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, claims 1-9, in the reply filed on July 7, 2026 is acknowledged. Claims 10-11 are withdrawn.
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 5, and claims 6-9 dependent thereon, 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 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 5 is indefinite because neither claim 5 nor the specification define the nucleotide sequence of the BR2 open reading frame. Accordingly, the location of the single thymine (T) insertion in the BR2 gene is unclear.
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th 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.
Claim 9 fails to further limit claim 8. Claim 8 is drawn to the corn plant of claim 7, wherein the native BR2 mutant allele is br2-MX. Claim 9 is drawn to the plant of claim 8, wherein the native BR2 mutant allele comprises an insertion of a transposon of 4.7 kb in Exon 5 of the BR2 gene. Claim 9 fails to further limit claim 8 because a native BR2 mutant allele that is br2-MX already comprises an insertion of a transposon of 4.7 kb in Exon 5 of the BR2 gene. See, e.g. paragraphs [0329] and [0338] of the specification. 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 § 102/ 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 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.
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 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Pilu et al. (Isolation and characterization of a new mutant allele of brachytic 2 maize gene. Molecular Breeding 20, 83-91 (2007)).
Claim 1 is drawn to a corn plant comprising at least one non-natural brachytic mutation, wherein the corn plant exhibits a semi-dwarf phenotype compared to a control corn plant not comprising the at least one non-natural brachytic mutation when grown under comparable conditions.
Pilu et al. teach a mutant allele (br2-23) of the brachytic 2 maize gene that has a useful intermediate phenotype in terms of plant height, ear height and leaf angle (semi-dwarf) when heterozygous (Br2-23/br2-23) (abstract). Plant height and ear height are reduced for homozygous and heterozygous br2-23 genotypes (Fig. 4). The girth (diameter) of the internodes (stalk) is enhanced in mutant plants, most predominantly in the second internode which is approximately 30% larger than its counterpart in control plants (Discussion first paragraph). The short stature and enhanced girth of br2-23 mutants enhances the strength of the stalk, with the mutant showing greater tolerance to wind lodging (Discussion first paragraph). Pilu et al. also teach that their finding that Br2-23/br2-23 heterozygotes exhibit a useful intermediate phenotype suggests that the effect of heterozygosity on grain yield, which is known to be reduced in other br2 mutants, should be explored when developing new maize hybrids (Discussion seventh paragraph). The br-23 mutant allele carries an eight-nucleotide deletion in the coding region (Fig. 6c).
Although the br-23 mutant allele is a spontaneously arising mutation isolated from the progeny of a selfed B73 inbred line plant (page 89 column 2 first full paragraph), and therefore was not made as a result of laboratory or experimental procedures or under the exposure to mutagens (non-natural as defined at paragraph [0071] of the specification), the claimed plant is anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over the plant of Pilu et al., because the claimed plant and the plant of Pilu et al. are identical in both structure and function, i.e. both plants are corn plants that comprise at least one brachytic mutation, with both corn plants exhibiting a semi-dwarf phenotype compared to a control corn plant, and because the use of laboratory and experimental procedures to produce known gene mutations in known genes was already practiced by those of skill in the art before the effective filing date of the instant application.
See MPEP 2112.01 I: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
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.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Multani et al. (Loss of an MDR transporter in compact stalks of maize br2 and sorghum dw3 mutants. Science. 2003 Oct 3;302(5642):81-4), Xing et al. (A rare SNP mutation in Brachytic2 moderately reduces plant height and increases yield potential in maize. J. Exp. Bot. 2015 Jul;66(13):3791-802. Epub 2015 Apr 28) and Pilu et al. (Isolation and characterization of a new mutant allele of brachytic 2 maize gene. Molecular Breeding 20, 83-91 (2007)) in view of Zhu et al. (Efficiency and Inheritance of Targeted Mutagenesis in Maize Using CRISPR-Cas9. J. Gent. Genomics. 2016 Jan 20;43(1):25-36. Epub 2015 Dec 21).
Claim 1 is drawn to a corn plant comprising at least one non-natural brachytic mutation, wherein the corn plant exhibits a semi-dwarf phenotype compared to a control corn plant not comprising the at least one non-natural brachytic mutation when grown under comparable conditions.
Claim 2 is drawn to the corn plant of claim 1, wherein the at least one non-natural brachytic mutation occurs in a BR gene reducing the activity of the BR gene and is not introduced via transposon, and wherein the corn plant does not comprise a br2-23 brachytic allele or SNP5259.
Claim 3 is drawn to the corn plant of claim 2, wherein the BR gene is a BR2 gene.
Claim 4 is drawn to the corn plant of claim 3, wherein the at least one non-natural brachytic mutation is selected from the group consisting of a substitution, an insertion, an inversion, a deletion, a duplication, and a combination thereof.
Claim 5 is drawn to the corn plant of claim 4, wherein the at least one non-natural brachytic mutation is a single thymine (T) insertion between nucleotide number 5420 and 5421 according to the BR2 open reading frame.
Claim 6 is drawn to the corn plant of claim 5, wherein the corn plant is heterozygous for the at least one non-natural brachytic mutation.
Claim 7 is drawn to the corn plant of claim 6, wherein the corn plant comprises a native BR2 mutant allele.
Claim 8 is drawn to the corn plant of claim 7, wherein the native BR2 mutant allele is br2-MX.
Claim 9 is drawn to the plant of claim 8, wherein the native BR2 mutant allele comprises an insertion of a transposon of 4.7 kb in Exon 5 of the BR2 gene.
Multani et al. teach that plants with short stature are of agronomic interest because of their ability to resist lodging, which allows them to effectively convert increased fertilized input into higher yields (page 81 paragraph spanning columns 1 and 2). Multani et al. also teach that maize (corn) brachytic2 (br2) mutants are characterized by short stature as a consequence of compact lower stalk internodes (abstract; page 82 column 1 first full paragraph). Multani et al. additionally teach that the girth (diameter) of affected stalk internodes is often enhanced (increased) in maize (corn) brachytic2 (br2) mutants (page 82 column 2). Multani et al. cloned the maize Br2 gene by using transposon tagging to disrupt the gene, and determined that maize plants having insertions in Exon 1 and Intron 4 of the gene exhibit a br2 mutant phenotype (page 82 column 3 second full paragraph; page 83 Fig. 3; Supporting Online Material). Multani et al. additionally teach the nucleotide sequence of the maize Br2 gene.
Xing et al. teach a naturally occurring maize (corn) brachytic2 (br2) mutant that is milder than known br2 mutants in that plant height is reduced with little or no effect on plant yield, with plant height also being reduced when the mutation is heterozygous (abstract). This (br2) mutant comprises a plant height QTL, qph1, that comprises a SNP (SNP5259) in Exon 5 of the Br2 gene that causes an amino acid substitution from arginine to leucine (page 3796 Fig. 4). The (br2) mutant that comprises the plant height QTL qph1 exhibits an incomplete (partial dominant) effect with respect to plant height (page 3794 column 1 first paragraph; Fig. 2a). Xing et al. also teach that the introgression of a recessive br2 gene of maize is considered to have great potential for reducing plant height, but that all recessive br2 alleles identified so far cause phenotypes that are too severe to make them practical for use in breeding improvement programs (page 3800 column 2). Xing et al. additionally teach that the milder br2 allele in qph1 has a more moderate effect on plant height and no or minimal negative effect of grain yield has the potential to be used to improve maize by marker assisted selection for reduced plant height and lodging resistance (paragraph spanning pages 3800-3801). Xing et al. further teach a corn plant exhibiting semi-dwarf phenotype that comprises a native BR2 mutant allele, wherein the native BR2 mutant allele is br2-MX as defined in the specification in paragraph [0337] (page 3798 paragraph spanning columns 1 and 2). The native BR2 mutant allele br2-MX has a 3.5 kb insertion of EnSpm-like transposon 660 bp upstream of the predicted TATA box and a complete gag/pol retro-transposon insertion of 4.7 kb in exon 5 which truncates the last 153 amino acids of the protein (page 3798 paragraph spanning columns 1 and 2). The native BR2 mutant allele br2-MX behaves as a recessive allele, with heterozygous and wild-type plants showing no significate difference in plant height in segregating populations (page 3798 column 2).
Pilu et al. teach a mutant allele (br2-23) of the brachytic 2 maize gene that has a useful intermediate phenotype in terms of plant height, ear height and leaf angle when heterozygous (Br2-23/br2-23) (abstract). Plant height and ear height are reduced for homozygous and heterozygous br2-23 genotypes (Fig. 4). The girth (diameter) of the internodes (stalk) is enhanced in mutant plants, most predominantly in the second internode which is approximately 30% larger than its counterpart in control plants (Discussion first paragraph). The short stature and enhanced girth of br2-23 mutants enhances the strength of the stalk, with the mutant showing greater tolerance to wind lodging (Discussion first paragraph). Pilu et al. also teach that their finding that Br2-23/br2-23 heterozygotes exhibit a useful intermediate phenotype suggests that the effect of heterozygosity on grain yield, which is known to be reduced in other br2 mutants, should be explored when developing new maize hybrids (Discussion seventh paragraph). The br-23 mutant allele carries an eight-nucleotide deletion in exon 5 of the coding region of the BR2 gene (Fig. 6c).
None of Multani et al., Xing et al. or Pilu et al. teach a corn plant comprising at least one non-natural brachytic mutation wherein the corn plant exhibits a semi-dwarf phenotype, wherein the at least one non-natural brachytic mutation is not introduced via transposon, and wherein the corn plant does not comprise a br2-23 brachytic allele or SNP5259.
Zhu et al. generally teach that the modification of pre-intended genomic loci with preferred mutations is an ideal goal for plant molecular biologists and crop breeders as crop plant genomic information becomes available (Introduction, page 25). Zhu et al. also teach that targeted genome editing technologies have been developed and applied to achieve this goal of producing non-natural gene mutations, technologies that employ engineered sequence-specific nucleases such as zinc finger nucleases and TALENs, which have been employed using multiple plant species including maize (i.e. corn) (Introduction, pages 25-26). Zhu et al. additionally teach that chimeric RNA/DNA oligonucleotides have successfully employed to make targeted gene mutations in maize, and that CRISPR-Cas9 can also be applied to mediate targeted gene mutagenesis in maize (Introduction, pages 25-26).
Given the teachings of Multani et al. that plants with short stature are of agronomic interest because of their ability to resist lodging, which allows them to effectively convert increased fertilized input into higher yields, given the teachings of Multani et al. that maize (corn) brachytic2 (br2) mutants having insertions in Exon 1 and Intron 4 of the maize Br2 gene that exhibit a br2 mutant phenotype characterized by short stature and enhanced girth as a consequence of compact lower stalk internodes can be made by gene disruption, given the teachings of Xing et al. that a maize (corn) brachytic2 (br2) mutant that comprises a SNP (SNP5259) in Exon 5 of the Br2 gene that causes an amino acid substitution from arginine to leucine is milder than known br2 mutants in that plant height is reduced with little or no effect on plant yield, with plant height also being reduced when the mutation is heterozygous, given the teachings of Xing et al. that the maize (corn) brachytic2 (br2) mutant br2-MX has a 3.5 kb insertion of EnSpm-like transposon 660 bp upstream of the predicted TATA box and a complete gag/pol retro-transposon insertion of 4.7 kb in exon 5 which truncates the last 153 amino acids of the protein exhibits a semi-dwarf phenotype, given the teachings of Xing et al. that while all recessive br2 alleles identified so far cause phenotypes that are too severe to make them practical for use in breeding improvement programs, the milder br2 allele in qph1tht has a more moderate effect on plant height and no or minimal negative effect of grain yield has the potential to be used to improve maize by marker assisted selection for reduced plant height and lodging resistance, given the teachings of Pilu et al. that a mutant allele (br2-23) of the brachytic 2 maize gene has a useful intermediate phenotype in terms of plant height, ear height and leaf angle when heterozygous, with plant height and ear height being reduced for homozygous and heterozygous genotypes, and the girth (diameter) of the internodes (stalk) being enhanced in mutant plants, given the teachings of Pilu et al. that the short stature and enhanced girth of br2-23 mutants enhances the strength of the stalk, with the mutant showing greater tolerance to wind lodging, given the teachings of Pilu et al. that their finding that Br2-23/br2-23 heterozygotes exhibit a useful intermediate phenotype suggests that the effect of heterozygosity on grain yield, which is known to be reduced in other br2 mutants, should be explored when developing new maize hybrids, given the teachings of Pilu et al. that the br-23 mutant allele carries an eight nucleotide deletion in exon 5 of the coding region of the BR2 gene , and given the teachings of Zhu et al. that the modification of pre-intended genomic loci with preferred mutations is an ideal goal for plant molecular biologists and crop breeders as crop plant genomic information becomes available, and that targeted genome editing technologies have been developed and applied to achieve this goal of producing non-natural gene mutations, including technologies that can be employed using maize (corn), 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 semi-dwarf corn plant comprising at least one non-natural brachytic mutation in a BR2 gene.
One skilled in the art would have been motivated to do so in order to produce corn plants exhibiting an agronomic trait (short stature) that is recognized as being agronomically beneficial (lodging resistance leading to effective conversion of increased fertilized input and higher yields). One skilled in the art would have has a reasonable expectation of success, given the success of Multani et al.in inducing mutations in the maize BR2 gene by using transposon tagging to disrupt the gene, given the knowledge of the structure of the maize BR2 gene and the knowledge of the structure of multiple brachytic mutations in the maize BR2 gene, including BR2 gene mutations that result in a semi-dwarf phenotype, and given the success of Zhu et al. and others in producing non-natural targeted gene mutations in maize. One skilled in the art would also have recognized that BR2 gene mutations that are similar to as well as the same as known BR2 gene mutations could produce a semi-dwarf phenotype, since the location and the structure of mutations that result in a semi-dwarf phenotype are known in the art, and would serve as a guide with respect to the type of mutations to produce.
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.
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
