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 September 22, 2025.
Currently, claims 62-64, 69, and 73-75 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.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 62-64, 69, and 73-75 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 April 21, 2025 and for the reasons set forth below.
Applicant's arguments filed on September 22, 2025 have been fully considered but they are not persuasive. Applicant argues that the claims as amended fully comply with the written description requirement because “utilization of various modified sugars and internucleotidic linkages at various positions has been widely reported and utilized in RNAi oligonucleotides.” Applicant even goes further to assert that the specification “demonstrates that such modifications can be incorporated into the claimed invention to provide oligonucleotides useful for various purposes”. In response, it is noted that applicant’s argument that use of modified sugars and linkages at various positions was well-known in the art of “RNAi oligonucleotides” is far from clearly pointing out where in the specification or in the prior art of record or in the IDS of record it was known that the 23-mer single-stranded oligonucleotide species disclosed in the instant specification as pointed out in the last Office action is representative of the “RNAi” function of reducing target transcript/protein thereof in a system provided by the genus of oligonucleotides that are “about 10 to 50 nucleotides in length” having 5ptzdT at position 1. In fact, the 23-mer oligonucleotide length that is merely disclosed in the specification without being actually tested in the method claimed in the instant case is the art-recognized single-stranded siRNA oligonucleotide length as evidenced by Prakash et al. (US 2016/0122761 A1, of record). Further, the mere fact that 2’-O-methyl, 2’-F, and phosphorothioate modifications were generally known to be incorporated into oligonucleotides for RNAi-mediated target transcription reduction purpose is not sufficient to adequately describe the genus of the claimed method that requires the presence of 5ptzdT at position 1 with other recited modifications at any positions within the oligonucleotide length of “about 10 to 50”, especially in view of the fact that single-stranded RNAi oligonucleotides having a specified modification at position 1 provide widely different target reduction levels (e.g., 41% vs. 5%) depending on the exact position (position 3 vs. position 6) of a sugar modification as reported by Chang et al. (2016, of record). Now, in the instant case, as already explained in the last Office action and as briefly reiterated above, the 23-mer oligonucleotides having the claimed 5’ end (position 1) modification are not tested in the claimed method. Hence, the examiner strongly disagrees with applicant’s assertion that the instant specification “demonstrates” the claimed method comprising using a genus of oligonucleotides as broadly claimed. Now, since there is no actual working example comprising using the oligonucleotide satisfying the claimed structural limitations, it remains unknown whether any 23-mer having 2’-F, 2’-O-methyl, and phosphorothioate modifications at any non-specified positions would provide the required target transcript level reduction in a system in view of the modification position-dependent unpredictable nature of 21-mer single-stranded siRNA oligonucleotides as taught by Chang published prior to the earliest effective filing date sought in the instant case, which is June 2, 2017.
Since applicant did not provide any objective, persuasive rebuttal arguments fully addressing the entire genus of the rejected claims, 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 62-64, 69, and 73-75 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.
Claim 62 as currently amended recites “each modified sugar in the other nucleosides is” in lines 10-11. There is insufficient antecedent basis for the limitation because the limitation “nucleosides”, let alone “the other nucleosides”, is not recited preceding the limitation. Since claims 63-64, 69, and 73-75 depend from claim 62, the dependent claims also have insufficient antecedent basis.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANA H SHIN/Primary Examiner, Art Unit 1635