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 CON of 17/843,028 06/17/2022 PAT 12109201, which is a CON of 17/024,127 09/17/2020 PAT 11395817, which is a CON of 16/789,709 02/13/2020 PAT 10799485, which is a CON of 16/447,300 06/20/2019 PAT 10603308, which is a CON of 16/356,517 03/18/2019 PAT 10363246, which is a CON of 16/013,500 06/20/2018 ABN, which is a CON of 15/673,737 08/10/2017 ABN, which claims benefit of 62/490,293 04/26/2017, and claims benefit of 62/373,589 08/11/2016.
2. Claims 1-20 are pending in the application.
Double Patenting
3. 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).
Claims 1-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable independently over claims 1 and 19 of During’s US 12,109,201, over claims 1 and 21 of During’s US 11,395,817, over claim 1 of During’s US 10,799,485, and over claims 1-13 of During’s US 10,603,308 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a method of treating Rett syndrome (i.e., seizure) comprising administering to a patient diagnosed with Rett syndrome a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof, see claim 1. Dependent claims 2-20 further limit the scope of methods, i.e., specific dose of ganaxolone and administration strategy.
During’s ‘201 claims a method of treating status epilepticus (i.e., seizure) comprising administering to a human patient diagnosed with status epilepticus an effective amount of ganaxolone, wherein the effective amount of ganaxolone is administered by a combination of a first intravenous dose and a second dose continuous infusion, and wherein the effective amount provides a consistent ganaxolone plasma concentration of about 500 ng/ml and provides improvement of at least one symptom of the human patient for at least 8 hours after administration, see claim 1 in column 38.
During’s ‘201 claims a method of treating status epilepticus comprising administering to a human patient diagnosed with status epilepticus a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition is administered intravenously to provide about 500 mg to 1000 mg/day ganaxolone and improves at least one symptom for more than 12 hours after administration of the pharmaceutical composition to the patient, see claim 19 in column 40.
During’s ‘817 claim a method of treating status epilepticus (i.e., seizure) comprising administering to a patient in need thereof a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof, or administered intravenously see claims 1 and 21 in columns 38 and 40 .
During’s ‘485 claims a method of treating PCDH19 related epilepsy (i.e., seizure)
comprising administering to a patient in need thereof a pharmaceutical composition
comprising ganaxolone or a pharmaceutically acceptable salt thereof, see column 38.
During’s ‘308 claims a method of treating CDKL5 deficiency disorder comprising administering to a patient in need thereof a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the patient is administered up to 1,800 mg of ganaxolone per day. The CDKL5 deficiency disorder is
frequency of seizures, the severity of seizures, or a combination thereof (i.e., epilepsy), see columns 38-39.
The difference between instant claims and During’s ‘201, ‘817, ‘485 and ‘308 is that the instant claims are embraced within the scope of During’s ‘201, ‘817, ‘485 and ‘308. It is noted that epilepsy affects up to 90% of individuals with Rett syndrome, with status epilepticus (prolonged or continuous seizures lasting over five minutes) occurring in up to 40% of patients.
One having ordinary skill in the art would find the claims 1-20 prima facie obvious because one would be motivated to employ the methods of use of During’s ‘201, ‘817, ‘485 and ‘308 to obtain the instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of During’s ‘201, ‘817, ‘485 and ‘308 would possess same activity to that which is claimed in the reference.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 27, 2026
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