DETAILED ACTION
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 .
Response to RCE
A request for continued examination under 37 CFR 1.114, including the fee set forth in
37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible
for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has
been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37
CFR 1.114.
Priority
The instant application is a 371 National Stage Entry of PCT/US2020/031608 filed on May 6, 2020 which claims benefit to domestic application Nos. 62/857,598 filed on June 5, 2019 and 62/843,801 filed on May 6, 2019.
Status of Claims
Acknowledgement is made of amended (33) and cancelled (10, 13-16 21, 24, 26-27) claims filed November 12, 2025. Claims 1-4, 6-8, 18, 29, 31-33 are pending.
Information Disclosure Statement
The information disclosure statements filed on March 30, 2026 have been considered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 states m is 0, which would indicate Y is never present, but the claim states Y is N or CR7 and Formula I includes Y and m. For clarity, it would help if Formula I were redrawn omitting Y and including the unsaturated bond required by ring A, and the limitations of Y and m excluded from the claim since they are no longer relevant.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN1.
STN teaches CAS# 2286545-88-6, CAS# 2286545-84-2, CAS# 2286542-56-9, CAS# 2286520-86-1, and CAS# 2286465-44-7.
CAS# 2286545-88-6
Instant Formula I
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140
288
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150
274
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CAS# 2286545-88-6 reads on instant Formula I when R1 is a C1 alkyl substituted with R8 and R8 is alkoxy specifically methoxy, R1' is H, R2 is H, R2' is H, R3 is H, R4 is H, R5 is H, R6 is alkylcycloalkyl specifically cyclopropyl, m is 0, Z is CH2, and X is C.
CAS# 2286545-84-2
Instant Formula I
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138
330
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150
274
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CAS# 2286545-84-2 reads on instant Formula I when R1 is a C1 alkyl substituted with R8 and R8 is alkoxy specifically methoxy, R1' is H, R2 is H, R2' is H, R3 is H, R4 is H, R5 is H, R6 is alkylaryl specifically methylene-fluorophenyl, m is 0, Z is CH2, and X is C.
CAS# 2286542-56-9
Instant Formula I
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140
370
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150
274
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CAS# 2286542-56-9 reads on instant Formula I when R1 is a C1 alkyl substituted with R8 and R8 is alkoxy specifically methoxy, R1' is H, R2 is H, R2' is H, R3 is H, R4 is H, R5 is H, R6 is alkylheteroaryl specifically ethylene-benzo[d]thiazole, m is 0, Z is CH2, and X is C.
CAS# 2286520-86-1
Instant Formula I
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156
326
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150
274
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CAS# 2286520-86-1 reads on instant Formula I when R1 is a C1 alkyl substituted with R8 and R8 is alkoxy specifically methoxy, R1' is H, R2 is H, R2' is H, R3 is H, R4 is H, R5 is H, R6 is alkylcycloalkyl specifically cyclohexane, m is 0, Z is CH2, and X is C.
CAS# 2286465-44-7
Instant Formula I
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138
284
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150
274
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CAS# 2286465-44-7 reads on instant Formula I when R1 is a C1 alkyl substituted with R8 and R8 is alkoxy specifically methoxy, R1' is H, R2 is H, R2' is H, R3 is H, R4 is H, R5 is H, R6 is alkylheteroaryl specifically methylene-isoxazole, m is 0, Z is CH2, and X is C.
Examiner’s Note: omitting “alkoxy” as a substituent for R8 would overcome this rejection.
Claims 1-4, 8, 29, 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/150119 A12.
Regarding claims 1-4, 8, and a compound of Formula I, WO’110 teaches species of Formula I (see WO’119 at p. 102, Example 27).
WO’119 Compound 27
Instant Formula I
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114
294
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150
274
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WO’119 Compound 27 reads on instant Formula I (and Formula II) when X is C, m is 0, Z is CH2, one of R1 or R1’ is joined with one of R2 or R2’ to form an aryl, specifically phenyl and is substituted with one R9 and R9 is H, R3 is OR10, R10 is H, R4 is C1 alkyl, R5 is C1 alkyl, R6 is
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54
92
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.
Regarding claim 29 and a composition, WO’119 teaches compositions comprising disclosed compounds and a pharmaceutically acceptable carrier or diluent (WO’119 claim 41).
Regarding claims 31-32 and inhibiting USP19, WO’119 teaches compounds for inhibiting USP19 including diabetes and muscular atrophy (see WO’119 at Title, and claims 49-50).
Examiner’s Note: omitting H as a substituent option for R9 (claim 1), omitting H as a substituent option for one or both of R13, R14 (claim 4), and rewriting claim 33 in independent form, would appear to overcome this rejection.
Allowable Subject Matter
Claims 6-7, 18 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.
Regarding claims 6-7, drawn to a compound of Formula II, the closest prior art to a compound of Formula II is JP 2002/047272 A3 which teaches CAS# 377081-14-6 (see JP’272 at p. 18 right col. Compound 37) or WO 2011/006794 A14 which teaches CAS# 1262417-76-4 (see WO’794 at p. 34 lines 29-30). The point of novelty appears to be the lack of a second carbonyl on instant Ring A or the limitations of R18 (optionally substituted alkylcycloalkyl, alkylphenyl, and alkylheteroaryl).
Instant Formula II
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130
147
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CAS# 377081-14-6
CAS# 1262417-76-4
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No clear suggestion or motivation was found to remove the second carbonyl to arrive at an anticipatory or obvious compound.
Regarding claim 18 and a compound drawn to Formula IV, the closest prior art to a compound of Formula IV is WO’119. WO’119 teaches structurally similar Compound 40, CAS# 2367630-14-4 (see WO’119 at p. 109). Applicant arguments regarding no clear motivation to add the double bond required in instant ring A were convincing.
Instant Compound 29
CAS# 2531753-50-9
WO’119 Compound 40
CAS# 2367630-14-4
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Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1-4, 6-8, 18, 29, 31-33 are objected to.
Claims 1-2, 4, 8, 29, 31-32 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./ Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 STN refers to:
CAS 2286545-88-6. CAS Registry File Accessed June 23, 2026 from STN, entered into STN March 15, 2019. Correlates with Cite No. 1 in the IDS filed 3/30/26.
CAS 2286545-84-2. CAS Registry File Accessed June 23, 2026 from STN, entered into STN March 15, 2019. Correlates with Cite No. 2 in the IDS filed 3/30/26.
CAS 2286542-56-9. CAS Registry File Accessed June 23, 2026 from STN, entered into STN March 15, 2019. Correlates with Cite No. 3 in the IDS filed 3/30/26.
CAS 2286520-86-1. CAS Registry File Accessed June 23, 2026 from STN, entered into STN March 15, 2019. Correlates with Cite No. 4 in the IDS filed 3/30/26.
CAS 2286465-44-7. CAS Registry File Accessed June 29, 2026 from STN, entered into STN March 15, 2019. Correlates with Cite No. 5 in the IDS filed 3/30/26.
2 Cited in a previous Office Action.
3 Cited in previous Office Action.
4 Cited in previous Office Action.
Prosecution Insights