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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) and under 35 U.S.C. 365(c) is acknowledged.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the independent claims 1 and 14, the claims are directed towards identifying treatment regions based on a known “symptom region of an atlas” identified from a “cohort of participants with the psychotic disorder”. As admitted by Applicant, the cohort must be “well characterized” (par. 0034 of the specification). However, it is difficult to characterize a cohort of psychotic patient to a specific symptom, as also admitted by Applicant (par. 0043 of the specification), as “individuals are very heterogenous in specific symptoms and severity” and “a combination of these symptoms [psychosis, ‘negative symptoms’ (e.g. amotivation), cognitive deficits, and mood] is defining characteristic of schizophrenia”. Applicant further characterizes the symptom types for the “symptom region” as “psychotic, negative, cognitive, mood” and again comments that the specific symptoms related to the disorder (i.e. schizophrenia) vary significantly between patients (par. 0046 of the specification). No specific brain regions are ever defined as associated with specific symptoms in the atlas. Although the cerebellum seems to be indicated as the symptom region in Figures 2 and 4A, it is never said which symptom is represents (e.g. psychotic, negative, cognitive, mood). Even if specific brain circuits that represent psychotic, negative, cognitive, mood symptoms exist, Applicant has not provided any disclosure how to identify the initial “symptom region” for each symptom. Instead, one of ordinary skill would expect there to be high variation between patients and find difficulty in finding a “well characterized” cohort to identify a specific symptom region for each symptom type. Further, no examples are given of possible locations for such a unique symptom region of an atlas (i.e. an ROI associated with each symptom type of psychotic, negative, cognitive, mood). Applicant also admits that no such published atlas exists (par. 0034). As such, Applicant has not shown possession of the invention for using “a symptom region of an atlas” in the context of psychotic disorders.
In addition, Applicant has only given the example of schizophrenia with symptoms of psychotic, negative, cognitive, mood, as the psychotic disorder. Other psychotic disorders present different combinations of symptoms, including species such as schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, substance-induced psychotic disorder, and psychotic disorder arising from other medical conditions (e.g. brain injuries, infections). Each of these species would be expected to present its own symptom regions associated with different symptoms or maybe not even have any identifiable symptom regions at all. These are all poorly understood disorders that do not present the same way, even within cohorts, and have combinations of symptoms with varying severities and origins. Even if Applicant is determined to have possession of identifying treatment regions for schizophrenia (species), Applicant has not demonstrated possession for any other types of psychotic disorder in the genus. As such, any claims directed to the overly broad genus of any and all psychotic disorders shows a lack of possession.
Claims 2-13 and 15-26 are rejected for their dependence on a rejected claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the scope of the claim with regard to “a symptom region of an atlas” associated with a “psychotic disorder” is not understood since psychotic disorders are not well understood and have a combination of symptoms and severity of symptoms. As discussed above under the USC 112(a) rejection, it is unclear what brain areas can represent such “a symptom region of an atlas”, especially when considering the breadth covered by the genus of all psychotic disorders.
Further regarding Claim 1, the claim requires “the treatment regions are specific to the patient and a symptom of the psychotic disorder”. It is not clear if this “symptom of the psychotic disorder” is the same as the symptom associated with the symptom region of an atlas. It seems like it would have to be but the claim does not maintain antecedent basis to define that relationship. Further, when applied to “a patient…who is at high risk for developing the psychotic disorder”, it is not understood what “a symptom of the psychotic disorder” can possibly represent, since the patient does not have the disorder and presumably does not display its symptoms. The scope of this limitation cannot be determined for this at risk patient type.
The same issues exist in claim 14 as for claim 1 above.
Claims 2-13 and 15-26 are rejected for their dependence on a rejected claim.
Closest Prior Art
US 20150119689 to Pascual-Leone (and US 10137307) teaches what appears to be the same steps as in claim 1 (and claim 14), including obtaining structural MRI and functional MRI data (par. 0058), selecting regions of interest that represent areas of dysfunction/symptom in the given disorder based on cohort analysis (par. 0063), identifying treatment regions (based on connectivity analysis of the fMRI data from the perspective of the region of interest, step 210, Figure 2). Pascual-Leone further teaches morphing the ROI from an atlas (par. 0065-0066, such as Talairach or MNI space) to identify the patient specific ROI, such as those specific areas listed in Table 1. However, Pascual-Leone teaches the method is applied to depression disorders and the associated ROIs are those representing symptoms relating to depression. In contrast, the claims require the method applied to psychotic disorders. While Pascual-Leone briefly mentions psychotic disorders in other studies (e.g. par. 0279), Pascual-Leone does not teach utilizing symptom region of an atlas associated with unique psychotic disorder symptoms. Upon reading Pascual-Leone, one of ordinary skill would also not know how to generate the symptom region of an atlas for psychotic disorders due to the complications discussed above in the USC 112(a) rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20230419484 to Moreno, US 20240144481 to Moreno, US 20250245828 to Moreno, US 11900603 to Moreno, US 12322102 to Moreno teaches determination of patient specific targets for magnetic therapy, including fMRI and connectivity analysis with cohort data, but is not available as prior art. US 20230096831 to Javitt teaches parcellations (connectomes) are generated for psychotic disorders (par. 0015 schizophrenia) to identify treatment ROIs associated with the disorders, but does not parse them out further into symptom type as required by the claims.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799