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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/27/26;11/3/25;9/10/25;5/6/25;4/9/25;3/6/25;7/24/24;6/28/24;4/4/24; 10/18/23;10/1/23 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
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 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)(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 24-38 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Munro et al. (US 2022/0257642) (“Munro”).
-Reference paragraphs used are non-exclusive areas of disclosure- [0089]
(claim 24) Munro discloses: a device for generation and release of nitric oxide (NO), comprising: (a) a nitrite source admixed with a gelling agent and/or a viscosity adjuster [0096], and (b) a reservoir for loading the nitrite source and configured for being applied to a body cavity or surface of a subject in need thereof [0095][0242].
Claim 25: the gelling agent comprising a material selected from the group consisting of honey, xanthan gum, guar gum, carrageenan gum, locust bean gum, sodium alginate, agar-agar, gelatin, modified starches, cellulose, crosslinked polyacrylic acids, and alkyl-substituted celluloses, wherein the gelling agent optionally further comprises a dilutor for adjusting the viscosity of the gelling agent. [0236][0433][0230-0235]
Claim 26: the nitrite source is entrapped in honey. [0238]
Claim 27: the gelling agent further comprises polyethylene glycol (PEG) [0033]
Claim 28: the gelling agent and/or the viscosity adjuster and their respective amounts are selected to provide an extended release of the therapeutically effective amount of the NO over a period of at least 24 hours. [0019]
Claim 29: the nitrite source comprises an alkali metal nitrite, an alkaline earth metal nitrite, a transition metal nitrite, an ammonium nitrite or any combination thereof. [0093]
Claim 30: the nitrite source comprises nitrite loaded nanoparticles. [0095 microencapsulated]
Claim 31: Munro further comprising a proton source physically separate from the nitrite source. See abstract,[0019]
Claims 32-35: the reservoir is further loaded with a thiol source;
the source of thiol group is thiol-containing molecules;
the thiol source is thiol-containing nanoparticles, which either have the having thiol groups covalently thereto or have thiol-containing molecules loaded in the nanoparticles;
the device further comprising a source of S-nitrosothiol (SNO) group. [0243] (US7135189--C5L16-23, abstract)
Claim 36: the nitrite source comprises an immediate release portion and an extended release portion [0411]
Claim 37: the reservoir is a sponge or a patch [0095]
Claim 38: the reservoir is configured for being inserted into a nostril of the subject [0095][0237]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm 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, Kevin Sirmons can be reached at 571-272-4965. 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.
/DEANNA K HALL/Primary Examiner, Art Unit 3783
Prosecution Insights