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
Applicant's amendments and remarks filed on January 16, 2026 are acknowledged. Claims 2-26, 28-48, 50-75, 77-79, 82, 84-94, 97-99, 101, 103-115, 117-125, 128, and 131 have been canceled. Claims 1, 27, 49, 126, 127, 129, and 130 were amended. Claims 1, 27, 49, 76, 80, 81, 83, 95, 96, 100, 102, 116, 126, 127, 129, 130, and 132-135 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 5, 6, 12, 20, 25, 27, 39, 49, 57, 60, 76, 80, and 81) and the following species:
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in the reply filed on August 11, 2025 is acknowledged.
Newly added claims 132-134 are drawn to the dsRNA agent, or a salt thereof and newly added claim 135 is drawn to a pharmaceutical composition comprising the dsRNA agent, or a salt thereof of claim 1; therefore, these claims are included in Applicant’s election of Group I.
Claims 83, 95, 96, 100, 102, and 116 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 11, 2025.
Claims 126 and 129 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 11, 2025.
Claims 1, 27, 49, 76, 80, 81, 127, 130, and 132-135 are examined on the merits herein.
Priority
This application is a continuation of PCT/US2021/029081 filed on April 26, 2021 which claims priority to U.S. provisional application 63/015,867, filed on April 27, 2020.
Withdrawn Objections
In view of Applicant’s amendments and response, the objections to the drawings are withdrawn.
Drawings
The drawings were received on January 16, 2026. These drawings are found acceptable by the examiner.
Specification
It is noted that the amendment to the specification filed on January 16, 2026 does not comply with the requirements of 37 CFR 1.121(b) because the amendment does not include clear instructions. Therefore, the amendment to the specification has not been entered. Specifically, the amendment to the specification indicates to replace paragraphs of the substitute specification dated February 2, 2023; however, a specification was not filed on February 2, 2023 as Applicant asserts. It is noted that a substitute specification was filed on February 6, 2023.
The disclosure is objected to because of the following informalities:
Page 24 of the specification under Figure 2:
A comma is missing in between “AD-1204706” and “AD-1204707”
There are two (2) instances of “AD-1204705”.
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed January 16, 2026 have been fully considered but they are not persuasive.
It is noted that the amendment to the specification filed on January 16, 2026 does not comply with the requirements of 37 CFR 1.121(b) because the amendment does not include clear instructions. Therefore, the amendment to the specification has not been entered. Specifically, the amendment to the specification indicates to replace paragraphs of the substitute specification dated February 2, 2023; however, a specification was not filed on February 2, 2023 as Applicant asserts. It is noted that a substitute specification was filed on February 6, 2023. Therefore, the Examiner is maintaining the objections to the specification.
Claim Objections
Claim 80 is objected to because of the following informality:
Claim 80: There should not be a space after the word “agent”.
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed January 16, 2026 have been fully considered but they are not persuasive.
Applicant canceled claim 131 thus rendering the objections to claim 131 moot. However, Applicant’s remarks did not address the objection to claim 80. Therefore, the Examiner is maintaining the objection to claim 80.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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, 27, 49, 80, 81, 127, 130, and 134 are rejected under 35 U.S.C. 103 as being unpatentable over Khvorova et al. (US 2020/0362341) in view of Manoharan et al. (US 2016/0376591) and Iribe et al. (ACS Omega 2017).
Regarding claims 1, 27, 49, 127, 130, and 134, Khvorova et al. teaches ApoE targeting sequences and oligonucleotides capable of treating neurodegenerative and amyloid-related diseases [abstract]. Khvorova et al. teaches the human ApoE mRNA targeting region of SEQ ID NO: 16 (e.g., designated as ID 64 in Table 7) which is 30 nucleotides in length. Table 7 also teaches a targeting sequence (Khvorova et al. SEQ ID NO: 20), a sense sequence, and an antisense sequence for targeting this region as reproduced below.
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Khvorova et al. SEQ ID NO: 20 (designated as Db), 20 nucleotides in length, is complementary to instant SEQ ID NO: 701 (designated as Qy), 23 nucleotides in length, as shown in the alignment below.
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Khvorova et al. SEQ ID NO: 20 (designated as Db), 20 nucleotides in length, has a match to instant SEQ ID NO: 691 (designated as Qy), 21 nucleotides in length, as shown in the alignment below.
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Khvorova et al. also teaches that siRNAs are designed by selecting one or more of the target sequences set forth in Table 7. Sense strands are designed based on the target sequence and preferably the portion (and corresponding sense strand) includes about 19 to 25 nucleotides [0308]. More preferably, the sense strand includes 21, 22, or 23 nucleotides [0344]. In some embodiments, the antisense and sense strands anneal such that 1-, 2-, 3-, 4-, 5-, 6- or 7-nucleotide overhangs are generated [0310]. Khvorova et al. teaches testing target regions of the gene with siRNAs bearing a methyl-rich chemistry pattern as shown in Figure 43 reproduced below [0580]. Based on Figure 43, all of the nucleotides of the sense strand and all of the nucleotides of the antisense strand are modified (2’-O-methyl or 2’-fluoro). In addition, Figure 43 shows phosphorothioate internucleotide linkage modifications.
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However, Khvorova et al. does not teach a thermally destabilizing modification in the seed region of the antisense strand, specifically a sugar modification. Khvorova et al. also does not teach conjugating a lipophilic moiety comprising a saturated or unsaturated C16 hydrocarbon chain to position 5, 6, or 7 of the sense strand counting from the 5’-end, specifically position 6.
Iribe et al. teaches that chemical modifications of 2′-O-methyl (2′ OMe) and locked nucleic acid (LNA) of the nucleotides in the seed region (positions 2−8) of the small interfering RNA (siRNA) guide strand significantly reduced seed-matched (SM) off-target effects. Specifically, siRNA with 2′-OMe modifications inhibited the expression of a completely-matched (CM) target gene, whereas that with LNA modifications did not inhibit the expression of the CM target [abstract]. Thus, the chemical modifications of DNA, PS, DNA− PS, 2′-OMe, and LNA in the seed region of the siRNA guide strand reduced the off-target effects of the guide strand SM targets and may also reduce those of the passenger strand CM and SM targets. Such off-target effects were greatly reduced without affecting the RNAi effects on the CM target using siRNA containing 2′-OMe modifications in the guide strand seed region [page 2062, left column, first full paragraph].
Manoharan et al. teaches iRNA agents, which preferably include a monomer in which the ribose moiety has been replaced by a moiety other than ribose that further includes a tether having one or more linking groups, in which at least one of the linking groups is a cleavable linking group. The tether in turn can be connected to a selected moiety, e.g., a ligand, e.g., a targeting or delivery moiety, or a moiety which alters a physical property [abstract]. Manoharan et al. also teaches that preferred positions for inclusion of a tethered ligand-conjugated monomer subunits, e.g., one in which a lipophilic moiety, e.g., cholesterol, is tethered to the carrier are at an internal position of the sense strand [0244]. Manoharan et al. also teaches an iRNA agent can be targeted to the liver by incorporation of a monomer derivatized with a ligand which targets to the liver [0436]. Further, the carbon containing moiety (e.g., hydrocarbon moiety) can be saturated or unsaturated C1-C100 [0383] – [0386], specifically a saturated C16 carbon moiety [0384] or an unsaturated C16 carbon moiety [0385].
Although Manoharan et al. does not explicitly teach conjugation of a lipophilic moiety comprising a saturated or unsaturated C16 hydrocarbon chain to position 6 of the sense strand, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to try because Khvorova et al. taught that patients with neurodegenerative diseases including Alzheimer's disease (AD) and Amyotrophic Lateral Sclerosis (ALS) have limited treatment options [0004] and there is an urgent need in the art for agents capable of CNS-modulation of ApoE expression [0006]. Further, there are a finite number of internal residues on the sense strand and thus one of ordinary skill in the art would have been motivated to test the effects of conjugating the lipophilic moiety at different internal residues because Manoharan et al. taught that conjugation with a lipophilic moiety enhances entry into cells [0483] and it is preferred to conjugate lipophilic moiety to an internal position of the sense strand.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dsRNA agent of Khvorova et al. by incorporating a thermally destabilizing modification in the seed region of the antisense strand because it would have amounted to combining known prior art elements to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Iribe et al. taught that chemical modifications of 2′-O-methyl (2′ OMe) and locked nucleic acid (LNA) of the nucleotides in the seed region (positions 2−8) of the small interfering RNA (siRNA) guide strand significantly reduced seed-matched (SM) off-target effects.
Regarding claim 80, Khvorova et al. teaches an isolated cell comprising a double-stranded ribonucleic acid (dsRNA) to inhibit expression of ApoE gene [0034].
Regarding claim 81, Khvorova et al. teaches pharmaceutical composition for inhibiting the expression of Apolipoprotein E (ApoE) gene in an organism, comprising the dsRNA and a pharmaceutically acceptable carrier [0032].
Claims 76 and 133 are rejected under 35 U.S.C. 103 as being unpatentable over Khvorova et al. (US 2020/0362341) in view of Manoharan et al. (US 2016/0376591) and Iribe et al. (ACS Omega 2017) as applied to claims 1, 27, 49, 80, 81, 127, 130, and 134 above, and further in view of Parmar et al. (Chembiochem 2016).
Regarding claims 76 and 133, the teachings of Khvorova et al., Manoharan et al., and Iribe et al. are discussed above.
However, Khvorova et al., Manoharan et al., and Iribe et al. do not teach a phosphate or phosphate mimic at the 5’-end of the antisense strand wherein the phosphate mimic is a 5’-vinyl phosphonate.
Parmar et al. teaches that incorporating 5’-(E)-vinyl-phosphonate, a metabolically stable phosphate mimic, to siRNA-GalNAc conjugates results in up to 20-fold improved in vitro potency and up to a threefold benefit in in vivo activity by promoting Ago2 loading and enhancing metabolic stability [abstract].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dsRNA of Khvorova et al., Manoharan et al., and Iribe et al. by incorporating a phosphate mimic at the 5’-end of the antisense strand as taught by Parmar et al. because it would have amounted to combining known prior art elements to yield predictable results. One of skill in the art would have been motivated to do so because Parmar et al. taught that incorporating 5’-(E)-vinyl-phosphonate to siRNA-GalNAc conjugates results in up to 20-fold improved in vitro potency and up to a threefold benefit in in vivo activity.
Claim 132 is rejected under 35 U.S.C. 103 as being obvious over Khvorova et al. (US 2020/0362341) in view of Manoharan et al. (US 2016/0376591) and Iribe et al. (ACS Omega 2017) as applied to claims 1, 27, 49, 80, 81, 127, 130, and 134 above, and further in view of Nair et al. (WO 2019/217459; reference cited by Applicant).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 132, the teachings of Khvorova et al., Manoharan et al., and Iribe et al. are discussed above.
However, Khvorova et al., Manoharan et al., and Iribe et al. do not teach wherein the 3’ end of the sense strand is protected via an end cap.
Nair et al. teaches lipophilic moieties-conjugated double-stranded iRNAs at one or more internal positions on at least one strand, optionally via a linker or carrier capable of gene silencing [abstract]. Nair et al. teaches that the carrier replaces the terminal nucleotide on the 3’ end of the sense strand, thereby functioning as an end cap protecting the 3’ end of the sense strand wherein the carrier is a cyclic group having an amine, for instance, the carrier may be pyrrolidinyl, pyrazolinyl, pyrazolidinyl, imidazolinyl, imidazolidinyl, piperidinyl, piperazinyl, [1,3]dioxolanyl, oxazolidinyl, isoxazolidinyl, morpholinyl, thiazolidinyl, isothiazolidinyl, quinoxalinyl, pyridazinonyl, tetrahydrofuranyl, or decalinyl [0018].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dsRNA agent of Khvorova et al., Manoharan et al., and Iribe et al. wherein the 3’ end of the sense strand is protected via an end cap as taught by Nair et al. because it would have amounted to combining known prior art elements to yield predictable results. One of skill in the art would have been motivated to do so because Nair et al. taught oligonucleotides having one or more lipophilic moieties conjugated to the oligonucleotide, optionally via a linker or carrier capable of reducing expression of a target gene in a subject [0764].
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim 135 is rejected under 35 U.S.C. 103 as being unpatentable over Khvorova et al. (US 2020/0362341) in view of Manoharan et al. (US 2016/0376591) and Iribe et al. (ACS Omega 2017) as applied to claims 1, 27, 49, 80, 81, 127, 130, and 134 above, and further in view of Toudjarska et al. (US 2014/0142162).
Regarding claim 135, the teachings of Khvorova et al., Manoharan et al., and Iribe et al. are discussed above.
However, Khvorova et al., Manoharan et al., and Iribe et al. do not teach a pharmaceutical composition comprising the dsRNA agent of claim 1 and a lipid formulation.
Toudjarska et al. teaches double-stranded ribonucleic acid (dsRNA) targeting a PROC gene capable of inhibiting expression of PROC [abstract]. Toudjarska et al. also teaches a pharmaceutical composition for inhibiting expression of a PROC gene having any of the dsRNA described herein and a pharmaceutical excipient wherein the pharmaceutical composition includes a lipid formulation [0012].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pharmaceutical composition of Khvorova et al., Manoharan et al., and Iribe et al. by incorporating a lipid formulation because it would have amounted to combining known prior art elements to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Khvorova et al. taught a pharmaceutical composition for inhibiting the expression of Apolipoprotein E (ApoE) gene in an organism, comprising the dsRNA and a pharmaceutically acceptable carrier and Toudjarska et al. taught a pharmaceutical composition comprising a dsRNA agent and a lipid formulation for inhibiting gene expression.
Response to Arguments
Applicant's arguments filed January 16, 2026 have been fully considered to the extent that they might apply to the new ground of rejection set forth above but they are not persuasive.
Applicant asserts the following:
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This argument is not found persuasive. Khvorova et al. teaches the human ApoE mRNA targeting region of SEQ ID NO: 16 in addition to a targeting sequence (SEQ ID NO: 20), a sense sequence, and an antisense sequence for targeting this region. Khvorova et al. also teaches that siRNAs are designed by selecting one or more of the target sequences (e.g., SEQ ID NO: 20). Sense strands are designed based on the target sequence and preferably the portion (and corresponding sense strand) includes about 19 to 25 nucleotides [0308]. More preferably, the sense strand includes 21, 22, or 23 nucleotides [0344]. In some embodiments, the antisense and sense strands anneal such that 1-, 2-, 3-, 4-, 5-, 6- or 7-nucleotide overhangs are generated [0310]. Further, the targeting sequence of Khvorova et al. matches to instant SEQ ID NOS: 701 and 691 as shown in the alignments below..
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Applicant asserts that one of ordinary skill in the art would not have been motivated nor would have reasonably expected to select in a predictable manner the specific dsRNA agents, or salts thereof, based on the large genus of sequences and possible modifications and possible ligands and possible placement of ligand. Applicant further asserts the following:
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These arguments are not found persuasive. At the time of the claimed invention, Khvorova et al. taught that patients with neurodegenerative diseases including Alzheimer's disease (AD) and Amyotrophic Lateral Sclerosis (ALS) have limited treatment options [0004] and there is an urgent need in the art for agents capable of CNS-modulation of ApoE expression [0006]. Therefore, one of skill would be motivated to design a dsRNA agent for inhibiting APOE expression capable of treating neurodegenerative diseases. One of ordinary skill in the art would have had a reasonable expectation of success designing a dsRNA agent because the sequence of the target is known. Even if there are thousands of permutations based on the 1,166 base pair mRNA sequence of human APOE taught in SEQ ID NO: 1 and the numerous nucleotide modifications and numerous ligands taught by Khvorova et al. as Applicant asserts, this is finite number of dsRNA agents.
Applicant also asserts the following
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These arguments are not found persuasive. Contrary to Applicant’s assertions, AD-1204704 (corresponds to SEQ ID NO: 690 and 700) and AD-1204705 (corresponds to Applicant’s election of SEQ ID NO: 691 and 701) did not provide unexpected and improved results. As evidenced by Table 10 of the specification filed on February 6, 2023 (reproduced below), for example, AD-1204707 and AD-1204709 have the same modification pattern as AD-1204704 and AD-1204705. However, according to Figure 1A (reproduced below), only AD-1204704, AD-1204705, AD-1204708, and AD-1204712 knocked down APOE expression in the brain. Therefore, the specific structural features of AD-1204704 and AD-1204705 does not demonstrate superior ability to inhibit expression of APOE or provide unexpected and improved results.
Further, Khvorova et al. screened the human APOE gene with siRNAs bearing the methyl-rich chemistry pattern of Figure 43 by testing a number of target regions of the human APOE gene as shown in Figure 44A. Based on the screening, ID 64, 1125, 1129, 1133, 1139, and 1143 were chosen for further studies based on their high efficacy and potency [0580]. The targeting region of ID 64 is SEQ ID NO: 16 and has a targeting sequence designated as SEQ ID NO: 20. Khvorova et al. SEQ ID NO: 20 matches to instant SEQ ID NOS: 701 and 691 as shown in the alignments below..
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As shown in Figure 44B (reproduced below), it is expected that targeting region ID 64 would knockdown APOE expression.
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In an assertion of unexpected results, one must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. Specifically, Applicant did not compare the instantly claimed compounds to the compounds of the closest prior art, Khvorova et al. In addition, the claims are broader in scope than the exact sequences tested in Figure 1A and thus the results are not commensurate in scope with the claimed invention.
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Applicant asserts the following
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Applicant further asserts that the rejection constitutes a picking and choosing of various elements of the claims based, not on the teachings in the art, but rather based on the elements of the claims in the present application and thus constitutes an impermissible hindsight reconstruction of the claimed invention.
These arguments are not found persuasive. Parmar et al. teaches that the presence of the 5’-VP on the antisense strand resulted in an approximately threefold improvement in in vivo silencing thus demonstrating the benefit of a metabolically stable phosphate mimic for improving the activity of siRNA–GalNAc conjugates in vivo [page 987, left column, first full paragraph]. Parmar et al. also teaches that differences in the 5’-P dependence of the two additional sequences were observed with the presence of 5’-P significantly enhancing in vitro activity of conjugate 6 but not conjugate 5 [page 987, right column, last paragraph]. The effects observed in primary hepatocytes in vitro showed excellent correlation with in vivo results in mice, as shown in Figure 4. Again, conjugate 6 showed improvement in activity with 5’-VP, whereas no benefit was observed for conjugate 5. Taken together, the results suggest that siRNAs that are heavily dependent on 5’-P for in vitro activity could benefit from 5’-VP in vivo [page 988, left column, first paragraph].
Conclusion
No claims are 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 CHRISTINA TRAN whose telephone number is (571)270-0550. The examiner can normally be reached M-F 7:30 - 5:00pm.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637