`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GRÜNENTHAL GMBH,
`Petitioner
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner
`
`Case PGR2019-00028
`U.S. Patent No. 10,052,338
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`
`PATENT OWNER SUR-REPLY
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`
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`

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`U.S. Patent No. 10,052,338
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`PGR2019-00028
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`TABLE OF CONTENTS
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`I.
`II.
`
`III.
`
`The “method of treating” preamble language is limiting. ............................... 1
`The record supports construing “autonomic motor change” so that the
`claims are not indefinite. ................................................................................. 1
`Petitioner’s vague combination of references cannot support a finding
`of obviousness. ................................................................................................ 2
`IV. Petitioner’s failure to address a POSA’s facility with the Italian
`language undermines any contention that a POSA could have located
`non-patent references available only in Italian. ............................................... 3
`Petitioner has not proven that a POSA would have had a reasonable
`expectation of success in combining the teachings of the multiple non-
`patent references cited as rendering the claims obvious. ................................ 5
`VI. Petitioner has not met its burden with respect to claim 12. ...........................14
`VII. Petitioner has not produced evidence sufficient to support a legal
`conclusion of “printed publication” status for the asserted non-patent
`references. ......................................................................................................15
`VIII. Patent Owner need not rely on an expert in order to prevail. ........................22
`IX. CONCLUSION ..............................................................................................26
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`
`V.
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`
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`i
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`TABLE OF AUTHORITIES
`
` Page(s)
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`Cases
`Acceleration Bay, LLC v. Activision Blizzard Inc.,
`908 F.3d 765 (Fed. Cir. 2018) ................................................................ 15, 16, 21
`Adaptics Limited v. Perfect Company,
`Case IPR2018-01596, slip op. (PTAB Mar. 6, 2019)....................................... 2, 3
`Belden, Inc. v. Berk-Tek, LLC,
`805 F.3d 1064 (Fed. Cir. 2015) .......................................................................... 15
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) .............................................................................. 1
`Dynamic Drinkware, LLC v. Nat'l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .............................................................. 22, 24, 25
`Enzo Biochem, Inc. v. Gen-Probe, Inc.,
`424 F.3d 1276 (Fed. Cir. 2005) .......................................................................... 22
`Grünenthal GmbH v. Antecip Bioventures II LLC,
`PGR2018-00062, Paper 15 (PTAB Jan. 31, 2019) ............................................. 13
`Handi Quilter, Inc. v. Bernina Int’l AG,
`Case IPR2013-00364, slip op. (PTAB Sept. 25, 2014) ...................................... 24
`In re Klopfenstein,
`380 F.3d 1345 (Fed. Cir. 2004) .......................................................................... 20
`In re Lister,
`583 F.3d 1307 (Fed. Cir. 2009) .......................................................................... 19
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .............................................................. 22, 23, 24
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ............................................................ 2
`Samsung Electronics Co. Ltd. v. Ibex IP Holdings Co. Ltd.,
`Case IPR2018-00094, slip op. (PTAB May 7, 2019) ......................................... 20
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`Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms. Inc., USA,
`748 F.3d 1354 (Fed. Cir. 2014) .......................................................................... 12
`Spectra Logic Corp. v. Overland Storage, Inc.,
`Case IPR2013-00357, slip op. (PTAB Jan. 8, 2015) .......................................... 24
`SRI Int'l, Inc. v. Internet Sec. Sys., Inc.,
`511 F.3d 1186 (Fed. Cir. 2008) .......................................................................... 21
`Unified Patents Inc. v. Digital Stream IP, LLC,
`Case IPR2016-01749, slip op. (PTAB Mar. 9, 2018)......................................... 24
`Wasica Fin. GmbH v. Cont'l Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) .......................................................................... 17
`In re Wyer,
`655 F.2d 221 (C.C.P.A. 1981) ............................................................................ 16
`Statutes
`28 U.S.C. § 1746 ...................................................................................................... 20
`35 U.S.C. § 102(a) ................................................................................................... 15
`35 U.S.C. § 103 ........................................................................................................ 12
`35 U.S.C. § 112 .................................................................................................... 2, 12
`35 U.S.C. § 322(a)(3) ................................................................................................. 3
`Other Authorities
`37 C.F.R. § 1.68 ....................................................................................................... 20
`37 C.F.R. § 42.2 ....................................................................................................... 21
`37 C.F.R. § 42.53 ..................................................................................................... 21
`37 C.F.R. § 42.73(b) ................................................................................................ 23
`37 C.F.R. § 42.200(b) ................................................................................................ 2
`83 Fed. Reg. 51,340 ................................................................................................... 2
`Consol. Trial Practice Guide, § II.F (Nov. 2019) .................................................... 23
`iii
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`Consol. Trial Practice Guide, § II.I (Nov. 2019) ..................................................... 17
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`https://www.uspto.gov/patents-application-process/appealing-patent-
`decisions/decisions-and-opinions/informative-opinions-0 ................................... 3
`
`https://www.uspto.gov/patents-application-process/patent-trial-and-
`appeal-board/precedential-informative-decisions ............................................... 3
`
`U.S. Copyright Office, Compendium of U.S. Copyright Office
`Practices § 2202.2(A) (3d ed. 2017) .................................................................. 19
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`iv
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`I.
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`The “method of treating” preamble language is limiting.
`Petitioner contends that the preamble in this case is not limiting because it
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`allegedly does nothing more than state “an intended result or purpose.” (Reply, 1.)
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`That view is inconsistent with the plain reading of the preamble itself, which
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`claims “[a] method of treating.” The invention is a method of treating a condition
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`associated with CRPS. If the preamble language is ignored as having no bearing on
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`the rest of the claim, then the invention is simply administering neridronic acid to a
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`human being suffering from the condition, without regard to treatment efficacy.
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`That is not even an invention, let alone the invention at issue in this case. The
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`“method of treating” language is a typical example of language that is “necessary
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`to give life, meaning, and vitality to the claim,” as required by the case law. E.g.,
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`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir.
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`2002) (citation and quotation marks omitted). For this reason, and those stated in
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`the Patent Owner Response, the “method of treating” preamble language is
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`limiting.
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`II. The record supports construing “autonomic motor change” so that the
`claims are not indefinite.
`Petitioner’s contradictory argument is that a POSA would not have been able
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`to understand “autonomic motor change” and that a POSA would have understood
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`the very same term “could include autonomic dysfunction associated with CRPS,
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`motor changes associated with CRPS, or both.” (Reply, 3 (citing Ex. 1004, ¶¶ 74-
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`1
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`75).) Patent Owner has provided evidence to support its position that a POSA
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`would have understood “autonomic motor change” consistent with Petitioner’s
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`expert’s understanding. (Ex. 2002.) The record is thus ambiguous as to whether
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`“autonomic motor change” is indefinite. In this circumstance, the proper practice is
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`to construe the claims in a manner that will preserve their validity over § 112
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`issues. Phillips v. AWH Corp., 415 F.3d 1303, 1327 (Fed. Cir. 2005) (en banc) (“In
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`such cases, we have looked to whether it is reasonable to infer that the PTO would
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`not have issued an invalid patent, and that the ambiguity in the claim language
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`should therefore be resolved in a manner that would preserve the patent’s
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`validity.”).1
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`III. Petitioner’s vague combination of references cannot support a finding
`of obviousness.
`Petitioner defends its use of “and/or” by denigrating the cited authority.
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`(Reply, 12-14; Resp., 12 n. 6.) To be clear, it is the Board, not Patent Owner, that
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`has designated Adaptics as “informative,” as can be seen on the caption page of the
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`slip opinion from the Board, and from the Board’s running list of decisions it has
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`1 The Petition is this case was filed after the November 13, 2018, effective date of
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`the regulation changing the claim construction standard from “broadest reasonable
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`construction” to the Phillips standard. 37 C.F.R. § 42.200(b); 83 Fed. Reg. 51,340.
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`2
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`designated as “informative.” Adaptics Limited v. Perfect Company, Case IPR2018-
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`01596, slip op. at 1 (PTAB Mar. 6, 2019) (Paper 20) (informative). (See also
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`https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-
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`board/precedential-informative-decisions (discussing the “informative”
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`designation”) and https://www.uspto.gov/patents-application-process/appealing-
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`patent-decisions/decisions-and-opinions/informative-opinions-0 (alphabetical list
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`of decisions designated “informative”).) Petitioner elected to present its
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`combination of non-patent references using the “and/or” joinder, and the Board’s
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`informative authority holds such practice to be at odds with the requirement that
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`the petition present the grounds for unpatentability with particularity. 35 U.S.C.
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`§ 322(a)(3). The Board has discretion to reject the obviousness contentions in this
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`case on that basis alone.
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`IV. Petitioner’s failure to address a POSA’s facility with the Italian
`language undermines any contention that a POSA could have located
`non-patent references available only in Italian.
`Petitioner twists Patent Owner’s observation regarding the significance of
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`the Italian language of some of the cited non-patent references. (Reply, 14-16;
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`Resp., 20 n. 8.) Patent Owner does not contend that foreign language non-patent
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`references cannot qualify as “printed publications” under the law. That is not the
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`issue in this case. The issue here is whether the facts presented by Petitioner are
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`sufficient to allow the Board to arrive at the legal conclusion of “printed
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`3
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`publication” status. The facts thus have to show proof of either dissemination or
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`availability of each non-patent reference. Dissemination evidence has nothing to do
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`with a POSA’s ability to locate a reference because dissemination, if proven, might
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`suggest that the reference was effectively injected into the knowledge base of those
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`skilled in the art. Availability, on the other hand, involves the issue of whether a
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`POSA could have located the non-patent reference. This inquiry typically involves
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`reviewing evidence of indexing or cataloguing, or other means of organization that
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`would allow a POSA to locate the non-patent reference. In this case, Petitioner has
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`been intentionally vague about whether it is arguing dissemination versus
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`availability, or some combination. This is one of many reasons why Petitioner has
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`failed to carry its burden to show facts that would support a legal conclusion of
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`“printed publication” status. But, to the extent the argument is “printed
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`publication” based on availability, a POSA’s ability to read and understand the
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`foreign language of the asserted non-patent reference is absolutely relevant. No
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`case has directly addressed this question. Patent Owner’s point in raising it is
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`simply to suggest that it is among the many holes in Petitioner’s case for
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`supporting a legal conclusion of “printed publication” status, specifically with
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`regard to the Italian language references.
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`4
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`V.
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`Petitioner has not proven that a POSA would have had a reasonable
`expectation of success in combining the teachings of the multiple non-
`patent references cited as rendering the claims obvious.
`Petitioner’s first argument is that “[i]t defies belief that Patent Owner
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`continues to press this issue” of proving reasonable expectation of success. (Reply,
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`16.) It should not “defy belief” that Petitioner cannot prevail without evidence to
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`establish that a POSA would have had a reasonable expectation of success in
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`combining the five non-patent references asserted here. It should not “defy belief”
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`that Patent Owner is holding Petitioner to its proof. The Board should do likewise.
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`In any event, the premise for Petitioner’s accusation is particularly flawed. It relies
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`on statements made in a different PGR and in an ex parte prosecution regarding
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`different art, different patents, and different claims.
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`The cited statements from the Board in PGR2018-00062 (Reply, 16 (citing
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`FWD, 5, 28)) rely heavily upon M. Varenna et al., Treatment of complex regional
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`pain syndrome type I with neridronate: a randomized, double-blind, placebo-
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`controlled study, RHEUMATOLOGY 52: 534–42 (Nov. 2012) (“Varenna
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`Rheumatology”).2 Varenna Rheumatology is not prior art to the patent at issue nor
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`2 Varenna Rheumatology is Exhibit 1041. Patent Owner’s recitation of this
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`bibliographic information is not a concession (in this or any other PGR) that
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`5
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`is it among the five non-patent references of the asserted grounds of
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`unpatentability. The Board’s comments about Varenna Rheumatology in a separate
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`PGR are therefore irrelevant.
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`Petitioner’s reliance on the examiner’s statements in the ex parte
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`examination of application number 13/894,274 (“the ’274 application”)3 is
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`similarly misplaced. (Reply, 16.) First, the examiner made the cited statements
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`with respect to technology not at issue in this case, namely, the use of oral
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`zoledronic acid to treat pain associated with CRPS. The technology at issue in this
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`case involves the use of parenteral (not oral)4 preparations of neridronic acid (not
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`zoledronic acid) to treat conditions (other than pain) caused by CRPS. (Ex. 1011,
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`112-113.) Second, the cited statements relate to the application of art not asserted
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`
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`Petitioner has presented facts sufficient to support a legal conclusion that Varenna
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`Rheumatology qualifies as a “printed publication” as of any particular date.
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`3 The ’274 application is the senior-most utility application ancestor of the patent at
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`issue. Petitioner attached an incomplete version of the ’274 application file
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`wrapper as Exhibit 1011.
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`4 Claim 17 of the ’338 patent and some of its dependents do not include the
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`“parenterally” limitation.
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`6
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`in this case, namely Fox, Zaspel, de Castro, Leonard, Sebastin, Manicourt,
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`Robinson, and Varenna 2000.5 (Id.)6 The examiner’s statements were directed to
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`the alleged obviousness of oral zoledronic acid, not neridronic acid, based upon a
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`completely different set of references than those asserted in this case. The cited
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`examiner statements thus have no bearing whatsoever on whether a POSA would
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`have had a reasonable expectation of success in combining Varenna 2011, Gatti,
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`Muratore, Harden, and Drummond in the use of neridronic acid to treat CRPS.
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`Petitioner next contends that Gatti and Muratore disclose “data,” while
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`admitting that Varenna 2011 does not. (Reply, 17.) But Gatti and Muratore do not
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`in fact disclose data; they disclose conclusions without providing data. Petitioner’s
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`effort to prove otherwise by quoting these references is the best evidence of just
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`
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`5 Varenna 2000 is a different reference than the Varenna 2011 refence asserted in
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`this case.
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`6 Fox is U.S. Published Patent Application No. 2004/0063670. (Id.) The rest are
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`non-patent references. Their bibliographic information may be found at pages 119-
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`120 of Ex. 1011. Patent Owner does not concede that the citation to such
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`information constitutes facts that can support a legal conclusion of “printed
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`publication” status for any of these non-patent references.
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`7
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`how conclusory they are. And having a paid expert witness repeat the unsupported
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`conclusions does not make them any more credible or any less dubious.
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`Petitioner itself is in fact on record with its conviction that there was no data
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`available, even as of late 2016, that would have caused a POSA to have a
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`reasonable expectation of success in using neridronic acid to treat CRPS. Petitioner
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`admitted in 2016 that “[t]o date, no pharmacological therapy has been shown to
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`effectively treat the pain associated with CRPS” and that “[s]urveyed physicians
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`noted that a reduction of pain exceeding 30% would be considered a significant
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`improvement over existing off-label treatment options.” (Ex. 2003, 7 (under
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`“Overview of CRPS”) (emphasis added).)7 These admissions came in a “Form S-1
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`Registration Statement” filed with the Securities and Exchange Commission (id.,
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`1), where falsehoods and misrepresentations are made on pain of severe penalty to
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`the corporate filer. The filing was made by Thar, which company Petitioner
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`acquired later that year (2016). (Ex. 2004.) Petitioner repeated the same belief in a
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`press release announcing the acquisition, saying “[t]here is a significant unmet
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`medical need for those suffering from CRPS. Classic analgesics offer only limited
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`7 Available at https://www.sec.gov/Archives/edgar/data/1428369/
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`000119312516686457/d149128ds1.htm.
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`8
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`symptomatic relief; there are no sufficiently effective treatment options available.”
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`(Ex. 2004, 1 (emphasis added).)8
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`These are Petitioner’s own authentic views, articulated in 2016, outside the
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`context of the present proceeding. When being honest, Petitioner admits that
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`POSAs would have had nothing on which to base a reasonable expectation of
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`success. Paid expert testimony to the contrary cannot alter or undo that fact.
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`It is also important to note that both Gatti and Muratore purport to have been
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`published long before the Petitioner’s 2016 declarations that “no pharmacological
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`therapy has been shown to effectively treat the pain associated with CRPS” and
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`“there are no sufficiently effective treatment options available.” (Exs. 2003, 2004;
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`Exs. 1007, 1008.) Petitioner thus made these 2016 statements with full awareness
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`of the contents of both Muratore and Gatti. That means neither article contained
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`information that ran counter to Petitioner’s 2016 assertions.9
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`Petitioner’s paid expert has not explained why, contrary to Petitioner’s own
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`admissions, the conclusory and unsupported statements from Gatti and Muratore
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`8 Available at http://www.presseportal.de/pm/118252/3485652.
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`9 Either that, or neither had in fact been disseminated or otherwise made available
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`so that interested POSAs could have located them before Petitioner’s 2016
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`admissions.
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`9
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`would simply be taken as correct without question by a POSA. Gatti’s assertion
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`that “close to 80% of patients receiving neridronic acid had greater than 70%
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`symptomatic improvement” is particularly suspect when Petitioner has admitted
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`that “[s]urveyed specialists noted that a reduction of pain exceeding 30% would be
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`considered a significant improvement over existing off-label treatment options.”
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`(Reply, 15; Ex. 2003, 7.) These contradictory assertions would compel a POSA to
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`require more information before accepting the statements from Gatti and Muratore
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`as correct.
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`For example, the European Medicines Agency’s Committee for Orphan
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`Medicinal Products has identified the “particulars” that need to be available in
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`order to evaluate the accuracy of clinical study results for patients with CRPS. The
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`EMA offered the following, in the context of rejecting one such study:
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`In particular there is no data on important methodological aspects of the
`study that would affect the interpretation of the results, such as the
`randomization to the experimental groups or any measures to conceal
`allocation. In addition the results on pain are presented as a relative
`values but there is no data about baseline values. Finally the analysis of
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`10
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`the data is not described. All of these elements affect negatively the
`possibility to draw valid conclusions from the data. (Ex. 1011, 87-88.)10
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`Like the study rejected by the EMA, Gatti does not describe any
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`randomization to the experimental groups. (Ex. 1008, 5.) Neither Gatti nor
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`Muratore describe any measures to conceal allocation. (Ex. 1007, 6; Ex. 1008, 5.)
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`Furthermore, the results on pain in Gatti and Muratori are presented as relative
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`values, but there is no data about baseline values. (Ex. 1007, 6; Ex. 1008, 5.)
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`Finally, the analysis of the data is not described in either Gatti or Muratori. (Ex.
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`1007, 6; Ex. 1008, 5.) All of these elements negatively affect the possibility of
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`drawing valid conclusions from the data, but neither Petitioner nor its paid expert
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`has addressed them. Therefore, Petitioner has not met its burden of showing that
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`10 See note 3 regarding Exhibit 1011. The quoted language may be found at the
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`cited pages, which are part of Patent Owner’s response to an office action in which
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`Patent Owner block quotes the same language. The source document is not
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`included in Exhibit 1011, but it is available in Public PAIR, attached as Exhibit 4
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`to a declaration filed on March 10, 2014, in connection with the aforementioned
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`office action response. A copy is also filed herewith as Exhibit 2005, for ease of
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`reference.
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`11
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`there was a reasonable expectation of success, particularly in view of Petitioner’s
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`admissions to the contrary and the lack of valid and supported conclusions in
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`Muratore and Gatti.11
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`Petitioner’s failure to achieve success in 2019 further suggests that
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`expectations of success as of 2012 would not have been reasonable.12 Petitioner
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`responds that “Patent Owner has not provided … an explanation as to why those
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`11 Petitioner includes a strange suggestion that the patent at issue is invalid for lack
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`of written description support. (Reply, 18-19.) There is no such ground asserted in
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`this case, so the argument is irrelevant. To the extent the argument is that Gatti and
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`Muratore need not disclose data because the patent at issue does not disclose data,
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`it is nonsense. The requirements for written description support under 35 U.S.C.
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`§ 112 are completely unrelated to those for evaluating alleged prior art references
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`under 35 U.S.C. § 103.
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`12 Hindsight is not permitted in any obviousness analysis. But later knowledge,
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`such as evidence of unexpected results, is permissible to show nonobviousness.
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`Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms. Inc., USA, 748 F.3d
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`1354, 1360 (Fed. Cir. 2014). Similarly, evidence such as this, which helps to check
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`a hindsight assessment of reasonable expectation of success, is appropriate in
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`determining obviousness.
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`12
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`studies were terminated that would support” a conclusion “that neridronate is
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`categorically ineffective in treating CPRS.” (Reply, 20.) But Petitioner itself
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`admitted that it made a decision to discontinue its Phase II clinical trials of
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`neridronic acid to treat CRPS and that “[t]his decision was based upon the
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`outcome of a pre-planned interim futility analysis conducted by an independent
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`expert” which “indicated that our trials were unlikely to meet the primary
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`endpoint.” (Ex. 2001, 1 (emphasis added).) And in any case, Patent Owner has no
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`burden to show “that neridronate is categorically ineffective in treating CPRS.”
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`Rather, Petitioner has the burden of showing that a POSA would have had a
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`reasonable expectation of success, and Petitioner’s own admission of later failure
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`suggests that an earlier expectation of success could not be called reasonable.
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`Petitioner also raises “later studies performed by Dr. Varenna in 2012 and
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`2016” as allegedly showing reasonable expectation of success. (Reply, 20-21,
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`referring to Exs. 1041 and 1042, respectively).) But Petitioner’s failure to
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`reproduce Varenna’s alleged 2012 results also calls those results into question.
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`And Petitioner is incorrect to argue that Patent Owner took a contradictory position
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`regarding Varenna 2016 in a different proceeding. In PGR2018-00062, Patent
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`Owner argued that, for fracture as a predisposing event, “a
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`responder/nonresponder ratio of nearly 5 is significantly greater than the other
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`triggering event data, which vary from 1.33 to 2.22.” Grünenthal GmbH v. Antecip
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`Bioventures II LLC, PGR2018-00062, Paper 15 at 26 (PTAB Jan. 31, 2019). It is
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`entirely possible that, for CRPS patients in general, who have a lower
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`responder/nonresponder ratio, no reasonable expectation of success can be proven,
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`but for the patients with fracture as a predisposing event, which have a higher
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`responder/nonresponder ratio, there is a reasonable expectation of success.
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`Varenna Rheumatology and Varenna 2016 are hardly proof of concept for the
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`invention claimed in this case. Neither supports a finding of reasonable expectation
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`of success.
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`VI. Petitioner has not met its burden with respect to claim 12.
`Petitioner’s argument is that disclosure of treatment of patients suffering
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`“for at least 6 months” is all that is required to render obvious treatment of patients
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`suffering “for about 1 year to about 2 years.” (Reply, 22.) The only evidence is one
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`conclusory paragraph from the paid expert, where he says “[n]othing in the prior
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`art suggests that patients with longer durations could not be treated.” (Id. (citing
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`Ex. 1004, ¶ 118).) These words are telling. If the prior art taught or suggested using
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`neridronic acid to treat patients with CRPS with disease duration of “about 1 year
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`to about 2 years,” Dr. Poree would have been able to identify a statement from the
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`prior art that did this. Instead, Dr. Poree only identifies what is not in the prior art.
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`Since the prior art says nothing about using neridronic acid to treat patients with
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`CRPS with disease duration of “about 1 year to about 2 years,” of course it will not
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`say that it could not be done. This statement proves nothing.
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`Moreover, what a POSA would believe could be done is not sufficient to
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`establish obviousness. “[O]bviousness concerns whether a skilled artisan not only
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`could have made but would have been motivated to make the combinations or
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`modifications of prior art to arrive at the claimed invention.” Belden, Inc. v. Berk-
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`Tek, LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (emphasis added). A paid expert’s
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`statement about what “a POSA would have reasonably expected” without any
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`citation to the alleged prior art of record is not evidence that that the prior art
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`would have motivated a POSA to “administer[] neridronic acid” to treat a human
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`being that “has suffered from complex regional pain syndrome for about 1 year to
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`about 2 years.” Therefore, Petitioner has failed to meet its burden.
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`VII. Petitioner has not produced evidence sufficient to support a legal
`conclusion of “printed publication” status for the asserted non-patent
`references.
`Whether a non-patent reference qualifies as a “printed publication” is a
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`question of law based underlying questions of fact. Acceleration Bay, LLC v.
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`Activision Blizzard Inc., 908 F.3d 765, 772 (Fed. Cir. 2018). Issued patents (and
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`published patent applications), on the other hand, qualify automatically, without
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`the need for evidence. 35 U.S.C. § 102(a). The law distinguishes between patent
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`prior art and non-patent prior art because the law recognizes that POSAs would
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`easily be able to locate information published in patents. No such recognition is
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`afforded non-patent references. There must be evidence to show that the non-patent
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`reference was “disseminated or otherwise made available to the extent that persons
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`interested and ordinarily skilled in the subject matter or art, exercising reasonable
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`diligence, can locate it.” Acceleration Bay, 908 F.3d at 772 (emphasis added). This
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`is an affirmative duty that requires a showing by the proponent, not to be
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`supplanted by inference in the absence of proof. The C.C.P.A. put it this way in
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`1981: “the one who wishes to characterize the information … as a ‘printed
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`publication’ … should produce sufficient proof of its dissemination or that it has
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`otherwise been available and accessible to persons concerned with the art to which
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`the document relates and thus most likely to avail themselves of its contents.” In re
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`Wyer, 655 F.2d 221, 227 (C.C.P.A. 1981) (emphasis added, citation and quotation
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`marks omitted).
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`Facts sufficient to establish “printed publication” status as a matter of law
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`require evidence. Petitioner provided none with its Petition, as to either
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`dissemination or availability (except Ex. 1038, purporting but failing to show the
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`Internet availability of Ex. 1006 (see Resp. 14-16)). Petitioner simply pointed to
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`each non-patent reference itself as establishing its own “printed publication” status.
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`If the Board allows Petitioner to succeed, it puts the asserted non-patent references
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`in this case on equal footing with patents. Worse, it lays the foundation for others
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`to follow suit. No Federal Circuit or Supreme Court authority supports such parity.
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`Not only did the Petition omit facts and evidence supportive of “printed
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`publication” status, it largely omitted any argument at all as to whether each non-
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`patent reference was either disseminated, or otherwise made available, or some
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`combination. This effectively prevented Patent Owner from taking the other side of
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`the issue in anything more than an academic manner. Petitioner comes now in its
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`Reply with a raft of new evidence, factual allegations, and arguments in its first
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`effort to prove “printed publication” status as a matter of law. (Reply, 4-12; Exs.
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`1040, 1043, 1044, 1045, 1046, 1047.) All of it is improper new material because
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`(1) it goes to establishing a prima facie case for “printed publication” status and (2)
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`it could and should have been included with the Petition. See Consol. Trial Practice
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`Guide, § II.I (Nov. 2019). The Board should exclude or at least ignore this
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`improper material and render its “printed publication” determination based on the
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`materials included with the Petition. Wasica Fin. GmbH v. Cont'l Auto. Sys., Inc.,
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`853 F.3d 1272, 1286-87 (Fed. Cir. 2017) (“the expedited nature of IPRs bring with
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`it an obliga