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 .
Application Status
Applicant’s response filed June 15, 2026 is acknowledged. Claims 1-2, 16, 20, 38-39, 47, 54, 61-66, and 68-73 are pending.
Restriction/Election
Applicant’s election without traverse of Group I (claims 1-2, 16, 20, 38-39, 47, 54, and 73) in the reply filed on June 15, 2026 is acknowledged. Applicant’s election of the species of cationically ionizable lipid (“Compound IV-3”), polysarcosine-conjugated lipid (“C14pSar23”), and RNA (“RNA encoding the SARS-CoV-2 S protein variant having proline residue substitutions at positions 986 and 987 of SEQ ID NO: 11”) in the reply filed is also acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of species have been treated as elections without traverse (MPEP § 818.01(a)).
Claims 61-66, and 68-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 elected species are encompassed by the claims in Group I. Claims 1-2, 16, 20, 38-39, 47, 54, and 73 are under examination hereinafter, accordingly.
Priority
Applicant’s priority claims to Application Nos. PCT/EP2021/087748 and PCT/EP2022/087877 are acknowledged. Claims 1-2, 16, 20, 38-39, 47, 54, and 73 find support in Application No. PCT/EP2021/087748. The effective filing date of the claims under examination is December 28, 2021.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing.
Required response - Applicant must: Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Drawings
The drawings are objected to because of the following informalities:
The view numbers for the partial views for several figures (at least Figs. 1, and 3-4) are followed by "(contin.)" instead of a capital letter such as FIG. 1A, FIG. 1B, etc. 37 CFR 1.84 (u)(1) states “Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter.”
The view numbers of several figures (at least Figs. 2-3) are not oriented in the same direction as the view so as to avoid having to rotate the sheet. 37 CFR 1.84(p)(1) states “Reference characters (numerals are preferred), sheet numbers, and view numbers must be plain and legible, and must not be used in association with brackets or inverted commas, or enclosed within outlines, e.g., encircled. They must be oriented in the same direction as the view so as to avoid having to rotate the sheet.”
Appropriate correction is required.
Specification
The specification is objected to because of the following informalities:
The use of terms which are trade names or marks used in commerce, has been noted in this application, e.g., “Taxotere,” “Taxol” (pg. 184, line 28), and “Microvue” (pg. 211, line 20). The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16, 20, 39, 47, and 73 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 16 and 39 recite exemplary language, i.e., the phrases “e.g.,” and “such as,” which renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 20 and 73 are rejected for depending from claims 16 and 39, respectively, and failing to remedy the indefiniteness therein.
Claims 16, 20, 39, and 47 recite the term “about.” The term “about” is a relative term which is not defined by the claims. The specification recites that “the term “about” denotes an interval of accuracy that the person of ordinary skill will understand to still ensure the technical effect of the feature in question” (pg. 34, lines 23-25). The specification states that the “specific such deviation for a numerical value for a given technical effect will depend on the nature of the technical effect” (pg. 35, lines 13-15). This description does not provide a standard for ascertaining the requisite degree of “about” in the claims, because the degree is not clearly specified for any of the ranges recited in the claims, and the description amounts to stating that the meaning of the term “about” “depend[s].” One of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 73 is rejected for depending from claim 39 and failing to remedy the indefiniteness therein.
Claim 47 recites “at least a portion of (i) the RNA, (ii) the cationically ionizable lipid, and, if present, (iii) the one or more additional lipids is present in nanoparticles.” Claim 1 requires an “RNA,” a “cationically ionizable lipid,” and “at least one polysarcosine-conjugated lipid.” Because claim 47 refers generically to “one or more additional lipids,” and refers to their presence as an optional, it is not clear whether the phrase “the one or more additional lipids” is intended to refer to the “at least one polysarcosine-conjugated lipid” which is a specific, and non-optional element of claim 1. The term “the one or more additional lipids” lacks sufficient antecedent basis, accordingly.
Notice to Joint Inventors
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 Rejections - 35 USC § 103 – Elia in view of Ramishetti, Nogueria, and Jackson
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 1-2, 16, 20, 38-39, 47, 54, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Elia (Elia et al., 22 January 2021, ACS Nano, 2021, 15, pg. 9677-9637) in view of Ramishetti (Ramishetti et al., 30 January 2020, Adv. Mater. 2020, 32, 1906128, pg. 1-8), Nogueira (Nogueira et al., 25 September 2020, ACS Appl. Nano Mater. 2020, 3, pg. 103634-10645) and Jackson (Jackson et al., 12 November 2020, The New England Journal of Medicine, 383; 20, pg. 1920-1931).
The claims are examined as to the elected species, and accordingly, are interpreted hereinafter as a composition comprising: (i) an RNA encoding a SARS-CoV-2 S protein variant having proline residue substitutions at positions 986 and 987 of SEQ ID NO: 11, which is interpreted as a SARS-CoV-2 S protein having prolines at the residues corresponding to residues 986-987 of the wild-type SARS-CoV-2 S protein sequence set forth in SEQ ID NO: 11 (pg. 105) (it is noted that the elected species is not interpreted as requiring the sequence of SEQ ID NO: 11), (ii) a cationically ionizable lipid as set forth in structure IV-3 (pg. 156), and (iii) a polysarcosine-conjugated lipid as set forth in structure VII-1, wherein “n” = 23, corresponding to “C14pSar23” (pg. 172). Claims 1-2, 16, 20, and 54 are encompassed by the elected species, and therefore, art which anticipates or renders obvious the elected species, anticipates or renders obvious claims 1-2, 16, 20, and 54.
Regarding claims 1-2, 16, 20, and 54, Elia teaches a composition which is intended to be used as an “mRNA vaccine” for SARS-CoV-2, the causal agent of COVID-19, which at the time of Elia’s publication was “at the center of [a] current global human pandemic” (Abstract). Elia teaches the composition comprises (i) an RNA encoding a fragment of SARS-CoV-2 S protein (“SARS-CoV-2 spike (S) protein consists of S1, including receptor-binding domain (RBD)… For our vaccine platform, we chose the RBD of SARS-CoV-2 as the target antigen for the mRNA coding sequence, as described in Methods,” pg. 9630; “CleanCap, pseudouridine-substituted Fc-conjugated RBD mRNA (331-524 aa)… the Fc-conjugated RBD mRNA was designed to include the exact translated RBD-hFc protein sequence as the recombinant protein,” pg. 9633); (ii) a cationically ionizable lipid having substantially the same structure as set forth in structure IV-3 as shown in Fig. A below (“Lipid 15,” Fig. 1A); and (iii) PEG-DMG (“DMG-PEG”, Fig. 1B). Elia’s composition also comprises one or more additional lipids, i.e., “DSPC,” and “cholesterol” (Fig. 1B).
Figure A. “Lipid 15,” top; “IV-3,” bottom.
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As shown in Fig. A above, Lipid 15 of Elia is substantially identical in structure to the elected structure IV-3; Lipid 15 comprises a ethanolamine linker, and IV-3 comprises a hydroxylamine linker, between identical ionizable headgroups and lipid chains.
Ramishetti teaches substantially identical cationically ionizable lipids to Elia’s, which comprise ethanolamine and hydroxylamine linkers (Fig. 1; pg. 2). Ramishetti teaches that “these linkers are easily available” and need only “simple synthetic procedures” for modification (pg. 2, left col.). Ramishetti teaches substantially identical compositions to Elia’s comprising the cationically ionizable lipids with ethanolamine and hydroxylamine linkers (“LNPs were composed of ionizable lipid, cholesterol… DSPC[], and PEGylated lipids,” pg. 2, right col.; “we entrapped polo-like kinase 1 (PLK1) siRNA into the LNPs,” pg. 3, left col.). Based on Ramishetti’s results, the skilled artisan would expect that cationically ionizable lipids with ethanolamine and hydroxylamine linkers would function similarly. See, for example, the cell viability, uptake, and levels of immune system and liver enzymes, for Lipids 6 and 8, which comprise hydroxylamine and ethanolamine linker, respectively, with identical headgroups and lipid chains (Fig. 3A, E; Fig. 5). Ramishetti also teaches that “no major toxic events and immune activation were observed for the lipids with different linkers” (pg. 6, left col.).
MPEP 2144.09(I) states that “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).”
With respect to the elected cationically ionizable lipid, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the linker structure of Lipid 15 of Elia, to arrive at the elected cationically ionizable lipid species structure set forth in IV-3. Lipid 15 and IV-3 have identical headgroups and lipid chains, and substantially identical linkers. Lipid 15 and IV-3 also have substantially similar utilities, i.e., as cationically ionizable lipids in LNP compositions. As evidenced by Elia and Ramishetti, it was well within the purview of the skilled artisan to design and synthesize cationically ionizable lipids with different, but structurally similar, linkers. Based on the teachings of Ramishetti, the skilled artisan would expect that a hydroxylamine and ethanolamine linker would function similarly (i.e., link the headgroup and lipid chains), and result in a cationically ionizable lipid with substantially identical function. In an effort to prepare the effective mRNA vaccines to address the global human pandemic caused by SARS-CoV-2, the skilled artisan would have been motivated to make additional, structurally and functionally similar cationically ionizable lipids to Lipid 15, which Elia identifies as “superior… in terms of protein expression level and its duration in all three routes of administration” (pg. 9629, left col.).
Elia does not teach the composition comprises at least one polysarcosine-conjugated lipid, wherein the polysarcosine-conjugated lipid is the structure set forth in VII-1, wherein “n” = 23 (see specification, pg. 172).
Nogueria teaches substantially identical compositions to Elia’s composition, comprising (i) RNA, (ii) a cationically ionizable lipid, (iii) either “PEG-DMG” or a polysarcosine-conjugated lipid (“pSar”) as a “stealth moiety,” and one or more additional lipids, i.e., “DSPC,” and “cholesterol” (“As the stealthy moiety, either… PEG-DMG[] or pSar lipids were used,” see Fig. 1 and description). Nogueria’s compositions are used for the same purpose as Elia’s composition (“lipid nanoparticles (LNPs) for therapeutic application of messenger RNA,” Abstract). Nogueria teaches a polysarcosine-conjugated lipid having the structure set forth in VII-1, wherein “n” = 23 (“pSar23,” Figs. 1-2, 5-7). Nogueira teaches that of the polysarcosine-conjugated lipid-comprising compositions tested, pSar23-comprising compositions were most efficacious for RNA delivery (Fig. 5; pg. 10638). Nogueira teaches that compared to compositions comprising PEG lipids (e.g., “PEG-DMG”), pSar-comprising compositions confer “a higher protein secretion with a reduce immunostimulatory response” (Abstract). Nogueira discusses several disadvantages of PEG-lipid-comprising compositions for RNA delivery (pg. 10634-10635), and concludes that pSar-comprising compositions “enable safe and potent delivery of mRNA, thus signifying an excellent basis for the development of PEG-free RNA therapeutics” (Abstract).
With respect to the elected polysarcosine-conjugated lipid, it would have been obvious to one of ordinary skill in the art to substitute PEG-DMG in the composition of Elia, with pSar23 taught by Nogueira, which corresponds to the structure set forth in VII-1, wherein “n” = 23. It would have amounted to a simple substitution of two known “stealth moiety” lipids, by known means to yield predictable results. The skilled artisan would have had a reasonable expectation of success in substituting PEG-DMG for pSar23 because Elia’s and Nogueira’s composition are substantially identical, and used for the same purpose, and because Nogueira teaches that the two lipids perform the same function in the compositions (i.e., “stealth moiety”). The skilled artisan would have been motivated to substitute the lipids because Nogueira teaches that pSar23-comprising compositions are superior in several ways to PEG-lipid-comprising compositions for the purposes of RNA delivery, and particularly, offering higher protein secretion and reduced immunostimulatory response. The skilled artisan would recognize that these features could improve the therapeutic efficacy and tolerance of mRNA vaccines used to address the global human pandemic caused by SARS-CoV-2.
Elia’s RNA does not encode a SARS-CoV-2 S protein having prolines at the residues corresponding to residues 986-987 of the wild-type SARS-CoV-2 S protein sequence set forth in SEQ ID NO: 11. Elia, however, refers to Jackson et al., as disclosing “an mRNA vaccine by Moderna Inc. directed against the spike protein of SARS-CoV-2” (pg. 9627, right col.).
Jackson reports the results of a phase 1 clinical trial of an mRNA vaccine directed against the spike protein of SARS-CoV-2. The mRNA vaccine comprises an RNA encoding “the S-2P antigen,” which consists of “the SARS-CoV-2 glycoprotein with a transmembrane anchor and an intact S1-S2 cleavage site… stabilized in its prefusion conformation by two consecutive proline substitutions at amino acid positions 986 and 987, at the top of the central helix in the S2 subunit” (pg. 1921, right col.). The vaccine is a “lipid nanoparticle capsule composed of four lipids… formulated in a fixed ratio of mRNA and lipid” (pg. 1921, right col.). The trial concludes that the mRNA vaccine “induced anti-SARS-CoV-2 immune responses in all participants,” and identified “no trial-limiting safety concerns” (pg. 1920).
With respect to the elected RNA, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the RNA in the composition of Elia, for the RNA of Jackson which encodes a SARS-CoV-2 S protein having prolines at the residues corresponding to residues 986-987 of the wild-type SARS-CoV-2 S protein sequence. It would have amounted to a simple substitution of two RNAs used in mRNA vaccines directed against the spike protein of SARS-CoV-2, by known means to yield predictable results. The skilled artisan would have had a reasonable expectation of success in substituting the RNAs, because the RNAs are both directed against the spike protein, and functional in a lipid nanoparticle-based composition. The skilled artisan would have been motivated to substitute the RNAs because Jackson’s mRNA vaccine is explicitly referenced by Elia, and has demonstrated efficacy and safety in phase 1 trials. The skilled artisan would have recognized that using Jackson’s RNA, which has already demonstrated efficacy in safety in phase 1 trials, would expedite the development of mRNA vaccines used to address the global human pandemic caused by SARS-CoV-2.
Regarding claims 38-39, Elia teaches the composition further comprises one or more additional lipids, wherein the additional lipids are steroids, and wherein the steroid is cholesterol (“LNPs were synthesized by mixing one volume of lipid mixture of ionizable lipid, DSPC, cholesterol, and DMG-PEG… and three volumes of mRNA,” pg. 9633; Fig. 1B).
Regarding claim 47, Elia teaches the RNA is mRNA (“we present the design of an mRNA vaccine,” Abstract; “LNPs were synthesized by mixing one volume of lipid mixture of ionizable lipid, DSPC, cholesterol, and DMG-PEG… and three volumes of mRNA,” pg. 9633).
Regarding claim 73, Elia teaches the composition further comprises one or more additional lipids, wherein the additional lipids are phosphatidylcholines, and specifically, distearoylphosphatidylcholine (DSPC)( “LNPs were synthesized by mixing one volume of lipid mixture of ionizable lipid, DSPC, cholesterol, and DMG-PEG… and three volumes of mRNA,” pg. 9633; Fig. 1B).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application No. 18/036,677
Claims 1-2, 16, 20, 38-39, 47, 54, and 73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17, and 29 of co-pending Application No. 18/036,677 in view of Elia (Elia et al., 22 January 2021, ACS Nano, 2021, 15, pg. 9677-9637), Ramishetti (Ramishetti et al., 2020, Adv. Mater. 2020, 32, 1906128, pg. 1-8), and Nogueira (Nogueira et al., 25 September 2020, ACS Appl. Nano Mater. 2020, 3, pg. 103634-10645). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending claim 29 recites a “composition comprising lipid nanoparticles (LNPs)… wherein the LNPs comprise a cationically ionizable lipid and RNA,” “wherein: (i) the LNPs comprise at least 75% of the RNA comprised in the composition; (ii) the RNA is encapsulated within or associated with the LNPs; (iii) the RNA comprises a modified nucleoside selected from pseudouridine (Ψ), N1- methyl-pseudouridine (m1Ψ), and 5-methyl-uridine (m5U); (iv) the RNA comprises a 5' cap1 or 5' cap2 structure, a 5' UTR, a 3' UTR, a poly-A sequence, or a combination thereof; (v) the RNA encodes one or more polypeptides comprising an epitope for inducing an immune response against an antigen in a subject; or (vi) any combination of any two or more of (i) to (v),” and “wherein the RNA comprises an open reading frame (ORF) encoding: (i) a SARS-CoV-2 S protein, an immunogenic variant thereof, or an immunogenic fragment of the SARS-CoV-2 S protein or the immunogenic variant thereof; or (ii) a full-length SARS-CoV-2 S protein variant comprising proline residue substitutions at positions 986 and 987 of SEQ ID NO: 1, and wherein the SARS-CoV-2 S protein variant has at least 80% identity to SEQ ID NO: 7.” Instant SEQ ID NO: 1 is identical to instant SEQ ID NO: 11.
Co-pending claim 29 meets the limitations of instant claims 1-2, 16, 20, 47, and 54, with the exception of the specifically elected cationically ionizable lipid, and polysarcosine-conjugated lipid. However, it is noted that the co-pending claims encompass cationically ionizable lipids substantially structurally identical to the instantly elected species (see claim 13), as well as a polysarcosine-conjugated lipid (see claim 17).
With respect to the specifically elected cationically ionizable lipid and the polysarcosine-conjugated lipid, the teachings of Elia, Ramishetti, and Noguiera are described above and applied hereinafter. The obviousness of a preparing a composition comprising the elected cationically ionizable lipid and elected polysarcosine-conjugated lipid over Elia, Ramishetti, and Noguiera, is described above and applied hereinafter.
Co-pending claims 16-17 meet the limitations of instant claims 38-39, and 73. The compositions of instant claims are also obvious over the co-pending claims in view of Elia, Ramishetti, and Nogueira for the reasons described above.
Conclusion
No claims are allowed.
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/JENNA L PERSONS/Examiner, Art Unit 1637
/Soren Harward/Primary Examiner, TC 1600
Prosecution Insights