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 .
DETAILED ACTION
Claims 1, 8, 22, 27-31 and 37-39 are pending in the application. Claims 1, 8, 22, 31 and 37-39 are rejected. Claims 27-30 are withdrawn.
Response to Amendment / Argument
Objections and rejections made in the previous Office Action that do not appear below have been overcome by Applicant's amendments to the claims or the terminal disclaimer filed March 31st, 2026. Therefore, arguments pertaining to these objections and rejections will not be addressed.
Election/Restrictions
The search and examination has been extended to include the scope of instant claim 1, which is free of the prior art. Nevertheless, since the Markush type claim is not allowable, examination has been limited to claims embracing the elected species, which are 1, 8, 22, 31 and 37-39. Claims 27-30 are withdrawn as being drawn to non-elected species. Even if Applicant argued that the claims should be eligible for rejoinder without an art rejection, these claims would not be eligible for rejoinder since they are replete with instances of ring sizes and repeating variables limited by ring counts “about” certain ranges where parent claim 1 has been narrowed to only explicit endpoints.
Claim Objections
The word “or” should be added after the embodiment for R1 bridging Applicant labeled pages 5-7 of the claim set dated March 31st, 2026.
The word “or” should be added after the embodiment for R1 bridging Applicant labeled pages 8 and 9 of the claim set dated March 31st, 2026.
The word “or” should be added after the embodiment for R1 bridging Applicant labeled pages 10 and 11 of the claim set dated March 31st, 2026.
Claim Rejections - 35 USC § 112(b)
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 applicant regards as his invention.
Claims 1, 8, 22, 37, 38 and 39 are 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.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since the embodiment for R1 bridging Applicant labeled pages 5-7 of the claim set dated March 31st, 2026 contains a ring structure for variable Z (last option) with a variable “W” that is not defined for the embodiment.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since the embodiment for R1 bridging Applicant labeled pages 11-13 of the claim set dated March 31st, 2026 contains a ring structure for variable Z (last option) with a variable “W” that is not defined for the embodiment.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since the embodiment for R1 bridging Applicant labeled pages 24 and 25 of the claim set dated March 31st, 2026 contains a ring structure for variable Z (last option) with a variable “W” that is not defined for the embodiment.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since the embodiment for R1 bridging Applicant labeled pages 29 and 30 of the claim set dated March 31st, 2026 contains a ring structure for variable Z (last option) with a variable “W” that is not defined for the embodiment.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since the embodiment for R2 bridging Applicant labeled pages 35 and 36 of the claim set dated March 31st, 2026 contains a ring structure for variable Z (last option) with a variable “W” that is not defined for the embodiment.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since the embodiment for R2 bridging Applicant labeled pages 47 and 48 of the claim set dated March 31st, 2026 contains a ring structure for variable Z (last option) with a variable “W” that is not defined for the embodiment.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since the embodiment for R2 bridging Applicant labeled pages 52 and 53 of the claim set dated March 31st, 2026 contains a ring structure for variable Z (last option) with a variable “W” that is not defined for the embodiment.
Claims 1, 8, 22 and 37 are rejected as indefinite since the embodiment for R4 bridging Applicant labeled pages 63 and 64 of the claim set dated March 31st, 2026 contains a ring structure for variable Z (last option) with a variable “W” that is not defined for the embodiment.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since Applicant has amended the embodiment bridging pages 8 and 9 of the claim set dated March 31st, 2026 to replace structural options for the variable Z. The structures previously contained structures where the point of connection for the first five structures pointed left (in line with the connection to the remainder of the structure for the R1). The amended structures no longer contain such an alignment and it is unclear if Applicant is attempting to claim (for the third option) points of connection through only the 2-position of the azetidine ring or both the 1- and 2-positions as alternatives.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since Applicant has amended the embodiment on page 32 of the claim set dated March 31st, 2026 to replace structural options for the variable Z. The structures previously contained structures where the point of connection for the first five structures pointed left (in line with the connection to the remainder of the structure for the R1). The amended structures no longer contain such an alignment and it is unclear if Applicant is attempting to claim (for the third option) points of connection through only the 2-position of the azetidine ring or both the 1- and 2-positions as alternatives.
Claims 1, 8, 22, 38 and 39 are rejected as indefinite since Applicant has amended the embodiment on page 55 of the claim set dated March 31st, 2026 to replace structural options for the variable Z. The structures previously contained structures where the point of connection for the first five structures pointed left (in line with the connection to the remainder of the structure for the R2). The amended structures no longer contain such an alignment and it is unclear if Applicant is attempting to claim (for the third option) points of connection through only the 2-position of the azetidine ring or both the 1- and 2-positions as alternatives.
Claims 1, 38 and 39 are rejected as indefinite since the definition for R3 bridging Applicant labeled pages 55 and 56 of the claim set dated March 31st, 2026 contains an option for L, K and J with a repeat unit “n” that is not defined for the definition of R3.
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 1, 8, 22, 31 and 37-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/528,574 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recite a method of using a compound embraced by Applicant’s elected species. For instance, 1-[4-(4-cyano-but-1-ynyl)-phenyl]-2-(2,4-dichloro-phenyl)-5-methyl-1H-imidazole-4-carboxylic acid (1,1-dioxo-1λ6-thiomorpholin-4-yl)-amide recited in claim 18 of the copending case corresponds to the instant elected species where R4 is methyl.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626