1:23-cv-00359
BTL Industries Inc v. Advanced Regenerative Medicine LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: BTL Industries, Inc. (Delaware)
- Defendant: Advanced Regenerative Medicine LLC d/b/a Juvawave (Delaware), Advanced Regenerative Medicine USA LLC d/b/a Juvawave (Delaware), and James Vaughn (Florida)
- Plaintiff’s Counsel: Young Conaway Stargatt & Taylor, LLP
- Case Identification: 1:23-cv-00359, D. Del., 03/29/2023
- Venue Allegations: Venue is alleged to be proper in the District of Delaware as the corporate defendants are organized under the laws of Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s non-invasive body-contouring devices infringe four patents related to the use of time-varying magnetic fields for aesthetic treatments, such as muscle toning and fat reduction.
- Technical Context: The technology involves applying high-intensity focused electromagnetic fields to targeted body regions to induce powerful muscle contractions that are not achievable through voluntary exercise.
- Key Procedural History: The complaint alleges that Plaintiff sent a cease-and-desist letter to Defendants on February 22, 2023, identifying the patents covering its products. It further alleges that Defendant James Vaughn responded the same day with a defiant message, which may be presented as evidence supporting the allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2015-07-01 | U.S. Patent No. 9,636,519 Priority Date |
| 2016-07-01 | Priority Date for U.S. Patent Nos. 11,266,852; 10,695,575; and 10,478,634 |
| 2017-05-02 | U.S. Patent No. 9,636,519 Issued |
| 2018-06-01 | Plaintiff BTL launches its EMSCULPT device |
| 2019-11-19 | U.S. Patent No. 10,478,634 Issued |
| 2020-06-30 | U.S. Patent No. 10,695,575 Issued |
| 2022-03-08 | U.S. Patent No. 11,266,852 Issued |
| 2022-09-01 | Defendants allegedly began offering the Accused Devices for sale |
| 2023-02-22 | Plaintiff sends cease-and-desist letter to Defendants |
| 2023-03-29 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,266,852 - Aesthetic Method of Biological Structure Treatment by Magnetic Field
- Issued: March 8, 2022
The Invention Explained
- Problem Addressed: The patent background describes existing non-invasive aesthetic treatments, such as those using mechanical or thermal energy, as having significant drawbacks, including the risk of pain, skin damage, and an inability to effectively shape or tone muscle tissue (’634 Patent, col. 2:5-31).
- The Patented Solution: The invention uses a time-varying magnetic field with a high magnetic flux density to induce strong muscle contractions non-invasively (’634 Patent, col. 3:11-20). By using multiple, independently controlled magnetic field generating coils, the device can apply complex treatment protocols, such as generating different patterns of pulses, to remodel biological structures like muscle and adipose tissue for an improved aesthetic appearance (’852 Patent, col. 19:1-12).
- Technical Importance: This technology provided a method to non-invasively tone muscle and reduce fat simultaneously, a combination of effects the complaint alleges was not offered by prior aesthetic devices (Compl. ¶27).
Key Claims at a Glance
- The complaint asserts independent claim 9 (Compl. ¶57).
- The essential elements of claim 9 are:
- A treatment device with a first and second planar magnetic field generating coil.
- A first applicator comprising the first coil.
- The first coil is configured to generate a first time-varying magnetic field with a repetition rate of 1 Hz to 300 Hz and a magnetic flux density of 0.1 to 7 Tesla.
- The second coil is configured to generate a second time-varying magnetic field with the same rate and density ranges.
- The first coil generates its magnetic field independently of the second.
- Each coil is configured to generate a plurality of pulses.
- Each plurality of pulses comprises a first set of pulses at a first repetition rate and a second set of pulses at a different, second repetition rate.
- The coils are configured for placement near a body region (buttocks or abdomen) to cause muscle contraction and enhance visual appearance.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 10,695,575 - Aesthetic Method of Biological Structure Treatment by Magnetic Field
- Issued: June 30, 2020
The Invention Explained
- Problem Addressed: As with the related ’852 patent, the technology aims to overcome the limitations of prior aesthetic treatments which could not effectively and non-invasively tone muscle (’634 Patent, col. 2:26-31).
- The Patented Solution: The patent describes a method for toning muscles by using two independent applicators, each containing a magnetic field generating coil (’575 Patent, col. 107:50-57). The method involves positioning the applicators, generating specific magnetic impulses by discharging energy storage devices, and actively cooling the coils to allow for sustained treatment that causes muscle contractions sufficient to tone the muscles (’575 Patent, col. 108:13-22).
- Technical Importance: The method provides a specific, repeatable protocol for using dual applicators with defined energy parameters and cooling to achieve non-invasive muscle toning (Compl. ¶24).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶78).
- The essential steps of method claim 1 are:
- Positioning a first applicator on the patient, the applicator housing a first coil.
- Independently positioning a second applicator on the patient, housing a second coil with the same inductance as the first.
- Charging a first and a second energy storage device.
- Discharging the devices to their respective coils to generate first impulses of a first and second time-varying magnetic field.
- The impulses each have a magnetic flux density between 0.1 and 7 Tesla and a duration between 3 µs and 3 ms.
- Establishing a pulse duration where the impulse from the second coil is generated during the pulse duration of the first.
- Cooling each of the coils.
- Applying pluralities of impulses from both coils to cause muscle contractions and toning.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 10,478,634 - Aesthetic Method of Biological Structure Treatment by Magnetic Field
- Issued: November 19, 2019
Technology Synopsis
The patent claims a method for toning muscles by placing an applicator on a patient's abdomen or buttock and coupling the applicator to the patient using an adjustable flexible belt. Energy is then provided to a coil in the applicator to generate a time-varying magnetic field with a specified magnetic fluence sufficient to cause muscle contraction (Compl. ¶96; ’634 Patent, col. 95:52-67).
Asserted Claims
Independent claim 1 is asserted (Compl. ¶96).
Accused Features
The complaint alleges that Defendants instruct customers to use the Accused Devices by placing applicators on the abdomen or buttocks and securing them with flexible belts, thereby performing the claimed method (Compl. ¶¶99-100).
U.S. Patent No. 9,636,519 - Magnetic Stimulation Methods and Devices for Therapeutic Treatments
- Issued: May 2, 2017
Technology Synopsis
The patent claims a magnetic stimulation device with a specific cooling architecture. The claimed device comprises components including a coil, a casing, and at least one blower arranged on the circumference of the coil, configured so that fluid can flow between the coil and casing to cool both its upper and lower sides (’519 Patent, col. 6:21-30).
Asserted Claims
Independent claim 1 is asserted (Compl. ¶109).
Accused Features
The complaint alleges the Accused Devices include applicators that function as casings and house at least one fan (blower) that cools the internal coil, thereby embodying the claimed device structure (Compl. ¶¶116-117).
III. The Accused Instrumentality
Product Identification
The EMSLIM EMS Muscle Building Fat Reduction Machine (“EMSLIM device”), the EMSHAPE Super High EMS Electro Magnetic Muscle Building and Fat Reduction Machine (“EMSHAPE device”), and the EMSMART EMS Muscle Building Fat Reduction Machine (“EMSMART device”) (Compl. ¶3).
Functionality and Market Context
The Accused Devices are alleged to be non-invasive body-contouring machines that use electromagnetic energy to generate muscle contractions (Compl. ¶39). They are described as having multiple applicators or "handles" that can be configured to operate independently (Compl. ¶65), generate magnetic fields up to 7 Tesla at frequencies up to 100 Hz (Compl. ¶¶63-64), and are secured to a patient's body with flexible belts (Compl. ¶100). The complaint includes an image of applicators for the EMSLIM device secured to a patient's abdomen with a belt (Compl. p. 45, Ex. G at 6). The devices are also alleged to incorporate cooling features, such as "cooling vents" or a "controlled air cooled motor" (Compl. ¶88). The complaint alleges the Accused Devices are marketed as "knockoffs" of Plaintiff's products and promoted using data from clinical trials conducted on Plaintiff's EMSCULPT device (Compl. ¶¶3, 54).
IV. Analysis of Infringement Allegations
11,266,852 Patent Infringement Allegations
| Claim Element (from Independent Claim 9) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A treatment device for enhancing a visual appearance of a patient... | The Accused Devices are advertised as devices for "non-invasive body slimming and sculpting that builds muscle and burns fat" to achieve a "slim and sculpted [look]." | ¶59 | col. 18:4-31 |
| ...a first magnetic field generating coil and a second magnetic field generating coil, wherein both of the first and second magnetic field generating coils are planar... | The Accused Devices are electromagnetic devices that come with multiple applicators, each containing a planar coil that generates a magnetic field. | ¶61 | col. 8:9-11 |
| ...a first applicator, wherein the first applicator comprises the first magnetic field generating coil... | The Accused Devices come with multiple applicators (described as "handles"), each comprising a magnetic field generating coil. | ¶62 | col. 9:55-63 |
| ...wherein the first magnetic field generating coil is configured to generate a first time-varying magnetic field with a repetition rate in a range of 1 Hz to 300 Hz and a magnetic flux density in a range of 0.1 Tesla to 7 Tesla... | The Accused Devices are advertised as producing magnetic fields between 0 and 7 Tesla and at frequencies between 10 Hz and 100 Hz, which falls within the claimed ranges. | ¶63 | col. 4:1-3 |
| ...wherein the first magnetic field generating coil is configured to generate the first time-varying magnetic field independently of the second... | The Accused Devices' applicators are allegedly configured to generate magnetic fields independently, as shown in figures on Defendants' website that enable setting CH1 and CH2 independently for the EMSMART device. | ¶65 | col. 12:36-41 |
| ...wherein each of the plurality of pulses comprises a first plurality of pulses having a first repetition rate and a second plurality of pulses having a second repetition rate, wherein the first repetition rate differs from the second repetition rate... | The Accused Devices are allegedly configured to generate magnetic pulses at several different frequencies depending on user-set treatment parameters. | ¶67 | col. 27:36-41 |
| ...wherein the body region comprises one of a buttocks or an abdomen. | The Accused Devices are advertised for use on body areas including the abdomen and buttocks. | ¶71 | col. 18:31-33 |
- Identified Points of Contention:
- Technical Questions: A primary technical question will be whether the Accused Devices' operation meets the complex pulse structure required by claim 9—specifically, the limitation that "each of the plurality of pulses comprises a first plurality of pulses having a first repetition rate and a second plurality of pulses having a second repetition rate." The complaint's allegation on this point is based on "information and belief" that the devices can generate pulses at different frequencies, which may require discovery and expert analysis to substantiate (Compl. ¶67).
- Scope Questions: What evidence does the complaint provide that the coils in the accused devices are "planar" as required by the claim? While the product photos suggest a generally flat design, the specific internal structure of the coils will be a matter for discovery.
10,695,575 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for toning muscles of a patient... | Defendants allegedly encourage customers to use the Accused Devices for toning muscles and burning fat. | ¶80 | col. 18:4-31 |
| ...positioning a first applicator on the patient... independently positioning a second applicator on the patient... | The Accused Devices include at least two applicators that can be positioned independently, and Defendants instruct users on how to position them. | ¶¶81-82 | col. 10:50-58 |
| ...the second applicator housing a second magnetic field generating coil having the same inductance as the first... | The complaint alleges on information and belief that discovery will show the inductance of the coils in the two applicators is the same. | ¶82 | col. 107:55-57 |
| ...discharging the first energy storage device to the first magnetic field generating coil such that a first impulse of a first time-varying magnetic field is generated... | The Accused Devices are alleged to contain at least two energy storage devices configured to discharge energy to generate magnetic impulses. | ¶84 | col. 12:21-24 |
| ...wherein the first impulse... and the first impulse... each have a magnetic flux density in a range between 0.1 Tesla and 7 Tesla, and... an impulse duration in a range between 3 µs and 3 ms. | The applicators are allegedly configured to generate a magnetic flux density within the claimed range of 0-7 Tesla; the complaint does not specify the impulse duration. | ¶86 | col. 107:65-108:2 |
| ...cooling each of the first and the second magnetic field generating coils... | Defendants advertise the Accused Devices as having cooling features, such as "air cooling," a "controlled air cooled motor," or visible "cooling vents." A photograph of the EMSHAPE device's cooling vents is included in the complaint. | ¶88; Compl. p. 37, Ex. W at 1 | col. 34:13-16 |
| ...applying a first plurality of impulses... and applying a second plurality of impulses... to cause muscles of the body region to contract such that the muscles are toned. | Defendants allegedly instruct customers to use the devices in a manner that applies magnetic impulses to cause muscle contractions for the purpose of toning. | ¶89 | col. 108:16-22 |
- Identified Points of Contention:
- Technical Questions: The infringement theory for the "cooling" step relies on marketing terms like "air cooling" and images of vents (Compl. ¶88). A potential dispute is whether these features perform the specific function of "cooling each of the...coils" as required by the claim, or if they are merely for general heat dissipation of the device housing.
- Evidentiary Questions: The allegation that the coils have the "same inductance" is made on information and belief and explicitly reserved for discovery (Compl. ¶82). This presents a potential factual dispute that cannot be resolved from the face of the complaint.
V. Key Claim Terms for Construction
The Term: "cooling each of the first and the second magnetic field generating coils" (’575 Patent, Claim 1)
Context and Importance
This term is critical because infringement hinges on whether the Accused Devices' advertised "air cooling," "cooling vents," and internal fans meet this limitation (Compl. ¶88). Defendants may argue that these features provide general ventilation for the device housing, not the specific "cooling" of the coils required by the claim. Practitioners may focus on this term to determine if passive or general cooling is sufficient, or if a more active, targeted cooling mechanism is required.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification of the related ’634 patent states that for cooling, "a blower or blowers may be arranged to blow air on both sides of magnetic field generating device" ('634 Patent, col. 3:36-38), suggesting a general air-based cooling mechanism could suffice.
- Evidence for a Narrower Interpretation: The asserted patent family includes the ’519 patent, which is directed specifically to a cooling apparatus where a blower is arranged on the "circumference of the coil" to cool its "upper and lower sides" (’519 Patent, col. 6:21-30). This detailed embodiment could be cited to argue that "cooling" implies a specific, active, and directed fluid flow over the coil itself, not just general ventilation of the applicator.
The Term: "wherein each of the plurality of pulses comprises a first plurality of pulses having a first repetition rate and a second plurality of pulses having a second repetition rate, wherein the first repetition rate differs from the second repetition rate" (’852 Patent, Claim 9)
Context and Importance
This limitation defines a complex, multi-stage pulse structure that appears central to the claim's novelty. The infringement allegation relies on a general assertion that the devices can generate pulses at "several different frequencies" (Compl. ¶67). The viability of the infringement claim will depend heavily on whether a "pulse" can be construed to contain within it two distinct sub-sequences of pulses at different rates.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification describes applying magnetic pulses in "trains" and "bursts" where an "active treatment period" is followed by a "passive treatment" period (’634 Patent, col. 16:38-46). This could support a reading where a single "pulse" encompasses a complex treatment sequence with varying rates.
- Evidence for a Narrower Interpretation: Figure 8 of the related ’634 patent depicts a "pulse" as a period of treatment containing multiple "impulses," but does not explicitly show sub-pluralities with differing repetition rates within that single pulse. This could support a narrower definition where a "pulse" is a sequence of impulses at a single repetition rate, which would make the claim limitation more difficult to meet.
VI. Other Allegations
Indirect Infringement
The complaint alleges induced infringement of the method claims in the ’575 and ’634 patents. The basis for inducement is that Defendants allegedly encourage and instruct customers to use the Accused Devices in an infringing manner through promotional materials, websites, and emails (Compl. ¶¶79, 97). For example, the complaint alleges Defendants’ websites and promotional images, such as one showing the EMSLIM device strapped to a patient's abdomen, instruct users to perform the claimed step of coupling an applicator with a belt (Compl. ¶100, Compl. p. 42).
Willful Infringement
Willfulness is alleged for all four asserted patents. The claims are based on alleged pre-suit knowledge stemming from a February 22, 2023 cease-and-desist letter sent by Plaintiff to Defendants, which allegedly identified the patents covering Plaintiff's products (Compl. ¶74). The complaint further alleges that Defendant Vaughn sent a same-day response indicating an intent to continue the accused activities, which is presented as evidence of deliberate infringement (Compl. ¶¶7-8, 74).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof: can Plaintiff demonstrate through discovery that the Accused Devices, in operation, generate the specific electrical and magnetic parameters—including impulse durations, flux densities, and the complex multi-rate pulse structures—required by the asserted claims? The complaint's infringement theories for these technical limitations currently rest on marketing materials and allegations made on "information and belief."
- A key question of claim construction will be the scope of the term "cooling" as used in the ’575 patent. The case may turn on whether the term can be construed broadly to cover the general-purpose fans and air vents advertised for the Accused Devices, or if it requires a more specific, active cooling mechanism directed at the coils themselves, as detailed in other patents within the asserted family.
- A central question for damages will be willfulness: do the complaint's allegations regarding the pre-suit notice letter and the defendant's subsequent defiant response constitute conduct egregious enough to support a finding of willful infringement, potentially leading to an award of enhanced damages?