From:
`Sent:
`To:
`Cc:
`
`Subject:
`Attachments:
`
`Your Honors:
`
`Torczon, Richard (External)
`Monday, September 30, 2019 8:24 PM
`Precedential_Opinion_Panel_Request
`dscola@hbiplaw.com; mchakansky@hbiplaw.com; jfhdocket@hbiplaw.com;
`msolow@hbiplaw.com; Guise, Jeff; Johnson, Lee; Leachman, Nathaniel; Westin, Lori
`Request for Precedential Opinion Panel review, IPR2019-00451
`010 - NEURELIS rehearing request.pdf; 008 - DECISION instituting.pdf; 014 - DECISION
`denying rehearing.pdf
`
`In IPR2019‐00451, a panel of the Board granted institution on the basis of an unbriefed
`application of 37 CFR §1.57. Paper 8 (attached). Because neither party raised the issue before
`institution, Patent Owner Neurelis did not have an opportunity to advise the Board that the rule
`is not applicable, and that it would not have been applied in examination as the panel does at
`institution. The Board’s application of the rule is contrary to both binding case law and Office
`authorities. Neurelis filed a timely request for rehearing (Paper 10, attached) pointing out these
`errors. In response, the panel again shifted its rationale, quoting the rehearing request but
`replacing the key point with ellipses, then requiring Neurelis to meet a burden of production
`when Petitioner Aquestive never met its initial burden. Paper 14 (attached). The new theory is
`as contrary to law as the old one and highlights the recurring issue of the Board providing its
`own theory of the case (without advance notice and opportunity to respond), shifting rationales,
`and improperly shifting burdens (such as here, where Aquestive indisputably failed to address
`the entire disclosure in asserting a lack of written description).
`
`Neurelis requests review by a Precedential Opinion Panel, pursuant to the Board’s Standard
`Operating Procedure 2.
`
`Based on my professional judgment, I believe the institution decision is contrary to the
`following decisions of the Supreme Court of the United States, the United States Court of
`Appeals for the Federal Circuit, and the Board:
` Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc)
` Aristocrat Techs. v. Int’l Game Tech., 543 F.3d 657 (Fed. Cir. 2008)
` Exela Pharma Sciences, LLC v. Lee, 781 F.3d 1349 (Fed. Cir. 2015)
` Exxon Corp. v. Phillips Petroleum Co., 265 F.3d 1249 (Fed. Cir. 2001)
` Harari v. Hollmer, 602 F.3d 1348 (Fed. Cir. 2010)
` Magnivision, Inc. v. Bonneau Co., 115 F.3d 956 (Fed. Cir. 1997)
` Ex parte Maziere, 27 USPQ2d 1705 (BPAI 1993)
` McDonnell v. United States, 579 U.S. _, 136 S.Ct. 2355 (2016)
` SAS Inst. v. Iancu, 584 U.S. _, 138 S.Ct. 1348 (2018)
` Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)
`Additionally, the decision on rehearing is contrary to:
`1
`
`IPR2019-00451
`Ex. 3001 p. 1 of 3
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`

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` Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015)
`
`Based on my professional judgment, I believe the Board panel decision is contrary to the
`following constitutional provision, statutes, and regulations:
` U.S. Constitution, Amendment V
` 5 U.S.C. 557
` 35 U.S.C. 111
` 35 U.S.C. 112, first paragraph
` 35 U.S.C. 119
` 35 U.S.C. 120
` 35 U.S.C. 132
` 35 U.S.C. 312
` 35 U.S.C. 314
` 35 U.S.C. 318
` 37 CFR §1.57
` Manual of Patent Examining Procedure §608.01(p), I.B
`
`Based on my professional judgment, I believe this case requires an answer to three or more
`precedent-setting questions of exceptional importance:
`
`1. May the Board enforce a rule (here, 37 CFR §1.57) at variance to the plain language of the
`rule and contrary to specifically relevant patent operations guidance and consistent Board
`appellate decisions holding the rule inapplicable in the circumstances of this case, thus
`creating a conflict between Office practice generally and Board trial practice, when the
`Board’s new application is also inconsistent with binding case law?
`
`2. May the Board shift the burden of production to the patent owner when there is no dispute
`that the Petitioner has failed to address the most pertinent disclosure when asserting a lack of
`written description in a priority document, contrary to the authority the panel cites (Dynamic
`Drinkware), which affirms a Board decision that the Petitioner failed to address priority in a
`reference, and confirms that the burden of production shifts to the Patent Owner only after
`the Petitioner has made out a prima facie case (800 F.3d at 1378-79)?
`
`3. Also, may a panel provide its own, unbriefed theory for institution, plus continue to shift
`theories for institution, without giving a party advance notice of the unbriefed theory and a
`chance to respond, contrary to express requirements in the Administrative Procedure Act
`regarding preliminary decisions, as well as general principles of due process and fair play?
`
`The panel’s sua sponte application of an inapplicable rule without notice is improper by statute,
`even at a preliminary stage. The panel’s sua sponte application of an inapplicable rule shows the
`wisdom of this statutory bar against such surprise rulings. The panel’s silence on rehearing
`about the rule error and its shift to requiring the patent owner to meet a burden of production
`when there is no possible dispute that the petitioner failed to even address the most pertinent
`
`2
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`IPR2019-00451
`Ex. 3001 p. 2 of 3
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`

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`disclosure, thus failing to make out a facial case sufficient to shift any burden to the patent
`owner, simply compounds the error.
`
`For the reasons provided above, and those provided in greater detail in the request for rehearing,
`Patent Owner Neurelis respectfully requests review by a Precedential Opinion Panel to address
`both the due process issues and the conflict in Office authority created by the institution
`decision, and to deny institution. Neurelis can provide additional briefing on any of these
`questions if the Board wishes.
`
`Respectfully submitted,
`
`/Richard Torczon/
`Reg. No. 34,448
`ATTORNEY OF RECORD FOR NEURELIS
`
`Richard Torczon | Wilson Sonsini Goodrich & Rosati | 1700 K Street NW, Fifth Floor | Washington, D.C. 20006 
`Main: 202.973.8800 | Direct: 202.973.8811 | Facsimile: 202.973.8899 | www.wsgr.com 
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`
`3
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`IPR2019-00451
`Ex. 3001 p. 3 of 3
`
`