Introduction
`
`The invention relates to analysis of samples such as serum for glucose testing.
`
`At present, there is a two-stage analysis of samples, namely point-of-care and
`
`laboratory analysis. Typically the point-of-care analysis is performed using “dry
`
`. chemistry” techniques.
`
`This is because such techniques are simple and
`
`10.
`
`convenient to perform: a sample being placed on a strip coated with a dry
`
`reagent and the strip being inserted into an inspection instrument.
`
`The laboratory analysis is typically performed using “wet chemistry” techniques
`
`in which controlled volumes of fluid sample and reagent(s) are admixed and
`
`15
`
`optically inspected. The “wet chemistry” techniques are regarded a being full
`
`and reliable tests, whereas the “dry chemistry” techniques are reliable only for
`
`screening purposes. Thus, a large number of patients may be unnecessarily
`
`subjected to the trouble and worry of further unwarranted tests beyond the
`
`point-of-care.
`
`20
`
`The invention addresses this problem.
`
`Statements of Invention
`
`25
`
`According to the invention, there is provided a reagent cuvette comprising at
`
`least two reagent chambers for containing controlled quantities of reagents, and
`
`a valve for allowing transfer and admixture of the reagents.
`
`In one embodiment, the valve is configured for single and destructive use.
`ANCESTRY EX. 1018
`ANCESTRY EX. 1018
`
`
`
`The invention relates to analysis of samples such as serum for glucose testing.
`
`At present, there is a two-stage analysis of samples, namely point-of-care and
`
`laboratory analysis. Typically the point-of-care analysis is performed using “dry
`
`. chemistry” techniques.
`
`This is because such techniques are simple and
`
`10.
`
`convenient to perform: a sample being placed on a strip coated with a dry
`
`reagent and the strip being inserted into an inspection instrument.
`
`The laboratory analysis is typically performed using “wet chemistry” techniques
`
`in which controlled volumes of fluid sample and reagent(s) are admixed and
`
`15
`
`optically inspected. The “wet chemistry” techniques are regarded a being full
`
`and reliable tests, whereas the “dry chemistry” techniques are reliable only for
`
`screening purposes. Thus, a large number of patients may be unnecessarily
`
`subjected to the trouble and worry of further unwarranted tests beyond the
`
`point-of-care.
`
`20
`
`The invention addresses this problem.
`
`Statements of Invention
`
`25
`
`According to the invention, there is provided a reagent cuvette comprising at
`
`least two reagent chambers for containing controlled quantities of reagents, and
`
`a valve for allowing transfer and admixture of the reagents.
`
`In one embodiment, the valve is configured for single and destructive use.
`ANCESTRY EX. 1018
`ANCESTRY EX. 1018
`
`
`
`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.
`
`In a further embodiment, a chamber comprises a socket for receiving another
`
`chamber.
`
`in one embodiment, the socket comprises the piercing member.
`
`5
`
`10
`
`In another embodiment, the socket and chamber to lit in the socket are of
`
`generally cylindrical or frusto-conical configuration.
`
`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
`
`15
`
`reagent or sample.
`
`In another aspect, the invention provides a method of performing wet chemistry
`
`reagent admixture comprising the steps of:
`
`20
`
`providing a first chamber containing a controlled quantity of a first
`
`reagent,
`
`providing a second chamber containing a controlled quantity of a second
`
`25
`
`reagent, and
`
`pressing the chambers together to cause a valve to open so that one
`reagent flows into the chamber of the other reagent.
`
` . . J ._
`
`. mm-n am... {I-1nII=\M Imaue Database on 10/07/2004
`
`2
`
`
`
`-3-
`
`In one embodiment, the action of pressing the chambers together causes a
`
`membrane to be pierced.
`
`Detailed ‘Description of the Invention
`
`The invention will be more clearly understood from the following description of
`
`some embodiments thereof, given by way of example only with reference to the
`
`accompanying drawings in which:-
`
`10
`
`Fig.
`
`l
`
`is a two-step diagram showing use of a reagent cuvette of the
`
`invention.
`
`Referring to Fig. 1, a reagent cuvette of the invention comprises a base 1 and a
`
`top part 10. The base 1 comprises a first reagent chamber 2, above which there
`
`15
`
`is a socket 3 for receiving the top part 10. A foil membrane 4 extends across the
`
`top of the socket 3. The first reagent chamber 2 contains a reagent Rl to a
`
`specific controlled volume. The top part 10 contains a second reagent, R2, also
`
`to a specific controlled quantity. A foil membrane ll extends across an opening
`
`of the top part 10. Also, a piercing member 15 is an integral part of the base 1,
`
`being located immediately above the first; reagent chamber 2. The piercing
`
`member 15 and the membrane ll together form a single-use valve.
`
`ln use, the foil membrane 4 is removed to open the base. A controlled volume
`
`of sample S is dropped by pipette by an operator (such as general practitioner)‘
`
`25
`
`into the first reagent chamber 2.
`
`The (still sealed) top part 10 containing reagent R2 is pushed into the socket 3
`
`until its lower foil membrane 11 is pierced by the member 15. This allows a
`
`controlled quantity of reagent R2 to drop by gravity into the chamber 2. Thus,
`
`3
`
`
`
`
`
`-4.
`
`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.
`
`5
`
`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
`
`convenient manner.
`
`The invention funds application at many locations such a point-of-care
`emergency clinics, non-laboratory facilities in hospitals, and remote doctor
`
`10
`
`clinics in the developing world.
`
`The invention is not limited to the embodiments described but may be varied in
`
`
`
`construction and detail.
`
`-_.
`
`.. ..
`
`||anTn em... ll-ma n:w Imam: Database on 10/07/2004
`
`
`
`4
`
`
`
`Claims
`
`1.
`
`two reagent chambers for
`least
`A reagent cuvette comprising at
`containing controlled quantities of reagents, and a valve for allowing
`
`5
`
`transfer and admixture of the reagents.
`
`2.
`
`A reagent cuvette as claimed in claim 1, wherein the valve is configured
`
`for single and destructive use.
`
`10
`
`3.
`
`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
`
`are pressed towards each other.
`
`15
`
`4.
`
`A reagent cuvette as claimed in claim 3, wherein a chamber comprises a
`
`socket for receiving another chamber.
`
`5.
`
`A reagent cuvette as claimed in claim 4, wherein the socket comprises
`
`the piercing member.
`
`20
`
`6.
`
`25
`
`7.
`
`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
`
`configuration.
`
`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.
`
` -..
`
`_. .. . . Ietrrn 5...... nm u:w Imane Database on 10/07/2004
`
`5
`
`
`
`-5-
`
`8.
`
`A reagent cuvette substantially as described with reference to the
`
`drawings.
`
`9.
`
`A method of performing wet chemistry reagent admixture comprising the
`
`5
`
`steps of:
`
`providing a first chamber containing a controlled quantity of a first
`
`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
`
`‘
`
`reagent flows into the chamber of the other reagent.
`
`15
`
`10.
`
`A method as claimed in claim 9, wherein the action of pressing the
`
`chambers together causes a membrane to be pierced.
`
`11.
`
`A method of admixture of reagents substantially as described with
`
`20
`
`reference to the drawing.
`
`.‘
`
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`PA 1235187
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`II HIIIIH I I IH 11 III
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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‘
`1
`
`E ALA
`
`Certifying Officer
`
`
`
`8
`
`
`
`
`
`83no
`1 ,
`—-L
`
`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!
`(202) 393-5352
`E-MAIL: IPBJHIECOM
`INTERNET: www.JHIP.coM
`‘BAR OTHER THAN D.C.
`
`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:
`
`Ev
`¢$3
`M
`255:?!
`g
`_u;
`;:
`3% ‘-
`
`5
`
`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.
`
`Accompanying this application for filing is:
`
`X Filing Fee: __ Small Entity, $80.00 _X_ Large Entity, $160.00
`
`A Credit Card Payment Form authorizing the amount of $160.00 is
`enclosed to cover
`the Filing Fee. The Commissioner
`is hereby
`authorized to charge payment of any fees set forth in §§1.l6 or
`1.17 during the pendency of
`this application, or credit
`any
`overpayment,
`to Deposit Account No. 06-1358.
`A duplicate copy of
`this sheet is enclosed.
`
`CORRESPONDENCE ADDRESS:
`
`JACOBSON HOLMAN PLLC
`
`400 Seventh Street, N.W.
`Washington, D.C. 20004
`
`Respectfully submitted,
`
`JACOBSON HOLMAN PLLC
`
` Joh C. H lman
`Reg No. 22,769
`
`JCH:mch
`
`9
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