Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2, 5, 9, 40 and 55-58 are pending.
Claim 40 is withdrawn.
Claims 1-2, 5, 9 and 55-58 are examined.
Withdrawn objections
The objection to claim 58 is withdrawn in light of amendments made by Applicant.
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 57-58 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All
dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Applicant claims a plant comprising a dominant gain of function mutation in a LAZY4 nucleic acid sequence encoding for a protein having a LAZY4D motif wherein the LAZY4D motif is SEQ ID NO: 3, 4, 5, 6 or 73 and wherein the mutation is specified among a Markush group of amino acid residues in the LAZY4D motif. Applicant has elected SEQ ID NO: 3 (claim 1).
Claim 57 specifies that the plant of claim 1 is more drought resistant compared to a plant that does not comprise the mutation.
Claim 58 specifies that the plant of claim 1 has an average lateral root angle that is more downward compared to a plant that does not comprise the mutation.
Applicant describes a single nucleotide change in LAZY4 resulted in an R145K substitution. Applicant describes transforming an Arabidopsis thaliana plant with agrobacterium to comprise the R145K mutation in addition to R145A and R145E, all comprised a more vertical lateral root (page 35, paragraph 2). Applicant describes introducing an R143A into the LAZY2 protein sequence using agrobacterium-mediated transformation, the T1 progeny comprised a vertical lateral root trait (Example 2, page 35). Applicant describes mutant LAZY4 protein sequences C137A, P138A, V143A, D144A, R146A, S139A, L129A, P130A and R133A comprising a vertical lateral root trait in Arabidopsis thaliana (Example 3, pages 35-36).
Applicant does not describe the claimed genus of any plant comprising a dominant gain of function mutation in any LAZY4 nucleic acid wherein the mutation is in the LAZY4D motif as claimed in claim 1 wherein the plant has increased drought resistance and an average lateral root angle that is more downward. Applicant does not describe a representative number of species across the genus of any LAZY4 sequence in any plant encoding a protein comprising a LAZY4D motif comprising SEQ ID NO: 3, 4, 5, 6 or 73 as encompassed by claim 1 the specified mutations therein. Applicant does not describe any plant with improved drought resistant, though the average lateral root angle being more vertically downward hypothetically would improve drought tolerance. Therefore, Applicant’s described species are not representative of the full scope of the genus claimed.
Applicant has only described specific mutations conferring a specific phenotype of vertical lateral roots in a single species, Arabidopsis thaliana. The claims also encompass any homolog, paralog, orthologue and functional variant of a LAZY4 nucleic acid sequence comprising any dominant gain-of-function mutation. The species described by applicant are not representative of these genera. The described mutations are not sufficient to establish the structure-function relationship. The function conferred by the described mutations is limited to a more vertical lateral root growth trait. The teachings in the art regarding the structure-function relationship of mutations in a LAZY4 gene are limited. Dardick et al. (US20180094272) teaches one example resulting in a phenotype with more horizontal lateral root angles (Abstract); however, Dardick acknowledges that the knowledge of the mechanisms is limited and that few genes have been identified as regulators of deep rooting and root angle traits (paragraph 6). It is noted that Applicant states that AtDRO1 is also known as LAZY4 (Specification page 2, line 4). It is not clear that the claimed mutations would be sufficient to confer the dominant gain of function mutation in any plant comprising a LAZY4 nucleic acid sequence encoding a protein with a LAZY4D motif.
Therefore, Applicant has not satisfied the written description requirement.
Applicant’s arguments regarding rejection under 35 USC 112(a) for failing to comply with the written description requirement
The declaration under 37 CFR 1.132 filed 4/1/2026 is insufficient to overcome the rejection of claims 57-58 based upon 35 USC 112(a) for failing to comply with the written description requirement as set forth in the last Office action.
The declaration argues that the LAZY4D motif is highly conserved between different plants, sequences and amino acids which should be mutated have been disclosed as well as protocols for generating mutations to produce plants comprising the modified LAZY4D motif as well as how to identify them. The declaration argues that Exhibit A provides additional experiments in which a what EMS lazy4D mutant was generated with an R132W substitution, identified as Cadenza 1761, which had a steeper root angle than the wild-type. The declaration argues that the phylogenetic distance between Arabidopsis and wheat demonstrates the conservation of the LAZY protein across plants. The declaration argues that one of ordinary skill in the art can modify the conserved sequence of the lazy4D motif in any plant because a sequence to be mutated is disclosed as well as a method for identifying the desired phenotype. The declaration argues that using disclosed sequences and methods can be observed in other plants given the high conservation of the protein throughout plants and given the observations disclosed in both Arabidopsis and wheat.
Applicant's arguments in the Remarks filed 4/1/2026 have been fully considered but they are not persuasive.
Applicant refers to the Declaration, of which the arguments are summarized above.
These arguments have been fully considered but are not persuasive. The claimed LAZY4D motif, including the elected SEQ ID NO: 3, is found with 100% identity to many proteins in many plant species, of which the function is not characterized. See, for example, the alignment to locus VFU57918 (Genbank Accession No. VFU57918. 2020). Note that the variable residue “X” of SEQ ID NO: 3 encompasses the “S” residue of the accession; therefore, the sequences match with 100% identity. The claimed LAZY4D motif being relatively small at 10 residues in length and the lack of claimed requirement for the rest of the protein means that the claims encompass many plants comprising sequences with 100% identity in which it is not clear whether these plants would have the claimed functions. Therefore, Applicant has not satisfied the written description requirement because it would not be not clear to one of ordinary skill in the art which embodiments within the claimed scope of plants and modified proteins would comprise the claimed functions.
Alignment of SEQ ID NO: 3 to Genbank Accession No. VFU57918:
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Scope of Enablement - How to use
Claim 1-2, 5, 9 and 55-56 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for specific mutations within the AtLAZY4 motif with the resulting function of increasing the average downward angle of lateral roots in Arabidopsis thaliana, Applicant has not enabled a use of the claimed genus because the claims subject to this rejection do not claim a use. Therefore, interpreted as being intended for any use, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with the claim.
Applicant claims a plant comprising a dominant gain of function mutation in a LAZY4 nucleic acid sequence encoding for a protein having a LAZY4D motif wherein the LAZY4D motif is SEQ ID NO: 3, 4, 5, 6 or 73 and wherein the mutation is specified among a Markush group of amino acid residues in the LAZY4D motif. Applicant has elected SEQ ID NO: 3 (claim 1). However, the claim does not specific that the mutation would confer any phenotype to a plant or that it would have any function whatsoever.
Applicant claims the plant of claim 1 comprising an R substitution in position 9 in the LAZY4D motif of elected SEQ ID NO: 3 or in SEQ ID NO: 4, in position 20 of SEQ ID NO: 5, position 21 of SEQ ID NO: 6 or position 17 of SEQ ID NO: 73 (claim 2).
Applicant claims the plant of claim 1 wherein the nucleic acid sequence comprises at least 90% identity to SEQ ID NO: 1 (claim 5).
Applicant claims that the genetically altered plant of claim 1 comprises a mutation in the endogenous LAZY4 nucleic acid sequence (claim 9).
Applicant claims the plant of claim 1 is from a Markush group of plants representing a broad diversity (claim 55).
The claimed invention is drawn to a plant comprising a mutated sequence regardless of whether the DNA is able to confer a difference in phenotype to a plant or has any function whatsoever.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Applicant teaches a single nucleotide change in LAZY4 resulted in an R145K substitution. Applicant teaches transforming an Arabidopsis thaliana plant with agrobacterium to comprise the R145K mutation in addition to R145A and R145E, all comprised a more vertical lateral root (page 35, paragraph 2). Applicant teaches introducing an R143A into the LAZY2 protein sequence using agrobacterium-mediated transformation, the T1 progeny comprised a vertical lateral root trait (Example 2, page 35). Applicant teaches mutant LAZY4 protein sequences C137A, P138A, V143A, D144A, R146A, S139A, L129A, P130A and R133A comprising a vertical lateral root trait in Arabidopsis thaliana (Example 3, pages 35-36).
Applicants do not teach how one of skill in the art could use any of the products claimed wherein the mutated polypeptide is non-functional or has a function other than that which is described.
Given the lack of guidance in the instant specification, undue trial and error experimentation would have been required for one of ordinary skill in the art to use the claimed invention throughout the broad scope of the claim.
Therefore, given the breadth of the claim; the lack of guidance and working examples; the unpredictability in the art; and the state-of-the-art as discussed above, undue experimentation would have been required to practice the claimed invention, and therefore the invention is not enabled throughout the broad scope of the claims.
Applicant’s arguments regarding rejection under 35 USC 112(a) for failing to comply with the enablement requirement
Applicant's arguments filed 4/1/2026 have been fully considered but they are not persuasive.
The declaration under 37 CFR 1.132 filed 4/1/2026 is insufficient to overcome the rejection of claims 1-2, 5, 9 and 55-56 based upon 35 USC 112(a) for failing to comply with the enablement requirement as set forth in the last Office action.
The declaration argues that the LAZY4D motif is highly conserved between different plants, sequences and amino acids which should be mutated have been disclosed as well as protocols for generating mutations to produce plants comprising the modified LAZY4D motif as well as how to identify them. The declaration argues that one of ordinary skill in the art can follow the protocols without undue experimentation to produce plants with a steeper root phenotype. The declaration argues that Exhibit A provides additional experiments in which a what EMS lazy4D mutant was generated with an R132W substitution, identified as Cadenza 1761, which had a steeper root angle than the wild-type. The declaration argues that the phylogenetic distance between Arabidopsis and wheat demonstrates the conservation of the LAZY protein across plants. The declaration argues that one of ordinary skill in the art can modify the conserved sequence of the lazy4D motif in any plant because a sequence to be mutated is disclosed as well as a method for identifying the desired phenotype. The declaration argues that using disclosed sequences and methods can be observed in other plants given the high conservation of the protein throughout plants and given the observations disclosed in both Arabidopsis and wheat.
Applicant's arguments in the Remarks filed 4/1/2026 have been fully considered but they are not persuasive.
These arguments have been fully considered but are not persuasive. Applicant has not claimed a functional limitation which would allow one of ordinary skill in the art to determine whether a plant with a mutation in a LAZY4D motif reads on the claimed invention. Applicant would obviate the rejection for failing to comply with the enablement requirement by requiring a limitation such as is required by claims 57 and 58. It is noted that the lack of an unambiguous functional limitation is why the claims rejected for failing to comply with the enablement requirement are not also rejected for failing to comply with the written description requirement. Therefore, amending the claims to require a function such as is recited in claims 57 and 58 would not necessarily make the claims allowable because of issues related to lacking written description; however, Examiner acknowledges that claims 5 and 56 provide useful limitations regarding the definition of the LAZY4 protein and claim 55 limits the scope of plant species.
Closest prior art
Claims 1-2, 5, 9 and 55-58 are free of prior art. There is no teaching or suggestion in the prior art to introduce a gain-of-function mutation in the LAZY4D motif of a protein encoded by a LAZY4 nucleic acid sequence. The closest prior art is Dardick (US 2018094272) as applied to claims 1-2, 5, 9 and 12 under 35 USC 102(a)(1) in the Non-Final Rejection filed 9/18/2024. Dardick teaches overexpression of AtDRO1 resulted in reduced lateral root angles. Dardick does not disclose, teach or suggest introducing a gain-of-function mutation into the LAZY4D motif of a protein encoded by a LAZY4 nucleic acid sequence.
Conclusion
Claims 1-2, 5, 9 and 55-58 remain rejected.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R BYRNES/Examiner, Art Unit 1662
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