Detailed Action
The present office action is in response to the application filed on amendments filed 11 Jun 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
Claims 1-10 of the pending application have been examined on the merits. Claims 14-16 are withdrawn (see “Response to Applicant Elections” below). Acknowledgement is made of the amendments filed 11 Jun 2025. Acknowledgment is made of the cancellation of claims 11-13.
Priority
Applicants identify the instant application, Serial #: 17/785,585, filed 15 Jun 2022, as a National Stage Entry of International Patent Application #: PCT/US2020/066510, filed 22 Dec 2020, which claims foreign priority from Foreign Application #: IN201911053558, filed 23 Dec 2019.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 29 Aug 2022 and 16 Oct 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election of Group I, claims 1-10, in the reply filed on 11 Jun 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of the following species in the reply filed on 11 Jun 2025 is acknowledged:
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Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). No prior art was found against this species and examiner expanded the search to encompass the full scope of the generic claim. Prior art was found and so the restriction requirement remains in place.
Claims 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 Jun 2025.
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)(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) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-methyl-3-nitro-4-[4-(2-pyridinyl)-1-piperazinyl]-2(1H)-quinolinone (CAS 337337-99-2), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 22 May 2001; provided in IDS 10/16/23), hereinafter 337337-99-2.
The instant claims are drawn to compounds of Formula (I):
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337337-99-2 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-methyl-4-[4-(2-methylphenyl)-1-piperazinyl]-3-nitro-2(1H)-quinolinone (CAS 385392-20-1), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 22 Jan 2002; provided in IDS 10/16/23), hereinafter 385392-20-1.
385392-20-1 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-ethyl-3-nitro-4-[4-(2-pyridinyl)-1-piperazinyl]-2(1H)-quinolinone (CAS 433322-33-9), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 25 Jun 2002; provided in IDS 10/16/23), hereinafter 433322-33-9.
433322-33-9 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 4-[4-(2-fluorophenyl)-1-piperazinyl]-1-methyl-3-nitro-2(1H)-quinolinone (CAS 849918-13-4), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 06 May 2005; provided in IDS 10/16/23), hereinafter 849918-13-4.
849918-13-4 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-ethyl-4-[4-(2-methoxyphenyl)-1-piperazinyl]-3-nitro-2(1H)-quinolinone (CAS 850190-77-1), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 10 May 2005; provided in IDS 10/16/23), hereinafter 850190-77-1.
850190-77-1 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 4-[4-(3-Chlorophenyl)-1-piperazinyl]-1-methyl-3-nitro-2(1H)-quinolinone (CAS 850191-24-1), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 10 May 2005; provided in IDS 10/16/23), hereinafter 850191-24-1.
850191-24-1 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-ethyl-4-[4-(4-fluorophenyl)-1-piperazinyl]-3-nitro-2(1H)-quinolinone (CAS 850803-90-6), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 20 May 2005; provided in IDS 10/16/23), hereinafter 850803-90-6.
850803-90-6 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-ethyl-4-[4-(4-methoxyphenyl)-1-piperazinyl]-3-nitro-2(1H)-quinolinone (CAS 862210-59-1), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 31 Aug 2005; provided in IDS 10/16/23), hereinafter 862210-59-1.
862210-59-1 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 4-[4-(3-chlorophenyl)-1-piperazinyl]-1-ethyl-3-nitro-2(1H)-quinolinone (CAS 862486-67-7), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 06 Sep 2005; provided in IDS 10/16/23), hereinafter 862486-67-7.
862486-67-7 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-methyl-3-nitro-4-(4-phenyl-1-piperazinyl)-2(1H)-quinolinone (CAS 862487-66-9), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 06 Sep 2005; provided in IDS 10/16/23), hereinafter 862487-66-9.
862487-66-9 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 4-[4-(3-chlorophenyl)-1-piperazinyl]-1-ethyl-3-nitro-2(1H)-quinolinone (CAS 862488-87-7), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 06 Sep 2005; provided in IDS 10/16/23), hereinafter 862488-87-7.
862488-87-7 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 4-[4-(4-methoxyphenyl)-1-piperazinyl]-1-methyl-3-nitro-2(1H)-quinolinone (CAS 874463-49-7), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 17 Feb 2006; provided in IDS 10/16/23), hereinafter 874463-49-7.
874463-49-7 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 4-[4-(4-fluorophenyl)-1-piperazinyl]-1-methyl-3-nitro-2(1H)-quinolinone (CAS 874463-50-0), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 17 Feb 2006; provided in IDS 10/16/23), hereinafter 874463-50-0.
874463-50-0 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 4-[4-(2-methoxyphenyl)-1-piperazinyl]-1-methyl-3-nitro-2(1H)-quinolinone (CAS 877647-18-2), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 22 Mar 2006; provided in IDS 10/16/23), hereinafter 877647-18-2.
877647-18-2 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-ethyl-4-[4-(2-fluorophenyl)-1-piperazinyl]-3-nitro-2(1H)-quinolinone (CAS 877808-10-1), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 23 Mar 2006; provided in IDS 10/16/23), hereinafter 877808-10-1.
877808-10-1 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 4-[4-(2-fluorophenyl)-1-piperazinyl]-1-methyl-2(1H)-quinolinone (CAS 896634-20-1), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 28 Jul 2006; provided in IDS 10/16/23), hereinafter 896634-20-1.
896634-20-1 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-methyl-4-[4-(5-methyl-2-thiazolyl)-1-piperazinyl]-3-nitro-2(1H)-quinolinone (CAS 2324027-31-6), CAS Registry File Accessed 01 Oct 2025 from STN, entered into STN 04 Jun 2019; provided in IDS 10/16/23), hereinafter 2324027-31-6.
2324027-31-6 teaches the following compound:
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which anticipates the instant claims as a species of instant Formula (I).
Claim(s) 1-4 and 10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent No. 11,866,430, hereinafter ‘430, which was published 09 Jan 2024 and claims priority to Provisional Application No. 62/690,444, filed 27 Jan 2018.
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
‘430 teaches the following chemical compounds which are species of the instant Formula (I):
Compound #
Compound Structure
Location in ‘430
21
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Column 125
46
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199
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Column 141
138
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Column 199
146
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Column 203
156
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Column 211
200
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Column 235
201
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Column 236
253
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Column 279
‘430 also teaches pharmaceutical compositions comprising compounds of the reference document and one or more non-toxic, pharmaceutically-acceptable carriers and/or diluents and/or adjuvants (column 24, lines 13-17) Thus, ‘430 anticipates the instant claims.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 11,866,430, hereinafter ‘430. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of ‘430 teaches compounds of reference Formula (I):
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which overlaps with the instant claims when reference variable R4 is 2,3-dihydro-1H-indenyl. The definitions of R1, R2, and R3 overlap with the instant claims. Reference claim 8 teaches compound species where R4 is 2,3-dihydro-1H-indenyl, specifically Compound 21, Compound 46, Compound 138, Compound 146, Compound 156, Compound 200, Compound 201, and Compound 253.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gura et al. (Science, 1997, 278:1041-1042), hereinafter Gura, Johnson et al. (Br J Cancer, 2001, 84:1424-1431), hereinafter Johnson, and Kunnumakkara et al. (Exp Biol Med, 2019; 244:663-689), hereinafter Kunnumakkara are considered pertinent for showing that cancer drug discovery is unpredictable in terms of anticancer drug screening, correlating in vitro tumor inhibition activity to in vivo studies, and the breadth of factors that cause cancer which makes treating all cancers with a single drug highly unpredictable.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625