DCT
1:24-cv-00864
BTL Industries Inc v. Emszero Beauty Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: BTL Industries, Inc. (Delaware)
- Defendant: Emszero Beauty Inc. (Delaware)
- Plaintiff’s Counsel: Stamoulis & Weinblatt LLC; Patterson Intellectual Property Law, P.C.
- Case Identification: 1:24-cv-00864, D. Del., 07/24/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware as Defendant is a Delaware corporation with its principal place of business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s aesthetic body and facial contouring devices infringe patents related to methods and devices for muscle toning using magnetic fields and combined radiofrequency/pulsed electric current treatments.
- Technical Context: The technology at issue involves the non-invasive application of high-intensity electromagnetic fields and electrical energy for aesthetic purposes, such as muscle toning and skin rejuvenation, a significant and competitive segment of the medical aesthetics market.
- Key Procedural History: The complaint alleges that Plaintiff sent Defendant a demand letter on November 22, 2023, notifying Defendant of its alleged infringement, but that Defendant did not respond and continued its allegedly infringing activities. This allegation forms the basis for Plaintiff's claim of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2016-07-01 | Earliest Priority Date for ’634 Patent |
| 2018-01-01 | Plaintiff launches EMSCULPT® device (approximate date) |
| 2019-11-19 | ’634 Patent Issued |
| 2020-05-04 | Earliest Priority Date for ’255 Patent |
| 2022-03-01 | Plaintiff receives FDA clearance for EMFACE device (approximate date) |
| 2022-09-01 | Plaintiff releases EMFACE device (approximate date) |
| 2023-06-20 | ’255 Patent Issued |
| 2023-11-22 | Plaintiff sends demand letter to Defendant |
| 2024-07-24 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,478,634 - Aesthetic Method and Biological Structure Treatment by Magnetic Field (Issued Nov. 19, 2019)
The Invention Explained
- Problem Addressed: The patent describes existing non-invasive aesthetic methods as having significant drawbacks, such as being unable to enhance muscle appearance or having low efficiency and creating unwanted heat due to eddy currents in the treatment device (’634 Patent, col. 2:26-46).
- The Patented Solution: The invention proposes a method for aesthetic treatment, such as muscle toning, by applying a time-varying magnetic field with a high magnetic flux density sufficient to induce muscle contractions (’634 Patent, Abstract; col. 3:12-20). The method is intended to provide improved results in shorter time periods by optimizing energy use and increasing treatment effectiveness (’634 Patent, col. 3:12-17).
- Technical Importance: This technology provided a method for non-invasively targeting and stimulating muscles for aesthetic improvement, which the complaint alleges created a new market for non-invasive body contouring (Compl. ¶16).
Key Claims at a Glance
- The complaint asserts independent method Claim 1 (Compl. ¶41).
- Essential elements of Claim 1:
- A method for toning muscles using time-varying magnetic fields.
- Placing an applicator (with a magnetic field generating coil) in contact with skin/clothing on an abdomen or buttock.
- Coupling the applicator to the patient with an adjustable flexible belt.
- Providing energy to the coil to generate a time-varying magnetic field.
- Applying a magnetic fluence of 50 T cm² to 1,500 T cm² to the body region.
- Applying the field with a magnetic flux density sufficient to cause muscle contraction.
- The complaint reserves the right to assert other claims, including under the doctrine of equivalents (Compl. ¶42).
U.S. Patent No. 11,679,255 - Device and method for unattended treatment of a patient (Issued Jun. 20, 2023)
The Invention Explained
- Problem Addressed: The patent notes that unattended aesthetic treatment of uneven body areas like the face is challenging. Manually controlled devices are operator-dependent, while existing unattended devices like LED masks deliver low energy and have minimal thermal effect, making them unsuitable for significant in-office skin rejuvenation (’255 Patent, col. 1:43-col. 2:26).
- The Patented Solution: The invention discloses a device comprising a flexible pad with an embedded electrode and an adhesive layer, designed for attachment to a patient for unattended treatment (’255 Patent, Abstract). This device is configured to deliver both radiofrequency (RF) energy for heating and a pulsed electric current for muscle contraction, allowing for a combined, reproducible treatment on complex anatomical areas like the face, neck, or submentum (’255 Patent, col. 2:50-68).
- Technical Importance: This approach enables combined-energy, unattended aesthetic treatments on anatomically complex areas, which may increase treatment consistency and reduce the need for constant operator manipulation.
Key Claims at a Glance
- The complaint asserts independent device Claim 16 (Compl. ¶282).
- Essential elements of Claim 16:
- A device for treating a patient with RF energy and a pulsed electric current.
- It includes a flexible pad configured for attachment to a body part (face, neck, or submentum).
- The pad comprises a flexible substrate, an electrode coupled to the substrate's underside, and an adhesive coupled to both.
- The electrode is configured for contact with the body part via the adhesive.
- The electrode is configured to apply RF energy for heating.
- The electrode is configured to apply pulsed electric current for muscle contraction.
- A control unit is configured to control both the RF energy and the pulsed electric current.
- The complaint reserves the right to assert other claims, including under the doctrine of equivalents (Compl. ¶323).
III. The Accused Instrumentality
Product Identification
- The complaint identifies two groups of products: nineteen "First Accused Devices" for body sculpting (e.g., "EMSZERO Body Sculpting Machine Professional") and five "Second Accused Devices" for facial therapy (e.g., "EMSzero Facial Therapy Machine") (Compl. ¶31, ¶32). The complaint provides images of each device, such as the EMSZERO Body Sculpting Machine Professional, a wheeled device with multiple applicator handles (Compl. p. 9).
Functionality and Market Context
- The First Accused Devices are alleged to use "high-intensity Tesla coil[s] to generate a strong magnetic field" for muscle toning and are supplied with applicators and belts for use on the abdomen and buttocks (Compl. ¶45, ¶92, ¶135).
- The Second Accused Devices are alleged to use a "powerful combination of high intensity facial electromagnetic stimulation and radio frequency" via flexible pads for application to the face, neck, or submentum (Compl. ¶285, ¶294). An image of the EMSzero Facial Therapy Machine shows a console with multiple wand-like applicators and a separate pad-like component (Compl. p. 17).
- The complaint alleges Defendant markets these products using terms such as "HIFEM," "HI-EMT," and "HIFESTM," which are asserted to be identical or confusingly similar to Plaintiff's trademarks (Compl. ¶34). A social media advertisement for the "EMSZERO BODY SCULPTING ULTRA" explicitly states it is "powered by advanced High-Intensity Focused Electromagnetic Field (HIFEM) technology" (Compl. p. 20).
IV. Analysis of Infringement Allegations
'634 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for toning muscles in a patient using time-varying magnetic fields... | Defendant encourages and instructs customers to use the First Accused Devices for muscle toning using what are alleged to be time-varying magnetic fields. | ¶43-44 | col. 17:50-54 |
| placing a first applicator comprising a magnetic field generating coil in contact with a patient's skin or clothing at a body region of the patient, wherein the body region is an abdomen or a buttock; | The First Accused Devices include handles/applicators containing magnetic coils, and user manuals and landing pages allegedly instruct users to place them on the abdomen and buttocks. | ¶90, ¶92, ¶95 | col. 9:54-62 |
| coupling the first applicator to the patient with an adjustable flexible belt so that the belt holds the applicator to the patient's skin or clothing; | The First Accused Devices are represented as coming with adjustable belts that are used to fasten the applicator to the patient's body. | ¶134-135, ¶159 | col. 10:54-62 |
| providing energy to the magnetic field generating coil in order to generate a time-varying magnetic field; and | The devices include power cords and are alleged to use electricity to power a "high-intensity Tesla coil" to generate magnetic fields with frequencies stated to be in ranges such as "5–100 Hz," indicating time-variance. | ¶168-170, ¶47 | col. 11:7-13 |
| applying a magnetic fluence of 50 T cm² to 1,500 T cm² to the body region. | Based on marketing statements such as "high-intensity Tesla coil" and "high magnetic flux density," and on information and belief, the complaint alleges the devices apply a magnetic fluence within the claimed range. | ¶208, ¶209, ¶215 | col. 14:1-16 |
| wherein the time-varying magnetic field is applied to the body region with a magnetic flux density sufficient to cause a muscle contraction in the body region. | The devices are promoted as having the ability to cause muscle contractions, with landing pages allegedly stating they "stimulate... abdominal muscles, promoting muscle contractions." | ¶242, ¶244, ¶46 | col. 17:8-14 |
- Identified Points of Contention:
- Technical & Evidentiary Question: The complaint's allegation for the "magnetic fluence" limitation rests entirely on "information and belief" derived from marketing claims (Compl. ¶208). A central point of contention will be whether Plaintiff can produce empirical evidence that the accused devices actually generate a magnetic fluence within the specific numerical range of 50-1,500 T cm².
- Scope Question: The complaint at times alleges the devices cause muscle contraction by sending "electric impulses" (Compl. ¶245, ¶247), which is a different physical mechanism from the magnetic induction required by the patent. This raises the question of whether the complaint sufficiently alleges infringement via the claimed magnetic-field mechanism or conflates it with direct electrical stimulation.
'255 Patent Infringement Allegations
| Claim Element (from Independent Claim 16) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a flexible pad configured to be attached to a body part of a patient... wherein the body part comprises one of a face, a neck, or a submentum. | The Second Accused Devices are alleged to use flexible pads designed to be placed on a patient's face, neck, or submentum. | ¶294-295 | col. 3:41-45 |
| a flexible substrate comprising an underside... an electrode coupled to the underside... and an adhesive coupled to the underside... | On information and belief, the complaint alleges the flexible pads of the accused devices contain a flexible substrate, an electrode, and an adhesive. | ¶294, ¶296, ¶298 | col. 3:1-14 |
| wherein the electrode is configured to apply radiofrequency energy to the body part to cause heating... | Landing pages for the accused devices state they use "radio frequency treatments." The complaint alleges this is for the purpose of causing heating. | ¶289, ¶305 | col. 3:15-18 |
| wherein the electrode is configured to apply pulsed electric current to the body part to cause a muscle contraction... | Landing pages for the accused devices state they use "high-intensity facial electrical stimulation" or "electromagnetic stimulation." The complaint alleges this constitutes a pulsed electric current for muscle contraction. | ¶287, ¶291, ¶305 | col. 3:19-22 |
| a control unit configured to control the radiofrequency energy and the pulsed electric current... | The accused devices have a body and screen which, on information and belief, contain a control unit that controls the electrodes and their dual energy-delivery functions. | ¶316, ¶318-319 | col. 3:23-28 |
- Identified Points of Contention:
- Technical Question: A key dispute will be whether the accused products' "high intensity facial electromagnetic stimulation" (Compl. ¶285) is technically equivalent to the claimed "pulsed electric current." Defendant may argue that its technology operates on a different principle, potentially one of magnetic induction rather than direct current application.
- Evidentiary Question: The complaint's allegations regarding the physical construction of the pad (substrate, electrode, adhesive) are based on "information and belief" (Compl. ¶294, ¶296). This raises the question of what evidence, beyond marketing images, the Plaintiff possesses to support these structural limitations.
V. Key Claim Terms for Construction
For the ’634 Patent: "magnetic fluence"
- Context and Importance: This quantitative limitation (50 T cm² to 1,500 T cm²) is a central pillar of the infringement allegation. The definition of this term and the methodology for its measurement will be critical, as the complaint provides no direct measurements and relies on inference. Practitioners may focus on this term because it presents a high evidentiary bar for the Plaintiff.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides a clear formula: "MF = BPP * AMFGD" (magnetic fluence equals peak-to-peak magnetic flux density multiplied by the area of the magnetic field generating device) (’634 Patent, col. 14:1-7). This formula provides a concrete, though potentially contestable, basis for calculation.
- Evidence for a Narrower Interpretation: The specification provides numerous exemplary, but non-limiting, ranges for the fluence ('634 Patent, col. 14:8-20). A defendant could argue that the context of these examples limits the scope or the method by which the fluence should be determined in a manner that excludes their products.
For the ’255 Patent: "pulsed electric current"
- Context and Importance: The infringement theory hinges on equating the accused products' marketed "facial electromagnetic stimulation" with the claimed "pulsed electric current." The construction of this term will determine if the accused technology falls within the claim scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses various forms of electrotherapy, including "pulse direct current" and "alternating current," for muscle stimulation (’255 Patent, col. 13:5-40). This could support a construction that encompasses any electrical current delivered in pulses for the purpose of muscle contraction.
- Evidence for a Narrower Interpretation: Claim 16 distinctly recites "radiofrequency energy" for heating and "pulsed electric current" for muscle contraction. A defendant could argue this distinction implies that "pulsed electric current" must be a non-RF, lower-frequency current, potentially excluding a technology that uses a modulated high-frequency carrier wave to achieve muscle stimulation.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement for both patents. The allegations are based on Defendant’s user manuals, brochures, and website landing pages, which allegedly instruct and encourage customers to use the Accused Devices in a manner that directly infringes the asserted claims (Compl. ¶42, ¶323).
- Willful Infringement: Willfulness is alleged for both patents based on pre-suit knowledge. The complaint asserts that Defendant was aware of BTL's products and its online patent marking list. More significantly, it alleges that Plaintiff provided direct notice of infringement via a demand letter dated November 22, 2023, and that Defendant's allegedly infringing conduct has continued unabated (Compl. ¶35, ¶279, ¶324).
VII. Analyst’s Conclusion: Key Questions for the Case
- Evidentiary Sufficiency: A central question for the ’634 patent will be one of quantitative proof: can Plaintiff produce technical evidence, beyond the marketing-based inferences in the complaint, to demonstrate that the accused body sculpting devices generate a "magnetic fluence" that meets the specific numerical range required by Claim 1?
- Technological Equivalence: A key issue for the ’255 patent will be one of functional and definitional scope: does the accused "high intensity facial electromagnetic stimulation" operate as the claimed "pulsed electric current" for muscle contraction, or does it represent a different technological modality that falls outside the claim's distinction between low-frequency "current" and high-frequency "radiofrequency energy"?
- Willfulness and Intent: A critical question for damages will be one of pre-suit conduct: does the evidence show that Defendant's alleged continuation of sales after receiving the November 22, 2023, demand letter constituted objective recklessness, thereby supporting a finding of willful infringement and potential for enhanced damages?