DETAILED ACTION
Claims 1-9 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1 and 3-4 are objected to because of the following informalities:
In claims 1 and 3 “CaAIBZ1 (Capsicum annuum ASRF1-Interacting bZIP transcription factor 1)” should be replaced with ---Capsicum annuum ASRF1-Interacting bZIP transcription factor 1 (CaAIBZ1)--.
In claim 4, lines 1-3, “the introducing comprising” should be replaced with --introducing comprises--.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 6-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claim 4 is indefinite in its recitation of “ribonucleoprotein comprised of … a recombinant vector containing a DNA encoding the guide RNA specific to the target nucleotide sequence of the CaAIBZ1 gene and a nucleic acid sequence encoding the endonuclease protein”. Ribonucleoproteins do not comprise vectors. It is unclear what Applicant means by this.
Claim 6 is indefinite in claiming both a plant and a method of using it. When a claim mixes statutory classes, it is unclear when direct infringement occurs. See MPEP 2173.05(p) II. This rejection can be overcome by replacing “is” in line 2 with --was--.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Parent claim 6 is drawn to a genome-edited hot pepper plant with enhanced drought tolerance which is produced by the method of claim 3. Claim 7 is drawn to the plant of claim 6, where the plant is a bi-allelic CaAIBZ1 gene-edited plant. However, the specification teaches that mom-allelic CaAIBZ1 gene-edited plants have a drought tolerance that is similar to the control, that is, they do not have enhanced drought tolerance (¶75). Thus, the plant claimed in claim 6 must already be a bi-allelic CaAIBZ1 gene-edited plant, and claim 7 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-9 rejected under 35 U.S.C. 103(a) as being unpatentable over Lee et al (2020, KR 102101690; citations in the rejection are to the attached machine translation) in view of Yu et al (2021, WO 2021/055587) and Fu et al (2021, New Phytologist 229:370-387).
The claims are drawn to a method of editing the CaAIBZ1 gene in hot pepper, compositions used in the method, and a genome-edited hot pepper plant with enhanced drought resistance thereby produced.
Lee et al teach CaAIBZ1 and the nucleic acid encoding it (their SEQ ID NO:2 and 1, respectively; ¶8). They silenced the gene in chili pepper (Example 7); the resulting plants had enhanced drought tolerance (¶126-127). Lee et al do not teach inactivating the gene encoding CaAIBZ1 by gene editing.
Yu et al teach that both silenced and knock-out MYBS2 rice lines (MYSB2-Ri and MYSB2-Cas9, respectively) were drought tolerant (¶79). The MYSB2-Cas9 lines was made using a vector encoding a 24 bp MYBS2 guide RNA (¶65, 67).
Fu et al teaches Cas9 mutation of the MYBS2 gene. The loss-of-function mutants were generated by transforming a vector encoding guide RNAs targeting the first and second exons of the gene and encoding Cas9 into Nipponbare rice plants (pg 371, left column, paragraph 3; pg 383, left column, paragraph 1; Figure 5).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method of eliminating the expression of CaAIBZ1 in chili pepper taught by Lee et al to substitute eliminating the expression by Cas9-genetred gene knock out as described in Fu et al. One of ordinary skill in the art would have been motivated to do so because Yu et al teach that both silenced and knock-out MYBS2 rice lines have the same phenotype (¶79).
Knock-out mutations have the advantage over silenced genes because they are not subject to transgene inactivation over the generations and the resulting plants would be nontransgenic. As transgenes and T-DNA are no longer needed after the mutations are produced, plants without the transgene and T-DNA can be selected for and the transgene and T-DNA lost during rounds of selfing. These rounds of selfing would also produce genome-edited seed of the hot pepper plant.
One of ordinary skill in the art would target the guide RNAs to PAM-site (NGG) containing regions in either strand of the first third to first half of the CaAIBZ1 and screen the resulting plants for frame-shift mutations. The instant SEQ ID NOS:1, 3 and 4 are included in such PAM-site containing regions in the first 125 bases of the CaAIBZ1 coding region. Selection of the PAM-site containing regions in the CaAIBZ1 gene to test are a design choice.
One of ordinary skill in the art would expect that the resulting plants would have the same phenotype as the CaAIBZ1-silenced plants taught in Lee et al because Yu et al teach that silenced and knock-out plants have the same phenotype.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
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