Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
1997-04-18
2001-04-10
Housel, James C. (Department: 1641)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S005000, C435S006120, C435S007400, C435S007920, C435S007210, C435S007950, C436S500000, C436S510000, C436S517000, C436S518000, C436S525000, C436S527000, C422S050000, C422S051000, C422S073000, C422S082050, C422S082060, C422S082070, C536S024300, C536S024320, C536S024330
Reexamination Certificate
active
06214560
ABSTRACT:
BACKGROUND OF THE INVENTION
The following is an outline of relevant existing detection methods. It is also a summary of relevant science to aid the reader in understanding the details of the claimed invention. It should not be taken as an admission that any of the cited art is prior art to the claims. The cited art is hereby incorporated herein by reference so that the general procedures and methods in that art that are of use to practice of the present invention need not be rewritten herein. In particular, applicant incorporates those sections related to general methods of “binding-pair” methodology, and methods for measurement of light scattering herein.
Sensitive Analyte Assays
Binding-pair (also known as ligand-receptor, molecular recognition binding and the like) techniques play an important role in many applications of biomedical analysis and are gaining importance in the fields of environmental science, veterinary medicine, pharmaceutical research, food and water quality control and the like. For the detection of analytes at low concentrations (less than about 1 picomole analyte/sample volume analyzed) the use of fluorescent, luminescent, chemiluminescent, or electrochemiluminescent labels and detection methods are often used.
For the detection of low concentrations of analytes in the field of diagnostics, the methods of chemiluminescence and electrochemiluminescence are gaining wide-spread use. These methods of chemiluminescence and electro-chemiluminescence provides a means to detect low concentrations of analytes by amplifying the number of luminescent molecules or photon generating events many-fold, the resulting “signal amplification” then allowing for detection of low concentration analytes.
In addition, the method of Polymerase Chain Reaction (PCR) and other related techniques have gained wide use for amplifying the number of nucleic acid analytes in the sample. By the addition of appropriate enzymes, reagents, and temperature cycling methods, the number of nucleic acid analyte molecules are amplified such that the analyte can be detected by most known detection means. The high level of commercial activity in the development of new signal generation and detection systems, and the development of new types of test kits and instruments utilizing signal and analyte molecule amplification attests to the importance and need for sensitive detection methods.
However, the above mentioned methods of signal and analyte molecule amplification have associated limitations which makes the detection of analytes by these methods complicated, not easy to use, time consuming, and costly. Problems of interference of chemical or enzymatic reactions, contamination, complicated and multi-step procedures, limited adaptability to single step “homogeneous” (non-separation) formats, and the requirement of costly and sophisticated instrumentation are areas that those in the art are constantly trying to improve.
Thus, there is a tremendous need for easy to use, quantitative, multi-analyte, and inexpensive procedures and instruments for the detection of analytes. Such procedures, test kits, and instruments would overcome the disadvantages and limitations of the current methods of signal and analyte molecule amplification, and would be useful in research, individual point of care situations (doctor's office, emergency room, out in the field, etc.), and in high throughput testing applications.
It is the object of the present invention to provide a new means to more easily detect one or more analytes in a sample to low concentrations than was previously possible. The present invention can detect low concentrations of analytes without the need for signal or analyte molecule amplification.
The present invention provides a signal and detection system for the detection of analytes where the procedures can be simplified and the amount and types of steps and reagents reduced. The present invention provides for the quantitative detection of single or multiple analytes in a sample. The present invention also provides for substantial reductions in the number of different tests and amounts of sample material that are analyzed. Such reduction in the number of individual tests leads to reduced cost and waste production, especially medically-related waste that must be disposed of.
Light Scattering Detection Methods and Properties of Light Scattering Particles
There is a large body of information concerning the phenomenon of light scattering by particles, the use of particulate labels in diagnostic assays, and the use of light scattering methods in diagnostic assays which are now presented in the following discussion of relevant art none of which is admitted to be prior art to the pending claims. This art is provided as a background for understanding of the novelty and utility of the claimed invention.
The general study of light scattering comprises a very large field. The phenomena of light scattering has been studied intensely for about the last one hundred or so years and the applications of the knowledge of light scattering to different aspects of human endeavor are wide and varied.
The classical theory of light scattering by small, homogeneous, non light absorbing, spherical particles of a size of about {fraction (1/20)} or less the wavelength of the incident radiation was initially developed by Rayleigh. Later a more general phenomenological theory of light scattering by homogeneous, spherical particles of any size and composition was developed by Mie. The Mie theory applies both to light absorbing and nonabsorbing particles. It has also been shown from Mie theory that the expressions of Rayleigh can easily be generalized so as to apply to particles which absorb light as long as the particles are much smaller than the wavelength of incident light. For these small diameter particles, Mie theory and the generalized Rayleigh theory give similar results. Light scattering (elastic) can be viewed from a classical or quantum mechanical point of view. An excellent quantitative description can be obtained through the classical point of view.
A historical background as well as a description of the basic theories of scattered light and other electromagnetic radiation is provided in the following references;
Absorption and Scattering of Light By Small Particles
(1983), C. F. Bohren, D. R. Huffman, John Wiley and Sons;
The Scattering of Light and Other Electromagnetic Radiation
(1969), M. Kerker, Academic Press.
Further background information of the phenomenon of light scattering can be found in the following publications.
Zsigmondy,
Colloids and the Ultramicroscope—A Manual of Colloid Chemistry and Ultramicroscopy,
1914, John Wiley & Sons, Inc. is described various light scattering properties of gold particles and other types of particles.
Hunter,
Foundation of Colloid Science,
Vol, I, 105, 1991, describes use of optical microscopes, ultramicroscopes, and electron microscopes in observation of particles.
Shaw et al.,
Introduction to Colloid and Surface Chemistry,
2nd ed., 41, 1970, describe optical properties of colloids and the use of electron microscopy, and dark field microscopy e.g., the ultramicroscope.
Stolz, SpringerTracts, Vol. 130, describes time resolve light scattering methodologies.
Klein and Metz, 5
Photographic Science and Engineering
5-11, 1961, describes the color of colloidal silver particles in gelatin.
Eversole and Broida, 15
Physical Review
1644-1654, 1977, describes the size and shape effects on light scattering from various metal particles such as silver, gold, and copper.
Kreibig and Zacharias, 231
Z. Physik
128-143, 1970, describe surface plasma resonances in small spherical silver and gold particles.
Bloemer et al., 37
Physical Review
8015-8021, 1988, describes the optical properties of submicrometer-sized silver needles and the use of such needles is described in Bloemer, U.S. Pat. No. 5,151,956, where a surface plasmon resonance of small particles of metal to polarize light propagating in a wave guide is described.
Wiegel., 136
Zeitschrift fur Physik,
Bd., 642-653
Jackson Jeffrey T.
Kohne David E.
Yguerabide Evangelina E.
Yguerabide Juan
Gabel Gailene R.
Genicon Sciences Corporation
Housel James C.
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