DCT
1:19-cv-01642
Sysmex Corp v. Beckman Coulter Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Sysmex Corporation (Japan) and Sysmex America, Inc. (Delaware)
- Defendant: Beckman Coulter, Inc. (Delaware)
- Plaintiff’s Counsel: Richards, Layton & Finger, P.A.; Brinks Gilson & Lione
- Case Identification: 1:19-cv-01642, D. Del., 09/03/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant, Beckman Coulter, Inc., is a Delaware corporation and therefore "resides" in the judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s UniCel DxH series of hematology analyzers infringes two patents related to sample analyzers capable of operating in distinct modes for processing standard blood samples and other non-blood body fluids.
- Technical Context: The technology involves automated clinical laboratory instruments that provide increased flexibility by analyzing both high-cell-count blood samples and low-cell-count body fluids (e.g., cerebrospinal fluid), improving diagnostic efficiency.
- Key Procedural History: The complaint was filed on the same day that the two patents-in-suit issued, which suggests a coordinated litigation strategy by the Plaintiff.
Case Timeline
| Date | Event |
|---|---|
| 2007-02-01 | Earliest Priority Date for Patents-in-Suit |
| 2019-09-03 | U.S. Patent Nos. 10,401,350 and 10,401,351 Issued |
| 2019-09-03 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,401,350 - Sample Analyzer and Computer Program Product (Issued Sep. 3, 2019)
The Invention Explained
- Problem Addressed: The patent describes that while blood is routinely analyzed, other body fluids like cerebrospinal fluid are also used for diagnosis but present technical challenges. These fluids typically contain very few cells, and conventional blood analyzers are not optimized for such low-concentration samples, often requiring manual sample preparation by an operator (’350 Patent, col. 1:24-43; 1:56-62).
- The Patented Solution: The invention is a single automated analyzer that incorporates two distinct operating modes: a "blood measurement mode" and a "body fluid measurement mode." The analyzer's controller is programmed to execute different sequences of operations for each mode, such as using a longer measurement time for the body fluid sample to improve accuracy for low-cell-count specimens (’350 Patent, Abstract; col. 2:7-18; col. 11:24-30). This allows one instrument to handle both sample types effectively.
- Technical Importance: This technology allows clinical laboratories to automate the analysis of various non-blood body fluids on a single instrument platform, which can improve workflow efficiency and the consistency of results compared to manual methods (’350 Patent, col. 1:33-38).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-28 (Compl. ¶21, 58).
- The essential elements of independent claim 1 include:
- A sample analyzer comprising a plurality of detectors and a controller.
- The controller is programmed to selectively operate the analyzer in a "blood measuring mode" or a "body fluid measuring mode."
- Each mode includes a "sensing operation" and an "analyzing operation."
- The "sensing operation" in the body fluid mode is "different, at least partially," from the sensing operation in the blood mode.
- The plurality of detectors includes at least one "multi-mode detector" that can operate in both modes.
- The controller is programmed to perform the sensing operation in each respective mode to introduce the sample, operate the detector, and derive sample measurements.
U.S. Patent No. 10,401,351 - Sample Analyzer and Computer Program Product (Issued Sep. 3, 2019)
The Invention Explained
- Problem Addressed: The patent addresses the same problem as its sibling ’350 Patent: the difficulty of using a single automated analyzer for both blood and other body fluids (’351 Patent, col. 1:24-43).
- The Patented Solution: This invention focuses specifically on the user interface (UI) and control logic for managing the dual-mode capability. The analyzer's controller is programmed to display an input screen with concurrent options for both a "blood sample" and a "body fluid sample." It also separately displays available "test modes." The system then performs the correct measurement sequence based on two "respective discrete user inputs" from the operator: one selecting the sample type and another selecting the test mode (’351 Patent, col. 17:3-10; 18:7-50).
- Technical Importance: The claimed UI design aims to create a clear and error-resistant workflow, ensuring the operator correctly selects the appropriate analysis protocol for the specific sample type being processed on a multi-functional machine (’351 Patent, col. 10:1-12).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-29 (Compl. ¶21, 63).
- The essential elements of independent claim 1 include:
- A sample analyzer with detectors and a controller operable in a blood mode and a body fluid mode, with a different sensing operation for each.
- The controller is programmed to display on an input screen:
- (1) "at least two sample-type options that comprise concurrent display of a blood sample option and a body fluid sample option," each independently selectable.
- (2) "one or more test modes displayed separately" from the sample-type options.
- The selection of a sample type and a test mode is based on "respective discrete user inputs."
- In response to user inputs selecting the blood sample type and a test mode, the controller performs the sensing operation in the blood measuring mode.
- In response to user inputs selecting the body fluid sample type and a test mode, the controller performs the sensing operation in the body fluid measuring mode.
III. The Accused Instrumentality
Product Identification
- The accused products are the Beckman Coulter UniCel DxH 600, 800, 801, 1600, 1601, 2400, 2401, 900, 900 SMS, 900-2, 900-2 SMS, 900-3, and 900-3 SMS hematology analyzer systems (Compl. ¶6).
Functionality and Market Context
- The complaint alleges the Accused Products are analyzer systems that comprise a sample analyzer with a plurality of detectors, including at least one "multi-mode detector" that can operate in both a "blood measuring mode" and a "body fluid measuring mode" (Compl. ¶17).
- The complaint further alleges that the Accused Products have distinct system parameters for blood analysis and body fluid analysis (Compl. ¶23) and that they perform different sensing operations depending on the mode, such as performing a "pre-washing of a detector in the body fluid measuring mode" but not in the blood mode (Compl. ¶29).
- The Accused Products are alleged to be in direct competition with the Plaintiffs' products (Compl. ¶56).
IV. Analysis of Infringement Allegations
U.S. Patent No. 10,401,350 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A sample analyzer comprising: a plurality of detectors each configured to sense cells in a sample... | The Accused Products include a plurality of detectors. | ¶23 | col. 4:30-38 |
| a controller programmed to selectively operate the sample analyzer in a blood measuring mode or a body fluid measuring mode... | The Accused Products are alleged to operate in both a blood measuring mode and a body fluid measuring mode. | ¶25 | col. 2:7-12 |
| the sensing operation performed in the body fluid measuring mode being different, at least partially, from the sensing operation performed in the blood measuring mode. | The Accused Products allegedly perform pre-washing of a detector in the body fluid mode but do not perform pre-washing in the blood mode. | ¶29 | col. 2:15-18 |
| further wherein the plurality of detectors includes one or more multi-mode detectors configured to operate in both the blood measuring mode and the body fluid measuring mode. | The Accused Products are alleged to include a multi-mode detector, identified as using the "Coulter Principle," that operates in both modes. | ¶31 | col. 4:45-56 |
U.S. Patent No. 10,401,351 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| the controller programmed to: display on an input screen (1) at least two sample-type options that comprise concurrent display of a blood sample option and a body fluid sample option each independently selectable from the other on the input screen. | The complaint includes a screenshot of the Accused Product's UI, which allegedly shows a "Specimen Type" dropdown menu containing both a "Whole blood" option and body fluid options like "CSF" and "Synovial." | ¶47 | col. 10:1-12 |
| (2) one or more test modes displayed separately from a selected one of the at least two sample-type options. | The same screenshot allegedly shows a list of "Available Panels" (e.g., CBC, CDR) displayed in a separate area of the screen from the "Specimen Type" selection. | ¶49 | col. 10:1-12 |
| wherein selecting the body fluid sample option from the at least two sample-type options and setting a test mode from the one or more test modes is based on respective discrete user inputs separately received in the input screen. | The complaint provides a second screenshot from the Accused Product's UI, which purports to show an operator first selecting a body fluid option ("CSF") and then separately selecting a test mode ("BFC"). | ¶51 | col. 9:12-39 |
Identified Points of Contention:
- Scope Questions:
- For the ’350 Patent, a central question may be whether an ancillary step like "pre-washing of a detector" (Compl. ¶29) qualifies as part of the "sensing operation" and makes it "different, at least partially" as required by the claim, or if that language requires a more fundamental difference in the measurement methodology itself.
- For the ’351 Patent, a dispute may arise over the term "concurrent display." The complaint's visual evidence shows a dropdown menu for sample types (Compl. ¶47). This raises the question of whether options that are not simultaneously visible on the screen until a user clicks the menu meet the "concurrent display" limitation.
- Technical Questions: What evidence does the complaint provide that the "Available Panels" on the accused UI (Compl. ¶47) function as the "test modes" recited in claim 1 of the ’351 Patent? The analysis will require mapping the claimed UI structure and function onto the actual operation of the accused software.
V. Key Claim Terms for Construction
The Term: "sensing operation... being different, at least partially" (’350 Patent, Claim 1)
- Context and Importance: The infringement theory for the ’350 Patent hinges on this term. The outcome may depend on whether the alleged difference—performing a detector pre-wash in one mode but not the other—is sufficient to meet this limitation.
- Intrinsic Evidence for a Broader Interpretation: The patent specification provides an example of a difference being a longer measurement time for body fluids, which is a difference in a parameter, not necessarily the core technology (’350 Patent, col. 11:19-30). This may support an argument that any change in the operational sequence, including a preparatory step, qualifies as "different."
- Intrinsic Evidence for a Narrower Interpretation: The abstract and summary repeatedly refer to executing different "operations" for each mode (’350 Patent, Abstract; col. 2:15-18). This could support an argument that the difference must be in the core measurement or analysis operations, not in an ancillary cleaning step that precedes sample introduction.
The Term: "concurrent display" (’351 Patent, Claim 1)
- Context and Importance: Infringement of the ’351 Patent relies on the accused UI meeting this limitation. The complaint’s evidence is a screenshot showing a dropdown menu (Compl. ¶47), making the interpretation of "concurrent display" critical.
- Intrinsic Evidence for a Broader Interpretation: The claim requires "concurrent display of a blood sample option and a body fluid sample option," without specifying that all choices must be visible at all times. The patent's own Figure 8 depicts sample types listed horizontally, which could be argued as conceptually similar to options being available within the same UI element at the same time (’351 Patent, Fig. 8).
- Intrinsic Evidence for a Narrower Interpretation: The ordinary meaning of "display" implies visual presence. An argument could be made that options hidden within a menu until user interaction are not "concurrently displayed" with the visible option. The language may be interpreted to require two or more options to be simultaneously visible on the screen without further user action.
VI. Other Allegations
- Indirect Infringement: The complaint includes allegations of induced and contributory infringement, stating Defendant's conduct causes its customers or others to infringe (Compl. ¶58, 63). However, it does not plead specific facts to support the requisite knowledge and intent, such as by citing instructions in user manuals.
- Willful Infringement: Willfulness is alleged based on infringement continuing "at least after receipt of notice of this complaint" (Compl. ¶61, 66). This is a standard pleading for post-filing willfulness and does not allege pre-suit knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the phrase "sensing operation... being different, at least partially," as claimed in the ’350 Patent, be met by an ancillary preparatory step like pre-washing a detector, or does it require a more substantive change to the measurement process itself?
- A second central question will be one of UI interpretation: does the accused user interface, which allegedly uses a dropdown menu for sample selection, satisfy the "concurrent display" requirement of the ’351 Patent, or does that term require the sample options to be simultaneously visible on the screen?
- Finally, the procedural timing of the case is noteworthy. The filing of the lawsuit on the same day the patents issued suggests a high degree of preparation by the Plaintiff, which may have prosecuted the patent applications with the specific features of the Accused Products in mind.