DCT
1:16-cv-00679
Zimmer Surgical Inc v. Stryker Corp
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Zimmer Surgical, Inc. (Delaware) and Dornoch Medical Systems, Inc. (Illinois)
- Defendant: Stryker Corporation (Michigan) and Stryker Sales Corporation (Michigan)
- Plaintiff’s Counsel: Richards, Layton & Finger LLP; Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
- Case Identification: 1:16-cv-00679, D. Del., 08/08/2016
- Venue Allegations: Venue is alleged based on Defendants' substantial business contacts in Delaware and because a substantial part of the events giving rise to the claims occurred in the state.
- Core Dispute: Plaintiffs allege that Defendants’ Neptune 2 and Neptune 3 surgical waste management systems infringe a patent related to high-volume liquid waste collection and disposal technology.
- Technical Context: The technology concerns systems used in operating rooms to safely collect, contain, and dispose of large volumes of biological fluid waste generated during surgical procedures.
- Key Procedural History: The patent-in-suit, RE44,920, is a reissue of U.S. Patent No. 7,892,420 and claims priority to U.S. Patent No. 6,893,425. The complaint alleges that a Stryker patent related to medical waste disposal cites the ’425 patent, which may be used to support allegations of pre-suit knowledge.
Case Timeline
| Date | Event |
|---|---|
| 2002-03-04 | RE44,920 Patent Earliest Priority Date |
| 2014-06-03 | RE44,920 Patent Issue Date |
| 2016-08-08 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. RE44,920 - “High Volume Liquid Waste Collection and Disposal System”
The Invention Explained
- Problem Addressed: The patent background describes challenges with prior art methods for handling surgical fluid waste, such as the risk of spills and contamination from open "gravity buckets" and the complexity, expense, and difficulty in cleaning systems that use numerous small canisters linked in tandem (RE44,920 Patent, col. 1:49-col. 2:44).
- The Patented Solution: The invention is a two-part system comprising a mobile fluid collection cart and a stationary disposal unit. The cart uses one or more large, reusable containers to collect waste fluid via suction in the operating room. After use, the cart is moved and connected to the disposal unit, which automatically drains the waste, flushes the containers with water and disinfectant, and disposes of the treated fluid into a sanitary drain (RE44,920 Patent, Abstract; col. 4:5-20). Figure 9 of the patent illustrates the mobile cart (12) connecting to the stationary draining and cleaning station (173).
- Technical Importance: This approach aims to provide a safe and convenient method for managing large volumes of potentially infectious fluid waste, reducing manual handling and personnel exposure while simplifying the cleaning and reuse of collection components (RE44,920 Patent, col. 4:39-48).
Key Claims at a Glance
- The complaint asserts independent claims 15 and 29 (Compl. ¶14).
- Independent Claim 15 is a system claim with the following essential elements:
- A movable waste fluid collection cart with a flushing portion, a drain portion, and at least two containers to collect liquid waste via suction, where at least one suction port provides at least two different suction levels.
- A waste fluid disposal unit with a first portion that couples to the cart's flushing portion and connects to a water source, and a second portion that couples to the cart's drain portion and connects to a drain pump for disposal.
- Independent Claim 29 is a system claim with the following essential elements:
- A movable waste fluid collection cart with a flushing portion, a drain portion, and at least two containers to collect liquid waste via suction.
- The level of suction at one suction port is independently adjustable from the level of suction at another suction port.
- A waste fluid disposal unit with a first portion that couples to the cart's flushing portion to provide water, and a second portion that couples to the cart's drain portion to pump waste to a drain.
- The complaint also reserves the right to assert dependent claims 17-23, 25-28, 30, 32-38, 40, and 41 (Compl. ¶30).
III. The Accused Instrumentality
Product Identification
The Stryker Neptune 2 Waste Management System and the Stryker Neptune 3 Waste Management System (Compl. ¶9).
Functionality and Market Context
The accused systems are designed to collect and dispose of surgical fluid waste in operating rooms (Compl. ¶15). They consist of a mobile "Rover" and a stationary "Docking Station" (Compl. ¶16). The Rover is a mobile cart with four casters and two canisters used to suction and collect fluid waste from a surgical site (Compl. ¶16-17). The complaint includes a diagram, "Figure 1 To Collect Fluid Waste," illustrating the collection of fluids into the Rover's canisters (Compl. p. 6). After collection, the Rover is "relocated and mated" to the Docking Station, which provides a fixed connection to a hospital's water supply and sewer for "automated rover cleaning and waste offloading" (Compl. ¶16, 18).
IV. Analysis of Infringement Allegations
RE44,920 Patent Infringement Allegations (Claim 15)
| Claim Element (from Independent Claim 15) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) a movable waste fluid collection cart including: i) a body supported by a plurality of wheels; | The accused Neptune systems include a "Rover," which is a "mobile unit" supported by "four swivel casters" for mobility. | ¶16 | col. 14:59-62 |
| ii) a flushing portion and a drain portion; and | The Rover's canisters have an inlet connected to a flushing system and an outlet connected to a drain system. This is illustrated in a complaint diagram titled "Figure 4 To Clean the Canisters" (Compl. p. 6). | ¶18 | col. 15:7-8 |
| iii) at least two containers supported by the body, each container including a suction port, each container being configured to collect liquid waste from the patient via its respective suction port when a vacuum is applied to the container, at least one of the suction ports being configured to provide at least two different levels of suction... | The Rover includes a "two canister design." Each canister collects fluid via a suction port. Each canister is configured to provide at least two different levels of suction. | ¶17 | col. 15:9-14 |
| b) a waste fluid disposal unit including: i) a first portion coupleable to the flushing portion of the waste fluid collection cart, the first portion being connectable to a water source... to provide water to the waste fluid collection cart... | The Docking Station has a first portion that couples to the Rover's flushing portion. The complaint alleges the Docking Station includes a "Wash" option that applies water to rinse the canisters. The Docking Station connects to the hospital's water supply. | ¶16, 19 | col. 15:18-22 |
| ii) a second portion coupleable to the drain portion of the waste fluid collection cart, the second portion being connectable to a drain via a drain pump, wherein patient's waste fluid... is pumpable to the drain by the drain pump... | The Docking Station has a second portion that couples to the Rover's drain portion. It includes a "Quick Drain" option to drain the canister contents, which the complaint alleges is facilitated by a drain pump. A diagram titled "Figure 3 To Empty the Canisters" shows this connection (Compl. p. 7). | ¶20 | col. 15:23-28 |
RE44,920 Patent Infringement Allegations (Claim 29)
| Claim Element (from Independent Claim 29) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) a movable waste fluid collection cart including... iii) at least two containers supported by the body, each container including a suction port... a level of suction at one of the suction ports being independently adjustable of a level of suction at another of the suction ports... | The Rover includes a "two canister design" which "allows separate suction limit settings." The complaint alleges that "the level of suction at one of the suction ports is independently adjustable from the level of suction at the other suction port." The Neptune 3 is also alleged to have "[t]wo independently operated suction levels." | ¶17, 21 | col. 16:34-37 |
| b) a waste fluid disposal unit including... | The allegations for the "waste fluid disposal unit" elements are substantively identical to those for Claim 15, mapping the Docking Station's features to the claimed first (flushing) and second (drain) portions (as described in Section IV above). | ¶16, 19, 20 | col. 16:41-52 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether the combination of the physically separate "Rover" (cart) and "Docking Station" (disposal unit) constitutes a single "system for handling waste fluid" as claimed. While they are sold and used together, their separability may form the basis of a non-infringement argument.
- Technical Questions: The analysis may focus on whether the accused Rover's mechanism for setting suction levels meets the specific claim requirement of being "independently adjustable" (Claim 29) or providing "at least two different levels of suction" (Claim 15). The precise manner in which the Docking Station's "Wash" and "Drain" functions operate will be compared to the functions of the claimed "flushing portion" and "drain portion."
V. Key Claim Terms for Construction
The Term: "waste fluid disposal unit" (Claim 15, element b)
Context and Importance: This term defines the stationary component of the claimed system. The infringement case hinges on mapping Stryker's "Docking Station" to this element. Practitioners may focus on this term because its construction will determine what specific structural and functional features are required for infringement, beyond simply being a stationary unit that drains and cleans the mobile cart.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims themselves define the unit functionally by what it does: it has portions that are "coupleable" to the cart's flushing and drain portions and connect to water and drain lines, respectively (RE44,920 Patent, col. 15:17-28). This suggests the term could cover any device that performs these coupling and fluid-handling functions.
- Evidence for a Narrower Interpretation: The specification describes a specific embodiment of the station (173) that includes not just pumps and connectors, but also a microprocessor, a control panel, and a sink for cleaning separate canisters (RE44,920 Patent, FIG. 10; col. 8:35-49). A defendant may argue that these detailed features are integral to the meaning of the term.
The Term: "independently adjustable" (Claim 29, element a.iii)
Context and Importance: This term is a key differentiator in Claim 29. The infringement reading depends on showing that the two suction ports on the accused Rover can be controlled separately from one another. Practitioners may focus on this term because the dispute could turn on the degree of independence required (e.g., can one be on while the other is off, or must they simply be settable to different vacuum levels).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes using valve handles (108a, 108b, 110) to configure the vacuum for each container. One configuration allows for one container to have high suction while the other has a lower, "gravity drain" level of suction simultaneously (RE44,920 Patent, col. 5:11-26). This supports a reading that "independently adjustable" means the ability to operate the canisters under different suction profiles at the same time.
- Evidence for a Narrower Interpretation: The description focuses on a specific regulator (76) and a system of valves (86, 104, 94) to achieve this result (RE44,920 Patent, FIG. 4). A defendant might argue that the term is limited to a system that uses a similar bypass and regulator mechanism, rather than any system that allows for separate suction settings.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Stryker provides user manuals, such as an "Installation, Operation, and Maintenance Guide," that instruct end users on how to operate the Neptune systems in an infringing manner (Compl. ¶11, 28). It also alleges contributory infringement, asserting that the Rover and Docking Station are especially made for infringing use, are not staple articles of commerce, and have no substantial non-infringing uses (Compl. ¶10, 29).
- Willful Infringement: Willfulness is alleged based on both pre- and post-suit knowledge. The complaint alleges pre-suit knowledge by pointing out that Plaintiffs and Defendants are "direct and active competitors in the two-competitor field of fluid waste management" (Compl. ¶26). More specifically, it alleges that Stryker’s U.S. Patent No. 7,621,898 cites the ’425 patent, which is the parent patent to the asserted ’920 patent, suggesting Stryker knew of the patented technology (Compl. ¶26, 32).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope and system definition: Does the accused combination of a mobile "Rover" and a physically separate, stationary "Docking Station" constitute a single, integrated "system for handling waste fluid" as defined by the claims, or does their separability defeat a literal infringement reading?
- A second central question relates to knowledge and willfulness: Do the allegations that Stryker cited the parent patent in its own patent prosecution, combined with the context of a "two-competitor field," create a sufficiently strong inference of pre-suit knowledge to support a claim for willful infringement?
- A key evidentiary question will be one of technical operation: Does the evidence show that the accused Neptune systems' suction controls, flushing mechanisms, and draining functions perform in a manner that maps directly onto the specific limitations recited in independent claims 15 and 29, particularly the requirement for "independently adjustable" suction levels?