DETAILED ACTION
A non-final Office action was mailed 11 September 2025 (“Office Action”).
Applicant’s reply to the Office Action was received 10 December 2025 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1, 7, 10, 14, 16–19, 23, 24, 29–31, 33, 35, 81, 87–89, 94, 96, and 118–128 are pending.
Claims 1, 16, 17, 35, 81, 87, 88, and 94 are amended.
Claims 118–128 are new.
Claims 7, 14, 18, 19, 23, 29, and 33 are withdrawn.
Claims 2–6, 8, 9, 11–13, 15, 20–22, 25–28, 32, 34, 36–80, 82–86, 90–93, 95, and 97–117 are canceled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted with the Reply is acknowledged and has been considered.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Objections
Claims 1, 35, 118, and 120 are objected to for minor informalities.
The claims are directed to a method of treating Krabbe’s disease and/or globoid cell leukodystrophy. Those terms are redundant; i.e., they are the same disease. (Spec., 2:6–7) (page:lines).
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 102
(i) Claims 1, 10, 81, and 122 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by US 2007/0225292 A1 (“Amin”).
Amin discloses the compounds below that read on instant formula (IA) as follows:
A1 = N; A2, A3, A4 = CH;
R2a’ = -C1-4alkyl-C6-10 aryl (methylene-naphthyl), the C1-alkyl is substituted with (=O);
R1a = heterocycle or alkyl-heterocycle.
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176
181
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211
211
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(Amin, pp. 28–29).
Amin discloses pharmaceutical compositions comprising the compounds. (Id., e.g., ¶¶224–237; p.147, cl. 17).
Amin discloses a method of treating diseases, such as Parkinson’s disease, with the compounds. (Id., e.g., ¶¶210–213; p.147, cl. 15).
Amin discloses using the compounds in combination with additional therapeutic agents. (Id., ¶214).
In the Office Action, the claims were rejected over the above compounds in Amin, but based on a different combination of variables [R2a’ = C(O)Raa’].
(ii) Claims 87 and 94 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by US 8,058,455 (“Tasker”).
Tasker discloses compounds that read on instant formula (IIA) as follows:
A4 = N; A1, A2, A3 = CH or CR3a; R3a = halogen [Tasker R2];
R2a’ = SO2Raa’; Raa’ = heteroaryl [Tasker Y-R];
R1a = aryl substituted with halogen [Tasker R1].
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229
617
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201
612
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(Tasker, Table 5, 201–204) (columns).
Tasker discloses pharmaceutical compositions comprising an excipient and a compound of formula (IIa). (Id., 47:58–62) (col:lines).
Summary
Claims 7, 14, 18, 19, 23, 29, and 33 remain withdrawn.
Claims 1, 10, 81, 87, 94, and 122 are rejected.
Claims 1, 35, 118, and 120 are objected.
Claim 89 is allowed.
Claims 16, 17, 24, 30, 31, 35, 88, 96, 119, and 121–128 would be allowable if amended into independent form and/or if the issues identified above are resolved.
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 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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