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 .
Status of the Claims
Claims 1 – 2, 13 – 15, 25 – 32, 40, 45 and newly added claim 48 are pending.
Claims 15, 25 – 26, 28 and 30 – 32 are rejected.
Claims 27 and 48 are objected.
Claims 1 – 2, 13 – 14, 29, 40 and 45 are withdrawn.
Response to Applicant’s Remarks
Applicant’s remarks filed on March 27, 2026 have been fully considered.
The Improper Markush Grouping rejection of claims 15, 25 – 26 and 30 – 32 (claims 16 – 18 and 22 are cancelled) is withdrawn in view of amendments to recite proper Markush grouping such that the scope of variables R1 – R3, L and R5 – R9 is conserved across all species in the structure (II).
The rejection under 35 U.S.C. §112(b) of claims 25 – 28 and 30 – 32 (claims 16 – 18 and 22 are cancelled) is withdrawn in view of amendment to cancel claim 16, and limiting the instant claims to be dependent on claim 15.
The rejection under 35 U.S.C. §102(a)(1) of claims 15, 25 – 26 and 30 – 32 (claims 16 – 18 and 22 are cancelled) as being anticipated by CAS Registry RN 2129407-82-3 is withdrawn in view of amendment to recite the proviso, when two of R1, R2 and R3 taken together with the carbon to which they attach form a cycloalkyl (bicyclo[3.3.1]nonane) ring, and the other is H, then R8 or R9 is bromo”. Emphasis added.
The rejection under 35 U.S.C. §102(a)(1) of claims 15, 25 and 30 – 32 (claims 16 – 18 and 22 are cancelled) as being anticipated by CAS Registry RN 1789403-40-2 is withdrawn in view of amendment to recite the proviso, when three of R1, R2 and R3 taken together with the carbon to which they attach form a cycloalkyl (adamantyl) ring, then R6 is chloro”. Emphasis added.
Examination: Applicant’s amendments necessitate extending the search. The search has further extended to include the scope, wherein:
Each of Z1 and Z2 is independently CR8 or CR9,
R6 is chloro, and
One of R5 and R7 is chloro, and the other is H, or
each of R5 and R7 is H.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 27, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 15, line 8 of the claim: The phrase “L is an amide” is grammatically incorrect because it is missing proper punctuation mark (comma (,). In order to overcome the objection, Applicant may amend to insert a comma (,) at the end of the phrase “L is an amide”.
Claims 27 and 48 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.
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.
Claims 15, 25 – 26 and 30 – 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dornbush et al., Bioorg. Med. Chem. Lett. (2010), 20(17), pp. 5299-5301, cited in IDS dated January 24, 2023.
Dornbush et al. teach compound 11 as presented below:
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236
236
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. See, e.g., pp. 5300, Figure 1.
The prior art anticipates the genus of instant claims as presented below:
Claims 15 and 25 – 26, directed to a compound having the structure (II):
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252
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, wherein:
Three of R1, R2 and R3 taken together with the carbon to which they attach form a cycloalkyl (adamantyl) ring,
L is an amide,
Each of Z1 and Z2 is independently CR8 or CR9,
Each of R8 or R9 is H,
R6 is chloro, and
One of R5 and R7 is chloro, and the other is H.
Claim 28, wherein the compound has the structure:
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242
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.
With respect to claims 30 – 32, the limitations “for systemic administration”, “for oral administration” and “as a sustained release dosage form” are intended use limitations as governed by MPEP §2111.02(II). In this case, the intended uses only require that the compound is capable of being used for systemic administration, for oral administration and as a sustained release dosage form, but does not impart any specific limitations to the structure. Based on the teachings of Dornbush et al., compound 11 is capable of being used for systemic administration, for oral administration and as a sustained release dosage form.
Claims 15 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al., Tetrahedron (2018), 74: pp. 3712-3718 (publ. online May 21, 2018).
Han et al. teach compound 3cd as presented below:
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284
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. See, e.g., pp. 3713, Table 3.
The prior art anticipates the genus of instant claims as presented below:
Claims 15 and 25, directed to a compound having the structure (II):
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252
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, wherein:
Three of R1, R2 and R3 taken together with the carbon to which they attach form a cycloalkyl (adamantyl) ring,
L is an amide,
Each of Z1 and Z2 is independently CR8 or CR9,
Each of R8 or R9 is H,
R6 is chloro, and
Each of R5 and R7 is H.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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