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
This Office Action is responsive to the Response to Election/Restriction filed 06/25/2026.
Claims 70-89 are pending.
Priority
This application claims the following priority:
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71
660
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38
378
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Election/Restrictions
Applicant’s election without traverse of Group I, compounds and compositions thereof, and
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as the compound of formula (A), in the reply filed on 06/25/2026, is acknowledged.
Claims 71-85 and 88-89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and subject matter, there being no allowable generic or linking claim.
Claims 70 and 86-87 are examined on the merits herein.
Claim Objections
Claim 70 is objected to because of the following informalities:
-In claim 70, lines 5-6, the phrase “one of the bond connecting Q and N and the bond connecting N and Y is a double bond;” should be either deleted, or replaced with - -one of the bonds connecting Q and N, and N and Y, is a double bond- -.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 70 and 87 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.
-Claim 70 claims a compound of formula (A) on pg. 3 of the claim set and further recites “wherein the compound as shown in formula (A) is further represented by formula (A-1), (A-2), (A-3), (A-4), (A-5), (A-6), or (A-7),” on pg. 5 of the claim set, wherein formulas A-1 through A-7 are sub-genuses of formula (A). As such, it is not clear if formula (A-1)-(A-7) are further limitations or if they are exemplary of formula (A)
In view of compact prosecution, for the purpose of applying prior art, formulas (A-1)-(A7) are interpreted as exemplary of formula (A), and as not further limiting the claim.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 70 and 87 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2020/087170 to Crane (published 2020, IDS of 06/20/2024).
Crane teaches ATR kinase inhibitor compounds and compositions thereof (title, abstract). Regarding claim 70, Crane teaches the following compound:
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, which meets the limitation of instant Formula (A) when
RY is methyl
R is cyclohexyl substituted with hydroxyl
RZ is 0
X is CRx, wherein Rx is hydrogen
Q is C
Y is N
the bond connecting Q and N is a double bond and the bond connecting N and Y is a single bond.
"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. See MPEP 2131.02.
Regarding claim 87, Crane teaches compositions comprising its compounds and a pharmaceutically acceptable excipient (pg. 156, claim 20).
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 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.
Claims 70, and 86-87 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/087170 to Crane (published 2020, IDS of 06/20/2024).
Crane is applied to claims 70 and 87 as discussed above and incorporated herein.
While Crane teaches compound
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(pg. 60, #56), it differs from the elected species in that it does not teach
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159
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.
Crane teaches compounds wherein
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90
57
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is substituted at
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133
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(pg. 8, 20-21, 23, 24-26):
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136
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(pg. 60, #58),
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138
132
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(pg. 60, # 59),
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158
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(pg. 62, #97),
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338
558
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(pg. 62, #’s 101-103),
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352
569
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(pg. 63, #’s 104, 105, 106),
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337
548
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(pg. 63, #’s 110, 112, 113).
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167
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(pg. 63, #114),
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151
119
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(pg. 65, #132),
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156
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(pg. 65, #133), wherein these compounds have ATR IC50 (nm) values of 6, 10, 0.9, 1.7, 2.4, 1.1, 3.3, 0.7, 2.4, 0.8, 2.1, 0.8, 1.9, and 1.5, respectively (Tables 2-3, pgs. 120-148).
Crane additionally teaches that its cycloalkyls can be further substituted with an alkynyl (pgs. 40-41).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the H in
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185
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with an ethynyl group to arrive at
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. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Crane teaches that its cycloalkyls, i.e., cyclohexanol, can be further substituted by alkynyl groups,
-Crane exemplifies numerous cyclohexanols at the instant R position as substituted at the 4-position of the ring, and
-
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has an ATR IC50 of less than 5 and the majority of the compounds substituted at the 4-position have substantially lower ATR IC50 values, i.e., 0.9, 1.7, 2.4, 1.1, 3.3, 0.7, 2.4, 0.8, 2.1, 0.8, 1.9, and 1.5.
Thus, it would be obvious to try since Crane teaches similar compounds, wherein substitution at the 4 position leads to increased ATR inhibitor, and since Crane teaches alkynyl groups as further substituents on its cycloalkyls. See KSR(E), “The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397,” MPEP 2143.
An ordinary skilled artisan would have been motivated to make such a substitution to predictably arrive at a compound that is effective to inhibit ATR and treat ATR-related diseases.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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