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 .
DETAILED ACTION
Claims 1-65 are pending in the instant application.
Claims 60-65 are withdrawn from consideration.
Claims 1-59 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 63/375,167, filed on 09 September 2022. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 09 September 2022.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 07 June 2024, 07 June 2024, 07 June 2024, and 26 August 2026, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Election/Restrictions
Applicant’s election of Group I, claims 1-59, without traverse, in the reply filed on 25 August 2026 is acknowledged. In addition, the specie election of compound 569, which reads on claims 1, 4, 13, 15-27, 32-34, 37, 44, and 58-59, is acknowledged.
If the elected species is not identified in the art, the search will be expanded to additional species per MPEP 802.03.
The elected species was not identified in the art and the search was expanded to include all species.
Claims 60-65 are withdrawn for not reading on the elected group.
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 1-31 and 34-42 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 is directed to a compound of Formula (I) or (II). E is defined as a moiety that binds to an E3 ubiquitin ligase. “Binds to an E3 ubiquitin ligase” is a functional limitation which requires a compound fit into and interact with a binding pocket of an E3 ubiquitin ligase. The Applicant’s disclosure does not provide sufficient written description to support this functional limitation.
See MPEP 2163 II. A. 3. (a) (ii) with regards to the requirements for descriptive support and for functional limitations of generically described entities:
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”
“A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.”
There is no structure-function relationship for E3 ubiquitin ligases recognized by the prior art. The art teaches diverse structural features for E3 ubiquitin ligases, demonstrating they do not encompass just one structural genus. Toma-Fukai et al. (Molecules. 2021 Nov 4;26(21):6682) teaches there are over 600 E3 ligases exhibiting structural diversity to ensure precise substrate selection. Given the diversity of E3 ligases, and the diversity of the instant claims, there is no structure/function correlation linking the structural aspects of the claim to E3 ligase binding.
The specification does not provide an adequate representation of all the possible species of E3 ubiquitin ligases, in fact, the specification only provides one working example of a E3 ubiquitin ligases in all 735 preferred embodiments. Failure to represent all of the possible species of E3 ubiquitin ligases with a representative number of examples suggests the applicant is not in possession of the claimed invention.
To summarize, there is a lack of descriptive support since the claims recite a functional limitation and: (i) the provided species are not sufficiently representative of the genus of compounds having such function, (ii) multiple other species with the function are known in the art with completely different structural features and (iii) there is no general art-recognized structure-function relationship for compounds with the required functional activity.
Claim Objections
Claims 32-33 and 43-59 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
Claims 1-31 and 34-42 are rejected.
Claims 32-33 and 43-59 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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