NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Remarks, filed May 20, 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Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 have been canceled.
No claims have been amended, and 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Claims 59, 69, and 70 stand withdrawn as drawn to nonelected inventions and/or species.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, 56-58, 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, see Remarks, pp. 8-13, filed May 20, 2026, with respect to the rejection of claims 51-54, 56-58, 63, and 68 under 35 U.S.C. § 103 as unpatentable over Hege have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is set forth below.
NEW REJECTIONS
Claim Rejections - 35 U.S.C. § 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, 56, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Hege (WO 2014/134240, of record).
Hege discloses compounds of formula (I) as TOR kinase inhibitors for treating solid tumors, non-Hodgkins lymphoma or multiple myeloma (abstract; para. [0053]; Sec. 5.2.1).
In particular, Hege exemplifies the (R)- and (S)- enantiomers of the compound 1-(1-phenylethyl)-6-(quinolin-5-yl)-1 H-imidazo [4,5-c]pyridin-2(3H)-one (Table A, second- and third-listed compounds on p. 40), having the structural formulae,
Hege: Exemplified Compound of Formula (Ib)
(R)-enantiomer (CAS RN 1021917-30-5)
(S)-enantiomer (CAS RN 1021917-31-6)
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234
378
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Greyscale
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232
388
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Greyscale
which read on formula (I) as recited by claim 51, to the extent that X is hydrogen; Y is phenyl; and Z is quinolinyl.
The exemplified compound of Hege et al. differs from the claimed compounds in that
(1) the Y phenyl substituent is attached to the bicyclic core via a -CH(CH3)- linker, rather than directly; and
(2) the Z quinolinyl substituent is directly attached to the bicyclic core, rather than via a -NH- linker.
However, the compound of Hege is disclosed as a species of formula (Ib), having the structural formula,
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206
314
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,
wherein L is a direct bond, NH, or O (para. [00115]); and R2 is aryl, e.g., phenyl (para. [00123]).
Thus, Hege expressly discloses, teaches, and suggests modifying the exemplified compound of formula (Ib) by:
(1) attaching the Y phenyl substituent directly to the bicyclic core, rather than via a
-CH(CH3)- linker; and
(2) attaching the Z quinolinyl substituent to the bicyclic core via a -NH- linker, rather
than directly.
Making these modifications yields a compound having the structural formula:
Modified compound of Hege
Claimed Formula (I)
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326
525
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Greyscale
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196
276
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which reads on formula (I) as recited by claims 51 and 56, wherein X is H; Y is phenyl; and Z is C5-12 heteroaryl (quinolinyl).
The compounds of Hege are disclosed in compositions comprising a pharmaceutically acceptable carrier or vehicle (para. [00259]), as recited by claim 68.
While Hege discloses the compounds of formula (I) as TOR kinase inhibitors, rather than DNA-dependent protein kinase (DNA-PK) inhibitors as in the claimed compounds, the compounds of Hege 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 to modify the compound exemplified by Hege according to 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 useful in the treatment of solid tumors.
As recognized by MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have (1) very close structural similarities and (2) similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The prior art need not disclose a newly discovered property in order to establish 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.
A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). However, Applicant has not argued or pointed out any such evidence of unexpected results.
Claim Objections
Claims 52-54, 57, 58, and 63 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.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
WO 2008/051493; WO 2013059396; and WO 2013/126636 (all cited on PTO-892).
CONCLUSION
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 10:00 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 E. TOWNSLEY/Examiner, Art Unit 1629
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