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 .
DETAILED ACTION
Priority and Status of Claims
1. This application is a CIP of PCT/US2021/072851 12/10/2021, , which claims benefit of the provisional application 63124677 12/11/2020.
2. Amendment of claims 1-2, 4, 8-9 and 15-20, and cancelation of claims 3, 5-7, 10-14, 21-49, 52-152, 183-184, 186, 188-191, 193-198 ad 200-203 in the amendment filed on 1/23/2026 is acknowledged. Claims 1-2, 4, 8-9, 15-20, 50-51, 153-182, 185, 187, 192 and 199 are pending in the application.
Responses to Amendments/Arguments
3. Applicant's arguments regarding the rejection of claim 1 under 35 U.S.C. 103 (a) over Lynch et al. have been fully considered but they are not persuasive.
Applicants state “Claim 1 of the previously pending claims was directed to methods of treating a patient having Friedreich's ataxia comprising administering a therapeutically effective amount of omaveloxolone, wherein the patient is further defined as not currently taking a cytochrome P450 3A4 (CYP3A4) modulator. Claim 1 has been amended with this response to further define the patient as in need of therapy with a drug that functions as a CYP3A4 modulator and the claimed methods as comprising avoiding or discontinuing concomitant use or co-administration of the drug that functions as a CYP3A4 modulator and the compound.”, see page 9.
However, the instant claim 1 does not clearly limit the subpopulation of patients, who are previously or currently under an administration with CYP3A4 or with CYP3A4 and the instant compound omaveloxolone. Incorporation of the limitation of claim 2 into claim 1 would obviate the rejection.
Claim Objections
4. Claims 2, 4, 8-9, 15-20, 50-51, 153-182, 185, 187, 192 and 199 are objected as being dependent on rejected claim 1.
5. THIS ACTION IS MADE FINAL. 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 extension fee 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.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
March 09, 2026
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