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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/30/25 has been entered.
Rejection Maintained
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 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.
Claims 1, 20, 23, 35, and 168-169 are rejected under 35 U.S.C. 103 as being unpatentable over Bancel et al. (US20140193482A1) and Kwong et al. (USPGPubUS20160046675A1).
Bancel et al. teach for claims 1 and 35, a lipid nanoparticle and an RNA encoding an RSV antigen (paras 666, 819, and 831). For claims 1 and 35, Bancel et al. teach that the modification, 1-methyl-pseudouridine, has been shown to convey added protection over the standard combination of 5-ethylcytidine/ pseudouridine explored by others resulting in twice as much protein (see paragraph [1551]). For claim 35, the nanoparticle can be administered to induce an immune response (para 585). For claims 1, 20, 35, and 168, the lipids were combined to yield molar ratio of 50:10:38.5:1.5 (Lipid: DSPC: Cholesterol: PEG-c-DOMG) (para 1291). Here, DSPC is a neutral lipid and the sterol is cholesterol (para 1291).
For claims 1, 20, and 35, the nanoparticle can contain cationic lipid, PEG-modified lipid, a sterol and a non-cationic lipid including DLin-MC3-DMA including neutral lipid and cholesterol (paras 28 and 578). For claim 35, the RNA can be administered to treat a virus (para 837).
Bancel et al. do not teach RSV F.
For claims 1 and 35, Kwong et al. teach SEQ ID# 324 that is 99% identical (see sheet, NOTE NEW SHEET with seq 324 comparison). The four mutations are referred to a DSCAV-1 and are taught to form a pre-fusion stabilized RSV F and the construct can be expressed from plasmids in cell culture and used to induce a neutralizing antibody response (Example 8).
Kwong et al. teach that RSV F can be stabilized in prefusion conformation and is useful as an antigen in a vaccine as a nucleic acid. Kwong et al. includes nucleic acids encoding the RSV F constructs used as antigens and in methods to induce immune response (para 13), that the antigens can be used as vaccines (end of para 6) and “In additional embodiments, a therapeutically effective amount of a pharmaceutical composition including a nucleic acid encoding a disclosed PreF antigen is administered to a subject in order to generate an immune response. In one specific, non-limiting example, a therapeutically effective amount of a nucleic acid encoding a disclosed antigen is administered to a subject to treat or prevent or inhibit RSV infection (para 561).”
For claim 23, since the prior art has the same structure, the claims would have the same property of net neutral charge. For claim 169, the lipid nanoparticle can be administered intramuscularly (para 730).
One of ordinary skill in the art at the effective time of filing would have known RSV F protein and a nucleic acid encoding antigen for RSV as taught by Kwong et al.
One of ordinary skill in the art at the effective time of filing would have known that certain modifications improve the stability and expression of mRNA and would have been motivated to use the modifications to improve the mRNA in vivo along with the lipid nanoparticle adjuvant as a delivery component.
Thus, it would have been prima facie obvious before the effective time of filing to modify the particle of Bancel et al. with the expectation of success knowing that lipid nanoparticles are known to be effective in invoking an immune response and then to modify the composition to use the stabilized prefusion RSV F of Kwong et al. with the expectation of success knowing that it is taught to be immunogenic (abstract) and stabilized (Figure 12).
Applicant argues that the sequence does not contain two of the mutations, that Kwong et al. does not disclose an RSV F pre-fusion mRNA ORF, that protein-based vaccines are not interchangeable, that Kallen et al. say there are issues with mRNA vaccines, and that Geall et al teach there is issues with storage of self-amplifying RNA vaccines. Kwong et al. teach that the DSCAV-1 is expressed to make protein. This inherently indicates that there was mRNA
Applicant’s arguments have been fully considered and not found persuasive.
The sequence has been changed to the correct #324 but the four mutations are called DSCAV-1 and referred to many times as stabilized pre-fusion RSV F. The sequence meets the sequence requirements of the claims. Kwong et al. inherently teach mRNA encoding stabilized pre-fusion RSV F because the protein was expressed from plasmids. Additionally, the teachings refer to embodiments that include nucleic acids encoding the RSV F constructs.
Bancel et al. provides many examples that mRNA can be used to express antigens and the use is included in Kwong et al. as well as mRNA is shown to produce stabilized pre-fusion RSV F protein.
Applicant’s arguments about the art casting doubt are not persuasive. Applicant does not show how Bancel et al. falls short or compare and point out how the claimed invention is better and different. As to the stability and storage, there is no stability required in the claims.
The arguments of counsel cannot take the place of evidence in the record. In re Schulz, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”).
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/ Examiner, Art Unit 1671
/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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