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
Status of Application, Amendments, and/or Claims
1. Applicant’s election with traverse of Invention Group III (claims 69, 81, 99, and 100) in the reply filed on 02/13/2026 is acknowledged. In response to species election requirement, Applicant elected the following species: (i) neuropathic pain; (ii) an anti- FAM19A5 antibody comprising the heavy chain CDR1, CDR2, and CDR3 comprises the amino acid sequence set forth in SEQ ID NOs: 10-12, respectively, and the light chain CDR1, CDR2, and CDR3 comprises the amino acid sequence set forth in SEQ ID NOs: 13-15, respectively.
2. In view of the amended claims and Applicant’s traverse, a new restriction requirement is set forth below.
REQUIREMENT FOR UNITY OF INVENTION
18.18 REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
WHEN CLAIMS ARE DIRECTED TO MULTIPLE CATEGORIES OF INVENTIONS
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
Restriction is required under 35 U.S.C. 121 and 372
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
I. Claims 69, 81, 96, 99-103, drawn to an isolated antibody, or antigen-binding fragment thereof, that specifically binds to a human family with sequence similarity 19, member Al (FAM19A1) protein (anti-FAM19A1 antibody), a nucleic acid encoding the antibody, a method of producing an anti-FAM19A1 antibody, and a method of treating a central nervous system (CNS)-related disease or disorder in a subject in need thereof, comprising administering to the subject the anti-FAM19A1 antibody of claim 69.
II. Claims 104-105, drawn to a method of treating a central nervous system (CNS)-related disease or disorder in a subject in need thereof, comprising administering to the subject a nucleic acid encoding an anti-FAM19A1 antibody.
III. Claims 106-110, drawn to a method of determining an expression level of a family with sequence similarity 19, member Al (FAM19A1) protein (FAM19A1 protein expression level) in a subject in need thereof.
3. Applicant's amendment filed on 02/13/2026 has been entered. Claims 2, 4, 5, 15, 45, 55, 62, 64- 66, and 68 are canceled. Claim 69 is amended. New claims 102-110 are added. Claims 69, 81, 96, and 99-110 are pending. Claims 69, 81, 96, 99-103 are currently under consideration. Claims 104-110 are withdrawn from further consideration.
Information Disclosure Statement
4. The information disclosure statement filed on 1/08/2023 and 02/13/2026 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
5. The drawings filed on 09/01/2022 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
6. The following is a quotation of the first paragraph of 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.
7. Claims 102-103 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for a method of treating neuropathic pain in a subject in need thereof, comprising administering to the subject the anti-FAM19A1 antibody of claim 69, does not reasonably provide enablement for a method of treating a central nervous system (CNS)-related disease or disorder, such as a mood disorder, psychiatric disorder, glaucoma, or any combinations thereof in a subject in need thereof, comprising administering to the subject the anti-FAM19A1 antibody of claim 69. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors that are considered when determining whether a disclosure satisfies enablement requirement include: (i) the quantity of experimentation necessary; (ii) the amount of direction or guidance presented; (iii) the existence of working examples; (iv) the nature of the invention; (v) the state of the prior art; (vi) the relative skill of those in the art; (vii) the predictability or unpredictability of the art; and (viii) the breadth of the claims. Ex Parte Forman, 230 USPQ 546 (Bd Pat. App. & Int. 1986); In re Wands, 858 F. 2d 731, 8 USPQ 2d 1400 (Fed. Cir. 1988).
Claims 102-103 are drawn to a method of treating a central nervous system (CNS)-related disease or disorder, such as a mood disorder, psychiatric disorder, glaucoma, neuropathic pain, or any combinations thereof in a subject in need thereof, comprising administering to the subject the anti-FAM19A1 antibody of claim 69. The claims are broad and encompass a method of treating a broad range of central nervous system (CNS)-related disease or disorder.
The specification discloses therapeutic effects of the monoclonal anti-FAM19A1 antibody and confirms that neutralizing FAM19A1 activity could alleviate neuropathic pain (Examples 18-21). However, the specification does not provide sufficient guidance/direction or working examples on how to treat a central nervous system (CNS)-related disease or disorder, such as a mood disorder, psychiatric disorder, glaucoma, neuropathic pain, or any combinations thereof in a subject. The state of the prior art is such that there exists no cure for CNS disorders at present (see page 1, paragraph [0005] of the instant specification).
The courts have stated that patent protection is granted in return for an enabling disclosure. Reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. See Genetech v. Novo Nordick A/S (CAFC) 42 USPQ2d 1001 (1997). Similarly, as stated in Rasmusson v SmithKline Beecham Corp., 75 USPQ2d 1297-1303 (CAFC 2005), “if mere plausibility were the test for enablement under section 112, Applicants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the 'inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. The scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis. In the instant case, the evidence on the record supports that the specification does not enable the claimed invention commensurate in scope with these claims. It is unpredictable whether administering anti-FAM19A1 antibody of claim 69 could successfully treat broad genus of central nervous system (CNS)-related diseases or disorders recited in claims 102-103.
Due to the large quantity for experimentation necessary to treat a broad genus of central nervous system (CNS)-related diseases or disorders, the limited directions guidance presented in the specification regarding the same, the lack of working example directed to the same, the complex nature of the invention, the unpredictability in the art, and the breadth of the claims, undue experimentation would be required for the skilled artisan to use the claimed invention commensurate in scope with these claims.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
8. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
9. Claims 102-103 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 102 is indefinite because the term “a central nervous system (CNS)-related disease or disorder” is overly broad and fails to provide reasonable certainty as to the scope of the invention.
Claim 103 is indefinite because it recites “both combinations thereof”, which makes no sense in context.
Claim Objections
10. Claims 69, 81, 96, and 99-103 are objected to they recite non-elected subject matter (non-elected antibodies or non-elected CNS-related disease or disorder).
11. Claim 100 is objected to because the phrase 'instructions for use' does not impart patentable weight to the claim."
12. Claim 101 is objected to because “the nucleic acid of 96” should be amended to “the nucleic acid of claim 96”.
Conclusion
13. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, please contact the Electronic Business Center (EBC) at the toll-free phone number 866-217-9197.
/RUIXIANG LI/ Examiner, Art Unit 1674
February 21, 2026