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 .
Examiner invites applicant for an interview on the 112 issues described below.
Claim Status
Claims 1-12 are pending.
Claims 1-4, 6, 8-11 are newly amended.
Claims 13-20 are newly cancelled.
Claims 1-12 remain rejected.
Response to Amendment
In response to Applicant’s statement in the remarks dated 02/11/2026, the June 12, 2023 claims are treated as withdrawn.
Response to Applicant Arguments - 35 USC § 112 (Indefiniteness)
In response to Applicant’s arguments and amendments to the claims dated 02/11/2026, the indefiniteness rejections of record drawn to the indefinite nature of the names ZmDA2 are withdrawn.
With respect to the indefiniteness rejections due to the indefiniteness introduced by the recitation of “a genomic modification that reduces or disrupts the activity of ZmDA2”, applicant does not provide any remarks drawn to these rejections and applicant’s amendments fail to limit the scope of the claims to definite subject matter and as such the rejections of record are maintained.
Similarly, with respect to the indefiniteness rejections due to the indefiniteness introduced by the use of the term “reference sequence” in claims 10 and 12, applicant does not provide any remarks drawn to these rejections and applicant’s amendments fail to limit the scope of the claims to definite subject matter and as such the rejections of record are maintained.
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.
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.
Claims 1-12 remain 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 1 recites, “a genomic modification that reduces or disrupts the activity of ZmDA2” as compared to a plant not comprising the modification. This limitation is unclear because the scope conferred by the term “disrupts” is not clear. The plain meaning of disrupted activity means reduced activity or reduced ability to perform its biological function, however, given that the claim presents reduced activity and disrupted activity as alternatives, these terms appear to confer distinct scopes to the claim. It is not clear how the scope imparted by these two terms differs. The specification provides no definition of “disrupt” or “disrupts” and appears to use this term interchangeable with “reduce” or “reduces”, thus the metes and bounds imparted on the claim by the recitation of “disrupted activity” are not clear and the claim remains rejected as indefinite. Dependent claims 2-12 are included for depending on an indefinite claim and failing to limit the claim to definite subject matter.
Claims 10 and 12 depend on claim 2 and claim 8 respectively and add limitations drawn to modifications found within specific genomic regions of a reference sequence. Given the language of the claims it is unclear whether the broadest reasonable interpretation of the scope of each claim is drawn to a modified plant having a modification within the specified region of the exact sequence of SEQ ID NO: 3 or if instead the modification must be present within a region of any ZmDA2 sequence corresponding the specified sequence in reference sequence SEQ ID NO: 3.
This is unclear because of the use of the term “reference sequence SEQ ID NO: 3”. Including the term “reference” in the claim indicates that the sequence does not need to be the exact sequence of SEQ ID NO: 3, however because the claim omits the use of clear language such as “the modification is comprised within a genomic region corresponding to about position 1689 to about position 3733 of reference sequence SEQ ID NO: 3” it is unclear whether the claim scope is limited to plants comprising the exact sequence of SEQ ID NO: 3 which comprises a modification in the specified range or whether it is more broadly drawn to a ZmDA2 sequence having a modification in a region which corresponds to the specified regions in the reference sequence SEQ ID NO: 3.
For clarity, claim 12 includes distinct language in sections i) and ii). In section i) the claims states “with reference to sequence ID NO: 3” making clear that the claimed sequence only has to have the modification in the region which corresponds to the specified region in the reference. In contrast section ii) uses the language “of reference sequence SEQ ID NO: 3” and it is this language which remains rejected as indefinite.
Response to Applicant Arguments - 35 USC § 112 (Written Description)
Applicant’s arguments and amendments to the claims dated 02/11/2026 have been fully considered but are not found to be persuasive and therefore the written description rejections of record are maintained.
Applicant’s arguments appear to be drawn to the following concept:
The claim is amended to recite that the genomic modification is in an endogenous ZmDA2 gene encoding a protein having at least 95% sequence identity to SEQ ID NO:2, where this modification is a deletion, an insertion, a substitution, an inversion, or a duplication and wherein the modification is downstream of a sequence coding for a RING domain and therefore the claims have adequate written description.
In response the examiner notes that this amendment limits the scope of the claim by requiring direct modifications in the ZmDA2, however, there are several aspects of the invention of the amended claim which remain inadequately described.
Specifically, while applicant has amended the claim to provide a location of the modification (downstream of a sequence encoding for a RING domain) the claim still requires “a genomic modification that reduces or disrupts the activity of ZmDA2”.
Applicant has not provided description which would allow the ordinary artisan to identify if a modification reduces or disrupts the activity of ZmDA2. A structure function relationship between genomic modifications in an endogenous ZmDA2 gene downstream of a sequence coding for a RING domain and the function of reducing or disrupting the activity of ZmDA2 appears essential in describing the claimed invention. Without this relationship the structures required to produce the claimed phenotype are not clear and therefore it would not be clear if a modified corn plant, corn plant seed, corn plant part, etc. is the claimed modified corn plant, corn plant seed, corn plant part, etc. or if it is a distinct corn plant from that of the invention.
In the examples Applicant describes plants produced using their three gene editing constructs which target two regions of a single ZmDA2 sequence. While, applicant genotyped plants in each target region and assessed kernel/ear/yield potential of plants with edited alleles, Applicant concludes: “The field trial data presented in this example demonstrates that targeted editing of the ZmDA2 gene leads to the improvement of key yield component traits in hybrid corn, suggesting that these genomic edits may produce a dominant effect on increased yield traits” (Specification, Page 53, Paragraph 0166).
Thus, while applicant has investigated at least one species of the claimed genus of sequences, applicant does not appear to have assessed whether the introduced modifications have any effect on the activity of ZmDA2. In applicant’s own words, the genomic edits may produce a dominant effect on increased yield traits, however there is no description of the mechanism which may underly this phenomenon and there is no demonstration of a causal link between the introduced modifications and reduced or disrupted activity of ZmDA2. Instead applicant presents a correlation between the presence of these edits in hybrid corn and certain yield components without assaying the activity of ZmDA2.
Importantly, the only recitations of the word “activity” in applicant’s examples are:
“The edited ZmDA2 gene can encode modified proteins with, reduced, disrupted, or altered activity.”
“The modified ZmDA2 produced from the edited ZmDA2 gene may have reduced or disrupted activity, yet still be able to interact with other proteins.”
This is presented as evidence that applicant does not appear to have provided description of any assessment of the activity of ZmDA2, whether it be direct assessment of the activity of a protein or indirect assessment as measured by a specific phenotype, importantly the latter would require a clear structure function relationship between mutations in ZmDA2 and specific phenotypes. Without this relationship even narrowing the scope of the endogenous target sequences would not appear to limit the scope of the claim to subject matter having adequate written description.
Therefore, given that the claims remain drawn to genomic modifications that reduce or disrupt the activity of ZmDA2 and there is no description of the effects on ZmDA2 activity imparted by the induced modifications described in applicants examples it does not appear that the ordinary artisan would be able to determine if they were in possession of the claimed invention.
While Applicant’s amendments to the claims narrows the scope, there remain aspects of the claim which are not described such that it is clear that Applicant is in possession of the claimed invention and therefore the rejections of record are maintained.
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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 11/03/2025 as applied to claims 1-12. Applicant’s arguments filed on 02/11/2026 have been fully considered but they are not persuasive, see above for response to Applicant’s Arguments.
Claims 1-12 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 claims contain 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.
Applicant claims a modified corn plant, seed, plant part or plant cell comprising a genomic modification downstream of a RING domain in an endogenous ZmDA2 gene encoding a protein having at least 95% sequence identity to instant SEQ ID NO: 2 that reduces or disrupts the activity of ZmDA2.
Claim 2 is drawn to the plant, seed, plant part or plant cell where the modified corn plant, see, plant part or plant cell is homozygous for the modification.
Claim 3 is drawn to the modified plant wherein the genomic modification is an endogenous ZmDA2 gene encoding a protein having at least 96% sequence identity to the sequence of SEQ ID NO: 2.
Claim 4 depends on claim 2 and is drawn to the modification being in a transcribable region or in a downstream region of a sequence coding for a RING domain in as ZmDA2 gene.
Claim 5 depends on claim 4 and is drawn to modifications where the modification is in the exon of the ZmDA2 gene, an intron of the ZmDA2 gene or an exon region and intron region of the ZmDA2 gene.
Claim 6 depends on claim 1 and is drawn to plants that comprise a polynucleotide sequence selected from the group consisting of SEQ ID NOs: 9, 11-34.
Claim 7 depends on claim 6 is drawn to plants that comprise a first modification in a first allele of the ZmDA2 gene and a second modification in a second allele of the ZmDA2 gene, the two modifications being different from one another.
Claim 8 depends on claim 1 and is drawn to modification is located about 1960 nucleotides or more downstream from the 5’ end of reference sequence SEQ ID NO: 3 or is located at about 1473 nucleotides or more upstream from the 3’ end of reference sequence SEQ ID NO: 3.
Claim 9 depends on claim 1 and is drawn to plants comprising one of a series of specific modifications in at least one allele of the ZmDA2 gene.
Claims 10 depends on claim 1 and is drawn to plants where the modification is comprised within a genomic region of about position 1689-3733, 1964-2765 or 2654-2676 of reference sequence SEQ ID NO: 3.
Claim 11 depends on claim 8 and is drawn to plants where the modification comprises a deletion of at least 1 consecutive nucleotide.
Claim 12 depends on claim 8 and is drawn to plants wherein the modification is comprised within a genomic region from about nucleotide position 1964 to about nucleotide position 1987 or from about nucleotide position 2665 to about nucleotide position 2765 of reference sequence SEQ ID NO: 3.
While the claims as amended have been limited in scope, these claims still include several areas which add breadth. First, the independent claim is drawn to a modified corn plant, plant seed, corn plant part, or corn plant cell. Therefore, any single cell from any corn plant, in planta, in culture, or in any other state falls within in the scope of the claim. This is the case even if the plant or plant cell has previously undergone extensive modification such as EMS mutagenesis or any other mutation or modification. Similarly this scope includes any non-modified plant that is considered to be a corn plant.
A second an important recitation in the independent claim which adds breadth is the recitation of “a genomic modification that reduces or disrupts the activity of ZmDA2, as compared to the activity of ZmDA2 in an otherwise identical corn plant”.
Given the language recited above, the independent claim is broadly drawn to any deletion, insertion, substitution, inversion or duplication downstream of a RING domain in an endogenous ZmDA2 gene having at least 95% sequence identity to instant SEQ ID NO: 2 in any corn plant cell.
The key is that these modifications are required to reduce or disrupt the activity of ZmDA2. This broad recitation indicates that any function or activity of ZmDA2 can be reduced or disrupted. This includes canonical functions associated with DA2 genes but also any other function whatsoever carried out by that gene or protein. Additionally, the use of the term reduced indicates that the activity can be diminished to any degree.
In contrast to this broad scope, Applicant does not provide any description of how to measure the activity of the ZmDA2 gene or which modifications, specific target motifs or other details produce a plant having reduced or disrupted ZmDA2 activity. In fact in applicant’s examples there is no measurement or other assessment of the activity of ZmDA2.
Instead, Applicant describes generating corn plants comprising gene edited ZmDA2 alleles and devoid of editing T-DNA sequences, using the construct described earlier. These plants were outcrossed to produce hybrid plants (Specification, Page 51, Example 2). The plants were genotyped using amplicon sequencing, and plants with diverse edits were selected. These hybrid plants then underwent yield trails where ear size related traits were measured and analyzed (Specification, Page 52, Example 3).
Applicant describes the design of two other gene editing constructs targeting the ZmDA2 gene to produce novel variants which also target the same ZmDA2 gene downstream of the RING domain. One of these constructs targeted the same exact region as the construct described above, the other construct targeted a different exon (Specification, Page 53, Example 4, Paragraphs 0167-0168). The use of one of these constructs produced at least ten different modified plants having either heterozygous (one modified and one wild type allele) or biallelic (a different modification in each allele) modifications (Specification, Page 57, Table 6).
To reiterate, in the examples, Applicant describes plants produced using their three gene editing constructs which target two regions of a single ZmDA2 sequence. While, applicant genotyped plants in each target region and assessed kernel/ear/yield potential of plants with edited alleles Applicant concludes: “The field trial data presented in this example demonstrates that targeted editing of the ZmDA2 gene leads to the improvement of key yield component traits in hybrid corn, suggesting that these genomic edits may produce a dominant effect on increased yield traits” (Specification, Page 53, Paragraph 0166).
Thus, while applicant has investigated at least one species of the claimed genus of sequences, applicant does not appear to have assessed whether the introduced modifications have any effect on the activity of ZmDA2. In applicant’s own words, the genomic edits may produce a dominant effect on increased yield traits, however there is no description of the mechanism which may underly this phenomenon and there is no demonstration of a causal link between the introduced modifications and reduced or disrupted activity of ZmDA2. Instead applicant presents a correlation between the presence of these edits in hybrid corn and certain yield components without assaying the activity of ZmDA2.
Importantly, the only recitations of the word “activity” in applicant’s examples are:
“The edited ZmDA2 gene can encode modified proteins with, reduced, disrupted, or altered activity.”
“The modified ZmDA2 produced from the edited ZmDA2 gene may have reduced or disrupted activity, yet still be able to interact with other proteins.”
This is presented as evidence that applicant does not appear to have provided description of any assessment of the activity of ZmDA2, whether it be direct assessment of the activity of a protein or indirect assessment as measured by a specific phenotype, importantly the latter would require a clear structure function relationship between mutations in ZmDA2 and specific phenotypes. Without this relationship even narrowing the scope of the endogenous target sequences would not appear to limit the scope of the claim to subject matter having adequate written description.
Further and importantly, applicants provide only examples in what appears to be a single inbred corn plant line which target a single specific sequence which is in contrast to the claims which read broadly on any corn plant with any modification which reduces or disrupts ZmDA2 activity.
Given the scope of the claimed invention and the lack of a structure-function relationship between modifications in an endogenous ZmDA2 gene and reduced or disrupted function of the Applicant has not described the claimed genus modified endogenous ZmDA2 genes such that one of ordinary skill in the art would recognize that applicant was in possession of the claimed invention.
Given the lack of a relationship between genomic modifications and reduced or disrupted ZmDA2 the additional limitations of the claims do not overcome the lack of description of the claimed invention. Even in those dependent claims (Claims 2-5 and 9-10) where applicant has limited the plants to those which have a specific modification with respect to a reference sequence, applicant has not described the relationship between modifications and altered ZmDA2 activity such that the ordinary artisan would be able to determine if a sequence was a ZmDA2 sequence.
Further, even in claim 9 which limits the modified sequences to specific sequences the claims remain broadly drawn to any corn plant cell whatsoever which comprises one of these sequences as long as these cells have ZMDA2 activity which is reduced or disrupted. Again, it is not clear how to identify if ZmDA2 activity is reduced or disrupted and therefore the ordinary artisan would not be able to determine if they were in possession of the claimed invention without a structure function relationship between a specific modification in a specific target sequence in a corn plant cell and the function of reduced or disrupted activity of ZmDA2.
The prior art does not provide resolution for the lack of description provided by Applicant. Specifically, there is insufficient teaching in the art for the ordinary artisan to be able to determine if the genus of claimed modifications would result in reduced or disrupted ZmDA2 activity. Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Response to Applicant Arguments - 35 USC § 112 (Enablement)
Applicant’s arguments and amendments to the claims dated 02/11/2026 have been fully considered but are not found to be persuasive and therefore the enablement rejections of record are maintained.
Applicant’s arguments appear to be drawn to the following concept:
The claim is amended to recite that the genomic modification is in an endogenous ZmDA2 gene encoding a protein having at least 95% sequence identity to SEQ ID NO:2, where this modification is a deletion, an insertion, a substitution, an inversion, or a duplication and wherein the modification is downstream of a sequence coding for a RING domain and therefore the claims have adequate enabled guidance.
In response the examiner notes that this amendment limits the scope of the claim by requiring direct modifications in the ZmDA2, however, there are several aspects of the invention of the amended claim which still lack adequate enabled guidance for a skilled artisan to make and use the invention without undue experimentation.
Specifically, while applicant has amended the claim to provide a location of the modification (downstream of a sequence encoding for a RING domain in an endogenous ZmDA2 gene encoding a protein having at least 95% sequence identity to instant SEQ ID NO: 2), the claim still requires “a genomic modification that reduces or disrupts the activity of ZmDA2”.
Applicant has not provided guidance which would allow the ordinary artisan to produce the claimed invention without undue experimentation because Applicant has not provided any guidance on the relationship between modifications in ZmDA2 genes and the activity of ZmDA2. A structure function relationship between genomic modifications in an endogenous ZmDA2 gene downstream of a sequence coding for a RING domain and the function of reducing or disrupting the activity of ZmDA2 appears essential guidance to make and use the claimed invention. Without this relationship the structures required to produce the claimed phenotype are not clear and therefore it would not be clear if a modified corn plant, corn plant seed, corn plant part, etc. would be the claimed modified corn plant, corn plant seed, corn plant part, etc. or if it is a distinct corn plant from that of the invention without this guidance the ordinary artisan would be required to use extensive trial and error experimentation to make all of the possible modifications in the claimed sequence and then test those plants for reduced or disrupted ZmDA2 activity at all developmental timepoints and under varied growing conditions.
In the examples Applicant provides guidance on plants produced using their three gene editing constructs which target two regions of a single ZmDA2 sequence. While, applicant genotyped plants in each target region and assessed kernel/ear/yield potential of plants with edited alleles, Applicant concludes: “The field trial data presented in this example demonstrates that targeted editing of the ZmDA2 gene leads to the improvement of key yield component traits in hybrid corn, suggesting that these genomic edits may produce a dominant effect on increased yield traits” (Specification, Page 53, Paragraph 0166).
Thus, while applicant has investigated at least one species of the claimed genus of sequences, applicant does not appear to have assessed whether the introduced modifications have any effect on the activity of ZmDA2. In applicant’s own words, the genomic edits may produce a dominant effect on increased yield traits, however there is no guidance on the function of the mechanism which may underly this phenomenon and there is no demonstration of a causal link between the introduced modifications and reduced or disrupted activity of ZmDA2. Instead applicant presents a correlation between the presence of these edits in hybrid corn and certain yield components without assaying the activity of ZmDA2.
Importantly, the only recitations of the word “activity” in applicant’s examples are:
“The edited ZmDA2 gene can encode modified proteins with, reduced, disrupted, or altered activity.”
“The modified ZmDA2 produced from the edited ZmDA2 gene may have reduced or disrupted activity, yet still be able to interact with other proteins.”
This is presented as evidence that applicant does not appear to have provided guidance on the activity of ZmDA2, whether it be direct assessment of the activity of a protein or indirect assessment as measured by a specific phenotype, importantly the latter would require a clear structure function relationship between mutations in ZmDA2 and specific phenotypes. Without this relationship even narrowing the scope of the endogenous target sequences would not appear to limit the scope of the claim to subject matter having adequate enabled guidance.
Therefore, given that the claims remain drawn to genomic modifications that reduce or disrupt the activity of ZmDA2 and there is no guidance on ZmDA2 activity it does not appear that the ordinary artisan would be able to make and use the claimed invention without undue experimentation.
While Applicant’s amendments to the claims narrows the scope, there remain aspects of the claim which do not have adequate enabled guidance to make and use the invention without undue experimentation and therefore the rejections of record are maintained.
Claim Rejections - 35 USC § 112 (Enablement)
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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 11/03/2025 as applied to claims 1-12. Applicant’s arguments filed on 02/11/2026 have been fully considered but they are not persuasive, see above for response to Applicant’s Arguments.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant claims a modified corn plant, seed, plant part or plant cell comprising a genomic modification downstream of a RING domain in an endogenous ZmDA2 gene encoding a protein having at least 95% sequence identity to instant SEQ ID NO: 2 that reduces or disrupts the activity of ZmDA2.
Claim 2 is drawn to the plant, seed, plant part or plant cell where the modified corn plant, see, plant part or plant cell is homozygous for the modification.
Claim 3 is drawn to the modified plant wherein the genomic modification is an endogenous ZmDA2 gene encoding a protein having at least 96% sequence identity to the sequence of SEQ ID NO: 2.
Claim 4 depends on claim 2 and is drawn to the modification being in a transcribable region or in a downstream region of a sequence coding for a RING domain in as ZmDA2 gene.
Claim 5 depends on claim 4 and is drawn to modifications where the modification is in the exon of the ZmDA2 gene, an intron of the ZmDA2 gene or an exon region and intron region of the ZmDA2 gene.
Claim 6 depends on claim 1 and is drawn to plants that comprise a polynucleotide sequence selected from the group consisting of SEQ ID NOs: 9, 11-34.
Claim 7 depends on claim 6 is drawn to plants that comprise a first modification in a first allele of the ZmDA2 gene and a second modification in a second allele of the ZmDA2 gene, the two modifications being different from one another.
Claim 8 depends on claim 1 and is drawn to modification is located about 1960 nucleotides or more downstream from the 5’ end of reference sequence SEQ ID NO: 3 or is located at about 1473 nucleotides or more upstream from the 3’ end of reference sequence SEQ ID NO: 3.
Claim 9 depends on claim 1 and is drawn to plants comprising one of a series of specific modifications in at least one allele of the ZmDA2 gene.
Claims 10 depends on claim 1 and is drawn to plants where the modification is comprised within a genomic region of about position 1689-3733, 1964-2765 or 2654-2676 of reference sequence SEQ ID NO: 3.
Claim 11 depends on claim 8 and is drawn to plants where the modification comprises a deletion of at least 1 consecutive nucleotide.
Claim 12 depends on claim 8 and is drawn to plants wherein the modification is comprised within a genomic region from about nucleotide position 1964 to about nucleotide position 1987 or from about nucleotide position 2665 to about nucleotide position 2765 of reference sequence SEQ ID NO: 3.
While the claims as amended have been limited in scope, these claims include several areas which add breadth. First, the independent claim is drawn to a modified corn plant, plant seed, corn plant part, or corn plant cell. Therefore, any single cell from any corn plant, in planta, in culture, or in any other state falls within in the scope of the claim. This is the case even if the plant or plant cell has previously undergone extensive modification such as EMS mutagenesis or any other mutation or modification. Similarly this scope includes any non-modified plant that is considered to be a corn plant.
A second an important recitation in the independent claim which adds breadth is the recitation of “a genomic modification that reduces or disrupts the activity of ZmDA2, as compared to the activity of ZmDA2 in an otherwise identical corn plant”.
Given the language recited above, the independent claim is broadly drawn to any deletion, insertion, substitution, inversion or duplication downstream of a RING domain in an endogenous ZmDA2 gene having at least 95% sequence identity to instant SEQ ID NO: 2 in any corn plant cell.
The key is that these modifications are required to reduce or disrupt the activity of ZmDA2. This broad recitation indicates that any function or activity of ZmDA2 can be reduced or disrupted. This includes canonical functions associated with DA2 genes but also any other function whatsoever carried out by that gene or protein. Additionally, the use of the term reduced indicates that the activity can be diminished to any degree.
In contrast to this scope, Applicant does not provide any guidance on how to measure the activity of the ZmDA2 gene or which modifications, specific target motifs or other details produce a plant having reduced or disrupted ZmDA2 activity. In fact in applicant’s examples there is no measurement or other assessment of the activity of ZmDA2.
Instead, Applicant provides guidance on generating corn plants comprising gene edited ZmDA2 alleles and devoid of editing T-DNA sequences, using the construct described earlier. These plants were outcrossed to produce hybrid plants (Specification, Page 51, Example 2). The plants were genotyped using amplicon sequencing, and plants with diverse edits were selected. These hybrid plants then underwent yield trails where ear size related traits were measured and analyzed (Specification, Page 52, Example 3).
Applicant provides guidance on the design of two other gene editing constructs targeting the ZmDA2 gene to produce novel variants which also target the same ZmDA2 gene downstream of the RING domain. One of these constructs targeted the same exact region as the construct described above, the other construct targeted a different exon (Specification, Page 53, Example 4, Paragraphs 0167-0168). The use of one of these constructs produced at least ten different modified plants having either heterozygous (one modified and one wild type allele) or biallelic (a different modification in each allele) modifications (Specification, Page 57, Table 6).
To reiterate, in the examples, Applicant provides guidance on plants produced using their three gene editing constructs which target two regions of a single ZmDA2 sequence. While, applicant genotyped plants in each target region and assessed kernel/ear/yield potential of plants with edited alleles Applicant concludes: “The field trial data presented in this example demonstrates that targeted editing of the ZmDA2 gene leads to the improvement of key yield component traits in hybrid corn, suggesting that these genomic edits may produce a dominant effect on increased yield traits” (Specification, Page 53, Paragraph 0166).
Thus, while applicant has investigated at least one species of the claimed genus of sequences, applicant does not appear to have assessed whether the introduced modifications have any effect on the activity of ZmDA2. In applicant’s own words, the genomic edits may produce a dominant effect on increased yield traits, however there is no description of the mechanism which may underly this phenomenon and there is no demonstration of a causal link between the introduced modifications and reduced or disrupted activity of ZmDA2. Instead applicant presents a correlation between the presence of these edits in hybrid corn and certain yield components without assaying the activity of ZmDA2.
Importantly, the only recitations of the word “activity” in applicant’s examples are:
“The edited ZmDA2 gene can encode modified proteins with, reduced, disrupted, or altered activity.”
“The modified ZmDA2 produced from the edited ZmDA2 gene may have reduced or disrupted activity, yet still be able to interact with other proteins.”
This is presented as evidence that applicant does not appear to have provided guidance on the assessment of the activity of ZmDA2, whether it be direct assessment of the activity of a protein or indirect assessment as measured by a specific phenotype, importantly the latter would require a clear structure function relationship between mutations in ZmDA2 and specific phenotypes. Without this relationship even narrowing the scope of the endogenous target sequences would not appear to limit the scope of the claim to subject matter having sufficient enabled guidance.
Further and importantly, applicants provide only guidance in what appears to be a single inbred corn plant line which target a single specific sequence which is in contrast to the claims which read broadly on any corn plant with any modification which reduces or disrupts ZmDA2 activity.
Given the scope of the claimed invention and the lack of a structure-function relationship between modifications in an endogenous ZmDA2 gene and reduced or disrupted function of the Applicant has not provided sufficient enabled guidance such that one of ordinary skill in the art would be able to make and use the claimed invention without undue experimentation.
Without this guidance the ordinary artisan would be required to use extensive trial and error experimentation to make all of the possible modifications in the claimed sequence and then test those plants for reduced or disrupted ZmDA2 activity at all developmental timepoints and under varied growing conditions.
The prior art does not provide resolution for the lack of description provided by Applicant. Specifically, there is insufficient guidance for the ordinary artisan to be able to determine if a modification would reduce or disrupt the activity of ZmDA2. Therefore, the specification fails to provide sufficient enabled guidance such that a skilled artisan would be able to make and use the full scope of the claimed invention at the time of filing. The lack of predictability in the art and the lack of guidance provided by Applicant would not have enabled one of ordinary skill in the art to predictably make and use the full scope of the claimed invention without undue experimentation.
Response to Applicant Arguments - Claim Rejections - 35 USC § 103
In response to Applicant’s arguments and amendments to the claims dated 02/11/2026 the rejections of record are withdrawn.
Conclusion
All examined claims remain rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached on 7:30 to 5:00.
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, 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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