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 .
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 1-7, 11, 12, 14, 15, 18, 19, 22-26 and 28, drawn to a compound of Formula (I) and a pharmaceutical composition thereof, in the reply filed on January 13, 2026 is acknowledged with appreciation.
3. Claim 29, (Group II), drawn to a method of treatment, is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
4. In response to the requirement for an election of species, Applicant elects the species of compound 11:
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(Table 1), without traverse.
5. Claims 1-7, 11, 12, 14, 15, 18, 19, 22-26, and 28 are under examination and are the subject of this office action.
Information Disclosure Statement
6. The information disclosure statements (IDS) submitted on May 10, 2024 and June 27, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner, please refer to the signed copies of Applicant’s PTO-1449 forms, attached herewith.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-7, 11, 12, 14, 15, 18, 19, 22-26, and 28 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 claims contain 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.
9. In particular, support cannot be found for the full scope of compounds of formula (I), as instantly claimed.
10. The MPEP §2163 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 by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.
11. The factors considered in the Written Description requirement are:
(1) level of skill and knowledge in the art,
(2) partial structure,
(3) physical and/or chemical properties,
(4) functional characteristics alone or coupled with a known or disclosed
correlation between structure and function, and
(5) the method of making the claimed invention.
12. Level of skill and knowledge in the art: The level of skill to practice the art of the instantly claimed invention is high and requires a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks.
13. Partial structure; Physical and/or chemical properties; and Functional characteristics: In the instant case, it is evident that the genus of compounds embraced by formula (I) has substantial variance. The claimed genus of formula (I) is virtually without limit, embracing hundreds of millions, and potentially billions, of potential compounds bearing little structural resemblance to one another, i.e., presently the genus of compounds according to formula (I) embraces compound species wherein Cy can be any 3- to 6- membered cycloalkylene or heterocyclylene; R3 embraces any 6- to 12- membered aryl or any 5- to 12- membered heteroaryl ring; R4 embraces any 6- to 12- membered aryl or any 5- to 12- membered heteroaryl ring; and G3 can be any 5-membered heteroaryl ring. For example, the instantly claimed genus includes Compound 10:
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and Compound 40:
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(Table 1, pages 71-84), , which bear almost no structural overlap with each other.
The Specification teaches that the instant compounds are selective modulators of metabolic glutamate receptor 2, which are useful for treating various diseases and conditions including depression, anxiety, obsessive-compulsive disorder, cognitive disorders, Alzheimer’s disease, and autism spectrum disorders (paragraph [0005]).
14. The method of making the claimed invention: The instant Specification discloses the preparation of only approximately 83 compound species that correspond to a compound of formula (I) as recited in the claims, primarily wherein L1- is -O-alkylene; R1, R2, R5 and R6 are hydrogen; and R3 is phenyl or pyridyl, (see Table 1 at pages 71-84).
15. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of 84 somewhat structurally-related compounds does not adequately describe a subgenus embracing hundreds of millions of additional compound species bearing no structural relationship with those 84 disclosed compounds. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
16. 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.
17. As such, claims 1-7, 11, 12, 14, 15, 18, 19, 22-26, and 28 are rejected.
Conclusion
18. Claims 1-7, 11, 12, 14, 15, 18, 19, 22-26, 28 and 29 are present in the application. Claim 29 is presently withdrawn as directed to a non-elected invention. Claims 1-7, 11, 12, 14, 15, 18, 19, 22-26, and 28 are rejected. No claim is presently allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/
Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628