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 .
The Amendment filed September 9, 2025 has been entered.
Claims 2-3 are cancelled.
Claims 1 and 10 are currently amended.
Claim 18 is new.
Claims 1 and 4-18 are pending.
Claims 4-9 and 12-17 are withdrawn.
Claims 1, 10-11 and 18 are examined.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
All previous objections and rejections not set forth below have been withdrawn.
Withdrawn Claim Rejection
The rejection of claims 1, 10 and 11 under 35 U.S.C. 103 as being unpatentable over Takatsuji et al. (U.S. Patent No. 9,605,271, issued Mar. 28, 2017) in view of Gao et al. (U.S. Patent Application Publication No. 2017/0183677, published Jun. 29, 2017) is withdrawn in light of the claim amendments.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 10, 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grotewold (U.S. Patent No. 6,709,867, issued Mar. 23, 2004) in view of Gao et al. (U.S. Patent Application Publication No. 2017/0183677, published Jun. 29, 2017).
Claim 1 as currently amended is drawn to a plant cell modified to comprise a cisgenic gene construct, said cisgenic construct comprising a coding nucleic acid that is native to said plant cell and encodes a signaling moiety, said signaling moiety producing a signal in the electromagnetic spectrum that can be detected in intact plant tissues expressing the signal moiety, said coding sequence being operably linked to a known stress inducible regulatory element that is native to said plant cell, wherein the native genomic location of either the coding nucleic acid or the stress inducible regulatory element is retained, and said cisgenic gene construct expresses the signaling moiety under the control of said regulatory element, further wherein said regulatory element and coding sequence are not operably linked in a corresponding unmodified native plant cell.
Claim 10 as currently amended is drawn to the modified plant cell of claim 1, comprising a first cisgenic gene construct and a second cisgenic gene construct, said first cisgenic gene construct comprising a first stress inducible regulatory element operably linked to a nucleic acid sequence encoding a first signaling moiety and said second cisgenic gene construct comprising a second stress inducible regulator element operably linked to a nucleic acid sequence encoding a second signaling moiety, wherein the first and second inducible regulatory elements are native to the plant cell, wherein said first and second signaling moieties are native to the plant cell and said and second signaling moiety each produce a signal in the electromagnetic spectrum that can be detected in intact plant tissues expressing the signal moiety, and said regulatory element and coding sequence are not operably linked in a corresponding unmodified native plant cell.
Claim 11 is drawn to the modified plant cell of claim 10 wherein the first and second stress inducible regulatory elements are activated by the same abiotic or biotic factor.
New claim 18 is drawn to the plant cell of claim 1 wherein the signaling moiety is detectable by spectral analysis of whole plants by measuring wavelengths from about 380 to about 740 nanometers.
Grotewold teaches a modified grass plant cell, and a plant and plant part comprising a plurality of these cells, wherein the cells comprise a construct comprising a stress inducible regulatory element, operably linked to a nucleic acid sequence encoding one or more regulators of anthocyanin biosynthesis (a signaling moiety producing a signal in the electromagnetic spectrum that can be detected in intact plant tissues expressing the signal moiety), wherein said regulatory element and said nucleic acid sequence encoding one or more regulators of anthocyanin biosynthesis are both native to maize but are not operably linked to one another in maize (abstract; column 1 summary of invention; column 2 lines 55-64; column 3 line 13 to column 5 line 15; claims 1-6 and 9). In the event that the grass plant cell, plant and plant part comprising a plurality of these cells so modified is maize, the construct would be considered cisgenic. Grotewold also teaches that his transgenic plants exhibit a different color phenotype under conditions of stress, which allows actions such as the application of a pesticide, fertilizer or water to be taken in order to ameliorate the negative effects of the stress conditions (abstract; paragraph spanning columns 7-8). Grotewold additionally teaches that transformation of the plants can be determined by assaying for expression of the anthocyanin gene pigment, wherein the accumulation of anthocyanins is verified by extracting a small piece of blade tissue with acid methanol and measuring the absorbance of the extract at or around 530 nanometers using a spectrophotometer (column 7 last full paragraph). Grotewold further teaches the maize R gene, a combination of the maize C1 gene and the maize R gene, as well as a chimeric CRC protein, as examples of alternative anthocyanin pathway factors that can be used (columns 3-4; claim 9). Grotewold exemplifies the observation of anthocyanin accumulation in transgenic grass plants transformed with a DNA construct that expresses the maize R gene and the maize C1 gene (column 8 Example 1).
Grotewold does not teach a cisgenic construct wherein the native genomic location of either the coding nucleic acid or the stress inducible regulatory element is retained, or a modified plant cell comprising a first cisgenic gene construct and a second cisgenic gene construct.
Gao et al. teach that a regulatory element (promoter) endogenous (native) to a plant cell can be modified, using gene editing technology, by replacing the promoter or promoter fragment with a different promoter or promoter fragment, wherein the promoter replacement results in a new promoter activity, including an inducible promoter activity (paragraph [0280]). Gao et al. teach that the promoter (or promoter fragment) to be modified can be a promoter (or promoter fragment) that is endogenous (native) to the cell that is being edited, and that the replacement promoter (or replacement promoter fragment) can also be a promoter (or promoter fragment) that is endogenous (native) to the cell that is being edited (paragraph [0280]). Gao et al. provide a working example in which the native promoter of maize ARGOS8 gene is replaced with the maize GOS2 promoter, creating a cisgenic construct wherein the native genomic location of the coding nucleic acid of the maize ARGOS8 gene is retained (Example 8). Gao et al. also teach that multiple traits can be introduced into plants by transformation, by breeding and by gene editing technology, and that multiple chromosomal loci can be modified simultaneously using gene editing technology (paragraphs [0379], [0391], Example 2).
Given the teachings of Grotewold that a plant cell and plant comprising a construct comprising a nucleic acid encoding one or more native signaling moieties that produce a signal in the electromagnetic spectrum that can be detected in intact plant tissues expressing the signal moiety (i.e. one or more regulators of anthocyanin biosynthesis) operably linked to and expressed from a known native stress inducible regulatory element can be made by transformation, wherein said regulatory element and coding sequence are not operably linked in a corresponding unmodified native plant cell, and that these transgenic plants exhibit a different color phenotype under conditions of stress, which allows actions such as the application of a pesticide, fertilizer or water to be taken in order to ameliorate the negative effects of the stress conditions, given the teachings of Grotewold that the accumulation of anthocyanins in the transgenic plants can be determined spectrophotometrically by measuring absorbance at or around 530 nanometer wavelengths, given the teachings of Grotewold that the maize R gene, a combination of the maize C1 gene and the maize R gene, as well as a chimeric CRC protein, are among alternative anthocyanin pathway factors that can be used in the transgenic plants, given the teachings of Gao et al. that a regulatory element such as a promoter that is native to a plant cell can be modified by replacing the element with a different promoter, including a different native promoter, wherein the promoter replacement results in a new promoter activity, including an inducible promoter activity, given the teachings of Gao et al. that a modified plant cell comprising a cisgenic construct comprising a native coding nucleic acid operably linked to and expressed from a known native regulatory element can be made using gene editing technology, wherein said regulatory element and coding sequence are not operably linked in a corresponding unmodified native plant cell, and wherein the native genomic location of the coding nucleic acid is retained, and given the teachings of Gao et al. that multiple traits can be introduced into plants by transformation, by breeding and by gene editing technology, and that multiple chromosomal loci can be modified simultaneously using gene editing technology, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make a modified plant cell comprising one or more cisgenic constructs comprising one or more nucleic acids encoding a native signaling moiety that produces a signal in the electromagnetic spectrum that can be detected in intact plant tissues expressing the signal moiety (i.e. one or more regulators of anthocyanin biosynthesis) operably linked to and expressed from a known native stress inducible regulatory element, wherein said regulatory element and coding sequence are not operably linked in a corresponding unmodified native plant cell, and wherein the native genomic location of the coding nucleic acid is retained.
One skilled in the art would have been motivated to do so in order to alter the expression of the native signaling moiety coding nucleic acid(s) in the plant cell in order to allow for actions such as the application of a pesticide, fertilizer or water to be taken in order to ameliorate the negative effects of the stress conditions. One skilled in the art would have had a reasonable expectation of success, given the success of Grotewold in making a plant cell modified to comprise a gene construct made in vitro that comprises two nucleic acid sequences (the maize R gene and the maize C1 gene) encoding two signaling moieties that produce a signal in the electromagnetic spectrum that can be detected in intact plant tissues expressing the signal moiety and that is introduced into the plant cell by transformation of the cell with the construct, and given the success of Gao et al. in making a plant cell modified to comprise a cisgenic construct made in vivo using gene editing technology.
The choice of specific stress inducible regulator element(s) and signaling moiety coding sequence(s) would be determined by the desired expression conditions and the desired signal effects.
Thus, the claimed invention would have been prima facie obvious as a whole to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662