DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 05/12/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 - Obviousness
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 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al (Neuropsychopharmacology, 2012, 37, 2285-2298), in view of Weiner et al (US 2005/0148018 A1).
Williams taught a method for detecting locomotor suppression by the drug clozapine, in order to elucidate dysfunctional mechanisms in human gene pathways influential in the risk for schizophrenia [title and abstract]. The method comprised the following steps: administering to a mouse, a dose of clozapine (e.g., reads on ‘second-generation antipsychotic medication’); subjecting the mouse to an evaluation at a time point following administration of the medication; and, determining the level of sedation resulting from the dose [Abstract; p 2286, right col; p 2287; and p 2288, right col].
Williams showed that selective antagonists for the serotonin 2A receptor (5HT2AR) suppressed the locomotor activity of mice, and thus, mimic the sedating effects of clozapine. As per Williams, the sedating effects of clozapine are well known in the art, as is well known, the use of 5HT2AR antagonists as sleep aids [pg. 2286, left col, 2nd paragraph; page 2295, right column, 1st paragraph].
At Table 1 and Figures 3e and 3f, ziprasidone (e.g., reads on selective 5HT2AR antagonist second-generation antipsychotic medication) also suppressed the locomotor activity of mice, thus, mimicking the sedating effects of clozapine, for 60 minutes following drug administration [see also Figures 4a and 4b].
Williams suggested that the locomotor suppressive effects of clozapine and other second-generation antipsychotics (SGAs) in mice may play a role in the sedating effects of these medications in humans [pg. 2286, left col, 2nd and 3rd paragraphs]. Williams further suggested that investigation in humans is needed, in order to assess whether these results (e.g., sedation) translate across species [page 2295, right column, 1st paragraph].
Although Williams suggested that investigation in humans is needed, Williams did not specifically teach a human patient, as recited in claim 1.
Weiner taught administering selective [0042] inverse agonists of the 5-HT2A receptor (e.g., clozapine at Tables 1-3), in the treatment of schizophrenia [abstract]. Humans were most preferably the object of treatment, observation or experiment [0040-0041, 0091].
Since Williams taught administering antipsychotics to elucidate the risk for schizophrenia, where it was suggested that investigation in humans is needed, it would have been prima facie obvious to one of ordinary skill in the art to include human patients within the teachings of Williams, as was taught by Weiner. The ordinarily skilled artisan would have been motivated to include, within the study of schizophrenia, preferable objects of treatment, observation or experiment, as taught by Weiner at the abstract, and at paragraphs [0040-0041 and 0091].
The instant claim 1b recites that if the patient is asleep for at least 30 minutes after administration, then the patient does not have a psychotic disorder.
The instant claim 7 recites the time point following administration of the medication was from 5-10; 10-30; 15-60; 5-120; 10-180; or, for more than 180 minutes.
The instant claim 8 recites wherein if the patient is asleep for at least 1 hour after administration, then the patient does not have a psychotic disorder.
Williams taught sedation through 60 minutes, post drug administration. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claim 9, Williams taught sedation through one hour, rather than “for at least two hours”, as instantly is recited. Although Williams does not teach the two hour time point, it is prima facie obvious that Williams’ test subject does not have a psychotic disorder. This is because Williams taught sedation through one hour, where the originally filed disclosure [see the instant claim 1] defines having a psychotic disorder as sleeping for less than 30 minutes after administration of an antipsychotic dose.
The combined teachings of Williams and Weiner read on claims 1 and 5-9.
Response to Arguments
Applicant's arguments filed 05/12/2026 have been fully considered but they are not persuasive.
Applicant argued that Williams does not teach human patients, and that Williams was limited to mice.
The Examiner disagrees. Williams suggested that the therapeutic agents disclosed therein may play a role in the effects of those medications in humans [pg. 2286, left col, 2nd and 3rd paragraphs]. Williams further suggested that investigation in humans was needed, in order to assess whether the disclosed results (e.g., sedation) translated across species [page 2295, right column, 1st paragraph]. Furthermore, Williams was not relied upon for teaching humans, as Weiner was relied upon for the limitation. The Applicant is reminded against attacking references individually, where the combination of references were used to support the rejection. See MPEP 2145(IV).
Applicant argued that Weiner did not teach a method of detecting a psychotic disorder based on resistance to sedation following administration of a second generation antipsychotic medication, and does not provide any data or analysis demonstrating such an effect.
The Examiner responds that Weiner is not required to provide data or analysis. The Examiner reminds the Applicant again against attacking references individually [see the above analysis]. In the instant case, Williams was relied upon to teach a method of detecting a psychotic disorder based on resistance to sedation following administration of a second generation antipsychotic medication [see the obviousness rejection].
Applicant argued that the ordinarily skilled artisan would not have reasonably expected that a rodent model would be applicable in a human-based model.
The Examiner disagrees. Williams suggested that second-generation antipsychotics (SGAs) may play a role in the effects of those medications in humans [pg. 2286, left col, 2nd and 3rd paragraphs].
Applicant argued that the present invention provides antipsychotics other than clozapine, whereas Williams uses clozapine.
The Examiner responds that the present invention does not exclude clozapine.
Applicant requests rejoinder of claim 10.
The Examiner responds that no claims are allowed. Claim 10 remains withdrawn.
Conclusion
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 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.
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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