s arguments and are not persuaded
`that we misapprehended Patent Owner’s argument. We considered Patent
`Owner’s arguments and discussed them in our Decision. Dec. 22–24. With
`respect to the teachings of Kohwi, we relied not only on the specific
`statements in Kohwi, but also on the unrebutted testimony of Dr. Braun who
`stated that the bacteria used in Kohwi were immunostimulatory based on the
`evidence of record. Id. at 23, Ex. 1002 ¶ 184.
`With respect to the teachings of O’Mahony and Menard, we
`concluded that the references are ambiguous in their teachings with
`O’Mahony teaching that some strains of B. infantis are immunosuppressive,
`while others are immunostimulatory, and Menard teaching that no
`immunostimulatory effect was observed for B. adolescentis. Dec. 24. We
`expressly found that, based on the record before us at this stage of the
`proceeding, these references did not contradict the teachings of Kohwi and
`the testimony of Dr. Braun that the strains of B. adolescentis used in Kohwi
`were immunostimulatory and that one skilled in the art would have been
`motivated to combine the bacteria of Kohwi with the CPIs of Korman.
`
`6
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`PGR2019-00002
`Patent 9,855,302 B2
`C. Obviousness based on Mohania
`Patent Owner contends that we misapprehended Patent Owner’s
`argument with respect to Mohania, in particular Patent Owner’s argument
`that Petitioner failed to address the possibility that the reduced or decreased
`expression of PD-1 was the result of an immunosuppressive event. Reh’g.
`Req. 13–14. Patent Owner contends that there is nothing in Mohania which
`supports the conclusion that the reduction in PD-1 is attributed to any anti-
`cancer effect. Id.
`We have considered Patent Owner’s arguments and are not persuaded
`that we misapprehended Patent Owner’s position. As we noted in the
`Decision, Mohania specifically teaches that treatment with the probiotic
`containing Bifdobacterium is effective in reducing PD-1 indicating that the
`probiotic is effective in preventing and treating cancer. Dec. 29, Ex. 1008,
`106. This conclusion was also supported by the unrebutted testimony of
`Dr. Braun based on the evidence of record. Dec. 29, Ex. 1002 ¶ 203. As
`stated above, at this stage of the proceeding, and for purposes of deciding
`whether to institute a post-grant review, we view a genuine issue of material
`fact in the light most favorable to the petitioner. 37 C.F.R. § 42.208(c).
`D. Obviousness based on Dong.
`Patent Owner contends that since we determined that Petitioner was
`not likely to prevail with respect to the grounds involving Dong, we should
`withdraw our decision to institute on those grounds. Reh’g. Req. 14. We
`decline to withdraw the grounds based on Dong.
`On April 24, 2018, the Supreme Court held that a decision to institute
`may not institute review on fewer than all claims challenged in the petition.
`SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018). Also, in
`accordance with USPTO Guidance, “if the PTAB institutes a trial, the PTAB
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`PGR2019-00002
`Patent 9,855,302 B2
`will institute on all challenges raised in the petition.” See Guidance on the
`Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at
`https://www.uspto.gov/patents-application-process/patent-trial-and-
`appealboard/trials/guidance-impact-sas-aia-trial). Given the decision by the
`Supreme Court in SAS that the decision to institute is binary and the
`guidance issued by the USPTO to institute on all grounds raised in the
`petition, we decline to withdraw the grounds based on the teaching of Dong.
`IV. CONCLUSION
`For the foregoing reasons, Patent Owner has not demonstrated that we
`abused our discretion by misapprehending or overlooking any evidence or
`arguments in its Preliminary Response.
`V. ORDER
`Accordingly, it is hereby:
`ORDERED that Patent Owner’s Rehearing Request is denied.
`
`
`
`
`8
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`PGR2019-00002
`Patent 9,855,302 B2
`PETITIONER:
`
`John A. Bauer
`Kongsik Kim
`MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C.
`JABauer@mintz.com
`KKim@mintz.com
`
`PATENT OWNER:
`
`Scott E. Kamholtz
`Jennifer L. Robbins
`COVINGTON & BURLING LLP
`skamholtz@cov.com
`jrobbins@cov.com
`
`9
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`
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