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 1, claims 1-8, 16, 18, 22-24, 29-36, 50, and the Species i. a mutant allele of an endogenous brachytic 2 (br2) gene, in the reply filed on March 4th, 2026 is acknowledged. Because claims 16, 18, 22-24 are not pertinent to the elected Species, claims 16, 18, 22-24 and 29, are also withdrawn from consideration. This Restriction/Election Requirement is made FINAL.
Claims 1-8, 16, 18, 22-24, 29-36, 50, 53-61, 68, 72, 76-78, 82, 84, 87, 89-91, 93, 105- 109, 112-116, 118-119, 122-123, 127, 132-134, 137, 153, 155-156, 158, 160-161, 163-164, and 166 are pending. Claims 16, 18, 22-24, 29, 53-61, 68, 72, 76-78, 82, 84, 87, 89-91, 93, 105- 109, 112-116, 118-119, 122-123, 127, 132-134, 137, 153, 155-156, 158, 160-161, 163-164, and 166 are withdrawn from consideration. Claims 1-8, 30-36, and 50 are examined on their merit herein.
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 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claim 30 is 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 30 at line 2 invokes Markush Grouping. However, the claim recites “selected from the group including” such that the list of alternatives is not a closed grouping. Claim language defined by a Markush grouping requires selection from a closed group “consisting of” the alternative members. See MPEP 2117 and MPEP § 2111.03, subsection II.
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 1-3, 5-7, 30-35, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by VILLA, Genetic Study and Agronomic Evaluation of Brachytic 2 Mutant in Maize, 2010, submitted in IDS of 05/23/2024.
Claim 1 is drawn to a maize plant or maize plant part comprising a mutant allele of an endogenous brachytic 2 (br2) gene, and a mutant allele of an endogenous brown midrib 3 (bm3) gene.
Claim 2 is drawn to the maize plant or maize plant part of claim 1, wherein the mutant allele is an insertion, deletion, or substitution of one or more nucleotides, or any combination thereof, in the endogenous bm3 or br2 gene.
Claim 3 is drawn to the maize plant or maize plant part of claim 1, wherein the bm3 mutant allele is bm3-l, bm3-2, or bm3-3; and/or wherein the br2 mutant allele is br2-23, br2-7081, br2-7861, br2-qphl, br2-qpal, br2-NC238, or br2-1005.
Claim 5 is drawn to the maize of claim 1, wherein the bm3 mutant allele comprises one or more mutations relative to SEQ ID NO: 94, 95 and/or 96; and/or wherein the br2 mutant allele comprises one or more mutations relative to SEQ ID NO: 90, 91 and/or 92. (VILLA “the alignment of the 3’ Br2 (B73 allele) and br2–23 sequences, revealed that the mutant carries an eight nucleotide deletions in the coding region (Pilu et al., 2007). P.75, para.3)
Regarding claim 1, VILLA discloses a maize plant comprising both a br2 and a bm3 mutant allele: “…… introgression of br2 in an inbred line affected by the mutation brown midrib (bm3)” and “…… mutation br2 could be exploited to strengthen the stalk of bm3 producing inbred lines double mutants br2/br2 bm3/bm3 ……”; p. 75, para. 4.
Regarding claim 2, VILLA discloses that, for example, the br2 mutant allele is “br2–23 …… carries an eight nucleotide deletions in the coding region” (p. 75, para. 3). Additionally, VILLA discloses, via citation of Vignols F. et al., 1995, bm3 alleles “bm3-1 which has arisen from an insertional event producing a COMT mRNA altered in both size and amount”; and “the second bm3 allele, bm3-2, has resulted from a deletion of part of the COMT gene.” (Vignols, Abstract).
Regarding claim 3, VILLA discloses br2-23, and bm3-1, see above.
Regarding claim 5, and claim 31, although VILLA is silent regarding the wild type genomic sequences that are SEQ ID NO: 94, 95 or 96, by virtue of disclosing the mutant alleles comprising deletions and/or insertions compared with the wild type genomic sequences, VILLA inherently discloses the maize plant or part of claim 1, wherein the bm3 or br2 mutant allele comprises one or more mutations relative to the wild type genomic sequences of SEQ ID NO: 90, 91, 92, 94, 95 or 96.
Regarding claim 6, VILLA discloses “bm3-1 which has arisen from an insertional event producing a COMT mRNA altered in both size and amount”, as discussed above. This reads on “wherein the expression level and/or activity of the mRNA and/or protein encoded by the mutant allele of the endogenous bm3 gene is reduced”.
Regarding claim 7, VILLA discloses “double mutants br2/br2 bm3/bm3”, as discussed above, which reads on maize plant homozygous for the bm3 mutant allele and/or the br2mutant allele.
Regarding claims 30, and 35, VILLA discloses that in the double mutant plant, br2 could be exploited to strengthen the stalk of bm3 and reducing the susceptibility to lodging caused by bm3, since “the br2/br2 mutant has a greater stalk at base that would confer a greater resistance to lodging”. (p. 75, para. 4 to p. 76, para. 1) Therefore VILLA discloses the claimed maize plant having one or more traits of…... reduced root lodging, ……, and increased stem cross-section area.
Regarding claim 32, since VILLA discloses the introgressed maize line, it reads on the resulted maize plant as a hybrid.
Claims 33-34 are drawn to the maize plant of claim 1, wherein the maize plant has a shorter plant height as compared to the wild-type or control maize plant; wherein the maize plant has a plant height that is about 10% or more shorter than the wild-type or control maize plant;….. and/or wherein the maize plant or maize plant part comprises an increased NDFD over the wildtype or control maize plant or plant part of about 1 % or more. Claim 34 is interpreted according to “or” as having the listed traits as alternatives.
Regarding claims 33-34, VILLA discloses that br2 alleles cause reduced plant height, e.g., p. 74, para. 5; p. 76, para. 2; and so on; and particularly, 8 and 18% shorter in mutant plants than in Br2/Br2 wild-type (p. 74, para. 5).
Regarding claim 50, VILLA inherently discloses seed of the maize plant.
Therefore, claims 1-3, 5-7, 30-35, and 50 are anticipated by the prior art.
Claim 36 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by VILLA, 2010, as applied to claim 1, with evidence from CARTER (Patent US9238818B2, 2016).
Claim 36 is drawn to the maize plant of claim 1, wherein the maize plant or maize plant part comprises a protein content of about 2% or more; a lignin content of about 6% or less; a starch content of about 20% or more; a NDFD of about 50% or more; and/or an ADP of about 50% or less.
Since the claim uses “or” to indicate the limitations as alternative options, the claim is examined on one of the embodiments: lignin content.
VILLA discloses that the bm3 mutant alleles cause maize plant to have “low lignin content and a consequent high digestibility of the fiber” (p.75). However, VILLA is silent regarding the lignin content of the mutant maize plant.
CARTER shows that compared with the lignin content of ~6.6% in control plant, bm3 maize has a reduced lignin content of 1.7 or 1.2% (Table 3), which is lower than 6%.
Therefore, claim 36 is also anticipated by VILLA.
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 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over VILLA, 2010, as applied to claim 1 as discussed above, in view of BARTEN, WO2018119225A1, filed in 2017 and published in 2018.
Claim 1 and the teachings of VILLA are discussed supra.
Claim 4 is drawn to the maize plant of claim 1, wherein the bm3 and/or the br2 mutant allele of the endogenous gene is an edited allele.
Claim 8 is drawn to the maize plant of claim 1, wherein the maize plant is heteroallelic for the bm3 or br2.
VILLA does not teach gene editing or heteroallelic mutant.
BARTEN teaches genome editing-based crop engineering and production of brachytic maize plant (Title), methods for producing a semi-dwarf corn plant using a CRISPR based genome editing system wherein the semi-dwarf plants comprise at least one non-natural brachytic mutation in which the activity of a BR2 gene is reduced. (Abstract).
Furthermore, BARTEN teaches creating new brachytic plant by crossing a gene edited allele (br2-GE) with another br2 allele, br2-MX (Example 2, e.g., p. 66-67, para. [0340]) which is heteroallelic by comprising two different br2 mutant alleles. BARTEN teaches the mutant maize plant having reduced height, increased stem diameter, and no difference in yield traits compared with control plants (Tables 4-5, e.g.).
Therefore, it would have been prima facie obvious for a person having ordinary skills in the art at the time of filing of the instant application to have used the method and guidance of BARTEN to make an edited br2 mutant allele or the heteroallelic br2 and use in the br2/bm3 double mutant maize plant of VILLA, thereby arriving at the instantly claimed invention. The PHOSITA would have been motivated to do so given the teachings of VILLA regarding the advantage of br2 mutant to compensate for the lodging defects of bm3 mutant and the advantages of using edited br2 mutant alleles by BARTEN. The PHOSITA would have reasonable expectation of success given the teachings and success of BARTEN and VILLA.
Therefore, the claimed invention as a whole is prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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