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 .
Priority
Acknowledgment is made of Applicants’ claim for benefit to prior filed US Provisional application 63/237,714 (filed 08/27/2021).
Claim Status
Claims 1-7, 11-13, 15, 18, 20-21, 25-26, 28, 30, 33, 35-36, 40, 51, and 53 are pending, all of which have been considered on the merits.
Specification
The listing of references in the throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because Figure 4E is not labeled as to understand what is being shown. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7, 25-26, 30, 33, 36, 40, and 53 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Compans, et al. (US 2006/0216702 A1, US-IDS, filed, 06/18/2025, hereinafter “Compans”).
Regarding claims 1, 25, and 30, Compans discloses a composition of virus-like particles (VLPs) wherein the VLPs comprising a matrix glycoprotein from a first virus species and surface glycoproteins from at least two virus species (¶0033-0038).
Regarding claim 2, Compans discloses that the at least two virus species include a virus species different from the first virus species (¶0034-0038)
Regarding claim 3, Compans discloses that the at least two virus species include viruses from two virus families (¶0038).
Regarding claim 4 and 33, Compans discloses that the virus families are arenaviruses, filoviruses, coronaviruses, retroviruses, paramyxoviruses, alphaviruses, flaviviruses, rhabdoviruses, togaviruses, and orthomyxoviruses (¶0038).
Regarding claims 5 and 26, Compans discloses where in the matrix glycoprotein is from a coronavirus or influenza (¶0035).
Regarding claim 7 and 36, Compans discloses that the surface glycoproteins are NiV-F, RiV-G, EBOV-GP, and RVFV GnGc (¶0038).
Regarding claim 40, Compans discloses an immunogenic composition which comprises VLPs comprising the matrix glycoprotein and surface glycoproteins and a pharmaceutically acceptable carrier (¶0007 and ¶0033-0038).
Regarding claim 53, Compans discloses a method of producing VLPs comprising providing a cell with a nucleic acid (Claim 34) encoding a matrix protein (Claim 3) and surface glycoproteins (Claim 34) and having the host cell form the VLP (Claim 34), purifying the particles (¶0151) and creating an immunogenic composition (Claim 44).
Accordingly, the claimed inventions are anticipated by Compans.
Claims 1, 11-13, 15, 18, and 51 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Anasuya Chattopadhyay, et al. (Vaccine. 2018 Jun 22;36(27):3894-3900., hereinafter “Anasuya”).
Regarding claims 1 and 11, Anasuya discloses a vaccine comprising replication-incompetent virion comprising a matrix protein (VSV) and two surface glycoproteins (CHIKV E2 and Zika E) (Abstract and Methods 2.2 and 2.3).
Regarding claim 12, Anasuya discloses that the replication-incompetent virion is a pseudo typed VSV (Results 3.1).
Regarding claim 13, Anasuya discloses that the native envelop G protein of the rVSV is removed (Results 3.1).
Regarding claim 15, Anasuya discloses that the virion comprises surface glycoproteins from two virus species, ZIKV E and CHIKV E2 (Methods 2.2 and 2.3).
Regarding claim 18, the surface glycoprotein are from the virus family flaviviruses (Abstract).
Regarding claim 51, Anasuya discloses a method of making rVSVΔG by providing a host cell VSV DNA for the virion and matrix protein and CHIKV and ZIKV DNA to express the surface glycoproteins and using helper plasmids to create rVSV particles that were then purified (Methods 2.2-2.4).
Accordingly, the claimed invention was anticipated by Anasuya.
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.
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.
Claims 6 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Compans as applied to claims 1-5, 7, 25-26, 30, 33, 36, 40, and 53 above, and further in view of Lundstrom (Front Genome Ed. 2020 Oct 2;2:579297).
As discussed above claims 1-5, 7, 25-26, 30, 33, 36, 40, and 53 were anticipated by Compans.
Regarding claims 6 and 35, Compans teaches that the matrix glycoprotein is a beta-coronaviral species but does not teach that the matrix glycoprotein in from SARS-CoV-2, SARS-CoV-2, or MERS. However, Lundstrom teaches that the SARS-CoV-2 matrix glycoprotein is used in SARS-CoV-2 vaccines (pg. 8, column 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the matrix glycoprotein from the Avian Infectious Bronchitis Virus, a beta-coronavirus, taught by Compans for the matrix glycoprotein of SARS-CoV-2 taught by Lundstrom. Compans teaches that many different matrix glycoproteins can be used in making multivalent VLPs including beta-coronavirus matrix glycoproteins (¶0035) and that AIBV is a non-limiting example of beta-coronaviruses (¶0035). One of skill in the art would have substituted the matrix glycoprotein of AIBV taught by Compans with the matrix glycoprotein of SARS-CoV-2 taught by Lundstrom to create a multivalent VLP that is a vaccine against SARS-CoV-2. One of skill in the art would have had a reasonable expectation of success of substituting the matrix glycoproteins because they are both beta-coronavirus matrix glycoproteins.
Accordingly, the invention were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Anasuya as applied to claims 1, 11-13, 15, 18, and 51 above, and further in view of Fukushi, et al. (Methods Mol Biol. 2008;454:331-8., hereinafter “Fukushi”).
As discussed above claims 1, 11-13, 15, 18, and 51 were anticipated by Anasuya.
Regarding claims 20 and 21, Anasuya does not teach that the surface glycoprotein of the VSV is from SARS-CoV-1, SARS-CoV-2, or MERS. However, Fukushi teaches that the SARS S protein can be used to create SARS pseudo typed rVSV (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the envelope proteins (surface glycoproteins) from CHIKV or ZIKV, taught by Anasuya for the S protein of SARS taught by Fukushi. Anasuya and Fukushi teach that many different matrix glycoproteins can be used in making rVSV (Ansasuya, methods 2.2 and 2.3 and Fukushi Abstract). One of skill in the art would have substituted the envelope proteins (surface glycoproteins) from CHIKV or ZIKV taught by Anasuya with the S protein of SARS taught by Fukushi to create a rVSV that is a vaccine against SARS-CoV. One of skill in the art would have had a reasonable expectation of success of substituting the surface glycoproteins because they are both viral surface glycoproteins.
Accordingly, the invention were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Compans as applied to claims 1-5, 7, 25-26, 30, 33, 36, 40, and 53 above, and further in view of O’Hagan, et al. (CN 102762226 A, hereinafter “O’Hagan”).
As discussed above claims 1-5, 7, 25-26, 30, 33, 36, 40, and 53 were anticipated by Compans.
Regarding claim 28, Compans does not teach that the matrix protein is a Nipah or Hendra virus matrix protein. However, O’Hagan teaches that Nipah virus matrix protein is an epitope used for Nipah vaccines (¶0493).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the matrix glycoprotein from the VLP taught by Compans for the matrix glycoprotein of Nipah taught by O’Hagan. Compans teaches that many different matrix glycoproteins can be used in making multivalent VLPs (¶0035) and that the examples given are non-limiting (¶0035). One of skill in the art would have substituted the matrix glycoprotein taught by Compans with the matrix glycoprotein of Nipah taught by O’Hagan to create a multivalent VLP that is a vaccine against Nipah. One of skill in the art would have had a reasonable expectation of success of substituting the matrix glycoproteins because they are both viral matrix glycoproteins.
Accordingly, the invention were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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