DETAILED ACTION
Status of Application
The amendments and response filed 23 February 2026 are acknowledged. Claim 3 is cancelled and claims 17-18 are new. Thus, claims 1-3 and 4-18 are pending. Claims 10-16 remain withdrawn from consideration as being drawn to non-elected subject matter (See Election/Restriction below). Thus, claims 1-9 are subject to examination on the merits.
Applicant’s affirm the election of Group I, claims 1-9 as recited in the previous First Action on the Merits office action mailed 21 November 2025.
Withdrawal of Previous Objection/Rejection
The objection to claims 5-8 for minor typographical informalities is withdrawn in view of the amendments to claim 1 and claims 5-8.
The rejection of claims 1-9 under 35 U.S.C. 112(b) is withdrawn in view of the amendment to recite a comparative in claim 1 for the increased solubility.
The rejection of claim 4 under 35 U.S.C. 112(b), for two issues is withdrawn because in the first instance, the insertion that the twinkle enzyme is encoded by SEQ ID NO: 20; and second, because it makes clear that the enzyme is SEQ ID NO: 19 or encoded by SEQ ID NO: 20 and that these sequences are not just directed to the sequence of the SUMO tag.
The rejection of claims 1-9 under 35 U.S.C. 112(a) is withdrawn in view of the amendments to insert the SUMO tag into claim 1.
The rejection of claim(s) 1-3 and 8-9 under 35 U.S.C. 102(a)(1) as being anticipated by Farge et al. (Nucleic Acid Res., 2008 – cited previously) as evidenced by human Twinkle protein UniProt Q96RR.1, encoded by TWNK gene (cited previously) is withdrawn as Farge et al. do not teach a Twinkle enzyme comprising an N-terminal deletion and a SUMO tag fusion, and which has increased solubility.
The rejection of claim(s) 1-2 and 8-9 under 35 U.S.C. 102(a)(1) as being anticipated by Fernandez-Milan et al. (Nucleic Acid Res., 2015 – cited on IDS) as evidenced by human Twinkle protein UniProt Q96RR.1, encoded by TWNK gene (cited previously) is withdrawn as Fernandez-Milan et al. do not teach a Twinkle enzyme comprising an N-terminal deletion and a SUMO tag fusion, and which has increased solubility.
New Rejection – Necessitated by Amendment(s)
Claim Rejections - 35 USC § 112(b)
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.
Claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 recites the limitation (in line three) "wherein the soluble isolated truncated twinkle…." in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 has removed the term “isolated” from the claim.
Conclusion
Claims 1-2, 5-9, 17-18 are allowed. Claim 4 is rejected. Claims 10-16 are withdrawn.
It is noted, should the rejection of claim 4 be remedied and overcome, in order for rejoinder of the withdrawn claims to occur, several deficiencies with said withdrawn claims need fixing.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 13 April 2026
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