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 .
Status of Claims
The amendments received on 01/16/2026 have been entered. Claims 1-3, 10-11, and 69-70 are pending.
Claims 37-41, 51-54, and 66-68 have been canceled.
Claims 1-3, 10-11, and 69-70 are examined in this Office Action.
Objections/Rejections that are Withdrawn
The Objection to claim 10 has been withdrawn in light of Applicant’s amendment to the claim.
The 35 USC 112(b) Indefiniteness rejection of claims 1-3 and 69-70 has been withdrawn in light of Applicant’s amendment to the claims.
The 35 USC 112(a) Enablement rejection of claims 1-3, 10-11, and 69-70 has been withdrawn in light of Applicant’s amendment to the claims and accompanying arguments.
The 35 USC 102 rejection of claims 1, 10-11, and 70 has been withdrawn in light of Applicant’s amendment to the claims. However, Applicant’s amendment has raised new grounds for a 35 USC 103 rejection.
The 35 USC 102 rejection of claim 69 has been withdrawn in light of Applicant’s amendment to the claims. However, Applicant’s amendment has raised new grounds for a 35 USC 103 rejection.
Claim Rejections - 35 USC § 112
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 1-3, 10-11, and 69-70 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-3 and 69-70 are rendered indefinite by the recitation of “genotype of the corn event DP-051291-2”. It is unclear if the genotype is directed to just the junction sequences (SEQ ID NOs: 26-31) recited in the claims, or if the “genotype” comprises the nucleotide sequence of the entire corn event, junction sequences plus trait gene(s). Furthermore, if “genotype” does indeed comprise the entire event, the metes and bounds of what is encompassed by the two junction sequences are not defined. Thus, it is unclear what comprises the “genotype of the corn event DP-051291-2”.
Claims 10 and 11 are rendered indefinite by the recitation of “corn event DP-051291-2”. As stated above, it is unclear if “corn event DP-051291-2” is directed to just the junction sequences (SEQ ID NOs: 26 and 29) recited in the claims, or if the “corn event DP-051291-2” comprises the nucleotide sequence of the entire corn event. Furthermore, the metes and bounds of what is encompassed by the two junction sequences are not defined. Thus, it is unclear what comprises the “corn event DP-051291-2”.
Claims 69 and 70 are also indefinite because it is unclear if the genotype of corn event DP-051291-2 is variable or specific. If a corn plant comprises the genotype of corn event DP-051291-2, how then does the corn plant comprise 99% sequence identity to said corn event (instant claim 69), or a nucleotide sequence having 1 nucleotide change in one of SEQ ID NOs: 26-28 and SEQ ID NOs: 30-31.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. This is a new rejection necessitated by amendment.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The instant claims are directed to an event which is selected from a group of events, obtained by transformation with the same transforming DNA or back-crossing with plants obtained by such transformation, based on the phenotypic expression and stability of the transgenes and the absence of negative impact on the agronomic characteristics of the plant comprising it. The event is not only defined by the sequence of the transgene but also by the junction regions in which the transgene was integrated.
The instant Specification describes that the development of maize event DP-051291-2 resulted from the construction of 84 different construct designs tested in multiple transformation vectors to create 217 distinct vectors and the production of about 7,112 events containing IPD072 (instant SEQ ID NO: 4) as the single insect control gene over the course of approximately six years. Thousands of individual plants (inbred and hybrid) were analyzed, many of which were tested over numerous years across diverse environments using one or more criteria including but not limited to molecular testing, protein expression, efficacy testing, agronomic testing, and/or field testing, for the creation and selection of maize event DP-051291-2 (instant Specification, page 41, paragraph 0171).
Trait discovery and characterization included 2,711 TO plants which generated 6,285 events over the course of approximately six years, each containing IPD072 as the single insect control gene, including 4,557 late-stage events originating from 21 distinct vectors. First year field trials included 71 commercial track events. Of this pool, five were advanced to second year field trials and two were further advanced to third year field trials. Following the third year of testing, maize event DP-051291-2 was selected (instant Specification, page 41, paragraph 0172).
Figure 4 below shows a schematic Diagram of the Transformation and Development of DP-051291-2.
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Claims 1-3, 10-11, and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over CHRISTENSEN (Christensen et al., International Publication Number WO 2019/209700 A1, International Publication Date 31 October 2019; included on IDS dated 03/05/2024).
Claim 1 recites “[a] corn plant comprising the genotype of the corn event DP- 051291-2, wherein said genotype comprises the nucleotide sequences set forth in SEQ ID NO: 26 and SEQ ID NO: 29, and wherein a representative sample of seed of the corn event DP-051291-2 has been deposited with the American Type Culture Collection (ATCC) with Accession No. PTA-127358”.
CHRISTENSEN (2019) teaches that cassette designs for IPD072 (SEQ ID NO: 4) and DvSSJl expression used in the molecular stacks to generate commercial track events were chosen based upon their efficacy and expression in gene testing transformation experiments. A large number of different regulatory (promoters, introns) and other elements (terminators, RNAi hairpin designs) were evaluated in gene testing experiments. The large number of different regulatory elements were used to evaluate expression patterns for yield and trait efficacy.
Additionally, three gene testing experiments were carried out to evaluate about 40 different IPD072 single cassettes. These experiments involved a gene design screen and two construct matrices in which multiple promoters, terminators and subcellular targeting strategies were evaluated. Four IPD072 cassette designs were chosen from these experiments for inclusion in molecular stacks with DvSSJl (Christensen 2019, Example 1, pages 23-24, lines 30-35 and 1-8).
CHRISTENSEN (2019) further teaches that DP-023211-2 maize event was produced by Agrobacterium-mediated SSI transformation with plasmid PHP74643.
Over 2700 immature embryos were infected with PHP74643. After the 105-day selection and regeneration process, a total of 46 TO plantlets were regenerated. Samples were taken from all TO plantlets for PCR analysis to verify the presence and copy number of the inserted genes.
Plants that were determined to contain single copy of the inserted genes were selected for further greenhouse propagation. Samples from those PCR selected TO quality events were collected for further analysis using Southem-by-Sequencing to confirm that the inserted genes were in the correct target locus (also referred to herein as the “landing pad”) without any gene disruptions. Maize events DP-023211-2 were confirmed to contain a single copy of the T- DNA. These selected TO plants were assayed for trait efficacy and protein expression. TO plants meeting all criteria were advanced and crossed to inbred lines to produce seed for further testing. A schematic overview of the transformation and event development is presented in FIG. 4 (Christensen 2019, Example 2, page 26).
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CHRISTENSEN (2019) teaches that the description of various illustrated embodiments of the disclosure is not intended to be exhaustive or to limit the scope to the precise form disclosed. While specific embodiments of and examples are described herein for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. The teachings provided herein can be applied to other purposes, other than the examples described above. Numerous modifications and variations are possible in light of the above teachings and, therefore, are within the scope of the appended claims (Christensen 2019, page 51, lines 1-9).
In regard to claims 1-3, CHRISTENSEN (2019) teaches and claims a corn plant comprising the genotype of the com event DP-023211-2, wherein said genotype comprises a nucleotide sequence as set forth in SEQ ID NO: 31 and SEQ ID NO: 35 (Christensen 2019, claim 1); wherein said genotype comprises the nucleotide sequence set forth in SEQ ID NO: 32 and SEQ ID NO: 36 (Christensen 2019, claim 2); wherein said genotype comprises the nucleotide sequence set forth in SEQ ID NO: 33 and SEQ ID NO: 37 (Christensen 2019, claim 3).
Transformants will also contain unique junctions between a piece of heterologous insert DNA and genomic DNA, or two (2) pieces of genomic DNA, or two (2) pieces of heterologous DNA. A "junction" is a point where two (2) specific DNA fragments join. For example, a junction exists where insert DNA joins flanking DNA. A junction point also exists in a transformed organism where two (2) DNA fragments join together in a manner that is modified from that found in the native organism. “Junction DNA” refers to DNA that comprises a junction point. Junction sequences set forth in this disclosure include a junction point located between the maize genomic DNA and the 5’ end of the insert, which range from at least -5 to +5 nucleotides of the junction point (SEQ ID NO: 31), from at least -10 to +10 nucleotides of the junction point (SEQ ID NO: 32), from at least -15 to +15 nucleotides of the junction point (SEQ ID NO: 33), and from at least -20 to +20 nucleotides of the junction point (SEQ ID NO: 34); and a junction point located between the 3’ end of the insert and maize genomic DNA, which range from at least -5 to +5 nucleotides of the junction point (SEQ ID NO: 35), from at least -10 to +10 nucleotides of the junction point (SEQ ID NO: 36), from at least -15 to +15 nucleotides of the junction point (SEQ ID NO: 37), and from at least -20 to +20 nucleotides of the junction point (SEQ ID NO: 38) (Christensen 2019, pages 9-10, lines 21-34 and 1-3).
At the time the instant application was filed, it would have been obvious and within the scope of one of ordinary skill in the art to use the teachings of CHRISTENSEN (2019) for the selection of elite events as a standard tool in maize breeding. One of ordinary skill in the art seeking to arrive at a new elite event would be able to use routine selection procedures, analogous to those taught by CHRISTENSEN (2019), to arrive at the instantly claimed subject-matter. One would have been motivated to follow the teachings of CHRISTENSEN (2019) knowing that maize event DP-023211-2 taught by CHRISTENSEN (2019) had particularly good levels or patterns of transgene expression. The instantly claimed elite event is just one of many alternatives that would have resulted from such a selection process. The introduction in the claims of the junction regions as a technical feature defines the event more accurately, however junction regions would be identified by one of ordinary skill in the art by routine methods with a reasonable expectation of success. A position effect was known for heterologous DNA insertions in plants, so it should be expected that some insertion events are better than others. Therefore, the selection of a better event would be obvious except where a surprising effect can be demonstrated. Thus, one of ordinary skill in the art would have a high expectation of success by following the teachings of CHRISTENSEN (2019).
In regard to claim 10, CHRISTENSEN (2019) teaches and claims seed comprising com event DP-023211-2, wherein said seed comprises a DNA molecule chosen from SEQ ID NO: 31 and SEQ ID NO: 35, wherein a representative sample of the corn event DP-023211-2 seed of has been deposited with American Type Culture Collection (ATCC) with Accession No. PT A- 124722 (Christensen 2019, claim 10).
In regard to claim 11, CHRISTENSEN (2019) teaches and claims a corn plant, or part thereof, grown from the seed of claim 10 (Christensen 2019, claim 11).
In regard to claim 69, CHRISTENSEN (2019) teaches the insert T-DNA region of plasmid PHP74643, wherein SEQ ID NO: 2 is the T-DNA insert and SEQ ID NO: 3 is the insert T-DNA including the landing pads (Christensen, page 6, lines 33-34). The Applicant has used the open language “a” in instant claim 69 (…or a nucleotide sequence having at least 99% sequence identity to SEQ ID NO: 3), which encompasses nucleic acids that comprise the full-length sequence of SEQ ID NO: 3 or any portion of SEQ ID NO: 3. This claim is anticipated by any dinucleotide or larger oligonucleotide. SEQ ID NO: 3 taught by CHRISTENSEN (2019) shares 98.8% sequence identity with instant sequence SEQ ID NO: 3 (i.e., wherein the plant comprises a nucleotide sequence having at least 99% sequence identity to SEQ ID NO: 3) (see alignment in Non-Final Rejection dated 11/18/2025).
Although the sequences do not share the 99% identity required by the claim, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See MPEP 2144.05(i). In this case, SEQ ID NO: 3 taught by CHRISTENSEN (2019), which shares 98.8% sequence identity with instant sequence SEQ ID NO: 3, would likely lead to similar functions.
In regard to claim 70, CHRISTENSEN (2019) teaches “flanking DNA” can exist of either genomic DNA naturally present in an organism such as a plant, or foreign (heterologous) DNA introduced via the transformation process which is extraneous to the original insert DNA molecule, e.g., fragments associated with the transformation event. A “flanking region” or “flanking sequence” as used herein refers to a sequence of at least 20 bp which is located either immediately upstream of and contiguous with and/or immediately downstream of and contiguous with the original non-native insert DNA molecule. Transformation procedures of the foreign DNA may result in transformants containing different flanking regions characteristic and unique for each transformant. When recombinant DNA is introduced into a plant through traditional crossing, its flanking regions will generally not be changed. It may be possible for single nucleotide changes (i.e., a nucleotide sequence having 1 nucleotide change) to occur in the flanking regions through generations of plant breeding and traditional crossing (Christensen 2019, page 9, lines 9-21).
Response to Applicant’s Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
Initially, it is noted that this is a new rejection necessitated by amendment.
Applicant argues that amending claim 69 to require 99% sequence identity to SEQ ID NO: 3 renders the rejection moot.
The Examiner respectfully disagrees, as outlined in the new 35 USC 103 rejection above.
Summary
No claim is allowed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
CHRISTINA MEADOWS
Examiner
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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