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 .
DETAILED ACTION
Claims 1-10, 12-13, and 15-21 are pending in the instant application.
Claims 1-4, 12, 13, 15, and 18 are amended.
Claims 1-10, 12-13, and 15-21 are examined herein.
Priority
The instant application claims benefit of foreign priority to EP20206285.7, filed on 06 November 2020 and the benefit of priority to PCT/EP2021/080829, filed on 05 November 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 06 November 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 11 May 2023 and 21 August 2023, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 26 May 2026 has been entered.
In view of applicant amendment to claims 12 and 13, the 112(a)-enablement rejection of record is withdrawn.
In view of applicant amendment to claims 1, 3, and 13 the 112(b) rejections of record are withdrawn.
In view of applicant amendment to claim 1, the 103 rejection of record is withdrawn over claims 1-10, 16-17, and 19-20. Regarding claim 12 the amendment has not incorporated the limitation of claim 18 as seen in the amended claim 1, claim 12 has incorporated the limitation of the unamended claim 1. Therefore the rejection is maintained and modified below.
New rejections and objections are necessitated by amendment.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12-13 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. (WO2006000420A1) in view of Ciapetti et al. (The Practice of Medicinal Chemistry. Chapter 8. Molecular Variations Based on Isosteric Replacements. 2008;4:181-241).
Regarding claim 12, Ding teaches compounds of Formula (I) (pictured below) for the treatment of proliferative diseases (page 108). The reference Formula (I) (claim 1) overlaps with the instant Formula (I) when:
X is C-R5; wherein R5 is H
Y is C-R5; wherein R5 is H, halo or methyl (corresponds to instant R4)
Z is N (corresponds to instant W)
R1 is X5NR7R8 or X5OR7; wherein X5 is a bond; wherein R7 is C6-10aryl-C0-4alkyl, C5-10heteroaryl-C0-4alkyl, C3-10cycloalkyl-C0-4alkyl, or C3-10heterocycloalkyl-C0-4alkyl; and R8 is H or alkyl (corresponds to instant Z)
R2 is H
R3 is H or methyl (corresponds to instant R2)
R4 is substituted hydroxy
n is 0 or 1
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168
474
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182
386
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Ding teaches that two of the substituents of X, Y, and Z, have to be N, forming a pyrimidine core, not a pyridine as seen in the instant genus if the instant W is N.
Ciapetti teaches that pyrimidine and pyridines are bioisosteric replacements (page 193).
It would be prima facie obvious to one of ordinary skill in the art to replace the pyrimidine core, as taught by Ding for a pyridine, as these two nitrogen containing heterocycles are bioisostere and would be expected to exhibit similar properties.
Regarding claim 13, Ding teaches the method of treating a proliferative disease wherein the proliferative disease is cancer (page 110).
Regarding claim 21, Ding teaches the proliferative disease to be small cell lung cancer (page 111).
NEW REJECTIONS
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, and 19, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manfred (CH597160A5)
Regarding claims 1, 2, 4, and 19, Manfred teaches compounds of Formula (I) (pictured below) which overlaps with the instant genus when R1 and R2 are methyl. A specie of both the reference and instant genus from the STN search is also depicted below.
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154
366
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532
794
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Claim Objections
Claims 3, 5-10, 15-18, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-2, 4, 12-13, 19, and 21 are rejected.
Claims 3, 5-10, 15-18, and 20 are objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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