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
Acknowledgement is made of the response filed on October 10, 2025. In that response, claims 1, 5, and 10 were amended. Claims 1-21 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 102
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 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.
(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.
Claims 1, 2, 4-12, and 14-21 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Stasko (WO 2013/063354; see 11/15/2022 IDS).
Stasko teaches nitric oxide (NO) releasing soak and/or bath and nitric oxide releasing bath compositions for therapeutic effects, such as “wound healing, decreas[ing] inflammation and/or exert[ing] an antimicrobial effect” (para.0063; see title; abstract; paras.0005-06, 0043-48, 0063-67, 0081-82, 0088, 0091-94, 0101-02; claims 1-46; Figs.1, 2). Various suitable NO-releasing compounds include acidified nitrite (para.0046) which is both a nitrite component and an acidic component. “The NO-releasing compound may be a small molecule, … and may be in any suitable physical form, including, but not limited to, particles, … liquids, solutions and the like” (para.0046). Stasko teaches, “the nitric oxide releasing bath may effervesce… release of a gas, such as carbon dioxide, in an aqueous solution and produces bubbles, fizz, and/or foaming in an aqueous solution” (para.0068). “[E]ffervescence increases the half-life of the nitric oxide in the aqueous solution” (id.). Suitable effervescent couple includes those in instant claims 4, 5, 14, and 15 (paras.0069-71). The skilled person would understand that an effervescent couple is a combination of an acid and base that produces effervescence. “Properties of the NO-releasing compound may be controlled to affect the release rate of nitric oxide…” (para.0061; see para.0079), including over time (paras.0080, 0090; see paras.0045, 0055, 0061). In other words Stasko teaches an “extended time release…composition” in instant claims 7 and 17.
Figures 1 and 2 show open-top container, i.e., a vented housing. Stasko teaches aromatherapy agents in the bath (para.0072; claim 9).
The bath composition may be in the form of “a bead, …a tablet, a film, …a film-coated tablet, and/or a polymer sheet” in which the polymer may “dissolve or break down in water” (paras.0081-82; claim 23). Applicant explains with “the shape of the tablet (e.g., disc versus sphere) ...a sphere dissolves more slowly, thereby extending the release of NO” (Remarks, p.7-8, October 10, 2025). A bead is a sphere.
Stasko teaches using a surfactant (paras.0075, 0101) and an effervescent component, i.e., a foaming agent (para.0068). Gas bubbles rise up in an aqueous solution and therefore would form a layer on the bath medium. As noted above, Stasko notes, “effervescence increases the half-life of the nitric oxide in the aqueous solution” (id.) which would increase the transdermal absorption of NO.
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 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Stasko (WO 2013/063354) in view of Miller (US 2017/0209485).
Stasko does not specifically teach potassium or sodium nitrite in claims 3 and 13.
Miller is drawn to topical application of nitric oxide and teaches both nitrites as suitable for combining with an acid, such as those Stasko teaches, to generate NO (title; abstract; paras.0025, 0058; claims 26, 32, 37). Like Stasko, Miller teaches using sodium bicarbonate and surfactants in a liquid to generate a foamy topical preparation (paras.0011, 0014-19, 0059, 0066, 0077).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Stasko and Miller and use potassium or sodium nitrite in Stasko’s NO-releasing bath as recited in the instant claims. The skilled person would have been motivated to do so because both are drawn to generating nitric oxide in a liquid medium for topical absorption, Stasko teaches various NO-releasing compounds may be used, along with acids, and Miller teaches potassium or sodium nitrite in combination with the acids that Stasko teaches. Furthermore substituting equivalents known for the same purpose, where the equivalency has been recognized in the prior art, presents strong evidence of obviousness; an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. MPEP §2144.06 (II) (citations omitted).
Response to Arguments
Applicant's arguments filed October 10, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims “recite generating therapeutic NO in situ in the aqueous bath via the solution phase reaction between the dissolved nitrite salt and an acid, and can further…” whereas Stasko, “by contrast, is about nitric oxide releasing compounds, principally diazediumdiolate functionalized donor macromolecules, that release NO upon contact with water”. (Remarks, 9 second para. (emphasis added), October 10, 2025.) “Indeed, nothing in Stasko describes providing a discrete nitrite component and a discrete acidic component that dissolve in bath water and react together to generate NO gas;…” (Id. third para. (emphasis added)). Applicant further states, “in Stasko, acidified nitrite is not a stand alone 'compound' that both supplies nitrite and separately supplies acid in the manner the Applicant’s claims require; the claims call for distinct components that dissolve and then react in the bath to form NO”. (Id. at 9, first para. (emphasis added); see also p.10 under “Claim Rejections: 35 U.S.C. §103”.)
In response it is noted that “[t]hough understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim”. MPEP § 2111.01.II (citations omitted). Here Applicant’s argument does not reflect the claim language in claims 1 and 11. These claims recite, “wherein when combined in the bath, the nitrite component, the acidic component, and the bath medium are adapted to safely generate a therapeutically effective treatment dose of nitric oxide gas…”. Thus the claims do require generation of NO gas, but there is no mention of generating NO “via the solution phase reaction between the dissolved nitrite salt and an acid” as Applicant argues. In other words nothing in the claims require a chemical reaction between the nitrite component and the acidic component for the NO generation; but merely that “the nitrite component, the acidic component, and the bath medium are adapted to…generate” NO.
Applicant also argues that Miler does not rectify the alleged shortcomings of Stasko because it “discloses nitrite + acid chemistries for topical NO generation and discusses foamy preparations”, not “a bath system”. (Remarks, 10-11, October 10, 2025.)
In response it is again noted that the alleged shortcomings of Stasko, to wit, that it does not teaching generating NO via a chemical reaction between a separate nitrite component and an acidic component, is not recited in the claims, and therefore Applicant’s argument regarding Miller in relation to the alleged shortcomings is not pertinent to the present claims.
Applicant lastly argues that several claim elements remain missing from Stasko, including a bath container, a nitrite and/or acid component comprising “a solid portion”, and “’adapted and configured to control…extended release gas generation period,’ where control is achieved through the physical configuration of the separate media (shape, coating, compression), not donor chemistry”. (Remarks, 11-12.)
In response Stasko’s Figure 1 is noted for showing the recited “bath container” with a foot therein. According to Stasko, the “NO-releasing compound may be a small molecule, … and may be in any suitable physical form, including, but not limited to, particles,” (para.0046), i.e., a solid. Furthermore “control is achieved through the physical configuration of the separate media (shape, coating, compression)” are not concepts recited in the present claims. Claims 7 and 17 recite the nitrite and/or the acidic component, formed specifically as a tablet, with “extended time release shape, configuration, composition, and/or coating”.
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 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/758691 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to methods of delivering nitric oxide to a subject, comprising contacting the site with a foam formulation comprising NO, water, and a surfactant. The ‘691 application’s claims further recite the surfactant concentration, and therefore anticipate the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/101820 (reference application) in view of Stasko (WO 2013/063354).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to methods of delivering nitric oxide to a subject, comprising contacting the site with an aqueous solution comprising NO generated from a nitrite and an acid, water, and a surfactant. The ‘820 application’s claims further recite providing the NO-releasing components in a pod; however Stasko teaches providing NO-releasing compounds in a tablet. The skilled person would have recognized convenience in packaging a correct amount in a tablet.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed October 10, 2025 have been fully considered but they are not persuasive. Applicant “maintains that the claimed subject matter…is non-obvious” from those in the referenced applications, and furthermore requests the rejections be held in abeyance. (Remarks, 12, October 10, 2025.)
The provisional double patenting rejection are maintained for the reasons discussed herein. They will be maintained until Applicant submits properly executed terminal disclaimer or amendments or arguments that effectively overcome the rejections.
CONCLUSION
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/ Primary Examiner, Art Unit 1614
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