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 .
DETAILED ACTION
1. Claims 1-9 and 11-20 are pending and examined on the merits.
Applicant’s amendments to claims 1, 2 and 18-20 in the reply filed 2/4/2026 are acknowledged.
2. The rejections and objections not recited in this action are withdrawn.
Claim Rejections - 35 USC § 112
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.
Scope of Enablement
3. Claims 1-9, 11-20 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 dsRNA with a first strand that comprises at least 23 contiguous nucleotides of SEQ ID NO: 120 and a second strand that is fully complementary to the first strand, and wherein expression the dsRNA cause impeded growth to DBM , does not reasonably provide enablement for a dsRNA with any size. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
The claims are broadly drawn to dsRNA with a first strand having at least 23 contiguous nucleotides of SEQ ID NO: 120 and a second strand being complementary to the first strand.
The Office interprets that a second strand being complementary to the first strand reads on be fully complementary to any fragment of the first stands, Therefore, instant claims read on dsRNA with any size
The specification teaches dsRNA targeting Plutella xylostella gene encoding peptidoglycan recognition protein cause mortality of the insect larval (Figures 14, 19 and 20).
Thomas et al. (2001, The Plant Journal 25(4):417-425) teach that the lower size limit required for targeting reporter transgene mRNA de novo using PTGS was 23 nucleotides of complete identity, a size corresponding to that of small RNAs associated with PTGS in plant and RNAi in animals (abstract). Therefore, all of the DNA segments smaller than 23 nucleotides in instant claims are not enabled for silencing a target gene.
Therefore, given the claim breadth, lack of further guidance and additional working example, unpredictability of the art, undue experimentation would be required for a person skilled in the art to practice the invention.
To overcome the rejection, it is suggested to recite that a second strand is fully complementary to the first strand.
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.
4. Claims 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (2016, Acta Entomologica Sinica 5:489-499) as applied to claims 1-2 and 5-16 above, and further in view of Raemaekers et al. (US Patent No. 9,528,123) and Quay et al. (US Patent Application Publication No. 2010/0015708).
The claims are drawn to a method of silencing an insect immune response gene and an insect gene encoding structural components comprising providing for ingestion a dsRNA with a first strand having at least 23 contiguous nucleotides of SEQ ID NO: 120 and a second strand being complementary to the first strand, or wherein the target gene is involved in gut microbe recognition; or dsRNA comprises two separate RNA strands annealed together; or the target gene is pattern recognition protein in insect immune system; or the target gene is an orthologs of M. sexta-Peptidoglycan recognition protein 2; or wherein the dsRNA cause mortality of DBM; or wherein the insect is an Lepdoptera/Plutella xylostella; or wherein the dsRNA can form siRNA. The claims are also drawn to recombinant DNA encoding the dsRNA or transgenic plant/host cell comprising dsRNA. The claims are drawn to a method for silencing an insect immune response gene by providing or ingesting the dsRNA to an insect. Claims 3-4 further contain a limitation of synthetic carrier together with dsRNA such as liposome; or wherein a method for producing transgenic plant/improving crop yield by expressing the dsRNA targeting SEQ ID NO:120 or by topically applying the dsRNA, wherein the plant is a corn.
Zheng et al. teach a method causing increased mortality of Plutella xylostella (also known as DBM) comprising silencing the expression of PxPGRP-SA gene (abstract). Zheng et al. teach dsRNA was produced according the cDNA sequence of EU399240. (page 491, left column, 1st paragraph), which comprises instant SEQ ID NO:120 (see alignment below). According to the sequence search result shown below, instant SEQ ID NO:76 is also from EU399240. Zheng et al. teach PxPGRP-SA gene is pattern recognition protein in insect immune system (abstract). PxPGRP-SA gene of Zheng et al. is also considered as an orthologs of M. sexta-Peptidoglycan recognition protein 2. Zheng et al. teach silencing an insect immune response gene of PxPGRP-SA gene by providing the dsRNA to the Plutella xylostella larvae. Zheng et al. teach dsRNA is generated by in vitro transcription(page 492, right column), therefore recombinant DNA is inherently produced to perform in vitro transcription and T7 promoter is present construct.
Zheng et al. do not teach synthetic carrier such as liposome or generating transgenic plant expressing the dsRNA targeting SEQ ID NO:120 or topically applying the plant.
Raemaekers et al. teach a composition for controlling insect comprising dsRNA and carrier (paragraphs [164]). Raemaekers et al. teach a method for controlling insect by transforming DNA construct encoding dsRNA to the host plant (claims 20-22). Raemaekers et al. teach applying topically dsRNA on bean leaf (paragraph [0121]). Raemaekers et al. teach that the plant is a corn (paragraph [0153]).
Quay et al. teach liposome as a dsRNA carrier.
Given the teaching of Zheng et al. that PxPGRP-SA gene is a valid target gene for RNAi and that DBM is an important pest for crop such as cabbage, it would have been obvious for skill in the art to modify the method of Raemaekers et al. by using DNA construct encoding dsRNA targeting PxPGRP-SA gene of Zheng et al., resulting the instant invention with reasonable expectation for success. One would have been obvious to make such modification given the teaching that the method of Raemaekers et al. can be used in host plant such as cabbage for controlling pest such as DBM (claims 14 and 30). A composition further comprising a carrier such as liposome of Quay et al. is considered as an obvious design choice.
Although Zheng et al. do not teach siRNA, such siRNA would have been inherently produced by the in vivo silencing system after uptaking the dsRNA.
RESULT 1
EU399240
LOCUS EU399240 690 bp mRNA linear INV 01-DEC-2009
DEFINITION Plutella xylostella peptidoglycan recognition protein mRNA,
complete cds.
ACCESSION EU399240
VERSION EU399240.1
KEYWORDS .
SOURCE Plutella xylostella (diamondback moth)
ORGANISM Plutella xylostella
Eukaryota; Metazoa; Ecdysozoa; Arthropoda; Hexapoda; Insecta;
Pterygota; Neoptera; Holometabola; Lepidoptera; Glossata; Ditrysia;
Yponomeutoidea; Plutellidae; Plutella.
REFERENCE 1 (bases 1 to 690)
AUTHORS Jin,F., Xu,X. and Ren,S.
TITLE Molecular cloning and characterization of peptidoglycan recognition
protein (PGRP), an immune-inducible gene from diamondback moth,
Plutella xylostella
JOURNAL Unpublished
REFERENCE 2 (bases 1 to 690)
AUTHORS Jin,F., Xu,X. and Ren,S.
TITLE Direct Submission
JOURNAL Submitted (13-JAN-2008) South China Agricultural University,
College of Natural Resources and Environments, Tianhe WushN,
Guangzhou, Guangdong 510642, China
FEATURES Location/Qualifiers
source 1..690
/organism="Plutella xylostella"
/mol_type="mRNA"
/db_xref="taxon:51655"
CDS 28..615
/note="PGRP; immune-inducible gene"
/codon_start=1
/product="peptidoglycan recognition protein"
/protein_id="ACB32179.1"
/translation="MTLSFGVFLLISSVFCCCAHAGCGVVTRQQWDGLDPIQLEYLPR
PLGLVVVQHTATPACDTDAACVELVQNIQTNHMDVLKFWDIGPNFLIGGNGKVYEGPG
WLHVGAHTYGYNRKSIGISFIRNFNAKTPTKAALNAAEALLKCGVREGHLSHSYAVVG
HRQLIATESPGRKLYQIIRRWPNYLEDIDKIKNNK"
Query Match 100.0%; Score 439; DB 194; Length 690;
Best Local Similarity 100.0%;
Matches 439; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CCCGATACAGTTGGAGTACCTGCCCCGGCCCCTGGGGCTGGTGGTGGTCCAGCACACCGC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 132 CCCGATACAGTTGGAGTACCTGCCCCGGCCCCTGGGGCTGGTGGTGGTCCAGCACACCGC 191
Qy 61 CACCCCCGCGTGTGACACTGACGCCGCGTGTGTGGAGCTGGTGCAGAACATACAGACCAA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 192 CACCCCCGCGTGTGACACTGACGCCGCGTGTGTGGAGCTGGTGCAGAACATACAGACCAA 251
Qy 121 TCATATGGATGTGCTGAAGTTTTGGGATATTGGACCGAACTTCCTGATTGGTGGGAACGG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 252 TCATATGGATGTGCTGAAGTTTTGGGATATTGGACCGAACTTCCTGATTGGTGGGAACGG 311
Qy 181 CAAGGTGTACGAGGGCCCTGGTTGGCTGCACGTCGGCGCCCACACTTACGGCTACAACAG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 312 CAAGGTGTACGAGGGCCCTGGTTGGCTGCACGTCGGCGCCCACACTTACGGCTACAACAG 371
Qy 241 GAAGTCTATCGGGATCTCTTTCATTAGGAATTTTAATGCTAAGACCCCAACAAAAGCAGC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 372 GAAGTCTATCGGGATCTCTTTCATTAGGAATTTTAATGCTAAGACCCCAACAAAAGCAGC 431
Qy 301 GTTGAATGCGGCTGAAGCATTGCTGAAGTGTGGAGTGAGAGAAGGACACCTGTCTCACTC 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 432 GTTGAATGCGGCTGAAGCATTGCTGAAGTGTGGAGTGAGAGAAGGACACCTGTCTCACTC 491
Qy 361 ATACGCAGTGGTCGGCCATAGACAACTGATCGCAACAGAGAGCCCAGGCAGGAAACTGTA 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 492 ATACGCAGTGGTCGGCCATAGACAACTGATCGCAACAGAGAGCCCAGGCAGGAAACTGTA 551
Qy 421 CCAAATCATCAGGCGCTGG 439
|||||||||||||||||||
Db 552 CCAAATCATCAGGCGCTGG 570
EU399240 vs. SEQ ID NO:120
Sequence ID: Query_6218851Length: 439Number of Matches: 1
Range 1: 1 to 439GraphicsNext MatchPrevious Match
Alignment statistics for match #1
Score
Expect
Identities
Gaps
Strand
811 bits(439)
0.0
439/439(100%)
0/439(0%)
Plus/Plus
Query 132 CCCGATACAGTTGGAGTACCTGCCCCGGCCCCTGGGGCTGGTGGTGGTCCAGCACACCGC 191
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 1 CCCGATACAGTTGGAGTACCTGCCCCGGCCCCTGGGGCTGGTGGTGGTCCAGCACACCGC 60
Query 192 CACCCCCGCGTGTGACACTGACGCCGCGTGTGTGGAGCTGGTGCAGAACATACAGACCAA 251
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 61 CACCCCCGCGTGTGACACTGACGCCGCGTGTGTGGAGCTGGTGCAGAACATACAGACCAA 120
Query 252 TCATATGGATGTGCTGAAGTTTTGGGATATTGGACCGAACTTCCTGATTGGTGGGAACGG 311
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 121 TCATATGGATGTGCTGAAGTTTTGGGATATTGGACCGAACTTCCTGATTGGTGGGAACGG 180
Query 312 CAAGGTGTACGAGGGCCCTGGTTGGCTGCACGTCGGCGCCCACACTTACGGCTACAACAG 371
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 181 CAAGGTGTACGAGGGCCCTGGTTGGCTGCACGTCGGCGCCCACACTTACGGCTACAACAG 240
Query 372 GAAGTCTATCGGGATCTCTTTCATTAGGAATTTTAATGCTAAGACCCCAACAAAAGCAGC 431
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 241 GAAGTCTATCGGGATCTCTTTCATTAGGAATTTTAATGCTAAGACCCCAACAAAAGCAGC 300
Query 432 GTTGAATGCGGCTGAAGCATTGCTGAAGTGTGGAGTGAGAGAAGGACACCTGTCTCACTC 491
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 301 GTTGAATGCGGCTGAAGCATTGCTGAAGTGTGGAGTGAGAGAAGGACACCTGTCTCACTC 360
Query 492 ATACGCAGTGGTCGGCCATAGACAACTGATCGCAACAGAGAGCCCAGGCAGGAAACTGTA 551
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 361 ATACGCAGTGGTCGGCCATAGACAACTGATCGCAACAGAGAGCCCAGGCAGGAAACTGTA 420
Query 552 CCAAATCATCAGGCGCTGG 570
|||||||||||||||||||
Sbjct 421 CCAAATCATCAGGCGCTGG 439
Conclusion
No claim is 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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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/LI ZHENG/Primary Examiner, Art Unit 1662