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 the Claims
1. This application is a 371 PCT/EP2022/060260 04/19/2022, which claims benefit of the foreign application: EPO EP21169388.2 04/20/2021.
2. Amendment of claims 1, 3 and 20-23, and cancelation of claims 2, 10-13 and 16-17 in the amendment filed on 8/3/2026 is acknowledged. Claims 1, 3-9, 14-15 and 18-27 are pending in the application.
Responses to Amendments/Arguments
3. Since Doverskog et al. and Berglund et al. ‘486 do not disclose the instant methods of use, therefore they are distinct from the instant invention. The rejection of claim 1 under 35 U.S.C. 103 (a) over Doverskog et al. and Berglund et al. ‘486 has been overcome in the amendment filed on 8/3/2026.
4. Applicant's arguments regarding the rejection of claim 1 under the obviousness-type double patenting over Doverskog et al. ‘804 and Alhadeff et al. ‘351 have been fully considered but they are not persuasive.
Applicants state “Applicant believes that the Examiner intended to point to claim 19 of the '351 patent, which is directed towards a method of the treatment of hepatic encephalopathy. This is how alleged claim 1 of the '351 patent is described by the Examiner on page 7 of the Office Action. However, claim 1 of the '351 patent is directed towards a pharmaceutical formulation comprising golexanolone. The '804 patent is within the same family of Doverskog cited above in the 103 rejection, and is directed towards a method of treating hepatic encephalopathy. Similarly, claim 19 (see note above) of the '351 patent is also directed towards a method of treating hepatic encephalopathy. As discussed above, hepatic encephalopathy and PBC are different and distinct diseases with a substantially different underlying pathophysiology. The treatment of hepatic encephalopathy patients with golexanolone cannot be extrapolated to PBC patients merely on the basis that both diseases are somehow related to the liver. The '804 patent does not provide any suggestion or motivation that golexanolone may be effective in the treatment of fatigue in non- cirrhotic cholestatic patients suffering from the autoimmune disease PBC.”, see page 9.
However, it is noted that Doverskog et al. ‘804 claims methods of use for treating
hepatic encephalopathy and fatigue, comprising administering a pharmaceutically effective amount of 3α-ethynyl-3β-hydroxyandrostan-17-one oxime, see columns 23-24 and 6. Therefore Doverskog et al. ‘804 still renders obviousness over the instant invention.
Alhadeff et al. ‘351 claims a composition comprising a compound, i.e.,
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, is administered to a patient in need of such treatment for hepatic encephalopathy and congnitive impairment, see column 9 and 20-22. Therefore Alhadeff et al. ‘351 still renders obviousness over the instant invention. The rejection of claim 1 under the obviousness-type double patenting over Doverskog et al. ‘804 and Alhadeff et al. ‘351is maintained. Applicants are requested to file a terminal disclaimer to overcome the rejection.
Claim Objections
5. Claims 3-9, 14-15 and 18-27 are objected to as being dependent on rejected claim 1.
6. 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
August 25, 2026
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