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
Application status
Claims 1-22 are pending in this application.
Priority
It is acknowledged that the instant application is a CON of PCT/US2020/061542, filed on 11/20/2020, which claims the benefit of U.S. Provisional Application No. 63074279 filed on 09/03/2020, and 62938736 filed on 11/21/2019.
Election
Applicant's election without traverse of Group I, Claims 1-13 and 22 in the response filed on 09/30/2025, is acknowledged.
Claims 14-21 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention.
For the reasons provided above, this restriction requirement is deemed proper, and therefore, it is made final.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/20/2022, 08/26/2022 and 02/27/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Objections to the Specification
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825; Applicants’ attention is directed to the final rulemaking notice published at 55 FR 18230 (May 1, 1990), and 1114 OG 29 (May 15, 1990). To be in compliance, Applicants should identify nucleotide sequences of at least 10 nucleotides and amino acid sequences of at least 4 amino acids in the specification by a proper sequence identifier, i.e., “SEQ ID NO:” (see MPEP 2422.01). If these sequences have not been listed in the computer readable form and paper copy of the sequence listing, applicant must provide an initial computer readable form (CRF) copy of the “Sequence Listing”, an initial paper copy of the “Sequence Listing”, as well as an amendment directing its entry into the specification, and a statement that the content of the paper and CRF copies are the same and, where applicable, include no new matter as required by 37 C.F.R. 1.821(e) or 1.821(f) or 1.821(g) or 1.821(b) or 1.825(d). See particularly Figures 3A, 7D and 9B; and pages 10-13 and 58 of the specification containing amino acid/nucleic acid sequences, and therefore, those sequences should be represented by proper sequence identifier numbers.
If the noted sequences are not in a sequence listing as filed, Applicants must provide (1) an updated copy of the sequence listing containing the requisite sequences in computer readable form (CRF), (2) an amendment directing its entry into the specification, (3) a statement that no new matter has been added and (4) an amendment to the specification to identify each of the identified sequences by SEQ ID NO:, and (5) an incorporation by reference statement with the date of creation, sequence file name and size in bytes. – See also MPEP 2422.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 5 and 7 are rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 5 recites “at least about” which is indefinite. The term “about” encompasses a range which includes values which are higher and lower than the recited reference value. The term “at least” implies that only values equal to or higher than the recited reference value are encompassed. Therefore, in the absence of a clear definition of what is encompassed by the term “about”, the term "at least about" is unclear and confusing since the term refers to values which are equal or higher than undefined values which are either higher or lower than the recited reference value. In essence, the term eliminates the relevance of the recited reference point, i.e., 20 amino acid residues, because the reference value becomes variable and undefined.
Claim 7 recites the phrase “R28, E41, C84, G55 or Y58” is confusing and indefinite because there is no recitation of a corresponding SEQ ID NO where these amino acid positions can be found within a fragment of BLC6 polypeptide. In the interest of advancing prosecution, the noted phrase is interpreted as “R28, E41, C84, G55 or Y58 of SEQ IE NO: 1”.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 8-13 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kerres et al. ("Chemically Induced Degradation of the Oncogenic Transcription Factor BCL6," Cell Reports, 19 September 2017, Vol. 20, pp. 2860-2875, see IDS) with an evidentiary reference of Slabicki et al. ("Small-molecule-induced polymerization triggers degradation of BCL6," Nature, 3 December 2020,Vol. 588, pp. 164-168, see IDS).
The instant claims are drawn to a recombinant polypeptide comprising a fragment of a BCL6 polypeptide, wherein the fragment comprises a Broad complex/Tamtrack/Brick-a-brack (BTB) domain of the BCL6 polypeptide.
Kerres et al. teach a recombinant polypeptide comprising a fragment of a BCL6 polypeptide, wherein the fragment comprises a BTB domain of the BCL6 polypeptide, optionally a fusion polypeptide comprising the BTB domain linked to a heterologous amino acid sequence, i.e., DNA binding domain of ERR1 or TCF4, optionally wherein the BCL6 polypeptide comprises an amino acid linker at C-terminus of the BTB domain, wherein the BCL6 fragment is polymerizable which is induced by binding of BI-3802 (2-((6-((5-chloro-2-((3S.5R)-3,5-dimethylpiperidin-I-yl)pyrimidin-4-yl)amino)-1-methyl-2-oxo-1,2-dihydroquinolin-3-yl)oxy)-N-methylacetamide), which is a benzimidazolone compound (see Figure 5 on page 2868; Figure 1A and D on page 2862; Figure 3 on page 2866; and page 2861, left column, 3rd paragraph), thereby anticipating claims 1, 2, 4, 8, 10, 12 and 13. Kerres et al. further teach that upon biding of BI3802 to BTB domain of BCL6 via amino acid residues R28, M51 (hydrophobic), C53, V117 (hydrophobic), this enhances degradation of polymerized BCL6, i.e., a biomaterial, via ubiquitin-dependent degradation (see Figure 1A and D on page 2862; Figure 3 on page 2866; and page 2861, left column, 3rd paragraph), thereby anticipating claims 9, 11 and 22. Claims 3, 5 and 6 are included in this rejection because the fragment of BCL6 inherently comprises a degron comprising VxP binding motif (amino acids 241-260 of BCL6) as evidenced by Slabicki et al. (see pg. 167 of Slabicki et al., right column lines 6-10).
Therefore, teachings of Kerres et al. anticipate Applicants’ claimed invention.
Conclusion
Claims 1-13 and 22 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
The instant Office action is non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656