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 .
Applicant’s amendments filed 7/29/2026 have been entered.
Claims 1, 2, 5-10, 13, 15-16, 18, 20, and 22-26 are pending.
Claim Rejections - 35 USC § 112
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, 2, 5, 7-10, 13, 15, 16, 18, 20, 22-26 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.
For claims 1, 2, 5, 7-10, 13, 15, 16, 18, 20,22-26, the instant specification has support for the language of the claims, i.e., selective cereblon-dependent EP300 degrader, however, the court has held "generic claim language appearing in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus claimed." Id. at 1171, citing Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609, 1616 (Fed. Cir. 2002). In the instant case, the functional characteristic of selective cereblon-dependent degrading EP300 has not been coupled with a known or disclosed correlation between function and structure of the composition. There is no pharmacophore in the structural-activity relationship known in the art for selective cereblon dependent degradation of EP300.
In University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927-28 (Fed. Cir. 2004), the court reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification's function description, the specification did not provide an adequate written description of the claimed invention. Ariad, 94 USPQ2d at 1173.
Therefore, instant Specification does not provide adequate written description support for the invention of the claims because it does not describe enough species of pharmaceutical composition capable of achieving the claimed function. As the matter of fact, only one compound is disclosed (i.e., QJAD1) as disclosed as selective cereblon-dependent EP300 degrader. As such, the Specification would not reasonably convey to a person of ordinary skill in the art that Applicant had possession of the claimed invention as a whole. Applicant has not disclosed a sufficient number of species to support the claims as recited. The claims, therefore, extend beyond what are disclosed.
Thus, while one of ordinary skill in the art would conclude that the Applicant would have been in possession of QJAD1 as selective cereblon-dependent EP300 degrader at the time of filing, one of ordinary skill in the art would not conclude that the Applicant described a sufficient number of pharmaceutical compositions to be in possession of the claimed invention as a whole at the time of filing.
Response to Arguments
Applicant's arguments filed 7/29/2026 averring sufficient examples of selective cereblon-dependent EP300 degrader have been disclosed, have been fully considered but they are not persuasive. The examiner notes that the references cited in the arguments is not incorporated by reference in the instant case. There are very limited examples discussed. Specifically, only one EP300 targeting ligand example and a small subgenus compounds are disclosed (see claim 2, 8-9). As such, the Specification would not reasonably convey to a person of ordinary skill in the art that Applicant had possession of the claimed invention as a whole. Applicant has not disclosed a sufficient number of species to support the claims as recited. The claims, therefore, extend beyond what are disclosed. Accordingly, the rejection under 35 USC 112a is maintained.
Allowable Subject Matter
Claim 6 is 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.
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 SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
