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 .
Claim Status
Claims 1-4, 6, 7, 11, 15, 30, 70 and 80-84 are pending and examined. Claims 5, 8-10, 12-14, 16-29, 31-69, 71-79 and 85-95 have been cancelled.
The rejection of claims 15 and 81-84 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendments.
Specification
The objection to the specification is withdrawn in light of the amendments.
Claim Objections
The objection to claim 1 is withdrawn in light of the amendment.
Claim Rejections - 35 USC § 112
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 1-4, 6, 7, 11, 15, 30, 70 and 80-84 REMAIN 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 a maize plant comprising the mutant nucleotide sequences of SEQ ID NO: 77 and 79 to alter ear length or root width and length, does not reasonably provide enablement for making and using plants comprising the exhaustive genus of nucleic and amino acid sequences as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
The claims are broadly drawn to a corn plant comprising at least one mutation in AP2/ERF comprising a nucleotide sequence having as little as 90% sequence identity to the coding sequence of SEQ ID NO: 69 or the genomic nucleotide sequence of SEQ ID NO: 70 or a target nucleotide sequence of SEQ ID NO: 72-75 or the amino acid sequence of SEQ ID NO: 71, wherein the mutation is in a region having at least 90% sequence identity to any of the nucleotide sequences of SEQ ID NO: 72-75, wherein the plant exhibits any improved yield trait, a guide nucleic acid having as little as 90% sequence identity to the coding sequence of SEQ ID NO: 69 or the genomic nucleotide sequence of SEQ ID NO: 70 or a target nucleotide sequence of SEQ ID NO: 72-75 or the amino acid sequence of SEQ ID NO: 71, and wherein the mutated gene or amino acid sequence has as little as 90% sequence identity to SEQ ID NO: 77-82.
Meanwhile, the specification teaches edited alleles of the corn gene Zm00001 d007119 were recovered from a transformation experiment including the CRISPR guide nucleic acid comprising PWsp607 (SEQ ID NO:76) having complementarity to targets within the AP2/EFR gene. Three edited alleles designated “Allele A”, “Allele B” and “Allele C” of BD1-like were recovered and having deletions of various sizes or a nucleotide conversion and having the nucleotide sequences of SEQ ID NO: 77, 79 and 80, respectively, and the corresponding amino acid sequences of SEQ ID NO: 78, 80 and 81 (p. 99).
The specification teaches that edits of the AP2/ERF gene may have an effect on ear length suggesting these edits may affect plant yield while root observations indicate that some of the AP2/ERF edited alleles affect root width and length and may lead to an increase in plant yield or plant stability when grown in a field environment (p. 100 and 101).
Here, the specification fails to teach or provide guidance regarding the critical structures or motifs found within AP2/ERF comprising a nucleotide sequence having as little as 90% sequence identity to the coding sequence of SEQ ID NO: 69 or the genomic nucleotide sequence of SEQ ID NO: 70 or the amino acid sequence of SEQ ID NO: 71 that confer AP2/ERF functional activity such that if one were to mutate said sequences it would be unknown whether functional activity would be lost or modified in order to obtain any predictable phenotype. Moreover, the specification fails to provide working examples for making and using plants comprising the genus of mutated genes as claimed.
This guidance is essentially because a nucleic acid sequence having as little as 90% identity to SEQ ID NO: 70 would have 92 nucleic acid substitutions relative to SEQ ID NO: 70, while a polynucleotide encoding a polypeptide with as little as 90% identity to SEQ ID NO: 71 would have 30 amino acid substitutions relative to SEQ ID NO: 71.
These polynucleotide and polypeptides would encompass 392 and 1930 distinct gene and protein variants, respectively. In the absence of guidance indicating where in the sequence of SEQ ID NO: 70 and 71 such variations can be sustained, undue trial and error experimentation would be required to make the claimed polynucleotides of SEQ ID NO: 70, or to the make the polypeptide of SEQ ID NO: 71 which retains functional activity such that when it is mutated the function is abolished, reduced or altered to change any possible trait or those as recited in claim 11.
This analysis also applies to the mutating the genomic nucleotide sequence of SEQ ID NO: 69 and to making mutations in the nucleotides sequences of SEQ ID NO: 72-75 and 77, 79 or 81 in addition to mutations to the amino acid sequences of SEQ ID NO: 78, 80 or 82, or to a guide nucleic acid that binds to any of the aforementioned nucleotide or amino acid sequences.
The failure of the specification to teach the critical domains or motifs of the AP2/ERF is compounded by the state of the art, which teaches that this transcription factor family is large and is involved in several regulatory processes, such as the plant’s growth and development, fruit maturity, protection system, metabolism-responsive genes in the signaling pathways of ethylene, and biosynthesis pathways of phytohormones, i.e., ET, CK, GA, JA, ABA in plants (Cheng et al, 2023, Genes, 14(194)1-18; p. 2, ¶ 1 and 2).
Moreover, the AP2/ERFs include the following subfamilies: Apetala 2 (AP2), dehydration-responsive element-binding proteins (DREB), relation to abscisic acid-insensitive 3/ivviparous 1 (RAV), ethylene-responsive factors (ERF), and soloist which are involved in growth, floral development, leaf shape, and seed growth, metabolic regulations and might contribute to chromosomal duplication, tandem gene duplication, drought and salt-responsive responses, abiotic stress responses, regulation of leaf senescence and other stress responses (p. 2, ¶ 2).
Namely, because the claims are drawn to and large and diverse transcription factor family having many functions, and the fact that the claims encompass a large genus of sequences encoding said transcription factor family, the skilled practitioner would be unable to either predictably make or use the plants as claimed which encompass a plant having any conceivable improved yield trait that is not limited to the explicitly recited traits of claim 11.
Therefore, in light of the breadth of the claims, the lack of working examples commensurate in scope with the breadth of the claims, the failure of the specification to provide a structure-function correlation for the genes and amino acid sequences as claimed and the state of the art which teaches that the AP2/ERF transcription factor gene family has a multitude of roles in the plant, the skilled artisan would be required to engage in impermissible and excessive undue experimentation to arrive at the maize plant as claimed.
Response to Arguments
Applicant traverses the rejection in light of the amendments to the claims and because the specification describes and exemplifies how to make and use the claimed corn plant (Applicant reply dated 12 August 2026, p. 8, last ¶ and p. 9, ¶ 1).
This argument is unpersuasive and not commensurate in scope with what is claimed. The specification provides three working examples and two modified traits, yet the claims encompass an enormous genus of AP2/ERF structures when mutated result in a plant having an equally broad genus of phenotypes/traits.
Applicant traverses the rejection by arguing that Cheng teaches the structural and functional characteristics of AP2/ERF (Applicant reply dated 12 August 2026, p. 9, penultimate ¶).
This argument is not persuasive because Cheng does not teach any AP2/ERF structure that confer functions to alter ear length or root growth, let alone any of the uses for the corn plant as broadly encompassed by the claims.
Rather, Cheng reinforces that one would have to systematically test the broad genus of nucleotide sequences as claimed because AP2/ERF is known to be involved in a myriad of regulatory processes, such as the plant’s growth and development, fruit maturity, protection system, metabolism-responsive genes in the signaling pathways of ethylene, and biosynthesis pathways of phytohormones, i.e., ET, CK, GA, JA, ABA in plants, floral development, leaf shape, and seed growth, metabolic regulations and potential chromosomal duplication, tandem gene duplication, drought and salt-responsive responses, abiotic stress responses, regulation of leaf senescence and other stress responses.
However, the specification provides no guidance whatsoever for determining which nucleic acid sequences as claimed are involved in the aforementioned functions, and merely posits that AP2/ERF may have an effect on ear length, or root width and length, and may lead to an increase in yield or plant stability.
Claims 1-4, 6, 7, 11, 15, 30, 70 and 80-84 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.
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Claims 1-4, 6, 7, 11, 15, 30, 70 and 80-84 are broadly drawn to a corn plant comprising at least one mutation in AP2/ERF comprising a nucleotide sequence having as little as 90% sequence identity to the coding sequence of SEQ ID NO: 69 or the genomic nucleotide sequence of SEQ ID NO: 70 or a target nucleotide sequence of SEQ ID NO: 72-75 or the amino acid sequence of SEQ ID NO: 71, wherein the mutation is in a region having at least 90% sequence identity to any of the nucleotide sequences of SEQ ID NO: 72-75, wherein the plant exhibits any improved yield trait, a guide nucleic acid having as little as 90% sequence identity to the coding sequence of SEQ ID NO: 69 or the genomic nucleotide sequence of SEQ ID NO: 70 or a target nucleotide sequence of SEQ ID NO: 72-75 or the amino acid sequence of SEQ ID NO: 71, and wherein the mutated gene or amino acid sequence has as little as 90% sequence identity to SEQ ID NO: 77-82.
Meanwhile, the specification describes edited alleles of the corn gene Zm00001 d007119 were recovered from a transformation experiment including the CRISPR guide nucleic acid comprising PWsp607 (SEQ ID NO:76) having complementarity to targets within the AP2/EFR gene. Three edited alleles designated “Allele A”, “Allele B” and “Allele C” of BD1-like were recovered and having deletions of various sizes or a nucleotide conversion and having the nucleotide sequences of SEQ ID NO: 77, 79 and 80, respectively, and the corresponding amino acid sequences of SEQ ID NO: 78, 80 and 81 (p. 99).
The specification describes that edits of the AP2/ERF gene may have an effect on ear length suggesting these edits may affect plant yield while root observations indicate that some of the AP2/ERF edited alleles affect root width and length and may lead to an increase in plant yield or plant stability when grown in a field environment (p. 100 and 101).
Here, the specification fails to describe a representative number of species from the broad genus of sequences as claimed, and fails to describe the critical structures or motifs found within AP2/ERF comprising a nucleotide sequence having as little as 90% sequence identity to the coding sequence of SEQ ID NO: 69 or the genomic nucleotide sequence of SEQ ID NO: 70 or the amino acid sequence of SEQ ID NO: 71 that confer AP2/ERF functional activity such that if one were to mutate said sequences it would be unknown whether functional activity would be lost or modified in order to obtain any predictable phenotype. Moreover, the specification fails to provide working examples of the genus of mutated genes as claimed.
This description is critical because a nucleic acid sequence having as little as 90% identity to SEQ ID NO: 70 would have 92 nucleic acid substitutions relative to SEQ ID NO: 70, while a polynucleotide encoding a polypeptide with as little as 90% identity to SEQ ID NO: 71 would have 30 amino acid substitutions relative to SEQ ID NO: 71.
These polynucleotide and polypeptides would encompass 392 and 1930 distinct gene and protein variants, respectively. In the absence of guidance indicating where in the sequence of SEQ ID NO: 70 and 71 such variations can be sustained, the skilled practitioner would not be of the opinion that Applicant possesses genus of polynucleotides of SEQ ID NO: 70, or to the genus of polypeptides of SEQ ID NO: 71 which retains functional activity such that when it is mutated the function is abolished, reduced or altered to change any possible trait or those as recited in claim 11.
This analysis also applies to the mutating the genomic nucleotide sequence of SEQ ID NO: 69 and to making mutations in the nucleotides sequences of SEQ ID NO: 72-75 and 77, 79 or 81 in addition to mutations to the amino acid sequences of SEQ ID NO: 78, 80 or 82, or to a guide nucleic acid that binds to any of the aforementioned nucleotide or amino acid sequences.
The failure of the specification to describe the critical domains or motifs of the AP2/ERF is compounded by the state of the art, which describes that this transcription factor family is large and is involved in several regulatory processes, such as the plant’s growth and development, fruit maturity, protection system, metabolism-responsive genes in the signaling pathways of ethylene, and biosynthesis pathways of phytohormones, i.e., ET, CK, GA, JA, ABA in plants (Cheng et al, p. 2, ¶ 1 and 2).
Moreover, the AP2/ERFs include the following subfamilies: AP2, DREB, RAV, ERF, and soloist which are involved in growth, floral development, leaf shape, and seed growth, metabolic regulations and might contribute to chromosomal duplication, tandem gene duplication, drought and salt-responsive responses, abiotic stress responses, regulation of leaf senescence and other stress responses (p. 2, ¶ 2).
Namely, because the claims are drawn to a large and diverse transcription factor family having many functions, and the fact that the claims encompass a large genus of sequences encoding said transcription factor family, the skilled practitioner would not be led to believe that Applicant possessed the plants as claimed which encompass a plant having any conceivable improved yield trait that is not limited to the explicitly recited traits of claim 11.
Therefore, in light of the breadth of the claims, the lack of working examples commensurate in scope with the breadth of the claims, the failure of the specification to describe a structure-function correlation for the genes and amino acid sequences as claimed and the state of the art which describes that the AP2/ERF transcription factor gene family has a multitude of roles in the plant, the skilled artisan would not be of the opinion that Applicant was in possession of the plants, mutated genes and guide nucleic acids as broadly claimed.
Response to Arguments
Applicant traverses the rejection in light of the amendments to the claims, because the specification describes and exemplifies how to make and use the claimed corn plant, and because the domains and motifs of AP2/ERF were known in the art (Applicant reply dated 12 August 2026, p. 10, penultimate and last ¶; see also p. 11, ¶ 1).
This argument is unpersuasive and not commensurate in scope with what is claimed. The specification provides three working examples and two modified traits, yet the claims encompass an enormous genus of AP2/ERF structures then when mutated result in a plant having an equally broad genus of phenotypes/traits.
This argument is also unpersuasive because Cheng does not describe any AP2/ERF structure that confer functions to alter ear length or root growth, let alone any of the uses for the corn plant as broadly encompassed by the claims.
Rather, Cheng reinforces that one skilled in the art would not be of the opinion Applicant possesses the genus of nucleotide sequences as broadly claimed because AP2/ERF is known to be involved in a myriad of regulatory processes, such as the plant’s growth and development, fruit maturity, protection system, metabolism-responsive genes in the signaling pathways of ethylene, and biosynthesis pathways of phytohormones, i.e., ET, CK, GA, JA, ABA in plants, floral development, leaf shape, and seed growth, metabolic regulations and potential chromosomal duplication, tandem gene duplication, drought and salt-responsive responses, abiotic stress responses, regulation of leaf senescence and other stress responses.
However, the specification provides no description whatsoever of nucleic acid sequences as claimed that are involved in the aforementioned functions, and merely posits that AP2/ERF may have an effect on ear length, or root width and length, and may lead to an increase in yield or plant stability.
Moreover, the issue is not whether one could make and use the claimed plant. The issue is whether (1) the specification describes a representative number of species from the genus of nucleotide and amino acid sequences as claimed or (2) whether the specification provides structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed.
In the instant matter, the specification has failed to describe, in fact, either (1) or (2) such that the skilled practitioner would not be of the opinion that Applicant possesses the plants, genes and guide nucleic acids as broadly claimed.
Conclusion
No claim is allowed.
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 JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
Prosecution Insights