Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 32
`Date: October 29, 2019
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`PGR2018-00062
`Patent 9,707,245 B2
`____________
`
`
`Before TONI S. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`Paper 32
`Date: October 29, 2019
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`PGR2018-00062
`Patent 9,707,245 B2
`____________
`
`
`Before TONI S. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`
`
`
`
`
`
`
`
`
`
`PGR2018-00062
`Patent 9,707,245 B2
`
`
`I. INTRODUCTION
`This is a Final Written Decision in a post-grant review of claims 1–30
`of U.S. Patent No. 9,707,245 B2 (Ex. 1001, “the ’245 patent”). The Board
`has jurisdiction under 35 U.S.C. § 6. We issue this Final Written Decision
`pursuant to 35 U.S.C. § 328(a).
`We instituted review based on all grounds asserted in the Petition
`(Paper 2, “Pet.”). See Paper 11 (“Dec.”), 21. Thereafter, in timely sequence,
`Patent Owner filed a Response (Paper 15, “Resp.”), Petitioner filed a Reply
`(Paper 18), and Patent Owner filed a Sur-Reply (Paper 21). The Board held
`a final oral hearing on July 31, 2019. Paper 31 (“Tr.”). For reasons that
`follow, we find unpatentable claims 1–30 of the ’245 patent.
`
`A. Related Proceedings
`The Petition identifies three related post grant reviews that do not
`involve the ’245 patent. Pet. 5 (citing PGR2017-00008 (“PGR008”);
`PGR2017-00022 (“PGR022”); PGR2018-00001 (“PGR001”)). During the
`pendency of this proceeding, the Board entered a final written decision in
`each case. PGR008, Paper 43 (entered June 22, 2018); PGR022, Paper 50
`(entered November 14, 2018); PGR001, Paper 48 (entered April 29, 2019).
`After we instituted review, Petitioner identified as related five
`additional post grant reviews that do not involve the ’245 patent. Paper 30,
`2 (Petitioner’s Second Updated Mandatory Notices) (citing PGR2018-00092
`(“PGR092”); PGR2019-00003 (“PGR003”); PGR2019-00026 (“PGR026”);
`PGR2019-00027 (“PGR027”); PGR2019-00028 (“PGR028”)). The Board
`instituted review in each case. PGR092, Paper 7 (entered February 25,
`2019); PGR003, Paper 7 (entered May 7, 2019); PGR026, Paper 6 (entered
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`Patent 9,707,245 B2
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`July 30, 2019); PGR027, Paper 6 (entered July 30, 2019); PGR028, Paper 6
`(entered August 20, 2019).
`B. The ’245 Patent (Ex. 1001)
`The ’245 patent is titled “Neridronic Acid for Treating Complex
`Regional Pain Syndrome.” Ex. 1001, code (54). The Specification
`describes “[o]ral dosage forms of osteoclast inhibitors, such as nitrogen-
`containing bisphosphonates” for treating or mitigating “pain or related
`conditions such as complex regional pain syndrome” (“CRPS”). Id. at
`Abstract. The Specification identifies both zoledronic acid and neridronic
`acid as among the bisphosphonate compounds useful for treating CRPS by
`the method of the claimed invention. See Ex. 1001, Figs. 1–13, 2:44–3:24
`(figures and descriptions of figures, all pertaining to a method that employs
`zoledronic acid); see also id. at 3:29, 3:33, 6:62–67, 12:4–15, 63:3–5, 64:40–
`42, 65:14–15 (identifying zoledronic acid and neridronic acid as suitable
`bisphosphate compounds for use in the claimed method).
`The Specification also discloses the administration of bisphosphonates
`for treating “bone fractures or to enhance the healing of bone fractures” as a
`function separate from mitigating “pain associated with vertebral crush
`fractures.” Ex. 1001, 7:35–37, 7:65. On that point, Example 3 relates to
`“[t]he effect of orally administered zoledronic acid” in a “rat tibia fracture
`model of” CRPS. Id. at 43:6–8. Example 3 expressly reports, however, that
`zoledronic acid mitigates pain associated with CRPS, where the condition is
`induced in “rats by fracturing the right distal tibias of the animals.” Id.
`at 43:8–9. 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 43:25–44:31. In addition, Example 3 explains,
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`“[t]his animal model has been shown to replicate the inciting trauma” (for
`example, a bone “fracture”) that is “observed in human[s].” Id. at 43:11–16.
`The ’245 patent includes no working example that employs neridronic
`acid as the bisphosphonate. The general disclosure, however, provides
`dosing information pertaining to neridronic acid for use in the claimed
`method. Id. at 28:5–11, 28:42–45, 29:59–30:50.
`C. The Challenged Claims
`Claim 1, the only independent challenged claim, is illustrative and
`reproduced below:
`1. A method of treating pain associated with complex
`regional pain syndrome (CRPS) comprising administering
`neridronic acid to a human being with CRPS, wherein bone
`fracture was a predisposing event for CRPS, and wherein the
`neridronic acid is in a salt or an acid form.
`
`Ex. 1001, 84:59–63 (emphasis added).
`The other challenged claims (namely, claims 2–30) depend
`directly or indirectly from claim 1 and specify additional limitations
`pertaining 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 84:64–86:29.
`
`D. The Prosecution History
`We provide a brief overview of the prosecution history to
`supply context for Petitioner’s challenge. In our reproduction of
`claim 1 above, we emphasize a claim limitation that requires a human
`being “with CRPS, wherein bone fracture was a predisposing event
`for CRPS.” Id. at 84:61–62. Patent Owner added that limitation by
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`amendment after the Examiner rejected the claim as obvious over
`prior art that demonstrated bisphosphonates, prior to the date of the
`claimed invention, were generally recognized as useful for treating
`and effectively “relieving symptoms of CRPS.” Ex. 1022, 453, 510.
`The Examiner found, “employing any known bisphosphonates,
`including neridronic acid, in the method of treating CRPS would be
`reasonably expected to be effective.” Pet. 10 (citing Ex. 1022, 454).
`In other words, the absence of a working example, specifically
`directed to the use of neridronic acid, was of little import during
`patent prosecution, given that “the dosage forms and the herein
`claimed routes of administration and the dosing regimen are all well-
`known according to the teachings of the cited prior art.” Id.
`The Examiner allowed claim 1 to issue, however, only after
`Patent Owner included claim language that requires “bone fracture” as
`“a predisposing event for CRPS” (Ex. 1022, 506) and submitted
`evidence that patients “with fracture as the predisposing factor”
`exhibited a response to bisphosphonates that “was superior” to the
`response in patients “with other pre-disposing factors.” Id. at 548; see
`id. at 516–518 (data submitted during patent prosecution to show that
`humans suffering from CRPS were nearly three times as likely to
`respond favorably to bisphosphonate treatment when bone fracture
`was a predisposing event), 547 (notice of allowance). That evidence
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`consisted of results reported in 2017 by Varenna,1 in a printed
`publication that Patent Owner asserts here as evidence of unexpected
`results (Resp. 23–28). Earlier work conducted by Varenna, completed
`prior to the critical date of the invention,2 is the subject of an asserted
`prior art reference, which, as explained in the next section, we identify
`simply as “Varenna” (Ex. 1005).
`
`E. 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”);
`(2) S. Bruehl, “How common is complex regional pain syndrome-
`Type I,” PAIN 129:1–2 (2007) (Ex. 1006, “Bruehl”);
`(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. 1007, “Gatti”);
`(4) 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”);
`(5) D. Manicourt et al., Role of alendronate in therapy for
`posttraumatic complex regional pain syndrome type I of the lower extremity,
`
`
`1 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) (“Varenna 2017”).
`2 We agree that the “earliest possible priority date” of the ’245 patent “is
`May 14, 2013,” the date of filing of priority application No. 13/894,274.
`Pet. 34; see id. at 17–22 (for persuasive argument and evidence on point);
`Ex. 1001, code (63) (identification of asserted priority applications).
`
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`ARTHRITIS & RHEUMATISM 50(11): 3690–97 (Nov. 2004) (Ex. 1009,
`“Manicourt”);
`(6) 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 (Apr. 16–18, 2004) (certified English translation) (Ex. 1010,
`“Muratore”); and
`(7) Schwarzer & Maier, Complex regional pain syndrome, in GUIDE
`TO PAIN MANAGEMENT IN LOW-RESOURCE SETTINGS 249–54 (Kopf & Patel
`eds. 2010) (Ex. 1020, “Schwarzer”).
`F. Declaration Evidence
`Petitioner relies on the Declaration of Lawrence Poree, M.D., Ph.D.,
`in support of factual contentions and opinions regarding the level of ordinary
`skill and understanding in the art. Ex. 1003. Patent Owner submits no
`declaration testimony from a witness advanced as qualified to opine about
`the level of skill or understanding of an ordinarily skilled artisan.
`
`G. The Asserted Patentability Challenges
`We instituted review of claims 1–30 of the ’245 patent as follows.
`
`Claim(s) Challenged
`1–4, 9, 10, 12, 14, 16–
`18, 23, 24, 27–29
`1–29
`
`5–8, 21, 25
`30
`
`
`
`
`
`
`Statutory Basis
`35 U.S.C. § 102 (a)
`
`Reference(s)
`Varenna
`
`35 U.S.C. § 103
`
`35 U.S.C. § 103
`35 U.S.C. § 103
`
`Varenna, Bruehl, Gatti,
`La Montagna, Muratore
`Varenna, Manicourt
`Varenna, Schwarzer,
`Bruehl, Gatti, La
`Montagna, Muratore
`
`
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`7
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`Claim(s) Challenged
`1–30
`
`1–30
`
`Pet. 8; Dec. 21.
`
`Statutory Basis
`35 U.S.C. § 112
`(written description)
`35 U.S.C. § 112
`(enablement)
`
`Reference(s)
`
`
`
`
`II. ANALYSIS
`Petitioner directs us to persuasive evidence, which is not refuted
`effectively by Patent Owner, that the earliest possible priority date of the
`claims of the ’245 patent is May 14, 2013. Pet. 17–22 (and evidence cited
`therein). As an initial matter, based on the arguments and evidence provided
`by Petitioner (id.), we find that the ’245 patent is eligible for post-grant
`review. We first resolve whether Varenna qualifies as prior art. We then
`turn to the asserted patentability challenges.
`A. The Prior Art Status of Varenna (Ex. 1005)
`The prior art status of Varenna (Ex. 1005) emerged as a central
`
`dispute during the course of this review and was a focus of the final hearing.
`See Resp. 12–15; Reply 3–7; Sur-Reply 2–11 (both parties, devoting
`significant briefing to that issue); Tr. 9:14–12:15, 31:4–37:25, 51:14–55:17
`(devoting oral argument to that issue). Petitioner filed the Declaration of
`Dr. Philip Robinson in support of Reply arguments pertaining to that issue.
`Ex. 1031. Patent Owner submits, “this Reply evidence is improper and
`should be stricken or at least ignored.” Sur-Reply 9.
`For reasons set forth in this section, we find that a preponderance of
`the evidence demonstrates that Varenna qualifies as prior art, even if we set
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`aside Dr. Robinson’s Declaration. Alternatively, we are not persuaded that
`Dr. Robinson’s Declaration represents “improper reply evidence” and,
`further, we determine that his testimony bolsters our conclusion that
`Varenna qualifies as prior art. Id. (quoting Intelligent Bio-Systems, Inc. v.
`Illumina Cambridge, Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016)).
`a) Varenna (Ex. 1005) Includes Sufficient Indicia of Reliability
`Even if we set aside Dr. Robinson’s Declaration, substantial evidence
`supports a finding that Varenna (Ex. 1005) was “sufficiently accessible to
`the public interested in the art” and “disseminated or otherwise made
`available” to the interested public before the critical date. Blue Calypso,
`LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016). That reference
`was filed with the Petition, includes the legend “Original article,” the
`notation “Rheumatology 2013; 52:534–42,” and the statement “Advance
`Access publication 30 November 2012.” Ex. 1005, 534.
`An additional indicium joins that cluster of indicia to support the prior
`art status of Exhibit 1005: A copyright notice appears at the bottom of its
`first page: “© 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. A notation
`appears in Varenna, indicating that the article was downloaded from an
`academic website on December 6, 2017.3 Id. On this record, Exhibit 1005
`
`
`3 The date included in that notation (namely, December 6, 2017) does not
`undercut our finding that Exhibit 1005 is what it appears to be—a
`downloaded copy of a journal article from the journal Rheumatology
`published by Oxford University Press (and, therefore, available to the
`interested public) on “30 November 2012.” Ex. 1005, 534.
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`appears on its face to be a downloaded copy of an article by Varenna (listed
`first, with others) published by the Oxford University Press in the journal
`Rheumatology on November 30, 2012, well before May 14, 2013, the
`earliest priority date of the ’245 patent claims. Ex. 1005, 534; supra note 2.
`Patent Owner counters, “a reader of Rheumatology would not” expect
`to see the words “original article” or “advance access publication” on an
`article from that journal. Resp. 13–14 (bridging paragraph). Patent Owner
`directs us to nothing, beyond bare attorney argument, in support of that
`contention regarding how “a reader of Rheumatology” would interpret those
`indicia. Id. Accordingly, we find Patent Owner’s position lacks merit.
`In the alternative, we take notice that Rheumatology is a peer-
`reviewed medical journal that has been published monthly for over half a
`century by Oxford University Press, the largest university press in the world.
`See Tr. 9:22–10:10, 37:15–19, 54:14–17 (colloquy on whether the Board
`may take notice of a point not open to meaningful dispute). We agree with
`Petitioner that what is actually “being questioned here is the veracity of
`claims about a publication date made by Oxford University Press.” Tr.
`54:14–17. This is not a case involving, for example, a thesis, conference
`paper, or poster bearing none of the ordinary indicators of indexing or public
`distribution. This case involves a downloaded copy of an article from a
`medical journal bearing indicia of publication before the critical date.
`An additional circumstance informs our finding that Exhibit 1005 was
`publicly accessible as of November 2012. During patent prosecution,
`“Patent Owner submitted this reference to the PTO with a filename
`‘Varenna2012.pdf.’ and represented that it had a publication date of
`November 2012.” Reply 7 (citing Ex. 1022, 432, 440); Sur-Reply 2–11
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`(nowhere disputing that contention). The document identified by Patent
`Owner as “Varenna2012.pdf” is from the same journal (“Rheumatology”),
`bears the same page numbering (534–542), and includes the word-for-word
`identical title as Exhibit 1005 (“Treatment of Complex Regional Pain
`Syndrome Type I with Neridronate: A Randomized, Double-Blind, Placebo-
`Controlled Study”). Compare Ex. 1005, 534, with Ex. 1022, 432.
`Patent Owner submits that its identification of Exhibit 1005 during
`patent prosecution cannot “be taken as an admission that the reference is
`prior art against the claims.” Resp. 14 n.1.4 We do not imply an admission
`here, however; we simply observe that Patent Owner previously identified to
`the Office a publication date for Varenna that is consistent with the date of
`public access disclosed on the face of Exhibit 1005. Compare Ex. 1022, 430
`(reporting a publication date of November 2012), with Ex. 1005 (reporting a
`publication date of “30 November 2012”). Patent Owner disputes that
`Varenna (Exhibit 1005) was, in fact, published by November of 2012 – but
`does not contest that it previously represented the same reference to the
`Office as having a publication date of November 2012. Resp. 14 n.1
`
`
`4 By way of support, Patent Owner directs us to MPEP § 2129, which
`relates to disclosures of an “applicant’s own prior patent” during
`prosecution. MPEP § 2129 (quoting Riverwood Int’l Corp. v. R.A. Jones &
`Co., 324 F.3d 1345, 1354–55 (Fed. Cir. 2003)). The only other support cited
`by Patent Owner relates to “materiality,” which is not contested and differs
`from accessibility. Resp. 14 n.1 (quoting 37 C.F.R. § 1.97(h)).
`
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`(nowhere contesting that fact); Reply 6–7 (bridging paragraph, asserting that
`fact); Sur-Reply 2–11 (nowhere disputing that fact).
`Patent Owner further argues that the publication date that appears on
`the face of Varenna (Ex. 1005) is “inadmissible hearsay.” Resp. 13. We
`decline to entertain that objection because Patent Owner failed to preserve it
`within the ten-day window required by our rules, much less file a motion to
`exclude that would preserve an objection. Reply 4 (citing 37 C.F.R.
`§§ 42.65(b)(1), (c)); see Paper 13 (nowhere objecting to Exhibit 1005).
`Alternatively, we accept Petitioner’s position that “the publication and
`copyright dates in Varenna” fall into two hearsay exceptions (namely, the
`residual exception to hearsay as well as the exception that applies to
`documents generally relied upon by the public)—a position not refuted by
`Patent Owner. Reply 5 (citing Fed. R. Evid. 803(17), 807); see generally
`Sur-Reply (nowhere contesting the applicability of those exceptions to the
`hearsay objection at issue).
`Patent Owner submits that Exhibit 1005 is not authentic. Resp. 13–14
`(bridging paragraph). At the oral hearing, counsel for Patent Owner
`reiterated argument attempting to cast doubt on whether Exhibit 1005
`represents “the way it looked on the priority date, 2013.” Tr. 34:15–36:12
`(but nowhere disputing that Patent Owner submitted the same document to
`the Office during patent prosecution). Here again, Patent Owner did not
`preserve that objection within the ten-day window required by our rules or
`file a motion to exclude as necessary to preserve an objection. Reply 5–6
`(citing 37 C.F.R. §§ 42.65(b)(1), (c)); see Paper 13 (nowhere objecting to
`
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`Exhibit 1005). Alternatively, Patent Owner rests on bare attorney argument
`that we find insufficient to cast doubt on the authenticity of Exhibit 1005.
`For the above reasons, we find that Varenna (Ex. 1005) qualifies as
`prior art against the challenged claims of the ’245 patent, even if we set
`aside Dr. Robinson’s Declaration.
`b) Additional Support Provided by Dr. Robinson
`Petitioner offers Dr. Robinson’s Declaration as additional proof that
`Exhibit 1005 was publicly accessible prior to the critical date. Reply 5.
`Patent Owner objects to Dr. Robinson’s Declaration as untimely because
`Petitioner filed it with the Reply instead of the Petition. Paper 20, 2. We
`find that Dr. Robinson’s Declaration, however, supports Reply arguments
`that fairly respond to positions raised for the first time in the Response.
`Compare Reply 3–7, and Ex. 1031, with Resp. 12–15. Further, as a practical
`matter, we discern no prejudice from the timing of the filing, given that
`Patent Owner was afforded an opportunity (fully taken) to file a Sur-Reply
`on issues raised in Dr. Robinson’s Declaration. Sur-Reply 2–11.
`Dr. Robinson’s Declaration confirms the indicia of public
`accessibility that appear on the face of Varenna (Exhibit 1005). Reply 5
`(citing Ex. 1031). Specifically, Dr. Robinson attests, under oath, that he
`“accessed, reviewed, and posted about Varenna . . . on the social media site
`Twitter” before the critical date. Reply 5; Ex. 1031 ¶¶ 4–8. Dr. Robinson
`backs up his testimony with objective support. Specifically, he identifies an
`exhibit and attests, this is “my tweet,” which “can still be viewed publicly”
`and includes a link that “is still active and leads to Varenna.” Ex. 1031 ¶ 5,
`Exhibit A. Patent Owner advances no objective evidence tending to
`contradict Dr. Robinson’s statement that he has “personal knowledge” that
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`Varenna (Exhibit 1005) “was available and accessible to the public” before
`the critical date. Ex. 1031 ¶ 3. Instead, Patent Owner rests on conclusory
`assertions that Dr. Robinson’s sworn testimony “defies belief” and details a
`feat that would require “a photographic” or “infallible memory.” Sur-
`Reply 9. We find unpersuasive those bare attorney arguments.
`Dr. Robinson’s testimony bolsters our finding that Varenna
`(Ex. 1005) is what it appears to be – a downloaded copy of an article from a
`medical journal that was “sufficiently accessible to the public interested in
`the art” and “disseminated or otherwise made available” to the interested
`public by November 30, 2012. Blue Calypso, 815 F.3d at 1348.
`
`2. Additional Objections to Petitioner’s Evidence
`Patent Owner objects to Dr. Poree’s Declaration (Ex. 1003),
`
`Dr. Poree’s Curriculum Vitae (Ex. 1004), and the Certificate of Translation
`filed by Petitioner in connection with Muratore (Ex. 1010), a prior art
`reference published in Italian. Paper 13. Petitioner, for its part, objects to
`Patent Owner’s submission of Exhibits 2002, 2003, and 2004, which relate
`to Orange Book information pertinent to oral dosage forms of neridronic
`acid. Paper 17. We find that both parties waived their objections by failing
`to preserve them in a motion to exclude evidence, as required by 37 C.F.R.
`§ 43.64(c). Alternatively, we overrule those objections for reasons set forth
`in the next two subparts of our analysis.
`a) The Declaration of Dr. Poree (Ex. 1003)
`And the Curriculum Vitae of Dr. Poree (Ex. 1004)
`Patent Owner challenges Dr. Poree’s background and experience,
`disputes his qualifications as a technical expert or even “a lay witness,” and
`questions his citations to “facts and data from a number of sources,”
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`submitting that his opinions do not meet the requirements of Federal Rule of
`Evidence 702. Paper 13, 2–4. Patent Owner further objects to Dr. Poree’s
`Curriculum Vitae as “inadmissible hearsay under Rule 802” because “it
`consists of assertions not made while testifying at the current proceeding”
`and “which are being offered to prove the truth of the matter asserted.” Id.
`at 4–5.
`As an initial matter, we overrule the hearsay objection. Without
`exception, the Board accepts the filing of sworn witness declarations in lieu
`of live testimony in administrative patent trials. We also routinely accept
`curricula vitae filed in support of sworn witness declarations. That historical
`practice is a key feature of our streamlined administrative process. Fairness
`is ensured by the Board rule that provides an opposing party the opportunity,
`as of right, to cross-examine declarants under oath in a deposition.
`37 C.F.R. § 42.51(b)(ii). When effective, cross-examination testimony –
`taken under oath to facilitate reliability – may cast doubt on conflicting
`statements in a declaration or accompanying curriculum vitae.
`Patent Owner did not avail itself of the opportunity, provided as of
`right by our rules, to cross-examine Dr. Poree under oath in this case.
`Tr. 28:15–16. Instead, Patent Owner advances objections to Exhibit 1003
`(Dr. Poree’s Declaration) and Exhibit 1004 (Dr. Poree’s Curriculum Vitae)
`based on bare argument that Dr. Poree is not qualified to opine about the
`level of ordinary skill in the art. Paper 13, 2–4.
`It is worth providing here an overview of the uncontroverted (and
`quite extensive) record of Dr. Poree’s education, professional credentials,
`practical experience, and other qualifications. Dr. Poree holds a Ph.D. in
`Toxicology/Environmental Health Sciences from the University of
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`California and an M.D. from Stanford University School of Medicine.
`Ex. 1004, 1; Ex. 1003 ¶ 7. Dr. Poree “completed a Pain Fellowship at the
`University of California at San Francisco.” Ex. 1003 ¶ 7. He is currently
`involved in a research project directed to the management of pain associated
`with CRPS. Ex. 1004, 1. Dr. Poree is “an author of over 20 publications on
`the treatment of pain, including several papers on the treatment of CRPS in
`both animal models and clinical trials.” Ex. 1003 ¶ 10; Ex. 1004, 3–6. He is
`board certified by the American Academy of Pain Medicine and a member
`of the American and California Societies of Interventional Pain Physicians.
`Ex. 1004, 1. Dr. Poree “served on the editorial board for the journal Pain
`from 2009 to 2010.” Id.; Ex. 1003 ¶ 10. Dr. Poree has significant practical
`experience treating pain associated with CRPS. Ex. 1003 ¶ 8. Specifically,
`he has “over 20 years of experience treating patients with chronic pain and
`studying treatments for pain disorders including complex regional pain
`syndrome (‘CRPS’).” Id. Currently, Dr. Poree treats “patients at the
`University of California Pain Management Center, seeing approximately 30
`patients per week.” Id.
`Patent Owner observes that Dr. Poree does not mention “using
`neridronate or [an]other bisphosphonate” as part of his significant
`experience treating patients experiencing pain. Paper 13, 2. Patent Owner
`further observes that Dr. Poree does not mention “treating patients with
`intravenous or oral bisphosphonates” or “conducting research” specifically
`“involving intravenous or oral bisphosphonates.” Id. at 3. Patent Owner
`directs us to nothing, however – not even bare attorney argument – tending
`to show that such specialized experience is necessary to establish
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`Dr. Poree’s qualifications to opine about the level of ordinary skill in the art
`or otherwise provide useful information to the Board in this review. Id.
`Dr. Poree attests under oath that Exhibit 1004 is a copy of his
`Curriculum Vitae. Ex. 1003 ¶ 5; see id. at 45 (oath). Dr. Poree’s testimony
`on that point stands unrebutted by opposing evidence – such as cross-
`examination testimony taken under oath in a deposition. We discern no
`basis, on this record, for doubting the information provided by Dr. Poree in
`Exhibit 1004. Ex. 1003 ¶ 5.
`Accordingly, we overrule Patent Owner’s objections to Dr. Poree’s
`Declaration (Ex. 1003) and Curriculum Vitae (Ex. 1004). We find that
`Exhibit 1004 is a true copy of Dr. Poree’s Curriculum Vitae. Taking
`account of Dr. Poree’s sworn statements regarding his education,
`experience, and other qualifications, and in view of the level of ordinary
`skill resolved in our analysis below, 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. Further, we determine that his declaration testimony may
`be useful to the Board in resolving the dispute at hand.
`
`b) The Certificate of Translation Accompanying Muratore (Ex. 1010)
`Petitioner provides an English translation of Muratore (Ex. 1010)
`
`translated from the Italian language. Patent Owner objects to the
`Translator’s Declaration, dated April 10, 2018, and signed by Ms. Laura
`Archiapatti of Park IP Translations. Ex. 1010 (last page). Ms. Archiapatti
`attests that she possesses “advanced knowledge of the Italian and English
`languages” and that the translation provided “has been translated by me and
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`to the best of my knowledge and belief, is a true and accurate translation of”
`the Italian version of Muratore. Id.
`Patent Owner rests on bare attorney argument challenging
`Ms. Archiapatti’s “qualification or expertise regarding language translation”
`and questioning the sufficiency of the wording of her oath. Paper 13, 5.
`Patent Owner does not demonstrate that Ms. Archiapatti’s oath fails to
`comply with the form of evidence required for foreign language translations
`in our forum. 37 C.F.R. § 42.63(b). Nor does Patent Owner come forward
`with any objective evidence tending to cast doubt on the content of
`Ms. Archiapatti’s translation (for example, a conflicting translation provided
`under oath by a translator of Patent Owner’s choice). Paper 13, 5. We find
`unpersuasive Patent Owner’s conclusory challenge to the information
`provided under oath by Ms. Archiapatti. We overrule the objection.
`
`3. Petitioner’s Objections to Exhibits 2002, 2003, and 2004
`Petitioner objects to Exhibits 2002, 2003, and 2004, which Patent
`
`Owner submits in support of the Response to the Petition. Paper 17;
`Resp. 30. Exhibits 2002 and 2003 are advanced as Orange Book
`information about neridronic acid. Resp. 30. Exhibit 2004 is the
`Declaration of Mr. Brent A. Johnson and may relate to whether the FDA had
`approved oral neridronate products by the time of the invention. Paper 17,
`1. Petitioner argues that those exhibits are irrelevant and unfairly prejudicial
`to Petitioner. Id. We overrule those objections because they go to weight to
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`which the evidence is entitled, not admissibility. Further, Petitioner does not
`explain adequately why those exhibits are unfairly prejudicial. Id.
`Petitioner further asserts that Exhibits 2002 and 2003 (the Orange
`Book information) constitute “inadmissible hearsay.” Id. at 2. The
`gravamen of Petitioner’s objection, however, goes to whether Orange Book
`information reported years after the critical date is persuasive – which may
`affect the weight, but not the admissibility, of the evidence. Id.
`
`B. The Asserted Patentability Challenges
`We next turn to the merits of the patentability challenges. We
`
`organize this section into three subparts: First, we address the level of
`ordinary skill in the art. Second, we resolve several disputed issues of claim
`construction. Third, we turn to the merits of the patentability challenges
`asserted in the Petition. We divide that third section into four subparts that
`address the challenges based, respectively, on anticipation, obviousness, lack
`of written description support, and lack of enablement.
`
`1. Level of Ordinary Skill in the Art
`We consider the grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art at the time of the
`invention. Petitioner argues that an ordinarily skilled artisan would have had
`“an M.D. or a Ph.D. in a pain-medicine-relevant discipline, such as clinical
`health psychology or neuroscience, and at least 3–5 years of experience in
`the treatment of CRPS or related chronic pain conditions, or in the study of
`CRPS or related types of chronic pain.” Pet. 13 (citing Ex. 1003 ¶¶ 17–21).
`Patent Owner responds that the ordinarily skilled artisan “would have
`[had] an M.D. or a Ph.D. in a discipline related to the interaction of drugs
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`with a human body, such as biology, pharmacology, etc., and experience in
`supervising, carrying out, or collaborating in animal or human testings,
`including off-label treatment of patients, related
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