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 26, 2026.
Currently, claims 2-4, 13, 23-24, 78-79, 82-85, 90-91, 98, 115, 126-128, and 130 are pending in the instant application. Claims 90-91, 98, 115, and 126 are withdrawn from further consideration as being drawn to a nonelected invention. Accordingly, claims 2-4, 13, 23-24, 78-79, 82-85, 127-128, and 130 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.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 § 112
Claims 2-4, 13, 23-24, and 82-85 remain rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement for the reasons as set forth in the Office action mailed on October 27, 2025 and for the reasons stated below.
Applicant's arguments filed on February 26, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims as amended are sufficient to overcome the rejection. Contrary to applicant’s argument, the amendments filed on February 26, 2026 are not sufficient because the claims merely reciting the antisense strand sequence as comprising SEQ ID NO:191 are not sufficient to describe the entire genus of GPAM-inhibiting dsRNA agent. As explained in the last Office action, the instant specification at best discloses one and only dsRNA species comprising an intentionally altered base at position 1 of the antisense strand of SEQ ID NO:191, which is specifically hybridized with a sense strand of SEQ ID NO:56, which is intentionally altered base at position 21 compared to the naturally occurring, wild-type GPAM target sequence. The single species of dsRNA comprising SEQ ID NO:56 and SEQ ID NO:191 (e.g., “AD-1247135.1”) inhibiting GPAM expression by about 86% at 10 nM in HepG2 cells (see Table 7) is not representative of the genus of dsRNAs comprising SEQ ID NO:191 and an unspecified sense strand sequence as the instant specification is completely silent regarding the intended function of inhibiting GPAM for other structural variants having a sense strand other than SEQ ID NO:56.
Accordingly, this rejection is maintained.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 130 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 130 is a new claim, which does not recite any specific sense strand sequence by virtue of claim dependency from claim 2. Accordingly, for the same reasons stated in the last Office action and those reiterated hereinabove, all of which are fully incorporated by reference herein, claim 130 is deemed insufficient to comply with the written description requirement.
Claim Objections
Claim 127 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant is advised that should claim 127 be found allowable, claim 128, “(a)” will be deleted because “(a)” of claim 128 is the identical duplicate of claim 127.
Allowable Subject Matter
Claims 78-79 are in condition for allowance.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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