USO0RE42143E
(19) United States (12) Reissued Patent
(10) Patent Number: US RE42,143 E (45) Date of Reissued Patent: Feb. 15, 2011
Roche et a]. (54)
CONSUMABLE TUBE FOR USE WITH A FLOW CYTOMETRY-BASED HEMATOLOGY SYSTEM
(75) Inventors: John W. Roche, Scarborough, ME (U S); Peter W. Hansen, Canaan, NY (US);
FOREIGN PATENT DOCUMENTS EP EP EP EP W0
0 652 428 0 887 637 0 887 637 0 652 428 WO 99/20789
A1 A2 A3 B1
5/1995 12/1998 12/1999 2/2000 4/1999
Michelle L. Coleman, Yamouth, ME OTHER PUBLICATIONS
(US); Harold R. Crews, Coral Springs, FL (Us)
XP%)02358325: Young Ran Kim and Leonard Ornstein, Iso volumetric Sphering of Erythrocytes for More Accurate and Precise Cell Volume Measurement by FloW Cytometers,
(73) Assignee: IDEXX Laboratories, Inc., Westbrook, ME (U S)
Cytometry, vol. 3, No. 6, pp. 4194127 (NY 1983).
(Continued)
(21) App1.No.: 11/714,721 (22) Filed:
Primary ExamineriL. G Lauchman
Mar. 6, 2007
(74) Attorney, Agent, or FirmACarter, DeLuca, Farrell & Schmidt, LLP
Related U.S. Patent Documents
Reissue of:
7,064,823
(57)
Issued:
Jun. 20, 2006
Appl. No.: Filed:
10/159,944 May 31, 2002
The present invention is a How cytometry-based hematology
(64) Patent No.:
(62)
system use?ll in the analysis of biological samples, particu
Division of application No. 09/715,593, ?led on Nov. 17, 2000, now Pat. NO. 6,784,98l.
(60)
Provisional application No. 60/208,849, ?led on Jun. 2,
(2006.01) (2006.01)
scattered light, high-angle forward scattered light, right
(52)
U.S. Cl. ...................................... .. 356/246; 356/436
(58)
Field of Classi?cation Search .................. .. 356/39,
356/246, 436; 422/8205, 82.09, 82.11; 436/165, 436/ 168, 169
See application ?le for complete search history. (56)
References Cited U.S. PATENT DOCUMENTS 3,925,018 A 4,013,368 A
12/1975 Saunders 3/1977 Acker et a1.
larly Whole blood or blood-derived samples. The system is capable of determining at least a complete blood count (CBC), a ?ve-part White blood cell differential, and a reticu locyte count from a Whole blood sample. The system prefer ably uses a laser diode that emits a thin beam to illuminate cells in a How cell and a lensless optical detection system to measure one or more of axial light loss, loW-angle forward
2000.
(51) Int. Cl. G01N 1/10 G01N 21/00
ABSTRACT
angle scattered light, and time-of-?ight measurements pro duced by the cells. The lensless optical detection system contains no optical components, other than photoreactive elements, and does not include any moving parts. Finally, the system uses a unique system of consumable reagent tubes that act as reaction chambers, mixing chambers, and Waste chambers for the blood sample analyses. The consum able tubes incorporate reference particles, Which act as inter nal standards to ensure that the dilutions made during pro cessing of the samples have been carried out correctly, and to ensure that the instrument is Working properly. The present invention also relates to methods for using the system.
72 Claims, 29 Drawing Sheets
(Continued)
Amended
US RE42,143 E Page 2
US. PATENT DOCUMENTS
4,043,669 4,250,394 4,665,553 4,735,504 4,868,126 5,084,394 5,093,234 5,125,737 5,155,044 5,284,771 5,350,695 5,360,739 5,380,663 5,386,287 5,411,891 5,438,003 5,451,525 5,475,487 5,492,833 5,510,267 5,540,494 5,585,246 5,616,501 5,627,037 5,691,204 5,728,582 5,733,784 5,737,078
8/1977 2/1981 5/1987 4/1988 9/1989 1/1992 3/1992 6/1992 10/1992 2/1994 9/1994 11/1994 1/1995 1/1995 5/1995 8/1995 9/1995 12/1995 2/1996 4/1996 7/1996 12/1996 4/1997 5/1997 11/1997 3/1998 3/1998 4/1998
Gehatia et al. O’Connor Gershman et al.
Tycko Schwartz Vogt et al. Schwartz Rodriguez et al. Ledis et a1. Fan et al. Colella et al. Fan et al. Schwartz et al. Berssen et al. Fan et al. Colella et al. Shenkin et al.
Mariella, Jr. et a1. Rodriguez et al. Marshall Purvis, Jr. et al.
5,753,186 A
5/1998 Hanley et al.
5,798,827 A
8/1998 Frank et al.
5,858,667 5,872,627 5,874,310 5,874,311 5,917,584 5,939,326 6,067,157 6,074,879 6,228,652 6,232,125 6,261,519 6,271,035
1/1999 2/1999 2/1999 2/1999 6/1999 8/1999 5/2000 6/2000 5/2001 5/2001 7/2001 8/2001
A A A A A A A A B1 B1 B1 B1
Dertinger et al. Miers Li et al. Li et al. Li et al. Chupp et al. Altendorf Zelmanovic et al. Rodriguez et al. Deka et al. Harding et a1. Deka et al.
6,365,106 B1
4/2002 Nagai
6,410,337 B1 6,612,719 B2
9/2003 Richardson et al.
6/2002 Brady et al.
OTHER PUBLICATIONS
XP009015111: Robert F. Vogt, Jr., G. David Cross, L. Omar Henderson, and Donald L. Phillips, Model System Evaluat
Dubrow et al.
ing FluorescineiLabeled Microbeads as Internal Standards to Calibrate Flourescene Intensity on Flow Cytometers,
Rodriguez et al.
Cytometry, V01. 10, No. 3, pp. 2944302 (NY 1989).
Ward et al. Kim et al. Taki et al. Studholme et al. Takarada et al.
O?ice Action dated Jan. 28, 2010 for European Patent Appln. No. 01 937 695.3. O?ice Action dated Mar. 30, 2010 for Canadian Patent
Appln. No. 2,410,894.
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