Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving oxidoreductase
Reexamination Certificate
2000-10-27
2004-05-04
Warden, Jill (Department: 1744)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving oxidoreductase
C422S051000, C422S051000, C422S067000, C422S068100, C436S132000, C206S204000, C206S456000
Reexamination Certificate
active
06730494
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to alcohol concentration assay test systems, including compositions and methods for storing multiple alcohol concentration assay tests and compositions and methods for measuring the concentration of alcohol in a sample.
BACKGROUND OF THE INVENTION
Automobile crashes caused by individuals who are impaired by alcohol are a significant social and economic problem. Many individuals, some of whom may have had only a few drinks, drive impaired because they physically feel fine. Many of these drivers-do not know that their bodies have absorbed enough alcohol to increase their risk of getting into a crash.
If impaired individuals had an easy and safe way to check how much alcohol their bodies had absorbed prior to operating a motor vehicle instead of relying on how they physically felt, many would change their decision to drive and crashes would be prevented. There is much need for an assay test that would allow impaired individuals to check their alcohol concentration and determine their capacity to safely operate a motor vehicle.
There are many devices that test individuals' alcohol concentration that are available in the marketplace today. However, many of these devices are too complex or expensive for use by individuals outside of a laboratory or clinical setting. Additionally, many individuals have an aversion to blood and urine testing and would not be willing to self-administer such assay tests. Inexpensive breath assay tests are available as a less invasive alternative to blood and urine based assay tests. However, inexpensive breath assay tests are much less accurate than blood-based assay tests, the standard for which all alcohol assay tests are compared, and many are difficult to use. Saliva alcohol concentration assay tests, which exhibit a strong, direct correlation to blood alcohol concentration assay tests, are an inexpensive and less invasive alternative to blood and urine-based assay tests and some are proven to be accurate. However, saliva assay tests that adequately combine ease of use, small size, speed, accuracy, low cost, durability (e.g., temperature stability and shelf life), safety and interpretability, and that are designed for widespread distribution and use are not available. Furthermore, delivery systems for packaging, storing, carrying, preserving, and otherwise maintaining alcohol tests are not available so as to provide adequate ease of use, discrete use, accessibility, and durability of tests. This is readily apparent from the lack of widespread use of such tests. Although some assay tests meet some of the desired characteristics, no assay test meets enough of the criteria to facilitate widespread use for self-detection of alcohol concentration.
SUMMARY OF THE INVENTION
The present invention relates to alcohol concentration assay test systems, including compositions and methods for storing multiple alcohol concentration assay tests and compositions and methods for measuring the concentration of alcohol in a sample (e.g., a biological sample).
For example, the present invention provides a system comprising an assay for analyzing a sample for the presence of ethanol, said system comprising one or more alcohol concentration assay tests, a delivery system, and a desiccant. In preferred embodiments, the desiccant is provided as a desiccant entrained polymer storage container. However, in some embodiments, the desiccant is provided on or in the test assay itself. In some embodiments, the delivery systems contains a plurality of alcohol concentration assays tests (e.g., 2, 3, 4, 5, . . . 100, . . . ). In some preferred embodiments, the alcohol concentration assays tests comprises test strips. While the test strips are not limited to any particular size, in preferred embodiments, the test strips have a thickness of 0.5 millimeters or less, a length of 6.5 centimeters or less, and a width of 5 millimeters or less. In preferred embodiments, the alcohol concentration assays tests are stable in the desiccant entrained polymer storage container for at least one month, preferably for at least six months, more preferably for at least one year, and most preferably for at least two years.
In some embodiments of the present invention, assay tests are provided for the detection of any analyte from any sample type, wherein the assay test contains a desiccant (e.g., an entrained desiccant) directly associated with the assay test. This is in contrast to available systems where desiccants are provided in storage containers. In these embodiments of the present invention the desiccant is provided on the assay test so that the assay test provides its own desiccation, regardless of the environment it is in (e.g., regardless of whether it is in a container containing a desiccant). The desiccant is associated with the test assay using any suitable means and in any configuration. For example, where the test assay comprises a test strip, the desiccant can be provided on or in the material comprising the strip portion of the test strip or on or in the handle portion. The desiccant containing assay tests are amenable to movement from one container to another. The desiccant containing assay tests may be stored in any type of container, regardless of whether the containers contain a desiccant or not (e.g., the assay tests may be stored in foil or polymer protective enclosure with or without desiccant materials in the enclosure).
In some embodiments, the desiccant entrained storage container further comprises one or more protective storage compartments capable of enclosing one or more alcohol concentration assay tests in each of the one or more compartments. In further embodiments, the container comprises a cap connected to the container by a hinge wherein the lid can be closed to form an air tight seal. While the container can be of any desired size, in preferred embodiments, the container has a thickness of 5 millimeters or less (preferrably 2-3 millimeters or less), a height of 8 cm or less (preferrably 5 cm or less), and a diameter of 5 cm or less (preferrably 2.5 cm or less). The delivery system may also be of any desired shape including, but not limited to, circular, oval, and polygonal (e.g., trigonal, pentagonal, hexagonal, etc.).
In some embodiments, the desiccant entrained storage container is made of functional polymers comprising an anhydride, an amine, an acid, a cyanate, an isocyanate, or an hydroxy functionalized polymer. In preferred embodiments, the polymer comprises propylene maleic anhydride, polyethylene maleic anhydride (anydride), polyethylene acrylic acid, polyethylene-urethane, polyethylene-EVOH, polyethylene nylon, or polyamide. In some preferred embodiments, the polymer comprises a channeling agent. In some embodiments, the channeling agent comprises a polar compound having one or more hydroxy groups. In particularly preferred embodiments, the channeling agent comprises polyethylene glycol, polypropylene glycol, ethylene vinyl alcohol, polyvinyl alcohol, or glycerin.
In some embodiments, the delivery system does not contain a desiccant. For example, in some embodiments the alcohol tests are stored in a sealed, air-tight container in a low moisture environment (e.g., in a sealed flat foil container). In some embodiments, the desiccant is provided on the assay tests themselves. In some embodiments the desiccant is not entrained.
The present invention also provides a system comprising a plurality of test assays for analyzing a sample for the presence of ethanol, the system comprising a plurality of alcohol concentration assay tests within a delivery system, said delivery system preventing the alcohol concentration assay tests from being exposed to the environment wherein the delivery system is configured to dispense the plurality of alcohol concentration assay tests individually (e.g., one at a time). In some embodiments, the delivery system is configured to dispense the plurality of alcohol concentration assay tests individually without exposing the remaining alcohol concentration assay tests (i.e. the tes
Miller Brett
Singer Evan
Toranto Anthony
Cross LaToya J.
Guardian Angel Holdings, Inc.
Medlen & Carroll LLP
Warden Jill
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