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 .1
Status of Claims
Claims 1-66 are pending. Claims 1, 3-12, 14-17, 22, 30-35, 37, 38, 48, 49, 51, 54, 58 and 60 are under examination. Claims 2,13,18-21,23-29,36,39-47,50,52-53,55-57,59 and 61-66 are withdrawn.
Election/Restrictions
Claims 2,13,18-21,23-29,36,39-47,50,52-53,55-57,59 and 61-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions II and III and species of compounds, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 21, 2026.
Applicant’s election of Group I and below species of compound in the reply filed on April 21st is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant elected the below species of compound:2
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Based off the election of Group I and above species, claims 1, 3-12, 14-17, 22, 30-35, 37, 38, 48, 49, 51, 54, 58 and 60 are under examination.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on February 5, 2024 and May 14, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112 (Written Description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
Claims 1, 3-12, 14-17, 22, 30-35, 37, 38, 48, 49, 51, 54 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.
The instant Application’s claims are directed broadly to a compound of formula 1A:
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B is an optionally substituted 5-7 membered cycloalkyl ring, an optionally substituted 5-7
membered aryl ring, an optionally substituted 5-7 membered heteroaryl ring, or an optionally substituted 5-7 membered heterocyclic ring, wherein ring Bis fused to ring G through Y and Z;
and ULM is
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Dependent claims 3-12, 14-17, 22, 30-35, 37, 38, 48, 49, 51, 54 and 60 are similarly rejected as their scope is not supported by the specification.
The specification does not teach or disclose the full scope of the rejected compound claims to demonstrate that the inventors had possession of the clamed method.
Examples 1-8 starting at paragraph 378 of the specification, (which are the 8 specific claimed compounds of claim 58), at best support a scope of compounds where
Rd1, R3e3 and Rc1 are hydrogen;
G is a piperazinyl ring, where Wn and Z are carbons, n is 1 and Y is a nitrogen;
B is piperazinyl ring, where Z is a carbon and Y is a nitrogen;
R1 is linking chemical moiety such as
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or
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and ULM is one of the following ubiquitin linking moieties (ULM)
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Examples 1-8 cannot support the claimed subject matter as they are limited to the definitions of Rd1, Re3, Rc1, G, Wn, Z, N, Y, B, R1 and ULM as detailed above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-12, 14-17, 22, 30-35, 37, 38, 48, 49, 51, 54, 58 and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12448389 B2 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent encompasses the claims of the instant application, differing only in certain aspects of the generic claim. The reference patent teaches:
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.
The reference patent claims that the structural portion ULM is a small molecule E3 ubiquitin ligase (UL) binding moiety that binds a Cereblon E3 Ubiquitin Ligase (UL), while the equivalent position on the generic structure of the instant application is
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among others,
which falls into the genus of ULM on the reference application.
The reference patent claims a generic linker group, R1, while the equivalent position on the instant application requires a bond or ANY chemical moiety that links that links PTM and ULM.
Conclusion and Correspondence
In conclusion, no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 This application has PRO 63/383,753 11/15/2022.
2 CAS Registry Number: 3039508-78-3
N-(2,6-dioxopiperidin-3-yl)-2-fluoro-4-(4-(((3R,5S)-4-((S)-2-(2-hydroxyphenyl)-6,6a,7,8,9,10-hexahydro-5H-pyrazino[1',2':4,5]pyrazino[2,3-c]pyridazine-8-carbonyl)-3,5-dimethylpiperazin-1-yl)methyl)piperidin-1-yl)benzamide
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