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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`GRÜNENTHAL GMBH,
`Petitioner
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`v.
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`ANTECIP BIOVENTURES II LLC,
`Patent Owner
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`
`Case PGR2019-00028
`U.S. Patent No. 10,052,338
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`PATENT OWNER RESPONSE
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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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`Page
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II.
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`LEVEL OF SKILL IN THE ART ................................................................... 2
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`III. CLAIM CONSTRUCTION ............................................................................ 2
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`IV. PETITIONER HAS NOT PROVEN THAT VARENNA,
`MURATORE, GATTI, HARDEN, AND DRUMMOND QUALIFY
`AS “PRINTED PUBLICATION” PRIOR ART UNDER § 102. ................... 6
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`V. GROUND 1: PETITIONER HAS NOT PROVEN CLAIMS 1-16
`WOULD HAVE BEEN OBVIOUS OVER VARENNA,
`MURATORE, GATTI, AND HARDEN. .....................................................18
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`VI. GROUND 2: PETITIONER HAS NOT PROVEN CLAIMS 17-30
`ARE INDEFINITE. .......................................................................................25
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`VII. GROUND 3: PETITIONER HAS NOT PROVEN CLAIMS 17-30
`WOULD HAVE BEEN OBVIOUS OVER VARENNA,
`MURATORE, GATTI, HARDEN, AND DRUMMOND. ...........................26
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`VIII. CONCLUSION ..............................................................................................27
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`i
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`U.S. Patent No. 10,052,338
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`PGR2019-00028
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`
`Acceleration Bay, LLC v. Activision Blizzard Inc.,
`908 F.3d 765 (Fed. Cir. 2018) .....................................................................passim
`
`Adaptics Limited v. Perfect Company,
`Case IPR2018-01596, slip op. (PTAB Mar. 6, 2019)......................................... 12
`
`In re American Academy of Sci. Tech. Ctr.,
`367 F.3d 1359 (Fed. Cir. 2004) .......................................................................... 19
`
`Amgen Inc. v. F. Hoffman-La Roche Ltd,
`580 F.3d 1340 (Fed. Cir. 2009) .......................................................................... 18
`
`Arcelormittal v. Array Techs., Inc.,
`Case IPR2018-00801, slip op. (PTAB Oct. 2, 2019) ......................................... 12
`
`Blue Calypso, LLC v. Groupon, Inc.,
`815 F.3d 1331 (Fed. Cir. 2016) ........................................................................ 7, 8
`
`Boehringer Ingelheim Vetmedica, Inc. v. Schering–Plough Corp.,
`320 F.3d 1339 (Fed. Cir. 2003) .......................................................................... 22
`
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 808 (Fed. Cir. 2002) .............................................................................. 3
`
`Celltrion, Inc. v. Biogen, Inc.,
`Case IPR2016-01614, slip op. (PTAB Feb. 21, 2018) ................................... 7, 16
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .......................................................................... 18
`
`Harmonic Inc. v. Avid Technology, Inc.,
`815 F.3d 1356 (2016) ............................................................................................ 6
`
`In re Hogan,
`559 F.2d 595 (C.C.P.A. 1977) ............................................................................ 21
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ........................................................................ 6, 7
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`In re Klopfenstein,
`380 F.3d 1345 (Fed. Cir. 2004) ............................................................................ 9
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 18
`
`In re Lister,
`583 F.3d 1307 (Fed. Cir. 2009) ................................................................ 8, 10, 13
`
`In re Magnum Oil Tools International, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .................................................................... 10, 11
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`Massachusetts Inst. of Tech. v. AB Fortia,
`774 F.2d 1104 (Fed. Cir. 1985) ............................................................................ 9
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`Metalcraft of Mayville, Inc. v. The Toro Co.,
`848 F.3d 1358 (Fed. Cir. 2017) .......................................................................... 18
`
`In re NuVasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) .................................................................... 24, 25
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`PharmaStem Therapeutics, Inc. v. ViaCell, Inc.,
`491 F.3d 1342 (Fed. Cir. 2007) .......................................................................... 18
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`Samsung Elecs. Co. v. Infobridge Pte. Ltd.,
`929 F.3d 1363 (Fed. Cir. 2019) .................................................................... 11, 13
`
`SAS Inst., Inc. v. Iancu,
`138 S. Ct. 1348 (2018) .......................................................................................... 7
`
`SRI Int’l, Inc. v. Internet Sec. Sys., Inc.,
`511 F.3d 1186 (Fed. Cir. 2008) ............................................................................ 9
`
`Suffolk Techs., LLC v. AOL Inc.,
`752 F.3d 1358 (Fed. Cir. 2014) ............................................................................ 9
`
`Trivascular, Inc. v. Samuels,
`812 F.3d 1056 (Fed. Cir. 2016) .......................................................................... 11
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`Velander v. Garner,
`348 F.3d 1359 (Fed. Cir. 2003) .......................................................................... 19
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`iii
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`PGR2019-00028
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`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ................................................................ 23, 24, 25
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`Statutes
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`35 U.S.C. § 102 ................................................................................................ 6, 7, 13
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`35 U.S.C. § 102(a) ............................................................................................... 9, 15
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`35 U.S.C. § 103 ........................................................................................................ 18
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`35 U.S.C. § 312(a)(3) ................................................................................................. 6
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`35 U.S.C. § 316(e) ..................................................................................................... 6
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`35 U.S.C. § 322(a)(3) ........................................................................................... 6, 12
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`35 U.S.C. § 326(e) ..................................................................................................... 6
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`Other Authorities
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`37 C.F.R. § 42.65(a) ................................................................................................. 19
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`37 C.F.R. § 42.104(b) .............................................................................................. 12
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`iv
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`U.S. Patent No. 10,052,338
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`PGR2019-00028
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`I.
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`INTRODUCTION
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`Petitioner has not proven the claims of the ’338 patent1 to be unpatentable.
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`First, Petitioner purports to rely on five non-patent references to show obviousness,
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`but completely fails to prove, or even to address, the “printed publication” status of
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`each. Petitioner chose which arguments to include in its Petition and which to
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`leave out, and knowingly decided to omit any evidence or argument to show that a
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`person of ordinary skill in the art could have found each of the asserted non-patent
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`references before the priority date.
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`Second, even if the asserted references are assumed to qualify as “printed
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`publications,” Petitioner still fails to make a persuasive showing that a person of
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`ordinary skill in the art would have combined them with a reasonable expectation
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`of success. The testimony from Petitioner’s expert is conclusory, unsupported by
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`data, and thus unreliable.
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`Third, Petitioner has not shown that claims using the term “autonomic motor
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`change” are indefinite. Patent Owner’s evidence shows that a person of ordinary
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`skill in the art would have understood the term “autonomic motor system” such
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`that claims using the term “autonomic motor change” would have informed that
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`person of the scope of the invention with reasonable certainty.
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`1 U.S. Patent No. 10,052,338.
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`1
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`Petitioner has thus failed to carry its burden to prove the challenged claims
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`unpatentable. The Board should enter judgment for Patent Owner accordingly.
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`II. LEVEL OF SKILL IN THE ART
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`Patent Owner disagrees with Petitioner’s definition for a person of ordinary
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`skill in the art (“POSA”). (See Pet., 14 (“A person of ordinary skill in the art for
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`the ’338 patent (‘POSA’) would therefore have an M.D. or a Ph.D. in a pain-
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`medicine relevant discipline, such as clinical health psychology or neuroscience,
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`and at least 3-5 years of experience in the treatment of CRPS or related chronic
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`pain conditions, or in the study of CRPS or related types of chronic pain.”).)
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`The claims are directed to methods of treating allodynia or autonomic motor
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`changes associated with CRPS using a medication, namely, neridronic acid.
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`Therefore, a POSA would have had an M.D. or a Ph.D. in a discipline related to
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`the interaction of drugs with a human body, such as biology, pharmacology, etc.,
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`and experience in supervising, carrying out, or collaborating in animal or human
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`testing, including off-label treatment of patients, related to drug development in the
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`pain area. Training in an area such as clinical health psychology is not relevant to
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`treatment of pain conditions using a medication.
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`III. CLAIM CONSTRUCTION
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`Patent Owner’s position is that the preambles of claims 1 and 17 are
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`limiting.
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`2
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`Therefore, claim 1 requires that administering neridronic acid in a salt form
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`or an acid form to a human being suffering from allodynia associated with complex
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`regional pain syndrome have the effect of treating the allodynia. This means that
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`claim 1 requires the diagnosis, cure, mitigation, or prevention of allodynia
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`associated with complex regional pain syndrome, or otherwise affecting the
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`structure of function of the body of the human being in a way that relates to
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`allodynia associated with complex regional pain syndrome.
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`Similarly, claim 17 requires that administering neridronic acid in a salt form
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`or an acid form to a human being suffering from autonomic motor change
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`associated with complex regional pain syndrome have the effect of treating the
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`autonomic motor change. This means that claim 1 requires the diagnosis, cure,
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`mitigation, or prevention of autonomic motor change associated with complex
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`regional pain syndrome, or otherwise affecting the structure of function of the body
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`of the human being in a way that relates to autonomic motor change associated
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`with complex regional pain syndrome.
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`The preamble is limiting if “if it recites essential structure or steps, or if it is
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`necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc.
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`v. Coolsavings.com, Inc., 289 F.3d 808, 808 (Fed. Cir. 2002). The term “treating”
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`in the preamble of claims 1 and 17 is specifically defined in the specification:
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`3
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`The term “treating” or “treatment” broadly includes any kind of
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`treatment activity, including the diagnosis, cure, mitigation, or
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`prevention of disease in man or other animals, or any activity that
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`otherwise affects the structure or any function of the body of man or
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`other animals. (Ex. 1003, col. 7, ll. 42-46.)
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`Furthermore, with respect to claim 1, the specification states that “[s]ome
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`embodiments include administering … neridronic acid … to reverse established
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`allodynia and unweighting when administered at least 4 weeks after a precipitating
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`event such as fracture that is associated with CRPS.” (Ex. 1003, col. 3, ll. 19-24.)
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`Thus, the ’338 patent clearly asserts that bisphosphonates have a treatment effect
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`upon allodynia, especially with respect to claims 10, 11, and 12, which further
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`connect the treatment effect to the precipitating event, or the time from the
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`precipitating event.2 Therefore, the phrase “treating allodynia” brings life and
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`meaning into the claims based upon the disclosure of the specification the ’338
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`patent, and the preamble of claim 1 is limiting.
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`With respect to claim 17, as explained below, a POSA would have known
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`that “autonomic motor changes” are changes such as changes in skin blood flow,
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`
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`2 A human being who has suffered for at least 6 months (claim 10), about 6-12
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`months (claim 11), or about 1-2 years (claim 12) would have received the
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`neridronic acid at least 4 weeks after the precipitating event.
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`4
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`changes in temperature, such as temperature asymmetry, and sweating changes.
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`Example 3 states that “[z]oledronic acid reduced hindpaw warmth by 5% versus
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`vehicle treatment.” (Ex. 1003, col. 52, ll. 44-45.) A POSA would have known that
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`body temperature is controlled by the autonomic motor system. (Ex. 2002, 1056-
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`1057). Thus, since hindpaw warmth is an autonomic motor change, the ’338 patent
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`clearly asserts that bisphosphonates have a treatment effect upon an autonomic
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`motor change. Therefore, the phrase “treating autonomic motor change” brings life
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`and meaning into the claims based upon the disclosure of the specification of the
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`’338 patent, and the preamble of claim 17 is limiting.
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`“autonomic motor change”
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`With respect to the term “autonomic motor change” in claim 17, a POSA
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`would have known that blood flow, body temperature, and sweating are controlled
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`by the autonomic motor system. (Ex. 2002, 1056-1057.) As pointed out by
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`Petitioner’s expert, a POSA would have known that the diagnostic criteria for
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`CRPS includes “vasomotor changes” such as “changes in skin blood flow” and
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`“temperature asymmetry,” and “sudomotor changes” such as “sweating changes
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`and/or sweating asymmetry.” (Ex. 1004, ¶¶ 59, 61.) Thus, a POSA would have
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`known that “autonomic motor changes” are changes in skin blood flow, changes in
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`temperature, such as temperature asymmetry, and sweating changes.
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`5
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`IV. PETITIONER HAS NOT PROVEN THAT VARENNA, MURATORE,
`GATTI, HARDEN, AND DRUMMOND QUALIFY AS “PRINTED
`PUBLICATION” PRIOR ART UNDER § 102.
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`In a post-grant review, “the petitioner has the burden from the onset to show
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`with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v.
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`Avid Technology, Inc., 815 F.3d 1356, 1363 (2016) (emphasis added).3 That is why
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`the Federal Circuit says “[i]t is of the utmost importance that petitioners … adhere
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`to the requirement that the initial petition identify ‘with particularity’ the ‘evidence
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`that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys.,
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`Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35
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`
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`3 This case and many of the other cases cited herein deal specifically with inter
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`partes review proceedings (“IPR”), not post-grant review proceedings (“PGR”). In
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`each such instance, the distinction is one without a difference, given that both
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`statutory schemes are identical in the material aspects affecting the present
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`proceeding. Both require, for instance, petitions to identify “with particularity ...
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`the evidence that supports the grounds for the challenge to each claim.” Compare
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`35 U.S.C. § 312(a)(3) (regarding IPR) with 35 U.S.C. § 322(a)(3) (regarding PGR).
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`Both also put the burden of persuasion on the petitioner and require proof of
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`unpatentability by a preponderance of the evidence. Compare 35 U.S.C. § 316(e)
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`(regarding IPR) with 35 U.S.C. § 326(e) (regarding PGR).
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`6
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`U.S.C. § 312(a)(3); identical language found in 35 U.S.C. § 322(a)(3)). It is also
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`why the United States Supreme Court says “the petition [is] the centerpiece of the
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`proceeding both before and after institution.” SAS Inst., Inc. v. Iancu, 138 S. Ct.
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`1348, 1358 (2018).
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`Petitioner in this case asserts unpatentability on the basis of obviousness in
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`view of five non-patent references, alleged to be “printed publications” under 35
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`U.S.C. § 102. That means that Petitioner’s burden in this case includes proving that
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`each such non-patent reference actually qualifies as a printed publication under the
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`law. Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 772 (Fed.
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`Cir. 2018) (“As petitioner, Blizzard had the burden to prove Lin is a printed
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`publication.”). It also means that Petitioner was supposed to make that case in its
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`petition and accompanying evidence. Intelligent Bio-Sys., 821 F.3d at 1369 (“the
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`expedited nature of IPRs [and PGRs] bring with it an obligation for petitioners to
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`make their case in their petition to institute”); Celltrion, Inc. v. Biogen, Inc., Case
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`IPR2016-01614, slip op. at 20 (PTAB Feb. 21, 2018) (Paper 65) (“[P]etitioner
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`bears the burden of establishing unpatentability of the challenged claims by a
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`preponderance of the evidence [and] [t]hat burden includes establishing that
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`references relied upon as prior art are printed publications.”).
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`“To qualify as a printed publication, a reference ‘must have been sufficiently
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`accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc.,
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`7
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`815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re Cronyn, 890 F.2d 1158, 1160
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`(Fed. Cir. 1989)). “Because there are many ways in which a reference may be
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`disseminated to the interested public, ‘public accessibility’ has been called the
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`touch-stone in determining whether a reference constitutes a ‘printed publication.’”
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`Acceleration Bay, 908 F.3d at 772 (citation and quotation marks omitted). “A
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`reference will be considered publicly accessible if it was disseminated or otherwise
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`made available to the extent that persons interested and ordinarily skilled in the
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`subject matter or art exercising reasonable diligence, can locate it.” Blue Calypso,
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`815 F.3d at 1348 (citation and quotation marks omitted); In re Lister, 583 F.3d
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`1307, 1311 (Fed. Cir. 2009) (same).
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`Importantly, “public accessibility” means more than just technical
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`accessibility. Acceleration Bay, 908 F.3d at 773 (“The Board then correctly noted
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`that ‘public accessibility’ requires more than technical accessibility.”). In
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`Acceleration Bay, the petitioner was able to show that the Lin reference was stored
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`on a publicly accessible website, but was not able to show that the site was
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`meaningfully indexed, or that the search capability functioned properly. Id. The
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`Board found that the petitioner had “not shown sufficiently that the UCSD CSE
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`Technical Reports Library was searchable or indexed in a meaningful way so that a
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`person of ordinary skill in the art would have located Lin.” Id. “[T]he Board found
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`that although Lin was indexed by author and year, it was not meaningfully indexed
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`8
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`such that an interested artisan exercising reasonable diligence would have found it,
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`which is a proper consideration under our precedent.” Id. at 774 (emphasis
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`original). The Federal Circuit affirmed the Board’s conclusion that “Lin is not a
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`printed publication under § 102(a).” Id. at 773-74.
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`Even if not accessible, a reference might qualify as a printed publication “if
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`it was sufficiently disseminated at the time of its publication.” Suffolk Techs., LLC
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`v. AOL Inc., 752 F.3d 1358, 1365 (Fed. Cir. 2014); In re Klopfenstein, 380 F.3d
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`1345, 1350-51 (Fed. Cir. 2004). However, a reference is not “disseminated” simply
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`by being present on a publicly accessible network—dissemination requires proof
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`that the reference was “publicized or placed in front of the interested public.” SRI
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`Int'l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1197 (Fed. Cir. 2008). The
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`reference at issue in one case, for example, was found to be prior art by
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`dissemination where the evidence showed “between 50 and 500 persons interested
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`and of ordinary skill in the subject matter were actually told of the existence of the
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`paper and informed of its contents by the oral presentation, and the document itself
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`was actually disseminated without restriction to at least six persons.”
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`Massachusetts Inst. of Tech. v. AB Fortia, 774 F.2d 1104, 1109 (Fed. Cir. 1985).
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`There is no such evidence of dissemination in this case. Each of Petitioner’s
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`references purports to come from a periodical of some type, but Petitioner elected
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`not to provide any evidence of mailing or other distribution, of circulation
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`9
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`numbers, or of whether any of the alleged readership would have qualified as a
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`person of ordinary skill in the art.4 Petitioner has thus failed to prove “printed
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`publication” by way of “dissemination.”
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`That leaves “printed publication” by “accessibility.” Acceleration Bay, 908
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`F.3d at 773 (affirming Board decision to “focus[] on whether an interested skilled
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`artisan, using reasonable diligence, would have found” the reference, “[b]ecause
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`there was no evidence that [it] was disseminated to the public”). And the question
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`is not whether these non-patent references existed, or when they were written, or
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`even whether they were written before the patent’s priority date. Nor is the
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`question whether each was merely technically accessible to those who knew where
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`to look or whom to ask for a copy. The question is whether “persons interested and
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`ordinarily skilled in the subject matter or art exercising reasonable diligence,”
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`could have located each asserted non-patent reference at any time before the
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`priority date. In re Lister, 583 F.3d at 1311; Acceleration Bay, 908 F.3d at 773.
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`And the issue now before the Board is whether Petitioner has provided sufficient
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`evidence to prove such accessibility by a preponderance of the evidence. In re
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`
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`4 Patent Owner does not contend here that there is a certain circulation number that
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`must be shown. Patent Owner notes only that Petitioner has presented no
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`circulation evidence at all.
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`10
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`Magnum Oil Tools International, Ltd., 829 F.3d 1364, 1376-77 (Fed. Cir. 2016)
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`(disagreeing with the position “that the burden of production shifts to the patentee
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`upon the Board’s conclusion [of unpatentability] in an institution decision” and
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`holding that “the petitioner continues to bear the burden of proving unpatentability
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`after institution, and must do so by a preponderance of the evidence at trial”).5
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`
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`5 The Board’s acceptance of these non-patent references as “printed publications”
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`in its institution decision is irrelevant. The Federal Circuit recently rejected a
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`petitioner’s argument that the Board erred “for changing its view [regarding
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`printed publication status] from its institution decisions to its final written
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`decisions,” explaining:
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`We have repeatedly said … that “[t]he Board is free to change its view
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`of the merits after further development of the record, and should do so
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`if convinced its initial inclinations were wrong.” Trivascular, Inc. v.
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`Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016); see also In re Magnum
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`Oil Tools Int'l, Ltd., 829 F.3d 1364, 1377 (Fed. Cir. 2016) (“[T]he
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`Board has an obligation to assess the [validity] question anew after trial
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`based on the totality of the record.”). The Board did just that.
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`Samsung Elecs. Co. v. Infobridge Pte. Ltd., 929 F.3d 1363, 1373 (Fed. Cir. 2019).
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`
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`11
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`Petitioner did nothing in this case to shoulder its burden of proving each of
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`its asserted non-patent references actually qualifies as a printed publication. This
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`decision is fatal to both of its obviousness-based grounds for unpatentability
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`(Grounds 1 and 3), because each one relies on all or nearly all of these non-patent
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`references.6 The table below illustrates:
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`
`Varenna (Ex. 1006)
`Muratore (Ex. 1007)
`Gatti (Ex. 1008)
`Harden (Ex. 1009)
`Drummond (Ex. 1010)
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`
`Ground 1
`X
`X
`X
`X
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`
`Ground 3
`X
`X
`X
`X
`X
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`6 Petitioner uses “and/or” in listing the references that allegedly combine to render
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`the claims obvious. This practice tends to defeat the ability for the petition to state
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`its grounds with the “particularity” required by the controlling statute and
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`regulations. 35 U.S.C. § 322(a)(3); 37 C.F.R. § 42.104(b). The Board can reject
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`petitions employing this “and/or” convention on that basis alone. Adaptics Limited
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`v. Perfect Company, Case IPR2018-01596, slip op. at 24 (PTAB Mar. 6, 2019)
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`(Paper 20) (informative). If an “and/or” obviousness ground proceeds to trial, the
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`proper practice is to treat it as relying on all the asserted references, as it is not the
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`Board’s responsibility to “select the best combination of references” from a
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`vaguely-stated list. Arcelormittal v. Array Techs., Inc., Case IPR2018-00801, slip
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`op. at 7 n. 6 (PTAB Oct. 2, 2019) (Paper 32).
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`Despite knowing what was required of it, Petitioner did nothing more than
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`point to the date on the face of each document as proof of its printed publication
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`status. This is not proof (or even evidence) of accessibility. It is not proof that
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`“persons interested and ordinarily skilled in the subject matter or art exercising
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`reasonable diligence,” could have located the reference at any time before the
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`priority date. See In re Lister, 583 F.3d at 1311; Acceleration Bay, 908 F.3d at 773.
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`It is important to note here that Patent Owner does not contend that proof of
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`actual access is required. “[T]he standard for public accessibility is whether a
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`person of ordinary skill in the art could, after exercising reasonable diligence,
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`access a reference.” Samsung Elecs. Co. v. Infobridge Pte. Ltd., 929 F.3d 1363,
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`1374 (Fed. Cir. 2019) (emphasis original; vacating and remanding Board decision
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`because “the Board erred by confusing access with accessibility”). Patent Owner
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`demands of Petitioner nothing more than what the law requires—proof that a
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`POSA could have found the reference, not proof that an actual POSA ever in fact
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`did so.
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`For each of its five asserted references, Petitioner offers only a conclusory
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`and unsupported assertion that it is “a printed publication published before the ’338
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`patent’s earliest possible priority date.” (Pet., 26-27, 31-32, 56.) Whether a
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`reference qualifies as a “printed publication” under 35 U.S.C. § 102 is a question
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`of law, however, and Petitioner made no effort to provide any facts to support this
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`legal conclusion. Acceleration Bay, 908 F.3d at 772. What little evidence there is,
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`Patent Owner addresses below.
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`The contention that Varenna qualifies as a printed publication is supported
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`only by the document itself (Ex. 1006), a website where that document may
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`presently be found (Ex. 1038), and one paragraph of expert testimony (Ex. 1004,
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`¶ 40). The document (Ex. 1006) bears what appears to be a date of October 2011,
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`but the present-day website printout suggests it (or something having the same
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`name) was not uploaded until June 2015. (Ex. 1038, 3 (file path following
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`summary, reading
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`“http://www.giot.it/wp-content/uploads/2015/06/01varenna1.pdf”).) Neither
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`document provides any information about its dissemination or how it was
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`otherwise made available to the interested public, but the expert testified
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`nonetheless that, from these two documents, “a POSA would have concluded that
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`Varenna was published no later than October 2011.” (Ex. 1004, ¶ 40.)
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`There is no evidence to support that conclusion, but even if it were true, it
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`does not prove “printed publication” status. The expert does not purport to have
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`any knowledge of Varenna’s accessibility before the priority date, first-hand or
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`otherwise.7 There is no evidence on which to base a conclusion that a reasonably
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`diligent POSA would have been able to locate Exhibit 1006 at any time before the
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`priority date. There is, for example, no evidence from the webmaster behind the
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`Exhibit 1038 website as to its architecture, search capabilities, indexing or other
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`means by which the public might find the site, or whether the alleged Varenna
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`reference was posted there before the priority date. There is, for example, no
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`testimony from the expert or any other witness about “GIOT,” such as what it is
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`(i.e., its significance) and how POSAs access it, if at all. There is, for example, no
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`testimony from any POSA that “GIOT” is a publication that was known to them
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`before the priority date, or testimony on how they would have gone about
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`accessing it. There is, for example, no testimony from the “GIOT” publisher to
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`confirm that Exhibit 1006 was in fact published, or how it was published, or to
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`whom, or how the date on the face of a “GIOT” article typically relates to the date
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`of actual dissemination or publication.
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`7 Petitioner never actually argues a specific priority date, which makes the
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`shortcomings with its accessibility showing even more pronounced. The only
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`relevant inquiry, after all, is accessibility before the priority date. 35 U.S.C.
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`§ 102(a). Accessibility after the priority date does nothing to transform a reference
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`into a prior art printed publication.
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`All that Petitioner and its expert have to support the contention that Varenna
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`is a printed publication is Exhibit 1038, the website, but it does nothing to prove
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`accessibility before the priority date. And the Board has determined on at least one
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`occasion “that evidence merely demonstrating publication to the internet is not ‘a
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`satisfactory showing that such document has been disseminated or otherwise made
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`available to the extent that persons interested and ordinarily skilled in the subject
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`matter or art exercising reasonable diligence, can locate it.’” Celltrion, Inc. v.
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`Biogen, Inc., Case IPR2016-01614, slip op. at 20 (PTAB Feb. 21, 2018) (Paper 65)
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`(quoting SRI Int'l, 511 F.3d at 1194).
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`Muratore (Ex. 1007) suffers from the same failure of evidence, but even
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`more so. Neither Petitioner nor its expert point to any other evidence to corroborate
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`the alleged availability of Muratore, as they had for Varenna using the Exhibit
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`1038 website. The only evidence regarding Muratore comes from one paragraph in
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`the expert declaration, where the expert testifies that “[b]ased on the publication
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`date printed on Muratore, a POSA would have concluded that it was published no
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`later than April 2004.” (Ex. 1004, ¶ 50.) As is evident, this testimony is circular
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`and unreliable since it looks to the reference in question as proof of when the
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`reference was “published.” But the larger shortcoming is, again, that this is not
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`evidence of accessibility. It tells the trier of fact nothing about whether or how a
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`person of ordinary skill in the art exercising reasonable diligence could have found
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`Muratore before the priority date. More is needed, such as evidence from someone
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`with knowledge of Muratore, or its alleged publisher, or host periodical, or
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`knowledge that POSAs at the time would have known of that periodical, to state
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`just a few examples. Patent Owner does not contend that Petitioner would need all
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`of these types of proof, just that Petitioner needs more than a circular declaration
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`from an expert witness having no independent knowledge of Muratore.
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`Petitioner uses the same approach for Gatti (Ex. 1008). That is, there is no
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`evidence of accessibility at all, and the only evidence P