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 .
Priority
Acknowledgement is made of applicant’s claim for benefit under 35 U.S.C. 119(e). As such, the
effective filing date of Claims 1, 3-12, 18-21, 23-25, 27-29, 43-45 and 112 is 09/30/2020.
Election/Restrictions
Applicant’s election without traverse of Group I, encompassing Claims 1-12, 18-29, and 43-46 in the reply filed on 07/14/2025 remains acknowledged.
Applicant’s election without traverse of SEQ ID NOs: 179 and 180 regarding the WUS/WOX polypeptide and SEQ ID NOs: 215 and 216 regarding the ODP2 polypeptide in the reply filed on 07/14/2025 remains acknowledged.
Status of the Claims
Amendments dated 03/24/2026 have been entered.
Claims 2, 13-17, 22, 26, 46-11 and 113-126 have been cancelled by Applicant.
Claims 1, 3-12, 18-21, 23-25, 27-29, 43-45 and 112 are pending.
Claim 112 is withdrawn from consideration as being directed to a non-elected invention.
Claims 1, 3-12, 18-21, 23-25, 27-29, 43-45 are examined herein.
The objections to the specification have been withdrawn in view of Applicant’s amendments to the specification.
The objections to Claims 1, 18, and 20 are withdrawn in view of Applicant’s amendments to the claims.
The rejections of Claim 22 and 46 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicant’s cancellation of the claims.
Claim Interpretation
Claims 1, 25, and 46 recite, in part, “a regenerable plant structure containing the heterologous polynucleotide expression cassette”. MPEP 2111.03, Section I recites that the transitional word “containing” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. As such, the broadest reasonable interpretation of the regenerable plant structure that is recited in Claims 1, 25, and 46 includes regenerable plant structures that contain elements beyond the recited heterologous polynucleotide expression cassette— including the claimed morphogenic gene expression cassette.
Claims 5 and 46 recite the Agrobacterium-NOS promoter “having” SEQ ID NO: 290 and the ubiquitin (UBI) promoter “having” SEQ ID NO: 339. The instant specification does not provide a definition for the term “having” as it relates to specific nucleotide sequences or fragments thereof. As such, the broadest reasonable interpretation of the term “having”, as it related to specific nucleotide sequences, encompasses any nucleotide sequences that comprise the full-length sequences of SEQ ID NOs: 290 and 339.
If Applicant disagrees with these interpretations, an appropriate response should be made of record to that effect. No substantive reply will be taken as a confirmation by Applicant that the Office’s interpretation(s) are correct. Applicant is reminded that “the doctrine of prosecution disclaimer ensures that claims are not construed one way [by Applicant] in order to obtain their allowance and in a different way against accused infringers” (SandBox Logistics LLC v. Proppant Express Invs. LLC, 813 F. App'x 548, at 556 (Fed. Cir. 2020)) and, to that end, “[Applicant' s] failure to challenge the Examiner' s understanding amounts to a disclaimer” (SandBox v. Proppant infra at 554; citing Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090, at 1096 (Fed. Cir. 2013)).
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 should be amended to recite “SEQ ID NOs:” instead of “SEQ ID NO:”
Appropriate correction is required.
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.
---These are new rejections from those set forth in the Office Action dated 09/25/2026 made in view of further examination of the claims, which subsequently reopens prosecution. Applicant’s Remarks dated 03/34/2026 have been acknowledged and reviewed but are deemed inapposite to the new rejections.---
Claims 5 and 11 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.
Claim 5 recites the limitations "the Agrobacterium-NOS promoter" and “the ubiquitin (UBI) promoter” in lines 8 and 10. There is insufficient antecedent basis for these limitations in the claim. Claim 1, from which Claim 5 depends, does not recite any promoters operably linked to any polypeptides, much less the claimed morphogenic genes, much less an Agrobacterium-NOS promoter or a ubiquitin promoter, much less a specific Agrobacterium-NOS promoter or ubiquitin promoter sequence such as SEQ ID NOs: 290 and 339, respectively. As such, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention. For examination purposes, Claim 5 is broadly interpreted to encompass the morphogenic expression cassette polypeptides thereof recited in Claim 1 that are operably linked to a promoter that leads to high expression. This determination does not relieve the Applicant from their duty to amend the claim in any further correspondence.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 11 recites the broad recitation “Saccharum”, and the claim also recites "energycane" in parentheses which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
---The following is a new rejection from those set forth in the Office Action dated 09/25/2026 made in view of further examination of the claims, which subsequently reopens prosecution. Applicant’s Remarks dated 03/34/2026 have been acknowledged and reviewed but are deemed inapposite to the new rejections---
Claim 45 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (e.g., compositions of matter) (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1).
Claim 45 recites a plurality of monocot seeds produced from the regenerated transgenic monocot plant of claim 43. The broadest reasonable interpretation of Claim 45 encompasses a plurality of monocot seeds that are identical to those that would be found in nature. For example, if the transgenic plant recited in Claim 43 comprises only a single copy of heterologous polynucleotide comprised in the heterologous polynucleotide expression cassette of Claim 1, a subset (or population) of the plurality of seeds produced by the first-generation transgenic plant would be expected to be non-transgenic and identical to naturally derived monocot seeds as a result of genetic segregation, due to Mendelian inheritance and heterozygosity of the introduced heterologous polynucleotide expression cassette. Therefore, the specific limitations of Claim 45 recite a natural product.
MPEP 2106.04(c) states that if a claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application (Step 2A, Prong One: YES)
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are recited in the claim that would make the plurality of monocot seed structurally different from a from a naturally occurring monocot seed. MPEP 2106.04(d), subsection III states that a judicial exception alone is not eligible subject matter; therefore, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. As such, Claim 45 is directed to a natural product with no additional elements to demonstrate that the claims as a whole integrate the exception into a practical application (Step 2A, Prong 2: NO).
Claim 45 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not include any additional elements. MPEP 2106.05, subsection I states that additional elements in the claims must be evaluated to determine whether they amount to an inventive concept, which requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. However, because Claim 45 does not contain additional elements to demonstrate the claim as a whole integrates the exception into a practical application, the claim simultaneously does not recite significantly more than the exception itself. Since there are no meaningful limitations in the claim that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, and Claim 45 is not patent-eligible (Step 2B: NO).
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
---These are new rejections from those set forth in the Office Action dated 09/25/2026 made in view of further examination of the claims, which subsequently reopens prosecution. Applicant’s Remarks dated 03/34/2026 have been acknowledged and reviewed but are deemed inapposite to the new rejections.---
Claims 1, 3-5, 8-10, 11-12, 18-25, 27-29, and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (WO 2017074547 A1, published 05/04/2017; IDS Document) in view of Bidney et al. (AU 2002256227 A1, published 10/31/2002) and Boerman et al. (Plants 9.3 (2020): 369, 1-12, published 03/17/2020).
Regarding Claim 1, Anand et al. (herein referred to as Anand) broadly teaches methods for producing a transgenic plant, comprising (a) transforming a cell of an explant with an expression construct comprising (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; (ii) a nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or (iii) a combination of (i) and (ii); and (b) allowing expression of the polypeptide of (a) in each transformed cell to form a regenerable plant structure; and (c) germinating the regenerable plant structure to form the transgenic plant (Abstract), wherein the polypeptide comprising the two AP2-DNA binding domains is an ODP2 or BBM2 (pg. 6, lines 13-14).
In a narrower embodiment of the invention, Anand teaches for producing a transgenic plant, wherein the method comprises introducing a polynucleotide of interest into a target site in the genome of a plant cell, the method comprising (a) transforming one or more cells of an explant with an expression construct comprising: (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; (ii) a nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or (iii) a combination of (i) and (ii); and (b) allowing expression of the polypeptide of (a) in each transformed cell to form a regenerable plant structure in the absence of cytokinin, wherein no callus is formed; wherein transformation further comprises transforming a cell of an explant with a transfer cassette comprising a nucleotide sequence of interest flanked by nonidentical recombination sites; and wherein the explant is derived from a plant with a genome comprising a target site flanked by non-identical recombination sites which correspond to the flanking sites of the transfer cassette, as a method of directional, targeted integration of exogenous nucleotides (heterologous nucleotide sequences) into a transformed plant (pg. 122, lines 9-20). Anand teaches that the disclosed methods use novel recombination sites in a gene targeting system which facilitates directional targeting of desired genes and nucleotide sequences into corresponding recombination sites previously introduced into the target plant genome (pg. 122, lines 26-31).
In a working embodiment of the invention, Anand teaches maize explants were bombarded with an equimolar ratio of plasmids containing the following expression cassettes; FRT1 :PMI::PINII TERM:FRT87 + UBI PR0:UBI1ZM INTRON::MO-FLP::PINII TERM + ZM-PLTP PRO::ZM-ODP2 (ODP2 polypeptide)::PINII TERM + ZM-AXIG1 PRO::ZM-WUS2 (WUS/WOX polypeptide)::PINII TERM. After particle bombardment, the immature embryos remained on the high-osmotic medium overnight, and were then transferred to resting medium (13266K medium with 150 mg/1 G418) for 8 days. After the resting period, the embryos were transferred to maturation medium (2890 medium with 150 mg/1 G418) for 21 days, and then moved onto rooting medium (272X medium with 150 mg/1 G418) for 14- 17 days (until the roots were large enough for transplanting into soil). At the plantlet stage, leaf tissue was sampled for PCR analysis to confirm that the genes within the flanking FRT1 and FRT87 sites of the original target locus were no longer present and that the new genes within the donor cassette had recombined into the target locus correctly - and precise RMCE (Recombinase-Mediated Cassette Exchange) events were identified. This reduced the entire SSI cycle, from transformation to having precise RMCE-derived plants in the greenhouse, down to 43-50 days (regenerable plant structure formed between 6-7 weeks), depending on how long a time was required to produce adequate roots (Example 9, pg. 153, lines 12-29 ). In the same embodiment of the invention, Anand teaches the use of the heterologous nucleotide of interest DS-RED in an Agrobacterium mediated SSI method using constructs with AXIG1 PRO::WUS2 + PLTP PTO::ODP2. Two T-DNAs were delivered in two separate experiments; the first T-DNA containing PMI, WUS2, ODP2 and DsRED expression cassettes within the flanking FRT1 and FRT87 recombination sites (RB- UBI PRO:UBIlZM INTRON::MO-FLP::PINII TERM + CaMV35S TERM + FRT1 :PMI::PINII TERM + ZM- AXIG1 PRO::ZM-WUS2::IN2-l TERM + ZM-PLTP PRO::ZM-ODP2::OS-T28 TERM + UBI PR0::UBI1ZM INTRON::DsRED: FRT87-LB) (RV003866) and the second T-DNA containing only PMI and DsRED within the FRT1 and FRT87 sties (RB- + ZM-AXIG1 PRO::ZM-WUS2::IN2-l TERM + ZM-PLTP PRO::ZM-ODP2::OS-T28 TERM UBI PR0:UBI1ZM INTRON::MO-FLP::PINII TERM + CaMV35S TERM + FRT1:PMI::PINII TERM + UBI PR0::UBI1ZM INTRON : : D sRED : FRT87-LB) (RV004886). Each of the T- DNAs were delivered via Agro-mediated transformation into target lines with FRT1-FRT87 landing sites. Precise RMCE events were identified using a multiplex PCR assay. The use of AXIG1 PRO::WUS2 + PLTP PTO::ODP2 expression cassettes for Agro SSI reduced the entire SSI process by several weeks (at least 3-4 weeks), compared to the normal transformation method for generating SSI events (Example 9, pg. 153, lines 30-34 and pg. 154, lines 1-14).
Further regarding Claim 1, Anand teaches that explants useful in the methods of the invention can be derived from monocotyledonous plants (pg. 77, line 22) and that various explants can be used including embryos derived from leaf bases, leaves from mature plants, and leaf tips (pg. 76, lines 27-28).
However, Anand does not teach the feature of Claim 1, wherein the monocot leaf explant used in the method of the invention is haploid.
Regarding Claim 1, Bidney et al. (herein referred to as Bidney) teaches methods of transforming a cell from haploid somatic tissue such as embryo, meristem, leaf, root, inflorescence, callus tissue derived from such tissue, or seed (pg. 2, lines 26-28), wherein plants which can be used in the methods of the invention include monocotyledonous plants (pg. 2 , lines 14-15), including maize (pg. 8, line 32). Bidney teaches that haploid embryos, haploid seeds, or somatic haploid cells from a haploid plant can be harvested and transformed by any known means (pg. 4, lines 21-22). Bidney even teaches that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants, and/or stimulate chromosomal doubling efficiency (pg. 5, line 3-6).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use the haploid maize leaf tissue taught by Bidney in the methods and compositions taught by Anand rather than the, presumably, diploid maize leaf explant embryo derived from leaf tissues taught by Anand. One of ordinary skill in the art would have been motivated to use the haploid maize leaf tissue taught by Bidney in the methods and compositions taught by Anand because, unlike the presumably diploid maize leaf explant embryo derived from leaf tissues taught by Anand, the haploid maize leaf tissue taught by Bidney would be reasonably expected to have a degree of spontaneous chromosome doubling, as evidenced by Boerman et al. (pg. 4, Section 2.1, first paragraph) which would result in a population of transgenic 100% homozygous plants (comprising the heterologous polynucleotide taught by Anand) with restored fertility (Boerman; pg. 4, Section 2.1, first paragraph) that can be regenerated from the transformed haploid cells (Bidney; pg. 4, line 23-24), which bypasses traditional breeding cycles (Boerman, pg. 10, first paragraph). One of ordinary skill in the art would have been further motivated to use the haploid maize leaf tissue taught by Bidney in the methods taught by Anand, because Bidney explicitly suggests that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants, and/or stimulate chromosomal doubling efficiency in the methods of Bidney (pg. 5, line 3-6), which parallels the purpose of transforming plant cells with morphogenic gene regulators such as BBM, WUS/WOX, and ODP2 to decrease the amount of time it takes to produce regenerable plant structures containing heterologous polynucleotides taught in the methods of Anand. The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements were known in the prior art, and one of ordinary skill could have combined these elements as claimed with no change to their respective functions.
Regarding Claim 3, Anand teaches that the methods and composition of the disclosure can utilize a variety of transformation methods including Agrobacterium-mediated transformation and ballistic particle acceleration (pg. 102, lines 29 and 31).
Regarding Claim 4, Anand teaches that the methods and composition of the disclosure can utilize a variety of transformation methods including electroporation (pg. 102, line 28).
Regarding Claim 5, Anand teaches that in the methods of the invention that include expression constructs comprising site-specific recombinase excision sites, the nucleotide sequence encoding the WUS/WOX homeobox polypeptide; the nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or both nucleotide sequences can be operably linked to an auxin inducible promoter, a developmentally regulated promoter, or a constitutive promoter. Exemplary constitutive promoters useful in this context include UBI, LLDAV, EVCV, DMMV, BSV (AY) PRO, CYMV PRO FL, UBIZM PRO, SI-UB3 PRO, SB-UBI PRO (ALT1), USB 1ZM PRO, ZM- GOS2 PRO, ZM-HIB PRO (1.2 KB), IN2-2, NOS, the -135 version of the 35S PRO (or longer versions of the 35S promoter, and ZM-ADF PRO (ALT2). Exemplary auxin inducible promoters useful in this context include AXIG1 and DR5. Exemplary developmentally regulated promoters useful in this context include PLTP, PLTP1, PLTP2, PLTP3, LGL, LEA- 14A, and LEA-D34 (pg. 82, lines 14-25), wherein promoters that are going to have weaker expression profiles of the genes they are operably linked to, relative to the other promoters listed above, are NOS, IN2-2, the -135 version of 35S, CC-UBI1-PRO and ZM-ADF4-PRO promoters (pg. 83, lines 19-24). As such, it would be obvious to one of ordinary skill in the art to use a promoter selected from LLDAV, EVCV, DMMV, BSV (AY) PRO, CYMV PRO FL, UBIZM PRO, SI-UB3 PRO, SB-UBI PRO (ALT1), USB 1ZM PRO, ZM- GOS2 PRO, ZM-HIB PRO (1.2 KB), PLTP, PLTP1, PLTP2, PLTP3, LGL, LEA- 14A, and LEA-D34 to have increased expression of the WUS/WOX homeobox polypeptide and polypeptide comprising two AP2-DNA binding domains relative to the expression of WUS/WOX homeobox polypeptides and polypeptide comprising two AP2-DNA binding domains operably linked to NOS, IN2-2, the -135 version of 35S, CC-UBI1-PRO and ZM-ADF4-PRO.
Regarding Claim 8, Anand teaches that in the methods of the invention the polypeptide comprising the two AP2-DNA binding domains is an ODP2 polypeptide (pg. 92, lines 8-9). Anand also teaches that in the methods of the invention the polypeptide comprising the two AP2-DNA binding domains is a BBM2 polypeptide (pg. 92, lines 21-22). Additionally, Anand teaches that in the methods of the invention the WUS/WOX homeobox polypeptide can be a WUS1, WUS2, WUS3, WOX2A, WOX4, WOX5, or WOX9 (pg. 96, lines 14-15).
Regarding Claim 9, Anand teaches that the nucleotide sequence of interest can be exogenous to the transformed plant (pg. 122, lines 9-20), wherein the particular genes of interest can be any nucleotide sequence of interest known in the art, including those which provide a readily analyzable functional feature to the host cell and/or organism, such as marker genes, as well as other genes that alter the phenotype of the recipient cells, and the like. Thus, genes effecting plant growth, height, susceptibility to disease, insects, nutritional value, and the like may be utilized in the disclosure (pg. 128, lines 27-33).
Regarding Claim 10, Anand teaches that explants useful in the methods of the invention can be derived from leaf bases, leaves from mature plants, and leaf tips (pg. 76, lines 27-28).
Regarding Claim 11, Anand teaches that explants used in the disclosed methods can be derived from a monocot, including, but not limited to, Panicum virgatum (switchgrass), Sorghum bicolor (sorghum, sudangrass), Miscanthus giganteus (miscanthus), Saccharum sp. (energycane), Zea mays (corn), Triticum aestivum (wheat), Oryza sativa (rice), Pennisetum glaucum (pearl millet), Panicum spp., Sorghum spp., Miscanthus spp., Saccharum spp., Erianthus spp (pg. 78, lines 25-31).
Regarding Claim 12, Anand teaches that the explant used in the method of the invention can be derived from the species Poaceae (pg. 78, line 8).
Regarding Claim 18, Anand teaches that in the methods of the invention the WUS/WOX homeobox can comprise nucleotide sequences encoding the amino acid sequences shown in SEQ ID NOs: 6, which has 100% sequence identity relative to instant SEQ ID NO: 180 (See SEQ ID NO: 6 in Sequence Listing for WO 2017074547 A1 located in file wrapper). Additionally, Anand teaches that the BBM2 can comprise nucleotide sequences encoding the amino acid sequences shown in SEQ ID NOs: 18, which has 100% sequence identity relative to instant SEQ ID NO: 216 (See SEQ ID NO: 18 in Sequence Listing for WO 2017074547 A1 located in file wrapper).
Regarding Claim 19, Anand teaches that the addition of ZM-LEC1 into the expression cassettes comprising ZM-WU2 or ZM-ODP2 was effective at stimulating rapid formation of somatic embryos in maize transformants (pg. 168, lines 21-27 and pg. 169, lines 1-6).
Regarding Claim 20, Anand teaches that the site-specific recombinase used to control expression of the nucleotide sequence encoding the WUS/WOX homeobox polypeptide; the nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or both polynucleotide sequences, can be chosen from a variety of suitable site-specific recombinases. For examples, in various aspects, the site-specific recombinase is FLP, Cre, SSV1, lambda Int, phi C31 Int, HK022, R, Gin, Tnl721, CinH, ParA, Tn5053, Bxbl, TP907-1, or U153 (pg. 81, lines 19-25). Anand also teaches that the nucleotide sequence encoding a site-specific recombinase is operably linked to a constitutive promoter, an inducible promoter, or a developmentally- regulated promoter (pg. 81, lines 27-29).
Regarding Claims 21 and 23, Anand teaches a method using the excision-activated selectable marker HRA (nucleotide of interest) to increase the recovery of T0 plants in which the WUS2, ODP2 and CRE expression cassettes were excised and the remaining trait gene was single copy. Using maize with inbred HC69, 741 immature embryos were transformed with Agrobacterium containing PHP81814 (RB + SB-ALS PRO::HRA EXON1::LOXP + ZM-AXIG1 PRO::ZM-WUS2::IN2-1 TERM + ZM-PLT PRO::ZM-ODP2::OS-T28 TERM::PINII TERM::CZ19B1 TERM + ZMGLB-1 PR::MO-CRE EXONLST-LSI INTRON2::MO_CRE EXON2::PINII + SB-UBI PRO-ZS-GREEN::OS-UBI TERM + LOXP-HRA EXON2::SB-PEPCI TERM + -LB), and produced 315 T0 plants in the greenhouse, of which 30 were single-copy for HRA with all the other genes excised for a frequency of quality events of 4% (Example 19, pg. 172, lines 3-6) . Regarding Claim 24, the seeds of the T0 plant would be an obvious product of the transgenic plant produced by the methods of the invention described above.
Regarding Claims 21, 23 and 24, Anand teaches that the nucleotide sequence of interest can be exogenous to the transformed plant (pg. 122, lines 9-20), wherein the particular genes of interest can be any nucleotide sequence of interest known in the art, including those which provide a readily analyzable functional feature to the host cell and/or organism, such as marker genes, as well as other genes that alter the phenotype of the recipient cells, and the like. Thus, genes effecting plant growth, height, susceptibility to disease, insects, nutritional value, and the like may be utilized in the disclosure (pg. 128, lines 27-33).
Regarding Claim 22, Anand teaches in one embodiment of the invention that plants with gene editing machinery comprising ZM-ODP2 and ZM-WUS2 with the presence of the selectable marker ALS2 were sent to the greenhouse and sampled to confirm the presence of the genetic modification as well as the other nucleotide changes associated with the respective repair templates. Tl and T2 progeny of two T0 plants were analyzed to evaluate the inheritance of the edited ALS2 alleles. Progeny plants derived from crosses using pollen from wild type Hi-II plants were analyzed by sequencing and demonstrated sexual transmission of the edited alleles observed in the parent plant with expected 1: 1 segregation ratio (57:56 and 47:49, respectively). To test whether the edited ALS sequence conferred herbicide resistance, selected four- week old segregating Tl plants with edited and wild-type ALS2 alleles were sprayed with four different concentrations of chlorsulfuron (50, 100 (lx), 200, and 400 mg/liter). Three weeks after treatment, plants with an edited allele showed normal phenotype, while plants with only wild-type alleles demonstrated strong signs of senescence. In addition, embryos isolated from seed derived from plants pollinated with wild-type HI-II pollen were germinated on media with 100 ppm of chlorsulfuron. Fourteen days after germination, plants with edited alleles showed normal height and a well-developed root system, while plants with wild-type alleles were short and did not develop roots. As such, Anand teaches a population of plants that, after crosses using pollen from wild type Hi-II plants (breeding away), did not contain the genetic machinery comprising Zm-WUS and Zm-ODP2.
Regarding Claim 25, Anand teaches a regenerable plant structure derived from a cell of an explant with an introduced expression construct comprising (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; (ii) a nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or (iii) a combination of (i) and (ii); and (b) allowing expression of the polypeptide of (a) in each transformed cell to form a regenerable plant structure (Abstract), wherein the polypeptide comprising the two AP2-DNA binding domains is an ODP2 or BBM2 (pg. 6, lines 13-14).
In a narrower embodiment of the invention, Anand teaches a regenerable plant structure derived from one or more cells of an explant with an introduced expression construct comprising: (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; (ii) a nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or (iii) a combination of (i) and (ii); and (b) allowing expression of the polypeptide of (a) in each transformed cell to form a regenerable plant structure in the absence of cytokinin, wherein no callus is formed; wherein transformation further comprises transforming a cell of an explant with a transfer cassette comprising a nucleotide sequence of interest flanked by nonidentical recombination sites; and wherein the explant is derived from a plant with a genome comprising a target site flanked by non-identical recombination sites which correspond to the flanking sites of the transfer cassette, as a method of directional, targeted integration of exogenous nucleotides (heterologous nucleotide sequences) into a transformed plant (pg. 122, lines 9-20). Anand teaches that the novel recombination sites in the gene targeting system facilitates directional targeting of desired genes and nucleotide sequences into corresponding recombination sites previously introduced into the target plant genome (pg. 122, lines 26-31).
In a working embodiment of the invention, Anand teaches maize explants were bombarded with an equimolar ratio of plasmids containing the following expression cassettes; FRT1 :PMI::PINII TERM:FRT87 + UBI PR0:UBI1ZM INTRON::MO-FLP::PINII TERM + ZM-PLTP PRO::ZM-ODP2 (ODP2 polypeptide)::PINII TERM + ZM-AXIG1 PRO::ZM-WUS2 (WUS/WOX polypeptide)::PINII TERM. After particle bombardment, the immature embryos remained on the high-osmotic medium overnight, and were then transferred to resting medium (13266K medium with 150 mg/1 G418) for 8 days. After the resting period, the embryos were transferred to maturation medium (2890 medium with 150 mg/1 G418) for 21 days, and then moved onto rooting medium (272X medium with 150 mg/1 G418) for 14- 17 days (until the roots were large enough for transplanting into soil) for form a regenerable plant structure. At the plantlet stage, leaf tissue was sampled for PCR analysis to confirm that the genes within the flanking FRT1 and FRT87 sites of the original target locus were no longer present and that the new genes within the donor cassette had recombined into the target locus correctly - and precise RMCE (Recombinase-Mediated Cassette Exchange) events were identified. This reduced the entire SSI cycle, from transformation to having precise RMCE-derived plants in the greenhouse, down to 43-50 days (regenerable plant structure formed between 6-7 weeks), depending on how long a time was required to produce adequate roots (Example 9, pg. 153, lines 12-29 ). In the same embodiment of the invention, Anand also teaches the use of the heterologous nucleotide of interest DS-RED in an Agrobacterium mediated SSI method that results in regenerable plant structures using constructs with AXIG1 PRO::WUS2 + PLTP PTO::ODP2. Two T-DNAs were delivered in two separate experiments; the first T-DNA containing PMI, WUS2, ODP2 and DsRED expression cassettes within the flanking FRT1 and FRT87 recombination sites (RB- UBI PRO:UBIlZM INTRON::MO-FLP::PINII TERM + CaMV35S TERM + FRT1 :PMI::PINII TERM + ZM- AXIG1 PRO::ZM-WUS2::IN2-l TERM + ZM-PLTP PRO::ZM-ODP2::OS-T28 TERM + UBI PR0::UBI1ZM INTRON::DsRED: FRT87-LB) (RV003866) and the second T-DNA containing only PMI and DsRED within the FRT1 and FRT87 sties (RB- + ZM-AXIG1 PRO::ZM-WUS2::IN2-l TERM + ZM-PLTP PRO::ZM-ODP2::OS-T28 TERM UBI PR0:UBI1ZM INTRON::MO-FLP::PINII TERM + CaMV35S TERM + FRT1:PMI::PINII TERM + UBI PR0::UBI1ZM INTRON : : DsRED : FRT87-LB) (RV004886). Each of the T- DNAs were delivered via Agro-mediated transformation into target lines with FRT1-FRT87 landing sites. Precise RMCE events were identified using a multiplex PCR assay. The use of AXIG1 PRO::WUS2 + PLTP PTO::ODP2 expression cassettes for Agro SSI reduced the entire SSI process by several weeks (at least 3-4 weeks), compared to the normal transformation method for generating SSI events (Example 9, pg. 153, lines 30-34 and pg. 154, lines 1-14).
Further regarding Claim 25, Anand teaches that explants useful in the methods of the invention can be derived from monocotyledonous plants (pg. 77, line 22) and that various explants can be used including embryos derived from leaf bases, leaves from mature plants, and leaf tips (pg. 76, lines 27-28).
However, Anand does not teach the feature of Claim 1, wherein the monocot leaf explant used in the method of the invention is haploid.
However, Anand does not teach the feature of Claim 25, wherein the monocot leaf explant used in the method of the invention is haploid.
Regarding Claim 25, Bidney et al. (herein referred to as Bidney) teaches methods of transforming a cell from haploid somatic tissue such as embryo, meristem, leaf, root, inflorescence, callus tissue derived from such tissue, or seed (pg. 2, lines 26-28), wherein plants which can be used in the methods of the invention include monocotyledonous plants (pg. 2 , lines 14-15), including maize (pg. 8, line 32). Bidney teaches that haploid embryos, haploid seeds, or somatic haploid cells from a haploid plant can be harvested and transformed by any known means (pg. 4, lines 21-22). Bidney even teaches that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants, and/or stimulate chromosomal doubling efficiency (pg. 5, line 3-6).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use the haploid maize leaf tissue taught by Bidney in the methods and compositions taught by Anand rather than the, presumably, diploid maize leaf explant embryo derived from leaf tissues taught by Anand. One of ordinary skill in the art would have been motivated to use the haploid maize leaf tissue taught by Bidney in the methods and compositions taught by Anand because, unlike the presumably diploid maize leaf explant embryo derived from leaf tissues taught by Anand, the haploid maize leaf tissue taught by Bidney would be reasonably expected to have a degree of spontaneous chromosome doubling, as evidenced by Boerman et al. (pg. 4, Section 2.1, first paragraph) which would result in a population of transgenic 100% homozygous plants (comprising the heterologous polynucleotide taught by Anand) with restored fertility (Boerman; pg. 4, Section 2.1, first paragraph) that can be regenerated from the transformed haploid cells (Bidney; pg. 4, line 23-24), which bypasses traditional breeding cycles (Boerman, pg. 10, first paragraph). One of ordinary skill in the art would have been further motivated to use the haploid maize leaf tissue taught by Bidney in the methods taught by Anand, because Bidney explicitly suggests that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants, and/or stimulate chromosomal doubling efficiency in the methods of Bidney (pg. 5, line 3-6), which parallels the purpose of transforming plant cells with morphogenic gene regulators such as BBM, WUS/WOX, and ODP2 to decrease the amount of time it takes to produce regenerable plant structures containing heterologous polynucleotides taught in the methods of Anand. The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements were known in the prior art, and one of ordinary skill could have combined these elements as claimed with no change to their respective functions.
Regarding Claim 27, Anand teaches the polypeptide comprising the two AP2-DNA binding domains is an ODP2 polypeptide (pg. 92, lines 8-9). Anand also teaches that the polypeptide comprising the two AP2-DNA binding domains is a BBM2 polypeptide (pg. 92, lines 21-22). Additionally, Anand teaches that the WUS/WOX homeobox polypeptide can be a WUS1, WUS2, WUS3, WOX2A, WOX4, WOX5, or WOX9 (pg. 96, lines 14-15).
Regarding Claim 28, Anand teaches that the composition of the disclosure can utilize a variety of transformation methods including Agrobacterium-mediated transformation and ballistic particle acceleration (pg. 102, lines 29 and 31).
Regarding Claim 29, Anand teaches that the compositions of the disclosure can utilize a variety of transformation methods including electroporation (pg. 102, line 28).
Regarding Claim 43, Anand teaches that regenerable plant structures are defined as a multicellular structure capable of forming a fully functional fertile plant (paragraph bridging pgs. 76-77), wherein the regenerable plant structure is germinated to form the transgenic plant (Abstract) in multiple embodiments of the invention. Anand teaches that a transgenic plant is defined as a mature, fertile plant that contains a transgene (pg. 77, line 21).
Regarding Claim 44, in one embodiment of the invention, Anand teaches T0 maize plants of which 30 were single-copy for HRA with all the other genes (in this case, ZM-WUS2 and ZM-ODP2 and other components of the expression cassettes comprising the morphogenic genes) excised for a frequency of quality events of 4% (Example 19, pg. 172, lines 3-6).
Regarding Claim 45, seeds produced by the fertile transgenic plants described by Anand would be an obvious product of the transgenic plant germinated from the regenerable plant structure taught by Anand.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al. (WO 2017074547 A1, published 05/04/2017; IDS Document) in view of Bidney et al. (AU 2002256227 A1, published 10/31/2002) and Boerman et al. (Plants 9.3 (2020): 369, 1-12, published 03/17/2020) as applied to claim 1 above, and further in view of Lowe et al. (The Plant Cell 28.9 (2016): 1998-2015; IDS Document).
The teachings of Anand, Bidney, and Boerman as they are applied to Claim 1 are set forth previously herein and are incorporated by reference.
However, Anand, Bidney, and Boerman does not teach the limitation of Claim 6, wherein the monocot leaf explant is derived from a seedling and not directly derived from an embryo or a seed or an unmodified embryonic tissue; the limitation of Claim 7, wherein the monocot leaf explant is derived from a seedling that is about 8-20 days old, about 12-18 days old, about 10-20 days old, about 14-16 days old, about 16-18 days old or about 14-18 days old.
Regarding Claims 6 and 7, Lowe et al. (herein referred to as Lowe) teaches a method of transforming seedling-derived leaf segments using Agrobacterium-mediated transformation to assess the morphogenic plasticity of maize leaf cells in response to delivery of the Ubipro:Bbm and nospro:Wus2 expression cassettes (morphogenic gene expression cassettes). Agrobacterium strain containing pPHP54733 (pPHP54733-AGL1; See Supplemental Figure 1E) delivered T-DNA into leaf cells from 15- to 16-d-old seedlings (Figure 5E) in Pioneer inbred PHH5G, producing a scattered distribution of individual dividing leaf cells expressing the ZS-GREEN1 fluorescent protein (Figure 5F). With continued culture, multiple embryogenic events were often observed from the same original explant (Figures 5F to 5H). In 28 separate experiments (on separate days), 334 seedlings were used for explant preparation (12.4 ± 5 seedlings/experiment) and Agrobacterium transformation. From these experiments, 151 embryogenic calli were recovered 10 weeks after transformation initiation, giving a transformation frequency (on a per seedling basis) of 45%. Of these calli, 46% regenerated to produce T0 plants, of which 33% were single copy. Of the single-copy T0 plants, 45% produced qPCR results that indicated complete excision of CRE and the morphogenic genes. Thus, from 334 seedlings used to prepare leaf segments for transformation, a final total of 10 single-copy, morphogenic gene-minus (excised) T0 plants were produced. These T0 plants still contained Ubi pro:ZS-GREEN1:Sb-ACTIN 3′ sequence (heterologous polynucleotide expression cassette) and Sb-Ubipro:PMI:Sb-Ubi 3′ sequence expression cassettes left behind after morphogenic gene excision. All were phenotypically normal, fertile, and produced transgenic T1 progeny at the expected Mendelian frequencies (pg. 2004, Transformation of Seedling-Derived Leaf segments, paragraph bridging left and right columns). Lowe teaches that the explant used in the methods of the invention were leaf cells from 15- to 16-d-old maize seedlings (pg. 2004, Transformation of Seedling-Derived Leaf segments, paragraph section in the left column).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use the seedling-derived explant taught by Lowe in the methods and compositions taught by Anand rather than the embryo derived from leaf tissues taught by the combination of Anand, Bidney, and Boerman. One of ordinary skill in the art would have been motivated to use the seedling-derived explant taught by Lowe in the methods and compositions taught by Anand because, unlike the embryo derived from leaf tissues taught by Anand, the seedling-derived explant taught by Lowe does not rely on an intermediate callus-culture step to produce the transformable explant (pg. 2008, right column, first full paragraph). Lowe demonstrates that mesophyll cells from maize seedlings can be directly transformed using Agrobacterium-mediated delivery of Bbm/Wus2 (pg. 2008, right column, first full paragraph), cutting down on the time it takes to produce regenerable plant tissue by immediately having an available transformable explant. One of ordinary skill in the art would have a reasonable expectation of success in using the seedling-derived explant taught by Lowe in the methods and compositions taught by Anand because Lowe teaches that after transformation, the explant cells divide and appear to be the source of the embryogenic, regenerable callus produced experiments described above, wherein the transgenic plants produced from leaf-derived callus were healthy and fertile (pg. 2008, right column, first full paragraph). Additionally, one of ordinary skill in the art would have been motivated to use the seedling-derived explant taught by Lowe in the methods and compositions taught by Anand because the methods, compositions, explants, and transgenic plants produced by both Anand and Lowe are directed to the same plant material (monocot explants), the same morphogenic genes transformed into monocot explants (Bbm and Wus2) for the same purpose of decreasing the amount of time it takes to produce regenerable plant structures containing heterologous polynucleotides, wherein the morphogenic genes have been excised using site specific recombinases. As such, it would have been further obvious to try the explant type taught by Lowe in the methods and compositions taught by Anand. The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements were known in the prior art, and one of ordinary skill could have combined these elements as claimed with no change to their respective functions. Therefore, the invention is prima facie obvious in view of the prior art.
Non-statutory 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 1, 9, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 3-4, 6-8, and 10 of U.S. Patent No. 12,344,851 B1 in view of Anand et al. (WO 2017074547 A1, published 05/04/2017; IDS Document) and Bidney et al. (AU 2002256227 A1, published 10/31/2002). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claims of ‘851 teach method of editing a target polynucleotide in the genome of a first target plant cell, comprising: providing a Cas endonuclease to a first target plant cell in a first plant transformation; providing a heterologous morphogenic factor to a second adjacent plant cell in a second plant transformation, wherein the heterologous morphogenic factor stimulates cell division and transformation frequency of the first target plant cell, and the heterologous morphogenic factor is not provided to the first target plant cell as the first target plant cell benefits from the presence of the morphogenic factor in the second adjacent plant cell, and the second adjacent plant cell is separated from the first target plant cell; incubating the first target plant cell to allow for the Cas endonuclease and a guide RNA to form a complex that edits the target polynucleotide, wherein the editing is selected from the group consisting of insertion of at least one polynucleotide, deletion of at least one polynucleotide, molecular alteration of at least one polynucleotide, substitution of at least one polynucleotide, and a combination of at least two of the preceding; and obtaining the edited first target plant cell, wherein the edited first target plant cell does not comprise a genomic integration of a polynucleotide encoding the heterologous morphogenic factor (relevant to Claims 1 and 21), wherein the morphogenic factor is provided as a polynucleotide gene expression cassette (relevant to Claim 1), wherein the morphogenic factor is selected from the group consisting of Wuschel, Ovule Development Protein, and Babyboom (relevant to Claim 1), the method further comprising introducing a heterologous polynucleotide donor DNA molecule into the first target plant cell (relevant to Claim 1), the method further comprising regenerating an organism or tissue from the first target plant cell (relevant to Claim 1), wherein the first target plant cell and second adjacent plant cell are of a monocot plant cell or a dicot plant cell (relevant to Claim 1). Additionally, ‘851 teaches wherein said heterologous polynucleotide donor DNA molecule encodes a trait selected from the group consisting of: improved health, improved growth, improved fertility, improved fecundity, improved environmental tolerance, improved vigor, improved disease resistance, improved disease tolerance, improved tolerance to a heterologous molecule, improved fitness, improved physical characteristic, greater mass, increased production of a biochemical molecule, decreased production of a biochemical molecule, upregulation of a gene, downregulation of a gene, upregulation of a biochemical pathway, downregulation of a biochemical pathway, stimulation of cell reproduction, and suppression of cell reproduction (relevant to Claim 9).
The claims of ‘851 do not teach singular embodiment of the invention wherein the plant cell used in the methods of the invention is a monocot and wherein the plant cell is a cell from a leaf explant.
Anand et al. broadly teaches methods for producing a transgenic plant, comprising (a) transforming a cell of an explant with an expression construct comprising (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; (ii) a nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or (iii) a combination of (i) and (ii); and (b) allowing expression of the polypeptide of (a) in each transformed cell to form a regenerable plant structure; and (c) germinating the regenerable plant structure to form the transgenic plant (Abstract), wherein the polypeptide comprising the two AP2-DNA binding domains is an ODP2 or BBM2 (pg. 6, lines 13-14). Specifically, Anand teaches that explants (a multitude of plant cells) useful in the methods of transformation taught in the present invention can be derived from monocotyledonous plants (pg. 77, line 22) and that various explants can be used including embryos derived from leaf bases, leaves from mature plants, and leaf tips (pg. 76, lines 27-28). Based on the working examples of Anand, using a WUS/WOX homeobox polypeptide and ODP2 or BBM2 polypeptides in a morphogenic expression cassette would also decrease the time it takes for a regenerable plant structure to be formed from the transformed plant cells used in the methods of the invention (See Example 9, pg. 153, lines 30-34 and pg. 154, lines 1-14)
A person with ordinary skill in the art at the time this application was filed would have found using a plant cell derived from a monocot leaf explant taught by the instant application obvious in view of the teachings of Anand because using a monocot leaf explant as a type of plant cell to be used in a method of transformation (such as the method taught in ‘851) is routine and well-known in the art and field of study, as evidenced by Anand. Additionally, one of ordinary skill in the art would have a reasonable expectation of success, based on the teachings of Anand, that transforming a plant cell with an expression cassette containing WUS/WOX , BMM, or ODP2 would produce a regenerable plant structure (‘851, “regenerating an organism or tissue from the first target plant cell”) within 8 weeks or less of the transformation event. As such, a person with ordinary skill in the art would have found it obvious to use the instantly claimed monocot leaf explant in the claimed method of ‘851 with a reasonable expectation of arriving at the presently claimed subject matter.
The claims of ‘851 do not teach singular embodiment of the invention wherein the plant cell used in the methods of the invention is a haploid monocot leaf explant.
Bidney et al. (herein referred to as Bidney) teaches methods of transforming a cell from haploid somatic tissue such as embryo, meristem, leaf, root, inflorescence, callus tissue derived from such tissue, or seed (pg. 2, lines 26-28), wherein plants which can be used in the methods of the invention include monocotyledonous plants (pg. 2 , lines 14-15), including maize (pg. 8, line 32). Bidney teaches that haploid embryos, haploid seeds, or somatic haploid cells from a haploid plant can be harvested and transformed by any known means (pg. 4, lines 21-22). Bidney even teaches that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants, and/or stimulate chromosomal doubling efficiency (pg. 5, line 3-6).
A person with ordinary skill in the art at the time this application was filed would have found using a plant cell derived from a haploid monocot leaf explant taught by the instant application obvious in view of the teachings of Bidney because using a monocot leaf explant as a type of plant cell to be used in a method of transformation (such as the method taught in ‘851) is routine and well-known in the art and field of study, as evidenced by Bidney. Additionally, one of ordinary skill in the art would have a reasonable expectation of success, based on the teachings of Bidney, that transforming a plant cell with an expression cassette containing WUS/WOX , BMM, or ODP2 would produce a regenerable plant structure (‘851, “regenerating an organism or tissue from the first target plant cell”), as Bidney explicitly teaches that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants (Bidney; pg. 5, line 3-6).
As such, a person with ordinary skill in the art would have found it obvious to use the instantly claimed monocot leaf explant in the claimed method of ‘851 with a reasonable expectation of arriving at the presently claimed subject matter.
Claims 1, 12, 18, 20, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9-12, 17-20, and 25-29 of U.S. Patent No. 11,330,776 B2 in view of Anand et al. (WO 2017074547 A1, published 05/04/2017; IDS Document) and Bidney et al. (AU 2002256227 A1, published 10/31/2002). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claims of ‘776 teach method for producing a transgenic Poaceae plant, comprising: (a) transforming a cell of a Poaceae explant with an expression construct comprising a heterologous gene of interest; and (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; and (ii) a nucleotide sequence encoding a Babyboom (BBM) polypeptide or an Ovule Development Protein 2 (ODP2) polypeptide; and (b) allowing expression of the expression construct of (a) in each transformed cell for about 0 to about 7 days or for about 0 to about 14 days after initiation of transforming the cell, wherein a somatic embryo is formed within about 0 to about 7 days or within about 0 to about 14 days after initiation of transforming the cell in the absence of exogenous cytokinin; and (c) germinating the somatic embryo to form the transgenic Poaceae plant (relevant to Claims 1 and 12), wherein germinating comprises transferring the somatic embryo to a maturation medium and forming the transgenic Poaceae plant (relevant to Claims 1 and 12), wherein the expression construct further comprises a nucleotide sequence encoding a site-specific recombinase selected from FLP, Cre, SSV1, lambda Int, phi C31 Int, HK022, R, Gin, Tn1721, CinH, ParA, Tn5053, Bxb1, TP907-1, or U153 (relevant to Claim 20), wherein the nucleotide sequence encoding a site-specific recombinase is operably linked to a constitutive promoter, an inducible promoter, or a developmentally regulated promoter (relevant to Claim 20), wherein the WUS/WOX homeobox polypeptide comprises the amino acid sequence of any of SEQ ID NO: 4, 6, 8, 10, 12, 14, or 16, or wherein the WUS/WOX homeobox polypeptide is encoded by the nucleotide sequence of any of SEQ ID NO: 3, 5, 7, 9, 11, 13, or 15 and wherein the BBM polypeptide or the Ovule Development Protein 2 (ODP2) polypeptide comprises the amino acid sequence of any of SEQ ID NO: 18, 20, 63, 65, or 67, or wherein the BBM polypeptide or the Ovule Development Protein 2 (ODP2) polypeptide is encoded by the nucleotide sequence of any of SEQ ID NO: 17, 19, 21, 62, 64, 66, or 68 (relevant to Claim 18, wherein elected instant SEQ ID NO: 180 is identical to SEQ ID NO: 6, wherein elected instant SEQ ID NO: 216 is identical to SEQ ID NO: 18, wherein elected instant SEQ ID NO: 179 is identical to SEQ ID NO: 5, wherein elected instant SEQ ID NO: 215 is identical to SEQ ID NO: 17), and wherein the nucleotide sequence encoding the WUS/WOX homeobox polypeptide and the nucleotide sequence encoding the BBM polypeptide or the ODP2 polypeptide is excised (relevant to Claim 21).
Additionally, the claims of ‘776 teach a method for producing a transgenic Poaceae plant, comprising: (a) transforming a cell of a Poaceae explant with an expression construct comprising a heterologous gene of interest; and (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; and (ii) a nucleotide sequence encoding a Babyboom (BBM) polypeptide or an Ovule Development Protein 2 (ODP2) polypeptide; and (b) allowing expression of the expression construct of (a) in each transformed cell for about 0 to about 7 days or for about 0 to about 14 days after initiation of transforming the cell, wherein a somatic embryo is formed within about 0 to about 7 days or within about 0 to about 14 days after initiation of transforming the cell in the absence of exogenous cytokinin; and (c) germinating the somatic embryo to form the transgenic Poaceae plant; wherein the WUS/WOX homeobox polypeptide comprises the amino acid sequence of any of SEQ ID NO: 4, 6, 8, 10, 12, 14, or 16; or wherein the WUS/WOX homeobox polypeptide is encoded by the nucleotide sequence of any of SEQ ID NO: 3, 5, 7, 9, 11, 13, or 15; wherein the polypeptide comprising the BBM polypeptide or the ODP2 polypeptide comprises the amino acid sequence of any of SEQ ID NO: 18, 20, 63, 65, or 67; or wherein the polypeptide comprising the BBM polypeptide or the ODP2 polypeptide is encoded by the nucleotide sequence of any of SEQ ID NO: 17, 19, 21, 62, 64, 66, or 68 (Relevant to Claims 1, 12, and 18, wherein elected instant SEQ ID NO: 180 is identical to SEQ ID NO: 6, wherein elected instant SEQ ID NO: 216 is identical to SEQ ID NO: 18, wherein elected instant SEQ ID NO: 179 is identical to SEQ ID NO: 5, wherein elected instant SEQ ID NO: 215 is identical to SEQ ID NO: 17), wherein germinating comprises transferring the somatic embryo to a maturation medium and forming the transgenic Poaceae plant (relevant to Claims 1 and 12), wherein the expression construct further comprises a nucleotide sequence encoding a site-specific recombinase selected from FLP, Cre, SSV1, lambda Int, phi C31 Int, HK022, R, Gin, Tn1721, CinH, ParA, Tn5053, Bxb1, TP907-1, or U153 (relevant to Claim 20), wherein the nucleotide sequence encoding a site-specific recombinase is operably linked to a constitutive promoter, an inducible promoter, or a developmentally regulated promoter (relevant to Claim 20), wherein the nucleotide sequence encoding the WUS/WOX homeobox polypeptide and the nucleotide sequence encoding the BBM polypeptide or the ODP2 polypeptide is excised (relevant to Claim 21).
Additionally, the claims of ‘776 teach a method for producing a transgenic Poaceae plant comprising: (a) transforming a cell of a Poaceae explant with an expression construct comprising a heterologous gene of interest; and (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; and (ii) a nucleotide sequence encoding a Babyboom (BBM) polypeptide or an Ovule Development Protein 2 (ODP2) polypeptide; and (b) allowing expression of the expression construct of (a) in each transformed cell for about 0 to about 7 days or for about 0 to about 14 days after initiation of transforming the cell, wherein a somatic embryo is formed within about 0 to about 7 days or within about 0 to about 14 days after initiation of transforming the cell in the absence of exogenous cytokinin; and (c) germinating the somatic embryo of (b) for about 14 to about 60 days to form a plantlet; and (d) allowing the plantlet of (c) to grow into a Poaceae plant (relevant to Claims 1 and 12), wherein germinating comprises transferring the somatic embryo to a maturation medium and forming the transgenic Poaceae plant (relevant to Claims 1 and 12), wherein the expression construct further comprises a nucleotide sequence encoding a site-specific recombinase selected from FLP, Cre, SSV1, lambda Int, phi C31 Int, HK022, R, Gin, Tn1721, CinH, ParA, Tn5053, Bxb1, TP907-1, or U153 (relevant to Claim 20), wherein the nucleotide sequence encoding a site-specific recombinase is operably linked to a constitutive promoter, an inducible promoter, or a developmentally regulated promoter (relevant to Claim 20), wherein the WUS/WOX homeobox polypeptide comprises the amino acid sequence of any of SEQ ID NO: 4, 6, 8, 10, 12, 14, or 16, or wherein the WUS/WOX homeobox polypeptide is encoded by the nucleotide sequence of any of SEQ ID NO: 3, 5, 7, 9, 11, 13, or 15 and wherein the BBM polypeptide or the Ovule Development Protein 2 (ODP2) polypeptide comprises the amino acid sequence of any of SEQ ID NO: 18, 20, 63, 65, or 67, or wherein the BBM polypeptide or the Ovule Development Protein 2 (ODP2) polypeptide is encoded by the nucleotide sequence of any of SEQ ID NO: 17, 19, 21, 62, 64, 66, or 68 (relevant to Claim 18, wherein elected instant SEQ ID NO: 180 is identical to SEQ ID NO: 6, wherein elected instant SEQ ID NO: 216 is identical to SEQ ID NO: 18, wherein elected instant SEQ ID NO: 179 is identical to SEQ ID NO: 5, wherein elected instant SEQ ID NO: 215 is identical to SEQ ID NO: 17), wherein the nucleotide sequence encoding the WUS/WOX homeobox polypeptide and the nucleotide sequence encoding the BBM polypeptide or the ODP2 polypeptide is excised (relevant to Claim 21).
Claims 1-4, 9-12, 17-20, and 25-29 of ‘776 claim the same subject matter as instant Claims 1, 12, 18, 20, and 21, but are narrower in scope with the limitations “Poaceae explant” and “allowing expression of the expression construct of (a) in each transformed cell for about 0 to about 7 days or for about 0 to about 14 days after initiation of transforming the cell, wherein a somatic embryo is formed within about 0 to about 7 days or within about 0 to about 14 days after initiation of transforming the cell in the absence of exogenous cytokinin” which are still encompassed by the broad recitation of “monocot” and “regenerating a transgenic monocot plant from the regenerable plant structure” in the instant claims.
However, the claims of ‘776 do not explicitly teach the limitation wherein the Poaceae explant is a leaf explant.
Anand et al. broadly teaches methods for producing a transgenic plant, comprising (a) transforming a cell of an explant with an expression construct comprising (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; (ii) a nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or (iii) a combination of (i) and (ii); and (b) allowing expression of the polypeptide of (a) in each transformed cell to form a regenerable plant structure; and (c) germinating the regenerable plant structure to form the transgenic plant (Abstract), wherein the polypeptide comprising the two AP2-DNA binding domains is an ODP2 or BBM2 (pg. 6, lines 13-14). Specifically, Anand teaches that explants useful in the methods of transformation taught in the present invention can be derived from monocotyledonous plants (pg. 77, line 22), specifically derived from the species Poaceae (pg. 78, line 8), and that various explants can be used including embryos derived from leaf bases, leaves from mature plants, and leaf tips (pg. 76, lines 27-28). Based on the working examples of Anand, using a WUS/WOX homeobox polypeptide and ODP2 or BBM2 polypeptides in a morphogenic expression cassette would also decrease the time it takes for a regenerable plant structure to be formed from the transformed plant cells used in the methods of the invention (See Example 9, pg. 153, lines 30-34 and pg. 154, lines 1-14)
A person with ordinary skill in the art at the time this application was filed would have found using a leaf explant taught by the instant application obvious in view of the teachings of Anand because using a leaf explant, specifically derived from the Poaceae family of monocot plants, as a type of explant to be used in a method of transformation (such as the method taught in ‘776) is routine and well-known in the art and field of study, as evidenced by Anand. Additionally, one of ordinary skill in the art would have a reasonable expectation of success, based on the teachings of Anand, that transforming a plant cell with an expression cassette containing WUS/WOX , BMM, or ODP2 would produce a regenerable plant structure (‘776, “forming the transgenic Poaceae plant”) within 8 weeks or less of the transformation event. As such, a person with ordinary skill in the art would have found it obvious to use the instantly claimed leaf explant in the claimed method of ‘776 with a reasonable expectation of arriving at the presently claimed subject matter.
The claims of ‘776 do not teach singular embodiment of the invention wherein the plant cell used in the methods of the invention is a haploid monocot leaf explant.
Bidney et al. (herein referred to as Bidney) teaches methods of transforming a cell from haploid somatic tissue such as embryo, meristem, leaf, root, inflorescence, callus tissue derived from such tissue, or seed (pg. 2, lines 26-28), wherein plants which can be used in the methods of the invention include monocotyledonous plants (pg. 2 , lines 14-15), including maize (pg. 8, line 32). Bidney teaches that haploid embryos, haploid seeds, or somatic haploid cells from a haploid plant can be harvested and transformed by any known means (pg. 4, lines 21-22). Bidney even teaches that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants, and/or stimulate chromosomal doubling efficiency (pg. 5, line 3-6).
A person with ordinary skill in the art at the time this application was filed would have found using a haploid monocot leaf explant taught by the instant application obvious in view of the teachings of Bidney because using a haploid monocot leaf explant, specifically derived from the Poaceae family of monocot plants, as a type of explant to be used in a method of transformation (such as the method taught in ‘776) is routine and well-known in the art and field of study, as evidenced by Bidney. Additionally, one of ordinary skill in the art would have a reasonable expectation of success, based on the teachings of Bidney, that transforming a plant cell with an expression cassette containing WUS/WOX , BMM, or ODP2 would produce a regenerable plant structure (‘776, “forming the transgenic Poaceae plant”), as Bidney explicitly teaches that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants (Bidney; pg. 5, line 3-6).
As such, a person with ordinary skill in the art would have found it obvious to use the instantly claimed haploid monocot leaf explant in the claimed method of ‘776 with a reasonable expectation of arriving at the presently claimed subject matter. As such, the claims are rejected as being unpatentable over U.S. Patent No. 11,330,776 B2.
Claims 1, 12, 18, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 9-12, and 17-20 of copending Application No. 19/095,241 in view of Anand et al. (WO 2017074547 A1, published 05/04/2017; IDS Document) and Bidney et al. (AU 2002256227 A1, published 10/31/2002).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claims of ‘241 teach a method for producing a transgenic Poaceae plant, comprising:(a) transforming a cell of a Poaceae explant with an expression construct comprising a heterologous gene of interest; and(i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; and(ii) a nucleotide sequence encoding a Babyboom (BBM) polypeptide or an Ovule Development Protein 2 (ODP2) polypeptide; and(b) allowing expression of the expression construct of (a) in each transformed cell for about 0 to about 7 days or for about 0 to about 14 days after initiation of transforming the cell, wherein a somatic embryo is formed within about 0 to about 7 days or within about 0 to about 14 days after initiation of transforming the cell; and (c) germinating the somatic embryo to form the transgenic Poaceae plant (relevant to Claims 1 and 12), wherein germinating comprises transferring the somatic embryo to a maturation medium and forming the transgenic Poaceae plant (relevant to Claims 1 and 12), wherein the expression construct further comprises a nucleotide sequence encoding a site-specific recombinase selected from FLP, Cre, SSV lambda Int, phi C31 Int, HK022, R, Gin, Tn1721, CinH, ParA, Tn5053, Bxbl, TP907-1, or U153 (relevant to Claim 20), wherein the nucleotide sequence encoding a site-specific recombinase is operably linked to a constitutive promoter, an inducible promoter, or a developmentally regulated promoter (relevant to Claim 20).
Additionally, the claims of ‘241 teach a method for producing a transgenic Poaceae plant, comprising:(a) transforming a cell of a Poaceae explant with an expression construct comprising a heterologous gene of interest; and (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; and(ii) a nucleotide sequence encoding a Babyboom (BBM) polypeptide or an Ovule Development Protein 2 (ODP2) polypeptide; and(b) allowing expression of the expression construct of (a) in each transformed cell for about 0 to about 7 days or for about 0 to about 14 days after initiation of transforming the cell, wherein a somatic embryo is formed within about 0 to about 7 days or within about 0 to about l 4 days after initiation of transforming the cell; and (c) germinating the somatic embryo to form the transgenic Poaceae plant; wherein the WUS/WOX homeobox polypeptide comprises the amino acid sequence of any of SEQ ID NO: 4, 6, 8, 10, 12, 14, or 16; or wherein the WUS/WOX homeobox polypeptide is encoded by the nucleotide sequence of any of SEQ ID NO: 3, 5, 7, 9, 11, 13, or 15; wherein the polypeptide comprising the BBM polypeptide or the ODP2 polypeptide comprises the amino acid sequence of any of SEQ ID NO: 18, 20, 63, 65, or 67; or wherein the polypeptide comprising the BBM polypeptide or the ODP2 polypeptide is encoded by the nucleotide sequence of any of SEQ ID NO: 17, 19, 21, 62, 64, 66, or 68 (relevant to Claims 1, 12, and 18, wherein elected instant SEQ ID NO: 180 is identical to SEQ ID NO: 6, wherein elected instant SEQ ID NO: 216 is identical to SEQ ID NO: 18, wherein elected instant SEQ ID NO: 179 is identical to SEQ ID NO: 5, wherein elected instant SEQ ID NO: 215 is identical to SEQ ID NO: 17), wherein germinating comprises transferring the somatic embryo to a maturation medium and forming the transgenic Poaceae plant (relevant to Claims 1 and 12), wherein the expression construct further comprises a nucleotide sequence encoding a site-specific recombinase selected from FLP, Cre, SSV1, lambda Int, phi C31 Int, HK022, R, Gin, Tn1721, CinH, ParA, Tn5053, Bxbl, TP907-1, or U153 (relevant to Claim 20), wherein the nucleotide sequence encoding a site-specific recombinase is operably linked to a constitutive promoter, an inducible promoter, or a developmentally regulated promoter (relevant to Claim 20).
Additionally, the claims of ‘241 teach a method for producing a transgenic Poaceae plant comprising:(a) transforming a cell of a Poaceae explant with an expression construct comprising a heterologous gene of interest; and(i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; and(ii) a nucleotide sequence encoding a Babyboom (BBM) polypeptide or an Ovule Development Protein 2 (ODP2) polypeptide; and(b) allowing expression of the expression construct of (a) in each transformed cell for about 0 to about 7 days or for about 0 to about 14 days after initiation of transforming the cell, wherein a somatic embryo is formed within about 0 to about 7 days or within about 0 to about 14 days after initiation of transforming the cell; and (c) germinating the somatic embryo of (b) for about 14 to about 60 days to form a plantlet; and (d) allowing the plantlet of (c) to grow into a Poaceae plant (relevant to Claims 1 and 12), wherein germinating comprises transferring the somatic embryo to a maturation medium and forming the transgenic Poaceae plant (relevant to Claims 1 and 12), wherein the expression construct further comprises a nucleotide sequence encoding a site-specific recombinase selected from FLP, Cre, SSV1, lambda Int, phi C31 Int, HK022, R, Gin, Tn1721, CinH, ParA, Tn5053, Bxbl, TP907-1, or U153 (relevant to Claim 20), wherein the nucleotide sequence encoding a site-specific recombinase is operably linked to a constitutive promoter, an inducible promoter, or a developmentally regulated promoter (relevant to Claim 20).
Claims 1-4, 9-12, and 17-20 of ‘241 recite the same subject matter as instant Claims 1, 12, 18, 20, but are narrower in scope with the limitations “Poaceae explant” and “allowing expression of the expression construct of (a) in each transformed cell for about 0 to about 7 days or for about 0 to about 14 days after initiation of transforming the cell, wherein a somatic embryo is formed within about 0 to about 7 days or within about 0 to about 14 days after initiation of transforming the cell in the absence of exogenous cytokinin” which are still encompassed by the broad recitation of “monocot” and “regenerating a transgenic monocot plant from the regenerable plant structure” in the instant claims.
However, the claims of ‘241 do not explicitly teach the limitation wherein the Poaceae explant is a leaf explant.
Anand et al. broadly teaches methods for producing a transgenic plant, comprising (a) transforming a cell of an explant with an expression construct comprising (i) a nucleotide sequence encoding a WUS/WOX homeobox polypeptide; (ii) a nucleotide sequence encoding a polypeptide comprising two AP2-DNA binding domains; or (iii) a combination of (i) and (ii); and (b) allowing expression of the polypeptide of (a) in each transformed cell to form a regenerable plant structure; and (c) germinating the regenerable plant structure to form the transgenic plant (Abstract), wherein the polypeptide comprising the two AP2-DNA binding domains is an ODP2 or BBM2 (pg. 6, lines 13-14). Specifically, Anand teaches that explants useful in the methods of transformation taught in the present invention can be derived from monocotyledonous plants (pg. 77, line 22), specifically derived from the species Poaceae (pg. 78, line 8), and that various explants can be used including embryos derived from leaf bases, leaves from mature plants, and leaf tips (pg. 76, lines 27-28). Based on the working examples of Anand, using a WUS/WOX homeobox polypeptide and ODP2 or BBM2 polypeptides in a morphogenic expression cassette would also decrease the time it takes for a regenerable plant structure to be formed from the transformed plant cells used in the methods of the invention (See Example 9, pg. 153, lines 30-34 and pg. 154, lines 1-14)
A person with ordinary skill in the art at the time this application was filed would have found using a leaf explant taught by the instant application obvious in view of the teachings of Anand because using a leaf explant, specifically derived from the Poaceae family of monocot plants, as a type of explant to be used in a method of transformation (such as the method taught in ‘241) is routine and well-known in the art and field of study, as evidenced by Anand. Additionally, one of ordinary skill in the art would have a reasonable expectation of success, based on the teachings of Anand, that transforming a plant cell with an expression cassette containing WUS/WOX , BMM, or ODP2 would produce a regenerable plant structure (‘241, “forming the transgenic Poaceae plant”) within 8 weeks or less of the transformation event. As such, a person with ordinary skill in the art would have found it obvious to use the instantly claimed leaf explant in the claimed method of ‘241 with a reasonable expectation of arriving at the presently claimed subject matter.
The claims of ‘241 do not teach singular embodiment of the invention wherein the plant cell used in the methods of the invention is a haploid monocot leaf explant.
Bidney et al. (herein referred to as Bidney) teaches methods of transforming a cell from haploid somatic tissue such as embryo, meristem, leaf, root, inflorescence, callus tissue derived from such tissue, or seed (pg. 2, lines 26-28), wherein plants which can be used in the methods of the invention include monocotyledonous plants (pg. 2 , lines 14-15), including maize (pg. 8, line 32). Bidney teaches that haploid embryos, haploid seeds, or somatic haploid cells from a haploid plant can be harvested and transformed by any known means (pg. 4, lines 21-22). Bidney even teaches that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants, and/or stimulate chromosomal doubling efficiency (pg. 5, line 3-6).
A person with ordinary skill in the art at the time this application was filed would have found using a haploid monocot leaf explant taught by the instant application obvious in view of the teachings of Bidney because using a haploid monocot leaf explant, specifically derived from the Poaceae family of monocot plants, as a type of explant to be used in a method of transformation (such as the method taught in ‘241) is routine and well-known in the art and field of study, as evidenced by Bidney. Additionally, one of ordinary skill in the art would have a reasonable expectation of success, based on the teachings of Bidney, that transforming a plant cell with an expression cassette containing WUS/WOX , BMM, or ODP2 would produce a regenerable plant structure (‘241, “forming the transgenic Poaceae plant”), as Bidney explicitly teaches that polynucleotides or polypeptides involved in growth stimulation or cell cycle stimulation can be used to increase the recovery of transformed haploid plants (Bidney; pg. 5, line 3-6).
As such, a person with ordinary skill in the art would have found it obvious to use the instantly claimed haploid monocot leaf explant in the claimed method of ‘241 with a reasonable expectation of arriving at the presently claimed subject matter.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
This action is NON-FINAL.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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