DETAILED ACTION
Claims 67-86 are pending in the instant application.
2. Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 67, 69-86 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim 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 specification lacks enablement of the term “comprising administering a CRF1 antagonist or pharmaceutically acceptable salt”. While enabling for some CRF1 antagonist or pharmaceutically acceptable salt, which is in claim 67 as follow:
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, it is not seen where this is enables other types o a CRf1 antagonist compound or pharmaceutically acceptable salt. Therefore, the specification lacks enablement for the term “comprising administering a CRF1 antagonist or pharmaceutically acceptable salt”. It is recommended to amend claim 67 to the compounds in claim 68.
3. Claim Rejections - Obvious Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and, In re Thorington, 418 F.2d 528, 168 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130 (b).
Effective January 1,1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 67-86 are rejected under the judicially created doctrine obviousness-type double patenting as being unpatentable over the claims 1-21 of US 12,098,152. Although the conflicting claims are not identical, they are not patentably distinct from each other because the current invention embraces the invention claimed in the above patent.
Determination of the scope and content of the prior art (MPEP §2141.01)
‘152 claims analogues method for treating and compounds in claims 1-21 as the instant claims 67-86.
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02)
The difference between the instant claims 67-86 and the claims 1-21 of ‘152 patent is the claims are not word for word identical but the scope of the two sets of claims overlaps significantly with each other.
Finding of prima facia obviousness-rational and motivation (MPEP §2142.2143)
All the elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/NILOOFAR RAHMANI/
06/15/2026
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