DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-7 are pending. Claims 1-7 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-7 recite econazole nitrate cream 1%, fluocinonide cream 0.1% and clobetasol propionate cream, gel, or ointment 0.05%; however, it is unclear whether the recited percentages are %w/w, %w/v, or %v/v.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12102712.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-7 of the patent overlap with instant claims 1-7 except that the percentages of the econazole nitrate, fluocinonide, and clobetasol propionate are specific to %w/w in the patent. Instant claims 1-7 are generic to the type of ratio expressed by the percentages.
Closest Prior Art
The closest prior art appears to be WO 2010069519 A1 by Drewes et al. Drewes et al. disclose topical compositions for treatment of skin, hair or nails in need of an anti-infective, anti-mycotic, or anti-inflammatory treatment such as in disorders including tinea capitis, tinea barbae, etc. (page 1, lines 18-22). The prior further discloses that the composition contains active ingredients selected from anti-mycotic agents, hormones, and anti-inflammatory agents wherein econazole nitrate is an optional embodiment of mycotic agent and both clobetasol and fluocinonide are optional corticosteroids (Page 10, lines 10-25). Claim 8 of the prior art presents the instant compounds in a narrower list of active ingredients with the limitation that the ingredients are present in an amount of 0.05 to 8 wt.% (page 29); however, the prior art provides no guidance or motivation for optimizing the skincare composition that would lead a person of ordinary skill to implement a combination of econazole nitrate, and at least one of fluocinonide and clobetasol propionate in the required weight percentages and formulations of the instant claims.
Combination therapies combining antifungals and corticosteroids are known in the art for treating superficial fungal infections that present with symptoms of inflammation. Schaller et al. discuss (title) “Topical antifungal-corticosteroid combination therapy for the treatment of superficial mycoses” and report several of these combination therapies such as clotrimazole-betamethasone but note “there have also been concerns regarding the safety and tolerability of certain antifungal-corticosteroid combinations, mainly due to the characteristics and potency of the topical corticosteroid” (Mycoses 2016;59:365–73; page 4). In a consensus view on the use of antifungal-corticosteroid combination therapy in adults and children (Figure. 1), Schaller et al. report that agents with mild to medium potency are advised. Ference et al. provide a disclosure on “Choosing Topical Corticosteroids” (title) and categorize Fluocinonide 0.1% and Clobetasol Propionate 0.05% as ultra-high potency corticosteroids (Am Fam Physician. 2009;79(2):135-140; page 137, Table 2). Additionally, Ference et al. later note that application of high-potency steroids can induce a deep tissue tinea infection known as a Majocchi granuloma and state that combinations of antifungal agents and corticosteroids should be avoided to reduce the risk of severe, persistent, or recurrent tinea infections (page 138, paragraph 4). Therefore, even in seeking to implement a method of treating a fungal skin infection by applying combination therapies comprising antifungals and corticosteroids, a person of ordinary skill would not have been motivated to perform the method using the agents of the instant claims. For these reasons, the prior art neither anticipates nor renders obvious the instant claims.
Conclusion
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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