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, claims 1-18 in the reply filed on 01/27/2026 is acknowledged.
Claims 19-22 are withdrawn by the Examiner as being drawn to nonelected subject matter.
Claims 1-18 are examined herein on the merits.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al (USPGPUB 20200407741 filed on 03/04/2019) in view of Cost (US Patent 10179918) in view of Watanabe et al (WO2004035780), in view of Laga et al (WO2016128519) and further, in view of Hohn et al (USPGPUB20040086847).
The claims are drawn to polynucleotides and a vector comprising a site-specific nuclease expression cassette and a sequence that binds to a nuclear translocation factor and/or an intranuclear structure comprising a site-specific nuclease sequence and a 3’ UTR comprising a terminator wherein the sequence that binds is an insulator wherein the insulator is an insulator other than a scaffold/matrix attachment region wherein the insulator is ARS, Gypsy, Bead1, TEF or TEF2, wherein the terminator is a linked body of at least two terminators, wherein the binding sequence is located in the 3’ UTR and downstream of the terminator wherein the terminator is a 35S or an ACT3 or an extension terminator, wherein the cassette comprises a promoter and the promoter is a shoot apex expression promoter or a CmYLCV, UBQ, EF-1alpha or RPS5a promoter, wherein the polynucleotide comprises a geminivirus vector sequence wherein the vector is a BeYDV sequence, wherein the sequence further comprises a guide RNA expression cassette.
Mason et al teach a method for enhancing transgene expression in plants comprising using a polynucleotide sequence comprising a promoter, a terminator wherein the terminator is a double terminator, wherein the terminator is an extension terminator, and a matrix attachment region wherein the polynucleotide sequence comprises the geminivirus BeYDV vector sequence in the form of a BeYDV promoter and terminator (see “Double Terminators Enhance VLP expression” and the following section “Exemplary Plant Expression vectors”, and claims 1-6).
Mason et al do not teach the above with a site-specific nuclease, the guide RNA sequence, an insulator, nor the specified promoter of the instant claims.
Cost teaches using CRISP-Cas a site-specific nuclease using guide RNA sequences for increasing transgene activity, wherein the site-specific nuclease is used in a plant vector in conjunction with a 3’ UTR (see claims 1-11), including using insulators (see 3rd paragraph preceding “Delivery”).
Watanabe et al teach the use of the ARS insulator to prevent the silencing of transgenes (see background and Figure 1, for example).
Laga et al teach the use of a shoot apex promoter for increasing the expression of genes (see claims 1 and 2).
Hohn et al teach the use of CmYLCV promoters.
Given the state of the art, the disclosures by Mason et al, Cost, Watanabe et al, Laga et al and Hohn et al, it would have been obvious to one of ordinary skill in the art at the time of filing to practice the invention of Mason et al using CRISPR as taught by Cost, to improve the transgene expression as taught and suggested by Cost as well as using the ARS insulator sequence to prevent silencing of the gene as taught by Watanabe et al. The vector elements, known at the time of filing and taught by Laga et al and Hohn et al would have been design choices readily available to one of ordinary skill at the time of filing. One of ordinary skill in the art would have been motivated to practice the invention this way for the purpose of optimal transgene expression which was the same motivation provided by Cost.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663
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