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 .
Status of the Claims
Claims 1-19 are pending in the application and under current examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/11/24 and 12/6/24 have been considered by the examiner.
Claim Objections
Claims 6, 7, and 11-14 are objected to because of the following informalities: these claims include improperly capitalized common chemical names for instance of acids and oils. Appropriate correction is required.
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 6 and 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 6 and 7 contains the trademark/trade name Polysorbate. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe various polyoxyethylene-derived surfactants. Accordingly, the identification/description is indefinite.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 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 cures this deficiency. 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”) as applied to claims 1-7 and 9-19 above, and further in view of CA2667614 (Archambeau et al., hereafter “Archambeau”).
The teachings of Berman, Chousky, and Spann-wade have been delineated above. None of these specifies that the water in the topical formulations or emulsions is distilled as recited in claim 8.
Archambeau cures this deficiency. 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.
Berman, Chousky, Spann-wade, and Archambeau are all directed to drug-containing topically applicable formulations. 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, with a reasonable expectation of success. 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.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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