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 without traverse of Group I (to a method of treatment or prevention of a brain tumor), in the reply filed on 08/21/2025 is acknowledged.
Claims 1-19 and 21 are pending of which claims 17, 19 and 21 in Group II and III, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Claims 1-16 and 18 have been examined on the merits.
Please note, for clarity of the record, Applicant’s election of the species of compound (102) recited in claim 16, having the following structure:
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During the course of examination, no prior art was identified that relates to the elected or non-elected species.
Withdrawn Rejection
The rejection of claims 1, 3-5, 7-10, and 12-15 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), is withdrawn in view of the claim amendment.
Maintained Rejection
Claim Rejections - 35 USC § 112
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 8, 16 and 18 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.
The instant claims recite a compound of formula (11b) or formula (Ilc), wherein
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However, the specification does not reasonably disclose to a POSITA that the Applicants were in possession of compounds in which R3 is other than hydrogen at the time of filing. The specification does not disclose representative number of compounds across the full scope of R3 Markush group, but instead, the disclosure is limited to R3 is hydrogen only. However, while the claimed invention attempts to cover far more diverse set of R3 substituents spanning multiple chemical classes, but the specification does not commensurate with the full scope of the claimed invention. This is because, the mere recitation of R3 as variable substituents, without corresponding disclosure of representative species, working examples, or structural guidance demonstrating possession of the claimed invention, it is then obvious that the specification does not satisfy the written description requirement. The fact that the specification fails to disclose either representative example of compounds across the full scope of the claimed R3 genus, thus, the lack of representative species of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data for the claimed invention.
It is worth noted that the same written description deficiency also applies to R4, in which R4 is other than fluorine or hydrogen, while the claimed invention attempts to cover far more diverse set of R4 substituents spanning multiple chemical classes. For example,
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And yet the specification provides no representative species to demonstrate possession of the full scope of the claimed R4 genus. Given the breadth and chemical diversity of the claimed R3 and R4 substituents groups, and the absence of any working example or representative embodiment corresponding to these substituents, the specification clearly fails to demonstrate that the Applicant has possession of the claimed compound across the full scope at the time of filing.
Subject Matter Free of the Art of Record
The subject matter of claims 8, 16 and 18 are free of the art of record. The closest prior art are Flohr et al. (WO 2021/030711) and Ahn et al. (WO 2007/055514). While the prior art teaches quinazoline derivative of compound of formula I, however there is no motivation for a person of ordinary skill in the art to modify the teaching of prior art to arrive at the claimed compound. These claims are not allowable until the 112 rejection is overcome.
Response To Argument
Claim 1-16 and 18 are rejected under 35 U.S.C. l 12(a)
Applicant argues that the claim amendment necessitates withdrawal of the rejection. Applicant’s argument is not persuasive, because the amendments do not cure the deficiency. For example, the instant claim defines R3 broadly as to encompass thousands of structurally distinct substitutions, as each rise to a different compound. The specification does not disclose representative species spanning this breadth, nor does it provide any common structural features to recognize R3 substitution that falls within the claimed invention; thus, the rejection remained.
Conclusion
No claims are allowed.
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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