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 .
Claim Status
Claims 36 and 38-57 are pending and examined on the merits.
Response to Arguments - Claim Rejections - 35 USC § 102
Applicant’s amendments filed 28 August 2026 have overcome the rejection of record. It is noted that the claims have been amended to require SEQ ID NO:153 instead of SEQ ID NO:13. Humphry et al teach SEQ ID NO:29 which is the same as instant SEQ ID NO:153. The claims are now rejected as obvious over Humphrey et al.
Claim Rejections - 35 USC § 103
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) 36 and 38-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Humphry et al (WO2018237107).
Humphry et al teach a Nicotiana tabacum plant comprising mutations in Nic1 genes including SEQ ID NO:29 which is identical to instant SEQ ID NO:153. They teach means by which the mutation may be engineered to reduce alkaloid content including nicotine (page 13, 54, 61, 66). They teach that mutations can be mutations that introduce a premature STOP codon (p. 30, 38-39). They further contemplate that the invention can be practiced in burley, flue-cured, Oriental, or Turkish tobaccos (p. 55, lines 8-13) and the resultant tobacco can be used to make both smokeless and smokable tobacco products (p. 76-77).
Humphrey et al do not reduce to practice any specific mutant allele of SEQ ID NO:29 and thus report no data on the phenotypic impact of introducing a premature STOP codon in SEQ ID NO:29.
At the time of filing it would have been prima facie obvious for a person of ordinary skill in the art to produce any mutant allele of SEQ ID NO:29 which impairs function of the gene such that alkaloid content including nicotine is reduced. One such class of mutant allele is an allele comprising a premature stop codon. Achieving the claimed alkaloid/nicotine levels and leaf quality appear to be phenotypes that may be routinely optimized through the use of different mutant alleles and different genetic backgrounds. Accordingly, claims 36 and 38-57 is/are rejected under 35 U.S.C. 102(a)(2) as being obvious over by Humphry et al.
It is suggested that Applicant provide evidence and explanation as to why specific exemplified embodiments yielded unexpected results in context of the generic teachings of Humphrey et al and amend the claims to reflect the unexpected result. Although, please note that prosecution has been closed with this final rejection.
BFY84121
(NOTE: this sequence has 17 duplicates in the database searched.
See complete list at the end of this report)
ID BFY84121 standard; DNA; 672 BP.
XX
AC BFY84121;
XX
DT 21-FEB-2019 (first entry)
XX
DE Tobacco Nitab4.5_0004620g0095.1 (ERF16) genomic DNA, SEQ 29.
XX
KW ERF16 gene; Nitab4.5_0004620g0095.1; alkaloid; cell culture;
KW crop improvement; ds; gene; gene expression; plant; plant breeding;
KW transgenic plant.
XX
OS Nicotiana tabacum.
XX
CC PN WO2018237107-A1.
XX
CC PD 27-DEC-2018.
XX
CC PF 21-JUN-2018; 2018WO-US038679.
XX
PR 23-JUN-2017; 2017US-0524216P.
XX
CC PA (KENT ) UNIV KENTUCKY RES FOUND.
XX
CC PI Humphry ME, Yang S, Qin Q;
XX
DR WPI; 2019-00091P/06.
DR P-PSDB; BFY84124.
XX
CC PT Modulating alkaloid content of a plant, plant portion or cell culture
CC PT used to breed plant for producing plant product and leaf, and growing
CC PT crop, involves modifying plant or cell culture by modulating activity of
CC PT NIC1 ERF gene.
XX
CC PS Claim 1; SEQ ID NO 29; 169pp; English.
XX
CC The present invention relates to a novel method for modulating the
CC alkaloid content of a plant, plant portion or cell culture. The method
CC involves: modifying the plant or cell culture by modulating the activity
CC or expression of Nic1 ERF gene. The invention also provides: (1) a method
CC for modulating the content of a tobacco specific nitrosamine (TSNA) or a
CC precursor of TSNA in a tobacco plant or plant portion; (2) a method for
CC producing a plant or plant portion, cell culture, plant propagation
CC material, leaf, cut harvested leaf, processed leaf or cut and processed
CC leaf which has modulated alkaloid content; (3) a tobacco blend comprises
CC the cured tobacco material; (4) a tobacco industry product is prepared
CC from a tobacco plant, or plant portion or a tobacco cell culture, and
CC tobacco plant or portion propagated from tobacco plant propagation
CC material, and harvested leaf of a plant, where the plant is tobacco,
CC processed leaf; and (5) a mutant of a plant carrying a heritable mutation
CC in a nucleotide sequence of Nic1 ERF gene. The method is useful to breed
CC a plant for producing a plant product, and a leaf and a growing crop. The
CC modulating the alkaloid content in plants: can increase the value of said
CC plant as a biomass resource; can help to protect plants against insects
CC and herbivores; and for producing tobacco plants and products with
CC reduced nicotine may be desirable in view of the potential regulation of
CC nicotine ceilings. The present sequence is a tobacco
CC Nitab4.5_0004620g0095.1 (ERF16) genomic DNA, whose activity or expression
CC is modulated in the method of the invention for modulating the alkaloid
CC content of a plant, plant portion or cell culture.
XX
SQ Sequence 672 BP; 190 A; 150 C; 166 G; 166 T; 0 U; 0 Other;
Query Match 100.0%; Score 672; Length 672;
Best Local Similarity 100.0%;
Matches 672; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGAATTCAGCAGATGTAACCTTCTCTTTCTCTGATTTTAATCTCCTTGAATCCATTAAG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGAATTCAGCAGATGTAACCTTCTCTTTCTCTGATTTTAATCTCCTTGAATCCATTAAG 60
Qy 61 CAACATCTTTTAAATGATTCAGATTTTTCTGAAACTCTGTCGCCTATGAGTTCAAGTAAC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CAACATCTTTTAAATGATTCAGATTTTTCTGAAACTCTGTCGCCTATGAGTTCAAGTAAC 120
Qy 121 GGATTGCCTAACAGTCCTAGCTCAGGTTTTGGCAGCTCCCTTTCAGCAGAAAATAGCTTC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GGATTGCCTAACAGTCCTAGCTCAGGTTTTGGCAGCTCCCTTTCAGCAGAAAATAGCTTC 180
Qy 181 GAAATCTCCCTTTCGGACCAAAACTTTGAGGAAACAATACCAAATCTCGAAGAAAAGTCT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GAAATCTCCCTTTCGGACCAAAACTTTGAGGAAACAATACCAAATCTCGAAGAAAAGTCT 240
Qy 241 GAGTCCGAGGAGGAAATGAAGGGGAATGTGGTGGCGCGTGAGAATAACGCGCCGGAAGAT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GAGTCCGAGGAGGAAATGAAGGGGAATGTGGTGGCGCGTGAGAATAACGCGCCGGAAGAT 300
Qy 301 TGGAGGCGGTACATAGGAGTGAAACGGCGGCCATGGGGGACGTTTTCAGCGGAGATGAGA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TGGAGGCGGTACATAGGAGTGAAACGGCGGCCATGGGGGACGTTTTCAGCGGAGATGAGA 360
Qy 361 GACCCCGATAGGAGGGGGGCAAGACTGTGGTTAGGAACTTACGAGACCGCAGAGGATGCA 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GACCCCGATAGGAGGGGGGCAAGACTGTGGTTAGGAACTTACGAGACCGCAGAGGATGCA 420
Qy 421 GCGTTGGCGTACGATCAAGCCGCTTTCAAAATCCGCGGCTCGAGAGCTCGGCTCAATTTT 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 GCGTTGGCGTACGATCAAGCCGCTTTCAAAATCCGCGGCTCGAGAGCTCGGCTCAATTTT 480
Qy 481 CCTCACTTAATCGGTTCAAACATGCCTAAGCCGGCTAGAGTTACAGCGAGGCGTAGTCGT 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 CCTCACTTAATCGGTTCAAACATGCCTAAGCCGGCTAGAGTTACAGCGAGGCGTAGTCGT 540
Qy 541 ACGCGCTCACCCGAGCCATTGTCTTCTTCGTCCACCTCATCATCAGTAAATGTACCAAGA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 ACGCGCTCACCCGAGCCATTGTCTTCTTCGTCCACCTCATCATCAGTAAATGTACCAAGA 600
Qy 601 AAAAGGAAAATAGATGTGATCAATTCCATAGCCAAGGTTTGTCATGGTTGGAACCTCCAC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 AAAAGGAAAATAGATGTGATCAATTCCATAGCCAAGGTTTGTCATGGTTGGAACCTCCAC 660
Qy 661 ATGTTACTATAA 672
||||||||||||
Db 661 ATGTTACTATAA 672
Response to Arguments - Claim Rejections - 35 USC § 112
Applicant’s amendments filed 28 August 2026 have overcome the rejection of record, as the claims are now limited to Nicotiana tabacum.
Conclusion
No claims are allowed. THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
