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 .
Priority
Instant application 17/761,935 filed on 03/18/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1, 7, 9, 11, 12, 18, 20-22, 28-30, 33, 34, 36, and 38-42 are pending.
Response to Arguments/Amendments
The amendment filled on 01/15/2026 has been entered.
Applicant amended claims 1, 9, 11, 12, 20, 21, 28, 29, 30 and 33.
Applicant cancelled claims 27, 31 and 32 and added claims 38-42.
Applicant’s amendment has overcome the claim objections of record. Thus, the objections are withdrawn.
Regarding 103 rejection, Applicant’s amendment and Applicants arguments have overcome the rejection.
Applicant narrowed the scope of ring B. Amended claim 1 recites that ring B is “a 1 to 10 membered monocyclic heterocyclyl having from one to four heteroatoms independently selected from the group consisting of N, O, and S”. McGonagle recites “heterocyclyl” without identifying the size, number and type of heteroatoms, or other features of the heterocyclyl. Without a suggestion from prior art one of ordinary skill would have not been motivated to modify the compounds disclosed by McGonagle.
Thus, the 103 rejection is withdrawn.
Regarding the double patenting rejections Applicant's arguments filed on 01/15/2026 have been fully considered but they are not persuasive.
Applicant submitted:
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The instant application has been filed earlier. However, the ‘820 patent based on later filed application has been already issued. Examiners are still required to issue double patenting rejections in applications having earlier filing date.
MPEP 804.4 states; that “ even if the application under examination has the earlier patent term filing date, only a one-way determination of distinctness is needed to support a double patenting rejection in the absence of a finding: (A) that "the PTO is solely responsible for any delays" in prosecution of that application (In re Hubbell, 709 F.3d 1140, 1150, 106 USPQ2d 1032, 1039 (Fed. Cir. 2013)); and (B) that the applicant could not have filed the conflicting claims in a single (i.e., the earlier-filed) application ( In re Kaplan, 789 F.2d 1574, 229 USPQ 678 (Fed. Cir. 1986)).”
Further, the cited case is not currently precedential.
Therefore, the double patenting rejections are maintained below.
Election/Restrictions
Applicant elected of Group I in the reply filed on 07/08/2025.
Regarding species election, Applicant elected Example 102 in the reply filed on 07/08/2025.
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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, 9, 12, 18, 20-22, 28-30, 34, and 38-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US-12269820-B2.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of U.S. Patent No. 12269820-B2 recite the following compounds:
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their pharmaceutical salts, and pharmaceutical compositions comprising the compounds and acceptable excipients (see claims 9 and 12).
The species of U.S. Patent No. 12269820-B2 anticipate the instant genus because the compounds recited in claims of U.S. Patent No. 12269820-B2 fall under the instant Formula (I) wherein X2 is CH, X1 is N, R1 is C1 alkyl, R2 and R3 together with the carbon atom to which they are attached form cyclopropyl, Ar is 1,3,4-thiadiazoly, R5 and R6 are absent, R4 is difluoromethyl , B is piperazinyl substituted with Ra, Rb and Rc, Ra is hydrogen, Rb and Rc are each C1 alkyl.
Claims 1, 7, 9, 11, 12, 18, 20-22, 28-30, 34, and 38-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US-12269820-B2 in view of MCGONAGLE (WO-2016097749-A1).
The recitations of claims of U.S. Patent No. US-12269820-B2 have been discussed above and are incorporated herein by reference.
Regarding instant claim 11, the claims of US-12269820-B2 are silent about compounds of instant Formula (I) wherein R1 is cyano.
MCGONAGLE teaches compounds of formula IIb that function as PARG inhibitors:
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Applying KSR prong (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute methyl for cyano to arrive at the compounds recited in instant claim 11 with a reasonable expectation of success. A person of ordinary skill would expect retention of activity and would have been motivated to prepare further examples of PARG inhibitors.
Claims 1, 7, 9, 12, 18, 20-22, 28-30, 34, and 38-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-48 of copending Application No. 19/066,791 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the reference application recite a method for treating comprising administering the compounds having the structure:
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their pharmaceutical salts, and pharmaceutical compositions comprising the compounds and acceptable excipients (see claim 28).
The species of Application No. 19/066,791 anticipate the instant genus because the compounds recited in claims of Application No. 19/066,791 fall under the instant Formula (I) wherein X2 is CH, X1 is N, R1 is C1 alkyl, R2 and R3 together with the carbon atom to which they are attached form cyclopropyl, Ar is 1,3,4-thiadiazoly, R5 and R6 are absent, R4 is difluoromethyl , B is piperazinyl substituted with Ra, Rb and Rc, Ra is hydrogen, Rb and Rc are each C1alkyl.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 9, 11, 12, 18, 20-22, 28-30, 34, and 38-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-48 of copending Application No. 19/066,791 (reference application) in view of MCGONAGLE (WO-2016097749-A1).
The claims of the reference application recite a method for treating comprising administering the compounds having the structure:
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their pharmaceutical salts, and pharmaceutical composition compositions comprising the compounds and acceptable excipient.
Regarding instant claim 11, the claims of Application No. 19/066,991 are silent about compounds of instant Formula (I) wherein R1 is cyano.
MCGONAGLE teaches compounds of formula IIb that function as PARG inhibitors:
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Applying KSR prong (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute methyl for cyano to arrive at the compounds recited in instant claim 11 with a reasonable expectation of success. A person of ordinary skill would expect retention of activity and would have been motivated to prepare further examples of PARG inhibitors.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter/Claim Objections
Claims 33 and 36 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621