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 .
Withdrawn Rejections
The rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over de Fougerolles et al. (U.S. Patent Application No. 2013/0266640; published October 10, 2013; cited by applicant) and Geall et al. (WO2012006369; cited by applicant) has been withdrawn in view of applicant's arguments.
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 1-14 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 claim(s) contains 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 following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice .... reduction to drawings .... or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
The claims are directed to a betacoronavirus vaccine for a human subject, comprising a messenger ribonucleic acid (mRNA) formulated in a lipid nanoparticle, wherein the mRNA comprises an open reading frame encoding a full-length betacoronavirus spike protein, wherein the open reading frame comprises nucleosides consisting of N1-methylpseudouridine, adenosine, guanosine, and cytidine, wherein the lipid nanoparticle comprises an ionizable cationic lipid, a neutral lipid, a cholesterol, and a polyethylene glycol (PEG)-modified lipid, and wherein the vaccine is formulated for intramuscular injection to a human subject at a dose that comprises from 10-100 µg of the mRNA.
Claim 1 is rejected as lacking adequate descriptive support for a lipid nanoparticle (LNP) composed of any amount of an ionizable cationic lipid, any amount of a neutral lipid, any amount of a cholesterol, and any amount of a polyethylene glycol (PEG)-modified lipid, which results in the formation of the claimed betacoronavirus vaccine.
In support of the claimed genus, the application discloses several examples of potential lipids (see, for example, pages 15, 17 and 194), and there are examples (e.g., Examples 13, 18, 20 and 26) where specific components and the amounts for each component are recited for the lipid nanoparticles. However, the claims are not limited to these lipid nanoparticle formulations.
Further, while the claims provide both a structure and a function, the application fails to draw any correlation between the two. In other words, there is no evidence that any amount of the recited lipids as claimed can form a LNP. Optimization of the type and concentration of LNP is critical to ensure proper biodistribution and cellular entry, especially depending on the intended use or clinical application of the LNP (see Sects. 4.2.2, 4.5.3, 4.5.5 of Ernsting MJ, et. al. J Control Release. 2013 Dec 28;172(3):782-94. Epub 2013 Sep 25). As the prior and post- filing art clearly shows, there was and is great uncertainty in the LNP field, especially with respect to delivery of RNA for immunogenic therapeutic purposes, and choosing the right cationic lipid along with other components to formulate LNPs is a complex, highly empirical procedure, and it is unclear that the large breadth of lipid amounts encompassed by the claim would be able to generate the LNPs as claimed and form a mRNA vaccine composition. Thus, in view of the above, there would have been significant uncertainty as to the amounts of each recited lipid component that would formulate LNPs which could then be used in mRNA vaccines. In view of this uncertainty and the lack of any examples of the claimed genus, the claims are rejected for lack of adequate written description support.
Response to Arguments
In the reply dated /9/2026, applicant argues that the instant specification provides extensive written description support for LNPs consistent with the scope of the claims. Applicant’s arguments have been fully considered and not found persuasive.
Claim 1 is rejected as lacking adequate descriptive support for a lipid nanoparticle (LNP) composed of any amount of an ionizable cationic lipid, any amount of a neutral lipid, any amount of a cholesterol, and any amount of a polyethylene glycol (PEG)-modified lipid, which results in the formation of the claimed betacoronavirus vaccine.
In support of the claimed genus, the application discloses examples of potential lipids (see, for example, pages 15, 17 and 194), and there are examples (e.g., Examples 13, 18, 20 and 26) where specific components and the amounts for each component are recited for the lipid nanoparticles. However, the claims are not limited to these lipid nanoparticle formulations. The Examples do not demonstrate that any amount of ionizable cationic lipid, combined with any amount of a neutral lipid, combined with any amount of cholesterol, combined with any amount of a PEG-modified lipid will behave as or form a LNP and that said LNP, when combined with a betacoronavirus mRNA, will have vaccine properties.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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