UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`_________________
`
`Case IPR2020-01053
`U.S. Patent 9,815,827
`
`_________________
`
`
`
`PATENT OWNER’S REQUEST FOR REHEARING UNDER 37 CFR §
`42.71(d)
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`_________________
`
`Case IPR2020-01053
`U.S. Patent 9,815,827
`
`_________________
`
`
`
`PATENT OWNER’S REQUEST FOR REHEARING UNDER 37 CFR §
`42.71(d)
`
`
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`I.
`
`INTRODUCTION
`Patent Owner requests rehearing pursuant to 37 CFR §42.71(d) of the
`
`December 7, 2021 Final Written Decision.1 The Petition challenged all 75 claims
`
`of U.S. 9,815,827 (“the ‘827 patent”), and presented three grounds. Grounds I and
`
`II related to a subset of the claims, and raised a priority issue. Ground III was
`
`based on obviousness in view of Saji and applied to all 75 claims.
`
`The bulk of the Petition was directed towards the priority issue.2 In its
`
`Institution Decision, the Board focused exclusively on Grounds I and II, and
`
`instituted review based on these grounds.3 With respect to Ground III, the Board
`
`summarily stated that it raised fact issues.4 The oral hearing likewise focused
`
`primarily on the priority issue.5 Nevertheless, in an abrupt about-face, the Board
`
`decided only Ground III in its Final Written Decision, finding claims 1-75
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`unpatentable as obvious.
`
`
`1 Patent Owner concurrently is filing a Request for POP review.
`
` 2
`
` 3
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` 4
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` 5
`
`
`
` See Petition (Paper No. 2).
`
` Institution Decision (Paper No. 7) pp. 10-17.
`
` Id., p. 22.
`
` Transcript of oral hearing held Aug. 11, 2021 (Paper No. 28).
`
`1
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
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`
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`Patent Owner requests that the Board reconsider and reverse its obviousness
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`decision because it relies on a new ground of unpatentability.6 Specifically, the
`
`Petition alleged obviousness based on a single reference: Saji (Ex. 1009).7
`
`However, the Board ultimately found the challenged claims obvious over Saji in
`
`view of Horisawa (Ex. 1028).8 This was not the same ground raised in the Petition,
`
`which merely mentioned Horisawa in passing.9 The Board’s treatment of
`
`Horisawa is contrary to the Federal Circuit’s decision in EmeraChem Holdings,
`
`LLC v. Volkswagen Group of America, Inc., 859 F.3d 1341, 1348-49 (Fed. Cir.
`
`2017), which held that broad, general statements regarding a reference in the
`
`
`6 The Board’s decision included a number of legal and factual errors. Should the
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`Board deny this Request for Rehearing, Patent Owner reserves the right to raise
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`additional errors on appeal to the Federal Circuit. See In re Magnum Oil Tools
`
`Int’l, 829 F.3d 1364, 1377 (Fed. Cir. 2016).
`
`7 Petition (Paper No. 2), p. 14.
`
` 8
`
` Final Written Decision (Paper No. 29), pp. 22, 25.
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` 9
`
` Petition (Paper No. 2), pp. 51-54.
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`
`2
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`Petition did not provide adequate notice for purposes of relying on the reference to
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`support an obviousness ground.
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`Additionally, the Board’s analysis of priority was contrary to law. In its
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`Patent Owner Response, Patent Owner challenged earlier Board decisions in
`
`situations where, as here, the alleged new matter was added to a claim during
`
`prosecution via an amendment submitted after filing.10 Under a proper legal
`
`analysis, the Board lacked jurisdiction to consider the priority grounds via inter
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`partes review. Accordingly, Patent Owner requests the Board to reconsider and
`
`dismiss Grounds I and II for lack of jurisdiction.
`
`II. THE BOARD MIS-APPLIED THE LAW WHEN IT FOUND THE
`CLAIMS OBVIOUS BASED ON A NEW GROUND OF
`UNPATENTABILITY
`“[W]hile the PTO has broad authority to establish procedures for revisiting
`
`earlier-granted patents in IPRs, that authority is not so broad that it allows the PTO
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`to raise, address, and decide unpatentability theories never presented by petitioner
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`and not supported by record evidence.” In re Magnum Oil Tools Int’l, 829 F.3d
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`1364, 1381 (Fed. Cir. 2016); see also SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348,
`
`1357 (2018) (“the petitioner’s contentions, not the Director’s discretion, define the
`
`
`10 Patent Owner Response (Paper No. 14), pp. 32-33.
`
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`3
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`scope of the litigation all the way from institution through to conclusion”). The
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`Board’s decision on obviousness violates these principles.
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`The Petition alleged that claims 1-75 were obvious over Saji (Ex. 1009).11
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`The Petition then went on to summarize Saji, as well as a number of other
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`references, including Horisawa (Ex. 1028).12 The Petition explicitly stated:
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`“Ground 3 does not hinge on Horisawa being prior art.”13 The Petition then
`
`alleged: “Claims 1-75 are obvious over Saji patent (EX. 1009) in view of the prior
`
`art.”14 The only other discussion of Horisawa in the actual obviousness analysis
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`was in the form of a citation: “No clinically significant weight gain in one or more
`
`patients was expected because patients are diverse, and because ziprasidone, a
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`structurally related compound, was known to cause little or no weight gain. EX-
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`1002 ¶ 126, see also Horisawa-EX. 1029; EX.-1002 ¶ 127.”15
`
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`11 Petition (Paper No. 2), p. 14.
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`12 Id., pp. 50-54.
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`13 Id., p. 53 (emphasis in original).
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`14 Id., p. 54.
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`15 Id., p. 55. The Petition goes on to repeat this sentence two more times. See id.,
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`pp. 56, 59. In both cases, there is no more than a simple citation to Horisawa.
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`4
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`In the Institution Decision, the Board attempted to summarize Petitioner’s
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`obviousness argument and stated the following: “Petitioner also relies on other
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`prior art to show that no weight gain ‘was expected because patients are diverse,
`
`and because ziprasidone, a structurally related compound, was known to cause
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`little or no weight gain’ …. For example, Petitioner argues that Horisawa reports
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`that SM-13496’s body weight increasing action are weak because its bonding
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`affinity to α1, H1, and 5-HT2C receptors is low.”16 The Board made no further
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`findings, concluding instead that the parties presented “fact intensive issues” that
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`required a trial to resolve.17
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`In its Patent Owner Response, Patent Owner objected that the Petition failed
`
`to state the obviousness ground clearly and with particularity: “Slayback alleges
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`that claims 1-75 would have been obvious over Saji ‘372 (Ex. 1009). Slayback
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`also lists six additional references and alleges the claims are obvious over Saji ‘372
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`‘in view of the prior art.’ It is unclear whether Slayback includes any of these
`
`references as part of the ground, or if the ground is based on Saji ’372 alone.”18
`
`
`16 Institution Decision (Paper No. 7), p. 20 (emphasis in original; citations
`
`omitted).
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`17 Id., p. 22.
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`18 Patent Owner Response (Paper No. 14), p. 35.
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`5
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`In spite of the Petition’s failure to define the ground clearly and its cursory
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`mention of Horisawa, the Board, in its Final Written Decision, made extensive
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`findings related to Horisawa and how a POSA would interpret it.19 The Board also
`
`found that Horisawa was prior art, even though the Petition explicitly stated that
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`“Ground 3 does not hinge on Horisawa being prior art.”20
`
`The issue of whether Horisawa qualified as prior art was never squarely
`
`presented during the proceeding.21 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.
`
`The brief mention of Horisawa in both the Petition and the Institution
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`Decision does not provide sufficient notice to Patent Owner that the obviousness
`
`ground was based on a combination of Saji and Horisawa. In this regard, the
`
`
`
`19 Final Written Decision (Paper No. 29), pp. 20-22.
`
`20 Id., pp. 20-21; Petition (Paper No. 2), p. 53 (emphasis in original).
`
`21 In its Reply, Petitioner alleged that because Patent Owner failed to antedate
`
`Horisawa, patent owner conceded that Horisawa was prior art. Reply (Paper No.
`
`21), p. 26. However, because Horisawa was not officially part of Ground III,
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`Patent Owner was under no obligation to antedate.
`
`6
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`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`Federal Circuit’s decision in EmeraChem Holdings, LLC v. Volkswagen Group of
`
`America, Inc., 859 F.3d 1341 (Fed. Cir. 2017) is instructive. In EmeraChem, the
`
`petition included a ground alleging that claims 1-14 and 16-20 were obvious over a
`
`combination of four references, one of which was Stiles. 859 F.3d at 1344.
`
`However, in the case of claims 3, 16, and 20, claim charts included in the petition
`
`did not discuss Stiles. Id. The institution decision likewise did not discuss Stiles
`
`in the context of claims 3, 16, and 20. Id. Nevertheless, the Board relied on Stiles
`
`in the final written decision to find claims 3, 16, and 20 unpatentable. Id.
`
`On appeal, the Federal Circuit held that simply mentioning Stiles generally,
`
`while failing to apply it specifically to claims 3, 16, and 30, deprived patent owner
`
`of a full and fair opportunity to respond to an obviousness combination that
`
`included Stiles. Id. at 1348-49. The court stated:
`
`Where the petitioner uses certain prior art references to target
`specific claims with precision, or the Board does the same in its decision
`to institute, the patent owner is directed to particular bases for alleged
`obviousness. A general statement that lists all challenged claims and all
`asserted prior art is not a separate, additional articulation that each of the
`claims may be obvious over any combination of all listed prior art.
`Id. at 1349.
`As in EmeraChem, the Petition and Institution Decision included charts
`identifying the grounds. The Petition identified the grounds as:22
`
`22 Petition (Paper 2), p. 14.
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`7
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`Likewise, the Institution Decision identified the grounds as:23
`
`
`
`The Board repeated this chart in the Final Written Decision.24
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`Here, the failure to provide adequate notice is even more pronounced
`
`because the Petition never articulated that the basis of the obviousness challenge
`
`was Horisawa, and left Patent Owner guessing as to exactly what it entailed. See
`
`SAS, 138 S. Ct. at 1355 (“The statute envisions that a petitioner will seek an inter
`
`
`23 Institution Decision (Paper 7) p. 8.
`
`24 Final Written Decision (Paper 29), pp. 6-7.
`
`8
`
`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`partes review of a particular kind—one guided by a petition describing ‘each claim
`
`challenged’ and ‘the grounds on which the challenge to each claim is based.’ §
`
`312(a)(3).”). Indeed, Horisawa is not listed as a reference against any claim in any
`
`ground. The Board’s obviousness decision, therefore, is defective and should be
`
`reversed.
`
`III. THE BOARD’S PRIORITY ANALYSIS IS CONTRARY TO LAW
`
`The Board’s abrupt decision to focus on obviousness in the Final Written
`
`Decision, and to decline to rule on priority, came after Patent Owner challenged
`
`the legal basis of the Board’s priority analysis and argued that the Board lacked
`
`jurisdiction to consider Grounds I and II in inter partes review. Here, Patent
`
`Owner further requests that the Board reconsider and dismiss Grounds I and II for
`
`lack of jurisdiction.
`
`
`
`As explained in the Patent Owner response, the claims that are the subject of
`
`Grounds I and II were added by amendments filed during prosecution and after the
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`August 28, 2014 filing date of the ’827 patent.25 The Board, consistent with its
`
`decisions in Dr. Reddy’s Laboratories S.A. et al. v. Indivior UK Ltd., IPR2019-
`
`00329, Paper No. 49, pp. 10-11 (PTAB June 2, 2020) and Agilent Techs., Inc. v.
`
`Bio-Rad Labs., Inc., IPR2019-00266, Paper No. 8, pp. 12-13 (PTAB May 16,
`
`
`25 Patent Owner Response (Paper No. 14), pp. 32-33.
`
`
`9
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`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`2019), held that the claims were entitled to a filing date “no earlier than” August
`
`28, 2014, despite the fact that the specifications of the August 28, 2014 application
`
`and the priority application were identical.26
`
`
`
`In its Patent Owner Response, Patent Owner argued that the Board’s
`
`analysis was incorrect as a matter of law.27 It is Patent Owner’s position that even
`
`if these claims lack written description support in the earlier-filed provisional
`
`application (which they do not), the claims would not be entitled to the August 28,
`
`2014 filing date (or, for that matter, a filing date no earlier than August 28, 2014).
`
`Rather, they would be unpatentable under § 112, para. 1 as lacking written
`
`description in the application as filed. See ICU Medical, Inc. v. Alaris Medical
`
`Sys., Inc., 558 F.3d 1368, 1377 (Fed. Cir. 2009) (claims added during prosecution
`
`years after filing held invalid for lacking written description support in application
`
`as filed);
`
`
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`Grounds based on § 112, para. 1 (written description) are not proper grounds
`
`in an IPR petition. See 35 U.S.C. § 311 (IPR challenges limited to §§ 102 and 103
`
`grounds based on patents or printed publications). Therefore, the Board lacked
`
`jurisdiction to consider Grounds I and II.
`
`
`26 Institution Decision (Paper No. 7), pp. 13-14.
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`27 Patent Owner Response (Paper No. 14), pp. 32-33.
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`10
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`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`Grounds I and II do not present a situation where the claims could be
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`
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`unpatentable over prior art or, alternatively, for lack of written description under §
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`112, para. 1. Where the specifications of the priority application and the last-filed
`
`application are identical, claims added after filing are either supported by the
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`priority application or they have no support at all. In the latter case, they have no
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`filing date; rather they are unpatentable only under § 112, para. 1 and thus not
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`appropriate for consideration in an IPR proceeding.
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`
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`The Board’s priority analysis is contrary to law and has implications for
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`Board proceedings generally. Patent Owner respectfully requests the Board to
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`dismiss Grounds I and II for lack of jurisdiction.
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`IV. CONCLUSION
`
`For at least the reasons presented above, Patent Owner requests the Board to
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`reconsider and reverse its decision finding claims 1-75 unpatentable as obvious
`
`because it improperly relied on a new ground of unpatentability. Patent Owner
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`further requests the Board to dismiss Grounds I and II because the Board lacked
`
`jurisdiction to consider these grounds in an inter partes review.
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`
`
`
`
`11
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`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`Respectfully submitted,
`
`
`
`/Dorothy P. Whelan/
`Dorothy P. Whelan, Reg. No. 33,814
`
`
`
`
`
`
`
`Date: January 6, 2022
`
`
`
`Customer Number 26191
`Fish & Richardson P.C.
`Telephone:-(612) 337-2509
`Facsimile:-(612) 288-9696
`
`
`
`12
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`CERTIFICATE OF SERVICE
`Pursuant to 37 CFR § 42.6(e)(4) and 42.205(b), the undersigned certifies
`
`that on January 6, 2022, a complete and entire copy of this Patent Owner’s Request
`
`for Rehearing was provided via email, to the Petitioner by serving the email
`
`correspondence address of record as follows:
`
`Louis H. Weinstein
`Patrick G. Pollard
`Windels Marx Lane & Mittendorf, LLP
`1 Giralda Farms
`Madison, NJ 07940
`
`E-mail: lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
`
`
`
`/Diana Bradley/
`Diana Bradley
`Fish & Richardson P.C.
` 60 South Sixth Street, Suite 3200
` Minneapolis, MN 55402
` (858) 678-5667
`
`13
`
`
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