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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0045998 (Docherty) in view of CN 11481528 (Zhaouhi) and US 5229130 (Sharma).
Docherty teaches transdermal delivery formulations comprising lipophilic active agents with weak organic acids as accelerants and citric acid as an antioxidant (¶¶ 16 and 20). The composition is in the form of a microemulsion comprising water (¶ 16) with medium chain fatty acids, such as oleic acid (¶ 19).
Zhaouhi teaches transdermal delivery formulations can include nonionic emulsifiers, such as sorbitan fatty acid esters (abstract and claim 1)
Sharma teaches safflower oil was a well-known permeation enhancing oil (claim 1).
It would have been obvious to one of ordinary skill to have combined the ingredients of transdermal delivery formulation. See MPEP 2144.06. When adding a weak acid, it would have been obvious to vary the pH of the formulation to stabilize the acid. Further, while the prior art does not teach the specific stereoisomer, where the general compound is taught, it is reasonably expected that both forms will be present. As the claims are modified by “comprising”, having both reads on the limitation of having the cis-configuration present.
Claims 1-7 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over WO2021/262779A1 (Berman et al.; hereafter “Berman”) in view of CA3052863A1 (“Chousky”) and CA2599968 (Spann-wade et al., “Spann-Wade”).
The instant claims are drawn to a method of epicutaneous administration for a system comprising a composition comprising a homogeneous mixture of (a) one or more drugs or nutrients; (b) a solution comprising a precursor to nitric oxide and a transdermal accelerant comprising a weak organic acid; and (c) a microemulsion comprising a nonionic emulsifier, water, and a plant oil comprising a cis-unsaturated long-chain fatty acid, as further specified in the claims.
Berman teaches topical application of formulations of (1S)-1-phenyl-2-pyridin-2-ylethanamine, which is considered a drug, and a pharmaceutically acceptable topical carrier (see abstract, in particular)(“(a) one or more drugs or nutrients” as in claim 1) wherein the topical administration of the compositions to a subject are considered to provide systemic delivery of the one or more drugs or nutrients as recited in claim 1. Berman’s formulations are homogeneous creams or gels (see [0143]) with exemplary formulations demonstrating a pH of 5 (see [0198], Table 1 samples, limitation of claims 18) and further may be systems in the form of microemulsions (see [0109])(limitation of claims 1 and 15). Said microemulsions may contain thickening agents for instance, among other functional components (see [0109]) such as lecithin (see [0078])(limitation of claim 17) wherein the oleaginous phase may contain long-chain alcohols, esters, acids, oils, and waxes (see [0109]). Polysorbate-80 for instance is named among equivalent bioadhesive polymer components which may be desirably included to hydrate the skin and enhance the formulation’s permeability and further functioning as thickening agents (see [0107])(“nonionic emulsifier” as in claims 1, and 5-7). Bermans’ formulations include an acid which is acetic acid or citric acid for instance as a buffering agent or pH modifier to provide desirable compound stability and skin permeation and solubility features (see [0121])(limitation of claims 1-4). Bermans’ formulations further include a cis-unsaturated fatty acid which for instance may be sapienic or oleic acid (see Bermans claim 13 in particular)(limitation of claims 9-12), and vegetable, nut, and seed oils including castor oil as embodied and equivalent safflower oil are named as suitable lipophilic components (see [0077])(limitation of claims 1, 13, and 14). Berman’s emulsions for instance include water (see [0109], [0111], [0123]).
Regarding the precursor to nitric acid as in claim 1, Berman does not include this feature.
Chousky teaches a topical composition for increasing dermal nitric oxide wherein said composition comprises beet root extract as well as additional functional ingredients (see abstract, in particular) (limitations of claims 1 and 16). See Chousky example 1 for instance.
Both Berman and Chousky are directed to topical applications which may be used for instance to treat neuropathy. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to add beet root extract to topical formulations for the intended treatment of neuropathy, with a reasonable expectation of success. One would have been motivated to do so to increase nitric oxide to desirably facilitate vasodilation or providing its benefits such as reducing inflammation or preventing and repairing wounds, among other known benefits taught by Chousky (see Chousky page 3, lines 17-26 for instance).
Regarding the measured viscosity of the composition as in claim 1, Berman does teach viscosity adjustment (see [0105]) and gel and cream formulations which qualitatively appear to be the same or substantially the same as claimed, however Berman does not specify a viscosity range in quantitative units as claimed.
Spann-wade cures this deficiency. Spann-wade teaches topical gel compositions comprising an active drug, a thickener, and additional functional components to be applied to the surface of the skin (see abstract, in particular). Spann-wade teaches a viscosity to be between 2000 and 50000 cps, a range overlapping the instantly claimed range (see [00123])(limitations of claims 1 and 19).
Berman and Spann-wade both pertain to topical formulations having controlled and/or adjusted viscosity parameters; it is noted that both references encompass a breadth of active agents, but both may be used in applications to treat neuropathy for instance (see Spann-wade [00226]). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use Spann-wade’s quantified viscosity range for Berman’s qualitatively described composition in the absence of Berman’s quantification of cream or gel viscosity parameters recommended. One would have been motivated to do so since Spann-wade teaches topical formulations comprising a drug as well as thickeners used to adjust the final property of the product (see [0192]-[0195] of Spann-wade for instance).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over WO2021/262779A1 (Berman et al.; hereafter “Berman”) in view of CA3052863A1 (“Chousky”) and CA2599968 (Spann-wade et al., “Spann-Wade”), further in view of CA2667614 (Archambeau et al., hereafter “Archambeau”).
The teachings of Berman, Chousky, and Spann-wade are discussed above. They do not teach the water in the topical formulations or emulsions is distilled as recited in claim 8.
Archambeau teaches systems for making and using wound care formulations for cosmetic and/or therapeutic symptom treatments (see abstract, in particular). Neuropathy is among the conditions discussed. Archambeau specifies that distilled water is among the solvents which may be used to create solutions of the therapeutic formulations. Archambeau encompasses topical including transdermal formulations which for instance may be in the form of microemulsions, solutions, suspensions, etc.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute distilled water as taught by Archambeau in place of the water in topical gels, creams, or emulsions as in Berman, Chousky, and Spann-wade. One would have been motivated to do so to facilitate good stability resulting from the absence of impurities as removed through a distillation process as reasonably would have been recognized by the ordinary artisan as advantageous and as explicitly suggested by Archambeau.
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/942,968, 19/411,130, and 19/411,114 (reference applications). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending applications are all directed to the formulation claimed in the present method, some with further limitations which read on the instantly claimed composition. Where the composition is claimed as a topically applied systemic delivery system, it would have been obvious to use it as a transdermal composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
