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 Claims
Claims 1, 3-5, 12, 17, 20, 24, 30, 34, 40-41, 43-44, 50, 67, 70-71, and 85 are pending.
Claims 71 and 85 are withdrawn (see restriction/election below).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C.
120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to
Application Serial No. PCT/US2020/052953, filed 09/26/2020. The application also claims priority to FOR application number IN201941039277, filed on 09/27/2019. It is noted, however, that applicant has not filed a certified copy of the application as required by 37 CFR 1.55.
Information Disclosure Statement
All references from IDS(s) received 3/25/2022 and 2/11/2025 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 1/21/2026 have been fully considered and have been found not persuasive.
In a non-final dated 08/29/2025, Claims 1, 3-5, 12, 17, 20, 24, 30, 34, 40-41, 43-44, 50, 67, and 70 were examined upon their merits.
In a non-final dated 08/29/2025, Claims 1, 3-5, 12, 17, 20, 24, 30, 34, 40-41, 43-44, 50, 67, and 70 were rejected under 35 U.S.C. 103. In response, Applicant did not amend any claims.
With respect to the 103 rejection, the Applicant argues that the prior art provided by the Examiner (“KBP”) teaches BTK inhibitors while the instant application teaches EGFR inhibitors, and therefore a person skilled in the art would not be motivated to select embodiments from the gens structure taught by KBP to arrive at the instant invention. The Examiner argues that according to the MPEP a POSITAs motivation to produce a compound does not have to be the same as the instant application. “Where the claims are not limited to a particular use, and where the prior art provides other motivation to select a particular species or subgenus, a showing of a new use alone may not be sufficient to confer patentability. See Dillon, 919 F.2d at 692, 16 USPQ2d at 1900-01.” See MPEP 2145. Therefore, a person skilled in the art would be motivated to arrive at the elected specie as motivated by producing a BTK inhibitor. The claims of the instant application do not reflect the necessity for the compounds to be EGFR inhibitors and therefore, the compound itself would be taught by KBP. Therefore, the 103 rejection is maintained. Examiner would recommend scheduling an interview if the Applicant chooses to go RCE.
MAINTAINED 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.
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, 3-5, 12, 17, 20, 24, 30, 34, 40-41, 43-44, 50, 67, 70 are rejected under 35 U.S.C. 103 as being unpatentable over KBP Bioscience (WO2014089913A1; cited in IDS filed 3/25/2022; “KBP Bioscience”).
KBP Bioscience teaches an overlapping genus structure with Formula I (Claim 1) for use as a tyrosine kinase inhibitor in the treatment of diseases, such as blood cancer.
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KBP Bioscience teaches a structural example with almost each embodiment of the elected specie, with the exception of the phenyl of the elected specie is a cyclopropane in the prior art (see below).
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However, this embodiment holds the position of X in the prior art. KBP bioscience teaches X can be Ra and Ra can be a phenyl group (Claim 2). Therefore, KBP Bioscience teaches all the embodiments of the elected specie and therefore the limitations of the instant claims.
It would be obvious to a person skilled in the art to substitute the cyclopropane with other cyclic groups, including a phenyl group, as taught by KBP Bioscience.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement
to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a
reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same
field or a different one based on design incentives or other market forces if the variations are
predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of
ordinary skill to modify the prior art reference or to combine prior art reference teachings to
arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the structural example taught by KPB Bioscience and substitute the cyclopropane for a phenyl group, as required by the elected specie. A person skilled in the art would be motivated to make this substitution since it is also taught as an embodiment by KBP Bioscience. Therefore, claims 1, 3-5, 12, 17, 20, 24, 30, 34, 40-41, 43-44, 50, 67, 70 would be obvious to a person skilled in the art at the time. Further, structurally similar compounds are expected to have similar properties and the genus of the art links these compounds as having similar properties.
Conclusion
Claims 1, 3-5, 12, 17, 20, 24, 30, 34, 40-41, 43-44, 50, 67, 70 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 NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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