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 .
Claims 151-155 and 158-172 are pending and examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d)
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 152 and 163 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 151 recites that the tobacco plant “comprises an endogenous polynucleotide having a nucleic acid sequence encoding a polypeptide having an amino acid sequence of SEQ ID NO: 44”. The specification defines SEQ ID NO: 44 as a polypeptide found in Nicotiana tabacum and that “the endogenous polynucleotide encoding SEQ ID NO: 44” from Nicotiana tabacum comprises sequences SEQ ID NO: 8 and SEQ ID NO: 26, that are reference sequences as defined in the specification in [0043] on page 9 in lines 8-11.
Both claims 152 and 163 recite that “the endogenous polynucleotide” (of claim 151) has 95% sequence identity to the polynucleotide sequence of SEQ ID NO: 8 or 26 which are “nucleic acid sequences encoding a polypeptide having the amino acid sequence of SEQ ID NO: 44” recited in claim 151, and are both inherently “an endogenous sequence” as recited in claim 151; and thus the polynucleotide sequence having at least 95% sequence identity to SEQ ID NO: 8 or 26 (recited in claims 152 and 163) is broader in scope than a polynucleotide sequence encoding SEQ ID NO: 44, and claims 152 and 163 fail to further limit claim 151. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Applicant’s Arguments
Applicants assert that 37C.F.R. §1.75 clearly asserts that “claims in dependent form shall be construed to include all the limitations of the claim incorporated by reference into the dependent claim.” Since dependent claims 152 and 163 recite the limitations of SEQ ID NO: 8 and 26, then SEQ ID NO: 8 and 26 are relevant features of claim 151 as stated supra. Applicants’ assertion that reciting 95% identity to SEQ ID NO: 8 or 26 is further limiting “the endogenous polynucleotide” encoding SEQ ID NO: 44 of the Nicotiana tabacum plant of claim 151 is not persuasive because SEQ ID NO: 8 and 26 are “an endogenous polynucleotide” that are inherent structural features of the plant of claim 151. Applicants are claiming “the endogenous polynucleotide” having 95% identity to “the endogenous polynucleotide” or itself.
Applicants assert that claim 151 recites many different nucleic acid sequences due to the codon degeneracy is not persuasive because claim 151 is limited to “a reference sequence” that is “the endogenous sequence” encoding the polypeptide of SEQ ID NO: 44.
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 151-155 and 158-172 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.
The term “non-natural mutation” in claim 151 is a relative term which renders the claim indefinite. The term “non-natural mutation” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Non-natural mutation is not defined with respect to any particular alteration in a reference sequence and is indistinguishable from ‘natural mutation’ because both “natural” and “non-natural” are structurally agnostic to the method by which the mutation arises and either would potentially lead to a modified plant having reductions in activity or expression, or reductions in levels of nicotine relative to a control plant; and thus does not set forth the metes and bounds of the invention sufficient to notify the public of possible infringement.
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 151-155 and 158-172 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.
The claims are broadly drawn to a modified tobacco plant having any number of unspecified mutations in the polynucleotide encoding the polypeptide of SEQ ID NO: 44 whereby the expression or activity of the polypeptide is reduced or the level of nicotine is decreased and tobacco products thereof.
Applicant have claimed modified tobacco plants having any number of mutations in the endogenous gene encoding SEQ ID NO: 44 resulting in a reduction in the expression or activity of said gene. However, Applicants have not described which amino acid residues in SEQ ID NO: 44 that would result in a degree of reduction of gene expression or activity sufficient to reduce alkaloid or nicotine levels or tobacco plants or tobacco products modified thereof.
This claim is a “reach-through” claim in which the Applicant has described a starting material and at least one method step, however, they have not described the resulting product; and the genus of products that can be produced by the recited methods and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
Applicants only provide modified tobacco plants having been transformed with RNAi AO-1 and AO-2 constructs that showed reduced expression, alkaloids and nicotine (see figures 5-9). Applicants have not modified the amino acid structure of SEQ ID NO: 44.
Applicants assert that Claims 152 and 163 further limit claim 151 by reciting that the nucleic acid sequence is 95% identical to a nucleic acid sequence to a nucleic acid sequence selected from the group consisting of SEQ ID NO: 8 and 26 (page 2 of remarks filed 12/10/2025). The genus of endogenous polynucleotides having 95% sequence identity to SEQ ID NO: 26 encompasses polynucleotide sequences not encoding SEQ ID NO: 44 (see alignment below of endogenous Nicotiana tabacum polynucleotide sequence of SEQ ID NO: 66 from U.S. Patent 12239090 aligned against instant SEQ ID NO: 26).
Query SEQ 66 US12239090 vs Subject SEQ26 of 17781797 (95.87% Identity)
Range 1: 1 to 1938
Score:3133 bits(3474), Expect:0.0,
Identities:1858/1938(96%), Gaps:3/1938(0%), Strand: Plus/Plus
Query 1 ATGGCAACTGGTATCGCTTCAGGAAGCGGACAGTTACATTTGAGGAAGCCTGTCTACTGG 60
Sbjct 1 ......................T..................................... 60
Query 61 AGGAGTAGCTATGGAAAAGCTCACTGTCATTCCAATGCGATCCTGAATGGCATGCAAAAC 120
Sbjct 61 .......................G.............T...................... 120
Query 121 CAGATCCCTTGGTCTTATTGGGTTTCCAAATTCTTGCGAGTTCATAGAAGTAACTACTCA 180
Sbjct 121 ........................................................T... 180
Query 181 CAATGTCAAGTGAAAACAAACTGGAAGTCTCACACCGGAACAATCAATTCTTGCCAGAGA 240
Sbjct 181 ..................................G......................... 240
Query 241 GATGGCTCAACTAGGTATTTTGATTTTGCTGTGATTGGTAGTGGAATTGCTGGCCTTAGA 300
Sbjct 241 ....................C.....C..G...........................C.. 300
Query 301 TATGCTCTAGAAGTTGCAAAGCATGGAACTGTAGCTGTGATAACCAAGGCTGAGCCTCAT 360
Sbjct 301 ........T........C..A..........................A........A... 360
Query 361 GAGAGTAACACTAACTATGCTCAAGGTGGTGTAAGTGCTGTGTTCTGCCCTATGGATTCA 420
Sbjct 361 ..........................................C................. 420
Query 421 GTGGAGAGCCACATGCAAGACACAATTGTGGCAGGTGCTTACCTCTGTGATGAGGAGACT 480
Sbjct 421 ....................T........T.............................. 480
Query 481 GTTAGAGTTGTGTGTACCGAAGGACCTGAGAGAATTAGAGAACTGATTGCTATGGGTGCT 540
Sbjct 481 .....................................A...................... 540
Query 541 TCATTCGATCATGGGGAGGACGGGAATCTGCATCTAGCCAGGGAAGGGGGCCACTCCCAT 600
Sbjct 541 ....................T..A.................................... 600
Query 601 CGTCGAATTGTCCATGCTGCTGATATGACTGGCAGAGAGATAGAAAGGGCCCTATTAGAG 660
Sbjct 601 ............................................................ 660
Query 661 GCAGTTTTTAAGCATCCTAATATACATGTGTTTCAACACCATTTTGCTATAGATTTTTTG 720
Sbjct 661 ........................................................G... 720
Query 721 ACCACTCAGGATGGTTCTGACATAATATGTCATGGCGTTGATGCTATAAACACGGAAACG 780
Sbjct 721 ........................G.................A................A 780
Query 781 CAGGAAGTTATAAGATTCATTTCAAAAGTGACTTTGCTGGCATCAGGTGGAGCTGGGCAT 840
Sbjct 781 .....G...................................................... 840
Query 841 ATCTATCCAAGTACTACTAATCCACCGGTTGCAACTGGAGATGGAATGGCTATGGCTCAT 900
Sbjct 841 .C......T..............G.................................... 900
Query 901 CGAGCTCAAGCTGTAATTTCCAACATGGAGTTTGTGCAATTCCATCCAACTGCCTTGGCT 960
Sbjct 901 ....................T.......................C.....C..T...... 960
Query 961 GATGAAGGCCTTCCCAACAGAC---CAAGTGCCAGAGAGAATGCTTTTTTGATAACTGAA 1017
Sbjct 961 ................T.....CAA....AA..........C.................. 1020
Query 1018 GCTGTCAGAGGTGATGGAGGCATCCTTTACAACTTAGATATGGAGAGATTTATGCCAATG 1077
Sbjct 1021 ............................................................ 1080
Query 1078 TATGACAAAAGAGCAGAGCTTGCCCCGAGAGATGTGGTAGCAAGAAGTATAGATGACCAG 1137
Sbjct 1081 .....TG..................................................... 1140
Query 1138 CTCAAAAAGCGTGGCGAAAAGTATGTTCTTCTTGATATCAGTCACAAGCCCAGAGAGAAG 1197
Sbjct 1141 ..............T...........................T........C........ 1200
Query 1198 GTTCTGTCTCATTTTCCTAATATAGCTGCTGAGTGTCTCCGCCATGGGTTAGACATAACA 1257
Sbjct 1201 .....T...................................................... 1260
Query 1258 CAGCAGCCGATTCCGGTGGTTCCTGCTGCTCACTACATGTGTGGTGGAGTTCGTGCTGGA 1317
Sbjct 1261 ..............A...................................C......... 1320
Query 1318 CTTGAGGGTGAGACTAATGTGCAAGGCCTTTATGTGGCAGGTGAAGTTGCATGTACTGGT 1377
Sbjct 1321 ..C..............C.....T..T................................. 1380
Query 1378 TTACATGGTGCTAACCGACTTGCTAGCAACTCGTTGCTTGAAGCACTAGTGTTTGCACGA 1437
Sbjct 1381 ...........G................................................ 1440
Query 1438 AGAGCTGTACAACCTTCAATTGATCACGTGAATGTGTCTAGAATTGATCACTGTGCTTCA 1497
Sbjct 1441 ...........G...............A.......................G........ 1500
Query 1498 AGTTGGTGGCCGCGACCTGTAGCCCCAGTGGTAATAGGAGATACAGTACTTAACAAAGTC 1557
Sbjct 1501 .........T....G........T..CA..T..C...............A.GG....... 1560
Query 1558 ATTCGTCGGACAAGGGAAGTGAGGAAAGAACTACAGTCAATCATGTGGGAATATGTTGGA 1617
Sbjct 1561 ....AC..............A...........G........................... 1620
Query 1618 ATTGTTAGGTCTACCTCAAGACTAACCGCAGCTGAGAAGAGAATCAATGAGTTGGAGTTG 1677
Sbjct 1621 ..............................................GA............ 1680
Query 1678 GAATGGGAAACATACCTATTTCAGCATGGCTGGGAACCAACAATGGTTGGACTAGAGGCT 1737
Sbjct 1681 ...................................................G........ 1740
Query 1738 TGTGAGATGAGGAATCTCTTCTGTTGTGCCAACCTGGTAGTTAGCAGTGCTCTTTCTCGA 1797
Sbjct 1741 ...........................................A................ 1800
Query 1798 CACGAGAGTCGCGGGCTTCATTACACCATTGATTTTCCTCATGTTGTGGAAAGCAAGAGG 1857
Sbjct 1801 ..............T...............................A.........A... 1860
Query 1858 TTGCCAACAATCATTTTTCCTTCACAGCGAAATAGCTCGTGGAGCTCACGGCAATTACAC 1917
Sbjct 1861 ........G...........G.................A........G............ 1920
Query 1918 AGGCAGCAGATATGTTAG 1935
Sbjct 1921 .................. 1938
Applicants further assert that the genus of polynucleotide sequences encoding SEQ ID NO: 44 can be envisioned by one of ordinary skill by means of codon redundancy to obtain variants by back translating from the polypeptide sequence of SEQ ID NO: 44 (see page 2 of remarks filed 12/10/2025). This is not persuasive because the claims are limited to an endogenous sequence that is subject to a species-specific codon bias, which Applicants have not considered in their claim construction and remarks.
Therefore, given the lack of written description in the specification with regard to the structural characteristics of the claimed mutant coding sequences and modified tobacco plant, it is evident that Applicant was not in possession of the claimed genus at the time this application was filed. See Written Description guidelines provided in MPEP 2163. Given the claim breadth and lack of guidance as discussed above, the specification does not provide a written description of the genus as broadly claimed. Accordingly, one skilled in the art of tobacco breeding would not have recognized Applicant to have been in possession of the broadly claimed invention at the time of filing.
All claims are rejected.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL KALLIS whose telephone number is (571)272-0798. The examiner can normally be reached Monday-Friday 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 5712707058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUSSELL KALLIS/Primary Examiner, Art Unit 1663