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
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GRÜNENTHAL GMBH
`Petitioner,
`v.
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`
`Case PGR2019-00027
`Patent 10,039,774 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 1–29
`35 U.S.C. § 324
`
`
`
`
`
`

`

`PGR2019-00027
`Patent 10,039,774 B2
`
`
`I. INTRODUCTION
`Petitioner filed a Petition for post grant review of claims 1–29 of U.S.
`Patent No. 10,039,774 B2 (Ex. 1002, “the ’774 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. 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 1–29.
`
`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 ’774 patent. Pet. 4–5 (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. 5.
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`PGR2019-00027
`Patent 10,039,774 B2
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`
`Petitioner identifies as related two additional petitions for post grant
`review “filed concurrently with the instant Petition.” Id.; see PGR2018-
`00026 (“PGR026”); PGR2019-00028 (“PGR028”). Neither challenges a
`claim of the ’774 patent. PGR027, Paper 2; PGR028, Paper 2. We issue
`concurrently herewith a decision instituting review in PGR026. 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 ’774 patent and, like the ’774 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 ’774 patent is eligible for post grant
`review. Pet. 19–20. As it did with respect to the ’999 patent, challenged in
`PGR092, Petitioner avers in this case that the ’774 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 “fails to
`describe and enable the methods of—at a minimum—challenged claims 10–
`12, 13, 25–27, and 28.” Id. 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 ’774 patent or “would affect, or be affected by, a
`decision in this proceeding.” Id. at 6.
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`PGR2019-00027
`Patent 10,039,774 B2
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`
`B. The ’774 Patent (Ex. 1002)
`The ’774 patent is titled “Neridronic Acid for Treating Complex
`Regional Pain Syndrome.” Ex. 1002, (54). The challenged claims require
`parenteral (such as “intravenous or subcutaneous”) administration of
`neridronic acid to a human being suffering from a symptom (“changes in
`skin blood flow” or “abnormal sudomotor activity”) associated with
`complex regional pain syndrome (“CRPS”). Ex. 1002, 26:60–61
`(identifying modes of parenteral administration), claim 1 (independent claim
`specifying “changes in skin blood flow”); claim 16 (independent claim
`specifying “abnormal sudomotor activity”). 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. 1002, Figs. 1–16, Examples 1–3.
`Significant to our analysis below, all of the challenged claims, by their
`express terms or dependency from an independent claim, further require a
`“human being” that “has a pain intensity of at least 7 cm on the 10 cm visual
`analogue scale (VAS) or at least 7 on the 0–10 numerical rating scale
`(NRS).” Ex. 1002, claims 1 and 16 (the independent claims). The
`specification refers to VAS pain scores in Figures 10–12, and explains that
`the VAS and NRS scales would have been “[c]ommonly used measures of
`pain intensity” at the time of the invention. Ex. 1002, 10:9–11. The
`specification further makes plain that both scales involve a patient’s
`subjective qualification of pain, and explains how the two scales relate to
`each other and provide the same information regarding degrees of pain
`severity in human patients suffering from “any of the conditions described”
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`PGR2019-00027
`Patent 10,039,774 B2
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`in the ’774 patent. Id. at 10:9–39. The specification further describes
`decreases in pain severity following treatment with bisphosphonates
`according to the invention, as evaluated using the VAS and NRS scales. Id.
`at 10:40–59.
`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.” Id. at 1:52–54. The
`specification also identifies neridronic acid as a bisphosphonate suitable for
`use in the invention. Id. at 3:11–16, 16:66–17:3. The specification mentions
`neridronic acid alongside zoledronic acid when describing the
`bisphosphonate compounds useful in the invention, and further, does so
`specifically in the context of the administration of a bisphosphonate to a
`human being suffering from CRPS. Id. at 3:4–16, 8:38–48.
`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, 3:21–
`4:14 (description of figures), 49:34– 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 55:35, 57:16. The specification elsewhere
`describes blood plasma concentrations associated with the parenteral
`administration of zoledronic acid. Id. at 27:8–24.
`The specification contains information pertaining to daily oral dosing
`of neridronic acid. Compare id. at 31:40–45 (disclosing “oral” dosages for
`“neridronate”), with id. at claims 1, 16 (the independent claims, requiring
`parenteral, as opposed to oral, administration of neridronic acid). The
`specification, however, also refers to a “molecular complex comprising
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`Patent 10,039,774 B2
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`neridronic acid” that “is administered in an amount that results in” certain
`disclosed blood plasma concentration curves. Ex. 1002, 26:30–43.
`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 33:26–34:17. The specification compares oral
`dosage forms of bisphosphonates to “parenteral modes of administration,
`such as intravenous or subcutaneous” modes. Id. at 26:57–27:8.
`
`C. Illustrative Claim
`Claims 1 and 16 are the only independent challenged claims. They
`are illustrative and reproduced below:
`1. A method of treating changes in skin blood flow
`associated with complex regional pain syndrome, comprising
`parenterally administering neridronic acid in a salt or an acid
`form to a human being suffering from changes in skin blood flow
`associated with complex regional pain syndrome, wherein the
`human being has a pain intensity of at least 7 cm on the 10 cm
`visual analogue scale (VAS) or at least 7 on the 0–10 numerical
`rating scale (NRS).
`
`Ex. 1002 (claim 1).
`16. A method of treating abnormal sudomotor activity
`associated with complex regional pain syndrome, comprising
`parenterally administering neridronic acid in a salt or an acid
`form to a human being suffering from abnormal sudomotor
`activity associated with complex regional pain syndrome,
`wherein the human being has a pain intensity of at least 7 cm on
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`Patent 10,039,774 B2
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`
`the 10 cm visual analogue scale (VAS) or at least 7 on the 0–10
`numerical rating scale (NRS).
`Ex. 1002 (claim 16).
`Claims 2–15 depend directly or indirectly from claim 1. Id. at
`claims 2–15. Claims 17–29 depend directly or indirectly from
`claim 17. Id. at claims 17–29.
`
`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
`(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”);
`(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”); and
`
`
`(5) P. Drummond, Sensory Disturbances in Complex Regional Pain
`Syndrome: Clinical Observations, Autonomic Interactions, and Possible
`Mechanisms, PAIN MEDICINE 11:1257-66 (2010) (Ex. 1010, “Drummond”).
`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
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`Patent 10,039,774 B2
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`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 1–29 of the ’774 patent:
`(1) obviousness of claims 1–15 under 35 U.S.C. § 103 in view of the
`combined disclosures of Varenna, Muratore, Gatti, Harden, and Drummond;
`(2) obviousness of claims 16–29 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. 8.
`
`II. ANALYSIS
`A. Eligibility of the ’774 Patent for Post Grant Review
`Petitioner states, “during prosecution, the examiner treated the ’774
`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. 18–19
`(citing Ex. 1036, 212). 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
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`Patent 10,039,774 B2
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`requirements of § 112(a) in” an application filed prior to March 16, 2013.
`Id. at 19 (quotation omitted).
`Petitioner avers, in that regard, the pre-AIA application from which
`the ’774 patent allegedly claims priority—specifically, the ’538 application
`discussed above (supra 3) “fails to describe and enable the methods of” at
`least “claims 10–12, 13, 25–27, and 28.” Id. at 19–20. Claims 10–12
`and 25–27 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. 1002 (claims 10–12 and 25–27). According to Petitioner,
`“the ’538 application is devoid of any data, information, or other disclosures
`regarding lengths of time patients had suffered from CRPS.” Id. at 20. As
`for claims 13 and 28, which require a “human being” having “an age of
`about 30 years to about 40 years,” Petitioner similarly argues that “the ’538
`application is devoid of any data, information, or other disclosures regarding
`the age of the patients to be treated.” Id. at 21. Petitioner argues that those
`circumstances provide an independent basis for concluding that the ’774
`patent is eligible for post grant review. Id. at 21–22.
`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 ’774 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
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`“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.
`
`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
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`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, shown below, which are
`presented in the alternative, supported by citations to precedent and evidence
`of record, and unopposed by Patent Owner. Pet. 13–18.
`
`
`
`
`
`Pet. 14–15 (chart identifying Petitioner’s proposed claim constructions).
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`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: (1) obviousness of claims 1–15
`over Varenna, Gatti, Muratore, Harden, and Drummond; (2) obviousness of
`claims 16–29 over Varenna, Gatti, Muratore, and Harden; and (3) lack of
`written description support. Pet. 8.
`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 12 (citing Ex. 1004 ¶ 20). The Petition states that an ordinarily skilled
`artisan at the time of the invention “would have known that changes in skin
`blood flow are characteristic symptoms of CRPS.” Id. at 2 (observing that
`such changes “are expressly included” in the “generally accepted set of signs
`and symptoms known as the ‘Budapest Criteria’” as well as “in the 1994
`IASP criteria that preceded the Budapest Criteria”). That factual contention
`is demonstrated sufficiently by disclosures within the four corners of
`“Varenna” and “Harden” as well as several background references advanced
`in the Petition. Id. at 2, 3, Pet. 25 (citing Ex. 1004 ¶¶ 60–61 (providing
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`pinpoint citations to Varenna (Ex. 1006, 228) and Harden (Ex. 1009, 2784);
`Ex. 1032; Ex. 1009 (background references)). Petitioner further avers that
`the term “abnormal sudomotor activity” “is very broadly defined in the
`specification.” Id. at 52 (citing Ex. 1002, 7:43–47). Petitioner states,
`“‘[s]udomotor activity’ refers to stimulation of sweat glands and sweating.”
`Id. at 53 (citing Ex. 1004 ¶ 68). As an initial matter, we find that Petitioner
`shows sufficiently that both “changes in skin blood flow” and “abnormal
`sudomotor activity” are defining symptoms, signs, and diagnostic criteria of
`CRPS. Id. at 23–30, 53–55 (and evidence cited therein).
`Similar arguments and prior art references are advanced in the two
`grounds based on obviousness, therefore, we treat them together in our
`analysis below, addressing Drummond only as necessary to our discussion
`of claims 1–15.
`
`(1) Grounds Based on Obviousness
`Petitioner argues that claims 1–29 are obvious over the disclosure of
`
`Harden and Drummond (as to claims 1–15) or Harden alone (as to
`claims 16–29) in combination with any one of Varenna, Gatti, or Muratore.1
`Pet. 22–71. 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 31, 55–57.
`Specifically, in that regard, Varenna describes CRPS as a condition
`
`
`1 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; 34, 51.
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`characterized by “skin color changes” or abnormal “sudomotor” activity
`characterized by “sweating changes and/or sweating asymmetry,” depicts the
`condition in a human patient, and discloses a treatment of “demonstrated
`efficacy” by the intravenous administration of neridronate2 “at a dosage of
`100 mg per four infusions every fourth day.” Ex. 1006, 228, 230 (Fig. 1),
`233; Pet. 24–31; 53–55.
`We agree with Petitioner that Gatti and Muratore, like Varenna,
`disclose the intravenous administration of neridronic acid in human patients
`afflicted by CRPS.3 Id. at 31–33. 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
`
`
`2 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. 30 (citing Ex. 1004 ¶ 43).
`
` 3
`
` 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. 32. That testimony is supported by objective proof. See Pet. 32
`(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).
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`patients that exceeds the detail and specificity provided in the written
`description of the ’774 patent. Pet. 30–31, 33 (citing Ex. 1004, Dr. Poree’s
`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 and Drummond (as to claims 1–15) or Harden
`alone (as to claims 16–29). 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. 33–34 (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 changes in
`skin blood flow (claim 1) or abnormal sudomotor activity (claim 16)
`associated with CRPS. We further consider whether such administration
`would have included the treatment of patients experiencing the pain intensity
`specified in the independent claims.
`
`(a) Independent Claim 1 and Changes in Skin Blood Flow
`Petitioner directs us to Dr. Poree’s declaration testimony “that
`
`changes in skin blood flow are among the defining signs and symptoms of
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`CRPS that make up part of the diagnostic criteria for CRPS.” Pet. 24 (citing
`Ex. 1004 ¶¶ 58, 70–73). 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 changes
`in skin blood flow. Id. at 24–27 (including citations to Exs. 1006, 1009,
`1020, 1031, 1032, and 1038).
`For example, both Varenna and Harden refer to the “Budapest
`Criteria” for diagnosing CRPS—criteria that include “vasomotor” evidence
`of “skin color changes”—that is, “changes in the diameter of blood vessels,
`namely the dilation or constriction of blood vessels.” Pet. 27 (citing
`Ex. 1004 ¶ 71); Ex. 1006, 228 (Varenna); Ex. 1009, 274 (Harden) (referring
`also to both “temperature asymmetry” and “skin color . . . asymmetry” in the
`context of “vasomotor” evidence of CRPS)). Drummond provides
`additional evidence that an ordinarily skilled artisan “would have known that
`changes in skin blood flow are observed in CRPS patients, and that the
`vasomotor symptoms of temperature and skin color asymmetry are
`associated with changes in skin blood flow.” Pet. 28–29 (citing Ex. 1010,
`1260; Ex. 1004 ¶¶ 70–73).
`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 CPRS symptoms,
`including changes in skin blood flow. Pet. 35–37; Ex. 1004 ¶¶ 79–86.
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`“Petitioner is not aware of any objective indicia of nonobviousness” and, at
`this stage of the proceeding, Patent Owner has raised none. Pet. 51.
`
`(b) Independent Claim 16 and Abnormal Sudomotor Activity
`Similarly, Petitioner directs us to Dr. Poree’s declaration testimony
`
`“that abnormal sudomotor activity is a defining sign and symptom of CRPS
`that makes up part of the diagnostic criteria for CRPS.” Pet. 53 (citing
`Ex. 1004 ¶ 69). 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 abnormal sudomotor
`activity. Id. at 53–28 (including citations to Exs. 1006, 1009, 1020, 1031,
`1032, 1039). Here again, both Varenna and Harden refer to the “Budapest
`Criteria” for diagnosing CRPS—criteria that include both patients’ reports of
`“sweating changes and/or sweating asymmetry” and objective evidence of
`“abnormal sudomotor activity” on examination. Pet. 54–55; Ex. 1004 ¶¶ 59,
`61, 69; Ex. 1006, 228 (Varenna); Ex. 1009, 274 (Harden).
`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,
`including abnormal sudomotor activity. Pet. 55–59 (and citations to
`evidence therein, including Ex. 1004 ¶¶ 81–86). “Petitioner is not aware of
`any objective indicia of nonobviousness” and, at this stage of the
`proceeding, Patent Owner has raised none. Pet. 71.
`
`
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`(c) The Pain Intensity Limitations of Claims 1 and 16
`Independent claims 1 and 16 recited an additional limitation that
`
`requires a patient experiencing, for example, “a pain intensity of at least 7
`cm on the 10 cm visual analogue scale.” Ex. 1002, claims 1 and 16. On that
`point, Petitioner shows sufficiently that, although Varenna, Gatti, and
`Muratore fail to “expressly disclose the VAS scores of the patient
`populations treated,” in this particular field of endeavor, an ordinarily skilled
`artisan “would have known that CRPS is characterized by severe and
`continuing pain.” Pet. 34 (citing Ex. 1004 ¶ 90). In that regard, Dr. Poree
`directs us to objective proof that CRPS results in pain that is “spontaneous”
`and “very severe with intensity 10 in the worst moments, according to verbal
`numerical scale.” Ex. 1004 ¶ 90 (quoting Ex. 1031, 72). On this record, we
`find it would have been obvious at the time of the invention to employ the
`above-discussed prior art treatments of CPRS by intravenous administration
`of neridronic acid in patients reporting “a pain intensity of at least 7 cm on
`the 10 cm visual analogue scale” as specified in claims 1 and 16.
`Accordingly, for all of the reasons stated above, on this record,
`Petitioner demonstrates that independent claims 1 and 16 are more likely
`than not unpatentable as obvious under 35 U.S.C. § 103.
`(d) Dependent Claims 2–15 and 17–29
`We have considered the additional arguments and evidence presented
`in the Petition, which stand unrebutted at this juncture and tend to establish
`that the subject matter of dependent claims 2–15 and 17–29 would have
`been obvious to an ordinarily skilled artisan at the time of the invention.
`Pet. 39–50; 59–71 (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
`claims are unpatentable as obvious under 35 U.S.C. § 103. Id.
`
`(2) Ground Based on Lack of Written Description Support
`Petitioner asserts that claims 1–29 lack written description support in
`“[t]he ’774 patent specification.”4 Pet. 72; see id. at 8 (grounds chart). In
`the interest of completeness, and to provide guidance to the parties, we
`supply reasons for our finding that Petitioner has not met the threshold
`showing for post grant review of any challenged claim with respect to the
`ground based on lack of written description support. Nothing in this
`decision represents, or should be construed as, an invitation for Petitioner to
`supplement the information presented in the Petition on any ground.
`The ground based on lack of written description support is asserted
`“[a]lternatively” and only “to the extent” that the Board or Patent Owner
`“takes the position that the art cited in” connection with the obviousness
`ground “does not render claims 1–29 obvious.” Pet. 72 (heading and first
`paragraph of argument (emphasis omitted)). Patent Owner takes no position
`on the scope of that assertion at this juncture, having declined to file a
`preliminary response. We find that Petitioner waives the ground based on
`written description support only in the event that the Board determines in a
`final written decision that claims 1–29 are unpatentable as obvious. Id.
`
`4 The relevant inquiry is whether the subject matter of the challenged claims
`finds written description support “in the originally filed disclosure.” Purdue