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 .
Priority
This application was filed 02/07/2023 and is a 371 of PCT/IN2021/050754 (08/06/2021) which claims foreign priority to India 202021033796 (8/07/2020). Claims 1-4, 7-8 and 11-20 are before the Examiner.
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.
Claims 1-2, 7-8, 11-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Xu. Xu teaches nintedanib processes and intermediates on page 310 with compounds with compound 8a (for compound V) and compound 10a (for compound VIII). The difference between the process/compounds taught by Xu and the instantly claimed ones is the presence of Cl vs Br. However, it would have been obvious to one of ordinary skill in the art to be able to change the Cl for Br with no substantive change in the reaction. Rationale: the optimization of a process is within the skill of the ordinary artisan.
Claims 3-4, 13-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO2017198202. WO teaches the ethanesulfonate crystalline forms of nintedanib. WO teaches and incorporates prior references that make nintedanib. Then WO makes ethanesulfonate (esylate) crystalline forms of nintedanib that have overlapping XRD pattern peaks as instantly claimed. The crystalline form made in the WO use the same process as instantly claimed and have many overlapping peaks. The difference is the first process of making Nintedanib using Br vs Cl. However, it would have been obvious to optimize the process using a different halogen with the expectation of getting the same or similar product due to the similarity of action between Br and Cl.
Claims 3-4, 13-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO2004013099. WO teaches the ethanesulfonate crystalline forms of nintedanib. WO teaches and incorporates prior references that make nintedanib. Then WO makes ethanesulfonate (esylate) crystalline forms of nintedanib that have overlapping XRD pattern peaks as instantly claimed. See page 10 and Table 1. The crystalline form made in the WO use the same process as instantly claimed and have many overlapping peaks. The difference is the first process of making Nintedanib using Br vs Cl. However, it would have been obvious to optimize the process using a different halogen with the expectation of getting the same or similar product due to the similarity of action between Br and Cl.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625