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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 18, 2025 has been entered.
Response to Amendment
2. Claims 8 and 25 have been amended and claims 7, 10, 14, 15, 28, 30 and 32 canceled as requested in the amendment filed on November 18, 2025. Following the amendment, claims 8, 9 and 25-27, 29, 31 and 33 are pending in the instant application.
3. Claims 8, 9 and 25-27, 29, 31 and 33 are under examination in the instant office action.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on November 18, 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 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.
6. Claims 8, 9 and 25-27, 29, 31 and 33 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement for reasons of record in section 8 of Paper mailed on April 25, 2025 and section 6 of paper mailed on August 08, 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. 6-8 of the Response. Specifically, Applicant argues that, “a skilled artisan reading the present application would recognize the direct association between FAM19A5 level and cortical thickness. For instance, non-treated human patients having a mood disorder have increased FAM19A5 level (e.g., in the serum) and decreased cortical thickness. In contrast, control healthy subjects and patients that were being treated for a mood disorder have reduced FAM19A5 level and increased cortical thickness.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
Claims 8, 9 and 25-27, 29, 31 and 33 encompass methods for increasing thickness of a cortical gyrus in a subject having a mood disorder by administering to the subject FAM19A4 antagonist antibody. It appears reasonable to assume that in a real-world situation patients do not suffer from a pathology of having not enough thickness of a cortical gyrus, therefore, the utility of the instant invention is interpreted as a method for treatment of a mood disorder. The instant specification discloses antibodies that are critical to practice the invention, structure and production in detail, at Examples 1-5. At Examples 6-8, the specification discloses experimental results related to comparison of the levels of FAM19A5 protein in serum samples of subjects with depression, and measurements of thickness of cortical gyri. With respect to the instant claimed invention—methods of treatment by administration of “3-2” antibody—the disclosure is limited to a prophetic Example 9, which outlines a protocol of administering the antibody using a rat model for depression. There appears no further data, evidence, or sound scientific reasoning to support a conclusion that this limited information could be used to enable one of skill in the art to practice the invention without undue experimentation.
As fully explained earlier, the prior art does not recognize that FAM19A5 protein as directly associated with pathology of mood disorders in general. Furthermore, the art does not recognize that finding of a protein which is differentially expressed in blood during any pathology makes the antibody to the protein immediately suitable for clinical administration. Merely disclosing methods of production of antibodies and evaluating the levels of FAM19A5 protein in serum samples of individuals with depression does not commensurate with what is currently in claims—treatment by administration of an anti-FAM19A5 antibody “3-2” in vivo.
Under the enablement provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, each claimed invention must be evaluated to determine whether there is sufficient guidance provided and supported by working examples to inform a skilled artisan how to use the claimed invention without undue experimentation. Evaluation of adequate scope of enabled invention is made as an assessment from the perspective of one of ordinary skill in the art in view of the disclosure and any other evidence of record (e.g., test data, affidavits or declarations from experts in the art, patents or printed publications) that is probative of the Applicant's assertions. In the instant case the specification provides description of the “3-2” antibody (FAM19A5 antagonist antibody), data on levels of FA19A5 protein in serum of patients with major depressive disorder and bipolar disorder, data on cortical thickness of patients with MDD and serum FAM19A5 protein. There is no further guidance on how to administer an antagonist antibody, polynucleotide encoding it or a vector comprising the polynucleotide encoding the antagonist antibody to a subject suffering from any form of mood disorder in general and expect meaningful clinical benefits from the expected increased cortical thickness in a subject having a mood disorder. There is no factual evidence presented in the case that directly supports the inventive concept currently in claims.
The Examiner maintains that the claimed method of treatment—administration of anti-FAM19A5 antibody “3-2” or nucleic acid encoding it to treat any of the mood disorders or to increase thickness of a cortical gyrus in a subject—clearly lacks enablement, as disclosed.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
7. No claim 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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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
January 28, 2026
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