Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 31
`Entered: December 22, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`PGR2018-00092
`Patent 9,820,999 B2
`____________
`
`Before GRACE KARAFFA OBERMANN, SHERIDAN K. SNEDDEN,
`and CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`
`
`
`
`
`
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`PGR2018-00092
`Patent 9,820,999 B2
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`
`INTRODUCTION
`I.
`We issue this revised Final Written Decision after our decision to
`grant Petitioner’s Request for Rehearing (Paper 29) and vacate our original
`Final Written Decision (Paper 25).
`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 1–30 of U.S.
`Patent No. 9,820,999 B2 (Ex. 1001, “the ’999 patent”) are unpatentable.
`
`A. Procedural Background
`Petitioner filed a Petition requesting inter partes review of claims 1–
`30 (“the challenged claims”) of the ’999 patent. Paper 2 (“Pet.”). Patent
`Owner did not file a Patent Owner Preliminary Response. Upon
`consideration of the information presented in the Petition, we instituted an
`inter partes review of claims 1–30 of the ’999 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 10; “PO Resp.”), Petitioner filed a Reply (Paper 11; “Reply”), and
`Patent Owner filed a Sur-Reply (Paper 18; “Sur-Reply”).
`
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`PGR2018-00092
`Patent 9,820,999 B2
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`
`The Petition is supported by the Declaration of Lawrence Poree,
`M.D., Ph.D. Ex. 1003. In its Reply, Petitioner relies on the Declaration of
`Dr. Philip Robinson, MBChB, PhD, FRACP (Ex. 1044).
`Oral argument was conducted on November 21, 2019. A transcript is
`entered as Paper 23 (“Tr.”).
`Petitioner timely filed a Request for Rehearing (Paper 26, “Req.
`Reh’g.”) requesting rehearing of our original Final Written Decision (Paper
`25). We granted Petitioner’s request for rehearing and vacated our original
`Final Written Decision. Paper 29.
`In this revised, corrected Final Written Decision, we address all
`arguments and evidence set forth in the Papers to the extent necessary to
`resolve the dispute between the parties.
`
`B. The ’999 Patent (Ex. 1001)
`The ’999 patent is titled “Neridronic Acid for Treating Complex
`Regional Pain Syndrome.” Ex. 1001, [54]. The specification of the ’999
`patent describes “[o]steoclast inhibitors, such as neridronic acid, in an acid
`or salt form” for treating or alleviating “pain or related conditions, such as
`complex regional pain syndrome” (“CRPS”). Id., [57]. Two
`bisphosphonates specifically discussed in the specification are zoledronic
`acid and neridronic acid. See Ex. 1001, Figs. 1–16, 2:64–4:3 (figures and
`descriptions of figures, all pertaining to a method that employs zoledronic
`acid); see also id. at 2:50–60, 4:8 (identifying both zoledronic acid and
`neridronic acid as useful for treating CRPS triggered by bone fracture).
`The ’999 patent specification discusses a method of administering
`bisphosphonates—and, in particular, zolendronic acid or neridronic acid—
`for treating “bone fractures or to enhance the healing of bone fractures” in “a
`
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`PGR2018-00092
`Patent 9,820,999 B2
`
`human being that is treated for CRPS, suffered from a precipitating injury
`such as a bone fracture.” Id. at 8:27–37. The specification, moreover, states
`that “[a]n oral dosage form of bisphosphonate such as zoledronic acid may
`be used to treat, or provide relief of, any type of pain including, but not
`limited to,” for example, CRPS. Id. at 7:43–52. The specification identifies
`“bisphosphonate” compounds generally, and neridronic acid in particular, as
`useful for mitigating “pain associated” with, for example, “vertebral crush
`fractures” in a human being. Ex. 1001, 7:66–8:19, 8:64–67, 15:25–37, 91:5–
`7 (Embodiment 282), 93:50–94:5–32 (Embodiments 314–318).
`Example 3 relates to “[t]he effect of orally administered zoledronic
`acid” in a “rat tibia fracture model of” CRPS. Id. at 51:28–30. Example 3
`reports that zoledronic acid mitigates pain associated with CRPS, where that
`condition is induced in “rats by fracturing the right distal tibias of the
`animals.” Id. at 51:30–31. Example 3 discusses pain assessment methods
`and pain reduction achieved in the rat tibia fracture model when zoledronic
`acid is selected as the bisphosphonate. Id. at 51:47–52:11. In addition,
`Example 3 explains that “[t]his animal model has been shown to replicate
`the inciting trauma” (for example, a bone “fracture”) that is “observed in
`human CRPS patients.” Id. at 51:33–38.
`The ’999 patent includes no working example using neridronic acid as
`the bisphosphonate. The general disclosure provides dosing information
`pertaining to neridronic acid when that compound is selected for use in the
`claimed method. See, e.g., id. at 26:30–43.
`
`C. Illustrative Claim
`Claim 1, the only independent challenged claim, is illustrative and
`reproduced below:
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`PGR2018-00092
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`
`1. A method of treating pain associated with complex regional
`pain syndrome (CRPS) comprising selecting a human being
`having CRPS triggered by bone fracture and administering
`neridronic acid or a pharmaceutically acceptable salt thereof to
`the human being, wherein the treatment is effective in reducing
`pain.
`Ex. 1001, 106:25–30 (emphasis added).
`The other challenged claims (namely, claims 2–30) depend directly or
`indirectly from claim 1 and specify additional limitations that pertain to the
`type of CRPS, the form of neridronic acid, the method of administration, the
`age of the treated human being, baseline pain intensity, and dosing regimens.
`See id. at 106:31–107:26.
`
`D. Asserted Prior Art
`The Petition identifies the following references as prior art in the
`grounds of unpatentability:
`(1) M. Varenna et al., Treatment of complex regional pain syndrome
`type I with neridronate: a randomized, double-blind, placebo-controlled
`study, RHEUMATOLOGY 52:534–42 (NOV. 2012) (Ex. 1005,
`“Varenna 2012”);
`
`(2) M. Varenna et al., Predictors of responsiveness to bisphosphonate
`treatment in patients with complex regional pain syndrome type I: A
`retrospective chart analysis, PAIN MED. 18:1131–38 (2017) (Ex. 1015,
`“Varenna 2016”);
`
`(3) Manara et al., SAT0524 Predictors of a Clinical Response to
`Bisphosphonates Treatment in Patients with Complex Regional Pain
`Syndrome Type I, ANNALS OF THE RHEUMATIC DISEASES, 73 (Suppl. 2)
`(2014) (Ex. 1037, “Manara”);
`
`(4) S. Bruehl, “How common is complex regional pain syndrome-
`Type I?,” PAIN 129:1–2 (2007) (Ex. 1006, “Bruehl”);
`
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`
`(5) 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. 1007, “Gatti”);
`
`(6) G. La Montagna et al., Successful neridronate therapy in transient
`osteoporosis of the hip, CLIN. RHEUMATOL. 24: 67–69 (Aug. 2004) (Ex.
`1008, “La Montagna”);
`
`(7) D. Manicourt et al., Role of alendronate in therapy for
`posttraumatic complex regional pain syndrome type I of the lower extremity,
`ARTHRITIS & RHEUMATISM 50(11): 3690–97 (Nov. 2004) (Ex. 1009,
`“Manicourt”);
`
`(8) 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. 1010,
`“Muratore”); and
`
`(9) Schwarzer & Maier, Complex regional pain syndrome, in GUIDE
`TO PAIN MANAGEMENT IN LOW-RESOURCE SETTINGS 249–254 (Kopf & Patel
`eds. 2010) (Ex. 1020, “Schwarzer”).
`
`E. Asserted Grounds of Unpatentability
`We instituted review of claims 1–30 of the ’999 patent as follows.
`Paper 7.
`
`35 U.S.C. §1
`
`Reference(s)/Basis
`
`Claims
`1–4, 9, 10, 12, 14, 16–
`18, 23–25, 27–29
`
`1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. §§ 102 and 103. Because the
`’514 patent was filed before March 16, 2013 (the effective date of the
`relevant amendment), the pre-AIA version of § 103 applies.
`
` 102(a)
`
`Varenna 2012
`
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`

`35 U.S.C. §1
`
`Reference(s)/Basis
`
` 102(a)
`
`Varenna 2016
`
` 102(a)
`
`Manara
`Varenna 2012, Varenna 2016,
`Manara, Bruehl
`Gatti, La Montagna,
`Muratore
`Varenna 2012, Varenna 2016,
`Manara, and Manicourt
`Varenna 2012, Varenna 2016
`Manara, Schwarzer, Bruehl,
`Gatti, La Montagna, Muratore
`
`
`PGR2018-00092
`Patent 9,820,999 B2
`
`
`Claims
`1–4, 9, 10, 12, 14, 16–
`18, 23–25, 27–28
`1–4, 9, 10, 12, 14, 16–
`18, 24–25, 27–28
`
`1–4, 9–20, 22–29
`
` 103(a)
`
`5–8, 21
`
`30
`
`1–30
`
`
` 103(a)
`
` 103(a)
`
` 112(a),
`Enablement
`
`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 (“POSA”) 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. 13–14 (citing
`Ex. 1003 ¶ 20).
`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 CRPS using a
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`medication, i.e. neridronic 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. at 2–
`3.
`
`Having considered the parties’ positions and evidence of record,
`summarized above, we agree with Patent Owner that the claims are limited
`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. That said, we discern
`no material differences between the parties’ respective definitions that would
`alter the outcome of our decision based on our acceptance of one over the
`other.
`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)).
`
`B. Claim Construction
`For petitions filed before November 13, 2018, we interpret the claims
`of an unexpired patent that will not expire before issuance of a final written
`decision using the broadest reasonable interpretation in light of the
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`specification. See 37 C.F.R. § 42.100(b) (2018)2; Cuozzo Speed Techs., LLC
`v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under the broadest reasonable
`construction standard, claim terms are presumed to have their ordinary and
`customary meaning, as would be understood by one of ordinary skill in the
`art in the context of the entire disclosure. In re Translogic Tech., Inc.,
`504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms that are in controversy
`need to be construed, and then only to the extent necessary to resolve the
`controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999).
`Petitioner proposes claim constructions for the claim terms set forth in
`the table below. Pet. 14–18.
`Term
`Claims
`“A method of treating
`1–30
`pain associated with
`complex regional pain
`syndrome (CRPS)
`comprising selecting a
`human being having
`CRPS”
`
`Petitioner’s Proposed Construction
`Requires that neridronic acid be
`administered to a human being having
`CRPS for the purpose of diagnosing,
`curing, mitigating, or preventing pain
`associated with CRPS, or for activity
`that otherwise affects the structure or
`any function of the body in a human
`being with CRPS.
`Synonymous with fracture as a
`“precipitating event” or “predisposing
`event,” i.e., a bone fracture causes or
`contributes to the occurrence or onset of
`CRPS.
`
`“triggered by bone
`fracture”
`
`1–30
`
`
`2 An amendment to this rule does not apply here, because the Petition
`was filed before November 13, 2018. 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)
`(amending 37 C.F.R. § 42.200(b) effective November 13, 2018) (now
`codified at 37 C.F.R. § 42.100(b) (2019)).
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`“wherein the treatment
`is effective in
`reducing pain”
`
`1–30
`
`The treatment actually results in an
`observed and/or measured reduction in
`pain in a patient.
`
`We have considered Petitioner’s claim constructions and adopt
`Petitioner’s undisputed construction for the terms “triggered by bone
`fracture” and “wherein the treatment is effective in reducing pain.”
`Petitioner’s construction of those terms aligns with the plain words of the
`claim, finds support in the uncontroverted testimony of Dr. Poree, and is not
`contested by Patent Owner. Pet. 14–15; Ex. 1003 ¶¶ 35–41; see PO
`Resp. 3–4 (Patent Owner, nowhere opposing that construction).
`Patent Owner disputes Petitioner’s construction for “[a] method of
`treating pain associated with complex regional pain syndrome (CRPS)
`comprising selecting a human being having CRPS” in claim 1 of the ’999
`patent. PO Resp. 3–4. Patent Owner first notes that the term “comprising”
`transitions from the preamble “[a] method of treating pain associated with
`complex regional pain syndrome (CRPS)” to the body of the claim, which
`begins with the verb “selecting.” Next, Patent Owner contends that the first
`element in the body of the claims is “selecting a human being having CRPS
`triggered by a bone fracture,” and that Petitioner’s proposed construction
`reads the term “selecting” out of the claim. Id.
`We agree with Patent Owner the term “selecting” appears in the body
`of the claim and that “selecting a human being having CRPS triggered by
`bone fracture” is a required element of the claims. 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. Effective Filing Date of the ’999 Patent
`We next resolve the effective filing date of the ’999 patent. When
`discussing the prior art status of Varenna 2012, Petitioner indicates that the
`effective filing date of the ’999 patent is “May 14, 2013—the filing date of
`U.S. Patent Application No. 13/894,274” (“the ’274 application”). Pet. 32;
`see Ex. 1001, [63] (identifying the ’274 application as a priority document).
`Elsewhere in the Petition, however, Petitioner repeatedly asserts that the
`earliest possible effective filing date is December 7, 2016—that is, the filing
`date of Provisional Application No. 62/431,287 (“the ’287 application”),
`which is the third-filed of three provisional applications identified on the
`face of the ’999 patent. Pet. 9, 11–12, 16, 20, 24 n.1, 45–46; see Ex. 1001,
`[60] (claiming priority through three provisional applications, including the
`’287 application). For reasons explained below, we find that the effective
`filing date of the ’999 patent is May 14, 2013, the filing date of the ’274
`application. See Ex. 1001, [63] (identifying chain of priority from May 14,
`2013, the filing date of the ’274 application).
`Petitioner acknowledges that the ’999 patent claims the benefit of
`priority not only from the filing date of the ’274 application, but also from
`the filing date of Provisional Application No. 61/646,538 (“the ’538
`application”), which is the first-filed provisional application identified on the
`face of the ’999 patent. Pet. 32; see Ex. 1001, [60] (identifying the ’538
`application, filed May 14, 2012); see id. at [63] (claiming priority also
`through the ’247 application, filed May 14, 2013). The ’538 application was
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`filed on May 14, 2012. Petitioner argues that the disclosure of the ’538
`application, however, does not support the challenged claims because that
`application nowhere refers to the claim 1 limitation that requires “bone
`fracture as a triggering event for CRPS.” Id.3
`We find that Petitioner shows sufficiently that the disclosure of
`the ’538 application does not support the claims of the ’999 patent. See
`Pet. 20–24 (and evidence cited therein). Petitioner’s information on that
`point is not challenged. On this record, we agree with Petitioner that
`the ’538 application nowhere mentions any triggering events for CRPS and,
`further, that a person of ordinary skill in the art “would not have understood
`that administering neridronic acid to treat CRPS specifically triggered by
`bone fracture was an aspect of the alleged invention.” Pet. 20; Ex. 1003 ¶ 45
`(Dr. Poree’s assertion that “[t]he terms ‘bone,’ ‘fracture,’ and ‘triggered’ do
`not appear anywhere in the [’538] application”), ¶ 46 (Dr. Poree’s further
`assertion that “[n]othing in the ’538 application suggests that the patentee
`was in possession of a method of treating pain associated with CRPS
`
`
`3 Elsewhere in the Petition, Petitioner asserts that the ’999 patent claims are
`not entitled to the benefit of the filing date of the second-filed Provisional
`Application No. 62/378,140 (“the ’140 application”), which was filed on
`August 22, 2016. Pet. 29. We agree with Petitioner that the ’140
`application “does not even mention neridronic acid at all.” Id.; see generally
`Ex. 1029, 9–35 (the ’140 application). We disagree with Petitioner’s further
`contention, however, that the ’140 application does not support the
`limitation that requires bone fracture as a triggering event for CRPS.
`Pet. 46. In that regard, the ’140 application discloses “[t]he therapeutic
`efficacy of bisphosphonate treatment in the rat CRPS fracture model”—
`including data pertaining to a rat tibia fracture study, which demonstrates
`“that bisphosphonate therapy inhibits pain . . . in the rat fracture model
`of CRPS.” Ex. 1029, 9, 11, 23.
`
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`triggered by bone fracture” or “that this was even an aspect of the alleged
`invention”); see Ex. 1016, 4–6 (disclosure from the ’538 application,
`nowhere mentioning bone fracture as a triggering event for CRPS).
`Petitioner does not show adequately, however, that the ’999 patent is
`not entitled to claim the benefit of the filing date of the ’274 application,
`which was filed on May 14, 2013. Ex. 1001, [63] (the ’999 patent,
`identifying the ‘274 application as a priority document); see, e.g., Pet. 9, 11–
`12, 16, 20, 24 n.1, 45–46 (Petitioner, asserting that the earliest possible
`effective priority date is December 7, 2016, but failing to account adequately
`for the claim of priority that derives from the filing date of the ’274
`application). On that point, Petitioner argues only that the ’274 application
`contains no “additional information about how to treat CRPS with
`neridronate other than the limited information in the ’999 patent
`specification.” Pet. 29. Significantly, however, the ’274 application
`identifies “neridronate or neridronic acid” as “another bisphosphonate” that
`“may also be useful to treat complex regional pain syndrome” and “acute
`vertebral crush fracture.” Ex. 1024 ¶¶ 23, 37, claim 79. The ’274
`application expressly defines “[t]he term ‘treating’ or ‘treatment’” to
`“broadly include any kind of treatment activity, including . . . mitigation or
`prevention of disease in man . . . or any activity that otherwise affects the
`structure or any function of the body of man.” Id. ¶ 24. The ’274
`application also discloses data, in Example 3, which specifically addresses
`the efficacy of administering a bisphosphonate compound, and reports the
`results of a rat tibia fracture model study, which includes pain assessments
`performed on rats having CRPS triggered by bone fractures. Id. ¶¶ 97–101.
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`On this record, we reject Petitioner’s contention that the ’274
`application fails to support the limitation of claim 1 that requires the
`effective treatment of pain associated with CRPS triggered by bone fracture.
`Pet. 32. Accordingly, we assign the ’999 patent an effective filing date of
`May 14, 2013—the date of filing of the ’274 application. Ex. 1001, [63].
`
`D. Varenna 2012 is a Prior Art Printed Publication
`Inter partes review may be requested only “on a ground that could be
`raised under section 102 or 103 and only on the basis of prior art consisting
`of patents or printed publications.” 35 U.S.C. 311(b). 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 also 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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`
`In the present case, Patent Owner argues that Petitioner cites to no
`evidence to support its contention that Varenna 2012 was publicly accessible
`before the effective filing date of the invention and therefore prior art to the
`’999 patent. PO Resp. 4–13. Patent Owner contends that the only evidence
`entered in support of the Petition is Ex. 1005, “a .pdf file downloaded from
`the Internet on December 6, 2017.” PO Resp. 4–5; Ex. 1005. Patent Owner
`contends that “[s]omething downloaded from the Internet on December 6,
`2017, is obviously not prior art to something having a priority date of May
`14, 2013, such as the ’999 patent.” Id. at 5; Sur-Reply 6–7. Patent Owner
`further contends that a copyright notice standing alone does not constitute
`evidence demonstrating that Varenna 2012 was in fact publicly accessible
`before the priority date of May 14, 2013. PO Resp. 5–6; Sur-Reply 12–13.
`In its Reply, Petitioner contends that it has provided sufficient
`evidence demonstrating that Varenna 2012 is a prior art printed publication
`to the ’999 patent. Reply 5–11. Specifically, Petitioner argues that
`Varenna 2012 was plainly published, i.e. made publicly
`available, before [earliest possible priority date of May 14,
`2013]. At the top of the first page, Varenna 2012 expressly states
`that it is an article from the journal Rheumatology published on
`November 30, 2012. Ex. 1005 at 534. Moreover, the copyright
`line at the bottom of the first page reads: “© The Author 2012.
`Published by Oxford University Press on behalf of the British
`Society for Rheumatology. All rights reserved. For Permissions,
`please email: journals.permissions@oup.com.”
` Id.
` This
`indicates that Varenna 2012 was published in 2012 by a well-
`known and reputable publisher.
`Id. at 5. In its Reply, Petitioner additionally relies on the Declaration of Dr.
`Philip Robinson, who testifies that he accessed, reviewed, and posted about
`Varenna 2012 on the social media site Twitter in February 2013, which is
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`before the May 14, 2013 priority date of the ’999 patent. Ex. 1044;
`Reply 11.
`We have considered the parties’ positions, summarized above, and
`find Petitioner to have the better position. In reaching our determination, we
`weigh the totality of the evidence currently in the record to resolve the
`dispute between the parties of whether Varenna 2012 is a prior art printed
`publication. On one hand, we weigh the evidence supporting Petitioner’s
`position that Varenna 2012 was published and made available to the
`interested scientific community via the journal Rheumatology prior to the
`priority date of the ’999 patent, summarized above. Reply 7–11; Ex. 1005
`(indicia on the face of the document); Ex. 1044. To that point, we are
`persuaded that the information pertaining to the publication of Varenna 2012
`on the face of the document is sufficient to establish Varenna 2012 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, 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.”).
`In particular, 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
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`.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 can make inquiries (“Correspondence to: Silvano
`Adami, Rheumatology Unit, Policlinico GB Rossi, Piazzale Scuro, 37121
`Verona, Italy”). Ex. 1005.
`On the other hand, we consider the lack of evidence supporting Patent
`Owner’s position that Varenna 2012 is not a printed publication. In this
`regard, we note that Patent Owner provides no evidence to counter the
`indicia on the face of Varenna 2012 or the testimony of Dr. Philip Robinson.
`PO Resp. 4–13; Sur-Reply 5–13. Indeed, Patent Owner does not even
`contest that Oxford University Press is a known publisher or that
`Rheumatology is an established journal. Tr. 30:13–21. Rather, Patent
`Owner’s position is that Petitioner has failed to meet its burden of
`establishing Varenna 2012 as a prior art printed publication—that is, the
`indicia of publication on the face of the document are insufficient to
`establish the Varenna 2012 as a prior art printed publication. PO Resp. 8–
`10.
`
`We also consider Patent Owner’s attorney argument in response to the
`declaration evidence of Dr. Robinson, that
`This testimony does not show accessibility by interested POSAs.
`The declarant does not say, for example, whether he “accessed
`[and] reviewed” Varenna 2012 after a reasonably diligent search,
`or whether someone simply directed him to it. Nor does the
`declarant provide any information that would allow a conclusion
`that his mere possession of Varenna 2012 can be extrapolated to
`legally significant accessibility by interested POSAs at large.
`The declarant likewise says nothing about his Twitter following,
`that is, about whether some or all of his followers qualify as
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`POSAs. Further diluting things, the declarant also attaches two
`versions of Varenna 2012 he purports are the same as they were
`on February 3, 2013, but that testimony defies belief. It would
`require a photographic and infallible memory of things seen and
`read over six years ago. At best it shows merely that the two
`articles may or may not be similar or identical to something the
`declarant saw or thinks he saw six years ago. Hyperlinks on the
`Internet are not static, so retrieving an article from a URL today
`does nothing to prove that article was there yesterday, or what it
`looked like yesterday. This evidence fails to establish the public
`accessibility of Varenna 2012 to the level the law requires.
`Sur-Reply 23. It is well established that such bare attorney arguments
`cannot take the place of objective evidence and, thus, we accord them little
`evidentiary weight. In re Payne, 606 F.2d 303, 315 (CCPA 1979); In re
`Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a
`brief cannot take the place of evidence”). That bare attorney argument does
`not outweigh the objective proof advanced by Dr. Robinson showing that he
`accessed, reviewed, and posted about Varenna 2012 on the social media site
`Twitter in February 2013, which is before the May 14, 2013 priority date of
`the ’999 patent. See Ex. 1044 ¶¶ 5–7 (directing us to Exhibits A, B, and C,
`which tend to establish the veracity of Dr. Robinson’s testimony on point).4
`
`
`4 Patent Owner moved to strike Dr. Robinson’s Declaration and related
`portions of Petitioner’s Reply, which we denied. Papers 11 and 24. Even if
`we set aside Dr. Robinson’s Declaration, however, we are persuaded that the
`indicia of publication on the face of Varenna 2012 are sufficient to establish
`that Varenna 2012 was “sufficiently accessible to the public interested in the
`art” and “disseminated or otherwise made available” to the interested public
`before the critical date, and consequently, a printed publication. Blue
`Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016).
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`Having considered the parties’ positions and evidence of record,
`summarized above, we determine the totality of the evidence—the indicia of
`publication on the face of the document and testimony of Dr. Robinson—
`supports a finding that Varenna 2012 was publicly available as of November
`30, 2012, the “Advance Access” publication date on the face of the journal.
`We further credit the testimony of Dr. Robinson and are not persuaded by
`Patent Owner’s bare attorney argument to the contrary. Attorney argument
`cannot take the place of evidence lacking in the record. In re Pearson, 494
`F.2d at 1405.
`In view of the above, we determine that V