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 .
Status of Application, Amendments and/or Claims
1. Claims 1-4, 9, 11-12, 24-25, 43-45, 50, 52-53, 60 and 118-119 have been amended and claims 120-123 have been canceled as requested in the amendment filed February 9, 2026. Following the amendment, claims 1-4, 9, 11-12, 24-25, 43-45, 50, 52-53, 60 and 118-119 are pending in the present application.
2. As amended, previously withdrawn claims 24-25, 60 and 118-119 now read upon the elected invention and therefore are rejoined for examination.
3. Accordingly, claims 1-4, 9, 11-12, 24-25, 43-45, 50, 52-53, 60 and 118-119 are under examination in the current office action.
Withdrawn Claim Objections and Rejections
4. The warning for objections to claims 52 and 53 (for being substantial duplicates of claims 11 and 12) have been overcome in view of applicant’s amendments to these claims.
5. The rejection of claims 43-45 and 50 under 35 U.S.C. 112(a), as failing to comply with the written description requirement, set forth at section 6 of the 09/10/2025 Office action, is withdrawn in view of applicant’s amendments to the claims.
Maintained Claim Rejections
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.
6. Claims 1-4, 9, 11-12, 24-25, 43-45, 50, 52-53, 60 and 118-119 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The rejection is maintained for reasons of record pertaining to claims 1-4, 9, 11-12, 43-45, 50 and 52-53, and is further applied to amended, rejoined claims 24-25, 60 and 118-119.
The basis of this rejection has been set forth previously at section 7 of the 09/10/2025 Office action and therefore will not be reiterated here.
Response to Arguments
7. In the reply filed 02/09/2026, applicant asserts that the claims are now amended to recite that the Ab inhibitor comprises a Celsr3 peptide comprising an EGF7 domain, an EGF8 domain, or a Laminin G1 domain of Celsr3. Applicant asserts that they have “surprising discovered that Ab oligomers bind to Celsr3 in order to disrupt intercellular complexes” and that Applicant “has identified the claimed Celsr3 domains – EGF7, EGF8, and Laminin G1 – as potent inhibitors of Ab oligomer binding to Celsr3.” According to Applicant, administration of peptides comprising the EGF7, EGF8, and Laminin G1 domain is capable of binding to Ab in order to prevent Ab-Celsr3 binding and the disruption of intercellular signaling between neurons, as well as Ab-induced loss of synapses in subjects suffering from an Ab-mediated neurodegenerative disease. Applicant argues that the amendments to the claims address each deficiency noted in the previous office action, and the claims are now limited to the treatment of neurodegenerative diseases caused by Ab-induced loss of synapses.
8. Applicant’s arguments have been considered but are not persuasive. With respect to Applicant’s assertions stating that the administration of EGF7, EGF8, and Laminin G1 domain peptides can inhibit Ab-Celsr3 binding and thereby reduce synaptic loss, it is noted that the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See MPEP 716.01(c)(II).
Again, the present claims as amended broadly encompass the treatment and prevention of a neurodegenerative disease such as Alzheimer’s disease (AD) or Parkinson’s disease (PD). However, the specification provides no examples of administered Celsr3 peptides, or EGF7, EGF8, and Laminin G1 domains thereof, to either a neuronal cell culture (in vitro or ex vivo) or a subject (in vivo) having or at risk of having a neurodegenerative disease. There is no evidence provided that a Celsr3 peptide can block or otherwise inhibit the binding of Ab oligomers to Celsr3, and thus reduce loss of synapses in a neuronal population. The specification does not provide guidance or evidence that administered a Celsr3 peptide would function in a manner as claimed, much less that the peptide could be used in a therapeutic or prophylactic manner in subjects having or a risk of developing AD or PD. Note also that Down syndrome (trisomy 21) is a neurodegenerative disease associated with Ab-induced synaptic loss. Yet there is no evidence that the claimed peptides would be capable of treating or preventing a genetic disorder such as this.
Accordingly, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to practice the claimed invention in a manner reasonably correlated with the scope of the claims without undue experimentation. The rejection is therefore maintained.
Conclusion
9. No claims are allowed.
10. 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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly A. Ballard whose telephone number is (571)272-2150. The examiner can normally be reached Mon-Fri 8AM - 5PM EST.
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675