DCT
1:22-cv-02167
Fred Bergman Healthcare Pty Ltd v. Seneca Sense Tech Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Fred Bergman Healthcare Pty Ltd. and Simavita (Aust) Pty Ltd. (Australia)
- Defendant: Seneca Sense Technologies Inc. (Canada)
- Plaintiff’s Counsel: K&L Gates LLP
- Case Identification: 1:22-cv-02167, E.D. Va., 12/09/2021
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Virginia based on Defendant, a foreign corporation, conducting business through its U.S. Agent located in Hampton, Virginia, and having sufficient minimum contacts with the United States, including regulatory filings with the U.S. Food and Drug Administration (FDA) and Federal Communications Commission (FCC).
- Core Dispute: Plaintiff alleges that Defendant’s WeSense Technology, a smart incontinence monitoring system, infringes a patent related to systems that use mathematical models to characterize wetness events.
- Technical Context: The technology operates in the digital health and elder care market, providing wearable sensor systems to automate the monitoring of incontinence in healthcare facilities.
- Key Procedural History: The complaint alleges a prior business relationship, beginning in 2011, between Plaintiff Simavita and Defendant’s principal, Robert Tarasofsky. During this relationship, Mr. Tarasofsky allegedly gained access to Plaintiff’s confidential information and intellectual property, which the complaint suggests was later used to develop the accused competing product. This history is cited to support allegations of knowledge and willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2004-11-03 | Priority Date for U.S. Patent No. 7,977,529 |
| 2011-05-01 | Simavita and 7679149 Canada (Mr. Tarasofsky's Co.) enter agreement |
| 2011-07-12 | U.S. Patent No. 7,977,529 issues |
| 2012-10-01 | Simavita enters distribution agreement with Medline |
| 2013-08-22 | Plaintiff Simavita receives FDA 510(k) premarket notification |
| 2014-01-01 | Simavita and 7679149 Canada enter Services Agreement |
| 2017-11-01 | Defendant Seneca Sense begins trials/pilots of WeSense technology |
| 2018-05-31 | Defendant files U.S. trademark applications |
| 2018-10-11 | Defendant files for FDA registration for its WeSense system |
| 2019-11-01 | Defendant files for FCC equipment authorization |
| 2021-12-09 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,977,529: Incontinence Management System and Diaper (Issued July 12, 2011)
The Invention Explained
- Problem Addressed: The patent addresses the deficiencies of existing incontinence management, particularly the strain on staff resources from frequent manual checks and the inadequacy of simple detection systems that only provide binary wet/dry alerts without indicating the degree of wetness or type of event (’529 Patent, col. 1:41-61, col. 2:50-61). Such systems can lead to unnecessary patient disturbances and inefficient care (’529 Patent, col. 2:56-62).
- The Patented Solution: The invention proposes a system that moves beyond simple detection to intelligent analysis. It uses sensors in an absorbent article, but the core innovation lies in a processor that applies sensor data to a "pre-determined mathematical model" to "characterise a wetness event" (’529 Patent, Abstract). This characterization can include estimating the volume of fluid, which allows the system to provide more nuanced alerts (e.g., when a diaper is reaching capacity) and to create individualized care plans. The system is also designed to be adaptable, with the capability to reconfigure its mathematical models for different patients, sensor types, or absorbent articles (’529 Patent, col. 4:18-35).
- Technical Importance: This technology represents a shift from a simple alarm to a data-driven management tool, intended to improve the efficiency of care and the dignity of patients by providing more actionable information than a basic wetness alert (’529 Patent, col. 3:7-13).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶49).
- The essential elements of independent claim 1 include:
- A moisture monitoring system with an input, a processor, and a user interface.
- The processor executes an algorithm to analyze sensor signals.
- This analysis involves applying the sensor signals to a "pre-determined mathematical model to characterize a wetness event."
- Crucially, the system "has devised the pre-determined mathematical model using sensor signal data previously received by the system," with the model representing a relationship between sensor signal variables and a characteristic of the wetness event.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant's "WeSense Technology," which comprises the "WeSense Pod," a "WeSense printed sensor," and a "WeSense software application" (Compl. ¶46). The complaint also identifies the "FitRight Connect" system, developed by Defendant for its customer Medline, as an infringing product (Compl. ¶30, 33).
Functionality and Market Context
- The WeSense system uses a disposable sensor placed in an incontinence brief, which connects to a reusable, wearable "POD" (Compl. ¶16, 50). The POD detects wetness and transmits alerts via Wi-Fi to a software application on a caregiver's phone or tablet (Compl. ¶51, 58). The complaint provides a screenshot from the Apple App Store identifying "Seneca Sense Technologies Inc" as the developer of the "Connect by FitRight" application, which is described as a system to "alert caregivers as an incontinent product reaches capacity" (Compl. p. 12). The system is marketed as a tool to enable caregivers to change residents at the "right time," avoiding premature changes or prolonged wetness, thereby saving labor and improving care (Compl. ¶59, p. 24).
IV. Analysis of Infringement Allegations
’529 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A moisture monitoring system for monitoring wetness in one or more absorbent articles, the system including... | The WeSense Technology as a whole is identified as the infringing system, described as a "Solution for Real Time Care" (Compl. p. 16). | ¶50 | col. 15:42-44 |
| an input for receiving one or more sensor signals indicative of a presence of wetness in an absorbent article | The system's POD allegedly receives signals from a sensor when a "wetness event occurs," and the POD sends a signal to the user's device (Compl. p. 17). | ¶51 | col. 7:42-44 |
| a processor | The processor is alleged to be the phone or tablet running the WeSense or FitRight application, or alternatively, a processor located within the WeSense Pod itself (Compl. p. 19). The complaint includes a photograph of the WeSense Pod's internal circuit board as evidence of an onboard processor (Compl. ¶53). | ¶52, ¶53 | col. 7:43 |
| user interface for communicating with a user of the system | The software application on a phone or tablet, which displays patient status and alerts, is alleged to be the user interface (Compl. p. 19). | ¶54 | col. 7:44-45 |
| wherein the processor executes an algorithm to analyze the one or more sensor signals by applying the one or more received sensor signals to a pre-determined mathematical model to characterize a wetness event... | The complaint alleges this is met because the system alerts caregivers "only when the brief reaches a pre-determined capacity" (Compl. p. 20). This functionality is presented as the "characterization" of the wetness event. | ¶55 | col. 15:49-54 |
| wherein the system has devised the pre-determined mathematical model using sensor signal data previously received by the system... | The use of green, yellow, and red status indicators on the user interface is alleged to be evidence of a "mathematical model against which the sensors are calibrated" (Compl. p. 21). This implies the model was "devised" using prior data to set the thresholds for each status level. | ¶56 | col. 15:55-61 |
- Identified Points of Contention:
- Scope Questions: A central dispute may arise over the meaning of "pre-determined mathematical model." The question is whether the accused system's apparent use of tiered thresholds (e.g., low, medium, high saturation) satisfies this limitation, or if the patent requires a more complex model that, for example, estimates fluid volume as detailed in the specification (’529 Patent, col. 10:1-8).
- Technical Questions: The complaint infers that the accused system's model was "devised... using sensor signal data previously received," but does not provide direct evidence of this "devising" process. A key question for the court will be whether Plaintiff can produce evidence that the accused system's thresholds are the result of a data-driven development process as taught by the patent (’529 Patent, Fig. 4), or if they are simply pre-set, hard-coded values that do not meet the claim limitation.
V. Key Claim Terms for Construction
The Term: "pre-determined mathematical model"
- Context and Importance: This term is the technological core of Claim 1. The infringement analysis will likely depend on whether the accused system's logic for triggering alerts constitutes such a "model." Practitioners may focus on this term because its construction will determine whether a simple, multi-level threshold system infringes, or if a more sophisticated, analytical algorithm is required.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is general. The patent's abstract states broadly that "A mathematical model is used to characterise wetness events," which could arguably encompass any set of rules beyond a simple binary alert (’529 Patent, Abstract).
- Evidence for a Narrower Interpretation: The specification provides specific, detailed examples of such models, including a regression analysis to formulate parameters and an equation for estimating volume (’529 Patent, Fig. 4; col. 10:5-8, Eq 1). This could support an argument that the term is limited to models that perform quantitative estimations or are derived through a specific analytical process.
The Term: "characterize a wetness event"
- Context and Importance: This defines the function of the "mathematical model." The dispute will turn on what level of analysis is required to "characterize" an event.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term is not explicitly defined. A plaintiff could argue that classifying an event into one of several categories (e.g., low, medium, or high saturation, as implied by the accused product's alerts) is a form of characterization.
- Evidence for a Narrower Interpretation: The specification repeatedly links "characterizing" to specific, analytical outputs, such as determining an "estimated volume of exudate," the "nature of the exudate," or classifying the "type of incontinence" (’529 Patent, col. 3:29-32; col. 8:62-68). A defendant could argue that merely indicating a saturation level does not rise to the level of "characterization" as taught by the patent.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement (Compl. ¶75-78). Inducement is based on Defendant allegedly developing and offering the WeSense system with instructions that encourage infringing use by customers and end-users (Compl. ¶76). Contributory infringement is based on the allegation that the WeSense Pod is a material component of the invention, is not a staple article of commerce, and is especially made for use in an infringing manner (Compl. ¶48, 78).
- Willful Infringement: Willfulness is alleged based on Defendant having "acted with full knowledge of the '529 Patent" (Compl. ¶70). The factual basis for this allegation is the prior business relationship between Plaintiff and Defendant's principal, during which the principal allegedly had access to Plaintiff's intellectual property and technology (Compl. ¶16-22).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute will likely depend on the court's determination of two central questions:
A core issue will be one of definitional scope: can the claim term "pre-determined mathematical model", which the patent specification illustrates with examples of regression analysis and volume estimation, be construed broadly enough to read on the accused system's apparent use of tiered saturation thresholds (e.g., green, yellow, red alerts)?
A key evidentiary question will be one of technical proof: what evidence will emerge in discovery to show how the accused system's alerting logic was created? The infringement finding may hinge on whether Plaintiff can prove this logic was "devised... using sensor signal data previously received," as required by the claim, or whether Defendant can show it was developed using simple, pre-set engineering values that fall outside the patent's teachings.