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 .
Application Status
2. Applicant’s amendment and response, submitted May 14, 2026, has been reviewed by the examiner and entered of record in the file. Claims 1, 7, 12, 15 and 19 are amended, and claim 33 is newly added.
3. Claim 29, drawn to a method of treatment, remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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. Claims 1-7, 11, 12, 14, 15, 18, 19, 22-26, 28, and 33 are under examination and are the subject of this office action.
Previous Claim Rejections - 35 USC § 112
5. 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 1-7, 11, 12, 14, 15, 18, 19, 22-26, and 28 remain rejected and claim 33 is newly 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.
7. This rejection has been modified as a result of Applicant’s amendment to the claims.
8. In particular, support cannot be found for the full scope of compounds of formula (I), as instantly claimed.
9. 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.
10. 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.
11. 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.
12. 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 millions 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 phenyl, benzothiazolyl, pyridinyl, pyrrolyl, pyrazolyl, or indazolyl; R4 embraces phenyl, pyridinyl, thiazolyl, pyrazolyl, imidazolyl, oxazolyl, isoxazolyl, thienyl, furanyl, pyrazolo[1,5-a]pyrimidinyl, quinolinyl, isoquinolinyl, or
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; and G3 can be any 5-membered heteroaryl ring containing 1-3 heteroatoms selected from S, O, or N, or any 4- to 6- membered heterocyclyl containing 1-2 heteroatoms selected from S, O, or N. For example, the instantly claimed genus includes both 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]).
13. The method of making the claimed invention: The instant Specification discloses the preparation of only approximately 84 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).
14. 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.
15. 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.
16. As such, claims 1-7, 11, 12, 14, 15, 18, 19, 22-26, and 28 remain rejected.
Response to Arguments
17. Applicant amended claim 1 to narrow the definitions of R3 and R4 as follows: R3 is selected from phenyl, benzothiazolyl, pyridinyl, pyrrolyl, pyrazolyl, or indazolyl; and R4 is phenyl, pyridinyl, thiazolyl, pyrazolyl, imidazolyl, oxazolyl, isoxazolyl, thienyl, furanyl, pyrazolo[1,5-a]pyrimidinyl, quinolinyl, isoquinolinyl, or
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. Applicant alleges that the amendments to claim 1 narrow the definitions of R3 and R4, and are supported by paragraphs [0083], [0085], [0091], [00104], and [00241] (Table 1) of the Specification.
18. Applicant's arguments have been fully considered but they are not persuasive. While Applicant’s amendments narrow the definitions of the R3 and R4 moieties recited in formula (I), the claims still embrace a significantly broader scope of compounds than those for which support has been provided in the Specification. Applicant demonstrates possession of 83 compounds in Table 1, however the present claims still encompass a much broader scope than the disclosed 83 compounds, i.e., claim 1 includes compounds comprising the Cy moiety, wherein Cy can be any 4- to 6- membered heterocyclene; and claim 1 includes compounds comprising the G3 moiety, wherein G3 can be any 5-membered heteroaryl containing 1-3 heteroatoms selected from S, O, or N, or any 4- to 6- membered heterocyclyl containing 1-2 heteroatoms that are independently S, O, or N.
It is recommended that the claims be drafted commensurate in scope with the exemplified compounds demonstrated in Table 1 of the Specification.
Conclusion
19. Claims 1-7, 11, 12, 14, 15, 18, 19, 22-26, 28, 29 and 33 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, 28 and 33 are rejected. No claim is presently allowed.
20. 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.
21. 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.
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, 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
