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 and Claim Status
Applicants amendments and arguments filed 11/3/25 are acknowledged. Any rejection or objection from the 8/1/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 1 and the species of SEQ ID NO:1 were elected.
Claims 16 and 20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/24/25.
Claim 7 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/24/25.
Claims 4-6, 8-11, 13-15, 17-19 and 21-39 have been canceled.
Claims 1-3 and 12 are being examined.
Priority
The priority information is found in the filing receipt dated 10/5/22.
Claim Rejections - 35 USC § 103
The rejection below is a new rejection necessitated by amendment.
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.
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 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2006/0148711; ‘Lu’).
Lu teach inhibitors that disrupt binding between a PDZ protein and cognate ligands such as NMDA receptors (abstract) and specifically teach polypeptide inhibitors (claim 1). Lu teach specific sequences including LNSCSNRRVYKKMPSIESDV (2nd entry in Table 9 on page 43) and suggest sequences with high OD as advantageous and suggest applications (sections 0517 and 0105). Lu also recites the LNSCSNRRVYKKMPSIESDV sequence in Table 3 (page 46). Lu specifically recites inhibitors as those shown in Table 9 (section 0363). Lu teach that the polypeptide length can be 3-20 amino acids (claim 9 and sections 0010 and 0363). Lu recognizes that the stability of the inhibitors can be improved by terminal modifications including C-terminal amidation (sections 0369 and 0072). Lu teach compositions of the inhibitor including a carrier (claim 22).
Lu does not teach a specific example that reads on the instant claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Lu based on the specific teachings and suggestions of Lu. Lu teach specific sequences including LNSCSNRRVYKKMPSIESDV (2nd entry in Table 9 on page 43) and suggest sequences with high OD as advantageous and suggest applications (sections 0517 and 0105). Lu specifically recites inhibitors as those shown in Table 9 (section 0363) thus one would have been motivated to make LNSCSNRRVYKKMPSIESDV. Since Lu suggest as inhibitors (claim 1 and section 0363) and recognizes that the stability of the inhibitors can be improved by terminal modifications including C-terminal amidation (sections 0369 and 0072) one would have been motivated to make LNSCSNRRVYKKMPSIESDV-NH2. Since Lu teach that the polypeptide length can be 3-20 amino acids (claim 9 and sections 0010 and 0363) one would have been motivated to make various peptides lengths including LNSCSNRRVYKKMPS-NH2 (15-mer starting at 1st residue) and STPRVLNSCSNRRVY-NH2 (which comprises LNSCSNRRVY and the overlapping sequence based on the NMDAR2A sequence). Since Lu teach compositions of the inhibitor (claim 22) one would have been motivated to make compositions of the peptides. One would have had a reasonable expectation of success since Lu teach that synthesis methods were known (sections 0058 and 0114-0126).
In relation to claim 1, LNSCSNRRVYKKMPSIESDV-NH2 as discussed above comprises at least 6 consecutive amino acids of SEQ ID NO:14 (LNSCSN) and is 100% identical with residues 1445-1464 of SEQ ID NO:21 and is C-terminally amidated.
In relation to claim 2, Lu teach that the polypeptide length can be 3-20 amino acids (claim 9 and sections 0010 and 0363) thus suggesting LNSCSNRRVYKKMPS-NH2 (15-mer starting at 1st residue).
In relation to claim 3, Lu teach that the polypeptide length can be 3-20 amino acids (claim 9 and sections 0010 and 0363) thus suggesting STPRVLNSCSNRRVY-NH2 (which comprises LNSCSNRRVY and the overlapping sequence based on the NMDAR2A sequence) which comprises SEQ ID NO:14.
In relation to claim 12, Lu teach compositions of the inhibitor including a carrier (claim 22).
Conclusion
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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa 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.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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