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
This Office Action is a response to Applicant’s Amendment and Remarks filed July 17, 2026.
Claim 3 has been canceled. New claim 70 has been added. Claims 2, 4, 8, 11, 13, 28, and 68 have been amended.
Claims 2, 4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64 and 68-70 are pending in the present application.
Accordingly, claims 2, 4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64 and 68-70 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112
In the previous Office Action mailed February 19, 2026, claims 2-4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64, 68 were 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 pre-AIA the applicant regards as the invention. This rejection is moot against claim 3 in view of Applicant’s Amendment filed July 17, 2026 to cancel this claim. This rejection is withdrawn against the remaining claims in view of Applicant’s Amendment to the claims filed July 17, 2026.
Claim Rejections - 35 USC § 102
In the previous Office Action mailed February 19, 2026, claims 2-4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64, 68 and 69 were rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2015050990 A1 (submitted and made of record on the IDS filed April 16, 2024). This rejection is moot against claim 3 in view of Applicant’s Amendment filed July 17, 2026 to cancel this claim. This rejection is maintained against the remaining claims for the reasons of record set forth in the previous Office Action mailed February 19, 2026.
Response to Arguments
In response to this rejection, Applicants traverse and argue that claim 2 has been amended to indicate the antisense strand comprises at least 20 contiguous nucleotides differing by no more than 3 nucleotides from the antisense sequence set forth as SEQ ID NO: 180, wherein the dsRNA comprises at least one modified nucleotide. Applicants submit that WO 2015/050990 does not disclose all the elements of amended claim 2, and thus, cannot anticipate the presently claimed dsRNA. In view of the Amendments and Remarks, Applicant requests withdrawal of the rejection of the claims under 35 U.S.C. §102(a)(2).
Applicant’s traversal has been fully considered by the Examiner however, it is not found to be persuasive because contrary to Applicant’s Amendment and Remarks, WO 2015/050990 indeed teach and disclose an antisense strand comprising at least 20 contiguous nucleotides differing by no more than 3 nucleotides from the antisense sequence set forth as SEQ ID NO: 180 of the present invention, wherein the dsRNA comprises at least one modified nucleotide. See SEQ ID NO: 451 below:
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As detailed above, SEQ ID NO:451 of WO 2015050990 disclose all the elements of amended claim 2 and meets the structural limitations of the claims. It should be noted that (T) thymine is found in DNA, while (U) uracil is found in RNA, such as siRNA. That is, when designing or writing out siRNA sequences to target specific messenger RNAs, every location where a DNA template has a T, the corresponding RNA molecule incorporates a U to pair properly with adenine.
For the reasons discussed above, the Examiner maintains that claims 2, 4, 8, 11, 13, 17, 18, 28-30, 43, 44, 51, 53, 58, 59, 64, 68 and 69 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2015050990 A1.
Claim Rejections - 35 USC § 101
In the previous Office Action mailed February 19, 2026, claims 28 and 68 were rejected under 35 U.S.C. This rejection is withdrawn in view of Applicant’s Amendment to the claims filed July 17, 2026.
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In the previous Office Action mailed February 19, 2026, claims 2, 4, 8, 11, 17, 18, 28-30, 43, 44, 51, 53, 58, 59 and 69 were rejected under 35 U.S.C. 101. This rejection is withdrawn in view of Applicant’s Amendment to the claims filed July 17, 2026.
Applicant's Amendment filed July 17, 2026 necessitated the new ground(s) of rejection presented below:
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4.Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1 and 70 are rejected under 35 U.S.C. 103 as being obvious over WO 2015050990 A1 (submitted and made of record on the IDS filed April 16, 2024) in view of Foster et al. (Molecular Therapy Vol. 26 No 3 March 2018, pages 708-717, plus Supplementary Information).
The claims are drawn to a double-stranded ribonucleic acid (dsRNA) for inhibiting expression of leukocyte chemotactic factor 2 (LECT2), wherein said dsRNA comprises a sense strand and an antisense strand, the antisense strand comprising a region of complementarity to a LECT2 RNA transcript, wherein the antisense strand comprises at least 20 contiguous nucleotides differing by no more than 3 nucleotides from the antisense sequence set forth as SEQ ID NO: 180, wherein the dsRNA comprises at least one modified nucleotide, wherein the sense strand comprises the sequence and all the modifications set forth as SEQ ID NO: 56 and the antisense strand comprises the sequence and all the modifications set forth as SEQ ID NO: 57; or the sense strand comprises the sequence and all the modifications set forth as SEQ ID NO: 330 and the antisense strand comprises the sequence and all the modifications set forth as SEQ ID NO: 331.
WO 2015050990 is relevant and relied upon in its entirety as discussed in the previous Office Action mailed February 19, 2026 and supra.
WO 2015050990 teaches modified nucleotides, including 2’-O-methyl (2’-OMe) and 2’-deoxy-2’-fluoro (2’-F) ribosugar modifications and alternating patterns, but do not necessarily teach wherein the sense strand comprises the sequence and all the modifications set forth as SEQ ID NO: 56 and the antisense strand comprises the sequence and all the modifications set forth as SEQ ID NO: 57; or the sense strand comprises the sequence and all the modifications set forth as SEQ ID NO: 330 and the antisense strand comprises the sequence and all the modifications set forth as SEQ ID NO: 331 of the present invention.
Foster et al. teach advanced siRNA designs further improve in vivo performance of GalNAc-siRNA conjugates. For example, Foster et al. combines 2’-O-methyl (2’-OMe) and 2’-deoxy-2’-fluoro (2’-F) ribosugar modifications throughout both strands of the siRNA with terminal phosphorothioate (PS) linkages, which provide additional protection against 3’ and 5’ exonucleases. See Figures 2 and S1, for example. The patterned modifications of Foster et al. encompass and embrace the sense strand comprising the sequence and all the modifications set forth as SEQ ID NO: 56 and the antisense strand comprising the sequence and all the modifications set forth as SEQ ID NO: 57; or the sense strand comprising the sequence and all the modifications set forth as SEQ ID NO: 330 and the antisense strand comprising the sequence and all the modifications set forth as SEQ ID NO: 331 of the present invention.
Furthermore, regarding claim 70, the recited modification patterns are a design choice and rely on the well-known prior art teachings of Foster et al. to arrive at a particular modification pattern. That is, one of ordinary skill in the art could determine by routine experimentation the types and patterns of modified nucleosides to incorporate into a dsRNA to confer a desired property or optimization for a specific utility.
Before the effective filing date of the claimed invention a double-stranded ribonucleic acid (dsRNA) for inhibiting expression of leukocyte chemotactic factor 2 (LECT2), wherein said dsRNA comprises a sense strand and an antisense strand, the antisense strand comprising a region of complementarity to a LECT2 RNA transcript, wherein the antisense strand comprises at least 20 contiguous nucleotides differing by no more than 3 nucleotides from the antisense sequence set forth as SEQ ID NO: 180 of the present invention was known and routinely used in the prior art as taught and suggested by WO 2015050990.
A person of ordinary skill in the art would have been motivated to modify the dsRNA agents of WO 2015050990 and incorporate the chemical modification patterns of Foster et al. for the purpose of exonucleases protection and utility optimization.
A person of ordinary skill in the art would have expected reasonable success to modify the dsRNA agents of WO 2015050990 since Foster et al. taught successful optimization studies of chemical modification patterns, including the 2'-OMe, 2'-F, phosphorothioate linkage modifications is routine to maximize stability and potency of the dsRNA.
Before the effective filing date, the invention as a whole would therefore have been prima facie obvious to one of ordinary skill in the art.
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 Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 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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/TERRA C GIBBS/Primary Examiner, Art Unit 1635
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