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
2. The election without traverse filed 12/12/2025 in response to the Office Action of 11/18/2025 is acknowledged and has been entered.
Applicant has elected Group II, claim 2, drawn to a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of N-(3-Fluoro-4-(2-(5-((2-methoxyethylamino)methyl)pyridin-2-yl)thieno[3,2-b]pyridin-7-yloxy)phenyl)-N-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide; and a PD-(L)1/PD-1 checkpoint inhibitor.
3. Claims 1-7, 20-22, 24, 26, 28-31, 34-35 and 40-41 are pending in the application. Claims 1, 3-7, 20-22, 24, 26, 28-31, 34-35 and 40-41 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Claim 2 is currently under prosecution.
Priority
5. Applicant’s claim under 35 U.S.C. §§ 119(e) and/or 365(c) for benefit of the earlier filing date of applications, is acknowledged.
6. 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.
Claim Rejections - 35 USC § 102
7. 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.
8. Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doshi et al. (Journal of Clinical Oncology, February 26, 2019, Volume 37, Number 7_suppl, pages 1-2).
Claim 2 is herein drawn to a method of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of N-(3-Fluoro-4-(2-(5-((2-methoxyethylamino)methyl)pyridin-2-yl)thieno[3,2-b]pyridin-7-yloxy)phenyl)-N-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide; and a PD-(L)1/PD-1 checkpoint inhibitor.
N-(3-Fluoro-4-(2-(5-((2-methoxyethylamino)methyl)pyridin-2-yl)thieno[3,2-b]pyridin-7-yloxy)phenyl)-N-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide is also known as sitravatinib; see page 1 of specification.
Doshi et al. teach Phase II study of sitravatinib in combination with nivolumab (a PD-1 checkpoint inhibitor) in patients with advanced or metastatic urothelial carcinoma (UC); see entire document, e.g., abstract, pages 1-2.
Conclusion
9. No claim is allowed.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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