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 .
Sequence Requirements
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth on as follows:
The specification does not contain sequence identifiers (SEQ ID#s) in all locations where sequences are disclosed, see at least page 45.
Full compliance with the sequence rules is required in response to this Office Action. A complete response to this office action should include both compliance with the sequence rules and a response to the Office Action set forth below. Failure to fully comply with both these requirements in the time period set forth in this Office Action will be held non-responsive.
Claim Rejections - 35 USC § 112
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 1-25 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.
For claims 1-25, the reference sequence is unclear as it is to the 384-661 fragment not the mutation positions. It is suggested that the claims are amended to “as compared to the reference sequence SEQ ID No: 1 that comprises residues 384-661 of the HCV sE2 glycoprotein.”
Claim 7 is unclear because “said RNA and DNA” lacks antecedent basis. Additionally, It is not clear if the method is drawn to administering polypeptide, as in claim 1, or if it is to RNA and DNA or if it is further comprising RNA and DNA. The claim is not further treated.
In claims 8-10, for “use as a … vaccine” is not clear. The subject is not the polypeptide or vaccine. The polypeptide is used as a therapeutic or prophylactic vaccine. It is suggested the “for (potential) use as a … vaccine” be replaced with “and the polypeptide is a therapeutic (or prophylactic) vaccine.”
For claims 8-9, the term “for potential use” is not clear if this is conditional (and nothing can happen is one possibility and thus a 101 issue) or if the meaning is “…wherein… and the polypeptide is used as a therapeutic vaccine.”
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 1-6, 8-10, and 16-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not teach administering the recited mutant HCV sE2 polypeptides as an immunogen that induces a protective immune response.
The post filing art teaches that the double mutant induces a protective in the surrogate mouse model (abstract, Haga Y, et al. 2024. Hepatitis C virus modified sE2F442NYT as an antigen in candidate vaccine facilitates human immune cell activation. J Virol 98:e01809-23).
The prior art recognized that that an immune response to protect against HCV required response to multiple genes and administration with adjuvant (Abstract and Figure 1, Qui et al., Vaccine 26 (2008) pages 5537-5534).
With the lack of teaching in the specification and the showing in the prior art about what is required, it would require undue experimentation to make and use the invention as claimed.
Claims 21-25 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 HCV sE2 double mutation in a lipid coating as a vaccine and inducing a protective immune response, does not reasonably provide enablement for naked RNA or DNA or other single mutations as claimed. 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 use the invention commensurate in scope with these claims.
The specification makes and tests the mutants in vitro.
The specification does not teach inducing a protective immune response.
The post filing art teaches that the double mutant induces a protective in the surrogate mouse model using a lipid particle delivery system (abstract, Haga Y, et al. (2024. J Virol 98:e01809-23).
The prior art recognized that that an immune response to protect against HCV required response to multiple genes and administration with adjuvant (Abstract and Figure 1, Qui et al., Vaccine 26 (2008) pages 5537-5534).
With the lack of teaching in the specification as to protective immune response and the showing in the prior art about what is required, it would require undue experimentation to make and use the invention as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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