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 .
Response to Election/Restriction filed on October 14, 2025 is acknowledged.
Claim 3 has been cancelled.
Claims 1-2, 4-8, 10 and 14-15 are pending in this application.
Priority
5. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in EP 20192414.9 on 8/24/2020. The foreign priority document is in English. Therefore, the priority date is 8/24/2020.
Non-compliant amendment
6. Claim 4 is non-compliant. Claim 4 has markings in the claim, however, the status identifier has claim 4 as “(Previously Presented)”. For compact prosecution, the Examiner has interpreted the claim as “(Currently Amended)”. Applicant is required to correct this error in response to this office action.
Restriction
7. Applicant’s election of
PNG
media_image1.png
378
554
media_image1.png
Greyscale
PNG
media_image2.png
192
566
media_image2.png
Greyscale
as the species of a fully defined peptide in the reply filed on October 14, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The restriction is deemed to be proper and is made FINAL in this office action. Claims 1-2, 4-8, 10 and 14-15 are examined on the merits in this office action.
Objections
8. 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, paragraphs [0110], [0148] of instant specification US 2023/0272029 A1 disclose peptide sequences, but these are missing their sequence identifiers. 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).
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.
9. Claims 2 and 4 are objected for the following reason: Claims 2 and 4 recite amino acid sequences. The peptide sequences are missing the sequence identifiers. The proper way to claim a peptide sequence is for example, SSGA (SEQ ID NO: 40) (see 37 CFR 1.821(d)). These errors should be corrected.
10. Claim 6 is objected for the following: Claim 6 recites, “…wherein the peptide comprises has the amide modification…” Applicant is required to correct the error by deleting one of the term “comprises” or “has”.
11. Claim 8 is objected for the following: Claim 8 does not end with a period. Applicant is required to correct this error.
Rejections
U.S.C. 112(b)
12. 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.
13. Claims 1-2, 4, 7-8 and 10 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.
14. Claim 1 recites, “A compound comprising a peptide and a substituent…the peptide is SEQ ID NO: 47…X16 is K or E…X33 is S, K, or absent…wherein the substituent is attached to the peptide via Lysine (K) at position 16 or 33…” It is unclear where the substituent will attach if both X16 and X33 are not lysine, since X16 can be K or E, and X33 can be S, K, or absent. Because claims 2, 4 and 7 depend from indefinite claim 1 without clarifying the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
15. Claim 8 recites,
PNG
media_image3.png
696
700
media_image3.png
Greyscale
. It is unclear if the “H” at the N-terminal ends of each compound is the amino acid Histidine (H) or hydrogen of the NH2.
16. Claim 10 recites,
PNG
media_image4.png
202
794
media_image4.png
Greyscale
. It is unclear if the “H” at the N-terminal end of compound No. 47 is the amino acid Histidine (H) or hydrogen of the NH2.
U.S.C. 112(d)
17. 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.
18. Claim 10 is 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. 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.
19. Claim 10 recites,
PNG
media_image5.png
194
794
media_image5.png
Greyscale
. Claim 10 depends from claim 1. Claim 1 recites that X39 is absent. However, claim 10 has the amino acid residue “S” at the C-terminal end. Therefore, claim 10 does not further limit claim 1.
Closest Art
20. The closest art is Jiangsu Hansoh Pharmaceutical Group (WO 2020/207477, herein ‘Jiangsu’, filed with IDS and Google Patent English translation used and enclosed herein). Jiangsu teaches the following:
PNG
media_image6.png
704
1574
media_image6.png
Greyscale
(see p. 1). The closest peptide sequence is Y-Aib/Ala-EGTFTSDYSIYLEKQAAQEFV-Q/N-WLL-A/R-GGPSKGAPPP-S. The peptide sequence of Jiangsu has a C-terminal serine. Instant sequence of SEQ ID NO: 47 does not have a C-terminal S.
CONCLUSION
Claims 5-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 14-15 are allowable.
Claims 1-2, 4, 7-8 and 10 are rejected.
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.
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.
/JULIE HA/Primary Examiner, Art Unit 1654
1/15/2026