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 18494754 10/25/2023 PAT 12090155, which is a CON of 16/922,893 07/07/2020, ABN, which claims benefit of 62/871,170 07/07/2019.
2. Claims 1-28 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).
Claim 1 is rejected under the judicially created doctrine of obviousness-
type double patenting as being unpatentable over claim 1 of Mates et al. US 12,090,155, and over claims 1, 6 and 9 of Davis et al. US 12,478,623 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 for the treatment of Bipolar II Disorder, comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone, in free or pharmaceutically acceptable in mono-tosylate salt form, wherein the method comprises once daily administration of the lumateperone mono-tosylate in an amount equivalent to 6 to 60 mg of lumateperone free base, see claim 1.
Mates et al. ‘155 claims a method for the treatment of a major depressive episode associated with Bipolar II Disorder, comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone in mono-tosylate salt form, wherein the method comprises once daily administration of a tablet or capsule comprising about 60 mg of lumateperone mono-tosylate in combination or association with a pharmaceutically acceptable diluent or carrier, see claim 1 in column 14.
Davis et al. ‘623 discloses a compound/composition cpmprising a compound of formula (I), i.e.,
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, wherein Y is -C(=O)-, X is -N(CH3)-, in free , or pharmaceutical acceptable salt selected from monotosylate, and methods of use for treating bipolar disorder, see claims 1, 6 and 9 in columns 32-34.
The difference between instant claims and Mates et al. ‘155 and Davis et al. ‘623 is that the instant claim is embraced within the scope of Mates et al. ‘155 and Davis et al. ‘623.
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 Mates et al. ‘155 and Davis et al. ‘623 to obtain instant invention.
Moreover, the amount of a specific amount of ingredient lumateperone mono-tosylate the instant composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, optimization of parameters (dose, administration strategy) from known compositions and methods of use of Mates et al. ‘155 and Davis et al. ‘623 is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results based on factors such as the severity of the condition being treated for Bipolar II disorder, see MPEP 2144.05. Therefore Mates et al. ‘155 and Davis et al. ‘623 render obviousness over the instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Mates et al. ‘155 and Davis et al. ‘623 would possess similar activity to that which is claimed in the reference.
Claim Objections
4. Claims 2-28 are objected to as being dependent on rejected claim 1.
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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