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From:
`To:
`Cc:
`Subject:
`Date:
`Attachments:
`
`Dorothy Whelan
`Precedential_Opinion_Panel_Request
`IPR46094-0002IP1; lweinstein@windelsmarx.com; ppollard@windelsmarx.com; Michael Kane; Chad Shear
`IPR2020-01053
`Thursday, January 6, 2022 1:05:57 PM
`IPR2020-01053 Request for rehearing.pdf
`
`CAUTION: This email has originated from a source outside of USPTO. PLEASE CONSIDER THE SOURCE before responding, clicking on links, or opening attachments.
`
`Dear Precedential Opinion Panel:
`
`I write on behalf of Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo”) to request Precedential Opinion Panel review of the Board’s December 7,
`2021 final written decision in IPR 2020-01053 finding challenged claims 1-75 unpatentable as obvious (Ground 3) and declining to rule on Grounds
`1 and 2, which challenged priority. See Paper 29. Sumitomo is concurrently filing a request for rehearing, a copy of which is attached.
`
`QUESTIONS PRESENTED:
`
`1. Whether the Board erred in instituting the IPR on the basis of Grounds 1 and 2 when it applied an incorrect legal standard to find that
`certain claims were entitled to a filing date “no earlier than the filing date” of the latest-filed application, and then, relying on this legally
`erroneous filing date, found that an intervening printed publication anticipated these claims.
`
`2. Whether the Board erred in finding claims 1-75 unpatentable over Saji in view of Horisawa when the petition never raised this specific
`ground.
`
`In my professional judgment, and as further explained below and in Sumitomo’s request for rehearing, I believe the Board Panel Decision is
`contrary to the following decisions of the U.S. Supreme Court and the Court of Appeals for the Federal Circuit:
`
`1.
`ICU Medical Inc. v. Alaris Medical Sys., Inc., 558 F.3d 1368 (Fed. Cir. 2009);
`2. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016);
`3.
`In re Magnum Oil Tools Int’l, 829 F.3d 1364 (Fed. Cir. 2016);
`4.
`EmeraChem Holdings, LLC v. Volkswagen Group of America, Inc., 859 F.3d 1341(Fed. Cir. 2017);
`5.
`SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018).
`
`The odd procedural history of this case may have played a role in the Board’s belated reliance on a new ground of unpatentability in the final
`written decision. Here, the petition presented three grounds. Grounds 1 and 2 related to a subset of the claims, and raised a priority issue.
`Ground 3 was based on obviousness and applied to all 75 claims. The bulk of the petition was directed towards the priority issue. The Board
`based its Institution Decision on Grounds 1 and 2. With respect to Ground 3, the Board summarily stated that it raised fact issues. The Board
`never found that Ground 3 raised a reasonable likelihood that one of the challenged claims was obvious. See Cuozzo Speed Techs., LLC v. Lee, 136
`S. Ct. 2131, 2141-42 (2016) (institution decisions involving “shenanigans” may be reviewable on appeal).
`
`In its preliminary and patent owner response, Sumitomo argued that the Board lacked jurisdiction to consider Grounds 1 and 2 in an IPR. In
`particular, Sumitomo argued that where, as here, the specifications of the priority application and the last-filed application were the same, and
`allegedly new matter was added by amendment after filing, the challenged claims are not legally entitled to a priority date “no earlier than” the
`filing date of the last-filed application. Rather, the claims could only be unpatentable under § 112. See ICU Medical Inc. v. Alaris Medical Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) As such, neither Ground 1 nor Ground 2 was eligible for IPR, and that earlier Board decisions to the contrary were
`incorrectly decided.
`
`The Board disagreed and, consistent with earlier Board decisions, assigned a filing date “no earlier than” the filing date of the last-filed application,
`and then analyzed intervening printed publications alleged to anticipate the claims under § 102. The Board found that the intervening art was
`reasonably likely to anticipate and “[t]hus, we institute an inter partes review as to all challenges raised in the petition.” The Board erred by
`instituting review on “all challenges” based on an erroneous legal analysis of priority. This resulted in the petitioner arguing in its reply that
`“[b]ecause Patent Owner did not meet its priority burden the [intervening references] are prior art and the [] claims should be cancelled under
`Grounds 1 and 2.”
`
`Ground 3 alleged that claims 1-75 were obvious over Saji. The petition summarized Saji, as well as a number of other references, including
`Horisawa. The petition explicitly stated: “Ground 3 does not hinge on Horisawa being prior art.” Likewise, petitioner’s expert stated that his
`opinion was based on a POSA who did not know that “SM-13496” referred to in Horisawa was lurasidone hydrochloride (the active ingredient in
`the challenged claims). Ex. 1002, ¶ 109. The petition then alleged: “Claims 1-75 are obvious over Saji patent (EX. 1009) in view of the prior art.”
`The only other discussion of Horisawa in the actual obviousness analysis was in the form of a brief citation.
`
`In its patent owner response, Sumitomo objected that the petition failed to state the obviousness ground clearly and with particularity. However,
`in spite of the petition’s failure to define the ground clearly, its cursory mention of Horisawa, and the lack of expert testimony, the Board, in its
`final written decision, made extensive findings related to Horisawa and how a POSA would interpret it. The Board also found that Horisawa was
`
`IPR2020-01053
`Ex. 3002
`
`

`

`prior art, even though the petition explicitly stated that “Ground 3 does not hinge on Horisawa being prior art.”
`
`The issue of whether Horisawa qualified as prior art was never squarely presented during the proceeding. The Board’s decision to rely on
`Horisawa, and to treat it as prior art in its obviousness analysis, represented an improper new ground of unpatentability. See EmeraChem
`Holdings, LLC v. Volkswagen Group of America, Inc., 859 F.3d 1341 (Fed. Cir. 2017).
`
`The oral hearing focused primarily on the priority issue and included a discussion of the jurisdictional issue. Nevertheless, in an abrupt about-face,
`the Board dodged the jurisdictional issue and decided only Ground 3 in its Final Written Decision, finding claims 1-75 unpatentable as obvious.
`
`The Board’s belated shift from priority to obviousness resulted in a poorly reasoned obviousness decision that relied on a ground never squarely
`raised in the petition. Precedential Opinion Panel review is warranted to correct this error and to ensure application of uniform standards
`consistent with Cuozzo, ICU Medical, SAS, Magnum Oil, and EmerChem. Sumitomo is available to provide additional briefing on this issue, as well
`as the legal standards governing the priority analysis, should the panel so desire.
`
`Respectfully submitted,
`Dorothy Whelan, Reg. No. 33,814
`Counsel for Patent Owner
`
`Dorothy Whelan :: Sr. Principal :: Fish & Richardson P.C.
`612 337 2509 direct :: 651 230 7163 mobile :: whelan@fr.com
`fr.com :: Bio :: LinkedIn :: Twitter
`
`****************************************************************************************************************************
`This email message is for the sole use of the intended recipient(s) and may contain confidential and privileged
`information. Any unauthorized use or disclosure is prohibited. If you are not the intended recipient, please contact the
`sender by reply email and destroy all copies of the original message.
`****************************************************************************************************************************
`
`

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