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 .
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.
Claims 1, 4-11, and 13-19 are rejected under 35 U.S.C. 102a1 as being anticipated by Liu et. al. (A live-attenuated SARS-CoV-2 vaccine candidate with accessory protein deletions. Nat Commun 13, 4337, 2022).
For claim 1, Liu et al. teach an attenuated recombinant SARS-CoV-2 comprising a SARS-CoV-2 genome, a transcriptional regulatory sequences [TRS] comprising a nucleotide sequence of CCGGAT (the TRS of 3678 viruses were mutated from the wildtype (WT) ACGAAC to CCGGAT; page 2, first column, third paragraph) and ii) a deletion of open reading frames 3, 6, 7, and 8 (deleted open reading-frames (ORF) 3, 6, 7, and 8 (3678); abstract).
For claim 4, Liu et al. teach the SARS-CoV-2 comprising a heterologous S protein (full-genome sequencing of the P5 viruses identified an H655Y substitution in the spike protein; page 6, first column, fourth paragraph).
For claim 5, Liu et al. teach the heterologous S protein is a S protein variant (update vaccine antigen by swapping variant spike genes or glycoproteins into the current 3678 backbone; page 10, first column, first and second paragraphs).
For claim 6, Liu et al. teach the SARS-CoV-2 is a SARS-CoV-2 variant (update vaccine antigen to new SARS-CoV-2 variants by swapping variant spike genes or glycoproteins into the current 3678 backbone; page 10, first column, first and second paragraphs).
For claim 7, Liu et al. teach the nucleic acid encoding the attenuated recombinant SARS-CoV-2 is comprised in an expression cassette (expression cassette detailed with T7 promoter, L leader sequence, TRS transcription regulatory sequences, ORF open-reading frame, E envelope glycoprotein gene, M membrane glycoprotein gene, N nucleocapsid gene, UTR untranslated region, and pA poly A tails; fig. 1a).
For claim 8, Liu et al. teach the expression cassette is comprised in a plasmid backbone (deletions introduced into the backbone of a USA-WA1/2020 strain; fig 1a).
For claims 9-11, Liu et al. teach a nucleic acid segment encoding a reporter protein (mNG WT and mNG 3678 SARS-CoV-2s were generated by engineering the mNeonGreen (mNG) gene into the virus; page 10, second column, second paragraph).
For claim 13, Liu et al. teach a host cell comprises the attenuated recombinant SARS-CoV-2 (page 7, discussion).
For claim 14, Liu et al. teach a vaccine composition comprises the attenuated recombinant SARS-CoV-2 (SARS-CoV-2 (with deleted accessory proteins and modified TRS) live attenuated vaccine platform; page 2, first column, second and third paragraphs).
For claim 15, Liu et al. teach an assay for SARS-CoV-2 replication 3678 plaque assay to quantify viral RNA; fig 1b) comprising: contacting a cultured cell expressing or containing a SARS-CoV-2 nucleotide sequence forming a test cell 3678 virus inoculated onto Vero-E6 cells; fig 1e); contacting the test cell with a test agent (plaque assays were performed on stained Vero-E6 cells; fig 1b); and assessing the replication of the SARS-CoV-2 in the presence of the test agent (culture supernatants were measured for infectious virus titers using plaque assays on Vero-E6 cells; fig 1e).
For claim 16, Liu et al. teach the cultured cell is a Vero cell (page 7, discussion).
For claims 17-18, Liu et al. teach the cultured cell is assayed in a multi-well plate (mNG 3678 virus assayed in fluorescent focus reduction neutralization test (FFRNT) in a 96-well format; page 6, second column, third paragraph).
For claim 19, Liu et al. teach the cultured cells are incubated for about 24, 36, or 48 hours before measuring the reporter signal (24-, 36- and 48-hours post-infection measurements of mNG 3678 reporter signal; fig 1g).
Thus, Liu et al. anticipate 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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. as applied to claims 1, 4-11, and 13-19 above, and further in view of Harcourt et al. (www.ncbi.nlm.nih.gov/nuccore/MN985325 2021).
Liu et al. is discussed above.
Liu et al. does not teach 98% identity to SEQ ID #1.
Harcourt et al. the nucleic acid segment encoding the attenuated recombinant SARS-CoV-2 has a nucleic acid sequence that is at least 98% identical to the nucleic acid sequence of SEQ ID NO: 1 (SEQ ID NO: 1 of the instant application is 98.97% identical to NCBI accession number MN985325; entire document).
One of ordinary skill in the before the effective filing date would have been able to choose and exchange with similar art known products as it is routine to substitute like elements and would have had the expectation of success knowing it was a similar viral genome.
Thus, it would have been prima facie obvious before the effective date of filing to modify the attenuated SARS-CoVid-2 of Liu et al. with the sequence of Harcourt et al. with the expectation of success.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. as applied to claims 1, 4-11, and 13-19 above, and further in view of England et al. ("NanoLuc: A Small Luciferase is Brightening up the Field of Bioluminescence" pages 1-29. Bioconjugate Chem. (2016) 27 (5): 1175–1187).
Liu et al. is discussed above.
Liu et al. does not teach the luminescent protein is nanoluciferase protein.
England et al. teaches nanoluciferase protein (nanoluciferase assays; page 6, fifth paragraph).
One of ordinary skill in the before the effective filing date would have been motivated to use the nanoluciferase because England et al. teach that NanoLuciferase, a novel bioluminescence platform, offers several advantages over established systems, including enhanced stability, smaller size, and >150-fold increase in luminescence (abstract).
One of ordinary skill in the before the effective filing date would have had the expectation of success knowing the luciferase of England et al. is taught to have enhanced stability, smaller size, and >150-fold increase in luminescence (abstract).
Thus, it would have been prima facie obvious before the effective date of filing to modify the attenuated SARS-CoVid-2 of Liu et al. with the nanoluciferase of England et al. with the expectation of success.
Conclusion
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
100% SEQ ID #1 is free of the prior art.
Harcourt et al. cited above in the art reject is cited as the closest prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon, Tues, Thurs, Fri..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
Prosecution Insights