Ust 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- 31 are currently pending.
Claims 15, 16, 28, and 29 are withdrawn
Claims 1-14, 17-27, 30, and 31 are being examined on the merits.
Election/Restriction
Applicant's election without traverse Group I (claims 1-14, 17-27, and 31) with election of species a) sodium nitrite, b) citric acid, c) coco betaine, d) antiseptic as topical dermatological agent benzalkonium chloride in the reply filed on July 23, 2026, is acknowledged.
Claims 15, 16, 28, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 08, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application is a PRO of 63/503,319 (05/19/2023) as reflected in the filing receipt issued May 10, 2024.
Information Disclosure Statement
The Information Disclosure Statement(s) submitted on July 23, 2026, is being considered by the Examiner.
Claim Objections
For claims 8 and 22 recite “topical excipients including one or more of humectants, emulsifiers, preservatives, adhesives, and thickeners, or a combination thereof”. Be more consistent with the language of the claim and modify to state “wherein the one or more topical dermatological agents or topical excipients are selected from...”
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 8 and 10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation “group consisting of alcohol “and the claim also recites “(ethanol and isopropanol)”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
With regards to claims 1-9, 11, 17-23, 25-27, 30 and 31 are rejected under 35 U.S.C 102(a)(1) as being anticipated by Miller et al (US10751364B2; Published on August 25, 2020; Filled on August 14, 2018, cited in IDS).
Miller et al throughout teaches a topical application of nitric oxide for transdermal absorption.
For Claim 1: Miller teaches a composition of nitric oxide comprising: a first solution comprising water (reads on the aqueous solution of the claim), at least one nitrite reactant, and a cationic surfactant; a second solution comprising water (reads on the aqueous solution of the claim), at least one acidic reactant, and the cationic surfactant; a first foam obtained by aerating the first solution; a second foam obtained by aerating the second solution; and a collapsible foam obtained by mixing the first foam and the second foam (claim 1). Miller further discloses that the first solution comprises approximately 100 mL of water, 10g of sodium nitrite, and 1g of the cationic surfactant; and the second solution comprises approximately 100 mL of water, 5g of lactic acid (additional topical dermatological agent), 6g of citric acid, and 3 g of the cationic surfactant (Miller claim 2). Miller also discloses the first solution comprises approximately 100mL of water converts to (100 ml =100 grams of water), 10g of sodium nitrite (total weight 113g, 10/113 grams = 8.84 wt% of sodium nitrite(nitric oxide precursor), 2g of sodium bicarbonate (additional topical dermatological agent), and 1 g (total weight 113g, 1/113 grams = 0.88 wt% of the cationic surfactant); and the second solution comprises approximately 100 mL of water (100 ml =100 grams of water), 5g of lactic acid, 8g of citric acid (8/113 grams= 7 wt% of citric acid (reads on the protic acid of the claim)) , and 3g of the cationic surfactant (total weight 113 g, 3/113 grams= 2.65 wt% of surfactant ) (Miller claim 3).
For claims 2 and 3: Miller teaches first medium is a nitrite medium and generally provides the nitrite reactants in some suitable form, such as sodium nitrite, potassium nitrite, or the like (column 3 line 52-54).
For claims 4 and 5: Miller teaches the second medium is an acidified medium and generally provides at least one acidic reactant in some suitable form, such as citric acid, lactic acid, ascorbic acid, or the like (Column 3 line 53-57).
For claims 6 and 7: Miller teaches the surfactant may be a cationic surfactant that works in more acidic pH levels with suitable surfactant may include Coco-Betaine, or cocamidopropyl betaine (column 7 line 48-53). Miller further discloses that one embodiment teaches a first medium, or sodium nitrite solution, may be formulated to include 100 mL of water, 10g of sodium nitrite, and 1g of Coco Betaine (Miller column 3 lines 56-59). Another embodiment discloses that second medium, or acid solution may be formulated to include 100mL of water (100mL= 100g of water), 5g of lactic acid (additional topical dermatological agent), 6g of citric acid, and 3g of Coco Betaine (column 7 lines 60-63). Miller also teaches embodiments that state a first medium, or sodium nitrite solution, may be formulated to include 100 mL of water (100mL= 100g of water), 10g of sodium nitrite, 2g of baking soda (sodium bicarbonate), and 1g of Coco Betaine (column 8 lines 7-10). In one embodiment Miller discloses a second medium, or acid solution, may be formulated to include 100mL of water (100mL= 100g of water), 5g of lactic acid (additional topical dermatological agent), 8g of citric acid, and 3g of Coco Betaine (column 8 lines 11-14).
For claim 11: Miller teaches that a first foam obtained by aerating the first solution; a second foam obtained by aerating the second solution; and a collapsible foam obtained by mixing the first foam and the second foam (claim 1).
For claim 17: Miller teaches mixing solution comprises approximately 100 mL of water (100mL= 100g of water), 10 g of sodium nitrite , and 1g of the cationic surfactant; and the second solution comprises approximately 100 mL of water, 5g of lactic acid, 6g of citric acid, and 3g of the cationic surfactant ( Miller claim 21).
For claims 18 and 19: Miller teaches solution comprises approximately 100 mL of water (100mL= 100g of water), 10g of sodium nitrite (reads on the nitric oxide precursor of the claim) , and 1 g of the cationic surfactant; and the second solution comprises approximately 100 mL of water (100mL= 100g of water), 5g of lactic acid, 6g of citric acid, and 3g of the cationic surfactant (Miller claim 21).
For claim 20 and 21: Miller teaches mixing solution comprises approximately 100 mL of water (100mL= 100g of water), 10 g of sodium nitrite , and 1 g of the cationic surfactant; and the second solution comprises approximately 100 mL of water(100mL= 100g of water), 5 g of lactic acid, 6 g of citric acid (reads on the protic acid of the claim), and 3 g of the cationic surfactant (Miller claim 21).
For claim 22 and 23: Miller exemplifies that the medium includes KATHON CG (0.05% w/w) (reads on the anti-infective/antiseptic of the claim) (Miller column 5 lines 44-46).
For claim 25: Miller teaches and acid solution, may be formulated to include 100 mL of water (100mL= 100g of water), 5 g of lactic acid, 6 g of citric acid, and 3 g of Coco Betaine (Miller column 8 lines 1-4).
For claim 26: Miller teaches sodium nitrite solution , may be formulated to include 100 mL of water (100mL= 100g of water), 10 g of sodium nitrite, 2 g of baking soda (sodium bicarbonate), and 1 g of Coco Betaine (Miller column 8 lines 7-11).
For claim 27: Miller teaches and acid solution , may be formulated to include 100 mL of water (100mL= 100g of water), 5 g of lactic acid, 6 g of citric acid, and 3 g of Coco Betaine (Miller column 8 lines 1-4). Miller also teaches sodium nitrite solution , may be formulated to include 100 mL of water (100mL= 100g of water), 10 g of sodium nitrite, 2 g of baking soda (sodium bicarbonate), and 1 g of Coco Betaine (Miller column 8 lines 7-11).
For claim 30: Miller teaches and acid solution , may be formulated to include 100 mL of water (100mL= 100g of water), 5 g of lactic acid, 6 g of citric acid, and 3 g of Coco Betaine (Miller column 8 lines 1-4). Miller also teaches sodium nitrite solution , may be formulated to include 100 mL of water (100mL= 100g of water), 10 g of sodium nitrite (reads on nitric oxide of the claim) , 2 g of baking soda (sodium bicarbonate, and 1 g of Coco Betaine (Miller column 8 lines 7-11).
For claim 31: Miller teaches a acidified medium with distilled/deionized water (89.02% w/w), lactic acid (85% liquid solution; 3.00% w/w) and ascorbic acid (USP, crystalline; 3.00% w/w) may be stirred in until completely dissolved lines. Citric acid (crystalline; 3.00% w/w) may be added to adjust the mixture to a pH of 6.0. (Miller column 6 lines 6-11). Miller further discloses a nitrite medium with sodium nitrite (3.00% w/w) (reads on nitric oxide of the claim) and KATHON CG (0.05% w/w), METHOCEL™ (HPMC, cold dispersable; 1.75% w/w) (Miller column 5 lines 63-66) sodium hydroxide (10N to approximately pH 8; 0.09% w/w) (Miller column 6 line 1).
Claim Rejections - 35 USC § 103
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 8-10, 12, 13, 14 and 24 are rejected under 35 U.S.C 103 as being unpatentable over Miller et al (US10751364B2; Published on August 25, 2020; Filled on August 14, 2018, cited in IDS) in view of Coggan et al (WO2016007834A1; Published on January 14, 2016).
Miller et al throughout teaches a topical application of nitric oxide for transdermal absorption, as discussed above.
For claims 8: Miller teaches topical mixture that produces nitric oxide may be used for antimicrobial, antifungal, or similar cleaning purposes, including the breaking up or dispersing of a biofilm (column 4 line 56-58). Miller further exemplifies that the medium includes distilled/deionized water (94.94% w/w), sodium nitrite (3.00% w/w), and KATHON CG (0.05% w/w) (reads on the anti-infective/ antiseptic of the claim) (Miller column 5 lines 44-46).
For claim 9: Miller exemplifies that the medium includes KATHON CG (0.05% w/w) (reads on the anti-infective/antiseptic of the claim) (Miller column 5 lines 44-46).
For claim 12: Miller teaches and acid solution, may be formulated to include 100mL of water (100mL = 100 grams), 5g of lactic acid(additional topical dermatological agent) (5/114 grams = 4.38 wt% of additional topical dermatological agent), 6g of citric acid (6/114 grams= 5.26 wt% of citric acid (protic acid of the claim)) , and 3g of Coco Betaine (3/114 grams= 2.63 wt% of Coco Betaine )(Miller column 8 lines 1-4). Miller further discloses that the formulation amounts may be adjusted by plus or minus 10%( Miller column 8 lines 24-25).
For claim 13: Miller teaches sodium nitrite solution, may be formulated to include 100 mL of water (100mL = 100 grams), 10g of sodium nitrite (10/113 grams = 8.84wt% of sodium nitrite), 2g of baking soda (sodium bicarbonate)( 2/113 grams= 1.76 wt% of sodium bicarbonate(additional topical dermatologic agent), and 1g of Coco Betaine(1/113 grams= 0.88 wt% of Coco Betaine) (Miller column 8 lines 7-11). Miller further discloses that the formulation amounts may be adjusted by plus or minus 10%( Miller column 8 lines 24-25).
For claim 14: Miller teaches and acid solution may be formulated to include 100mL( 100mL= 100grams) of water, 5g of lactic acid (5/114 grams= 5.26 wt% of lactic acid( additional topical agent), 6g of citric acid(6/114 grams= 5.26 wt% of citric acid) and 3g of Coco Betaine (3/114 grams= 2.63 wt% of Coco Betaine) (Miller column 8 lines 1-4). Miller also teaches sodium nitrite solution may be formulated to include 100mL ( 100mL= 100grams) of water, 10g of sodium nitrite (10/113 grams= 8.84 wt% of sodium nitrite) , 2g of baking soda (sodium bicarbonate)(additional topical agent)(2/113 grams= 1.75 wt% of sodium bicarbonate), and 1g of Coco Betaine (1/113 grams= 0.88 wt% of ( Coco Betaine)(Miller column 8 lines 7-11). Miller further discloses that the formulation amounts may be adjusted by plus or minus 10%( Miller column 8 lines 24-25).
Miller does not teach the topical dermatological agent includes an alcohol… benzalkonium chloride… or a combination thereof, as recited in claims 10 and 24. Miller also does not explicitly teach the weight precent of ingredients recited in claims 12,13, and 14.
However, Coggan et al exemplifies a topical antiviral composition with nitric oxide releasing activity where composition can be embodied in different forms and should not be construed as limited to the embodiments set forth herein (Coggan paragraph 0008).
With regards to claim 10 and 24: Coggan exemplifies a topical composition that includes antimicrobial agents and preservatives present in the first composition not limited to alcohols, benzalkonium chloride, phenol, and any combinations thereof (Coggan paragraph 00119).
With regards to claims 10 and 24, Miller teaches a topical application of nitric oxide for transdermal absorption, as discussed above. Coggan exemplifies a topical composition that includes preservatives present in the first composition not limited to alcohols, benzalkonium chloride, phenol and any combinations thereof as discussed above. Both Miller and Coggan teach topical compositions for skin protection or treatment. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Coggan by incorporating ingredients such as alcohol and benzalkonium chloride into the topical composition taught by Miller. One ordinary skill in the art would have been motivated to do so for because alcohols and benzalkonium chloride are known antimicrobial and preservative agents. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Coggan teach the incorporation of alcohols and benzalkonium chloride in topical composition for toe production of nitric oxide.
With regards to claims 12, 13 and 14, Miller teaches a topical application of nitric oxide for transdermal absorption, as discussed above. One of ordinary skill in the art would have found it prima facie obvious and would have been motivated to optimize ingredients such as the additional topical dermatological agent, protic acid, coca betaine, and nitric oxide precursor in the formulation because Miller teaches that the that the formulation amounts may be adjusted by plus or minus 10%.
The adjustment of particular conventional working conditions (e.g., determining optimal or workable amount of polymer and solid content is deemed merely a matter of judicious selection and routine optimization, which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results, absent evidence of unexpected results. Where 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.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Examiner’s Suggestions
There are several claims that follow oxford comma convention and have a comma just before “or a combination thereof” and at least one lacks this comma. For consistency purposes the examiner asks that all claims are consistent with either using or not using oxford comma convention.
Conclusion
Claims 1-14, 17-27, 30, and 31 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASMINE A EVANS whose telephone number is (571)272-9796. The examiner can normally be reached Mon-Fri 8:00-5:00EST.
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/J.A.E./ Examiner, Art Unit 1616 /ERIN E HIRT/ Primary Examiner, Art Unit 1616
