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
Applicant’s election without traverse of Group I (drawn to a compound or a stereoisomer, pharmaceutically acceptable salt or tautomer thereof), in the reply filed on 01/21/2025 is acknowledged.
Claims 1, 5, 8, 10, 12, 16-18, 21, 29, 36, 38, 52, 58-60, 70, 77-79 are pending of which, claim 79 in Group II, is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1, 5, 8, 10, 12, 16-18, 21, 29, 36, 38, 52, 58-60, 70, 77-79 have been examined on the merits.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/2026 has been entered.
Withdrawn Rejections
The rejection of claims 1, 5, 8, 10, 12,52, 58, 70 and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8 11 and 16 of U.S. Patent No. 12,145,956 is withdrawn in view of the filed Terminal Disclaimer.
Withdrawn Restrictions/Elections Requirement
The restriction for claim 79 has been withdrawn, thus claim 79 now included for full examination on the merit.
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.
Claim 79 is 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.
Claim 79 recites “A method of treating a disease” and “wherein at least one M is a biologically active moiety effective for treating the disease.” Thus, the claimed subject matter encompasses a broad genus covering essentially any disease and any therapeutic M moiety, without providing sufficient representative of therapeutic species able to treat a wide range of diseases. The specification, while listing numerous diseases and general classes of agents, does not reasonably convey possession of the full scope of this genus. For example, the specification (page 99 and 107, respectively) recites the following (the text was highlighted for emphasis):
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These statements explicitly point to functional capability but do not provide sufficient detail demonstrating that Applicant was in possession of the claimed subject matter at the time of filing. The specification lists a large number of unrelated diseases and yet provides no specific data, no working examples, and no correlation between the claimed compound and their therapeutic efficacy across this cast range of unrelated diseases. Furthermore, the specification does not describe how any particular M moiety, when incorporated into the claimed structure, would be effective for treating each disease category. Therefore, a person of ordinary skill in the art would recognize that Applicant was not in possession of the full scope of the claimed method of treating any disease using any biologically active moiety incorporated as M. This further supports the conclusion that the specification lacks adequate written description of the claimed subject matter.
Subject Matter Free of the Art of Record
The subject matter of claim 1 are free of the art of record. The closest prior art is Matray et al. (WO 2017/177065), however, this reference does not explicitly teach or fairly suggest the various options for La. Thus, claims 5, 8, 10, 12, 36, 38, 52, 58-60, 70, 77 and 78 are allowed. However, claim 79 is not allowed until the 112 rejection is resolved.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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