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 .
DETAILED ACTION
1. Claims 1, 2, 6-8, 14, 17, 18, 21, 24, 25, 29-35, 37-40 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 1/30/2023; 6/12/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
3. 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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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 § 103
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.
4. Claims 1, 6, 14, 17, 18, 21, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. (WO2014100913)(cited in applicant’s IDS submitted 1/30/2023) in view of Anderson et al. (WO2021198769)(See PTO-892: Notice of References Cited).
See claims 1, 6, 14, 17, 18, 21, 25 as submitted 11/17/2022.
Qian et al. teaches: fusion protein comprising therapeutic polypeptide and scaffold protein (abstract)(as recited in claim 17); wherein scaffold protein forms a stable trimeric structure (abstract)(as recited in claim 14); including nucleic acids, vectors (abstract)(as recited in claim 21); wherein human proteins can form homo-trimers may also serve as scaffold proteins (p. 8); including resistin (p. 8)(as recited in claim 1); adjuvant (p. 24)(as recited in claim 18); promoter (p. 15)(as recited in claims 21, 25); recombinant expression (p. 15)(as recited in claim 25).
Qian et al. does not teach: viral surface antigen; wherein the second portion comprises an amino acid sequence having at least 70% identity to the full length of the amino acid sequence set forth in SEQ ID NO: 3.
Anderson et al. teaches: coronavirus epitopes (abstract); including SARS-CoV-2 modified spike glycoprotein SEQ ID NO: 22 for treating subject having coronavirus infection, which has 99.9% identity with instant SEQ ID NO: 3 (See Result of STIC Sequence Search Result 20250908_002418_us-17-999-071-3.rag in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use peptide as taught by Anderson et al. with the fusion protein as taught by Qian et al. Qian et al. teaches use of therapeutic peptide, and Anderson et al. teaches such a peptide (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using peptide as taught by Anderson et al. with the fusion protein as taught by Qian et al.
There would have been a reasonable expectation of success given the underlying materials (peptide as taught by Qian et al. and Anderson et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
5. Claims 2, 37, 38 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. as applied to claims 1, 6, 14, 17, 18, 21, 25 above, and further in view of Renner et al. (WO02056907A2)(See PTO-892: Notice of References Cited).
See claims 2, 37, 38 as submitted 11/17/2022.
See the teachings of Qian et al. in view of Anderson et al. above.
Qian et al. in view of Anderson et al. does not teach: wherein the first portion comprises an amino acid sequence having at least 85% sequence identity to the full length of the amino acid sequence set forth in SEQ ID NO: 1.
Renner et al. teaches: resistin protein which has 100% identity with instant SEQ ID NO: 1 (See Result 5 of STIC Sequence Search Result 20250908_002418_us-17-999-971-1.rag in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use protein as taught by Renner et al. with the fusion protein as taught by Qian et al. in view of Anderson et al. Qian et al. in view of Anderson et al. teaches use of resistin protein, and Renner et al. teaches such a resistin protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using protein as taught by Renner et al. with the fusion protein as taught by Qian et al. in view of Anderson et al. There would have been a reasonable expectation of success given the underlying materials (resistin peptide as taught by Renner et al. and Qian et al. and Anderson et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
6. Claims 39, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. and further in view of Renner et al. as applied to claims 2, 37, 38 above, and further in view of Tan et al. (WO2004109289A1)(See PTO-892: Notice of References Cited).
See claims 39, 40 as submitted 11/17/2022.
See the teachings of Qian et al. in view of Anderson et al. and further in view of Renner et al. above.
Qian et al. in view of Anderson et al. and further in view of Renner et al. does not teach: method as claimed; immobilization.
Tan et al. teaches: method of diagnosing SARS-Coronavirus Infection (title); wherein sample is serum [0068]; immunoassay, including antigen immobilized on a solid support prior to contacting with patient sample [0069](as recited in claims 39, 40); using expressed antigenic protein to determine if patient has generated antibodies [0066].
One of ordinary skill in the art would have been motivated to use fusion protein as taught by Qian et al. in view of Anderson et al. and further in view of Renner et al. with the method as taught by Tan et al. Tan et al. teaches use of antigen in immunoassay, and Qian et al. in view of Anderson et al. and further in view of Renner et al. teaches such an antigen (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using fusion protein as taught by Qian et al. in view of Anderson et al. and further in view of Renner et al. with the method as taught by Tan et al. There would have been a reasonable expectation of success given the underlying materials (coronavirus peptide as taught by Qian et al. in view of Anderson et al. and further in view of Renner et al. and Tan et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
7. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. as applied to claims 1, 6, 14, 17, 18, 21, 25 above, and further in view of De Groot et al. (WO2021163427)(See PTO-892: Notice of References Cited).
See claim 7 as submitted 11/17/2022.
See the teachings of Qian et al. in view of Anderson et al. above.
Qian et al. in view of Anderson et al. does not teach: sequence with at least 85% identity with SEQ ID NO: 5.
De Groot et al. teaches: SARS-CoV-2 spike protein SEQ ID NO: 444, which has 92.8% identity with instant SEQ ID NO: 5 (See Result 29 of STIC Sequence Search Result 20250908_002418_us-17-999-071-5.rag in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use protein as taught by De Groot et al. with the fusion protein as taught by Qian et al. in view of Anderson et al. Qian et al. in view of Anderson et al. teaches use of SARS-CoV-2 protein, and De Groot et al. teaches such a protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using protein as taught by De Groot et al. with the fusion protein as taught by Qian et al. in view of Anderson et al. There would have been a reasonable expectation of success given the underlying materials (peptide as taught by De Groot et al. and Qian et al. and Anderson et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
8. Claims 29, 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. as applied to claims 1, 6, 14, 17, 18, 21, 25 above, and further in view of Tan et al. (cited above).
See claims 29-35 as submitted 11/17/2022.
See the teachings of Qian et al. in view of Anderson et al. above.
Qian et al. in view of Anderson et al. does not teach: method as claimed; microtiter plate.
See the teachings of Tan et al. above. Tan et al. also teaches microtiter plate [0075](as recited in claim 33).
One of ordinary skill in the art would have been motivated to use fusion protein as taught by Qian et al. in view of Anderson et al. with the method as taught by Tan et al. Tan et al. teaches use of antigen in immunoassay, and Qian et al. in view of Anderson et al. teaches such an antigen (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using fusion protein as taught by Qian et al. in view of Anderson et al. with the method as taught by Tan et al. There would have been a reasonable expectation of success given the underlying materials (coronavirus peptide as taught by Qian et al. in view of Anderson et al. and Tan et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
9. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. and further in view of Tan et al. as applied to claims 29, 31-35 above, and further in view of De Groot et al. (WO2021163427)(cited above).
See claim 30 as submitted 11/17/2022.
See the teachings of Qian et al. in view of Anderson et al. and further in view of Tan et al. above.
Qian et al. in view of Anderson et al. and further in view of Tan et al. does not teach: sequence with at least 85% identity with SEQ ID NO: 5.
See the teachings of De Groot et al. above.
One of ordinary skill in the art would have been motivated to use protein as taught by De Groot et al. with the fusion protein as taught by Qian et al. in view of Anderson et al. and further in view of Tan et al. Qian et al. in view of Anderson et al. and further in view of Tan et al. teaches use of SARS-CoV-2 protein, and De Groot et al. teaches such a protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using protein as taught by De Groot et al. with the fusion protein as taught by Qian et al. in view of Anderson et al. and further in view of Tan et al. There would have been a reasonable expectation of success given the underlying materials (peptide as taught by De Groot et al. and Qian et al. in view of Anderson et al. and further in view of Tan et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Graversen et al. (US20100028995)(See PTO-892: Notice of References Cited) teaches: tetranectin trimerizing polypeptides and fusion proteins (abstract); trimeric complexes (abstract); heterologous peptides including viral coat antigens [0069]; fusing viral envelope antigens for treatment of infectious diseases [0077].
11. SEQ ID NOs: 5, 7, 8, 18 are free of the prior art of record. Thus, claims 8, 24 are objected to for depending on rejected claims.
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1671