Trials@uspto.gov
`571-272-7822
`
`Paper 7
`Date: July 31, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GLAXOSMITHKLINE
`CONSUMER HEALTHCARE HOLDINGS (US) LLC,
`Petitioner,
`v.
`CIPLA LTD.,
`Patent Owner.
`
`IPR2020-00370
`Patent 9,259,428 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 U.S.C. § 325(d)
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 7
`Date: July 31, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GLAXOSMITHKLINE
`CONSUMER HEALTHCARE HOLDINGS (US) LLC,
`Petitioner,
`v.
`CIPLA LTD.,
`Patent Owner.
`
`IPR2020-00370
`Patent 9,259,428 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 U.S.C. § 325(d)
`
`
`
`
`
`
`
`
`
`IPR2020-00370
`Patent 9,259,428 B2
`
`
`I. INTRODUCTION
`GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
`(“Petitioner”) filed a Petition to institute an inter partes review of claims 1–
`30 (“the challenged claims”) of U.S. Patent No. 9,259,428 B2
`(“the ’428 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 ’428 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. 1:14-cv-01453-LPS (D. Del.) (dismissed on May 17, 2017).
`Pet. 63–64; Paper 5, 1.
`The parties also identify as related Argentum Pharmaceuticals LLC v.
`Cipla Ltd., IPR2017-00807 (PTAB) (“the Argentum IPR”), an instituted
`proceeding challenging U.S. Patent No. 8,168,620 B2 (“the ’620 patent,”
`Ex. 1001), which is related to the ’428 patent. Pet. 63–64; Paper 5, 1. The
`Board terminated the proceeding prior to issuing a final written decision.
`Petitioner concurrently filed three other petitions, challenging patents
`related to the ’428 patent: IPR2020-00368 (challenging U.S. Patent
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`Patent 9,259,428 B2
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`No. 8,163,723 B2 (“the ’723 patent,” Ex. 1002)); IPR2020-00369
`(challenging the ’620 patent), and IPR2020-00371 (challenging U.S. Patent
`No. 9,901,585 B2 (“the ’585 patent,” Ex. 1004)). Paper 5, 1–2.
`B. The ’428 Patent
`The ’428 patent is titled “Combination of Azelastine and Fluticasone
`for Nasal Administration.” Ex. 1003, code (54). The ’428 patent relates to
`pharmaceutical formulations comprising azelastine and fluticasone, which
`can be used to minimize or prevent allergic reactions. Id. at 1:32–34, 7:19–
`45. The Specification explains that it is known to use antihistamines, e.g.,
`azelastine hydrochloride, in nasal sprays to treat allergy-related conditions.
`Id. at 1:41–46. The Specification explains that it is also known to treat
`allergy-related conditions with a corticosteroid such as fluticasone to
`suppress nasal inflammatory conditions. Id. at 1:47–54. 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 1:55–59.
`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 1:60–2:2. “The combination can provide, in a single administration or
`dosing regime[n], the antihistaminic properties of azelastine and the anti-
`inflammatory (and/or other) properties of the steroid, without any significant
`interference between the two, or adverse reaction in situ.” Id. at 2:2–7.
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`The Specification discloses that the formulation may be in the form of
`a nasal spray, and that “[t]he formulations preferably contain a preservative
`and/or stabilizer.” Id. at 2:18–25, 2:31–50. Preferred preservatives include
`edetate disodium, benzalkonium chloride, and phenyl ethyl alcohol. Id. at
`2:55–3:7. The formulations may include further auxiliary substances:
`specifically surfactants, e.g., polyethoxylated sorbitan fatty acid esters
`(polysorbate); isotonization agents, e.g., glycerine, glucose, and sodium
`chloride; and thickening agents, e.g., methyl cellulose, and carboxymethyl
`cellulose sodium. See id. at 3:30–43, 3:44–47, 3:57–4:5. The Specification
`explains that “[i]t is also possible to add to the formulations buffer
`substances . . . to adjust the formulations to a pH value of 3 to 7, preferably
`4.5 to 6.5.” Id. at 4:14–19.
`The Specification further teaches “a method for the prophylaxis or
`treatment in a mammal, such as a human, of conditions for which
`administration of one or more anti-histamine and/or one or more steroid is
`indicated.” Id. at 7:30–33. The method of treatment comprises
`administration of a therapeutically effective amount of a pharmaceutical
`formulation containing azelastine and fluticasone described in the
`Specification. Id. at 7:33–45.
`C. Representative Claim
`Petitioner challenges claims 1–30 of the ’428 patent, of which
`claims 1, 14, and 28 are independent. Pet. 1. Claim 1 is representative of
`the claimed subject matter, and is reproduced below.
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`1. A method for the treatment of seasonal allergic rhinitis,
`comprising administration of a therapeutically effective
`amount of a nasal spray formulation comprising:
`from 0.001% (weight/weight) to 1% (weight/weight) of
`azelastine hydrochloride;
`from 0.0357% (weight/weight) to 1.5% (weight/weight) of
`fluticasone propionate;
`one or more preservatives;
`one or more thickening agents;
`one or more surfactants; and
`one or more isotonization agents.
`Ex. 1003, 11:51–61.
`D. The Asserted Grounds of Unpatentability
`Petitioner asserts the challenged claims are unpatentable on the
`following grounds.
`References
`35 U.S.C. §
`Claims Challenged
`PDR 1999,1 Segal2
`103(a)
`1–30
`Cramer,3 PDR 1999
`103(a)
`1–30
`In support of its patentability challenge, Petitioner relies on the
`Declarations of Maureen D. Donovan, Ph.D. (Ex. 1059), and Robert P.
`Schleimer, Ph.D. (Ex. 1063).
`
`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
`
`
`1 Physicians’ Desk Reference (53rd ed. 1999) (Ex. 1010).
`2 WO 98/48839 A1, published Nov. 5, 1998 (Ex. 1012).
`3 EP 0 780 127 A1, published June 25, 1998 (Ex. 1011).
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`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 ’428 patent and the
`related ’620 patent, and that Petitioner fails to identify a material error in the
`Office’s analysis. Prelim. Resp. 20–28.
`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.
`Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential).
`In applying this two-part framework, we consider several non-
`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
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`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. Braun Melsungen AG, 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
`Petition presents substantially the same art and arguments previously
`presented to the Office.
`A. Relevant Prosecution History
`The ’428 patent issued from Application No. 14/661,720, which
`claims priority through a series of applications to Application
`No. 10/518,016, filed as application No. PCT/GB03/02557 on June 13,
`2003, now the ’620 patent. Ex. 1003, codes (21), (22), (60). We discuss the
`prosecution of both the ’620 patent and the ’428 patent below.
`During the prosecution of the ’620 patent, the Examiner rejected the
`claims as anticipated by Cramer or as having been obvious over Cramer
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`combined with other references. See Ex. 2001, 497–512, 603–622, 721–
`742.4 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 was identified in an Information Disclosure
`Statement filed by the applicants, and the Examiner identified it as having
`been considered. Id. at 785–786.
`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.
`Ex. 2001, 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. 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, respectively. See id.
`Following the response, the Examiner allowed the claims. Ex. 2001,
`192–199. In the Reasons for Allowability, the Examiner discussed in detail
`the Chopra, Maus, and Rajan declarations supporting objective evidence of
`non-obviousness. Id. at 195–198. The Examiner found that “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.
`
`
`4 We cite to the page numbers that Patent Owner added to Exhibit 2001.
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`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.
`During the prosecution of the ’428 patent, the Examiner rejected the
`claims on the ground of non-statutory double patenting as being
`unpatentable over claims in the ’620 and ’723 patents. Ex. 1007, 5–6.5 The
`applicant submitted a terminal disclaimer to overcome the double patenting
`rejection. Id. at 21. The Examiner allowed the claims after the filing of the
`terminal disclaimer. Id. at 39. In the Reasons for Allowance, the Examiner
`stated that “[t]he claims are free of the prior art of record,” and “are drawn to
`a method of use of a composition that is more narrowly claimed than the
`composition” in the ’620 patent. Id. The Examiner further stated that “the
`claims are allowed also for the reasons provided in the Notices of
`Allowance” for the ’620 patent. Id.
`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
`
`
`5 We cite to the page numbers that Petitioner added to Exhibit 1007.
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`that previously were presented to the Office.6 Petitioner asserts Cramer,
`Segal, and PDR 1999 against the challenged claims of the ’428 patent.
`Petitioner admits that the Examiner cited Cramer during prosecution.
`Pet. 65. Although the Examiner did not use the prior art of record to reject
`the claims during the prosecution of the ’428 patent, the Examiner relied on
`Cramer, both alone and in combination with other references, to reject
`pending claims in three Office Actions during the prosecution of the ’620
`patent. 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 during
`prosecution of the ’620 patent 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. 30. Petitioner also asserts that Cramer’s formulations may contain other
`ingredients, i.e., excipients, “such as pH adjusters (e.g., an acid such as
`
`
`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.
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`HCl), emulsifiers or dispersing agents, buffering agents, preservatives,
`wetting agents, and jelling agents (e.g., methylcellulose).” Id. at 31.
`Additionally, Petitioner, like the Examiner, relies on Cramer’s Example III.
`Id. at 31–32. Thus, Petitioner makes the same arguments the Office
`previously considered regarding Cramer.
`Although Petitioner does not address whether Segal and PDR 1999
`were presented to the Office during the ’620 patent’s prosecution, we find
`that Segal was previously presented to the Office and that PDR 1999 is
`cumulative of references the Examiner considered during prosecution.
`Starting with Segal, the applicant listed it on an Information Disclosure
`Statement that the Examiner considered. Ex. 2001, 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 was 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 challenged ’428 patent), stated that “all the
`references cited by the Argentum Petition are of record and have been
`previously evaluated, or disclose information redundant to information 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. 65. Accordingly, Segal was previously presented to the Office
`and Petitioner makes the same arguments the Office previously considered
`regarding Segal.
`
`
`7 We cite to the page numbers that Petitioner added to Exhibit 1008.
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`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. In particular, PDR 1999 discloses
`monotherapy nasal spray formulations comprising either azelastine
`hydrochloride or fluticasone propionate, and Petitioner relies on PDR 1999
`for those teachings. See, e.g., Pet. 4–6; 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
`of the ’620 patent 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 points out, 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 (citing Ex. 1001, 1:20–30).8 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.
`
`
`8 The ’428 patent specification contains the same statement. See
`Ex. 1003, 1:41–51.
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`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 and,
`accordingly, the ’428 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
`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. 65. 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.
`As described above, during the prosecution of the ’620 patent the
`applicant submitted the Malhotra declarations 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 the Chopra, Maus, and Rajan declarations to support the
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`assertions of commercial success, unexpected results, and long-felt need,
`respectively. Id. at 328–34, 358–64, 458–62.
`In the Reasons for Allowability for the ’620 patent, which are
`incorporated into the Reasons for Allowance of the ’428 patent, the
`Examiner discussed in detail the Chopra, Maus, and Rajan declarations. Id.
`at 195–98; Ex. 1007, 39. 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.” Ex. 2001, 196. The Examiner found Dr. Rajan’s declaration “also
`supports that the invention fills a long unmet need,” and agreed with
`Dr. Maus’s conclusion that the results obtained with the combination of
`azelastine and fluticasone would have been unexpected. Id. at 196–197.
`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.
`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. 60. Before turning to
`Petitioner’s arguments, we note that Petitioner cites to about 60 paragraphs
`of Dr. Schleimer’s declaration (paragraphs 485–543) to support its
`contentions in this regard, but the discussion in the Petition mentions only
`four of those paragraphs (paragraphs 486–489). See id. at 60–61. “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
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`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. 60–61. 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 61.
`Dr. Schleimer testifies similarly. Ex. 1063 ¶¶ 487–489.
`Even if we agreed with Petitioner that the applicant did not compare
`the claimed invention to the closest prior art, Petitioner has not shown
`sufficiently on this record that the Examiner erred in allowing the challenged
`claims. The Examiner did not allow the claims solely based on the
`applicant’s showing of unexpected results; the Examiner also found
`persuasive the applicant’s commercial success and long-felt need evidence,
`including the Chopra and Rajan declarations. Ex. 2001, 195–198.
`Petitioner does not discuss either of these declarations, and does not
`even mention commercial success. With respect to long-felt but unmet need,
`Petitioner only states that “Cipla has not shown that the claimed invention
`satisfied a long-felt but unmet need, for at least the reason that Cipla has not
`shown that any such need that was not already satisfied by co-administration
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`of commercially available azelastine hydrochloride and fluticasone
`propionate nasal sprays.” Pet. 63. This conclusory attorney argument is not
`supported by any evidence, and is not enough to show that the Examiner
`committed any material error.
`Moreover, Petitioner’s argument is substantially similar to one made
`in the Argentum IPR that the Examiner already considered during
`prosecution of the related ’585 patent. Ex. 1008, 37 (“With regard to the
`Declaration by Maus, the Argentum Petition asserts that the relevant
`comparator for the inventive formulation is concurrent use of fluticasone
`propionate nasal spray and azelastine nasal spray.”). There, the Examiner
`determined that assertion “is not persuasive because at the time of the
`invention, the field as a whole was divided as to whether oral or nasal
`administration of antihistamine was better.” Id. Petitioner, however, does
`not attempt to explain how the Examiner erred in that determination. Also,
`Petitioner does not discuss the Maus declaration,9 which the Examiner found
`persuasive. See, e.g., Ex. 1008, 41 (describing the Maus declaration as
`reviewing several studies, including “a non-prior art study which concludes
`that there is no evidence that a combination of intranasal corticosteroids with
`intranasal antihistamines provides any additional therapeutic benefit, in
`comparison with intranasal steroids alone”).
`
`
`9 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.
`
`16
`
`
`
`IPR2020-00370
`Patent 9,259,428 B2
`
`
`In sum, the record demonstrates that the Examiner determined the
`claims were nonobviousness based on the totality of the evidence. Petitioner
`has not demonstrated a material error by the Office in the prior consideration
`of the same or substantially the same art or arguments presented in the
`Petition.
`
`III. CONCLUSION
`The Petition relies on the same and substantially the same references,
`and presents arguments that are substantially the same as those the Examiner
`considered and the applicant overcame during prosecution of the ’620
`patent, and, accordingly, during the prosecution of the ’428 patent.
`Petitioner does not demonstrate that the Examiner materially erred in
`considering such. Accordingly, in light of the circumstances of this case, we
`exercise our discretion and deny institution of a trial under 35 U.S.C.
`§ 325(d).10
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby
`ORDERED that the Petition is denied, and no trial is instituted.
`
`
`
`
`
`
`
`
`
`
`10 Patent Owner argues that we should deny institution for several other
`reasons. Prelim. Resp. 5–11, 29–61. Because we deny the Petition under
`§ 325(d), we do not reach those additional arguments.
`
`17
`
`
`
`IPR2020-00370
`Patent 9,259,428 B2
`
`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
`Nathan K. Kelley
`
`PERKINS COIE LLP
`White-ptab@perkinscoie.com
`Greb-ptab@perkinscoie.com
`Kelley_nathan-ptab@perkinscoie.com
`
`
`
`18
`
`
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