DETAILED ACTION
Claims 14, 15, 17-25, 28, and 33 are currently pending in the instant application and are rejected.
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
Claims 28 and 33 are directed to an allowable product (excluding the below double patenting rejection). Pursuant to the procedures set forth in MPEP § 821.04(b), claims 14, 15, and 17-25, directed to the process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claim 27 directed to the invention(s) of Group IV has been canceled and does not require all the limitations of an allowable product claim, and has NOT been rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between groups I-III as set forth in the Office action mailed on 18 October 2024 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 12 March 2026 have been fully considered and entered into the instant application. Applicant’s amendment and arguments have overcome the objection to claim 33 as being objected as claim 33 has been amended to be independent. The 35 USC 102(a)(1) rejections of claim 26 as being anticipated by Registry No. 148256-40-0 and by US Patent No. 5,232,917 are overcome as claim 26 is canceled.
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.
Claim14, 15, 17-25, 28 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No.12,209,107. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are claiming a chromatography-free process for preparing alloprenanolone which comprises:
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. The process of conflicting claim 1 utilizes the process of instant claim 14. The process of conflicting claim 2 anticipates the instant claimed process of claim 15 wherein the 3-carboxylic ester of allopregnanolone is subjected to hydrolysis under neutral conditions, mild basic conditions or energetic basic conditions. Conflicting claim 4 provides the solvent system of instant claim 17 which comprises water and a water soluble organic solvent. Conflicting claim 5 provides the 3-carboxylic ester of allopregnanolone is precipitated in a solvent system comprising water and for example 1,4-dioxane as seen in instant claim 18. Conflicting claim 6 provides the use of an alcohol without adding any acid or based as in instant claim 19. Conflicting claim 7 provides where the hydrolysis utilizes a base whose conjugate acid has a pKa less than or equal to 11 as in instant claim 20. Conflicting claim 8 provides where the base is an alkali or alkaline earth carbonate or bicarbonate as in instant claim 21. Conflicting claim 9 provides that the level of 3a-hydroxy-4a,17a-pregnan-20-one is in an amount of 0.5% or less as in instant claim 22. Conflicting claim 10 provides wherein the base is an alkali or alkaline earth C1-6 alkoxide or hydroxide as in instant claim 23. Conflicting claim 12 provides the content of 5a-pregn-2-en-20-one and 3a-hydroxy-5a,17a-pregnan-20-one of 0.15% or below as in instant claim 25. Conflicting claim 3 provides, for example the use of a 3-carboxylic ester of allopregnanolone comprising the carboxylate of a carboxylic acid paving a pKa of 3 or less, said ester containing an amount of 5a-pren-2-en-20-one of 0.5% or less, which is for example selected from trifluoracetic acid which anticipates instant claim 28 and instant claim 33.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 12 March 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 27 March 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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