Paper No. 13
`Filed: January 13, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`
`Petitioner
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`
`Patent Owner.
`____________
`
`PGR2019-00028
`U.S. Patent No. 10,052,338
`____________
`
`PETITIONER’S REPLY
`
`

`

`I.
`II.
`
`TABLE OF CONTENTS
`Person of Ordinary Skill in the Art .................................................................. 1
`Claim Construction .......................................................................................... 1
`A.
`The Preambles Are Not Limiting .......................................................... 1
`B.
`Patent Owner Presented No Evidence to Support Its
`Proposed Construction of “Autonomic Motor Change” ....................... 3
`The Non-Patent References Are Unquestionably Prior Art ............................ 4
`III.
`IV. Ground 1: Claims 1-16 Are Obvious Over Varenna 2011
`and/or Gatti and/or Muratore, in Combination with Harden ......................... 12
`A.
`Petitioner’s Use of “and/or” to Clearly Identify
`Interchangeable, Cumulative References Is Entirely
`Proper .................................................................................................. 12
`The Fact that Varenna 2011 and Muratore Were
`Originally Written in Italian Is Irrelevant ........................................... 14
`Petitioner Has Proven That a POSA Would Have Had a
`Reasonable Expectation of Success .................................................... 16
`1.
`Patent Owner’s Arguments Regarding a Lack of
`“Data” in the Prior Art Are Meritless ....................................... 17
`The Termination of Two Phase III Clinical Trials
`in 2019 Does Not Undermine Reasonable
`Expectation of Success ............................................................. 19
`Patent Owner Presents No Evidence to Refute
`Petitioner’s Showing that Claim 12 Is Obvious .................................. 21
`Ground 2: Claims 17-30 Are Indefinite ........................................................ 23
`V.
`VI. Ground 3: Claims 17-30 Are Obvious Over Varenna 2011
`and/or Gatti and/or Muratore, in Combination with Harden and
`Drummond ..................................................................................................... 24
`VII. Conclusion ..................................................................................................... 25
`
`B.
`
`C.
`
`2.
`
`D.
`
`i
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`Adaptics Ltd. v. Perfect Co.,
`IPR2018-01596, Paper 20 (P.T.A.B. Mar. 6, 2019) ......................................13
`Allen Eng’g Corp. v. Bartell Indus., Inc.,
`299 F.3d 1336 (Fed. Cir. 2002) ....................................................................... 1
`ArcelorMittal v. Array Technologies, Inc.,
`IPR2018-00801, Paper 32 (P.T.A.B. Oct. 2, 2019) .......................................13
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) ...................................................................1, 2
`Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) ......................................................................... 1
`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc.,
`807 F.2d 955 (Fed. Cir. 1986) .......................................................................15
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ....................................................................... 6
`Ford Motor Co. v. Cruise Control Techs. LLC,
`IPR2014-00291, Paper 44 (P.T.A.B. June 29, 2015) ...................................... 7
`GoPro, Inc. v. Contour IP Hldg. LLC,
`908 F.3d 690 (Fed. Cir. 2018) ......................................................................... 8
`Grünenthal GmbH v. Antecip Bioventures II LLC,
`PGR2018-00001, Paper 47 (P.T.A.B. Feb. 7, 2019) ....................................... 9
`Grünenthal GmbH v. Antecip Bioventures II LLC,
`PGR2018-00062, Paper 15 (P.T.A.B. Jan. 31, 2019) ....................................21
`Grünenthal GmbH v. Antecip Bioventures II LLC,
`PGR2018-00062, Paper 31 (P.T.A.B. July 31, 2019) ...................................19
`Grünenthal GmbH v. Antecip Bioventures II LLC,
`PGR2018-00062, Paper 32 (P.T.A.B. Oct. 29, 2019) ........................... passim
`
`ii
`
`

`

`Grünenthal GmbH v. Antecip Bioventures II LLC,
`PGR2018-00092, Paper 23 (P.T.A.B. Nov. 21, 2019) ..............................9, 10
`In re American Academy of Sci. Tech. Ctr.,
`367 F.3d 1359 (Fed. Cir. 2004) .....................................................................18
`In re O’Farrell,
`853 F.2d 894 (Fed. Cir. 1988) .......................................................................18
`In re Orbital Techs. Corp.,
`603 F. App’x 924 (Fed. Cir. Jan. 20, 2015) ...................................................15
`Jazz Pharm., Inc. v. Amneal Pharm., LLC,
`895 F.3d 1347 (Fed. Cir. 2018) ....................................................................... 8
`Provepharm Inc. v. Wista Labs. Ltd.,
`IPR2018-00182, Paper 16 (P.T.A.B. Jul. 5, 2018) .......................................... 7
`Rayvio Corp. v. Nitride Semiconductors Co., Ltd.,
`IPR2018-01141, Paper 14 (P.T.A.B. Dec. 4, 2018) ........................................ 7
`Takeda Pharm. Co. Ltd. v. Actavis Labs. FL, Inc.,
`No. 15-451-RGA, 2016 WL 3193188 (D. Del. June 6, 2016) ........................ 1
`Velander v. Garner,
`348 F.3d 1359 (Fed. Cir. 2003) .....................................................................18
`Warner-Lambert Co. v. Teva Pharms. USA, Inc.,
`418 F.3d 1326 (Fed. Cir. 2005) ....................................................................... 6
`Statutes
`35 U.S.C. § 102 .......................................................................................................... 8
`35 U.S.C. § 103 ........................................................................................................19
`35 U.S.C. § 324(a) ..................................................................................................... 5
`35 U.S.C. § 326(e) ..................................................................................................... 6
`Regulations
`37 CFR § 42.63(b) ...................................................................................................15
`
`iii
`
`

`

`I.
`
`Person of Ordinary Skill in the Art
`Patent Owner argues that Petitioner’s definition of the person of ordinary
`
`skill in the art (POSA) is incorrect because it includes experience and education in
`
`clinical psychology. While Petitioner maintains that its definition is correct, the
`
`differences between the two definitions have no impact on the asserted grounds.
`
`II.
`
`Claim Construction
`A.
`The Preambles Are Not Limiting
`Patent Owner is incorrect that the preambles of claims 1 and 17 are limiting.
`
`As a general rule a preamble does not limit the claims. Allen Eng’g Corp. v.
`
`Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). The exception is where
`
`the preamble “recites essential structure or steps, or if it is necessary to give life,
`
`meaning, and vitality to the claim.” Catalina Mktg. Int'l, Inc. v. Coolsavings.com,
`
`Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (internal quotation marks omitted). In
`
`method claims, statements of intended result or purpose in a preamble are
`
`generally not limiting where the “method [is] performed in the same way
`
`regardless whether or not the [intended result actually ensues] . . . .” Takeda
`
`Pharm. Co. Ltd. v. Actavis Labs. FL, Inc., No. 15-451-RGA, 2016 WL 3193188, at
`
`*7 (D. Del. June 6, 2016) (citing Bristol-Myers Squibb Co. v. Ben Venue Labs.,
`
`Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001)). Here, the steps of the claimed
`
`methods are performed in exactly the same way regardless of whether the
`
`allodynia or autonomic motor change is in fact “treated.” The steps are also
`1
`
`

`

`performed the same way regardless of whether the neridronic acid was
`
`administered to a patient suffering from allodynia or autonomic motor change
`
`associated with CRPS for the specific purpose of treating said allodynia or
`
`autonomic motor change, or instead for the purpose of treating other signs or
`
`symptoms of CRPS, or for the purpose of treating CRPS generally.
`
`Patent Owner argues that the preambles “bring[] life and meaning into the
`
`claims” because the specification allegedly discloses examples and figures related
`
`to treating allodynia and autonomic motor change with zoledronic acid in a rat
`
`model of CRPS. See Patent Owner Response (“POR,” Paper 11) at 4-5. But, the
`
`recitation of the intended result of the claimed method in the specification is
`
`simply not sufficient to render a preamble limiting. See Bristol-Myers Squibb Co.,
`
`246 F.3d at 1375 (finding preamble phrase “an antineoplastically effective
`
`amount” non-limiting where “[t]hat expression of intended result essentially
`
`duplicates the dosage amounts recited in the claims that are also described in the
`
`specification as ‘antineoplastically effective.’”). Even if the specification
`
`purportedly “asserts that bisphosphonates have a treatment effect upon” allodynia
`
`and autonomic motor changes, such a disclosure is legally irrelevant to whether the
`
`preambles are limiting.
`
`2
`
`

`

`B.
`
`Patent Owner Presented No Evidence to Support Its Proposed
`Construction of “Autonomic Motor Change”
`Patent Owner’s attorneys argue without support that “a POSA would have
`
`known that ‘autonomic motor changes’ are changes such as changes in skin blood
`
`flow, changes in temperature, such as temperature asymmetry, and sweating
`
`changes.” POR at 4-5. But Patent Owner fails to point to any intrinsic or extrinsic
`
`evidence to support this proposed construction. Patent Owner cites only a textbook
`
`that generally describes what the autonomic motor system is (see Ex. 2002). Yet
`
`that textbook contains no evidence regarding what “autonomic motor change”
`
`would mean to a POSA in the context of the methods of treating CRPS claimed in
`
`the ’338 patent.
`
`Patent Owner also misconstrues Dr. Poree’s unrebutted testimony. Dr.
`
`Poree testified that autonomic motor change “is not…generally used to describe a
`
`symptom of CRPS” and that claims 17-30 are “indefinite because it is unclear what
`
`Patent Owner is attempting to claim.” Ex. 1004 ¶¶74, 137. The record is devoid
`
`of any support for Patent Owner’s proposed construction and claims 17-30 are
`
`unpatentable for indefiniteness. See Section V. But to the extent the Board finds
`
`the claims are not indefinite, Dr. Poree’s unrebutted construction that, to the extent
`
`a POSA could have understood the term at all, autonomic motor changes “could
`
`include autonomic dysfunction associated with CRPS, motor changes associated
`
`with CRPS, or both” should be adopted. Ex. 1004 ¶75.
`3
`
`

`

`III. The Non-Patent References Are Unquestionably Prior Art
`Patent Owner devotes the bulk of its POR to arguing that Petitioner has not
`
`provided sufficient evidence to show that Petitioner’s five cited non-patent
`
`references qualify as printed publication prior art. In essence, without providing
`
`any evidentiary support, Patent Owner stakes its entire case on its argument that
`
`documents that are clearly articles published in scientific journals were not actually
`
`disseminated or accessible to the public. The Board should reject this argument
`
`just as it rejected similar contentions made by this Patent Owner in the related
`
`PGR2018-00062. Grünenthal GmbH v. Antecip Bioventures II LLC, PGR2018-
`
`00062, Paper 32 at 8-13 (P.T.A.B. Oct. 29, 2019) (“PGR2018-00062 FWD”).
`
`Contrary to Patent Owner’s arguments, Petitioner did adduce sufficient
`
`evidence demonstrating that the five non-patent references cited in the Petition are
`
`prior art. See Petition (“Pet.,” Paper 2) at 27, 31-32. It is indisputable that the
`
`earliest possible priority date that any of the ’338 patent claims could be entitled to
`
`is the May 14, 2012 filing date of Provisional Application No. 61/646,538. And it
`
`is readily evident from the face of the five non-patent references that they are
`
`articles published in periodical journals by an identified and reputable publisher
`
`prior to May 14, 2012 as shown in the table below.
`
`4
`
`

`

`Reference
`
`Varenna 2011
`(Ex. 1006)
`
`Muratore
`(Ex. 1007)
`
`Gatti
`(Ex. 1008)
`
`Harden
`(Ex. 1009)
`
`Periodical
`Journal
`Giornale
`Italiano di
`Ortopedia e
`Traumatologia
`Progressi in
`Reumatologia
`
`Expert
`Opinion on
`Drug
`Metabolism &
`Toxicology
`Pain
`
`Publisher
`
`Pacini Editore
`SRL
`
`Collegio Dei
`Reumatologi
`Ospedalieri
`Informa UK
`Ltd., Taylor &
`Francis
`
`Publication
`Date
`October 2011
`
`Copyright
`Year
`
`
`Before July 19,
`2004
`
`September 17,
`2009
`
`2009
`
`Elsevier B.V. April 30, 2010 2010
`
`Drummond
`(Ex. 1010)
`
`Pain Medicine Wiley
`Periodicals,
`Inc.
`In its Institution Decision, the Board concluded that, based on the evidence
`
`2010
`
`before it, Petitioner made a threshold showing that it is more likely than not that
`
`the non-patent references were invalidating prior art. See Institution Decision,
`
`(“D.I.,” Paper 6) at 10-16. Notwithstanding Patent Owner’s arguments to the
`
`contrary, the fact that the Board made this initial determination is in no way
`
`“irrelevant” as Patent Owner insists. POR at 11 n.5. In a PGR, the standard to
`
`invalidate a patent claim in a final written decision is a preponderance of the
`
`evidence, which is not meaningfully different from the “more likely than not”
`
`standard required to institute PGR. Compare 35 U.S.C. § 324(a) with 35 U.S.C.
`
`5
`
`

`

`§ 326(e); see, e.g., Warner-Lambert Co. v. Teva Pharms. USA, Inc., 418 F.3d
`
`1326, 1341 n.15 (Fed. Cir. 2005) (defining “preponderance of the evidence”
`
`standard for patent infringement as requiring proof “that infringement was more
`
`likely than not to have occurred”). To be sure, Patent Owner is correct that “the
`
`Board is free to change its view of the merits after further development of the
`
`record.” POR at 11 n.5 (internal quotation marks omitted) (emphasis added). But
`
`Patent Owner has not further developed the record in this PGR at all. After the
`
`Institution Decision, the burden of production shifted to Patent Owner to come
`
`forward with evidence showing that the references were not prior art. See
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir.
`
`2015). Yet Patent Owner did not; the POR presents only unsubstantiated attorney
`
`argument alleging that the references may not have been publicly accessible or
`
`disseminated. Patent Owner has not presented any evidence to suggest any
`
`particular reference was not published and disseminated on the stated publication
`
`date.
`
`Patent Owner complains that the evidence Petitioner relies upon, namely
`
`dates on the faces of several documents, is insufficient as proof of their prior art
`
`status. It also contends, without supporting authority, that all manner of additional
`
`evidence is required such as evidence of mailing or distribution, circulation
`
`numbers, and testimony from webmasters and publishers. See POR at 14-15. But
`
`6
`
`

`

`as the Board noted in its final written decision in PGR2018-00062, wherein it
`
`rejected a similar argument from this Patent Owner, “[t]his is not a case involving,
`
`for example, a thesis, conference paper, or poster bearing none of the ordinary
`
`indicators of indexing or public distribution. This case involves a downloaded
`
`copy of an article from a medical journal bearing indicia of publication before the
`
`critical date.” PGR2018-00062 FWD at 10. Because it is evident from the face of
`
`the documents and Dr. Poree’s testimony that the cited non-patent references are
`
`prior art printed publications, no further evidence is required. Absent any evidence
`
`to the contrary, Petitioner’s proffered evidence is sufficient to show that these
`
`references qualify as prior art as the Board correctly found at the institution phase.
`
`See Ford Motor Co. v. Cruise Control Techs. LLC, IPR2014-00291, Paper 44 at 6-
`
`11 (P.T.A.B. June 29, 2015) (finding reference was prior art where Patent Owner
`
`“offere[d] no rebuttal vis-à-vis the printed copyright notice” on face of reference);
`
`Rayvio Corp. v. Nitride Semiconductors Co., Ltd., IPR2018-01141, Paper 14 at 26-
`
`27 (P.T.A.B. Dec. 4, 2018) (reference’s pre-filing copyright date and statement that
`
`it was “[p]ublished . . . by Oxford University Press” established it was prior art);
`
`Provepharm Inc. v. Wista Labs. Ltd., IPR2018-00182, Paper 16 at 17-18 (P.T.A.B.
`
`Jul. 5, 2018) (article’s “submitted” and “published” dates established publication
`
`date).
`
`7
`
`

`

`Patent Owner’s reference to “circulation numbers” and “whether any of the
`
`alleged readership would have qualified as a person of ordinary skill in the art”
`
`(see POR at 9-10) represent a misunderstanding of the law. Petitioner does not
`
`need to establish a threshold circulation level for any of these publications for the
`
`Board to accept them as prior art. The Federal Circuit has “interpreted § 102
`
`broadly, finding that even relatively obscure documents qualify as prior art so long
`
`as the relevant public has a means of accessing them.” GoPro, Inc. v. Contour IP
`
`Hldg. LLC, 908 F.3d 690, 693 (Fed. Cir. 2018) (citing Jazz Pharm., Inc. v. Amneal
`
`Pharm., LLC, 895 F.3d 1347, 1354-60 (Fed. Cir. 2018)). And, “there is no
`
`requirement to show that particular members of the public actually received the
`
`information.” Id. at 693. Simply put, the fact that these articles were published in
`
`scientific journals means that they were publicly accessible for purposes of
`
`establishing them as prior art. Patent Owner never pointed to a single instance
`
`where a USPTO board, court, or any other tribunal has found that an article
`
`published in a scientific journal was not publicly accessible for purposes of § 102.
`
`These arguments (i.e., that there is no evidence that these journal articles are
`
`actually publicly disseminated) are particularly surprising when it comes to Harden
`
`(Ex. 1009). Harden was published in the Journal of the International Association
`
`for the Study of Pain (PAIN) (“Pain”), which at the time was published by
`
`Elsevier, a particularly well-known publisher of scientific, technical and medical
`
`8
`
`

`

`content. Ex. 1009 at 1. During prosecution of the ’338 patent, Patent Owner
`
`submitted eleven different references from the journal Pain with publication dates
`
`ranges from 1988 to 2013. For Patent Owner to continue to argue that Pain is not
`
`a well-known journal in the relevant field or that each of those eleven references
`
`were obtained by Patent Owner by some means that is foreclosed to the public is
`
`disingenuous. See Grünenthal GmbH v. Antecip Bioventures II LLC, PGR2018-
`
`00092, Paper 23 at 28-29 (P.T.A.B. Nov. 21, 2019); Grünenthal GmbH v. Antecip
`
`Bioventures II LLC, PGR2018-00001, Paper 47 at 47 (P.T.A.B. Feb. 7, 2019).
`
`Patent Owner’s arguments with respect to Drummond (Ex. 1010) are
`
`similarly dubious. Drummond is an article published in 2010 in the journal “Pain
`
`Medicine.” As is evident from its face, Drummond was published by the well-
`
`known publisher Wiley Periodicals, Inc. in association with the American
`
`Academy of Pain Medicine and the International Spine Intervention Society. Ex.
`
`1010 at 1. Patent Owner submitted three references from this journal—which it
`
`now argues may not have been accessible to the public—during prosecution of the
`
`’338 patent and their citations were printed in the ’338 patent as issued. See Ex.
`
`1001 at 4, 6, 8; Ex. 1037 at 192, 216, 231. In fact, for one such article authored by
`
`Coderre, et al., Patent Owner entitled the electronic copy of the reference it
`
`submitted to the USPTO “Coderre2010.pdf,” acknowledging and accepting a
`
`9
`
`

`

`printed publication date similar to the dates it now questions before the Board. See
`
`Ex. 1037 at 238; Ex. 1047.
`
`Patent Owner also overlooks other indicia of publication provided by
`
`Petitioner. For example, for the Muratore reference (Ex. 1007), Petitioner
`
`provided a photocopy of the front page of the journal volume that provides the
`
`time and date that it was received by the National Library of Medicine, where the
`
`copy of the publication in Ex. 1007 was obtained. See Ex. 1043 (Declaration of
`
`David E. Cannady). Patent Owner’s counsel agrees that such evidence is sufficient
`
`to prove public accessibility.1 Grünenthal GmbH v. Antecip Bioventures II LLC,
`
`PGR2018-00092, Paper 23 at 27-28 (P.T.A.B. Nov. 21, 2019).
`
`As noted by Patent Owner, for Varenna 2011, in addition to providing the
`
`publication itself with a stated publication date of October 2011, Petitioner
`
`submitted a screenshot from the journal’s website that corroborates the stated
`
`Varenna 2011 publication date by noting in two separate instances that Varenna
`
`2011 was part of the fifth issued volume of Giornale Italiano di Ortopedia e
`
`1 This Board previously found Muratore prior art to U.S. Patent 9,707,245.
`
`PGR2018-00062 FWD at 27, 41.
`
`10
`
`

`

`Traumatologia in 2011.2,3 Ex. 1038 at 1, 3. An October 2011 publication date for
`
`Varenna 2011 is also supported by the noted receipt and accepted for publication
`
`dates (July 15, 2011 and August 30, 2011, respectively). Last, while such
`
`information should not be necessary to establish the prior art status of references
`
`from scientific journals, Petitioner submits herewith a declaration from Pacini
`
`Editore SRL, the publisher of the Giornale Italiano di Ortopedia e Traumatologia,
`
`and Supporting Declaration of Antonio Tarquini, which prove beyond any question
`
`that Varenna 2011 was publicly available before the ’338 patent’s earliest possible
`
`priority date. Ex 1045 (Declarations of Antonio Tarquini and Pacini Editore SRL);
`
`Ex. 1046 (translation).
`
`2 In 2011, the Giornale Italiano di Ortopedia e Traumatologia was published
`
`bimonthly, six times a year. Ex. 1040.
`
`3 The date the .pdf of Varenna 2011 was uploaded to the GIOT webpage is
`
`irrelevant; Petitioner is relying on the actual printing and circulation of the journal
`
`issue to establish Varenna 2011 as prior art. To the extent that Patent Owner is
`
`questioning the authenticity of Varenna 2011, that argument was waived.
`
`11
`
`

`

`Similarly, Petitioner provided a screenshot of the publisher of Gatti (Taylor
`
`& Francis) that notes that the journal Expert Opinion on Drug Metabolism &
`
`Toxicology is available in both print and online.4 Ex. 1008 at 1. The screenshot
`
`also shows that in addition to Gatti being published in the tenth issue of 2009 that
`
`Gatti was also published online on September 17, 2009.5 Id. Again, while such
`
`information should not be necessary to establish the prior art status of references
`
`from scientific journals, Petitioner submits herewith Ex. 1044, the Declaration of
`
`Corinne Militello, Esq., which proves beyond any question that Gatti was publicly
`
`available before the ’338 patent’s earliest possible priority date.
`
`IV. Ground 1: Claims 1-16 Are Obvious Over Varenna 2011 and/or Gatti
`and/or Muratore, in Combination with Harden
`A.
`Petitioner’s Use of “and/or” to Clearly Identify Interchangeable,
`Cumulative References Is Entirely Proper
`Patent Owner incorrectly argues in a footnote that the Board should “reject”
`
`the Petition for failing to state its grounds with particularity simply because
`
`Petitioner used “and/or” in listing the asserted prior art references. POR at 11 n.5.
`
`4 The International Standard Serial Number in the footer of Gatti (ISSN 1742-
`
`5255) corresponds to the print version of the reference.
`
`5 This Board previously found Gatti prior art to U.S. Patent 9,707,245. PGR2018-
`
`00062 FWD at 27, 41.
`
`12
`
`

`

`But the Board had no trouble understanding Petitioner’s grounds in the Institution
`
`Decision. D.I. at 14-15. The Board correctly understood “and/or” as indicating
`
`that Varenna 2011, Gatti, and Muratore are interchangeable with respect to
`
`disclosing the use of neridronic acid to treat CRPS, and that one or more of them
`
`combined with Harden would render the claims obvious.
`
`The cases Patent Owner characterizes as “informative” are instead
`
`inapposite. In Adaptics Ltd. v. Perfect Co., unlike here, the petition listed ten
`
`references connected by “and/or,” resulting in a large and uncertain number of
`
`potential prior art combinations. IPR2018-01596, Paper 20 at 18 (P.T.A.B. Mar. 6,
`
`2019). Also, unlike the instant Petition, the Adaptics petition also incorrectly cited
`
`to exhibits, contained discrepancies between the text and headings of asserted
`
`grounds, and relied upon additional references beyond those named in each ground
`
`to fill in gaps in disclosure, all of which contributed to the lack of particularity. Id.
`
`at 9 n.6 & n.7, 18-24. ArcelorMittal v. Array Technologies, Inc. is also
`
`distinguishable because there, unlike here, the Petitioner’s listing of seven
`
`reverences separated by “and/or” or “optionally” amounted to an “invitation for
`
`[the Board] to select the best combination of references” from many potential
`
`combinations. IPR2018-00801, Paper 32 at 7 n.6 (P.T.A.B. Oct. 2, 2019). Here,
`
`the Petition plainly indicates which references are interchangeable, and that one or
`
`13
`
`

`

`more of Varenna 2011, Gatti, or Muratore can be combined with Harden to render
`
`the claims obvious.
`
`B.
`
`The Fact that Varenna 2011 and Muratore Were Originally
`Written in Italian Is Irrelevant
`In yet another footnote, Patent Owner contends that Dr. Poree’s conclusions
`
`are “muddled” because he relies on translations of Varenna 2011 and Muratore,
`
`and the translator’s declaration “indicates no facility or even familiarity with the
`
`technology at issue.” POR at 20 n.8. Patent Owner made a similar challenge to
`
`translations offered in PGR2018-00062, which the Board rejected. See PGR2018-
`
`00062 FWD at 18. The Board should similarly reject Patent Owner’s arguments
`
`here because, as in that PGR, “Patent Owner does not demonstrate that [the
`
`translator’s] oath fails to comply with the form of evidence required for foreign
`
`language translations in our forum [under] 37 C.F.R. § 42.63(b).” Id. “Nor does
`
`Patent Owner come forward with any objective evidence tending to cast doubt on
`
`the content of [the translator’s] translation (for example, a conflicting translation
`
`provided under oath by a translator of Patent Owner’s choice).” Id. Patent Owner
`
`also does not specify how any translation error—it points to no such error—would
`
`have “muddled” Dr. Poree’s opinions.
`
`Moreover, there is no requirement that a translator have expertise in the
`
`technology at issue in a prior art document. The Code of Federal Regulations
`
`merely requires that “[w]hen a party relies on a document or is required to produce
`14
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`a document in a language other than English, a translation of the document into
`
`English and an affidavit attesting to the accuracy of the translation must be filed
`
`with the document.” 37 CFR § 42.63(b). Petitioner satisfied this requirement here.
`
`See Declarations of Laura Archiapatti attached to Ex. 1006, 1007. Indeed, Patent
`
`Owner could have deposed the translator—and Dr. Poree, for that matter—to probe
`
`their understanding of these documents and their alleged “unique lexicon,” or
`
`employed its own translator to challenge the translation’s accuracy, but it chose not
`
`to. See POR at 20 n.8.
`
`Next, Patent Owner inexplicably contends that because Varenna 2011 and
`
`Muratore are written in Italian, “POSAs happening upon them would not even
`
`have grasped their significance.” POR at 20 n.8. This is, of course, absurd and
`
`wholly unsupported. The POSA is not a real, physical person that speaks a
`
`particular language; it is a hypothetical construct that is presumed to be aware of
`
`everything that qualifies as prior art. See Custom Accessories, Inc. v. Jeffrey-Allan
`
`Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). This includes foreign language
`
`patents and printed publications from anywhere in the world. See 35 U.S.C.
`
`§ 102(a). Indeed, it is beyond dispute that foreign language references can form
`
`the basis of an obviousness ground. See, e.g., In re Orbital Techs. Corp., 603 F.
`
`App’x 924, 932 (Fed. Cir. Jan. 20, 2015) (affirming claim rejections in
`
`reexamination based upon translation of Japanese reference). Patent Owner’s
`
`15
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`argument that a POSA would ignore Varenna 2011 and Muratore because they are
`
`written in Italian is meritless.
`
`C.
`
`Petitioner Has Proven That a POSA Would Have Had a
`Reasonable Expectation of Success
`The only substantive arguments in the POR focus on Patent Owner’s
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`contention that “Petitioner has not met its burden of showing that there was a
`
`reasonable expectation of success in treating complex regional pain syndrome by
`
`administering neridronic acid.” POR at 19. It defies belief that Patent Owner
`
`continues to press this issue. As discussed in the Petition, the examiner of the ’338
`
`patent’s earliest non-provisional parent application concluded that the successful
`
`use of any bisphosphonate to treat CRPS was well known to the POSA. Ex. 1011
`
`at 100-120. Moreover, in the related PGR2018-00062, the Board noted that the
`
`examiner of the related patent-at-issue in that PGR found that “employing any
`
`known bisphosphonates, including neridronic acid, in the method of treating CRPS
`
`would be reasonably expected to be effective.” PGR2018-00062 FWD at 5. And,
`
`most importantly, the Board there credited Dr. Poree’s opinion that, based on the
`
`Gatti and Muratore references at issue here, a POSA would have reasonably
`
`expected neridronic acid treatment to be effective and useful to treat pain
`
`associated with CRPS. Id. at 28. This should end the inquiry into whether a POSA
`
`would have reasonably expected that neridronic acid is useful to treat CRPS.
`
`16
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`Nonetheless, Patent Owner advances two arguments against a reasonable
`
`expectation of success, both of which are meritless as discussed below.
`
`1.
`
`Patent Owner’s Arguments Regarding a Lack of “Data” in
`the Prior Art Are Meritless
`Patent Owner first argues that Petitioner has not proven a reasonable
`
`expectation of success because the prior art references Dr. Poree relies upon
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`“contain no data.” See POR at 19. This is incorrect. Varenna 2011, Gatti, and
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`Muratore all teach that clinical studies demonstrated that neridronic acid is
`
`effective in treating CRPS. Ex. 1006 at 233; Ex. 1007; Ex. 1008 at 5. Varenna
`
`2011 states that the data are “[s]oon to be published,” but Gatti and Muratore do, in
`
`fact, disclose their data. Gatti, for example, teaches that a Phase II clinical trial
`
`showed that close to 80% of patients receiving neridronic acid had greater than
`
`70% symptomatic improvement. Ex. 1008 at 5. And Muratore teaches that CRPS
`
`patients treated with neridronate showed “a significant well-correlated reduction of
`
`VAS and the redistribution of the load on the foot as an ‘objective’ expression of
`
`the reduction of pain symptoms, but the most surprising datum is the speed of
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`functional recovery, already almost complete after 15 days.” Ex. 1007 (emphasis
`
`added). It is unclear what additional “data” Patent Owner contends is required.
`
`In any event, the law does not require that the prior art disclose any
`
`particular type of “data.” Obviousness requires only a reasonable expectation of
`
`success, not absolute predictability of success. In re O’Farrell, 853 F.2d 894, 903
`17
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`(Fed. Cir. 1988). Patent Owner cites no legal authority or expert in support of its
`
`contention that the prior art must disclose some particular quantum of “data.”
`
`In addition, Patent Owner’s suggestion that Dr. Poree’s testimony is
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`“unsupported” and “entitled to little weight” is legally erroneous. See POR at 19.
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`Patent Owner’s cited cases do not require experts to rely on prior art disclosing
`
`“data” to establish a reasonable expectation of success. Rather, they merely stand
`
`for the unremarkable proposition that expert testimony regarding the contents of
`
`the prior art must have objective evidentiary support beyond the expert’s mere
`
`personal opinions. See In re American Academy of Sci. Tech. Ctr., 367 F.3d 1359,
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`1368 (Fed. Cir. 2004) (upholding examiner’s determination that declarations
`
`consisted only of expert’s “personal opinions” and were not persuasive); Velander
`
`v. Garner, 348 F.3d 1359, 1370-71 (Fed. Cir. 2003) (upholding