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.
`
`IPR2020-00371
`Patent 9,901,585 B2
`
`
`
`
`
`
`
`
`
`Before ZHENYU YANG, CHRISTOPHER M. KAISER, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`ANKENBRAND, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 325(d)
`
`
`
`
`
`
`
`

`

`IPR2020-00371
`Patent 9,901,585 B2
`
`
`INTRODUCTION
`I.
`GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
`(“Petitioner”) requests an inter partes review of claims 1–30 of U.S. Patent
`Number 9,901,585 B2, (“the ’585 patent,” Ex. 1004). Paper 1 (“Pet.”).
`Cipla Ltd. (“Patent Owner”) filed a Preliminary Response. Paper 6
`(“Prelim. Resp.”).
`Based on the particular circumstances of this case, we exercise our
`discretion under 35 U.S.C. § 325(d) and do not institute an inter partes
`review of the challenged claims.
`II. BACKGROUND
`A. Related Matters
`The parties do not identify any related matters involving the ’585
`patent. See Pet. 66; Paper 4, 1–2. The parties identify the following
`concluded district court litigation involving U.S. Patent Number 8,168,620
`(“the ’620 patent”), which is related to the ’585 patent: Meda
`Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., No. 1:15-cv-
`00785-LPS (D. Del.); Meda Pharmaceuticals Inc. v. Perrigo UK FINCO
`Ltd., No. 1:16-cv-00794-LPS (D. Del.); Meda Pharmaceuticals, Inc. v.
`Apotex Inc., No. 1:14-cv-01453-LPS (D. Del.). Pet. 66–67; Paper 4, 1.
`The parties also identify as related Argentum Pharmaceuticals LLC v.
`Cipla Ltd., IPR2017-00807 (PTAB) (“the Argentum IPR”) an instituted
`proceeding challenging the ’620 patent that the Board terminated prior to
`issuing a final written decision. Pet. 67; Paper 4, 1.
`Patent Owner also identifies three petitions requesting an inter partes
`review that Petitioner filed challenging patents related to the ’585 patent:
`IPR2020-00368, challenging U.S. Patent Number 8,163,723; IPR2020-
`
`2
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`IPR2020-00371
`Patent 9,901,585 B2
`
`00369, challenging the ’620 patent; and IPR2020-00370, challenging U.S.
`Patent Number 9,259,428. Paper 4, 1–2.
`
`B. The ’585 Patent
`The ’585 patent, titled “Combination of Azelastine and Fluticasone
`for Nasal Administration,” issued on February 27, 2018. Ex. 1004, codes
`(45), (54). The ’585 patent relates to pharmaceutical formulations
`comprising azelastine (4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-
`1H-azepin-4-yl)-1(2H)-phthalazinone) and a corticosteroid. Id. at 1:64–66,
`2:15–22. The corticosteroid may include fluticasone. Id. at 2:46–54.
`The Specification explains that it is known to use antihistamines, e.g.,
`azelastine hydrochloride, in nasal sprays to treat allergy-related conditions.
`Id. at 1:44–49. The Specification further explains that it is also known to
`treat allergy-related conditions with a corticosteroid to suppress nasal
`inflammatory conditions. Id. at 1:50–53. The Specification states that “[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 1:58–63.
`According to the Specification, the applicants “found that, very
`surprisingly, azelastine . . . can advantageously be combined with a steroid
`. . . to provide a stable, very effective combination product.” Id. at 1:64–2:6.
`“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 2:7–11.
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`
`The Specification discloses that the formulation may be in the form of
`an aqueous solution nasal spray. Id. at 2:47–54. The Specification explains
`that “[t]he formulations preferably contain a preservative and/or stabilizer.”
`Id. at 2:60–61. Preferred preservatives include edetate disodium,
`benzalkonium chloride, and phenyl ethyl alcohol. Id. at 2:61–3:12. 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 3:36–50, 3:51–54, 3:66–4:14. 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
`4:23–28.
`
`C. Illustrative Claim
`Petitioner challenges claims 1–30 of the ’585 patent, of which claims
`1, 16, and 27 are independent. Pet. 1. Claim 1 of the ’585 patent is
`illustrative of the claimed subject matter and recites:
`1. 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. 1004, 11:62–12:3.
`
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`IPR2020-00371
`Patent 9,901,585 B2
`
`
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–30 of the ’585
`patent based on the following grounds:
`References/Basis
`Claims Challenged
`35 U.S.C. §1
`PDR 1999,2 Segal3
`1–30
`103(a)
`Cramer,4 PDR 1999
`1–30
`103(a)
`Petitioner supports the Petition with the testimony of Maureen D.
`Donovan, Ph.D. (Ex. 1060) and Robert P. Schleimer, Ph.D. (Ex. 1064).
`III. ANALYSIS
`A. Discretionary Denial under 35 U.S.C. § 325(d)
`Patent Owner argues that we should exercise our discretion to deny
`the Petition under 35 U.S.C. § 325(d) because Petitioner presents
`substantially the same prior art and arguments the Office previously
`considered during the prosecution of the ’585 patent and the related ’620
`patent, and fails to identify a material error in the Office’s analysis. Prelim.
`Resp. 20–28.
`Section 325(d) provides that in determining whether to institute an
`inter partes review, “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.” We use a two-part
`
`
`1 Because the claims at issue have an effective filing date before March 16,
`2013, the effective date of the applicable provisions of the Leahy Smith
`America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011) (“AIA”), we
`apply the pre-AIA version of 35 U.S.C. § 103 in this decision.
`2 Physicians’ Desk Reference, Flonase (fluticasone propionate) entry 1112–
`1124 and Astelin (azelastine hydrochloride) entry 3191–3192 (53rd ed.
`1999) (Ex. 1010).
`3 WO 98/48839 A1, published Nov. 5, 1998 (Ex. 1012).
`4 EP 0 780 127 A1, published June 25, 1997 (Ex. 1011).
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`IPR2020-00371
`Patent 9,901,585 B2
`
`framework in determining whether to exercise 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 the 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 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 at 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
`previously were 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,
`
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`IPR2020-00371
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`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.
`
`For the reasons set forth below, under the facts and circumstances of
`this case, we exercise our discretion under § 325(d) to deny institution of a
`trial. Before turning to the two-part framework, we briefly discuss the
`asserted references and the relevant prosecution history of the ’585 and ’620
`patents.
`
`1. Asserted references
`Below, we provide a brief summary of the references that Petitioner
`asserts against the challenged claims of the ’585 patent.
`a) PDR 1999 (Ex. 1010)
`Petitioner relies on PDR 1999 for its disclosure of nasal spray
`compositions containing either fluticasone propionate, marketed under the
`brand name Flonase, or azelastine hydrochloride, marketed under the brand
`name Astelin. See, e.g., Pet. 4–5. The flonase prescribing information
`describes the commercially available “FLONASE Nasal Spray 50 mcg [as]
`an aqueous suspension of microfine fluticasone propionate for topical
`administration to the nasal mucosa by means of a metering, atomizing spray
`pump.” Ex. 1010, 1122. The formulation contains 0.05% w/w fluticasone
`propionate. Id. The “FLONASE Nasal Spray also contains microcrystalline
`cellulose and carboxymethylcellulose sodium, dextrose, 0.02% w/w
`benzalkonium chloride, polysorbate 80, and 0.25% w/w phenylethyl alcohol,
`and has a pH between 5 and 7.” Id.
`The Astelin prescribing information describes the commercially
`available “Astelin® (azelastine hydrochloride) Nasal Spray, 137 micrograms
`
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`IPR2020-00371
`Patent 9,901,585 B2
`
`(mcg), [as] an antihistamine formulated as a metered Spray solution for
`intranasal administration.” Ex. 1010, 3191. “Astelin® Nasal Spray contains
`0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also
`contains benzalkonium chloride (125 mcg/mL), edetate disodium,
`hydroxypropyl methyl cellulose, citric acid, dibasic sodium phosphate,
`sodium chloride, and purified water.” Id.
`b) Cramer (Ex. 1011)
`Cramer describes “novel nasal spray compositions comprising a safe
`and effective amount of a glucocorticosteroid and an antihistamine.”
`Ex. 1011, 2:5–6. Cramer teaches the “[g]lucocorticoid agents most useful to
`the present invention include those selected from the group consisting of
`beclomethasone, flunisolide, triamcinolone, fluticasone, mometasone,
`budesonide, pharmaceutically acceptable salts thereof.” Id. at 3:15–18. The
`glucocorticoid concentration in the compositions may range “from about
`0.001% to about 0.2%, more preferably from about 0.01% to about 0.1%.”
`Id. at 3:19–20. Cramer teaches useful antihistamines “include cetirizine,
`loratadine, azelastine and the like . . . at a concentration of from about 0.01%
`to about 4.0%, more preferably from about 0.01% to about 1%.” Id. at 3:24–
`30.
`
`Cramer teaches “[p]referred nasal dosage forms are solutions,
`suspensions and gels, which normally contain sodium chloride in a major
`amount of water (preferably purified water) in addition to the antihistamine
`and glucocorticoid.” Id. at 3:45–47. Cramer teaches the compositions may
`include “[m]inor amounts of other ingredients such as pH adjusters (e.g., an
`acid such as HCl), emulsifiers or dispersing agents, buffering agents,
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`IPR2020-00371
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`
`preservatives, wetting agents and jelling agents (e.g., methylcellulose).” Id.
`at 3:47–49. “Most preferably, the nasal composition is isotonic.” Id. 3:49.
`Cramer describes a specific example of a pharmaceutical composition
`as Example III, reproduced below.
`Component
`triamcinolone acetonide
`azelastine HCl
`polysorbate 80
`glycerin
`hydroxypropyl methyl
`cellulose
`sodium chloride
`ethylenediamine
`tetraacetic acid
`benzalkonium chloride
`distilled water
`
`Wgt%
`0.050
`0.070
`0.050
`2.000
`1.000
`
`0.900
`0.050
`
`0.020
`q.s. to vol.
`
`
`Id. at 6:26–42. Cramer teaches that the composition is used to provide relief
`from allergy symptoms and “substantially similar results are also obtained
`using, in whole or in part, equivalent amounts of other glucocorticoid agents
`such as fluticasone, mometasone, budesonide, pharmaceutically acceptable
`salts thereof and mixtures thereof.” Id. at 6:43–46.
`c) Segal (Ex. 1012)
`Segal describes “topically applicable nasal compositions comprising a
`therapeutically effective amount of a topical anti-inflammatory agent and a
`therapeutically effective amount of at least one agent suitable for topical
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`Patent 9,901,585 B2
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`nasal administration and selected from the group consisting of . . . an
`antihistamine.” Ex. 1012, 2:10–15. Segal discloses that the topical anti-
`inflammatory agent is a corticosteroid, e.g., fluticasone propionate. Id. at
`2:23–26. Segal also discloses suitable antihistamines, including azelastine.
`Id. at 3:19–20. Segal teaches that “[t]he use of an additional therapeutic
`agent in combination with an anti-inflammatory agent provides additive and
`synergistic effects in the treatment of nasal and sinus conditions.” Id. at 3:9–
`12.
`
`Segal teaches “[t]he compositions of the present invention can be
`conveniently administered nasally to a human subject in dosage unit form to
`elicit the desired therapeutic effect of the anti-inflammatory agent and the
`additional therapeutic agents described above. The compositions may be
`administered in the form of a nasal spray.” Id. at 4:20–23. Segal describes
`“nasal sprays containing a water buffered aqueous solution as a carrier.” Id.
`at 4:4–7. “The compositions are preferably isotonic,” e.g., sugars and
`sodium chloride, and may contain additional agents, including a humectant,
`e.g., glycerin, pharmaceutically acceptable preservatives, and pH adjusters.
`Id. at 4:5–14.
`
`2. Relevant prosecution history
`The ’585 patent issued from Application No. 15/070,839, which
`claims priority through a series of parent applications to Application
`No. 10/518,016, filed as application No. PCT/GB03/02557 on June 13,
`2003, now the ’620 patent. Ex. 1004, at [21], [60]. We discuss the
`prosecution of both the ’620 patent and the ’585 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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`IPR2020-00371
`Patent 9,901,585 B2
`
`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 in the claimed amounts,
`further including the claimed excipients. See, e.g., id. at 606–608 (citing,
`inter alia, Cramer’s Example III).
`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, respectively. See id.
`Following the response, the Examiner allowed the claims. See id. at
`192–199. In the Reasons for Allowability, the Examiner 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.
`And the Examiner found that “Dr. Maus concludes that the superior results
`obtained with the combination of nasal fluticasone propionate and azelastine
`
`
`5 We cite to the page numbers that Patent Owner added to Exhibit 2001.
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`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 ’585 patent, the Examiner rejected the
`claims as anticipated by Cramer, or as having been obvious over Cramer
`with additional optional references. Ex. 1008, 4–5.6 In so doing, the
`Examiner incorporated by reference the Office’s “explanation of disclosures
`of the prior art and rationales for combing the disclosures of [the]
`references” as set forth in the ’620 patent’s prosecution, among others. Id. at
`5. In other words, the Examiner relied on the Office’s previous findings and
`conclusions regarding Cramer, including Cramer’s disclosure of a nasal
`spray containing azelastine and fluticasone, as well as Cramer’s Example III.
`See, e.g., Ex. 2001, 501–502.
`In a response filed August 1, 2017, the applicant argued that one of
`Dr. Malhotra’s declarations submitted during the ’620 patent’s prosecution
`established that Cramer’s Example III was inoperable. See id. at 20–23.
`The applicant further argued that the Chopra, Maus, and Rajan declarations
`submitted during the ’620 patent’s prosecution were evidence of secondary
`considerations that the claimed formulations were nonobvious. See id. at
`23–27. The applicant also submitted an Information Disclosure Statement
`
`
`6 We cite to the page numbers that Petitioner added to Exhibit 1008.
`
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`Patent 9,901,585 B2
`
`(“IDS”) listing the Argentum IPR petition, which asserted Segal, Hettche,7
`Phillipps,8 and Flonase Label9 against challenged claims of the ’620 patent,
`all of which the Examiner considered. Ex. 1008, 36–37 (“The references
`provided in the Information Disclosure were evaluated for their disclosure in
`view of the claims of the instant application.”); Ex. 3001, 2 (August 1, 2017,
`IDS, first entry, titled “Petition for Inter Partes Review on U.S. Patent No.
`8,168,620, No. IPR2017-00807 filed February 2, 2017, Argentum
`Pharmaceuticals LLC v. Cipla Ltd., 73 pages”).
`Following the Response, the Examiner allowed the claims. Id. at 36–
`42. The Examiner addressed the Argentum IPR petition, explaining “[w]ith
`regard to obviousness, all the references cited by the Argentum Petition are
`of record and have been previously evaluated, or disclose information
`redundant to information of record.” Id. at 37. The Examiner further stated:
`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. The assertion is not persuasive because
`at the time of the invention, the field as a whole was divided as
`
`
`7 US 5,164,194, issued Nov. 17, 1992 (Ex. 1013). Hettche teaches a
`“medicament for nasal use . . . which contains as [an] active ingredient
`azelastine or a physiologically acceptable salt.” Id. at Abstract.
`8 US 4,335,121, issued June 15, 1982 (Ex. 1009). Phillipps discloses topical
`nasal sprays comprising fluticasone propionate formulated with one or more
`pharmaceutical carriers or excipients. Id. at 32:46–50, 32:57–60, 36:7–10.
`9 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product
`Information (Dec. 1998) (Ex. 1010). The Flonase Label discloses an aqueous
`suspension of microfine fluticasone propionate that also contains
`microcrystalline cellulose and carboxymethylcellulose sodium, dextrose,
`0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25% w/w
`phenylethyl alcohol. Id. at 1122.
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`
`to whether oral or nasal administration of antihistamine was
`better.
`Id. at 37. The Examiner considered arguments against the Chopra
`Declaration, finding that “[t]he Argentum Petition also argues that evidence
`of commercial success requires evidence of relative product pricing and
`marketing. Careful analysis of the Chopra data refutes the argument.” Id. at
`38.
`
`In the Reasons for Allowance, the Examiner found that the Chopra
`Declaration supported commercial success, the Chopra and Rajan
`Declarations supported the invention filling a long-felt need, and the Maus
`Declaration supported superior unexpected results. See id. at 39–42 (making
`similar findings regarding the applicant’s objective evidence to those the
`Examiner made during the ’620 patent’s prosecution). Accordingly, the
`Examiner found that the claims that issued as the ’585 patent “are narrower
`than the independent claims allowed as US Patent No. 8168620” and that
`“the invention is unexpectedly and surprisingly unobvious over, different
`from, and superior to the prior art of record.” Id. at 42.
`3. Whether the same or substantially the same prior art or
`arguments previously were presented to the Office
`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.10 Petitioner asserts Cramer,
`
`
`10 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
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`Segal, and PDR 1999 against the challenged claims of the ’585 patent.
`Petitioner admits that the Examiner cited Cramer during prosecution of the
`’585 patent. Pet. 68. Indeed, as set forth above, the Examiner rejected all
`pending claims “as anticipated by, or in the alternative[,] . . . as obvious over
`the disclosure of Cramer, optionally further in view of [additional
`references].” Ex. 1008, 4–5. 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. 31. 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. And, like the Examiner, Petitioner
`points to Cramer’s Example III. Id. at 31–32. Thus, Petitioner makes the
`same arguments the Office previously considered regarding Cramer.
`
`
`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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`
`Although Petitioner does not address whether Segal and PDR 1999
`were presented to the Office during the ’585 patent’s prosecution, we find
`that Segal previously was 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 IDS 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 also was asserted against the ’620 patent claims
`in the Argentum IPR petition that the Examiner reviewed and discussed
`during the ’585 patent’s prosecution. See Ex. 1008, 36–39 (Notice of
`Allowability discussing in detail the Argentum IPR petition); Ex. 3001, 2
`(listing the Argentum IPR petition). And Petitioner admits that the Petition
`contains “similar arguments” to those in the Argentum IPR. Pet. 68.
`Accordingly, Segal previously was presented to the Office and Petitioner
`makes the same arguments the Office previously considered regarding
`Segal.
`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, including the references asserted in the
`Argentum IPR. See Ex. 1008, 37 (“[A]ll the references cited by the
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`Argentum Petition are of record and have been previously evaluated, or
`disclose information redundant to information of record.”). Petitioner
`concedes as much, stating that “the Argentum IPR was instituted based on
`the cited prior art and similar arguments.” Pet. 68. Further, as explained
`above, PDR 1999 discloses monotherapy nasal spray formulations
`comprising either azelastine hydrochloride or fluticasone propionate and
`Petitioner relies on PDR 1999 for those teachings, as well as for disclosing
`certain excipients the challenged claims require. See, e.g., Pet. 4–5; see also
`Ex. 1010, 1122 (PDR 1999 entry for Flonase, fluticasone propionate nasal
`spray), 3191 (PDR 1999 entry for Astelin, azelastine hydrochloride nasal
`spray). The Argentum IPR asserted similar references with essentially the
`same teachings, including Hettche, which discloses a nasal medicine that
`contains azelastine or a physiologically acceptable salt of azelastine, and
`Phillipps and Flonase Label, which each disclose nasal spray formulations
`comprising fluticasone propionate and other pharmaceutical carriers or
`excipients. See Argentum IPR, Paper 11 at 14–22; Ex. 1013, Abstract;
`Ex. 1009, 32:46–50, 32:57–60, 36:7–10; Ex. 1010, 1. 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 ’585 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 ’585 patent.
`4. 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
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`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. Indeed, Petitioner does not
`discuss or even cite to our precedential Becton, Dickinson factors. See
`generally Pet. Nevertheless, Petitioner asserts that the ’585 patent applicant
`overcame the Examiner’s rejection of its claims over Cramer “based solely
`on alleged objective indicia of nonobviousness,” Pet. 68, and that the
`applicant’s “alleged evidence does not demonstrate nonobviousness.” Id. at
`63. Accordingly, we focus on the arguments Petitioner provides as to
`objective indicia of nonobviousness.
`Petitioner is correct that the Examiner allowed the ’585 patent claims
`after considering objective indicia of nonobviousness. See, e.g., Ex. 1008,
`23–27, 36–42. As set forth above, the applicant’s objective evidence of
`nonobviousness was extensive, as was the Examiner’s analysis of that
`evidence. See supra § III.A.2; Ex. 1008, 23–27, 36–42.
`Petitioner argues that the applicant failed to show “unexpected results
`supportive of nonobviousness” during prosecution because the applicant did
`not compare “the claimed invention to the closest prior art.” Pet. 64 (citing
`Ex. 1064 ¶¶ 473–531). Before turning to Petitioner’s arguments, we note
`that Petitioner cites for support more than 50 paragraphs of Dr. Schleimer’s
`declaration, but the Petition’s discussion mentions only three of those
`paragraphs, i.e., paragraphs 476–478. “A brief must make all arguments
`accessible to the judges, rather than ask them to play archeologist with the
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`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 three paragraphs on which Petitioner’s
`arguments rely.
`Petitioner contends that “the closest prior art is a pharmaceutical nasal
`formulation comprising both azelastine and fluticasone,” such as those that
`Cramer and Segal teach. Id. 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 . . . or to co-administration of commercially
`available azelastine hydrochloride nasal spray and fluticasone propionate
`nasal spray.” Id. Dr. Schleimer testifies similarly. Ex. 1064 ¶¶ 476–478.
`Petitioner’s arguments and Dr. Schleimer’s testimony are substantially
`similar to arguments the Examiner already considered during the ’585
`patent’s prosecution, including those made in the Argentum IPR. Ex. 1008,
`37 (“Wit