DETAILED ACTION
This office action is in response to the Applicant’s filing dated October 08th, 2025.
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 Claims
Claims 1-6, 9-20, 22 and 24 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on April 21st, 2023. Acknowledgment is made of Applicant’s amendment of claims 3-6, 9-14, 18, 20, 22 and 24; and the cancelation of claims 7-8, 21 and 23.
Election/Restrictions
Applicant's election without traverse of Group I in the reply filed on October 08th, 2025 is acknowledged.
Claims 22 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group. Election was made without traverse in the reply filed on October 08th, 2025.
Applicant's election of species without traverse of Example 3 in the reply filed on October 08th, 2025 is acknowledged.
A prior art search was conducted for the elected species Example 3:
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Example 3 is the third compound in claim 19 and listed in the specification on pages 61-63. Example 3 is a species of genus Formula (I); wherein R1 is C1 alkylene-R4, and R4 is 1,2,3-triazolyl substituted by C1 haloalkyl (specifically difluoromethyl) and C1 alkyl; wherein R2 is CO2H; wherein R3 is methyl; wherein X is CR5R6, and R5 is C1 alkyl and R6 is H; wherein m is 1; and wherein n is 1.
This search retrieved prior art. Therefore, the Examiner’s search will not be extended unnecessarily to additional species of genus Formula (I) in/for/during this Office Action.
Claims 13 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Election was made without traverse in the reply filed on October 08th, 2025. Claims 1-6, 9-12, 14-16, and 18-20 read on the elected species, and will be examined herein.
Claim Objections
Claims 1, 6, 9 and 15 are objected to because of the following informalities: In claim 1 line 5 it is recited “R1 is C1-4alkylene-R4;”. It should recite “R1 is C1-4 alkylene-R4;” with a space between “C1-4” and “alkylene”. This type of absent spacing error is repeated several times throughout the instant claims. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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.
Claims 1-6, 9-12, 14-16, and 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Blaney et al (US 12,098,148 B2).
Regarding claims 1-6, 9-12, 14-16, and 18-20, Blaney teaches the compound shown below:
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which is a compound of Formula IC (Column 25, first formula) wherein R1 is
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(Column 17, paragraph [18]); wherein R2 is F, and wherein R3 is Cl (Column 17, paragraphs [20-21]); wherein R4 and R5 taken together with the nitrogen atom to which they are attached form
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, substituted by C1 alkyl (Columns 18-19, paragraph [37]); wherein R6 is H (Column 20, paragraph [45]); and wherein R9 is C1 alkyl (Column 20, paragraph [52]). This is the elected compound Example 3 of the instant claims. Blaney further teaches a pharmaceutical composition comprising the elected compound and one or more pharmaceutically acceptable excipients (Column 66, lines 15-23).
Thus, the teachings of Blaney anticipate the compound and composition of instant claims 1-6, 9-12, 14-16, and 18-20.
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 1-6, 9-12, 14-16, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. US 12,098,148 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because compounds of Formula (I) in the instant application are found in the issued patent. Specifically, the elected compound of the instant claims is found in the reference patent as a compound of Formula IC as noted in the above rejection. Moreover, the method of treatment claimed in the instant application has significant overlap with the issued patent’s claimed method of treatment. The same compounds, such as the elected compound of the instant claims, are being used to treat the same diseases.
Claims 1-6, 9-12, 14-16, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of copending Application No. 17/920,244 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the only structural difference between the elected compound of the instant claims and the reference application’s Formula IC is a substitution at at the R8C position of the reference application with OH. The carboxylic acid substituent formed at the R2 position of the elected compound in the instant claims is an obvious variant of the reference application’s carbonyl group at the R8 position in Formula IC. Moreover, the method of treatment claimed in the instant application has significant overlap with the reference application’s claimed method of treatment. The same compounds are being used to treat the same diseases.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-6, 9-12, 14-16, and 18-20 are rejected.
Claims 1, 6, 9 and 15 are objected to.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691