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
Applicant’s amendment and response, submitted April 25, 2026, has been reviewed by the examiner and entered of record in the file. Claim 21 is amended.
Claim 77, drawn to a method of treatment, remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 21, 23-30, 65-67 and 76 are under examination and are the subject of this office action.
Specification
5. The corrected abstract submitted on April 25, 2026 to delete the term “novel,” from line 1 of the abstract is sufficient to overcome the previous objection to the disclosure.
New Claim Rejections - 35 USC § 112(b)
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
7. Claims 21, 23-30, 65-67 and 76 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
8. Claim 21 recites the limitation: “--- is absent” in line 11, however there is insufficient antecedent basis for this limitation because there is no prior recitation of
“---” in the claim. In structural formula (IIIA), none of the bonds are represented by
“---”. Clarification is requested.
9. Claims 23-30, 65-67 and 76 are rejected as being dependent upon and failing to further limit claim 21.
Previous Claim Rejections - 35 USC § 112(a)
10. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
11. Claims 21, 23-25, 66, and 76 remain 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 claim(s) contains 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, regarding the scope of compounds of formula (IIIA).
12. In particular, support cannot be found for the full scope of compounds of formula (IIIA), as instantly claimed.
13. 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. The specification must demonstrate that the Applicant has made a generic invention that achieves the claimed result and do so by showing that the Applicant has invented sufficient alternative species to support the claim to the generically-defined genus.
14. 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.
15. 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.
16. 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 (IIIA) has substantial variance. The claimed genus of formula (IIIA) is virtually without limit, embracing hundreds of thousands of potential compounds bearing little structural resemblance to one another, i.e., presently the genus of compounds according to formula (IIIA) embraces compound species wherein X is CH; Y1 and Y2 are CH; Z1 is NH; Z2 is C=O; and the ring containing R4 and R5 is 5-membered; and compound species wherein X is N; Y1 is N and Y2 is CH; Z1 is NH; Z2 is S=(O)2; and the ring containing R4 and R5 is 3-membered, which bear almost no structural overlap with each other.
The Specification teaches that the instant compounds are methionine aminopeptidase 2 (MetAP-2) inhibitors which are useful for treating various diseases and conditions including cancer, obesity, diabetes, rheumatoid arthritis and psoriasis (paragraph [0006]).
17. The method of making the claimed invention: The instant Specification discloses the preparation of only approximately 12 compound species that correspond to a compound of formula (IIIA), as recited in claim 65, i.e., compound species wherein the bicyclic ring is limited to indoline, pyrrolopyridine, pyrrolopyrazine, or benzoisothiazole (also see Examples 12-23 at pages 54-84).
18. 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 12 structurally related compounds does not adequately describe a subgenus embracing hundreds of thousands of additional compound species bearing no structural relationship with those 12 disclosed compounds. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
19. 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.
20. As such, claims 21, 23-25, 66, and 76 remain rejected.
Response to Arguments
21. Applicant amended claim 21 “to significantly narrow the claim scope with regard to R4 and R5: ‘R4 and R5, together with the carbon atom to which they are attached, form a 3- to 5-membered cycloalkyl ring’,” (Applicant’s Remarks, page 10).
Applicant additionally amended claim 21 to significantly narrow the claim scope with regard to limitation "or a pharmaceutically acceptable form or an isotope derivative thereof” by deleting the recitation of “or an isotope derivative thereof.”
Applicant alleges that “the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed” and that claim 21 fulfills the written description requirement under 35 U.S.C. § 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (Applicant’s remarks, page 10).
22. Applicant's arguments have been fully considered but they are not persuasive. While Applicant’s amendment to claim 21 limits the scope of the ring formed by R4, R5, and the carbon atom to which they are attached, as well as deleting the recitation of “an isotope derivative,” the claim is still broadly written with substantial variance among the bicyclic moiety containing X, Y1, Y2, Z1 and Z2. That is, said moiety presently embraces indoline, benzopyrazole, benzoisothiazole, pyrrolopyridine, pyrrolopyrimidine, pyrrolopyrazine, isothiazolopyridine, isothiazolopyrimidine, and isothiazolopyrazine, for example.
However, the instant Specification demonstrates possession of only approximately 12 compound species that correspond to a compound of formula (IIIA), as recited in claim 65, i.e., compound species wherein the bicyclic moiety is limited to indoline, pyrrolopyridine, pyrrolopyrazine, or benzoisothiazole (also see Examples 12-23 at pages 54-84). As such, the Specification has not demonstrated support for all of the alternatives embraced by the genus of structural formula (IIIA).
Therefore the previous rejection of claims 21, 23-25, 66, and 76 is maintained.
Conclusion
23. Claims 21, 23-30, 65-67, 76 and 77 are present in the application. Claim 77 is withdrawn. Claims 21, 23-25, 66, and 76 are rejected. No claim is presently allowed.
24. 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
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