Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2000-11-03
2004-02-10
Bugaisky, Gabriele (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C530S350000, C536S023710, C424S094400
Reexamination Certificate
active
06689743
ABSTRACT:
BACKGROUND OF THE INVENTION
The soil microbe
Bacillus thuringiensis
(
B.t
.) is a Gram-positive, spore-forming bacterium characterized by parasporal crystalline protein inclusions. These inclusions often appear microscopically as distinctively shaped crystals. The proteins can be highly toxic to pests and specific in their toxic activity. Certain
B.t
. toxin genes have been isolated and sequenced, and recombinant DNA-based
B.t
. products have been produced and approved for use. In addition, with the use of genetic engineering techniques, new approaches for delivering
B.t
. endotoxins to agricultural environments are under development, including the use of plants genetically engineered with endotoxin genes for insect resistance and the use of stabilized intact microbial cells as
B.t
. endotoxin delivery vehicles (Gaertner, F. H., L. Kim [1988
] TIBTECH
6: S4-S7). Thus, isolated
B.t
. endotoxin genes are becoming commercially valuable.
Until the last ten years, commercial use of
B.t
. pesticides has been largely restricted to a narrow range of lepidopteran (caterpillar) pests. Preparations of the spores and crystals of
B. thuringiensis
subsp.
kurstaki
have been used for many years as commercial insecticides for lepidopteran pests. For example,
B. thuringiensis
var.
kurstaki
HD-1 produces a crystal called a &dgr;-endotoxin which is toxic to the larvae of a number of lepidopteran insects.
In recent years, however, investigators have discovered
B.t
. pesticides with specificities for a much broader range of pests. For example, other species of
B.t
., namely israelensis and tenebrionis (a.k.a.
B.t
. M-7, a.k.a.
B.t
. san diego), have been used commercially to control insects of the orders Diptera and Coleoptera, respectively (Gaertner, F. H. [1989] “Cellular Delivery Systems for Insecticidal Proteins: Living and Non-Living Microorganisms,” in
Controlled Delivery of Crop Protection Agents
, R. M. Wilkins, ed., Taylor and Francis, New York and London, 1990, pp. 245-255). See also Couch, T. L. (1980) “Mosquito Pathogenicity of
Bacillus thuringiensis
var. israelensis,”
Developments in Industrial Microbiology
22: 61-76; Beegle, C. C., (1978) “Use of Entomogenous Bacteria in Agroecosystems,”
Developments in Industrial Microbiology
20: 97-104. Krieg, A., A. M. Huger, G. A. Langenbruch, W. Schnetter (1983) Z. ang. Ent. 96: 500-508, describe
Bacillus thuringiensis
var.
tenebrionis
, which is reportedly active against two beetles in the order Coleoptera. These are the Colorado potato beetle,
Leptinotarsa decemlineata
, and
Agelastica alni.
Recently, new subspecies of
B.t
. have been identified, and genes responsible for active &dgr;-endotoxin proteins have been isolated (Höfte, H., H. R. Whiteley [1989
] Microbiological Reviews
52(2): 242-255). Höfte and Whiteley classified
B.t
. crystal protein genes into 4 major classes. The classes were CryI (Lepidoptera-specific), CryII (Lepidoptera- and Diptera-specific), CryIII (Coleoptera-specific), and CryIV (Diptera-specific). The discovery of strains specifically toxic to other pests has been reported. (Feitelson, J. S., J. Payne, L. Kim [1992
] Bio/Technology
10: 271-275).
The cloning and expression of a
B.t
. crystal protein gene in
Escherichia coli
has been described in the published literature (Schnepf, H. E., H. R. Whitely [1981
] Proc. Natl. Acad. Sci. USA
78: 2893-2897). U.S. Pat. No. 4,448,885 and U.S. Pat. No. 4,467,036 both disclose the expression of
B.t
. crystal protein in
E. coli
. U.S. Pat. Nos. 4,797,276 and 4,853,331 disclose
B. thuringiensis
strain san diego (a.k.a.
B.t. tenebrionis
, a.k.a. M-7) which can be used to control coleopteran pests in various environments. U.S. Pat. No. 4,918,006 discloses
B.t
. toxins having activity against Dipterans. U.S. Pat. No. 4,849,217 discloses
B.t
. isolates which have activity against the alfalfa weevil. U.S. Pat. No. 5,151,363 and U.S. Pat. No. 4,948,734 disclose certain isolates of
B.t
. which have activity against nematodes. As a result of extensive research and investment of resources, other patents have issued for new
B.t
. isolates and new uses of
B.t
. isolates. However, the discovery of new
B.t
. isolates and new uses of known
B.t
. isolates remains an empirical, unpredictable art.
Dipteran insects are serious nuisances as well as being vectors of many human and animal diseases such as malaria, onchocerciasis, equine encephalitis, and dog heartworm. The activity spectrum of
B.t
. &dgr;-endotoxins to insects of the order Diptera includes activity against mosquitoes as well as black flies. See Couch, supra; Beegle, supra.
The two varieties of
B.t
. known to kill mosquitoes and blackflies are
B.t. israelensis
(
B.t.i
.) (Goldberg, L. J., J. Margalit [1977
] Mosquito News
37: 355-358) and
B.t. morrisoni
(
B.t.m
.) (Padua, L. E., M. Ohba, K. Aizawa [1984
] J. Invertebrate Pathology
44: 12-17). These
B.t
. are not harmful to non-target organisms (Mulla, M. S., B. A. Federici, H. A. Darwazeh [1982
] Environmental Entomology
11: 788-795), and play an important role in the integrated management of dipteran pests. They are safe to use in urban areas, and can be used in aquatic environments without harm to other species.
Dipteran pests are also a major problem in the poultry and cattle industries. The horn fly, a serious cattle pest, is killed by
B.t
. in the larval stages (Temeyer, K. B. [1990] “Potential of
Bacillus thuringiensis
for fly control,”
Fifth International Colloquium on Invertebrate Pathology and Microbial Control, Society for Invertebrate Pathology
, 352-356). European Patent Application 90307204.9 (Publication No. 0 409 438) discloses
Bacillus thuringiensis
dipteran-active isolates PS71M3 and PSI23D1.
Flies are an abundant species that can be found almost everywhere. They usually occur in such large numbers as to constitute a nuisance. The majority of the Diptera are considered pests and are of economic importance. A number of adult species are blood-sucking and cause irritation to man and domestic animals. Others are scavenging flies that mechanically transmit organisms and pathogens that contaminate food. Both types of flies are important vectors of disease, such as malaria, yellow fever, filariasis, sleeping sickness, typhoid fever, and dysentery. Larvae of a few species are pests of major agriculture crops. The larvae can feed on all parts of the plant such as seeds, roots, leaves and fruits. Larvae of certain species feed on fungus causing damage to mushroom production. Larvae can irritate domestic animals when they develop in the animal. Both the adults and larval forms of dipterans are considered pests to man and in agriculture.
House flies (family Muscidae) are an important pest from the order Diptera. They are considered a nuisance and are vectors of human and animal diseases. Their habits of walking and feeding on garbage and excrement and on the human person and food make them ideal agents for the transfer of disease (Metcalf, C. and Flint, W. 1962
. Destructive and Useful Insects
, McGraw-Hill Book Co., NY, pp. 1030-1035). House flies are also a pest to animals and transmit disease through open wounds. The family Muscidae also includes the little house fly, face fly, stable fly, and horn fly, all of which are pests of livestock. These species are pests of cattle, poultry, horses and other types of livestock. They breed in manure and decaying straw located near the animals. The horn and stable flies are biting flies which cause stress to dairy cattle reducing milk production. The family Muscidae is considered an economic problem domestically and worldwide.
Leafmining flies cause damage and yield loss to economically important crops such as potatoes, tomatoes and celery. Dipteran leafminers are also considered a major pest in the ornamental flower industry (Parrella, M. P. [1987] “Biology of Liriomyza,”
Ann. Rev. Entomol
. 32: 201-224). The most common leafminers are found in the family Agromyzidae althou
Michaels Tracy Ellis
Narva Kenneth E.
Payne Jewel
Stalder Christine Julie
Uyeda Kendrick Akira
Bugaisky Gabriele
Mycogen Corporation
Saliwanchik Lloyd & Saliwanchik
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