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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, 9-12, 16-18, 22-24, 49-50 in the reply filed on 05/05/2026 is acknowledged.
Claim 51 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/05/2026.
Upon further consideration species election is withdrawn.
Claim Warning
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Both claims recite identical nucleic acids comprising at position 14 a nucleotide forming wobble base pair with the target.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 17 depends on claim 16 and adds a limitation that base pair between sense and antisense strands at antisense strand position 14 is canonical or non-canonical. Such two options cover all possible base pairing, therefore claim 17 does not further limit claim 16.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-12, 16-18, 23-24, 49-50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown (WO 2010/080129, July 2010, cited from IDS).
Concerning claims 1, 3 and 23 Brown discloses double stranded RNAs for reducing expression of target gene in a cell, comprising sense and antisense strands (see Abstract, Figure 1), such antisense (named “second”) strand can be 27-53 nucleotides in length and sufficiently complementary to a target gene RNA along at least 19 ribonucleotides (see lines 12-27 on page 3), such complementarity can be at least 90% or 100% (see bridging paragraph between pages 57 and 58). The antisense strand can comprise a mismatch preferably at position 14 (see lines 5-13 on page 16).
Concerning claim 2 Brown demonstrates such double stranded RNA in Figure 6, where position 14 of antisense strand is substituted with U instead of C, and the target nucleotide is guanosine.
Concerning claims 4-7 and 18 Brown discloses that the mismatch can be a wobble base pair such as U:U or I:A, I:U and I:C (see lines 8-13 on page 75).
Concerning claims 9-11 Brown discloses that such antisense strand can comprise 2’-O-methyl modifications (see lines 29-31 on page 7) and phosphorothioate modifications (see line 5 on page 28).
Concerning claim 12 Brown discloses that antisense strand can be 21-23 nucleotides long (see lines 11-13 on page 74).
Concerning claim 16 Brown discloses sense (named “first”) strand of double stranded RNA, which can be 27-49 nucleotides long and forms a duplex with antisense strand (see lines 15-25 on page 3).
Concerning claims 17 and 24 Brown discloses non-canonical base pairing between sense strand (top) and antisense strand (bottom) position 14 on Figure 7, sixth duplex:
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Such antisense strand on the bottom satisfies all structural requirements of instant claim 24: U in position 14 of the strand forms non-canonical base pair with G of sense strand or target RNA, b is 13.
Concerning claims 49 and 50 Brown disclose pharmaceutical compositions comprising double stranded RNAs and cationic lipids (counterions) or pharmaceutically acceptable carriers (see lines 1-20 on page 135).
Claim(s) 1, 9-12, 16, 24, 49-50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feinstein et al (WO 2009/044392, April 2009).
Concerning claims 1 and 16 Feinstein disclose siRNA compounds comprising sense and antisense strands complementary to each other and each 18-40 nucleotides long, wherein antisense strand is fully complementary to target mRNA (see lines 10-29 on page 12). In specific embodiment antisense strand can comprise abasic moiety at position 14 (see lines 26-28 on page 15).
Concerning claims 9-11 Feinstein disclose that such antisense strand can comprise 2’-O-methyl modifications (see lines 19-20 on page 13) and phosphorothioate linkages (see lines 14-16 on page 85).
Concerning claim 12 Feinstein disclose that antisense strand can be 18-27 nucleotides long (see line 9 on page 15).
Concerning claim 24 Feinstein disclose antisense strand in Figure 20A named CASP2_4_AS4, which satisfies structural requirements of claim 24 (“ab” stands for abasic), b is 5:
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Concerning claims 49 and 50 Feinstein disclose pharmaceutical compositions comprising siRNAs (see lines 11-12 on page 11), which can comprise salts (counterions) or pharmaceutically acceptable carriers (see lines 23-26 on page 84).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9-12, 16-18, 22-24, 49-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown, above, as applied to claims 1-7, 9-12, 16-18, 23-24, 49-50, and in further view of Bettencourt et al (WO 2012/177784, December 2012).
Teachings of Brown are discussed above. Brown further teaches that double stranded RNAs can be conjugated to other moieties to improve cellular uptake and enhance cellular targeting activities (see lines 24-29 on page 129).
Brown do not teach conjugation to N-acetylgalactosamine (GalNAc) moieties.
Bettencourt teach conjugation of double stranded RNAs to GalNAc moieties (see lines 24-28 on page 3) for targeted delivery of such RNAs (see lines 13-15 on page 20).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to conjugate double stranded RNAs taught by Brown to GalNAc moieties taught by Bettencourt. One of the ordinary skill in the art would be motivated to do so, because Bettencourt teach targeted delivery of double stranded RNAs by conjugation them to GalNAc and Brown also suggests conjugation of double stranded RNAs to improve their delivery.
Claim(s) 1, 9-12, 16, 22, 24, 49-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feinstein, above, as applied to claims 1, 9-12, 16, 24, 49-50, and in further view of Bettencourt et al, above.
Teachings of Feinstein are discussed above. Feinstein further teach that siRNAs can be conjugated to other moieties (see lines 17-21 on page 88).
Feinstein do not teach conjugation to N-acetylgalactosamine (GalNAc) moieties.
Bettencourt teach conjugation of double stranded RNAs to GalNAc moieties (see lines 24-28 on page 3) for targeted delivery of such RNAs (see lines 13-15 on page 20).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to conjugate siRNAs taught by Feinstein to GalNAc moieties taught by Bettencourt to improve their delivery. One of the ordinary skill in the art would be motivated to do so, because Bettencourt teach targeted delivery of double stranded RNAs such as siRNAs by conjugation them to GalNAc.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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