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 March 13, 2024 is acknowledged. Claims 1-20 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 3, 2024 was considered by the examiner.
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 1-16 and 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Petsch et al. (US Application Publication US 2021/0030864 A1).
Petsch et al., disclose a hantavirus vaccine, comprising an engineered messenger ribonucleic acid (mRNA) comprising an open reading frame encoding an antigenic Gn protein (see Claim 1 "RNA comprising at least one coding sequence encoding at least one antigenic peptide or protein derived from at least one virus of the order Bunyavirales."; (see claims 1-139, Examples 1-3, paragraph [0323]).
Petsch et al. discloses a hantavirus vaccine, comprising an engineered messenger ribonucleic acid (mRNA) comprising an open reading frame encoding an antigenic Gn, Gc, or Gn and Gc protein (see claims 1, 5, 6, 8, 127).
Regarding Claim 5. Petsch et al., disclose the artificial RNA according to claim 1 to 3, wherein the at least one virus is selected from Andes hantavirus (ANDV). 6. The artificial RNA according to claims 1 to 5, wherein the at least one antigenic peptide or protein comprises or consists of a Glycoprotein.";
Regarding claim 6, Petsch et al., further discloses that the mRNA is linear (para [0570]; "RNA may be obtained by DNA-dependent in vitro transcription of an appropriate DNA template, which according to the present invention is preferably a linearized plasmid DNA template"; para [0041]; "vector may be a vector which is suitable for transferring nucleic acid molecules into cells or organisms, for example, viral vectors (DNA virus or RNA virus)"; para [0041]; "An expression vector may be used for production of expression products such as RNA, e.g., mRNA, or peptides, polypeptides or proteins. For example, an expression vector may comprise sequences needed for transcription of a sequence stretch of the vector, such as a promoter sequence, e.g., an RNA polymerase promoter sequence").
Regarding claim 7, Petsch et al., discloses further comprising a 5' UTR (para [0041]; "the vector may comprise a sequence corresponding, e.g., to a desired mRNA sequence or a part thereof, such as a sequence corresponding to the coding sequence and the 3-UTR and/or the 5-UTR of an mRNA").
Regarding Claim 8, Petsch et al., discloses the vaccine further comprising a 3' UTR (see paragraph [0041]).
Regarding claim 18, Petsch et al., discloses a DNA construct encoding the vaccine (para [0041]; "A vector in the context of the present invention may be, e.g., an RNA vector or a DNA vector as defined above comprising a nucleic acid sequence, preferably at least one coding sequence encoding at least one amino acid sequence derived from a virus of the order Bunyavirales").
Regarding claim 19, Petsch et al., discloses a method method of inducing an antigen-specific immune response in a subject, the method comprising administering to the subject the vaccine of claim 1 (see paragraph [0070]).
Thus, by this disclosure Petsch et al., anticipate the present claims.
Claim Objection
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Petsch et al. discloses a nucleotide that is 51.0% identical to SEQ ID NO: 17 (SEQ ID NO: 8364; nt 1-1953 51.0% sequence identity). There is nothing of record to lead one of ordinary skill in the art to modify CureVac to arrive at the claimed invention.
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
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