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
Response to Amendment
1. Claim 8 has been amended and claim 27 canceled as requested in the amendment filed on June 01, 2026. Following the amendment, claims 8, 9, 25, 26, 29, 31 and 33 are pending in the instant application.
2. Claims 8, 9, 25, 26, 29, 31 and 33 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. Applicant’s arguments filed on June 01, 2026 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.
5. Claims 8, 9, 25, 26, 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, section 6 of Paper mailed on August 08, 2025 and in section 6 of Paper mailed on January 01, 2026. 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.
At p. 7 of the Response, Applicant submits that, “the Examiner has alleged that "[i]t 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." […] Applicant respectfully submits that this recharacterization of the claims is improper and has led the Examiner to apply an incorrect enablement standard.” Applicant further explains that, “[A] skilled artisan reading the present application would recognize that claim 8 (when read as
a whole) is directed to a specific, measurable physiological endpoint-i.e., increasing cortical
thickness-not to treatment of a major depressive disorder and/or bipolar disorder broadly. The
preamble specifically recites "[a] method of increasing thickness of a cortical gyrus." As "in a
subject having a major depressive disorder and/or bipolar disorder," Applicant respectfully submits that the phrase defines the subject population and not the method objective. The final "wherein" clause further requires that "the thickness of the cortical gyrus is increased as compared to the corresponding thickness prior to the administration"-providing a specific, measurable before-and- after comparison.” Applicant continues at p. 8, “the enablement inquiry asks whether a skilled artisan could make and use the invention without undue experimentation. The enablement inquiry does not require proof od “meaningful clinical benefit” nor demand that factual evidence ‘directly supporting the inventive concept.’” Applicant’s arguments have been carefully considered but found to be not persuasive for reasons that follow.
Appellant’s attention is directed to MPEP 2107. II, section B, which states:
“(B) Review the claims and the supporting written description to determine if the applicant has asserted for the claimed invention any specific and substantial utility that is credible.” In the instant case, the utility of the instant invention is stated within its title, “Use of anti-family with sequence similarity 19, member A5 antibodies for the treatment and diagnosis of mood disorders,” (emphasis added), and the same within at least [0002].
Next, section 112(a), first paragraph, of the patent statute describes what must be contained in the patent specification. Among other things, it must contain “a written description of the invention, and of the manner and process of making and using it … [such] as to enable any person of ordinary skill in the art to which it pertains … to make and use the same … ,” (emphasis added). If Applicant’s position is that the instant invention is limited to a method of using the factors of FAM19A5 antagonists solely for increasing thickness of cortical gyrus in a subject, then this utility is not specific and substantial within the meaning of 35 U.S.C. 101. As a consequence, one skilled in the art clearly would not know how to use Applicant’s invention as currently claimed.
The Examiner has interpreted the utility of the instant claims based on the information provided within the instant disclosure, which is “FAM19A5 antagonist for treating a mood disorder in a subject in need thereof,” [0011], for example. Using the FAM19A5 antagonist to achieve changes in the anatomy of the brain structure is using it as an object of future research. The instant situation was addressed in Brenner v. Manson, 148 U.S.P.Q. 689 (Sus. Ct, 1966), in which the court expressed the opinion that an invention must have either an immediate obvious or fully disclosed “real world” utility. The court held that:
“The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility”, “[u]nless and until a process is refined and developed to this point-where specific benefit exists in currently available form-there is insufficient justification for permitting an applicant to engross what may prove to be a broad field”, and “a patent is not a hunting license”, “[i]t is not a reward for the search, but compensation for its successful conclusion”.
The instant claims are drawn to a method of treating an individual afflicted with a major depressive disorder and/or bipolar disorder by administration of FAM19A5 antagonist. The only information presented within the specification is limited to data on cortical thickness of patients with MDD and associated levels of serum FAM19A5 protein. However, in the absence of knowledge of the biological significance of FAM19A5, thickness of a cortical gyrus and pathology of depression, one skilled in the art would not reasonably expect that administration of FAM19A5 antagonist to an individual would result in any particular effect. Therefore, there is no immediately obvious patentable use for a method of administration of FAM19A5 antagonist to affect thickness of a cortical gyrus in the subject suffering from depression.
To employ FAM19A5 antagonist of the instant invention in a method of increasing thickness of a cortical gyrus in a subject suffering from depression would clearly be using it as the object of further research, which would require one skilled in the art to partake in a substantial amount of undue experimentation in order to practice Applicant’s invention as currently claimed
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
6. No claim is allowed.
7. 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 OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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, 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
June 9, 2026
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