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 without traverse of Group I, encompassing claims (1-14) and species election of SEQ ID 23, in the reply filed on 12/17/2025 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/17/2025. Therefore, claims 1-14 are under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application provisional application 63029990, filed on 05/26/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was filed before the mailing date of the non-final first action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code ( See page 14- line 35). 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.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweizer et al ( Current Gene Therapy, 2010).
Regarding claim 1, Schweizer et al teach a lentiviral packaging system and a method of producing a lentiviral vector in order to manufacture sufficient materials for gene therapy purposes to treat acquired or inherited diseases.( See Abstract). Schweizer et al’s packaging system comprises of four plasmids: one plasmid encodes envelope proteins (Env plasmid) linked to one promoter, one plasmid encodes lentiviral Gag and Pol proteins (Gag-Pol plasmid) linked to another promoter, one plasmid encodes a lentiviral Rev protein (Rev plasmid) also linked to its own promoter, and one plasmid comprises a transgene of interest (TOI) that is also linked to its own promoter, this reads on steps (a) and (b). Schweizer et al also teach that the transgene (i.e.green fluorescent protein (GFP) is placed under the control of a CMV/β-actin promoter (CAG), the gag-pol and env (VSV-G) genes are placed under the control of CMV promoter, whereas the rev gene is placed under the control of RSV promoter, this reads on step (c) of the instant claim, as the system of Schweizer et al comprises of at least three promoters that are unique).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marceau et al ( US 2014/0315294 A1).
Regarding claim 1, Marceau et al also teach a lentiviral packaging system and a method of producing a lentiviral vector in order to manufacture sufficient materials for therapeutic applications such as gene therapy and/or DNA vaccination, for use in clinical trials and/or commercial use. ( See abstract). Marceau et al’s lentiviral packaging system comprises of four plasmids, wherein one plasmid encodes envelope proteins (Env plasmid) linked to one promoter, one plasmid encodes lentiviral Gag and Pol proteins (Gag-Pol plasmid) that is linked to another promoter, one plasmid encodes a lentiviral Rev protein (Rev plasmid) linked to its own promoter, and one plasmid comprises a transgene of interest (TOI) that is also linked to its own promoter, this reads on steps (a) and (b). ( See Fig.1, and paragraph [0022]). Marceau et al do not explicitly state the type of promoter used in the aforementioned plasmids; however, Marceau et al cite Schweizer et al as a source reference of the plasmids that can be adapted for producing lentiviral vectors. ( See paragraph [0021]. As discussed above, the lentiviral packaging system of Schweizer comprises of four plasmids, wherein three of which comprise unique promoter each. For example, the plasmid encoding the transgene contains a CMV/β-actin promoter (CAG), the plasmids comprising the gag-pol and env (VSV-G) genes contain CMV promoter, whereas the plasmid comprising the rev gene contains RSV promoter, this reads on step (c) of the instant claim, and therefore Marceau et al anticipate claim1.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Marceau et al ( US 2014/0315294 A1), in view of Shin et al (WO 2021/127076 A1, with a priority date of 12/18/2019).
Regarding claims 11 and 13, the teachings of Marceau et al are set forth above. Marceau et al do not teach a codon-optimized VSVG or REV.
Shi et al teach a lentivirus packaging system comprising of four plasmids and a method of producing a lentiviral vector, comprising: transfecting a mammalian cell with a first nucleic acid encoding REV under control of a first promoter and an ENV gene under control of a second promoter, a second nucleic acid encoding a gene of interest under control of a third promoter, and a third nucleic acid encoding (GAG/POL) under control of a fourth promoter; culturing the transfected mammalian cell; and isolating the lentiviral vector. ( See paragraph [0005]). Shi et al also teach nucleic acids comprising codon-optimized VSVG and REV genes, in which both genes are codon-optimized to match the codon usage of a host cell (i.e. the cells used to produce viral particle). ( See paragraphs [0028-0029]) and, [0057]). Shi et al teach do not explicitly state that the REV and VSVG are optimized for expression in Hek293 cells; however, Shi et al clearly state that the REV and VSVG must be optimized to match the codon usage of the host cell, and because Shi et al exemplified the production of viral particles using Hek293, the REV and VSVG are presumed to be optimized to match the codon usage of Hek293. ( See paragraph [0057]). According to Shi et al, codon optimizing a gene to match a host cell’s codon use preferences enhances gene expression. ( See paragraph [0028-0029]).
Therefore, claims 11 and 13 would have been obvious to one of ordinary skill in the art, as there was some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Marceau et al teach a lentiviral packaging system, but fail to teach a codon-optimized REV and VSVG. Shi et al teach a lentiviral packaging system, as well as codon-optimized VSVG and REV, and strongly suggest to codon optimize viral genes to match the codon usage of a host cell, such as Hek293 cells, in order to enhance gene expression. Therefore, one with ordinary skill in the art who had reviewed Marceau et al could have come across Shi et al and immediately noticed the strong possibility of using codon-optimized REV and VSVG gene, as taught by Shi, to enhance the expression of both genes in the host cell. There is a reasonable expectation of success, when constructing lentiviral packaging system, to use codon-optimize REV and VSVG to match the codon usage of a host cell, such as Hek293 cells, that the lentiviral packaging system of claim 1 could be successfully produced.
Allowable Subject Matter
Claims 2-10,12, and 14 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638