DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on November 26, 2025 has been entered. The claims pending in this application are claims 8-17 and 19-35 wherein claims 21-29 have been withdrawn due to the restriction requirement mailed on May 16, 2025. The objections and rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendments filed on November 26, 2025. Claims 8-17, 19, 20, and 30-35 will be examined.
Claim Objections
Claim 8 is objected to because of the following informality: “a second vector comprising a 5’-side transposase recognition sequence, a 3’-side transposase recognition sequence, and a first enhancer sequence arranged therebetween; wherein the second vector further comprises in order from 5’ to 3’ a second promoter sequence, a 5’-side fragment of a second reporter gene, the 5’-side transposase recognition sequence, the 3’-side transposase recognition sequence, and the first enhancer sequence arranged therebetween, a 3’-side fragment of the second reporter gene; and wherein the 5’ side fragment of the second reporter gene and the 3’-side fragment of the second reporter gene have been obtained by dividing the second reporter gene into the 5’-
side fragment and into the 3'-side fragment” should be “a second vector comprising, in order from its 5’ end to its 3’ end, a second promoter sequence, a 5’-side fragment of a second reporter gene, 5’-side of a transposase recognition sequence, a first enhancer sequence, 3’-side of the transposase recognition sequence, and a 3’-side fragment of the second reporter gene; and wherein the 5’-side fragment of the second reporter gene and the 3’-side fragment of the second reporter gene are obtained by dividing the second reporter gene into the 5’-side fragment and the 3’-side fragment”.
Claim 9 is objected to because of the following informality: “the second reporter gene is inactivated by being divided into two” should be “the second reporter gene is inactivated because it is divided into the 5’ side fragment and the 3’ side fragment”.
Claim 11 or 17 is objected to because of the following informality: “wherein, in the second vector, a second enhancer sequence is ligated to upstream of the second promoter sequence” should be “wherein the second vector further comprises a second enhancer sequence ligated to upstream of the second promoter sequence”.
Claim 12 or 13 or 30 or 31 or 32 or 33 or 34 is objected to because of the following informality: “a base sequence” should be “a sequence”.
Claim 13 is objected to because of the following informalities: (1) “the second reporter gene 5’-side fragment” should be “the 5’-side fragment of the second reporter gene”; and (2) “the second reporter gene 3’-side fragment” should be “the 3’-side fragment of the second reporter gene”.
Claim 16 is objected to because of the following informalities: (1) “a second reporter gene 5’ side fragment” should be “5’ side fragment of a second reporter gene”; (2) “a second reporter gene 3’ side fragment” should be “3’ side fragment of the second reporter gene”; and (3) “wherein a 5’-side fragment of the second reporter gene and a 3’-side fragment of the second reporter gene are obtained by dividing a second reporter gene into the 5’-side fragment and into the 3’-side fragment” should be “wherein the 5’-side fragment of the second reporter gene and the 3’-side fragment of the second reporter gene are obtained by dividing the second reporter gene into the 5’-side fragment and the 3’-side fragment”.
Claim 19 is objected to because of the following informality: “a second vector comprising a 5’-side transposase recognition sequence, a 3’-side transposase recognition sequence, and a first enhancer sequence arranged therebetween; wherein the second vector further comprises in order from 5’ to 3’ a second promoter sequence, a 5’-side fragment of a second reporter gene, the 5’-side transposase recognition sequence, the 3’-side transposase recognition sequence, and the first enhancer sequence arranged therebetween, a 3’-side fragment of the second reporter gene; and wherein the 5’ side fragment of the second reporter gene and the 3’-side fragment of the second reporter gene are obtained by dividing the second reporter gene into the 5’-side fragment and into the 3'-side fragment” should be deleted since claim 8 has this limitation.
Claim 35 is objected to because of the following informalities: (1) “a first enhancer sequence” should be “the first enhancer sequence”; and (2) “including the same sequence with the 5’-side transposase recognition sequence in mutually opposite directions” should be “is identical to the 5’-side transposase recognition sequence but is in a mutually opposite direction in the second vector relative to the 5’-side transposase recognition sequence”.
Appropriate correction is required.
Claim Rejections - 35 USC § 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 is rejected as vague and indefinite. Since claim 14 does not require that a first vector comprises a sequence involved in expression of the first reporter gene, it is unclear why the sequence involved in expression of the first reporter gene can be substituted with a transposase target sequence. Please clarify.
Claim 15 is rejected as vague and indefinite. Since claim 14 requires that the sequence involved in expression of the first reporter gene in the first vector is substituted with a transposase target sequence, it is unclear why the first vector in claim 15 can further comprise the sequence involved in expression of the first reporter gene that is selected from the group consisting of an entire sequence of the first enhancer sequence, the first promoter sequence, the first reporter gene, and a partial sequence thereof. Please clarify.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 3-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 10 and 20 are objected to as being dependent upon objected base claims, but would be allowable if rewritten in independent form including all of the limitations of the base claims and any intervening claims.
No claim is allowed.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
February 4, 2026