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 .
Detailed Action
Response to Restriction
Applicants’ election without traverse of the species of KPV (Claims 1-13 and 16-19) in the reply filed on 19 August 2026 is acknowledged.
Status of Application
The instant application, filed 9 November 2025, is a continuation in part of Application 19/186065, filed 22 April 2025. Claims 1-19 are currently pending. Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 August 2026. Claims 1-13 and 16-19 are examined on the merits within.
Claim Rejections – 35 U.S.C. 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.
Claim(s) 1-2, 4, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaufman (U.S. Patent Application Publication No. 2022/0202844).
Regarding instant claims 1-2, Kaufman discloses lyophilized NAD+ product formulations used in iontophoretic patches. See paragraph [0018].
Regarding instant claim 4, Kaufman discloses compositions and methods of chemical delivery drug enhancer dosage forms with synergistic effects for improving the delivery of dosage forms of different compounds and chemicals into the body from their co-administration that include pharmaceuticals, nutraceuticals, cosmeceuticals, hormones, cells, genomic materials, enzymes, botanical extracts, peptides, molecular structures, growth hormones, viruses, bacteria, toxins, neurotoxins, bioactive agents, dietary supplements, and other chemicals. See paragraph [0242].
Regarding instant claim 11, Kaufman also discloses the use of microneedles. See paragraph [0252].
Thus the instant claims are anticipated by Kaufman.
Claim Rejections – 35 U.S.C. 103
5. 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.
6. Claim(s) 1-7, 9, 11-13, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (U.S. Patent Application Publication No. 2022/0202844) in view of Zhang et al. (U.S. Patent Application Publication No. 2015/0080291).
Kaufman teaches lyophilized NAD+ product formulations used in iontophoretic patches. See paragraph [0018]. Kaufman teaches a method for delivering a therapeutic agent in blood stream or tissue of a body, the method comprising the steps of: administering nicotinamide adenine dinucleotide or a derivative or a precursor thereof; and upon administration, administering a chemical drug delivery enhancer composition. See claim 6. The method further comprises administering resveratrol or pterostilbene. See claim 15. Nicotinamide adenine dinucleotide is combined with a non-phosphate citrate buffer. See Example 3. Example 1 comprises 2-8% of a non-phosphate buffer, 0 to 20% water, and 5 to 25% nicotinamide adenine dinucleotide. This disclosure teaches compositions and methods of chemical delivery drug enhancer dosage forms with synergistic effects for improving the delivery of dosage forms of different compounds and chemicals into the body from their co-administration that include pharmaceuticals, nutraceuticals, cosmeceuticals, hormones, cells, genomic materials, enzymes, botanical extracts, peptides, molecular structures, growth hormones, viruses, bacteria, toxins, neurotoxins, bioactive agents, dietary supplements, and other chemicals. See paragraph [0242]. Kaufman also teaches the use of microneedles. See paragraph [0252].
Kaufman does not teach KPV tripeptide.
Zhang et al. teach lipidated di-or tri-peptides analogs of KPV that exhibit antimicrobial activity. See abstract. Due to their small size, the peptides are expected to be able to gain by themselves some level of permeability through the skin; however, certain techniques may be used to amplify this movement. For example, lipophilic (non-polar) groups can be added to the peptides, or the peptides can be delivered to the skin in a lipophilic excipient, in order to enhance peptide accessibility to the stratum corneum to allow translocation to the lower epidermal layers. In this manner such lipophilic modifications may be considered as a pro-drug. Permeation enhancers such as known solvents and surfactants may be used in the excipient to allow better peptide absorption. Special techniques that are anticipated to be useful in enhancing peptide access to the targeted tissue/injury include iontophoresis, electrophoresis and ultrasound. An iontophoretic device consists of two electrodes immersed in an electrolyte solution and placed on the skin. When an electric current is applied across the electrodes, an electric field is created across the stratum corneum that drives the delivery of the peptides. See paragraph [0060].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one peptide for another, i.e., KPV peptide of Zhang et al. for the peptides in Kaufman, to deliver in conjunction with NAD+ because Kaufman teach delivery of NAD+ and peptides through iontophoretic devices. One would have been motivated, with a reasonable expectation of success, because Zhang et al. teach effectively delivering KPV through iontophoretic devices. It would have been well within the purview of the skilled artisan to modify the amount of each ingredient to achieve the desired therapeutic effect. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one citrate buffer for another to yield predictable results.
7. Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (U.S. Patent Application Publication No. 2022/0202844) in view of Zhang et al. (U.S. Patent Application Publication No. 2015/0080291) as applied to claims 1-7, 9, 11-13, and 16-19 above and further in view of Haak et al. (WO91/16943).
Kaufman and Zhang et al. do not teach a container comprising water and a container comprising the composition.
Haak et al. teach iontophoretic devices comprising a donor electrode which is the electrode from which the ionic substance, medicament, drug precursor or drug is delivered into the body. The other is the counter or return electrode which closes the electrical circuit through the body. See page 2. There also may be the problem of controlling pH in an iontophoretic drug delivery devices. Changes in pH of the drug reservoir can affect drug transport as well as cause damage and irritation to the skin. See page 4. Figure 1 comprises a donor electrode, an electrolyte reservoir and an agent reservoir comprising the beneficial agent. The counter electrode assembly includes a counter electrode and an electrolyte reservoir. See page 11-12. The electrolyte reservoir contains pharmacologically acceptable electrolyte species which are capable of dissociating once the reservoir is hydrated, i.e., water. See page 13.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to place water in a reservoir that is different than the reservoir holding the NAD+ and KPV as a common way to effectively deliver therapeutic agents using iontophoretic devices. It would have been well within the purview of the skilled artisan to modify the pH to one that is acceptable to effectively deliver the therapeutic agents while not creating adverse reactions such as damage to the skin.
Double Patenting
8. 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.
9. Claims 1-13 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19/186065 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 19/186065 are directed to compositions comprising nicotinamide adenine dinucleotide and one or more therapeutic peptides. The only difference lies in the fact that the instant claims include a transdermal delivery device. Although Application No. 19/186065 does not claim a transdermal delivery device, the specification states a composition comprising a combination of (a) NAD+, and (b) one or more additional therapeutic compounds, wherein one or more additional therapeutic compounds are compatible with transdermal delivery, such as iontophoretic delivery, while providing minimal skin irritation. See paragraph [0009]. Thus the two are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
10. No claims are allowed at this time.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
