DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/29/2025 has been entered.
Previous Rejections
Applicant’s arguments, filed 04/08/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Nonstatutory Double Patenting
A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 181-204 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,858,932, in view of Chen et al (USP 8,030,304 B2).
Claims 181-204 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,098,152, in view of Chen et al (USP 8,030,304 B2).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite all of the features instantly recited except for a method of treating congenital adrenal hyperplasia (CAH) in a subject, wherein the subject is in a fed state. The instant claims require a method of treating congenital adrenal hyperplasia in a subject, wherein the subject is in a fed state, and such limitations are not recited by the issued claims.
Chen taught a method of treating CAH in a patient (e.g., human at [col 3, line 52]) in need thereof [col 2, lines 56-62], comprising administering a therapeutically effective amount [col 3, lines 47-53] of a CRF1 receptor antagonist [abstract], wherein the CRF1 receptor antagonist was:
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(e.g., specific compound at [Example 16]; general formula at [col 2, lines 15-31], where R1 and R2 were independently ethyl, R3 is Cl and R4 is morpholin-4-yl).
It would have been prima facie obvious to one of ordinary skill in the art to include, within the limitations of the issued claims, treating CAH, as taught by Chen. The ordinarily skilled artisan would have been motivated to treat a subject in need thereof, as taught by Chen et al.
Furthermore, the claims of the issued patent differ from the instant claims in that they do not recite treating a subject in a fed state.
However, MPEP 804(II)(B)(1) states that “it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.”
In this case, the specifications of the issued patents disclose that the compound of their invention can be used for treating a subject in a fed state [col 36, lines 21-23 of 11,858,932; col 36, lines 20-22 of 12,098,152].
Accordingly, when the claims of the reference patent are properly construed using the reference patent’s specification, the claimed limitation of treating a subject in a fed state is obvious over the claims to the compound, since this same utility for the compound is disclosed in the specifications of the reference 11,858,932 and 12,098,152 patents.
Claims 181-204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/043,264.
Claims 181-204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/043,275.
Claims 181-204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/043,303.
Claims 181-204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 446-447, 450-451, 456-457, 464-4667, 476-479, 488-493, 498-501, 510-511, 524-525, 532-534, 537-546, 850-853, 858, 866, 868, 885-888 of copending Application No. 19/043,303.
Although the claims at issue are not identical, they are not patentably distinct from each other, because the species recited in the copending claims (methods of treating subjects comprising administering CRF1 antagonists) falls within the genus (corticotropin releasing factor receptor antagonists) recited in the claims of the instant application, and thus read on the instant claims.
Furthermore, the copending claims differ from the instant claims in that they do not recite treating a subject in a fed state.
However, MPEP 804(II)(B)(1) states that “it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.”
In this case, the specification of the copending applications disclose that the compound therein can be used for treating a subject in a fed state [¶ 0034 of 19/043,264; ¶ 0022 of 19/043,275 and 19/043,303; ¶ 0224 of 17/311,310].
Accordingly, when the copending claims are properly construed using the copending application’s specification, the claimed limitation of treating a subject in a fed state is obvious over the claims to the reference compound, since this same utility for the compound is disclosed in the specification of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612