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 .
Preliminary Amendment
The preliminary amendment dated 5/24/2023 has been entered. Claims 1, 3, 4, 6-7, 13-14, 16-19, 21-26, 38-40 are pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest possible effective filing date for the instant claims is November 24, 2020 based on the filing date of the application PCT/CN2020/131098.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
i) the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference of the material consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 16 and 21 are objected to because of the following informalities: Claim shout be written as follows: “….. wherein the … comprises the RBD of the spike protein…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 6, 19, and 23 are rejected because they recite “…a sequence of a SEQ ID NO:….”. There are multiple interpretations for this recitation. For example, it can be interpreted as 1) the full sequence or as 2) any subsequence therein. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Claims 13-14, 16-19 and 21-25 are rejected as indefinite because of multiple interpretations. Claim 13 is drawn to a vaccine combination for use in a subject against SARS-CoV-2 virus infection comprising: 1) a DNA vaccine comprising a polynucleotide sequence encoding a polypeptide of the SARS-CoV-2 virus; and 2) an antigen peptide vaccine, wherein the antigen peptide is an antigen peptide of the SARS- CoV-2 virus. Claims 14, 16-19 and 21-25 are dependent on claim 13. These claims can be interpreted as both a product claim or a method (for use) claim. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
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.
Claim 23 is 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 an antigen peptide comprising the amino acid sequence of SEQ ID NO: 7, it does not reasonably provide enablement for any antigen peptide with sequence identity of 80% or more to SEQ ID NO: 7. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The art teaches that protein chemistry is probably one of the most unpredictable areas of biotechnology. For example, conservative replacement of a single “lysine” residue at position 118 of acidic fibroblast growth factor by “glutamic acid” led to the substantial loss of heparin binding, receptor binding and biological activity of the protein (Burgess et al., J of Cell Bio. 111:2129-2138, 1990). In transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen (Lazar et al. Molecular and Cellular Biology 8:1247-1252, 1988). As these references illustrate, it is unpredictable that a variant of SEQ ID NO; 7 will also function as a vaccine. Thus, even a single substitution can change the biological property of an antigen peptide.
In summary, these examples above teach that the biological function of an antigen peptide variants is unpredictable because even a single mutation can abolish activity or give a different function.
Since the art teaches that it is unpredictable whether or not peptide variants of known inhibitors will function as such and it is also unpredictable that even a known inhibitory peptide that functions in vitro will function in vivo, and the specification does nothing to ameliorate these concerns, one would be burdened with undue experimentation to use the products of instant claims as broadly as they are currently claimed.
Claim 23 is 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.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming.
Claim 23 is drawn to a vaccine combination, wherein the antigen peptide comprises an amino acid sequence of SEQ ID NO: 7 or a functional variant with sequence identity of 80% or more to SEQ ID NO: 7.
When one goes to the specification to identify a representative species of this genus, it seems as if Applicant has only provided SEQ ID NO: 7. This species, or even just a few species, is not sufficient to represent such a broad genus comprising of sequences that are 80% or more to SEQ ID NO: 7.
“[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.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
MPEP § 2163 states that 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, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics (vaccine) coupled with a known or disclosed correlation between vaccine function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, as here in which amino acids of the amino acid sequence having at least 80% identity with the amino acid sequence SEQ ID NO:7., one must describe a sufficient variety of species to reflect the variation within the genus. However, only one peptide is provided. Yet, one of skill in this art cannot envision the structure of any other antigen peptide, other than those taught by Applicant. There is no guarantee there are many others. There is no way to predict which changes may occur. There is equally no way to know if such a amino acid changes would still be able to function as a vaccine. All this requires guidance by Applicant or future research to uncover. Therefore, since only one species, or very few, are provided to represent the genus recited, the claims encompassing the same clearly fail the written description requirement.
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. See ABBVIE DEUTSCHLAND GMBH & 2 CO. v. JANSSEN BIOTECH, INC., Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV. See also Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011).
In the case of instant claim 23, for a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“Functional” terminology may be used “when the art has established a correlation between structure and function” but “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing one has invented a genus and not just a species.” Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F3d 1336, 94 USPQ2d 1161, 1171 (Fed Cir. 2010). Since the peptide structure is responsible for its antigenicity and tumor-specificity, and said structure varies between T-cell epitopes, there is no correlation between structure and function between the members of such a large T-cell epitope genus as currently recited. The group need have no common structure at all. Thus, functional language should not be used to define the genus. Rather, structure should be used.
Even when several species are disclosed, these are not necessarily representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, as here, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. Since each genus recited in the instant claims is large, it would be very challenging to describe sufficient species to cover the structures of the entire genera. Fourteen highly similar and related species is certainly not adequate just as the related species of Joe-9 derivatives above were inadequate.
A representative number of species has not been taught to describe the genus of antigen peptides. The genus is very large and would encompass many peptides encoding the same that cannot be visualized from the prior art or instant disclosure. Any future structure may or may not be encompassed, and if it is, it would not have been represented in Applicant’s disclosed species. Thus, the described species cannot be considered representative of the recited genus. E.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, the claims are rejected here.
As discussed above, an applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, or representative number of species, the specification does not provide adequate written description of the claimed genus.
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, 3-4, and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aurisicchio (US 2023/0285540 A1 Priority date April 30, 2020).
Aurisicchio teaches polynucleotides encoding antigens of the SARS-CoV-2 coronavirus spike protein (instant claims 1 and 3) and uses thereof as vaccines for the prevention and treatment of COVID-19 infection (instant claim 7), (abstract). The polynucleotides are capable of immunizing subjects against SARS-CoV-2 and variants thereof or can be used in therapy against SARS-CoV-2, since they generate an RBD protein capable of competing with the virus itself (reads on instant claim 3 since the RBD is found in the Spike protein) [0075]. These polynucleotides can be advantageously used for mammals such as humans [0083], (instant claim 4). The sequences are extracted from the genome data of SARS-Co V-2 and members of the same family of RNA viruses. The sequences are designed in a laboratory using optimization of codons for humans [0089], (instant claims 1). Aurisicchio teaches that the polynucleotide comprises or consists of a sequence selected from SEQ ID NO: 1 and a sequence having a percent identity greater than or equal to 80% compared to sequence SEQ ID NO: 1 (Aurisicchio’s claim 1). When comparing Aurisicchio’s SEQ ID NO: 1 and the instant SEQ ID NO: 3, many fragments with 100% homology can be found within these sequences (instant claim 6):
Title: US-18-254-373A-3
Sequence: 1 atgttcgtgttcctggtgct..........tgaagctccactacacatga 3822
Database : US-17-997-527A-1.seq:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 518.6 13.6 669 1 US-17-997-527A-1 Polynucleotides en
ALIGNMENTS
RESULT 1
US-17-997-527A-1
Query Match 13.6%; Score 518.6; DB 1; Length 669;
Best Local Similarity 85.9%;
Matches 575; Conservative 0; Mismatches 94; Indels 0; Gaps 0;
Qy 955 AGAGTGCAGCCTACAGAGTCTATCGTGAGATTCCCAAACATCACAAACCTGTGCCCTTTC 1014
|| |||||||| || |||||||||||| | || || || ||||||||||||||||| ||
Db 1 AGGGTGCAGCCAACCGAGTCTATCGTGCGCTTTCCTAATATCACAAACCTGTGCCCATTT 60
Qy 1015 GGCGAGGTGTTCAACGCTACACGGTTCGCTTCTGTGTACGCTTGGAACCGGAAGCGGATC 1074
||||||||||||||||| || ||||||| |||||||| ||||| ||||||| |||
Db 61 GGCGAGGTGTTCAACGCAACCAGGTTCGCAAGCGTGTACGCATGGAATAGGAAGCGCATC 120
Qy 1075 TCTAACTGCGTGGCCGACTACTCTGTGCTGTACAACTCCGCCTCTTTCTCCACATTCAAG 1134
|||||||||||||||||||| |||||||||||||||||||||||| ||| || |||
Db 121 TCTAACTGCGTGGCCGACTATAGCGTGCTGTACAACTCCGCCTCTTTCAGCACCTTTAAG 180
Qy 1135 TGCTACGGCGTGAGCCCAACAAAGCTGAACGACCTGTGCTTCACAAACGTGTACGCCGAC 1194
||||| |||||| ||| ||||||||||| ||||||||||| || ||||||||||||||
Db 181 TGCTATGGCGTGTCCCCCACAAAGCTGAATGACCTGTGCTTTACCAACGTGTACGCCGAT 240
Qy 1195 TCTTTCGTGATCCGGGGCGACGAGGTGAGGCAGATCGCTCCAGGCCAGACAGGCAAGATC 1254
|||||||||||| |||||||||||||| | |||||||| || || |||||||||||||||
Db 241 TCTTTCGTGATCAGGGGCGACGAGGTGCGCCAGATCGCACCTGGACAGACAGGCAAGATC 300
Qy 1255 GCCGACTACAACTACAAGCTCCCCGACGACTTCACAGGCTGCGTGATCGCTTGGAACTCT 1314
||||||||||| || ||||| || ||||| ||||| |||||||||||||| ||||||
Db 301 GCCGACTACAATTATAAGCTGCCAGACGATTTCACCGGCTGCGTGATCGCCTGGAACAGC 360
Qy 1315 AACAACCTGGACTCTAAGGTGGGCGGCAACTACAACTACCTGTACAGACTGTTCCGGAAG 1374
||||| ||||| || || ||||||||||||||||| || |||||| | ||||| | |||
Db 361 AACAATCTGGATTCCAAAGTGGGCGGCAACTACAATTATCTGTACCGGCTGTTTAGAAAG 420
Qy 1375 TCTAACCTGAAGCCTTTCGAGCGGGACATCTCTACCGAGATCTACCAGGCCGGCAGCACC 1434
|| |||||||| |||||| ||||||||||||| || |||||||||||||||||||||
Db 421 AGCAATCTGAAGCCCTTCGAGAGGGACATCTCTACAGAAATCTACCAGGCCGGCAGCACC 480
Qy 1435 CCTTGCAACGGCGTGGAGGGCTTCAACTGCTACTTCCCACTGCAGTCTTACGGCTTCCAG 1494
|||||||| |||||||||||||| ||||| || |||||||||||||| ||||||||||||
Db 481 CCTTGCAATGGCGTGGAGGGCTTTAACTGTTATTTCCCACTGCAGTCCTACGGCTTCCAG 540
Qy 1495 CCTACAAACGGCGTGGGCTACCAGCCATACCGGGTGGTGGTGCTGTCCTTCGAGCTCCTC 1554
|| ||||||||||||||||| ||||| ||||| |||||||||||| ||| ||||| ||
Db 541 CCCACAAACGGCGTGGGCTATCAGCCTTACCGCGTGGTGGTGCTGAGCTTTGAGCTGCTG 600
Qy 1555 CACGCCCCCGCTACAGTGTGCGGCCCAAAGAAGTCCACAAACCTCGTGAAGAACAAGTGC 1614
||||| || || ||||||||||| || ||||||||||| || || |||||||||||||||
Db 601 CACGCACCAGCAACAGTGTGCGGACCCAAGAAGTCCACCAATCTGGTGAAGAACAAGTGC 660
Qy 1615 GTGAACTTC 1623
|||||||||
Db 661 GTGAACTTC 669
Therefore, the reference teachings anticipate the claimed invention.
Claim Rejections - 35 USC § 103
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 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.
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, 3-4, 6-7, 13-14, 16-17,19, 21-26 and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Aurisicchio in view of Jalah (PLOS ONE, March 2014 | Volume 9 | Issue 3 | e91550).
Aurisicchio teachings regarding instant claims 1, 3-4 and 6-7 have been described above and incorporated herein. Furthermore, the sequence comparison between Aurisicchio’s SEQ ID NO: 1 and the instant SEQ ID NO: 3 above also teaches the polynucleotide fragments of instant claim 19.
In addition, Aurisicchio also teaches that the immunization with one or more antigens of SARSCoV-2 subunits, administered as purified proteins (reads on antigen peptide vaccine, instant claim 13) or expressed by viral vectors, an RNA or a DNA, is one of the possible approaches for the design of a vaccine [0007]. Antibodies specific for the SARS-CoV-2 RBD can cross-react with the SARS-CoV-2 RBD protein and the SARS-CoV-2 virus is neutralized by SARS-CoV-2 RBD-induced antisera, providing further evidence that a vaccine having this domain of the S protein as a target could be effective [0012], (instant claims 16, and 21). In addition, methods of preventing or treating SARS-CoV-2 comprising administering a polynucleotide encoding an amino acid sequence, an expression vector comprising said polynucleotide, an amino acid sequence encoded by said polynucleotide, or a pharmaceutical composition comprising said polynucleotide, vector, or amino acid sequence in combination with one or more excipients and/or adjuvants are taught (Aurisicchio claim 29), (instant claim 24). The amino acid sequence further comprises one or more domains of the S1 subunit of the spike protein of the SARS-CoV-2 (Aurisicchio claim 31), (instant claim 22). The vaccines can be administered intramuscularly (Aurisicchio claim 43), (instant claims 25 and 40) following a prime-boost scheme (i.e. two administrations two weeks apart [0201] (instant claim 39).
Aurisicchio further teaches SEQ ID NO: 20 that is 100% identical to the full length instant SEQ ID NO: 7 and fragments thereof (instant claim 23). See alignment below.
Title: US-18-254-373A-7
Sequence: 1 MFVFLVLLPLVSSQCVNLTT..........IGAGICASYQTQTNSPRRAR 685
US-17-997-527A-20
Sequence 20, US/17997527A
Publication No. US20230285540A1
GENERAL INFORMATION
APPLICANT: TAKIS SRL
TITLE OF INVENTION: Polynucleotides encoding antigens of SARS-CoV-2 and their use in medical field as vaccines
FILE REFERENCE: PCT44884
CURRENT APPLICATION NUMBER: US/17/997,527A
CURRENT FILING DATE: 2022-10-28
PRIOR APPLICATION NUMBER: IT 102020000009625
PRIOR FILING DATE: 2020-04-30
NUMBER OF SEQ ID NOS: 28
SEQ ID NO 20
LENGTH: 825
TYPE: PRT
ORGANISM: SARS-CoV-2
Query Match 100.0%; Score 3668; Length 825;
Best Local Similarity 100.0%;
Matches 685; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MFVFLVLLPLVSSQCVNLTTRTQLPPAYTNSFTRGVYYPDKVFRSSVLHSTQDLFLPFFS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MFVFLVLLPLVSSQCVNLTTRTQLPPAYTNSFTRGVYYPDKVFRSSVLHSTQDLFLPFFS 60
Qy 61 NVTWFHAIHVSGTNGTKRFDNPVLPFNDGVYFASTEKSNIIRGWIFGTTLDSKTQSLLIV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NVTWFHAIHVSGTNGTKRFDNPVLPFNDGVYFASTEKSNIIRGWIFGTTLDSKTQSLLIV 120
Qy 121 NNATNVVIKVCEFQFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDLE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NNATNVVIKVCEFQFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDLE 180
Qy 181 GKQGNFKNLREFVFKNIDGYFKIYSKHTPINLVRDLPQGFSALEPLVDLPIGINITRFQT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GKQGNFKNLREFVFKNIDGYFKIYSKHTPINLVRDLPQGFSALEPLVDLPIGINITRFQT 240
Qy 241 LLALHRSYLTPGDSSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSETK 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LLALHRSYLTPGDSSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSETK 300
Qy 301 CTLKSFTVEKGIYQTSNFRVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISN 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 CTLKSFTVEKGIYQTSNFRVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISN 360
Qy 361 CVADYSVLYNSASFSTFKCYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIAD 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 CVADYSVLYNSASFSTFKCYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIAD 420
Qy 421 YNYKLPDDFTGCVIAWNSNNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 YNYKLPDDFTGCVIAWNSNNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPC 480
Qy 481 NGVEGFNCYFPLQSYGFQPTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVN 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 NGVEGFNCYFPLQSYGFQPTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVN 540
Qy 541 FNFNGLTGTGVLTESNKKFLPFQQFGRDIADTTDAVRDPQTLEILDITPCSFGGVSVITP 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 FNFNGLTGTGVLTESNKKFLPFQQFGRDIADTTDAVRDPQTLEILDITPCSFGGVSVITP 600
Qy 601 GTNTSNQVAVLYQDVNCTEVPVAIHADQLTPTWRVYSTGSNVFQTRAGCLIGAEHVNNSY 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GTNTSNQVAVLYQDVNCTEVPVAIHADQLTPTWRVYSTGSNVFQTRAGCLIGAEHVNNSY 660
Qy 661 ECDIPIGAGICASYQTQTNSPRRAR 685
|||||||||||||||||||||||||
Db 661 ECDIPIGAGICASYQTQTNSPRRAR 685
Jalah teaches the combination of DNA with protein (instant claim 13) to improve the anti-HIV Env systemic and mucosal humoral immune responses. Rhesus macaques were vaccinated with DNA, DNA and protein co-immunization (instant claims 24 and 38) or DNA prime followed by protein boost (abstract). The magnitude and mucosal dissemination of the antibody responses and induction of robust humoral responses by optimized DNA vaccination were greatly increased upon administration of a protein boost. Jalah also teaches the development of intramuscular (IM) DNA injection (page 1, Introduction 1st paragraph). The DNA vaccine was administered by IM injection. The protein was administered by subcutaneous and intramuscular injections into the same sites. (Figure 2) (instant claim 40). Three groups of macaques were immunized 4 times (V1 to V4) with using regimens that included DNA (D) only, DNA & protein co-immunization, and DNA prime-protein boost (Figure 3A), (instant claim 39).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Aurisicchio with Jalah above and generate DNA vaccines (codon optimized) and/or antigen peptide vaccines and a method to administer an effective dose of these vaccines separately or co-administer them as a combination (as taught by Jalah) to treat SARS-CoV-2 infection in a subject including humans. It would further be obvious for the polypeptide and the antigen peptide to comprise the RBD of the Spike protein S1 subunit as taught by Aurisicchio. The artisan would have been motivated to administer the DNA vaccine, or the combination of DNA and peptide vaccines, because Aurisicchio teaches both types of vaccines (DNA and protein vaccines, including the protein of SEQ ID NO: 20 which is 100% identical to instant SEQ ID NO: 7)) and Jalah teaches an example of such combination of vaccines (co-administration of DNA and protein vaccines) for HIV virus that can be co-administered intramuscularly at least 3 times. There would be a reasonable expectation of success when generating the DNA vaccine and/or the peptide antigen vaccine to treat or prevent SARS-CoV-2 because Jalah teaches us that a combination of DNA and peptide vaccine was successful for HIV since the antibody responses and induction of robust humoral responses by optimized DNA vaccination were greatly increased upon administration of a protein boost.
It would further be obvious with that the vaccination regime (number of immunization) or similar parameters are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. It would have been customary for an artisan of ordinary skill to determine the optimal number of immunizations needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 2. In addition, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
9. Claims 1, 6, 13, 14, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Aurisicchio and Jalah in view of GenBank: MN908947.1 (GenBank: MN908947.1 Wuhan seafood market pneumonia virus isolate Wuhan-Hu-1, complete genome. VRL 12-JAN-2020 https://www.ncbi.nlm.nih.gov/nuccore/MN908947.1), and further in view of Tort (Virus Research 283 (2020) 19797 Available online 12 April 2020) and Xing (Xing (World J Gastroenterol 2005;11(29):4583-4586)
Aurisicchio and Jalah teachings have been discussed above and incorporated herein. In addition, Aurisicchio teaches using sequences extracted from the genome data of SARS-Co V-2 and members of the same family of RNA viruses and the sequences are designed in a laboratory using optimization of codons for humans [0089] (instant claim 1 and 14). The S protein amino acid sequence SEQ ID NO: 11 is also taught, and is 100% identical to the instant SEQ ID NO: 1 (please see sequence alignment below). According to the instant application, the wildtype (S-FL-wt, SEQ ID NO; 2) and codon optimized SARS-CoV-2 spike protein (SEQ ID NO: 1) full length gene sequence (S-FL-opt, SEQ ID NO: 3) were commercially synthesized based on the Wuhan-Hu-1 (GenBank:MN908947). (DNA vaccine construction and production section page 9). Aurisicchio also teaches that the vaccine expression vector is selected from the group consisting of a plasmid, a bacterial plasmid, an RNA, a replicating RNA, amplicons obtained by PCR or a viral vector (Aurisicchio claim 44), (instant claim 18).
SEQUENCE ALIGMENT BETWEEN SEQ ID NO: 11 AND INSTANT SEQ ID NO: 1
Title: US-18-254-373A-1
Sequence: 1 MFVFLVLLPLVSSQCVNLTT..........CKFDEDDSEPVLKGVKLHYT 1273
US-17-997-527A-11
(NOTE: this sequence has 1 duplicate in the database searched)
Sequence 11, US/17997527A
Publication No. US20230285540A1
GENERAL INFORMATION
APPLICANT: TAKIS SRL
TITLE OF INVENTION: Polynucleotides encoding antigens of SARS-CoV-2 and their use in
TITLE OF INVENTION: medical field as vaccines
FILE REFERENCE: PCT44884
CURRENT APPLICATION NUMBER: US/17/997,527A
CURRENT FILING DATE: 2022-10-28
PRIOR APPLICATION NUMBER: IT 102020000009625
PRIOR FILING DATE: 2020-04-30
NUMBER OF SEQ ID NOS: 28
SEQ ID NO 11
LENGTH: 1275
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: amino acid sequence of SARS-CoV-2 Spike protein
Query Match 100.0%; Score 6722; Length 1275;
Best Local Similarity 100.0%;
Matches 1273; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MFVFLVLLPLVSSQCVNLTTRTQLPPAYTNSFTRGVYYPDKVFRSSVLHSTQDLFLPFFS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MFVFLVLLPLVSSQCVNLTTRTQLPPAYTNSFTRGVYYPDKVFRSSVLHSTQDLFLPFFS 60
Qy 61 NVTWFHAIHVSGTNGTKRFDNPVLPFNDGVYFASTEKSNIIRGWIFGTTLDSKTQSLLIV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NVTWFHAIHVSGTNGTKRFDNPVLPFNDGVYFASTEKSNIIRGWIFGTTLDSKTQSLLIV 120
Qy 121 NNATNVVIKVCEFQFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDLE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NNATNVVIKVCEFQFCNDPFLGVYYHKNNKSWMESEFRVYSSANNCTFEYVSQPFLMDLE 180
Qy 181 GKQGNFKNLREFVFKNIDGYFKIYSKHTPINLVRDLPQGFSALEPLVDLPIGINITRFQT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GKQGNFKNLREFVFKNIDGYFKIYSKHTPINLVRDLPQGFSALEPLVDLPIGINITRFQT 240
Qy 241 LLALHRSYLTPGDSSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSETK 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LLALHRSYLTPGDSSSGWTAGAAAYYVGYLQPRTFLLKYNENGTITDAVDCALDPLSETK 300
Qy 301 CTLKSFTVEKGIYQTSNFRVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISN 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 CTLKSFTVEKGIYQTSNFRVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISN 360
Qy 361 CVADYSVLYNSASFSTFKCYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIAD 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 CVADYSVLYNSASFSTFKCYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIAD 420
Qy 421 YNYKLPDDFTGCVIAWNSNNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 YNYKLPDDFTGCVIAWNSNNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPC 480
Qy 481 NGVEGFNCYFPLQSYGFQPTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVN 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 NGVEGFNCYFPLQSYGFQPTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVN 540
Qy 541 FNFNGLTGTGVLTESNKKFLPFQQFGRDIADTTDAVRDPQTLEILDITPCSFGGVSVITP 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 FNFNGLTGTGVLTESNKKFLPFQQFGRDIADTTDAVRDPQTLEILDITPCSFGGVSVITP 600
Qy 601 GTNTSNQVAVLYQDVNCTEVPVAIHADQLTPTWRVYSTGSNVFQTRAGCLIGAEHVNNSY 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GTNTSNQVAVLYQDVNCTEVPVAIHADQLTPTWRVYSTGSNVFQTRAGCLIGAEHVNNSY 660
Qy 661 ECDIPIGAGICASYQTQTNSPRRARSVASQSIIAYTMSLGAENSVAYSNNSIAIPTNFTI 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 ECDIPIGAGICASYQTQTNSPRRARSVASQSIIAYTMSLGAENSVAYSNNSIAIPTNFTI 720
Qy 721 SVTTEILPVSMTKTSVDCTMYICGDSTECSNLLLQYGSFCTQLNRALTGIAVEQDKNTQE 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 SVTTEILPVSMTKTSVDCTMYICGDSTECSNLLLQYGSFCTQLNRALTGIAVEQDKNTQE 780
Qy 781 VFAQVKQIYKTPPIKDFGGFNFSQILPDPSKPSKRSFIEDLLFNKVTLADAGFIKQYGDC 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 VFAQVKQIYKTPPIKDFGGFNFSQILPDPSKPSKRSFIEDLLFNKVTLADAGFIKQYGDC 840
Qy 841 LGDIAARDLICAQKFNGLTVLPPLLTDEMIAQYTSALLAGTITSGWTFGAGAALQIPFAM 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 LGDIAARDLICAQKFNGLTVLPPLLTDEMIAQYTSALLAGTITSGWTFGAGAALQIPFAM 900
Qy 901 QMAYRFNGIGVTQNVLYENQKLIANQFNSAIGKIQDSLSSTASALGKLQDVVNQNAQALN 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 QMAYRFNGIGVTQNVLYENQKLIANQFNSAIGKIQDSLSSTASALGKLQDVVNQNAQALN 960
Qy 961 TLVKQLSSNFGAISSVLNDILSRLDKVEAEVQIDRLITGRLQSLQTYVTQQLIRAAEIRA 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 TLVKQLSSNFGAISSVLNDILSRLDKVEAEVQIDRLITGRLQSLQTYVTQQLIRAAEIRA 1020
Qy 1021 SANLAATKMSECVLGQSKRVDFCGKGYHLMSFPQSAPHGVVFLHVTYVPAQEKNFTTAPA 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 SANLAATKMSECVLGQSKRVDFCGKGYHLMSFPQSAPHGVVFLHVTYVPAQEKNFTTAPA 1080
Qy 1081 ICHDGKAHFPREGVFVSNGTHWFVTQRNFYEPQIITTDNTFVSGNCDVVIGIVNNTVYDP 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 ICHDGKAHFPREGVFVSNGTHWFVTQRNFYEPQIITTDNTFVSGNCDVVIGIVNNTVYDP 1140
Qy 1141 LQPELDSFKEELDKYFKNHTSPDVDLGDISGINASVVNIQKEIDRLNEVAKNLNESLIDL 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 LQPELDSFKEELDKYFKNHTSPDVDLGDISGINASVVNIQKEIDRLNEVAKNLNESLIDL 1200
Qy 1201 QELGKYEQYIKWPWYIWLGFIAGLIAIVMVTIMLCCMTSCCSCLKGCCSCGSCCKFDEDD 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 QELGKYEQYIKWPWYIWLGFIAGLIAIVMVTIMLCCMTSCCSCLKGCCSCGSCCKFDEDD 1260
Qy 1261 SEPVLKGVKLHYT 1273
|||||||||||||
Db 1261 SEPVLKGVKLHYT 1273
Aurisicchio does not specifically teach the codon optimization process that lead to SEQ ID NO: 11 or vaccines utilizing pSW3891 plasmids
MN908947.1 teaches the first nucleotide sequences of SARS-CoV-2.
MN908947.1 does not teach how to codon optimize the SARS-CoV-2 sequence.
Tort teaches a comprehensive analysis of the genome composition and codon usage patterns of emerging coronaviruses (title and entire article). A codon usage, amino acid usage, dinucleotide frequencies, base composition, the relative synonymous codon usage (RSCU), total GC content, GC content in the third position of the codon (GC3s) and effective numbers of codons (ENC) were calculated using the program CodonW ((page 2, second column, 2nd paragraph). Table 1, 2 and section 3.5 teach the codon usage adaptation in SARS-CoV-2 (instant claim 1, 6, 14 and 19).
Xing teaches a novel DNA vaccine, pSW3891/HBc, encoding HBV core gene that was constructed using a vector plasmid pSW3891 (page 4583, Abstract, methods), (instant claim 18).
It would be obvious to one skill in the art to combine Aurisicchio with MN908947.1 and Tort to codon optimize the MN908947.1 sequence in a manner taught by Tort to come up with the codon optimized nucleotide sequence of SEQ ID NOs 3 and 4 (instant claims 6 and 19) that when translated in to an amino acid sequence one would obtain Aurisicchio SEQ ID NO: 11 (which is 100% identical to instant SEQ ID NO; 1). The artisan would be motivated to do so because Aurisicchio codon optimized the nucleotide sequences found in the genome data of SARS-CoV-2 (such as MN908947.1) to get the SEQ ID NO; 11 amino acid sequence, and Tort teaches us how to codon optimized emerging coronaviruses genomes. There would be a reasonable expectation of success since the codon optimization is known to increase the expression levels of the ORFs and because SEQ ID NO: 11 is 100% identical to instant SEQ ID NO: 1
It would further be obvious to one skill in the art to combine Aurisicchio with Xing and include the plasmid psW3891 taught by Xing as one of the plasmids of Aurisicchio. The artisan would be motivated to do so because pSW3891 has been used to construct DNA vaccines targeting viruses. In addition, it would save the practitioner(s) time and economy as they don’t need to make their own vector. There would be a reasonable expectation of success because pSW3891 is a readily available plasmid and has been used in multiple laboratories in the world.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/ Supervisory Patent Examiner, Art Unit 1671