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 .
DETAILED ACTION
Status of Application/Amendment/Claims
Applicant's response filed 04/08/2026 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 11/10/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With entry of the amendment filed on 04/08/2026, claims are pending. Claims 1-35 and 39 are currently under examination. Claims 36-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The 112(b) rejection is withdrawn in response to claim amendments.
The 102 rejection as being anticipated by McSwiggen et al. (US 20070032441 cited on IDS 11/11/22) is withdrawn.
The double patenting over claims 1-43 and 45 of Patent No 11,530,409 is withdrawn in response to the Terminal Disclaimer filed and accepted on 04/08/2026.
Maintained Rejections
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1-3, 6, 12, 13, 17 and 24-29 under 35 U.S.C. 102(a)(2) as being anticipated by Inturrisi et al. (US 20110293628) is maintained for the reasons of record.
Response to Applicant’s Argument
Applicant’s arguments have been acknowledged but not found persuasive. Applicant argues Inturrisi et al. does not disclose that the X-L-Y sequence has at least four contiguous nucleotides recognized by RNase H. As discussed above with regard to the anticipation rejection based on McSwiggen et al., the "at least four contiguous nucleotides recognized by RNAse H" must be double-stranded, whereby one strand must be DNA or DNA wherein at least one of a base moiety, phosphodiester bond moiety, and sugar moiety has been modified, such as in an oligodeoxyribonucleotide, and the other strand must be RNA or RNA wherein at least one of a base moiety, phosphodiester bond moiety, and sugar moiety has been modified, such as in an oligoribonucleotide.
Applicant appears to argue limitations that are not claimed. The claims do not recite “the at least four contiguous nucleotides recognized by RNAse H" must be double-stranded, whereby one strand must be DNA or DNA wherein at least one of a base moiety, phosphodiester bond moiety, and sugar moiety has been modified. In response, the claims require X or Y to comprise nucleotides “that are independently selected from a deoxyribonucleotide, ribonucleotide and sugar-modified nucleotide and that contains at least one nucleotide of which at least one of a sugar moiety, base moiety and phosphate moiety has been modified”. The claims do not require one strand to be DNA and the other strand to be RNA.
Inturrisi et al. teach the claimed structure and in [0008] teach the double stranded molecule can comprise a DNA or RNA sequence and further teach the oligonucleotides can comprise modified backbones, internucleotide linkages and sugar modifications (see at least 0093-0096). In [0079], Inturrisi et al. teach the oligonucleotide has a stretch of contiguous nucleotides 10-18 that are complementary to a DNA or RNA. Given Inturrisi et al. teach the double stranded molecule can comprise DNA or RNA, this is interpreted to mean it could encompass at least four contiguous nucleotides recognized by RNase H.
Claim Rejections - 35 USC § 103
The rejection of claims 1-35 and 39 rejected under 35 U.S.C. 103 as being unpatentable over McSwiggen et al. (US 20070032441) and Yakota et al. (US 20140302603) is maintained for the reasons of record.
Response to Applicant’s Arguments
Applicant’s arguments are acknowledged but not found persuasive. Applicant argues the claims require "at least four contiguous nucleotides recognized by RNAse H" as described in the present application, must be double-stranded, whereby one strand must be DNA or DNA wherein at least one of a base moiety, phosphodiester bond moiety, and sugar moiety has been modified, such as in an oligodeoxyribonucleotide, and the other strand must be RNA or RNA wherein at least one of a base moiety, phosphodiester bond moiety, and sugar moiety has been modified, such as in an oligoribonucleotide. McSwiggen et al. does not disclose at least four contiguous base pairs that are part of a double-stranded sequence, wherein one strand is DNA or modified DNA and the other strand is RNA or modified RNA.
Applicant appears to argue limitations that are not claimed. The claims do not recite the "at least four contiguous nucleotides recognized by RNAse H must be double-stranded, whereby one strand must be DNA or DNA wherein at least one of a base moiety, phosphodiester bond moiety, and sugar moiety has been modified”. The claims require X or Y to comprise nucleotides that are independently selected from a deoxyribonucleotide, ribonucleotide and sugar-modified nucleotide and that contains at least one nucleotide of which at least one of a sugar moiety, base moiety and phosphate moiety has been modified. The claims do not require one strand to be DNA and the other strand to be RNA.
Further, Yakota et al. et al. teach when an oligonucleotide strand is introduced into a cell that binds to a target mRNA, a partial double strand is formed which inhibits transcription and teach the expression suppressing effect is higher when the strand is DNA. This is why Yakota et al. suggests that an antisense strand comprise at least four nucleotides that are recognized by RNase H (0007-0008 and 0129). In [0115], Yakota et al. defines "DNA nucleotide" means a naturally occurring DNA nucleotide, or a DNA nucleotide with a modified base, sugar, or phosphate linkage subunit.
Yakota et al. teach an oligonucleotide strand comprising at least four nucleotides that are recognized by RNase H when the strand is hybridized to the transcription product or mRNA (0017). Yakota et al. further teach "DNA nucleotide" means a naturally occurring DNA nucleotide, or a DNA nucleotide with a modified base, sugar, or phosphate linkage subunit [0129]. Yakota et al. also teach in [0129] the “DNA having a strand length of four is not however limited to just DNA nucleotides. It is contemplated that the first nucleic acid strand comprises at least 4 consecutive nucleotides that are recognized by RNase H when the first nucleic acid strand is hybridized to a transcription product. From the viewpoint that the antisense effect occurring as a result of heteroduplex formation with the targeted transcription product is excellent”. Thus Yakota et al. teach these four nucleotides that are recognized by RNase H is not limited to DNA and has shown LNA that are recognized by RNase H.
Applicant’s argument is that the actual structure of McSwiggen must have one strand of DNA and one strand of RNA to meet the limitations of comprising at least four nucleotides that are recognized by RNase H which appears to go against what is taught in the art and also not supported by the instant claim limitations. McSwiggen et al. teach a strand can comprise DNA and further teach the strands can comprise LNA (0066, 0124 and 0892).
Therefore it would have obvious to use the oligonucleotide structure of McSwiggen et al. and incorporate four contiguous nucleotides recognized by RNase H, wherein the nucleotides are not all deoxyribonucleotides, comprises modified nucleotides and can be a multimeric composition.
Applicant further argues McSwiggen et al. relates to a technique of short interfering nucleic acid (siNA), typically represented by siRNA (see, e.g., paragraph 0003 of McSwiggen et al.). As for the siNA mechanism, siNA does not function alone. Rather, siNA is incorporated into the RNA-induced silencing complex (RISC) in cytoplasm, and then Argonaute (Ago) protein constituting the RISC hydrolyzes specific target RNA able to pair with an antisense sequence of siNA (see, e.g., Fig. 17 of McSwiggen et al.).The technique of siNA of McSwiggen et al. differs from the technique of antisense oligonucleotides (ASO) of both (a) the claimed invention (represented by claim 1 of the present application) and (b) Yakota et al. In particular, for the ASO, an ASO hybridizes with a target RNA to form a double strand, and the double strand portion is recognized by RNase H to degrade a target RNA.
This argument is not persuasive. The claims are interpreted as a double stranded oligonucleotide which is taught by McSwiggen et al. and further taught by Yakota et al. The claims do not recite mechanisms to degrade target RNA as recited in steps (i)-(v) in the argument. The prior art meets the structural limitations of the claimed structure and there it would have been obvious to use the oligonucleotide structure of McSwiggen et al. and incorporate four contiguous nucleotides recognized by RNase H.
Conclusion
No claims are 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 extension fee 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 KIMBERLY CHONG at (571)272-3111. The examiner can normally be reached Monday thru Friday 9-5 pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/Primary Examiner, Art Unit 1636
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