CTNF 18/573,514 CTNF 95294 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Applicant’s election without traverse of claims 1-9, 17-19, and 22-29 in the reply filed on 01/15/2026 is acknowledged. Claims 1-9, 17-19, and 22-29 are currently under examination and the subject of the present Office Action. Claims 10-16 and 20-21 are cancelled; claims 22-29 are new. As such, the restriction is made final. Information Disclosure Statement The information disclosure statements (IDS) filed on 03/19/2024, 03/21/2024, 06/18/2024, 09/18/2024, and 01/15/2026 have been considered here. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 4 is 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. Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of search and examination the claim is understood to read “organic and inorganic nitrates, acidified nitrite, nitrogen oxides, and mixtures thereof.” Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-5, 7-8, 17-19, 24, and 27 are rejected under 35 U.S.C. 102( a)(1) and (a)(2 ) as being anticipated by US PGPUB 20030175362 A1 (Kross, 2003; as submitted on IDS of 01/15/2026) . In regards to claims 1-2, 7, and 19, Kross teaches a composition for disinfecting a substrate comprising a protic acid and a nitrite salt (see Kross, claims 1 and 14). It is taught that the substrate is skin or mucous membranes (see Kross, claims 12 and 25). In regards to claims 3-5, the protic acid is taught to be citric acid, lactic acid, tartaric acid, mandelic acid, glycolic acid, and mixtures thereof (see Kross, claims 6 19) and the nitrite salt is taught to be sodium nitrite (see Kross, claims 3 16). In regards to claim 8, the amount of acid is taught to be 0.03% to about 3% by weight of the total composition and the amount of nitrite salt is taught to be from about 0.01% to about 1.0% by weight based on the total weight of the composition (see Kross, claims 2, 7, 15, and 20). These amounts overlap with the instant claim. In regards to claim 24, the composition comprises water (i.e., a solvent) (see Kross, claim 1). In regards to claims 17-18 and 27, the composition is taught to comprise a gelling agent (see Kross, claim 26) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1-9, 17-19, and 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20240016831 A1 (Munro, 2024) . In regards to claims 1-6, 19, 24, and 27, Munro teaches a nitric oxide (NO) or nitric oxide releasing composition (see Munro, abstract) comprising a proton source such as one or more acid selected from organic carboxylic acids and organic non-carboxylic acids (see Munro, paragraph 0004) and a nitrite salt (see Munro, paragraph 0032). Munro teaches that the organic carboxylic acid is selected from citric acid, glycolic acid, mandelic acid, tartaric acid, lactic acid, malic acid, among others, which would be understood as activator substances as described in the instant specification as filed (see Munro, paragraph 0190; instant specification as filed, paragraph bridging pages 8-9). It is taught that the nitrite salt is sodium nitrite (see Munro, paragraph 0131). It is taught that the composition comprises a solvent, such as water as well (which would also be an adjuvant) (see Munro, paragraph 0118). In regards to claims 9 and 28, it is taught that the nitrite salt and organic carboxylic acid are stored separately or in separate containers in a kit and are brought together for use by mixing (see Munro, paragraph 0090). Further reference WO 02/20026, which is incorporated by reference, teaches a nitrate containing composition and an acid containing composition dispensed from a twin barreled dispenser, which compositions are then mixed to cause the acid to react with the nitrite before being spread on the skin (see Munro, paragraph 0018). Further in regards to the delivery of the nitric oxide into/through the epithelial layer, epidermis, skin or mucosa and claims 7 and 29, Munro incorporates by reference WO 02/20026, which teaches a composition comprising citric acid (i.e., a proton source) and a nitrite containing composition for delivery to the skin (see Munro, paragraph 0018). Munro also incorporates by reference WO 2014/188174, which teaches a dressing system and transdermal delivery system in which the dressing system comprises a proton source and a nitrite salt for delivery into the skin (see Munro, paragraph 0026). In regards to claim 8, the nitrite salt is taught to be used in an amount of no more than about 0.4% by weight when the salt is sodium nitrite (see Munro, paragraph 0131). Further it is taught that the organic carboxylic acid has a concentration before reaction with the nitrite salt of about 0.001M to about 5M (see Munro, paragraph 0196). Using citric acid as an example, this would be about 0.02% w/w to about 66% w/w. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976). In regards to claims 17-18 and 25-26, the composition is taught to comprise polyacrylic acid (see Munro, paragraphs 0190, 0826). The composition is also taught to comprise polyethylene glycol (see Munro, paragraphs 0054-0055, 0071-0072, 0347). Both of these compounds are taught as gelling agents known in the art in the instant specification as filed (see page 9, lines 20-25 of instant specification as filed). In regards to claims 22-23, it is taught that the composition comprises ascorbic acid (see Munro, paragraphs 0102, 0206). Munro does not teach the claims with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Munro with a reasonable expectation of success to obtain the system of the instant claims. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[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”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings 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.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the system of the instant claims with predictable results . Double Patenting 08-33 AIA 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. 08-37 AIA Claim s 1-9, 17-19, and 22-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-29 of copending Application No. 19/252324 (the reference application) in view of US PGPUB 20240016831 A1 (Munro, 2024). The claims of the reference application are directed to a composition comprising an alpha-hydroxy acid in a concentration of from 0.1-20% and a nitric oxide precursor at a concentration of from 0.01-1% (see claim 1). These amounts overlap with the amounts from the instant claims. Further the reference application teaches additional components such as a succinoglycan and the compounds of reference application claims 6-29, which would be considered adjuvants. Reference claims 2 and 4 specify that the acid is glycolic acid and the nitric oxide precursor is sodium nitrite. Reference claim 16 also teaches the use of ascorbic acid in the composition. The reference application is silent on the composition being used on an epithelial layer, a container for the composition or keeping the components of the system separate, polyethylene glycol, polyacrylic acid, or applying the composition via dressing. The teachings of Munro have been described supra . In regards to claims 1-9, 17-19, and 22-29, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of the reference application with the teachings of Munro as both references teach compositions comprising identical compounds for similar uses. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would be motivated to combine the composition of Munro with the composition of the reference application according to the known method of applying these compounds to the skin (see Munro, paragraphs 0018, 0026) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results . This is a provisional nonstatutory double patenting rejection. Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Isis A Ghali/Primary Examiner, Art Unit 1611 /A.A.A./Examiner, Art Unit 1611 Application/Control Number: 18/573,514 Page 2 Art Unit: 1611 Application/Control Number: 18/573,514 Page 3 Art Unit: 1611 Application/Control Number: 18/573,514 Page 4 Art Unit: 1611 Application/Control Number: 18/573,514 Page 5 Art Unit: 1611 Application/Control Number: 18/573,514 Page 6 Art Unit: 1611 Application/Control Number: 18/573,514 Page 7 Art Unit: 1611 Application/Control Number: 18/573,514 Page 8 Art Unit: 1611 Application/Control Number: 18/573,514 Page 9 Art Unit: 1611