`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC,
`Petitioner,
`
`V.
`
`CIPLALTD,
`Patent Owner.
`
`Case IPR2020-00369
`Patent No. 8,168,620
`
`PETITIONER'S NOTICE OF APPEAL
`
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`
`
`Case IPR2020-00369
`Patent No. 8,168,620
`
`Pursuant to 37 C.F.R. §§ 90.2(a) and 90.3 , and 35 U.S.C. §§ 141 and 142,
`
`and 28 U.S.C. § 1295(a)(4)(A), Petitioner GlaxoSmithKline Consumer Healthcare
`
`Holdings (US) LLC ("Petitioner") provides notice that it appeals to the United
`
`States Court of Appeals for the Federal Circuit from the Decision Denying
`
`Institution of Inter Partes Review in Case No. IPR2020-00369 entered July 31 ,
`
`2020 (Paper 7), and from all underlying orders, decisions, rulings, and opinions.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), the issues on appeal are
`
`anticipated to include, but are not limited to, whether the USPTO's discretionary
`
`denial of institution in IPR2020-00369 was improper as based upon an improperly
`
`promulgated or inappropriately applied rule and whether the discretionary denial of
`
`institution in the underlying IPR should be vacated. See 35 U.S.C. § 316(a)(2), 5
`
`U.S.C. § 706(2)(D); 5 U.S.C. § 553; 5 U.S.C. § 706(2)(C).
`
`A copy of the decision being appealed is attached to this Notice.
`
`Pursuant to 35 U.S.C. § 142 and 37 C.F.R. § 90.2(a), this Notice is being
`
`filed with the Director of the United States Patent and Trademark Office, and a
`
`copy of this Notice is being concurrently filed with the Patent Trial and Appeal
`
`Board. In addition, a copy of this Notice and the required docketing fees are being
`
`filed with the Clerk's Office for the United States Court of Appeals for the Federal
`
`Circuit via CM/ECF.
`
`- 1 -
`
`
`
`Case IPR2020-00369
`Patent No. 8,168,620
`
`Dated: October 1, 2020
`
`Respectfully submitted,
`
`By: / Charles E. Lipsev I
`Charles E. Lipsey, Lead Counsel
`Reg. No. 28,165
`
`- 2 -
`
`
`
`Case IPR2020-00369
`Patent No. 8,168,620
`CERTIFICATE OF SERVICE AND FILING
`
`The undersigned certifies that on this 1st day of October 2020, in addition to
`being filed and served electronically through the Board's E2E system, a true and
`correct copy of the foregoing PETITIONER'S NOTICE OF APPEAL was filed
`and served on the Director of the United States Patent and Trademark Office via
`hand delivery at the following address:
`
`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`Madison Building East, Room 1 0B20
`600 Dulany Street
`Alexandria, VA 22314
`
`The undersigned also hereby certifies that on this 1st day of October 2020, a
`true and correct copy of the foregoing PETITIONER'S NOTICE OF APPEAL
`and the filing fee were filed with the Clerk's Office of the United States Court of
`Appeals for the Federal Circuit via CM/ECF.
`
`The undersigned also hereby certifies that on this 1st day of October 2020, a
`true and correct copy of the foregoing PETITIONER'S NOTICE OF APPEAL
`was served electronically via email on counsel of record for the Patent Owner as
`follows:
`
`Brandon M. White
`Nathan K. Kelley
`Perkins Coie LLP
`700 13 th St., NW, Suite 600
`Washington, DC 2005
`
`
`
`Case IPR2020-00369
`Patent No. 8,168,620
`
`White-ptab(a)pcrkinscoie.com
`Kelley nathan-ptab@perkinscoie.com
`
`Emily J. Greb
`Perkins Coie LLP
`33 East Main Street, Suite 201
`Madison, WI 53703
`Greb-ptabri~perklnscole.corn
`
`dymista(iv,perkinscoie.com
`
`I William Esper I
`William Esper
`Legal Assistant
`FINNEGAN, HENDERSON, f ARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`Trials@)uspto.gov
`571-272-7822
`
`Paper 7
`Date: July 31, 2020
`
`UNITED ST ATES PA TENT AND TRADEMARK OFFICE
`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`GLAXOSMITHKLINE
`CONSUMER HEALTHCARE HOLDINGS (US) LLC,
`Petitioner,
`
`V.
`
`CIPLALTD.,
`Patent Owner.
`
`IPR2020-00369
`Patent 8,168,620 B2
`
`Before JO-ANNE M. KOKOSKI, ZHENYU YANG, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`KOKOSKI, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 USC§ 325(d)
`
`
`
`IPR2020-003 69
`Patent 8,168,620 B2
`
`I. INTRODUCTION
`GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
`("Petitioner") filed a Petition to institute an inter partes review of claims 1-
`18, 21 , 22, 24-26, 28, 29, 31, 33, and 35-48 ("the challenged claims") of
`U.S. Patent No. 8,168,620 B2 ("the '620 patent," Ex. 1001). Paper 1
`("Pet."). Cipla Ltd. ("Patent Owner") filed a Preliminary Response. Paper 6
`("Prelim. Resp.").
`
`We have authority, acting on the designation of the Director, to
`determine whether to institute an inter partes review under 35 U.S.C. § 314
`and 37 C.F.R. § 42.4(a). For the reasons that follow, we exercise our
`discretion under 35 U.S.C. § 325(d) and deny institution of inter partes
`review.
`
`A. Related Proceedings
`Petitioner identifies the following district court proceedings involving
`the '620 patent: Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA,
`Inc., No. 1: 15-cv-00785-LPS (D. Del.) (dismissed on July 28, 2017); Meda
`Pharmaceuticals Inc. v. Perrigo UK FINCO Ltd. , No. 1: 16-cv-00794-LPS
`(D. Del.) (dismissed on July 7, 2017); and Meda Pharmaceuticals, Inc. v.
`Apotex Inc. , No. l:14-cv-01453-LPS (D. Del.) (dismissed on May 17, 2017).
`Pet. 62; Paper 5, 1.
`The parties also identify as related Argentum Pharmaceuticals LLC v.
`Cipla Ltd., IPR201 7-00807 (PT AB) ("the Argentum IPR"), an instituted
`proceeding challenging the '620 patent that the Board terminated prior to
`issuing a final written decision. Pet. 62; Paper 5, 1.
`Petitioner concurrently filed three other petitions, challenging patents
`related to the ' 620 patent: IPR2020-00368 (challenging U.S. Patent
`
`2
`
`
`
`IPR2020-00369
`Patent 8,168,620 B2
`
`No. 8,163,723 B2 (Ex. 1002)); IPR2020-00370 (challenging U.S. Patent
`No. 9,259,428 B2 (Ex. 1003)), and IPR2020-00371 (challenging U.S. Patent
`No. 9,901,585 B2 ("the '585 patent," Ex. 1004)). Paper 5, 1- 2.
`B. The '620 Patent
`The '620 patent is titled "Combination of Azelastine and Steroids."
`Ex. 1001, code (54). The '620 patent relates to pharmaceutical formulations
`comprising azelastine and a steroid, preferably a corticosteroid such as
`fluticasone. Id. at 1:54- 60, 2: 18-25. The Specification explains that it is
`known to use antihistamines, e.g., azelastine hydrochloride, in nasal sprays
`to treat allergy-related conditions. Id. at 1 :20-25. The Specification
`explains that it is also known to treat allergy-related conditions with a
`corticosteroid to suppress nasal inflam~natory conditions. Id. at 1 :26-33.
`According to the Specification, "[i]t would be highly desirable, however, to
`provide a treatment that combines the effects of anti-histamine treatments
`and steroid treatments, in a pharmaceutically acceptable formulation, which
`is tolerated in situ, without significantly disrupting the potency of the
`constituent pharmaceuticals." Id. at 1 :34-38.
`The Specification states that the applicants "found that, very
`surprisingly, azelastine . · .. can advantageously be combined with a
`steroid ... to provide a stable, very effective combination product." Id. at
`. 1 :39-48. "The combination can provide, in a single administration or dosing
`regime[n ], the antihistaminic properties of azelastine and the anti(cid:173)
`inflammatory (and/or other) properties of the steroid, without any significant
`interference between the two, or adverse reaction in situ." Id. at 1 :48- 53.
`The Specification discloses that the formulation may be in the form of
`a nasal spray, and that "[t]he formulations preferably contain a preservative
`
`3
`
`
`
`IPR2020-00369
`Patent 8,168,620 B2
`
`35 u.s.c. §
`103(a)
`
`References
`PDR 1999, 1 Segal2
`PDR 1999, Segal, Hettche3
`Cramer, 4 PDR 1999
`
`and/or stabilizer." Id. at 2: 18-25, 2:31-50. The formulations also may
`include, for example, surfactants, isotonization agents, and thickening
`· agents. See id at 3:21-24, 3:36- 39, 5:20-30.
`C Representative Claim
`Petitioner challenges claims 1- 18, 21, 22, 24-26, 28, 29, 31, 33, and
`35-48 of the '620 patent, of which claims 1, 21, 24, 25, 47, and 48 are
`independent. Pet. 1. Claim I is representative of the claimed subject matter,
`and is reproduced below.
`1. A pharmaceutical formulation comprising:
`azelastine, or a pharmaceutically acceptable salt thereof, and
`a pharmaceutically acceptable ester of fluticasone,
`wherein said pharmaceutical dosage formulation is in a dosage
`form suitable for nasal administration.
`Ex. 1001, 11 :46- 51.
`D. The Asserted Grounds of Unpatentability
`Petitioner asserts the challenged claims are unpatentable on the
`following grounds.
`Claim(s) Challenged
`1-18, 21,22,24-26,
`28,29,31,33,35-47
`48
`1-18,21,22,24-26,
`28,29,31,33,35-48
`
`103(a)
`
`I 03(a)
`
`1 Physicians' Desk Reference (53rd ed. 1999) (Ex. 1010).
`2 WO 98/48839 Al, published Nov. 5, 1998 (Ex. 1012).
`3 U.S. Patent No. 5,164,194, issued Nov. 17, 1992 (Ex. 1013).
`4 EP O 780 127 Al, published June 25, 1998 (Ex. 1011).
`
`4
`
`
`
`IPR2020-00369
`Patent 8,168,620 B2
`
`In support of its patentability challenge, Petitioner relies on the
`Declarations of Maureen D. Donovan, Ph.D. (Ex. 1057), and Robert P.
`Schleimer, Ph.D. (Ex. 1061).
`
`II. ANALYSIS
`Institution: of inter partes review is discretionary. See 35 U.S.C.
`§ 314(a); 37 C.F.R. § 42.108; see also Harmonic Inc. v. Avid Tech, Inc., 815
`F.3d 1356, 1367 (Fed. Cir. 2016) ("the PTO is permitted, but never
`compelled, to institute an IPR proceeding"). Our discretion as to whether to
`institute is guided by 35 U.S.C. § 325(d), which states that "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." Patent Owner contends that Petitioner's challenges
`rely on the same or substantially the same prior art and arguments that were
`already considered during the prosecution of the '620 patent, and that
`Petitioner fails to identify a material error in the Office's analysis. Prelim.
`Resp. 21-29.
`When evaluating whether the same or substantially the same prior art
`or arguments previously were presented to the Office under§ 325(d), the
`Board uses a two-part framework in determining whether to exercise its
`discretion under § 325( d), specifically:
`( 1) whether the same or substantially the same art previously was
`presented to the Office or whether the same or substantially the
`same arguments previously were presented to the Office; and
`(2) if either condition of the first part of the framework is
`satisfied, whether the petitioner has demonstrated that the Office
`erred in a manner material to the patentability of challenged
`claims.
`
`5
`
`
`
`IPR2020-00369
`Patent 8,168,620 B2
`
`Advanced Bionics, LLC v. Med-El Elektromedizinische Gerate GmbH,
`IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential).
`In applying this two-part framework, we consider several non(cid:173)
`exclusive factors, including: (a) the similarities and material differences
`between the asserted art and the prior art involved during examination;
`(b) the cumulative nature of the asserted art and the prior art evaluated
`during examination; ( c) the extent to which the asserted art was evaluated
`during examination, including whether the prior art was the basis for
`rejection; (d) the extent of the overlap between the arguments made during
`examination and the manner in which Petitioner relies on the prior art or
`Patent Owner distinguishes the prior art; ( e) whether Petitioner has pointed
`out sufficiently how the Examiner erred in its evaluation of the asserted prior
`art; and (f) the extent to which additional evidence and facts presented in the
`Petition warrant reconsideration of the prior art or arguments. Becton,
`Dickinson & Co. v. B. BraunMelsungenAG, IPR2017-01586, Paper 8, 17-
`18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph).
`If, after review of factors (a), (b), and (d), we determine that the same
`or substantially the same art or arguments were previously presented to the
`Office, then factors ( c ), ( e ), and (f) relate to whether the petitioner
`demonstrates that the Office erred in a manner material to the patentability
`of the challenged claims. Advanced Bionics, Paper 6 at 10. "At bottom, this
`framework reflects a commitment to defer to previous Office evaluations of
`the evidence or record unless material error is shown." Id. at 9.
`After considering all of the relevant factors and the parties'
`arguments, we are persuaded, for the reasons set forth below, that the
`
`6
`
`
`
`IPR2020-00369
`Patent 8,168,620 B2
`
`Petition presents substantially the same arguments previously presen'ted to
`the Office.
`A. Relevant Prosecution History
`The '620 patent issued from Application No. 10,518,016, filed as
`application No. PCT/GB03/02557 on June 13, 2003. Ex. 1001, codes (21),
`(22), (86). During the prosecution of the '620 patent, the Examiner rejected
`the claims as anticipated by Cramer or as having been obvious over Cramer
`combined with other references. See Ex. 2001, 497-512, 603-622, 721-
`742.5 For example, the Examiner found that Cramer discloses a nasal spray
`composition containing azelastine and fluticasone that also includes the
`claimed excipients. See, e.g., id. at 606-608 (citing, inter alia, Cramer's
`Example III). In addition, Segal and Hettche were identified in Information
`Disclosure Statements filed by the applicants, and the Examiner identified
`both having been considered. Id. at 637, 786.
`In response, the applicant filed three declarations from inventor
`Ms. Geena Malhotra as evidence supporting unexpected stability of the .
`claimed formulation and the inoperability of Cramer's Example III. See id.
`at 336-339, 568-570, 698-700. After a non-final rejection of the claims as
`anticipated by Cramer, the applicant amended the claims and filed additional
`declarations from Mr. Nikhil Chopra, Joachim Maus, M.D., and Sujeet
`Rajan, M.D. See id. at 254-283, 328-334, 358-364, 458-462. The
`additional declarations supported the applicant's assertions of commercial
`success, unexpected results, and long-felt need. See id.
`Following the response, the Examiner allowed the claims. See
`Ex. 2001, 192-199. In the Reasons for Allowability, the Examiner
`
`5 We cite to the page numbers that Patent Owner added to Exhibit 2001.
`
`7
`
`
`
`IPR2020-00 3 69
`Patent 8,168,620 B2
`
`discussed in detail the Chopra, Maus, and Rajan declarations supporting
`objective evidence of non-obviousness. See id. at 195- 198. The Examiner
`found "the Chopra Declaration supports that the product of the invention has
`been a commercial success for both the inventors and the copiers . . . [ and]
`that the product of the invention has filled a long-felt, but unmet need for an
`improved treatment for allergic rhinitis." Id. at 196. The Examiner found
`Dr. Rajan's declaration "also supports that the invention fills a long unmet
`need." Id. The Examiner further found that "Dr. Maus concludes that the
`superior results obtained with the combination of nasal fluticasone
`propionate and azelastine HCl would have been unexpected at the time of
`filing of the application. On the basis of this information and declaration,
`the examiner concurs in this conclusion." Id. at 197 (internal citation
`omitted). Accordingly, the Examiner concluded "the invention [of the '620
`patent] is unexpectedly and surprisingly unobvious over, different from, and
`superior to the prior art of record." Id. at 198.
`B. Same or Substantially the Same Prior Art or Arguments
`We first consider whether Petitioner asserts the same or substantially
`the same prior art or arguments that previously were presented to the Office.
`Advanced Bionics, Paper 6 at 8. We conclude that Petitioner asserts not only
`substantially the same prior art, but also substantially the same arguments
`that previously were presented to the Office. 6 Petitioner asserts Cramer,
`
`6 Under Advanced Bionics, either the same or substantially the same prior art
`previously must have been presented to the Office or the same or
`substantially the same arguments previously must have been presented to the
`Office to reach the second part of the framework, i.e., a showing of error
`material to patentability. Advanced Bionics, Paper 6 at 8. Here, however,
`both conditions of the first part of the framework are satisfied. Thus, we
`discuss both.
`
`8
`
`
`
`IPR2020-003 69
`Patent 8,168,620 B2
`
`Segal, PDR 1999, and Bettche against the challenged claims of the '620
`patent. Petitioner admits that the Examiner cited Cramer during prosecution
`of the '620 patent. Pet. 63- 64. Specifically, the Examiner relied on Cramer,
`both alone and in combination with other references, to reject pending
`claims in three Office Actions. Ex. 2001 , 497- 512, 603- 622, 721- 742.
`Thus, Cramer previously was presented to the Office.
`Further, as explained above, the Examiner rejected the claims after
`finding that Cramer teaches nasal spray compositions comprising azelastine
`and fluticasone in the recited amounts, and suggests pharmaceutically
`acceptable salt forms, including hydrochloride and propionate. See, e.g,
`Ex. 2001, 606-608. The Examiner also found that Cramer's composition
`may contain certain excipients, such as those recited in the claims. Id. at
`606- 607 (citing, inter alia, Cramer's Example III). Petitioner relies on the
`same teachings. For example, Petitioner asserts that Cramer discloses nasal
`spray formulations comprising fluticasone and azelastine or
`pharmaceutically acceptable salt forms of each. Pet. 29-30. Petitioner also
`asserts that Cramer's formulations may contain other ingredients, i.e.,
`excipients, such as emulsifiers, pH adjusters, buffering agents, preservatives,
`wetting agents, and jelling agents. Id. at 51- 57. Additionally, Petitioner,
`like the Examiner, relies on Cramer's Example III. Id. at 29- 30. Thus,
`Petitioner makes the same arguments the Office previously considered
`regarding Cramer.
`Although Petitioner does not address whether Segal, PDR 1999, and
`Hettche were presented to the Office during the '620 patent's prosecution,
`we find that Segal and Hettche were previously presented to the Office and
`that PDR 1999 is cumulative of references the Examiner considered during
`
`9
`
`
`
`IPR2020-003 69
`Patent 8,168,620 B2
`
`prosecution. Starting with Segal and Hettche, the applicant listed them on
`Information Disclosure Statements that the Examiner considered.
`Ex. 2001, 637, 786; see Advanced Bionics, Paper 6 at 7- 8 (explaining that
`previously presented art includes "art made of record by the Examiner, and
`art provided to the Office by an applicant, such as on an Information
`Disclosure Statement (IDS), in the prosecution history of the challenged
`patent").
`Segal and Hettche were asserted against the '620 patent claims in the
`Argentum IPR petition. The Examiner, in allowing the claims of the '585
`patent (a later-issued patent related to the '620 patent), stated that "all the
`references cited by the Argentum Petition are of record and have been
`previously evaluated, or disclose information redundant to infonnation of
`record." Ex. 1008, 37. 7 Petitioner admits that "the Argentum IPR was
`instituted based on the cited prior art and similar arguments" as in this
`Petition. Pet. 64. Accordingly, Segal and Hettche were previously
`presented to the Office and Petitioner makes the same arguments the Office
`previously considered regarding Segal and Hettche.
`Turning next to PDR 1999, we acknowledge that it was not before the
`Examiner during prosecution, but we agree with Patent Owner that the
`teachings in PDR 1999 do not differ "in any material way from the art and
`arguments already considered and overcome during prosecution." Prelim.
`Resp. 24. In other words, the disclosures in PDR 1999 are substantively the
`same as the disclosures in other references the Examiner considered and
`evaluated during prosecution. PDR 1999 discloses monotherapy nasal spray
`formulations comprising either azelastine hydrochloride or fluticasone
`
`7 We cite to the page numbers that Petitio~er added to Exhibit 1008.
`
`10
`
`
`
`IPR2020-00369
`Patent 8,168,620 B2
`
`propionate, and Petitioner relies on PDR 1999 for those teachings. See, e.g. ,
`Pet. 5; see also Ex. 1010, 1122 (PDR 1999 entry for Flonase, fluticasone
`propionate nasal spray), 3191 (PDR 1999 entry for Astelin, azelastine
`hydrochloride nasal spray). Cramer, which was considered by the Examiner,
`and declarations submitted during prosecution to traverse the rejections,
`described the prior-art practices of using antihistamines and corticosteroids
`as monotherapies. Ex. 1011, 2:19-22; Ex. 2001, 568- 596. Moreover, as
`Patent Owner notes, these teachings were already considered by the
`Examiner because "the specification itself recognizes that azelastine and
`fluticasone as monotherapies to treat allergy-related conditions were known
`in the art." Prelim. Resp. 14-15 (citing Ex. 1001, 1:20-30). Thus, PDR
`1999 is cumulative of the art the Examiner considered during prosecution,
`and Petitioner makes the same arguments that the Office previously
`considered when evaluating the '620 patent claims.
`Given the foregoing, we determine that the Petition presents not only _
`substantially the same prior art, but also the same arguments that were
`previously presented to the Office during prosecution of the '620 patent.
`C. Error material to patentability
`Because we find that the "same or substantially the same prior art or
`arguments previously were presented to the Office," we turn to whether
`Petitioner demonstrates that the Office erred in a manner material to the
`patentability of the challenged claims. Advanced Bionics, Paper 6 at 8, 10;
`see Becton, Dickinson, Paper 8 at 24. We conclude that Petitioner does not
`demonstrate an error material to patentability.
`Petitioner does not explicitly allege error in the Examiner's previous
`consideration of the prior art or arguments, and does not discuss or cite to
`
`11
`
`
`
`IPR2020-003 69
`Patent 8,168,620 B2
`
`the factors listed in the Board's precedential decision in Becton, Dickinson.
`See generally Pet. Nevertheless, Petitioner asserts that, during prosecution,
`the applicant overcame the rejections over Cramer "based solely on alleged
`objective indicia of nonobviousness, none of which demonstrates
`nonobviousness." Pet. 63-64. Petitioner is correct that the Examiner
`allowed the claims of the '620 patent after considering objective indicia of
`nonobviousness. Ex. 2001, 195-98. Petitioner, however, has not shown
`sufficiently that the Examiner erred in doing so.
`During the prosecution of the '620 patent, the applicant submitted
`several declarations from inventor Geena Malhotra as evidence supporting
`unexpected stability of the claimed formulation and the inoperability of
`Cramer's Example III. Ex. 2001, 336-39, 568-70, 698- 700. The applicant
`also submitted declarations from Mr. Nikhil Chopra, Joachim Maus, M.D.,
`and Sujeet Rajan, M.D. to support the assertions of commercial success,
`unexpected results, and long-felt need, respectively. Id. at 328- 34, 358- 64,
`458-62.
`After considering those declarations, the Examiner allowed the
`claims. See id. at 192-99. As set forth above, in the Reasons for
`Allowability, the Examiner discussed the Chopra, Maus, and Rajan
`declarations in detail. Id. at 195-98. The Examiner: (1) found that the
`Chopra declaration supports the commercial success of the combination
`product, and that it filled a long-felt and unmet need; (2) found that the
`Rajan declaration supports that the combined product met a long-felt but
`unmet need; and (3) agreed with Dr. Maus that the results obtained when
`using the combined azelastine-fluticasone product would have been
`unexpected. Id. at 196-197. Accordingly, the Examiner concluded that "the
`
`12
`
`
`
`IPR2020-003 69
`Patent 8,168,620 B2
`
`invention [of the '620 patent] is unexpectedly and surprisingly unobvious
`over, different from, and superior to the prior art of record." Id. at 198.
`Petitioner argues that there are no "unexpected results supportive of
`nonobviousness" because, during prosecution, the applicant did not compare
`"the claimed invention to the closest prior art." Pet. 59. Before turning to
`Petitioner's arguments, we note that Petitioner cites about 60 paragraphs of
`Dr. Schleimer's declaration to support its contentions, but the discussion in
`the mentions only four of those paragraphs (paragraphs 603- 606). See id.
`at 59- 60. "A brief must make all arguments accessible to the judges, rather
`than ask them to play archeologist with the record." DeSilva v. DiLeonardi,
`181 F.3d 865, 866- 67 (7th Cir. 1999); see also 37 C.F.R. § 42.22(a)(2)
`(2018) (Petitioner must "includ[ e] a detailed explanation of the significance
`of the evidence including material facts"). Further, "[ a ]rguments must not
`be incorporated by reference from one document into another
`document." 37 C.F.R. § 42.6(a)(3) (2018). Accordingly, we consider only
`the paragraphs on which Petitioner's arguments rely.
`According to Petitioner, "the closest prior art is a pharmaceutical
`nasal formulation comprising both azelastine and fluticasone, such as those
`taught by Cramer and Segal." Pet. 59. Thus, Petitioner asserts that the
`applicant did not show unexpected results because it did not present "results
`comparing the claimed invention to a pharmaceutical nasal formulation
`comprising both azelastine and fluticasone, such as those taught by Cramer
`and Segal, or to co-administration of commercially available azelastine
`hydrochloride nasal spray and fluticasone propionate nasal spray." Id. at 60.
`Dr. Schleimer testifies similarly. Ex. 1061 11 604- 606.
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`Even ifwe agreed with Petitioner that the applicant did not compare
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`the claimed invention to the closest prior art, Petitioner has not shown
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`sufficiently on this record that the Examiner erred in allowing the challenged
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`claims. The Examiner did not allow the claims solely based on the
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`applicant's showing of unexpected results; the Examiner also found
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`persuasive the applicant's commercial success and long-felt need evidence,
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`including the Chopra and Rajan declarations. Ex. 2001, 195-198.
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`Petitioner does not discuss either of these declarations, and does not
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`mention commercial success. With respect to long-felt but unmet need,
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`Petitioner only states that "Cipla has not shown that the claimed invention
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`satisfied a long-felt but unmet need, for at least the reason that Cipla has not
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`shown that any such need that was not already satisfied by co-administration
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`of commercially available azelastine hydrochloride and fluticasone
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`propionate nasal sprays." Pet. 61. This conclusory attorney argument is not
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`supported by any evidence, and is not enough to show that the Examiner
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`committed any material error.
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`Moreover, Petitioner's argument is substantially similar to one made
`
`in the Argentum IPR that the Examiner already considered during
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`prosecution of the related '585 patent. Ex. 1008, 37 ("With regard to the
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`Declaration by Maus, the Argentum Petition asserts that the relevant
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`comparator for the inventive formulation is concurrent use of fluticasone
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`propionate nasal spray and azelastine nasal spray."). There, the Examiner
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`determined that assertion "is not persuasive because at the time of the
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`invention, the field as a whole was divided as to whether oral or nasal
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`administration of antihistamine was better." Id. Petitioner, however, does
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`not attempt to explain how the Examiner erred in that determination.
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`Petitioner also does not discuss the Maus declaration, 8 which the Examiner
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`found persuasive. See, e.g., Ex. 1008, 41 ( describing the Maus declaration
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`as reviewing several studies, including "a non-prior art study which
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`concludes that there is no evidence that a combination of intranasal
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`corticosteroids with intranasal antihistamines provides any additional
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`therapeutic benefit, in comparison with intranasal steroids alone").
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`Accordingly, the record demonstrates that the Examiner determined
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`the claims were nonobviousness based on the totality of the evidence.
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`Petitioner has not demonstrated a material error by the Office in the prior
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`consideration of the same or substantially the same art or arguments
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`presented in the Petition.
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`III. CONCLUSION
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`The Petition relies on the same and substantially the same references,
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`and presents arguments that are substantially the same as those the Examiner
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`considered and the applicant overcame during prosecution of the ' 620
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`patent. Petitioner does not demonstrate that the Examiner materially erred in
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`considering such. Accordingly, in light of the circumstances of this case, we
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`exercise our discretion and deny institution of a trial under 35 U.S.C.
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`§ 325(d). 9
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`8 Petitioner also argues that a declaration by inventor Geena Malhotra does
`not support nonobviousness. Pet. 54. But, as Petitioner acknowledges, "the
`Examiner did not cite [the Malhotra] declaration in issuing the patents." Id.
`Thus, we do not find Petitioner's arguments directed to the Malhotra
`declaration as relevant in determining whether Petitioner shows that the
`Examiner erred in a manner material to patentability.
`9 Patent Owner argues that we should deny institution for several other
`reasons. Prelim. Resp. 5-11 , 29- 62. Because we deny the Petition under
`§ 325(d), we do not reach those additional arguments.
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`IV. ORDER
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`In consideration of the foregoing, it is hereby
`ORDERED that the Petition is denied, and no trial is instituted.
`
`FOR PETITIONER:
`Charles E. Lipsey
`Trenton A. Ward
`Richard B. Racine
`Joann M. Neth, Ph.D.
`Shana K. Cyr, Ph.D.
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER LLP
`charles.lipsey@finnegan.com
`trenton.ward@finnegan.com
`rich.racine@finnegan.com
`joann.neth@finnegan.com
`shana.cyr@finnegan.com
`
`FOR PATENT OWNER:
`
`Brandon M. White
`Emily J. Greb
`Na than K. Kelley
`PERKINS COIE LLP
`White-ptab@perkinscoie.com
`Greb-ptab@perkinscoie.com
`Kelley_ nathan-ptab@perkinscoie.com
`
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