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 in the reply filed on 27 May 2026 is acknowledged.
Claims 32-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 May 2026.
Claim Status
Claims 21-40 are pending and newly presented.
Claims 32-40 are withdrawn from consideration.
Claims 21-31 are examined on the merits.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 22, 28, and 31 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 pre-AIA the applicant regards as the invention.
Claim 22 recites, “wherein the one or more genetic modifications is an insertion or deletion of at least one nucleotide in or near the NAC7 coding region and wherein the insertion or deletion effects a frameshift in the endogenous NAC7 gene.” It is unclear how a mutation near but not in the coding region of the NAC7 gene can cause a frameshift mutation. It is unclear what structure such a mutant allele would have. As such, the metes and bounds of the claim cannot be determined.
Claim 28 recites the limitation "wherein the one or more genetic modifications in at least one allele of the NAC7 genomic locus" in 21. Claim 21 fails to recite anything regarding alleles. There is insufficient antecedent basis for this limitation in the claim. While claim 21 does recite, “one or more genetic modifications” the lack of connection to the phrase, “at least one allele” renders claim 28 unclear. It is as if this recitation in claim 28 seems to indicate that claim 21 does not require that that “at least one allele” comprises “one or more genetic modifications,” but this is not possible given the plain language of claim 21. As such, the metes and bounds of the claim cannot be determined.
Claim 31 is drawn to methods of modifying the NAC7 motif in maize (requiring the use of CRISPR/Cas to modify a motif set for in N1-N9 wherein N1=F,R,T,V, or Y; N2=W; N3=H,K,R,N, or S; N4=S,P,T,I,A, or K; N5=T,S,A,V, or E; N6= G,A, or C; N7=R,K,A,S,T,P, or N; N8= D,S,T,E, or P; or N9=K,E,C,G,T, or R. NAC7 in maize appears to only comprise a single embodiment of this large genus of motifs in residues 96-104 SEQ ID NO:3 comprises YWKATGKDR. It is unclear how the maize gene could comprise any more of these motifs such that they could be targeted in the method. This issue is worsened by the fact that the conjunction “or” is used between the listing of N8 and N9. As such, the metes and bounds of the claims cannot be determined.
Improper Claim Dependency
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.
.
Claim 27 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 27 is drawn to the method of claim 25, wherein the functional motif is edited or replaced. Claim 25 already requires that there are one or more modifications in the functional motif. It is unclear how the “one or more modifications in the functional motif” are considered anything more than edits given that the modifications are required to be introduced via a Cas endonuclease as claims 25 depends upon claim 21. As such, claim 27 fails to further limit claim 25. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fengler et al 2016 (WO 2016/099918 A1) and further in view of Zhu et al (US 2016/0264982 A1).
Fengler et al disclose reduced activity of YEP6 gene (same as instant NAC7, see alignment below) results in favorable phenotypes including increase staygreen and drought tolerance (see entire document). They teach that there are several ways to reduce YEP6 activity including inducing mutations and detection of such mutations using TILLING and that the effected plant is maize (p. 3-6, 24, 32-33, 37, 59-60, 93-97). Note that TILLING is used to detect substitution mutations; therefore, such mutations are contemplated. The additional claimed features regarding kernel phenotype and moisture naturally flow from the reduction in YEP6 activity and thus those limitations are also met. Further note that Example 3 in the instant specification indicates that reduction in activity in maize NAC7 via either promoter mutation or coding sequence mutation leads to a dominant phenotype (paragraph 0561).
Fengler et al do not teach to make the claimed modifications or to use CRISPR to modify a NAC7 gene.
Zhu et al teach methods of modifying plant genomes using the CRISPR system which uses a Cas endonuclease and a guide RNA (see entire document). They further teach that donor template can be used to make multiple mutations via insertion, deletion, and/or replacement and contemplate that this method can be used to modify expression regulatory elements, including promoters (paragraphs 37-38, 171, claim 5).
At the time of filing, it would have been obvious for a person of ordinary skill in the art to make reduced function NAC7 alleles in plants to the end of achieving the improved phenotype taught by Fengler et al which would be dominant mutation based on the findings of the instant specification. A person of ordinary skill in the art would have recognized that the method of Zhu et al would have been useful in creating such mutant alleles, including mutations in the promoters to reduce expression as Zhu et al suggest their method is useful in altering expression regulatory elements. Moreover, a person skilled in the art would have recognized that targeting any region conserved among NAC proteins would likely lead to a loss of function. It is particularly well-understood in the art that substitution of prolines tend to interfere with function as substitution to any other amino acid residue will dramatically change the geometry of the peptide backbone at that site. Additionally, it is widely known that indel mutations that are not of base 3 in number generally lead to introduction of a premature stop codon and often loss of function. Accordingly, claims 21-31 are rejected under 35 U.S.C. 103 as being unpatentable over Fengler et al and further in view of Zhu et al.
BDB53953
ID BDB53953 standard; protein; 338 AA.
XX
AC BDB53953;
XX
DT 11-AUG-2016 (first entry)
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DE Zea mays NAC-domain containing protein (YEP6) sequence, SEQ ID 2.
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KW NAC-domain containing protein; YEP6 protein; abiotic stress tolerance;
KW biomass; crop improvement; dna polymorphism; gene silencing;
KW genetic marker; plant; rna interference; screening; seed;
KW transgenic plant.
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OS Zea mays.
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CC PN WO2016099918-A1.
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CC PD 23-JUN-2016.
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CC PF 03-DEC-2015; 2015WO-US063639.
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PR 17-DEC-2014; 2014US-0092933P.
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CC PA (DUPO ) PIONEER HI-BRED INT INC.
CC PA (DUPO ) DU PONT DE NEMOURS & CO E I.
CC PA (UYIL-) UNIV ILLINOIS URBANA-CHAMPAIGN.
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CC PI Fengler K, Gupta R, Li B, Moose SP, Weers B, Fengler W;
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DR WPI; 2016-38266T/46.
DR N-PSDB; BDB53952.
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CC PT Plant has reduced endogenous YEP6 gene expression, where YEP6 gene
CC PT encodes YEP6 polypeptide, and plant exhibits phenotype i.e. increased
CC PT yield, abiotic stress tolerance, staygreen or biomass as compared to
CC PT control plant.
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CC PS Claim 4; SEQ ID NO 2; 132pp; English.
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CC The present invention relates to a transgenic plant having reduced
CC endogenous NAC-domain containing protein (YEP6) gene expression. The
CC transgenic plant exhibits at least one phenotype selected from increased
CC yield, abiotic stress tolerance, staygreen or biomass as compared to a
CC control plant. The invention further relates to: (1) a suppression DNA
CC construct for reducing the expression of endogenous YEP6 gene in a plant,
CC which comprises a polynucleotide that is operably linked in sense or
CC antisense orientation to a heterologous promoter; (2) a method for
CC producing a transgenic plant having reduced endogenous YEP6 gene
CC expression, which involves introducing the suppression DNA construct into
CC the plant; (3) a method for enhancing seed yield in a plant; (4) a method
CC for identifying one or more alleles associated with increased yield in a
CC population of maize plants, which involves detecting polymorphisms in a
CC genomic region encoding a polypeptide or a regulatory region controlling
CC expression of a polypeptide in a population of maize plants and
CC identifying alleles at polymorphisms that are associated with increased
CC yield; and (5) a method for identifying trait loci or gene controlling
CC trait loci, which involves developing breeding population of maize
CC plants, where the breeding population is generated by crossing first
CC maize inbred line characterized as high protein line with second maize
CC inbred line characterized as low protein line, selecting progeny maize
CC plants based on phenotype of interest, performing marker analysis for
CC phenotypes identified in progeny of plants, and identifying trait loci or
CC gene controlling trait loci. The suppression DNA construct is sense
CC suppression construct, antisense suppression construct, ribozyme
CC construct, RNA interference construct or miRNA construct, preferably RNA
CC interference construct. The methods of the invention can be used for
CC producing a transgenic plant exhibiting increased yield, abiotic stress
CC tolerance, staygreen or biomass. The present sequence is a Zea mays NAC-
CC domain containing protein sequence, whose encoding gene is used in the
CC invention as a target for producing a transgenic plant exhibiting
CC increased yield, abiotic stress tolerance, staygreen or biomass.
XX
SQ Sequence 338 AA;
Query Match 100.0%; Score 1803; DB 23; Length 338;
Best Local Similarity 100.0%;
Matches 338; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSMSFLSMVEAELPPGFRFHPRDDELICDYLAPKLGAKPGFSGCRPPMVDVDLNKVEPWD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSMSFLSMVEAELPPGFRFHPRDDELICDYLAPKLGAKPGFSGCRPPMVDVDLNKVEPWD 60
Qy 61 LPVAASVGPREWYFFSLKDRKYATGQRTNRATVSGYWKATGKDRPVVAARRGALVGMRKT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LPVAASVGPREWYFFSLKDRKYATGQRTNRATVSGYWKATGKDRPVVAARRGALVGMRKT 120
Qy 121 LVFYQGRAPKGRKTEWVMHEYRMEPAAPLLDHQPSSSNSKDEDWVLCRVICKKKLAAGGR 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LVFYQGRAPKGRKTEWVMHEYRMEPAAPLLDHQPSSSNSKDEDWVLCRVICKKKLAAGGR 180
Qy 181 AGGGSSRSLVASNGGRETAPATPPPPPLPPRMDTDATLAQLQAAMHATAGALEQVPCFSS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AGGGSSRSLVASNGGRETAPATPPPPPLPPRMDTDATLAQLQAAMHATAGALEQVPCFSS 240
Qy 241 FNNNTASSRAAAAAAAAQPCYLPSMATGGSHGTTSYYLDHAMLPPELGGCFDPLHGDKKL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FNNNTASSRAAAAAAAAQPCYLPSMATGGSHGTTSYYLDHAMLPPELGGCFDPLHGDKKL 300
Qy 301 LKAVLGQLGGDAVAPGLSLQHEMAAGAVVASSAWMNHF 338
||||||||||||||||||||||||||||||||||||||
Db 301 LKAVLGQLGGDAVAPGLSLQHEMAAGAVVASSAWMNHF 338
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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