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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/01/2025 has been entered.
Status of Claims
Claims 55-94 are pending. Claims 58, 61-67, 69-70, 75-77, 80, 82-83, 86-87, and 90 are withdrawn.
Priority
Instant application 17/620,303, filed 12/17/2021 claims priority as follows:
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Response to Arguments/Amendment
Claims 55-57, 59, 60, 68, 71-74, 78, 79, 81, 84, 85, 88, 89, and 91-94 were previously rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (US 20210139530 A1; cited in IDS) alone and further in view of Dansey (Eur. J. Med. Chem., vol. 45, no. 7, July 2010, p. 3063–69).
In the Remarks filed 12/01/2025, applicant argues that (i) one of ordinary skill would not have select the cited compound for further modification based on the cited disclosures, and (ii) none of the cited references provide a reasonable expectation of success to modify the cited compound via expansion of ring A.
Applicants’ arguments have been fully considered and are persuasive. Therefore, the previous rejection under section 103 is withdrawn.
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. 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.
18/771,262
Claims 55-57, 59, 60, 68, 71-74, 78, 79, 81, 84, 85, 88, 89, and 91-94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 514-542 of copending Application No. 18/771,262 (reference application, cited in IDS 07/14/2025), alone and in view of Dansey (cited previously).
The reference application recites multiple homologs of the instantly claimed compounds. As one example, the compound I-D9 is recited in claim 522:
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The sole difference between the compound of I-D9 and instant compound 10 is that compound 10 is a homolog (i.e., a compound differing by addition of a -CH2- group to the A ring) of compound of I-D9.
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). The homolog is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the homolog. This circumstance has arisen many times. See In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
Therefore, compound 10 of the instant claims having the structure shown above and its utility for treating a CNS-related disorder would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a homolog of the compound of I-D9 in the reference application with a reasonable expectation of success in obtaining a compound with utility for treating CNS-related disorders or modulating a GABAA receptor.
Claim 531 of the reference application teaches an expanded A ring. Moreover, Dansey provides evidence that the 3α-hydroxyl group on the steroid A ring does not need to be kept in a fixed position by a rigid A ring in order to achieve GABAergic activity in neuroactive steroids (page 1, right side, first paragraph); and that expanding the A ring to the 7-membered homolog results in comparable activity to the positive control allopregnanolone in a TBPS binding assay (see e.g. Table 2, compound 15 vs compound 1).
Therefore, a skilled artisan would have enjoyed at least a reasonable expectation of success that preparing a homolog of compound of I-D9 having a 7-membered A ring would result in a compound having similar properties.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19/234,399
Claims 55-57, 59, 60, 68, 72-74, 78, 79, 81, 84, 85, and 91-94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-80 of copending Application No. 19/234,399 (reference application, cited in IDS 07/14/2025), alone and in view of Dansey (cited previously).
The reference application recites multiple homologs of the instantly claimed compounds. For example, see the compounds 19, 20, 24, 26:
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The sole difference between the reference application compounds and those of the instant claims is that the reference application compounds are homologs (i.e., a compound differing by addition of a -CH2- group to the A ring or D ring) of the claimed compounds.
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). The homolog is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the homolog. This circumstance has arisen many times. See In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
Therefore, compounds of the instant claims having utility for treating a CNS-related disorder would have been prima facie obvious before the effective filing date of the instant application in view of the claims of the reference application. A skilled artisan would have been motivated to prepare a homolog of the compounds recited in the reference application with a reasonable expectation of success in obtaining a compound with utility for treating CNS-related disorders or modulating a GABAA receptor.
Compounds 19, 20, 24, and 26 of the reference application teach an expanded A ring or D ring. Moreover, Dansey provides evidence that the 3α-hydroxyl group on the steroid A ring does not need to be kept in a fixed position by a rigid A ring in order to achieve GABAergic activity in neuroactive steroids (page 1, right side, first paragraph); and that expanding the A ring to the 7-membered homolog results in comparable activity to the positive control allopregnanolone in a TBPS binding assay (see e.g. Table 2, compound 15 vs compound 1).
Therefore, a skilled artisan would have enjoyed at least a reasonable expectation of success that preparing a homolog of the reference application compounds would result in a compound having similar properties.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 55-57, 59, 60, 68, 71-74, 78, 79, 81, 84, 85, 88, 89, and 91-94 are rejected. Claims 58, 61-67, 69-70, 75-77, 80, 82-83, 86-87, and 90 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621