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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on February 17, 2026.
Currently, claims 1, 7-13, 16-19, and 24-30 are pending in the instant application. Claims 28-30 are withdrawn from further consideration as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 1, 7-13, 16-19, and 24-27 are under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 103
Claims 1, 7-13, 16-19, and 24-27 remain rejected under 35 U.S.C. 103 as being unpatentable over Bui in view of Leblond et al., Elbashir et al., and Zhang et al. for the reasons as set forth in the Office action mailed on November 17, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 17, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious because none of the cited references alone or in combination teach the SEQ ID NOs recited in claim 1 and dependent claims thereof. In response, it is noted that applicant’s elected siRNA sequence of SEQ ID NO:20 previously recited in claims 2-9, wherein SEQ ID NO:20 forms a duplex with SEQ ID NO:19, and was rendered prima facie obvious over the combined teachings of the instantly cited references as set forth and explained in detail in the last Office action. See pages 8-12. Since applicant did not provide any substantial rebuttal arguments addressing the supposed errors of the obviousness rationale of record pertaining to the claimed duplex comprising SEQ ID NOs:19-20, this rejection is maintained.
Claim Rejections - 35 USC § 101
Claims 26-27 remain rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as encompassing a human organism for the reasons as set forth in the Office action mailed on November 17, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 17, 2026 have been fully considered but they are not persuasive. Applicant argues that the rejection should be withdrawn in view of the claim amendments. In response, the “recombinant or isolated cell” reads on a “recombinant” cell, which is administered into a human being, who consequently has the recombinant cell. As such, the claims as amended encompass a human organism comprising the recombinant cell. Accordingly, this rejection is maintained.
Double Patenting
Claims 1, 7-13, 16-19, and 24-27 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of Application No. 18/730,190 for the reasons as set forth in the Office action mailed on November 17, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 17, 2026 have been fully considered but they are not persuasive. Applicant argues that the rejection should be withdrawn because the instant application is the earlier-filed application. In response, it is noted that the instant provisional rejection is not the only outstanding rejection in the instant application. Hence, the guidance provided in MPEP §804 does not apply. Accordingly, this rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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/DANA H SHIN/Primary Examiner, Art Unit 1635