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, 2, 4, 6-8, 15, 16, 23, 24 and 27 are pending in the instant application.
Election/Restrictions
Applicant’s election of Group I,
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and the species of Compound 126, found on page 54 of the instant specification (reproduced below),
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in the reply filed on December 17, 2024 was acknowledged in the previous Office Action. The requirement was deemed proper and therefore made FINAL in the previous Office Action.
Claims 25 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on
December 17, 2024. Claims 25 and 26 have been cancelled per the Amendment filed September 2, 2025.
Rejections and objections made in the previous Office Action that do not appear below have been overcome by Applicant’s amendments to the claims and the filing of a proper terminal disclaimer. Therefore, arguments pertaining to these rejections and objections will not be addressed.
Terminal Disclaimer
The terminal disclaimer filed on June 17, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11,091,447 has been reviewed and is accepted. The terminal disclaimer has been recorded.
As a result of the current amendments to the claims and the filing of new claim 27, the following rejections now apply
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, 2, 4, 6-8, 15, 16, 23, 24 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/635,905 (reference application), US 2024/0342138. Although the claims at issue are not identical, they are not patentably distinct from each other because copending Application No. 18/635,905 claims a method of treating cancer comprising administering a compound that anticipates the instant claimed invention (the elected species of the instant invention and claimed in instant claim 23).
The instant application and copending Application No. 18/635,905 share at least one common inventor. Further, the instant application and copending Application No. 18/635,905 are not related to each and thus, no 35 USC 121 shield exists here. See MPEP 804.01. Therefore, the claims in copending Application No. 18/635,905 render obvious the instant claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4, 6-8, 15, 16, 23, 24 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/711,570 (reference application), US 2025/0017906. Although the claims at issue are not identical, they are not patentably distinct from each other because copending Application No. 18/711,570 claims a method of treating cancer comprising administering a compound that anticipates the instant claimed invention (the elected species of the instant invention and claimed in instant claim 23).
The instant application and copending Application No. 18/711,570 share at least one common inventor. Further, the instant application and copending Application No. 18/711,570 are not related to each and thus, no 35 USC 121 shield exists here. See MPEP 804.01. Therefore, the claims in copending Application No. 18/711,570 render obvious the instant claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed September 2, 2025 have been fully considered. Applicant argues that the provisional nonstatutory double patenting rejections over each of copending Application No. 18/635,905 and copending Application No. 18/711,570 should be withdrawn because the Response filed September 2, 2025 in the instant application overcomes all other matters and the instant application has the earlier patent term filing date.
In response, the provisional nonstatutory double patenting rejections are not the only remaining rejections of record. See below rejections. Therefore, each of the provisional nonstatutory double patenting rejections are maintained.
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 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)(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.
Claims 1, 2, 4, 6-8, 15, 16 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
a) the compound of Chemical Abstracts Registry Number 1319042-92-6 {indexed in the Registry file on STN CAS ONLINE August 17, 2011},
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[a compound of instant Formula (I),
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Z1 = CH;
Z2 = CH;
X = N;
ring A = phenyl substituted with 1 R5 group where R5 = C1 alkoxy;
Y = -CH2;
R1 = halo(C2)alkoxy;
R3 = hydrogen; and
p = zero];
b) the compound of Chemical Abstracts Registry Number 1385702-06-6 {indexed in the Registry file on STN CAS ONLINE August 2, 2012},
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[a compound of instant Formula (I),
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Z1 = CH;
Z2 = N;
X = N;
ring A = furanyl;
Y = -CH2;
R1 = -NRcRd where Rc and Rd together with the nitrogen atom they are bound
form a 5-membered heterocyclyl (i.e., pyrrolidinyl);
R3 = hydrogen; and
p = zero];
c) the compound of Chemical Abstracts Registry Number 1837031-15-8 {indexed in the Registry file on STN CAS ONLINE December 27, 2015},
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[a pharmaceutically acceptable salt of a compound of instant Formula (I),
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Z1 = CH;
Z2 = CH;
X = N;
ring A = phenyl substituted with 1 R5 group where R5 = halo (i.e., bromo);
Y = -CH2;
R1 = -NRcRd where
Rc = hydrogen, and
Rd = hydrogen;
R3 = hydrogen; and
p = zero];
and
d) the compound of Chemical Abstracts Registry Number 1316119-67-1 {indexed in the Registry file on STN CAS ONLINE August 11, 2011},
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[a compound of instant Formula (I),
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,
Z1 = N;
Z2 = CH;
X = N;
ring A = phenyl substituted with 1 R5 group where R5 = C1 alkoxy;
Y = -CH2;
R1 = halo(C2)alkoxy;
R3 = hydrogen; and
p = zero].
Each of the above cited prior art disclose at least one compound that is embraced by the instant currently amended claimed invention. Further, the Registry record for the compound of Chemical Abstracts Registry Number 1319042-92-6, for instance, discloses the predicted solubility of the compound in water. The instant specification discloses that water is a pharmaceutically acceptable carrier used in the compositions {paragraph [0024] on page 6}. Therefore, each of the above cited prior art anticipate the instant currently amended claimed invention.
Note to Applicant: Not every piece of prior art found in the database search or class/subclass search which would anticipate and/or render obvious the instant claimed invention under examination has been applied against the instant currently pending claims under examination. See MPEP §904.03.
The elected species of Compound 126, found on page 54 of the instant specification, is not allowable. See the above provisional nonstatutory double patenting rejections over the claims in copending Application No. 18/635,905 (claim 1) and over the claims in copending Application No. 18/711,570 (claim 1).
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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
December 11, 2025
Book XXVIII, page 123