Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
2002-04-29
2004-06-01
Forman, B. J. (Department: 1634)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S007100, C435S174000, C435S283100, C435S287200, C435S288700, C435S320100, C435S325000, C422S068100, C422S082050, C422S082010, C356S335000, C356S340000, C536S023100, C536S024300, C530S300000, C530S350000
Reexamination Certificate
active
06743581
ABSTRACT:
FIELD OF THE INVENTION
This present invention provides an advanced mutifunctional biochip (AMB) that combines integrated circuit elements, electro-optical excitation and detection systems, and molecular receptor probes in a self-contained integrated microdevice. Methods for the use of such devices in the detection and quantitation of biomolecules, and their application to diagnostic and therapeutic regimens are also provided.
DESCRIPTION OF RELATED ART
Living systems possess exquisite recognition elements (e.g., antibody, enzyme, gene probes, etc.), often referred to as bioreceptors, which allow specific identification and detection of complex chemical and biological species. Biosensors exploit this powerful molecular recognition capability of bioreceptors. Due to the exquisite specificity of the DNA hybridization process, there is an increasing interest in the development of DNA bioreceptor-based analytical systems (Kumar et al., 1994; Eggers et al., 1994; Schena et al., 1995; Vo-Dinh et al., 1994; Stevenson et al., 1994; Isola et al., 1996; Alarie et al., 1992; Vo-Dinh et al., 1987a; 1987b; Vo-Dinh et al., 1991; Saiki et al., 1988; Graham et al., 1992; Steffan and Atlas, 1991; Vogelstein and Kinzler, 1992; Sambrook et al., 1989; Vo-Dinh et al., 1998a; 1998b; Isola et al., 1998; http://www.Affymetryx.com; http://www.Nanogen.com).
Most biosensors previously reported are based on fiber optic probes, glass and silica plates used as the probe substrates which are externally connected to a photo sensing system, which generally consists of a conventional detection device, such as a photomultiplier, or a charge-coupled device (CCD). In general, the sampling platform containing the probes is small (the sampling platform is often referred as to a “DNA chip” or “gene chip”), but the entire device containing excitation laser sources and detection systems (often a confocal microscope system) is relatively large, e.g. table-top size systems (e.g., the Affymetrix system). Nanogen has also developed a biochip system, but this device is mainly designed to move DNA with electric field manipulation, and has been used only for DNA samples. Until now, there is no truly integrated biochip system that comprises probes, samplers, detector as well as amplifier and logic circuitry on board and that is capable of multifunction diagnostics capability.
There is a strong interest in the development of non-radioactive bioreceptor probes using DNA, enzymes, and/or antibody probes for use in a wide variety of diagnostic and quantitative applications, such as identification of the causal agents of infectious disease, diagnosis and therapy of a variety of medical conditions, and detection of biomolecules in samples from industry, biotechnology, and the environment. The use of such techniques in the areas of agriculture, genetic engineering, agribiotechnology, and bioremediation is also contemplated to facilitate the detection and quantitation of a variety of macromolecules, including those of biological and microbiological origins.
One type of devices, often referred to as a “biochip” combines semiconductor detection system with biotechnology-based probes, and has received increasing interest. The inventor has developed a variety of self-contained biochip devices and systems (e.g., U.S. patent application Ser. No. 08/979,672, filed Nov. 26, 1997; Intl. Pat. Appl. Ser. No. PCT/US98/25294, filed Nov. 25, 1998, and U.S. patent application Ser. No. 09/236,758, filed Jan. 25, 1999, the entire contents of each of which is incorporated herein by reference in its entirety). While such biochips (as well as other currently available biochip devices) have several detection channels, they are, however, designed to use only one specific type of bioreceptor at a time, and are therefore unsuitable for simultaneous multidetection of a plurality of species. While these earlier biochip systems may be used for detecting either an individual or a plurality of a particular biochemical species on a single chip at the same time (e.g., in detecting one or more polynucleotides or in detecting one or more polypeptides, they were not devised to detect multiple biochemical species at the same time on the same chip (i.e. the simultaneous detection of polypeptides and polynucleotides on a single chip).
DEFICIENCIES IN THE PRIOR ART
Until now, most DNA biosensors previously reported are based on fiber optic probes, glass and silica plates used as the probe substrates which are externally connected to a photo sensing system, which generally consists of a conventional detection device, such as a photomultiplier, or a charge-coupled device (CCD). Although the probes on the sampling platform are small (often referred to as a ‘DNA chip’ or ‘gene chip’), the entire device containing excitation laser sources and detection systems (often a confocal microscope system) is relatively large, e.g., tabletop size systems. Although these systems have demonstrated their usefulness in genomics research and analysis, they are laboratory-oriented and involve relatively expensive equipment.
There is a critical demand for a rapid, simple, cost-effective technique for screening samples, such as blood or other clinical samples, for the presence of biomolecules (including polynucleotides, polypeptides, etc.) to assist in the diagnosis and treatment of medical diseases, including those caused by infectious pathogens, and the like, as well as provide efficient means for quantitating such molecules in pathology and forensics samples. The development of inexpensive screening analyses that would permit simultaneous analyses of multiple biological molecules would allow rapid detection and improved treatments of many illnesses, facilitate improvements in quality control and manufacturing, as well as provide rapid, affordable devices for detection of biomolecules in the areas of environmental contamination and remediation processes.
The development of rapid and effective screening tests for simultaneous assay of two or more different types of molecules (e.g., detecting antibodies and polynucleotides in a sample on a single biochip) would also reduce the cost of diagnostic testing services, biochemical analyses and assay systems, as well as overall costs in the health care industry. For example, a critical factor in medical diagnostics is rapid, selective, and sensitive detection of biochemical substances (protein, metabolites, nucleic acids), biological species or living systems (bacteria, virus or related components) at ultra-trace levels in biological samples (e.g., tissues, blood and other bodily fluids). To achieve the required level of sensitivity and specificity in detection, it is often necessary to use a biosensor that is capable to identify and differentiate a large number of biochemical constituents in complex samples. The development of a cost-effective biochip alternative to simultaneous quantitation of pluralities of differing biological molecules would be a revolutionary advance in the fields of analytical chemistry and medicine.
To that end, there is currently a strong need for a truly advanced multifunctional biochip system that comprises the necessary probes, samplers, detectors, amplifier and logic circuitry on a single biochip useful in the detection of pluralities of different biomolecular targets. Such a system would be useful in many environments, including inter alia, diagnostic laboratories, environmental sites, remediation or hazardous materials clean-up sites, physicians' offices, health care clinics, hospitals, and even mobile analytical chemistry devices.
Likewise, there is also a need to extend the application of biochip-based sensors to the detection and quantitation of macromolecules other than polypeptides and DNAs. The development of sensors useful in the detection of molecules such as RNAs, peptide-nucleic acids (PNAs), ribozymes, antibodies, enzymes, and peptide fragments, would represent a significant advance in the art and provide new methods and devices for the detection of molecules of biological importance. Furthermore, becau
Akerman & Senterfitt
Forman B. J.
UT-Battelle, LC
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