Thursday, May 31, 2012

Isotonic(x) Patent Construction Pending

MEMORANDUM OPINION re Markman hearing. Ordered by ChiefJudge Joseph F.
Bataillon. (SMS, ).Wednesday, November 12, 2008. ...request
construction of the term" isotonic(x) suspension medium." The
defendants...of the '500 Patent reads: "an isotonic(x) suspension m
edium , wherein each , Bayer ADVIA System , the Sysm ex XE2100 System
, or the like. Ex. A, col. 1, ll. 26-29. The patentnotes that these im
proved autom ated instrum ents can m easure oneor m ore of: 1)
reticulocytes, 2) red blood cells, 3) nucleated red blood cells, 4)
platelets, 5) reticulated platelets, 6) white blood cells, including
lym phocytes,m onocytes, neutrophils, eosinophils, basophil and 7)
white blood cells with all phenotypes. Id.,col. 1, ll. 29-36.
2
2
8:06-cv-00458-JFB-FG3 Doc # 135 Filed: 11/12/08 Page 3 of 21 - Page ID # 2875
patent), col. 1, ll. 5-11. In addition, several other patents are
incorporated by reference into the patents at issue.3 The Streck
patents at issue are all entitled¡°Hematology Control and System for
Multi-parameter Hematology Measurements¡± and the patents describe the
material and process for making integrated control compositions that
¡°comprise a reticulocyte component, a white blood cell component, a
red blood cell component, a nucleated red blood cell component, a
platelet component, and a reticulated platelet component¡± that ¡°are
particularly useful as a control for multi-parameter automated
instrument systems.¡± See, e.g., Filing No. 1, Complaint, Ex. A
(the¡¯500 patent) at 1, Abstract. The control composition provides
values for various constituents of blood that a multi-parameter
instrument is capable of measuring.Id., column (¡°col.¡±) 1, lines
(¡°ll.¡±) 64-66. The claims of the patents presently at issue, broadly
speaking, involve a control that hasa five-differential white blood
cell component and a reticulocyte component. The ¡°background¡±
section of the ¡®500 patent provides that in the preferred embodiment,
the control composition includes ¡°a liquid suspension of particulates
that hascharacteristics like whole blood¡± and ¡°includes one or more
blood cell components (i.e., components treated to simulate such a
component as found in whole blood), or their analogs, that may or may
not be fixed, stabilized, or prepared by other treatment prior to
final suspension.¡± Id., Ex. A (the ¡®500 patent), column 1, ll.
38-46. The ¡°components of the control preferably are suspended in a
suitable suspension medium that permits the control
3
These include U.S. Pat. No. 5,262,327 (¡°the ¡®327 patent¡±)for the
diluent SUPERTRATE, U.S. Pat. No. 5,529,933 (¡°the ¡®933 patent) for
suspension m edia for alligator and avian red blood cells as analogs
for white blood cells, U.S. Pat. No. 5,432,089 (¡°the¡®089 patent¡±)
for preparation ofthe reticulocyte com ponent, U.S. Pat. No. 5,459,073
for fixed whiteblood cells for flow cytom etry. See, e.g., Filing No.
1, Com plaint,Ex. A (the ¡®500 patent), col. 1, ll. 49-50; col. 4, ll.
62-64. 3
8:06-cv-00458-JFB-FG3 Doc # 135 Filed: 11/12/08 Page 4 of 21 - Page ID # 2876
to be processed through the automated instrument.¡± Ex. A., col. 2,
ll. 16-22.; col. 3, ll. 2123;see also Ex. B., ¡®668 patent, col.ll.
6-9. The ¡®500 patent further provides that the ¡°blood cell
components or analog materials may be derived from a source that will
exhibit the size, shape or othercharacteristics of human, animal, or
other whole blood,¡± incorporating other patents involving these types
of blood cell components or analogs. Id., col. 1, lines 46 to 53. The
hematology control composition claimed in the¡®500 patent ¡°comprises
components for simulating reticulocyte, white blood cell, red blood
cell, nucleated red blood cell,platelet or reticulated platelet
constituents of whole blood.¡± Id., col. 2, ll. 1-4. The ¡®388 patent
contemplates a control compositionthat has components that simulate
the readouts on an instrument and¡°exhibit similar light scattering,
conductivity, impedence, optical (including fluorescence),
photometric, or other property responses detected by the instrument in
operation, as would the corresponding components of whole blood.¡±
Id., Ex. C (the¡®388 patent), col. 2, ll. 5160. A. of...specifications
of the patents. 1. " Isotonic(x) Suspension Medium" future
construction pending.

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