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 .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 11/7/25 is acknowledged.
Claims 28-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/7/25.
Claims 1-27 and 59-61 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/15/23, 4/2/24, 12/6/24, 7/25/25, 10/28/25 and 3/12/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 59 are objected to because of the following informalities: the claim recites in line 1, “CoV” without also providing what this acronym stands for. While the acronym DNA can be recited without spelling out its mean, DNA is also a well recognized acronym, whereas CoV is not. It is therefore suggested that claim 1 be amended to recite, “A vaccine for preventing coronavirus (CoV) infection…”. Appropriate correction is required
Claim Rejections - 35 USC § 101
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is
directed to a naturally-occurring element of nature that is not patent-eligible pursuant to the
Supreme Court decision in Association for Molecular Pathology V. Myriad Genetics, Inc., --
U.S. -- (June 13, 2013) (hereafter "Myriad").
Claims 1-9, 11, 12, 16-27 and 59-60 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally-occurring element of nature that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology V. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013) (hereafter "Myriad").
Based upon an analysis with respect to the claims as a whole, claim(s) 1-9, 11, 12, 16-27 and 59-61 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility)
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes the claims are directed to an ineligible product/process as further detailed below. In this case, claim(s) 1-9, 11, 12, 16-27 and 59-60 recite a multivaccine comprising one or more than one protein antigen derived from antigens encoded within a CoV genome, the protein antigens are encoded by CoV genome or RNA encoded genetic information, the protein antigens are genetic information from a genetic vector, the CoV is a beta-coronavirus, such as SARS-CoV-2 and at least protein derived from a protein is selected from CoV spike, membrane, nucleocapsid, envelope, replicase 1a/1b, ORF4, 9, 10 and 13. In addition, the RNA sequence or protein sequence are from a Beta coronavirus, such as SARS-CoV-2. Therefore, these claims are drawn to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, a naturally occurring protein or RNA sequence) that are directed to a judicial exception (in this case, a natural phenomenon)(Step 2A).
Pandey et al. (OFID, 2020, pages 1-9) teach that at least one isolate of a SARS-CoV-2, which would include the genetic information (RNA) that codes for the coronavirus spike, membrane, nucleocapsid, envelope, replicase 1a/1b, ORF4, 9, 10 and 13 proteins. Therefore, this isolate possesses the structural requirements of the claimed multivalent vaccine.
Therefore, the claimed vaccine is interpreted as naturally occurring.
Thus the claimed product is not markedly different from its naturally occurring counterpart. To summarize, the claims read upon a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A and the claims do not recite the integration of the judicial exception into a practical application.
Further, in view of Step 2B and the "No" pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception. The claimed invention does not require a limitation that does not amount to significantly more than the judicial exception. For example, the rejection could be overcome by requiring that an adjuvant be present with the vaccine comprising the claimed RNA or protein sequences.
As pursuant to the Office's interpretation of the Myriad decision, a recitation of a
naturally-occurring nucleic acid, protein and virus, or any natural product of nature that does not have a substantial or marked difference from the natural product is not patent eligible subject matter.
Therefore, claims 1-9, 11, 12, 16-27 and 59-60 as written, read upon a polypeptide that was found to have occurred naturally in nature without being subject to the "hand-of-person" and resulting in a substantial or markedly different product from that found in nature.
Therefore, claim(s) 1-9, 11, 12, 16-27 and 59-60 do not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter. This rejection is necessitated by expanded 35 USC § 101 USPTO training in view of the
USPTO's interpretation of Myriad. Applicant is directed towards the USPTO memos, which support the analysis of the claims; please review the latest materials regarding 35 USC § 101 rejections. Applicant is cautioned to amend the claims according to these suggestions utilizing limitations for which the application would have support.
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 1-27 and 59-61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a multivalent vaccine capable of inducing an immune response against a coronavirus epitope, does not reasonably provide enablement for a multivalent vaccine for preventing Coronavirus infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Nature of the invention/Breadth of the claims. The claims are drawn to a multivalent vaccine for preventing CoV infection comprising more than one protein antigen derived from antigens encoded within a CoV genome; or a multivalent vaccine for preventing CoV infection comprising more than one of (i) a protein antigen derived from antigens encoded within a first CoV genome, (ii) RNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iii) DNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iv) a genetic information within a genetic vector which codes for the express of a protein antigen derived from antigens encoded within the first CoV genome.
State of the prior art/Predictability of the art. The state of the art related to coronavirus vaccines, such as vaccines for vaccinating against COVID-19, teaches that some vaccines are effective at reducing severe illness, but that preventing infection is not realistic. For example, Table 19 presented herein is from the package insert of a SPIKEVAX injectable vaccine by ModernaTX, Inc. This vaccine has proven to be reliable at reducing the severity of COVID-19 infections. This version of the COVID-19 vaccine is a 2025-2026 formula. Table 19 summarized the vaccine efficacy of SPIKEVAX at 93% in all 14, 287 participates tested. However, approximately 9.6 per 1,000 Persons of those receiving the vaccine still contracted COVID-19. Therefore, the SPIKEVAX vaccine has been proven to be effective, but it did not prevent infection in all recipients that received it.
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Working examples. Applicants have provided a prophetic example in which two transgene expression cassettes are to be generated that individually encode a Spike protein and a Membrane protein of a SARS-CoV-2 virus. These cassettes are present in an adenovirus vector. SARS Nucleocapsid is also contemplated as being expressed by the adenovirus vector. However, no working example is disclosed that teach generating the claimed vaccine or testing it in vivo.
Guidance in the specification. The specification provides guidance towards using the claimed multivalent vaccine that comprises coronavirus proteins, DNA or RNA that encode these proteins.
Amount of experimentation necessary. Additional research is required in order to determine if preventing a CoV infection would be achievable by a multivalent vaccine comprising more than one protein antigen derived from antigens encoded within a CoV genome; or a multivalent vaccine for preventing CoV infection comprising more than one of (i) a protein antigen derived from antigens encoded within a first CoV genome, (ii) RNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iii) DNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iv) a genetic information within a genetic vector which codes for the express of a protein antigen derived from antigens encoded within the first CoV genome.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
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 11, 14 and 16 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.
Claim 11 recites, “wherein at least one of the more than one protein antigens is genetic information within a genetic vector.” However, it is unclear how a protein, which is made up of amino acids can also be genetic information within a genetic vector, which is made up of nucleic acids.
Claim 14 recites, “wherein the viral genetic vector is a bacterium.” However, it is unclear how a bacterium can be a viral genetic vector since bacteria and viruses are fundamentally distinct organisms.
Claim 16 recite, “wherein the CoV is a Beta-CoV”. These claims depend from claim 1, which recites at least two CoV (one causing the infection and one providing the RNA, protein or the DNA sequence). Therefore, it is unclear if claim 16 is further limiting the CoV causing the infection, the CoV providing the RNA, Protein or DNA sequence, or both.
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.
Claim(s) 1-9, 11, 12, 16-19, 22-27, 59 and 60 are rejected under 35 U.S.C. 102a1 as being anticipated by Graham et al. (Communications Biology, 2018, Vol. 1, pages 1-10).
The claimed invention is drawn to a multivalent vaccine comprising more than one protein antigen derived from antigens encoded within a coronavirus (CoV) genome. At least one of the more than one proteins are selected from the group consisting of:
a protein antigen; RNA-encoded genetic information, DNA-encoded genetic information, genetic information within a genetic vector and combinations thereof.
At least one of the more than one protein antigens is a protein expressed on or by a CoV particle; or on or by a cell infected with CoV; or is a protein obtained from a production cell (eukaryotic cell, bacterium or fungus cell) transfected with CoV genetic information to produce the protein; or the protein antigen is RNA-encoded genetic information which codes for the expression of the at least one of the more than one protein antigens. An example of the genetic information is within a viral vector.
The CoV is a Beta-CoV selected from a SARS related (SARSr), such as SARS-1 or SARS-2, or MERS virus.
The multivalent vaccine comprises at least 3 different protein antigens derived from antigens encoded by within a CoV genome; or at least one of the more than one proteins antigens is selected from a CoV spike, CoV membrane, CoV nucleocapsid, a CoV envelope, a replicase 1a/1b protein, and ORF 4, 9, 10 and 13 encoded protein; or the vaccine comprises a protein antigen derived from a CoV s protein and at least one protein antigen derived from a CoV M, CoV N and CoV E proteins.
Additionally, the multivalent vaccine comprises more than one of: (i) a protein antigen derived from antigens encoded within a first CoV genome, (ii) RNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iii) DNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iv) a genetic information within a genetic vector which codes for the express of a protein antigen derived from antigens encoded within the first CoV genome.
The first CoV genome is from a SARSr genome of a MERS genome.
The claimed limitation of “for preventing CoV infection” of claims 1 and 59 is interpreted as an intended use limitation, which MPEP § 2111.02 (II) recites, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the pre-amble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limita-tions, then the preamble is not considered a limitation and is of no significance to claim construction.” Therefore, the claimed multivalent vaccine is examined based on the structural requirements and not how it may be used.
The claimed limitation of “a protein obtained from a production cell transfected with CoV genetic information to produce the protein” [claim 5] and the production cell is “eukaryotic cell”, “bacterium cell” or a “fungus” [claims 6, 7 and 8, respectively] Are interpreted as product by process claim limitations. The MPEP § 2113 recites, “Even though product-by-process claims are lim-ited by and defined by the process, determination of patentability is based on the product itself. The patent-ability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
*With regard to the claimed limitation of a “protein antigen derived from…” is interpreted to include CoV antigen, such as Spike, Membrane, Envelope and Nucleocapsid, since derived is not defined in the claims or specification to require a specific size, length, function or the exclusion of full-length CoV protein or antigen.
Graham et al. teach the formulation of attenuated SARS coronavirus (a beta coronavirus) compositions that have been studied for their vaccination abilities in mice. [see abstract and methods section] Graham et al. teach the attenuation of the SARS coronavirus by modifying a guide sequence of the SARS genome for each ORF. [see page 2, left column, last paragraph and right column, first paragraph of Results section] The attenuated SARS possess RNA genome sequences and the Spike protein, Membrane protein, Nucleocapsid protein and Envelope protein, which makes their attenuated SARS virus a multivalent vaccine, based on the breadth of the claimed invention. [see figure 1]
Therefore, Graham et al. anticipate the instant invention.
Claim(s) 1-9, 11, 12, 16-18, 21-27, 59 and 60 are rejected under 35 U.S.C. 102a1 as being anticipated by Deng et al. (Emerging Microbes and Infections, 2018, Vol. 7, NO. 60, pages 1-10).
The claimed invention is drawn to a multivalent vaccine comprising more than one protein antigen derived from antigens encoded within a coronavirus (CoV) genome. At least one of the more than one proteins are selected from the group consisting of:
a protein antigen; RNA-encoded genetic information, DNA-encoded genetic information, genetic information within a genetic vector and combinations thereof.
At least one of the more than one protein antigens is a protein expressed on or by a CoV particle; or on or by a cell infected with CoV; or is a protein obtained from a production cell (eukaryotic cell, bacterium or fungus cell) transfected with CoV genetic information to produce the protein; or the protein antigen is RNA-encoded genetic information which codes for the expression of the at least one of the more than one protein antigens. An example of the genetic information is within a viral vector.
The CoV is a Beta-CoV is a MERS virus.
The multivalent vaccine comprises at least 3 different protein antigens derived from antigens encoded by within a CoV genome; or at least one of the more than one proteins antigens is selected from a CoV spike, CoV membrane, CoV nucleocapsid, a CoV envelope, a replicase 1a/1b protein, and ORF 4, 9, 10 and 13 encoded protein; or the vaccine comprises a protein antigen derived from a CoV s protein and at least one protein antigen derived from a CoV M, CoV N and CoV E proteins.
Additionally, the multivalent vaccine comprises more than one of: (i) a protein antigen derived from antigens encoded within a first CoV genome, (ii) RNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iii) DNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iv) a genetic information within a genetic vector which codes for the express of a protein antigen derived from antigens encoded within the first CoV genome.
The first CoV genome is from a MERS genome.
The claimed limitation of “for preventing CoV infection” of claims 1 and 59 is interpreted as an intended use limitation, which MPEP § 2111.02 (II) recites, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the pre-amble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limita-tions, then the preamble is not considered a limitation and is of no significance to claim construction.” Therefore, the claimed multivalent vaccine is examined based on the structural requirements and not how it may be used.
The claimed limitation of “a protein obtained from a production cell transfected with CoV genetic information to produce the protein” [claim 5] and the production cell is “eukaryotic cell”, “bacterium cell” or a “fungus” [claims 6, 7 and 8, respectively] Are interpreted as product by process claim limitations. The MPEP § 2113 recites, “Even though product-by-process claims are lim-ited by and defined by the process, determination of patentability is based on the product itself. The patent-ability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
*With regard to the claimed limitation of a “protein antigen derived from…” is interpreted to include CoV antigen, such as Spike, Membrane, Envelope and Nucleocapsid, since derived is not defined in the claims or specification to require a specific size, length, function or the exclusion of full-length CoV protein or antigen.
Deng et al. teach the formulation of inactivated MERS coronavirus (a beta coronavirus) compositions with an adjuvant that have been studied for their vaccination abilities in mice. [see abstract and page 2, right column, 2nd paragraph] The MERS coronavirus was inactivated by a 7 day treatment with 0.4% formaldehyde. [see Method section-S Protein and inactivated MERS-CoV] Deng et al. teach the testing of the immunity induced by vaccines developed from the S protein and the inactivated MERS with an adjuvant. Adult female BALB/c mice were given three i.m. immunizations at 4-week intervals of combined adjuvant alone or a formulation with either the S protein or inactivated MERS. After the first priming, a robust S protein-specific immunoglobulin response was detected in both the S and IV vaccine [see page 3, left column, 2nd paragraph and Figure 2] The attenuated MERS possess RNA genome sequences and the Spike protein, Membrane protein, Nucleocapsid protein and Envelope protein, which makes their attenuated SARS virus a multivalent vaccine, based on the breadth of the claimed invention. [see figure 1]
Therefore, Deng et al. anticipate the instant invention.
Claim(s) 1-8, 10-19, 22-27 and 59-61 are rejected under 35 U.S.C. 102a1 as being anticipated by Anderson et al. (US PGPub 2013/0216566).
The claimed invention is drawn to a multivalent vaccine comprising more than one protein antigen derived from antigens encoded within a coronavirus (CoV) genome. At least one of the more than one proteins are selected from the group consisting of:
a protein antigen; RNA-encoded genetic information, DNA-encoded genetic information, genetic information within a genetic vector and combinations thereof.
At least one of the more than one protein antigens is a protein expressed on or by a CoV particle; or on or by a cell infected with CoV; or is a protein obtained from a production cell (eukaryotic cell, bacterium or fungus cell) transfected with CoV genetic information to produce the protein; or the protein antigen is RNA-encoded genetic information which codes for the expression of the at least one of the more than one protein antigens. An example of the genetic information is within a viral vector.
The CoV is a Beta-CoV selected from a SARS related (SARSr), such as SARS-1.
The multivalent vaccine comprises at least 3 different protein antigens derived from antigens encoded by within a CoV genome; or at least one of the more than one proteins antigens is selected from a CoV spike, CoV membrane, CoV nucleocapsid, a CoV envelope, a replicase 1a/1b protein, and ORF 4, 9, 10 and 13 encoded protein; or the vaccine comprises a protein antigen derived from a CoV s protein and at least one protein antigen derived from a CoV M, CoV N and CoV E proteins.
Additionally, the multivalent vaccine comprises more than one of: (i) a protein antigen derived from antigens encoded within a first CoV genome, (ii) RNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iii) DNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iv) a genetic information within a genetic vector which codes for the express of a protein antigen derived from antigens encoded within the first CoV genome and the multivalent vaccine further comprising more than one of (i) a protein antigen derived from antigens encoded within a second CoV genome, (ii) RNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the second CoV genome, (iii) DNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the second CoV genome, (iv) a genetic information within a genetic vector which codes for the express of a protein antigen derived from antigens encoded within the second CoV genome.
The first CoV genome is from a SARSr genome.
The claimed limitation of “for preventing CoV infection” of claims 1 and 59 is interpreted as an intended use limitation, which MPEP § 2111.02 (II) recites, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the pre-amble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limita-tions, then the preamble is not considered a limitation and is of no significance to claim construction.” Therefore, the claimed multivalent vaccine is examined based on the structural requirements and not how it may be used.
The claimed limitation of “a protein obtained from a production cell transfected with CoV genetic information to produce the protein” [claim 5] and the production cell is “eukaryotic cell”, “bacterium cell” or a “fungus” [claims 6, 7 and 8, respectively] Are interpreted as product by process claim limitations. The MPEP § 2113 recites, “Even though product-by-process claims are lim-ited by and defined by the process, determination of patentability is based on the product itself. The patent-ability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
*With regard to the claimed limitation of a “protein antigen derived from…” is interpreted to include CoV antigen, such as Spike, Membrane, Envelope and Nucleocapsid, since derived is not defined in the claims or specification to require a specific size, length, function or the exclusion of full-length CoV protein or antigen.
Anderson et al. teach multivalent SARS coronavirus vaccine compositions. For example, Anderson et al. in paragraph 104 teach that “…the present invention envisions an attenuated or non-replicating vector (in mammalian cells), such as a DNA plasmid, MVA, ALVAC, NYVAC, or a baculovirus that employs a mammalian promoter such as a CMV promoter or an SV40 promoter, for expressing one or more SARS proteins, such as S and/or S1 and/or S2 and/or E and/or M and/or N in vivo…Generally, a plasmid for a vaccine or immunological composition can comprise DNA encoding an antigen (e.g., SARS S, S1, S2, E, M, N or combinations thereof)…”. Anderson et al. also teach immunogenic, immunological or vaccine compositions, containing, consisting essentially of or consisting of one or more isolated SARS antigens, immunogens or epitopes, e.g., one or more of S, S1, S2, E, M, N, such as N1 such as combinations thereof, S or S1 and/or S+E and/or M and/or N such as N1. [see paragraph 105] Additionally, Anderson et al. teach compositions that contain SARS proteins and/or vectors and/or plasmids expressing SARS proteins from more than one isolate, e.g., from two or more isolates, such as from three different isolates. Advantageously, compositions contain S proteins or portions thereof, e.g., S1 or S2, from three different isolates, or vectors or plasmids that express such S proteins or portions thereof from three different isolates. Isolates should be selected so as to maximize the immunogenic response to the composition. [see paragraph 106] Therefore, Anderson et al. also teach a multivalent vaccine that comprises a protein antigen from a first CoV genome and a protein antigen from a second CoV genome, which can be protein based, or encoded by vectors or plasmids.
Therefore, Anderson et al. teach a multivalent coronavirus vaccine.
Claim(s) 1-8, 10-13, 16-20, 22-27 and 59-60 are rejected under 35 U.S.C. 102a2 as being anticipated by Georges et al. (US PGPub 20210260181).
The claimed invention is drawn to a multivalent vaccine comprising more than one protein antigen derived from antigens encoded within a coronavirus (CoV) genome. At least one of the more than one proteins are selected from the group consisting of:
a protein antigen; RNA-encoded genetic information, DNA-encoded genetic information, genetic information within a genetic vector and combinations thereof.
At least one of the more than one protein antigens is a protein expressed on or by a CoV particle; or on or by a cell infected with CoV; or is a protein obtained from a production cell (eukaryotic cell, bacterium or fungus cell) transfected with CoV genetic information to produce the protein; or the protein antigen is RNA-encoded genetic information which codes for the expression of the at least one of the more than one protein antigens. An example of the genetic information is within a viral vector.
The CoV is a Beta-CoV selected from a SARS related (SARSr), such as SARS-2.
The multivalent vaccine comprises at least 3 different protein antigens derived from antigens encoded by within a CoV genome; or at least one of the more than one proteins antigens is selected from a CoV spike, CoV membrane, CoV nucleocapsid, a CoV envelope, a replicase 1a/1b protein, and ORF 4, 9, 10 and 13 encoded protein; or the vaccine comprises a protein antigen derived from a CoV s protein and at least one protein antigen derived from a CoV M, CoV N and CoV E proteins.
Additionally, the multivalent vaccine comprises more than one of: (i) a protein antigen derived from antigens encoded within a first CoV genome, (ii) RNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iii) DNA-encoded genetic information which codes for the expression of a protein antigen derived from antigens encoded within the first CoV genome, (iv) a genetic information within a genetic vector which codes for the express of a protein antigen derived from antigens encoded within the first CoV genome.
The first CoV genome is from a SARSr genome.
The claimed limitation of “for preventing CoV infection” of claims 1 and 59 is interpreted as an intended use limitation, which MPEP § 2111.02 (II) recites, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the pre-amble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limita-tions, then the preamble is not considered a limitation and is of no significance to claim construction.” Therefore, the claimed multivalent vaccine is examined based on the structural requirements and not how it may be used.
The claimed limitation of “a protein obtained from a production cell transfected with CoV genetic information to produce the protein” [claim 5] and the production cell is “eukaryotic cell”, “bacterium cell” or a “fungus” [claims 6, 7 and 8, respectively] Are interpreted as product by process claim limitations. The MPEP § 2113 recites, “Even though product-by-process claims are lim-ited by and defined by the process, determination of patentability is based on the product itself. The patent-ability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
*With regard to the claimed limitation of a “protein antigen derived from…” is interpreted to include CoV antigen, such as Spike, Membrane, Envelope and Nucleocapsid, since derived is not defined in the claims or specification to require a specific size, length, function or the exclusion of full-length CoV protein or antigen.
Georges et al. teach a SARS-CoV-2 based multivalent vaccine that comprises more than one antigen epitope. [see paragraph 123] Georges et al. also a multivalent composition comprising an expression cassette of the replication defective adenoviral vector further comprises a coding sequence encoding one or more of SARS-CoV-2 structural proteins envelope (E), membrane (M) or nucleocapsid (N). [see paragraph 179]. Therefore, Georges et al. anticipate the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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