Trials@uspto.gov
`Tel: 571-272-7822
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`
`Paper 6
`Entered: July 30, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GRÜNENTHAL GMBH
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`
`Case PGR2019-00026
`Patent 9,931,352 B2
`
`
`
`
`
`
`
`
`
`
`
`Before GRACE KARAFFA OBERMANN, CHRISTOPHER M. KAISER,
`and WESLEY B. DERRICK, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Post Grant Review of Claims 1–30
`35 U.S.C. § 324
`
`
`
`
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`
`I. INTRODUCTION
`
`Petitioner filed a Petition for post grant review of claims 1–30 of U.S.
`
`Patent No. 9,931,352 B2 (Ex. 1001, “the ’352 patent”). Paper 2 (“Pet.”).
`
`Patent Owner did not file a preliminary response. Applying the standard set
`
`forth in 35 U.S.C. § 324(a), which requires demonstration that it is more
`
`likely than not that at least one challenged patent claim is unpatentable, we
`
`institute a post grant review of the challenged claims based on the grounds
`
`of unpatentability identified in the Petition. Pet. 7–8 (statement of grounds).
`
`The following preliminary findings of fact and conclusions of law are
`
`made for the sole purpose of determining whether to institute review. Any
`
`final decision will be based on the full trial record, including any response to
`
`the Petition timely filed by Patent Owner. Taking account of the
`
`information presented in the Petition, we find Petitioner meets the threshold
`
`showing necessary to support institution of post grant review of claims 1–30.
`
`A. Related Proceedings
`
`The Petition identifies six post grant review proceedings in which
`
`Petitioner challenges patents owned by Patent Owner—but none includes a
`
`challenge against any claim of the ’352 patent. Pet. 4 (citing PGR2017-
`
`00008 (“PGR008”); PGR2017-00022 (“PGR022”); PGR2018-00001
`
`(“PGR001”); PGR2018-00062 (“PGR062”); PGR 2018-00092 (“PGR092”);
`
`PGR2019-00003 (“PGR003”)).
`
`Final written decisions have issued in the first three proceedings.
`
`PGR008, Paper 43; PGR022, Paper 50; PGR001, Paper 48. The Board
`
`instituted post grant reviews in the other three proceedings (PGR062,
`
`PGR092, and PGR003), which are in various stages of our administrative
`
`process. See Pet. 4.
`
`2
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`
`Petitioner identifies as related two additional petitions for post grant
`
`review “filed concurrently with the instant Petition.” Id.; see PGR2018-
`
`00027 (“PGR027”); PGR2019-00028 (“PGR028”). Neither challenges a
`
`claim of the ’352 patent. PGR027, Paper 2; PGR028, Paper 2. We issue
`
`concurrently herewith a decision instituting review in PGR027. A timely
`
`decision whether to institute review in PGR028 will issue in due course.
`
`The Petition states that each of the above cases involves a patent that
`
`“shares the same inventor as the ’352 patent and, like the ’352 patent,
`
`concerns the use of bisphosphonate drugs to treat pain conditions.” Pet. 5.
`
`The Petition also states that some of those cases involve patents “in the same
`
`or related patent families.” Id.
`
`In PGR092, we made a preliminary finding that that the disclosure of
`
`Provisional Application No. 61/646,538 (“the ’538 application”) does not
`
`support the claims of U.S. Patent No. 9,820,999 (“the ’999 patent”).
`
`PGR092, Paper 7, 14. The Petition in the instant case raises a similar issue
`
`in the context of establishing that the ’352 patent is eligible for post grant
`
`review. Pet. 20. As it did with respect to the ’999 patent, challenged in
`
`IPR092, Petitioner avers in this case that the ’352 patent is not entitled to the
`
`benefit of the May 14, 2012, filing date of the ’538 application. Id.
`
`Specifically, Petitioner avers that the ’538 application, as well as nine
`
`other applications filed prior to March 16, 2013 (the effective date of the
`
`America Invents Act (“the AIA”)), from which the ’352 patent claims the
`
`benefit of priority, “fail to describe and enable the methods of—at a
`
`minimum—challenged claims 10–12, 13, 26–28, and 29.” Id.; see id. at 18
`
`(identifying ten priority applications, including the ’538 application, that
`
`potentially support a filing date for the ’352 patent that precedes the
`
`3
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`March 16, 2013 effective date of the AIA). We address that averment in our
`
`analysis below of post grant review eligibility.
`
`Petitioner states that it is aware of no “other judicial or administrative
`
`matters” that involve the ’352 patent or “would affect, or be affected by, a
`
`decision in this proceeding.” Id. at 5.
`
`B. The ’352 Patent (Ex. 1001)
`
`The ’352 patent is titled “Neridronic Acid for Treating Complex
`
`Regional Pain Syndrome.” Ex. 1001, (54). The challenged claims require
`
`parenteral (such as “intravenous or subcutaneous”) administration of
`
`neridronic acid to a human being suffering from a symptom (“hyperalgesia”
`
`or “edema”) associated with complex regional pain syndrome (“CRPS”).
`
`Ex. 1001, 27:12–13 (identifying modes of parenteral administration),
`
`claim 1 (independent claim specifying “hyperalgesia”); claim 17
`
`(independent claim specifying “edema”). To foreshadow several issues
`
`raised in the Petition, we observe that the specification describes the oral (as
`
`opposed to parenteral) administration of zoledronic acid (as opposed to
`
`neridronic acid) in a study of rats (as opposed to human patients). See, e.g.,
`
`Ex. 1001, Figs. 1–16, Examples 1–3.
`
`According to the specification, “[i]t has been discovered that oral
`
`dosage forms of bisphosphonate compounds, such as zoledronic acid, can be
`
`used to treat or alleviate pain or related conditions.” Ex. 1001, 1:65–67.
`
`The specification also identifies neridronic acid as a bisphosphonate suitable
`
`for use in the invention. Id. at 3:11–16, 16:63–67. The specification
`
`mentions neridronic acid alongside zoledronic acid when describing the
`
`bisphosphonate compounds useful in the invention, and further, does so
`
`4
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`specifically in the context of the administration of a bisphosphonate to a
`
`human being suffering from CRPS. Id. at 3:11–22, 8:37–47.
`
`All of the figures and working examples set forth in the specification
`
`relate to the oral administration of zoledronic acid. Id. at Figs. 1–16, 3:27–
`
`4:17 (description of figures), 49:52– 65:26 (Examples 1– 10). None of the
`
`working examples mentions neridronic acid. Id. Examples 7 and 8 discuss
`
`zoledronic acid that is administered intravenously (a form of parenteral, as
`
`opposed to oral, delivery). Id. at 55:40, 57:16. The specification elsewhere
`
`describes blood plasma concentrations associated with the parenteral
`
`administration of zoledronic acid. Id. at 27:27–42.
`
`The specification contains information pertaining to daily oral dosing
`
`of neridronic acid. Compare id. at 31:58–63 (disclosing “oral” dosages for
`
`“neridronate”), with id. at claims 1, 17 (the independent claims, requiring
`
`parenteral, as opposed to oral, administration of neridronic acid). The
`
`specification, however, also refers to a “molecular complex comprising
`
`neridronic acid” that “is administered in an amount that results in” certain
`
`disclosed blood plasma concentration curves. Ex. 1001, 26:34, 49–62.
`
`The specification contains other general information pertaining to the
`
`dosing of neridronic acid—describing, for example, administration of “[a]ny
`
`suitable amount of an osteoclast inhibitor, including a bisphosphonate” from
`
`a list that includes “neridronic acid,” and identifying broad dosing ranges
`
`(from about 0.005 mg to about 2000 mg) as well as the administration of
`
`“any amount of osteoclast inhibitor in a range bounded by, or between, any
`
`of these values.” Id. at 33:44–34:35. The specification compares oral
`
`dosage forms of bisphosphonates to “parenteral modes of administration,
`
`such as intravenous or subcutaneous” modes. Id. at 27:9–13.
`
`5
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`
`C. Illustrative Claim
`
`Claims 1 and 17 are the only independent challenged claims. They
`
`are illustrative and reproduced below:
`
`1. A method of treating hyperalgesia associated with
`complex regional pain syndrome, comprising parenterally
`administering neridronic acid in a salt form or in an acid form to
`a human being suffering from hyperalgesia associated with
`complex regional pain syndrome.
`
`Ex. 1001 (claim 1).
`
`17. A method of treating edema associated with complex
`regional pain syndrome, comprising parenterally administering
`neridronic acid in a salt form or in an acid form to a human being
`suffering from edema associated with complex regional pain
`syndrome.
`
`Ex. 1001 (claim 17).
`
`Claims 2–16 depend directly or indirectly from claim 1. Id. at
`
`claims 2–16. Claims 18–30 depend directly or indirectly from
`
`claim 17. Id. at claims 18–30.
`
`D. Evidence Relied Upon
`
`The Petition identifies the following references as prior art in the
`
`grounds of unpatentability:
`
`(1) M. Varenna, L’inquadramento clinico della sindrome
`algodistrofica (Complex Regional Pain Syndrome di tipo I). Recenti
`Acquisizioni, The clinical framework of algodystrophy (Complex Regional
`Pain Syndrome type I). An Update, GIOT 37:227–234 (OCT. 2011) (certified
`English translation) (Ex. 1006, “Varenna”);
`
`(2) M. Muratore et al., Il neridronato nel trattamento
`dell’algodistrofia simpatica riflessa dell’anca: confronto in aperto con il
`clodronato, PROGRESSI IN RHEUMATOLOGIA, ABSTRACT BOOK VII
`CONGRESSO NAZIONALE COLLEGIO DEI REUMATOLOGI OSPEDALIERI 5
`
`6
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`(Suppl. 1): 89 (April 16–18, 2004) (certified English translation) (Ex. 1007,
`“Muratore”);
`
`(3) D. Gatti et al., Neridronic acid for the treatment of bone
`metabolic diseases, EXPERT OP. ON DRUG METABOLISM & TOXICOLOGY
`5(10): 1305–11 (Sept. 2009) (Ex. 1008, “Gatti”); and
`
`(4) Harden et al., Validation of proposed diagnostic criteria (the
`“Budapest Criteria”) for Complex Regional Pain Syndrome, PAIN 150:268–
`274 (2010) (Ex. 1009, “Harden”).
`
`The Petition is supported by the Declaration of Lawrence Poree,
`
`M.D., and Ph.D. Ex. 1004. For purposes of this decision, based on his
`
`statement of qualifications and curriculum vitae, we find that Dr. Poree is
`
`qualified to opine about the perspective of a person of ordinary skill in the
`
`art at the time of the invention. See Ex. 1004 ¶¶ 6–13 (Dr. Poree’s statement
`
`of qualifications); see especially id. at ¶ 9 (explaining that Dr. Poree’s
`
`qualifications include “over 20 years of experience treating patients with
`
`chronic pain and studying treatments for pain disorders including complex
`
`regional pain syndrome”); see also Ex. 1005 (Dr. Poree’s curriculum vitae).
`
`E. The Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds of unpatentability against
`
`claims 1–30 of the ’352 patent:
`
`(1) obviousness of claims 1–16 under 35 U.S.C. § 103 in view of the
`
`combined disclosures of Varenna, Muratore, Gatti, and Harden;
`
`(2) obviousness of claims 17–30 under 35 U.S.C. § 103 in view of the
`
`combined disclosures of Varenna, Muratore, Gatti, and Harden; and
`
`(3) lack of written description support under 35 U.S.C. ¶ 112(a).
`
`Pet. 7–8.
`
`
`
`
`
`7
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`
`II. ANALYSIS
`
`A. Eligibility of the ’352 Patent for Post Grant Review
`
`Petitioner states, “during prosecution, the examiner treated the ’352
`
`patent as” originating from “an application filed on or after March 16, 2013
`
`and therefore subject to the first-to-file provisions of the AIA.” Pet. 19
`
`(citing Ex. 1035, 187). That fact, standing alone, tends to support a finding
`
`of PGR eligibility. Petitioner further observes, correctly, that, in this forum,
`
`a patent is eligible for post grant review if it contains “at least one claim that
`
`was not disclosed in compliance with the written description and enablement
`
`requirements of § 112(a) in” an application filed prior to March 16, 2013.
`
`Id. (quotation omitted).
`
`Petitioner avers, in that regard, “the pre-AIA applications” from
`
`which the ’352 patent allegedly claims priority “are devoid of any data,
`
`information, or other disclosures regarding lengths of time patients have
`
`suffered from CRPS,” and, on that basis, contends that none supports
`
`claims 10–12 or 26–28. Id. at 20. Those claims require a “human being”
`
`suffering from CRPS “for ‘at least 6 months,’ ‘about 6 months to about 12
`
`months,’ and ‘about 1 year to about 2 years.’” Id.; Ex. 1001 (claims 10–12
`
`and 26–28). According to Petitioner, therefore, none of claims 10–12 or 26–
`
`28 is supported by a pre-AIA application—a circumstance that supports a
`
`finding that the ’352 patent is eligible for post grant review. Pet. 21.
`
`Petitioner further avers that “the pre-AIA priority applications are
`
`devoid of any data, information, or other disclosures regarding the age of the
`
`patients to be treated.” Id. at 21–22. Petitioner argues that circumstance
`
`provides an independent basis for concluding that the ’352 patent is eligible
`
`for post grant review. Id. Specifically, Petitioner asserts that claims 13
`
`8
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`and 29, which include limitations on the age of treated patients, are not
`
`supported by any pre-AIA application. Id. at 21–22; see Ex. 1001
`
`(claims 13 and 29).
`
`For purposes of this decision only, we accept Petitioner’s
`
`representations on those points, which are not opposed by Patent Owner at
`
`this juncture. Based on Petitioner’s averments, we preliminarily find that
`
`the ’352 patent is eligible for post grant review. Patent Owner may dispute
`
`that finding in a timely-filed response to the Petition.
`
`B. Level of Ordinary Skill in the Art
`
`We consider the grounds of unpatentability in view of the
`
`understanding of a person of ordinary skill in the art at the time of the
`
`invention. Petitioner argues that an ordinarily skilled artisan would have had
`
`“an M.D., or a Ph.D. in a pain-medicine-relevant discipline, such as clinical
`
`health psychology or neuroscience, and at least 3–5 years of experience in
`
`the treatment of CRPS or related chronic pain conditions, or in the study of
`
`CRPS or related types of chronic pain.” Pet. 13 (citing Ex. 1004 ¶ 21).
`
`Petitioner’s definition, which is unchallenged at this stage of the
`
`proceeding, is comparable to the level of skill reflected in the asserted prior
`
`art references. On this record, we find that the prior art itself is sufficient to
`
`demonstrate the level of ordinary skill in the art at the time of the invention.
`
`See Okajima v. Boudreau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior
`
`art itself can reflect the appropriate level of ordinary skill in the art). To the
`
`extent that a more specific definition is required, for purposes of this
`
`decision only, we adopt Petitioner’s unopposed definition. Pet. 13.
`
`
`
`
`
`9
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`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`
`C. Claim Construction
`
`We apply the claim construction standard articulated in Phillips
`
`v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See Changes to
`
`the Claim Construction Standard for Interpreting Claims in Trial
`
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340
`
`(Oct. 11, 2018) (codified at 37 C.F.R. § 42.200(b) (2019) (noting rule
`
`change is applicable to post grant reviews filed on or after November 13,
`
`2018). Petitioner acknowledges that standard. Pet. 13. Under Phillips,
`
`claim terms are afforded “their ordinary and customary meaning.” Phillips,
`
`415 F.3d at 1312. “[T]he ordinary and customary meaning of a claim term
`
`is the meaning that the term would have to a person of ordinary skill in the
`
`art in question at the time of the invention.” Id. at 1313. Only terms in
`
`controversy need be construed, and then only as necessary to resolve the
`
`controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`
`803 (Fed. Cir. 1999).
`
`At this juncture, for the sole purpose of deciding whether to institute
`
`review, we adopt Petitioner’s constructions, which are presented in the
`
`alternative, supported by citations to precedent and evidence of record, and
`
`unopposed by Patent Owner. Pet. 14–18.
`
`
`
`10
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`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`
`
`
`Pet. 14 (chart identifying Petitioner’s proposed claim constructions).
`
`We emphasize that the above constructions are preliminary and invite
`
`Patent Owner to address any issue of claim construction, as necessary to
`
`defend against the patentability challenges, in a timely-filed response to the
`
`Petition. Further, we place both parties on express notice that any final
`
`written decision entered in this case may include final claim constructions
`
`that differ from the preliminary constructions set forth above or any
`
`discussion of claim scope provided in our analysis below. Any final claim
`
`constructions shall be based on the full trial record, including timely-filed
`
`information provided by a party during the course of this proceeding.
`
`D. The Asserted Grounds of Unpatentability
`
`In this section, we address in turn the following grounds of
`
`unpatentability advanced in the Petition against claims 1–30:
`
`(1) obviousness over Varenna, Gatti, Muratore, and Harden; and (2) lack of
`
`written description support. Pet. 7–8.1
`
`
`1 The Petition purports to identify two obviousness grounds, but both rely
`on the same asserted references (Varenna, Muratore, Gatti, and Harden)
`under the same statutory provision (35 U.S.C. § 103). Accordingly, our
`
`11
`
`

`

`PGR2019-00026
`Patent 9,931,352 B2
`
`
`The Petition identifies CRPS as “a chronic pain syndrome that often
`
`develops after trauma such as a fracture, surgery, or soft tissue injury.”
`
`Id. at 24 (citing Ex. 1004 ¶ 20). The Petition states, “[h]yperalgesia is ‘[a]n
`
`increased response to a stimulus which is normally painful.’” Id. at 23
`
`(quoting Ex. 1020, 227; Ex. 1004 ¶ 62). The Petition further states,
`
`“[e]dema clinically manifests as swelling, often of a limb, due to the
`
`accumulation of excessive fluid in the tissue.” Id. at 49. As an initial
`
`matter, we find that Petitioner identifies information sufficient to show that
`
`hyperalgesia and edema are defining symptoms, signs, and diagnostic
`
`criteria of CRPS. Id. at 23–28, 49–52 (and evidence cited therein).
`
`(1) Ground Based on Obviousness
`
`
`
`Petitioner argues that claims 1–30 are obvious over the disclosure of
`
`Harden in combination with any one of Varenna, Gatti, or Muratore.2
`
`Pet. 22–67. At the outset, on this record, we determine that Varenna,
`
`standing alone, demonstrates sufficiently that an ordinarily skilled artisan
`
`would have recognized parenteral administration of “neridronic acid” as
`
`“effective for treating CRPS” in a human patient. Id. at 28, 52. Specifically,
`
`in that regard, Varenna describes CRPS as a condition characterized by
`
`
`analysis addresses a single obviousness ground based on separate arguments
`directed to claims 1–16 as a first group and claims 17–30 as a second group.
`
` 2
`
` The phrase “and/or” appears in the argument sections of the Petition and
`indicates an intention to include a challenge based on Harden in combination
`with any one of the other three asserted references. Pet. 22; 48; see id. at 32
`(asserting that Varenna “and/or Gatti and/or Muratore, considered on their
`own or in combination,” show “that neridronic acid and its salts are effective
`to treat CRPS”) (citing Ex. 1004 ¶¶ 38, 56).
`
`12
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`

`PGR2019-00026
`Patent 9,931,352 B2
`
`“hyperalgesia” or “edema,” depicts the condition in a human patient, and
`
`discloses a treatment of “demonstrated efficacy” by the intravenous
`
`administration of neridronate3 “at a dosage of 100 mg per four infusions
`
`every fourth day.” Ex. 1006, 228, 230 (Fig. 1), 233; Pet. 28–29; 49–52.
`
`We agree with Petitioner that Gatti and Muratore, like Varenna,
`
`disclose the intravenous administration of neridronic acid in human patients
`
`afflicted by CRPS.4 Id. at 29–32. In fact, on this record, we preliminarily
`
`find that Varenna, Gatti, and Muratore describe dosing regimens and report
`
`efficacy data, for the intravenous administration of neridronic acid in human
`
`patients that exceeds the detail and specificity provided in the written
`
`description of the ’352 patent. Pet. 30–32 (citing Ex. 1004, Dr. Poree’s
`
`
`3 For purposes of this decision, we accept Petitioner’s unchallenged
`assertion that a person of ordinary skill in the art would have known that
`Varenna’s reference to “‘neridronate’ indicates that a salt form of neridronic
`acid was used to treat CRPS” as contemplated by the independent
`challenged claims. Pet. 29 (citing Ex. 1004 ¶ 43).
`
` 4
`
` For purposes of this decision, we accept also Petitioner’s unchallenged
`assertions that Gatti (by reference to “algodystrophy”) and Muratore (by
`reference to “[r]eflex sympathetic algodystrophy”) involve the treatment
`of CRPS. Ex. 1004 ¶¶ 49 (citing Ex. 1006, 1308 (Gatti)), 51 (citing
`Ex. 1007, 89 (Muratore)). On that point, we acknowledge Dr. Poree’s
`declaration testimony that an ordinarily skilled artisan would have
`understood “that CRPS has been identified by many names over the years,
`and that, for example, ‘algodystrophy,’ ‘reflex sympathetic dystrophy,’ and
`‘reflex sympathetic algodystrophy’ are synonyms for CRPS.” Ex. 1004
`¶ 53; Pet. 30. That testimony is supported by objective proof. See Pet. 30
`(citing Ex. 1004 ¶ 53 (citing Ex. 1019, 713 (explaining that CRPS “is the
`current diagnostic label for the syndrome historically referred to as reflex
`sympathetic dystrophy, causalgia, and a variety of other terms.”))). The
`disclosure of Varenna, which equates algodystrophy with CRPS, also
`corroborates Dr. Poree’s testimony on that point. Ex. 1006, 227 (Title).
`
`13
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`

`PGR2019-00026
`Patent 9,931,352 B2
`
`declaration testimony); see Ex. 1004 ¶¶ 39–52 (providing pinpoint citations
`
`to relevant and detailed disclosures in Varenna, Gatti, and Muratore).
`
`The challenge based on obviousness does not appear, at this stage of
`
`the proceeding, to depend on any combination of Varenna, Gatti or
`
`Muratore—because any one of those references, standing alone, discloses all
`
`that is required to render obvious the claimed subject matter when
`
`considered in view of Harden. Nonetheless, at this stage of the proceeding,
`
`we accept Dr. Poree’s unopposed testimony that an ordinarily skilled artisan
`
`would have been led to combine the disclosures of Varenna, Gatti, and
`
`Muratore. Pet. 30 (citing Ex. 1004 ¶¶ 38, 56). Patent Owner is invited to
`
`address in any timely-filed response to the Petition whether Petitioner
`
`articulates with reasonable clarity a rational reason for the proposed
`
`combination of Varenna, Gatti, and Muratore, and whether any combination
`
`of their disclosures is necessary to support the asserted challenge.
`
`We next turn to whether an ordinarily skilled artisan would have been
`
`led to administer neridronic acid to a human being suffering from
`
`hyperalgesia (claim 1) or edema (claim 17) associated with CRPS.
`
`(a) Independent Claim 1 and Hyperalgesia
`
`
`
`Petitioner directs us to Dr. Poree’s declaration testimony “that
`
`hyperalgesia is a defining sign and symptom of CRPS that makes up part of
`
`the diagnostic criteria for CRPS.” Pet. 24 (citing Ex. 1004 ¶ 63). That
`
`testimony is supported by persuasive objective evidence (including, but not
`
`limited to, disclosures within the four corners of Varenna and Harden) that
`
`CRPS is defined by the signs and symptoms it produces in patients—signs
`
`and symptoms that include hyperalgesia. Id. at 23–28 (including citations to
`
`Exs. 1006, 1009, 1020, 1032, and 1038). For example, both Varenna and
`
`14
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`

`PGR2019-00026
`Patent 9,931,352 B2
`
`Harden refer to the “Budapest Criteria” for diagnosing CRPS—criteria that
`
`include “evidence of hyperalgesia (to pinprick).” Ex. 1004 ¶ 61; Ex. 1006,
`
`228 (Varenna); Ex. 1009, 274 (Harden); Pet. 25 (citing Ex. 1004 ¶ 61).
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`Petitioner shows sufficiently that “CRPS is defined by the signs and
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`symptoms it produces in patients” and, further, that an ordinarily skilled
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`artisan would have understood that the treatment of CPRS by intravenous
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`administration of neridronic acid (as disclosed in Varenna, Gatti, or
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`Muratore) would have encompassed the treatment of CPRS symptoms,
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`including hyperalgesia. Pet. 32–35; Ex. 1004 ¶¶ 79–86. “Petitioner is not
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`aware of any objective indicia of nonobviousness” and, at this stage of the
`
`proceeding, Patent Owner has raised none. Pet. 47–48. Accordingly, on this
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`record, Petitioner demonstrates that the subject matter of claim 1 is more
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`likely than not unpatentable as obvious under 35 U.S.C. § 103.
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`(b) Independent Claim 17 and Edema
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`
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`Similarly, Petitioner directs us to Dr. Poree’s declaration testimony
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`“that edema is a defining sign and symptom of CRPS that makes up part of
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`the diagnostic criteria for CRPS.” Pet. 49 (citing Ex. 1004 ¶ 65). That
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`testimony is supported by persuasive objective evidence (including, but not
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`limited to, disclosures within the four corners of Varenna and Harden) that
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`CRPS is defined by the signs and symptoms it produces in patients—signs
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`and symptoms that include edema. Id. at 49–52 (including citations to
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`Exs. 1006 and 1009). Here again, both Varenna and Harden refer to the
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`“Budapest Criteria” for diagnosing CRPS—criteria that include both
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`patients’ reports of “edema” and objective evidence of “edema” on
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`examination. Pet. 50–51; Ex. 1004 ¶¶ 61, 65, 79; Ex. 1006, 228 (Varenna);
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`Ex. 1009, 274 (Harden).
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`Patent 9,931,352 B2
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`Petitioner shows sufficiently that “CRPS is defined by the signs and
`
`symptoms it produces in patients” and, further, that an ordinarily skilled
`
`artisan would have understood that the treatment of CPRS by intravenous
`
`administration of neridronic acid (as disclosed in Varenna, Gatti, or
`
`Muratore) would have encompassed the treatment of CRPS symptoms,
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`including edema. Pet. 52–55; Ex. 1004 ¶¶ 79–86. “Petitioner is not aware
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`of any objective indicia of nonobviousness” and, at this stage of the
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`proceeding, Patent Owner has raised none. Pet. 67. Accordingly, on this
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`record, Petitioner demonstrates that the subject matter of claim 17 is more
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`likely than not unpatentable as obvious under 35 U.S.C. § 103.
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`(c) Dependent Claims 2–16 and 18–30
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`We have considered the additional arguments and evidence presented
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`in the Petition, which stand unrebutted at this juncture and tend to establish
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`that the subject matter of dependent claims 2–16 and 18–30 would have
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`been obvious to an ordinarily skilled artisan at the time of the invention.
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`Pet. 36–47; 56–67 (and evidence cited therein). Based on the information
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`presented, we find Petitioner shows that it is more likely than not that those
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`claims are unpatentable as obvious under 35 U.S.C. § 103. Id.
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`(2) Ground Based on Lack of Written Description Support
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`Petitioner asserts that claims 1–30 lack written description support in
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`“[t]he ’352 patent specification.”5 Pet. 68; see id. at 8 (grounds chart). In
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`
`5 The relevant inquiry is whether the subject matter of the challenged claims
`finds written description support “in the originally filed disclosure.” Purdue
`Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000).
`Unless otherwise indicated, we adopt Petitioner’s convention of referring to
`the ’352 patent specification, rather than Application No. 15/703,981, which
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`the interest of completeness, and to provide guidance to the parties, we
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`supply reasons for our finding that Petitioner has not met the threshold
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`showing for post grant review of any challenged claim with respect to the
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`ground based on lack of written description support. Nothing in this
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`decision represents, or should be construed as, an invitation for Petitioner to
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`supplement the information presented in the Petition on any ground.
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`The ground based on lack of written description support is asserted
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`“[a]lternatively” and only “to the extent” that the Board or Patent Owner
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`“takes the position that the art cited in” connection with the obviousness
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`ground “does not render claims 1–30 obvious.” Pet. 68 (heading and first
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`paragraph of argument (emphasis omitted)). Patent Owner takes no position
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`on the scope of that assertion at this juncture, having declined to file a
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`preliminary response. We find that Petitioner waives the ground based on
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`written description support only in the event that the Board determines in a
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`final written decision that claims 1–30 are unpatentable as obvious. Id.
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`Patent Owner may dispute that preliminary finding, and raise any other
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`arguments pertaining to waiver, in a timely-filed response to the Petition.
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` “[T]he hallmark of written description is disclosure.” Ariad Pharms.,
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`Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A
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`patent disclosure is sufficient if it “reasonably conveys to those skilled in the
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`art that the inventor had possession of the claimed subject matter as of the
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`filing date,” based on an “objective inquiry into the four corners of the
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`specification.” Id. Petitioner argues that the ’352 patent specification “does
`
`
`matured to issue as the ’352 patent. See Pet. 68–72 (repeatedly referring to,
`and citing, the ’352 patent specification); Ex. 1001, (21) (identification of
`Application No. 15/703,981).
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`not specifically describe administration of neridronic acid to human beings
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`to treat hyperalgesia” (claims 1–16) or “edema” (claims 17–30) associated
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`with CRPS. Pet. 69, 70.
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`We find Petitioner’s information on point insufficient for two
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`independent reasons. First, the original claims set forth in the patent
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`application that matured to issue as the ’352 patent are part of the disclosure
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`that we consider when assessing the question of compliance with the written
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`description requirement. See Ex. 1035, 129–1316 (prosecution history,
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`claims as originally filed). It is well settled that “original claims constitute
`
`their own description.” In re Koller, 613 F.2d 819, 823 (CCPA 1980); see
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`In re Gardiner, 475 F.2d 1389, 1391 (CCPA 1973) (“[A]n original claim, in
`
`itself constituted a description in the original disclosure equivalent in scope
`
`and identical in language to the total subject matter now being claimed.”).
`
`Claim 1, as issued, is identical to claim 1 as originally filed. Compare
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`Ex. 1035, 129 (original claim 1), with Ex. 1001, claim 1. Claim 17, as
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`issued, contains a slight word change compared to claim 17 as originally
`
`filed. Compare Ex. 1035, 130 (original claim 17, reciting, in relevant part,
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`“neridronic acid in a salt or acid form”), with Ex. 1001, claim 17 (as issued,
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`reciting, in relevant part, “neridronic acid in a salt form or acid form”). That
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`circumstance, on this record, lays to rest any question that independent
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`claim 1 or 17 lacks written description support.
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`Petitioner raises no written description argument specific to any
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`limitation of a dependent claim. Pet. 69–72. In any event, a straightforward
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`comparison of original claims 1–30 to claims 1–30, as issued, reveals that
`
`
`6 Regarding Exhibit 1035, we cite to page numbers added by Petitioner not
`original page numbers assigned during patent prosecution.
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`they are essentially identical. Compare Ex. 1035, 129–131 (original
`
`claims 1–30), with Ex. 1001, claims 1–30 (revealing that, in addition to the
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`slight word change to claim 17, original claim 14 was modified to spell out
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`the meaning of two acronyms—“VAS” and “NRS”—in the claim as issued).
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`On this record, therefore, the original claims represent “a description in the
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`original disclosure equivalent in scope” to the subject matter of the
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`challenged claims. In re Gardiner, 475 F.2d at 1391. “Nothing more is
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`necessary for compliance with the description requirement of the first
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`paragraph of 35 U.S.C. § 112.”7 Id.
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`Second, we find insufficient Petitioner’s argument that the ’3