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 13, 2026.
Currently, claims 169, 174-176, 179-181, 186, 188-205, and 209-218 are pending and 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.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
Double Patenting
Claims 169, 174-176, 179-181, 186, 188-203, 209-210, and 213-214 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-66 of U.S. Patent No. 12,397,013 in view of McSwiggen et al., Maier et al., Hinkle et al., and Kamola et al. for the reasons as set forth in the Office action mailed on November 13, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 13, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious because of the lack of predictability that the instantly claimed RNAi molecule would be “high performing” in vivo as evidenced by the instant specification’s disclosure pertaining to a single dose administration of AD-961583 and AD-454973. In response, it is noted that claims 169, 174-176, 179-181, 186, 188-190, 209-210, and 213-214 are merely drawn to an RNAi agent, which is not claimed to have a pharmaceutical function or an in vivo function, much less “high performing” activity. Further, claim 195 is not drawn to an in vivo or treatment method. In addition, the rejected claims in the instant rejection are not directed to or require AD-961583 and AD-454973, which are not representative of the “high performing” function for RNAi agent species encompassed by the instantly rejected genus claims, wherein the RNAi agent as written in the rejected claims is not claimed with a specific length and a specific modification pattern as in AD-961583 and AD-454973. Hence, the rejected claims are not commensurate in scope with the allegedly unpredictable “high performing” activity provided by AD-961583 and AD-454973. Note that the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” See MPEP §716.02. Accordingly, this rejection is maintained.
Claims 169, 174-176, 179-181, 186, 188-194, 209-210, and 213-214 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, and 11-28 of U.S. Patent No. 12,005,074 in view of McSwiggen et al., Maier et al., Hinkle et al., and Kamola et al. for the reasons as set forth in the Office action mailed on November 13, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 13, 2026 have been fully considered but they are not persuasive. Applicant argues that the same arguments provided above in the ‘013 patent apply. In response, it is noted that the instantly rejected claims, except claims 191-194, are merely drawn to an RNAi agent, which is not claimed to have any particular in vivo function, let alone “high performing” in vivo function. In addition, the RNAi in all of the rejected claims in the instant rejection does not require a specific length and a specific modification pattern as in AD-961583 and AD-454973. Hence, the rejected claims are not commensurate in scope with the allegedly unpredictable “high performing” activity provided by AD-961583 and AD-454973. Note that the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” See MPEP §716.02. Accordingly, this rejection is maintained.
Claims 169, 174-176, 179-181, 186, 188-194, 204, and 209-218 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 108-121 of copending Application No. 17/619,633 for the reasons as set forth in the Office action mailed on November 13, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 13, 2026 have been fully considered but they are not persuasive. Applicant argues that the same arguments provided above in the ‘013 patent apply. In response, it is noted that the instantly rejected claims including claim 204 reads on AD-961583 and AD-454973, which are fully encompassed by the ‘633 claims in view of the ‘633 specification that defines the APP-targeting RNAi agent includes AD-454973 and AD-961583. See Table 6. Hence, applicant’s argument pertaining to AD-454973 and AD-961583 as provided in the ‘013 patent is not applicable in the instant rejection. Accordingly, this rejection is maintained.
Claims 169, 174-176, 179-181, 186, 188-194, 209-210, and 213-214 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 40-48 of copending Application No. 17/774,477 in view of McSwiggen et al., Maier et al., Hinkle et al., and Kamola et al. for the reasons as set forth in the Office action mailed on November 13, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 13, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant rejection should be withdrawn in accordance with MPEP §804. In response, it is noted that the instant rejection is not the only outstanding rejection in the instant application. Accordingly, this rejection is maintained.
Claims 169, 174-176, 179-181, 186, 188-203, 209-210, and 213-214 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-20, and 23-29 of copending Application No. 18/651,230 in view of McSwiggen et al., Maier et al., Hinkle et al., and Kamola et al. for the reasons as set forth in the Office action mailed on November 13, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 13, 2026 have been fully considered but they are not persuasive. Applicant argues that the same arguments provided above in the ‘013 patent apply. In response, it is noted that the rejected claims in the instant rejection are not commensurate in scope with RNAi agents with a specific length and a specific modification pattern as in AD-961583 and AD-454973. Hence, the rejected claims are not commensurate in scope with the allegedly unpredictable “high performing” activity provided by AD-961583 and AD-454973. Note that the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” See MPEP §716.02. Accordingly, this rejection is maintained.
Claims 169, 174-176, 179-181, 186, 188-203, and 209-218 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, 37-38, and 70-71 of copending Application No. 18/548,634 for the reasons as set forth in the Office action mailed on November 13, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 13, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant rejection should be withdrawn in accordance with MPEP §804. In response, it is noted that the instant rejection is not the only outstanding rejection in the instant application. Accordingly, this rejection is maintained.
Claims 169, 174-176, 179-181, 186, 188-205, and 209-218 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-9, 20-24, 29, 32, 38, 41-42, 48, 51, 56, and 60 of copending Application No. 18/690,200 for the reasons as set forth in the Office action mailed on November 13, 2025 and for the reasons set forth below.
Applicant's arguments filed on February 13, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant rejection should be withdrawn in accordance with MPEP §804. In response, it is noted that the instant rejection is not the only outstanding rejection in the instant application. 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