DCT

3:24-cv-00295

Hi Dow Iphc Inc v. MC Innovations LLC

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-00295, TXSD, 12/04/2024
  • Venue Allegations: Venue is alleged to be proper in the Southern District of Texas as Defendant is a Texas limited liability company that resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s ePulse Wireless 1600 electrical stimulation device infringes patents related to systems for wirelessly controlling multiple stimulation units from a single remote.
  • Technical Context: The technology pertains to Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS) devices, used for drug-free pain management and muscle recovery.
  • Key Procedural History: The U.S. Patent No. 11,351,361 is a continuation-in-part of the application that matured into U.S. Patent No. 9,415,217, indicating a shared specification and potential overlap in the disclosed technology. The complaint does not mention any other prior litigation, inter partes review proceedings, or licensing history.

Case Timeline

Date Event
2014-07-10 Earliest Priority Date for '217 and '361 Patents
2016-08-16 '217 Patent Issued
2021-01-01 Approx. Date of Hi-Dow Founding
2022-06-07 '361 Patent Issued
2023-05-01 Alleged Infringement by Defendant Begins (on or after this date)
2024-12-04 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,415,217 - Wireless Electrical Stimulation System, issued August 16, 2016

The Invention Explained

  • Problem Addressed: The patent identifies the inconvenience of conventional electrical stimulation systems, which typically use a control unit hard-wired to electrodes. This tethered design is described as limiting treatments to a single area at a time and providing little information to the user about the therapy being delivered ('217 Patent, col. 1:22-29; Compl. ¶13).
  • The Patented Solution: The invention is a wireless system comprising a single remote-control transmitter that can independently operate at least two separate electrical stimulation units ('217 Patent, Abstract). The transmitter can select different units ("channels"), choose from various operating modes, and adjust intensity, with a display providing feedback to the user on the selected parameters ('217 Patent, col. 4:1-13, col. 5:1-12). This allows for simultaneous, customized treatment of multiple body areas without physical wires connecting them to the controller ('217 Patent, col. 10:18-36). The complaint includes a photograph of Plaintiff's own product, which depicts a handheld remote and a separate, wireless stimulation "puck" attached to an electrode pad, illustrating this untethered concept (Compl. p. 3).
  • Technical Importance: This approach seeks to improve user convenience and the versatility of TENS/EMS therapy by untethering the controller from the stimulation points and enabling coordinated control over multiple, discrete treatment sites ('217 Patent, col. 1:30-38).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2, 4, 5, and 11 (Compl. ¶24).
  • Independent Claim 1 of the '217 patent recites:
    • A system with at least two electrical stimulation units, each having electrodes.
    • A transmitter for remotely and wirelessly controlling each unit.
    • The control occurs by transmitting operating instructions on "separate channels at different frequencies."
    • Control is established by "matching a code sent by each of the electrical stimulation units with a predetermined code."
    • The transmitter includes a "unit selector" to choose which stimulation unit to control.

U.S. Patent No. 11,351,361 - Wireless Electrical Stimulation System, issued June 7, 2022

The Invention Explained

  • Problem Addressed: As a continuation-in-part of the '217 patent's application, this patent addresses the same general problems of wired, single-treatment TENS/EMS systems ('361 Patent, col. 1:28-44).
  • The Patented Solution: The '361 patent claims a system with a wireless controller and at least two stimulation units, but its claims focus more specifically on the physical and structural arrangement of the components ('361 Patent, Abstract). The invention describes a system where the electrical stimulation unit (the "puck" containing the electronics) is a discrete component that connects to a separate substrate (the electrode pad) via "fasteners." This allows the electronic unit to be attached to and detached from the pad that contacts the skin ('361 Patent, col. 5:36-54, Fig. 7).
  • Technical Importance: This modular design, separating the reusable electronic "puck" from the potentially disposable electrode pad "substrate," provides a distinct physical architecture for a wireless stimulation system ('361 Patent, col. 5:36-49).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2, 6, 11, and 13 (Compl. ¶30).
  • Independent Claim 1 of the '361 patent recites:
    • A wireless controller with a channel control.
    • At least two electrical stimulation units.
    • At least two "substrates" (e.g., electrode pads) for application to the body.
    • Each substrate carries at least two electrodes on one side and at least two "fasteners" on the other side.
    • Each electrical stimulation unit "electronically connects to the at least two fasteners" and is in "direct contact with the other side" of the substrate.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "ePulse Wireless 1600" device (Compl. ¶19).

Functionality and Market Context

The complaint alleges the ePulse Wireless 1600 is a wireless electrical stimulation device (Compl. ¶19). A photograph of the product's packaging provided in the complaint describes it as featuring "WIRELESS TECH," "16 MODES," and the ability to treat "UP TO 6 TREATMENT AREAS AT ONCE" (Compl. p. 4). This marketing language suggests a system composed of a central wireless controller and multiple, independently controllable receiver units, aligning with the general architecture described in the patents-in-suit.

IV. Analysis of Infringement Allegations

The complaint references exemplary infringement charts (Exhibits A-1 and B-1) that were not included with the filed complaint; the following analysis is based on the narrative allegations and visual evidence within the complaint itself.

'217 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A wireless electrical stimulation system comprising: at least two electrical stimulation units... The ePulse Wireless 1600 is a system that includes a remote controller and multiple wireless receiver units. The packaging advertises capability for "UP TO 6 TREATMENT AREAS AT ONCE," which suggests the presence of at least two stimulation units. The packaging image depicts a remote and at least one receiver unit. ¶19, p. 4 col. 4:45-50
a transmitter for remotely, wirelessly controlling each of the electrical stimulation units... The ePulse Wireless 1600 includes a handheld remote control, identified as the transmitter, which is used to wirelessly operate the receiver units. ¶19, p. 4 col. 4:1-13
...transmitting operating instructions... on separate channels at different frequencies... The complaint alleges the system provides "wireless electrical stimulation" but does not provide specific facts regarding the use of separate channels or different frequencies. ¶8, 21 col. 10:11-17
...matching a code sent by each of the electrical stimulation units with a predetermined code... The complaint does not provide specific factual allegations detailing a code-matching or pairing protocol between the transmitter and receiver units. ¶23 col. 8:8-14
...wherein the transmitter includes a unit selector configured to allow a user to select one... units The remote control pictured on the product packaging includes a button labeled "CHANNEL," which is alleged to function as the claimed unit selector for choosing between different receiver units. p. 4 col. 4:56-61
  • Identified Points of Contention:
    • Technical Question: The complaint provides no specific facts about the communication protocol used by the ePulse Wireless 1600. A central question will be whether discovery reveals that the device actually operates on "separate channels at different frequencies" and performs a "matching a code sent by" the receiver, as strictly required by the claim language, or if it uses a different protocol (e.g., a simple one-way broadcast or a standard protocol like Bluetooth that may not meet the specific claim limitations).

'361 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
...at least two substrates, each substrate adapted to be applied to a surface of the subject's body... The ePulse Wireless 1600 system includes electrode pads, which function as the claimed substrates applied to a user's body. ¶19, p. 4 col. 10:25-29
...wherein at least two electrodes are carried on one side of each substrate... The electrode pads inherently carry electrodes to deliver stimulation. ¶19, p. 4 col. 5:36-49
...and at least two fasteners are disposed on the other side of each substrate... The complaint does not provide specific allegations or visuals showing the fasteners on the electrode pads, but this structure is implied by the separate "puck" and pad design. ¶29 col. 13:41-45
...each electrical stimulation unit electronically connects to the at least two fasteners of each of the... substrates The receiver "puck" (the electrical stimulation unit) shown on the packaging appears to be a separate component designed to attach to an electrode pad, implying a connection via fasteners. p. 4 col. 13:45-53
  • Identified Points of Contention:
    • Scope Question: Does the term "fasteners" read on the specific connection mechanism used by the accused product? The patent specification discusses metal snaps as an example ('361 Patent, col. 10:46-51). The scope of "fasteners" will likely be a disputed issue, focusing on whether it is limited to the disclosed embodiments or can cover other connection types.
    • Technical Question: Infringement requires a specific physical arrangement where the "electrical stimulation unit" is in "direct contact" with the "substrate" through the "fasteners". The court will need to examine the actual construction of the accused device to determine if it meets this precise structural limitation.

V. Key Claim Terms for Construction

For the '217 Patent:

  • The Term: "matching a code sent by each of the electrical stimulation units with a predetermined code"
  • Context and Importance: This term appears to describe a specific two-way authentication or pairing protocol. Infringement will depend on whether the accused product performs this exact sequence, where the stimulation unit initiates by sending a code that the transmitter then matches. This is distinct from a protocol where the transmitter initiates pairing or simply broadcasts a signal.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Narrower Interpretation: The claim language specifies the directionality: a code is "sent by" the stimulation unit, which the transmitter then "matches." This phrasing suggests the stimulation unit initiates the handshake, a specific sequence that may not be present in all wireless protocols ('217 Patent, cl. 1). The specification reinforces this by stating the transmitter "matches the code sent by each electrical stimulation units with a predetermined code before connecting" ('217 Patent, col. 8:8-11).

For the '361 Patent:

  • The Term: "fasteners"
  • Context and Importance: Practitioners may focus on this term because the '361 patent's claims are highly dependent on the physical structure of the device. The definition of "fasteners" is critical to determining whether the accused product's mechanism for connecting the control "puck" to the electrode pad falls within the claim scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term itself is generic and could be argued to encompass any means of removably securing two objects together.
    • Evidence for a Narrower Interpretation: The specification, which is incorporated from the parent application, explicitly describes the fasteners as "male metal snaps" and "female metal snaps" ('361 Patent, col. 5:43-49, referring to elements from the parent). A defendant may argue that the term should be limited to such snap-fastener embodiments.

VI. Other Allegations

  • Indirect Infringement: The complaint does not plead a cause of action for indirect infringement; it alleges only direct infringement pursuant to 35 U.S.C. § 271(a) (Compl. ¶22, 28).
  • Willful Infringement: The complaint alleges that "Defendant has had knowledge of infringement... since at least the filing of the Complaint" (Compl. ¶16). This allegation, on its face, supports only a claim for post-filing willfulness and does not provide a factual basis (such as prior correspondence or knowledge of the patents) for pre-suit willful infringement. The prayer for relief seeks enhanced damages based on this allegation (Compl. p. 7, ¶B).

VII. Analyst’s Conclusion: Key Questions for the Case

  1. A central issue will be one of structural scope: For the '361 patent, can the general term "fasteners" be construed to cover the specific mechanism used to connect the ePulse Wireless 1600's control unit to its electrode pads, or will the term be narrowed to the metal snap embodiments described in the specification?
  2. A key evidentiary question will be one of operational correspondence: For the '217 patent, can Plaintiff demonstrate that the accused system performs the specific, directional "code matching" protocol required by the claims, an operational detail not addressed in the complaint's initial allegations?
  3. A further question will concern willfulness: Given that the complaint's allegations for willfulness are based solely on knowledge from the filing of the suit itself, a key issue will be whether Plaintiff can develop sufficient evidence of pre-suit knowledge or egregious post-filing conduct to support a claim for enhanced damages.