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 .
2, Amendment after Non-final office action filed on August 13, 2026 is acknowledged.
3. Claims 5 has been cancelled.
4. Claims 13-14 were previously cancelled.
5. Claims 1-4 and 6-12 are pending in this application.
6. Applicant elected without traverse of Group 1 (claims 1-6) and elected Alzheimer’s disease as the species of cognitive dysfunction, and a modified peptide having an acetylated N-terminus and an amidated C-terminus as the species of medication in the reply filed on March 17, 2026. Restriction was deemed to be proper and was made FINAL in the previous office action. Claims 7-12 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 1-4 and 6 are examined on the merits in this office action.
This application contains claims 7-12, drawn to an invention nonelected without traverse in the paper of 3/17/2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Withdrawn Objection and Rejections
7. Objection to the drawings is hereby withdrawn in view of Applicant filing replacement sheets on August 13, 2026.
8. Rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is hereby withdrawn in view of Applicant’s amendment to the claim. However, claim 3 remains rejected under 35 U.S.C. 112(b) as set forth below.
9. Rejection of claim 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is hereby withdrawn in view of Applicant’s cancellation of the claim.
10. Rejection of claims 3-5 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is hereby withdrawn in view of Applicant’s amendment to the claims.
11. Rejection of claims 1-6 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is hereby withdrawn in view of Applicant’s amendment to the claims.
Priority
12. Applicant claims foreign priority to KOREA 10-2020-0074556 (6/18/2020) and KOREA 10-2021-0079219 (6/18/2021). The certified copies have been received by the Office. However, certified English translations have not been provided. Therefore, the foreign priority dates have not been perfected. Thus, the effective priority of instant application is 6/18/2021 until the foreign priority dates are perfected.
Response to Applicant’s Arguments
13. Applicant has not responded to this and has not filed English translations of the foreign documents.
Maintained Objections
14. The specification is objected to for containing referring to sequences without also identifying them by the sequence identifier assigned to them in the sequence listing as required by 37 CFR 1.821(d). The specification discloses peptide sequences, and these are missing their respective sequence identifiers. For example, FIG. 1, FIG. 2A, FIG. 2B, and paragraph [0060] of instant specification US 2023/0414701 A1 disclose peptide sequences, but these are missing their sequence identifiers that are in the sequence listing. The examiner would like to bring the applicant’s attention to the following excerpt from MPEP §2422.03:
37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application. This requirement is also intended to permit references, in both the description and claims, to sequences set forth in the "Sequence Listing" by the use of assigned sequence identifiers without repeating the sequence in the text of the description or claims. Sequence identifiers can also be used to discuss and/or claim parts or fragments of a properly presented sequence. For example, language such as "residues 14 to 243 of SEQ ID NO:23" is permissible and the fragment need not be separately presented in the "Sequence Listing." Where a sequence is embedded in the text of an application, it must be presented in a manner that complies with the requirements of the sequence rules.
The applicant is therefore required to amend the specification to comply with 37 CFR 1.821(d). The figures and the paragraph [0060] disclose the peptide sequence PFTAIRE. However, this sequence has not been filed in the sequence listing and therefore, the PFTAIRE sequence is sequence non-compliant.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Response to Applicant’s Arguments
15. Applicant argues that “…an updated sequence listing is submitted herewith, along with a substitute specification referring to the sequence listing. Applicant has also amended the specification to refer to the SEQ ID NOs in the Brief Description of the Drawings and in the portion of the specification noted in the Office action.”
16. The Examiner acknowledges that Applicant did file a new sequence listing and also has added the sequence identifiers to the peptide sequence PFTAIRE. However, this is different from the sequence that was filed in the sequence listing filed on August 13, 2026. The sequence filed on August 13, 2026 is TFTAIRE. Therefore, Applicant is still deficient in that the sequence in the sequence listing (i.e., SEQ ID NO: 1) does not correspond to the sequence disclosed in the drawings and in the specification. Applicant is required to correct this error.
Maintained and Revised Rejections
U.S.C. 112(b)
17. 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.
18. Claims 1-4 and 6 remain/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.
19. Claim 1 recites, “A method of treating cognitive dysfunction in a subject in need thereof, comprising: administering a pharmaceutical composition comprising a peptide represented by the amino acid sequence of SEQ ID NO: 1 as an active ingredient.” The metes and bounds of the claim is unclear. The instant specification (Figures and paragraph [0060]) appears to indicate that SEQ ID NO: 1 has the sequence PFTAIRE. However, the previous sequence listing filed has SEQ ID NO: 1 as TFEAIRE. The sequence listing was updated and now indicates that SEQ ID NO: 1 has the sequence TFTAIRE. Therefore, it is unclear to the Examiner what instant SEQ ID NO: 1 actually is. Because claims 2-4 and 6 depend from indefinite claim 1 without clarifying the point of confusion, these claims are also rejected under 35 U.S.C. 112(b). For the purposes of examination, the new sequence TFTAIRE was searched for prior art.
Response to Applicant’s Arguments
20. Applicant argues that “Applicant respectfully traverses, and believes that the updated sequence listing submitted herewith addresses the Office’s concerns.”
21. Applicant’s arguments have been fully considered but are not found persuasive. The new sequence listing submitted with Applicant’s response indicates that SEQ ID NO: 1 has the sequence TFTAIRE. This is different from what is disclosed throughout as SEQ ID NO: 1 (i.e., PFTAIRE). Previously, the SEQ ID NO: 1 submitted with the sequence listing is TFEAIRE. Therefore, the metes and bounds of the claim is still indefinite.
New Objection
New Matter to the Specification
22. The amendment filed August 13, 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 filed on August 13, 2026 introduces new matter into the application. The sequence that was filed on August 13, 2026 is as follows:
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494
506
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. This is new matter because the previous sequence filed with the sequence listing is:
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438
542
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. Thus, the sequence TFTAIRE is not the same as TFEAIRE. Additionally, the sequence TFTAIRE is different from the sequence PFTAIRE in the drawings and throughout the specification. The sequence previously disclosed in the specification has the residue proline (P) at the N-terminal end, not threonine (T). Therefore, Applicant has introduced new matter into the specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
CLOSEST ART TO SEQ ID NO: 1
The closest art to instant SEQ ID NO: 1 (i.e., TFTAIRE) is Whitley et al (US Patent No. 12,545,900). Whitley et al teach a protein sequence having 344 residues comprising a sequence that is 91.2% sequence identity to instant SEQ ID NO: 1 (see SEQ ID NO: 24197, residues 59-65:
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66
214
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).
Please note: the new sequence SEQ ID NO: 1 (TFTAIRE) has been searched for this office action.
CONCLUSION
No claim is 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 JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm 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, 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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/JULIE HA/Primary Examiner, Art Unit 1654
9/8/2026
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