Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
2000-04-21
2002-07-09
Graser, Jennifer E. (Department: 1645)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S004000, C435S040500, C435S040520, C436S506000, C436S507000
Reexamination Certificate
active
06416955
ABSTRACT:
BACKGROUND
1. Technical Field
The invention relates to methods and materials involved in the diagnosis of eosinophil degranulating conditions.
2. Background Information
Mucositis, the inflammation of mucosal tissue, is a serious medical problem that affects millions of people worldwide. For example, conservative estimates indicate that between 20 to 40 million Americans suffer from chronic rhinosinusitis, an inflammation of the nasal cavity and/or paranasal sinuses. In addition, chronic rhinosinusitis has been estimated to account for up to 90 percent of all cases of rhinosinusitis with acute rhinosinusitis (e.g., allergic rhinitis) accounting for the remaining 10 percent. While it is known that large numbers of eosinophils infiltrate the nasal tissue in patients with chronic rhinosinusitis as well as in patients with allergic rhinitis, the pathophysiology of these and other mucositis conditions remains unknown.
SUMMARY
The invention involves methods and materials related to the diagnosis of eosinophil degranulating conditions. Specifically, the invention provides methods that allow clinicians to determine whether or not a patient has an eosinophil degranulating condition. These methods involve visual types of analysis (e.g., microscopic analysis) that are used to determine the presence or absence of a horseshoe-shaped eosinophil granule structure within a mucus sample collected from a mammal. The presence of a horseshoe-shaped eosinophil granule structure within a patient's mucus indicates that the patient has an eosinophil degranulating condition. In addition, the invention provides methods that involve immunological types of analysis (e.g., immunoassays) that are used to determine if a patient's mucus contains a tissue-damaging amount of eosinophil granule content that is outside the eosinophil granule and within the mucus. Like the presence of a horseshoe-shaped eosinophil granule structure, the presence of a tissue-damaging amount of eosinophil granule content outside the eosinophil granule and within the mucus indicates that the patient has an eosinophil degranulating condition. The invention also provides diagnostic kits that allow clinicians to determine whether or not a patient has an eosinophil degranulating condition. Specifically, these kits contain a mucus collecting device and a fixative such that mucus samples can be analyzed microscopically. In addition, kits are provided that contain a binding reagent (e.g., an antibody) having binding specificity for an eosinophil granule molecule and a mucus collecting device. Additionally, kits are provided that contain a binding reagent having binding specificity for an eosinophil granule molecule and a mucolytic agent.
In one aspect, the invention features a method for diagnosing an eosinophil degranulating condition within mucus of a patient. The method includes providing a mucus sample from the patient, and determining whether or not the sample contains a horseshoe-shaped eosinophil granule structure. The presence of the structure indicates that the patient has the eosinophil degranulating condition. The condition can be a non-invasive fungus-induced mucositis condition such as non-invasive fungus-induced rhinosinusitis, non-invasive fungus-induced otitis media, and/or non-invasive fungus-induced bowel disease. The condition can be an asthma condition such as an asthma condition that is responsive to antifungal treatment. The condition can be chronic, and the patient can be a human or some other mammalian species (e.g., dog, cat, horse, etc.). The sample can include nasal mucus, middle ear mucus, bowel mucus, and/or sputum. The determining step can include microscopic analysis (e.g., electron microscopy).
In another embodiment, the invention features a method for diagnosing an eosinophil degranulating condition within mucus of a patient. The method includes providing a sample of mucus from the patient, and examining the sample to determine if mucus of the patient contains a tissue-damaging amount of eosinophil granule content that is outside the eosinophil granule. The tissue-damaging amount of the content outside the granule indicates that the patient has the eosinophil degranulating condition. The condition can be a non-invasive fungus-induced mucositis condition such as non-invasive fungus-induced rhinosinusitis, non-invasive fungus-induced otitis media, and/or non-invasive fungus-induced bowel disease. The condition can be an asthma condition such as an asthma condition that is responsive to antifungal treatment. The condition can be chronic, and the patient can be a human or some other mammalian species (e.g., dog, cat, horse, etc.). The sample can include nasal mucus, middle ear mucus, bowel mucus, and/or sputum. The content can contain major basic protein. The determining step can include an immunological analysis. For example, the immunological analysis can include (a) contacting the sample with a capture antibody to form a molecule-antibody complex where the content contains a molecule, and the capture antibody has specificity for the molecule, (b) determining the amount of the complex, where the amount of the complex indicates the amount of the content outside the granule, and (c) determining if the amount of the content outside the granule is the tissue-damaging amount.
In another aspect, the invention features a diagnostic kit containing an antibody and a mucolytic agent (e.g., N-acetyl-L-cysteine, dithiotlireitol, and recombinant human DNase). The antibody has specificity for a molecule from an eosinophil granule. The molecule can be major basic protein.
In another embodiment, the invention features a diagnostic kit containing an antibody and a mucus collector. The antibody has specificity for a molecule from an eosinophil granule. The molecule can be major basic protein. The mucus collector can be a brush, spatula, forceps, suction device, and/or suction bulb.
Another embodiment of the invention features a diagnostic kit containing a mucus collector, fixative, and instructions. The instructions indicate that the mucus collector is used to collect a sample of mucus from a patient, and that the fixative is used to fix the sample such that the sample can be examined to determine whether or not the patient has an eosinophil degranulating condition within mucus. The fixative can include Trump's fixative. The mucus collector can be a brush, spatula, forceps, suction device, and/or suction bulb.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
Other features and advantages of the invention will be apparent from the following detailed description, and from the claims.
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Lusk,Otolaryngology Head Neck Surger
Kern Eugene
Kita Hirohito
Ponikau Jens
Sherris David
Fish & Richardson P.C. P.A.
Graser Jennifer E.
Mayo Foundation for Medical Education and Research
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