DETAILED ACTION
Notice of 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
The amendments filed 7/11/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 7/11/2025, have been fully considered.
The rejection of claims 11, 12, 14 and 15 under 35 U.S.C. 112(a) has been WITHDRAWN in view of Applicant’s amendments to and/or cancellation of the claims.
Applicant traverses the rejections of now pending claims 1-2, 4, 12-13 and 15 on the grounds of nonstatutory double patenting over previously copending Application No. 17/620,239 (now U.S. Patent No. 12,344,613) and currently copending Application No. 17/620,242.
Regarding U.S. Patent No. 12,344,613, Applicant argues that “the claims… of the ‘613 patent… are directed to a single species, not a genus… while the present claims are directed to six compound species that are patentably distinct from the single compound” of the ‘613 Patent (Applicant Arguments, Page 5).
Yet, as indicated in the basis of the rejection, the only difference between the single compound species recited by the ‘613 claims and a compound of the instant claims is a single fluorine atom, as follows:
US 12,344,613:
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Instant claims:
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(i.e., 2-(4,7-dichloro-6-(4-morpholinophenyl)-2H-indazol-2-yl)-2-(6,7-dihydro-5H- pyrrolo[1,2-c]imidazol-1-yl)-N-(thiazol-2-yl)acetamide).
As discussed by MPEP 2144.09(I), a prima facie case of obviousness may be made when chemical compounds have very close structural similarities to chemical compounds in the prior art, based on “the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties” (quoting In re Payne, 606 F.2d 303 (CCPA 1979)). And, as indicated in the basis of the rejection, there is nothing non-obvious in replacing a fluorine atom with a hydrogen atom. An ordinarily skilled artisan – desiring to make compounds similar in structure to the compound of US 12,344,613 in the expectation that said compounds would have similar properties – would have found it prima facie obvious to replace the fluorine atom in the ‘613 compound with a hydrogen atom to arrive at the instantly claimed compound.
As such, the rejection of claims is MAINTAINED.
Regarding copending Application No. 17/620,242, Applicant argues that “the pending claims of the ‘242 Application are directed to a list of individual compounds, not a genus … while the present claims are directed to six compound species that are patentably distinct from compounds recited in the claims of the ‘242 Application” (Applicant Arguments, Page 5).
The argument is found persuasive. The claims in the ‘242 Application have been amended and, as such, the closest compounds therein differ from the instantly claimed compounds in at least two atoms/groups (e.g., the ‘242 compound comprising a fluorine atom where the instantly claimed compounds comprise a hydrogen atom and further comprising a methyl group where the instantly claimed compounds comprise a halogen atoms). While it may have been obvious to carry out each of the modifications individually, it would not have been obvious to carry out both modifications to arrive at the instantly claimed compounds with a reasonable expectation of success.
As such, the rejection of claims is WITHDRAWN.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4, 12-13 and 15 are MAINTAINED rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,344,613.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘239 claims are drawn structurally related compounds – differing in comprising a fluorine atom in place of a hydrogen atom which would have been obvious to modify – for the treatment and prophylaxis of cancers generally and non-small cell lung cancer specifically.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No new ground(s) of rejection are 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611