Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 22
`Entered: May 5, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`PGR2019-00003
`Patent 9,867,839 B2
`____________
`
`Before TONI R. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`
`
`
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`
`Paper 22
`Entered: May 5, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`PGR2019-00003
`Patent 9,867,839 B2
`____________
`
`Before TONI R. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2019-00003
`Patent 9,867,839 B2
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`
`INTRODUCTION
`I.
`This Final Written Decision is issued pursuant to 35 U.S.C. § 328(a)
`and 37 C.F.R. § 42.73. Petitioner bears the burden of proving
`unpatentability of the challenged claims, and that burden of persuasion never
`shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). The evidentiary standard is a
`preponderance of the evidence. See 35 U.S.C. § 326(e) (2012); 37 C.F.R.
`§ 42.1(d) (2018).
`For the reasons that follow, we determine that Petitioner has
`established by a preponderance of the evidence that claims 1–14 of U.S.
`Patent No. 9,867,839 B2 (Ex. 1001, “the ’839 patent”) are unpatentable. We
`also determine that Petitioner has failed to establish by a preponderance of
`the evidence that claims 15–30 of the ’839 patent are unpatentable.
`
`A. Procedural Background
`Grünenthal GMBH (“Petitioner”) filed a Petition (Paper 2, “Pet.”)
`requesting post grant review of claims 1–30 the ’839 patent. Antecip
`Bioventures II LLC (“Patent Owner”) did not file a preliminary response.
`Upon consideration of the information presented in the Petition, we
`instituted a post grant review of claims 1–30 of the ’839 patent on each
`ground of unpatentability set forth in the Petition. See infra Section I.E.
`Subsequently, Patent Owner filed a Patent Owner Response (Paper 9;
`“PO Resp.”), Petitioner filed a Reply (Paper 14; “Reply”), and Patent Owner
`filed a Sur-Reply (Paper 16; “Sur-Reply”).
`The Petition is supported by the Declaration of Lawrence Poree,
`M.D., Ph.D. Ex. 1003.
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`
`Oral argument was conducted on February 4, 2020. A transcript is
`entered as Paper 21 (“Tr.”).
`We address herein the arguments and evidence set forth in the Papers
`to the extent necessary to resolve the dispute between the parties with regard
`to each of the challenged claims.
`
`B. The ’839 Patent (Ex. 1001)
`The ’839 patent is titled “Osteoclast Inhibitors for Joint Conditions”
`(Ex. 1001, code (54)), and issued on January 16, 2018, from application
`number 15/438,513 (“the ’513 application”), filed February 21, 2017.
`According to the Specification of the ’839 patent, bisphosphonate
`compounds, such as neridronic acid and zoledronic acid, “are potent
`inhibitors of osteoclast activity, and are used clinically to treat bone-related
`conditions such as osteoporosis and Paget’s disease of bone; and cancer-
`related conditions including multiple myeloma, and bone metastases from
`solid tumors.” Id. at 1:46–50. In addition, according to the Specification,
`“neridronic acid and zoledronic acid, in an acid or a salt form, can be used to
`treat or alleviate pain or related conditions, such as joint conditions” (id.,
`Abstract), including osteoarthritis, rheumatoid arthritis, and complex
`regional pain syndrome (CRPS) (id. at 14:21–24).
`“Commonly used measures of pain intensity include the visual analog
`scale (VAS) and the numerical rating scale (NRS).” Id. at 8:61–62. “With
`the VAS approach, patients rate the severity of their pain by marking a point
`on a 10-cm (or 100 mm) VAS . . . [w]ith the NRS approach, patients rate the
`severity of their pain by verbally responding to a 10-pt NRS.” Id. at 8:62–
`67. With either approach, 0 equals no pain, and 10 equals the worst possible
`pain. Id. at 8:67–9:1. “Knee pain in a person with a VAS score of 5 cm . . .
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`or higher, or an NRS score of 5 or higher, may be referred to herein as
`moderate to severe knee pain.” Id. at 9:6–9.
`Finally, the Specification teaches that “the daily oral dose of
`neridronate[1] is about 10 mg to about 1,000 mg, about 50 mg to about 500
`mg, about 100 mg to about 500 mg, or about 150 mg to about 300 mg,” and
`“the parenteral dose . . . is about 5 mg to about 500 mg, about 5 mg to about
`200 mg, or about 10 mg to about 150 mg.” Id. at 30:17–22.
`
`C. Illustrative Claims
`Claims 1 and 15, the only independent claims, are illustrative:
`1. A method of treating pain associated with a joint comprising:
`administering neridronic acid in an acid form or a salt form to a
`patient who has suffered for at least 3 months with 1) pain
`associated with a joint and 2) a pain intensity of 5 or greater
`measured using the 0–10 numerical rating scale (NRS) or 5 cm
`or greater using the 10 cm visual analog scale (VAS).
`
`15. A method of treating pain associated with a joint comprising:
`orally administering zoledronic acid in an acid form or a salt
`form to a patient having 1) pain associated with a joint and 2) a
`pain intensity of 5 or greater measured using the 0–10 NRS or 5
`cm or greater using the 10 cm VAS, wherein a total of about 400
`mg to about 600 mg of zoledronic acid is administered in 2 or 3
`individual doses within a period of about a month.
`Ex. 1001, 105:38–44, 106:14–21.
`
`D. Asserted Prior Art
`The Petition identifies the following references as prior art in the
`grounds of unpatentability:
`
`1 Dr. Poree explains that “‘neridronate’ is synonymous with neridronic
`acid.” Ex. 1003 ¶ 150 (citing Ex. 1001, 32:6).
`
`4
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`
`Ex. 1005: M. Varenna et al., Treatment of complex regional pain
`syndrome type I with neridronate: a randomized, double-blind,
`placebo-controlled study, 52 RHEUMATOLOGY 534–42 (2012)
`(“Varenna 2012”).
`
`Ex. 1006: M. Muratore et al., Il neridronato nel trattamento
`dell’algodistrofia simpatico riflessa del’anca: confront in aperto con
`il clodronato, 5 PROGRESSI IN RHEUMATOLOGIA, ABSTRACT BOOK VII
`CONGRESSO NATIONALE COLLEGIO DEI REUMATOLOGI OSPEDALIERI 89
`(2004) (certified English translation: Neridronate in the treatment of
`reflex sympathetic hip algodystrophy: open comparison with
`clodronate) (“Muratore”).
`
`Ex. 1007: D. Gatti et al., Neridronic acid for the treatment of bone
`metabolic diseases, 5 EXPERT OPIN. DRUG METAB. TOXICOL. 1305–11
`(2009) (“Gatti 2009”).
`
`Ex. 1009: G.S.E. Dowd et al., Complex regional pain syndrome with
`special emphasis on the knee, 89-B JOURNAL OF BONE AND JOINT
`SURGERY 285–290 (2007) (“Dowd”).
`
`Ex. 1010: M. Walsh, WO 2007/092338 A2, published August 16,
`2007 (“Walsh”).
`
`Ex. 1011: D. Thompson at al., WO 2005/107751 A1, published
`November 17, 2005 (“Thompson”).
`
`Ex. 1012: Fox et al., US 2004/0063670 A1, published April 1, 2004
`(“Fox”).
`
`Ex. 1013: M. Rossini et al., Intra-articular clodronate for the
`treatment of knee osteoarthritis: dose ranging study vs hyaluronic
`acid, 48 RHEUMATOLOGY 773–78 (2009) (“Rossini”).
`
`Ex. 1014: M. Varenna, Efficacy Study of Neridronate to treat Painful
`Osteoarthritis of the Knee With Bone Marrow Lesions (2013)
`available at
`https://clinicaltrials.gov/ct2/show/record/NCT01803360?view=record
`(“Varenna Protocol”).
`
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`
`Ex. 1015: A. de Castro et al., Zoledronic acid to treat complex
`regional pain syndrome type I in adult, 12 REV DOR. SÃO PAULO 71–
`73 (2011) (“de Castro”).
`
`Ex. 1016: J. Zaspel et al., Treating CRPS I in the early stage –
`cortisone (methyl prednisone) versus bisphosphonate (zoledronic
`acid), GERMAN CONGRESS FOR ORTHOPEDICS AND TRAUMA SURGERY
`(2007) (“Zaspel”).
`
`Ex. 1017: M. Hanna et al., WO 2011/097269, published August 11,
`2011 (“Hanna”).
`The Petition is supported by the Declaration of Lawrence Poree,
`
`M.D., Ph.D. Ex. 1003. 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 (Dr. Poree’s curriculum vitae).
`
`E. Asserted Grounds of Unpatentability
`We instituted review of claims 1–30 of the ’839 patent as follows.
`Paper 7.
`
`Claims
`1–14
`1–14
`1–14
`
`35 U.S.C. §2
`112(a)
`112(a)
`103
`
`1–9, 13, 14
`
`103
`
`Reference(s)/Basis
`Written Description
`Enablement
`Varenna 2012, Muratore,
`Gatti 2009, Dowd
`Varenna Protocol,
`Rossini
`
`
`2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 285–88 (2011), amended 35 U.S.C. §§ 102 and 103. Because the
`’839 patent was filed before March 16, 2013 (the effective date of the
`relevant amendment), the pre-AIA version of § 103 applies.
`
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`Claims
`
`1–9, 13, 14
`
`15–30
`
`
`35 U.S.C. §2
`
`103
`
`103
`
`Reference(s)/Basis
`Walsh, Thompson, Fox,
`Gatti 2009, Rossini
`De Castro, Zaspel,
`Dowd, Hanna
`
`II. ANALYSIS
`
`A. 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 a person of ordinary skill in the art 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 joint pain and/or other related types of pain, or
`in the study of joint pain and/or other related types of pain.” Pet. 13–14
`(citing Ex. 1003 ¶¶ 18–21).
`Patent Owner disputes Petitioner’s definition for a person of ordinary
`skill in the art. PO Resp. 2. Patent Owner contends that the “claims are
`directed to methods of treating pain associated with a joint using a
`medication, i.e. neridronic acid or zoledronic acid,” and as such, “a POSA
`would have an M.D. or a Ph.D. in a discipline related to the interaction of
`drugs with a human body, such as biology, pharmacology, etc., and
`experience in supervising, carrying out, or collaborating in animal or human
`testing, including off-label treatment of patients, related to drug development
`in the pain area.” Id.
`Having considered the parties’ positions and evidence of record,
`summarized above, we agree with Patent Owner that the claims are limited
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`to methods of treating pain associated with CRPS and agree that the
`definition of a person of ordinary skill in the art should likewise include
`those persons having the relevant education and sufficient clinical expertise
`in treating patients with pain associated with CRPS. Accordingly, we adopt
`Patent Owner’s definition of a POSA for the purposes of this decision. That
`said, we discern no appreciable difference in the respective definitions of a
`POSA as that definition relates to the dispositive issues of this case,
`discussed below.
`We further note that prior art may also demonstrate the level of skill
`in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d
`1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding
`ordinary skill level are not required “where the prior art itself reflects an
`appropriate level and a need for testimony is not shown”) (quoting Litton
`Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir.
`1985)). We determine that the prior art here reflects an appropriate level of
`skill in the art and is consistent with the definition of a person of ordinary
`skill in the art, discussed above.
`
`B. Claim Construction
`For petitions filed before November 13, 2018, as is the situation here,
`we interpret claims in an unexpired patent using the “broadest reasonable
`construction in light of the specification of the patent in which [they]
`appear[].” 37 C.F.R. § 42.300(b) (2018).3 Under this standard, we interpret
`
`
`3 Petitioner filed the Petition on October 16, 2018, prior to the effective date
`of the rule change that replaces the broadest reasonable interpretation
`standard with the federal court claim interpretation standard. See Changes to
`the Claim Construction Standard for Interpreting Claims in Trial
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`claim terms using “the broadest reasonable meaning of the words in their
`ordinary usage as they would be understood by one of ordinary skill in the
`art, taking into account whatever enlightenment by way of definitions or
`otherwise that may be afforded by the written description contained in the
`applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
`1997); see In re Smith Int’l, Inc., 871 F.3d 1375, 1382–83 (Fed. Cir. 2017)
`(“[The] broadest reasonable interpretation . . . is an interpretation that
`corresponds with what and how the inventor describes his invention in the
`specification.”). “Under a broadest reasonable interpretation, words of the
`claim must be given their plain meaning, unless such meaning is inconsistent
`with the specification and prosecution history.” TriVascular, Inc. v.
`Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016).
`Petitioner proposes constructions for two terms, listed in the chart
`below.
`Term
`“A method of treating
`pain associated with a
`joint”
`
`Claims
`1–30
`
`Petitioner’s Proposed Construction
`Requires that neridronic acid (claims
`1–14) or zoledronic acid (claims 15–
`30) be administered to a patient having
`pain associated with a joint for the
`purpose of diagnosing, curing,
`mitigating, or preventing pain
`associated with a joint, or for activity
`that otherwise affects the structure or
`
`
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340
`(Oct. 11, 2018) (now codified at 37 C.F.R. § 42.100(b) (2019) (“This rule is
`effective on November 13, 2018 and applies to all IPR, PGR and CBM
`petitions filed on or after the effective date.”).
`
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`
`“pain associated with
`a joint”
`
`any function of the body in a patient
`with pain associated with a joint.
`
`Any pain related to a joint in any way.
`
`1–30
`
`
`Pet. 14 (chart identifying Petitioner’s proposed claim constructions); see
`also, id. at 15 (citing Ex. 1003 ¶¶ 39–41) (“given its broadest reasonable
`interpretation, ‘pain associated with a joint’ means ‘any pain related to a
`joint in any way.’”).
`Patent Owner responds by first noting that claims 1 and 15 require “a
`patient who has suffered for at least 3 months with 1) pain associated with a
`joint and 2) a pain intensity of 5 or greater measured using the 0–10
`[numerical rating scale (NRS)] or 5 cm or greater using the 10 cm [visual
`analog scale (VAS)].” Ex. 1001, 105:38–44, 106:14–21; PO Resp. 2–3.
`Patent Owner further contends that
`the specification clearly states that for “patients with clinical
`knee osteoarthritis,” the decrease in VAS pain intensity was far
`greater for patients having a VAS score of 5 cm or greater as
`compared to patients having a VAS less than 5 cm. (Ex. 1001,
`col. 53, ll. 48-49; col. 54, ll. 25-46.) The specification further
`states “pain reduction was greater in patients with OARSI Grade
`0 joint space narrowing, and greatest in patients with both
`baseline VAS≥50 mm and OARSI Grade 0 joint space
`narrowing.” (Ex. 1001, col. 54, ll. 44-48 (emphasis added).)
`Sur-Reply 1. Thus, according to Patent Owner, the plain language of the
`claims when read in light of the Specification would indicate to a person of
`ordinary skill in the art that the pain intensity limitation is in connection to
`joint pain. Id.; PO Resp. 2–3.
`Furthermore, Patent Owner points out that Petitioner’s expert, Dr.
`Poree, testified that he understood the claims to refer to joint pain intensity.
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`PO Resp. 2–3; Sur-Reply 1. Specifically, Patent Owner directs our attention
`to the following testimony of Dr. Poree:
`[Claim 1] covers (a) administration of neridronic acid for the
`purpose of treating any type of pain related to a joint in any way,
`as “treating” is broadly defined in the ’839 patent, (b) to a patient
`who has suffered from such pain that is greater than 5 cm on the
`VAS, (3) for at least 3 months.
`Ex. 1003 ¶ 83 (emphasis omitted); PO Resp. 2–3; Sur-Reply 1.
`In its Reply, Petitioner contends that
`By the plain language of the claims, the patient need not have
`joint-associated pain with intensity of 5 or greater; he or she need
`only have joint-associated pain and pain with intensity of 5 or
`greater. Patent Owner does not point to any evidence in the
`intrinsic record that would compel a deviation from the plain
`reading of the claims. Patent Owner could have worded the
`claims to read “a patient who has suffered for at least 3 months
`with pain associated with a joint having intensity of 5 or greater,”
`but it did not. Instead, it wrote claims with two separate, clearly
`delineated requirements, which squarely contradicts Patent
`Owner’s proposed construction.
`Reply 5 (emphases omitted).
`Having considered the parties’ positions and evidence of record,
`summarized above, we agree with Patent Owner the challenged claims are
`directed to “treating pain associated with a joint” and that the plain reading
`of the claims, as well as the intrinsic evidence, support a conclusion that the
`term “pain intensity” is properly interpreted to refer to the intensity of joint
`pain. See e.g. Ex. 1001, Abstract (“neridronic acid and zoledronic acid . . .
`can be used to treat or alleviate pain or related conditions, such as joint
`conditions”). To the extent further discussion of the meaning of this term is
`necessary to our decision, we provide that discussion below in our analysis
`of the asserted grounds of unpatentability.
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`We determine that no express construction of any other claim term is
`necessary to determine whether Petitioner has shown by a preponderance of
`the evidence that the claims are unpatentable in this case.
`
`C. Printed Publication
`1. Summary of Law
`In a proceeding before the Board, there is no presumption in favor of
`finding that a reference is a printed publication. Hulu, LLC v. Sound View
`Innovations, LLC, IPR2018-01039, Paper 29 at 12–14 (PTAB Dec. 20,
`2019) (precedential). To qualify as a “printed publication” within the
`meaning of § 102, a reference “must have been sufficiently accessible to the
`public interested in the art” before the critical date. In re Cronyn, 890 F.2d
`1158, 1160 (Fed. Cir. 1989). Whether a reference is publicly accessible is
`determined on a case-by-case basis based on the “facts and circumstances
`surrounding the reference’s disclosure to members of the public.” In re
`Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009).
`A reference is considered publicly accessible if it was disseminated or
`otherwise made available to the extent that persons interested and ordinarily
`skilled in the subject matter or art, exercising reasonable diligence, can
`locate it. Id.; see Acceleration Bay, LLC v. Activision Blizzard Inc., 908
`F.3d 765, 772 (Fed. Cir. 2018) (“A reference is considered publicly
`accessible if it was ‘disseminated or otherwise made available to the extent
`that persons interested and ordinarily skilled in the subject matter or art,
`exercising reasonable diligence, can locate it.’”).
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`2. Parties’ Arguments
`In the present case, Patent Owner argues that Petitioner cites to no
`evidence to support its contention that any of the relied upon eight non-
`patent references were publically accessible before the effective filing date
`of the invention and therefore prior art to the ’839 patent. PO Resp. 3–9.
`Patent Owner contends that “Petitioner did nothing more than point to the
`date on the face of each document as proof of its printed publication status”
`and that “[t]he law requires considerably more than that.” Id. at 8. Patent
`Owner further contends that
`It is likely that Petitioner will respond by essentially arguing that
`its non-patent references are from reputable publishers, or
`trustworthy sources, or that POSAs would recognize them as
`such. Indeed, Petitioner has already made such an argument with
`regard to Varenna Protocol. (Pet. at 39; Ex. 1003, ¶¶ 212–215.)
`But that only begs the question of why Petitioner failed to make
`even this minimal (and inadequate) effort for the other seven
`non-patent references. For each one, Petitioner offered no expert
`testimony and nothing that could qualify as argument or evidence
`to support a finding of printed publication status.
`Id. at 9 (citing Pet. 26 (Ex. 1009), 27 (Ex. 1014), 29 (Ex. 1006), 30
`(Ex. 1007), 59–60 (Ex. 1013), 68 (Ex. 1015), and 69 (Ex. 1016)); see Sur-
`Reply 4–8 (“Petitioner has not presented any evidence of the public
`accessibility of the eight non-patent references it has advanced as
`‘printed publication’ prior art.”).
`In its Reply, Petitioner, with regard to Verrena, Muratore, Gatti 2009,
`Dowd, Rossini, and deCastro, contends that “[i]t is evident from the face of
`six of the non-patent references [(i.e. Ex. 1005, Ex. 1006, Ex. 1007, Ex.
`1009, Ex. 1013, and Ex. 1015)] that they are articles published in periodical
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`journals by an identified and reputable publisher prior to March 16, 2013.”
`Reply 1.
`With regard to Zaspel, Petitioner contends that
`The seventh reference, Zaspel (Ex. 1016), is a meeting abstract
`from the German Congress for Orthopedics and Trauma Surgery
`published by German Medical Science GMS Publishing House,
`which is also plainly prior art. It bears a publication date of
`October 9, 2007 and a copyright date of 2007.
`Id. at 2.
`With regard to Varenna Protocol, Petitioner contends that
`The eighth reference, the Varenna Protocol (Ex. 1014), falls into
`a different category because it is not a published journal article
`or meeting abstract, but rather is a record of a clinical trial from
`the website clinicaltrials.gov. For this reason, Petitioner
`provided additional proofs and expert testimony concerning this
`reference’s publication date.
`Reply 2 (citing Pet. 39; Ex. 1003 ¶¶ 212–215; Ex. 1001, 5); see Ex. 1003
`¶ 214 (Dr. Poree testifying that “[a] POSA would have considered the
`posting dates cited at clinicaltrials.gov to be trustworthy and authoritative,
`and would have understood that the Varenna Protocol was published online
`on March 4, 2013 and last updated on March 14, 2013.”).
`Petitioner further contends that
`Patent Owner did not timely object to any of the cited non-patent
`references within ten business days of the institution of trial as
`required by 37 C.F.R. § 42.64(b)(1). Patent Owner therefore
`waived any evidentiary objections to the non-patent references,
`including their printed publication and copyright dates. Thus,
`those dates are properly before the Board; and absent any
`evidence to the contrary, they must be accepted as true and are
`sufficient evidence to show that these references qualify as prior
`art as the Board correctly found at the institution phase.
`Reply 3–4.
`
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`3. Discussion
`In post grant review proceedings, documents are admitted into
`evidence subject to an opposing party asserting objections to the evidence
`and moving to exclude the evidence. 37 C.F.R. § 42.64. Where, as here, a
`ground of unpatentability is based upon a reference that is alleged to be prior
`art as a printed publication, there may be issues regarding both the
`admissibility of that evidence and the sufficiency of that evidence.
`Generally, admissibility is addressed in a motion to exclude, and sufficiency
`is addressed within a party’s papers. See, e.g., Standard Innovation Corp. v.
`LELO, Inc., IPR2014-00148, Paper 42 (PTAB Apr. 23, 2015); Valeo North
`America, Inc., et al. v. Magna Electronics, Inc., IPR2014-01208, Paper 49
`(PTAB Dec. 21, 2015).
`In this case, Patent Owner does not challenge the admissibility of
`evidence, which would have required Patent Owner to serve objections
`within the required ten business days of institution of trial and to file a
`motion to exclude. 37 C.F.R. §§ 42.64(b)(1), 42.64(c). Consequently, we
`only consider Patent Owner’s challenge to the sufficiency of the evidence in
`its Patent Owner Response.
`Regarding Patent Owner’s challenge to the sufficiency of the
`evidence, we have considered the parties’ positions and evidence of record,
`summarized above, and find Petitioner has made a sufficient showing that
`each of these references qualify as a prior art printed publication. Regarding
`Varenna 2012, Muratore, Gatti 2009, Dowd, Rossini, deCastro, and Zaspel,
`each of these references bears several hallmarks suggesting that each was
`published as part of a regularly distributed medical journal. For example,
`Varenna 2012 appears to have been published and made available to the
`
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`Patent 9,867,839 B2
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`interested scientific community via the journal Rheumatology in 2012, prior
`to the priority date of the ’839 patent. Reply 7–11; Ex. 1005 (indicia on the
`face of the document); Ex. 1044 (Patent Owner Response in PGR2017-
`00022). Varenna 2012 bears several hallmarks suggesting it was published
`in 2012 as part of a regularly distributed medical journal. These hallmarks
`include the name of the journal (“Rheumatology”); citation information
`reflecting the date, the volume number, and the pertinent page numbers of
`the journal (“2013; 52:534–542”); the dates the article was available to the
`public (“Advance Access publication 30 November 2012”); a link to the
`website of the journal (“www.rheumatology.oxfordjournals.org”); the
`publisher of the journal (“© The Author 2012. Published by Oxford
`University Press on behalf of the British Society for Rheumatology”); and
`where readers interested in learning more about the topic of Varenna 2012
`could make inquiries (“Correspondence to: Silvano Adami, Rheumatology
`Unit, Policlinico GB Rossi, Piazzale Scuro, 37121 Verona, Italy”).
`Likewise, each of Muratore, Gatti 2009, Dowd, Rossini, de Castro, and
`Zaspel provides similar indicia of publication. Ex. 1005; Ex. 1006; Ex.
`1007; Ex. 1009; Ex. 1013; Ex. 1015; Ex. 1016.
`We are persuaded that the information pertaining to the publication on
`the face of each of Muratore, Gatti 2009, Dowd, Rossini, de Castro, and
`Zaspel is sufficient to establish each document qualifies as a printed
`publication. See, e.g., Telefonaktiebolaget LM Ericsson v. TCL Corp., 941
`F.3d 1341, 1344 & 1347 (Fed. Cir. 2019) (holding that “the date on the face
`of the journal” was part of the substantial evidence supporting PTAB’s
`finding that a journal article was prior art); Hulu, IPR2018-01039, Paper 29
`
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`Patent 9,867,839 B2
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`at 17–20 (“[T]he indicia on the face of a reference, such as printed dates and
`stamps, are considered as part of the totality of the evidence.”).
`Varenna Protocol differs from the other cited references in that it is a
`printout from a website not associated with a regularly distributed
`publication. Rather, Varenna Protocol is a printout from the website
`https://www.clinicaltrials.gov. Varenna Protocol, however, contains similar
`indicia of publication, in particular a “First Posted” date and a “Last Update
`Posted” date, indicating that the study record disclosed in Varenna Protocol
`was first available on clinicaltrials.gov on March 4, 2013, and that the
`information contained in the study record has not changed since March 14,
`2013. Ex. 1014, 1; Pet. 39; Ex. 1003 ¶¶ 212–213.
`Other indicia indicate that the website is associated with the U.S.
`National Library of Medicine at the National Institutes of Health (NIH). Ex.
`1014, 1. In this regard, Dr. Poree testifies that clinicaltrials.gov is a reliable
`and trustworthy source for information about scheduled, ongoing, and
`completed clinical trials, and one of ordinary skill in the art would have
`considered the posting dates cited at clinicaltrials.gov to be trustworthy and
`authoritative. Ex. 1003 ¶ 214.
`Having considered such evidence, we determine that the totality of the
`evidence—the indicia of publication on the face of the document and
`undisputed testimony of Dr. Poree—supports a finding that Varenna
`Protocol was publically available as of March 4, 2013, the “First Posted”
`date on the face of the document. We further credit the testimony of Dr.
`Poree and are not persuaded by Patent Owner’s bare attorney argument to
`the contrary. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974)
`(attorney argument cannot take the place of evidence lacking in the record).
`
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`Patent 9,867,839 B2
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`In view of the above, we determine that Varenna Protocol qualifies as a prior
`art printed publication to the ’839 patent.
`
`D. The Asserted Grounds of Unpatentability
`1. Written Description Support
`Petitioner asserts that claims 1–14 lack written description support
`because “the ’839 patent specification nowhere describes . . . administering
`neridronic acid to a patient having pain associated with a joint measuring ≥5
`cm on the VAS for at least 3 months, as recited in claim 1.” (Pet. 22 (citing
`Ex. 1003 ¶ 63)). Petitioner acknowledges that “the ’839 patent specification
`generally discusses administration of bisphosphonates to a patient that has
`‘suffered from [an] inflammatory condition for at least 1 month, at least 2
`months, at least 3 months, at least 6 months, or at least 1 year,’” but
`contends that “disease duration is not the same as pain duration.” Id. at 23
`(citing Ex. 1001, 8:19–25). “Consequently,” Petitioner contends that the
`’839 patent’s disclosure “would not demonstrate to a POSA that the inventor
`was in possession of and actually invented methods of treating patients
`having pain associated with a joint measuring ≥5 cm on the VAS for
`particular periods of time, such as “‘at least 3 months.’” Id. (citing Ex. 1003
`¶¶ 66–68).
`It is well settled that “original claims constitute their own
`description.” In re Koller, 613 F.2d 819, 823 (CCPA 1980); see also
`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.”).
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`Patent 9,867,839 B2
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`Claim 1, as originally filed, is as follows:
`A method of treating pain associated with a joint comprising:
`administering neridronic acid in an acid or a salt form to a patient
`that has suffered for at least 3 months with 1) pain associated
`with a joint and 2) a pain intensity of 5 or greater measured using
`the 0–10 numerical rating scale (NRS) or 5 cm or greater using
`the 10 cm visual analog scale (VAS).
`Ex. 1002, 14 (file history of the ’839 patent). Original claim 1 is
`equivalent in scope and virtually identical in language to the subject
`matter of challenged claim 1. Accordingly, we determine that claim 1
`constitutes its own description.
`On this record, we determine that Petitioner has failed to establish that
`claims 1–14 are unpatentable for lack of written description support.
`
`2. Enablement
`Petitioner contends that claims 1–144 lack enablement because the
`Specification does not teach one of ordinary skill in the art how to
`administer neridronic acid to a patient who has suffered for at least 3 months
`with complex regional pain syndrome (CRPS). Pet. 46. Petitioner notes that
`“[t]he ’839 specification does not contain any examples of methods of
`treatment involving neridronic acid, let alone examples of the use of
`neridronic acid to treat pain associated with CRPS wherein the patient has
`been suffering for 3 months from CRPS and a specific pain intensity.” Id. at
`
`
`4 Petitioner notes that claims 10, 11, and 12 depend from claims 1, 2, and 3,
`respectively, and each specifies that the patient to be treated is suffering
`from complex regional pain syndrome (CRPS). Pet. 46–47. Petitioner
`contends that claims 1–9, 13, and 14 also lack enablement because they
`encompass treatment of CRPS.
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`48 (citing Ex. 1003 ¶¶ 72–73). Petitioner further notes that the Specification
`“broadly
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