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 .
Status of the Claims
Claims 1-9, 11, 15, 16, and 20-22 are pending. Acknowledgment is made of the amendment of claims 1-9, 11, 15, and 16, the cancellation of claims 10, 12-14, and 17-19, and the addition of new claims 20-22, in the reply filed 10/10/2025.
Formal Matters
Applicant’s petitions under 37 CFR 1.78(e) and 37 CFR 1.55(e) to claim priority of PCT/EP2021/060021 and European Application No. 20170326.1 were dismissed on 03/11/2026. Therefore, the effective filing date of the instant application is 10/28/2021, as set forth in the non-final rejection mailed 06/13/2025.
Withdrawn Objections/Rejections
Applicant’s amendment to the claims, filed 10/10/2025, overcomes the objection to claims 1-4, 6, 7, and 9-13 for minor informalities. The objection to claims 1-4, 6, 7, and 9-13 has been withdrawn.
Applicant’s cancellation of claim 10, in the reply filed 10/10/2025, renders the rejection of claim 10 under 35 U.S.C. 101 moot. The rejection of claim 10 has been withdrawn.
Applicant’s amendment to the claims, filed 10/10/2025, overcomes the rejection of claims 10-19 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 10-19 has been withdrawn.
Applicant’s amendment to the claims, filed 10/10/2025, overcomes the rejection of claims 8 and 10-19 under 35 U.S.C. 112(b) for indefiniteness. The rejection of claims 8 and 10-19 has been withdrawn.
Applicant’s statement in compliance with 35 U.S.C. 102(b)(2)(C) overcomes the rejection of claims 1-16 under 35 U.S.C. 102(a)(2) and 103 as being anticipated by or unpatentable over Cecere et al. (WO 2021198124 A1). The rejection of claims 1-16 has been withdrawn.
Maintained Rejections
Nonstatutory 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 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. US 11,739,095 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘095 teaches, in claims 1 and 2, the compound 7-chloro-6-(2,6-difluorophenyl)-1,4-dimethyl-8-(trifluoromethyl)-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine, labeled example 92, shown below.
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While the exact compound of 7-chloro-6-(2,6-difluorophenyl)-1-methyl-8-(trifluoromethyl)-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine, from instant claims 5-7, is not disclosed by patent ‘095, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “methyl” group to a hydrogen.
Claims 8, 9, 11, 15, 16, and 20-22 are objected to as being dependent upon a rejected claim.
Applicant Argues:
Applicant states that the claims have been amended to overcome this rejection.
Examiner Responds:
No amendment was made in the reply that overcomes the rejection above. The scope of the compounds of Patent ‘095 overlaps with the instant compounds and differ only by the presence of a methyl in place of a hydrogen.
New Objections
Necessitated by Claim Amendment
Claim 8 is objected to because of the following informalities:
Claim 8 reads “A process for preparing of the compound …”(emphasis added) and should read “A process for preparing the compound…”.
Appropriate correction is required.
Advisory Notice
Claims 8, 9, 11, 15, 16, and 20-22 appear allowable if rewritten in independent form.
Conclusion
Claims 1-7 are rejected.
Claims 8, 9, 11, 15, 16, and 20-22 are objected to.
THIS ACTION IS MADE FINAL. 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 RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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