Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
2001-08-30
2004-01-27
Swartz, Rodney P (Department: 1645)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S007100, C435S007200, C435S007210, C435S007300, C435S007310, C435S007500, C435S007930, C435S007940, C435S007950, C530S300000, C530S350000
Reexamination Certificate
active
06682894
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a novel method to detect epsilon immunoglobulin (IgE). The present invention also includes novel kits to detect IgE as well as methods to produce the detection reagent.
BACKGROUND OF THE INVENTION
Diagnosis of disease and determination of treatment efficacy are important tools in medicine. In particular, detection of IgE production in an animal can be indicative of disease. Such diseases include, for example, allergy, atopic disease, hyper IgE syndrome, internal parasite infections and B cell neoplasia. In addition, detection of IgE production in an animal following a treatment is indicative of the efficacy of the treatment, such as when using treatments intended to disrupt IgE production.
Until the discovery of the present invention, detection of IgE in samples obtained from non-human animals has been hindered by the absence of suitable reagents for detection of IgE. Various compounds have been used to detect IgE in IgE-containing compositions. In particular, antibodies that bind selectively to epsilon idiotype antibodies (i.e., anti-IgE antibodies) have been used to detect IgE. These anti-IgE antibodies, however, can cross-react with other antibody idiotypes, such as gamma isotype antibodies. The discovery of the present invention includes the use of a Fc epsilon receptor (Fc
&egr;
R) molecule to detect the presence of IgE in a putative IgE-containing composition. A Fc
&egr;
R molecule provides an advantage over, for example anti-IgE antibodies, to detect IgE because a Fc
&egr;
R molecule can bind to an IgE with more specificity (i.e., less idiotype cross-reactivity) and more sensitivity (i.e., affinity) than anti-IgE binding antibodies.
Lowenthal et al., 1993,
Annals of Allergy
71:481-484, dog serum can transfer cutaneous reactivity to a human. While it is possible that Lowenthal et al. properly teach the binding of human Fc
&egr;
R to canine IgE. Lowenthal et al., however, do not provide data defining the particular cellular proteins responsible for the transfer of cutaneous reactivity. As such, a skilled artisan would conclude that the transfer of cutaneous reactivity taught by Lowenthal et al. could be due to a variety of different molecular interactions and that the conclusion drawn by Lowenthal et al. is merely an interpretation. In addition, Lowenthal et al. do not teach the use of purified human Fc
&egr;
R to detect canine IgE. The subunits of human Fc
&egr;
R have been known as early as 1988 and have never been used to detect canine, feline or equine IgE. Indeed, U.S. Pat. No. 4,962,035, to Leder et al., issued Oct. 9, 1990, discloses human Fc
&egr;
R but does not disclose the use of such a human Fc
&egr;
R to detect human or non-human IgE. The use of purified human Fc
&egr;
R avoids complications presented by use of Fc
&egr;
R bound to a cell, such as non-specific binding of the Fc
&egr;
R-bearing cell due to additional molecules present on the cell membrane. That purified human Fc
&egr;
R detects non-human IgE is unexpected because inter-species binding between a Fc
&egr;
R and an IgE is not predictable. For example, human Fc
&egr;
R binds to rat IgE but rat Fc
&egr;
R does not bind to human IgE.
The high affinity Fc
&egr;
R consists of three protein chains, alpha, beta and gamma. Prior investigators have disclosed the nucleic acid sequence for: the alpha chain (Kochan et al.,
Nucleic Acids Res.
16:3584, 1988; Shimizu et al.,
Proc. Natl. Acad. Sci. USA
85:1907-1911, 1988; and Pang et al.,
J. Immunol.
151:6166-6174, 1993); the beta chain (Kuster et al.,
J. Biol. Chem.
267:12782-12787, 1992); and the gamma chain (Kuster et al.,
J. Biol. Chem.
265:6448-6452, 1990).
Thus, methods and kits are needed in the art that will provide specific detection of non-human IgE.
SUMMARY OF THE INVENTION
The present invention includes detection methods and kits that detect IgE. One embodiment of the present invention is a method to detect IgE comprising: (a) contacting an isolated human Fc
&egr;
receptor (Fc
&egr;
R) molecule with a putative IgE-containing composition under conditions suitable for formation of a Fc
&egr;
R molecule:IgE complex, wherein the IgE is selected from the group consisting of canine IgE, feline IgE and equine IgE; and (b) determining the presence of IgE by detecting the Fc
&egr;
R molecule:IgE complex, the presence of the Fc
&egr;
R molecule:IgE complex indicating the presence of IgE. A preferred Fc
&egr;
R molecule in which a carbohydrate group of the Fc
&egr;
R molecule is conjugated to biotin.
Another embodiment of the present invention is a method to detect IgE comprising: (a) contacting a recombinant cell with a putative IgE-containing composition under conditions suitable for formation of a recombinant cell:IgE complex, in which the recombinant cell includes: a recombinant cell expressing a human Fc
&egr;
R molecule; and a recombinant cell expressing an antibody that binds selectively to an IgE including canine IgE, feline IgE and equine IgE; and (b) determining the presence of IgE by detecting the recombinant cell:IgE complex, the presence of the recombinant cell:IgE complex indicating the presence of IgE. A preferred recombinant cell includes a RBL-hFc
&egr;
R cell.
Another embodiment of the present invention is a method to detect flea allergy dermatitis comprising: (a) immobilizing a flea allergen on a substrate; (b) contacting the flea allergen with a putative IgE-containing composition under conditions suitable for formation of an antigen:IgE complex bound to said substrate; (c) removing non-bound material from the substrate under conditions that retain antigen:IgE complex binding to the substrate; and (c) detecting the presence of the antigen:IgE complex by contacting the antigen:IgE complex with a Fc
&egr;
R molecule. Preferably, the flea allergen is a flea saliva antigen and more preferably flea saliva products and/or flea saliva proteins.
The present invention also includes a kit for performing methods of the present invention. One embodiment is a kit for detecting IgE comprising a human Fc
&egr;
receptor (Fc
&egr;
R) molecule and a means for detecting an IgE including canine IgE, feline IgE and equine IgE. Another embodiment is a general allergen kit comprising an allergen common to all regions of the United States and a human Fc
&egr;
receptor (Fc
&egr;
R) molecule. Another embodiment is a kit for detecting flea allergy dermatitis comprising a human Fc
&egr;
receptor (Fc
&egr;
R) molecule and a flea allergen.
Another embodiment of the present invention is an isolated human Fc
&egr;
receptor (Fc
&egr;
R) alpha chain protein, in which a carbohydrate group of the Fc
&egr;
R alpha chain protein is conjugated to biotin. A preferred Fc
&egr;
R alpha chain protein comprises PhFc
&egr;
R&agr;
172
-BIOT.
REFERENCES:
patent: 4962035 (1990-10-01), Leder et al.
patent: 5113443 (1993-05-01), None
patent: WO 90/04640 (1990-05-01), None
patent: WO 91/06570 (1991-05-01), None
patent: WO 97/24617 (1997-07-01), None
Kochan, et al., (1988)Nucleic Acids Res. 16(8), p. 3584.
Küster, et al., (1990)J. Biol. Chem. 265(11), pp. 6448-6452.
Küster, et al., (1992)J. Biol. Chem. 267(18), pp. 12782-12787.
Lowenthal, et al., (1993)Annals of Allergy 71,pp. 481-484.
Pang, et al., “Characterization of the Gene for the Human High Affinity IgE Receptor (Fc&egr;RI) &agr;-Chain,” (1993)J. Immunol. 151(11), pp. 6166-6174.
Shimizu, et al., (1988),Proc. Natl. Acad. Sci. USA(85), pp. 1907-1911.
Patent Abstract of Japan, vol. 095, No. 007, Aug. 31, 1995 and JP 07 092167 A (Kinki Univ;; Others: 01), Apr. 7, 1995.
Patent Abstract of Japan, vol. 095, No. 006, Jul. 31, 1995 and JP 07 072150 A (Tonen Corp.; Others: 01), Mar. 7, 1995.
Frank Glenn R.
Porter James P.
Rushlow Keith E.
Wassom Donald L.
Heska Corporation
Heska Corporation
Swartz Rodney P
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