DCT
8:06-cv-00458
Streck v. Research & Diagnostic Systems
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Streck, Inc. (Nebraska)
- Defendant: Research & Diagnostic Systems, Inc. (Minnesota); Techne Corporation (Minnesota)
- Plaintiff’s Counsel: Fraser, Stryker, Meusey, Olson, Boyer & Bloch, P.C.; Howrey LLP
- Case Identification: 8:06-cv-00458, D. Neb., 06/29/2006
- Venue Allegations: Venue is alleged to be proper under 28 U.S.C. §§ 1391(b), (c), and 1400(b).
- Core Dispute: Plaintiff alleges that Defendants’ integrated hematology control products infringe patents related to multi-component compositions used for calibrating and testing automated hematology instruments.
- Technical Context: Hematology controls are reference materials with known properties, essential for ensuring the accuracy and reliability of automated instruments that count and analyze various components of blood.
- Key Procedural History: The patents-in-suit are part of a family, with U.S. Patent No. 6,221,668 being a continuation-in-part of the application leading to U.S. Patent No. 6,200,500, and U.S. Patent No. 6,399,388 being a continuation of the application for the ’668 patent. The ’388 patent is subject to a terminal disclaimer, which may limit its enforceable term to that of an earlier patent in the family.
Case Timeline
| Date | Event |
|---|---|
| 1999-08-20 | Earliest Priority Date for ’500, ’668, ’388 Patents |
| 2001-03-13 | U.S. Patent No. 6,200,500 Issued |
| 2001-04-24 | U.S. Patent No. 6,221,668 Issued |
| 2002-06-04 | U.S. Patent No. 6,399,388 Issued |
| 2006-06-29 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
No probative visual evidence provided in complaint.
U.S. Patent No. 6,200,500 - "Hematology Control and System for Multi-Parameter Hematology Measurements," issued March 13, 2001
The Invention Explained
- Problem Addressed: As automated hematology instruments evolved to measure an increasing number of blood parameters simultaneously, a need arose for a single, integrated quality control composition that could be used to calibrate and verify the performance of these complex machines without requiring multiple, separate control samples (ʼ500 Patent, col. 1:15-34).
- The Patented Solution: The patent describes a single hematology control composition that combines multiple distinct components designed to simulate various constituents of whole blood. These include analogs for reticulocytes, white blood cells, red blood cells, nucleated red blood cells, platelets, and reticulated platelets, all suspended in an isotonic medium, allowing for comprehensive quality control of a multi-parameter instrument from one sample (ʼ500 Patent, Abstract; col. 2:17-23).
- Technical Importance: This approach provided a more efficient and comprehensive method for quality assurance in clinical laboratories, streamlining the process of validating advanced hematology analyzers that had become central to modern diagnostics (ʼ500 Patent, col. 1:53-59).
Key Claims at a Glance
The complaint alleges infringement of "one or more claims" without specifying any particular claim (Compl. ¶16). Independent claim 1 is representative of the core invention and recites:
- 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, mixed in an isotonic suspension medium.
U.S. Patent No. 6,221,668 - "Hematology Control and System for Multi-Parameter Hematology Measurements," issued April 24, 2001
The Invention Explained
- Problem Addressed: The patent addresses the challenge of creating a durable and reliable hematology control that not only contains multiple components but also accurately simulates the different subpopulations of white blood cells (a "five-part differential") for an extended shelf life (ʼ668 Patent, col. 1:35-47, col. 2:1-5).
- The Patented Solution: The invention is a hematology control composition characterized by two key features: a "stabilized reticulocyte component" and a "fixed and stabilized white blood cell component" that is specifically designed to be "capable of exhibiting a five-part differential." The specification details methods for creating these components, such as encapsulating RNA into red blood cells to form reticulocytes and using specific fixatives and stabilizers to preserve the distinct characteristics of the five white blood cell types (ʼ668 Patent, Claim 1; col. 3:25-50).
- Technical Importance: This invention enabled the production of commercially viable, long-shelf-life quality controls for the most advanced hematology analyzers, which is critical for ensuring consistent and accurate diagnostic results over time in a clinical setting (ʼ668 Patent, col. 16, Table 7, describing stability for 200 days).
Key Claims at a Glance
The complaint asserts "one or more claims" of the patent (Compl. ¶20). Independent claim 1 is representative and recites a composition comprising:
- a stabilized reticulocyte component; and
- a fixed and stabilized white blood cell component capable of exhibiting a five-part differential.
U.S. Patent No. 6,399,388 - "Hematology Control and System for Multi-Parameter Hematology Measurements," issued June 4, 2002
- Patent Identification: U.S. Patent No. 6,399,388, "Hematology Control and System for Multi-Parameter Hematology Measurements," issued June 4, 2002 (Compl. ¶10).
- Technology Synopsis: The ʼ388 Patent discloses a hematology control composition comprising a stabilized reticulocyte component, a lipoprotein, a red blood cell component, a platelet component, and a white blood cell component made from "analogs" capable of showing a five-part differential. The inclusion of lipoprotein is described as important for providing a scattergram that properly represents whole blood, particularly for the five white blood cell subpopulations (ʼ388 Patent, Abstract; col. 11:20-27).
- Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶24). Independent claim 1 is representative.
- Accused Features: The "CBC-XE" and "CBC-4K Plus Retics" integrated hematology controls are alleged to contain the claimed multi-component composition (Compl. ¶23).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the "CBC-XE" and "CBC-4K Plus Retics" hematology controls (Compl. ¶7).
Functionality and Market Context
- The complaint alleges these are "integrated hematology control products" used to assist in the calibration, operation, and quality control of automated blood cell counting instruments (Compl. ¶6). They are described as "complete" or "integrated" controls, which suggests they contain particles corresponding to multiple blood components, such as red blood cells, white blood cells, and platelets, for comprehensive instrument verification (Compl. ¶6). The complaint alleges that Defendants developed and sold these products after recognizing the value of Streck's technology (Compl. ¶7).
IV. Analysis of Infringement Allegations
The complaint does not provide a claim chart or specific factual allegations mapping product features to claim elements. The following summary is based on the general allegation that the accused products infringe the patents-in-suit.
’500 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) a reticulocyte component; | The "CBC-XE" and "CBC-4K Plus Retics" are alleged to be integrated hematology controls that contain a component for simulating reticulocytes. | ¶15 | col. 2:33-42 |
| b) a white blood cell component; | The accused products are alleged to contain a component for simulating white blood cells. | ¶15 | col. 2:43-60 |
| c) a red blood cell component; | The accused products are alleged to contain a component for simulating red blood cells. | ¶15 | col. 2:61-65 |
| d) a nucleated red blood cell component; | The accused products are alleged to contain a component for simulating nucleated red blood cells. | ¶15 | col. 3:1-3 |
| e) a platelet component; and | The accused products are alleged to contain a component for simulating platelets. | ¶15 | col. 3:4-14 |
| f) a reticulated platelet component... | The accused products are alleged to contain a distinct component for simulating reticulated platelets. | ¶15 | col. 3:15-19 |
’668 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) a stabilized reticulocyte component; and | The "CBC-XE" and "CBC-4K Plus Retics" are alleged to be integrated controls containing a reticulocyte component that is stabilized to ensure a long shelf life. | ¶19 | col. 3:9-24 |
| b) a fixed and stabilized white blood cell component capable of exhibiting a five-part differential. | The accused products are alleged to contain a white blood cell component that is processed (fixed and stabilized) in a manner that preserves the distinct physical characteristics of the five white blood cell subpopulations, allowing for their separate detection and quantification by an automated instrument. | ¶19 | col. 4:13-39 |
Identified Points of Contention
- Factual Questions: A primary point of contention will be factual: do the accused "CBC-XE" and "CBC-4K Plus Retics" products actually contain every component recited in the asserted claims? The requirement for both a "platelet component" and a separate "reticulated platelet component" in claim 1 of the ’500 Patent, for instance, raises an evidentiary question of whether the accused products incorporate such a distinct element.
- Scope Questions: The case may turn on the scope of terms such as "fixed and stabilized" from the ’668 Patent. The dispute will likely involve whether the specific chemical processes and agents used by Defendants to preserve their control products fall within the meaning of these terms as construed in light of the patent's specification.
V. Key Claim Terms for Construction
For the ’500 Patent
- The Term: "a reticulated platelet component"
- Context and Importance: This term appears in claim 1 and is distinct from the "platelet component" also required by the claim. The viability of the infringement claim may depend on whether the accused products contain an element that can be separately identified as a "reticulated platelet" analog, beyond a standard platelet analog. Practitioners may focus on this term because proving the existence of this specific, less-common component is a high evidentiary bar for the plaintiff.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not limit the source or structure, suggesting any particle that simulates the properties of a reticulated platelet could suffice.
- Evidence for a Narrower Interpretation: The specification provides a specific, non-limiting example: "goat red blood cells with encapsulated nucleic acids would constitute one example of a reticulated platelet component" (’500 Patent, col. 3:15-19). This specific embodiment could be used to argue that the term requires a distinct, engineered particle with features like encapsulated RNA, not merely a subset of other stabilized platelets.
For the ’668 Patent
- The Term: "fixed and stabilized"
- Context and Importance: This term is central to claim 1 and defines the nature of the white blood cell component. The patent’s contribution relates to creating a long-shelf-life control, and the method of preservation is key. The infringement analysis will hinge on whether the Defendants' preservation techniques meet the "fixed and stabilized" limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent states that "any suitable manner sufficient to denature the protein on the cell surface" may be used, and that the fixing agent can be "an aldehyde, an alcohol, a heterocyclic urea ... or a mixture thereof" (’668 Patent, col. 5:16-24). This language may support a construction that is not limited to one specific chemical process.
- Evidence for a Narrower Interpretation: The specification provides detailed examples of fixing processes, including specific agents like glutaraldehyde, formaldehyde, and NUOSEPT 145, as well as multi-day fixing protocols at specific temperatures (’668 Patent, col. 5:32-44; col. 6:1-16). This could support a narrower construction limited to the types of processes and chemical agents explicitly disclosed.
VI. Other Allegations
- Indirect Infringement: The complaint makes conclusory allegations of induced and contributory infringement for all asserted patents (Compl. ¶¶16, 20, 24). It does not, however, plead specific facts to support the required elements of knowledge and intent, such as referencing user manuals or marketing materials that instruct on an infringing use.
- Willful Infringement: Willfulness is alleged for all three patents based on the assertion that Defendants' infringement was carried out in "deliberate and willful disregard of Streck's patent rights" (Compl. ¶¶17, 21, 25). The complaint does not allege any facts to support pre-suit knowledge of the patents, such as prior correspondence or a citation of the patents by Defendants.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: can Plaintiff demonstrate that the accused "CBC-XE" and "CBC-4K Plus Retics" products contain every single element recited in the asserted composition claims? This is particularly salient for claim 1 of the ’500 patent, which requires six distinct components, including the potentially rare "reticulated platelet component."
- A key legal and technical question will be one of claim scope: does the term "fixed and stabilized," as used in the ’668 patent, cover the specific chemical preservation techniques employed in Defendants' products? The outcome of this claim construction dispute will likely determine whether there is a literal infringement or a need to argue under the doctrine of equivalents.
- The case may also present a significant validity challenge: given the dense field of prior art for hematology controls, as evidenced by the patents themselves, a core dispute will likely revolve around whether the specific combinations of components claimed by Streck were truly novel and non-obvious at the time of invention.