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 .
Applicant’s preliminary amendment filed on April 18, 2023 is acknowledged. Claims 1-9 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 25, 2024 and April 18, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 4 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.
Claim 4 recites “A fusion protein that is used as a vaccine antigen and comprising an antigen of a virus and/or bacterium and an antigen against which a vaccinated subject has antibodies in a body.”
The claim is rejected because Applicant’s specification lacks written description support for the entire genus of fusion proteins encompassed by the present claims. The claims are drawn to a large genus of vaccine antigens comprising any viral or bacterial antigen. Applicant’s specification contemplates vaccine compositions comprising receptor-binding domain (RBD) of SARS-CoV-2 and influenza virus hemagglutinin. Applicant’s specification fails to provide written description support of the entire genus of viral and bacterial antigens encompassed by the present claim 4.
Additionally, the recitation of “used” is interpreted as intended use that fails to limit the claimed product. Correction is required.
Thus, the present claims are rejected for lack of written description support.
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)(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 1-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by OOstvogels et al. (US Patent Application Publication US 2022/0211838).
OOstvogels et al. teach a vaccine composition comprising a fusion protein comprising a receptor-binding domain (RBD) of SARS-CoV-2 and influenza virus hemagglutinin (see paragraph [0102], [0186], [0215, 0216], claims 1-30).
Regarding present claim 2. OOstvogels et al. teach hemagglutinin protein that is H1, type, H3 type, H5 type or H7 type (see paragraph [0704] The at least one influenza A virus may be selected from influenza A viruses characterized by a hemagglutinin (HA) selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, H16, H17 and H18. Preferably the influenza A virus is selected from an Influenza virus characterized by a hemagglutinin (HA) selected from the group consisting of H1, H3, H5, H7, H9, or H10).
Regarding present claim 3. OOstvogels et al. teach methods of treating a subject having SARS-CoV-2 infection (see paragraph [1477], and [1520-1526]).
Regarding present claim 4. OOstvogels et al. teach administering the vaccine in a subject infected with the SARS-CoV-2 (see [1520-1526]. However, the intended use of the claimed composition is not considered limiting.
Regarding present claim 6. OOstvogels et al. teach an optional adjuvant (see paragraph [0712]).
Regarding present claims 7-9. OOstvogels et al. teach methods of eliciting an immune response, comprising administering the vaccine comprising a fusion protein comprising a receptor-binding domain (RBD) of SARS-CoV-2 and influenza virus hemagglutinin y injection and intranasally (see paragraph [1444-1452]). A vast majority of the population has been infected with and has antibodies against the influenza virus and for the is reason the limitations of claim 7 are inherently anticipated by the disclosure of OOstvogels et al.
Thus, by this disclosure OOstvogels et al. anticipate the present claims.
Pertinent references
Kim et al. (EBioMedicine, May 2020, p. 1-12) teaches corona virus vaccines.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648