DETAILED ACTION
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 .
Status of the Application
Claims 1, 3-5, 8, 10-12, 14-17, 19-20, and 35-43 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 04/13/2026 are acknowledged. Claims under consideration in the instant office action are claims 1, 3-5, 8, 10-12, 14-17, 19-20, and 35-43.
Applicants' arguments, filed 04/13/2026, with respect to claims 1, 3-5, 8, 10-12, 14-17, and 19-34 have been considered but are moot due to Applicant’s amendments. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. Due to Applicant’s amendments, the rejection of the claimed invention in view of Vyas et al., Berecz et al., and Li has been reintroduced. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 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.
Claims 1, 4-5, 8, 10-12, 14-17, 19-20, 35-40, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Vyas et al. (An evaluation of lumateperone tosylate for the treatment of schizophrenia, Expert Opinion on Pharmacotherapy, published 11/30/2019, 21:2, pp. 139-145, as disclosed in IDS) in view of Berecz et al. (WO 2019/102240, already of record).
Vyas et al. is drawn towards an evaluation of lumateperone tosylate for the treatment of schizophrenia (see abstract). Vyas et al. teaches treating schizophrenia patients aged 18-60 years receiving 60 mg once daily, and that peak D2RO for 60 mg lumateperone was 39%, which is lower than other second-generation antipsychotics at their effective doses and probably contributes to the favorable safety and tolerability profile of lumateperone, with no clinically significant changes in vital signs, cardiometabolic measurements and a reduced risk for movement disorders and hyperprolactinemia (pg. 142, right column, first paragraph). Vyas et al. teaches that 'atypical' or second-generation antipsychotics such as risperidone can still result in side effects including dyslipidemia, hypotension, weight gain, sexual dysfunction, and metabolic side effects including elevated lipids and diabetes mellitus, which has led to a need for a drug with a benign adverse effect profile (pg. 140, left column, second and third paragraph). As a consequence, it would follow that one of ordinary skill in the art would administer lumateperone to treat patients that have previously been treated with atypical antipsychotics and suffer from diabetes mellitus, dyslipidemia, or weight gain in order to avoid such side effects. Vyas et al. discloses the administration of discrete amounts of lumateperone (see Table 1), which reads on the limitation wherein lumateperone is administered without dose titration. Vyas et al. teaches that at 60 mg, lumateperone also reduced PANSS positive symptom score of schizophrenia as compared to placebo (pg. 142, left column, first paragraph). Regarding claims 4-5, Vyas et al. is silent as to the recited subpopulations of schizophrenia patients, and would not be precluded from the methods of treatment for the general schizophrenia patient population as disclosed in Vyas et al. Regarding claims 5 and 37, Vyas et al. is silent as to patients under concomitant treatment with a CYP3A4 inducer or wherein the patient does not have moderate or severe hepatic impairment, which would read on the limitations of claim 5.
Vyas et al. does not teach lumateperone tosylate in the crystalline form or formulated in a capsule.
Berecz et al. is drawn towards the manufacture of lumateperone and its salts (see abstract). Berecz et al. teaches lumateperone in the form of a crystalline structure (pg. 16, lines 4-26). Berecz et al. teaches compositions comprising lumateperone can further comprise conventional pharmaceutical carriers such as talc (pg. 45, lines 12-16). Berecz et al. teaches such formulations prepared as a capsule (pg. 45, lines 5-9).
It would have been obvious to one of ordinary skill in the art to treat schizophrenia wherein lumateperone tosylate is in the crystalline form or in a preparation such as a capsule, as suggested by Berecz et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since producing lumateperone tosylate in the crystalline form allows for achieving high levels of chemical and stereochemical purity as taught by Berecz et al. (pg. 10, lines 17-21), and formulations comprising lumateperone are conventionally formulated in capsule form for oral administration (pg. 45, lines 1-9).
Regarding claims 1, 14-17, 42-43, when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 14). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the adverse effect profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). (MPEP 2111.04 I).
Claims 3 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Vyas et al. (An evaluation of lumateperone tosylate for the treatment of schizophrenia, Expert Opinion on Pharmacotherapy, published 11/30/2019, 21:2, pp. 139-145, as disclosed in IDS) and Berecz et al. (WO 2019/102240, already of record) as applied to claims 1, 4-5, 8, 10-12, 14-17, 19-20, 35-40, and 42-43 above, and further in view of Li (US 2019/0192511, already of record).
The teachings of Vyas et al. and Berecz are presented above.
Vyas et al. and Berecz do not teach lumateperone tosylate further comprising croscarmellose sodium, gelatin, magnesium stearate, mannitol, talc, and colorants.
Li is drawn towards dispersions of lumateperone for the treatment of schizophrenia (see abstract; paragraphs 0004, 0122; claim 9). Li teaches such dispersions further comprising croscarmellose sodium, gelatin, magnesium stearate, mannitol, and colorants (paragraph 0118).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to formulate a composition further comprising croscarmellose sodium, gelatin, magnesium stearate, mannitol, talc, and colorants, as suggested by Li, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since such components are conventionally formulated in compositions comprising lumateperone as taught by Li, with a reasonable expectation of success absent evidence of criticality of the particular formulation.
Conclusion
Claims 1, 3-5, 8, 10-12, 14-17, 19-20, and 35-43 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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