DCT
1:15-cv-09986
Baxter Intl Inc v. CareFusion Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Baxter International, Inc. (Delaware)
- Defendant: CareFusion Corporation (Delaware) and Becton, Dickinson and Company (New Jersey)
- Plaintiff’s Counsel: Roeser Bucheit & Graham LLC; Barclay Damon LLP
- Case Identification: 1:15-cv-09986, N.D. Ill., 01/26/2016
- Venue Allegations: Venue is alleged to be proper based on Defendants’ places of business within the district, extensive business transactions and solicitations in Illinois, and commission of infringing acts in the district.
- Core Dispute: Plaintiff alleges that Defendants’ Alaris System, a modular intravenous infusion pump, infringes three patents related to battery monitoring technology, modular pump design, and automated medication control.
- Technical Context: The technology concerns intravenous (IV) infusion pumps, which are critical medical devices for delivering fluids, nutrients, and medications to patients in clinical and home-care settings.
- Key Procedural History: The complaint is a First Amended Complaint. Post-filing, two of the patents-in-suit were subject to Inter Partes Review (IPR) proceedings. The IPRs resulted in the cancellation of all asserted claims of U.S. Patent No. 5,764,034 and the cancellation of asserted independent claim 1 and dependent claims 2-3 of U.S. Patent No. 6,231,560.
Case Timeline
| Date | Event |
|---|---|
| 1996-04-10 | Priority Date for ’034 and ’805 Patents |
| 1998-06-09 | Issue Date for U.S. Patent 5,764,034 |
| 1998-07-21 | Issue Date for U.S. Patent 5,782,805 |
| 1999-02-10 | Priority Date for ’560 Patent |
| 2001-05-15 | Issue Date for U.S. Patent 6,231,560 |
| 2015-03-17 | Becton and CareFusion Merger Effective Date |
| 2016-01-26 | First Amended Complaint Filing Date |
| 2016-07-19 | IPRs filed against ’034 and ’560 Patents |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,764,034 - "Battery Gauge For A Battery Operated Infusion Pump"
The Invention Explained
- Problem Addressed: The patent asserts that prior art battery monitors for medical infusion pumps were often inaccurate because they only measured battery voltage. This could lead to conservative, premature low-battery warnings or, conversely, unexpected power failures when a device was being used by an ambulatory patient. (’034 Patent, col. 1:49-65).
- The Patented Solution: The invention proposes a more accurate and cost-effective method for estimating the remaining operational time of a battery-powered infusion pump. The solution involves periodically sampling not only the battery's voltage but also the amount of current being drawn from it. A microprocessor then uses these sampled signals to calculate and display the amount of time left under battery power, potentially as a graphical representation. (’034 Patent, Abstract; col. 2:20-34).
- Technical Importance: For mobile medical devices, accurately predicting remaining battery life is critical for patient safety and continuity of care, particularly during transport or in situations without immediate access to AC power. (’034 Patent, col. 1:41-49).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶27).
- Essential elements of independent claim 1 include:
- A pump drive mechanism and a battery to power it.
- A circuit to monitor both the voltage and current from the battery.
- A circuit responsive to the monitoring circuit to determine the remaining time of charge.
- A "battery alarm" for when charge is below a first predetermined level and a "battery low alert" for when charge is below a second, higher predetermined level.
- Display means for showing the remaining time of charge.
- The complaint reserves the right to assert dependent claims 2, 3, 9, 10, 11, and 12. (Compl. ¶27).
U.S. Patent No. 5,782,805 - "Medical Infusion Pump"
The Invention Explained
- Problem Addressed: The patent notes that hospitals traditionally needed to maintain large inventories of specialized infusion pumps for different clinical applications (e.g., general care, pediatrics, critical care). It also notes that administering multiple fluids to a single patient required multiple separate pumps, crowding the patient's bedside. (’805 Patent, col. 1:37-60).
- The Patented Solution: The invention describes a modular infusion pump system. It features a central "main body portion" containing a primary display and a microprocessor, to which one or more "removably secured" pump modules can be attached. Each pump module is described as having its own "auxiliary display" for "supplemental user interface information." This modularity allows a single pump system to be configured with a variable number of channels and adapted for different clinical needs. (’805 Patent, Abstract; col. 2:6-17).
- Technical Importance: This modular design offered greater clinical flexibility, potentially reducing capital equipment costs for healthcare facilities and simplifying the setup for complex, multi-channel infusions. (’805 Patent, col. 1:61-col. 2:5).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 36. (Compl. ¶34).
- Essential elements of independent claim 1 include:
- A main body portion with a display.
- At least one pump module that is removably secured to the main body.
- An auxiliary display on the pump module for supplemental information.
- A microprocessor in the main body for generating user interface information on the displays.
- Means for generating pictorial graphic representations on the main display.
- A plurality of selectable sets of configuration parameters.
- Essential elements of independent claim 36 include:
- A main body portion with a display and at least one removable pump module.
- A battery providing power.
- Means for determining the charge of the battery.
- A pictorial graphic representation of the battery's charge included as user interface information.
- The complaint reserves the right to assert numerous dependent claims. (Compl. ¶34).
U.S. Patent No. 6,231,560 - "Method And Apparatus For Automatically Controlling The Level Of Medication"
- Technology Synopsis: This patent discloses a method and apparatus for automatically adjusting medication delivery in a patient-controlled analgesia (PCA) setting. The system is designed to capture patient-specific information regarding pain level, side effects, and functional impairment, and then use a pre-programmed algorithm to automatically modify the medication's basal rate and bolus dose to optimize treatment. (’560 Patent, Abstract; col. 2:37-52).
- Asserted Claims: The complaint asserts independent claims 1 and 9, as well as dependent claims 2, 3, 10, and 11. (Compl. ¶41).
- Accused Features: The complaint accuses the Alaris System's PC Unit and PCA Module, potentially in conjunction with SpO2 and EtCO2 monitoring modules and the CareFusion Guardrails Suite MX software, of infringement. (Compl. ¶41).
III. The Accused Instrumentality
Product Identification
- The Alaris System. (Compl. ¶11).
Functionality and Market Context
- The complaint describes the Alaris System as a modular intravenous infusion system. The core of the system is the Alaris Model 8000 or 8015 "PC Unit," which serves as the central controller and user interface. (Compl. ¶11).
- Various functional modules can be physically attached to this PC Unit, including the Alaris Model 8100 Pump Module, Model 8110 Syringe Module, and Model 8120 Patient-Controlled Analgesia (PCA) Module. The system can also incorporate monitoring modules (e.g., SpO2, EtCO2) and an Auto-ID module. The system's operation is governed by firmware and application software, such as the CareFusion Guardrails Suite MX software. (Compl. ¶11).
- The complaint alleges the Accused Product is used for the delivery of fluids and drugs to patients. (Compl. ¶9).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
5,764,034 Infringement Allegations
The complaint does not provide sufficient detail for a complete analysis, as infringement is alleged in a conclusory manner. The table below summarizes the allegations based on the identified components.
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a pump drive mechanism...a battery for powering the pump drive mechanism | The Alaris PC Unit in conjunction with the Pump, Syringe, and/or PCA Modules, which contain battery-powered pump mechanisms. | ¶27 | col. 16:1-4 |
| a circuit which monitors the voltage and current from the battery | The firmware and hardware within the Accused Product that allegedly monitor battery voltage and current. | ¶27 | col. 16:5-6 |
| a circuit responsive to the monitoring circuit which determines the remaining time of charge in the battery | The firmware and hardware within the Accused Product that allegedly calculate remaining battery life. | ¶27 | col. 16:7-9 |
| a battery alarm...a battery low alert... | The alert and alarm systems of the Accused Product, which allegedly activate at different, predetermined levels of remaining battery charge. | ¶27 | col. 16:10-15 |
| display means for displaying the remaining time of charge in the battery | The display screen on the PC Unit of the Accused Product, which allegedly displays the calculated remaining battery time. | ¶27 | col. 16:16-17 |
5,782,805 Infringement Allegations
The complaint does not provide sufficient detail for a complete analysis. The tables below summarize the allegations based on the identified components.
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a main body portion; a display contained on the main body portion... | The Alaris PC Unit, which contains a main display screen. | ¶¶11, 34 | col. 20:12-15 |
| at least one pump module removably secured to the main body portion... | The Alaris Pump, Syringe, and/or PCA modules, which are described as being attachable to the PC Unit. | ¶¶11, 34 | col. 20:16-20 |
| an auxiliary display contained on the pump module for displaying supplemental user interface information | The individual displays on the Alaris modules, which allegedly show supplemental information. | ¶¶11, 34 | col. 20:21-23 |
| microprocessor means...for generating user interface information on the display areas | The processor within the Alaris PC Unit, which drives the main display and module displays. | ¶¶11, 34 | col. 20:24-26 |
| means for generating a plurality of pictoral graphic representations... | The software and processor in the Alaris PC Unit that allegedly generate graphical icons and displays. | ¶¶11, 34 | col. 20:27-29 |
| wherein a plurality of sets of configuration parameters are included... | The Alaris system's software (e.g., Guardrails Suite MX), which allegedly allows users to select from different clinical configurations. | ¶¶11, 34 | col. 20:30-34 |
| Claim Element (from Independent Claim 36) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a main body portion; a display...at least one pump module removably secured... | The modular Alaris system, comprising the PC Unit and one or more attachable modules. | ¶¶11, 34 | col. 22:58-65 |
| a battery which provides electrical power... | The battery within the Alaris system. | ¶¶11, 34 | col. 23:1-4 |
| means for determining the charge of the battery | The battery monitoring hardware and software within the Alaris system. | ¶¶11, 34 | col. 23:5-6 |
| wherein a pictoral graphic representation of the charge of the battery is included as user interface information | The graphical battery icon or gauge allegedly displayed on the Alaris system's user interface. | ¶¶11, 34 | col. 23:7-9 |
Identified Points of Contention
- Claim Validity: A threshold issue is that all asserted claims of the ’034 Patent and asserted claims 1-3 of the ’560 Patent were cancelled in IPRs initiated after the complaint was filed. This raises a significant question about the viability of the infringement counts for those patents.
- Scope Questions: For the ’805 Patent, a dispute may arise over the meaning of "removably secured," and whether the Alaris modules meet that definition. The scope of "supplemental user interface information" on the "auxiliary display" will also be a key issue, questioning whether the information on the Alaris modules' displays qualifies as "supplemental."
- Technical Questions: The complaint does not specify how the Alaris System determines remaining battery life. A central technical question is whether its method is equivalent to the one described in the ’034 patent, which involves specific calculations based on both current and voltage readings. For the ’805 patent, it is an open question whether the Alaris system provides a "pictoral graphic representation of the charge of the battery" as required by claim 36.
V. Key Claim Terms for Construction
Patent: ’034 Patent
- The Term: "circuit responsive to the monitoring circuit which determines the remaining time of charge in the battery" (claim 1)
- Context and Importance: This is a functional limitation that is central to the invention. The scope of this term will define what method of battery-life calculation is covered. Practitioners may focus on this term to determine if its scope is limited to the specific algorithm disclosed or if it can cover any method that uses both voltage and current.
- Intrinsic Evidence for a Broader Interpretation: The Abstract describes the solution broadly as a "method... applied to the sampling signals by a microprocessor." (’034 Patent, Abstract).
- Intrinsic Evidence for a Narrower Interpretation: The specification details a specific algorithm for calculating remaining time, which involves extrapolating remaining minutes based on a series of true RMS voltage samples over time. (’034 Patent, col. 13:50-col. 14:48; FIG. 14). A defendant would likely argue the claim scope is limited to this disclosed algorithm and its equivalents.
Patent: ’805 Patent
- The Term: "auxiliary display contained on the pump module for displaying supplemental user interface information" (claim 1)
- Context and Importance: This term distinguishes the module's display from the main display and is a core element of the claimed modular system. The infringement analysis for claim 1 depends on whether the displays on the Alaris modules meet this definition.
- Intrinsic Evidence for a Broader Interpretation: The patent abstract distinguishes between "user interface information" on the main display and "supplemental user interface information" on the auxiliary display, which could be argued to mean any information on the module display that supplements the main display. (’805 Patent, Abstract).
- Intrinsic Evidence for a Narrower Interpretation: The specification describes the auxiliary display area (29) as an "eight-character display area" used to "prompt or instruct the user" and provide an "indication of the status of the infusion." (’805 Patent, col. 5:15-21). This could be argued to limit the term to a more basic, character-based status display rather than a full graphical interface.
VI. Other Allegations
- Indirect Infringement: The complaint does not provide sufficient detail for analysis of any indirect infringement theory.
- Willful Infringement: The complaint alleges that Defendants' infringement will be willful, deliberate, and intentional because they have had actual notice of the patents-in-suit at least since the commencement of the action. (Compl. ¶¶30, 37, 44). This forms a basis for post-filing willfulness, and the prayer for relief seeks enhanced damages under 35 U.S.C. § 284. (Compl. Request for Relief, ¶D).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central, dispositive issue will be one of claim viability: Given that post-filing IPR proceedings resulted in the cancellation of all asserted claims of the ’034 patent and the primary asserted claims of the ’560 patent, a threshold question for the court is whether the infringement counts related to those patents can proceed.
- For the surviving claims of the ’805 patent, the case will likely turn on claim construction: Can the term "auxiliary display... for displaying supplemental user interface information" be construed to read on the specific displays of the Alaris modules? Similarly, does the accused product's battery indicator meet the definition of a "pictoral graphic representation of the charge of the battery"?
- A key evidentiary question will be one of technical proof: The complaint makes conclusory allegations of infringement without providing detailed factual support for how the accused Alaris System performs the functions required by the claims. The case will hinge on whether discovery produces technical evidence that can map the specific operation of the Alaris System to the limitations of the asserted claims.