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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, filed 1/27/2026, with respect to the rejections under 35 U.S.C. 102(a)(1) and (a)(2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of amendment.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-24, drawn to a compound represented by Formula I in the reply filed on 8/11/2025 is acknowledged. The traversal is on the ground(s) that it would not be an undue burden on the Examiner to search both Groups I and II as they share the same technical feature. This is not found persuasive.
As described in the restriction/election requirement, Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a compound represented by Formula I, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Segall et al. (US 2004/0002441 A1, published 1/1/2004), as cited on the European Search Report.
Segall teaches cell growth modulators, methods of screening for such modulators, and methods of using such modulators. Segall claims the peptide Trp-Lys-His-Tyr, which reads on the instant Formula I. Thus, the common technical feature among the instant claims is not a special technical feature as it does not make a contribution over the prior art in view of Segall. This leaves unity of invention broken and the claims subject to this restriction/election requirement.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of compound 34 in the reply filed on 8/11/2025 is acknowledged.
Upon further search and examination, the elected species was broadened to include compounds 1-79, which were found to be free of the art. The closest art is US20180141998A1, published 5/24/2018, which discloses SEQ ID NO: 1344907, a 9 amino acid peptide that comprises “HKFY”. US20180141998A1 does not teach a peptide consisting of HKFY nor any of the modifications claimed in the instant application. Therefore, compounds 1-79 are novel and not obvious.
Claim Status
Claims 1-24, 29, and 33-34 are pending under examination. Claims 29, 33, and 34 were previously withdrawn as a non-elected invention. Claims 1 and 14-23 are currently amended. Claims 25-28 and 30-32 were previously cancelled.
Priority
The instant application is the 371 national stage entry of PCT/KR2021/003045, filed 3/11/2021, which claims priority to KR10-2020-0030303, filed 3/11/2020. The priority date of 3/11/2020 is acknowledged, although it is noted that no translation has been made of record.
Drawings
The drawings are objected to because the corrected Figure 91 is missing a key/legend to indicate what each of the symbols in the upper graph represent. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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).
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.
Specifically, compounds 1-79 require the same SEQ ID NO’s listed in the claims to also appear in the Specification; there are also sequences without SEQ ID NO’s on 1) Pg 23, lines 28-29 and line 34, 2) Pg 25, line 11, and 3) Pg 25, line 15 through Pg 61 of the specification, each time “HKFY-#” is mentioned, especially in the Examples starting on Pg 28 and Table 1 on Pg 54.
It is also noted that the Sequence Listing entry for SEQ ID NO: 79 appears to be blank or “000”.
Specification
The amendment filed 1/27/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The Sequence Listing for SEQ ID NO: 81-83 recites that the X residues can be any of A, R, N, D, C, Q, E, G, H, I, L, K, M, F, P, S, T, W, Y or V, but this is not supported by the originally filed specification. Also see new matter rejection of claims below.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Interpretation
Claim 1 recites that R9 is selected from -OH or -NH2 and R10 is hydrogen, an amine protecting group, or biotin, all of which are terminal groups that do not allow for the addition of more amino acids. Thus, claim 1 and dependents 2-14 are being interpreted as tetrapeptide(s).
Claims 15-20 further recite the tetrapeptide of claim 1 with additional amino acids added. These claims are being interpreted as peptides of the exact length described, no shorter or longer (i.e., claim 15 recites the addition of two amino acids to the N-terminus of the tetrapeptide, resulting in a 6-residue peptide). Claims 21-23 are also being interpreted in this manner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Per the claim interpretation above, claim 1 has been interpreted to mean that formula I represents a tetrapeptide with N- and C-terminal groups that do not allow for the addition of more amino acids to either terminus, which are -NHR10 and -C(=O)R9, respectively. However, dependent claims 15-20 recite the tetrapeptide of Formula I with the addition of amino acids to either the N- or C-terminus. Thus, the scope of these claims is indefinite. As described above, for the purpose of examination, the peptides of claims 15-20 are being interpreted as exactly the described length, no longer or shorter (i.e., claim 15 recites the addition of two amino acids to the N-terminus of the tetrapeptide, resulting in a 6-residue peptide).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Per the claim interpretation above, claim 1 has been interpreted to mean that formula I represents a tetrapeptide with terminal appendages that do not allow for the addition of more amino acids to either end. Dependent claims 15-20 recite the tetrapeptide of Formula I with the addition of amino acids to either the N- or C-terminus. Thus, claims 15-20 do not recite all the limitations of claim 1 from which they depend and are rejected here.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16, 19, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The above claims recite peptide sequences comprising X residues in which the X residues are selected from 20 amino acids, wherein the 20 amino acids comprise Ala, Arg, Asn, Asp, Cys, Gln, Glu, Gly, His, Ile, Leu, Lys, Met, Phe, Pro, Ser, Thr, Trp, Tyr, and Val. The originally filed application does not support that the limitation “20 amino acids” refers to the 20 amino acids now listed in said claims; additionally, the Remarks submitted on 1/27/2026 fail to indicate where in the specification such support can be found.
This is a new matter rejection.
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.
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.
Claim(s) 1, 3, 5, 9-12, 18-19, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Segall et al. (US20040002441A1, published 1/1/2004) in view of Pang et al. (Identification of arginine- and lysine-methylation in the proteome of Saccharomyces cerevisiae and its functional implications. BMC Genomics 11, 92 (2010).).
Segall teaches the peptide Trp-Lys-His-Tyr ([0093]; claim 31), which meets the limitations of claim 1 wherein A is -C(-R0); Cy is a 5-6 membered heteroaryl, wherein said heteroaryl contains at least one heteroatom selected from the group consisting of N, S, or O; R3 is hydrogen, R0 and R2 are linked to each other to form a benzene ring together with the two carbon atoms to which they are attached; n is 4; R4-R8 are all hydrogen; R9 is -OH; and R10 is hydrogen.
Segall does not teach that R4 is a C1-10 alkyl or a C1-C20 alkylcarbonyl.
Pang teaches that proteins with methylated (C1 alkyl) lysine residues exhibit longer half-lives than proteins that are unmethylated (Abstract – Results; “Biological function, sub-cellular localization, abundance and half-life of methylated proteins” on Pg 7 until “Interplay of methylation and other post-translational modifications”; Figure 3; “Interplay of methylation and other post-translational modifications”, Pg 11, first paragraph). Pang hypothesizes that the introduction of a methyl group to a lysine residue blocks ubiquitination and degradation of the peptide, thereby extending its half-life (Pg 7-8, “Interplay of methylation and other post-translational modifications”; Pg 11, “Interplay of methylation and other post-translational modifications”, first paragraph).
Based on these teachings, regarding claim 1, it would be obvious to methylate the Lys residue of the Trp-Lys-His-Tyr peptide taught by Segall. One of ordinary skill in the art would be motivated to do so in order to increase the half-life of the peptide by reducing its chance of being ubiquitinated and degraded. One would have a reasonable expectation of success given that Pang established that methylation of lysine residues in peptides causes them to have longer half-lives.
Regarding claim 3, as stated above, the peptide Trp-Lys-His-Tyr of Segall meets the limitations wherein R0 and R2 are linked to each other to form a benzene ring together with the two carbon atoms to which they are attached ([0093]; claim 31).
Regarding claim 5, as stated above, the peptide Trp-Lys-His-Tyr of Segall meets the limitations wherein A is -C(-R0) ([0093]; claim 31).
Regarding claim 9, as stated above, the peptide Trp-Lys-His-Tyr of Segall meets the limitations wherein R6 is hydrogen ([0093]; claim 31).
Regarding claim 10, as stated above, the peptide Trp-Lys-His-Tyr of Segall meets the limitations wherein R7 and R8 are hydrogen ([0093]; claim 31).
Regarding claim 11, as stated above, the peptide Trp-Lys-His-Tyr of Segall meets the limitations wherein R9 is -OH ([0093]; claim 31).
Regarding claim 12, as stated above, the peptide Trp-Lys-His-Tyr of Segall meets the limitations wherein R10 is hydrogen ([0093]; claim 31).
Regarding claims 18 and 19, Segall also teaches the addition of 1-2 residues to the C-terminus of the Trp-Lys-His-Tyr peptide ([0095, 0097, 0098]; claims 35, 39, 41).
Regarding claim 24, Segall also teaches that peptides of the invention are preferably administered with a pharmaceutically acceptable carrier or excipient, thereby reading on a pharmaceutical composition ([0113]).
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 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, and 12-25 of copending Application No. 18/557,576 (‘576, reference application, claims filed 10/26/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘576 recites the same compound of Formula 1 recited in the instant claim 1; the only difference between the two compounds is that R4 can be H in copending Application No. ‘576 but cannot be H in the instant claims. Dependent claims include species of each of the variable groups recited in claim 1 (claims 2-13) as well as peptide species (claims 14-23), and a composition thereof (claims 24 and 25).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm 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, Melissa L Fisher can be reached at 571-270-7430. 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.
/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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