CMPD LICENSING, LLCDownload PDFPatent Trials and Appeals BoardMar 2, 20212020002594 (P.T.A.B. Mar. 2, 2021) 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. 15/273,276 09/22/2016 Jay Richard Ray II 8138-83 (0318844) 4147 30448 7590 03/02/2021 AKERMAN LLP P.O. BOX 3188 WEST PALM BEACH, FL 33402-3188 EXAMINER MATOS NEGRON, TAINA DEL MAR ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 03/02/2021 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 2020-002594 Application 15/273,276 Technology Center 1600 __________ Before ERIC B. GRIMES, FRANCISCO C. PRATS, and LILAN REN, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 8, 10, 12, and 13. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies CMPD Licensing LLC. as the real party in interest. Appeal Br. 2. Appeal 2020-002594 Application 15/273,276 2 STATEMENT OF THE CASE The sole rejection before us for review is the Examiner’s rejection of claims 8, 10, 12, and 13 under 35 U.S.C. § 103 as being unpatentable over Goldstein,2 Dooley,3 and Herold.4 Ans. 3–10. Appellant’s claim 8, the sole independent claim on appeal, is illustrative and reads as follows: 8. A topical composition for treating a fungal skin condition and associated inflammation made by a process comprising: combining (a) between approximately 3% and approximately 8% by weight itraconazole, or pharmaceutically acceptable salt, ester, or derivative thereof; (b) between approximately 0.5% and 2.5% by weight fluticasone, or pharmaceutically acceptable salt, ester, or derivative thereof; (c) meadowsweet flower extract in a polyethylene glycol ointment base; and (d) polyethylene glycol 300 MW, NF liquid.. Appeal Br. A-2 (Claims Appendix). DISCUSSION The Examiner’s Rejection The Examiner cited Goldstein as disclosing topical compositions, in the forms of gels or creams, that include itraconazole as an antifungal ingredient and fluticasone as an anti-inflammatory agent. Ans. 4. The 2 WO 2004/037197 A2 (published May 6, 2004). 3 US 2016/0022653 A1 (published Jan. 28, 2016). 4 D. A. Herold et al., Toxicity of Topical Polyethylene Glycol, 65 TOXICOLOGY AND APPLIED PHARMACOLOGY 329–335 (1982). Appeal 2020-002594 Application 15/273,276 3 Examiner noted Goldstein’s disclosure that a variety of excipients, including polyethylene glycols, were useful in its compositions. Id. The Examiner found that Goldstein’s compositions differ from the compositions recited in Appellant’s claim 8 in that Goldstein’s compositions do not include the meadowsweet flower extract and polyethylene glycol recited in the claim. Id. at 5. The Examiner cited Dooley as disclosing that claim 8’s meadowsweet flower extract (in the form of the Spira-Wash™ gel) and polyethylene glycol 300 MW were known in the art to be useful as viscosity-imparting agents for drug-containing topical compositions in the form of gels or creams. Ans. 5. Based on the combined teachings of Goldstein and Dooley, the Examiner reasoned that it would have been obvious to use Dooley’s Spira- Wash™ and polyethylene glycol as viscosity-imparting agents for Goldstein’s topical antifungal/anti-inflammatory compositions. Ans. 6. In particular, the Examiner reasoned that “[m]otivation to include the Spira- WashTM Gel of Dooley et al. in the topical composition of Goldstein et al. would have risen from the fact that Spira-Wash™ Gel is an excipient useful in topical composition and is suitable to be mix[ed] with active agents to be delivered topically.” Id.; see also id. at 9 (“In addition, the skilled artisan would have been motivated to combine meadowsweet flower extract in PEG ointment base and PEG 300 because Dooley et al. taught that both components are used as viscosity agents.”). The Examiner cited Herold as further evidence that it would have been obvious to include the polyethylene glycol 300 MW of Appellant’s representative claim 8 in Goldstein’s topical compositions. Specifically, the Examiner cited Herold as disclosing the use of an animal model to study the Appeal 2020-002594 Application 15/273,276 4 toxicity of polyethylene glycol from repeated topical applications. See Ans. 6, 9. Analysis—Claim 8 [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); see also In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (holding that requiring an applicant to identify “reversible error” in an examiner’s rejection is consistent with long standing Board practice). In the present case, having carefully considered all of the evidence and argument presented by Appellant and the Examiner, we are not persuaded that Appellant has shown reversible error in the Examiner’s conclusion of obviousness as to the composition recited in Appellant’s representative claim 8. As the Supreme Court has explained, “when the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant inquiry is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Here, it is undisputed that all of the ingredients in the composition of Appellant’s claim 8 were known in the art to be useful in topical compositions. And, Appellant does not identify any persuasive evidence suggesting that the claimed combination of ingredients provides an unpredictable result. Appeal 2020-002594 Application 15/273,276 5 Specifically, Goldstein discloses “stable topical formulations containing an antifungal agent and an anti-inflammatory steroid.” Goldstein 1. Goldstein discloses that, “[i]n one embodiment, the dosage form is one of cream, ointment, gel and lotion.” Id. at 7. Goldstein discloses that the useful concentration ranges for its antifungal agent and anti-inflammatory steroid overlap the concentration ranges of itraconazole and fluticasone recited in Appellant’s claim 8. See Goldstein 7 (“Generally, the formulation will contain between 0.01 wt% and 5.0 wt% of an antifungal agent and between 0.01 wt% and 5 wt% of an anti- inflammatory steroid agent.”). As the Examiner found, moreover, Goldstein discloses that itraconazole is useful as the antifungal agent, and fluticasone propionate is useful as the anti-inflammatory steroid, in its topical compositions. See Goldstein 4, 5. We are unpersuaded by Appellant’s contention that the combination of itraconazole and fluticasone recited in Appellant’s claim 8 would have been unobvious because, given the number of antifungal and steroid ingredients in the lists disclosed in Goldstein, a skilled artisan only had 0.38% chance in arriving at claim 8’s itraconazole/fluticasone combination. See Appeal Br. 10–12; Reply Br. 4–5. The fact that itraconazole and fluticasone propionate appear in longer lists of useful ingredients does not negate Goldstein’s express disclosure that itraconazole is useful as the antifungal agent, and fluticasone propionate is useful as the anti-inflammatory steroid, in its topical compositions. As explained by our reviewing court, that a reference “discloses a multitude of effective combinations does not render any particular formulation less Appeal 2020-002594 Application 15/273,276 6 obvious.” Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (species claim held obvious where it recited one of 1200 possible combinations of embodiments disclosed by reference and where reference suggested no preference for claimed embodiment). Appellant also does not persuade us that the Examiner erred reversibly in determining that it would have been obvious to include meadowsweet flower extract in a polyethylene glycol ointment base, and polyethylene glycol 300 MW, as recited in Appellant’s claim 8, in Goldstein’s topical compositions. See Appeal Br. 13–15; Reply Br. 6–9. As the Examiner found, and Appellant does not dispute, Appellant’s Specification discloses that the “Spira-WashTM Gel” product is a meadowsweet flower extract in a polyethylene glycol ointment base encompassed by Appellant’s claim 8: [T]he topical base Spira-Wash™ Gel . . . [is] marketed by Professional Compounding Centers of America (PCCA), Houston, TX. Spira-Wash™ Gel is a water miscible topical base including a blend of Meadowsweet Flower Extract, which is rich in phenolic compounds, salicylates, and flavonoids, in a polyethylene glycol (PEG) ointment base. Spira-Wash ™ Gel is a soft, adherent gel, which is easily water washable. It has potential use in dermatologic formulations for different applications, such as wound care, an occlusive agent, a topical humectant or infection treatment. Spec. 6 As the Examiner found, Dooley discloses pharmaceutical compositions in the form of a “viscous liquid and semi-solid (e.g., gel, cream, or emulsion) . . . for use in mucosal delivery (e.g., for rectal or vaginal application),” the compositions containing “viscosity agents— polyethylene glycol, methyl cellulose, and Spira-Wash Gel™ base.” Dooley Appeal 2020-002594 Application 15/273,276 7 ¶ 167; see also id. (“Note that Spira-Wash Gel™ is an extemporaneous compounding base that contains polyethylene glycols and propylene glycol, among other ingredients.”); see also id. ¶ 166 (table showing Spira-Wash Gel™ as viscosity agent in Dooley’s sample #7 and polyethylene glycol 300 MW as a viscosity agent in Dooley’s samples #8, #9, and #10). As the Examiner found, Goldstein discloses polyethylene glycol as a useful solvent excipient in its topical compositions. See Goldstein 5. Thus, to summarize, Goldstein discloses preparing its antifungal/steroid compositions in the form of gels and creams, and also discloses that a variety of excipients, including polyethylene glycols, are useful in those compositions. Dooley, in turn, discloses that Spira-Wash Gel™ and polyethylene glycol 300 are both useful as viscosity agents in pharmaceutical compositions prepared in the form of gels and creams. Given these teachings, we agree with the Examiner that a skilled artisan had a good reason for, and a reasonable expectation of success in, using both Spira-Wash Gel™ and polyethylene glycol 300 as viscosity agents when preparing Goldstein’s antifungal/steroid compositions prepared in the form of gels and creams. Appellant does not persuade us, therefore, that the Examiner erred reversibly in concluding that the composition recited in Appellant’s claim 8 would have been obvious. See KSR, 550 U.S. at 417 (“[W]hen a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976))). In the present case, Appellant does not identify any persuasive evidence suggesting Appeal 2020-002594 Application 15/273,276 8 that claim 8’s composition produces unexpected results or has unexpected properties. We acknowledge, as Appellant contends, that Dooley’s compositions are for treating psychiatric disorders (see Dooley, abstract), unlike Goldstein’s antifungal compositions. Appeal Br. 13; Reply Br. 6–7. Nonetheless, the fact that Dooley’s compositions are for treating psychiatric disorders does not negate Dooley’s express disclosure that Spira-Wash Gel™ and polyethylene glycol 300 are both useful as viscosity agents in pharmaceutical compositions prepared in the form of gels and creams, precisely the physical forms of the compositions taught in Goldstein. Similarly, the fact that Dooley describes its gels and creams as being used for mucosal application (see Appeal Br. 13–14; Reply Br. 7–8) does not negate Dooley’s disclosure that both Spira-Wash Gel™ and polyethylene glycol 300 are useful viscosity agents for preparing pharmaceutical gels and creams, which, again, are the same physical forms as the pharmaceutical compositions taught in Goldstein. We acknowledge, as Appellant contends, that Dooley does not disclose using Spira-Wash Gel™ and polyethylene glycol 300 together as viscosity agents in its compositions. See Appeal Br. 14–15; Reply Br. 8–9. Nonetheless, given Dooley’s disclosure that Spira-Wash Gel™ and polyethylene glycol 300 are each useful as viscosity agents in pharmaceutical compositions prepared in the form of gels and creams, a skilled artisan would have reasonably inferred that the combination of the two viscosity agents would also be useful for imparting viscosity to pharmaceutical gels or creams, like those taught in Goldstein. See KSR, 550 U.S. at 418 (The obviousness analysis “need not seek out precise teachings Appeal 2020-002594 Application 15/273,276 9 directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”); see also id. at 421 (“A person of ordinary skill is . . . a person of ordinary creativity, not an automaton.”). Appellant also does not persuade us that Herold teaches away from the composition recited in Appellant’s claim 8. See Appeal Br. 8–10; Reply Br. 2–4. We acknowledge Herold’s disclosure that one formulation tested using its animal model included polyethylene glycol 300. See Herold 330 (“The PEG vehicle (Solu-Base) is a blend of three PEG fractions whose average molecular weights are 300 (63%), 1000 (5%), and 4000 (32%).”). We acknowledge Herold’s disclosure that the polyethylene glycol 300-containing vehicle by itself produced toxic reactions in the test animals, similar to the drug-containing formulation: In our studies, repeated topical application of a PEG- based agent to open wounds in rabbits resulted in the same fatal syndrome observed in burn patients treated with FSD [nitrofurazone (0.2%) dispersed in a PEG vehicle]. Although nitrofurazone and PEG may produce a combined nephrotoxicity, PEG alone reproduced all of the findings seen with the combination. This syndrome resulted from the absorption of PEGs from the topical cream and their subsequent oxidation to aldehydes and acids. Herold 334 (emphasis added; citations omitted). Ultimately, however, rather than stating that polyethylene glycol should not be used in topical compositions, Herold discloses that “[t]he findings in this study document the need to critically evaluate, in an appropriate animal model, those topical medicaments that may be applied routinely to injured or altered skin.” Herold 334. Appeal 2020-002594 Application 15/273,276 10 We are not persuaded that Herold’s directive, that topical medicaments routinely applied to injured or altered skin should be evaluated using an appropriate animal, equates to a direct teaching that topical pharmaceutical compositions should not contain any amount of polyethylene glycol 300, even a small amount. To the contrary, as the Examiner contends, despite Herold’s warning in 1982 about the potential toxicity of a particular polyethylene vehicle composition, both Goldstein (published in 2004) and Dooley (published in 2016) expressly state that polyethylene glycol is useful in gels and creams applied topically as well as mucosally, as noted above. Appellant does not persuade us, therefore, that Herold teaches away from including polyethylene glycol 300, or polyethylene glycol- containing viscosity agents such as Spira-Wash Gel™, in Goldstein’s pharmaceutical gel or cream compositions. In sum, for the reasons discussed, Appellant does not persuade us of error in the Examiner’s conclusion of obviousness as to Appellant’s claim 8. We therefore affirm the Examiner’s rejection of claim 8 for obviousness over Goldstein, Dooley, and Herold. Analysis—Claims 10, 12, and 13 Appellant argues that the Examiner erred in concluding that the compositions recited in Appellant’s claims 10, 12, and 13 would have been obvious over Goldstein, Dooley, and Herold. Appeal Br. 15–17; Reply Br. 10–13. We select Appellant’s claim 10 as representative of the grouping including claims 10, 12, and 13. See 37 C.F.R. § 41.37(c)(1)(iv). Claim 10 reads as follows: Appeal 2020-002594 Application 15/273,276 11 10. The topical composition made by the process of claim 8, wherein the meadowsweet flower extract in a polyethylene glycol ointment base and the polyethylene glycol 300 MW, NF liquid are combined at a ratio between approximately 8:1 and approximately 9:1 meadowsweet flower extract in a polyethylene glycol ointment base to polyethylene glycol 300 MW, NF liquid. Appeal Br. A-2 (Claims Appendix). The Examiner found that arriving at the claimed ratios of polyethylene glycol and Spira-Wash Gel™ for use in Goldstein’s antifungal/steroid compositions would have been a matter of routine optimization, based on the teachings in Dooley and Herold: It is obvious from the prior art of Dooley et al. and Herold et al. that the amounts of PEG 300 and SpiraWash™ gel can be used to determine the viscosity of the composition. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456[](CCPA 1955) M[PEP] §2144.05 (II) (A). Ans. 9. Appellant does not persuade us that the Examiner erred reversibly in concluding that the composition recited in Appellant’s claim 10 would have been obvious to a skilled artisan. As discussed above, because Dooley discloses that Spira-Wash Gel™ and polyethylene glycol 300 are both useful as viscosity agents in pharmaceutical compositions prepared in the form of gels and creams, we agree with the Examiner that a skilled artisan had a good reason for, and a reasonable expectation of success in, using a combination including both Appeal 2020-002594 Application 15/273,276 12 Spira-Wash Gel™ and polyethylene glycol 300 as the viscosity-imparting agent when preparing Goldstein’s antifungal/steroid gels and creams. Accordingly, for reasons similar to those discussed above, Appellant does not persuade us that Herold teaches away from the composition recited in claim 10, or that a skilled artisan would have been dissuaded from including both Spira-Wash Gel™ and polyethylene glycol 300 in Goldstein’s compositions. See Appeal Br. 16; Reply Br. 10–11. Moreover, because the viscosity-imparting effects of Spira-Wash Gel™ and polyethylene glycol 300 were known in the art (see Dooley ¶ 167), Appellant does not persuade us that the Examiner erred in determining that the ratio of the two ingredients was a result-effective variable that a skilled artisan would have routinely optimized. As explained by our reviewing court, in situations such as the present one, “[w]here ‘the difference between the claimed invention and the prior art is some range or other variable within the claims . . ., the [applicant] must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results.’” Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (quoting In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990)). In the present case, Appellant points to no unexpected results or properties provided by the composition recited in claim 10. In sum, for the reason discussed, Appellant does not persuade us that the Examiner erred reversibly in determining that the composition recited in Appellant’s claim 10 would have been obvious. We therefore affirm the rejection of claim 10 for obviousness over Goldstein, Dooley, and Herold. Claims 12 and 13 fall with claim 10. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2020-002594 Application 15/273,276 13 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 8, 10, 12, 13 103 Goldstein, Dooley, Herold 8, 10, 12, 13 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation