Chemistry: analytical and immunological testing – Food or dairy products
Reexamination Certificate
1998-11-13
2001-05-15
Snay, Jeffrey (Department: 1743)
Chemistry: analytical and immunological testing
Food or dairy products
C436S024000, C436S172000
Reexamination Certificate
active
06232124
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention is in the general field of methods, reagents, and apparatus for authenticating or monitoring sample composition.
Authenticating and monitoring products to discriminate between very similar complex mixtures is useful for various reasons. First, the use of counterfeit substances (e.g., misbranded material from a competitor or misformulated material from a licensee/franchisee) should be detected to preserve the integrity of a brand.
Characteristics of a product can be used to identify its lot. Similar methods can be used in quality control tests. Also, product counterfeiting raises serious health and safety issues. In 1995, a counterfeit-labeled version of infant formula reportedly was distributed to 15 states in the continental United States. Counterfeit wine, spirits, perfume, infant formula, soft drinks, cosmetics, and pharmaceuticals are estimated to cost United States businesses 200 billion dollars per year (“The Boston Phoenix,” Section One, Dec., 2, 1994).
It is important to develop rapid, cost effective, and enforceable methods to identify fraudulent or tampered products. It is also important to determine manufacturing compliance using automated methods to decrease the amount of time spent identifying fraudulent products. It is desirable to minimize the time required from highly skilled researchers and technicians to conduct and record the results of on-line, off-line, and off-the-shelf product authenticity/compliance tests.
There have been attempts to determine product (e.g., infant formula) authenticity by protein electrophoresis, which requires substantial time (and expense) for set up and analysis. In other industries, e.g. wine and spirits, Fourier-transform infrared analysis, gas chromatography, pH, Raman spectroscopy and other analytical methods have been used or proposed for product authentication (Constant et al., Differentiation of Alcoholic Beverages FT-IR Spectra. An Original Multivariate Approach, ACS Abstract presented at 208th ACS National Meeting, Aug. 25, 1994, published in the Issue of Chemical and Engineering News, 10 1994).
Biocode, Limited has used fluorescent labeled antibodies to determine ingredients in products.
U.S. Pat. No. 5,429,952 discloses adding light-emissive chemicals to a product for analysis, as exogenous product tags which do not ordinarily form part of the product.
The use of standard analytical methods to monitor every lot or batch for a product or competitor product for authenticity or compliance with laboratory equipment can often be costly.
SUMMARY OF THE INVENTION
I have discovered an automated method of developing a database to store information for “fingerprint”-type analysis of products (even as to product lot numbers and batch). The automated analysis is a method of evaluating and discriminating products, even within a narrow field or industry, competing and otherwise, e.g., to establish authenticity or point of origin of the product. The invention relates to a method for identifying analytes such as key ingredients and/or the relative amounts of analytes such as key ingredients in products. The method allows for authenticating and monitoring products for fraud and quality control using light emission. The invention also relates to light-emissive-compounds (e.g., including one or more light emissive compounds) which can be used to identify and quantitate the relative amounts of analytes in products.
In general, the methods pertain to obtaining an emission profile of a sample. An “emission profile”, as used herein, refers to data collected relating to emission, for example, emission intensity or time of emission. The data collected for the emission profile can be expressed in relative terms, e.g. relative emission intensity or time of relative emission, when data for the sample and a standard and/or a control are compared.
In one aspect, the invention features a method for determining relatedness of a sample to a standard known to be authentic or known to have at least one selected characteristic of authentic material. The method includes: a) providing a mixture of sample and least one light-emissive compound (“LEC”); (b) irradiating the sample mixture with an irradiating wavelength of light; (c) monitoring at least one emitted wavelength of light (generated in response to the irradiating) to establish a sample emission profile; and (d) providing a standard fingerprint characteristic of a standard mixture; and (e) comparing the sample emission profile with the standard fingerprint to determine whether the sample is authentic. The standard mixture includes the standard and the light-emissive compound. The standard fingerprint is generated by irradiating several of the standard mixture with the irradiating wavelength and monitoring the emitted wavelength in response thereto.
In preferred embodiments, two and preferably three or more light-emissive compounds are employed, and a fingerprint profile of several light-emissive compounds is compared to the corresponding emission intensities for the sample. Most preferably, the light-emissive compounds emit light at nonoverlapping wave lengths, whereby multiple compounds can be added to the sample and/or standard at the same time.
In preferred embodiments, the method further includes: providing a background control mixture which includes the light-emissive compound without the sample or the standard; irradiating the background control mixture with the irradiating wavelength and monitoring the emitted wavelength in response thereto, to establish background emission; and determining the emission profile of the sample based on at least one difference between the emission of the control mixture and the emission of the sample mixture. It is preferred that the standard be a composition having a predetermined relative amount of a component characteristic of authentic material. The sample fingerprint is generated based on a first change in emission, determined by comparing the background emission and the emission from the sample mixture. The standard fingerprint is generated based on a second change in emissions, determined by comparing the background emission and the standard emission for each measurement. The comparing step includes comparing the first change in emission to the background adjusted fingerprint, e.g., to quantify relative amounts of sample component.
In another aspect of the invention, a method is provided for determining whether a product is authentic. A liquid sample of a test product is obtained and a light emissive compound then is added to the liquid sample to form a test sample. The light emissive compound interacts with an analyte of the product. The test sample is irradiated, and the intensity of light emitted from the test sample at a wavelength is determined. The intensity of light emitted from the test sample at this wavelength then is compared to the intensity of light emitted at the wavelength as a result of irradiating a mixture of the light emitting compound and an authentic liquid standard of the product, wherein similarity of light emission intensity is determinative of authenticity of the sample and this similarity of light emission intensity is determinative of nonauthenticity of the sample. In one important embodiment, the intensity of light emitted from the test sample is compared to the intensity of light emitted from a plurality of the mixture, and wherein authenticity requires the intensity of light emitted from the test sample to be within a pre-selected confidence limit defining a range of intensity calculated from the intensity of light emitted from the plurality of said mixture. The plurality of said mixture is at least four standards containing a mixture of the light emitting compound and an authentic liquid standard of the product, and preferably is four such mixtures.
In certain of the foregoing embodiments, the chemical composition of the product is unknown. In other of the embodiments, the chemical structure of the analyte to which the light emitting compound binds is unknown. In still other embodimen
Snay Jeffrey
Verification Technologies, Inc.
Wolf Greenfield & Sacks P.C.
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