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 .
Election/Restrictions
In response to a restriction requirement on 11/06/2025, Applicant elected Group I, claims 1-6, drawn to a composition for transdermal supplementation. Claims 1-6 are hereby examined on the merits. Claims 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.12(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 02/04/2026.
Priority
This application is a non-provisional utility application filed 04/12/2023.
Information Disclosure Statement
No information disclosure statement has been filed by Applicant.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
The specification filed on 04/12/2023 does not recite appropriate sequence identifiers in the form of SEQ ID number. For example, please see page 10 [0028] line 7. The sequence recited in the specification must include a SEQ ID number to properly identify the sequence. Appropriate correction is required.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Geetha Kalahasti et al., hereinafter Kalahasti (US 2021/0251882A1; published 19 Aug, 2021).
Regarding claims 1-3, Kalahasti teaches topical compositions to improve skin conditions, included in a wide range of product formulations e.g., gels [0002]. Kalahasti discloses a composition that relies on any one of, any combination of or all of, extract, hesperidin methyl chalcone, palmitoyl tetrapeptide-7, etc (see page 6; [0041]). Palmitoyl tetrapeptide-7 is the reaction product of palmitic acid and a synthetic peptide containing glycine, glutamine, proline and arginine (see page 7; [0049][0050]). Embodiments of the specification disclose palmitoyl tripeptide -7, also known as palmitoyl oligopeptide, with sequence palmitoyl-Gly-Gln-Pro-Arg-OH (see page 10 [0028]). The sequence of palmitoyl tripeptide -7 in the instant specification is identical to palmitoyl tetrapeptide-7 as taught in Kalahasti. Kalahasti teaches compositions in Table 1 and Table 2, which include palmitoyl tetrapeptide-7, glycerin and hesperidin methyl chalcone (see page 12; Example 1). The composition does not include steareth-20 and dipeptide-2 (valyl-tryptophane). However, Kalahasti specifically teaches that hesperidin methyl chalcone can be obtained from Sederma SAS’s product EyelissTM, which is a combination of water, glycerin, hesperidin methyl chalcone, steareth-20, dipeptide-2 (valyl-tryptophane) and palmitoyl tetrapeptide-7 (Pal-GQPR). This provides a clear motivation to include steareth-20 and dipeptide-2 (valyl-tryptophane) in the composition disclosed in Kalahasti, since the reference clearly teaches the use of commercial formulations which include them. Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis). Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosed composition of Kalahasti, to include steareth-20 and dipeptide-2 (valyl-tryptophane). One motivated to do so would have a reasonable expectation of success as Kalahasti teaches combining the commercial composition EyelissTM with the composition as taught by Kalahasti, to generate the composition as claimed (see MPEP § 2143).
Regarding claim 4, Kalahasti teaches chlorhexidine digluconate (see page 2; [0013]). Molecular formula of chlorhexidine digluconate (C34H54Cl2N10O14; PubChem CID 5360565) is identical to the molecular formula of chlorhexidine gluconate as claimed (C34H54Cl2N10O14; PubChem CID 9552081).
Regarding claims 5 and 6, Kalahasti teaches grapeseed oil (see page 9; [0063], page 10 [0065]) and shea butter (see page 9; [0063]) as moisturizing agents and antioxidants that can be used with the composition of the invention.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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, Melissa Fisher can be reached at 5712707430. 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.
/ARCHANA VARADARAJ/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658