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 63/180,534 (filed 04/27/2021).
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1-19 and 21-22, and SEQ ID NO: 26 in claim 10, SEQ ID NO: 29 in claim 13, and SEQ ID NO: 31 in claim 14, in the reply filed 16 April 2026 is acknowledged. Claims 3, 5, 20, and 23-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 April 2026. Claims 1-2, 4, 6-19, and 21-22 were examined on the merits.
Specification
The listing of references in 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.
Claim Interpretation
Claim 13 is drawn to SEQ ID NO: 29 which is the codon optimized antigenomic cDNA sequence of SARS-CoV-2 S-6P RRAR(682-685)GSAS GS-opt. The Specification defined S-6P as a spike protein with the mutations K986P, V987P, F817P, A892P, A899P, and A942P (pg. 3 lines 15-16), RRAR(682-685)GSAS as a substitution in the S1/S2 protease cleavage site (pg. 28 line 16), and GS-opt as a heterologous gene that has been codon-optimized for human expression using GenScript (pg. 42 lines 57-58).
For the purposes of compact prosecution and applying prior art, claim 13 was interpreted as an antigenomic cDNA that encodes the SARS-CoV-2 spike protein with the 6P and RRAR(682-685)GSAS mutations and which was codon optimized for human expression.
Claim 14 is drawn to SEQ ID NO: 31 which is the antigenomic cDNA sequence of rB/HPIV3-SARS-CoV-2/S-6P RRAR(682-685)GSAS. The Specification defined S-6P as a spike protein with the mutations K986P, V987P, F817P, A892P, A899P, and A942P (pg. 3 lines 15-16) and RRAR(682-685)GSAS as a substitution in the S1/S2 protease cleavage site (pg. 28 line 16).
For the purposes of compact prosecution and applying prior art, claim 14 was interpreted as antigenomic cDNA that encodes the rB/HPIV3 backbone and SARS-CoV-2 spike protein with the 6P and RRAR(682-685)GSAS mutations.
Claim Rejections - 35 USC § 112
Indefiniteness
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 10-11 and 13-14 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.
The phrase "the amino acid sequence set forth as" in claims 10 (line 3), 11 (lines 3, 5, 8, 10, 12, and 15) is indefinite. One of ordinary skill would not be able to reasonably ascertain the invention.
For purposes of compact prosecution and applying prior art, the claims were broadly interpreted to require a protein comprising the amnio acid sequence of the respective SEQ ID NOs. For example, “the amino acid sequence comprises SEQ ID NO: 1” (claim 11 lines 2-3).
It is noted any interpretation of the claims set forth above does not relieve
Applicant of the responsibility of responding to this rejection. If the actual interpretation
of the claims is different than that posited by the Examiner, additional rejections and art
may be readily applied in a subsequent final Office action.
Written Description
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 1-2, 4, 6-7, 10-12, 15-19, and 21-22 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 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 inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Instant claims 1-2, 4, 6-7, 10-19, and 21-22 broadly encompass a recombinant chimeric bovine/human parainfluenza virus 3 with a genome comprising the heterologous gene that encodes a recombinant SARS-CoV-2 S protein that comprises the mutations K986P and V987P and is at least 90% identical to instant SEQ ID NO: 22. Instant claim 10 further recites that the SARS-CoV-2 S protein is at least 90% identical to instant SEQ ID NO: 26 and instant claim 11 further recites that the B/HPIV3 genes are at least 90% identical to their corresponding sequences (SEQ ID NOs: 1-7 and 10).
The Specification has failed to sufficiently describe the structural features that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the spike protein to function as a SARS-CoV-2 spike protein or for the B/HPIV3 genes to function correctly.
“[A]n amino acid sequence at least 90% identical to SEQ ID NO: 22 (1-7, 10, and 26)” encompasses a large pool of sequences, as allowing for changes to 10% of the amino acid residues allows for many proteins. SEQ ID NOs: 22 and 26 are 1273 amino acids in length while SEQ ID NOs: 1-7 and 10 vary in length (515aa, 596aa, 201aa, 412aa, 351aa, 539aa, 572aa, 2235aa, respectively). A variant sharing only 90% identity to SEQ ID NOs: 22 and 26 can have anywhere from 1 to 127 substitutions, deletions, or additions in any combination, along any length of the sequence while for SEQ ID NOs 1-7 and 10 it ranges from 20 – 223 substitutions, deletions, or additions. Thus, just for substitutions with canonical amino acids alone, the instant claims encompass an enormous genus (e.g., 20127 = 1.70 x 10165) comprising trillions upon trillions of sequences.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences the Specification has only adequately described and successfully reduced to practice specific rB/HPIV3s (SEQ ID NOs: 30, 31, 42, and 43). As such, the Specification reasonably demonstrates that the Applicant was in possession of SEQ ID NOs: 30-31 and 42-43. However, this is not representative of the extremely large genus of sequenced claimed since these sequences only encompass the claimed rB/HPIV3 and not the innumerable sequences contained within a genus of sequences comprising all rB/HPIV3 which contain a heterologous gene that encodes a functional SARS-CoV-2 S protein, having at least 90% identity to the amino acid sequences of SEQ ID NOs: 22 or 26 or within a genus of sequences comprising all rB/HPIV3 which contain the B/HPIV3 genes that are functional. Having at least 90% identity to the amino acid sequences of SEQ ID NOs: 1-7 and 10.
The data generated for SEQ ID NOs: 1-7, 10, 22, and 26 described in the Specification cannot reasonable be extrapolated and applied to support possession of the entire claimed genus of variants because no one species, combination, or variant accounts for the variability amongst the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Xia (Viruses. 2021 Jan 14;13(1):109.) provides a review of the SARS-CoV-2 spike protein and the domains and function of the protein which requires the full-length glycoprotein to interact with the ACE2 receptor (Abstract). Schmidt, et al. (J Virol. 2001 May;75(10):4594-603., NPL-IDS, filed, 10/12/2023, hereinafter “Schmidt”) provides a review of the rB/HPIV3 backbone used to express heterologous genes, to properly express the proteins, the genes are required to be full-length (pg. 4595 column 2). While Applicant may have possession of portions or variants of these proteins, the portions or variants have not been shown to be functional proteins.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
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.
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.
Claims 1-2, 6-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Collins, et al. (WO 2018222573, FOR-IDS, filed, 10/12/2023, hereinafter “Collins”) and further in view of Csiszovszki, et al. (US 10973909 B1, hereinafter “Csiszovszki”) and McFadden, et al. (WO 2021202971 A1, hereinafter “McFadden”).
Regarding claims 1 and 8-9, Collins teaches a recombinant chimeric bovine/human parainfluenza virus 3 comprising a genome comprising, in a 3’ to 5’ order, a 3’ leader region, a BPIV3 N gene, a heterologous gene, BPIV3 P and M genes, HPIV3 F and HN genes, a BPIV3 L gene, and a 5’ trailer region and wherein the HPIV3 HN gene encodes a HPIV3 HN protein comprising T263 and P370 with reference to instant SEQ ID NO: 7 and wherein the recombinant B/HPIV3 is infectious, attenuated, and self-replicating (Claim 1).
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Collins does not teach that the heterologous gene is a recombinant SARS-CoV-2 S protein with an amino acid sequence at least 90% identical to instant SEQ ID NO: 22.
However, Csiszovszki teaches a recombinant SARS-CoV-2 S protein that is 100% identical to instant SEQ ID NO: 22 (SEQ ID NO: 122).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have substituted the heterologous gene (encoding recombinant RSV G) taught by Collins for a gene that encodes the recombinant SARS-CoV-2 S protein taught by Csiszovszki to create a rBHPIV3 vaccine expressing the SARS-CoV-2 S protein. Collins teaches that a heterologous gene is a gene (including recombinant) from a different genetic source and that RSVG is a non-limiting example (pg. 10 lines 8-11). One of ordinary skill in the art would have substituted the heterologous protein (encoding RSVG) taught by Collins with the SARS-CoV-2 spike protein taught by Csiszovszki to create a vaccine against SARS-CoV-2. One of skill in the art would have had a reasonable expectation of success of substituting the genes because they both encode immunogenic viral protein used in vaccines.
Collins and Csiszovszki do not teach that the SARS-CoV-2 spike protein comprises the K986P and V987P mutations. However, McFadden teaches the S protein mutations KV986/7>PP which are helpful to stabilize the pre-fusion S protein (¶0023).
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 combined the teachings of Collins and Csiszovszki for a rB/HPIV3 expressing the SARS-CoV-2 S protein and the teachings of McFadden for the double proline mutations of the S protein. McFadden provides motivation by teaching that the double proline mutation stabilize the pre-fusion S protein (¶0023). One of skill in the art would have had a reasonable expectation of success in combining Collins, Csiszovszki, and McFadden because they all teach viral vaccines.
Regarding claim 2, McFadden teaches the S protein substitutions of F817P, A892P, A899P, and A942P which further stabilize the pre-fusion S protein (¶0023).
Regarding claims 6-7 and 10, McFadden teaches reference SEQ ID NO: 14 which is 100% identical to instant SEQ ID NO: 26 and contains the RARR(682-685)GSAS substitution which inhibits S1/S2 protease cleavage (SEQ ID NO: 14 and ¶0023).
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Regarding claim 11, Collins teaches that the BPIV3 N gene encodes an N protein with 100% identity to instant SEQ ID NO: 1 (REF SEQ ID NO: 1 and claim 12)
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BPIV3 P gene encodes the P, C, and V proteins with 100% identity to instant SEQ ID NOs: 2, 3, and 4 (REF SEQ ID NOs: 2-4 and claim 12)
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BPIV3 M gene encodes a M protein with 100% identity to instant SEQ ID NO: 5 (REF SEQ ID NO: 5 and claim 12)
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BPIV3 F gene encodes a F protein with 100% identity to instant SEQ ID NO: 6 (REF SEQ ID NO: 6 and claim 12)
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BPIV3 HN gene encodes a HN protein with 100% identity to instant SEQ ID NO: 7 (see above for alignment) (REF SEQ ID NO: 7 and claim 12)
BPIV3 L gene encodes a L protein with 100% identity to instant SEQ ID NO: 10 (REF SEQ ID NO: 10 and claim 12).
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Regarding claim 12, Collins teaches codon optimizing the heterologous gene for expression in human cells (claim 13).
Regarding claim 13, Collins teaches that the heterologous gene that is codon optimized for human expression is an antigenomic cDNA sequence (claim 14). Collins does not teach that the heterologous gene is a recombinant SARS-CoV-2 S protein with an amino acid sequence at least 90% identical to instant SEQ ID NO: 22. However, Csiszovszki teaches a recombinant SARS-CoV-2 S protein that is 100% identical to instant SEQ ID NO: 22 (SEQ ID NO: 122, see alignment above in claim 1). Collins and Csiszovszki do not teach the 6P and the RRAR(682-685)GSAS mutations. However, McFadden teaches the 6P (¶0023) and the RRAR(682-685)GSAS (¶0023 and SEQ ID NO: 14) mutations. As discussed above, SEQ ID NO:29 is being interpreted as an antigenomic cDNA (Collins) that encodes the SARS-CoV-2 spike protein (Csiszovszki) with the 6P and RRAR(682-685)GSAS mutations (McFadden) and which was codon optimized for human expression (Collins). Instant SEQ ID NO: 29 is a result of combining the SARS-CoV-2 spike protein taught by Csiszovszki, the pre-fusion stabilizing mutations taught by McFadden, and the optimization of antigenomic cDNA for human expression taught by Collins. Therefore, instant SEQ ID NO: 29 was prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention over the SARS-CoV-2 spike protein taught by Csiszovszki, the stabilizing mutations taught by McFadden, and the optimization of antigenomic cDNA for human expression taught by Collins.
Regarding claim 14, Collins teaches that the rB/HPIV3 genome comprises an antigenomic cDNA sequence (claim 15). Collins further teaches a recombinant chimeric bovine/human parainfluenza virus 3 comprising a genome comprising, in a 3’ to 5’ order, a 3’ leader region, a BPIV3 N gene, a heterologous gene, BPIV3 P and M genes, HPIV3 F and HN genes, a BPIV3 L gene, and a 5’ trailer region and wherein the HPIV3 HN gene encodes a HPIV3 HN protein comprising T263 and P370 with reference to instant SEQ ID NO: 7 and wherein the recombinant B/HPIV3 is infectious, attenuated, and self-replicating (Claim 1). Collins does not teach that the heterologous gene is a recombinant SARS-CoV-2 S protein with an amino acid sequence at least 90% identical to instant SEQ ID NO: 22. However, Csiszovszki teaches a recombinant SARS-CoV-2 S protein that is 100% identical to instant SEQ ID NO: 22 (SEQ ID NO: 122, see alignment above in claim 1). Collins and Csiszovszki do not teach the 6P and the RRAR(682-685)GSAS mutations. However, McFadden teaches the 6P (¶0023) and the RRAR(682-685)GSAS (¶0023 and SEQ ID NO: 14) mutations. As discussed above, SEQ ID NO: 31 is being interpreted as antigenomic cDNA (Collins) that encodes the rB/HPIV3 backbone (Collins) and SARS-CoV-2 spike protein (Csiszovszki) with the 6P and RRAR(682-685)GSAS mutations (McFadden). Instant SEQ ID NO: 31 is a result of combining the SARS-CoV-2 spike protein taught by Csiszovszki, the pre-fusion stabilizing mutations taught by McFadden, and the rB/HPIV3 backbone and antigenomic cDNA taught by Collins. Therefore, instant SEQ ID NO: 31 was prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention over the SARS-CoV-2 spike protein taught by Csiszovszki, the stabilizing mutations taught by McFadden, and the rB/HPIV3 backbone and antigenomic cDNA taught by Collins.
Regarding claim 15, Collins teaches that the rBHPIV3 induced an immune response to the heterologous gene, HPIV3 F protein and HPIV3 HN protein (claim 16). Collins does not teach that the heterologous gene is the spike protein of SARS-CoV-2. However, Csiszovszki teaches the SARS-CoV-2 spike protein and that the spike protein is highly immunogenic (¶8).
Regarding claim 16, Collins teaches the rB/HPIV3 induces an immune response that neutralizes HPIV3 and the virus of the heterologous gene (Claim 17). Collins does not teach that the heterologous gene is the spike protein of SARS-CoV-2. However, McFadden teaches the SARS-CoV-2 spike protein and that the spike protein is the main target for neutralizing antibodies (¶0019).
Regarding claim 17, Collins teaches a nucleic acid molecule comprising the nucleotide sequence of the genome of the rBHPIV3 backbone (claim 18). Collins does not teach that the heterologous gene is a recombinant SARS-CoV-2 S protein with an amino acid sequence at least 90% identical to instant SEQ ID NO: 22. However, Csiszovszki teaches a recombinant SARS-CoV-2 S protein that is 100% identical to instant SEQ ID NO: 22 (SEQ ID NO: 122, see alignment above in claim 1).
Regarding claim 18, Collins teaches a vector encoding the nucleic acid the comprises the nucleotide sequence of the genome of the rBHPIV3 backbone (claim 19). Collins does not teach that the heterologous gene is a recombinant SARS-CoV-2 S protein with an amino acid sequence at least 90% identical to instant SEQ ID NO: 22. However, Csiszovszki teaches a recombinant SARS-CoV-2 S protein that is 100% identical to instant SEQ ID NO: 22 (SEQ ID NO: 122, see alignment above in claim 1).
Regarding claim 19, Collins teaches a host cell comprising the vector encoding the nucleic acid the comprises the nucleotide sequence of the genome of the rBHPIV3 backbone (claim 20). Collins does not teach that the heterologous gene is a recombinant SARS-CoV-2 S protein with an amino acid sequence at least 90% identical to instant SEQ ID NO: 22. However, Csiszovszki teaches a recombinant SARS-CoV-2 S protein that is 100% identical to instant SEQ ID NO: 22 (SEQ ID NO: 122, see alignment above in claim 1).
Regarding claims 21, Collins teaches a rB/HPIB3 produced by transfecting a permissive cell culture with teaches a vector encoding the nucleic acid the comprises the nucleotide sequence of the genome of the rBHPIV3 backbone, incubating the cell culture for a sufficient period of time to allow for viral replication and purifying the replicated virus to produce the rB/HPIV3 (claims 21-11). Collins does not teach that the heterologous gene is a recombinant SARS-CoV-2 S protein with an amino acid sequence at least 90% identical to instant SEQ ID NO: 22. However, Csiszovszki teaches a recombinant SARS-CoV-2 S protein that is 100% identical to instant SEQ ID NO: 22 (SEQ ID NO: 122, see alignment above in claim 1).
Regarding claim 22, Collins teaches an immunogenic composition comprising a pharmaceutically acceptable carrier and the rB/HPIV3 described above (claim 1). Collins does not teach that the heterologous gene is a recombinant SARS-CoV-2 S protein with an amino acid sequence at least 90% identical to instant SEQ ID NO: 22. However, Csiszovszki teaches a recombinant SARS-CoV-2 S protein that is 100% identical to instant SEQ ID NO: 22 (SEQ ID NO: 122, see alignment above in claim 1).
Accordingly, the claimed inventions were prima facie obvious to one or ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Collins, Csiszovszki, and McFadden as applied to claims 1-2, 11-12, 15-19, and 21-22 above, and in further view of Wang, et al. (bioRxiv 2021.01.25.428137, hereinafter “Wang”).
As discussed above, claims 1-2, 11-12, 15-19, and 21-22 were rendered prima facie obvious over Collins, Csiszovszki, and McFadden.
Regarding claim 4, Collins, Csiszovszki, and McFadden do not teach that the SARS-CoV-2 S protein comprises K417N, E484K, N501Y, D614G, and A701V substitutions. However, Wang teaches the antibody resistant SARS-CoV-2 variant B.1.351 which contains mutations in the spike protein of SARS-CoV-2 which included D614G (S1 subunit), K417N (RBD), E484K (RBD), N501Y (RBD), and A701V (furin cleavage site) mutations (pg. 3, line 66-72).
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 combined the teachings of Collins, Csiszovszki, and McFadden for a rB/HPIV3 where the heterologous gene is SARS-CoV-2 with pre-fusion stabilizing spike protein mutations with the teachings of Wang for the B.1.351 variant. Wang provides motivation by teaching that the B.1.351 variant cannot be neutralized by most neutralizing antibodies due to the mutations in the spike protein (pg. 2 lines 49-52). One of skill in the art would have had a reasonable expectation of success in combining the teachings of Collins, Csiszovszki, McFadden, and Wang because they all teach viral vaccines.
Accordingly, the claimed inventions were prima facie obvious to one or ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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