Method of separating biomolecule-containing samples with a...

Chemistry: electrical and wave energy – Processes and products – Electrophoresis or electro-osmosis processes and electrolyte...

Reexamination Certificate

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C204S450000, C204S452000

Reexamination Certificate

active

06726820

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to microdevices, such as those used in the pharmaceutical and biotechnological fields.
BACKGROUND OF THE INVENTION
In low-throughput situations, sample tracking and record keeping can often be handled adequately in a manual fashion. For example, one or several words about a sample, and/or an alphanumeric identifier, can be written or typed on a label that is applied to a container holding the sample. In some cases, additional (e.g., more detailed) information is kept in paper form, e.g., notebooks, and/or manually entered into a spreadsheet or database on a computing device, such as a personal computer (PC).
With the advent of medium- to high-throughput sample processing, it has become more challenging to track each sample and maintain information on it for ready accessing. Providing sample containers with bar codes has provided some advantages in sample tracking. As a practical matter, a bar code, per se, carries very little information, simply being an identifier. Further, there is a lower limit on the size of container with which a bar code can be used. In addition, a bar code itself is static information. That is, once a bar code is written and placed on a sample container, it cannot be readily changed.
Sample tracking and information maintenance will become even more challenging as the industry moves toward microdevice, very high-throughput formats.
In an effort to meet the challenges presented by very high-throughput sample processing, a great deal of effort has been focused on software and networking solutions to large-scale information management. It is envisioned that software and networking technologies will permit instruments and applications of all types to communicate with one another and to share database resources for tracking the many, many samples being processed. Many of today's popular commercial LIMS (laboratory information management systems), for example, are moving toward the use of open systems architectures and platforms to offer client/server capabilities and enterprise-wide access to lab information.
Notwithstanding the advantages offered by such LIMS, it will happen that a sample, or many samples in a microdevice, will need to be physically transported between sites, machines and/or computers that are not connected by a network or LIMS.
SUMMARY OF THE INVENTION
Aspects of the invention provide a microdevice including a memory integrated into the microdevice. The memory can be, for example, a readable-writable-rewritable memory (also referred to herein simply as a “rewritable” memory).
Further aspects of the invention provide a sample-processing station (e.g., for genetic analysis, electrophoresis, pcr, sample preparation and/or sample cleanup, etc.) configured for reading from, and/or writing/rewriting to, the memory integrated into a microdevice.
A wide variety of information can be written to the memory of a microdevice. For example, sample ID, sample history, sample lineage, a person's notes pertaining to a sample, etc. In various embodiments, a memory that is integrated into a substrate defining, at least in part, a microdevice carries instructions that can be read by an apparatus for acting on samples held by the microdevice, which the apparatus can read and carry out. Optionally, the apparatus can then write to the memory of the microdevice (e.g., results pertaining to the act(s) performed, etc.).
A microdevice of the invention can be transported from one place to another, and the memory accessed at each location. The information (written to the integrated memory) and the microdevice (including any sample(s) therein) can conveniently be transported and/or stored (etc.) as a unit.
A microdevice of the present invention can find use alone, or in combination with one or more other sample tracking and information storage/retrieval technologies, such as those previously discussed.
Among other things, the present invention provides advancements in methods and devices for tracking samples, and/or storing and retrieving information pertaining thereto. Such advancements can be used as an alternative or a supplement to known methods and devices, such as those previously discussed.
Aspects of the invention provide a microdevice, various embodiments of which comprise a substrate or body, such as a plate, wafer, chip, slide, disc, or the like, including one or more microfluidic structures (e.g., channels, wells, chambers, reservoirs, or any combination thereof), and a readable-writable-rewritable memory integrated into the substrate, with the memory being adapted for storing binary coded information.
In various embodiments, at least one of the one or more microfluidic structures comprises a channel having a cross-sectional dimension of no greater than 500 micrometers (e.g., no greater than 250 micrometers, no greater than 100 micrometers, or no greater than 75 micrometers).
According to various embodiments, one or more of the microfluidic structures comprises a chamber, well or reservoir configured to hold a micro-volume of a fluidic sample, the micro-volume being no more than about 250 &mgr;l (e.g., about 100 &mgr;l, 75 &mgr;l, 50 &mgr;l, or less).
According to various embodiments, the integrated memory can be permanently fixed in or to the substrate, or it can be removably attached to the substrate.
In various embodiments, the memory is selected from the group consisting of integrated circuit memories, optical memories, thin film semi-conductor memories, ferromagnetic memories, molecular memories, biomolecular memories, and any combination thereof.
Various embodiments further include a microcontroller chip supported by (e.g., integrated into) the substrate and adapted for communication with the memory.
In various embodiments, machine-readable computer code is stored in the memory.
According to various embodiments, at least one read-only memory is also integrated into the substrate.
Further aspects of the invention provide an electrophoresis microdevice, various embodiments of which comprise a substrate including one or more microscale structures configured to support one or more fluidic samples; and a readable-writable-rewritable memory integrated into the substrate.
According to various embodiments, an electrophoresis microdevice can further include (i) one or more electrodes (e.g., microelectrodes integrated into the substrate), and (ii) a power source (e.g., a DC power source); with the one or more electrodes being connectable to the power source to generate one or more electrical fields along at least one of the one or more microscale structures.
In another of its aspects, the present invention provides a thermal cycling microdevice, various embodiments of which include a substrate including one or more microscale structures (e.g., wells or reservoirs) adapted to receive or support one or more biomolecule-containing samples (e.g., DNA-containing samples); a readable-writable-rewritable memory integrated into a region of the substrate; and a temperature control element or device, adapted to modulate (cycle) the temperature within at least one of the one or more microscale structures.
Another aspect of the present invention provides an apparatus for acting on one or more biomolecule-containing samples supported by a microdevice, such as a microdevice including an integrated readable-writable-rewritable memory. In various embodiments, an apparatus includes: a housing; a reader-writer unit mounted in the housing, with the reader-writer unit being adapted to receive a region of the microdevice into which the memory is integrated; and a support mounted in the housing, for holding the microdevice while the samples are acted upon and while the memory region is received within the reader-writer unit.
According to various embodiments, an apparatus further includes a detector operably coupled to a region whereat a microdevice is located when held by the support.
In various embodiments, an apparatus further comprises a temperature control module adapted to regulate the temperature of at least a port

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