Trials@uspto.gov
`571.272.7822
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`
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`
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` Paper No. 12
`
` Entered: December 7, 2017
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CSL BEHRING GMBH and CSL BEHRING LLC,
`Petitioner,
`v.
`SHIRE VIROPHARMA INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01512
`Patent 9,616,111 B2
`____________
`
`
`Before LORA M. GREEN, MICHAEL J. FITZPATRICK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
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`
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`Page 1 of 17
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`CSL EXHIBIT 1068
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`571.272.7822
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`
`
`
`
`
`
`
` Paper No. 12
`
` Entered: December 7, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CSL BEHRING GMBH and CSL BEHRING LLC,
`Petitioner,
`v.
`SHIRE VIROPHARMA INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01512
`Patent 9,616,111 B2
`____________
`
`
`Before LORA M. GREEN, MICHAEL J. FITZPATRICK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`Page 1 of 17
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`CSL EXHIBIT 1068
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`
`
`IPR2017-01512
`Patent 9,616,111 B2
`
`
` INTRODUCTION
`CSL Behring GmbH and CSL Behring LLC (collectively “Petitioner”
`or “CSL”) filed a Petition requesting an inter partes review of claims 1‒18
`of U.S. Patent No. 9,616,111 B2 (Ex. 1001,1 “the ’111 patent”). Paper 1
`(“Pet.”). Shire ViroPharma Inc. (“Patent Owner” or “Shire”) filed a
`Preliminary Response to the Petition. Paper 8 (Prelim. Resp.).
`Institution of an inter partes review is authorized by statute when “the
`information presented in the petition . . . and any response . . . shows that
`there is a reasonable likelihood that the petitioner would prevail with respect
`to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see
`37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition, the Preliminary
`Response, and the cited evidence, we decline to institute an inter partes
`review of any of the challenged claims.
`A.
`Related Proceedings
`The ’111 patent is asserted in Shire ViroPharma Inc. v. CSL Behring
`LLC, Case No. 17-414 (D. Del.). Pet. 63; Paper 5, 1.
`The ’111 Patent (Ex. 1001)
`B.
`The ’111 patent issued April 11, 2017, with Stephen Ruddy,
`Mark Cornell Manning, and Ryan Erik Holcomb as the listed co-inventors.
`Ex. 1001-A. The patent “provides compositions and methods for the
`
`
`1 We note that Petitioner attempted to file the ’111 patent as Exhibit 1000,
`and its prosecution history as Exhibit 1001. Allowed exhibit numbers for
`Petitioner, however, start at “1001,” and, thus, both the ’111 patent and the
`prosecution history are designated in PTAB E2E as Exhibit 1001. Given
`that we are denying institution, we are not requiring Petitioner to correct the
`numbering of its exhibits. In this Decision, we cite the ’111 patent as
`Ex. 1001-A and its file history as Ex. 1001-B.
`2
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`IPR2017-01512
`Patent 9,616,111 B2
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`treatment and/or prevention of disorders associated with C1 esterase
`inhibitor deficiency.” Id. at 1:20‒22.
`
`The ’111 patent teaches that “[h]ereditary angioedema (HAE) is a
`rare, life-threatening, genetic disorder caused by a deficiency of the C1
`esterase inhibitor.” Id. at 1:31‒33. The disorder is “a result of a defect in
`the gene controlling the synthesis of the C1 esterase inhibitor.” Id. at 1:39‒
`41. According to the ’111 patent, the “restoration of active C1 esterase
`inhibitor levels in patients having a disorder associated with deficient or
`reduced levels of active C1 esterase inhibitor (e.g., HAE) is an effective
`measure for treating such disorders.” Id. at 2:7‒10. The ’111 patent notes
`that intravenous administration of a C1 esterase inhibitor, such as that under
`the trade-name of Cinryze, was known. Id. at 2:10‒13. The ’111 patent
`teaches “[s]urprisingly, the subcutaneous [‘sc’] administration of the C1
`esterase inhibitor is sufficient to maintain the blood levels of the C1 esterase
`inhibitor.” Id. at 2:15‒18. Thus, the ’111 patent teaches formulations for
`subcutaneous administration. Id. at 2:13‒15.
`Challenged Claims
`C.
`Petitioner challenges claims 1‒18 of the ’111 patent. Claim1 is the
`only independent challenged claim and is reproduced below:
`
`1.
`A method for treating hereditary angioedema (HAE),
`said method comprising subcutaneously administering to a
`subject in need thereof a composition comprising a C1 esterase
`inhibitor, a buffer selected from citrate or phosphate, and
`having a pH ranging from 6.5-8.0, wherein the C1 esterase
`inhibitor is administered at a concentration of at least about 400
`U/mL and a dose of at least about 1000 U, and wherein the
`administration of the composition comprising the C1 esterase
`inhibitor increases the level of C1 esterase inhibitor in the blood
`of the subject to at least about 0.4 U/mL, and wherein the C1
`esterase inhibitor comprises an amino acid sequence at least
`
`3
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`Patent 9,616,111 B2
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`95% identical to residues 23 to 500 of SEQ ID NO:1.
`
`Ex. 1001—A, 13:13—25.
`
`D.
`
`The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1—1 8 of the ’ 1 11
`
`patent on the following grounds (Pet. 15, 38):
`
` Schranz2 (as evidenced by
`
`§ 103(a)
`
`1—18
`
`Cim'yze Label3 and Bock“),
`Gatlin,5 Pharrnin ,6 and Levi7
`
`2 Schranz et al-, Safety, Pharmacokinetics (PK), and Pharmacodynamics
`(PD) ofSubcutaneous (SC) CINRYZE® (C1 Esterase Inhibitor
`[Human])with Recombinant Human Hyaluronidase (rHuPH20) in Subjects
`with Hereditary Angioedema (HAE), ViroPharma Incorporated, Poster L21
`presented at the 2012 American Academy of Allergy, Asthma &
`Immunology annual meeting (Ex. 1004) (“Schranz”).
`
`3 Cinryze® Prescribing Information, ViroPharma Incorporated, Nov. 2012
`(Ex. 1010) (“Cinryze label”).
`
`4 Bock et al., Human C1 Inhibitor: Primary Structure, cDNA Cloning, and
`Chromosomal Localization, 25 BIOCHEM. 4292—4301 (1986) (EX. 1011)
`(“Bock”)-
`
`5 Larry A. Gatlin & Carol A. Brister Gatlin, Formulation and
`Administration Techniques to Minimize Injection Pain and Tissue Damage
`Associated with Parenteral Products, Chapter 17 in INJECTABLE DRUG
`DEVELOPMENT: TECHNIQUES TO REDUCE PAIN AND
`IRRITATION 401—421 (Pramod K. Gupta & Gayle A. Brazeau, eds,
`Interpharm Press 1999) (EX- 1006) (“Gatlin”).
`
`6 Mannesse et al., WO 2007/073186 A2, published June 28, 2007
`(Ex. 1007) (“Pharming”).
`
`7 Levi et al., Self-administration ofC1 -inhibitor concentrate in patients with
`hereditary or acquired angioedema caused by C1 -inhibitor deficiency, 117
`J. ALLERGY CLIN. IMMUNOL. 904—908 (2006) (Ex. 1009) (“Levi”).
`
`Page 4 of 17
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`4
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`Patent 9,616,111 B2
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`Jiang8 (as evidenced by
`Cinryze Label and Bock),
`Gatlin, Pharming, Zuraw? and
`Levi
`
`
`
`§ 103(a)
`
`1—18
`
`Petitioner relies also on the Declaration of Timothy Craig, D.O.
`
`(Ex. 1012), the Joint Declaration of Thomas Machnig, MD, and Hanno
`
`Waldhauser (Ex. 1013-A10), the Declaration of Hubert Metzner, Dr. rer. nat.
`
`(Ex. 1014), and the Declaration of Christopher J. Roberts, Ph.D. (Ex. 1015).
`
`II. ANALYSIS
`
`A.
`
`Claim Construction
`
`We interpret claims using the “broadest reasonable construction in
`
`light of the specification of the patent in which [they] appear[].” 37 CPR.
`
`§ 42.100(b); see also Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`
`2144—46 (2016). Under the broadest reasonable construction standard, claim
`
`terms are generally given their ordinary and customary meaning as would be
`
`understood by one of ordinary skill in the art at the time of the invention. In
`
`re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). “Absent
`
`claim language carrying a narrow meaning, the PTO should only limit the
`
`8 Jiang et al., Subcutaneous Infusion ofHuman C1 Inhibitor in Swine, 136
`CLIN. IMMUNOL. 323—328 (2010) (Ex. 1005) (“Jiang”).
`
`9 Zuraw et al., Nanofiltered C1 Inhibitor Concentratefor Treatment of
`Hereditary Angioedema, 363(6) N. ENGL. J-MED. 513—522 (2010)
`(Ex. 1008) (“Zuraw”).
`
`‘0 Exhibit 1013 submitted with the Petition was refiled as Exhibit 1013-A
`
`after authorization by the Board to add language in a form prescribed by
`28 U.S.C. § 1746, and the signatures of those individuals executing the
`declaration. Paper 9, 3.
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`claim based on the specification . . . when [it] expressly disclaim[s] the
`broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). We
`determine that no explicit construction of any claim term is necessary to
`determine whether to institute a trial in this case. See Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir.
`2017) (“[W]e need only construe terms ‘that are in controversy, and only to
`the extent necessary to resolve the controversy. . . .’” (quoting Vivid Techs.,
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
`B. Obviousness over the Combination of Schranz (as evidenced by
`Cinryze Label and Bock), Gatlin, Pharming, and Levi
`Petitioner asserts that claims 1‒18 are rendered obvious by the
`combination of Schranz (as evidenced by Cinryze Label and Bock), Gatlin,
`Pharming, and Levi. Pet. 15‒37. Patent Owner contends that Petitioner has
`not established a reasonable likelihood that the claims are rendered obvious
`by the combination of Schranz (as evidenced by Cinryze Label and Bock),
`Gatlin, Pharming, and Levi. Prelim. Resp. 6‒53. And in particular, Patent
`Owner asserts that Petitioner has not established that Schranz is prior art to
`the challenged patent. Id. at 6‒16.
`Availability of Schranz (Ex. 1004) as Prior Art
`i.
`35 U.S.C. § 311(b) states that a “petitioner in an inter partes review
`may request to cancel . . . claims of a patent 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.” Before considering the ground before us
`based on Schranz, we must address whether Petitioner has provided a
`sufficient threshold showing that Schranz constitutes prior art under
`35 U.S.C. § 102—a legal question based on underlying factual
`determinations. Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568
`
`6
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`Patent 9,616,111 B2
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`(Fed. Cir. 1987); Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d
`1340, 1350 (Fed. Cir. 2008).
`Schranz, as Petitioner acknowledges, “is a hardcopy handout of a
`poster that was presented at the 2012 American Academy of Allergy,
`Asthma & Immunology (‘AAAAI’) annual meeting that was held from
`March 2 to March 6 in Orlando, Florida.” Pet. 15 (citing Ex. 1013-A, ¶¶ 2‒
`3). Relying on In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 2004),
`Petitioner asserts that Schranz “qualifies as a printed publication under
`35 U.S.C. § 102(b).” Pet. 17.
`
`Petitioner relies heavily on the Joint Declaration of Thomas Machnig
`and Hanno Waldhauser (Ex. 1013-A, “Joint Declaration”) in asserting that
`Schranz is a printed publication. Pet. 17‒18. Specifically, Petitioner relies
`on the Joint Declaration in asserting that the “AAAAI meeting at which
`Schranz was presented was attended by nearly 5,000 physicians and
`specialists in the area of allergy and immunology, as well as by academics
`and industry representatives in the field,” that the “poster was displayed on
`March 6th and was accessible to all attendees, and the authors were present
`near the poster to answer questions,” and that “the poster’s abstract was
`published prior to the meeting in February 2012, and handouts of the poster
`were also freely available at the meeting.” Id. at 17 (citing Ex. 1013-A ¶¶ 2‒
`5).
`Patent Owner responds that Exhibit 1013-A has two declarants, and,
`
`as such, it “‘obscures the precise nature and origin of a number of factual
`assertions’ to such an extent that it fails to demonstrate that Schranz was
`disseminated at all.” Prelim. Resp. 9 (quoting Dep’t of Justice v. Iris Corp.
`Berhad, IPR2016-00497, 9–10 (July 25, 2016) (Paper 7) (holding a joint
`
`7
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`declaration to be an improper “combined document”) (hereinafter, “Dep’t of
`Justice”)); (also citing Fed. R. Evid. 602 (“Need for Personal Knowledge”)).
`Again quoting Dep’t of Justice, Patent Owner asserts that the “Joint
`Declaration here also ‘invites innumerable practical difficulties . . . in
`assessing the reliability of the statements made.’” Id. at 9‒10 (quoting Dep’t
`of Justice 10).
`
`We agree with Patent Owner that the Joint Declaration of Thomas
`Machnig, M.D. and Hanno Waldhauser presents practical difficulties in the
`ability to determine the reliability of the statements made and the knowledge
`of each of the individual declarants. Dr. Machnig is a “trained physician for
`internal medicine and hold[s] the position of Director Medical Affairs at
`CSL Behring since Sept. 2010.” Ex. 1013-A ¶ 1.a. In contrast,
`Mr. Waldhauser is a “trained commercial clerk and marketing /
`communication specialist and hold[s] currently the position of Director
`Marketing at CSL Behring and was acting as Senior Global Product
`Manager in March 2012 at time of the 2012 AAAAI Annual Meeting
`(March 2-6, 2012).” Ex. 1013 ¶ 1.b.
`
`The declarants jointly state that “[w]e both attended the 2012
`American Academy of Allergy, Asthma & Immunology (AAAAI) annual
`meeting that was held from March 2 to March 6 in Orlando, Florida.” Id.
`¶ 2. The declarants also note jointly that the Schranz poster was “displayed
`as a late breaker abstract” in the poster viewing area that was accessible to
`all registered delegates and exhibitors that attended the conference. Id. ¶ 4.
`In particular, the declarants jointly state “[i]n our recollection, the poster was
`presented by one of the authors on-site (as mandated by the conference) and
`discussed with relevant physicians who are actively treating patients with
`
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`Hereditary Angioedema as well as other industry representatives of other
`manufacturers of HAE therapies (including CSL Behring) while it was on
`display.” Id. In addition, Dr. Machnig and Mr. Waldhauser jointly declare
`that “[h]andouts of the poster were freely available and picked-up by us as
`well as by other poster viewers.” Id. ¶ 5.
`
`As was the case in Dep’t of Justice, the use of a joint declaration
`“invites innumerable practical difficulties in cross-examining the witnesses,
`in assessing the reliability of the statements made, and in evaluating the
`weight to be accorded to the opinions expressed.” Dep’t of Justice 10. For
`example, Dr. Machnig and Mr. Waldhauser declare in “our recollection.”
`Ex. 1013-A ¶ 4. It is unclear how two different declarants can have the
`same “recollection.” In addition, the declarants state that “[h]andouts of the
`poster . . . [were] picked up by us.” Id. ¶ 5. It is unclear from the Joint
`Declaration, however, if both declarants were together when the hand-out
`was picked-up, or if each declarant picked up the handout at separate times.
`
`We, therefore, afford the Joint Declaration of Dr. Machnig and
`Mr. Waldhauser little weight. See Dep’t of Justice 11. As it is the primary
`evidence on which Petitioner relies to demonstrate that Schranz is prior art,
`we determine that Petitioner has not made a threshold showing that Schranz
`is prior art to the ’111 patent. As Petitioner has not sufficiently
`demonstrated that Schranz is prior art to the ’111 patent, we determine that
`the Petition does not demonstrate a reasonable likelihood that challenged
`claims 1‒18 are rendered obvious by the combination of Schranz (as
`evidenced by Cinryze Label and Bock), Gatlin, Pharming, and Levi.
`
`
`
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`C. Obviousness Over the Combination of Jiang (as evidenced by
`Cinryze Label and Bock), Gatlin, Pharming, Zuraw, and Levi
`Petitioner asserts that claims 1‒18 are rendered obvious by the
`combination of Jiang (as evidenced by Cinryze Label and Bock), Gatlin,
`Pharming, Zuraw, and Levi. Pet. 38‒50. Patent Owner contends that
`Petitioner has not established a reasonable likelihood that the claims are
`rendered obvious by the combination of Jiang as evidenced by Cinryze
`Label and Bock, Gatlin, Pharming, Zuraw, and Levi. Prelim. Resp. 17‒47,
`53‒55. Among other arguments, Patent Owner asserts that we should
`exercise our discretion under 35 U.S.C. § 325(d), as the United States Patent
`and Trademark Office (“Office”) already has considered Jiang. Id. at 53‒55.
`Analysis: 35 U.S.C. § 325(d)
`i.
`Petitioner contends that the Examiner rejected the claims as being
`rendered obvious over Jiang as combined with a reference that
`recommended a total injection volume of approximately 2mL for
`subcutaneous administration. Pet. 11 (citing Ex. 1001-B, 3034‒38); see also
`id. at 2 (noting that the Examiner relied on Jiang as the closest prior art, “and
`its disclosure of subcutaneous (‘sc’) administration of a 100U/mL
`formulation of C1-INH.”).
`
`According to Petitioner:
`With the aid of a declaration from a Shire employee,
`Dr. Schranz, which pointed to no evidence or support in the
`prior art, Shire made three main arguments: (1) there was a
`consensus in the field that C1-INH could not be formulated at a
`high-concentration in view of its large size, high glycosylation,
`high viscosity, and propensity to aggregate; (2) the claimed
`high-concentration formulations exhibited unexpected
`bioavailability; and (3) there was a long-felt need for
`subcutaneously-administered C1-INH that others had tried and
`
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`failed to satisfy. Ex. 1002, 5-11 (¶¶ 11-24); Ex. 1001[-B],
`2854-55, 2859-62, 3078-85.
`Id. at 12 (footnote omitted); see also Ex. 1002 (Declaration of Dr. Schranz
`submitted during prosecution).
`
`Petitioner notes that the Examiner initially did not find the Declaration
`of Dr. Schranz to be persuasive, with the Examiner stating that proteins of
`150 kilodaltons or larger were known to be administered subcutaneously
`without major problems, and that the ordinary artisan would have reasonably
`expected that doubling the dosage would lead to roughly doubling of the
`bioavailability. Id. at 12‒13 (citing Ex. 1001, 3040‒3044). Petitioner
`asserts, however, that the Examiner withdrew the rejection and allowed the
`claims on essentially the same information, “concluding that ‘[t]he
`declaration and evidence as submitted by the Applicants as of 11 November
`2016 has been found sufficient by the Examiner to establish secondary
`considerations in the form of long felt need and failure of others to rebut the
`prima facie case of obviousness.’” Id. at 13 (quoting Ex. 1001-B, 3453); id.
`at 50. Petitioner contends that “the Office . . . was mistakenly persuaded by
`Shire’s unsubstantiated and misleading claims of long-felt need.” Id. at 13;
`see also id. at 38 (stating that “Shire never overcame the Office’s prima
`facie rejection based on Jiang.”) In addition, Petitioner asserts that the
`“Examiner also overlooked the closest prior art,” Schranz, “which Shire
`submitted for the first time in an IDS one week before receiving a Notice of
`Allowance.” Id. at 13‒14 (footnote omitted) (citing Ex. 1001-B, 3129‒
`3132).
`
`Petitioner asserts that “Shire’s arguments regarding these alleged
`secondary considerations mischaracterized the evidence, misrepresented the
`facts, and misled the Examiner into concluding that those skilled in the art
`
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`had tried and failed to achieve a high-concentration sc C1-INH formulation.”
`Pet. 50. Specifically, Petitioner contends that, as evidenced by Schranz, any
`need had been met at the time of invention, that is, March 2013. Id. at 52‒
`53, 56. In addition, relying on Media Technologies Licensing, LLC v. Upper
`Deck Co., 596 F.3d 1334, 1338‒39 (Fed. Cir. 2010) (rejecting long-felt-but-
`unresolved-need argument that proposed an “overbroad” definition of the
`need and an “exceedingly narrow” definition of success), Petitioner argues
`that Applicant Shire defined the need overly broadly, that is, as
`subcutaneous treatment of HAE, and at the same time, defined success
`overly narrowly, that is, subcutaneous delivery of 1000‒2000 U C1-INH in
`two to four milliliters, which “misled the Office into allowing the ’111
`patent.” Id. at 51 (citing Ex. 1001-B, 2854, 2861).
`
`In challenging the claims, the Petition relies on Jiang for disclosing a
`comparison on subcutaneous and intravenous administration of Cinzyme
`prepared at a concentration of 100U/ml. Pet. 38. According to the Petition,
`“[a]s the Office acknowledged, Jiang does not teach the claimed
`concentration of at least 400U/mL.” Id. at 39 (citing Ex. 1001-B, 3035).
`The Petition then relies on Gatlin for teaching that the ordinary artisan
`would have understood that subcutaneous injections should be limited to
`about 2 mL. Id. In that regard, we note that Petitioner acknowledges that,
`although the Examiner did not rely on Gatlin, the Examiner relied upon a
`reference with similar teachings in rejecting the claims. Id. at n.10. Thus,
`according to the Petition, “by increasing the concentration of Jiang’s
`formulations from 100U/mL to 400-575U/mL, [the ordinary artisan] could
`have administered the same 800-1150U doses in 2mL injections.” Id. at 39
`(citing Ex. 1012 ¶ 53; Ex. 1015 ¶ 52).
`
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`Patent Owner counters that we should deny institution under
`
`35 U.S.C. § 325(d) “because CSL advances substantially the same art and
`arguments that were considered—and rejected—by the Patent Office during
`prosecution.” Prelim. Resp. 3. In particular, Patent Owner argues that the
`Examiner did not just consider Jiang, but used that reference as combined
`with a reference with a similar disclosure to that of Gatlin in multiple
`rejections over the prior art. Id. at 3‒4, 53.
`
`According to Patent Owner, Petitioner is incorrect in asserting that the
`Examiner determined that Shire (Patent Owner) had not overcome the prima
`facie case, as the Examiner withdrew the rejection based not only on the
`secondary considerations, but also because Shire had overcome Jiang. Id. at
`54. Specifically, Patent Owner notes that the Examiner stated in the
`Reasons for Allowance that “no obviousness rejection can be made in light
`of the secondary consideration[s] and nothing in the prior art suggests the
`dosages as instantly claimed for subcutaneous administration.” Id. at 54‒55
`(quoting Ex. 1001-B, 3453) (alteration original).
`We have discretion under 35 U.S.C. § 325(d) to reject a petition when
`the same or substantially the same prior art or arguments were presented
`previously in another proceeding before the Office. The relevant portion of
`that statute is reproduced below:
`In determining whether to institute or order a proceeding under
`this chapter, chapter 30, or chapter 31, the Director may take
`into account whether, and reject the petition or request because,
`the same or substantially the same prior art or arguments
`previously were presented to the Office.
`35 U.S.C. § 325(d).
`
`In the instant proceeding, we agree with Patent Owner that Petitioner
`is essentially making the same arguments as to obviousness over Jiang that
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`the Examiner already considered. The prosecution history demonstrates that
`the Examiner considered many of the same issues with respect to the
`Schranz Declaration as Petitioner is arguing here. Although the Examiner
`noted in allowing the claims that Applicant Shire had established the
`secondary consideration of long-felt need and failure of others, the Examiner
`also stated that the art did not suggest the claimed dosage.
`
`We determine, therefore, that the Examiner did address the Schranz
`Declaration, and the Examiner’s concerns are similar to those raised by
`Petitioner in the instant proceeding. That is, as the Examiner stated:
`
`The Examiner has considered the arguments found in
`Dr. Schranz’s declaration concerning difficulty in higher
`concentration formulation. However, Dr. Schranz’s declaration
`provides little more than an assertion that it is difficult to reach
`such a concentration formulation, as opposed to actual evidence
`establishing that this (1) was a recognized problem in the art
`and (2) was generally not achievable via other means.
`
`Ex. 1001-B, 3041. Thus, the Examiner did acknowledge the lack of
`supporting evidence in the Schranz Declaration demonstrating that it was
`difficult to reach the claimed concentration.
`
`The Examiner also addressed the issue of long-felt need. Id. at 3043‒
`3044. Again, the Examiner noted that Dr. Schranz’s Declaration “merely
`provide[s] assertions,” without providing any supporting evidence. Id. at
`3043. According to the Examiner: “The long-felt need may be present as
`alleged, but the arguments as such are right now merely assertions/opinions
`of a single expert, rather than evidence from the art as a whole that this is
`truly an art-recognized long felt need.” Id. at 3044. The prosecution history,
`thus, does not support Petitioner’s assertion that the Examiner was misled
`into allowing the challenged claims. See Pet. 51. Moreover, to the extent
`
`14
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`IPR2017-01512
`Patent 9,616,111 B2
`
`that Petitioner is relying on the Schranz poster presentation as evidence that
`there was no long-felt need, as discussed above, Petitioner has not made a
`threshold showing to demonstrate that Schranz is prior art to the challenged
`patent.
`Further, in indicating allowable subject matter, the Examiner noted
`that the prior art did not provide a dose of at least 400 U/ml, as the claims
`require. Ex. 1001-B, 3453. The Examiner noted that the declaration and
`evidence submitted by applicants was sufficient “to establish secondary
`considerations in the form of long felt need and failure of others,” stating
`that “[a]s no obviousness rejection can be made in light of the secondary
`consideration[s] and nothing in the prior art suggests the dosages as instantly
`claimed for subcutaneous administration, the claims are found to be novel
`and unobvious.” Id. Again, the prosecution history does not support
`Petitioner’s assertion that the claims were allowed based on secondary
`considerations alone (Pet. 51), but also on the basis that the prior art did not
`suggest the claimed dosage. Importantly, Petitioner does not address that
`statement in the Petition, but instead characterizes the Examiner’s statement
`of reasons for allowance (Ex. 1001-B, 3453) as being based on only the
`secondary consideration of long-felt need. See Pet. 50.
`We determine, therefore, that Jiang was previously presented to, and
`considered by, the Office in the same substantive manner as Petitioner now
`advocates, and, thus, the same prior art and arguments were previously
`presented to the Office. Accordingly, balancing the competing interests and
`taking full account of the facts and equities involved in this particular matter,
`we exercise our discretion to deny the Petition as to the combination of Jiang
`(as evidenced by Cinryze Label and Bock), Gatlin, Pharming, Zuraw, and
`
`15
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`IPR2017-01512
`Patent 9,616,111 B2
`
`Levi and decline to institute an inter partes review of that ground under
`35 U.S.C. § 325(d).
`
` CONCLUSION
`For the foregoing reasons, we deny the Petition and do not institute
`trial as to any of the challenged claims of the ’111 patent. Specifically, as to
`the challenge over the combination of Schranz (as evidenced by Cinryze
`Label and Bock), Gatlin, Pharming, and Levi, Petitioner has not made a
`threshold showing that Schranz is prior art to the challenged claims. And as
`to the challenge over the combination of Jiang (as evidenced by Cinryze
`Label and Bock), Gatlin, Pharming, Zuraw, and Levi, we exercise our
`discretion under 35 U.S.C. § 325(d) and decline to institute that challenge as
`we determine that essentially the same prior art and arguments were
`previously presented to the Office.
` ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all the challenged claims
`of the ’111 patent.
`
`
`
`
`
`
`16
`
`Page 16 of 17
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`
`
`IPR2017-01512
`Patent 9,616,111 B2
`
`PETITIONER:
`
`Anthony C. Tridico
`Amanda K. Murphy
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP,
`anthony.tridico@finnegan.com
`amanda.murphy@finnegan.com
`
`
`PATENT OWNER:
`
`Edgar H. Haug
`Angus Chen
`Andrew S. Wasson
`Andrew S. Roper
`HAUG PARTNERS LLP
`EHaug@haugpartners.com
`AChen@haugpartners.com
`AWasson@haugpartners.com
`aroper@haugpartners.com
`
`
`
`17
`
`Page 17 of 17
`
`
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