CMPD LICENSING, LLCDownload PDFPatent Trials and Appeals BoardNov 24, 20202020001661 (P.T.A.B. Nov. 24, 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. 14/819,342 08/05/2015 Jay Richard Ray II 8138-69 (0304197) 3276 30448 7590 11/24/2020 AKERMAN LLP P.O. BOX 3188 WEST PALM BEACH, FL 33402-3188 EXAMINER SOLOLA, TAOFIQ A ART UNIT PAPER NUMBER 1625 NOTIFICATION DATE DELIVERY MODE 11/24/2020 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): ip@akerman.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAY RICHARD RAY II Appeal 2020-001661 Application 14/819,342 Technology Center 1600 Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and TAWEN CHANG, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 5, 6, and 8–12. 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 CMPD Licensing LLC. Appeal Br. 2. Appeal 2020-001661 Application 14/819,342 2 STATEMENT OF THE CASE The Specification states that, “[d]espite advances in the understanding of the pathology of fungal infections, especially fungal infections that affect a subject’s appendages (such as one foot or both feet), there is still a need for compositions and methods that efficiently treat or prevent the progression and reoccurrence of fungal infections.” Spec. ¶ 8. CLAIMED SUBJECT MATTER The claims are directed to a method of treating or preventing a fungal infection in a subject. Claim 1, the only independent claim, is reproduced below: 1. A method of treating or preventing a fungal infection in a subject, the method comprising: (i) compounding a footbath treatment mixture comprising mixing a therapeutically effective dosing amount of powdered fluconazole, an excipient base powder comprising a blend of micronized xylitol and poloxamers, and water; (ii) agitating the footbath treatment mixture within a footbath using an agitator; and (iii) contacting the agitated footbath treatment mixture with at least a portion of one or both feet of a subject that are infected or suspected to be infected with a fungal infection. Appeal Br. A-1 (Claims App.). Appeal 2020-001661 Application 14/819,342 3 REJECTION Claims 1, 5, 6, and 8–12 are rejected under 35 U.S.C. 103(a) as being unpatentable over PCCA 1,2 PCCA 2,3 Shih,4 and Freels.5 OPINION A. Issue The Examiner finds that PCCA1 teaches that LoxaSperse™ is a “powder excipient base[] for dispersibility and solubility of antifungal and/or antibacterial agents useful for nebulization and irrigations of wounds.” Ans. 4. The Examiner finds that PCCA1 further teaches that LoxaSperse™ is a “blend of micronized xylitol and optimized ratio of poloxamers and that multiple drugs with varying solubility may be combined with it.” Id. The Examiner finds that PCCA2 discloses studies comparing the “Minimum Inhibitory Concentration (MIC) of various antifungal agents when used with LoxaSperse[™] compared with the antifungal agents alone, including fluconazole and itraconazole.” Ans. 4. The Examiner finds that PCCA2 teaches that, “[f]or itraconazole, the MIC is reduced . . . when used with LoxaSperse[™],” because “LoxaSperse[™] enhanced the dissolution 2 Professional Compounding Centers of America, PCCA LoxaSperse™: Powder Excipient Base for Use in Nebulization and Irrigation Compound, PCCA # 30-4701 (2013) (“PCCA1”). 3 Professional Compounding Centers of America, STUDIES: PCCA LoxaSperse™ Base Studies (2013–2014) (“PCCA2”). 4 Shih et al., U.S. 5,710,280, issued Jan. 20, 1998 (“Shih”). 5 Nicole G. Freels, How to Make an Antifungal Foot Soak for Treatment of Foot Fungus, LEXINGTON PODIATRY: THE FOOT AND ANKLE SPECIALIST (Feb. 27, 2011), http://www.lexingtonkypodiatry.com/how-to-make-an- antifungal-foot-soak-for-treatment-of-foot-fungus (“Freels”). Appeal 2020-001661 Application 14/819,342 4 rate and saturation solubility of itraconaxole and therefore, provided a higher dissolved concentration of the drug, leading to enhanced inhibition of microbes.” Id. The Examiner finds that the combination of PCCA1 and PCCA2 discloses using LoxaSperse™ with itraconazole rather than fluconazole and teaches wound irrigation instead of irrigation of foot. Ans. 4–5. However, the Examiner finds that Shih teaches that “fluconazole is useful for treating various fungal infections and a process of making aqueous solution thereof, which may require some heat,” and that Freels teaches an “easy” procedure for “treatment and prevention of foot fungal infection by soaking foot in water comprising anti-fungal agent.” Id. The Examiner concludes that a skilled artisan would have been motivated by Shih . . . to use fluconazole for the treatment of “various fungal infections” and would have known to use LoxaSperse[™] and fluconazole with reasonable expectation of success at the time the invention was made, given the results of the studies and conclusions in PCCA2 (see tables 1, pp. 3, 5). Application of agitation (nebulization or irrigation) device is obvious from PCCA1/PCCA2 and treatment of foot fungal infection is motivated by the teachings of Freels. Ans. 5. Appellant contends, among other things, that the Examiner has not established “a prima facie case of obviousness with regard to using the ingredients of PCCA1, PCCA2, and Shih in a footbath.” Appeal Br. 5. The issue with respect to this rejection is whether a preponderance of evidence of record supports the Examiner’s conclusion that a skilled artisan Appeal 2020-001661 Application 14/819,342 5 would have had reason to use a mixture comprising fluconazole and LoxaSperse™ in a footbath. B. Analysis We agree with Appellant that the Examiner has not established a prima facie case that a skilled artisan would have had a reason to use a mixture comprising fluconazole and LoxaSperse™ in a footbath. The Examiner asserts that using an aqueous solution of fluconazole and LoxaSperse™ to irrigate wound and treat fungal infection, such as athlete’s foot, is obvious from the combination of PCCA1, PCCA2, and Shih, and cites to Freels as teaching “treatment and prevention of foot fungal infection by soaking foot in water comprising anti-fungal agent.” Ans. 4–5, 6. The Examiner asserts that “Freels teaches his procedure is easy . . . and embraced using any antifungal agent.” Id. at 7, 10. The Examiner asserts that “[t]here is no scientific evidence” that the treatment in Freels would not work without the constituents specifically listed therein. Ans. 8–9. We understand the Examiner’s position. Nevertheless, “the examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In this case, Freels teaches a specific method for treating or preventing foot fungus comprising soaking feet in a foot bath containing a specific mixture (i.e., water, sea salt, baking soda, tea tree oil, cypress oil, and geranium oil). The Examiner has not persuasively shown that a skilled artisan would understand such a mixture to be equivalent to a mixture comprising fluconazole, LoxaSperse™, and water. Thus, the Examiner has not established a prima facie case that it would have been Appeal 2020-001661 Application 14/819,342 6 obvious for a skilled artisan to use a mixture of fluconazole, LoxaSperse™, and water in Freels’ process. In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious.”). Accordingly, for the reasons stated above, we reverse the Examiner’s rejection of claim 1 as obvious over the combination of PCCA1, PCCA2, Shih, and Freels. We reverse the rejections of claims 5, 6, and 8–12 for the same reasons. In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988) (“Dependent claims are nonobvious under section 103 if the independent claims from which they depend are nonobvious.”). CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 5, 6, 8– 12 103(a) PCCA1, PCCA2, Shih, Freels 1, 5, 6, 8–12 REVERSED Copy with citationCopy as parenthetical citation