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 .
Election/Restrictions
Applicant’s election of (i) the isolated nucleic acid (DNA) of SEQ ID NO: 2 (claims 3 and 4); (ii) VP1 of SEQ ID NO: 4 (claim 12); (iii) VP1 of SEQ ID NO: 4 (claim 15); and (iv) the pharmaceutical composition for preventing SARS-CoV2 associated infection (claim 19) in the reply filed on 12/2/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (for example, see pages 2 and 16). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Drawings
The drawings are objected to because Figure 4 is not labeled as Figure 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 5, 8, and 16 are objected to because of the following informalities:
Claim 5 should recite “wherein the isolated nucleic acid is a codon-optimized nucleotide sequence”.
Claim 8 should recite “the nucleic acid of SEQ ID NO: 3”.
Claim 16 should recite “the expression cassette comprises the nucleic acid of SEQ ID NO: 3”.
Appropriate correction is required.
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.
Claims 10-12, 15-19 and 23-26 are 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 immunogenic composition for inducing specific immunity against SARS-CoV-2, does not reasonably provide enablement for a vaccine or for a composition for preventing a SARS-CoV-2 infection. 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/or use the invention commensurate in scope with these claims.
The rejected claims are directed to a composition for a method or the “prevention” of SARS-CoV-2 infection.
Example 5 demonstrates that the AAV5-RBD-S product can induce, in mice, antibodies specific to the RBD-S protein. However, none of the examples demonstrate that the claimed AAV5-RBD-S product or induced antibodies were able to prevent SARS-CoV-2 infection in a subject.
Claims 23 and 24 are directed to a vaccine against SARS-CoV-2.
The specification contains examples showing the production and immunogenicity of the RBD-S “vaccine” and examples where mice were administered the RBD-S protein and produced RBD-S specific antibodies. However, there are no examples showing vaccination with the claimed composition comprising AAV5-RBD-S or RBD-S and challenge with SARS-CoV-2 resulting in protection or prevention of SARS-CoV-2 infection.
The disclosure also fails to provide any guidance pertaining to the development of a persistent and protective SARS-CoV-2-specific immune response. It is not readily apparent if the recited SARS-CoV-2 vaccine will generate a SARS-CoV-2-specific immune response of sufficient magnitude and duration that long-lasting protection against SARS-CoV-2 infection would be provided.
While the specification does contain statements regarding the use of the AAV5-RBD-S or RBD-S as a vaccine, there is no indication that a SARS-CoV-2-specific immune response has been generated and that such a response, if generated, would be protective following exposure to SARS-CoV-2. Applicants have not provided any evidence in the instant specification that the disclosed immunogens can prevent SARS-CoV-2 infection following the administration of said vaccine.
Accordingly, when all the aforementioned factors are considered in toto, it would require undue experimentation for one skilled in the art to practice the claimed invention.
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 1-12, 15-19 and 23-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 7, 9 and 15 recite that the sequence is “represented by” SEQ ID NO: 1. With the use of the phrase “represented by”, it is not clear if applicant intends that the sequence “comprises” or “consists of” SEQ ID NO: 1.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Allowable Subject Matter
SEQ ID NOs: 1 and 2 are free of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas 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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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672