DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1 & 3-18 are under examination on the merits.
The objections to claims 13 & 15 are withdrawn in light of Applicant’s amendments.
The rejection of claim 1 under 35 U.S.C. 101 is withdrawn in light of Applicant’s amendments.
The rejection of claims 3-7 & 9-12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s amendments.
The rejection of claim(s) 1-3, 5, 7, 9-10, 12-13 & 16-17 under 35 U.S.C. 102(a)(1) as being anticipated by Chakraborty et al (2016) Plant Cell Tiss Organ Cult. 125(3), 521-535 taken with the evidence of NCBI Accession number KC505186.1 is withdrawn in light of Applicant’s amendments.
Nucleotide and/or Amino Acid Sequence Disclosures
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825.
The incorporation of sequence listing (page 1, lines 4-7) provides the size of the file in kilobytes, but the size of the file in bytes is required for an incorporation paragraph. See 37 CFR 1.823(b)(iii).
Full compliance with the sequence rules is required in response to this Office action. A complete response to this Office action must include both compliance with the sequence rules and a response to the issues set forth herein. Failure to fully comply with both of these requirements in the time period set forth in this Office action will be held to be non-responsive.
Claim Rejections - 35 USC § 112
Written Description
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 & 3-18 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(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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9/18/2025, as applied to claims 1-18. Applicant' s arguments filed 1/20/2026 have been fully considered but they are not persuasive.
Claims 1 & 3-12 require a polynucleotide that has regulatory activity comprising a polynucleotide of SEQ ID NO: 156 or having at least 95% identity to the nucleic acid sequence of SEQ ID NOs: 156 or a fragment comprising at least 100 contiguous nucleotides of SEQ ID NO: 156-160. Claims 13-18 require a regulatory element capable of increasing expression of a heterologous polynucleotide and comprising a nucleotide sequence of SEQ ID NOs: 156 or at least 95% identical to SEQ ID NOs: 156 or a fragment or variant of the nucleotide sequence of SEQ ID NOs: 156-160 comprising at least 100 contiguous nucleotides having regulatory activity in a plant cell.
Nucleic acid sequences having 95% identity to SEQ ID NO: 156 encompass polynucleotides with 75 substitutions relative to the 1506 bp long SEQ ID NO: 156. 100 contiguous nucleotides represent 6.6% of the 1506 bp long SEQ ID NO: 156, 22.8% of the 438 bp long SEQ ID NO: 157, 73% of the 137 bp long SEQ ID NO: 158, 869 bp long SEQ ID NO: 159, and 17.6% of the 568 bp long SEQ ID NO: 160.
The instant specification defines a fragment as a portion of a nucleic acid sequence that may or may not retain the biological activity of initiating transcription (page 15 line 27-page 16 line 2). Thus, claims 1 & 3-18 encompass polynucleotides with as few as 100 nucleotides that have regulatory activity in a plant cell. The instant specification defines a variant as a polynucleotide sequence comprising a deletion and/or addition of one or more nucleotides at one or more internal sites within a polynucleotide sequence and/or substitutions of one or more nucleotides at one or more sites (page 16, lines 8-10). The specification suggests that variants generally have at least about 40% sequence identity to a particular nucleotide sequence (page 16, lines 14-18).
Thus, claims 1 & 3-12 broadly require any polynucleotide sequence with regulatory activity and comprising any 100 contiguous nucleotides found in any of SEQ ID NO: 156-160 or with 95% sequence identity to SEQ ID NO: 156 while claims 13-18 broadly require a regulatory element capable of increasing expression of a polynucleotide and comprising a sequence comprising 100 contiguous nucleotides of SEQ ID NO: 156, or at least 95% identical to SEQ ID NO: 156, or comprising 100 contiguous nucleotides with at least 40% identity to SEQ ID NOs: 156-160 that have regulatory activity in a plant cell.
The instant specification describes 206 polynucleotide sequences with regulatory activity, but only SEQ ID NOs: 156-160 and 34 are Cicer arietinum UBI promoters (table 1). SEQ ID NOs: 156 and 34 have 99.6% sequence identity, see alignment below. SEQ ID NOs: 157-160 are fragments of SEQ ID NO: 156. See second alignment below.
Sequence 34, US/18006423
GENERAL INFORMATION
APPLICANT: Pioneer Hi-Bred International, Inc.
APPLICANT: Bhyri, Priyanka
TITLE OF INVENTION: PLANT REGULATORY ELEMENTS AND METHODS OF USE THEREOF
FILE REFERENCE: 7667
CURRENT APPLICATION NUMBER: US/18/006,423
CURRENT FILING DATE: 2023-01-23
NUMBER OF SEQ ID NOS: 206
SEQ ID NO 34
LENGTH: 1500
TYPE: DNA
ORGANISM: Cicer arietinum
Query Match 99.6%; Score 1500; Length 1500;
Best Local Similarity 100.0%;
Matches 1500; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATTTGTCTCCATCGAAGAGTCATATCAGATATCTCTCAACATTGTTATTTTTATGATTTA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATTTGTCTCCATCGAAGAGTCATATCAGATATCTCTCAACATTGTTATTTTTATGATTTA 60
Qy 61 AATATTTATTTGATTATATAGATATATTATTTTTTATATTAGTCTATATAAATTTTATTG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AATATTTATTTGATTATATAGATATATTATTTTTTATATTAGTCTATATAAATTTTATTG 120
Qy 121 TTTAAATTTAATTATTATAAAATTAAAGATAATTAATTTTTAGTTTAAAAAAAGAGTTAA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TTTAAATTTAATTATTATAAAATTAAAGATAATTAATTTTTAGTTTAAAAAAAGAGTTAA 180
Qy 181 TAAATTGCAGGATAAGTGAATTTATAAATACACATAAATATATTTTTTATGAAATATTAA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 TAAATTGCAGGATAAGTGAATTTATAAATACACATAAATATATTTTTTATGAAATATTAA 240
Qy 241 AAATTAAAACATTTTATAATATTAATTAATTATTTAATAATTAGTATTATTTTATAAAAA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 AAATTAAAACATTTTATAATATTAATTAATTATTTAATAATTAGTATTATTTTATAAAAA 300
Qy 301 AATACAAATAAAAATTAAAAGAATATTTTAAAAGTGTTTTAAAACTTCGTTATTCTTTTA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 AATACAAATAAAAATTAAAAGAATATTTTAAAAGTGTTTTAAAACTTCGTTATTCTTTTA 360
Qy 361 TATTAATTTGATATTAAGAACTAAAACCATTTATAAAATTTAATTCAAAATTTTTTATAG 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TATTAATTTGATATTAAGAACTAAAACCATTTATAAAATTTAATTCAAAATTTTTTATAG 420
Qy 421 AAACTAAAATAAAAAAATTATATTCATAAAAATTAAATATATATTTTTTAAATATATTTT 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 AAACTAAAATAAAAAAATTATATTCATAAAAATTAAATATATATTTTTTAAATATATTTT 480
Qy 481 ACTATAAATACAAATTTTGTTTTTTTACTCATAAAACTCGAACTTAATACCATATCGAAC 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 ACTATAAATACAAATTTTGTTTTTTTACTCATAAAACTCGAACTTAATACCATATCGAAC 540
Qy 541 CAATAGTATGATAGTAGAACCAAAAAATTAATTTATTTAACATTGTAAAAAAAAATACAA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 CAATAGTATGATAGTAGAACCAAAAAATTAATTTATTTAACATTGTAAAAAAAAATACAA 600
Qy 601 TTTATTTAACCATTCTAATATTCTCTTTGTTGAATTTAATATAATTTTCATAGCAGTCGG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 TTTATTTAACCATTCTAATATTCTCTTTGTTGAATTTAATATAATTTTCATAGCAGTCGG 660
Qy 661 CCTTCCAACGGTGGAGTGGAGTTCATATTGTAAAACAGACGACGTGGGCCCATACGAAAT 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 CCTTCCAACGGTGGAGTGGAGTTCATATTGTAAAACAGACGACGTGGGCCCATACGAAAT 720
Qy 721 AAGTGACCCAATAAAGTAACGCCGTGGTAACGATTAATCCAGATTCCAGTAGAAGGTTGC 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 AAGTGACCCAATAAAGTAACGCCGTGGTAACGATTAATCCAGATTCCAGTAGAAGGTTGC 780
Qy 781 ATTCGACTCCGTCAAGATTAAACGCCAACTACCATTTCCCAATTGCAATTAATAATTTCC 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 ATTCGACTCCGTCAAGATTAAACGCCAACTACCATTTCCCAATTGCAATTAATAATTTCC 840
Qy 841 GAGAAAGACCGCCCTGAACGCATTGGATACCAAAACTAAGCCAGATACAACAAGCAACCC 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 GAGAAAGACCGCCCTGAACGCATTGGATACCAAAACTAAGCCAGATACAACAAGCAACCC 900
Qy 901 AACAACTAGCACCGAATGACATATAATCAAGACACGTGTCACAATTCTAGTGGTTACGTT 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 AACAACTAGCACCGAATGACATATAATCAAGACACGTGTCACAATTCTAGTGGTTACGTT 960
Qy 961 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT 1020
Qy 1021 ATTGAATTACTTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAGGTATTTTCCAT 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 ATTGAATTACTTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAGGTATTTTCCAT 1080
Qy 1081 TTCTTTTCTGATTTTCGATTCGGGTTTTCGTCTTTCCTTTCGTAGATCGTTTAGAAATCG 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 TTCTTTTCTGATTTTCGATTCGGGTTTTCGTCTTTCCTTTCGTAGATCGTTTAGAAATCG 1140
Qy 1141 ATTAGACAGAGTTTATATAAGCTATATTTATTAGAAATGATCTCAGATCGTTTTCTAATA 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 ATTAGACAGAGTTTATATAAGCTATATTTATTAGAAATGATCTCAGATCGTTTTCTAATA 1200
Qy 1201 TATATTCTCAATAAATCTGTTTGAATTGCATGATCGTCAATTAGGTTTGTTGTATCTGGT 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 TATATTCTCAATAAATCTGTTTGAATTGCATGATCGTCAATTAGGTTTGTTGTATCTGGT 1260
Qy 1261 TTATGAACAGGTTTTGCATGAACGGATCTGATAACGTTTAATTTGAAATGCTTCATATTC 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 TTATGAACAGGTTTTGCATGAACGGATCTGATAACGTTTAATTTGAAATGCTTCATATTC 1320
Qy 1321 GTTTGTTATACACTGTTTTTAATATGTATTAGAGTCAATTCAATTTCTGGTGTTTGATTT 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 GTTTGTTATACACTGTTTTTAATATGTATTAGAGTCAATTCAATTTCTGGTGTTTGATTT 1380
Qy 1381 TAGTTTATTTGTTGTTTTGATCTCAAGCTGTTTTGGTCTGTTGTTATAGATTCATAATCC 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1381 TAGTTTATTTGTTGTTTTGATCTCAAGCTGTTTTGGTCTGTTGTTATAGATTCATAATCC 1440
Qy 1441 AGTTTCTAATTCGATTTCTGGCGTTTGATTCTGATTTATTTGTTGCTGCTACTTCCACAG 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1441 AGTTTCTAATTCGATTTCTGGCGTTTGATTCTGATTTATTTGTTGCTGCTACTTCCACAG 1500
160 ------------------------------------------------------------
156 ATTTGTCTCCATCGAAGAGTCATATCAGATATCTCTCAACATTGTTATTTTTATGATTTA
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 AATATTTATTTGATTATATAGATATATTATTTTTTATATTAGTCTATATAAATTTTATTG
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 TTTAAATTTAATTATTATAAAATTAAAGATAATTAATTTTTAGTTTAAAAAAAGAGTTAA
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 TAAATTGCAGGATAAGTGAATTTATAAATACACATAAATATATTTTTTATGAAATATTAA
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 AAATTAAAACATTTTATAATATTAATTAATTATTTAATAATTAGTATTATTTTATAAAAA
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 AATACAAATAAAAATTAAAAGAATATTTTAAAAGTGTTTTAAAACTTCGTTATTCTTTTA
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 TATTAATTTGATATTAAGAACTAAAACCATTTATAAAATTTAATTCAAAATTTTTTATAG
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 AAACTAAAATAAAAAAATTATATTCATAAAAATTAAATATATATTTTTTAAATATATTTT
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 ACTATAAATACAAATTTTGTTTTTTTACTCATAAAACTCGAACTTAATACCATATCGAAC
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 CAATAGTATGATAGTAGAACCAAAAAATTAATTTATTTAACATTGTAAAAAAAAATACAA
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ------------------------------------------------------------
160 ------------------------------------------------------------
156 TTTATTTAACCATTCTAATATTCTCTTTGTTGAATTTAATATAATTTTCATAGCAGTCGG
157 -------------------------------GAATTTAATATAATTTTCATAGCAGTCGG
158 ------------------------------------------------------------
159 -------------------------------GAATTTAATATAATTTTCATAGCAGTCGG
160 ------------------------------------------------------------
156 CCTTCCAACGGTGGAGTGGAGTTCATATTGTAAAACAGACGACGTGGGCCCATACGAAAT
157 CCTTCCAACGGTGGAGTGGAGTTCATATTGTAAAACAGACGACGTGGGCCCATACGAAAT
158 ------------------------------------------------------------
159 CCTTCCAACGGTGGAGTGGAGTTCATATTGTAAAACAGACGACGTGGGCCCATACGAAAT
160 ------------------------------------------------------------
156 AAGTGACCCAATAAAGTAACGCCGTGGTAACGATTAATCCAGATTCCAGTAGAAGGTTGC
157 AAGTGACCCAATAAAGTAACGCCGTGGTAACGATTAATCCAGATTCCAGTAGAAGGTTGC
158 ------------------------------------------------------------
159 AAGTGACCCAATAAAGTAACGCCGTGGTAACGATTAATCCAGATTCCAGTAGAAGGTTGC
160 ------------------------------------------------------------
156 ATTCGACTCCGTCAAGATTAAACGCCAACTACCATTTCCCAATTGCAATTAATAATTTCC
157 ATTCGACTCCGTCAAGATTAAACGCCAACTACCATTTCCCAATTGCAATTAATAATTTCC
158 ------------------------------------------------------------
159 ATTCGACTCCGTCAAGATTAAACGCCAACTACCATTTCCCAATTGCAATTAATAATTTCC
160 ------------------------------------------------------------
156 GAGAAAGACCGCCCTGAACGCATTGGATACCAAAACTAAGCCAGATACAACAAGCAACCC
157 GAGAAAGACCGCCCTGAACGCATTGGATACCAAAACTAAGCCAGATACAACAAGCAACCC
158 ------------------------------------------------------------
159 GAGAAAGACCGCCCTGAACGCATTGGATACCAAAACTAAGCCAGATACAACAAGCAACCC
160 --------------------------------CACGTGTCACAATTCTAGTGGTTACGTT
156 AACAACTAGCACCGAATGACATATAATCAAGACACGTGTCACAATTCTAGTGGTTACGTT
157 AACAACTAGCACCGAATGACATATAATCAAGACACGTGTCACAATTCTAGTGGTTACGTT
158 --------------------------------CACGTGTCACAATTCTAGTGGTTACGTT
159 AACAACTAGCACCGAATGACATATAATCAAGACACGTGTCACAATTCTAGTGGTTACGTT
****************************
160 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT
156 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT
157 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT
158 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT
159 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT
************************************************************
160 ATTGAATTACTTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAGGTATTTTCCAT
156 ATTGAATTACTTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAGGTATTTTCCAT
157 ATTGAATTACTTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAG-----------
158 ATTGAATTACTTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAG-----------
159 ATTGAATTACTTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAGGTATTTTCCAT
*************************************************
160 TTCTTTTCTGATTTTCGATTCGGGTTTTCGTCTTTCCTTTCGTAGATCGTTTAGAAATCG
156 TTCTTTTCTGATTTTCGATTCGGGTTTTCGTCTTTCCTTTCGTAGATCGTTTAGAAATCG
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 TTCTTTTCTGATTTTCGATTCGGGTTTTCGTCTTTCCTTTCGTAGATCGTTTAGAAATCG
160 ATTAGACAGAGTTTATATAAGCTATATTTATTAGAAATGATCTCAGATCGTTTTCTAATA
156 ATTAGACAGAGTTTATATAAGCTATATTTATTAGAAATGATCTCAGATCGTTTTCTAATA
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 ATTAGACAGAGTTTATATAAGCTATATTTATTAGAAATGATCTCAGATCGTTTTCTAATA
160 TATATTCTCAATAAATCTGTTTGAATTGCATGATCGTCAATTAGGTTTGTTGTATCTGGT
156 TATATTCTCAATAAATCTGTTTGAATTGCATGATCGTCAATTAGGTTTGTTGTATCTGGT
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 TATATTCTCAATAAATCTGTTTGAATTGCATGATCGTCAATTAGGTTTGTTGTATCTGGT
160 TTATGAACAGGTTTTGCATGAACGGATCTGATAACGTTTAATTTGAAATGCTTCATATTC
156 TTATGAACAGGTTTTGCATGAACGGATCTGATAACGTTTAATTTGAAATGCTTCATATTC
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 TTATGAACAGGTTTTGCATGAACGGATCTGATAACGTTTAATTTGAAATGCTTCATATTC
160 GTTTGTTATACACTGTTTTTAATATGTATTAGAGTCAATTCAATTTCTGGTGTTTGATTT
156 GTTTGTTATACACTGTTTTTAATATGTATTAGAGTCAATTCAATTTCTGGTGTTTGATTT
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 GTTTGTTATACACTGTTTTTAATATGTATTAGAGTCAATTCAATTTCTGGTGTTTGATTT
160 TAGTTTATTTGTTGTTTTGATCTCAAGCTGTTTTGGTCTGTTGTTATAGATTCATAATCC
156 TAGTTTATTTGTTGTTTTGATCTCAAGCTGTTTTGGTCTGTTGTTATAGATTCATAATCC
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 TAGTTTATTTGTTGTTTTGATCTCAAGCTGTTTTGGTCTGTTGTTATAGATTCATAATCC
160 AGTTTCTAATTCGATTTCTGGCGTTTGATTCTGATTTATTTGTTGCTGCTACTTCCACAG
156 AGTTTCTAATTCGATTTCTGGCGTTTGATTCTGATTTATTTGTTGCTGCTACTTCCACAG
157 ------------------------------------------------------------
158 ------------------------------------------------------------
159 AGTTTCTAATTCGATTTCTGGCGTTTGATTCTGATTTATTTGTTGCTGCTACTTCCACAG
160 ------
156 GGATCC
157 ------
158 ------
159 ------
The instant specification describes that motifs for transcription factor binding such as a TATA-box may be present in regulatory elements and describes how sequence motifs in regulatory elements may be found in the PLACE database (page 12, lines 14-21).
Regulatory elements are known in the art, including ubiquitin promoters. Peykari et al (2019) Crop Biotech. 25: 35-45 (published 2019, hereafter Peykari) analyzed the features present in the sequence of a Cicer arietinum Ubiquitin 10 promoter and found TATA-boxes, CAAT-boxes, GATA-boxes, Inr elements, and other known regulatory element features (table 2). Hernandez-Garcia et al (2014) Plant Science. 217-218: 109-119 (published 12/14/2013, hereafter Hernandez Garcia) also describes promoters of Ubiquitin genes as highly active in almost all organs and tissues throughout most of a plant’s life cycle (page 112, left column, paragraph 2). Strong polyubiquitin promoters comprise a well-conserved G-box like motif (figure 3) and often also contain leading introns in the 5’UTR that may be included as part of the promoter to enhance transgene expression (page 114, left column, paragraph 3). However, Hernandez-Garcia describes how polyubiquitin promoters may have contrasting expression levels in different plants, and transgene expression may not be fully predictable as factors to regulate promoters may not exist in heterologous systems (page 116, right column, paragraph 5).
Structural features responsible for promoter activity, including promoter activity of constitutive ubiquitin genes are known in the art and familiar to one of ordinary skill. However, the polynucleotides required by the claims of the instant specification are not limited to promoters or to ubiquitin promoters specifically but encompass polynucleotides of as little as 100 nucleotides found within SEQ ID NOs: 156-160, and for claims 13-18, essentially any sequence since variants are encompassed, with any regulatory activity.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of this broad genus in view of the disclosed species.
Hence, Applicant has not, in fact, described polynucleotides that have regulatory activity comprising any 100 contiguous nucleotides found in any of SEQ ID NO: 156-160 or with 95% sequence identity to SEQ ID NO: 156; or a regulatory element capable of increasing expression of a polynucleotide and comprising a sequence at least 95% identical to SEQ ID NO: 156, or comprising 100 contiguous nucleotides with at least 40% identity to SEQ ID NOs: 156-160 that have regulatory activity in a plant cell over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Applicant urges that amended claims require at least 100 contiguous nucleotides and so one of ordinary skill in the art would recognize that the Applicant was in possession of the claimed invention at the time of filing (Remarks, page 5, paragraph 8-page 6 paragraph 2).
This argument is unpersuasive, because the claims encompass any polynucleotide with any regulatory activity comprising 100 contiguous nucleotides of SEQ ID NOs: 156-160 or, in the case of claims 13-18, with as little as 40% identity to SEQ ID NOs: 156-160. Applicant has not described examples of the encompassed regulatory elements over the full scope of the claims nor has Applicant described a required structural feature responsible for the regulatory activity that would distinguish the claimed genus of polynucleotides from other polynucleotides not encompassed by the claims. Thus, Applicant has not provided sufficient Written Description to demonstrate possession of the full scope of claimed polynucleotides at the time of filing of the instant application.
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.
Claim(s) 1,3, 5, 7, 9-10, 12-13 & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chakraborty et al (2016) Plant Cell Tiss Organ Cult. 125(3), 521-535 (published 3/25/2016, hereafter Chakraborty) in view of NCBI reference NW_004515387.1 (bases 3691155 to 3695226, available 12/27/2018) taken with the evidence of NCBI reference XM_004496716.1 (available 6/8/2015).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9/18/2025, as applied to claims 1-3, 5, 7, 9-10, 12-13 & 16-17. Applicant' s arguments filed 1/20/2026 have been fully considered but they are not persuasive.
Claims 1,3, 5, 7, 9-10, 12-13 & 16-17 are drawn to a recombinant polynucleotide comprising a polynucleotide with at least 95% sequence identity to SEQ ID NO: 156, or a fragment comprising at least 100 contiguous nucleotides of SEQ ID NO: 156, a DNA construct comprising the regulatory element polynucleotide, or a heterologous cell or transgenic plant or seed comprising the DNA construct or nucleic acid molecule and a method for expressing a polynucleotide in a plant comprising introducing into a plant cell a recombinant polynucleotide comprising a regulatory element comprising a nucleotide sequence of SEQ ID NO: 156 or a fragment or variant with regulatory in a plant cell. Claims 13 & 16-17 do not require expression of a heterologous polynucleotide, only that the regulatory element is capable of increasing expression of one.
Chakraborty teaches that chickpea is the third most important grain legume worldwide but is affected by damage from Helicoverpa armigera (page 521, right column, paragraph 2). Chakraborty teaches cry1Ac as a Bt gene beneficial for pyramiding of insect resistance traits (page 522, left column, paragraph 4).
Chakraborty teaches the isolation of a ubiquitin promoter from C. arietinum DNA of the sequence found in Accession number KC505186 (page 523, left column, paragraphs 1-2). Chakraborty teaches cloning the isolated promoters into a pUC18 vector upstream of a cry1Ac gene and a chloroplast transit sequence, which were then cloned into the plant expression vector pCAMBIA2301 carrying a nptII gene as a selectable marker and uidA (gus) gene as a reporter system and transformed into Agrobacterium (page 523, left column, paragraph 3-right column paragraph 1; figure 1). Chickpea was transformed with the vectors (page 523, right column, paragraph 3). T1 seeds were obtained from primary transformants and segregation pattern for the cry1Ac transgene was calculated in T2 progeny (page 524, left column, paragraph 3). T1 progeny carrying the Ubi-cry1Ac construct were found (figure 6d). Transgenic plants carrying the Ubi-cry1Ac construct led to higher larval mortality when fed to insects (figure 9d).
Chakraborty teaches a motivation to generate transgenic plants carrying the Cry protein to mitigate synthetic pesticide use but that high expression of a cry1Ac gene often negatively affects plant regeneration. However, expression in chickpeas using homologous promoters led to normal plant growth and development (page 531, left column, paragraph 2-right column, paragraph 1). Charkaborty also teaches a motivation to use a ubi promoter rather than a CaMV35S promoter for expression because CaMV35S expression has variable efficacy in different plant species and parts and multiple transformations with a single promoter can lead to silencing of genes in successive generations (page 522, right column, paragraph 2).
Chakraborty does not teach a nucleotide sequence that is at least 95% identical to SEQ ID NO: 156.
NCBI reference NW_004515387.1 (bases 3691155 to 3695226) teaches a nucleotide sequence complementary to a sequence with 99% sequence identity to 1500 bp found in instant SEQ ID NO: 156, including fragments of at least 100 contiguous nucleotides with 100% identity to SEQ ID NO: 156. See alignment below, SEQ ID NO: 156 is on top.
Score
Expect
Identities
Gaps
Strand
2726 bits(1476)
0.0
1492/1500(99%)
0/1500(0%)
Plus/Minus
Query 1 ATTTGTCTCCATCGAAGAGTCATATCAGATATCTCTCAACATTGttatttttatgattta 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 3346 ATTTGTCTCCATCGAAGAGTCATATCAGATATCTCTCAACATTGTTATTTTTATGATTTA 3287
Query 61 aatatttatttgattatatagatatattattttttatattagtctatataaattttattg 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 3286 AATATTTATTTGATTATATAGATATATTATTTTTTATATTAGTCTATATAAATTTTATTG 3227
Query 121 tttaaatttaattattataaaattaaagataattaatttttagtttaaaaaaagagttaa 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 3226 TTTAAATTTAATTATTATAAAATTAAAGATAATTAATTTTTAGTTTAAAAAAAGAGTTAA 3167
Query 181 taaattGCAGGATAAGTGaatttataaatacacataaatatattttttatgaaatattaa 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 3166 TAAATTGCAGGATAAGTGAATTTATAAATACACATAAATATATTTTTTATGAAATATTAA 3107
Query 241 aaattaaaacattttataatattaattaattatttaataattagtattattttataaaaa 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 3106 AAATTAAAACATTTTATAATATTAATTAATTATTTAATAATTAGTATTATTTTATAAAAA 3047
Query 301 aatacaaataaaaattaaaagaatattttaaaagtgttttaaaaCTTCGTTATTCTTTTA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 3046 AATACAAATAAAAATTAAAAGAATATTTTAAAAGTGTTTTAAAACTTCGTTATTCTTTTA 2987
Query 361 TATTAATTTGatattaagaactaaaaccatttataaaatttaattcaaaattttttatag 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2986 TATTAATTTGATATTAAGAACTAAAACCATTTATAAAATTTAATTCAAAATTTTTTATAG 2927
Query 421 aaactaaaataaaaaaattatattcataaaaattaaatatatattttttaaatatatttt 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2926 AAACTAAAATAAAAAAATTATATTCATAAAAATTAAATATATATTTTTTAAATATATTTT 2867
Query 481 actataaatacaaattttgtttttttaCTCATAAAACTCGAACTTAATACCATATCGAAC 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2866 ACTATAAATACAAATTTTGTTTTTTTACTCATAAAACTCGAACTTAATACCATATCGAAC 2807
Query 541 CAATAGTATGATAGTAGAACCAAAAAATTAATTTATTTAACATTGTaaaaaaaaaTACAA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2806 CAATAGTATGATAGTAGAACCAAAAAATTAATTTATTTAACATTGTAAAAAAAAATACAA 2747
Query 601 TTTATTTAACCATTCTAATATTCTCTTTGTTGAATTTAATATAATTTTCATAGCAGTCGG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2746 TTTATTTAACCATTCTAATATTCTCTTTGTTGAATTTAATATAATTTTCATAGCAGTCGG 2687
Query 661 CCTTCCAACGGTGGAGTGGAGTTCATATTGTAAAACAGACGACGTGGGCCCATACGAAAT 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2686 CCTTCCAACGGTGGAGTGGAGTTCATATTGTAAAACAGACGACGTGGGCCCATACGAAAT 2627
Query 721 AAGTGACCCAATAAAGTAACGCCGTGGTAACGATTAATCCAGATTCCAGTAGAAGGTTGC 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2626 AAGTGACCCAATAAAGTAACGCCGTGGTAACGATTAATCCAGATTCCAGTAGAAGGTTGC 2567
Query 781 ATTCGACTCCGTCAAGATTAAACGCCAACTACCATTTCCCAATTGCAATTAATAATTTCC 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2566 ATTCGACTCCGTCAAGATTAAACGCCAACTACCATTTCCCAATTGCAATTAATAATTTCC 2507
Query 841 GAGAAAGACCGCCCTGAACGCATTGGATACCAAAACTAAGCCAGATACAACAAGCAACCC 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2506 GAGAAAGACCGCCCTGAACGCATTGGATACCAAAACTAAGCCAGATACAACAAGCAACCC 2447
Query 901 AACAACTAGCACCGAATGACATATAATCAAGACACGTGTCACAATTCTAGTGGTTACGTT 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2446 AACAACTAGCACCGAATGACATATAATCAAGACACGTGTCACAATTCTAGTGGTTACGTT 2387
Query 961 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2386 TTTGACCCTTTTGCTATAAATTAACCCCAATGCTCCCATACAAATCGCAGTTTCATTTCT 2327
Query 1021 ATTGAATTACTTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAGGTattttccat 1080
|||||||| ||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2326 ATTGAATTCATTTCTTTGAGCCCTATCTACTTCTCAACAAATCCTCAAGGTATTTTCCAT 2267
Query 1081 ttcttttctgattttcgattcgggttttcgtctttcctttcgTAGATCGTTTAGAAATCG 1140
|||||||||||||||||||||||||||||||||||||||||||||||| ||||||||||
Sbjct 2266 TTCTTTTCTGATTTTCGATTCGGGTTTTCGTCTTTCCTTTCGTAGATCTGTTAGAAATCG 2207
Query 1141 ATTAGACAGAGTTTATATAAGCTATATTTATTAGAAATGATCTCAGATCGTTTTCTAATA 1200
||||||||||||||||||||||| |||||||||||||||||||||||| |||||||||
Sbjct 2206 ATTAGACAGAGTTTATATAAGCTTAATTTATTAGAAATGATCTCAGATCTGTTTCTAATA 2147
Query 1201 TATATTCTCAATAAATCTGTTTGAATTGCATGATCGTCAATTAGGTTTGTTGTATCTGGT 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2146 TATATTCTCAATAAATCTGTTTGAATTGCATGATCGTCAATTAGGTTTGTTGTATCTGGT 2087
Query 1261 TTATGAACAGGTTTTGCATGAACGGATCTGATAACGTTTAATTTGAAATGCTTCATATTC 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2086 TTATGAACAGGTTTTGCATGAACGGATCTGATAACGTTTAATTTGAAATGCTTCATATTC 2027
Query 1321 GTTTGTTATACACTGTTTTTAATATGTATTAGAGTCAATTCAATTTCTGGTGTTTGATTT 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 2026 GTTTGTTATACACTGTTTTTAATATGTATTAGAGTCAATTCAATTTCTGGTGTTTGATTT 1967
Query 1381 TAGTTTATTTGTTGTTTTGATCTCAAGCTGTTTTGGTCTGTTGTTATAGATTCATAATCC 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1966 TAGTTTATTTGTTGTTTTGATCTCAAGCTGTTTTGGTCTGTTGTTATAGATTCATAATCC 1907
Query 1441 AGTTTCTAATTCGATTTCTGGCGTTTGATTCTGATTTATTTGTTGCTGCTACTTCCACAG 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1906 AGTTTCTAATTCGATTTCTGGCGTTTGATTCTGATTTATTTGTTGCTGCTACTTCCACAG 1847
NCBI reference XM_004496716.1 provides evidence that the sequence of NCBI NW_004515387.1 (bases 3691155 to 3695226) encompasses a sequence predicted to encode a Cicer arietinum polyubiquitin mRNA. See alignment of the two sequences below, mRNA sequence on top.
Alignment statistics for match #1
Score
Expect
Identities
Gaps
Strand
2490 bits(1348)
0.0
1348/1348(100%)
0/1348(0%)
Plus/Minus
Query 294 AGATGCAAATCTTCGTGAAAACCCTCACCGGCAAGACAATCACTCTCGAGGTAGAGAGTT 353
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1848 AGATGCAAATCTTCGTGAAAACCCTCACCGGCAAGACAATCACTCTCGAGGTAGAGAGTT 1789
Query 354 CTGATACTATCGATAACGTAAAGGCCAAGATCCAGGACAAGGAAGGAATTCCTCCGGACC 413
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1788 CTGATACTATCGATAACGTAAAGGCCAAGATCCAGGACAAGGAAGGAATTCCTCCGGACC 1729
Query 414 AGCAACGTCTCATCTTCGCCGGAAAGCAGCTTGAGGACGGCCGTACCCTTGCCGACTACA 473
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1728 AGCAACGTCTCATCTTCGCCGGAAAGCAGCTTGAGGACGGCCGTACCCTTGCCGACTACA 1669
Query 474 ACATCCAGAAGGAGTCAACTCTCCATCTCGTCCTCCGTCTTCGTGGAGGCATGCAGATCT 533
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1668 ACATCCAGAAGGAGTCAACTCTCCATCTCGTCCTCCGTCTTCGTGGAGGCATGCAGATCT 1609
Query 534 TCGTCAAGACCCTCACAGGCAAGACCATCACTCTTGAGGTCGAAAGCTCCGACACCATCG 593
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1608 TCGTCAAGACCCTCACAGGCAAGACCATCACTCTTGAGGTCGAAAGCTCCGACACCATCG 1549
Query 594 ATAACGTTAAAGCCAAGATCCAAGACAAGGAAGGAATTCCCCCGGACCAGCAGAGACTTA 653
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1548 ATAACGTTAAAGCCAAGATCCAAGACAAGGAAGGAATTCCCCCGGACCAGCAGAGACTTA 1489
Query 654 TCTTCGCCGGAAAGCAACTTGAGGACGGTCGTACCCTCGCCGACTACAATATCCAGAAGG 713
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1488 TCTTCGCCGGAAAGCAACTTGAGGACGGTCGTACCCTCGCCGACTACAATATCCAGAAGG 1429
Query 714 AATCTACCCTTCATCTCGTCCTCCGTCTTCGTGGAGGTATGCAGATCTTTGTGAAGACCC 773
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1428 AATCTACCCTTCATCTCGTCCTCCGTCTTCGTGGAGGTATGCAGATCTTTGTGAAGACCC 1369
Query 774 TCACCGGTAAGACCATCACTCTCGAAGTTGAAAGCTCTGACACCATCGACAACGTGAAGG 833
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1368 TCACCGGTAAGACCATCACTCTCGAAGTTGAAAGCTCTGACACCATCGACAACGTGAAGG 1309
Query 834 CTAAGATCCAAGACAAGGAAGGAATCCCACCAGACCAGCAGAGACTCATCTTCGCCGGAA 893
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1308 CTAAGATCCAAGACAAGGAAGGAATCCCACCAGACCAGCAGAGACTCATCTTCGCCGGAA 1249
Query 894 AGCAGCTTGAAGATGGCCGCACCTTAGCTGACTACAACATCCAGAAGGAGTCAACCCTTC 953
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1248 AGCAGCTTGAAGATGGCCGCACCTTAGCTGACTACAACATCCAGAAGGAGTCAACCCTTC 1189
Query 954 ACCTTGTGTTGCGTCTTCGTGGTGGTATGCAAATCTTCGTGAAGACCCTCACTGGTAAAA 1013
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1188 ACCTTGTGTTGCGTCTTCGTGGTGGTATGCAAATCTTCGTGAAGACCCTCACTGGTAAAA 1129
Query 1014 CTATTACCCTTGAGGTGGAGAGTTCTGACACAATCGACAACGTTAAGGCCAAGATCCAGG 1073
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1128 CTATTACCCTTGAGGTGGAGAGTTCTGACACAATCGACAACGTTAAGGCCAAGATCCAGG 1069
Query 1074 ATAAGGAAGGTATTCCCCCAGATCAGCAGAGGTTGATCTTCGCCGGAAAGCAGCTGGAAG 1133
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1068 ATAAGGAAGGTATTCCCCCAGATCAGCAGAGGTTGATCTTCGCCGGAAAGCAGCTGGAAG 1009
Query 1134 ATGGAAGGACCCTCGCTGATTACAACATCCAGAAGGAGTCTACCCTTCACCTTGTGTTGC 1193
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1008 ATGGAAGGACCCTCGCTGATTACAACATCCAGAAGGAGTCTACCCTTCACCTTGTGTTGC 949
Query 1194 GTCTTCGTGGTGGTATGCAGATTTTTGTGAAGACCTTGACTGGGAAGACAATTACCCTTG 1253
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 948 GTCTTCGTGGTGGTATGCAGATTTTTGTGAAGACCTTGACTGGGAAGACAATTACCCTTG 889
Query 1254 AGGTGGAGAGCTCTGATACCATTGATAATGTGAAGGCAAAAATTCAGGATAAAGAAGGTA 1313
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 888 AGGTGGAGAGCTCTGATACCATTGATAATGTGAAGGCAAAAATTCAGGATAAAGAAGGTA 829
Query 1314 TCCCACCGGACCAGCAGAGGTTGATCTTTGCAGGGAAGCAGTTGGAGGATGGAAGGACCC 1373
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 828 TCCCACCGGACCAGCAGAGGTTGATCTTTGCAGGGAAGCAGTTGGAGGATGGAAGGACCC 769
Query 1374 TTGCTGATTACAATATTCAGAAGGAGTCCACCCTTCACCTTGTGCTCCGTCTTCGTGGTG 1433
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 768 TTGCTGATTACAATATTCAGAAGGAGTCCACCCTTCACCTTGTGCTCCGTCTTCGTGGTG 709
Query 1434 GTTTCTAATCTGTGGCTGTGGGATTAATATCTGTCTGATGTTTCTTTTACTTGTTGTGGA 1493
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 708 GTTTCTAATCTGTGGCTGTGGGATTAATATCTGTCTGATGTTTCTTTTACTTGTTGTGGA 649
Query 1494 AGTGATAGGGCCTGTGTTGGCCCAGTAGAATAAGTTTACGATGTTATGAATTTTATGGTT 1553
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 648 AGTGATAGGGCCTGTGTTGGCCCAGTAGAATAAGTTTACGATGTTATGAATTTTATGGTT 589
Query 1554 CTTTGTGAATAATGAATTAATCAGTACTTTTGCTTATGTAATTTGTGTATTATGTTTACT 1613
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 588 CTTTGTGAATAATGAATTAATCAGTACTTTTGCTTATGTAATTTGTGTATTATGTTTACT 529
Query 1614 TTTTATGACATGATTATGTTGTCAATTT 1641
||||||||||||||||||||||||||||
Sbjct 528 TTTTATGACATGATTATGTTGTCAATTT 501
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to substitute the promoter of a ubiquitin gene from C. arietinum taught by Chakraborty for the upstream region another polyubiquitin gene in C. arietinum. One of ordinary skill in the art would have been motivated to substitute one ubi promoter for another, especially when transforming with more than one transgene, because using a single promoter can lead to silencing of genes in successive generations. One of ordinary skill in the art would have had reasonable expectation of success, because upstream regions of genes often comprise promoters, and ubiquitin promoters from the same species would be expected to successfully increase expression in the same species.
The Ubi promoter of NCBI reference NW_004515387.1 reads on a recombinant polynucleotide comprising a fragment of at least 100 contiguous nucleotides of SEQ ID NO: 156 with regulatory activity, and vectors comprising the Ubi promoter and a Cry1Ac transgene read on the recombinant polynucleotide comprising a heterologous polynucleotide (claim 1) as well as a DNA construct comprising a heterologous transcribable polynucleotide molecule which is a gene of agronomic interest capable of providing plant pest control operably linked to the regulatory element polynucleotide (claims 3, 5 & 7). The transformed chickpea plants comprise and therefore read on a heterologous cell and a dicot plant cell stably transformed with the molecule or the construct (claims 8-10). The T1 & T2 progeny read on seeds of the transgenic plant (claim 12). Finally, the method of Chakroborty to transform chickpea modified by the promoter sequence found in NCBI reference NW_004515387.1 reads on increasing expression and thus reads on claims 13, 16, & 17.
Applicant urges that amended claims recite at least 100 contiguous nucleotides which renders the rejection moot (Remarks, page 6, paragraph 7).
This argument is unpersuasive, because the sequence of NW_004515387.1, which was taught in the art to be the upstream region of a Cicer ubiquitin gene, comprises fragments of at least 100 contiguous nucleotides identical to SEQ ID NO: 156. Because it would have been obvious to one of skill in the art to substitute an upstream region of a Cicer arietinum polyubiquitin gene of the sequence of NW_004515387.1 for another C. arietinum ubiquitin promoter, the regulatory element comprising at least 100 contiguous nucleotides of SEQ ID NO: 156 would still have been obvious to one of ordinary skill in the art.
Claim(s) 4, 6, 11, 14, 15 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chakraborty, NCBI reference NW_004515387.1, and NCBI reference XM_004496716.1 as applied to claims 1, 3, 5, 7, 9-10, 12-13 & 16-17 above, and further in view of Abbitt et al US 2017/0218384 A1 (published 8/3/2017, hereafter Abbitt).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9/18/2025, as applied to claims 1-18. Applicant' s arguments filed 1/20/2026 have been fully considered but they are not persuasive.
Claims 4, 6, 11, 14, 15 & 18 are drawn to a DNA construct comprising a regulatory element polynucleotide further comprising a heterologous polynucleotide or a gene capable of providing herbicide resistance, a monocotyledon plant cell stably transformed with the DNA construct, and a method for expressing a polynucleotide in a monocot plant comprising introducing a recombinant polynucleotide comprising a regulatory element capable of increasing expression of a polynucleotide encoding a gene product involved in organ development or an endogenous gene of the plant. Claim 14 requires the gene product be involved in organ development, stem cell development, cell growth stimulation, organogenesis, somatic embryogenesis initiation, and development of the apical meristem. Claims 13-18 do not require expression of a heterologous polynucleotide, only that the regulatory element is capable of increasing expression of one.
The teachings of Chakraborty, NCBI reference NW_004515387.1, and NCBI reference XM_004496716.1 are presented above. They do not teach the DNA construct introduced into a monocot or the heterologous polynucleotide molecule as a gene providing herbicide resistance, encoding a gene producing involved in organ development, or an endogenous gene.
Abbitt teaches ubiquitin promoters from sorghum, maize, and foxtail millet that allow transcription initiation in a plant (table 1, table 2). Abbitt teaches that isolation of ubiquitin promoters can serve as regulatory elements for constitutive expression of sequences of interest (paragraph [0004]). Abbitt teaches that the promoters were identified from sequences with coding sequences of related proteins and contain TATA boxes (paragraph [0167]). Abbitt teaches transformation of plants expressing GUS under one of the Ubi promoters, and seeds were grown to evaluate T1 expression (paragraph [0168]). All transformants produced a positive GUS stain.
Abbitt also teaches chimeric synthetic promoters including the Ubi regulatory elements and elements from other promoters, and teaches a motivation to include regulatory elements from various promoters to create promoters that are stronger or have a different expression pattern (paragraph [0172] table 4).
Abbitt envisions the transformation of other plants with these sequences, such as chickpea and other legumes in addition to monocots (paragraph [0056 & 0053]). Abbitt also envisions methods of increasing expression of an endogenous polynucleotide sequence encoding a polypeptide involved in abiotic stress tolerance by inserting a heterologous regulatory polynucleotide fragment of an ubi promoter into the maize genome (Abbitt claims 30-31).
Abbitt teaches methods of expressing polynucleotides in a plant by introducing recombinant polynucleotides comprising a regulatory element comprising a fragment or variant of the ubi promoters of Abbitt SEQ ID NO: 1-6, wherein the heterologous polynucleotide of interest encodes a gene product involved in organ development, stem cell development, cell growth stimulation, organogenesis, somatic embryogenesis initiation, and development of the apical meristem, or wherein the gene product confers herbicide tolerance, or is an endogenous gene of the plant (paragraphs [0017-0018]). Abbitt teaches that Bacillus thuringiensis proteins are one example of insect resistance genes that can be used with the regulatory sequences (paragraphs [0068-0070]).
Before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to modify the chickpea transformation method of Chakraborty to transform a monocot such as maize, as taught by Abbitt. One of ordinary skill in the art would have been motivated to transform a maize plant with a Bt gene such as cry1Ac to provide insect resistance. One of ordinary skill in the art would have had reasonable expectation of success to substitute one ubiquitin promoter for another, because ubiquitin promoters were known as constitutive promoters suitable for expression of transgenes. Thus, a monocot plant stably transformed with the DNA construct comprising the Cicer arietinum promoter reads on the monocotyledon plant cell of instant claim 11 and the method of increasing expression of a heterologous polynucleotide of instant claim 18.
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to modify the Cicer arietinum ubi promoter taught by NCBI reference NW_004515387.1 to also comprise heterologous polynucleotide sequence comprising regulatory element regions of other promoter regions, as taught by Abbitt. One of ordinary skill in the art would have been motivated to do so in order to strengthen or modify the expression pattern of the promoter. One of ordinary skill in the art would have had reasonable expectation of success, because Abbitt created such chimeric synthetic promoters using ubi promoters from sorghum and foxtail millet. Thus, instant claim 4 to the regulatory element polynucleotide further comprising a heterologous polynucleotide is obvious.
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to substitute an herbicide tolerance gene, a gene encoding a product involved in organ development, or an endogenous polynucleotide sequence encoding a polypeptide involved in abiotic stress tolerance for the cry1Ac insect resistance gene in the method taught by Chakraborty. One of ordinary skill in the art would have been motivated to do so, because Abbitt suggests that such genes would appropriate to place under regulatory control of a ubi promoter and that ubi promoters provide constitutive expression of transgenes. One of ordinary skill in the art would have had reasonable expectation of success, because ubiquitin promoters were known to serve as regulatory elements for constitutive expression of heterologous nucleotide sequences of interest. Thus, a DNA construct comprising the regulatory element polynucleotide operably linked to a gene capable of providing herbicide resistance (instant claim 6) and a method for expressing a heterologous polynucleotide encoding a gene product involved in organ development, stem cell development, cell growth stimulation, organogenesis, somatic embryogenesis initiation, and development of the apical meristem, a gene product that confers herbicide tolerance, or an endogenous gene of the plant (instant claims 14-16) are obvious.
Claims 1, 3, 5, 7, 9-10, 12-13 & 16-17 are mapped to the teachings of Chakraborty, NCBI reference NW_004515387.1, and NCBI reference XM_004496716.1 above. Therefore, claims 1 & 3-18 are obvious over Chakraborty, NCBI reference NW_004515387.1, NCBI reference XM_004496716.1, and Abbitt.
Applicant urges that amended claims recite at least 100 contiguous nucleotides which renders the rejection moot (Remarks, page 7, paragraph 2).
This argument is unpersuasive, because the sequence of NW_004515387.1, which was taught in the art to be the upstream region of a Cicer ubiquitin gene, comprises fragments of at least 100 contiguous nucleotides identical to SEQ ID NO: 156. Because it would have been obvious to one of skill in the art to substitute an upstream region of a Cicer arietinum polyubiquitin gene of the sequence of NW_004515387.1 for another C. arietinum ubiquitin promoter, the regulatory element comprising at least 100 contiguous nucleotides of SEQ ID NO: 156 would still have been obvious to one of ordinary skill in the art.
Claim(s) 1, 3, 9-10, 13 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Peykari et al (2019) Crop Biotech. 25: 35-45 (published 2019, hereafter Peykari; uploaded with English machine translation appended to end of the file) in view of NCBI reference NW_004515387.1 (bases 3691155 to 3695226, available 12/27/2018) taken with the evidence of NCBI reference XM_004496716 (available 6/8/2015).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9/18/2025, as applied to claims 1-3, 9-10, 13 & 17. Applicant' s arguments filed 1/20/2026 have been fully considered but they are not persuasive.
Claim(s) 1,3, 9-10, 13 & 17 are drawn to a recombinant polynucleotide comprising a polynucleotide with at least 95% sequence identity to SEQ ID NO: 156 or 100 contiguous nucleotides of SEQ ID NO: 156, a DNA construct comprising the regulatory element polynucleotide, or a heterologous cell or transgenic plant comprising the DNA construct or nucleic acid molecule and a method for expressing a polynucleotide in a plant comprising introducing into a plant cell a recombinant polynucleotide comprising a regulatory element comprising a nucleotide sequence of SEQ ID NO: 156 or a fragment or variant with regulatory in a plant cell. Claims 13 & 16-17 do not require expression of a heterologous polynucleotide, only that the regulatory element is capable of increasing expression of one.
Peykari teaches a polyubiquitin promoter for the Cicer arietinum CaUBQ10 gene to express a β-glucoronidase reporter gene in tobacco (abstract).
Peykari teaches that using the natural promoter of a plant for gene expression in the same plant is more efficient compared to gene expression from a promoter of human origin (page 36, right column; see page 1 of machine translation appended to original document).
Peykari teaches that housekeeping genes, including ubiquitins, are excellent candidates for isolating high-expression, persistent promoters (page 36, left column; page 2 of machine translation).
Peykari teaches amplifying the CaUBQ10 promoter by PCR from genomic DNA, cloning the promoter into plant vector pBI121, and transferring the construct into Agrobacterium strain AGL1 (page 37, left column; page 4 of machine translation). Peykari teaches that cleavage sites of MspI and Xba1 were selected for the primers for cloning (page 37, left column; page 4 of machine translation).
Tobacco plants were transformed with the construct comprising the CaUBQ10 promoter and transgenic plants were transferred to soil after 4 months and confirmed with PCR (page 41, left column; page 12 of machine translation). Plants transfected with the CaUBQ10 promoter construct had staining (figure 3), showing that CaUBQ10 functions as a promoter in dicotyledonous plants (page 41 left column; page 12 of machine translation).
Figure 1 depicts the DNA construct comprising the CaUBQ10 promoter and a gusA gene. Peykari teaches that the genomic sequence used for the design of the primers comes from GenBank reference NC_021163.1 (page 37, left column, paragraph 1; page 4 of machine translation).
Peykari teaches that the CaUBQ10 promoter has a large number of TATA-box and CAAT box elements as well as other known motifs but no DPE promoter element downstream of the promoter (table 2, page 39, right column; page 7 of machine translation).
Peykari does not teach the sequence of the CaUBQ10 promoter.
The teachings of NCBI reference NW_004515387.1 and NCBI reference XM_004496716.1 are presented above.
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to modify the method of Peykari to substitute the undisclosed sequence of the CaUBQ10 promoter for the sequence taught by NCBI reference NW_004515387.1. One of ordinary skill in the art would have been motivated to substitute one ubiquitin promoter for another promoter of a homologous gene of the same species through routine optimization of the ubi promoter sequence. One of ordinary skill in the art would have had reasonable expectation of success, because Peykari teaches that promoters of ubiquitins are excellent candidates for isolating high-expression, persistent promoters.
Thus, the construct to comprising a GUS reporter gene linked to a polynucleotide comprising a CaUBQ10 regulatory element makes obvious the recombinant polynucleotides of claims 1 & 2, the DNA construct of claim 3, the stably transformed heterologous cell and transgenic plants of claims 8-10, and the method for expressing a polynucleotide in a plant of claims 13 & 17.
Applicant urges that amended claims recite at least 100 contiguous nucleotides which renders the rejection moot (Remarks, page 7, paragraph 4).
This argument is unpersuasive, because the sequence of NW_004515387.1, known in the art to be the upstream region of a Cicer ubiquitin gene, comprises fragments of at least 100 contiguous nucleotides identical to SEQ ID NO: 156. Because it would have been obvious to one of skill in the art to substitute an upstream region of a Cicer arietinum polyubiquitin gene of the sequence of NW_004515387.1 for another C. arietinum ubiquitin promoter, the regulatory element comprising at least 100 contiguous nucleotides of SEQ ID NO: 156 would still have been obvious to one of ordinary skill in the art.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/VICTORIA L DELEO/Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1663
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