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 .
Election/Restrictions
The restriction requirement between the compounds of formula (I) and their methods of use and the election of species requirement are withdrawn. The prior art reference used to support the rejections of the elected species is no longer applicable prior art following the submission of the certified foreign priority documents. The original basis for the restriction and election requirements no longer exists. All claims previously withdrawn from consideration have been reinstated and examined on the merits.
Priority
The instant application is a continuation of PCT/GB2020/051778, filed July 24, 2020, which claims the benefit of priority to GB Application No. 1910607.9, filed July 24, 2019, and GB Application No. 2005739.4, filed April 20, 2020.
Current Status of 17/581,504
Claims 28-35 and 40-47 of the amended claims of 03/04/2025 have been examined on the merits.
Response to Arguments
Rejections 35 U.S.C. §112(b)
Applicants have amended the claim language of claim 28, removing "tautomeric forms, enantiomers, isotopic variants, and solvates." This amendment renders the previous rejection moot. The previous rejection is withdrawn.
Rejections 35 U.S.C. §103
Applicants note that WO 2019145726 is prior art under USC §102(a)(2) and that the reference and the instant application were owned by the same person. Applicants have provided a Statement of Common Ownership. This argument is persuasive, and the previous rejection is withdrawn.
Double Patenting
Applicants have not traversed the nonstatutory double patenting rejection. Applicants state in their response of 09/24/2025 that a terminal disclaimer would be filed after resolution of other issues; however, no terminal disclaimer has been filed. Because the restriction requirements have been withdrawn, the previously withdrawn claims are now reinstated and are included in this rejection. Accordingly, the rejection is maintained and applied to all pending claims.
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.
Claims 28-35 and 40-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. 11,364,246 in view of Silverman.
‘246 discloses compounds of formula (Ie)
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(Col 15, line 1) which read on the instantly claimed compounds. ‘246 teaches pharmaceutical compositions comprising the compounds of formula (Ie) with pharmaceutically acceptable excipients ( Compound 17 of the instant application is used as an example and has the following structure
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(pg. 137, line 10). When R1 is C1 alkyl optionally substituted with 3 fluoro groups; R2 and R3 combine to form a 3-membered carbocyclic ring; R11c is fluorine; R11a is hydrogen; and R11b is a C4 haloalkyl group, more specifically this is a sec-butyl group where the methyl moiety is a CF3. These substitutions afford the following structure for (Ie)
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. The arrows shown in compound 17 and in the compound derived from the disclosed substitutions of (Ie) identify the difference that distinguishes the compounds. Silverman teaches that bioisosteres are substituents or groups that have chemical or physical properties that produce broadly similar biological properties. Bioisosteres are important lead modifications that can attenuate pharmacokinetic properties (pg. 29, first paragraph). Table 2.2 of Silverman highlights that OH groups are classical isosteres of CH3.
The compound described above is identical to compound 17 with the exception of the indicated methyl group. However, it would be obvious to one of ordinary skill in the art to substitute the methyl group with a hydroxyl group because hydroxyl groups are known isosteres of methyl groups. The artisan would expect that replacing the methyl group with a hydroxyl group would alter the pharmacokinetics of the molecule while preserving the biological activity of the larger structure. It would have been similarly obvious to use the newly modified compound with a pharmaceutically acceptable excipient as part of a pharmaceutical composition. The artisan would expect that the hydroxyl substituted compound would possess similar biological activity to the methyl substituted analog as part of a pharmaceutical composition.
Close Art
No prior art documents not under common ownership to Applicants disclosing compounds of general formula (I) were retrieved. The closest compound found was compound 48
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of WO 2005/042524 A1, found in IDS filed 01/03/2024. Compound 48 differs from the instantly claimed compounds through the substitutions of the phenyl rings and the substitution pattern of the central pyridine core. The compounds of '524 are HIV integrase inhibitors and the reference does not teach or suggest that structurally similar compounds would be useful in modulating TMEM16A.
WO 2018/195127 A1 and Namkung et al. (found in IDS filed 01/03/2024) disclose TMEM16A inhibitors that are structurally unrelated to the claimed compounds (see Examples 1-51 of '127, and Table 1 of Namkung). The references teach the use of the compounds for the treatment of respiratory disorders.
Starting from any of the compounds of the references discussed above, the artisan would not have been motivated to make the multiple structural modifications required to arrive at the instantly claimed compounds. There is no teaching or suggestion in the prior art that such modifications would result in compounds possessing TMEM16A modulatory activity. Accordingly, the claimed compounds and the methods using these compounds are considered nonobvious over the prior art.
Conclusion
No claims are allowed.
Claims 46 and 47 are objected to as being dependent upon a rejected base claim, but would be allowable if the claims were rewritten in independent form including all the limitations of the base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625