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`Introduction
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`The invention relates to analysis of samples such as serum for glucose testing.
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`At present, there is a two-stage analysis of samples, namely point-of-care and
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`laboratory analysis. Typically the point-of-care analysis is performed using “dry
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`. chemistry” techniques.
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`This is because such techniques are simple and
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`10.
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`convenient to perform: a sample being placed on a strip coated with a dry
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`reagent and the strip being inserted into an inspection instrument.
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`The laboratory analysis is typically performed using “wet chemistry” techniques
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`in which controlled volumes of fluid sample and reagent(s) are admixed and
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`15
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`optically inspected. The “wet chemistry” techniques are regarded a being full
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`and reliable tests, whereas the “dry chemistry” techniques are reliable only for
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`screening purposes. Thus, a large number of patients may be unnecessarily
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`subjected to the trouble and worry of further unwarranted tests beyond the
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`point-of-care.
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`20
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`The invention addresses this problem.
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`Statements of Invention
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`25
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`According to the invention, there is provided a reagent cuvette comprising at
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`least two reagent chambers for containing controlled quantities of reagents, and
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`a valve for allowing transfer and admixture of the reagents.
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`In one embodiment, the valve is configured for single and destructive use.
`ANCESTRY EX. 1018
`ANCESTRY EX. 1018
`1
`1
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`
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`mbodiment, the value comprises a membrane across an opening of
`In another e
`a chamber, and a piercing member in another chamber, whereby the
`membrane is pierced as the chambers are pressed towards each other.
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`In a further embodiment, a chamber comprises a socket for receiving another
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`chamber.
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`in one embodiment, the socket comprises the piercing member.
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`5
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`10
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`In another embodiment, the socket and chamber to lit in the socket are of
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`generally cylindrical or frusto-conical configuration.
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`In a further embodiment, the piercing member comprises a pointed tip at the
`extremity of a plurality of radial supports having gaps therebetween for flow of
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`15
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`reagent or sample.
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`In another aspect, the invention provides a method of performing wet chemistry
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`reagent admixture comprising the steps of:
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`20
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`providing a first chamber containing a controlled quantity of a first
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`reagent,
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`providing a second chamber containing a controlled quantity of a second
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`25
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`reagent, and
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`pressing the chambers together to cause a valve to open so that one
`reagent flows into the chamber of the other reagent.
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`2
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`In one embodiment, the action of pressing the chambers together causes a
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`membrane to be pierced.
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`Detailed ‘Description of the Invention
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`The invention will be more clearly understood from the following description of
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`some embodiments thereof, given by way of example only with reference to the
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`accompanying drawings in which:-
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`10
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`Fig.
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`l
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`is a two-step diagram showing use of a reagent cuvette of the
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`invention.
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`Referring to Fig. 1, a reagent cuvette of the invention comprises a base 1 and a
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`top part 10. The base 1 comprises a first reagent chamber 2, above which there
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`15
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`is a socket 3 for receiving the top part 10. A foil membrane 4 extends across the
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`top of the socket 3. The first reagent chamber 2 contains a reagent Rl to a
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`specific controlled volume. The top part 10 contains a second reagent, R2, also
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`to a specific controlled quantity. A foil membrane ll extends across an opening
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`of the top part 10. Also, a piercing member 15 is an integral part of the base 1,
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`being located immediately above the first; reagent chamber 2. The piercing
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`member 15 and the membrane ll together form a single-use valve.
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`ln use, the foil membrane 4 is removed to open the base. A controlled volume
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`of sample S is dropped by pipette by an operator (such as general practitioner)‘
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`25
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`into the first reagent chamber 2.
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`The (still sealed) top part 10 containing reagent R2 is pushed into the socket 3
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`until its lower foil membrane 11 is pierced by the member 15. This allows a
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`controlled quantity of reagent R2 to drop by gravity into the chamber 2. Thus,
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`3
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`-4.
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`the chamber 2 now contains the exact desired volumes of reagents R1 and R2
`together with the sample 3. The cuvette is than placed in an optical analysis
`instrument for a full analysis. All of this takes place at the point-of-care.
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`5
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`Thus, the invention provides for wet chemistry analysis at the point-of-care,
`effectively bringing full laboratory analysis to the point-of-care in a simple and
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`convenient manner.
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`The invention funds application at many locations such a point-of-care
`emergency clinics, non-laboratory facilities in hospitals, and remote doctor
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`10
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`clinics in the developing world.
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`The invention is not limited to the embodiments described but may be varied in
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`construction and detail.
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`4
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`Claims
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`1.
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`two reagent chambers for
`least
`A reagent cuvette comprising at
`containing controlled quantities of reagents, and a valve for allowing
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`5
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`transfer and admixture of the reagents.
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`2.
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`A reagent cuvette as claimed in claim 1, wherein the valve is configured
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`for single and destructive use.
`
`10
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`3.
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`A reagent cuvette as claimed in claim 2, wherein the value comprises a
`membrane across an opening of a chamber, and a piercing member in
`another chamber, whereby the membrane is pierced as the chambers
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`are pressed towards each other.
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`15
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`4.
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`A reagent cuvette as claimed in claim 3, wherein a chamber comprises a
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`socket for receiving another chamber.
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`5.
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`A reagent cuvette as claimed in claim 4, wherein the socket comprises
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`the piercing member.
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`20
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`6.
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`25
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`7.
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`A reagent cuvette as claimed in claim 4 or 5, wherein the socket and
`chamber to fit in the socket are of generally cylindrical or frusto-conical
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`configuration.
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`A reagent cuvette as claimed in any of claims 3 to 6, wherein the piercing
`member comprises a pointed tip at the extremity of a plurality of radial
`supports having gaps therebetween for flow of reagent or sample.
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`5
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`-5-
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`8.
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`A reagent cuvette substantially as described with reference to the
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`drawings.
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`9.
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`A method of performing wet chemistry reagent admixture comprising the
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`5
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`steps of:
`
`providing a first chamber containing a controlled quantity of a first
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`reagent,
`
`10
`
`providing a second chamber containing a controlled quantity of a second
`
`reagent, and
`
`pressing the chambers together to cause a valve to open so that one
`
`‘
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`reagent flows into the chamber of the other reagent.
`
`15
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`10.
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`A method as claimed in claim 9, wherein the action of pressing the
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`chambers together causes a membrane to be pierced.
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`11.
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`A method of admixture of reagents substantially as described with
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`20
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`reference to the drawing.
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`PA 1235187
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`UNITED STATES DEPARTMENT OF COMMERCE
`
`United States Patent and Trademark Office
`
`October 12, 2004
`
`THIS IS TO CERTIFY THAT ANNEXED HERETO IS A TRUE COPY FROM
`THE RECORDS OF THE UNITED STATES PATENT AND TRADEMARK
`OFFICE OF THOSE PAPERS OF THE BELOW IDENTIFIED PATENT
`APPLICATION THAT 1\/[ET THE REQUIREMENTS TO BE GRANTED A
`FILING DATE
`335 USC 111.
`
`APPLICATION NUIVIBER: 60/523,104
`FILING DATE: November 19, 2003
`
`
`
`PRIORITY DOCUMENT
`SUBMITTED OR TRANSMITTED IN
`COMPLIANCE WITH
`RULE 17.1(a) OR (b)
`
`
`
`
`
`’
`3
`<
`By Authority of the
`I‘]\”’\' \ X ‘UL COMMISSIONERIOF PATENTS AND TRADEMARKS
`J‘
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`E ALA
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`Certifying Officer
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`83no
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`g:
`HWY B. JACOBSON. JR.
`JOHN CLARKE HOLMAN
`SI
`L. MOSKOWITZ
`A
`S. MELSER
`M
`EL R. SLOBASKY
`M
`HA 6. GENTNER
`JONATHAN L. SCHERER
`IRWIN M. AISENBERG
`GEORGE W. LEWIS
`WILLIAM E. PLAYER
`YOON S. HAM
`PHILIP L. O'NEILL
`LINDA J. SHAFIRO
`LEESA N. WEISS
`SUZIN C. BAILEY‘
`MATTHEW J. CUCCIAS
`DANIEL K. DORSEY
`SUZANNAH K. SUNDBY'
`
`LAW OFFICES OF
`
`JACOBSONHOLMAN
`PROFESSIONAL LIMITED LIABILITY COMPANY
`
`«400 SEVENTH srnras-:1‘. N. w.
`
`WASHINGTON, D.C. 20004
`(202) eaa-sees
`
`November 19, 2003
`
`H
`""°°°s°" °"”"" STERN
`‘
`OF‘ COUNSEL
`MARVIN R. STERN
`NATHANIEL A. HUMPHRIES
`TELEFAX:
`(202) 383-5350
`(202) 393-535!
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`‘BAR OTHER THAN D.C.
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`r Atty. Docket No.: P69294080
`c: c: F- u: an
`C)C‘.anI-JEW figkl
`
`Mail Stop Provisional Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA
`
`22313-1450
`
`Sir:
`
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`Transmitted herewith for filing is a PROVISIONAL APPLICATION of
`Michael 0’DONOVAN residing at County Cork, Ireland for A DEVICE.
`The application comprises a_§_-page specification and_;_ sheet of
`drawings.
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`Accompanying this application for filing is:
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`X Filing Fee: __ Small Entity, $80.00 _X_ Large Entity, $160.00
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`Respectfully submitted,
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`JACOBSON HOLMAN PLLC
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` Joh C. H lman
`Reg No. 22,769
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`JCH:mch
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`9
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