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 .
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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. See MPEP 2163.
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 it 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).
Applicant has argued (see response June 8, 2026) that par. 0046 of the specification discusses the precise identification of the dysfunctional brain circuits, thereby implicating these circuits are symptom specific and distinct. However, no examples of how to identify the circuits, what the circuits are, or where the circuits are located is presented. In the same paragraph, it also discusses how the brain networks “vary significantly from each other in the spatial organization (or location)” and “individuals vary significantly in their specific symptoms related to schizophrenia and therefore the network(s) of interest can vary between patients depending on their individual clinical needs”. Lastly, it is stated how important the therapy targeting is, “small differences in TMS targeting lead to significant differences in clinical effects”. It is reasonable to conclude that a precise treatment location must be identified in order to successfully carry out the TMS therapy. However, only a theoretical atlas is given as the way to find the treatment location without addressing the challenges unique to psychotic disorders (i.e. high variability) that make characterizing treatment locations in neural pathways difficult. From a reading of the disclosure, Applicant has not reduced the invention to practice.
In contrast, US 20150119689 to Pascual-Leone (and US 10137307) is provided to show the level of skill and predictability in the art. Pascual-Leone 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 (a disease with low variability in the affected neural pathways). 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 (e.g. high variability between patients).
In addition, Applicant has only given the example of schizophrenia (i.e. species) 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, for sake of argument, 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. Based on a lack of reduction to practice, review of the drawings, level of one of ordinary skill in the art, and lack of disclosure of relevant, identifying characteristics of the targeted neural pathways, Applicant has not demonstrated possession of the claimed invention. 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.
Taking all the evidence together, Applicant has not shown possession of the invention for using “a symptom region of an atlas” in the context of psychotic disorders (i.e. the genus) or in the context of schizophrenia specifically (i.e. the species).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”).
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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.
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.
Response to Arguments
Applicant's arguments filed June 8, 2026 have been fully considered but they are not persuasive.
With regard to the rejection under USC 112(a) for lack of possession, Applicant argues that par. 0046 of the specification discusses the precise identification of the dysfunctional brain circuits, thereby implicating these circuits are symptom specific and distinct. However, no examples of how to identify the circuits, what the circuits are, or where the circuits are located is presented. In the same paragraph, it also discusses how the brain networks “vary significantly from each other in the spatial organization (or location)” and “individuals vary significantly in their specific symptoms related to schizophrenia and therefore the network(s) of interest can vary between patients depending on their individual clinical needs”. Lastly, it is stated how important the therapy targeting is, “small differences in TMS targeting lead to significant differences in clinical effects”. It is reasonable to conclude that a precise treatment location must be identified in order to successfully carry out the TMS therapy. However, only a theoretical atlas is given as the way to find the treatment location without addressing the challenges unique to psychotic disorders (i.e. high variability) that make characterizing treatment locations in neural pathways difficult. The issue is that the atlas does not exist, it is theoretical. Applicant theorizes that distinct circuits for schizophrenia exist and therefore symptom specific circuits can be identified. The secret sauce to make the therapy work is to precisely aim it at the location that is malfunctioning, i.e. the distinct symptom specific circuit. However, there is no evidence to suggest that Applicant has identified such distinct symptom specific circuits since no examples are given or could identify it using the steps disclosed, since the patient pool for psychotic disorders is highly variable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
