DCT

1:25-cv-23404

BTL Industries Inc v. Lexter Microelectronic Engineering Systems SL

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-23404, S.D. Fla., 07/29/2025
  • Venue Allegations: Venue is alleged to be proper because Defendants are residents of and have their principal places of business within the Southern District of Florida.
  • Core Dispute: Plaintiff alleges that Defendants’ "WonderFace" facial-contouring devices infringe two patents related to the unattended aesthetic treatment of a patient using a combination of radiofrequency energy and pulsed electric current.
  • Technical Context: The technology relates to non-invasive aesthetic devices that simultaneously heat skin tissue with radiofrequency energy to promote collagen production and stimulate facial muscles with electrical currents to improve tone and firmness.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant WellFit with pre-suit notice of its intellectual property rights via certified mail on December 13, 2024.

Case Timeline

Date Event
2020-05-04 Priority Date for ’255 and ’167 Patents
2022-03 BTL receives FDA clearance for its EMFACE® device
2022-09 BTL launches its EMFACE® aesthetic facial-contouring device
2023-06-20 U.S. Patent No. 11,679,255 issues
2023-11-29 Alleged first advertisement of Accused Device by Defendant Wonder
2024-01-23 U.S. Patent No. 11,878,167 issues
2024-06-13 Alleged first advertisement of Accused Device by Defendant WellFit
2024-07-28 Alleged first advertisement of Accused Device by Defendant We202
2024-12-13 BTL allegedly informs Defendant WellFit of infringement via certified mail
2025-07-29 Complaint filed

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

U.S. Patent No. 11,679,255 - "Device and Method for Unattended Treatment of a Patient"

  • Issued: June 20, 2023

The Invention Explained

  • Problem Addressed: The patent's background section describes the technical challenge of providing uniform and reproducible aesthetic treatments to uneven or rugged body areas like the face, especially in an "unattended" manner where an operator is not manually moving the applicator. (’255 Patent, col. 1:45-56).
  • The Patented Solution: The invention proposes a device featuring a flexible pad that can conform to a patient's facial contours. (’255 Patent, col. 3:9-12). This pad contains one or more "active elements" (electrodes) and an adhesive layer, allowing it to be attached to the skin for unattended treatment. The device is designed to deliver multiple forms of energy, such as radiofrequency energy for tissue heating and a secondary energy like electric current for muscle stimulation, through the same applicator. (’255 Patent, Abstract; col. 3:42-53).
  • Technical Importance: This approach enables a non-invasive aesthetic therapy that combines two distinct treatment modalities—thermal skin rejuvenation and electrical muscle toning—in a single, hands-free application, a capability previously difficult to achieve on anatomically complex areas like the face. (Compl. ¶¶2, 30).

Key Claims at a Glance

  • The complaint asserts at least independent claim 16. (Compl. ¶56).
  • The essential elements of independent claim 16 include:
    • A device for treating a patient by radiofrequency energy and a pulsed electric current, the device comprising:
    • a flexible pad configured to be attached to a body part of a patient, the flexible pad comprising:
    • a flexible substrate comprising an underside configured to face the body part during a treatment;
    • an electrode coupled to the underside of the flexible substrate; and
    • an adhesive coupled to the underside of the flexible substrate and to the electrode,
    • wherein the electrode is configured to be in contact with the body part via the adhesive;
    • wherein the electrode is configured to apply radiofrequency energy to the body part to cause heating of the body part, and
    • wherein the electrode is configured to apply pulsed electric current to the body part to cause a muscle contraction of a muscle within the body part; and
    • a control unit configured to control the radiofrequency energy and the pulsed electric current to provide the heating and the muscle contraction of the body part during the treatment,
    • wherein the body part comprises one of a face, a neck, or a submentum.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’255 Patent.

U.S. Patent No. 11,878,167 - "Device and Method for Unattended Treatment of a Patient"

  • Issued: January 23, 2024

The Invention Explained

  • Problem Addressed: Similar to the ’255 Patent, the background addresses the need for an improved medical device that can provide more than one type of treatment energy (e.g., electromagnetic and electric current) in an unattended manner suitable for uneven areas like the face. (’167 Patent, col. 2:35-44).
  • The Patented Solution: This patent discloses a specific device architecture comprising two distinct generators: a first generator for electromagnetic energy (e.g., radiofrequency for heating) and a second generator for electric current (for muscle stimulation). (’167 Patent, Abstract). Both generators are coupled via a conductive lead to a single electrode embedded in a flexible pad, which is sized for facial application and controlled by an integrated control unit. (’167 Patent, col. 5:45-col. 6:11).
  • Technical Importance: By explicitly claiming separate generators for the different energy modalities, the invention provides a distinct technical blueprint for a device that can safely and effectively deliver a combination therapy through a single, conformable applicator. (Compl. ¶¶28, 53).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶74).
  • The essential elements of independent claim 1 include:
    • A device for a treatment of a patient, comprising:
    • a first generator configured to generate an electromagnetic energy;
    • a second generator configured to generate an electric current;
    • a pad having a surface area in a range of 0.1 cm² to 150 cm² and configured to be attached to a body part of the patient, the pad comprising:
    • a substrate comprising an underside configured to face the patient during the treatment;
    • a conductive lead; and
    • an electrode having a surface area in a range of 1 cm² to 25 cm², coupled to the underside of the substrate, and coupled to the first generator and second generator via the conductive lead; and
    • a control unit configured to control the first generator and the second generator,
    • wherein the electrode is configured to be coupled with the body part during the treatment, and
    • wherein the electrode is configured to provide the electromagnetic energy to the body part, thereby causing heating of skin of the body part, and is configured to provide the electric current to the body part, thereby causing contractions of a muscle within the body part.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’167 Patent.

III. The Accused Instrumentality

Product Identification

  • The "WonderFace" devices and associated facial-contouring services. (Compl. ¶¶4, 38).

Functionality and Market Context

  • The WonderFace device is alleged to be a non-invasive aesthetic facial-contouring system that uses flexible pads applied to a patient's face. (Compl. ¶52). The system is alleged to employ a combination of "synchronized Radiofrequency (RF) and Neuromuscular technologies," which involves applying radiofrequency energy to heat the skin and delivering pulsed electric currents to stimulate and contract facial muscles. (Compl. ¶¶52, 60). Marketing materials cited in the complaint describe this as "synchronized neuromuscular + radiofrequency," capable of delivering "1,500 contractions in just 25 minutes." (Compl. ¶¶60, 67). An image provided in the complaint shows an operator interacting with a tablet to control the device, which is alleged to function as the "control unit." (Compl. ¶26). The complaint alleges the device is marketed as a non-invasive alternative for improving skin tone, reducing wrinkles, and achieving a "firmer, more sculpted and younger look." (Compl. ¶12). A promotional image from Defendants' website shows the flexible pads of the Accused Device conforming to a patient's face during treatment. (Compl. p. 11).

IV. Analysis of Infringement Allegations

11,679,255 Patent Infringement Allegations

Claim Element (from Independent Claim 16) Alleged Infringing Functionality Complaint Citation Patent Citation
A device for treating a patient by radiofrequency energy and a pulsed electric current... The Accused Devices are marketed as using "synchronized Radiofrequency (RF) and Neuromuscular technologies" to treat patients. ¶60 col. 14:1-3
a flexible pad configured to be attached to a body part of a patient... The Accused Devices include flexible pads that are shown flexing to the contours of a patient's face. ¶61 col. 3:9-12
a flexible substrate comprising an underside configured to face the body part during a treatment... The pads are alleged to be formed from a flexible substrate with an underside that faces the patient's skin. An Instagram video allegedly shows the pad's underside facing the patient when it is removed. ¶62 col. 14:9-12
an electrode coupled to the underside of the flexible substrate... The pads are alleged to include electrodes coupled to their underside to deliver the pulsed electric current. ¶63 col. 14:13-15
an adhesive coupled to the underside of the flexible substrate and to the electrode... The flexible pads are alleged to adhere to the patient's face via an adhesive that is coupled to the substrate and the electrodes. ¶64 col. 14:16-18
wherein the electrode is configured to apply radiofrequency energy...to cause heating... The Accused Devices are described as using radiofrequency to generate heat in the skin to promote collagen production. ¶66 col. 15:8-11
wherein the electrode is configured to apply pulsed electric current...to cause a muscle contraction... The Accused Devices are alleged to use pulsed electric current to cause muscle contractions, with marketing material claiming "1,500 contractions in just 25 minutes." ¶67 col. 15:12-15
a control unit configured to control the radiofrequency energy and the pulsed electric current... An operator is shown interacting with a tablet to select and modify the device's energy output, which the complaint alleges is the claimed "control unit." ¶68 col. 15:16-20
wherein the body part comprises one of a face, a neck, or a submentum. Social media posts allegedly show the Accused Devices' pads attached to a patient's face and submentum. ¶69 col. 15:21-23
  • Identified Points of Contention:
    • Scope Questions: A central question may be how the term "control unit" is construed. Does the accused tablet, which functions as a user interface, perform the specific integrated "control" of both RF energy and pulsed current to provide the claimed heating and muscle contraction, as required by the patent?
    • Technical Questions: What evidence does the complaint provide that the single "electrode" element in the accused pads is configured to perform the dual functions of applying both RF energy for heating and pulsed electric current for muscle contraction, as opposed to having separate conductive elements for each function? A screenshot from a Defendants' Instagram post shows the Accused Devices' flexible pads coupled to electrodes. (Compl. p. 19).

11,878,167 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a first generator configured to generate an electromagnetic energy; The Accused Devices are alleged to include a "first generator" that generates electromagnetic energy in the form of radiofrequency, which "generates heat in the deepest layers of the skin." ¶79 col. 5:45-48
a second generator configured to generate an electric current; The Accused Devices are alleged to include a "second generator" that treats patients using pulsed electric current for "electrical stimulation of facial muscles." ¶80 col. 5:49-51
a pad having a surface area in a range of 0.1 cm² to 150 cm² and configured to be attached to a body part of the patient... The complaint alleges, based on marketing videos, that the Accused Devices use pads configured to attach to a patient's body and that discovery will show the pads meet the claimed surface area range. ¶81 col. 5:52-55
an electrode having a surface area in a range of 1 cm² to 25 cm², coupled to the underside of the substrate... The complaint alleges, based on videos, that the pads include an electrode on the underside and that discovery will show it meets the claimed surface area. ¶84 col. 5:61-63
and coupled to the first generator and second generator via the conductive lead... Training videos allegedly show a conductive lead coupling the device (containing the generators) to the electrodes in the pad. ¶83 col. 5:64-66
a control unit configured to control the first generator and the second generator... Operators are allegedly shown using a tablet to select and modify the device's radiofrequency energy and pulsed electric current, which is alleged to constitute the claimed "control unit." ¶85 col. 6:2-5
wherein the electrode is configured to provide the electromagnetic energy...thereby causing heating...and is configured to provide the electric current...thereby causing contractions of a muscle... Marketing materials are cited to show the Accused Devices simultaneously treat skin and facial muscles by heating the dermis with RF and using "Neuromuscular technologies" to cause contractions. ¶87 col. 6:9-17
  • Identified Points of Contention:
    • Architectural Questions: The infringement theory depends on whether the accused device contains two distinct "generators" as claimed. A key question for the court will be whether the accused product's internal architecture includes two structurally separate generators or if it uses a single power source with different output circuits, and whether the latter would fall within the scope of the claim.
    • Evidentiary Questions: The complaint states that discovery will show the accused pads and electrodes meet the specific surface area ranges recited in the claim (0.1-150 cm² for the pad, 1-25 cm² for the electrode). The sufficiency of the pre-suit investigation into these specific dimensional limitations may be examined. A screenshot from Defendants' website shows the claimed tablet control and describes "efficient, hands-free operation." (Compl. p. 26).

V. Key Claim Terms for Construction

  • Patent: U.S. Patent No. 11,679,255
  • The Term: "a control unit configured to control the radiofrequency energy and the pulsed electric current to provide the heating and the muscle contraction"
  • Context and Importance: This term is critical because infringement turns on whether the accused device's controller (allegedly a tablet) performs the specific, integrated function of managing both energy types to achieve the claimed dual therapeutic outcomes. Practitioners may focus on whether "control" requires direct, low-level hardware regulation or if it can be satisfied by a high-level user interface that initiates pre-programmed routines.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the "control unit" in general terms as potentially comprising a "CPU which may include a flex circuit or a printed circuit board and may include a microprocessor or memory for controlling the device." (’255 Patent, col. 3:55-62). This language could support an interpretation where a general-purpose processor running software suffices.
    • Evidence for a Narrower Interpretation: The specification also details more specific functions, stating the CPU "controls the primary electromagnetic generator 6" and can deliver energy in different modes (CM or pulse), and that it "may drive and provide information from the switching circuitry 14." (’255 Patent, col. 6:53-61). This may suggest a more deeply integrated control function is required.
  • Patent: U.S. Patent No. 11,878,167
  • The Term: "a first generator...and...a second generator"
  • Context and Importance: The claim requires two separate generators. The core of the dispute for this patent will likely be the structural definition of a "generator." Practitioners may focus on this term because the defendant could argue its device uses a single power supply with multiple, differentiated outputs, and that these do not constitute two distinct "generators."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent abstract states the device comprises "a first generator...and a second generator," suggesting two functionally distinct sources are contemplated, which might not require complete physical separation. (’167 Patent, Abstract). The complaint alleges the device works with "two separate power sources." (Compl. ¶53).
    • Evidence for a Narrower Interpretation: Figure 1 of the patent depicts "Primary electromagnetic generator" (6) and "Secondary generator" (9) as two separate and distinct blocks within the main unit, which could support a narrower construction requiring two physically separate hardware modules. (’167 Patent, Fig. 1).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants induce infringement by "encouraging, promoting, and instructing customers to use the Accused Devices" in a manner that directly infringes, citing user support and promotional activities. (Compl. ¶¶44, 59, 77).
  • Willful Infringement: Willfulness is alleged based on both pre-suit and post-suit knowledge. The complaint alleges pre-suit knowledge for Defendant WellFit based on a certified mail letter sent on December 13, 2024, and for all Defendants based on constructive knowledge of Plaintiff's patent portfolio. (Compl. ¶¶42, 51, 70). Post-suit knowledge is based on the filing and service of the complaint itself. (Compl. ¶43).

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

  • A key technical question will be one of architectural correspondence: does the accused "WonderFace" device contain two structurally distinct "generators" for electromagnetic and electric energy as recited in the ’167 patent, or does it utilize a single power source with multiplexed outputs, and would the latter meet the claim's requirements?
  • A central issue will be one of functional specificity: does the accused device’s tablet-based "control unit" perform the integrated function of simultaneously managing both heating and muscle contraction parameters to "provide the heating and the muscle contraction" as required by the ’255 patent, or does it operate as a more general-purpose user interface that simply initiates separate, pre-set programs?
  • An evidentiary question will be one of dimensional compliance: can Plaintiff prove through discovery that the physical dimensions of the accused pads and their internal electrodes fall within the specific numerical ranges recited in claim 1 of the ’167 patent, an allegation made in the complaint on information and belief pending further investigation?