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. Application Status The preliminary amendment filed on 7/29/2024 is acknowledged. Claims 1-8 and 16-39 are currently pending and under consideration. Information Disclosure Statement The information disclosure statement filed on 8/22/2024 is acknowledged and has been considered except where lined through. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 8 recites the limitation " CBz " as a variable in the compounds having the structure s : and . However, claim 1 , from which claim 8 depends , does not specifically define R8 which is part of X1=NR8 as encompassing a CBz group generically. Note: CBz has the following structure: . Accordingly, t here is insufficient antecedent basis for this limitation in the claim. 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 . Claim s 1-8 and 16-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 32-34, 37-44 of copending Application No. 18/294,283 (reference application) as evidenced by Biondi et al. (Current Pain and Headache Reports 2006; 10: 167-178) . Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating a migraine or symptoms related to a migraine, the method comprising administering to a subject in need thereof a therapeutically effect amount of a compound encompassed and claimed in the instant application substantially overlaps in scope with the instant application. For example, the compounds claimed in the method of claim 39 of the reference application are also claimed in the present application. Note: As evidenced by Biondi et al. (Current Pain and Headache Reports 2006; 10: 167-178), the hypothesis that migraine is a neuropathic pain disorder can be upheld and confirmed by means of several diagnostic guidelines (page 175, conclusion). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-8 and 16-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10, 12, 25-32 of copending Application No. 18/003,829 (reference application) . Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds claimed in the reference application substantially overlap in scope with the compounds claimed in the instant application. See for example, the dispiro compounds claimed in claim 31 of the reference application. Moreover, it is noted that the application of the reference application contemplates the use of the compounds for treating neuropathic pain, Lupus, viral infection-induced pain… Fragile E syndrome (see page 1 of the related applications specification). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Claims 1-8 and 16-39 are free of the prior art. The closest prior art is considered to be Effector Therapeutics INC (WO2018/218038A1, 2018-11-29, IDS) whom teaches compounds of the formula: , wherein the majority of the variables are encompassed by the instantly claimed compound of formula (I). Specifically, the WO document teaches a compound having the structure: (See claims 75 and 76 of the WO document). Thus, while the WO defines R2 and R3 taken together with the carbon atoms to which they are attached to form a carbocycle or heterocycle which can be substituted with 1, 2 or 3 J groups, the prior art does not teach or suggest that said J groups can be taken together with the atoms to which they are attached to form a carbocycle or heterocycle. In other words, the prior art does not teach or suggest the di spiro compounds as instantly claimed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BRANDON J FETTEROLF whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2919 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 6AM-4PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Jeffrey S Lundgren can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-5541 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. FILLIN "Examiner Stamp" \* MERGEFORMAT BRANDON J. FETTEROLF, PHD Primary Patent Examiner Art Unit 1626 /BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626