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Patent 2483392 Summary

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(12) Patent Application: (11) CA 2483392
(54) English Title: COMPUTERIZED ANALYSIS FOR ABNORMAL CELLS IN A CELL BLOCK
(54) French Title: ANALYSE INFORMATISEE DE CELLULES ANORMALES DANS UN BLOC DE CELLULES
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • G01N 15/10 (2006.01)
  • A61B 10/00 (2006.01)
  • C12Q 1/02 (2006.01)
  • G01N 1/36 (2006.01)
  • G01N 15/14 (2006.01)
  • G01N 33/48 (2006.01)
  • G01N 35/00 (2006.01)
  • G01N 1/06 (2006.01)
  • G01N 21/17 (2006.01)
(72) Inventors :
  • FRIST, STEPHEN (United States of America)
  • SCOTT, RICHARD S. F. (United States of America)
  • RUTENBERG, MARK (United States of America)
(73) Owners :
  • CDX (ORALSCAN) LABORATORIES, INC. (United States of America)
(71) Applicants :
  • CDX (ORALSCAN) LABORATORIES, INC. (United States of America)
(74) Agent: RIDOUT & MAYBEE LLP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2003-04-22
(87) Open to Public Inspection: 2003-10-30
Examination requested: 2004-10-21
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2003/012534
(87) International Publication Number: WO2003/089905
(85) National Entry: 2004-10-21

(30) Application Priority Data:
Application No. Country/Territory Date
60/375,150 United States of America 2002-04-22

Abstracts

English Abstract




A system for analysis of cell blocks utilizing a computerized system to
examine cell blocks cut from a pellet of cells, the cell block being mounted
on the computerized system to examine a variety of characteristics including
morphological color and boundary conditions between cells. The cell block may
be cut in various ways to present different characteristics for examination by
the computerized system.


French Abstract

La présente invention concerne un système d'analyse de blocs de cellules faisant appel à un système informatisé pour examiner un bloc de cellules découpé dans un amas de cellules, le bloc de cellules étant monté sur le système informatisé pour examiner une diversité de caractéristiques comprenant la couleur morphologique et les conditions aux limites entre les cellules. Le bloc de cellules peut être découpé de différentes façons pour présenter différentes caractéristiques à examiner par le système informatisé.

Claims

Note: Claims are shown in the official language in which they were submitted.




5

CLAIMS:

1.~A system for analysis of cells of tissue comprising:
a computerized system to examine a large number of cell parameters
to detect suspect cells;
apparatus to form a pellet of cells and slicing means to slice said pellet
to form a cell block for analysis; and
mounting means for mounting said cell blocks to be examined by said
computerized system.

2. ~A system for analysis of cells of tissue according to claim 1, wherein
said
slicing means is controllable to form prescribed cell blocks with preset
parameters.

3. ~A system for analysis of cells of tissue according to claim 2, wherein
said
preset parameters are geometrical.

4. ~A system for analysis of cells of tissue according to claim 3, wherein
said
geometrical parameters include cell block thickness.

5. ~A system for analysis of cells of tissue according to claim 1, wherein
said
suspect cells are precancerous.

6. ~A system for analysis of cells of tissue according to claim 5, wherein
said
suspect cells are cancerous.

7. ~A system for analysis of cells of tissue according to claim 1, wherein
said
computerized system examines morphological characteristics.

8. ~A system for analysis of cells of tissue according to claim 1, wherein
said
computerized system examines color characteristics.



6

9. A system for analysis of cells of tissue according to claim 1, wherein said
computerized system examines geometric characteristics of said cell block.

10. A system for analysis of cells of tissue according to claim 1, wherein
said computerized system examines boundary characteristics between cells.

Description

Note: Descriptions are shown in the official language in which they were submitted.




CA 02483392 2004-10-21
WO 03/089905 PCT/US03/12534
Ct~MPUTERI~Efl ANALYSIS FOR
ABNORMAL CELLS 1N A CELL BLOCK
BACKGROUND OF THE INVENTION
This invention relates to computer assisted cell!anaiysis, and mare
particularly
computer assisted cell analysis for cell blocks. Computer assisted cell
analysis is
widely employed, see references.
To the invenfiors' knowledge, all prior systems examine histologically or
cytologically removed cells as they are normally found; in tissue. To the
inventors'
knowledge, there is no prior computerized system which employs computer
assisfied
cell analysis to examine cells in a cell block.
The following references are identified and ince~rporated by reference:
Computer Assisted Cytology and Histology: 6,5;53,15; Douglass , et al. April
22, 2003, Method and apparatus for automated imam analysis of biological
specimens;~6,327,377 Rutenberg , et al. December 4,~~OO~t, Automated
cytofogfcaf
specimen classification s~~tem and method; 6,026,17 Palcic , et al. February
15,
2000, Sys_t~m and method for automatically detectinglmalianant cells and cells
having rx~ali~ancy-associated chances; 5,939,278 Boon , et al. August 17,
1999,
Automated histologiical specimen classification systeni and method; 5,287,272
Rutenberc,~. ,et al. February 15, 1994, Automated ~t~c~caf specimen
classification
sv sr tem andjmethod; 5,25T,782 Luck , et al. October 2~, 1993, Morphological
classif~catioyystem and t~etf~fld; and, 4,9f5,?25 Rut~nfcerg flctflbet~ 23,
9990,
Neural nefin~ork based automated cytological specimeh classification system
and
method.
Cell Block related: 5,318,795 Stokes , et al. June 7, 1994, Staining-methods
for histoio ~'r and cYtoloayspecimens; and, 5,817,0321111i11iamson,111, et a1.
October



CA 02483392 2004-10-21
WO 03/089905 PCT/US03/12534
2
6, 1998, Mans arid method for ~hat~estma and bandaahg tisst~~ sat~n~les for
biot~sy
anal sis
Brus~t Biopsy: 6,494,845 Rutenberg E?ecerr~ber' 17, 2002, Retractable brush
for use with en~o_pe for brush biopsy; and, 6,297,044 Eisen , et al. October
2,
~f~fl'( , 1111inirjna~i invasive ai~paratus for tesfing lesions of she orai
cavity and similar
epithelium
SUiVIPJi9~RY ~t~ID DESCRIPTIf3l~t OF 11t-IE IN~fENTfC~~t
Applicants have developed and have recognized the significant benefit of
employing computer assisted analysis with cells block.
Com~~terized ana-lysis provides increased accuracy and speed, and with
specially prepared cell blocks for use with a computerized examination system
major
benefits are realized, especially in the examination of ~ESSUe fragments or
micro-
biopsies. dell blocks are formed by putting the cells i~to a liquid, floating
them in
the Iiqt~id, a~td spinwing the ~I-iyid down in a centnft~g~! to obta-i-n a
pellet of thecells.
This pellet i',s embedded in something similar to paraffin so that the density
of the
paraffin any the cells is simitar, and one may cut this resultant hardened
mass with a
microtome end not shatter it. The cell block preparation technique is employed
in
samples co~faining numerous tissue fragments, for e~tample fine needle
aspiration
samples (5"817.,02 Williamson., IV., et al ) or brush biopsy samples
(5.,297,044
Eisen, et al.,) which may be too small to be processed ihistolog'ically and
too large to
be viewed on a sm.ea.rr cytospin or other Lictu.id cytolog.~ preparation.
The primary difference between examining celliblock material as compared to
.materia.l fra~n .s.mears .ar .other .cytologicaa prepa.rati.on .~s that
~i.ng.l.e .cel.ls .o.r .clusters .of
cells in the smear are intact cells, whereas in a cell block, the cells are
artificially



CA 02483392 2004-10-21
WO 03/089905 PCT/US03/12534
3
-forced toge~h~r -into -a -pellet arid -instead -ef -looking at a -cell en a
slide, -one-sees a
cross-sectional slice through the cell. For example, if one were to consider
the
=nucleus to kav a sphere, when it is in its lying etorrrn ccrrt-d-ition-, it
will a~lway~ ha a a-
certain diameter. Vllhen one slices the nucleus located in the cell block, the
resultant
diameter depends on the -unknown ~p~sition ofithe slid. -In cantrast-to
histo~log~ical
_prc~paration,of a specimen, where the large-scale tissue architecture is
intact and can
be examined in the sliced- specimen, the tissue archifpcfure visible in a calf
block is
limited to thrr tissue fragments present in the liquid.
Prior art computer assisted analysis of cytology and histology has not
.ad.dressed .~:xaminati.on .~f .tiss.ue .frag.ments _or .micro-..t~i-opsies.,
.too .Larg.e to -be
examined cytoiogically, where tissue architecture is preserved intact on a
small
scale, but I~cks=large scale.tiss~e structures- used io. h~~stological~
diagnosis.
Computer assisted analysis has materially advanced the detection of suspect
cells.
This is because computer assisted analysis has the capability of examining.
huge
numbers ofiindividual specimens by analyzing a large!number of parameters very
rapidly. Clearly, computers can work 24 hours a day, and the ability to
process
enormous amounts of data makes the computer assisted analysis an effective
tool
for the pathologist examining cellular material to find s~,uspect cells which
may be w
indicative o~ or a precursor to cancer. One of the advantages of the present
invention is !that computer assisted smear analysis prdvides a cerfain
percentage
accuracy in!detecting suspect cells, whereas cell block analysis also has a
certain
percentage~accuracy as well. By combining both systems, the accuracy of
detecting
suspect cells material increases. Of course, the preparation of the cell block
for
proper analysis enhances the effectiveness of the system.



CA 02483392 2004-10-21
WO 03/089905 PCT/US03/12534
4
Although some of the computer analysis will bei looking at layered cells in
the
same manner as previously encountered, the computer analysis will examine
different morphological and color characteristics as rebated to cell block
characteristics. Additionally, boundary characteristics;between cells will
also be
difFerent in ~ cell block, and an examination of the bo~indaries between cells
as
indicating suspect cells will also be examined.
It is anticipated that the computer assisted cell Mock analysis will select
perhaps only 100 or 200 cells out of hundreds of thousands to find the most
suspect
cells. Ultimately, at the conclusion of the computer assisted analysis, a
trained
pathologist inrill then examine the most suspect or representative cells to
determine
the likelihood of precancerous conditions.
The planar cuts, the direction of the planes andl the thickness of the cuts
may
all be easily. varied and will produce different characteristics for computer
assisted
analysis.
It should be understood that the preferred embodiment was described to
provide the;best illustration of the principles of the inv~ntian and its
practical
application fio thereby enable one of ordinary skill in th;~e art to utilize
the invention in
various embodiments and with various modifications ~s are suited to the
particular
use contemplated. Ali such modifications and variations are within the scope
of the
invention a~ detenrined,by the appended claims when interpreted in accordance
with the breadth to which they are fairly legally and eqhitably entitled.

Representative Drawing

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Administrative Status

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Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 2003-04-22
(87) PCT Publication Date 2003-10-30
(85) National Entry 2004-10-21
Examination Requested 2004-10-21
Dead Application 2009-07-08

Abandonment History

Abandonment Date Reason Reinstatement Date
2008-07-08 R30(2) - Failure to Respond
2009-04-22 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Request for Examination $800.00 2004-10-21
Application Fee $400.00 2004-10-21
Maintenance Fee - Application - New Act 2 2005-04-22 $100.00 2004-12-30
Registration of a document - section 124 $100.00 2005-10-21
Maintenance Fee - Application - New Act 3 2006-04-24 $100.00 2005-12-30
Maintenance Fee - Application - New Act 4 2007-04-23 $100.00 2007-01-02
Maintenance Fee - Application - New Act 5 2008-04-22 $200.00 2007-12-18
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
CDX (ORALSCAN) LABORATORIES, INC.
Past Owners on Record
FRIST, STEPHEN
RUTENBERG, MARK
SCOTT, RICHARD S. F.
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Cover Page 2005-02-24 1 29
Abstract 2004-10-21 1 50
Claims 2004-10-21 2 48
Description 2004-10-21 4 212
Correspondence 2005-02-22 1 26
Fees 2007-01-02 1 29
PCT 2004-10-21 2 64
Assignment 2004-10-21 3 91
Fees 2004-12-30 1 27
Assignment 2005-10-21 6 252
Correspondence 2005-10-21 3 97
Assignment 2005-11-04 7 305
Correspondence 2005-11-04 4 143
Assignment 2004-10-21 6 189
Fees 2005-12-30 1 27
Prosecution-Amendment 2008-01-08 2 64
Fees 2007-12-18 1 29