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 .
Election/Restrictions
Applicant’s election without traverse of Group I (drawn to a compound of Formula I), in the reply filed on 04/20/2026 is acknowledged.
Claims 1-19 and 25-26 are pending of which claims 19 and 25-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1-18 have been examined on the merits.
Please note, for clarity of the record, Applicant’s election of compound 37, wherein R1b is C6 cycloalkyl, R2a is C6 heterocycle, and R2b is cyano:
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Please also note, in the interest of compact prosecution, that during the course of examination any prior art identified that relates to non-elected subject matter is applied to demonstrate the non-allowability of the generic claims and/or as discussed below.
Claim Objections
Claim 17 recites a list of chemical structure without appropriate commas between the items. For clarity and proper interpretation, commas should be inserted to separate each element in the list (e.g., “A, B and C”). Applicant is required to correct the claims by inserting commas between each item in the list.
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.
Claims 1 and 4-16 are 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.
Claims 4-7 recite the limitations "R1a" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 4-7 depend directly from independent claim 1, which does not recite/depict a chemical structure with R1a substituents. Thus, definition of R1a substituents in dependent claims 4-7 creates an ambiguity regarding what is being referenced. Appropriate correction is required.
Claims 9-10 recite the limitations "R1b" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 9-10 depend directly from independent claim 1, which does not recite/depict a chemical structure with R1b substituents. Thus, definition of R1b substituents in dependent claims 9-10 creates an ambiguity regarding what is being referenced. Appropriate correction is required.
Claims 11-12 and 14-16 recite the limitation "R2a" in line 2. There is insufficient antecedent basis for this limitation in the claim. Each of claims 14-16 depend directly from independent claim 1, which does not recite/depict a chemical structure with an R2a substituent. Thus, definition of R2a in dependent claims 11-12 and 14-16 creates an ambiguity regarding what is being referenced. Appropriate correction is required.
Claim 13 recites the limitations "R2b" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 13 depends directly from independent claim 1, which does not recite/depict a chemical structure with R2b substituents. Thus, definition of R2b substituents in dependent claim 13 creates an ambiguity regarding what is being referenced. Appropriate correction is required.
Claim 16 recites the limitations "R1a", "R1b", and "R2b" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends directly from independent claim 1, which does not recite/depict a chemical structure with R1a, R1b, and R2b substituents. Thus, definition of R1a, R1b, and R2b substituents in dependent claim 16 creates an ambiguity regarding what is being referenced. Appropriate correction is required.
Claim 12 recites monocyclic of bicyclic C3-C7heterocycle, which lacks clear and definite meaning. The phrase “monocyclic of bicyclic C3-C7heterocycle” renders the scope uncertain because it is unclear whether monocylic heterocycles, bicyclic heterocycles, or both are intended.
Claim 1, 8, and 11 recite C2-C8heteroaryl and C2-C8heteroaryloxy. The term “C2-heteroaryl” “C2-heteroaryloxy” is unclear because aromatic ring systems require at least three members to form a ring and are not ordinarily understood to contain less than 3 ring atoms. Therefore, a POSITA would unable to recognize the scope of the claimed subject matter, which renders the claims indefinite.
Claim Rejections – 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by PubChem CID 84561761 (2014-10-21) “PubChem.”
Regarding claims 1-2, PubChem CID 84561761 discloses the following compound as part of a chemical library on or 2014-10-21. This compound clearly meets each and every chemical structure variable as listed in the instant claims, wherein n is 2; R1 is methyl and R2 is fluorine.
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Therefore, claims 1-2 are anticipated.
Claims 1, 3-6, 8-11, and 13-17 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by CAS Registry Number 2416224-66-1 (11 May 2020) “CAS”.
Regarding claims 3-6, 8-11, 13, and 16-17, CAS Registry Number 2416224-66-1 discloses the following compound as part of a chemical library on or 11 May 2020. This compound clearly meets each and every chemical
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structure variable as listed in the instant claims, wherein R1a is pyrrolidine, R1b is cyclohexane, R2a is piperazine, and R2a is fluorine; which is comparable to compound 1 of the instant claims (specification, page 40).
Therefore, claims 1, 3-6, 8-11, 13, and 16-17 are anticipated.
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 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 18 is rejected under 35 U.S.C. 103 as being unpatentable over CAS Registry Number 2416224-66-1 “CAS” as applied to claims 1-6, 8-11, 13, and 16-17 in in view of Wisniewski et al., ACS Med Chem Lett. 2016 Mar 28;7(5):508-13.
CAS and PubChem disclose compounds comparable to the instant claims, however CAS and PubChem do not explicitly teach a pharmaceutical composition.
Regarding claim 18, and as applied to claims 1-6, 8-11, 13, and 16-17 above, Wisniewski (abstract; page 510, Figure 3) discloses various structurally related compounds having
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comparable core scaffold to that of CAS and PubChem. Wisniewski (page 508-509 and 511-512) teaches that such compounds are useful candidate therapeutic agents or β‑Catenin/BCL9 inhibitors. Given that both CAS and PubChem do not explicitly disclose a pharmaceutical composition, thus POSITA would have been motivated to evaluate the CAS and PubChem’S compounds as an additional member of this class BCL9 inhibitor in order to determine their potency or biological activity. Therefore, a POSITA would have reasonably formulated the CAS and PubChem’ compounds into a pharmaceutical composition comprising a pharmaceutical acceptable carrier to the determine its potency and to arrive at the claimed invention.
Subject Matter Free of the Art of Record
The subject matter of claims 7 and 12 are free of the art of record. The closest prior art is the CAS Registry Number 2416224-66-1. While CAS teaches compound of formula Ia and Ib, however CAS does not explicitly teach “monocyclic of bicyclic C3-C7heterocycle” and there is no motivation for POSITA to modify the teaching of CAS to arrive at the claimed compound containing “monocyclic of bicyclic C3-C7heterocycle”. The claim is not allowable until the 112 issues are resolved.
Conclusion
Claims 1 and 4-16 are rejected under 35 U.S.C. 112(b). Claims 1-6, 8-11, 13, and 16-17 are rejected as being anticipated. Claims 1-6, 8-11, 13, and 16-18 are rejected as being obvious. Claim 17 is objected to. Claims 19 and 25-26 are withdrawn. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (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, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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