`Tel: 571-272-7822
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`Paper 36
`Date: April 17, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`PGR2018-00062
`Patent 9,707,245 B2
`____________
`
`
`
`Before TONI S. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request on Rehearing of Final Written Decision
`37 C.F.R. § 42.71(d)
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`Case PGR2018-00062
`Patent 9,707,245 B2
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`I. INTRODUCTION
`Patent Owner filed a Request for Rehearing (Paper 33, “Req. Reh’g”)
`seeking review of the Board’s Final Written Decision (Paper 32, “Dec.”), in
`which we held unpatentable claims 1–30 of U.S. Patent No. 9,707,245 B2
`(Ex. 1001, “the ’245 Patent”). Patent Owner thereafter filed a request for
`review by the Precedential Opinion Panel (“POP”), which was denied.
`Paper 34 (request for POP review); Paper 35 (decision denying request). We
`also refer to the Petition (Paper 2, “Pet.”), Patent Owner’s Response
`(Paper 15, “Resp.”), Petitioner’s Reply (Paper 18, “Reply”), and Patent
`Owner’s Sur-Reply (Paper 21, “Sur-Reply”).
`Upon a request for rehearing, we review our decision for an abuse of
`discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should
`be modified lies with the party challenging the decision.” 37 C.F.R.
`§ 42.71(d). “The request must specifically identify 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.” Id.
`We deny the Request for Rehearing based on application of those principles.
`
`II. DISCUSSION
`A. Background of the Dispute
`The claimed invention relates to a method of treating pain by
`administration of neridronic acid. Ex, 1001, code (54). Claim 1 is the sole
`independent claim and requires administration of neridronic acid in salt or
`acid form to a human being with chronic regional pain syndrome (“CRPS”).
`Id. at 84:59–63 (claim 1). During the trial, a key dispute emerged relating to
`the limitation of claim 1 specifying, “wherein bone fracture was a
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`predisposing event for CRPS.” Id. at 84:61–62; see Dec. 4–6, 21–34
`(framing the issue, which first arose during patent prosecution).
`The Board determined that work published by Varenna1 before the
`critical date of the invention anticipates, or would have made obvious in
`combination with other references, the claimed invention, based on evidence
`cited in the Petition, including uncontroverted testimony from Petitioner’s
`witness, Dr. Lawrence Poree. Dec. 15–17 (Board’s overview of Dr. Poree’s
`“uncontroverted” and “quite extensive” record of professional
`accomplishments, supporting our finding “that Dr. Poree is qualified to
`opine about the perspective of” an ordinarily skilled artisan), 41 (the Board’s
`chart of conclusions). Patent Owner opposed the Petition, but did not
`advance expert testimony from a witness of its own choosing, or cross-
`examine Petitioner’s expert witness. See Dec. 7, 15 (pointing out that Patent
`Owner advanced no expert testimony and declined to depose Petitioner’s
`witness, Dr. Lawrence Poree).
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`B. Patent Owner’s Three Asserted Grounds for Modification
`Patent Owner requests modification of the Final Written Decision on
`three grounds. First, Patent Owner submits, the Board overlooked Patent
`Owner’s Sur-Reply arguments and authority. Req. Reh’g 2–5. Second,
`according to Patent Owner, the Board misapprehended the law regarding the
`evidentiary analysis required to conclude that Varenna would have been
`publicly available at the time of the invention. Id. at 5–10. Third, Patent
`
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`1 M. Varenna et al., Treatment of complex regional pain syndrome
`type I with neridronate: a randomized, double-blind, placebo-controlled
`study, RHEUMATOLOGY 52: 534–42 (Nov. 2012) (Ex. 1005, “Varenna”).
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`Patent 9,707,245 B2
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`Owner argues that the Board misapprehended the law regarding Petitioner’s
`burden of proof, improperly drew inferences in favor of Petitioner, and
`erroneously permitted Petitioner to present evidence of Varenna’s public
`availability for the first time in the Reply. Id. at 11–15. We address in turn
`each of those asserted grounds for modification.
`1) Sur-Reply Arguments and Authority
`Patent Owner alleges that the Board reversibly erred by failing to
`“address or distinguish any of the cited Board decisions or the other
`arguments and authority Patent Owner Discussed in its Sur-Reply.” Req.
`Reh’g. 3 (citing Sur-Reply 8–13). The non-binding Board decisions cited in
`the Sur-Reply do not control the outcome here. In any event, as Patent
`Owner observes, those decisions acknowledge that a copyright notice
`“standing alone” may “not [be] enough” to “establish public availability.”
`Sur-Reply 8 (and citations to non-precedential Board decisions therein).
`Those decisions are inapplicable here, where the copyright notice was
`merely one indicia, among a cluster of indicium, contributing to the
`substantial evidence supporting our finding that Petitioner demonstrated that
`Varenna was publicly available at the time of the invention. Dec. 9–13.
`Patent Owner asserts in the Sur-Reply that a copyright notice on a
`reference deserves “no fealty whatsoever for purposes of proving ‘printed
`publication’ status, unless accompanied by other evidence to suggest that
`public availability around the stated date actually occurred.” Sur-Reply 7.
`Here again, however, we did not rely on the copyright notice alone. Dec. 9–
`13. Further, Patent Owner relies in the Sur-Reply on a non-binding Board
`decision subsequently reversed in a precedential opinion. Id. at 8 (quoting
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`Case PGR2018-00062
`Patent 9,707,245 B2
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`Hulu, LLC v. Sound View Innovations, LLC, Case IPR2018-01039, Paper 12
`at 12 (PTAB Dec. 3, 2018), rev’d Paper 29 at 13 (PTAB Dec. 20, 2019)
`(precedential)).
`Our findings regarding Varenna align with the guidance provided in
`that precedential opinion, which sets forth a case-by-case approach in which
`a copyright notice may contribute to the totality of evidence weighed that is
`relevant to public availability. See Hulu, Paper 29 at 9–11, 17–19
`(discussing the case-by-case analysis turning on particular circumstances,
`including the nature of the reference (distinguishing a thesis from a journal
`article) and the indicia of public accessibility appearing on the face of the
`reference). Significantly, the facts here include the “conventional markers of
`publication, such as a copyright date, edition identifier, [and] publication by
`a commercial publisher” that the Hulu panel identified as relevant. Id. at 17.
`Further, the record in this case included a compelling additional
`factor. Specifically, Patent Owner previously identified to the Office, during
`patent prosecution, a publication date for Varenna consistent with the
`November 2012 date that appears on the face of the document. See Dec. 10–
`12 (analyzing that additional factor). The totality of circumstances support
`our finding that Petitioner established by a preponderance of evidence that
`Varenna was publicly available prior to the critical date of the invention.
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`2) Law Regarding the Evidentiary Analysis Pertaining to
`Public Availability of Varenna at the Time of the Invention
`Patent Owner submits that the Board “did not determine whether” the
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`evidence of record “shows that Varenna was in fact disseminated or
`otherwise made available such that reasonably diligent and interested
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`Patent 9,707,245 B2
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`persons of skill in the art could have located it.” Req. Reh’g 1 (emphasis in
`original). On the contrary, we addressed with particularity the substantial
`evidence tending to show that Varenna “was ‘sufficiently accessible to the
`public interested in the art’ and ‘disseminated or otherwise made available’
`to the interested public before the critical date.” Dec. 9 (quoting Blue
`Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016)).
`
`In our Decision, we properly credited “indicia on the face of [the]
`reference, such as printed dates and stamps,” which are “part of the totality
`of the evidence” bearing on the issue of public accessibility. Hulu, Paper 29
`at 17–18 (citing Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d
`1365, 1377 (Fed. Cir. 2018)). Those indicia included not only details of the
`copyright notice, indicating publication of Varenna “by Oxford University
`Press on behalf of the British Society for Rheumatology” in “2012;” but also
`additional legends, including “the statement ‘Advance Access publication 30
`November 2012,’” and a conventional edition identifier from the journal
`Rheumatology. Id. at 9–10 (quoting Ex. 1005). Patent Owner advanced no
`evidence tending to cast doubt on that publication date. Although the burden
`of proof never shifted to Patent Owner on the issue of Varenna’s public
`availability, where Patent Owner declined to advance counter evidence on
`point, the Board did not err by crediting the indicia, which appear on the
`face of Varenna, as part of the totality of evidence bearing on the issue.
`Patent Owner suggests that the Decision erroneously “endorses
`allowing a reference to stand alone as proof of its own public accessibility.”
`Req. Reh’g 8. On the contrary, the indicia on the face of Varenna do not
`stand alone, but are consistent with compelling additional proof on point.
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`Patent 9,707,245 B2
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`For example, uncontested evidence shows that Patent Owner submitted a
`copy of Varenna to the Examiner during patent prosecution and indicated to
`the Office that the reference (bearing the same Rheumatology journal edition
`identifier and word-for-word identical title) was published in 2012. Id. at 11
`(comparing Ex. 1005, with Ex. 1022, 432). Against that backdrop, we
`reasoned, “[t]his is not a case involving, for example, a thesis, conference
`paper, or poster bearing none of the ordinary indicators of indexing or public
`distribution.” Id. at 10. We reasonably relied on Petitioner’s uncontested
`position that, “[d]uring patent prosecution, ‘Patent Owner submitted this
`reference to the PTO with a filename ‘Varenna2012.pdf.’ and represented
`that it had a publication date of November 2012.’” Dec. 10 (quoting Reply 7
`(citing Ex. 1022, 432, 440); Sur-Reply 2–11 (Patent Owner, declining to
`contest that contention)).
`Petitioner filed a Declaration of Dr. Philip Robinson in support of
`Reply arguments pertaining to the issue of whether Varenna was publicly
`available at the time of the invention. Dec. 8 (citing Ex. 1031). We observed,
`in an alternative holding, that Dr. Robinson’s Declaration was submitted
`“under oath” and “explains that he ‘accessed, reviewed, and posted about
`Varenna . . . on the social media site Twitter’ before the critical date.”
`Dec. 13 (quoting Reply 5; Ex. 1031 ¶¶ 4–8). We considered the uncontested
`nature of that testimony, given that Patent Owner declined the opportunity,
`provided as of right by our rules, to cross-examine Dr. Robinson regarding
`that testimony. Id. at 15. In addition, we took account of objective
`supporting evidence on point advanced by Petitioner; namely, an exhibit Dr.
`Robinson identified as “‘my tweet,’ which ‘can still be viewed publicly’ and
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`includes a link that ‘is still active and leads to Varenna.’” Id. at 13 (quoting
`Ex. 1031 ¶ 5, Exhibit A). Under these circumstances, we did not err by
`finding unpersuasive Patent Owner’s “conclusory assertions that
`Dr. Robinson’s sworn testimony ‘defies belief’ and details a feat that would
`require ‘a photographic’ or ‘infallible memory.’” Id. at 14 (quoting Sur-
`Reply 9).
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`Rather than pointing out any matters that the panel misapprehended or
`overlooked, Patent Owner expresses disagreement with the Decision, and
`attempts to offer additional reasoning and argument not advanced during
`trial. Req. Reh’g 5–15. That effort is ineffective to establish reversible error.
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`3) Petitioner’s Burden, Board Inferences, and Reply Evidence
`Patent Owner also reargues its view that the Board should have set
`aside Dr. Robinson’s Declaration because Petitioner submitted that evidence
`in support of the Reply. Req. Reh’g 11–15; Sur-Reply 9–10. Here again,
`simple disagreement with the Board’s ruling is insufficient to establish
`reversible error.
`The precedential decision in Hulu is instructive here, and specifically
`recognizes “limited opportunities” that “exist for the petitioner to present
`new evidence” pertaining to the question of public availability. Hulu,
`Paper 29 at 14. One opportunity expressly identified in Hulu is “in a reply to
`the patent owner response” where “the patent owner challenges a reference’s
`status as a printed publication.” Id., Paper 29, 14–15. That is precisely the
`circumstance here. Patent Owner shows no reversible error in our finding
`that Dr. Robinson’s Declaration, submitted with Petitioner’s Reply, responds
`to arguments raised for the first time in Patent Owner’s Response. Dec. 13
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`(comparing Reply 3–7 and Ex. 1031, with Resp. 12–15). In any event, in our
`alternative holding, we explain why substantial evidence supports our
`finding of public availability, “[e]ven if we set aside Dr. Robinson’s
`Declaration.” Dec. 9.
`This is not a situation where Petitioner submitted Reply evidence that
`changed the theory of the patent challenge or, as Patent Owner suggests,
`represents a circumstance comparable to raising “a new obviousness
`argument” not advanced in the Petition. Req. Reh’g 11 (quotation omitted);
`see Pet. vii (identification of Varenna and its alleged publication date of
`“Nov. 2012”), 3–4 (bridging paragraph, asserting that Varenna was
`“published in 2012”), 33 (asserting that “Varenna 2012 is one of dozens of
`references” presented during patent prosecution). Moreover, no prejudice
`attended allowance of the Reply evidence, where we also allowed Patent
`Owner a Sur-Reply to address that evidence. Dec. 13.
`Patent Owner takes issue with the Board’s observation that “Patent
`Owner was afforded an opportunity (fully taken) to file a Sur-Reply on
`issues raised in Dr. Robinson’s Declaration.” Id. (citing Sur-Reply 2–11).
`Patent Owner points out that the Sur-Reply included “only a short
`paragraph” countering that Declaration, but acknowledges that this
`circumstance was the result of Patent Owner’s own assessment of the
`relative importance of the evidence. Req. Reh’g 2–3 n.2. Patent Owner’s
`strategic calculation, regarding how much space or effort to devote to
`countering Dr. Robinson’s testimony, does not denigrate the opportunity
`afforded in the Sur-Reply, or reveal reversible error in the Decision.
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`The Board did not, as Patent Owner argues, “shift[] the burden of
`proof to Patent Owner to prove that Varenna was not disseminated or
`otherwise made available to the public.” Id. at 1 (emphasis in original). On
`the contrary, the Board reasonably weighed the objective proof of public
`availability against Patent Owner’s bare attorney arguments on point. See
`Dec. 8–15 (reasoning that the indicia of public accessibility appearing on the
`face of Varenna, combined with Patent Owner’s conduct during patent
`prosecution and information submitted under oath in Dr. Robinson’s
`Declaration, outweigh Patent Owner’s conclusory attorney arguments, which
`are supported by no objective proof). The objective evidence points in one
`direction; namely, that Varenna is what it appears to be, a copy of a journal
`article published in Rheumatology by the Oxford University Press in
`November of 2012. Id.
`Patent Owner shows no reversible error in the Decision relating to the
`Board’s assignment of Petitioner’s burden of proof, any inferences drawn
`from the evidence of record, or the alternative holding that Dr. Robinson’s
`testimony bolsters the substantial evidence of record showing that Varenna
`was publicly available at the time of the invention.
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`III. CONCLUSION
`For the above reasons, we deny Patent Owner’s Request for
`Rehearing of the Board’s Final Written Decision in this proceeding.
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`IV. ORDER
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`It is
`ORDERED that Patent Owner’s Request for Rehearing of the Final
`Written Decision is denied.
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`Case PGR2018-00062
`Patent 9,707,245 B2
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`For PETITIONER:
`
`Bruce Haas
`bchaas@venable.com
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`Justin Oliver
`joliver@venable.com
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`Katherine Adams
`keadams@venable.com
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`For PATENT OWNER:
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`Brent Johnson
`bjohnson@mabr.com
`
`Parrish Freeman
`pfreeman@mabr.com
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