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
Applicant’s election without traverse of Group I, claims 1-6, in the reply filed on March 27th, 2026 is acknowledged.
Applicant’s election without traverse of R1: H; AA1: E; AA2: V; AA3: F; R2: OR3; R3:H in the reply filed on March 27th, 2026 is acknowledged.
Claims 7-12 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 27th, 2026.
The species elected on March 27th, 2026 has been examined, according to the elected variables of formula (I), and the remaining species that are claimed or specifically disclosed are withdrawn from consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, filed March 8th, 2023.
Claims Status
The claims listing filed on March 27th, 2026 is pending. Claims 7-12 are withdrawn from further consideration for the reasons set forth in the restriction requirement, 37 CFR 1.142(b). Claims 1-6 are being examined on the merits in this office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 8th, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner.
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 - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in [0055].
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seki et al. (Seki, E., Yamamoto, A., Fujiwara, Y., Yamane, T., Satsu, H., & Ohkubo, I. (2020 Jun 10). Dipeptidyl Peptidase-IV Inhibitory Activity of Katsuobushi-Derived Peptides in Caco-2 Cell Assay and Oral Glucose Tolerance Test in ICR Mice. Journal of agricultural and food chemistry, 68(23), 6355–6367).
Seki et al. teaches that among other bonito stock tripeptides, Glu-Val-Phe (elected compound of general formula (I)), inhibits dipeptidyl peptidase-IV (DPP-IV) with an IC50 values for DPP-IV inhibition of 525.56 μM [Abstract line 3]. Glu-Val-Phe is present in the N5-2 purification fraction at an amount of 8.18 mg/100g [pg 7 Table 6]. This equates to a weight percentage of 0.00818%.
Regarding the preamble’s disclosure of a “composition for modulating the production of sebum”, the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The intended use does not result in a structural difference between N5-2 fraction with 0.00818 % (w/w) Glu-Val-Phe and the instant invention. Since, Seki’s composition is capable of performing the intended use, Seki et al anticipate a composition comprising from 0.001% (w/w) to 10% (w/w) of Glu-Val-Phe In re Spada [MPEP 2112.01].
Regarding claim 2, the intended use limitation “wherein the modulating the production of sebum reduces the production of sebum does not confer any structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since, Seki’s composition is capable of performing the intended use, Seki anticipates a composition comprising from 0.001% (w/w) to 10% (w/w) of Glu-Val-Phe In re Spada [MPEP 2112.01].
Regarding claim 3, Seki’s tripeptide Glu-Val-Phe is the elected species and reads on SEQ ID NO:1.
Regarding claim 4, to purify DPP-IV Inhibiting peptides from Katsuobushi, Seki et al. carried out a stepwise gradient elution for ethanolic extracts, obtaining non adsorbed and water-eluted, 10% ethanol-eluted, 25% ethanol-eluted, and 50% ethanol-eluted fractions [pg 2 pgh 6 line 3]. The N5-2 fraction, in which Glu-Val-Phe eluded was the 10% ethanol-eluted fraction [pg 3 pgh 4 line 2]. Therefore, a composition with 80%-100% (w/w) solvent is anticipated because Glu-Val-Phe was present in a solvent of 10%-ethanol/water in 100% w/w.
Regarding claim 5, the 10%-ethanol/water solution is a solubilizer.
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.
In the reply filed on March 27th, 2026, applicant’s elected R1: H; AA1: E; AA2: V; AA3: F; R2: OR3; R3: H. The elected species has been foud in the prior art, so no other species have been examined.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Seki et al. as previously applied to claims 1-5, and in further view of Thielitz et al (Thielitz, A., Reinhold, D., Vetter, R., Bank, U., Helmuth, M., Hartig, R., Wrenger, S., Wiswedel, I., Lendeckel, U., Kähne, T., Neubert, K., Faust, J., Zouboulis, C. C., Ansorge, S., & Gollnick, H. (2007). Inhibitors of dipeptidyl peptidase IV and aminopeptidase N target major pathogenetic steps in acne initiation. The Journal of investigative dermatology, 127(5), 1042–1051) and Velliquette et al (US10532024B2; Published 2020).
Seki et al. teaches that Glu-Val-Phe (elected compound of general formula (I)), inhibits dipeptidyl peptidase-IV (DPP-IV) Abstract line 3]. Glu-Val-Phe is present in the N5-2 purification fraction at an amount of 8.18 mg/100g [pg 7 Table 6]. This equates to a weight percentage of 0.00818%. Seki et al does not teach a composition with 10% to 20% (w/w) of an emulsifier, 0.1% to 5% (w/w) of a preservative, and 0.1% to 5% (w/w) of a solubilizer.
Velliquette et al. teaches a composition for suppressing sebum production containing a skin benefit agent that includes Lithospermum erythrorhizon [Abstract]. A topical composition comprising “an active or an extract of the root of Lithospermum erythrorhizon in an amount ranging from about 0.05% to about 10.0% by weight of the total composition” is claimed [claim 1]. Velliquette et al. teaches that the in certain embodiments:
the lipophilic solubilizers are present in an amount from about 1.0% to about 20.0% by weight [Col 9 line 34]
the emulsifier or surfactant is present in an amount from about 0.5% to about 5% by weight [Col 11 line 53]
the preservative is present in an amount from about 0.3% to about 0.9% by weight [Col 13 line 4].
Seki et al. and Velliquette do not teach the motivation for using a peptide that inhibits DPP-IV in a Velliquette’s composition for suppressing sebum production.
Thielitz et al postulates that because dipeptidyl peptidase-IV is highly expressed on the surface of human SZ95 sebocytes in vitro, sebocytes could be effectively targeted by peptidase inhibitors [pg 6 pgh 3 line 1]. They demonstrate that inhibitors of DPP-IV significantly suppress enzyme activity and SZ95 sebocyte proliferation in a dose-dependent manner [pg 6 pgh 4 line 1]. These “antiproliferative and prodifferentiative effects will not induce hyperseborrhea, because despite an increase in the single-cell lipid content by enhanced differentiation, the total neutral lipid collected from cells cultivated for 2 days in the presence of inhibitors tends to decrease after a short incubation period” [pg 6 pgh 5 line 5]. This means that the lipid or sebum decreases when sebocyte proliferation is inhibited by DPP-IV inhibitors.
Therefore, it would have been obvious, prior to effective filing date, for an artisan of ordinary skill to use the tripeptide Glu-Val-Phe taught by Seki et al. as the skin benefit agent in a weight percentage taught by Velliquette et al’s composition because Glu-Vla-Phe inhibits DPP-IV and Thielitz et al teaches that DPP-IV’s inhibition suppresses sebocyte proliferation and decreases lipid secretion. Thus, there was a reasonable expectation prior to the effective filing date that the elected peptide would be successful at modulating sebum secretion in the mode provided by Velliquette.
Summary
No Sequence Listing has been filed for sequences in disclosure. Claims 1-5 are rejected under 35 U.S.C. 102(a)(1). Claim 6 is rejected under 35 U.S.C. 103.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SACHI JAUHARI whose telephone number is (571)272-3769. The examiner can normally be reached Mon-Fri 9-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SACHI JAUHARI/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
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