DETAILED ACTION
Claims 1-6, 8-9 and 16, submitted 24 March 2026, are pending in the application. Claim 7 has been cancelled. Claims 1-6, 8-9 and 16 are subject to examination in the instant Office 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 .
Restrictions – Modified and Maintained
The status of the previous rejected claims in the Office Action mailed on 24 September 2025 are set out below.
Rejections under 35 U.S.C. §112(a)
The Applicant’s arguments are not sufficient to overcome the previous rejection for the reasons set out below.
Response to Arguments
Applicant's arguments filed 24 March 2026 have been fully considered but they are not persuasive.
The Applicant has argued that independent claim 1 is drawn to compositions of matter of the instant Formula I’ genus and thus there is no requirement to provide the structure-activity relationship between the target ligase and the compounds. However, line 20 of claim 1, found on the 3rd page of the claims, recites the limitation “TBM is a target binding moiety that binds to a target protein selected from BRD4 and EGFR”, which requires the compounds to functionally bind to the target protein. Therefore, evidence must be brought forward to provide structure-activity relationship of the compound and E3 ubiquitin ligand binding moiety through experimentation in vitro or through binding assays. This lack of experimentation leads to uncertainty and unpredictability in the claimed method of target protein binding, negatively affects the ability of ordinary skilled artisans to be able to identify which compounds of the claimed genus would possess or not possess the recited function, and is an important consideration in assessing whether Applicant had possession of the full scope of the claimed genus.
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.
Modified - Claims 1-6, 8-9, and 16 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 1 recites the limitation of a compound of Formula (I’) and also recites “TBM is a target binding moiety that binds to a target protein selected from BRD4 and EGFR” for which the specification does not provide adequate written description to convey that the inventors were in possession of the full scope of the claimed invention.
The Applicant has provided adequate written description for certain aspects of
the instantly claimed invention. Applicant has provided guidance with respect to the
method of making the claimed invention by teaching the synthesis of the compounds
found in the specification from page 450 to page 454, encompassing 8 schemes of
compound preparation. Additionally, the applicant has provided evidence of written
description with regards to the exemplification of the claimed compounds by teaching
the exemplified compounds, I-1 to I-89, in Table 1 found in the specification from page
220 to page 238. Applicant has also provided evidence of written description by
providing Table 2 which teaches exemplary drugs, what the drug is used for, and the
gene identifier for the target protein which is found in the specification starting on page
239 and ending on page 449.
However, the Applicant does not provide adequate written description with
regards to the structure-activity relationship of the compound and the E3 ubiquitin ligand
binding moiety through experimentation in vitro or binding assays. The instant
specification provides examples in paragraphs 00431-00440, which are drawn to
general synthetic methods of preparing the compounds. The exemplification does not
teach the function of the compound in binding assays, in vitro experimental function, nor
in in vivo experimental function.
It’s known in the art that medicinal chemistry and pharmacology are
unpredictable areas. Even with carefully designed protein degraders there is not always
a guarantee that they function as expected and as such, there would be uncertainty in a
novel ubiquitin binding ligase ability to bind to the target binding ligase.
Regarding the requirement for written description of chemical entities, Applicant's
attention is directed to the MPEP §2163. In particular, Regents of the
University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert.
denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written
description requires a precise definition, such as by structure, formula, chemical name,
or physical properties, "not a mere wish or plain for obtaining the claimed chemical
invention.” Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set
forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent
Applications under the 35 U.S.C. 112.1 "Written Description" Requirement
("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description
requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional
characteristics when coupled with a known or disclosed correlation between function
and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed.
Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover,
although Eli Lilly and Enzo were decided within the factual context of DNA sequences,
this does not preclude extending the reasoning of those cases to chemical structures in
general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y.
2003). Based on the language of the specification and absence of adequate
experimental material, the Examiner concludes that the Applicant does not have
possession of the claimed invention.
Conclusion
No claims are allowed.
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 JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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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.
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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