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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 7, 8, 11, 16, 17, 20, 24, 26, 30, 31, 34, 39, 40, 42, 55, 56, 60, 61, 64, 68, 69 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ashley et al (Cell, 2018).
Ashley et al teach RNA transcripts from Drosophila that comprise the Arc 5’UTR, 3’UTR sequences and the ORF of darc1, considered an mRNA as it encodes the GAG-like protein (considered an antigen or a peptide) and comprises a poly(A). See the abstract, Fig. 2U, p. 262, last ¶ to p. 263 first col. The expression of the Arc protein packages the Arc/cargo mRNA into extracellular vesicles comprising GFP (considered a small molecule), which can be collected from cells by sedimentation (abstract, Fig. 1). A system comprising DNA encoding GFP with the Arc 3’ UTR and the genomic Arc DNA was used to prepare fluorescent EV’s (Fig. 3, p.265 first col., last ¶ to second col. 2nd ¶). The vectors used to prepare the system (pTWM, pENTR-DTOPO, supplemental page e4) are considered plasmids and comprised a heterologous promoter (e.g. GAL4-dependent) relative to the GFP sequence or the Arc sequence.
Claim(s) 1, 3, 6, 7, 8, 11, 15-17, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Das et al (Sci. Adv., 2018, of record) as evidence by Ashley et al (Cell, 2018) and Genbank entries AF177701 and AF162777.
Das et al teach RNA transcripts from Drosophila transgenic mice that comprise the Arc 5’UTR, 3’UTR sequences and the Arc protein coding sequence, considered an mRNA as it encodes the GAG-like protein (considered an antigen or a peptide) and inherently comprises a poly(A). See the abstract and Fig. 2A. Instant SEQ ID NO: 2, the murine Arc 5’ UTR (Genbank AF177701, 1742-1937) is considered to be inherent to the RNAs of Das et al, as is instant SEQ ID NO: 6, the murine Arc 3’UTR (Genbank AF177701, 1381-3048).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5-7-8, 11, 15-17, 20 and 55 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1, 3, 5-7-8, 11, 15-17, 20 and 55 is/are directed to RNA transcripts and extracellular vesicles comprising Arc 5’ and 3’UTR’s and Arc mRNA’s and thus are not markedly different from the same Arc mRNAs, proteins and vesicles found in nature. See the teachings of Ashley and Das et al above regarding the naturally occurring Arc genes, RNA’s and vesicles found in mice and Drosophila. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited RNAs and vesicles are no different in their biological properties than those found in the organism from which they were derived, i.e. the recited RNAs perform the same biological function (package RNA and form vesicles) with the same structure (Arc mRNA, Arc proteins) as the molecules found in nature. As such, the claimed RNAs and vesicles cannot be considered to comprise “significantly more” than the same biomolecules found in nature.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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