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 March 20, 2026.
Currently, claims 1 and 7-18 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.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
Claim Rejections - 35 USC § 112
Claims 1 and 7-18 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 January 8, 2026 and for the reasons stated below.
Applicant's arguments filed on March 20, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims as currently amended are sufficient to address all issues set forth in the last Office action. Contrary to applicant’s argument, the claims as amended are not sufficient to address all written description issues raised in the last Office action. For instance, “at nucleotide positions 7 of the 5’ region” are so ambiguous to the extent the limitation reads on all seven positions in the 5’ region. See the §112(b) rejection below. Furthermore, even if the newly added limitation should be interpreted as nucleotide position 7 from the 5’ end of the antisense strand, such potentially intended limitation is not sufficient to render the claims fully compliant with the written description requirement because applicant did not address/amend the claims pertaining to the limitation “wherein each of the strands has 15 to 35 nucleotides” as well as specific position-dependent chemical modifications. Note that it was explicitly stated that the “19-mer sense strand length is not representative of the range of 15-35, nor is the 21-mer antisense strand length representative of the range of 15-35 comprising at least one “formula (I)”, wherein “the specific position-dependent chemical modifications in the sense strand forming a one blunt-ended duplex with the antisense strand having specific chemical modifications at specific nucleotide positions are not sufficient to describe the generically claimed modifications of an siRNA molecule having “formula (I)” for providing RNAi activity that is inherently required by the claimed “siRNA”.” See pages 10-12 of the last Office action. Note that there is no single claim that simultaneously recites chemical modification patterns for both strands.
Accordingly, this rejection is maintained.
Double Patenting
Claims 1 and 7-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-20 of Application No. 18/287,756 for the reasons as set forth in the Office action mailed on January 8, 2026 and for the reasons stated below.
Applicant's arguments filed on March 20, 2026 have been fully considered but they are not persuasive. Applicant argues that the conflicting claims are patentably distinct because the instant claims pertain to “a chemical modification strategy”, whereas the ‘756 do not focus on the modification but rather focus on “target-specific siRNA sequences.” The examiner is bewildered by applicant’s argument and is unable to understand the argument. Is applicant arguing that the ‘756 claims do not claim the instantly claimed structure whose antisense strand comprises the instantly claimed modification? If so, applicant’s attention is directed to the fact that the ‘756 claims do recite the following structures, which are 100% identical to what is being claimed in the instant claims.
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Further, the very fact that the ‘756 claims do recite “position 7” and also specific SEQ ID NOs for each of the sense strand and the antisense strand does support that the generically claimed subject matter in the instant claims is indeed anticipated by and overlaps in scope with the ‘756 claims, which would thus render the conflicting claims patentably indistinct from each other.
In view of the foregoing, this rejection is maintained.
Claims 1 and 7-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of Application No. 18/710,716 for the reasons as set forth in the Office action mailed on January 8, 2026 and for the reasons stated below.
Applicant's arguments filed on March 20, 2026 have been fully considered but they are not persuasive. Applicant provided a single argument for addressing all of the provisional NSDP rejections. Hence, for the same reasons stated above, applicant’s arguments are not whatsoever found legally proper, thus found unpersuasive. Note that the ‘716 claims do recite the same modifications as shown above and also do expressly claim “position 7”. Accordingly, this rejection is maintained.
Claims 1 and 7-18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 11-17, 19-23, and 25 of Application No. 18/719,828 for the reasons as set forth in the Office action mailed on January 8, 2026 and for the reasons stated below.
Applicant's arguments filed on March 20, 2026 have been fully considered but they are not persuasive. Applicant provided a single argument for addressing all of the provisional NSDP rejections. Hence, for the same reasons stated above, applicant’s arguments are not whatsoever found legally proper, thus found unpersuasive. Note that the ‘828 claims do recite the same modifications as shown above and also do expressly claim “position 7”. Accordingly, this rejection is maintained.
New Rejections Necessitated by Amendment
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 1 and 7-18 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.
The instant claims are now amended to recite “at nucleotide positions 7 of the 5’ region thereof”. It is unclear whether the chemical modification of formula (I) is required to be at all 7 “positions” in the 5’ region of the antisense strand or whether the chemical modification is required to be present only at a single position, position 7, of the 5’ region, thereby rendering the claimed structure indefinite.
Conclusion
No claim is allowed.
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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