DETAILED ACTION
Claims 1-20 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because in line 3 the comma should be removed after “genome”.
Claim Rejections - 35 USC § 112
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 the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claim 1 is indefinite in its recitation of “consisting of a plurality of molecules …”. It is not clear what consists of the plurality of molecules. By position in the claim, the phrase modifies “plant genome”, but genomes are not ostreolysin and pleurotolysins.
Claim 3 lacks antecedent basis for the limitation “the control plant”. It is suggested that “the” be replaced with --a--.
Claim 19 lacks antecedent basis for the limitation “bi-component protein complex as defined in claim 1”. Claim 1 is drawn to a method, not a bi-component protein complex.
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
Claim 19 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth 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 19 is drawn to s transgenic plant or progeny thereof which expresses or is capable of expressing a bi-component protein complex as defined in claim 1. However, claim 1 is drawn to a method, not a bi-component protein complex. Thus, the claim fails to include all the limitations of the claim upon which it depends.
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.
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.
Claims 1-4, 6-16 and 18-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bing et al (2008, US 7,323,556) in view of Lukoyanova et al (2015, PLoS Biol 13(2): e1002049. doi: 10.137 1/journal.pbio. 1002049), Sakurai et al A (2008, GenBank BAD66666), Sakurai et al B (2008, GenBank BAD66669), and Centre for Advanced Molecular Imaging (2015, https://imagingcoe.org/carnivorous-mushrooms-reveal-human-immune-trick/).
The claims are drawn to a method comprising expressing a pleurotolysin A, including one with 95% identity to SEQ ID NO:2, and a pleurotolysin B, including one with 95%-100% identity to SEQ ID NO:4, in a plant, including maize.
Bing et al teach transformation of maize with a construct encoding both subunits of the Cry34/35Ab1 binary toxin to produce western corn rootworm resistance plants (example 1). Bing et al do not teach transforming maize with a construct encoding pleurotolysin A and pleurotolysin B.
Lukoyanova et al teach pleurotolysin subunits pleurotolysin A (PlyA) and pleurotolysin B (PlyB), where PlyB is the MACPF subunit (pg 3, (4) which act together to form a lytic pore (Figure 6). PlyA and PlyB have 98.7% and 100% identity to SEQ ID NO:2 and 4, respectively:
Q8X1M9_PLEOS
ID Q8X1M9_PLEOS Unreviewed; 138 AA.
AC Q8X1M9;
DT 01-MAR-2002, integrated into UniProtKB/TrEMBL.
DT 01-MAR-2002, sequence version 1.
DT 25-MAY-2022, entry version 51.
DE SubName: Full=Pleurotolysin A {ECO:0000313|EMBL:BAD66666.1};
DE SubName: Full=PriA {ECO:0000313|EMBL:AAL57035.1};
GN Name=PlyA {ECO:0000313|EMBL:BAD66668.1};
GN Synonyms=plyA {ECO:0000313|EMBL:BAD66666.1};
OS Pleurotus ostreatus (Oyster mushroom) (White-rot fungus).
OC Eukaryota; Fungi; Dikarya; Basidiomycota; Agaricomycotina; Agaricomycetes;
OC Agaricomycetidae; Agaricales; Pleurotaceae; Pleurotus.
OX NCBI_TaxID=5322 {ECO:0000313|EMBL:AAL57035.1};
RN [1] {ECO:0000313|EMBL:AAL57035.1}
RP NUCLEOTIDE SEQUENCE.
RA Ma A.M., Kwan H.S.H.;
RL Submitted (DEC-2000) to the EMBL/GenBank/DDBJ databases.
RN [2] {ECO:0000313|EMBL:BAD66666.1}
RP NUCLEOTIDE SEQUENCE.
RX PubMed=15245918;
RA Sakurai N., Kaneko J., Kamio Y., Tomita T.;
RT "Cloning, expression, and pore-forming properties of mature and precursor
RT forms of pleurotolysin, a sphingomyelin-specific two-component cytolysin
RT from the edible mushroom Pleurotus ostreatus.";
RL Biochim. Biophys. Acta 1679:65-73(2004).
RN [3] {ECO:0007829|PDB:4OEB, ECO:0007829|PDB:4V2T}
RP X-RAY CRYSTALLOGRAPHY (1.85 ANGSTROMS).
RX PubMed=25654333; DOI=10.1371/JOURNAL.PBIO.1002049;
RA Lukoyanova N., Kondos S.C., Farabella I., Law R.H., Reboul C.F.,
RA Caradoc-Davies T.T., Spicer B.A., Kleifeld O., Traore D.A., Ekkel S.M.,
RA Voskoboinik I., Trapani J.A., Hatfaludi T., Oliver K., Hotze E.M.,
RA Tweten R.K., Whisstock J.C., Topf M., Saibil H.R., Dunstone M.A.;
RT "Conformational changes during pore formation by the perforin-related
RT protein pleurotolysin.";
RL PLoS Biol. 13:e1002049-e1002049(2015).
CC -!- SIMILARITY: Belongs to the aegerolysin family.
CC {ECO:0000256|ARBA:ARBA00010795}.
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DR EMBL; AF331453; AAL57035.1; -; mRNA.
DR EMBL; AB177869; BAD66666.1; -; mRNA.
DR EMBL; AB177871; BAD66668.1; -; Genomic_DNA.
DR PDB; 4OEB; X-ray; 1.85 A; A/B/C/D=1-138.
DR PDB; 4V2T; EM; 11.00 A; 0/2/3/5/6/8/9/B/C/E/F/H/I/K/L/N/O/Q/R/T/U/W/X/Z/b/c=2-136.
DR PDB; 4V3A; EM; 15.00 A; A/B=2-136.
DR PDB; 4V3M; EM; 17.00 A; A/B=2-136.
DR PDB; 4V3N; EM; 14.00 A; A/B=2-136.
DR PDBsum; 4OEB; -.
DR PDBsum; 4V2T; -.
DR PDBsum; 4V3A; -.
DR PDBsum; 4V3M; -.
DR PDBsum; 4V3N; -.
DR TCDB; 1.C.97.1.1; the pleurotolysin pore-forming (pleurotolysin) family.
DR VEuPathDB; FungiDB:PLEOSDRAFT_1090164; -.
DR GO; GO:0019836; P:hemolysis by symbiont of host erythrocytes; IEA:InterPro.
DR InterPro; IPR009413; Aegerolysin-typ.
DR Pfam; PF06355; Aegerolysin; 1.
DR PIRSF; PIRSF007951; PIRSF007951; 1.
PE 1: Evidence at protein level;
KW 3D-structure {ECO:0007829|PDB:4OEB, ECO:0007829|PDB:4V2T}.
SQ SEQUENCE 138 AA; 15136 MW; D8925B0E6AE1968C CRC64;
Query Match 98.7%; Score 739; DB 12; Length 138;
Best Local Similarity 98.6%;
Matches 136; Conservative 0; Mismatches 2; Indels 0; Gaps 0;
Qy 1 MAYAQWVIIIIHNVGSKDVKIVNLKPSWGKLHADGDKDTEVSASKYEGTVIKPDEKLQIN 60
||||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||
Db 1 MAYAQWVIIIIHNVGSKDVKIKNLKPSWGKLHADGDKDTEVSASKYEGTVIKPDEKLQIN 60
Qy 61 ACGRSDAAEGTTGTFDLVDPADGDKQVRHFYWDCPWGSKANTWTVSGSNTKWMIEYSGQN 120
||||||||||||||||||||||||||||||||||||||| ||||||||||||||||||||
Db 61 ACGRSDAAEGTTGTFDLVDPADGDKQVRHFYWDCPWGSKTNTWTVSGSNTKWMIEYSGQN 120
Qy 121 LDSGALGTITVDTLKKGN 138
||||||||||||||||||
Db 121 LDSGALGTITVDTLKKGN 138
Q5W9E8_PLEOS
ID Q5W9E8_PLEOS Unreviewed; 523 AA.
AC Q5W9E8;
DT 07-DEC-2004, integrated into UniProtKB/TrEMBL.
DT 07-DEC-2004, sequence version 1.
DT 19-JAN-2022, entry version 46.
DE SubName: Full=Pleurotolysin B {ECO:0000313|EMBL:BAD66667.1};
DE SubName: Full=Precursor of pleurotolysin B {ECO:0000313|EMBL:BAD66669.1};
GN Name=plyB {ECO:0000313|EMBL:BAD66669.1};
OS Pleurotus ostreatus (Oyster mushroom) (White-rot fungus).
OC Eukaryota; Fungi; Dikarya; Basidiomycota; Agaricomycotina; Agaricomycetes;
OC Agaricomycetidae; Agaricales; Pleurotaceae; Pleurotus.
OX NCBI_TaxID=5322 {ECO:0000313|EMBL:BAD66669.1};
RN [1] {ECO:0000313|EMBL:BAD66669.1}
RP NUCLEOTIDE SEQUENCE.
RX PubMed=15245918;
RA Sakurai N., Kaneko J., Kamio Y., Tomita T.;
RT "Cloning, expression, and pore-forming properties of mature and precursor
RT forms of pleurotolysin, a sphingomyelin-specific two-component cytolysin
RT from the edible mushroom Pleurotus ostreatus.";
RL Biochim. Biophys. Acta 1679:65-73(2004).
RN [2] {ECO:0007829|PDB:4OEJ, ECO:0007829|PDB:4OV8}
RP X-RAY CRYSTALLOGRAPHY (2.15 ANGSTROMS) OF 49-523.
RX PubMed=25654333; DOI=10.1371/JOURNAL.PBIO.1002049;
RA Lukoyanova N., Kondos S.C., Farabella I., Law R.H., Reboul C.F.,
RA Caradoc-Davies T.T., Spicer B.A., Kleifeld O., Traore D.A., Ekkel S.M.,
RA Voskoboinik I., Trapani J.A., Hatfaludi T., Oliver K., Hotze E.M.,
RA Tweten R.K., Whisstock J.C., Topf M., Saibil H.R., Dunstone M.A.;
RT "Conformational changes during pore formation by the perforin-related
RT protein pleurotolysin.";
RL PLoS Biol. 13:e1002049-e1002049(2015).
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DR EMBL; AB177870; BAD66667.1; -; mRNA.
DR EMBL; AB177872; BAD66669.1; -; Genomic_DNA.
DR PDB; 4OEJ; X-ray; 2.20 A; A=1-523.
DR PDB; 4OV8; X-ray; 2.15 A; A=49-523.
DR PDB; 4V2T; EM; 11.00 A; 1/4/7/A/D/G/J/M/P/S/V/Y/a=50-523.
DR PDB; 4V3A; EM; 15.00 A; C=49-523.
DR PDB; 4V3M; EM; 17.00 A; C=1-523.
DR PDB; 4V3N; EM; 14.00 A; C=49-523.
DR PDBsum; 4OEJ; -.
DR PDBsum; 4OV8; -.
DR PDBsum; 4V2T; -.
DR PDBsum; 4V3A; -.
DR PDBsum; 4V3M; -.
DR PDBsum; 4V3N; -.
DR SMR; Q5W9E8; -.
DR TCDB; 1.C.97.1.1; the pleurotolysin pore-forming (pleurotolysin) family.
DR VEuPathDB; FungiDB:PLEOSDRAFT_1090161; -.
DR InterPro; IPR020864; MACPF.
DR InterPro; IPR040971; PlyB_C.
DR Pfam; PF01823; MACPF; 1.
DR Pfam; PF18684; PlyB_C; 1.
DR PROSITE; PS51412; MACPF_2; 1.
PE 1: Evidence at protein level;
KW 3D-structure {ECO:0007829|PDB:4OEJ, ECO:0007829|PDB:4OV8}.
FT DOMAIN 34..356
FT /note="MACPF"
FT /evidence="ECO:0000259|PROSITE:PS51412"
FT REGION 499..523
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
SQ SEQUENCE 523 AA; 57094 MW; 67B9713731376D51 CRC64;
Query Match 100.0%; Score 2694; DB 12; Length 523;
Best Local Similarity 100.0%;
Matches 523; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MEAVLSRQAATAEAIGRFQDSSTSVGLVAGSPSTRIRRQADNVVLKSTSQAGDTLNDVIQ 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MEAVLSRQAATAEAIGRFQDSSTSVGLVAGSPSTRIRRQADNVVLKSTSQAGDTLNDVIQ 60
Qy 61 DPTRRNKLINDNNLLKGIIMGRDGPVPSSRELIVRPDTLRAIINNRATIETTTMEAEFTE 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DPTRRNKLINDNNLLKGIIMGRDGPVPSSRELIVRPDTLRAIINNRATIETTTMEAEFTE 120
Qy 121 TLMESNYNSASVKVSAPFITANSEYSESSSFKNTETEKSMYTSSRYLFPQGRIDFTTPDS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TLMESNYNSASVKVSAPFITANSEYSESSSFKNTETEKSMYTSSRYLFPQGRIDFTTPDS 180
Qy 181 GFDDVIKLSPQFTSGVQAALAKATGTEKREALQNLFQEYGHVFRTKVHIGGVLSAHTMET 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GFDDVIKLSPQFTSGVQAALAKATGTEKREALQNLFQEYGHVFRTKVHIGGVLSAHTMET 240
Qy 241 FSRSENETEVKQDVKAGLEGAVKGWGGGATAGHGNTQGTITTSQNRKLNVKYIVNGGDYT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FSRSENETEVKQDVKAGLEGAVKGWGGGATAGHGNTQGTITTSQNRKLNVKYIVNGGDYT 300
Qy 301 KIQNTEEWVASTNQSEHWRVIEVTEVTAVADLLPQPIRGQVKDLLKPLLGKWVDVEKVPG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 KIQNTEEWVASTNQSEHWRVIEVTEVTAVADLLPQPIRGQVKDLLKPLLGKWVDVEKVPG 360
Qy 361 LESLPVSVYRPKGAIPAGWFWLGDTADASKALLVKPTLPARSGRNPALTSLHQGSGMTEQ 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LESLPVSVYRPKGAIPAGWFWLGDTADASKALLVKPTLPARSGRNPALTSLHQGSGMTEQ 420
Qy 421 PFVDLPQYQYLSTYFGSFAHDTPPGSTLRGLRPDHVLPGRYEMHGDTISTAVYVTRPVDV 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 PFVDLPQYQYLSTYFGSFAHDTPPGSTLRGLRPDHVLPGRYEMHGDTISTAVYVTRPVDV 480
Qy 481 PFPEDECFDLKSLVRVKLPGSGNPPKPRSALKKSMVLFDSGEK 523
|||||||||||||||||||||||||||||||||||||||||||
Db 481 PFPEDECFDLKSLVRVKLPGSGNPPKPRSALKKSMVLFDSGEK 523
Centre for Advanced Molecular Imaging suggests expressing the genes for these pleurotolysins in plants to kill pests (pg 2, paragraph 4).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to replace the nucleic acids encoding the Cry34/35Ab1 binary toxin, in the construct taught by Bing et al, with nucleic acids encoding pleurotolysin A and B. One of ordinary skill in the art would have been motivated to do so because Centre for Advanced Molecular Imaging suggests expressing the genes for these pleurotolysins in plants to kill pests (pg 2, paragraph 4).
Because Bing teaches that it is possible to transform plants with multiple constructs that express proteins that interact with each other, one of ordinary skill in the art would have had a reasonable expectation of success in transforming plants with other multiple constructs that express proteins that interact with each other, like those encoding pleurotolysin A and B.
The resulting plants would be inherently protected against pests, including those of the family Chrysomelidae, insects, including larvae, imagos, those the genus Leptinotarsa, including Leptinotarsa decemlineata, and those the genus Diabrotica, including Diabrotica virgifera virgifera.
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under 35 U.S.C. 103(a) as being unpatentable over Bing et al in view of Lukoyanova et al, Sakurai et al, Sakurai et al, and Centre for Advanced Molecular Imaging as applied to claims 1-4, 6-16 and 18-20 above, and further in view of Ota et al (2013, Biochimie 95:1855-1864, including supplemental material).
The claims are drawn to a method comprising expressing an ostreolysin, including one with 95% identity to SEQ ID NO:1, and a pleurotolysin B with 95%-100% identity to SEQ ID NO:4 in a plant.
The teachings of Bing et al in view of Lukoyanova et al, Sakurai et al, Sakurai et al, and Centre for Advanced Molecular Imaging are discussed above. Bing et al in view of Lukoyanova et al, Sakurai et al, Sakurai et al, and Centre for Advanced Molecular Imaging do not teach use of a nucleic acid encoding ostreolysin.
Ota et al teach an ostreolysin with 100% identity to SEQ ID NO:1 (Figure S3):
ID OLYA6_PLEOS Reviewed; 138 AA.
AC P83467; M4QNV2;
DT 01-NOV-2002, integrated into UniProtKB/Swiss-Prot.
DT 16-OCT-2013, sequence version 2.
DT 23-FEB-2022, entry version 43.
DE RecName: Full=Ostreolysin A6;
GN Name=OlyA6;
OS Pleurotus ostreatus (Oyster mushroom) (White-rot fungus).
OC Eukaryota; Fungi; Dikarya; Basidiomycota; Agaricomycotina; Agaricomycetes;
OC Agaricomycetidae; Agaricales; Pleurotaceae; Pleurotus.
OX NCBI_TaxID=5322;
RN [1]
RP NUCLEOTIDE SEQUENCE [MRNA], AND FUNCTION.
RX PubMed=23806422; DOI=10.1016/j.biochi.2013.06.012;
RA Ota K., Leonardi A., Mikelj M., Skocaj M., Wohlschlager T., Kunzler M.,
RA Aebi M., Narat M., Krizaj I., Anderluh G., Sepcic K., Macek P.;
RT "Membrane cholesterol and sphingomyelin, and ostreolysin A are obligatory
RT for pore-formation by a MACPF/CDC-like pore-forming protein, pleurotolysin
RT B.";
RL Biochimie 95:1855-1864(2013).
RN [2]
RP PROTEIN SEQUENCE OF 2-51, FUNCTION, SUBUNIT, AND DEVELOPMENTAL STAGE.
RC STRAIN=Plo 5; TISSUE=Fruiting body;
RX PubMed=12020804; DOI=10.1016/s0304-4165(02)00190-3;
RA Berne S., Krizaj I., Pohleven F., Turk T., Macek P., Sepcic K.;
RT "Pleurotus and Agrocybe hemolysins, new proteins hypothetically involved in
RT fungal fruiting.";
RL Biochim. Biophys. Acta 1570:153-159(2002).
CC -!- FUNCTION: Has hemolytic activity against bovine erythrocytes at
CC nanomolar concentrations in vitro. Promotes active pleurotolysin B
CC (PlyB)-dependent permeabilization of membranes rich in cholesterol and
CC sphingomyelin. May play an important role in the initial phase of
CC fungal fruiting. {ECO:0000269|PubMed:12020804,
CC ECO:0000269|PubMed:23806422}.
CC -!- SUBUNIT: Monomer. {ECO:0000269|PubMed:12020804}.
CC -!- DEVELOPMENTAL STAGE: Expression begins during formation of the
CC primordia, increases remarkably as the fruiting bodies develop and
CC declines as they mature. {ECO:0000269|PubMed:12020804}.
CC -!- SIMILARITY: Belongs to the aegerolysin family. {ECO:0000305}.
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DR EMBL; KC012711; AGH25589.1; -; mRNA.
DR PDB; 6MYI; X-ray; 1.15 A; A/B/C/D=1-138.
DR PDB; 6MYJ; X-ray; 1.33 A; A/B/C/D=1-138.
DR PDB; 6MYK; X-ray; 1.80 A; A/B/C/D=1-138.
DR PDBsum; 6MYI; -.
DR PDBsum; 6MYJ; -.
DR PDBsum; 6MYK; -.
DR SMR; P83467; -.
DR TCDB; 1.C.119.1.2; the aegerolysin (aegerolysin) family.
DR TCDB; 1.C.97.3.2; the pleurotolysin pore-forming (pleurotolysin) family.
DR VEuPathDB; FungiDB:PLEOSDRAFT_1090164; -.
DR GO; GO:0019836; P:hemolysis by symbiont of host erythrocytes; IEA:InterPro.
DR InterPro; IPR009413; Aegerolysin-typ.
DR Pfam; PF06355; Aegerolysin; 1.
DR PIRSF; PIRSF007951; PIRSF007951; 1.
PE 1: Evidence at protein level;
KW 3D-structure; Cytolysis; Direct protein sequencing; Hemolysis.
FT INIT_MET 1
FT /note="Removed"
FT /evidence="ECO:0000269|PubMed:12020804"
FT CHAIN 2..138
FT /note="Ostreolysin A6"
FT /id="PRO_0000156988"
FT STRAND 6..13
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 15..17
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 19..33
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 36..40
FT /evidence="ECO:0007829|PDB:6MYI"
FT HELIX 43..45
FT /evidence="ECO:0007829|PDB:6MYI"
FT TURN 46..48
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 56..62
FT /evidence="ECO:0007829|PDB:6MYI"
FT TURN 65..68
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 71..78
FT /evidence="ECO:0007829|PDB:6MYI"
FT TURN 80..84
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 86..94
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 96..98
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 102..106
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 112..117
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 122..124
FT /evidence="ECO:0007829|PDB:6MYI"
FT STRAND 127..135
FT /evidence="ECO:0007829|PDB:6MYI"
SQ SEQUENCE 138 AA; 15093 MW; F2A51BD2DC21426A CRC64;
Query Match 100.0%; Score 748; DB 1; Length 138;
Best Local Similarity 100.0%;
Matches 138; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAYAQWVIIIIHNVGSQDVKIKNLKASWGKLHADGDKDAEVSASNYEGKIVKPDEKLQIN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAYAQWVIIIIHNVGSQDVKIKNLKASWGKLHADGDKDAEVSASNYEGKIVKPDEKLQIN 60
Qy 61 ACGRSDAAEGTTGTFDLVDPADGDKQVRHFYWDCPWGSKTNTWTVSGSNTKWMIEYSGQN 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ACGRSDAAEGTTGTFDLVDPADGDKQVRHFYWDCPWGSKTNTWTVSGSNTKWMIEYSGQN 120
Qy 121 LDSGALGTITVDTLKKGN 138
||||||||||||||||||
Db 121 LDSGALGTITVDTLKKGN 138
Ota et al teach that ostreolysin is homologous to pleurotolysin A (pg 1858, left column, paragraph 4) and interacts with pleurotolysin B to form pores (paragraph spanning the columns on pg 1858). Ota et al teach primers used for cloning the ostreolysin gene (Table S1).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to replace the pleurotolysin A in the plants taught by Bing et al in view of Lukoyanova et al, Sakurai et al, Sakurai et al, and Centre for Advanced Molecular Imaging with the ostreolysin described in Ota et al. One of ordinary skill in the art would have been motivated to do so because like pleurotolysin A, ostreolysin forms pores with pleurotolysin B (Ota et al, paragraph spanning the columns on pg 1858). Thus, one of skill in the art would expect that ostreolysin could be substituted for pleurotolysin B in the plants of Centre for Advanced Molecular Imaging and that the plants would still kill or control pests.
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over are rejected under 35 U.S.C. 103(a) as being unpatentable over Bing et al in view of Lukoyanova et al, Sakurai et al, Sakurai et al, and Centre for Advanced Molecular Imaging as applied to claims 1-4, 6-16 and 18-20 above, and further in view of Perlak et al (1993, Plant Mol. Biol. 22:313-321).
The claims are drawn to a method comprising expressing a pleurotolysin A and a pleurotolysin B in a potato plant.
The teachings of Bing et al in view of Lukoyanova et al, Sakurai et al, Sakurai et al, and Centre for Advanced Molecular Imaging are discussed above. Bing et al in view of Lukoyanova et al, Sakurai et al, Sakurai et al, and Centre for Advanced Molecular Imaging do not teach expressing pleurotolysin A and pleurotolysin B in potato.
Perlak et al teach transformation of potato with a nucleic acid encoding CryIIIA (pg 315, left column, paragraph 2, to pg 316, left column, paragraph 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to transform potato plants with nucleic acid encoding pleurotolysin A and pleurotolysin B to make plants like the maize plants taught by Bing et al in view of Lukoyanova et al, Sakurai et al, Sakurai et al, and Centre for Advanced Molecular Imaging. One of ordinary skill in the art would have been motivated to do so because potato is subject pest damage (Perlak et al, pg 313); on of ordinary skill in the art would want to control the damage to reduce growing costs.
The resulting plants would be inherently protected against pests, including herbivorous insects, larvae and imagos, and Colorado potato beetle because the instant specification teaches that these proteins inherently are toxic to the herbivorous pest Colorado potato beetle (I on pg 37).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,049,637 in view of Bing et al (2008, US 7,323,556) and Centre for Advanced Molecular Imaging (2015, https://imagingcoe.org/carnivorous-mushrooms-reveal-human-immune-trick/).
‘637, the parent of the instant application, claims a method of protecting a plant from a plant pest by applying a composition comprising applying to a plant a pleurotolysin B with 95% identity to SEQ ID NO:4 and either an ostreolysin with 95% identity to SEQ ID NO:1 or a pleurotolysin A with 95% identity to SEQ ID NO:2.
‘637 does not claim expressing the protein combinations in a plant.
The teachings of each of Bing et al and Centre for Advanced Molecular Imaging are discussed in the 35 USC 103 rejections above.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to transform nucleic acids encoding pleurotolysin A and B or nucleic acids encoding ostreolysin and pleurotolysin B in a plant using the transformation methods taught in Bing et al. One of ordinary skill in the art would have been motivated to do so because Centre for Advanced Molecular Imaging suggests expressing the genes for these pleurotolysins in plants to kill pests (pg 2, paragraph 4).
Because Bing teaches that it is possible to transform plants with multiple constructs that express proteins that interact with each other, one of ordinary skill in the art would have had a reasonable expectation of success in transforming plants with other multiple constructs that express proteins that interact with each other, like those encoding pleurotolysin A and B or ostreolysin and pleurotolysin B.
Because the claims of ‘637 treat ostreolysin and pleurotolysin A as equivalents, one of ordinary skill in the art would expect plants transformed with constructs encoding ostreolysin and pleurotolysin B to also be protected from insect pests.
The resulting plants would be inherently protected against pests, including those of the family Chrysomelidae, insects, including larvae, imagos, those the genus Leptinotarsa, including Leptinotarsa decemlineata, and those the genus Diabrotica, including Diabrotica virgifera virgifera.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,049,637 in view of Bing et al (2008, US 7,323,556) and Centre for Advanced Molecular Imaging (2015, https://imagingcoe.org/carnivorous-mushrooms-reveal-human-immune-trick/) and further in view of Perlak et al (1993, Plant Mol. Biol. 22:313-321).
What is made obvious by ‘637 in view of Bing et al and Centre for Advanced Molecular Imaging is discussed above. ‘637 in view of Bing et al and Centre for Advanced Molecular Imaging alone do not make obvious expressing the proteins in potato.
Perlak et al teach transformation of potato with a nucleic acid encoding CryIIIA (pg 315, left column, paragraph 2, to pg 316, left column, paragraph 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to transform potato plants with nucleic acid encoding pleurotolysin A and pleurotolysin B or ostreolysin and pleurotolysin B. One of ordinary skill in the art would have been motivated to do so because potato is subject to pest damage (Perlak et al, pg 313); on of ordinary skill in the art would want to control the damage to reduce growing costs.
The resulting plants would be inherently protected against pests, including herbivorous insects, larvae and imagos, and Colorado potato beetle because the instant specification teaches that these proteins inherently are toxic to the herbivorous pest Colorado potato beetle (I on pg 37).
Conclusion
No claim is allowed.
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/Anne Kubelik/Primary Examiner, Art Unit 1663