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 .
Claim Status
Claims 12-14 and 16-26 are pending.
Claim 12 is currently amended.
Claims 1-11, 15, and 26-56 were cancelled.
Claim 16 is withdrawn as directed to a non-elected species. Dated 1/28/2021
Claims 12-14 and 17-26 have been examined.
Priority
This application is a CON of 16/166,984 10/22/2018 PAT 10538558
This application is a DIV of 12/895,454 09/30/2010 PAT 10138276
16/166,984 has PRO 61/247,033 09/30/2009
Sequence Compliance
The amendment to claim 12 satisfies sequence compliance.
Modified Rejection
Claim Rejections - 35 USC § 112
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 12-14 and 17-26 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.
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NEW MATTER Rejection because the disclosure in the SPEC does not support the peptide formula in claim 12.
Applicant disclosed individual class I peptide inhibitor sequences of SEQ ID Nos: 1-26, but the limited disclosure of individual peptide sequences does not support the entire genus of the peptide formula in claim 12 modified with insertion, deletion, and/or consensus as well non-consensus substitutions encompasses 5,760 distinct peptide sequences summarized by the examiner shown as follows. Applicant improperly utilizes domain swap of Y5 tetrapeptide found in one peptide sequence to another peptide sequence to create new peptide sequences not supported by the disclosure. Thus, many individual class I peptide inhibitor sequences such as SEQ ID NO; 17 (GYRTPTLKVFGGFNFSQIL) or SEQ ID NO: 97 (GRKGYRPTPIRVAFGNL) are no longer reading on the NEW MATTER peptide formula in claim 12.
112(a) rejection based on insufficient disclosure.
The specification failed to provide a representative number of class I peptide inhibitor sequences to support the entire genus of the peptide formula comprising 5,760 distinct peptide sequences in claim 12 as evidenced by many disclosed class I peptide inhibitor sequences such as SEQ ID NO; 17 (GYRTPTLKVFGGFNFSQIL) or SEQ ID NO: 97 (GRKGYRPTPIRVAFGNL) are no longer reading on the peptide formula in claim 12.
Applicant failed to establish correlation of a peptide sequence and class I peptide inhibitor. Applicant disclosed individual class I peptide inhibitor sequences of SEQ ID Nos: 1-26, but not the derivative peptide sequences created by domain swap of Y5 as well as insertion, deletion, and substitution in all possible positions in the peptide formula. Without establishing a correlation between a peptide sequence and the function of class I peptide inhibitor, the specification failed to satisfy written description requirements.
Claims 13-14 and 17-26 are rejected as depending on claim 12.
The rejection may be overcome by distinctly claiming a peptide sequence with SEQ ID No disclosed in the specification.
Applicant’s Arguments
The Examiner promised that Y5 support would be accepted when provided on the basis of specific peptides (Remarks, p6, last 3 para)
Class I and Class III are characterized by two positively charged residues spaced apart by 4 and 8 amino acids (Remarks, p7, last 4 para to p8).
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s argument (i) is not persuasive because the examiner did not promise anything under lack of sufficient written description. Adding SEQ ID NOs to the tetrapeptide merely makes this application for sequence compliance but does not overcome the 112(a) rejection. The use of domain swap to introduce new peptide sequences is improper without sufficient support by showing the tetrapeptide of Y5 independently correlated with the function of Class 1 peptide inhibitor. In fact, many disclosed Class 1 peptide inhibitor sequences such as SEQ ID NO: 17 and SEQ ID NO: 97 in claim 25 are no longer reading on the improperly created peptide formula in claim 12.
Applicant’s argument (ii) is not persuasive because the general description from limited disclosure of Class I peptide inhibitor sequences in SEQ ID Nos: 1-26 is insufficient to establish a correlation between the claimed 5,760 distinct peptide sequences and the function of class I inhibitor. The software or AI generated information may or may be always correct. More specific data support is required to establish correlation of peptide sequence and it function.
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 25 is 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.
Claim 25 recites the limitation "Class I peptide inhibitor" in 12. There is insufficient antecedent basis for this limitation in the claim. At least the peptide SEQ ID NO 17 and 97 as claimed do not read on the peptide formula in claim 12 shown by the highlighted sequences.
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Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive because many claimed peptides in claim 25, such as SEQ ID Nos: 17 and 97, do not read on the amended peptide formula in claim 12. Thus, claim 25 is properly rejected for lack of antecedent basis. See the highlighted peptide sequence of SEQ ID Nos of 17 and 97 above.
Examiner Note:
The closest prior art references Sigalow (WO 2008/0762675 A2, previously cited 05/10/2021) disclosed a lipid-peptide conjugate formula (Fig 11), but did not teach the elected peptide species of SEQ ID NO: 96.
Allowable Subject Matter
The elected species of SEQ ID NO: 96 is allowable as the examiner did not find a prior art teaching the peptide sequence of SEQ ID NO: 96.
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.
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/J.L/Examiner, Art Unit 1658
06-January-2026
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654