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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/07/2024 and 07/10/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-145 and Compound 104
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100
351
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in the reply filed on 07/10/2026 is acknowledged.
Claims 2-6, 9-18, 20-22, 27-29, 31-59, 64-81, 84-141, 143 and 146-149 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/10/2026.
The elected species was not found in the prior art, and the search was extended until art was found.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 7-8, 19, 23-26, 30, 60-63, 82-84, 142 and 144-145 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2022006534A1 (effectively filed 02 July 2020) to Abdi.
Abdi teaches the compound
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119
189
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(p. 4) which is identical to Compound # 88 of claim 144 and is a compound of Formula I of claim 1 wherein:
A is
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82
166
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;
X1 is NR5;
X2 is H;
n is 1;
p is 0 and R3 and R4 are not present;
Ar1 is aryl (i.e., phenyl) optionally substituted with two halo (i.e., two Cl);
R1 and R5 together with the atoms to which they are attached form an unsubstituted 3-6 membered ring (i.e.,
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44
47
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); and
R2 is H.
Pharmaceutical compositions are described at p. 90. Accordingly, claims 1, 7-8, 19, 23-26, 30, 60-63, 82-84, 142 and 144-145 are anticipated.
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, 7-8, 19, 23-26, 30, 60-63, 82-84, 142 and 144-145 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 13, 17-19, 29-30, 32-34, 40, 42, 44, 46, 50, 52, 54, 113 and 115-123 of copending Application No. 17759265 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the copending application is drawn to compounds of Formula 1a:
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138
354
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with numerous exemplary compounds of claim 113 anticipating the instant claims such as
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100
477
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. With respect to claims 60-63 and 82-84, X1 can be NR6 and R2-R6 can form –(Cr13R14)- where R is an integer from 1 to 5. With respect to claim 144, copending claim 113 contains obvious variants of claimed compounds in the context of the claims as a whole. For example, compound 153 above differs from instantly claimed compound 35
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485
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in the attachment point of the imidazolyl ring. Such a variant would have been obvious given that the claims provide that R5 is an optionally substituted heteroaryl and that several variants exist within claim 113 indicating variant optionally substituted imidazolyl and other heterocyclyl attachment points (see for example compound 99). This provides sufficient blaze marks to arrive at a compound such as claimed compound 35. Accordingly, the instant claims are anticipated and/or obvious in view of the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 7-8, 19, 23-26, 30, 60-63, 82-84, 142 and 144-145 are rejected.
Claims 2-6, 9-18, 20-22, 27-29, 31-59, 64-81, 84-141, 143 and 146-149 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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