Padilla, Angel et al.Download PDFPatent Trials and Appeals BoardMay 19, 202013462466 - (D) (P.T.A.B. May. 19, 2020) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/462,466 05/02/2012 Angel Padilla 078807.37 2562 27805 7590 05/19/2020 THOMPSON HINE L.L.P. 10050 INNOVATION DRIVE SUITE 400 DAYTON, OH 45342-4934 EXAMINER RODRIGUEZ, RAYNA B ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 05/19/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): ipdocket@thompsonhine.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ANGEL PADILLA and GEORGE BAKLAYAN ____________ Appeal 2019-005504 Application 13/462,446 Technology Center 1600 ____________ Before DONALD E. ADAMS, ERIC B. GRIMES, and RYAN H. FLAX, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals2 from Examiner’s decision to reject claims 69–76 and 78–88 (Appeal Br. 2). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Bausch & Lomb Pharma Holding Corp., of Rochester, NY” (Appellant’s December 20, 2018 Appeal Brief (Appeal Br.) 2). 2 Appellant identifies Application 13/462,375 (Appeal 2019-002793), now abandoned, as “potentially related” to the present Appeal. A Decision on Appeal was entered into the record of Appeal 2019-002793 January 9, 2020 affirming rejections under 35 U.S.C. § 103 and nonstatutory double patenting. Appeal 2019-005504 Application 13/462,446 2 STATEMENT OF THE CASE Appellant’s disclosure relates to methods of using “compositions comprising bepotastine as a free base, pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof, and at least one corticosteroid as a free form, pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof, the composition which is effective for suppressing nasal inflammatory conditions” (Spec.3 1). Appellant’s independent claims 69, 79, 86, and 88 are reproduced below: 69. A method of treating at least one of rhinitis, mucosal inflammation associated with rhinitis, sinusitis, rhinosinusitis, and runny nose and stuffy nose symptoms associated with rhinitis, mucosal inflammation associated with rhinitis, sinusitis, or rhinosinusitis in a patient in need of such treatment, the method comprising: nasally administering a pharmaceutical composition, the composition consisting essentially of: a corticosteroid, the corticosteroid formulated with a sufficient concentration of a suspending agent excipient to result in a corticosteroid suspension, the corticosteroid as a free form, pharmaceutically acceptable salt, or solvate; bepotastine as a free base, pharmaceutically acceptable salt, or solvate at a concentration ranging from 0.5% w/v to 8.00% w/v in aqueous solution; at least one pharmaceutically compatible buffer; at least one tonicity agent; at least one chelating agent; and one of either a blend of microcrystalline cellulose and carboxymethyl cellulose with polyoxyethylene (20) sorbitan monooleate (polysorbate 80) or hydroxypropylmethylcellulose (HPMC) 3 Appellant’s May 2, 2012 Specification. Appeal 2019-005504 Application 13/462,446 3 E15 LV with citric acid monohydrate and a taste-masking agent; the composition administered to the patient in need thereof in a dose regimen effective to treat at least one of rhinitis, mucosal inflammation associated with rhinitis, sinusitis, rhinosinusitis, and runny nose and stuffy nose symptoms associated with rhinitis, mucosal inflammation associated with rhinitis, sinusitis, or rhinosinusitis. (Appeal Br. 9 (emphasis added).) 79. A method to treat at least one of rhinitis, mucosal inflammation associated with rhinitis, sinusitis, rhinosinusitis, and runny nose and stuffy nose symptoms associated with rhinitis, mucosal inflammation associated with rhinitis, sinusitis, or rhinosinusitis, the method comprising: nasally administering to a patient in need thereof a composition consisting essentially of: bepotastine besilate; a corticosteroid, the corticosteroid formulated with a sufficient concentration of a suspending agent excipient to result in a corticosteroid suspension, the corticosteroid as a free form, pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof; dibasic sodium phosphate heptahydrate; sodium chloride, edetate disodium; benzalkonium chloride; and one of either: a blend of microcrystalline cellulose and carboxymethyl cellulose and/or polyoxyethylene (20) sorbitan monooleate (polysorbate 80), or hydroxypropylmethyl cellulose (HPMC), citric acid monohydrate, and taste-masking agent; under conditions to treat at least one of rhinitis, mucosal inflammation associated with rhinitis, sinusitis, rhinosinusitis, and runny nose and stuffy nose symptoms associated with Appeal 2019-005504 Application 13/462,446 4 rhinitis, mucosal inflammation associated with rhinitis, sinusitis, or rhinosinusitis. (Id. at 11 (emphasis added).) 86. A method of treating at least one of rhinitis, mucosal inflammation associated with rhinitis, sinusitis, rhinosinusitis, and runny nose and stuffy nose symptoms associated with rhinitis, mucosal inflammation associated with rhinitis, sinusitis, or rhinosinusitis in a patient in need of such treatment, the method comprising nasally administering to the patient in need thereof, in a dose regimen effective to treat at least one of rhinitis, mucosal inflammation associated with rhinitis, sinusitis, rhinosinusitis, and runny nose and stuffy nose symptoms associated with rhinitis, mucosal inflammation associated with rhinitis, sinusitis, or rhinosinusitis, a pharmaceutical composition consisting of a corticosteroid, the corticosteroid formulated with a sufficient concentration of a suspending agent excipient to result in a corticosteroid suspension, the corticosteroid as a free form, pharmaceutically acceptable salt, solvate, bepotastine as a free base, pharmaceutically acceptable salt, solvate at a concentration ranging from 0.5% w/v to 8.00% w/v in aqueous solution; dibasic sodium phosphate heptahydrate at a concentration of 0.10% w/v to 1.00% w/v; sodium chloride at a concentration of 0.9% w/v with 0.5% bepotastine, 0.4% w/v with 2.00%-3.00% bepotastine, 0.3% w/v with 4.00% bepotastine, 0.2% w/v with 6.00% bepotastine, 0.1 % w/v with 8.00% bepotastine; edetate disodium at a concentration of 0.005% w/v to 0.100% w/v; benzalkonium chloride at a concentration of 0.002% w/v to 0.200% w/v; and one of either: a blend of microcrystalline cellulose and carboxymethyl cellulose at a concentration of 0.5% w/v to 2.5% w/v and polyoxyethylene (20) sorbitan monooleate (polysorbate 80) at a concentration of 0.005% w/v to 0.050% w/v, or Appeal 2019-005504 Application 13/462,446 5 hydroxypropylmethylcellulose (HPMC) E15 LV at a concentration of 0.01 % w/v to 1.00% w/v, citric acid monohydrate at a concentration of 0.10% w/v to 1.00% w/v, and a taste-masking agent at a concentration of 0.01 % w/v to 1.00% w/v. (Id. at 12–13 (emphasis added).) 88. A method of treating at least one of rhinitis, mucosal inflammation associated with rhinitis, sinusitis, rhinosinusitis, and runny nose and stuffy nose symptoms associated with rhinitis, mucosal inflammation associated with rhinitis, sinusitis, or rhinosinusitis in a patient in need of such treatment, the method comprising nasally administering a pharmaceutical composition consisting essentially of a corticosteroid as a free form, pharmaceutically acceptable salt, or solvate in suspension; bepotastine as a free base, pharmaceutically acceptable salt, solvate at a concentration ranging from 0.5% w/v to 8.00% w/v in aqueous solution; and at least one of (a) a blend of microcrystalline cellulose and carboxymethyl cellulose, (b) polyoxyethylene (20) sorbitan monooleate (polysorbate 80), and (c) hydroxypropyl methyl cellulose (HPMC) to the patient in need thereof, in a dose regimen effective to treat at least one of rhinitis, mucosal inflammation associated with rhinitis, sinusitis, rhinosinusitis, and runny nose and stuffy nose symptoms associated with rhinitis, mucosal inflammation associated with rhinitis, sinusitis, or rhinosinusitis. (Id. at 13–14 (emphasis added).) Appeal 2019-005504 Application 13/462,446 6 Grounds of rejection before this Panel for review:4 Claims 69–73, 76, 78, and 88 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Pipkin.5 Claims 79–85 and 88 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Pipkin, Flonase,6 and Bepreve.7 Claims 74, 75, 86, and 87 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Pipkin, Flonase, Bepreve, and Bountra.8 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? ANALYSIS The rejection of claims 69–73, 76, 78, and 88: Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious in view of Pipkin (Ans.9 4–8; see also Final Act.10 4–9). We are not persuaded. 4 Application 13/462,375 abandoned March 17, 2020. Thus, the provisional nonstatutory obviousness-type double patenting rejection over this Application is moot and will not be discussed further. 5 Pipkin et al., US 2009/0312724 A1, published Dec. 17, 2009. 6 FLONASE®, Nasal Spray, 50 mcg, Prescribing Informaiton, 1–13 (GlaxoSmithKline, March 2004). 7 ISTA Pharmaceuticals, Inc., Bepreve™ Ophthalmic Solution (Highlights of Prescribing Information) (Aug. 2009). 8 Bountra et al., WO 2010/026129 Al, published Mar. 11, 2010. 9 Examiner’s March 8, 2019 Answer. 10 Examiner’s June 22, 2018 Final Office Action. Appeal 2019-005504 Application 13/462,446 7 The transitional phrase “consisting essentially of,” as set forth in Appellant’s independent claims 6911 and 88, limits the scope of the nasally administered pharmaceutical composition to the specified materials “and those that do not materially affect the basic and novel characteristic(s)” of that composition. See In re Herz, 537 F.2d 549, 551–52 (CCPA 1976). As Appellant explains, on this record, “[t]he composition of [Pipkin’s] invention is a corticosteroid solution comprising a corticosteroid and SAE- CD” (Appeal Br. 6 (citing Pipkin ¶ 82)). Pipkin discloses: By including SAE-CD in a liquid composition containing corticosteroid, the corticosteroid is dissolved. The corticosteroid exhibits greater stability in the presence of SAE- CD than it does in its absence. When a second active agent is present, the second active agent can also exhibit greater stability in the presence of SAE-CD than it does in its absence. (Pipkin ¶ 83; see also Appeal Br. 6.) Thus, as Appellant explains, “the presence of SAE-CD[, in Pipkin’s composition,] materially affects the behavior of the corticosteroid in the formulation” (Appeal Br. 6). We agree. For the foregoing reasons, we are not persuaded by Examiner’s assertion that “SAE-CD is an excipient (e.g. solubilizer)” and “it is unclear how the inclusion of other excipient agents would materially change the characteristics of [Appellant’s] invention” (Ans. 17; see also Final Act. 5). For the foregoing reasons, the rejection of claims 69–73, 76, 78, and 88 is reversed. 11 Appellant’s claims 70–73, 76, 78 depend directly or indirectly from claim 69 (see Appeal Br. 9–11). Appeal 2019-005504 Application 13/462,446 8 The rejection of claims 79–85 and 88: Examiner finds that “Pipkin suggests all the limitations of claims 79, 80, and 88 . . ., except wherein the composition comprises bepotastine besilate and fluticasone propionate, dibasic sodium phosphate heptahydrate, sodium chloride, edetate disodium, benzalkonium, and a blend of microcrystalline cellulose and carboxymethyl cellulose” (Ans. 9 and 10; see also Final Act. 10). To make up for these deficiencies in Pipkin, Examiner relies on Flonase to disclose “a fluticasone propionate nasal spray comprising microcrystalline cellulose, carboxymethylcellulose sodium, benzalkonium chloride, and polysorbate” and Bepreve to disclose “a composition comprising bepotastine besilate, benzalkonium chloride, sodium chloride, and monobasic sodium phosphate dehydrate” (Ans. 10–11 (citing Flonase 1 and Bepreve 9); see also Final Act. 11 (citing Flonase 1 and Bepreve 9)). Thus, based on the combination of Pipkin, Flonase, and Bepreve, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to one of ordinary skill in the art to select sodium chloride, edetate disodium, benzalkonium, and a blend of microcrystalline cellulose and carboxymethyl cellulose to formulate a composition consisting of fluticasone propionate and bepotastine besilate based on the fact that these are known components useful in formulating commercially available compositions of fluticasone propionate and/or bepotastine besilate . . . [and] formulate the composition rendered obvious by the prior art formulated in any of the administration devices disclosed based on the fact that these are methods known in the art that are suitable for administering a composition for the treatment of allergic rhinitis, resulting in the practice of the Appeal 2019-005504 Application 13/462,446 9 method of claims 81-85 with a reasonable expectation of success. (Ans. 11–12; see also Final Act. 11–12.) We are not persuaded. The transitional phrase “consisting essentially of,” as set forth in Appellant’s independent claims 7912 and 88, limits the scope of the nasally administered pharmaceutical composition to the specified materials “and those that do not materially affect the basic and novel characteristic(s)” of that composition. See Herz, 537 F.2d at 551–52. As discussed above, the presence of SAE-CD, in Pipkin’s composition, is evidenced to materially affect the behavior of the corticosteroid in the formulation and Examiner failed to establish that Flonase or Bepreve, either alone or in combination, cure this deficiency in Pipkin (see Appeal Br. 7 (Appellant contends that “neither Flonase nor Bepreve, either alone or in combination, cure the noted deficiencies of Pipkin”). The rejection of claims 74, 75, 86, and 87: Examiner finds that the combination of Pipkin, Flonase, and Bepreve, as discussed above, suggests all the limitations of the rejected claims with the exception of “the claimed amount of the claimed components” and relies on Bountra to make up for this deficiency (Ans. 12–13; see also Final Act. 12–13). According to Examiner, “[t]he amount of the agents present is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize” (Ans. 13; see also Final Act. 13). We are not persuaded. 12 Appellant’s claims 80–85 depend directly or indirectly from claim 79 (see Appeal Br. 9–11). Appeal 2019-005504 Application 13/462,446 10 Appellant’s claims 74 and 75 depend from Appellant’s independent claim 69. The transitional phrase “consisting essentially of,” as set forth in Appellant’s independent claim 69 and, thus, its dependent claims 74 and 75, limits the scope of the nasally administered pharmaceutical composition to the specified materials “and those that do not materially affect the basic and novel characteristic(s)” of that composition. See Herz, 537 F.2d at 551–52. As discussed above, the presence of SAE-CD, in Pipkin’s composition, is evidenced to materially affect the behavior of the corticosteroid in the formulation and Examiner failed to establish that Flonase, Bepreve, or Bountra, either alone or in combination, cure this deficiency in Pipkin (see Appeal Br. 7 (Appellant contends that “none of Flonase, Bepreve, and Bountra, either alone or in combination, cure the noted deficiencies of Pipkin”). Appellant “additionally note[s] the use of the transitional phrase ‘consisting of,’ and the lack of SAE-CD listed in . . . claim [86]. Thus, claim 86 clearly excludes SAE-CD” (Appeal Br. 7). We agree. Because Appellant’s claim 87 depends from claim 86, the rejection of claim 87 suffers from the same deficiency as the rejection of Appellant’s claim 86. CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 69–73, 76, 78, and 88 under 35 U.S.C. § 103(a) as unpatentable over Pipkin is reversed. The rejection of claims 79–85 and 88 under 35 U.S.C. § 103(a) as unpatentable over the combination of Pipkin, Flonase, and Bepreve is reversed. Appeal 2019-005504 Application 13/462,446 11 The rejection of claims 74, 75, 86, and 87 under 35 U.S.C. § 103(a) as unpatentable over the combination of Pipkin, Flonase, Bepreve, and Bountra is reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 69–73, 76, 78, 88 103 Pipkin 69–73, 76, 78, 88 79–85, 88 103 Pipkin, Flonase, Bepreve 79–85, 88 74, 75, 86, 87 103 Pipkin, Flonase, Bepreve, Bountra 74, 75, 86, 87 Overall Outcome 69–76, 78–88 REVERSED Copy with citationCopy as parenthetical citation