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 05/12/2026 has been entered. Claims 1,-2, 4, 7-9, 11-14, 16-17, 19, 22, 25-27, 34-35, 37-40 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/19/2024; 02/19/2025 and 08/13/2025 are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 04/20/2021 based on the filing date of the provisional application 63/117,133.
Election/Restriction
Applicant’s election without traverse of Group I in the reply filed on 05/12/2026 is acknowledged.
Claims 16, 17, 19, 22, 25-27, 34-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic claim as claims 19, 34-38 are withdrawn.
Applicant’s species election in the reply filed on 05/12/2026 is acknowledged. Applicant elected SEQ ID NO: 6 (corresponds to an amino acid sequence encoding the receptor binding domain of SARS-CoV-2 spike protein).
However, applicant’s election is not drawn to the to the attachment of an immunizing
antigen derived from a variety of sources comprised of SEQ ID NO: 1, 7, or 20-22 to the vaccine adjuvant/fusion protein. The election of SEQ ID NO: 6 is problematic because claims 1, 2, 7, 11, 12, 14 and 39 do not read on the elected species as those claims are drawn to an osteopontin sequence and no SEQ ID NO was elected for osteopontin as required in the Restriction Requirement. Since applicant did not traverse the election and for the purpose of compact prosecution, the examiner has elected SEQ ID NO: 1 for osteopontin.
Claims 7 and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species. Claim 39 recites: “….herein exon 4, exon 5, or both exon 4 and exon 5 of osteopontin are not present in the N-terminal domain of osteopontin or the fragment thereof”. According to the specification [0003] this limitation is required by SEQ ID NO: 20-22 but not SEQ ID NO: 1
Claims 1-2, 4, 8-9, 11-14 and 40 are examined on their merits.
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 Rejections - 35 USC § 112
Claims 4, 8 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 4 recites “a vaccine adjuvant wherein the N-terminal domain of osteopontin is conjugated to an immunizing antigen selected from a protein or fragment thereof, a nucleic acid, a virus, a pseudovirus, a bacterium, and a parasite, wherein the virus, the pseudovirus, the bacterium or the parasite is inactivated or attenuated.” that is capable of functioning as a vaccine, which encompasses a genus of agents.
Claim 8 recites a vaccine adjuvant, wherein the immunizing antigen is a viral protein, a bacterial protein, or a parasitic protein, or a subunit or fragment thereof. Claim 8 is dependent from Claim 4
Claim 9 recites a vaccine adjuvant, wherein the immunizing antigen is a viral protein or fragment thereof derived from SARS-CoV-2. and claim 9 is dependent on claim 8, which is dependent from claim 4.
These claims do not materially limit the genus of agents, especially regarding the nature of the immunizing agent and are therefore included in the rejection. These claims do not require that the genus of the claims possess any particular structure or other distinguishing feature that is characteristic of the genus as a whole. Therefore, the claims are drawn to a genus of “immunizing agents” for which there is inadequate written description.
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 (see MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus MPEP 2163(II)(3)(a)(i)(C).
In the instant case, the only identifying characteristic present in the claim is a recitation of requisite activity (------------------able to function as a vaccine). There is not an identification of any particular portion of a structure that must be conserved for said activity. Regarding the genus of the claims the specification describes one specific species within the genus claimed (the OPN-COV fusion protein described in the Examples 1-4). From the specification, it is clear that Applicant is in possession of species the OPN-COV fusion protein. The claims, however are not limited to those species but also includes a protein or fragment thereof, a nucleic acid, a virus, a pseudovirus, a bacterium, and a parasite, wherein the virus, the pseudovirus, the bacterium or the parasite is inactivated or attenuated., and the specification fails to provide a representative number of the species cited above within the recited genus. 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 § 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 and 11 are rejected under 35 U.S.C. 101 because the claims recite “nature-based products” as a limiting element or step without having markedly different characteristics than the nature-based product itself. The claimed inventions are directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application because, the osteopontin is not markedly different from its naturally occurring counterpart because it conveys the same genetic information and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for patent subject matter eligibility analysis.
A claim that focuses on use of a natural product must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural product itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
The recent Interim Eligibility Guidance addresses the subject matter eligibility analysis for all claims (i.e., machine, composition of matter, manufacture and process claims). The analysis is to be used for evaluating whether a claim is drawn to patent-eligible subject matter.
Step 1 determines whether the claim is directed to a process, machine, manufacture, or composition of matter. If the claim is directed to a statutory category, proceed to Step 2.
Step 2 is the two-part analysis from Alice Corp. (also called the Mayo test) for claims directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions).
In Step 2A, determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea (judicial exceptions) – Prong 1. “Directed to” means the exception is recited in the claim, i.e., the claim sets forth or describes the exception. If yes, determine if the claim recite additional elements that integrate the judicial exception into a practical application – Prong 2. If no, proceed to step 2B.
In Step 2B determine whether the claim as a whole amounts to significantly more than the exception.
Claims 1 is drawn to a vaccine adjuvant comprising an N-terminal domain of osteopontin or a fragment thereof, the N-terminal domain of osteopontin or the fragment thereof comprising an amino acid sequence having at least 80% sequence identity with SEQ ID NO: 1
Claim 2 is drawn to the vaccine adjuvant wherein the N-terminal domain of osteopontin or the fragment thereof comprises a secretion signal sequence.
Claim 11 is drawn to the vaccine adjuvant wherein the N-terminal domain of osteopontin or the fragment thereof comprises SEQ ID NO: 1, SEQ ID NO. 20, SEQ ID NO: 21, or SEQ ID NO: 22 (only SEQ ID NO: 1 is examined as it is the elected species).
The present claims are directed to a composition of matter so Step 1 is satisfied.
Claims 1-2 and 11 are directed to N-terminal domain of osteopontin or the fragment thereof comprising an amino acid sequence having at least 80% sequence identity with SEQ ID NO: 1. and does not result in an amino acid sequence that exhibits any markedly different characteristics with respect to structure, function, or any other property to distinguish from its naturally occurring N-terminal domain of its counterpart at 100% sequence identity. See Sequence alignment results below between SEQ ID NO 1 and the wild type human osteopontin taught in AAA86886n (GenBank: AAA86886.1 PRI 06-FEB-1996).
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As such, all of the instant claims recite judicial exceptions in the form of a natural phenomenon (product of nature) (Step 2A, Prong 1- YES).
The core of the claims is the N-terminal domain of osteopontin but the instant claims do not recite any additional elements that integrate this judicial exception into a practical application. Rather, the instant claims merely recite natural product. As such, the instant claims do not recite additional elements that integrate the judicial exception into a practical application (Step 2A, Prong 2- NO).
The claimed N-terminal domain of osteopontin is a naturally occurring fragment as demonstrated above and does not reasonably provide an inventive concept or recite any elements beyond the judicial exceptions themselves. Under current U.S. patent law, isolating or purifying a naturally occurring substance (such as a protein or a fragment of one) from its natural environment is not enough to make it patent-eligible. If the protein fragment is identical to or has the same characteristics as something that exists in nature (or something that could theoretically form in the body), it is considered a natural phenomenon. As such, the instant claims do not recite any additional elements that amount to significantly more than the judicial exception (Step 2B- NO).
Accordingly, claims 1-2 and 11, do not constitute patent eligible subject matter under 35 U.S.C. § 101.
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.
1. Claims 1, 2 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Staffler (US 2017/0137509 A1 Publication date May 18, 2017).
Staffler teaches vaccines comprising at least one isolated osteopontin peptide (abstract) and [0126]). It also teaches SEQ ID NO: 17, which is 100% identical to instant SEQ ID NO:1. Both sequences have the same length, 168 amino acids. See alignment below.
Title: US-18-555-940-1
Perfect score: 896
Sequence: 1 MRIAVICFCLLGITCAIPVK..........VVPTVDTYDGRGDSVVYGLR 168
US-15-322-356-17
Sequence 17, US/15322356
Publication No. US20170137509A1
APPLICANT: Affiris AG
TITLE OF INVENTION: Vaccines and monoclonal antibodies targeting truncated
TITLE OF INVENTION: variants of osteopontin and uses thereof
FILE REFERENCE: R67614
CURRENT APPLICATION NUMBER: US/15/322,356
CURRENT FILING DATE: 2016-12-27
PRIOR APPLICATION NUMBER: EP 14175005.9
PRIOR FILING DATE: 2014-06-30
NUMBER OF SEQ ID NOS: 58
SEQ ID NO 17
LENGTH: 168
TYPE: PRT
ORGANISM: Homo sapiens
FEATURE:
OTHER INFORMATION: ThrOpn
Query Match 100.0%; Score 896; Length 168;
Best Local Similarity 100.0%;
Matches 168; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MRIAVICFCLLGITCAIPVKQADSGSSEEKQLYNKYPDAVATWLNPDPSQKQNLLAPQNA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MRIAVICFCLLGITCAIPVKQADSGSSEEKQLYNKYPDAVATWLNPDPSQKQNLLAPQNA 60
Qy 61 VSSEETNDFKQETLPSKSNESHDHMDDMDDEDDDDHVDSQDSIDSNDSDDVDDTDDSHQS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VSSEETNDFKQETLPSKSNESHDHMDDMDDEDDDDHVDSQDSIDSNDSDDVDDTDDSHQS 120
Qy 121 DESHHSDESDELVTDFPTDLPATEVFTPVVPTVDTYDGRGDSVVYGLR 168
||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 DESHHSDESDELVTDFPTDLPATEVFTPVVPTVDTYDGRGDSVVYGLR 168
While Staffler does not explicitly disclose the properties of their osteopontin fragment (such as adjuvant properties, secretion signal or the exons in the fragment), these properties would inherently be the same properties and functions since both SEQ ID NO; 1 and SEQ ID NO: 17 are exactly the same. The instant application discloses that SEQ ID NO: 18 encodes the secretory signal (page 2). A comparison with instant SEQ ID NO: 18 and Staffler’s SEQ ID NO: 17 shows the presence of the secretion signal in SEQ ID NO: 17.
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401
760
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"Applicant is reminded that products of identical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01".
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.
2. Claims 1-2, 4, 8-9, 11-14 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Chappell (WO 2018/176103 A1. Priority date: March 30, 2017), and Zhu (US 2023/0416309 A1 Priority date Oct 23, 2020) in view of Staffler (supra) and Ashkar (Science, 2000 287: 860–864. IDS NPL citation 1).
Chappell teaches fusion proteins based on universal oligomerization domains (UOD) for
oligomerizing any heterologous molecule of interest into oligomers, particularly trimers (see paragraph 394). A specific UOD is Osteopontin (see page 68, at line 40). Chappell additionally teaches chimeric polypeptides based on viral membrane (that is viral antigens) fusion proteins (see Abstract and paragraphs 124 and 125). More particularly, Chappell discloses chimeric polypeptides that comprise a virion surface exposed portion of a viral fusion protein and a heterologous structure stabilizing moiety, and to complexes of those chimeric polypeptides (Abstract). Chappell also discloses the use of these chimeric polypeptides in compositions and methods for eliciting an immune response to a fusion protein of an enveloped virus, or complex of the fusion protein, and/or for treating or preventing an enveloped virus infection (Abstract). Specific examples of exposed proteins located on the surface of a virus include the spike protein from SARS-CoV (see paragraphs 124 and 311).
However, Chappell fails to provide a specific sequence for their Osteopontin sequence, which is at least 80% sequence identity to SEQ ID NO: 1; or that the immunizing antigen is a viral protein or fragment thereof derived from SARS-CoV-2, such as the protein having at least 80% identity to SEQ ID NO: 6
Zhu teaches one or more fusion proteins comprising a structural domain of the SARS-Cov-2 spike protein (instant claims 4, 8 and 9). In particular SEQ ID NO: 39 (NTD-RBD-6His) comprises the RBD and is 97.6% identical to the instant SEQ ID NO: 6 (Receptor binding domain of spike glycoprotein of SARS-CoV-2 with a His tag) (as required by instant claims 12- 14 and 40). The difference between both sequences is due to a deletion of 8 amino acids in SEQ ID NO: 6 before the addition of the His tag). See alignment below:
Title: US-18-555-940-6
Perfect score: 1459
Sequence: 1 LLKYNENGTITDAVDCALDP..........TVCGPKKSTNGSGHHHHHHH 267
US-18-249-904-39
Sequence 39, US/18249904
Publication No. US20230416309A1
GENERAL INFORMATION
APPLICANT: JIANGSU PROVINCIAL CENTER FOR DISEASE CONTROL AND PREVENTION
APPLICANT: (PUBLIC HEALTH RESEARCH INSTITUTE OF JIANGSU PROVINCE);
APPLICANT: Jiangsu Recbio Technology Co., Ltd.;
APPLICANT: Beijing Abzymo Biosciences Co., Ltd.
TITLE OF INVENTION: FUSION PROTEIN AND APPLICATION THEREOF
FILE REFERENCE: 0107-PA-002US
CURRENT APPLICATION NUMBER: US/18/249,904
CURRENT FILING DATE: 2023-04-20
NUMBER OF SEQ ID NOS: 111
SEQ ID NO 39
LENGTH: 536
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: NTD-RBD-6His
Query Match 97.6%; Score 1424.5; Length 536;
Best Local Similarity 96.4%;
Matches 264; Conservative 0; Mismatches 3; Indels 7; Gaps 1;
Qy 1 LLKYNENGTITDAVDCALDPLSETKCTLKSFTVEKGIYQTSNFRVQPTESIVRFPNITNL 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 263 LLKYNENGTITDAVDCALDPLSETKCTLKSFTVEKGIYQTSNFRVQPTESIVRFPNITNL 322
Qy 61 CPFGEVFNATRFASVYAWNRKRISNCVADYSVLYNSASFSTFKCYGVSPTKLNDLCFTNV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 323 CPFGEVFNATRFASVYAWNRKRISNCVADYSVLYNSASFSTFKCYGVSPTKLNDLCFTNV 382
Qy 121 YADSFVIRGDEVRQIAPGQTGKIADYNYKLPDDFTGCVIAWNSNNLDSKVGGNYNYLYRL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 383 YADSFVIRGDEVRQIAPGQTGKIADYNYKLPDDFTGCVIAWNSNNLDSKVGGNYNYLYRL 442
Qy 181 FRKSNLKPFERDISTEIYQAGSTPCNGVEGFNCYFPLQSYGFQPTNGVGYQPYRVVVLSF 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 443 FRKSNLKPFERDISTEIYQAGSTPCNGVEGFNCYFPLQSYGFQPTNGVGYQPYRVVVLSF 502
Qy 241 ELLHAPATVCGPKKSTN-------GSGHHHHHHH 267
||||||||||||||||| | ||||||
Db 503 ELLHAPATVCGPKKSTNLVKNKCVNFGSHHHHHH 536
Zhu does no teach osteopontin as part of the fusion protein with the RBD.
Staffler’s teachings have been discussed above and applied herein (instant claims 1, 2 and 11).
Staffler does not teach a fusion protein comprising a viral antigen such as the RBD of SARS-CoV-2.
Ashkar teaches that osteopontin is an early component of Type-1 (cell mediated ) immunity (Title) which is necessary for immune protection against most intracellular pathogens (that is viruses), (Abstract). Because Osteopontin imprints type-1 responses after immunization may also be valuable components of viral vaccines (page 862, first column, last paragraph).
It would have been obvious to one of ordinary skill in the art to generate a vaccine by creating a fusion polypeptide as disclosed by Chappell and Zhu (a fusion protein comprising a viral antigen (including SEQ ID NO: 6)) with Staffler’s teachings (an osteopontin fragment such as SEQ ID NO: 1) and Ashkar’s. One of ordinary skill would have been motivated to do so because Chappell teaches a viral antigen fused to a heterologous polypeptide (osteopontin) capable of eliciting an immune response to the fusion protein (that is, the fusion protein can function as a adjuvant vaccine) and this heterologous polypeptide can be osteopontin since Ashkar teaches the role of vaccine adjuvant by osteopontin as a as an early component enhancing the Type-1 immunity, necessary for immune protection against viruses.
There would be a reasonable expectation of success because viral immunogenic proteins such as the spike protein or its RBD are known to develop an immune response and the molecular biology techniques necessary to construct any fusion protein are well known in the art.
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
/BENJAMIN P BLUMEL/ Primary Examiner, Art Unit 1671
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