DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application, filed on 07 March, 2024, is a 371 of PCT/EP2022/074845 filed on 07 September, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 April, 2024 has been considered by the examiner.
Status of Application, Amendments, and/or Claims
The response filed on 07 March, 2024 has been entered in full. These are the amended claims of the original claim set received on 07 March, 2024. In the amendment, claims 1-18 are cancelled and claims 19-38 are new. Therefore, claims 19-38 are pending and are the subject of this Office Action.
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 - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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 paragraph, 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 21, 23, 25, and 27 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claims 21,23, 25, and 27 recite the phrase “comprising or consisting of.” The use of multiple, alternative transitional phrases in a single claim element renders the scope of the claim unclear, because “comprising”, and “consisting of” each have different legal meanings which define different mutually exclusive scopes with respect to additional, unrecited components (See MPEP 2111.03). In the instant claim it is unclear which transitional phrase governs the scope of the claims making them indefinite. For the purpose of further examination, the claims will be interpreted under the transitional phrase “comprising.” Under this interpretation, the scope of the claim is inclusive and does not exclude the presence of additional, unrecited components.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19-21, 25-36, and 37 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sallberg and Frelin (US 2023/0330211; Priority date 03/27/2020).
In regards to claim 19 and 26 Sallberg and Frelin anticipate a polypeptide (fusion protein) (SEQ ID No: 70 of Sallberg and Frelin) which comprises a spike protein of coronavirus (SEQ ID No: 56 of Sallberg and Frelin), and a nucleocapsid (nucleoprotein) (SEQ ID NO: 36 of Sallberg and Frelin) (pg.16, col 1, lines 30-50).
In regards to claims 20 and 35 Sallberg and Frelin anticipate the coronavirus being SARS-CoV-2 (pg.16, col 1, lines 30-33).
In regards to claims 21 and 27 Sallberg and Frelin anticipate the polypeptide containing the spike protein SEQ ID No: 56 which has a 99.8% identity to SEQ ID NO: 16 of the instant application as shown below.
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Further the polypeptide contains a nucleocapsid (SEQ ID NO: 36 of Sallberg and Frelin) which comprises 100% of SEQ ID No: 2 of the instant application as shown below.
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In regards to claims 25 and 27 Sallberg and Frelin anticipates the polypeptide SEQ ID No: 70 which has 84% sequence identity to SEQ ID No: 28 of the instant application as shown in the sequence alignment summary below.
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In regards to claim 28 Sallberg and Frelin anticipates the polypeptide being encoded by a nucleic acid molecule (SEQ ID No: 63 of Sallberg and Frelin).
In regards to claim 29 Sallberg and Frelin anticipates the nucleic acid being provided in a recombinant vector such as pVAX1 (pg.3, col 1, lines 21-23).
In regards to claim 30 Sallberg and Frelin anticipates carrying the oligonucleotide encoding the polypeptide is a lipid nanoparticle to protect it from degradation during passage through the bloodstream (pg.9, col 2, lines 15-20).
In regards to claim 31 Sallberg and Frelin anticipate the polypeptide as part of an immunogenic composition (pg.2, col 2, lines 59-64).
In regards to claim 32 Sallberg and Frelin anticipate the immunogenic composition can serve as a vaccine (pg.11, col 1, lines 5-7), and further the immunogenic compositions can comprise adjuvants such as alum and/or QS21 (pg.3, col 1, lines 18-21).
In regards to claim 33 Sallberg and Frelin anticipates the polypeptide being used in pharmaceutical compositions depending on intended route of administration (pg.9, col 1, lines 53-55).
In regards to claim 34 Sallberg and Frelin anticipate the immunogenic composition being administered to treat or prevent coronavirus infection (pg.3, col 1, lines 23-26).
In regards to claim 36 Sallberg and Frelin anticipated intranasal injection as an administration technique readily known to those skilled in the art (pg.9, col 1, lines 41-50).
Claim 37 of the instant application recites claim to a kit comprising the fusion protein of claim 19 without adding any further components that limit the scope of the claim, therefore the kit does not preclude the structure and claim 37 is anticipated by Sallberg and Frelin.
Claims 19 and 22 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Benmohamed (WO 2021/211760) as evidenced by PBD entry 1RFO (released 03/30/2004).
In regards to claim 19 Benmohamed anticipates a fusion protein comprising a spike protein from coronavirus and a nucleoprotein from coronavirus (pg.4, lines 20-28/ Figure 1).
In regards to claim 22 and 23 Benmohamed further teaches the fusion protein can comprise a T4 fibritin-derived foldon domain to increase immunogenicity by multivalent display (pg.7, lines 14-17). SEQ ID No:19 of the instant application is the T4 fibritin-derived foldon domain as evidenced by PDB entry 1RFO which, shows the sequence for the T4 fibritin-derived foldon domain which is identical to SEQ ID No: 19 of the instant application (alignment shown below) and thus Benmohamed anticipates the SEQ ID No: 19 trimerization domain as evidenced by the PDB entry 1RFO.
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Claims 19, 24 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herrera et al. (2021) Characterization of the SARS-CoV-2 S Protein: Biophysical, Biochemical, Structural, and Antigenic Analysis ACS Omega 6, 85-102 (hereafter Herrera).
In regards to claim 19 and 24 Herrera anticipates a multiantigen protein (fusion protein) comprising a coronavirus spike protein and a nucleocapsid (pg.90, col 1, lines 46-51) wherein the spike protein is OptSpike2 which contains a thrombin cleavage site or OptSpike1 which has a TwinStrep Tag (pg.87, col , line 13 – col 2 line 4).
In regards to claim 38 Herrera anticipates using the multiantigen protein to detect (diagnose) COVID 19 in human serum (pg.90, col 2, lines 8-17/ Figure 5) to allows for simultaneous analyzing of the antibody response to multiple antigens in a high-throughput format and to validate the use of recombinant S protein in an antigen detection platform (pg.90, col 2, lines 18-22).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DASIA A ALDARONDO whose telephone number is (571)272-1977. The examiner can normally be reached on Monday – Friday from 8:30am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at telephone number (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/D.A.A/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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