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. Claims 1, 3-9, 14-15 and 18-27 are pending in the application.
3. 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 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.
Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claim 1 is rejected under 35 U.S.C. 103(a) as being obvious over Doverskog et
al. US 2016/0339040 A1, and Berglund et al. Hepatology v70, suppl. 1, 2019, or see
Berglund et al. CAS: 631815486, 2019.
Applicants claim a method for the treatment of fatigue or cognitive impairment, or a combination thereof, in a non-cirrhotic primary biliary cholangitis (PBC) patient, whereby the compound golexanolone (3α-ethynyl-3β-hydroxyandroxyandrostan-17-one oxime17-one oxime) of formula (I)
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, or a pharmaceutically acceptable salt thereof, is
administered to a patient in need of such treatment, see claim 1.
Determination of the scope and content of the prior art (MPEP §2141.01)
Doverskog et al. disclose that golexanolone is used for treating Type C hepatic
encephalopathy patients with cirrhosis, and cirrhosis cause fatigue and loss of energy
and cognitive impairment, see section [0034] and [0040] in column 3.
Berglund et al. ‘486 discloses that golexanolone is used for treating cognitive disorders.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Doverskog et al. and Berglund et al. ‘486 is that the instant claims are embraced within the scope of Doverskog et al. and Berglund et al. ‘486.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ the methods of use of Doverskog et al. and Berglund et al. ‘486 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Doverskog et al. and Berglund et al. ‘486 would possess similar activity to that which is claimed in the reference.
Double Patenting
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 1 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Doverskog et al. US 10,342,804, and over claim 1 of Alhadeff et al. US 11,123,351. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a method for the treatment of fatigue or cognitive impairment, or a combination thereof, in a non-cirrhotic primary biliary cholangitis (PBC) patient, whereby the compound golexanolone (3α-ethynyl-3β-hydroxyandroxyandrostan-17-one oxime17-one oxime) of formula (I)
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216
354
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, or a pharmaceutically acceptable salt thereof, is
administered to a patient in need of such treatment, see claim 1.
Doverskog et al. ‘804 claims a method of treating hepatic encephalopathy, comprising administering a pharmaceutically effective amount of 3α-ethynyl-3β-hydroxyandrostan-17-one oxime, method of treating hepatic encephalopathy, comprising administering a pharmaceutically effective amount of 3α-ethynyl-3β-hydroxyandrostan-17-one oxime,
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128
220
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, or a pharmaceutically acceptable salt thereof, to a patient in need thereof, wherein said hepatic encephalopathy is selected from the group consisting of minimal hepatic encephalopathy, overt hepatic encephalopathy, type A hepatic encephalopathy, type B hepatic encephalopathy and type C hepatic encephalopathy, and wherein the treatment comprises the co-administration of 3α-ethynyl-3β-hydroxyandrostan-17-one oxime with an ammonia-lowering compound. or a pharmaceutically acceptable salt thereof, to a patient in need thereof, wherein said hepatic encephalopathy is selected from the group consisting of minimal hepatic encephalopathy, overt hepatic encephalopathy, type A hepatic encephalopathy, type B hepatic encephalopathy and type C hepatic encephalopathy, and wherein the treatment comprises the co-administration of 3α-ethynyl-3β-hydroxyandrostan-17-one oxime with an ammonia-lowering compound, see column 23-24. It is noted that treating Type C hepatic encephalopathy patients are with cirrhosis, and cirrhosis cause fatigue and loss of energy and cognitive impairment.
Alhadeff et al. ‘351 claims a method for the treatment of hepatic encephalopathy, whereby the pharmaceutical formulation comprising a compound, i.e.,
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, is administered to a patient in need of such treatment, see claims 1 and 19 in columns 20-22. It is noted that Type C of hepatic encephalopathy patients are with cirrhosis, and cirrhosis cause fatigue and loss of energy and cognitive impairment.
The difference between instant claims and Doverskog et al. ‘804 and Alhadeff et al. ‘351 is that the instant claims are embraced within the scope of Doverskog et al. ‘804 and Alhadeff et al. ‘351.
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ the methods of use of Doverskog et al. ‘804 and Alhadeff et al. ‘351 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Doverskog et al. ‘804 and Alhadeff et al. ‘351 would possess similar activity to that which is claimed in the reference.
Claim Objections
6. Claims 3-9, 14-15 and 18-27 are objected to as being dependent on rejected claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to REI TSANG SHIAO whose telephone number is
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
January 26, 2026