DETAILED ACTION
This office action is in response to applicant’s filing dated November 24, 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 – 3 and 6 - 23 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of invention Group I, claims 1-3, 6, 12, and 18, directed to a compound of Formula I or Formula II, in the reply filed on November 24, 2025 is acknowledged.
Claims 7 – 11, 13 – 17, and 19 – 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 November 24, 2025.
Applicant’s election without traverse of invention compound of formula:
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as a single species, in the reply filed on November 24, 2025 is acknowledged.
Upon performing the search of prior art Examiner detected compounds related to non-elected species. Hence, the election of species has been withdrawn and examination will proceed to the full scope of claims 1-3, 6, 12, and 18, Group I invention.
Claims 1-3, 6, 12, and 18 are under consideration in the present office action.
Priority
The present application is a 371 of PCT/US2021/046117, filed August 16, 2021, which claims the benefit of priority to U.S. Provisional Application No. 63/065,766, filed August 14, 2020, U.S. Provisional Application No. 63/178,350, filed April 22, 2021, and U.S. Provisional Application No. 63/229,392, filed August 4, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/30/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schönbrunn et al (WO 2017/066428 A1, cited in IDS, filed 05/30/2023, hereinafter Schönbrunn).
Instant claims are drawn to a compound of genus formula I
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or formula II
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, where R1 is selected from C1-C6 alkyl, C3-C6 cycloalkyl, and aryl; R2- is selected from hydrogen and halo; R3 is selected from C1-C6 alkyl and halo; R4 is selected from C1-C6 alkoxy, aryloxy, and C3-C6 cycloalkyoxy; R5 and R7 is C1-C6 alkoxy, C3-C6 cycloalkoxy,C1-C6 alkyl, halo, cyano, and hydroxy; L is selected from a bond, C1-C3 alkyl, or -O-(C1-C3 alkyl)-; R6 is selected from optionally substituted C4-C8 heterocycle or optionally substituted heteroaryl; m is 0 or 1; n is 0, 1 or 2. The exemplary compounds of formula I(II) are:
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,
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. Instant claims are further directed to a pharmaceutical composition comprising compounds of formula I(II) and pharmaceutically acceptable carrier.
Schönbrunn teaches compounds of genus formula (I)
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, where R3a and R3b is hydrogen, L1 is (CH2)n, where n is 0 or 1; R5a, R5b, R5d, and R5e are independently hydrogen, C1-C6 alkoxy, C1-C6 alkyl, hydroxy (page 12, lines 5 – 19); R5c is -L2Q2, where L2 is (CH2)n, n is 0 or 1 and Q2 is heterocyclyl, e.g.:
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(page 16, lines 11 – 15); Q1 is
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wherein R6a, R6b, R6c, R6d, R6e are independently hydrogen, halogen or (CH2)nSO2R3d, R3d is substituted or unsubstituted C1-C10 alkyl, substituted or unsubstituted C3-C10 cycloalkyl, substituted or unsubstituted C6-C12 aryl (page 13, lines 9 – 20). The exemplary compounds of Schönbrunn are:
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(MA2-014, page 48, Table 1),
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(SG3-014, page 56, Table 1),
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(SG3-059-01, page 57, Table 1),
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(MA4-012-1, page 60, Table 1). Schönbrunn further teaches pharmaceutical compositions that comprise a compound of formula (I) in combination with a pharmaceutically acceptable carrier (page 81, lines 21 - 22).
Thus, since Schönbrunn teaches compounds of the same core, as well as all the structural elements in the same positions as instantly claimed compounds, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention, to combine teachings of prior art and make various known compounds of similar structure, to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an active pharmaceutical agent possessing similar or improved desired properties with the reasonable expectation of success.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 6 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, 8, 10 – 15, 18 and 20 of U.S. Patent No. US 10106507 B2 in view of Schönbrunn et al (WO 2017/066428 A1, cited in IDS, filed 05/30/2023).
Instant claims are drawn to a compound of genus formula I
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or formula II
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, where R1 is selected from C1-C6 alkyl, C3-C6 cycloalkyl, and aryl; R2- is selected from hydrogen and halo; R3 is selected from C1-C6 alkyl and halo; R4 is selected from C1-C6 alkoxy, aryloxy, and C3-C6 cycloalkyoxy; R5 and R7 is C1-C6 alkoxy, C3-C6 cycloalkoxy,C1-C6 alkyl, halo, cyano, and hydroxy; L is selected from a bond, C1-C3 alkyl, or -O-(C1-C3 alkyl)-; R6 is selected from optionally substituted C4-C8 heterocycle or optionally substituted heteroaryl; m is 0 or 1; n is 0, 1 or 2. The exemplary compounds of formula I(II) are:
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,
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. Instant claims are further directed to a pharmaceutical composition comprising compounds of formula I(II) and pharmaceutically acceptable carrier.
Claims of U.S. Patent No. US 10106507 B2 are directed to a compound of formula (IIA)
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, where X is nitrogen, R1 is C1-C6 alkyl, such as methyl, or halogen; R2 is hydrogen; R3 is NHSO2R5, where R5 is C1-C6 alkyl, C3-C6 cycloalkyl, n is 1 and wherein R3 is in meta position; C6 is C1-C6 alkyl, such as methyl, R7 is hydrogen, C1-C6 alkoxy, C1-C6 alkyl, halide, cyano, and hydroxy; R8 is -OH or =O and p is 0. Patented claims are also directed to a pharmaceutical composition, comprising compound of formula (IIA) and pharmaceutically acceptable carrier.
Although compound of formula (IIA) of U.S. Patent No. US 10106507 B2 have variable R3 in meta position, while instant compounds of formula II (claim 2) have an equivalent variable in para position, Schönbrunn teaches compounds of genus formula (I)
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, where R3a and R3b is hydrogen, L1 is (CH2)n, where n is 0 or 1; R5a, R5b, R5d, and R5e are independently hydrogen, C1-C6 alkoxy, C1-C6 alkyl, hydroxy (page 12, lines 5 – 19); R5c is -L2Q2, where L2 is (CH2)n, n is 0 or 1 and Q2 is heterocyclyl, e.g.:
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(page 16, lines 11 – 15); Q1 is
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where any of R6a, R6b, R6c, R6d, R6e are independently hydrogen, halogen, (CH2)nSO2R3d, R3d is substituted or unsubstituted C1-C10 alkyl, or substituted or unsubstituted C3-C10 cycloalkyl, (page 13, lines 9 – 20).
Thus, since Schönbrunn teaches compounds of the same core, as well as all the structural elements in the same positions as instantly claimed compounds, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention, to combine teachings of prior art and make various known compounds of similar structure, to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an active pharmaceutical agent possessing similar or improved desired properties with the reasonable expectation of success.
Conclusion
Claims 1-3, 6, 12, and 18 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./ Examiner, Art Unit 1691
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691