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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 29, 2025 has been entered.
Response to Amendment
2. Claims 3, 16, 20, 37 have been amended, claim 36 canceled and claim 43 added as requested in the amendment filed on November 08, 2025. Following the amendment, claims 1-3, 5, 7, 10, 12, 16, 17, 20, 23-24, 26, 31, 34, 37, 39 and 41-43 are pending in the instant application.
3. Claims 1, 2, 5, 7, 10, 12 and 17 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 19, 2025.
4. Claims 3, 16, 20, 23-24, 26, 31, 34, 37, 39 and 41-43 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
6. Applicant’s arguments filed on November 08, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections - 35 USC § 112
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.
7. Claims 3, 16, 23-24, 26, 31, 34, 37, 39 and 42 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.
8. Claim 3 is vague and indefinite insofar as it employs the term “psychiatric drug that treats depression” as a limitation. This term is not known in the relevant prior art of record as being associated with well-defined genus of molecular embodiments. One skilled in the art readily appreciates that most of drugs known to be prescribed to treat patients with depression treat various symptoms of different types of depressive disorders. Therefore, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of a “psychiatric drug that treats depression”, an artisan cannot determine if a compound which meets all of the other limitations of a claim would then be included or excluded from the claimed subject matter by the presence of this limitation.
9. Claim 37 is rejected as being incomplete for being dependent from a cancelled claim. See MPEP § 608.01(n), V.
10. Claims 16, 23-24, 26, 31, 34, 39 and 42 are indefinite for being dependent from indefinite claim.
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.
11. Claims 3, 16, 20, 23-24, 26, 31, 34, 37, 39, 41 and 42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of determining suitability of a subject suffering from depression to be treated by Bupropion, Nortriptyline and Citalopram, does not reasonably provide enablement for the full scope of the claimed subject matter. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. See reasons of record in section 11 of Paper mailed on May 28, 2025 and in section 7 of Paper mailed on October03, 2025. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant traverses the rejection at pp. 11-12 of the Response. Specifically, Applicant submits that, “[T]he Office Action has acknowledged the enabling data provided for PITX2 expression. The morphological biomarkers recited in claim 3 are all supported by data in the specification.” This statement is not disputed. Applicant further argues that data related to “Bupropion, Nortriptyline and Citalopram […] is exemplified in Figures 4A, 4B and 4C,” and that “this data supports all of the recited morpholocal phenomena as biomarkers or drug response in cells from subjects suffering from depression. A skilled artisan would find it reasonable that these are biomarkers that can be applied to all psychiatric drugs that can treat depression as recited in claim 3.” While this has been fully considered, the argument is not persuasive.
First, the term “psychiatric drug that treats depression,” as in claim 3, is not known in the relevant prior art of record as being associated with well-defined genus of drugs. As explained earlier, a skilled in the art readily appreciates that most of “psychiatric” drugs known to be prescribed to treat patients with depression do not treat the disorder, they treat various symptoms of depression, see section 7 above. Thus, it is not clear and cannot be ascertained from the claims or the specification as filed, what specific drugs are intended by the claims. This alone stands for undue experimentation.
Next, the Examiner maintains that the limited data pertained to three drugs being evaluated by the instant claimed method cannot be simply extrapolated to all the “psychiatric drug that treats depression.” The specification provides no evidence of common physiological pathways that are associated with pathology of depression and changes in recited biomarkers. There is also no scientific evidence presented at the time of filing to support a conclusion that results of using three drugs within the experimental protocol of the disclosure are predictive of using any “psychiatric drug that treats depression.”
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
12. Claims 3, 16, 20, 23-24, 26, 31, 34, 37, 39, 41 and 42 are rejected. Claim 43 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
January 27, 2026
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