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 1-2, 8, 10, 12-13, 20-21, 23-24, 28, 30-31, 35, 37-39, 42-43, 46-49, 51-54, 59-60, 72, 75-76, 80, 87, 91, 95-97 and 100 are pending.
Claims 12-13, 20-21, 23-24, 28, 30-31, 35, 87, 91, 95-97 and 100 are withdrawn (see election/restriction below)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/US2021/060403, filed 11/22/2021; and further claims priority to PRO application number 63/116,484, filed 11/20/2020.
Information Disclosure Statement
All references from IDS(s) received 05/18/2023 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/17/2025 is acknowledged.
Claims 87, 91, 95-97 and 100 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
Applicant’s election without traverse of compound 65 (see below) in the reply filed on 12/17/2025 is acknowledged.
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Claims 12-13, 20-21, 23-24, 28, 30-31, and 35 are withdrawn as not reading on the elected species as they require a different degradation moiety.
With respect to the elected specie, no art was identified, however the Examiner expanded her search pursuant to MPEP 803. The expanded species is Compound 50 (seen in rejection), and is rejected in an obviousness type rejection, see 103 rejection below.
Claims 42 and 46 are withdrawn as not reading on the expanded specie.
Claims 1-2, 8, 10, 37-39, 42-43, 46-49, 51-54, 59-60, 72, 75-76, 80 will be examined upon their merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 76 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim references a Table 1 in the Specification for a list of compounds. The claims cannot reference material in the Specification. The claims must be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP 2173.05(s)
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 1-2, 8, 10, 37-39, 43, 47-49, 51-54, 59-60, 72, 75-76, 80 are rejected under 35 U.S.C. 103 as being unpatentable over Jin, M. et al. (WO2016118666A1; “Jin”) in further view of Sintchak, M. (WO2020251972A1; claims priority to PRO 62/859,309 with an earlier effective filing date of 6/10/2019; cited in IDS filed 5/18/2023; “Sintchak”).
This rejected applies to the expanded species.
Jin teaches bifunctional compounds with a partial overlapping structure of compound 50. More specifically, Jin teaches the part circled below of compound 50 (or the “degradation moiety” of the compound aka Formula C1 of instant claim 39).
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Jin fails to teach the specific linker of the expanded specie. However Jin does teach a linker that falls within the limitations of the instant claims, specifically the linker structure below of instant claim 72.
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(Linker, Instant Claim 72)
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(Jin, Claim 13)
Jin fails to teach the targeting moiety of the expanded species.
Sintchak teaches an overlapping genus structure that encompasses the targeting moiety of the instant claims conjugated to a degradation moiety. Sintchak also teaches a structural example of the targeting moiety and degradation compound of the expanded species. of the instant claims.
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(Sintchak, Compound I-5)
Sintchak also teaches the compounds for use as SMARCA inhibitors. SMARCA4 is an alternate reference to BRG1, as taught by the Instant specification. Finally, Sintchak teaches the compounds as useful for the modulation of SMARCA and/or polybromo-1 (PB-1) protein via ubiqitination and/or degradation by compounds, as well as the compounds are useful in treatment of cancer.
Therefore, although neither Jin or Sintchak explicitly teach the compounds of the instant claims, it would be obvious to a person skilled in the art to extract the bifunctional molecule taught by Jin and substitute the targeting moiety for the SMARCA inhibitor taught by Sintchak. A person skilled in the art would be motivated to do so because Sintchak teaches the inhibitors to be use in degradation and Jin provides a framework to conjugate the known inhibitor to the degradation molecule taught by Jin. Therefore, claims 1-2, 8, 10, 37-39, 43, 47-49, 51-54, 59-60, 72, 75-76, 80 would be obvious to a person skilled in the art at the time.
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 compound, a bifunctional compound, as taught by Jin and substitute the targeting moiety for another known targeting moiety, especially one known to be useful in degradation and cancer, as taught by Sintchak.
A person skilled in the art would be motivated to do so because Sintchak teaches the inhibitors to be use in degradation and Jin provides a framework to conjugate the known inhibitor to the degradation molecule taught by Jin. Therefore, claims 1-2, 8, 10, 37-39, 43, 47-49, 51-54, 59-60, 72, 75-76, 80 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1-2, 8, 10, 37-39, 43, 47-49, 51-54, 59-60, 72, 75-76, 80 are rejected.
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.
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/N.M.B./ Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621