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
Applicant’s election of Group I, drawn to a stable crystalline, in the reply filed on 11/20/2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-23 are pending of which claims 16-23 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1-6 and 8-15 have been examined on the merits.
Note: The newly added claims 24-25 are directed to a nonelected invention under the restriction requirement. Therefore, these claims have not been examined on the merits, and are withdrawn from consideration.
Withdrawn Rejections
The rejection of claims 1, 11 and 15 under 35 U.S.C. 112(b) is withdrawn in view of the claim amendment.
Objection to the specification and Objection to claims 2, 8, 10 and 15 are withdrawn in view of the claim amendment.
Objections
Claim Objections
Claim 2, 4-5, 8-10, and 14 are objected due to typographical error. For example, in claim 2, the phrase “claims 1” is incorrect and is believed to be intended as “claim 1.” It is requested Applicant amends the claim to correct the error to ensure clarity and accuracy of the record.
Maintained Rejections
Claim Rejections - 35 USC § 112 (Enablement)
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.
Claims 10-12 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 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.
Claim 10 recites the use of the claimed compound for inhibiting protein tyrosine kinases (PTKs), a large and structurally diverse family of enzymes. While claim 12 further recites inhibition of cancer cell lines of pancreas, prostate, sarcoma, thyroid; however, the specification does not disclose inhibition data for the whole PRK genus, encompassed by the claims. The specification also does not disclose structure-activity relationship, mechanistic explanations, or other technical rationale demonstrating that inhibition of the tested kinases, as disclosed in Table 9, is representative of, or predictive for, inhibition across the full PTK genus. Given the functional, structural, and diversity PKTs, and the known unpredictability of kinase inhibition, a POSITA would not reasonably conclude from the limited disclosure that the claimed compound inhibits all PTK species. This is supported the specification (page 37, Table 9) which discloses a limited number of kinases that clearly does not reasonably convey that Applicant was in possession of the claimed compounds against the entire genus of PTKs as claimed.
Similarly, with regard to claim 12, the specification (page 38-39, Table 11-12) discloses in vitro activity only against specific, individual cancer cell line, such as SKOV3 (ovary), SKBR3 (breast), and HCT-116 (colon). However, the claim broadly encompasses inhibition of cancer cell lines of entire cancer types (e.g., pancreas, prostate, lung and colon), which include numerous biologically distinct cell lines with different drug sensitivity. The specification does not provide data or technical rational demonstrating a single disclosed cell line is predictive of activity against all or most cell lines of the same cancer type. Furthermore, the specification also fails to provide sufficient guidance enabling a POSITA to practice the full scope of the claimed inhibition activity across the broad range of recited cancer cell types without undue experimentation.
Moreover, the limited disclosure of activity against a small number of specific kinases and individual cell lines does not indicate that applicant was in possession of the full PTK genus or the full range of cancer cell line genera as cited in the claims. Consequently, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data to the claimed invention.
Subject Matter Free of the Art of Record
The subject matter of claims 1-15 are free of the prior art of record. The closest prior art is the Guoqing Paul Chen, US PG-PUB 2010/0048599 “Chen”. While Chen teaches 5 -(2-(4-(4-Fluoro-2-methyl-1H-indol-5-yloxy)-6 methoxyquinolin-7-yloxy)ethyl)-5-aZaspiro[2.4]-heptan-7-one, however there is no motivation for a POSITA to modify the teaching of Chen to arrive at the claimed compound. These claims are not allowable until the objections and 112 issues are resolved.
Response to Argument
Applicant argues that the specification evaluates nine (9) protein tyrosine kinases (PTKs), including members of the FGFR, VEGFR, and PDGFR families, and further evaluates sixteen (e.g., SKOV3, SKBR3, HCT-116) cancer cell lines representing multiple cancer cell types. While Applicant’s arguments have been considered, however such arguments are not persuasive because the claims are substantially broader in scope. The specification does not provide sufficient evidence demonstrating inhibitory activity across the full scope of the claimed cancer types. Inhibitory activity against a limited number of cancer cell lines does not necessarily establish that the claimed compounds will inhibit all cancer cell lines or cancer types encompassed by the claims without undue experimentation. Moreover, the claims are not limited to the specifically tested cell lines or kinase targets. Rather, the claims encompass a broad genus of therapeutic applications extending beyond the experimental data presented in the specification. Therefore, although a POSITA would recognize that cell lines such as SKOV3, SKBR3, HCT-116 are commonly used and validated models for particular cancer types; however, it would also be evident to a POSITA that the use of such models does not establish that the Applicants were in possession of, or enabled, the full scope of the claimed inhibition activity for all recited cancer types. For example, Applicant relies upon activity against Saos-2 cell line as evidence supporting inhibition of sarcoma cancers. However, Saos-2 is an osteosarcoma derived cell line and represents only a single subtype within the broader sarcoma genus (including but not limited, osteosarcoma, liposarcoma synovial sarcoma and Ewing sarcoma).
Conclusion
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 PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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