DETAILED ACTION
Applicant’s amendment and remarks filed May 20, 2026 are acknowledged and entered. Any objection or rejection that is not repeated or addressed below is withdrawn or moot in view of Applicant’s amendment.
The provisional rejections on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/150,960 (reference application) are all withdrawn in view of Applicant’s amendments to the instant claims.
Claims Summary
Claims 1, 2, 4-8 and 10-12
Claim 1 is directed to a composition comprising a self-amplifying RNA (saRNA) (which is also known as self-replicating RNA (srRNA)) complexed or associated with a LNP comprising an ionizable lipid, a neutral lipid, a steroid, and a polymer-conjugated lipid. The saRNA comprises:
A 5’ cap; represented by Formula II (claim 4); the nucleotide immediately downstream (5’ to 3’) of the cap comprises guanine (claim 6)
A 5’ UTR; having at least 90% sequence identity to SEQ ID NO: 12 (claim 2), representing a VEEV 5’ UTR
A coding region for at least four nonstructural proteins derived from VEEV mutant strain TC83, comprising a polynucleotide sequence having at least 90% sequence identity to SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15 and SEQ ID NO: 16, representing NSP1-4, in that order
A first subgenomic promoter derived from an alphavirus; comprising a polynucleotide sequence having at least 90% sequence identity to SEQ ID NO: 17 (claim 2), representing a VEEV subgenomic promoter
A first ORF encoding a first gene of interest derived from influenza virus HA; comprising a polynucleotide having at least 90% sequence identity to SEQ ID NO: 18 (claim 2), representing HA of A/Wisconsin/588/2019 H1N1
A second subgenomic promoter derived from an alphavirus; comprising a polynucleotide having at least 90% sequence identity to SEQ ID NO: 19 (claim 2), representing a VEEV subgenomic promoter
A second ORF encoding a second gene of interest derived from influenza virus NA
A 3’ UTR; comprising a polynucleotide having at least 90% sequence identity to SEQ ID NO: 21 (claim 2), representing a VEEV 3’ UTR, and
A 3’ polyA sequence; comprising at least 20 consecutive adenines (claim 2), or comprises 30-200 adenines (claim 12)
At least 10% of the total nucleotides in the saRNA are replaced with modified or unnatural nucleotides, such as pseudouridine, among others (claim 5). The composition comprises at least two saRNA molecules, and at least 50% of the saRNA molecules is full length (claim 7), or at least 80% (claim 8). According to the specification at paragraph [0010] of the published application (US 20240009296) “full length” includes a 5’ cap and a polyA tail. The LNP comprises at least one cationic lipid comprising ALC-0315, at least one neutral lipid comprising DSPC, at least one steroid comprising cholesterol, and at least one PEG-lipid comprising ALC-0159 wherein n has a mean value ranging from 30-60 (claim 10), having a molar ratio of about 20-60% cationic lipid, 5-25% neutral lipid, 25-55% sterol, and 0.5-15% PEG-lipid (claim 11).
Claims 13-18
Claim 13 is directed to a composition comprising an saRNA that is complexed or associated with a LNP comprising an ionizable lipid, a neutral lipid, a steroid, and a polymer-conjugated lipid, comprising:
A 5’ cap; represented by Formula II (claim 14); the nucleotide immediately downstream (5’ to 3’) of the cap comprises guanine (claim 15)
A 5’ UTR
A coding region for at least four nonstructural proteins derived from VEEV mutant strain TC83, comprising a polynucleotide sequence having at least 90% sequence identity to SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15 and SEQ ID NO: 16, representing NSP1-4, in that order
A subgenomic promoter derived from an alphavirus
An ORF encoding a gene of interest derived from influenza virus
A 3’ UTR, and
A 3’ polyA sequence
At least 25% of a total population of a particular nucleotide in the saRNA has been replaced with one or more modified or unnatural nucleotides selected from the group consisting of 5-methyluridine, N1-methylpseudouridine, 5-methoxyuridine, and 5-methylcytosine. The composition comprises at least two saRNA molecules and at least 50% of the saRNA molecules are full length (claim 17), or at least 80% (claim 18).
Claims 19, 20 and 22
Claim 19 is directed to a method for inducing an immune response in a subject comprising administering a composition comprising a plurality of saRNA encapsulated in a LNP. The saRNA comprises:
A 5’ cap
A 5’ UTR
A coding region for at least four nonstructural proteins derived from VEEV mutant strain TC83, comprising a polynucleotide sequence having at least 90% sequence identity to SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15 and SEQ ID NO: 16, representing NSP1-4, in that order
A first subgenomic promoter derived from an alphavirus
A first ORF encoding a gene of interest derived from influenza virus HA
A second subgenomic promoter derived from an alphavirus
A second ORF encoding a second gene of interest derived from influenza virus
A 3’ UTR, and
A 3’ polyA sequence
The composition elicits an immune response comprising a T cell response (claim 20). The composition is formulated as an octavalent influenza vaccine, comprising four of the saRNA encapsulated in a LNP.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-8, 10-15, 17-20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed embodiments wherein the various elements of the saRNA are defined by sequences. The claims encompasses a large genus of saRNA having the following elements:
The 5’ UTR having at least 90% sequence identity to SEQ ID NO: 12 (44 nt), allowing for up to about 5 nt changes
The coding regions for NSP1-4 have at least 70% sequence identity to:
SEQ ID NO: 13 (1605 nt), allowing for up to about 161 nt changes
SEQ ID NO: 14 (2382 nt), allowing for up to about 239 nt changes
SEQ ID NO: 15 (1671 nt), allowing for up to about 168 nt changes
SEQ ID NO: 16 (1825 nt), allowing for up to about 183 nt changes
A first subgenomic promoter having at least 90% sequence identity to SEQ ID NO: 17 (61 nt), allowing for up to about 7 nt changes
A first ORF encoding a first gene of interest comprising a polynucleotide having at least 90% sequence identity to SEQ ID NO: 18 (1706), allowing for up to about 171 nt changes
A second subgenomic promoter comprising a polynucleotide having at least 90% sequence identity to SEQ ID NO: 19 (59 nt), allowing for up to about 6 nt changes
A 3’ UTR having at least 90% sequence identity to SEQ ID NO: 21 (117 nt), allowing for up to about 12 nt changes
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, the claims provide a partial structure in the form of a recitation of percent identity. As outlined above, there are many permutations encompassed by the degree of sequence identity. The functions provided for the various elements are, respectively, UTRs, coding regions for replicase, ORFs, and subgenomic promoters. However, there is no identification of which portions of the claimed sequences must be retained in order for the respective functions to remain intact. Tables 3 and 5 outline the claimed constructs, but no variants of those constructs appear to have been made within the confines of the percent identity limitations. The specification does not appear to provide a nexus between the partial structures and the necessary functions. The specification does not appear to provide any examples of variants having the required functions. While variants within the recited percent identities can be made, one would not know where to make the changes and still reasonably expect to have a functional UTR, replicase, ORFs, and subgenomic promoters, all functioning as an saRNA. The one species provided for each of the elements (SEQ ID NO: 12-19 and 21, respectively) does not represent the genus claimed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Applicant’s remarks filed May 20, 2026 have been carefully considered but fail to persuade. Applicant notes that the application describes the technology of bicistronic saRNA constructs, dosing and safety. In response, the issue remains that one species does not represent the genus. With the 10% variability in the constructs’ components, no examples of such variants that have the claimed function of being a saRNA, and no nexus between the degree of variability and the claimed function, one of skill in the art would not be put in possession of the claimed invention.
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.
Claims 1, 4, 6-8, 10-12, 19, 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kamrud et al. (US 2018/0104359) in view of Boles et al. (Nat. Biotechnol., 2017, 35(7):672-675, “Boles”), Magini et al. (PLoS ONE, 11(8):e0161193, published August 15, 2016, of record in the IDS filed 06/21/2024), and Rauch et al. (US 2021/0379181 A1, published December 9, 2021, filed April 15, 2021, “Rauch”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Kamrud discloses viral-based expression systems for the production of molecules of interest (see abstract) and their administration to animals and humans (see paragraphs [0100]- [0103]) (claim 19). Figure 3 is a schematic of a replicon comprising a 5’ cap, 5’UTR with T2G mutation, NSP1-4, a 26S subgenomic promoter, influenza HA, a 3’UTR and a polyA tail, having, for example, 40 A residues (see paragraph [0116]) (claims 1, 6 and 12). Kamrud contemplates more than one expression cassette, each comprises a 26S subgenomic promoter (see paragraphs [0010]) (claim 1). Kamrud does not teach which antigen to use in the additional expression cassettes, but suggests any gene of interest encoding any polypeptide of interest (see paragraph [0011]). It would have been obvious to have selected any other influenza antigen, such as NA, as disclosed by Boles. Boles discloses a VEEV replicon expressing HA (see Figure 2c), and also discloses the HA and NA amplicons (see Figure 2d). It would have been obvious to have included both HA and NA in Kamrud’s expression cassettes in order to increase immunogenicity with additional an antigen (claim 1). One would have had a reasonable expectation of success given the similar replicon constructs and Kamrud’s suggestion to use any polypeptide of interest (see paragraph [0011]).
Kamrud’s VEEV replicon uses strain TC-83, but whether the sequences of the NSPs represented in Kamrud’s construct match Applicant’s SEQ ID NO: 13-16 has not been determined. However, it would have been obvious to have used any known sequences for the NSPs of TC-83, such as those from Boles’ VEEV replicon backbone (relevant portions and alignments with SEQ ID NO: 13-16 reproduced below), with a reasonable expectation of success (claim 1). The regions of Boles’ sequence that correspond with 100% identity to Applicant’s SEQ ID NO: 13-16 are as follows:
Applicant’s SEQ ID NO: 13 aligns with Boles’ sequence, nt 93-1697
Applicant’s SEQ ID NO: 14 aligns with Boles’ sequence, nt 1698-4079
Applicant’s SEQ ID NO: 15 aligns with Boles’ sequence, nt 4080-5750
Applicant’s SEQ ID NO: 16 aligns with Boles’ sequence, nt 5750-7574
Kamrud’s Figure 3 indicates the presence of a CleanCap®, but the trademark does not indicate the type of cap. Magini’s Figure 1a shows a schematic of a self-amplifying mRNA vector comprising a m7G cap (claim 4), a 5’-UTR (stem/loop structure), NSP1-4, a 26S subgenomic promoter, influenza M1, a second 26S subgenomic promoter, influenza NP. It would have been obvious to have used an m7G cap in Kamrud’s replicon given the similarity of the replicon constructs with a reasonable expectation of success.
Kamrud, Boles and Magini do not suggest formulation of their RNA constructs with, for example, lipid nanoparticles. However, it would have been obvious to have done so with a reasonable expectation of success. One would have been motivated by Rauch’s disclosure that RNA constructs complexed with or encapsulated in LNPs are protected from degradation (see paragraphs [0818]). Rauch’s LNP formulation comprises, for example, ALC-0315, DSPC, cholesterol (steroid), and a PEG-lipid ALC-0159, where n is 45, in a ratio of 50:10:38.5:1.5 (see paragraph [0879] (claims 1, 10 and 11). As for the composition comprising a plurality of saRNA molecules, such as four molecules, this would have been obvious to one of ordinary skill in the art with a reasonable expectation of success. Including more than a single molecule of saRNA, such as two, four or more than four in the composition would improve the immunogenicity of the composition because more immunogen would be produced (claims 7, 8 and 22). Further, regarding the limitations of claims 7 and 8, Kamrud’s constructs are full-length (i.e., including a 5’ cap and a polyA tail), and there is no suggestion to use any less than the full-length constructs. Thus, at least 50% and at least 80% of the saRNA molecules are full-length.
Regarding the induction of a T-cell response, Kamrud does not appear to comment on this, aside from disclosing the induction of an immune response (see paragraph [0038]). However, since the same antigens are being used in Kamrud’s construct as in Applicant’s claimed construct, i.e., influenza HA and a second influenza protein, then the effect of eliciting a T cell response is a natural outcome of doing what the prior art suggests (claim 20).
Therefore, the claimed embodiments would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kamrud et al. (US 2018/0104359) in view of Boles et al. (Nat. Biotechnol., 2017, 35(7):672-675, “Boles”), Magini et al. (PLoS ONE, 11(8):e0161193, published August 15, 2016, of record in the IDS filed 06/21/2024), and Rauch et al. (US 2021/0379181 A1, published December 9, 2021, filed April 15, 2021, “Rauch”), as applied to claim 1 above, and further in view of Geall et al. (US 2011/0300205 A1, “Geall”).
The combined teachings of Kamrud, Boles, Magini and Rauch are outlined above, none of which disclose the replacement of at least 10% or at least 25% of certain nucleotides with modified or unnatural nucleotides. However, it would have been obvious to have done so with a reasonable expectation of success in view of Geall. Geall discloses self-replicating RNA molecules that contain 1-25% modified nucleotides, such as pseudouridine or 5’methyluridine (see abstract and paragraphs [0066]-[0068]). One would have been motivated to modify Kamrud’s construct with modified or unnatural nucleotides in order to increase stability and resistance to degradation and clearance in vivo, among other advantages (see paragraph [0044]). Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 13, 15, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kamrud et al. (US 2018/0104359) in view of Boles et al. (Nat. Biotechnol., 2017, 35(7):672-675, “Boles”), Rauch et al. (US 2021/0379181 A1, published December 9, 2021, filed April 15, 2021, “Rauch”) and Geall et al. (US 2011/0300205 A1, “Geall”).
The combined teachings of Kamrud, Boles and Rauch are outlined above (addressing claims 13 and 15), none of which disclose the replacement of at least 10% or at least 25% of certain nucleotides with modified or unnatural nucleotides. However, it would have been obvious to have done so with a reasonable expectation of success in view of Geall. Geall discloses self-replicating RNA molecules that contain 1-25% modified nucleotides, such as pseudouridine or 5’methyluridine (see abstract and paragraphs [0066]-[0068]). One would have been motivated to modify Kamrud’s construct with modified or unnatural nucleotides in order to increase stability and resistance to degradation and clearance in vivo, among other advantages (see paragraph [0044]) (claim 13). Further, regarding the limitations of claims 17 and 18, Kamrud’s constructs are full-length (i.e., including a 5’ cap and a polyA tail), and there is no suggestion to use any less than the full-length constructs. Thus, at least 50% and at least 80% of the saRNA molecules are full-length.
Therefore, the claimed embodiments would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kamrud et al. (US 2018/0104359) in view of Boles et al. (Nat. Biotechnol., 2017, 35(7):672-675, “Boles”), Rauch et al. (US 2021/0379181 A1, published December 9, 2021, filed April 15, 2021, “Rauch”) and Geall et al. (US 2011/0300205 A1, “Geall”) as applied to claim 13, above, and further in view of Magini et al. (PLoS ONE, 11(8):e0161193, published August 15, 2016, of record in the IDS filed 06/21/2024).
The teachings of Kamrud, Boles, Rauch and Geall are outlined above. Kamrud’s Figure 3 indicates the presence of a CleanCap®, but the trademark does not indicate the type of cap. Magini’s Figure 1a shows a schematic of a self-amplifying mRNA vector comprising a m7G cap, a 5’-UTR (stem/loop structure), NSP1-4, a 26S subgenomic promoter, influenza M1, a second 26S subgenomic promoter, influenza NP. It would have been obvious to have used an m7G cap in Kamrud’s replicon given the similarity of the replicon constructs with a reasonable expectation of success. Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments
In the remarks filed May 20, 2026, Applicant argues that Kamrud, Magini and Rauch fail to teach the claims as amended. In response, the rejections have been modified to address the amended claims.
Applicant also argues that their bicistronic saRNA compositions are dose-sparing compared to modRNA (presumably chemically modified RNA), and unexpectedly able to elicit comparable or superior immunogenicity compared to quadrivalent HA-encoding modRNA-LNP and an inactivated vaccine (FluAd). In response, Applicant has not explained why these results are unexpected. The evidence that Applicant has presented is comparing different constructs. The instant invention is saRNA, which is structurally different from modRNA and an inactivated vaccine. Merely have superior results to other products is not evidence of unexpected results. One would have to establish with evidence that the expected result would be A, but the actual result was B. Therefore, the rejections are maintained.
Alignment of Applicant’s SEQ ID NO: 13 (“Qy”) with Boles’ sequence (“Db”)
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Alignment of Applicant’s SEQ ID NO: 13 (“Qy”) with Boles’ sequence (“Db”)
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Alignment of Applicant’s SEQ ID NO: 13 (“Qy”) with Boles’ sequence (“Db”)
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812
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Alignment of Applicant’s SEQ ID NO: 13 (“Qy”) with Boles’ sequence (“Db”)
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412
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Alignment of Applicant’s SEQ ID NO: 14 (“Qy”) with Boles’ sequence (“Db”)
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840
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Alignment of Applicant’s SEQ ID NO: 14 (“Qy”) with Boles’ sequence (“Db”)
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804
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Alignment of Applicant’s SEQ ID NO: 14 (“Qy”) with Boles’ sequence (“Db”)
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814
558
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Alignment of Applicant’s SEQ ID NO: 14 (“Qy”) with Boles’ sequence (“Db”)
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830
556
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Alignment of Applicant’s SEQ ID NO: 14 (“Qy”) with Boles’ sequence (“Db”)
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812
548
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Alignment of Applicant’s SEQ ID NO: 14 (“Qy”) with Boles’ sequence (“Db”)
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100
414
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Alignment of Applicant’s SEQ ID NO: 15 (“Qy”) with Boles’ sequence (“Db”)
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828
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Alignment of Applicant’s SEQ ID NO: 15 (“Qy”) with Boles’ sequence (“Db”)
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802
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Alignment of Applicant’s SEQ ID NO: 15 (“Qy”) with Boles’ sequence (“Db”)
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812
562
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Alignment of Applicant’s SEQ ID NO: 15 (“Qy”) with Boles’ sequence (“Db”)
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506
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Alignment of Applicant’s SEQ ID NO: 16 (“Qy”) with Boles’ sequence (“Db”)
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838
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Alignment of Applicant’s SEQ ID NO: 16 (“Qy”) with Boles’ sequence (“Db”)
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710
556
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Alignment of Applicant’s SEQ ID NO: 16 (“Qy”) with Boles’ sequence (“Db”)
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810
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Alignment of Applicant’s SEQ ID NO: 16 (“Qy”) with Boles’ sequence (“Db”)
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808
556
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Alignment of Applicant’s SEQ ID NO: 16 (“Qy”) with Boles’ sequence (“Db”)
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88
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Conclusion
No claim is allowed.
The combination of sequences SEQ ID NO: 12-18 and 21 in a single saRNA molecule is free of the prior art of record.
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.
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/STACY B CHEN/Primary Examiner, Art Unit 1672
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