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 .
Status of the Claims
Claims 1, 4, 6, 8, 10, 15-17, 21, 23 and 26-35 are pending in the instant application and subject to examination herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/10/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - Withdrawn
The prior rejection of claims 10 and 26-29 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 claims contain 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had possession of the claimed invention, has been overcome by Applicant’s amendment of claim 10, and is accordingly withdrawn. The amendment of claim 10, removing the compound(s) of Formula VII, has overcome the prior rejection.
The prior rejection of claim 1 under 35 U.S.C. 102(a)(2) as being anticipated by Crew (U.S. Patent No. 10,584,101 B2) has been overcome by Applicant’s amendment of claim 1, and is accordingly withdrawn. The amendment of claim 1 to remove the option of the element “X” to be simply a bond has overcome the prior rejection.
The prior rejection of claims 1, 15-17 and 21 under 35 U.S.C. 102(a)(2) as being anticipated by Chan (US 2020/0369679 A1)1 has been overcome by Applicant’s argument and is accordingly withdrawn. Applicant is correct that the compound 2-(2,6-dioxopiperidin-3-yl)-3-oxoisoindoline-4-carbonitrile is not disclosed in Chan’s priority provisional patent 62/852,844 and the same compound is disclosed in Applicant’s priority provisional patent 62/949,027; therefore Chan is not valid prior art with respect to the compound.
The prior rejection of claims 1, 4, 15 and 30 under 35 U.S.C. 102(a)(2) as being anticipated by Liu (WO 2020/038415 A1)2 has been overcome by Applicant’s amendment of claim 1 and is accordingly withdrawn. Applicant’s amendment of claim 1 to further limit the structure of a compound of Formula II, specifically with respect to the moieties “X” and R6” has overcome the prior rejection.
The prior rejection of claims 1 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Tweedie (Tweedie, D., et al.; Journal of Neuroscience Methods, v183, pp182-187; 2009)3 has been overcome by Applicant’s amendment of claim 1 and is accordingly withdrawn. Applicant’s amendment of claim 1 to further limit the structure of a compound of Formula III, specifically in regard to the moiety “X” has overcome the prior rejection.
The prior rejection of claim 10 under 35 U.S.C. 102(a)(1) as being anticipated by CAS 16477-31-9 (Chemical Abstracts Services, registry number 16477-31-9, originally entered on 11/16/1984) has been overcome by Applicant’s amendment of claim 10, and is accordingly withdrawn. Applicant’s amendment of claim 10 to limit the structure of a compound of Formula VIII, such that R8 cannot by hydrogen, has overcome the prior rejection.
The prior rejection of claims 10, 15, 26-29 and 33 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Phillips_2017 (WO 2017/197051 A1)4 has been overcome by the combination of Applicant’s amendment of claim 10 and Applicant’s argument, and is accordingly withdrawn. Applicant’s amendment of claim 10, specifically to further limit the structure of a compound of Formula X such that R7 must be a (C1-C3)alkyl group has overcome the prior rejection, and Applicant argument is correct that Phillips’ compound 174 does not have a (C1-C3)alkyl at R7.
The prior rejection of claims 10, 15, 26-27, 29 and 35 under 35 U.S.C. 102(a)(2) as being anticipated by Hwang (US PG Pub 2022/0105188 A1) has been overcome by Applicant’s amendment of claim 10 and is accordingly withdrawn. Applicant’s amendment of claim 10, specifically to further limit the structure of a compound of Formula IX such that each of R12-R15 can have only one Rw group, has overcome the prior rejection.
The prior rejection of claims 15 and 33 under 35 U.S.C. 102(a)(2) as being anticipated by Phillips_2020 (US PGPub 2020/0140456 A1) has been overcome by Applicant’s amendment of the claims and is accordingly withdrawn. Applicant’s amendment of claims 15 and 33, specifically to remove claim to the compounds 3-(quinoxalin-2-ylamino)piperidine-2,6-dione and 3-(quinazolin-2-ylamino)piperidine-2,6-dione has overcome the prior rejection.
The prior rejection of claims 15 and 33 under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1495439-14-9 (Chemical Abstracts Services, registry number CAS 1495439-14-9, originally entered on 12/15/2013 by Aurora Fine Chemicals) has been overcome by Applicant’s amendment of the claims and is accordingly withdrawn. Applicant’s amendment of claims 15 and 33, specifically to remove the compound 3-(2-pyrimidinylamino)-2,6-piperidinedione has overcome the prior rejection.
The prior rejection of claims 15 and 33 under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1910778-49-2 (Chemical Abstracts Services, registry number 1910778-49-2, originally entered on 05/15/2016 by Aurora Fine Chemicals) has been overcome by Applicant’s amendment of the claims and is accordingly withdrawn. Applicant’s amendment of claims 15 and 33, specifically to remove the compound N-(2,6-dioxo-3-piperidinyl)-1,6-dihydro-6-oxo-2-pyridinecarboxamide piperidinedione has overcome the prior rejection.
The prior rejection of claims 15 and 35 under 35 U.S.C. 102(a)(1) as being anticipated by CAS 2250288-86-7 (Chemical Abstracts Services, registry number 2250288-86-7, originally entered on 11/30/2018) has been overcome by Applicant’s amendment of the claims and is accordingly withdrawn. Applicant’s amendment of claims 15 and 33, specifically to remove the compound 3-(4-oxo-1,2.3-benzotriazin-3(4H)-yl)-2,6-piperidinedione has overcome the prior rejection.
Claim Rejections - 35 USC § 102 – Maintained
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.
The prior rejection of claims 1, 8, 16-17 and 23 under 35 U.S.C. 102(a)(2) as being anticipated by Duplessis (WO 2021/083949 A1)5 is maintained.
Although Applicant has not specifically traversed the prior rejection, Applicant has asserted that the currently amended claim 1 is not anticipated by Duplessis because the limitations of claim 1 no longer allow for multiple Rw groups the R4 substituent of a compound of Formula IV. Applicant’s assertion has been considered, but is not found persuasive, because the compound “Example 111”6 cited from Duplessis in the prior rejection does not have multiple Rw groups at the R4 substituent position. Duplessis’ Example 111 has a single Rw substituent that is further substituted, as permitted under the current limitations of the “Rw” group definition of instant claim 1 – claim 1 does not assert that further substitution of an Rw group constitutes additional Rw group(s), as shown below:
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298
1272
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Reiterated Rejection:
Claims 1, 8, 16-17 and 23 are anticipated by Duplessis.
Claims 1, 8, 16-17 and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Duplessis (WO 2021/083949 A1)7.
Claim 1 is drawn to a compound or pharmaceutically acceptable salt thereof, selected form a set of formulae, including formula IV, representing a genus of (1-oxo-2,3-dihydro-isoindolinyl)-piperazine-2,6-diones that are substituted at the 7-position of the isoindolinone ring, as shown in the table below.
Duplessis discloses bifunctional compounds that cause the degradation of a subunit protein of the Switch/Sucrose Non Fermentable (SWI/SNF) complex, namely SWI/SNF-Related Actin-Dependent Regulator of Chromatin, Subfamily A, Member 2 (SMARCA2). As part of the invention, Duplessis discloses a compound, designated as “Example 111”8, that anticipates the limitations of instant Formula IV of claim 1, as shown in the table below (page 224, lines 11-15):
Claim Number(s) of Instant Application
Instant Application
Duplessis
1
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218
358
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wherein:
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148
342
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Thus, claim 1 is anticipated by the disclosure of Duplessis.
Claim 8 further limits Formula IV of claim 1 to a narrower genus that is met by Duplessis’ “Example 111”.
Claim 16 further limits claim 1 to a composition comprising a pharmaceutically effective amount of the compound of claim 1 and a pharmaceutically acceptable carrier. Duplessis further discloses that the invention disclosed therein includes pharmaceutical compositions comprising a compound disclosed therein or a pharmaceutically acceptable salt thereof, and therapeutically inert carrier (page 3, lines 17-19).
Claim 17 further limits claim 16 to a method of treating a cancer comprising administering the composition of claim 16 to a subject in need thereof, wherein the cancer to be treated is selected from a Markush group that includes breast cancer. Duplessis discloses a method of treating SMARCA2-mediated disorders in a subject, comprising administering a compound disclosed therein or a pharmaceutically acceptable salt thereof, to the subject (page 42, lines 16-19) and further discloses that SMARCA2-mediated disorders include cancers, including breast cancers (pages 42-43, bridging paragraph).
Claim 23 further limits claim 16 to a Markush group of methods that includes a method of modulating proteasomal degradation of a protein, comprising administering the composition of claim 16 to a subject in need thereof. Duplessis discloses that the compounds disclosed therein cause the degradation of SMARCA2 protein via the targeted ubiquination of SMARCA2 protein and subsequent proteasomal degradation.
Thus, claims 8, 16-17 and 23 are anticipated by the disclosure of Duplessis.
Claims Free of the Prior Art
Claims 10, 15 and 26-35 are allowed. Prior art does not teach or reasonably suggest, alone or in combination, a compound of any of Formulae VI, VIII, IX and X. Prior art does not teach or reasonably suggest, alone or in combination, any of the specific compounds of claim 15, or a composition comprising any of the specific compounds of claim 15 and further comprising a pharmaceutically acceptable carrier. Prior art does not teach or reasonably suggest, alone or in combination, a method of treatment of cancer or an autoimmune disease, wherein the method comprises administering a composition comprising a compound of claim 15 and a pharmaceutically acceptable carrier. Prior art does not teach or reasonably suggest, alone or in combination, a method of modulating cereblon or modulating proteasomal degradation of a protein, or modulating sequestration of a protein to the proteasome, comprising administering a compound of claim 15 and a pharmaceutically acceptable carrier.
Claims 4, 6 and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (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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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Effective filing date: 05/24/2019.
2 Cited in Applicant’s Information Disclosure Statement dated 03/07/2025.
3 Cited in Applicant’s Information Disclosure Statement dated 05/30/2024.
4 Cited in Applicant’s Information Disclosure Statement dated 10/18/2023.
5 Effective filing date: 10/29/2019
6 3-[7-[[1-[9-[4-[4-[3-[3-amino-6-(2-hydroxyphenyl)pyridazin-4-yl]oxy-1-piperidyl]phenyl]piperazin-1-yl]-9-oxo-nonyl]triazol-4-yl]methylamino]-1-oxoisoindolin-2-yl]piperidine-2,6-dione
7 Effective filing date: 10/29/2019
8 3-[7-[[1-[9-[4-[4-[3-[3-amino-6-(2-hydroxyphenyl)pyridazin-4-yl]oxy-1-piperidyl]phenyl]piperazin-1-yl]-9-oxo-nonyl]triazol-4-yl]methylamino]-1-oxoisoindolin-2-yl]piperidine-2,6-dione
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