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 Status
This action is in response to the papers filed on 7/04/2024. Claims 1 – 20 are pending.
Claim Objections
Claims 2, 3, 11, 12 and 20 are objected to because of the following informalities: “PC2” should be “P2C”. Appropriate correction is required.
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)(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.
(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, 10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rasgon et al. (U.S. Patent Application Publication No. 2020/0299731 A1; cited on IDS, hereinafter Rasgon).
Regarding claims 1 and 10, Rasgon (para. [0006]) discloses method(s) for targeting molecules to oocytes of insects and the product by process (i.e. recombinant oocyte). Rasgon teaches that the oocyte targeting molecule in one embodiment is a yolk protein precursor (YPP), which includes precursors such as: vitellogenin, lipophorin, YP1, P2, P2C, or a functional fragment or functional variant thereof. Rasgon further discloses that gene editing may be accomplished by targeting gene editing molecules such as: CRISPR/Cas, TALEN, and Zinc Finger Nucleases to the oocyte. Rasgon teaches (para [0044]) that the targeting molecule may be vitellogenin ligands that bind to oocyte receptors.
Regarding claim 15, Rasgon further discloses (para. [0181]) the development of Receptor-Mediated Ovary Transduction of Cargo (ReMOT Control) to deliver Cas9 RNP (ribonuclear protein) to the insect germline by injection into adult females.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 – 9, 11 – 14, 16 – 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rasgon in view of Zhang et al. (C.A. Patent Application Publication No. 3178165 A1; hereinafter Zhang) as evidenced by Systems Biosciences (PiggyBac™ Transposon Vector System, User Manual; hereinafter SBI).
Regarding claims 2, 4, 11 and 19, Rasgon discloses the genetic vector pET28-P2C-Cas9 (para. [0220]), but does not explicitly disclose a fusion peptide comprising a pBas-P2C hybrid vector. Also, Table 9 of Rasgon discloses a P2C-Cas9 and a BtKV-Cas9 vector.
However, Zhang discloses the use of the PiggyBac (para. [1196]) viral integration or a double-strand transposase method, which allows for the integration of DNA at splice acceptor sites using (Transposase A) TnpA-dCas9 fusions. Zhang provides motivation for using this system by disclosing that the aforementioned integration of DNA by TnpA-dCas9 fusions could allow for repair of endogenous gene mutations by providing replacement exons. Also, it is well-known that the binding of the P2C peptide to Cas proteins of the large CRISPR-Cas9 system, tends to show a low transformation efficiency.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the Cas9 protein of the ReMOT Control system of Rasgon with the HypBase (PiggyBac) transposase system of Zhang. The transformation efficiency of methods based on the combination of the P2C peptide with other proteins is inversely proportional to the size of said proteins. Therefore, the motivation would be to improve the transformation efficiency of the P2C fusion peptide.
Regarding claims 3, 5, 8, 12 and 13, SBI discloses (p. 3, A. Overview; Figure on page) that the “bound” PiggyBac transposase recognizes transposon-specific inverted terminal repeat sequences (ITRs) located on both ends of the transposon vector and efficiently moves the contents from the original sites and efficiently integrates them into TTAA chromosomal sites. The ITRs, bound transposases, and gene editing function capability are inherent to the PiggyBac transposon system.
Regarding claims 7, 9, 14 and 17, The limitations of claims 7, 9, 14 and 17 are outlined in the section on PiggyBac Transposon System Vectors (p. 13, E; Figures on page). SBI discloses a PB51x Dual Promoter series and a PB53x EF1 Series with IRES Co-expressed markers. Regarding claim 7, the entire PB51x cassette is flanked by genomic insulator elements for stabilized expression and PiggyBac Inverted Terminal repeats for mobilization and integration. Regarding claims 9 and 14, SBI (PB51x, p. 13) discloses a genetic vector comprising: a gene of interest, more than one inverted terminal repeat sequence, an antibiotic resistant selection gene, a promoter, and a polyadenylation sequence. Regarding claim 17, SBI discloses all of the common vector elements as stated above (PB51x, p. 13) and a translation initiation sequence (PB53x can add an IRES along with a promoter), sequences that encode self-cleavage peptide sequences (Xbal), and a replication origin sequence (pUC).
Regarding claims 6 and 16, Rasgon discloses that the insect of interest can be a mosquito (Claim 27).
Regarding claim 20, SBI discloses modifiable vectors (as mentioned in the rejections of claims 7, 9, 14 and 17; p. 13, E; Figures on page) that can be adjusted with the teachings from Rasgon regarding the P2C peptide; and the teachings from Zhang regarding the PiggyBac transposon system, as stated above.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rasgon and Zhang with the SBI manual for generating P2C-PiggyBac HypBase vectors. Doing so would improve the transformation efficiency, as PiggyBac transposon vectors are generally smaller than CRISPR/Cas9 vectors. As stated in the rejection of claims 2, 4, 11 and 19, the transformation efficiency of methods based on the combination of the P2C peptide with other proteins is inversely proportional to the size of said proteins. The motivation would be to improve the transformation efficiency of the P2C fusion peptide.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rasgon and Zhang as applied to claims 2 – 9, 11 – 14 and 16 – 20 above, and further in view of Craig et al. (W.O. Patent Application Publication 01/29204 A2; hereinafter Craig).
Regarding claim 18, Rasgon teaches all of the elements of the current invention as stated above but does not explicitly disclose a black fly as an insect of interest. However, Craig discloses an invention that relates to a method for producing a protein of interest in an insect via any active transposable element (p. 6, Transposons, line 23, Piggybac), in which the desired insect can be from the Simulium genus (p. 8, Choice of Insect, line 13, black fly). The motivation would be to expand the amount of target species for the method.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the black fly from Craig with Rasgon’s method for generating recombinant insect oocytes under the motivation of adding more target species to the protocol.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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