From:
`Sent:
`To:
`Cc:
`Subject:
`
`Kamholz, Scott <SKamholz@cov.com>
`Monday, April 29, 2019 4:28 PM
`Precedential_Opinion_Panel_Request
`jabauer@mintz.com; KKim@mintz.com; Robbins, Jennifer L; PGR2019-00002
`Precedential Opinion Panel Recommendation – PGR2019-00002
`
`To the members of the Precedential Opinion Panel,
`I write on behalf of The University of Chicago (“Patent Owner”) regarding the Post-Grant
`Review Petition for PGR2019-00002 concerning Patent 9,855,302. On April 15, 2019, a panel
`of the Board instituted review on the petition. Paper 8.
`Patent Owner has submitted a request for rehearing of the Board’s decision to institute review
`(Paper 11), and respectfully recommends that the matter be heard by the Precedential Opinion
`Panel pursuant to Standard Operating Procedure 2, rev. 10.
`Question Presented
`Based on my professional judgment, I believe this case requires an answer to one or more
`precedent-setting questions of exceptional importance, including:
`1. Whether denial of an entire petition for post-grant review under 35 U.S.C. § 324(a) is
`warranted to avoid compelling a patent owner to defend its patent claims against even one
`legally insufficient challenge in the petition.
`The Board excused Petitioner from its burden to present evidence essential to one of its
`grounds of unpatentability.
`The Board instituted post-grant review on all claims for non-enablement and for
`obviousness. As explained more fully in the request for rehearing, the Board instituted the non-
`enablement challenge despite the petitioner not having presented any evidence that the required
`experimentation, even if large in quantity, was “undue,” aside from its expert’s unsupported
`assertion that “[u]nquestionably, such testing is burdensome and undue.” That was error,
`because evidence of “undue” experimentation is essential to any challenge for non-enablement.
`This situation is analogous to that in Cephalon, in which the Federal Circuit held that a
`challenger failed “as a matter of law” to prove non-enablement where the only evidence of
`undue experimentation was an expert’s assertion that the testing would be “difficult” and
`“complicated.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 (Fed. Cir. 2013).
`In instituting this review, the Board stated that the petitioner “more likely than not” will prevail
`in proving the claims unpatentable for non-enablement, despite the petitioner’s case being
`legally insufficient, just as in Cephalon. The Board thus has relieved the petitioner of its burden
`to prove non-enablement by a preponderance of the evidence. 35 U.S.C. § 326(e).
`PGR2019-00002
`Ex. 3001
`p. 1 of 3
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`1
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`The Board’s decision to institute in the absence of essential evidence creates a de facto
`burden shift to Patent Owner.
`By instituting review and determining that the petitioner is “more likely than not” to prove non-
`enablement despite legally insufficient evidence, the Board effectively has raised a presumption
`of non-enablement and expressed its belief that the petitioner need do nothing further to prevail.
`The Board has prejudiced Patent Owner by assigning it the burden of disproving this
`presumption of non-enablement. This burden shift violates principles established in, e.g., In re
`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1377–78 (Fed. Cir. (2016) for the immutable
`burden of proof in inter partes reviews that are equally applicable, by identical statutory
`language, to post-grant reviews. 35 U.S.C. § 326(e).
`Denial of the entire petition under 35 U.S.C. § 324(a) is warranted to avoid compelling
`Patent Owner to defend its claims against the petitioner’s legally insufficient enablement
`challenge.
`The Office has expressed its intention to deny institution of inter partes review proceedings as a
`tool in the statutory charge to the Director to safeguard the “integrity of the patent system.” SAS
`Q&A’s, Part D, Effect of SAS on Future Challenges that Could Be Denied for Statutory
`Reasons (June 5, 2018, available at
`https://www.uspto.gov/sites/default/files/documents/sas_qas_20180605.pdf) (“[T]he panel will
`evaluate the challenges and determine whether, in the interests of efficient administration of the
`Office and integrity of the patent system (see 35 USC § 316(b)), the entire petition should be
`denied under 35 USC § 314(a).” The Director is identically charged to consider the “integrity of
`the patent system” in administering post-grant review. 35 U.S.C. § 326(b).
`Fairness and consistency dictate that Patent Owner not be compelled to defend the claims of the
`’302 patent against the petitioner’s legally deficient enablement challenge. To do otherwise
`damages the integrity of the patent system by upending statutes and precedent concerning
`burden-shifting, as well as those concerning enablement. The Precedential Opinion Panel
`should take the opportunity this case presents to reaffirm the applicability of these lines of
`Federal Circuit precedent to the statutes establishing post-grant review, while post-grant review
`is still in its formative period.
`For the reasons above and as described in more detail in the request for rehearing, Patent Owner
`respectfully requests that the Precedential Opinion Panel convene to rehear and assess the issues
`described in this recommendation.
`
`Respectfully submitted,
`/s/ Scott E. Kamholz
`Scott E. Kamholz
`Lead Counsel for Patent Owner The University of Chicago
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`PGR2019-00002
`Ex. 3001
`p. 2 of 3
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`Scott E. Kamholz, M.D., Ph.D.
`Of Counsel
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001-4956
`Direct +1 202 662 5339 | Mobile +1 617 678 0222
`skamholz@cov.com | Bio | LinkedIn | www.cov.com 
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`PGR2019-00002
`Ex. 3001
`p. 3 of 3
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