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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-9; species of second-generation antipsychotic, further limited to ziprasidone, in the reply filed on 01/19/2026, is acknowledged.
The traversal is on the ground(s) that a serious search burden does not exist between the search of Group II, versus that of Group I. This is not found persuasive because:
1. The inventions have acquired a separate status in the art in view of their different
classification.
2. The inventions have acquired a separate status in the art due to their recognized
divergent subject matter.
3. The inventions require a different field of search (e.g., searching different
classes /subclasses or electronic resources, or employing different search strategies or search queries).
For example, methods for detecting psychotic disorders by administering antipsychotics for schizophrenia (Group I) is classified A61P25/18; methods for detecting altered serotonin receptor levels or activity (Group II), is classified in either A61K38/1787; C07K14/70571; or, C07K16/286. As such, a serious search burden exists in searching between Groups I and II.
The requirement is still deemed proper, and is therefore made FINAL.
Claims 2-3 and 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/19/2026.
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 4-9 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 as 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 4-9.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612