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
As the applicant has pointed out, the Examiner incorrectly identified the priority of the applicant’s invention in the Requirement for Restriction on 31 March 2026 . This application is a national stage application, filed under 35 U.S.C. § 371, of International Application No. PCT/US2022/029966, filed May 19, 2022, which claims the benefit of priority under 35 U.S.C. § l 19(e) to U.S. Provisional Application No: 63/190,931, filed May 20, 2021, and U.S. Provisional Application No: 63/318, 114, filed March 9, 2022.
Requirement for Election/Restriction -Status of the Claims
In response to the Restriction and Election of Species Requirement dated February 6, 2026 in the above-identified application. Applicant elects Group II, claims 35-59 are drawn to a compound of formula (II). The Examiner has also required Applicant to elect a single compound of formula (II). Applicant elects compound 56 (shown below).
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243
478
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Claims 35-47, 51, 54, 55 and 60 read on the elected species are pending and are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statements received November 8, 2023 (3 references), April 29, 2024 (6 references) and March 18, 2025 (9 references) and are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
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 35, 36-41, 43-45, 51, 54, 58 and 60 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.
Claim 35 and its dependent claims 36-41, 43-45, 51, 54, 58 and 60 are indefinite for the wide variation of possibilities of the Targeting Ligand, Linker (L) and a Degron (D). The Targeting Ligand includes variables A1, A2, R1-R3, W1-W4, X1 and R1-R3. The variables for these options in claim 35 include:
X1 is a bond, CH2, CHMe, NH, NMe, or O;
W1 is CR4 or N;
W2 is CR4 or N;
each R4 is independently hydrogen, optionally substituted (C1-C6) alkyl,
optionally substituted (C1-C6) haloalkyl, optionally substituted (C1-C6) alkoxy,
optionally substituted (C1-C6) haloalkoxy, halogen, NO2, OH, CN, optionally
substituted amino, optionally substituted Cs-C6 carbocyclyl or optionally substituted
5- or 6-membered heterocyclyl;
W3 is CHorN;
W4 is CH orN;
R1 is hydrogen, optionally substituted (C1-C6) alkyl, optionally substituted (C1-C6)
haloalkyl, optionally substituted (C1-C6) alkoxy, optionally substituted (C1-C6)
haloalkoxy, halogen, NO2, NH2, OH, or CN;
R2 is hydrogen, optionally substituted (C1-C6) alkyl, optionally substituted (C1-C6) haloalkyl, optionally substituted (C1-C6) alkoxy, optionally substituted (C1-C6) haloalkoxy, halogen, NO2, OH, CN, optionally substituted amino, optionally substituted C5-C6 carbocyclyl, optionally substituted aryl, optionally substituted 5- or 6-membered heterocyclyl, or optionally substituted heteroaryl;
R3 is (C1-C6) alkoxy, NH(C1-C6) alkyl, NHaryl, NH-5- or 6-membered heteroaryl,
NHC(O)aryl, NHC(O)-5- or 6-membered heteroaryl, NHC(O)(C1-C6) alkyl,
NHSO2(C1-C6) alkyl, NHSO2aryl, SO2NH2, SO2NH(C1-C6) alkyl, SO2NHaryl,
C(O)NH2, C(O)NH(C1-C6) alkyl, C(O)NHaryl, C(O)NH-5- or 6-membered
heteroaryl, or optionally substituted 5- to IO-membered heterocyclyl, or R3 is 0, NH, N(C1-C6) alkyl, SO2NH, SO2N(C1-C6) alkyl, C(O)NH, or optionally
substituted 5- to 10-membered heterocyclyl, when R3 is bound to the Linker; and
A1 and A2 are each independently optionally substituted aryl or optionally
substituted 5- to 6- membered heteroaryl; and the degron is a moiety that binds an E3 ubiquitin ligase.
The bifunctional compounds identified by the applicant as a targeting ligand and a degron bound by a linker is indefinite for reciting a degron that binds an E3 ubiquitin ligase because the number and variation of degrons that can bind the E3 ubiquitin are numerous in the art and one of ordinary skill in the art could not reasonably determine the structural metes and bounds of the described degron in claim 35. Therefore, claim 35 and its dependent claims 36-41, 43-45, 51, 54, 58 and 60 are indefinite.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 35 and its dependent claims 36-41, 43-45, 51, 54, 58 and 60 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 35 defines a genus of compound of Formula II which includes a targeting ligand (including variables A1, A2, R1-R3, W1-W4, X1 and R1-R3) ,a Linker (L) and a Degron (D) each defined in very broad terms; specifically, the Degron is defined as a binding moiety that binds E3 ubiquitin ligase.
In support of this very broad compound genus, applicant has provided 23 compounds without specifically identifying the degron and 47 compounds in which the linker is not identified as to the number of attachment locations of the linker and the degron to the targeting ligand.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL RANDALL GAUGER whose telephone number is (571)272-1325. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffery Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.R.G./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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