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 .
Status of the Claims
Claims 1, 6, 7, 10, and 16-25 are pending. Acknowledgment is made of the amendment of claims 1, 6, 7, 10, 16, and 17, the cancellation of claim 2-5, 8, 9, and 11-15, and the addition of new claims 22-25, in the reply filed 05/06/2026. Claim 16-19 are withdrawn. Claims 1, 6, 7, 10, and 20-25 are currently under examination.
Election/Restriction Requirement
Applicant elected, with traverse, Group I, directed to compounds of Formula I, claims 1, 6, 7, 10, and 20-25, in the reply filed on 12/29/2025.
Applicant further elected the species of Example 2, shown below, which reads on instant claims 1, 6, 7, 10, 20, 21, 24, and 25.
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Claims 16-19, 22, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b). Claims 1, 6, 7, 10, 20, 21, 24, and 25 are currently under examination.
Withdrawn Rejections
Applicant’s amendment to the claims, filed 05/06/2026, overcomes the rejection of claims 1-5, 10-15, and 21 on the basis of containing an improper Markush grouping. The rejection of claims 1-5, 10-15, and 21 has been withdrawn.
Applicant’s amendment to the claims, filed 05/06/2026, overcomes the rejection of claims 1-6, 10-15, and 21 under 35 U.S.C. 112(a) for failing to comply with the written description requirement. The rejection of claims 1-6, 10-15, and 21 has been withdrawn.
Applicant’s amendment to the claims, filed 05/06/2026, overcomes the rejection of claims 1-6, 10-15, and 21 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 1-6, 10-15, and 21 has been withdrawn.
Applicant’s amendment to the claims, filed 05/06/2026, overcomes the rejection of claims 1-6, 10-15, and 21 under 35 U.S.C. 112(b) for indefiniteness. The rejection of claims 1-6, 10-15, and 21 has been withdrawn.
Applicant’s amendment to the claims, filed 05/06/2026, overcomes the rejection of claims 1-6 and 10-15 under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (cited in previous office action). The rejection of claims 1-6 and 10-15 has been withdrawn.
Applicant’s amendment to the claims, filed 05/06/2026, overcomes the rejection of claims 1-6, 10-15, and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Ding et al. (cited in previous office action). The rejection of claims 1-6, 10-15, and 21 has been withdrawn.
Applicant’s amendment to the claims, filed 05/06/2026, overcomes the provisional rejection of claims 1-3, 10, 11, and 21 on the ground of nonstatutory double patenting over Application No. 18/702,540. The provisional rejection of claims 1-3, 10, 11, and 21 has been withdrawn.
Modified Rejections
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1, 6, 7, 10, 20, 21, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Dobrusin et al. (cited in previous office action), further in view of Ding et al. (cited in previous office action).
Dobrusin et al. teaches, in claim 7, compounds having the formula shown below.
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A specific compound taught, in Example 11 of Table 5, is 1-cyclopentyl-3,4-dihydro-7-[[4-(4-methyl-1-piperazinyl)phenyl]amino]-pyrimido[4,5-d]pyrimidin-2(1H)-one, shown below.
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The compound shown above is taught, on page 5 lines 12-15, to be an inhibitor of growth factor mediated tyrosine kinases, specifically EGFR. It is taught, in claim 38 and on page 5 lines 16-19, that since this compound is an inhibitor of EGFR, it can be used to treat lung cancer.
The compound above differs from the instant elected species in that it does not contain a methoxy group on the phenyl ring.
However, it is taught in claims 1 and 8, that the phenyl group may be substituted with an alkoxy.
Additionally, Ding et al. teaches, in paragraph [0248], the EGFR inhibitor shown below (compound XSL1790), where in Formula I of the instant claims, A and the ring containing B1-3 is
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, R0 is a substituted pyrrolidinyl group, R7 is methoxy, R8- is N-methyl piperazinyl, and R12 is methyl.
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It is taught, in claims 7 and 8, that the compound is used in a pharmaceutical composition for the treatment of lung cancer. Ding et al. teaches, on pages 7-8 of the English translation (cited in previous office action), that the composition further comprises an anti-cancer agent which includes those listed in instant claim 21.
Therefore, in view of the compounds taught by Ding et al., which are taught to be EGFR inhibitors that are used to treat lung cancer, it would be prima facie obvious to select a methoxy substituent taught by Dobrusin et al., since similar compounds that are taught to be used for the same purpose by Ding et al. are shown to have a methoxy substituent on the phenyl group.
The close structural similarity and the same function (EGFR inhibition and treatment of lung cancer) taught by both Dobrusin et al. and Ding et al. would lead one of ordinary skill in the art to have a reasonable expectation of success in adding a methoxy substituent on the compound taught by Dobrusin et al., since it is suggested by both Dobrusin et al. and Ding et al. to do so, and it is common practice in the art to create derivatives of known compounds in order to test their biological efficacy.
Regarding claim 21, it is taught by Ding et al. that the composition can further contain the anticancer agents listed in claim 21. It is also taught by Dobrusin et al., on page 18 lines 22-23, that the composition can contain other compatible therapeutic agents. Therefore, it would be prima facie obvious to include additional anticancer agents, such as those of instant claim 21, since these are taught to be compatible in the composition to treat lung cancer by both Ding et al. and Dobrusin et al.
Applicant Argues:
Applicant states that a lead compound was not selected and that one of ordinary skill in the art would not be motivated to select Example 11 as the lead compound. Applicant states that evidence is not provided that Example 11 is a “particularly potent or effective compound”. Applicant states that the compounds taught by Dobrusin et al. and Ding et al. are EGFR inhibitors and not NUAK1/2 inhibitors, as in the instant compounds.
Examiner’s Response:
Applicant's arguments filed 05/06/2026 have been fully considered but they are not persuasive. It can be seen in Table 1 of Dobrusin et al. that Example 11 significantly outperforms (by a factor of 10 or more in most cases) all other compounds in cdk4/D inhibition. Additionally, in Table 3, Example 11 again outperforms all other compounds in PDGF inhibition. In the final test, Example 11 was in the top three compounds for inhibiting c-Src. Using all of these results, it would be obvious to one in the art to select Example 11 as the lead compound. Regarding Ding et al., most compounds (e.g., compounds 1, 4-12, 22-31, 42, 45-48, 51-59, and 62-66) contain a methoxy substituent on the phenyl ring. Therefore, one of ordinary skill in the art would be motivated to make this specific substitution on the structurally similar Example 11 by Dobrusin et al., since the compounds are taught to be used for the same purpose (EGFR inhibitors to treat lung cancer). Regarding NUAK1/2 inhibition, that is not a required limitation of the instant claims.
Conclusion
Claims 1, 6, 7, 10, 20, 21, 24, and 25 are rejected.
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 RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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