NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Feb. 9, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 1-50, 55, 60-62, and 64-67 are canceled.
Claims 51 and 57 have been amended and incorporate no new matter.
No new claims have been added.
Claims 59, 69, and 70 stand withdrawn as drawn to nonelected inventions and/or species.
Thus, claims 51-54, 56-59, 63, and 68 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
RESPONSE TO ARGUMENTS
Applicant's arguments filed Feb. 9, 2026 have been fully considered but they are not persuasive.
Applicant contends that the amendments to the claims negate the obviousness rejections over Katamreddy et al. and Hege (Remarks, p. 4).
However, upon further consideration, the newly amended claims remain rejected over Hege, as detailed below.
NEW 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.
Claims 51-54, 56-58, 63, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Hege (WO 2014/134240).
Hege discloses compounds of formula (I) as TOR kinase inhibitors for treating neuroendocrine tumors of non-gut origin (abstract; claim 1).
In particular, Hege discloses a subgenus of compounds of formula (Ib), shown side-by-side with claimed formula (I) for comparison:
Hege formula (Ib) (para. [00115])
Claimed formula (I) (claim 51)
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wherein -L-R1 in formula (Ib) corresponds to -NH-Z in claimed formula (I); and R2 in formula (Ib) corresponds to Y in claimed formula (I), due to the inverted orientation.
Hege defines formula (Ib) as follows (paras. [00115]-[00128]):
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Thus, formula (Ib) of Hege overlaps with formula (I) as recited by claims 51 and 56-58, wherein, for example, L is -NH-; R1 is substituted or unsubstituted heteroaryl, e.g., quinoline, pyrimidine, or indole (para. [00118]); and R2 is aryl (phenyl), cycloalkyl, or heterocycloalkyl (paras. [00122]-[00123]).
For example, to demonstrate this overlap, Hege expressly discloses, teaches, and suggests a structural core or scaffold of formula (Ib) which is readily envisaged from the subgenus defined in paras. [00115]-[00128]:
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which reads on formula (I) as recited by amended claims 51 and 56-58, wherein X is H; Y is heterocycloalkyl (e.g., piperidinyl); and Z is C5-12 heteroaryl (e.g., pyrimidinyl).
Hege discloses that the heteroaryl at R1 is substituted or unsubstituted (para. [00118]); and further discloses that illustrative examples of substituents include, e.g., alkyl (para. [0035]), as recited by claim 63.
In addition, Hege exemplifies compounds wherein N1 is substituted by methyl (p. 41),
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(R)-1-methyl-3-(1-phenylethyl)-5-(quinolin-5-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one;
(S)-1-methyl-3-(1-phenylethyl)-5-(quinolin-5-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one;
which reads on formula (I) as recited by claims 51-54, wherein X is methyl.
Therefore, it would have been predictable to one of ordinary skill in the art to modify the compounds of formula (Ib) to arrive at the claimed compounds with a reasonable expectation of success, because all compounds of Hege are disclosed to function as TOR kinase inhibitors with either hydrogen or methyl in this position.
The compounds of Hege are disclosed in compositions comprising an effective amount of a TOR kinase inhibitor of formula (I) and a pharmaceutically acceptable carrier or vehicle (para. [00259]), as recited by claim 68.
While the compounds of Hege are disclosed as TOR kinase inhibitors, rather than DNA-dependent protein kinase (DNA-PK) inhibitors as in the claimed compounds, they are disclosed to have the same utility for treating cancers, e.g., solid tumors (paras. [00053], [00294]-[00297]).
Therefore, it would have been predictable to one of ordinary skill in the art as of the effective filing date to prepare compounds of formula (Ib) of Hege to arrive at compounds falling within the scope of claimed formula (I) with a reasonable expectation of success, because the close structural similarity of the prior art genus, and its teaching for the same use as the claimed genus, create a reasonable expectation that compounds in the overlapping portion would exhibit similar properties, functions, and utilities.
The closer the chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., In re Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904 (and cases cited therein); and In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995).
The rationale to explore structurally similar variants within formula (Ib) of Hege to arrive at the claimed compounds is premised upon the significant structural overlap of the prior art genus with the claimed genus, including a common core and comparable variable substituents, alongside the express teaching of the prior art genus for the same utility in treating cancer.
The prior art need not disclose a newly discovered property in order for there to be a prima facie case of obviousness (In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990)). If the claimed invention and the structurally similar prior art compounds share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species.
Obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).
CORRESPONDENCE
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629