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 .
It is noted that the amendment to the claims filed on 11/10/2025 does not comply with the requirements of 37 CFR 1.121(c) because not all of the claims has not been given the proper status identifiers, such as claims 30-33 and 39 should have the status identifier “Withdrawn”. However, in the interest of compact prosecution, the amendment to the claims has been entered.
Election/Restriction
Applicant's election without traverse of Group I, drawn to claims 1-25, in the reply filed
on 07/28/2025 is acknowledged.
Applicant's election without traverse of SEQ ID NO: 482 in the reply filed on 07/28/2025
is acknowledged.
Claims 30-33 and 39 are withdrawn from further consideration pursuant to 37
CPR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or
linking claim. Election was made without traverse in the reply filed on 07/28/2025.
Claims 3-9, 12-18 and 21-25 where canceled in Applicant’s amendment filed 11/10/2025.
Claims 1, 2, 10, 11, 19 and 20 are currently under examination.
Claim Objections
Claims 10 and 19 are objected to because of the following informalities:
Claim 10 recites an abbreviation shown as “His6-tag”. The abbreviation in its first instance must be written out and the abbreviation placed in parenthesis next to the term or phrase.
Claim 19 recites two abbreviations shown as “HDR” and “DSB”, respectively. The abbreviation in its first instance must be written out and the abbreviation placed in parenthesis next to the term or phrase.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
This is a NEW Rejection necessitated by amendment to the claims.
Claims 2, 11 and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Independent claims 1, 10 and 19 recite “An isolated polypeptide comprising a ubiquitin polypeptide variant having at least 95% sequence identity to SEQ ID NO: 482”, “An isolated fusion polypeptide comprising a ubiquitin polypeptide variant having at least 95% sequence identity to SEQ ID NO: 482 and an N-terminal His6-tag” and “…an isolated polypeptide having at least 95% sequence identity to SEQ ID NO: 482”, respectively. Claims 2, 11 and 20 that rely upon the independent claims recite “a sequence of SEQ ID NO: 482” which is broader in scope as the phrase “a sequence” does not specify a percent identity required of the sequence or whether the entire sequence is required. The phrase “a sequence” is interpreted as two or more consecutive amino acids within the sequence that show 100% identity to one another. Therefore, the dependent claims are broader in scope than the independent claims from which they rely. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Amendments - Claim Rejections - 35 USC § 112
The previous rejection of claims 3-9 under 35 U.S.C. 112(d), also known as 4th paragraph, as being in improper dependent form has been withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 11 and 20 are rejected under 35 U.S.C. 102(a)(l)/(a)(2) as being anticipated by Durocher et al (WO 2017/132746 Al; Cited in a prior office action). This is a previous rejection made in a prior office action mailed on 09/05/2025 and rewritten to address the amendments to the claims filed by application on 11/10/2025.
Regarding claims 2, 11 and 20, the claims are interpreted as if they were written in independent form due to the broader scope of the current claims as they are amended from the independent claims from which they rely upon. The phrase “a sequence” is interpreted as two or more consecutive amino acids within the sequence that show 100% identity to one another.
Durocher teaches inhibitors of 53BP1 which can bind and occlude the tandem Tudor domain of 53BP1, effectively blocking its ability to accumulate at sites of DNA damage (Page 1, Lines 28-30). Durocher teaches the inhibitors enhance gene targeting and chromosomal gene conversion via two HR reactions (Page 1, Lines 30-31). Durocher teaches the 53BP1 binding polypeptides comprising at least three amino acid modifications compared to the wild type ubiquitin polypeptide outlined as SEQ ID NO: 1 (100% identity to two or more consecutive amino acid within instant SEQ ID NO: 482) (Page 2, Lines 11-14; See new Appendix I). Durocher teaches a modified polypeptide disclosed herein has at least 60%, 70%, 80%, 90%, 95% or 99% identity in its amino acid sequence to SEQ ID NO: 1 (Page 6, Lines 19-20).
Claim Rejections - 35 USC § 102
The previous rejection of claims 1-9 under 35 U.S.C. 102(a)(l)/(a)(2) as being anticipated by Matsuda et al (WO 2015/125702 Al), as evidenced by the machine translation of WO 2015/125702 Al wherein all page numbering below refers to the machine translation, has been withdrawn in view of Applicant’s amendments to the claims.
The previous rejection of claims 1-9 and 19-25 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Durocher et al (WO 2017/132746 A1), has been maintained in view of Applicants amendments to the claims and arguments filed on 11/10/2025 and rewritten to address the amendments to the claims filed by Applicant.
Applicant’s arguments have been considered but are not found to be persuasive.
Applicant argues that not all of the claimed features are anticipated by the single prior art reference and therefore the claim rejections should be withdrawn.
As it pertains to claims 1, 10, 19, 30-33 and 39, these claims have been found to be free of the art, however, due to the dependent claims 2, 11 and 19 being of broader scope than the claims from which they depend upon, the claims were examined as independent claims based on their broad scope. Therefore, the claims are not allowable.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ALEXANDRA ROSE LIPPOLIS/ Examiner, Art Unit 1637
/Jennifer Dunston/ Supervisory Patent Examiner, Art Unit 1637