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 .
Priority
This application filed on 09/15/2023 is a U.S. National Stage filing under 35 U.S.C. Q 371 of International Application No. PCT/US2022/020364, filed on 03/15/2022, which claims the benefit of priority to U.S. Provisional Applications No. 63/161,129, filed on 03/15/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 05/12/2025, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
Applicant’s amendment and arguments filed on 08/24/2026 have been received and have been fully considered. Claims 26 and 29 were amended and claims 27-28, 30-34 were cancelled and claims 1-25 were previously cancelled. Claims 26, 29, and 35-45 are pending.
Election/Restriction
Applicant’s response filed on 04/03/2026 to Restriction/Election Requirement filed on 02/03/2026, is acknowledged. Applicant elected without traverse Group I drawn to a compound of formula I, II, Ia, Ib, Ic, Id, Iaa, Iaaa1, Iaaa2, Iaaa3, Iaaa4, Iaaa5, Iba, Ibaa1, Ibaa2, Ibaa3, Ibaa4, or Ibaa5. Claims 26 and 29 read on the elected Group. Claims 35-45 of Group II are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pursuant to the Election of Species Requirement, Applicant respectively elected without traverse, (1S,4S)-N-(tert-butyl)-5-(5-(5-(trifluoromethyl)-1,2,4-oxadiazol-3-yl) pyridin-2-yl)-2,5- diazabicyclo [2.2.1] heptane-2-carboxamide depicted below for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable:
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Claims 26 and 29 read on the elected species. Applicant’s elected species was searched, and determined to be free of the art of record. Pursuant to MPEP § 803.02, the search and examination was extended to the non-elected species discussed below, which new search species falls within the scope of instant claims 26 and 29 (i.e., claims to proper Markush groupings that include both the new search species as well as the originally elected species. MPEP § 803.02(III)(C)(2)). The new search species underlies rejections of these claims pursuant to 35 U.S.C. § 102. As such, the election of species requirement is maintained as provisional, and claims 35-45 are provisionally withdrawn from consideration pursuant to 37 CFR 1.142(b). See, MPEP § 803.02.
Thus, claims 26, 29 and 35-45 are pending with claims 35-45 are withdrawn from further consideration, and claims 26 and 29 are under consideration.
Withdrawn Abstract Objection
Objection to the Abstract for improper language is withdrawn in view of Applicant amendment to the Abstract filed on 08/24/2026.
Withdrawn Claims Objection
Objection to claim 26 for repeating the term “aryl”, is withdrawn in view of Applicant amendment to claim 26 filed on 08/24/2026.
Withdrawn Rejections 35 U.S.C. 112(b)
Rejection to claims 29 and 34 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn in view of Applicant amendment filed on 08/24/2026 that cancelled claim 34 and amended claim 29 by removing reference to Table.
Claim Rejections - 35 USC § 112(a)- Written Description
Rejection to claims 26-34 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in view of Applicant amendment filed on 08/24/2026 that amended claim 26 to support applicant possession of the claimed invention. 112a written Description to the claim 26 for reciting the term “prodrug” is withdrawn in view of Applicant amendment filed on 08/24/2026 that removed the term.
Withdrawn Claim Rejections — Improper Markush Group
Rejection to claims 26-34 on the judicially-created basis that it contains an improper Markush grouping of alternatives, is withdrawn in view of Applicant amendment filed on 08/24/2026 that amended claim 26 to remove the improper Markush grouping.
Withdrawn Claim Rejections - 35 USC § 102
Rejection to claims 26, 30, 32, and 33 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by S. Ghosh, et al. (WO2013/066831A1, 05/10/2013), is withdrawn in view of Applicant amendment filed on 08/24/2026 that amended R10 of claim 26 to include only bicyclic rings.
Rejection to claims 26, 30, 32, and 33 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by A. Walji et al. (WO 2017/222951A1, 12/28/2017), is withdrawn in view of Applicant amendment filed on 08/24/2026 that amended R10 of claim 26 to include only the bicyclic rings recited in the claim.
New Rejection Necessitated by the Amendment
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 26 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by M. Baroni et al. US PG PUB 2012/0245150A1, 09/27/2012, “Baroni” cited in the PTO-892).
Baroni discloses compounds tert-Butyl 8-[5-(N-hydroxycarbamimidoyl)pyridin-2-yl]-3,8-diazabicyclo[3.2.1]octane-3-carboxylate [0306]:
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268
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Baroni's compound above anticipates instant claim 26 compound of Formula (II), wherein:
R7 is CH; R8 is CH; R9 is
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; and R10 is
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.
Baroni also discloses compound tert-Butyl 8-(5-cyanopyridin-2-yl)-3,8-diazabicyclo[3.2.1]octane-3-carboxylate [0305]:
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246
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Baroni's compound above anticipates instant claim 26 compound of Formula (II), wherein:
R7 is CH; R8 is CH; R9 is cyano; and R10 is
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42
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.
Objection to claims
Claim 29 is 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.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The closest prior art is considered to be S. Ghosh, et al. (WO2013/066831A1, 05/10/2013 "Ghosh" cited in the IDS dated 05/12/2025).
Ghosh discloses compounds for the treatment of diseases or conditions ameliorated by inhibition of HDAC, i.e., HDAC6, activity and pharmaceutical compositions comprising these compounds [Pg. 1, In. 5-8, 18]. Ghosh discloses, for example, compound of Example 25 [Pg. 64, In. 23]:
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Ghosh’s above compound reads on instantly claimed compound of claim 29 below wherein R7 is N; R8 is CH; R9 is
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; and differs in R10 as depicted in the below table:
[Ghosh’s compound Ex. 25]
Instant claim 29 compound
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In order to arrive at a compound of claim 29, for example the compound above, one of ordinary skill in the art would have to modify Ghosh’s compound of Ex. 25 above and replace the highlighted monocyclic dinitrogen ring with bicyclic dinitrogen ring to arrive a compound of instant claim 29. However, Ghosh’s disclosure does not provide sufficient guidance and motivation to one of ordinary skill in the art to perform the functional modifications to arrive at the instant claim 29 compounds. Therefore, Ghosh does not anticipate or render claim 29 obvious.
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 26 is rejected and claim 29 is objected to.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/
Supervisory Patent Examiner, Art Unit 1622
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