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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7 and 10, in the reply filed on 02/05/2026 is acknowledged. The Applicant elected the following species in claim 2:
(a) Marker M5 on one side of the ALS-herbicide tolerant endogenous ALS allele in the
first parent;
(b) Marker M6 on the other side of the ALS-herbicide tolerant endogenous ALS allele in
the same (first) parent;
(c) Marker M5 on one side of the ALS-herbicide tolerant endogenous ALS allele in the
second parent; and
(d) Marker M12 on the other side of the ALS-herbicide tolerant endogenous ALS allele in the 2nd parent.
The traversal is on the ground that “examination of all groups together would not impose an undue burden because the claims share a common technical focus…” (response, page 2, para 7, line 1-2). This is not found persuasive because the application is a 371 of PCT where different non-permissible categories of inventions and/or lack of unity among inventions sharing a common technical feature justify restriction, as described in the Office action dated 12/17/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-20 are pending.
Claims 8-9 and 11-20 are withdrawn from the examination as being part of non-elected inventions.
Claims 1-7 and 10 are being examined.
Claim Interpretation
All the elected claims are drawn to a product (a Beta vulgaris plant, seed, or a part thereof). In this instant case, the product is produced by a specific process. These are product-by-process claims where patentability of the product does not depend on the process. See MPEP § 2113. Moreover, claim 1 recites, “…at position 569, said Beta vulgaris hybrid plant or seed being obtainable by…” (line 4-5).
The Examiner interprets that any Beta vulgaris plant and seed (not necessarily produced by the claimed process including introgression) having the same structure as the claimed plant or seed would satisfy the claim limitations in terms of its patentability. All the claim limitations recited after “obtainable” (underlined) does not constitute claim limitation because the hybrid plant was not obtained, but obtainable by the process recited after obtainable. The plant or the seeds thereof can very well be obtained by other methods and still fulfill all the claim limitations of claim 1.
Claim Objections
Claims 1-3 and 5-6 are objected to because of the following informalities:
The claims recite “gene allele”. The terms “gene” and “allele” refer to a DNA sequence in a specific location in a chromosome encoding either a protein or an RNA. The terms are identical and used interchangeably in the art.
It is suggested to delete one of the terms.
Claim 5 recites, “… at least 90% sequence identity to the nucleotide sequence of SEQ ID NO: 16.”
SEQ ID NO: 16 is a protein sequence. It is suggested to replace “nucleotide” (underlined) with “polypeptide” or “amino acid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 5 recite, “… ALS-herbicide tolerant endogenous ALS gene allele encoding an ALS protein comprising leucine at position 569…”. It is not clear to the Examiner which protein sequence is used as a reference sequence (no SEQ ID NO) to specify position 569 in the polypeptide.
Claim 1 also recites, “…chromosomal region of chromosome 5 introgressed….said parent plant is sufficiently small to avoid or decrease inbred depression and/or increase heterosis and/or increase sugar yield in said Beta vulgaris hybrid plant.” It is not clear to the Examiner what the reference plant is, to quantify the decrease in inbred depression, increase in heterosis, and/or increase sugar yield in the claimed Beta vulgaris hybrid plant. Is the inbred depression, heterosis, and/or sugar yield of the said Beta vulgaris hybrid plant compared to another Beta vulgaris plant which does not have the ALS-herbicide tolerant endogenous ALS gene comprising leucine at position 569; OR, another Beta vulgaris hybrid plant comprising an upstream and/or downstream region of the ALS inhibitor tolerant endogenous ALS gene in said parent plant that is not “sufficiently small” ; or some other plant altogether?
Further in claim 1: the recitation, “sufficiently small” also renders the claim indefinite. The specification defines “sufficiently small” to mean “that the chromosomal region is freed from donor material upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene allele in said parent plant, preferably by truncation of the region, whereby the region remains a continuous region derived from the donor.” This definition itself is ambiguous. The definition indicates that the chromosomal region is “freed” of donor material, but that “the region remains a continuous region derived from the donor”, which seems to be a contradictory statement. Further, it is unclear what is meant by “freed”. It is unclear if this ONLY means that nucleotide bases upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene allele are deleted, as opposed to substituting a specific polynucleotide sequence from that in the donor sequence.
Claim 4 recites the limitation "the markers" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 1 and neither claim 1 nor claim 4 recite any marker before “the markers” in line 2.
Claim 4 also recites, “… at the varying position of the markers… of the parent plants”. It is not clear to the Examiner which parent (out of the two parents) is referred to.
Regarding claim 5, the phrase "such as" (in line 3) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if ALS-herbicide tolerant gene/allele is limited to the two examples recited in lines 4-7 of the claim or can also be others. MPEP 2173.05(d).
Regarding claims 6 and 10, It is not clear to the Examiner what the Applicant means by the term “reference”. Does the recitation refer only to seed within the recited deposit, or does it encompass other seed. It is suggested to delete the term “reference”.
Claim Rejections - 35 USC § 112(a)
Written Description
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim 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.
Claim 1 recites, “…said parent plant is sufficiently small to avoid or decrease inbred depression and/or increase heterosis and/or increase sugar yield in said Beta vulgaris hybrid plant.”
The Applicant does not describe how small would be "sufficiently small". The Applicant defines "sufficiently small" as “the chromosomal region is freed from donor material upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene allele in said parent plant, preferably by truncation of the region, whereby the region remains a continuous region derived from the donor. In this way a decrease of inbred depression and/or an increase of heterosis and/or an increase sugar yield or biomass yield in said Beta vulgaris hybrid plant is detectable/measurable” ((page 47, para 00103, line 6-10).
The Applicant also does not describe the entire ALS inhibitor tolerant endogenous ALS gene; i.e., where the gene starts (promoter and/or any relevant upstream regulatory element(s)) and where the gene ends (terminator sequence). The Applicant also does not describe if the marker sequences comprising SEQ ID NOs: 5-6 and 12 are the boundaries of the “sufficiently small” region comprising the upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene. As such, the specification does not describe the boundaries of the “sufficiently small” region so that a skilled artisan would know which sequences need not be present upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene and which polynucleotide sequences are included in that “sufficiently small” region, and correlate such “sufficiently small” region to the recited decrease in inbred depression and/or increase in heterosis and/or increase in sugar yield properties of the claimed hybrid plant. Any Beta vulgaris hybrid plant developed by crossing two different parents each having the same ALS inhibitor tolerant endogenous ALS gene encoding a protein with a leucine at position 569, will have decrease of inbred depression, an increase of heterosis, and/or an increase sugar yield, irrespective of how small or large the difference in upstream and/or downstream sequence of the ALS inhibitor tolerant endogenous ALS gene is. Decrease of inbred depression, increase of heterosis, and/or an increase sugar yield or biomass yield in the Beta vulgaris hybrid plants are detectable/measurable in all the lines starting from PO-13 to PO-19 even though the difference in upstream and/or downstream sequences of the ALS inhibitor tolerant endogenous ALS gene varies (Fig. 2).
Claim 5 recites, “… ALS-herbicide tolerant endogenous ALS gene allele encodes an
ALS protein comprising leucine at position 569 such as an ALS-herbicide tolerant endogenous ALS gene allele comprising a nucleotide sequence having at least 90% sequence identity to
to the nucleotide sequence of SEQ ID NO: 15 or encoding an amino acid sequence having at least 90% sequence identity to the nucleotide sequence of SEQ ID NO 16.”
The Applicant described an ALS-herbicide tolerant endogenous ALS allele encodes an ALS protein comprising leucine at position 569 having 100% sequence identity to instant SEQ ID NOs: 15-16. The Applicant does not describe any example of an ALS-herbicide tolerant endogenous ALS gene allele encodes an ALS protein comprising leucine at position 569 with less than 100% sequence identity with either SEQ ID NO: 15 or SEQ ID NO: 16, while claiming the board genus.
Mutating up to 10% of the amino acid s in the 665 amino acid long SEQ ID NO: 16 or 1998 nucleotide long SEQ ID NO: 15 would allow an artisan to mutate up to 66 amino acids or up to 199 nucleotides in the encoded polypeptide or in the gene along the entire length of the proteins or the allele, respectively. Moreover, mutating up to 199 nucleotide along the entire length of the coding sequence would imply mutating up to 199 amino acid, depending on the codons being mutated.
The Applicant also does not describe any structure function relationship between specific mutation(s) in the endogenous ALS gene(s) in terms of ALS herbicide tolerance function. It is known in the art that mutating even a single amino acid, which might be crucial for its stability and/or any specific function of the polypeptide including protein-protein interaction(s) and/or polynucleotide-protein interaction(s), can drastically change the function(s) of the polypeptide. The Applicant describes that a “single base pair substitutions at specific sites of the ALS gene can lead to more or less resistant ALS enzyme variants which show different levels of inhibition by the ALS inhibitor herbicides. Plants comprising mutant ALS alleles therefore show different levels of tolerance to ALS inhibitor herbicides, depending on the chemical structure of the ALS inhibitor herbicide and the site of the point mutation in the ALS gene” (page 3, para 0010).
Considering the breadth of the claims, lack of representative species of the broad genus claimed, lack of structure function relationship of the broad genus claimed, and unpredictability of the art, the Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Scope of Enablement
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a Beta vulgaris hybrid plant, or hybrid seed, or a part thereof, comprising an ALS-herbicide tolerant endogenous ALS gene on chromosome 5 and encoding an ALS protein comprising leucine at position 569, does not reasonably provide enablement for a Beta vulgaris hybrid plant, or hybrid seed, or a part thereof, comprising an ALS-herbicide tolerant endogenous ALS gene on chromosome 5 encoding an ALS protein comprising leucine at position 569, said Beta vulgaris hybrid plant or seed being obtainable by crossing two parent Beta vulgaris plants from different heterotic pools, wherein each parent plant comprises the ALS-herbicide tolerant endogenous ALS gene in homozygous state and wherein the ALS-herbicide tolerant endogenous ALS gene allele in each parent plant is introgressed from the same ALS- herbicide tolerant endogenous ALS gene allele donor plant, characterized in that chromosomal region of chromosome 5 introgressed from said ALS-herbicide tolerant endogenous ALS gene allele donor plant and located upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene allele in said parent plant is sufficiently small to avoid or decrease inbred depression and/or increase heterosis and/or increase sugar yield in said Beta vulgaris hybrid plant. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 1 recites, “…said parent plant is sufficiently small to avoid or decrease inbred depression and/or increase heterosis and/or increase sugar yield in said Beta vulgaris hybrid plant.”
The Applicant does not define how small would be "sufficiently small". The Applicant defines "sufficiently small" as “the chromosomal region is freed from donor material upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene allele in said parent plant, preferably by truncation of the region, whereby the region remains a continuous region derived from the donor. In this way a decrease of inbred depression and/or an increase of heterosis and/or an increase sugar yield or biomass yield in said Beta vulgaris hybrid plant is detectable/measurable” ((page 47, para 00103, line 6-10).
The Applicant also does not define of the ALS inhibitor tolerant endogenous ALS gene; i.e., where the gene starts (promoter and/or any relevant upstream regulatory element(s)) and where the gene ends (terminator sequence). The Applicant also does not describe if the marker sequences comprising SEQ ID NOs: 5-6 and 12 are the boundaries of the “sufficiently small” region comprising the upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene. In the absence of further guidance, undue experimentation would be required to determine the boundaries of the “sufficiently small” region so that a skilled artisan would know which sequences need not be present upstream and/or downstream of the ALS inhibitor tolerant endogenous ALS gene and which polynucleotide sequences are included in that “sufficiently small” region. Any Beta vulgaris hybrid plant developed by crossing two different parents each having the same ALS inhibitor tolerant endogenous ALS gene encoding a protein with a leucine at position 569 will have decrease of inbred depression, an increase of heterosis, and/or an increase sugar yield, irrespective of how small or large the difference in upstream and/or downstream sequence of the ALS inhibitor tolerant endogenous ALS gene is. The percentage or amount decrease of inbred depression, increase of heterosis, and/or an increase sugar yield may vary depending on how small or large the difference in upstream and/or downstream sequence of the ALS inhibitor tolerant endogenous ALS gene is. However, the decrease of inbred depression, increase of heterosis, and/or an increase sugar yield or biomass yield in the Beta vulgaris hybrid plants are detectable/measurable in all the lines starting from PO-13 to PO-19 even though the difference in upstream and/or downstream sequences of the ALS inhibitor tolerant endogenous ALS gene varies (Fig. 2).
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a Beta vulgaris hybrid plant or hybrid seed comprising a nucleotide sequence having 100% sequence identity to SEQ ID NO: 15 or encoding a protein comprising 100% sequence identity to SEQ ID NO: 16, does not reasonably provide enablement for a Beta vulgaris hybrid plant or hybrid seed comprising a nucleotide sequence having at least 90% sequence identity to SEQ ID NO: 15 or encoding a protein comprising 90% sequence identity to SEQ ID NO: 16. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The Applicant described an ALS-herbicide tolerant endogenous ALS allele encodes an ALS protein comprising leucine at position 569 having 100% sequence identity to instant SEQ ID NOs: 15-16. The Applicant does not provide any example of an ALS-herbicide tolerant endogenous ALS gene allele encodes an ALS protein comprising leucine at position 569 with less than 100% sequence identity. It is known in the art that mutating even a single amino acid, which might be crucial for its stability and/or any specific function of the polypeptide including protein-protein interaction(s) and/or polynucleotide-protein interaction(s), can drastically change the function(s) of the polypeptide.
Mutating up to 10% of the amino acid s in the 665 amino acid long SEQ ID NO: 16 or 1998 nucleotide long SEQ ID NO: 15 would allow an artisan to mutate up to 66 amino acids or up to 199 nucleotides in the encoded polypeptide or in the gene along the entire length of the proteins or the allele, respectively. Moreover, mutating up to 199 nucleotides along the entire length of the coding sequence would imply mutating up to 199 amino acids, depending on the codons being mutated.
Undue trial and error experimentations would be needed to mutate up to 66 or 199 amino acids, or up to 199 nucleotides and retain the function of ALS-herbicide tolerance.
Based on breadth of the claims, lack of any working example, lack of guidance in the instant description or in prior art, the specification at the time of the application filed would not have taught one skilled in the art how to make and use the full scope of the claimed invention without performing undue experiments.
Enablement
Claims 6 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 6 requires the ALS-herbicide tolerant endogenous ALS gene allele donor plant to be that grown from the seed deposited as NCIMB 41705. Claim 10 requires the claimed plant or seed to comprise the chromosomal region of chromosome 5 of a B. vulgaris ALS inhibitor tolerant plant comprising an ALS-herbicide tolerant endogenous gene, seed of which has been deposited as NCIMB 41705. The plant reference seed is deposited as NCIMB 41705. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Beta vulgaris hybrid plant or hybrid seeds or part thereof.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material, and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. The specification describes, “The founder genotype carrying the BvALSW569L ALS gene allele conferring tolerance to ALS inhibitor herbicides, such as sulfonyl urea herbicides, indicated hereinafter as SU-12-1, was derived by selecting spontaneous ALS mutations in calli cultivated from diploid sugar beet genotype 7T9044” (page 81, para 00201, line 1-4). It is also not clear if the same material comprises any other “spontaneous” mutation(s) (e.g., due to somaclonal variation) in the Beta vulgaris genome. A skilled artisan would not be able to make the same deposited material or use the invention defined in and commensurate with the claims without access to the specific biological material.
It is noted that Applicants have deposited biological material but there is no indication in the specification that the deposit satisfies the deposit rules of 37 CFR 1.801-1.809. It is also noted that prior art refers to seed deposited in NCIMB 41705. However, the prior art does not make clear whether the deposited material is publicly available. Therefore, a deposit at a recognized depository, meeting the requirements of 37 CFR 1.801-1.809, may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Claim Rejections - 35 USC § 102(a)(1)
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 1, 5-7 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hain et al. (US 2013/0247253 A1).
Hain et al. teaches ALS inhibitor herbicide tolerant sugar beet (Beta vulgaris) plants comprising an endogenous acetolactate synthase (ALS) gene, wherein the ALS gene encodes an ALS polypeptide containing an amino acid different from tryptophan at a position 569 of the ALS polypeptide (abstract; claim 1) and the amino acid replacing the tryptophan (W) at a position 569 is leucine (page 5, para 0057, last line; claim 2). Hain et al. also describes herbicide tolerant Beta vulgaris plants which are homozygous for the mutation (claim 6) and shows a better agronomical level of ALS inhibitor tolerance (page 7, Para 0088, line 5-7). A homozygous Beta vulgaris plants comprises the same DNA molecule in both the chromosomes (as recited in claim 10) of chromosome 5 comprising the ALS-herbicide tolerant endogenous ALS gene with the specific mutation.
Hain describes the acetolactate synthase (ALS) gene having more than 90% (100%) sequence identity to instant SEQ ID NO: 16 (as recited in claim 5), as shown below.
RESULT 1
US-13-821-966-4
Sequence 4, US/13821969
Patent No. 10544426
GENERAL INFORMATION
APPLICANT: Bayer CropScience AG
TITLE OF INVENTION: Use of ALS inhibitor herbicides for control of unwanted
vegetation in ALS inhibitor herbicide tolerant Beta vulgaris plants
FILE REFERENCE: BCS 09-1020 / 2923343-034000
CURRENT APPLICATION NUMBER: US/13/821,966
CURRENT FILING DATE: 2013-03-08
PRIOR APPLICATION NUMBER: PCT/EP11/67922
PRIOR FILING DATE: 2011-10-13
PRIOR APPLICATION NUMBER: EP 10187759.5
PRIOR FILING DATE: 2010-10-15
PRIOR APPLICATION NUMBER: US 61/394,469
PRIOR FILING DATE: 2010-10-19
NUMBER OF SEQ ID NOS: 4
SEQ ID NO 4
LENGTH: 665
TYPE: PRT
ORGANISM: Beta vulgaris
FEATURE:
NAME/KEY: MISC_FEATURE
LOCATION: (569)..(569)
OTHER INFORMATION: Substitution of a Tryptophan by a Leucine
Query Match 100.0%; Score 3413; Length 665; Best Local Similarity 100.0%;
Matches 665; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
Qy 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
Qy 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
Qy 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
Qy 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
Qy 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
Qy 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
Qy 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
Qy 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
Qy 541 QELATIRVENLPVKIMLLNNQHLGMVVQLEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 QELATIRVENLPVKIMLLNNQHLGMVVQLEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
Qy 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
Qy 661 GRTSY 665
|||||
Db 661 GRTSY 665
Hain et al. also describes hybrid plants comprising the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) gene (page 3, para 0031, line 3-6). It is an inherent property of a hybrid plant to show increased heterosis and decrease inbreed depression.
The gene is located in chromosome 5. A standard BLAST search using SEQ ID NO: 4 (having 100% sequence identity to instant SEQ ID NO: 16), as described by Hain et al., identifies an ALS allele (GenBank accession No. XP_010695365) in Beta vulgaris having 99.8% sequence identity with the instant SEQ ID NO: 16 and having only one amino acid mismatch in position 569 where tryptophan was present instead of leucine, as described by Hain et al.. The allele (GenBank gene ID/symbol: LOC104908017) is located in chromosome 5, as show below.
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Hain et al. also describes depositing the seeds of the mutant beet plants with the NCIMB, Aberdeen, UK, under Number NCIMB 41705 (page 8, para 0115; page 2, para 0023), as recited in claim 6.
Regarding claim 7; sugar beet plants expression the ALS-herbicide tolerant ALS allele is not expected to affect sugar yield much or in a significant way if at all, because there is no extra metabolic energy/resource used to express the allele compared to the non-herbicide tolerant ALS allele, and the activity of the ALS enzyme is not known to be affected by the SNP(s) in the herbicide tolerant allele(s). It is known in the art that weeds can significantly impact sugar beet’s quality and yield. Weed control in sugar beet cultivation (by any means including using ALS herbicides which ALS herbicide tolerant plants can withstand and grow normally) significantly impact and improve both quality and yield in terms of higher sucrose content, higher purity, improved extractable sugar percentage, enhanced root yield and boost overall sugar yield1.
The data obtained in 2020 from the KWS’ SMART seed varieties like SMART JANNINKA KWS, which contains ALS-herbicide tolerant ALS allele(s), indicates that the yield is more than 90% compared to a non-herbicide tolerant control variety2, which would be reflected in sugar yield from the plants.
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hain et al. as applied to claims 1, 5-7 and 10 above, and further in view of Nadeem et al. (DNA molecular markers in plant breeding: current status and recent advancements in genomic selection and genome editing, 2018, Biotechnology & Biotechnological Equipment, 32:261–285) and McGrath et al. ((A contiguous de novo genome assembly of sugar beet EL10 (Beta vulgaris L.); bioRxiv 15:29831; published on 09/16/2020)).
Hain et al. describes a Beta vulgaris plant comprising an ALS-herbicide tolerant endogenous ALS allele which is homozygously present on chromosome 5 and encoding an ALS protein comprising leucine at position 569, and located at chromosome 5, as discussed above. Hain teaches that the herbicide tolerant Beta vulgaris plants which are homozygous (page 7, para 0088, line 5-7; page 9, para 0134, line 3-4) for the mutation revealed a better agronomical level of ALS inhibitor herbicide tolerance (page 7, para 0088, line 5-7).
However, Hain et al. does not describe any genetic marker comprising SEQ ID NOs: 5, 6, and 12.
Use and development of molecular/genetic markers is a routine and standard practice in the art, as described by Nadeem et al. (abstract), especially once the whole genome is sequenced and published. Nadeem et al. also described use of such markers in in heterosis (page 268, right column, last para) and introgression (page 269, right column, last para) based plant breeding (applied to hybrid plants) and detecting hybrid plants (page 269, left column, para 1, last line).
Before the effective filing date one with ordinary skill in the art would have been motivated to develop molecular markers, as described by Nadeem et al., for the ALS-herbicide tolerant ALS allele in a Beta vulgaris plant, as described by Hain et al.. A standard BLAST search using the known Beta vulgaris genomic database (EL10), as described by McGrath et al., identifies all the three markers, as recited in claims 2-4 and 10 (as it depends from claim 8 reciting the markers) in chromosome 5 and those markers are closely linked, as shown below.
Sequence identity to SEQ ID NO: 5;
>jgi:EL10_2_Chr5_782 Bvulgarissspvulgaris|782|EL10.2_2
Length=67929547
Score = 111 bits (122), Expect = 1e-23
Identities = 61/61 (100%), Gaps = 0/61 (0%)
Strand=Plus/Plus
Query 1 CCTATTATCAACGTCAATCACCACCAAAGTCATGAAACTTCAAGATTTTCCAGCCTAGTT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46886778 CCTATTATCAACGTCAATCACCACCAAAGTCATGAAACTTCAAGATTTTCCAGCCTAGTT 46886837
Query 61 G 61
|
Sbjct 46886838 G 46886838
Sequence identity to SEQ ID NO: 6;
>jgi:EL10_2_Chr5_782 Bvulgarissspvulgaris|782|EL10.2_2
Length=67929547
Score = 111 bits (122), Expect = 1e-23
Identities = 61/61 (100%), Gaps = 0/61 (0%)
Strand=Plus/Minus
Query 1 TATCGGAGGTTTTGTCTTTGCTTGCTGTGGCCGAGGTGAAATGTTTTTCGAAAGATTAAA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 47408424 TATCGGAGGTTTTGTCTTTGCTTGCTGTGGCCGAGGTGAAATGTTTTTCGAAAGATTAAA 47408365
Query 61 T 61
|
Sbjct 47408364 T 47408364
Sequence identity to SEQ ID NO: 12:
>jgi:EL10_2_Chr5_782 Bvulgarissspvulgaris|782|EL10.2_2
Length=67929547
Score = 109 bits (120), Expect = 4e-23
Identities = 60/60 (100%), Gaps = 0/60 (0%)
Strand=Plus/Plus
Query 1 ACCTTCTCTGTTTCCGTGATACCATTCTGTAATCCATTTGAACTCCCAACGTTAAATGCT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 47086389 ACCTTCTCTGTTTCCGTGATACCATTCTGTAATCCATTTGAACTCCCAACGTTAAATGCT 47086448
The ordinarily skilled artisan would have been motivated to develop and use molecular markers to identify and/or develop different hybrid Beta vaulgaris plants, which is an economically important plant, by stacking the ALS-herbicide tolerant ALS allele with other commercially important traits in other sugar beet varieties. The markers would have been also helpful to develop homozygously present ALS allele in sugar beet plants comprising the same ALS-herbicide tolerant ALS allele in both the chromosomes to get a better agronomical level of ALS herbicide tolerance, as taught by Hain et al.It is an experimental design choice for the Artisan to use any specific markers including instant SEQ ID NOs: 5-6 and 12 without affecting the outcome.
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 1-7 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/687,796 (reference application) in view of Hain et al. and McGrath et al. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference application recites a sugar beet plant comprising an ALS enzyme having at least 95% sequence identity with the amino acid sequence of SEQ ID NO. 1 and further comprising a leucine at a position corresponding to amino acid position 569 instead of the naturally occurring tryptophan. Instant SEQ ID NO: 16 encodes such a protein where the amino acid sequence of SEQ ID NO. 1 and further comprising a leucine at a position corresponding to amino acid position 569 instead of the naturally occurring tryptophan. Sequence alignment between these two sequences and (grey) highlighting the substitution of tryptophan with leucine at a position corresponding to amino acid position 569, is shown below.
Title: US-18-687-799-16
Perfect score: 3413
Sequence: 1 MAATFTNPTFSPSSTPLTKT..........IPSGAGFKDTITEGDGRTSY 665
Searched: 1 seqs, 660 residues
Database : US-18-687-796-1.pep:*
RESULT 1
US-18-687-796-1
Query Match 99.0%; Score 3380; DB 1; Length 660; Best Local Similarity 99.8%;
Matches 659; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
Qy 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
Qy 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
Qy 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
Qy 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
Qy 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
Qy 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
Qy 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
Qy 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
Qy 541 QELATIRVENLPVKIMLLNNQHLGMVVQLEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
|||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||
Db 541 QELATIRVENLPVKIMLLNNQHLGMVVQWEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
Qy 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
However, claim 1 in the reference application does not recite a hybrid plant.
Hain et al. describes that the ALS gene is in chromosome 5, as discussed above. Hain et al. also describes hybrid plants comprising the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) gene (column 5, line 32-36). It is well known in the art that hybrid plants exhibit increased heterosis (hybrid vigor) by showing superior growth, yield, and fertility compared to their parents, primarily due to increased heterozygosity3.
It would have been obvious to an ordinarily skilled artisan to develop hybrid plants (as described by Hain et al. by crossing the sugar beet plant comprising the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) gene, as recited in reference claim 1, with an elite sugar beet variety. It is an inherent property of a hybrid plant to show increased heterosis and decrease inbreed depression.
An ordinarily skilled artisan would have been motivated to stack different traits in a commercially important elite sugar beet variety along with the ALS inhibitor herbicide tolerance trait conferred by the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) gene.
Hain et al. also teaches all the claim limitations of claims 2-7 and 10 in view of McGrath et al., as discussed above. Development of hybrid plants, use and development of molecular/genetic markers in plant breeding is a routine and standard practice in the art, especially once the whole genome is sequenced and published. McGrath et al. (in its entirety) describes Beta vulgaris genomic sequence database (EL10).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-6 of copending Application No. 18/699,357 (reference application) in view of Hain et al. and McGrath et al. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 (which depends from claim 1) recites a Beta vulgaris plant comprising a polynucleic acid encoding a mutated endogenous acetolactate synthase (ALS) protein or comprising a mutated endogenous allele encoding an ALS protein comprising at position 569 an amino acid different than tryptophan (W); and claim 6 recites, “… ALS is homozygous or heterozygous”.
However, claim 1 and 5-6 in the reference application does not recite leucine substituting the tryptophan at position 569.
Hain et al. describes a Beta vulgaris plant comprising an ALS-herbicide tolerant endogenous ALS allele which is homozygously present on chromosome 5 and encoding an ALS protein comprising leucine at position 569, and located at chromosome 5, as discussed above. Hain teaches that the herbicide tolerant Beta vulgaris plants which are homozygous for the
mutation revealed a better agronomical level of ALS inhibitor herbicide tolerance. Hain et al. also describes hybrid plants comprising the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) gene, as discussed above. It is an inherent property of a hybrid plant to show increased heterosis and decrease inbreed depression.
It would have been obvious to an ordinarily skilled artisan to replace the tryptophan at position 569, as recited in claim 5 of the reference application, with leucine, as described by Hain et al., with the realistic motivation to develop commercially important ALS-herbicide tolerance trait in an economically important crop of sugar beet (Beta vulgaris). Plants homozygous for the ALS inhibitor herbicide tolerant gene would have made a better agronomical level of ALS inhibitor tolerance, as described by Hain et al.
It is well known in the art that hybrid plants exhibit increased heterosis (hybrid vigor) by showing superior growth, yield, and fertility compared to their parents, primarily due to increased heterozygosity3. Hain et al. also teaches all the claim limitations of claims 2-7 and 10 in view of McGrath et al., as discussed above. Development of hybrid plants, use and development of molecular/genetic markers in plant breeding is a routine and standard practice in the art, especially once the whole genome is sequenced and published, as described above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10865406 B2 (hereafter referred as ‘406B) in view of Hain et al. and McGrath et al.
Claim 1 of ‘406B is drawn to a method of producing an ALS inhibitor herbicide tolerant Beta vulgaris plant or parts thereof. Reference claim 1 recites, “… wherein the plantlets comprise a mutation at a position corresponding to nucleotides 1705-1707 of the endogenous
acetolactate synthase (ALS) gene shown in reference sequence SEQ ID NO: 1, wherein the mutated ALS gene encodes an ALS polypeptide containing leucine at position 569 of the ALS polypeptide shown in reference amino acid sequence SEQ ID NO: 2, and wherein the plantlets are homozygous for the mutation of the endogenous ALS gene.”
Instant SEQ ID NO: 16 encodes such a protein where the amino acid sequence of SEQ ID NO. 2 comprises 99.8% sequence identity, as shown below.
RESULT 1
AASEQ2_03032026_173410
Query Match 99.8%; Score 3407; DB 1; Length 665; Best Local Similarity 99.8%;
Matches 664; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
Qy 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
Qy 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
Qy 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
Qy 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
Qy 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
Qy 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
Qy 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
Qy 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
Qy 541 QELATIRVENLPVKIMLLNNQHLGMVVQLEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
|||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||
Db 541 QELATIRVENLPVKIMLLNNQHLGMVVQWEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
Qy 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
Qy 661 GRTSY 665
|||||
Db 661 GRTSY 665
Sequence alignment between these two sequences and (grey) highlighting the substitution of tryptophan with leucine at a position corresponding to amino acid position 569.
It would have been obvious to an ordinarily skilled artisan to modify the teaching as recited in reference claim 1 to make hybrid sugar beet plants using the ALS inhibitor herbicide tolerant Beta vulgaris plant as one of the parents and crossing that with an elite Beta vulgaris cultivar.
It is well known in the art that hybrid plants exhibit increased heterosis (hybrid vigor) by showing superior growth, yield, and fertility compared to their parents, primarily due to increased heterozygosity3. Development of hybrid plants, use and development of molecular/ genetic markers in plant breeding is a routine and standard practice in the art, especially once the whole genome is sequenced and published, as described above.
A standard BLAST search using the known Beta vulgaris genomic database (EL10), as described by McGrath et al., identifies the ALS herbicide tolerant gene and all the three markers, as recited in claims 2-5 and 10 (SEQ ID NOs: 5-6 and 12) are in chromosome 5 and those markers are closely linked, as shown above.
The ordinarily skilled artisan would have been motivated to develop and use molecular markers to identify and/or develop different hybrid Beta vaulgaris plants, which is an economically important plant, by stacking the ALS-herbicide tolerant ALS allele with other commercially important traits in other sugar beet varieties. The markers would have been also helpful to develop homozygously present ALS allele in sugar beet plants comprising the same ALS-herbicide tolerant ALS allele in both the chromosomes to get a better agronomical level of ALS herbicide tolerance, as taught by Hain et al., as discussed above. It is an experimental design choice for the artisan to use any specific markers including instant SEQ ID NOs: 5-6 and 12 without affecting the outcome.
Regarding claim 6, Hain et al. describes a Beta vulgaris plant comprises a mutation in codon 1705-1707 of an endogenous ALS gene encoding an ALS protein containing a leucine at position 569 (claims 1 and 5). The seeds of the sugar beet plant have been deposited as NCIMB 41705.
Regarding claim 7; sugar beet plants expression the ALS-herbicide tolerant ALS allele is not expected to affect sugar yield much or in a significant way if at all, because there is no extra metabolic energy/resource used to express the allele compared to the non-herbicide tolerant ALS allele, and the activity of the ALS enzyme is not known to be affected by the SNP(s) in the herbicide tolerant allele(s). It is known in the art that weeds can significantly impact sugar beet’s quality and yield. Weed control in sugar beet cultivation (by any means including using ALS herbicides which ALS herbicide tolerant plants can withstand and grow normally) significantly impact and improve both quality and yield in terms of higher sucrose content, higher purity, improved extractable sugar percentage, enhanced root yield and boost overall sugar yield. The data obtained in 2020 from the KWS’ SMART seed varieties like SMART JANNINKA KWS, which contains ALS-herbicide tolerant ALS allele(s), indicates that the yield is more than 90% compared to a non-herbicide tolerant control variety, which would be reflected in sugar yield from the plants.
Regarding claim 10: claim 1 of the reference patent anticipates claim 10. Instant claim 10 encompasses the plant produced by the patented method.
Claims 1-7 and 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 19 of U.S. Patent No. US 10,544,426 B2 (hereafter referred as ‘426B) in view of Hain et al. and McGrath et al.
Claim 1 of ‘426B is drawn to a method for controlling unwanted vegetation in a Beta
vulgaris growing area. Claim 1 or “426B recites a, “… B. vulgaris plant has a mutation in the endogenous acetolactate synthase (ALS) gene of SEQ ID NO: 1, thereby encoding an ALS protein containing leucine at position 569 of SEQ ID NO:2, and wherein this mutation is the only mutation in the ALS protein that confers resistance to the one or more ALS inhibitor herbicides…”. Claim 19 of ‘426 B recites, “… the mutation is homozygously present in the endogenous ALS gene”
Instant SEQ ID NO: 16 encodes such a protein where the amino acid sequence of SEQ ID NO. 2 comprises 99.8% sequence identity, data not shown.
It would have been obvious to an ordinarily skilled artisan to modify the teaching as recited in reference claim 1 to make hybrid sugar beet plants using the ALS inhibitor herbicide tolerant Beta vulgaris plant as one of the parents and crossing that with an elite Beta vulgaris cultivar.
It is well known in the art that hybrid plants exhibit increased heterosis (hybrid vigor) by showing superior growth, yield, and fertility compared to their parents, primarily due to increased heterozygosity3. Development of hybrid plants, use and development of molecular/ genetic markers in plant breeding is a routine and standard practice in the art, especially once the whole genome is sequenced and published, as described above.
A standard BLAST search using the known Beta vulgaris genomic database (EL10), as described by McGrath et al., identifies the ALS herbicide tolerant gene and all the three markers, as recited in claims 2-5 and 10 (SEQ ID NOs: 5-6 and 12) are in chromosome 5 and those markers are closely linked, as shown above.
The ordinarily skilled artisan would have been motivated to develop and use molecular markers to identify and/or develop different hybrid Beta vaulgaris plants, which is an economically important plant, by stacking the ALS-herbicide tolerant ALS allele with other commercially important traits in other sugar beet varieties. The markers would have been also helpful to develop homozygously present ALS allele in sugar beet plants comprising the same ALS-herbicide tolerant ALS allele in both the chromosomes to get a better agronomical level of ALS herbicide tolerance, as taught by Hain et al., as discussed above. It is an experimental design choice for the artisan to use any specific markers including instant SEQ ID NOs: 5-6 and 12 without affecting the outcome.
Regarding claim 6, Hain et al. describes a Beta vulgaris plant comprises a leucine at position 569 (reference claim 1). The seeds of the sugar beet plant have been deposited as NCIMB 41705.
Regarding claim 7; sugar beet plants expression the ALS-herbicide tolerant ALS allele is not expected to affect sugar yield much or in a significant way if at all, because there is no extra metabolic energy/resource used to express the allele compared to the non-herbicide tolerant ALS allele, and the activity of the ALS enzyme is not known to be affected by the SNP(s) in the herbicide tolerant allele(s). It is known in the art that weeds can significantly impact sugar beet’s quality and yield. Weed control in sugar beet cultivation (by any means including using ALS herbicides which ALS herbicide tolerant plants can withstand and grow normally) significantly impact and improve both quality and yield in terms of higher sucrose content, higher purity, improved extractable sugar percentage, enhanced root yield and boost overall sugar yield. The data obtained in 2020 from the KWS’ SMART seed varieties like SMART JANNINKA KWS, which contains ALS-herbicide tolerant ALS allele(s), indicates that the yield is more than 90% compared to a non-herbicide tolerant control variety, which would be reflected in sugar yield from the plants.
Regarding claim 10, claim 1 of the reference patent anticipates claim 10. Instant claim 10 encompasses the plant that is used in the method of claim 1 of ‘426B.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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Jay Chatterjee
Patent Examiner
Art Unit 1662
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
1 Hamed et al. (Enhancing Sugar Beet (Beta vulgaris L.) Yield and Quality: Evaluating the Efficiency of Chemical and Mechanical Weed Control Strategies, 2023, Agronomy, 13:2951) provides the evidence that weed control in sugar beet cultivation significantly impact and improve both quality and yield in terms of higher sucrose content, higher purity, improved extractable sugar percentage, enhanced root yield and boost overall sugar yield (page 2, para 5, line 9-14).
2 KWS UK Ltd. (Revolutionary weed control – five years on, published on 7th March 2025) provides the evidence that sugar beet variety containing an ALS-herbicide tolerant ALS allele gives an yield (in 2020) more than 90% compared to a non-herbicide tolerant control variety.
3 Hochholdinger et al. (Heterosis in plants, 2018, Current Biology, 28:R1089-R1092) provides the evidence that hybrid plants exhibit increased heterosis (page R1089, left most column, line 1-15)