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 .
Restriction
In response to the communication received on May 5th, 2026, from Micheal D. Bucci, the election of Group III, claims 22-23, without traversal, is acknowledged. Applicants have added claims 24-29, which depend from claim 22. Examiner notes that there are two claims labeled as 28 (see Claim Objection below).
Priority
Applicant’s claim for the benefit of a prior-filed provisional application no. 63/268,406 filed February 23rd, 2022 and PCT/US2023/062981 filed February 22nd, 2023 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Thus, the earliest possible priority for the instant application is February 23rd, 2022.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on June 26th, 2025 and May 13th, 2026, were considered, initialed, and attached hereto. A signed copy of the list of references cited is included with this Office Action.
Status of Claims
Claims 1-11, 15-29 filed May 5th, 2026 are pending. Examiner notes that there are two claims labeled as 28 (see Claim Objection below).
Claims 12-14 are cancelled.
Claims 1-11 and 15-21 are withdrawn.
Claims 22-29 are examined herein.
Specification
The disclosure is objected to because of the following informalities: The specification references FIG. 3 when describing vector construction of guides and templates (see pg. 50, ln. 17) and FIG. 4 when describing the insertion of the different genomic fragments at DSL individually or in combination (see pg. 51, ln. 12). The specification only describes FIGs. 1-2C in the brief description of the drawings and sequence listings and the provided drawings only show FIGs. 1-2C.
The specification references FIG. 2 in Example 1, stating that FIG. 2 shows a schematic drawing of the locations of target sites [pg. 49, lns. 14-15]. However, the brief description of the drawings recites that FIGs. 2A-C illustrate possible scenarios to create a multi disease resistance stack. It is unclear which figure demonstrates the locations of target sites, or if all FIGs. 2A-C are meant to show locations of the target sites.
The specification states that a list of potentially acceptable sites in DSL1 is provided in Tables 1 and 2 [pg. 49, lns. 14-15], however Table 1 appears to be short stature loci in corn [pg. 3], a second, unlabeled table appears to be a description of the sequence listing [pg. 9-10], and a table labeled Table 2 appears to be genomic window comprising a CTL1 on chromosome 1 of maize [pg. 42-43]. Table 3 appears to be acceptable sites in DSL1 [pg. 49-50] and Table 4 the markers flanking DSL1 [pg. 50].
Appropriate correction is required.
Claim Objections
In claims 22-26, “cM” is used as abbreviation. It is suggested to insert a definition for cM
without bringing in new matter, immediately before the first appearance of “cM” in claim 22; and to enclose the appearance of “cM” in parentheses (in claim 22 only).
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 28 and 29 have been treated as 29 and 30, respectively, for purpose of examination.
Claim Interpretation
Claim 22 recites a corn plant comprising a first genomic locus and a modified genomic locus located on the same arm of the chromosome and within about 1, 5, 10, and 30 cM from one another, according to dependent claims 23-26. As there are no defining features of the first genomic locus, other than being within a certain distance from the modified genomic locus, this is interpreted read on any genomic locus conferring any trait at any point along the chromosome. Thus, any genomic locus would read upon the first genomic locus. Examiner notes that claims 27-30 define functional features of the first genomic locus and are interpreted as such.
Claim 22 recites a “modified genomic locus” comprising “modified target sites”. A “modified target site” is defined in the instant specification as a target sequence with an undefined length that comprises at least one alteration when compared to a non-altered target sequence, and includes only exemplary language as to what the alterations may be, such as replacement, deletion, or insertion of at least one nucleotide, or any combination [pg. 33, lns. 29-32; pg. 34, lns. 1-5]. Thus, a modified genomic locus need only to comprise a target sequence that comprises any alteration to the as few as one nucleotide or many nucleotides.
Claim 22 recites that the first and second polynucleotide are “heterologous” to the modified genomic locus. “Heterologous” in reference to a sequence is defined in the instant specification as a sequence that originates from a foreign species, or, if from the same species, is substantially modified from its native form in composition and/or genomic locus by deliberate human intervention [pg. 46, lns. 8-10]. Accordingly, Examiner notes that due to the indication of deliberate human intervention, no rejection under 35 USC § 101 has been made.
Claim Rejections – 35 USC § 112(b)
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.
Indefiniteness
Claims 22-30 are rejected I 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.
The term “enhanced resistance” in claim 22 is a relative term which renders the claim indefinite. The term “enhanced” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant specification states that “enhanced” resistance refers to an increased level of resistance against a particular pathogen, a wide spectrum of pathogens, or an infection caused by the pathogen(s) and that an increased level of resistance against a particular fungal pathogen, such as Et, for example, constitutes “enhanced” or improved fungal resistance [pg. 20, lns. 20-25]. The instant specification states that “resistance” is a relative term, indicating that the infected plant produces better plant health or yield of maize than another more susceptible plant. However, the claims and the instant specification do not provide a clear standard of comparison. Is a more susceptible plant a control? Or could it be a differently modified plant?
Claims 23-30 are rejected insofar as they depend from claim 22, and do not overcome the stated rejection.
The term “about” in claims 22-26 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “about” is used in the context of determining the location of the modified genomic locus to the first genomic locus, but is generally an undefined estimation denoting a margin of uncertainty. One skilled in the art would not be clear on what falls within less than about 1 cM between the first genomic locus and modified genomic locus, as recited in claim 22. Should this be interpreted as less than 1 cM or would higher ranges fall within this, such as 2 cM?
Claims 27-30 are rejected insofar as they depend from claim 22, and do not overcome the stated rejection.
Additionally, it is not clear that any chromosome arm over the entire corn genome would logically be able to encompass a modified genomic locus and a first genomic locus located on the same arm as a chromosome that could be anywhere from 1-30 cM from one another, as recited in claims 23-26. Chromosome lengths and chromosome arm lengths vary throughout the corn genome, including A and B chromosomes. The B chromosome has one tiny short arm, demonstrated to be less than 0.75 Mb, or 750 Kb1 (see figure below, tiny short arm segment indicated with outlined box). Given that 1 cM is estimated to be around 1460 Kb, or around 1.46 Mb2, a modified genomic locus and a first genomic locus falling within about 1-30 cM from one another on the same chromosome arm may not necessarily fit within the bounds of any chromosome depending on the size of the chromosome. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention and the subject matter is not distinctly pointed out.
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Claim Rejections – 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
Written Description
Claims 22-30 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 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.
The claims are broadly drawn to a corn plant comprising a first genomic locus and a modified genomic locus, the modified genomic locus comprising at least two modified target sites, each comprising a native polynucleotide sequence conferring enhanced disease resistance to any plant disease, wherein the polynucleotide sequences are less than about 1 cM from one another, the genomic loci are on the same chromosome arm, and the modified genomic locus is not transgenic. The claims are further drawn to the first genomic locus conferring a transgenic trait, including short stature, insect control, herbicide tolerance, or comprising a transgene encoding a fern-derived pesticidal protein, a Bt-derived pesticidal protein, a bacterial-derived pesticidal protein, an RNA-based insect control agent, transgenic event MON95379, or one or more of Cry1B, Cry1D, DvSnf7, Cry75A, or Vip4Da2.
The Applicant describes:
A selected DSL1 on chromosome 1, approximately 0.5 cM from the CTL1, and a list of “potentially acceptable” target sites within the DSL.
Construction of a DNA construct comprising guide RNA and Cas endonuclease for Agrobacterium-mediated transformation for template integration by HDR.
Exemplary genomic fragments for insertion at different unspecified target sites of NLB18 or HT1 conferring resistance against Northern Leaf Blight and Rppk conferring resistance against Southern Rust.
The possibility of improved agronomic traits with the insertion of DSL locus in proximity to another trait of interest, and possible sites near the location used for transgenic insertion of Cry1B, Cry1D, DvSnf7, Cry75A, and/or Vip4Da2, as well as transgenic corn event MON95379, as described in another patent (US 20200032289 A1) at theoretical locations varying from 1-30 cM.
A DSL that could be inserted on the same chromosome arm, or, as exemplary distances, within about 1-30 cM from short stature genes (BR, GA oxidase, and/or a nucleotide change at the D8 genomic locus that comprises a gibberellic acid biosynthesis or signaling pathway) identified in prior art and in other patents.
The expected planting density and the expected maturation and planting dates of DSL plants.
The Applicant does not describe:
A corn plant comprising a first genomic locus and a modified genomic locus that may be modified by any means.
A corn plant comprising a modified genomic locus wherein the modified genomic locus comprises any two modified target sites.
A corn plant comprising a first and a second polynucleotide sequence capable of conferring enhanced resistance to any plant disease.
A corn plant comprising a first genomic locus conferring any transgenic trait or any short stature trait.
A corn plant comprising a first genomic locus conferring an insect control trait for any insect, an herbicide tolerance trait for any herbicide, or a combination of any insect and herbicide tolerance.
The instant disclosure does not describe a corn plant comprising a first genomic locus and a modified genomic locus which may be modified by any means. The modification of the modified genomic locus appears to be the insertion of maize genomic fragments by Agrobacterium--mediated transformation at target sites within DSL1 for homology directed repair. The DSL could then be used for introgression into another germplasm. The modified genomic locus appears to be the DSL with the inserted genomic maize fragments conferring plant disease resistance, as described in Example 1 of the instant application.
Modifications, including mutations, insertions, deletions, and/or substitutions can have varying
effects on gene expression, and, as claimed, may be purely natural variation, leading to a broad genus of possible for the modified genomic locus. Ge, F. et al. (2024, Review of Computational Methods and Database Sources for Predicting the Effects of Coding Frameshift Small Insertion and Deletion Variations,” ACS Publications, 9:2032-2047) teaches, for example, silent mutations may not change the protein structure and thus do not result in increased gene expression, while others, such as frameshift mutations, can cause a premature stop codon resulting in a truncated protein that is not functional [pg. 2032, col. 1, ¶1].
As Applicant only provides exemplary insertion of maize genomic fragments conferring resistance against Northern Leaf Blight and Southern Rust with NLB18, HT1, and Rppk [Example 1], any type of modification is not reduced to practice. Undue experimentation would be required to confirm that the structure of the modification performs the function of enhanced resistance to a plant disease and the specification lacks sufficient variety of species to reflect the variance within the genus of modification.
The instant disclosure does not describe that the modified genomic locus may have any modified target site in the modified genomic locus to provide the function of enhanced disease resistance. The instant disclosure provides merely a list of “potentially acceptable” sites within the DSL1 for the target sites [Table 3], but states that target sites needed to be less than 2.5 kb from any native gene annotation and necessitated a PAM sequence (which would be dependent on the Cas variant used for transformation) and some level of precision to avoid off-target activity [pg. 49, lns. 1-15]. Thus, any target site would not necessarily perform the function of comprising a polynucleotide sequence that would be able to successfully confer enhanced disease resistance, as any random target site may result in off-target effects that could alter neighboring, beneficial resistance alleles, for example. Undue experimentation would be required to determine the specific modified target site for resistance to a specific pathogen, especially given that the claims do not require resistance to a particular plant disease. The examples provided do not support the broad genus of any modified target site comprising a polynucleotide that would reliably enhance disease resistance to a plant disease.
The instant disclosure does not describe that a polynucleotide with undefined structure can confer the function of resistance to any plant disease. Sufficient species are not provided to support the genus of enhanced resistance to any plant disease. Even though the modified target sites within the DSL are not specified, the instant disclosure describes insertion of maize genomic fragments of NBL18 and HT1 conferring resistance against Northern Leaf Blight and genomic fragment of RppK gene conferring resistance against Southern Rust [pg. 51, lns. 6-12]. Although the instant disclosure describes how these genes may be stacked, it does not provide any working examples or quantitative data of the actual corn plant with the DSL inserted or in addition to the first genomic locus wherein the first genomic locus confers a certain transgenic trait, such as short stature.
The instant disclosure states that the compositions presented lead to maize plants that have enhanced resistance to diseases including, but not limited to northern leaf blight, anthracnose stalk rot, grey leaf spot, southern rust, tar spot, Stewart's Bacterial Wilt, Goss's Bacterial Wilt and Blight, Holcus Spot, Bacterial Leaf Blight, Bacterial Stalk Rot, Bacterial Leaf Streak, Bacterial Stripe and Leaf Spot, Chocolate Spot, Kernel Crown Spot, Corn Stunt, Maize Bushy Stunt, Seed Rot, Seedling Blight, and Damping-off, Pythium Root Rot (and Feeder Root Necrosis), Rhizoctonia Crown and Brace Root Rot, Fusarium Root Rot Diseases, Red Root Rot, Southern Corn Leaf Blight, Northern Corn Leaf Blight, Northern Corn Leaf Spot, Rostratum Leaf Spot, Physoderma Brown Spot, Eyespot, Anthracnose Leaf Blight, Gray Leaf Spot, Sorghum Downy Mildew, Java Downy Mildew, Philippine Downy Mildew, Sugarcane Downy Mildew, Rajasthan Downy Mildew, Spontaneum Downy Mildew, Leaf Splitting Downy Mildew, Graminicola Downy Mildew, Crazy Top, Brown Stripe Downy Mildew, Ergot, Common Smut, Head Smut, False Smut, Common Rust, Southern Rust, Tropical Rust, Gibberella Stalk Rot, Diplodia (Stenocarpella) Stalk Rot, Anthracnose Stalk Rot, Charcoal Rot, Fusarium Stalk Rot, Pythium Stalk Rot, Late Wilt, Aspergillus Ear Rot, Diplodia Ear Rot, Fusarium Kernel or Ear Rot, Gibberella Ear Rot or Red Rot, Nigrospora Ear or Cob Rot, Penicillium Ear Rot and Blue Eye, Mycotoxins and Mycotoxicoses, Maize Dwarf Mosaic, Maize Chlorotic Dwarf, Maize Streak, Maize Rough Dwarf, Root-Knot Nematodes, Lesion Nematodes, Sting Nematodes, Needle Nematodes, Stubby-Root Nematodes, Awl Nematodes, Corn Cyst Nematode, Dagger Nematodes, Lance Nematodes, Ring Nematodes, Spiral Nematodes, Stunt Nematodes, disease caused by a parasitic seed plant such as Witchweed [pg. 11-12]. It is not clear that a maize plant comprising a modified genomic locus comprising two modified target sites, each with polynucleotide sequences conferring plant disease resistance would actually be able to provide plant resistance to any of the listed diseases without more structure specified to perform the function.
The instant disclosure further provides SEQ ID NOs. for alternative genes, but does not specify the resistance provided with insertion [pg. 9-10]. These sequences appear to be known and used in the art and in published patents, however the instant disclosure does not reduce to practice that the corn plant comprising the modified genomic locus as claimed has enhanced resistance to any plant disease.
Similarly, the instant disclosure does not reduce to practice the combination of a first genomic locus and a modified genomic locus, wherein the first genomic locus confers any transgenic trait and the modified genomic locus confers enhanced disease resistance to any plant disease. The Applicant deliberates placement of the DSL insertion at a location of 10, 5, 4, 3, or 1 cM from insect control transgene (Cry1B, Cry1D, DvSnf7, Cry75A and/or Vip4Da2) during introgression to be passed to progeny during introgression and the insertion of a (undefined) DSL inserted on the same chromosome arm as transgenic corn event MON95275 (with reference to US 20200032289 A1), without providing data to show that the theoretical structure leads to the function [Example 3]. The Applicant does not reduce to practice that transgenic insertion of these genes would lead to insect control of any insect.
The Applicant additionally describes short stature maize plants with reference to US 20200199609 A1, which teaches methods and compositions to modulate plant stature including plant height [Example 4]. Applicant describes a particular BR sequence of US 20200199609 A1, but does not incorporate it into a plant as instantly claimed in combination with the modified genomic locus. The Applicant describes GA oxidase genes known to corn and states that a DSL maize plant is created by inserting a DSL on the same chromosome (e.g., within about 30 cM, about 20 cM, about 15 cM, about 10 cM…) of a nucleotide change at the D8 genomic locus that comprises a gibberellic acid biosynthesis or signaling pathway, citing a sequence of US 20200199609 A1. The instant specification does not provide any examples of herbicide tolerance conferred from the first genomic locus.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed corn plant, Applicant does not appear to have been in possession of the claimed genus at the time of filing.
Scope of Enablement
Claims 22-30 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 claims contain 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.
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: (1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the
presence or absence of working examples of the invention; (4) the nature of the invention; (5) the state
of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the
art; (8) the breadth of the claim. In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988).
The claims are broadly drawn to a corn plant comprising a first genomic locus and a modified genomic locus, the modified genomic locus comprising at least two modified target sites, each comprising a native polynucleotide sequence conferring enhanced disease resistance to any plant disease, wherein the polynucleotide sequences are less than about 1 cM from one another, the genomic loci are on the same chromosome arm, and the modified genomic locus is not transgenic. The claims are further drawn to the first genomic locus conferring a transgenic trait, including short stature, insect control, herbicide tolerance, or comprising a transgene encoding a fern-derived pesticidal protein, a Bt-derived pesticidal protein, a bacterial-derived pesticidal protein, an Rna-based insect control agent, transgenic event MON95379, or one or more of Cry1B, Cry1D, DvSnf7, Cry75A, or Vip4Da2. Thus, the claims are drawn to a large genus of modified target sites, polynucleotide sequences conferring plant disease resistance, and transgenic traits.
However, the Applicant does not provide working examples for a corn plant comprising a first genomic locus conferring a transgenic trait and a modified genomic locus, wherein the modified genomic locus comprises at least two modified target sites each comprising a polynucleotide sequence that confers enhanced disease resistance to the same or different plant disease.
The Applicant does teach:
A selected DSL1 on chromosome 1, approximately 0.5 cM from the CTL1, and a list of “potentially acceptable” target sites within the DSL.
Construction of a DNA construct for insertion of genomic regions conferring resistance comprising guide RNA and Cas endonuclease for Agrobacterium-mediated transformation for template integration by HDR.
Exemplary genomic fragments for insertion at different unspecified target sites of NLB18 or HT1 conferring resistance against Northern Leaf Blight and Rppk conferring resistance against Southern Rust.
The possibility of improved agronomic traits with the insertion of DSL locus in proximity to another trait of interest, and possible sites near the location used for transgenic insertion of Cry1B, Cry1D, DvSnf7, Cry75A, and/or Vip4Da2, as well as transgenic corn event MON95379, as described in another patent (US 20200032289 A1) at theoretical locations varying from 1-30 cM.
A DSL that could be inserted on the same chromosome arm, or, as exemplary distances, within about 1-30 cM from short stature genes (BR, GA oxidase, and/or a nucleotide change at the D8 genomic locus that comprises a gibberellic acid biosynthesis or signaling pathway) identified in prior art and in other patents.
The expected planting density and the expected maturation and planting dates of DSL plants.
However, it is not clear that a corn plant is actually produced by the exemplary information in the examples that specifically comprises the claimed limitations. For example, Example 1 discloses the insertion of maize genomic fragments conferring resistance against Northern Leaf Blight and Southern Rust, stating that one genomic fragment may contain a single source of resistance or multiple sources molecularly stacked to create genomic insertions at DSL1. The instant disclosure teaches that, in certain aspects, the coding sequences present in the fragment are driven by their native regulatory sequences, such as native promoter and/or enhancer sequences, and provides the genomic DNA, cDNa, and protein sequences for NLB18, HT1, and Rppk, without integration into the genome. The instant disclosure further states that single and stacked insertions at different target sites within DSL1 can be used individually or late combined by breeding. A working example of insertion at DSL1 is not provided. Examples 6 and 7 merely provide expected planting density and maturation date of the DSL plants, indicating that no maize plants with the claimed combination of features and functions were made and that no insertions were combined by breeding.
Further, the instant disclosure provides merely a list of “potentially acceptable” sites within the DSL1 for the target sites [Table 3], but states that target sites needed to be less than 2.5 kb from any native gene annotation and necessitated a PAM sequence (which would be dependent on the Cas variant used for transformation) and some level of precision to avoid off-target activity [pg. 49, lns. 1-15]. Thus, any target site would not necessarily be able to be used to successfully confer enhanced disease resistance, as any random target site may result in off-target effects that could alter neighboring, beneficial resistance alleles, for example. The Applicant does not provide any working examples of the modified target sites with the exemplary polynucleotides conferring enhanced resistance. No data is provided to show that the corn plant as claimed actually has enhanced resistance over another plant without the modifications. Undue experimentation would be required to determine the specific modified target site for resistance to a specific pathogen, especially given that the claims do not require resistance to a particular plant disease.
With regard to the broad claim of enhanced plant disease resistance, Applicant provides the genomic DNA, cDNa, and protein sequences for NLB18, HT1, and Rppk [pg. 51, lns. 4-12], as well as other sequences without defining what disease resistance they might confer resistance to [pg. 9], and an extensive, but not limiting, list of potential plant diseases that may be improved with the claimed corn plant [pg. 10-11]. Undue experimentation would be required to determine which sequences enhanced resistance to which plant disease and feasible integration of these sequences in a gene stack while targeting a locus with a defined transgenic trait. Sufficient guidance was not provided to ensure that issues like silencing due to complex insertion do not occur.
Transgene stacking is known in the art, but faces several challenges. Multigenic resistance breeding is complex as resistance (R) genes are generally unlinked making creating and maintaining R gene combinations in breeding programs a difficult and laborious task (Jost, M. et al. 2023, “Plant and pathogen genomics: essential approaches for stem rust resistance gene stacks in wheat”, Front. Plant Sci., 14:1223504. doi: 10.3389/fpls.2023.1223504) [Abstract]. The art teaches that genes introduced into transgene stack must function together at the specific genomic target site(s) without interfering with the plant’s normal growth or resulting in yield drag. Genes may be limited based on the size that is can feasibly be inserted into a chromosome location and as gene stacks increase in size the addition of more genes becomes progressively more difficult [pg. 6, col. 2, ¶2]. Additionally, some traits may need several genes to alter the several interconnected pathways regulating the complex traits.
Jost teaches that in wheat and wild wheat, genetic background has the potential to suppress a member of a transgene stack that would not be readily detected unless the function of all genes in the stack was reconfirmed prior to deployment [pg. 9, col. 2, ¶2]. Jost further teaches that in some pathosystems, gene stacks may be an entirely inappropriate method for disease protection such as those with prolific asexual and sexual reproductive cycles that can rapidly overcome individual R genes [pg. 10, col. 1, ¶3]. Combining the available R genes into a gene stack could promote the evolution of super-virulent isolates causing severe management issues.
Additionally, Li, R. et al. (2022, “Target Lines for in Planta Gene Stacking in Japonica Rice”, Int J Mol Sci. 23(16):9385. doi: 10.3390/ijms23169385) teaches that specific target sites can make the process more precise and predictable, reducing the likelihood that an insertion would be near a gene coding region and disrupt host function [pg. 11, ¶2]. Li teaches that only through experience in field trials can one be certain of a lack of adverse effect on agronomic traits, which is why having multiple known target sites available could be of value. Transgenes engineered to have different expression patterns might not always be compatible with one another; and indeed, Li shows that targeting new DNA affected the expression of previously placed DNA [pg. 11, ¶5]. Given that possibility, it may be necessary to cluster transgenes with only similar types of expression patterns.
Gao, H. et al. (2020, “Complex Trait Loci in Maize Enabled by CRISPR-Cas9 Mediated Gene Insertion”, Front. Pl. Sci. 11:535, as cited in IDS filed 05/13/2026) concurs that plant gene targeting via HDR and gene expression in CTL1 of maize was dependent on several factors, including chromatin structure, DNA sequence of target sites and homology arms, all of which can influence the efficacy of CRISPR-Cas9 and HDR [pg. 8, col. 2, ¶2]. Gao teaches that trait genes can be inserted directly at selected CRISPR-Cas9 target sites via HDR, efficiencies for CRISPR-Cas9 enabled gene insertions are low and constructs need to be screened and tested in the early stages of development [pg. 2, col. 2, ¶3]. CRISPR-Cas9 target sites were selected based on the following criteria: the site must be away from any known gene by 2 kb, the site DNA sequence is unique in the genome and conserved among the targeted inbred line, the genomic sequences of 200-500 bp flanking the sites within a QTL are unique to the genome, and spacing of the sites within a QTL accommodates genetic crossing to recombine traits [pg. 2, col. 2, ¶2]. Gao teaches that it is not yet practical to directly insert trait gene cassettes on a large scale at present and used a specific strategy for trait gene insertion [pg. 2, col. 2, ¶3].
Furthermore, Gao teaches that transgenic event recovery has been suggested to be dependent on the selectable marker or screenable marker to be expressed, meaning that events in regions of the genome where silencing occurs will not be recovered [pg. 10, col. 1, ¶1]. Gao indicates that while most of the sites tested in the present study supported gene expression, it is possible that such repressive locations exist in the maize genome. Gao teaches that expression at identical sites was significantly different across different genetic backgrounds of maize lines.
Therefore, although gene stacking is utilized in the art, there is significant unpredictability including, for example, the transgenes used, the size of the genomic fragments, the target sites, interference with native genes, and yield drag. One of ordinary skill in the art would not be enabled to make or use the invention as claimed given the broad guidance provided. Insertion of a DSL with variable undefined genomic fragments at any target site, with only potentially acceptable target sites specified (Table 3), as well as the variability of the additional genomic locus is unpredictable. The art does not cure the deficiencies of the instant application.
Examiner acknowledges that prophetic examples may be acceptable for compliance with the enablement requirement and an applicant need not have actually reduced the invention to practice prior to filing. In Gould v. Quigg, 822 F.2d 1074, 1078, 3 USPQ 2d 1302, 1304 (Fed. Cir. 1987). Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art (see MPEP § 2164.02). A prophetic example describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved, but should be described in future or present tense. In the instant case, several aspects are of the specification are drafted in past tense, such as the vector construction [pg. 50, lns. 6-14] and delivery to maize embryos by Agrobacterium-mediated transformation [pg. 50, lns. 20-22], but the actual integration by homology directed repair is referred to in future tense [pg. 50, lns. 22-24]. It is thus not clear that one of ordinary skill in the art would be enabled to make or use the invention as claimed with the information provided.
Therefore, given the breadth of the claims; the lack of guidance and working examples; the unpredictability in the art; and the state of the art as discussed above, undue experimentation would be required to make and use the claimed invention, and therefore, the invention is not enabled.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 22-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao, H. et al. "Generating Northern Leaf Blight Resistant Maize", International Publication No. WO 2018/071362 A1, published April 19th, 2018 (see, IDS filed 06/26/2025).
The applied reference has common applicants and inventors with the instant application. Based upon the earlier publication date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1) and does not qualify for an exception under 35 U.S.C. 102(b)(1).
Claim 22 recites a corn plant comprising a first genomic locus and a modified genomic locus, wherein
a. the modified genomic locus comprises at least a first modified target site and second modified target site;
b. the first modified target site comprises a first polynucleotide sequence that confers enhanced disease resistance to a first plant disease;
c. the second modified target site comprises a second polynucleotide sequence that confers enhanced disease resistance to the first plant disease or to a second plant disease;
d. the first and the second polynucleotide sequences are heterologous to the modified genomic locus and are each located less than about 1 cM from the other; and
e. the modified genomic locus and the first genomic locus are located on the same arm of a chromosome,
wherein the modified genomic locus, comprising the first and second modified target sites, is not transgenic and comprises only native corn plant polynucleotide sequence.
Claim 23 recites the plant of claim 22, wherein the modified genomic locus is located within about 30 cM from the first genomic locus.
Claim 24 recites the plant of claim 22, wherein the modified genomic locus is located within about 10 cM from the first genomic locus.
Claim 25 recites the plant of claim 22, wherein the modified genomic locus is located within about 5 cM from the first genomic locus.
Claim 26 recites the plant of claim 22, wherein the modified genomic locus is located within about 1 cM from the first genomic locus.
Gao teaches compositions and methods for generating Northern corn leaf blight (NCLB) resistant maize plants. Gao teaches that resistance to specific races of the pathogen can be controlled by certain native disease resistance maize genes, such as Ht1, Ht2, Ht3, Htm 1, Htn 1, HtN, HtP, ht4 and rt [pg. 2, lns. 4-7]. Gao teaches plants with modified Ht1 nucleotide sequences, modified NLB18 sequences, or both, introduced to the maize genome by double-strand breaks to modify the genomic sequence in order to enhance northern leaf blight resistance (i.e., a corn plant comprising a modified genomic locus) [Abstract]. The limitations of conventional breeding for introgressing NCLB resistance into maize lines can be overcome through the editing of genes that confer enhanced resistance to NCLB, such as, for example, Ht1 and NLB18, or by the movement of resistant alleles of Ht1 and NLB18 to another site in the genome such that enhanced resistance to NCLB can be obtained by introgressing a single genomic locus comprising multiple nucleotide sequences, each conferring enhanced resistance to northern leaf blight, into maize plants [pg. 2, lns. 17-14].
Gao teaches that the methods for obtaining a maize plant cell with an edited genomic locus comprising at least one nucleotide sequence that confers resistance to NCLB includes introducing a double strand break or site-specific modification at one or more target sites in a genomic locus [pg. 5, lns. 16-20] and that the guide polynucleotides comprise variable targeting domains complementary to target sites in the endogenous Ht1 encoding sequence and NLB18 encoding sequence, or the CTL1 genomic locus (i.e., the modified genomic locus comprises at least a first modified target site and a second modified target site; the first modified target site comprises a first polynucleotide sequence that confers enhanced disease resistance to a first plant disease; the second modified target site comprises a second polynucleotide sequence that confers enhanced disease resistance to the first plant disease or to a second plant disease) [pg. 7, lns. 6-9].
Gao teaches that the target site can be an endogenous site in the genome of a cell, or alternatively, the target site can be heterologous to the cell and thereby not be naturally occurring in
the genome of the cell, or the target site can be found in a heterologous genomic location compared to where it occurs in nature (i.e., the first and the second polynucleotide sequences are heterologous to the modified genomic locus) [pg. 31, lns. 11-15; claim 38; claim 55]. Gao teaches that three sites on CTL 1, TS8, TS10, and TS45, were selected for relocating the NCLB resistant genes NLB18-PH26N, Ht1-PH4GP, and NLB18-PH26N, respectively [pg. 59, lns. 2-6]. FIG. 6 of Gao shows the location of three loci comprising target sites (TS8, TS45, and TS10) for the guide RNA/Cas endonuclease system at CTL 1 on chromosome 1 of maize, displaying that TS45 and TS10 are 0.4 cM from one another (i.e., the first and second polynucleotide sequences are each located less than about 1 cM from the other). Gao teaches that the plant has a site-specific modification at least one target site in an endogenous genomic locus (i.e., wherein the modified genomic locus is not transgenic and comprises only native corn plant polynucleotide sequences).
This rejection is made to the extent that instant claim 22 does not specify what the first genomic locus is or any structural features, or what function the genomic locus may confer. Thus, this is any genomic locus and there are genomic loci on the same arm as the chromosome of the modified genomic locus within about 30, 10, 5, or 1 cM from the modified genomic locus (i.e., the plant of claim 22, wherein the modified genomic locus is located within about 30, 10, 5, or 1 cM from the first genomic locus, as respectively recited in claims 23-26) (see Claim Interpretation above).
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.
Claims 22 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ailing, Z. et al. "Nucleic Acid Molecules for Conferring Insecticidal Properties in Plants", WO 2022235606 A1, published 11/10/2022 with priority date 05/04/2021, in view of Gao, H. et al. "Generating Northern Leaf Blight Resistant Maize", WO 2018/071362 A1, published 10/13/2016 (see, IDS filed 06/26/2025).
Claim 22 recites a corn plant comprising a first genomic locus and a modified genomic locus, wherein
a. the modified genomic locus comprises at least a first modified target site and second modified target site;
b. the first modified target site comprises a first polynucleotide sequence that confers enhanced disease resistance to a first plant disease;
c. the second modified target site comprises a second polynucleotide sequence that confers enhanced disease resistance to the first plant disease or to a second plant disease;
d. the first and the second polynucleotide sequences are heterologous to the modified genomic locus and are each located less than about 1 cM from the other; and
e. the modified genomic locus and the first genomic locus are located on the same arm of a chromosome,
wherein the modified genomic locus, comprising the first and second modified target sites, is not transgenic and comprises only native corn plant polynucleotide sequence.
Claim 27 recites the plant of claim 22, wherein the first genomic locus confers a transgenic trait or short stature trait
Claim 28 recites the plant of claim 22, wherein the first genomic locus is transgenic and confers an insect control trait, an herbicide tolerance trait, or both insect control and herbicide tolerance traits.
Claim 29 (claim renumbered, see Claim Objection) recites the plant of claim 28, wherein the first genomic locus comprises a transgene encoding a Bacillus thurigiensis (Bt)- derived pesticidal protein.
Claim 30 (claim renumbered, see Claim Objection) recites the plant of claim 22, wherein the first genomic locus is transgenic and comprises transgenic event MON95379.
Ailing teaches nucleic acid sequences to confer expression of insecticidal proteins and that expression of foreign genes encoding insecticidal proteins in transgenic plants has reduced use of pest control chemicals, wherein the plant may be corn (i.e., a corn plant comprising a first genomic locus; wherein the first genomic locus confers a transgenic trait; wherein the first genomic locus is transgenic and confers an insect control trait) [Abstract; pg. 1, 23-25; claim 14; pg. 2, lns. 8-11]. Ailing teaches that genes coding for Cry proteins have been isolated and their expression in crop plants has been shown to provide another tool for the control of economically important insect pests, but that it is still susceptible to resistance breakdown [pg. 1, lns. 27-29]. Ailing teaches that the term "Cry protein" is an insecticidal protein of a Bacillus thuringiensis crystal delta-endotoxin type (i.e., wherein the first genomic locus comprises a transgene encoding a Bt-derived pesticidal protein) [pg. 17, lns. 5-6]. Insect pests that now have resistance against the Cry proteins expressed in certain transgenic plants are known, such as fall armyworm (Spodoptera frugiperda), which has documented field-evolved resistance to Cry1F, Cry1A.105 and Cry2Ab2 in certain countries [pg. 2, lns. 4-8].
Ailing teaches that one or more nucleic acids of interest encode one or more second pest control agens, e.g., a Bt insecticidal protein, which may be a Cry protein, a vegetative insecticidal protein (VIP), or insecticidal proteins present at transgenic events including the MON95379 event (i.e., wherein the first genomic locus comprises transgenic event MON95379) [pg. 50, lns. 21-31; pg. 51, ln. 9].
Ailing teaches that genes encoding Bt toxin proteins can be inserted into plant cells using a variety of techniques which are well known in the art and that polynucleotides can be stacked at a desired genomic location using a site-specific nuclease or recombination system (e.g., FRT/Flp, Cre/Lox, TALE-endonucleases, zinc finger nucleases, CRISPR/Cas and related technologies) [pg. 37, lns. 14-17; claim 41]. The CRISPR/Cas system does not require the generation of customized proteins to target specific sequences but rather a Cas nuclease can be programmed by an RNA guide (gRNA) to recognize a specific nucleic acid target, in other words the Cas nuclease can be recruited to a specific nucleic acid target locus of interest using said short RNA guide [pg. 60, lns. 11-15]. Ailing teaches that a transgenic plant comprising one or more desired traits can be used as the target to introduce further traits by subsequent transformation [pg. 37, lns. 8-10]. Ailing teaches that other traits of interest include fungal resistance [pg. 37, lns. 26-30].
Ailing therefore teaches nucleic acid sequences to confer expression of insecticidal proteins (i.e., conferring a transgenic trait, conferring an insect control trait, comprising a transgene encoding a Bt-derived pesticidal protein or comprising transgenic event MON95379) that can be targeted to any genomic locus near other traits of interest, such as fungal resistance, in corn plants.
Ailing does not explicitly teach a corn plant with a modified genomic locus, wherein the first modified genomic locus comprises at least a first and second modified target site, each site comprising a polynucleotide sequence heterologous to the genomic locus that confers enhanced disease resistance to a plant disease, are within 1 cM of one another, and are native corn plant sequences.
However, Gao teaches compositions, methods, and corn plants thereof resistant to Northern corn leaf blight (NCLB), a disease induced by the fungal pathogen Exserohilum turcicum [Abstract; pg. 1, lns. 19-26]. Gao teaches that the pathogen can reduce the amount of leaf surface area and thus reduce photosynthetic capacity and grain yield. Gao teaches resistance to specific races of the pathogen that can be controlled by certain native disease resistance maize genes [pg. 2, lns. 4-7]. Gao teaches plants with modified endogenous Ht1 nucleotide sequences, modified endogenous NLB18 sequences, or both, introduced to the maize genome by double-strand breaks to modify the genomic sequence in order to enhance northern leaf blight resistance (i.e., a corn plant comprising a modified genomic locus; the modified genomic locus comprises a first and second polynucleotide sequence that confers enhanced disease resistance to a plant disease; wherein the modified genomic locus is not transgenic and comprises only native corn plant nucleotide sequences) [Abstract].
Gao teaches that the methods for obtaining a maize plant cell with an edited genomic locus comprising at least one nucleotide sequence that confers resistance to NCLB includes introducing a double strand break or site-specific modification at one or more target sites in a genomic locus [pg. 5, lns. 16-20] and that the guide polynucleotides comprise variable targeting domains complementary to target sites in the endogenous Ht1 encoding sequence and NLB18 encoding sequence, or the CTL1 genomic locus (i.e., the modified genomic locus comprises at least a first modified target site and a second modified target site) [pg. 7, lns. 6-9].
Gao teaches that the limitations of conventional breeding for introgressing NCLB resistance into maize lines can be overcome through the editing of genes that confer enhanced resistance to NCLB, such as, Ht1 and NLB18, or by the movement of resistant alleles of Ht1 and NLB18 to another site in the genome (i.e., the first and second polynucleotide sequences are heterologous to the modified genomic locus) [pg. 2, lns. 17-14]. Gao teaches that the target site can be heterologous to the cell and thereby not be naturally occurring in the genome of the cell, or the target site can be found in a heterologous genomic location compared to where it occurs in nature [pg. 31, lns. 11-15; claim 38; claim 55].
Gao teaches that three sites on CTL 1 (Complex Trait Locus 1, a maize genomic window spanning from ZM01:13.7 MM to ZM01:16.4MM on chromosome 1), TS8, TS10, and TS45, were selected for relocating the NCLB resistant genes NLB18-PH26N, Ht1-PH4GP, and NLB18-PH26N, respectively [pg. 59, lns. 2-6]. FIG. 6 of Gao shows the location of three loci comprising target sites (TS8, TS45, and TS10) for the guide RNA/Cas endonuclease system at CTL 1 on chromosome 1 of maize, displaying that TS45 and TS10 are 0.4 cM from one another (i.e., the first and second polynucleotide sequences are each located less than about 1 cM from the other).
Gao teaches that the nucleotide sequences that confer enhanced resistance to northern leaf blight are in tight linkage with one another (at one locus) [pg. 46, lns.7-11]. Gao teaches that linkage drag is often an issue with introgressing resistance genes to lines of maize [pg. 2, lns. 9-12], and that the tight linkage reduces the number of specific loci that require trait introgression through backcrossing and minimizes linkage drag from nonelite resistant donors [pg. 46, lns.7-11].
Given that Ailing teaches nucleic acid sequences to confer expression of insecticidal proteins (i.e., conferring a transgenic trait, conferring an insect control trait, comprising a transgene encoding a Bt-derived pesticidal protein or comprising transgenic event MON95379) that can be targeted to any genomic locus near other traits of interest, such as fungal resistance, in corn plants; and given that Gao teaches a corn plant with a modified genomic locus, wherein the first modified genomic locus comprises at least a first and second modified target site, each site comprising a polynucleotide sequence heterologous to the genomic locus that confers enhanced NCLB resistance, are within 1 cM of one another, and are native corn plant sequences, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the polynucleotides conferring expression of insecticidal proteins that can be targeted to any genomic locus in corn of Ailing with the corn plant of Gao that comprises a modified genomic locus with two polynucleotide sequences conferring enhanced NCLB resistance, as Ailing teaches that a transgenic plant comprising one or more desired traits, such as fungal resistance (e.g. NCLB) can be used as the target to introduce further traits by subsequent transformation to enhance pest and disease control in corn.
Gao further teaches tight linkage of polynucleotides conferring enhanced disease resistance to NCLB by using three sites on CTL 1, citing that tight linkage can reduce the number of loci required for inheritance of the trait, making it harder to break the linkage when backcrossing. As the nucleic acids conferring insect control of Ailing may be targeted to a specific locus, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to target a locus within the CTL 1 of Gao to promote easier trait introduction with the NCLB resistance to obtain the desired phenotype of insect control, the transgene encoding a Bt-derived pesticidal protein, or transgenic event MON95379. Thus, one would have been motivated to target the transgene of Ailing to the same arm of the chromosome of the modified genomic locus for more successful stable trait integration into progeny.
One would have been motivated to combine the inventions for the end result of a corn plant comprising a first genomic locus conferring a transgenic trait such as insect control and a modified genomic locus comprising polynucleotide sequences conferring enhanced disease resistance to NCLB as Gao and Ailing both teaches that fungal and insect pathogens are a major threat to corn yields and that alternative means to the current methodologies of introgression of naturally resistant genes into corn inbreds and widespread chemical applications are necessary. Although the native Ht1 and NBL18 genes can be used for NCLB as shown by Gao, the addition of a transgene for insect control at a genomic locus as taught by Ailing provides additional desired traits that are not endogenous to the corn genome.
A skilled artisan would have reasonable expectation of success as both components are explicitly taught by Ailing and Gao, and Ailing teaches that a transgenic plant comprising one or more desired traits, such as fungal resistance, can be used as the target to introduce further traits by subsequent transformation and teaches how CRISPR/Cas can be used to target a specific site, and Gao teaches CTL 1 that already comprises three sites modified for fungal resistance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 22-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 30 and 40-41 of copending Application No. 18/041,714 (reference application), US Publication No. US20230295650A1. The applications share two common inventors, Jeffrey Habben and Girma M. Tabor, and the same applicant, Pioneer Hi Bred. Although the claims at issue are not identical, they are not patentably distinct from each other. The subject matter claimed in the instant application is fully disclosed in the referenced patent, and the referenced patent and the instant application are claiming common subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims 22-26 are drawn to a corn plant comprising a first undefined genomic locus and a modified genomic locus, wherein the modified genomic locus comprises at least two modified target sites, each comprising a polynucleotide that confers enhanced disease resistance to a plant disease, wherein the polynucleotide sequences are heterologous to the modified genomic locus and are each located less than about 1 cM from one another, the modified genomic locus and the first locus are located on the same arm of a chromosome, and the modified genomic locus is not transgenic and comprises only native corn plant polynucleotide sequences.
Conflicting claim 30 is drawn to a corn plant comprising a modified genomic locus, the locus comprising one or more modified target sites, wherein the one or more modified sites are not transgenic and comprise only native corn plant polynucleotide sequences, wherein the one or more target sites comprise a first and second native polynucleotide sequence that confers enhanced disease resistance to a plant disease, wherein the polynucleotide sequences are heterologous to the modified genomic locus and the modified genomic locus is non-transgenic.
Conflicting claim 40 is drawn to the corn plant of claim 30 further comprising a third heterologous polynucleotide, wherein the first, second, and third heterologous polynucleotides are located at a single locus in a plant.
Conflicting claim 41 is drawn to the corn plant of claim 40, wherein the single locus comprises 1 cM.
The instant and conflicting claims differ in that the instant claims 22-26 recite a corn plant comprising a first genomic locus and a modified genomic locus one the same arm of a chromosome and within a specific cM distance from one another, while conflicting claims 30 and 40-41 do not recite a first genomic locus. As no structural, locational, or functional features of the first genomic locus are defined in the claims, this is interpreted to be any genomic locus, which may be at any distance from the modified genomic locus (see Claim Interpretation). Thus, the recitation of a first genomic locus in the instant claims does not provide a limitation that would render the claims patentably distinct.
The instant and conflicting claims further differ in that instant claims 22-26 recite a corn plant comprising a modified genomic locus comprising at least two modified target sites, each with a polynucleotide sequence conferring enhanced resistance to a plant disease that are each located less than about 1 cM from the other. Conflicting claims 30 and 40-41 recite a corn plant with three polynucleotides, wherein the three polynucleotides are at a single locus of the plant, the locus comprising 1 cM, 5 cM, or 10 cM. Given that the instant claims may comprise additional modified target sites with polynucleotide sequences at one modified genomic locus (i.e., a single locus) and given that the conflicting claims require the single locus to be 1 cM, the feature of the first and second polynucleotide sequences being less than about 1 cM from one another of the instant claims is an obvious variant of the conflicting claims.
Therefore, one of ordinary skill in the art, at the time the claimed invention was filed, would have readily recognized that the conflicting claims 30 and 40-41 of the copending Application No. 18/041,714 and the claims 22-26 in the instant application are obvious variants and are not patentably distinct. Furthermore, there is no apparent reason why Applicants would have been prevented from presenting claims corresponding to those of the instant application in the previously granted patent. In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
Regarding the instant dependent claims 27-30, with regard to the above 103 rejection (Ailing, Z. et al. in view of Gao, G. et al.), the claims are deemed obvious. Thus, the dependent claims 27-30 are included in the non-statutory rejection of independent claim 22.
Conclusion
No claims allowed.
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/EMILY K JOHNSON/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
1 Liu Q. et al. (2025. “Genome assembly of the maize B chromosome provides insight into its epigenetic characteristics and effects on the host genome.” Genome Biol. 26(1):47. doi: 10.1186/s13059-025-03517-6) teaches that the B chromosome contributes to genetic variation in some maize cultivars beyond the basic A chromosome set, including the tiny short arm chromosome arm [pg. 2, ¶1].
2 Civardi, L. et al. (1994. “The relationship between genetic and physical distances in the cloned a1-sh2 interval of the Zea mays L. genome.” Proc. Natl. Acad. Sci. USA. 91:8268-8272), teaches that, genetically, the entire genome of maize contains at least 2061 cM (but may be as large as 3000 cM), which encompasses 3 x 106 kb of DNA [pg. 8271, col. 1, ¶3]. Therefore, over the entire genome, the value of 1 cM is estimated to be 1460 kb.
Prosecution Insights