DETAILED ACTION
Disposition of Claims
Claims 1-2, 4, 8-9, 13-14, 19-20, 22-23, 29-30, 33-35, 37-38, 43, and 45 are pending.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230416309A1, Published 12/28/2023.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Optional Authorization to Initiate Electronic Communications
The Applicant’s representative may wish to consider supplying a written authorization in response to this Office action to correspond with the Examiner via electronic mail (e-mail). This authorization is optional on the part of the Applicant’s representative, but it should be noted that the Examiner may not initiate nor respond to communications via electronic mail unless and until Applicant’s representative authorizes such communications in writing within the official record of the patent application. A sample authorization is available at MPEP § 502.03, part II. If Applicant’s representative chooses to provide this authorization, please ensure to include a valid e-mail address along with said authorization.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/20/2023 and 09/18/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings and Specification; Sequence Disclosure Requirements
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below.
The drawings and specification are objected to because: Figures 4 and 7 comprise sequence that does not identify said sequence with a corresponding SEQ ID NO: within the figure itself or within the figure legend of the specification. Additionally, the text in Figures 4 and 7 is illegible, making it difficult to discern the data provided within said figure.
The objection to the drawings will not be held in abeyance. Applicants must comply with sequence rules in order to be considered a complete response to this Office Action; a complete response would be to either submit corrected drawing sheets as noted below or to amend the specification to include the SEQ ID NO:s within the figure legend. Either amendment must comply with the requirements of 37 CFR 1.821 through 1.825.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: the definition of the abbreviation “SARS-CoV-2” is not provided. For clarity, it is requested that the first recitation of an abbreviation within a claim set be preceded by its full-length name (i.e. … severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2)...).
Appropriate correction is required.
Claim 35 is objected to because of the following informalities: the wording of the claim is awkward, as “HA” is an abbreviation for “hemagglutinin”, so it is confusing as to why it is recited as written. One suggestion is along the lines of the following: “…at least one kind of hemagglutinin (HA) protein from human influenza virus.”. Appropriate correction is required.
Claim 43 is objected to because of the following informalities: the definition of the abbreviation COVID-19 is not provided. For clarity, it is requested that the first recitation of an abbreviation within a claim set be preceded by its full-length name (i.e. … coronavirus disease 2019 (COVID-19)...).
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
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 1-2, 4, 8-9, 13, 30, 34, 37-38, and 45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally-occurring severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2) spike (S) proteins and fragments thereof without significantly more. The claims recite a fusion protein comprising the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein (S protein) or functionally active fragment thereof, and the N-terminal domain (NTD) of the SARS-CoV-2 spike protein (S protein) or functionally active fragment thereof, wherein said RBD or functionally active fragment thereof is directly or indirectly linked to said NTD or functionally active fragment thereof. This judicial exception is not integrated into a practical application because the RBD and NTD are found naturally “fused” together in a full-length, wild-type S protein, and the “linkage” can under broadest reasonable interpretation (BRI) be interpreted as the naturally-occurring amino acid linkages through peptide bonds. The claims, as recited, do not include additional heterologous elements that would distinguish them from their naturally-occurring counterparts. For instance, SEQ ID NO: 90 in instant claim 30 appears to be a natural sequence found within the S protein, and therefore does not provide patentability through the use of a “linker”. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because those limitations claimed, such as sequences, linkers, mutations, and compositions read upon naturally-occurring proteins, and the compositions do not include elements that markedly change the naturally occurring proteins. The methods are recited at such a high level of generality that they do not distinguish said method from methods of delivering the protein via natural infection and raising an immune response therefor. It is suggested that limitations from claims not included in this rejection be introduced into the independent claims, or elements in the protein, compositions, and/or methods be added that would markedly change the claimed S protein from its naturally occurring counterpart (e.g. inclusion of heterologous sequences or elements in the fusion S protein, inclusion of adjuvants in the immunogenic composition, inclusion of specific method steps that would not reasonably read upon natural infection by SARS CoV-2.)
For at least these reasons, the indicated claims are drawn to subject matter that is not patent eligible.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
Claim 1 and dependent claims 2, 4, 8-9, 13-14, 19-20, 22-23, 29-30, 33-35, 37-38, 43, and 45 thereof 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 term “receptor binding domain” in claim 1 is a relative term which renders the claim indefinite. The term “receptor binding domain” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. At the specification, ¶[0161] provides a vague definition of what is the “receptor binding domain” or “RBD”, but the interpretation provided is broad and does not specifically limit the RBD to only be a certain set or sequence of amino acids found in a full-length SARS CoV-2 S protein sequence and is only claiming this domain or fragment thereof functionally. One suggestion is to clarify what is, and what is not, considered the RBD by providing a specific frame of reference (e.g. “… wherein the RBD of a SARS CoV-2 S protein corresponds to amino acids 310-560 of SEQ ID NO: X.”).
The term “N-terminal domain” in claim 1 is a relative term which renders the claim indefinite. The term “N-terminal domain” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. At the specification, ¶[0165] provides a vague definition of what is the “N-terminal domain” or “NTD”, but the interpretation provided is broad and does not specifically limit the NTD to only be a certain set of amino acids found in a full-length SARS CoV-2 S protein sequence, and can reasonably be interpreted as any grouping of amino acids in the S protein that is immediately upstream of the final amino acid in the S protein or fragment thereof. One suggestion is to clarify what is, and what is not, considered the NTD by providing a specific frame of reference (e.g. “… wherein the NTD of a SARS CoV-2 S protein corresponds to amino acids 13-353 of SEQ ID NO: X.”).
Additionally, the use of “the” before “SARS-CoV-2 spike protein (S protein)” in lines 2 and 4 has unclear antecedent basis as there are multiple SARS-CoV-2 isolates, mutants, and variants known in the art with their own unique S protein sequences. It is suggested to clarify the antecedent basis of this limitation through the use of the indefinite article “a” instead of “the”.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 1 is rejected on the grounds of being indefinite. Claims 2, 4, 8-9, 13-14, 19-20, 22-23, 29-30, 33-35, 37-38, 43, and 45 are also rejected since they depend from claim 1 but do not remedy these deficiencies of claim 1.
Claim 4 is 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 4 is rejected for claiming the limitation of amino acid positions within a protein sequence without providing an appropriate frame of reference for said sequence. Said frame of reference can be provided by referencing a sequence disclosed within the application (i.e. a sequence with a SEQ ID NO: identifier) or by referencing a start position for said sequence (i.e. “…wherein said amino acid is at position X from the starting methionine of the protein…”).
As the metes and bounds of the claim are unclear, claim 4 is rejected for being indefinite.
Claim 9 is 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 9 is rejected for claiming the limitation of amino acid positions within a protein sequence without providing an appropriate frame of reference for said sequence. Said frame of reference can be provided by referencing a sequence disclosed within the application (i.e. a sequence with a SEQ ID NO: identifier) or by referencing a start position for said sequence (i.e. “…wherein said amino acid is at position X from the starting methionine of the protein…”).
Additionally, claim 9 recites a Markush grouping of single amino acid sites which may be mutated, with the exception of “L242-244” at line 3. It is unclear as to what single amino acid site is referenced by this limitation, and is suggested that this limitation be amended to include each amino acid for each position (e.g. “…L242, X243, X244, and R246.” with “X” representing the amino acid found at this position.) Alternatively, if it is meant that the residues at L242-244 are all deleted (see e.g. ¶[0251]), it should be claimed as such.
As the metes and bounds of the claim are unclear, claim 9 is rejected for being indefinite.
Claim 22 is 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 22 is drawn to the fusion protein of claim 14, wherein said foldon domain or functionally active fragment thereof comprises C-terminal amino acid residues C-terminal domain of bacteriophage T4 fibrin. It is unclear what exactly is being claimed from the wording of the claim. The wording is also confusing in the specification, as it refers to both “T4 fibrin” and “T4 fibritin” (¶[0218-0219]). Turning to the art, “foldon” is the natural trimerization domain of T4 fibritin (See e.g. Meier S, et. al. J Mol Biol. 2004 Dec 3;344(4):1051-69.) Given the guidance from the art, it is not readily clear that the limitation in claim 22 is further limiting, as the “C-terminal domain of T4 fibritin” and “foldon domain” appear to be the same things.
For at least these reasons, the metes and bounds of claim 22 are unclear.
Claim 45 is 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 45 recites the limitation "the subjects" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is suggested this limitation be amended to recite “…comprises administering the fusion protein of claim 1 to a subject in need thereof.”
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 1 is drawn to a fusion protein comprising:
a) the receptor-binding domain (RBD) of a SARS-CoV-2 spike protein (S protein) or functionally active fragment thereof, and
b) the N-terminal domain (NTD) of a SARS-CoV-2 spike protein (S protein) or functionally active fragment thereof,
wherein said RBD or functionally active fragment thereof is directly or indirectly linked to said NTD or functionally active fragment thereof.
Further limitations on the fusion protein of claim 1 are wherein said RBD and NTD are derived from a wild-type SARS-CoV-2 strain or variants thereof (claim 2); wherein said RBD has a mutation in one or more amino acid sites selected from the following group consisting of: K417, L452, T478, E484 and N501 (claim 4); wherein said RBD comprises the amino acid sequence as set forth in any one of SEQ ID NOs.: 18, 19, 76, 83 and 97-108 (claim 8); wherein said NTD comprises a mutation at one or more amino acid sites selected from the following groups consisting of L18, T19, T20, P26, D80, D138, R190, D215, L242-244, and R246 (claim 9); wherein said NTD comprises an amino acid sequence as set forth in any one of SEQ ID NOs: 37, 38, 77, 84 and 109-111 (claim 13); wherein the fusion protein further includes one or more polypeptides selected from the following group: P2 or functionally active fragment thereof, foldon domain or functionally active fragment thereof, ferritin or functionally active fragment thereof, and hepatitis B surface antigen (HBsAg) or functionally active fragment thereof (claim 14), wherein said N-terminal of the polypeptide is directly or indirectly linked to the C- terminal of said RBD or functionally active fragment thereof, and the N-terminal of said RBD or functionally active fragment thereof is directly or indirectly linked to the C- terminal of said NTD or functionally active fragment thereof (claim 19), wherein said P2 or functionally active fragment thereof comprises an epitope peptide of tetanus toxin (claim 20), wherein said foldon domain or functionally active fragment thereof comprises C- terminal amino acid residues C-terminal domain of bacteriophage T4 fibrin (claim 22); wherein said foldon domain or functionally active fragment thereof comprises an amino acid sequence as set forth in any one of SEQ ID NOs.: 67-69 and 78 (claim 23), wherein said hepatitis B surface antigen or functionally active fragment thereof comprises an amino acid sequence as set forth in SEQ ID NO: 73 (claim 29); wherein said direct or indirect linking comprises the linking via a linker, wherein said linker comprises an amino acid sequence as set forth in any one of SEQ ID Nos.: 89-90 (claim 30); comprising an amino acid sequence as set forth in any one of SEQ ID NOs.: 39-44, 79, 85 and 96 (claim 33); an immunogenic composition, comprising the fusion protein of claim 1 (claim 34), which further comprises at least one kind of hemagglutinin (HA) protein from human influenza virus (claim 35); one or more isolated nucleic acid molecules, which encode(s) the fusion protein in claim 1 (claim 37), and wherein the nucleic acid comprises mRNA (claim 38).
Claim 43 is drawn to a method for making a COVID-19 subunit vaccine, which comprises: preparing the fusion protein of claim 1; and mixing the fusion protein with a pharmaceutically acceptable adjuvant.
Claim 45 is drawn to a method of treating COVID-19, which comprises administering the fusion protein of claim 1 to a subject in need thereof.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 1-2, 4, 8-9, 13-14, 19, 22-23, 30, 33-34, 37-38, 43, and 45 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by King et. al. (US20240277831A1; Pub. 11/02/2023, Priority 02/07/2020; hereafter “King”.)
The Prior Art
King teaches SARS CoV-2 S proteins and antigenic fragments thereof which comprise specific antigenic and/or functional portions of the S protein, such as the receptor binding domain (RBD) and an N-terminal domain (NTD)(¶[0009][0048][0050]; instant claim 1). King teaches the sequences may be from any known SARS CoV-2 S protein variants (reference claim 18; Tables 1-2; ¶[0006][0033][0040][0044-0048][0054-0055]; instant claim 2), and can include variants which comprise mutations in the RBD such as K417N, E484K, N501Y (SEQ ID NO: 143; Table 1), L452R, and T478I (¶[0056]; instant claim 4). King teaches RBD sequences which are identical to those of the instant claims (e.g. instant SEQ ID NO: 19 is 100% identical to reference SEQ ID NO: 125; instant claim 8). King further teaches a NTD from S protein may have mutations, such as L18F, T20N, P26S, D80A, D138Y, R190S, and D215G (¶0056]; instant claim 9), wherein King teaches NTD regions which comprise NTD sequences of the instant claims (instant SEQ ID NO: 37 is 100% identical to reference SEQ ID NO: 29; instant claim 13). King teaches that the S protein may comprise heterologous domains, such as a foldon domain (SEQ ID NO: 98; Table 2; instant claims 14, 22) at the C-terminus of the S protein (¶[0243]; instant claim 19). Instant SEQ ID NO: 67 and reference SEQ ID NO: 99 have portions with 100% identity to one another; the use of the indefinite article “an” before “amino acid” in instant claim 23 allows this claim to read upon full length and fragments of the sequences listed (see alignment below; instant claim 23).
SEQIDNO67 1 PEAPRDGQAYVRKDGEWVLLSTFL 24
||||||||||||||||||||||||
SEQIDNO99 20 PEAPRDGQAYVRKDGEWVLLSTFL 43
Instant SEQ ID NO: 90 is found within reference SEQ ID NO: 30 with 100% identity to one (Table 1; instant claim 30). Instant SEQ ID NO: 39 (Qy) and reference SEQ ID NO: 30 (Db) are 98% identical with 100% similarity between SEQ ID NO: 39 aa 1-528 (see alignment below); as instant claim 33 is drawn to a protein “comprising an amino acid sequence as set forth in any one of SEQ ID NOs: 39-44, 79, 85 and 96”, the use of the indefinite article “an” allows this claim to read upon full length and fragments of the sequences listed. As King teaches an amino acid fragment of SEQ ID NO: 39, this reads upon the limitations of instant claim 33.
Query Match 98.0%; Score 2844; DB 1; Length 1511;
Best Local Similarity 100.0%;
Matches 528; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QCVNLTTRTQLPPAYTNSFTRGVYYPDKVFRSSVLHSTQDLFLPFFSNVTWFHAIHVSGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 33 QCVNLTTRTQLPPAYTNSFTRGVYYPDKVFRSSVLHSTQDLFLPFFSNVTWFHAIHVSGT 92
Qy 61 NGTKRFDNPVLPFNDGVYFASTEKSNIIRGWIFGTTLDSKTQSLLIVNNATNVVIKVCEF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 93 NGTKRFDNPVLPFNDGVYFASTEKSNIIRGWIFGTTLDSKTQSLLIVNNATNVVIKVCEF 152
Qy 121 QFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDLEGKQGNFKNLREFV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 153 QFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDLEGKQGNFKNLREFV 212
Qy 181 FKNIDGYFKIYSKHTPINLVRDLPQGFSALEPLVDLPIGINITRFQTLLALHRSYLTPGD 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 213 FKNIDGYFKIYSKHTPINLVRDLPQGFSALEPLVDLPIGINITRFQTLLALHRSYLTPGD 272
Qy 241 SSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSETKCTLKSFTVEKGIY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 273 SSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSETKCTLKSFTVEKGIY 332
Qy 301 QTSNFRVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISNCVADYSVLYNSAS 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 333 QTSNFRVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISNCVADYSVLYNSAS 392
Qy 361 FSTFKCYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIADYNYKLPDDFTGCV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 393 FSTFKCYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIADYNYKLPDDFTGCV 452
Qy 421 IAWNSNNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPCNGVEGFNCYFPLQ 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 453 IAWNSNNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPCNGVEGFNCYFPLQ 512
Qy 481 SYGFQPTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVNF 528
||||||||||||||||||||||||||||||||||||||||||||||||
Db 513 SYGFQPTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVNF 560
King teaches vaccines and other immunogenic compositions which comprise the SARS CoV-2 S protein comprising the NTD and RBD (¶[0090-0091]; instant claim 34), and that said compositions may comprise an adjuvant added to the immunogenic mixture (¶[0089]; instant claim 43). King teaches nucleic acid molecules, such as mRNA, which encode said protein (¶[0010]; instant claims 37-38). King teaches the immunogenic compositions comprising said SARS CoV-2 S protein may be used to treat or inhibit SARS CoV-2 infection in a subject in need thereof (abstract; reference claim 47; instant claim 45).
For at least these reasons, King teaches the limitations of instant claims 1-2, 4, 8-9, 13-14, 19, 22-23, 30, 33-34, 37-38, 43, and 45, and anticipates the invention encompassed by said claims.
Claims 1-2, 14, 19-20, 22-23, 29, 35, 37-38, 43, and 45 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kahvejian et. al. (US20230193311A1; Pub. 06/22/2023, Priority 02/07/2020; hereafter “Kahvejian”) as evidenced by
Guthe et. al. (Güthe S, et. al. J Mol Biol. 2004 Apr 2;337(4):905-15., Associated NCBI Reference Sequence: WP_442823166.1; hereafter “Guthe”) and
De Maddalena et. al. (De Maddalena C, et. al. Virology. 2007 Aug 15;365(1):113-24. Epub 2007 Apr 23., Associated NCBI Reference Sequence: ABQ43819.1; hereafter “De Maddalena”.)
The Prior Art
Kahvejian teaches circular polyribonucleotides which encode multiple peptide antigens from at least two different heterologous sources (entire document; see abstract.) At least one antigen would be an antigen derived from SARS CoV-2, such as a full-length spike (S) protein or a fragment thereof that at least comprises the RBD of said S protein (¶0273]). Said sequence may be a wild-type sequence or a derivative or variant thereof (¶[0291-0292]; instant claim 2). As the full-length S polypeptide of Kahvejian would inherently comprise both an NTD and RBD linked directly through peptide bonds, this teaches the limitatio7ns of instant claims 1-2 and 37.
Kahvejian teaches further aspects of the instant claims, such as the addition of heterologous antigens encoded by the circular polyribonucleotide. Said antigens include hepatitis B virus surface antigen (HBsAg)(¶[0259][0283]), tetanus toxoid (¶[0277]), and foldon (¶[0672-0677]; instant claims 14, 20, 22). As wild-type sequences of foldon and HBsAg comprise SEQ ID NOs: 67 and 73, respectively, as evidenced by the teachings of Guthe and De Maddalena, Kahvejian inherently teaches the limitations of instant claims 23 and 29. Kahvejian also teaches additional antigens may be from influenza virus, such as HA (¶[0220-0224][0249]; instant claim 35). Kahvejian teaches the immunogens may be linked together to form a fusion protein, which inherently includes linking the two immunogens at their N- and C-terminal domains (¶[0314]; See Fig. 13; instant claim 19). Kahvejian teaches the nucleic acid encoding the antigens may be mRNA (¶[0173]; instant claim 38). Kahvejian teaches the composition may be a polypeptide encoded by the polyribonucleotide combined with an adjuvant (reference claims 49-50, 54-57; ¶[0015]; instant claim 43). Kahvejian teaches the polypeptide-encoding polyribonucleotide may be used in a method to treat a subject against a disease, disorder, or condition (reference claim 43) such as disease caused by SARS CoV-2 (Example 12 at ¶[0654]; instant claim 45).
For at least these reasons, Kahvejian either expressly or inherently teaches every aspect of instant claims 1-2, 14, 19-20, 22-23, 29, 35, 37-38, 43, and 45, and anticipates the invention encompassed by said claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671