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 .
Elections/Restrictions
Applicant's election, without traverse, of Group II, encompassed by claims 6-7, 9-11, and 28 in the reply filed on 06/23/2026 is acknowledged.
Claims 1, 3, 5, 12, 15, 17-18, 20-23, 26, 27, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to GB Application No. 2205562.8, filed April 14, 2022. The certified copy has been filed in this application.
The effective filing date is April 14, 2022.
Status of the Claims
Amendments dated 07/09/2025 and election dated 06/23/2026 are entered:
Claims 1, 3, 5 pending.
Claims 1, 3, 5, 12, 15, 17-18, 20-23, 26, 27, and 30 are withdrawn.
Claims 6-7, 9-11, and 28 are examined herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/24/2025 is acknowledged and is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities:
should recite “pseudooxynicotine (PON)” instead of “PON”.
Claim 28 is objected to because of the following informalities:
Referencing the withdrawn claim 27.
Claim Interpretations
Regarding claims 6-7, 9-11, and 28, Specification para 0116 defines the term “modifying” or “modified” as meaning “a plant (e.g. a tobacco plant) or nucleic acid sequence that has been altered or changed” and adds that “the present invention comprises the modification of plants using techniques for genetic modification of plants or non-genetic modification of plants. Such methods are well known in the art and examples of genetic modification techniques include transformation, transgenics, cisgenics, and gene editing methods. Examples of non-genetic modification techniques include fast-neutron mutagenesis, chemical mutagenesis e.g. ethyl methanesulfonate (EMS) mutagenesis and modern population analysis approaches” (emphasis provided).
Regarding claims 6-7, 9-11, and 28, Specification para 0120 defines the term “Myc-type, basic helix-loop-helix protein” as referring to “a sequence specific DNA-binding protein that belongs to the MYC group of bHLH proteins” adding that “the Myc-type basic helix-loop-helix protein comprises a basic helix-loop-helix structural motif.”
Regarding claims 6-7, 9-11, and 28, Specification para 0494 defines the term “homologue” as meaning “an entity having a certain homology with the subject amino acid sequences and the subject nucleotide sequences” and adds that “the term ‘homology’ can be equated with ‘identity’.”
Regarding claims 6-7, 11, and 28, Specification para 0272 defines the term “precursor thereto” “when used in relation to at least one tobacco-specific nitrosamine [as] refer[ing] to one or more chemicals or compounds of a tobacco plant that give rise to the formation of a tobacco-specific nitrosamine or are involved in the nitrosation reaction leading to tobacco-specific nitrosamine production.” This term, “precursor thereto,” is being given the broadest reasonable interpretation of being synonymous with the term “precursor” as recited in claims 6-7, 11, and 28.
Regarding claim 7, Specification para 0337 defines the term “plant propagation material” as referring to “any plant matter taken from a plant from which further plants may be produced” and adds that “a plant propagation material may be selected from a seed, plant calli and plant clumps.”
Regarding claim 28, which recites “a comparable plant”, the term “a comparable plant” is not defined in the specification. The term “a comparable product” is defined in Specification para 0115 such that the term “a comparable plant” is being given the broadest reasonable interpretation of referring to a plant (e.g. a tobacco plant) which had not been modified according to the present invention, but in which all other relevant features were the same (e.g. plant species, growing conditions, method of processing the plant, e.g. tobacco, etc.).”
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written Description
Claims 6-7, 9-11, and 28 are rejected under 35 U.S.C. 112(a) first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. Details are listed below.
“[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). To satisfy the written description requirement of 35 USC 112, first paragraph, the specification must describe the invention in sufficient detail so “that one skilled in the art can clearly conclude that the inventor[s] invented the claimed invention as of the filing date sought.” Lockwood
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v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). “[The written description] inquiry is a factual one and must be assessed on a case-by-case basis.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). “In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Id. Nonetheless, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. Id., (“Put another way, one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims.”) While the written description requirement does not demand either examples or an actual reduction to practice, actual “possession” or reduction to practice outside of the specification is not enough. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Rather, it is the specification itself that must demonstrate possession. Id.
Appearance of a claim in the specification in ipsis verbis does not guarantee that the written description requirement is satisfied, see, e.g., Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002), nor does a failure to meet that standard require a finding that a claim does not comply with the written description requirement, In re Edwards, 568 F.2d 1349, 1351-52 (Fed. Cir. 1978). All that is required is that the specification demonstrate to a person of ordinary skill in the art that the inventor was in possession of the invention. Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008).
The claims are broadly drawn to a tobacco plant or part thereof or a tobacco cell or cell culture, having been modified to decrease the activity or expression of a Myc-type, basic helix-loop-helix protein and comprising decreased alkaloid and or TSNA precursor content in comparison to an unmodified plant or unmodified cell or cell culture.
Applicant has reduced to practice:
Example 1, “Virus-Induced Gene Silencing (VIGS) of Nitab4.5_0000611g0080.2 [(i.e., a gene encoding Myc-type, basic helix-loop-helix protein) ] Decreases Alkaloid Content in Leaves.” Nitab4.5_0000611g0080.2 has genomic sequence of SEQ ID NO: 1, the coding sequence of SEQ ID NO: 2, and the amino acid sequence of SEQ ID NO: 3 using the 300-nucleotide cDNA fragment with SEQ ID NO: 41.
In para 0537, “VIGS of Nitab4.5_0005842g0010.2 in tobacco leads to a decrease in alkaloid content in the tobacco leaves, in particular a decrease in nicotine, nornicotine, anabasine, PON and anatabine content.”
Applicant has not reduced to practice:
Reduction of all possible alkaloids in tobacco plants
Modification of the activity or expression of a Myc-type, basic helix-loop-helix protein or nucleotide or amino acid sequence with at least 80% identity to SEQ ID NO:1-3, or homologues thereof, other than SEQ ID NOs: 1-3.
If alkaloid content can be increased and TSNA precursors maintained or reduced or vice versa (i.e., the plant comprising decreased alkaloid and/or TSNA precursor content).
Decrease of a Myc-type, basic helix-loop-helix protein’s activity in a plant.
Any plant propagation material obtained from the tobacco plant comprising decreased activity or expression of a Myc-type, basic helix-loop-helix protein from the heritable modification.
Regarding claims 27-28 a mutant of all possible plants with decreased Myc-type, basic helix-loop-helix protein activity or expression and decreased alkaloid and/or TSNA precursor content, other than tobacco.
Regarding claims 27-28, any plant part with decreased Myc-type, basic helix-loop-helix protein activity or expression and decreased alkaloid and/or TSNA precursor content, other than tobacco leaves.
First, the instant claims recite decreased alkaloid and/or TSNA precursor content in comparison to an unmodified plant. With the VIGS modification of Example 1, the instant disclosure describes silencing of Nitab4.5_0000611g0080.2 (i.e., a gene encoding Myc-type, basic helix-loop-helix protein). The results of the relative content of pyridine alkaloids were determined by LC-MS/MS, for analytes nicotine, anabasine, anatabine, nornicotine, PON (Specification paras 0495-0496). Alkaloid content of 5-week-old tobacco leaves silenced for Nitab4.5_0005997g0050.2 is shown in Fig. 1. Although the Applicant claims that VIGS of Nitab4.5_0005997g0050.2 leads to a decrease in alkaloid content in leaves, only nicotine, nornicotine, anabasine, PON, and anatabine content are depicted in Fig. 1 as being significantly decreased. Myosmine, recited in claim 9, is not included in Fig 1. Also, tobacco plants synthesize other alkaloids not listed in the specification or addressed in this disclosure. Cotinine and β-nicotyrine, are identified as “tobacco minor alkaloids” and are described on page 2 paragraph 2 in Chen (Chen, Peter X., et al. "Analysis of minor alkaloids in tobacco: a collaborative study." BEITRAGE ZUR TABAKFORSCHUNG INTERNATIONAL 21.7 (2005): 369).
Given the limited description in the instant specification of a few alkaloids in tobacco plants, a skilled artisan would not have reasonably recognized Applicant to be in possession of the full metes and bounds of the claims, all possible alkaloids, at the time the application was filed.
Next, modifications, including mutations, insertions, deletions, and/or substitutions, can have varying effects on gene expression. Ge (Ge, Fang, et al. "Review of computational methods and database sources for predicting the effects of coding frameshift small insertion and deletion variations." ACS omega 9.2 (2024): 2032-2047) teaches, for example, silent (i.e. synonymous) mutations may not change the protein structure and thus do not result in increased gene expression, while others, such as frameshift mutations, can cause a premature stop codon resulting in a truncated protein that is not functional (see page 1 paragraph 1). Al Aboud (Al Aboud, NM., et al. Genetics, Epigenetic Mechanism. [Updated 2023 Aug 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532999) teaches, in the section title “Cellular,” that modifications to alter gene expression or activity includes epigenetic changes through alterations in the chromosome, rather than the DNA sequence, and regulating gene expression through chemical modifications. Modification may refer to the alteration of the peptide or gene encoding the peptide by any means, including merely natural modifications. Such modifications may or may not result in an increase or decrease in activity or expression of a Myc-type, basic helix-loop-helix protein, however, there is not sufficient structure to indicate that any modification would result in the function of decreasing activity or expression of a Myc-type, basic helix-loop-helix protein in a reliable and predictable manner.
As the Applicant only provides the one example of the VIGS technique, which is a small species in the large genus of “modification”, all possible modifications are not reduced to practice. Further, it appears that Applicant reduced to practice decreasing activity Myc-type, basic helix-loop-helix protein through silencing (i.e. reduction in expression) and thus the plant comprises decreased nicotine content (see Example 1). This is not equivalent to decreasing the activity of a Myc-type, basic helix-loop-helix protein without decreasing expression (activity or expression).
Further, VIGS can serve as an alternative to mutant collections or stable transgenic plants to allow the characterization of gene functions in a wide range of angiosperm species, but is a generally a transient method of genetic transformation. This was described in the abstract of Lange (Lange, Matthias, et al. "Virus-induced gene silencing (VIGS) in plants: an overview of target species and the virus-derived vector systems." Virus-Induced gene silencing: Methods and protocols (2013): 1-14.). Applicant has not reduced to practice VIGS in any tissue other than leaves. Applicant has not provided any examples of a plant, plant propagation material, or any sort of processed leaf or product produced from the tobacco leaves with the VIGS modification.
As VIGS are known to be transient and no examples of a plant grown from the tobacco plant with the modification with decreased activity or expression of Myc-type, basic helix-loop-helix protein or decreased alkaloid content are reduced to practice, Applicant has not sufficiently linked the structure to the function.
Further still, per the claim interpretation, Applicant's definition Myc-type, basic helix-loop-helix protein covers a large range of evolutionarily related sequences of amino acids and nucleotides sharing a common ancestor and exhibiting similarity in sequence, and/or domains. The instant disclosure provides a singular example of VIGS of Nitab4.5_0005842g0010.2 purportedly reducing alkaloid content in leaves (Example 1). The VIGS construct uses a 300-nucleotide cDNA fragment of Nitab4.5_0005842g0010.2 (SEQ ID NO: 41). The results show a significant decrease in some alkaloids, but not all possible alkaloids in tobacco (refer to Chen , page 2 paragraph 2). Applicant’s description of “homologues of SEQ ID NOs: 1, 2 and 3” in Table 1 is acknowledged. However, the identification of homologues does not in and of itself guarantee they share same functionality as SEQ ID NOs: 1-3. Homologue testing in Example 3 simply states that the effects of the homologues of SEQ ID NO: 3, namely those listed in Table 1, are tested in assays as described in the above example. Additionally, Table 1 does not provide all nucleotide and amino acid sequences with 80% similarity to SEQ ID NOs: 1-3 and the specification does not display any data describing the influence of VIGS on these homologous genes or on, putatively downstream, alkaloid and/or TSNA precursor content.
A related homolog, or sequence with 80% similarity to Myc-type, basic helix-loop-helix protein is a broad term for any character, gene, or structure that shares a common ancestral origin. Though Xu (Xu, Zilong, et al. 2023. "Phylogenetic Inference of Homologous/Orthologous Genes Among Distantly Related Plants." Bio-protocol 13.23.; see page 2 para 1) teaches that homologous/orthologous genes among different plants typically perform similar or equivalent functions, a representative number of species was not described to represent the claimed entire genus of decreasing the activity or expression of the vastness of the Myc-type, basic helix-loop-helix protein genus. Sufficient structure was not provided of the homolog-related peptides that share a common ancestor and still maintain the same function in the claims.
Björklund (Björklund, Åsa K., et al. "Domain rearrangements in protein evolution." Journal of molecular biology 353.4 (2005): 911-923) teaches on page 1 paragraphs 1-2 that “proteins are composed of domains, recurrent protein fragments with distinct structure, function and/or evolutionary history” and that “it has been estimated that single-domain proteins from the same domain family have a 67% chance of having similar functions, whereas the corresponding number for two-domain proteins with just one of the domains in common [i.e., homologues or functional variants or functional fragments] is 35%.” Applicant does not provide working examples of a homologue as recited in claim 6 and claim 28, which incorporates claim 27.
Due to the functional unpredictability of homologous sequences, and variants thereof, undue experimentation would be required to ensure that all variants and fragments of the claimed sequences still maintained the functionality of reducing the alkaloid and/or TSNA precursor content since Applicant has not done so.
Finally, as the above paragraphs have highlighted, Applicant has only reduced to practice a singular example of VIGS of Nitab4.5_0005842g0010.2 in tobacco leaves leading to reduced content of 5 specific alkaloids content in aid tobacco leaves (Example 1), yet claims, in claim 28, all possible mutations in all possible homologs of SEQ ID NO: 3 in all possible plants compared to a control of any of the all possible plants which does not have the mutation at hand. There is no definition of plants in the specification and the specification only has one example which is in a tobacco plant.
The Specification fails to provide an adequate written description to support the breadth of the claims. Therefore, one skilled in the art would not have recognized Applicants to be in possession of the claimed invention at the time the application was filed. See Written Description guidelines published in 2008 online at https://www.uspto.gov/ sites/default/files/web/menu/written.pdf.
Claim Rejections - 35 USC § 101
Claims 6-7, 9-11, and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon including products of nature, or an abstract idea) without significantly more. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. The rationale for this determination is explained below.
This rejection is made on the basis that “modified” means “a plant (e.g. a tobacco plant) or nucleic acid sequence that has been altered or changed” and that Burner’s MYC2a is a Myc-type, basic helix-loop-helix protein and homologue of the instant SEQ ID NO: 3. See Claim Interpretations above.
The claims are broadly drawn to a tobacco plant or part thereof or a tobacco cell or cell culture, having been modified to decrease the activity or expression of a Myc-type, basic helix-loop-helix protein and comprising decreased alkaloid and or TSNA precursor content in comparison to an unmodified plant or unmodified cell or cell culture.
SEQ ID NO: 3 is the amino acid sequence of a Tobacco Myc-type, basic helix-loop-helix protein, and appears to be naturally occurring in Tobacco plants, absent evidence to the contrary.
Burner (Burner N, et al. Analyses of diverse low alkaloid tobacco germplasm identify naturally occurring nucleotide variability contributing to reduced leaf nicotine accumulation. Mol Breed. 2022 Jan 11;42(1):4. doi: 10.1007/s11032-021-01274-5. PMID: 37309485; PMCID: PMC10248598.) teaches that “recent suggestions for mandated lowering of nicotine content in cigarettes have prompted tobacco breeders to search for N. tabacum germplasm[i.e., naturally occurring plants] with allelic variability contributing to low alkaloid accumulation” and then discloses that “a newly discovered 5 bp deletion[i.e., having been modified; mutation] in the gene MYC2a [i.e., homologue of SEQ ID NO: 3] was found to likely partially underlie the ultra-low alkaloid phenotype [i.e., decreased alkaloid] of TI 313” (emphasis provided; Abstract). Burner does not explicitly teach reduced activity of the mutated MYC2a protein. However it is inherent and apparent from the reduced alkaloid levels that the mutated MYC2a has diminished activity in comparison to an unmutated MYC2a from the same locus (see Burner Figure 4).
Thus, a tobacco plant having been modified (i.e., Burner’s discovered natural 5 bp deletion) to decrease the activity or expression of a Myc-type, basic helix-loop-helix protein and comprising decreased alkaloid in comparison to an unmodified plant exists in nature. Thus tobacco cells and seeds (i.e., plant propagation material) having been modified (i.e., Burner’s discovered 5 bp deletion) to decrease the activity or expression of a Myc-type, basic helix-loop-helix protein and comprising decreased alkaloid in comparison to an unmodified cell or seed also exists in nature.
The claimed plant and mutant plant are indistinguishable from the above described naturally occurring plant and the naturally occurring Myc-type, basic helix-loop-helix protein sequence therein., The claimed invention does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention is directed to naturally-occurring process(es), genes, cells, and organisms, with naturally occurring gene. The judicial exception is not integrated into a practical application because the claimed invention is directed to naturally-occurring plant, gene, and processes. A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S.Ct. 1289,101 USPQ2d 1961 (2012), at 1966. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. Plant cell culture is well known in the art and does not amount to significantly more than the naturally occurring plant, plant cell, plant seed and progeny plants inheriting the 5 bp deletion in the MYC2a gene as described by Burner.
Thus, the claimed products are not patent-eligible pursuant to the Supreme Court decision in Ass'n. for Molecular Pathology v. Myriad Genetics (formerly v. USPTO), 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011), cert. granted, judgment vacated and remanded to the Court of Appeals for the Federal Circuit, No. 11-725, 80 U.S.L.W. 3380, 2012 BL 72224 (U.S. Mar. 26, 2012), reversed, ---- S.Ct. ----, 106 USPQ2d 1972, 1974-75 (2013). The claimed invention does not rise to a level that is markedly different in structure from what exists in nature. See “The 2019 Revised Patent Subject Matter Eligibility Guidance”, issued January 7, 2019, available from the USPTO website at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 6-7, 9-11, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rushton (US Application Publication No. 20180340180 A1 titled “DOMINANT-NEGATIVE GENETIC MANIPULATION TO MAKE LOW-NICOTINE TOBACCO PRODUCTS”, assigned to 22nd Century Limited, LLC, Published 2018, Cited in IDS) taken with the evidence of Veitia (Veitia RA. Exploring the molecular etiology of dominant-negative mutations. Plant Cell. 2007 Dec;19(12):3843-51. doi: 10.1105/tpc.107.055053. Epub 2007 Dec 14. PMID: 18083908; PMCID: PMC2217636).
This rejection is made on the basis that the protein encoded by Rushton’s SEQ ID NO: 10 is a Myc-type, basic helix-loop-helix protein and homologue of the instant SEQ ID NO: 3.
Regarding instant claim 6, Rushton’s claim 19 depends from Rushton’s claim 17 and is drawn to a genetically engineered Nicotiana plant (i.e., A tobacco plant or part thereof or a tobacco cell or cell culture, having been modified) having reduced nicotine content as compared to a non-transformed control plant, wherein the plant comprises plant cells comprising a chimeric nucleic acid construct comprising, in the 5′ to 3′ direction, a promoter suitable for directing expression in the Nicotiana plant cell operably linked to at least one transcription repressor sequence in translational fusion with at least one transcription factor sequence encoding for a transcription factor or fragment thereof that positively regulates nicotine biosynthesis, wherein expression of the chimeric nucleic acid results in production of a dominant negative form of the transcription factor and the plant having a reduced nicotine content (c.f., instant claims 9-10) as compared to a non-transformed control plant grown under similar conditions (i.e., comprising decreased alkaloid content in comparison to an unmodified plant), and wherein the transcription factor that positively regulates nicotine biosynthesis is selected from the group consisting of SEQ ID NO: 7 (NtMYC1a), SEQ ID NO: 8 (NtMYC1b), SEQ ID NO: 9 (NtMYC2a), or SEQ ID NO: 10 (NtMYC2b).
Rushton’s SEQ ID NO: 10 shares some homology or identity with instant SEQ ID NO: 3 (data not shown) and is, thus, a homologue of instant SEQ ID NO: 3 (c.f., claim 6).
Veitia explains, in the abstract, the meaning of a term “dominant negative” used in the Rushton primary reference: “the classical definition of dominant-negative (DN) mutations [are] those leading to mutant polypeptides that disrupt the activity of the wild-type gene when overexpressed.” This reads on the instant claim 6 recitation of a “modified to decrease the activity or expression of a Myc-type, basic helix-loop-helix protein.”
Regarding instant claim 7, Rushton’s claim 22 that is drawn to “seeds [i.e., plant propagation material] from the genetically engineered Nicotiana plant of claim 17, wherein the seeds comprise the chimeric nucleic acid construct” (i.e., the plant propagation material comprising (i) decreased activity or expression of the Myc-type, basic helix-loop-helix protein, and(ii) decreased alkaloid and/or TSNA precursor content in comparison to a plant propagation material obtained from an unmodified tobacco plant).
Regarding instant claims 9-10, the above Rushton teaching and claims include the limitation that “the plant having a reduced nicotine content [c.f., instant claims 9-10] as compared to a non-transformed control plant grown under similar conditions” (Rushton claim 17).
Regarding instant claim 11, Rushton teaches in para 0096 that “plants produce seeds containing the genes for the introduced trait and can be grown to produce plants that will produce the selected phenotype.”
Regarding instant claim 28 limitations incorporated from instant claim 27, Rushton’s claim 19 recites a chimeric nucleic acid construct comprising at least one transcription repressor sequence in translational fusion with at least one transcription factor sequence, encoding for a transcription factor (i.e., Rushton SEQ ID NO: 10) that positively regulates nicotine biosynthesis. The fusion of a transcription repressor to the Myc-type, basic helix-loop-helix protein encoded by Rushton’s SEQ ID NO: 10 is the mutation and the effect of the mutation comprising nucleic acid in tobacco plants is the reduced activity of the Myc-type, basic helix-loop-helix protein. Regarding instant claim 28, which depends from instant claim 27, Rushton’s claim 19 is drawn to a genetically engineered Nicotiana plant (i.e., mutant plant) having reduced nicotine content as compared to a non-transformed control plant, wherein the plant comprises a chimeric nucleic acid construct comprising at least one transcription repressor sequence in translational fusion with SEQ ID NO: 10, which encodes NtMYC2b (a Myc-type, basic helix-loop-helix protein), wherein expression of the chimeric nucleic acid results in production of a dominant negative form of the transcription factor (decreases the activity of the Myc-type, basic helix-loop-helix protein) and the plant having a reduced nicotine content as compared to a non-transformed control plant (i.e., wherein the mutant plant has decreased alkaloid content relative to a comparable plant which does not carry said mutation) and Rushton teaches in para 0096 that “plants produce seeds containing the genes for the introduced trait and can be grown to produce plants that will produce the selected phenotype” (i.e., the mutation is heritable).
Thus, Rushton anticipates the claimed invention.
Conclusion
No claims allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YVETTE B TAMUKONG whose telephone number is (571)272-1040. The examiner can normally be reached M-Th 730-5 EST.
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/YVETTE B. TAMUKONG/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662
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