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 April 8, 2026.
Currently, claims 198-203, 208, and 213-215 are pending in the instant application. Claim 203 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Accordingly, claims 198-202, 208, and 213-215 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.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
Double Patenting
Claims 198-202, 208, and 213-215 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-233 of copending Application No. 18/715,684 for the reasons as set forth in the Office action mailed on December 9, 2025 and for the reasons stated below.
Applicant's arguments filed on April 8, 2026 have been fully considered but they are not persuasive. Applicant argues that the rejection should be withdrawn pursuant to MPEP §804. In response, it is noted that the instant rejection is not the only outstanding rejection in the instant application. In addition, the claim amendments in the instant application are not sufficient to patentably distinguish from the subject matter encompassed by the ‘684 application claims. 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.
Claims 198-202, 208, and 213-215 are 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. This is a new matter rejection.
The instant claims are currently amended to recite “positions 174-221 of SEQ ID NO:1339” as the target region of the claimed oligonucleotide.
In the remarks filed on April 8, 2026, applicant points out original claims 22, 26-27, and 45 as well as Tables 13 and 15 of the instant specification for support. Contrary to applicant’s argument, none of the claims and Tables pointed out by applicant provides adequate written description support for the instantly claimed range of nucleotide positions “174-221” of SEQ ID NO:1339. Furthermore, there is no such disclosure pertaining to the claimed range for SEQ ID NO:1339 in the specification as originally filed. Accordingly, claim 198 and all dependent claims thereof introduce new matter that is not described in the specification/claims as originally filed.
Applicant is advised to amend claim 198 to recite a specific nucleotide position range of SEQ ID NO:1339 that is expressly disclosed in the specification, for instance, paragraph 00239.
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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