Endonovo Therap Inc v. Bioelectronics Corp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Endonovo Therapeutics, Inc. (Delaware)
  • Defendant: BioElectronics Corporation (Maryland)
  • Plaintiff’s Counsel: Manning & Kass, Ellrod, Ramirez, Trester LLP
• Case Identification: 2:19-cv-04465, C.D. Cal., 05/22/2019
• Venue Allegations: Plaintiff alleges venue is proper because Defendant maintains a regular and established place of business within the district, including a sales office and an agent for service of process.
• Core Dispute: Plaintiff alleges that Defendant’s line of ActiPatch therapeutic devices infringes two patents related to the use of Pulsed Electromagnetic Fields (PEMF) for medical treatment.
• Technical Context: The technology involves generating specific, low-power electromagnetic waveforms, delivered via portable devices, to stimulate biological healing processes such as pain reduction and tissue repair.
• Key Procedural History: The patents-in-suit, originally assigned to Ivivi Technologies, were acquired by Plaintiff Endonovo in December 2017. The complaint highlights that in December 2016, Defendant filed a 510(K) premarket notification with the FDA for its accused ActiPatch device, which listed a product allegedly covered by the patents-in-suit as a predicate device. This filing is central to the allegations of pre-suit knowledge and willful infringement.

Case Timeline

Date	Event
2004-04-26	U.S. Patent No. 7,740,574 Priority Date
2005-09-10	U.S. Patent No. 7,758,490 Priority Date
2010-06-22	U.S. Patent No. 7740574 Issue Date
2010-07-20	U.S. Patent No. 7758490 Issue Date
2016-12-01	Defendant files 510(K) premarket notification for ActiPatch device
2017-12-26	Plaintiff Endonovo acquires patents-in-suit
2019-05-22	Complaint Filing Date

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

U.S. Patent No. 7,740,574 - "Electromagnetic Treatment Induction Apparatus and Method for Using Same" (Issued June 22, 2010)

The Invention Explained

• Problem Addressed: The patent describes a need for electromagnetic therapy devices that are lightweight, portable, and disposable, and can be used more effectively with miniaturized circuitry (ʼ574 Patent, col. 3:15-24). Prior art did not adequately account for the specific dielectric properties of tissue, limiting the efficiency of signal coupling for therapeutic effect (ʼ574 Patent, col. 2:58-65).
• The Patented Solution: The invention is a method for delivering therapeutic electromagnetic signals using a lightweight inductive apparatus, such as a coil, that is combined with a therapeutic device like a wrap or bandage (’574 Patent, col. 9:36-41). The core of the method is the configuration of a specific waveform using a mathematical "signal to noise ratio" (SNR) model, which ensures the therapeutic signal is detectable by the target cells or tissues above their natural background thermal noise, thereby optimizing the treatment's biological effectiveness at low power (’574 Patent, col. 9:46-54; FIG. 1).
• Technical Importance: This approach sought to enable the creation of smaller, more power-efficient, and targeted PEMF devices by moving away from brute-force signal application toward a model-based signal configuration designed for optimal biological coupling (’574 Patent, col. 3:5-14).

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶36).
• The essential elements of Claim 1 are:
  • Combining at least one inductive apparatus with a therapeutic device, positioned in proximity to a target pathway structure.
  • Configuring a waveform according to a mathematical model.
  • Choosing a waveform parameter value to satisfy an SNR model, making the waveform detectable above background activity in the target.
  • Generating an electromagnetic signal from the configured waveform.
  • Coupling the signal to the target pathway structure using the inductive apparatus to provide treatment.
• The complaint reserves the right to assert additional claims (Compl. ¶36).

U.S. Patent No. 7,758,490 - "Integrated Coil Apparatus for Therapeutically Treating Human and Animal Cells, Tissues and Organs with Electromagnetic Fields and Method for Using Same" (Issued July 20, 2010)

The Invention Explained

• Problem Addressed: The patent addresses the same challenges as the ʼ574 Patent, namely the need for a programmable, lightweight, and portable induction apparatus that delivers a signal based on a mathematical model (’490 Patent, col. 3:10-23).
• The Patented Solution: The ʼ490 Patent claims a method that also uses a mathematically configured waveform, but its unique step involves integrating the signal-generating "coupling device" (e.g., a coil) so that it is an "integral portion of a positioning device" like a surgical dressing, garment, or pad (’490 Patent, Abstract; col. 10:55-65). This creates a self-contained therapeutic apparatus.
• Technical Importance: This invention focuses on embedding the therapeutic signal source directly into common medical or consumer items (e.g., bandages, clothing), aiming to make treatment inconspicuous and convenient (’490 Patent, col. 4:20-33).

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶61).
• The essential elements of Claim 1 are:
  • Configuring a waveform according to a mathematical model.
  • Choosing a waveform parameter value to satisfy an SNR model.
  • Generating an electromagnetic signal from the configured waveform.
  • Integrating at least one coupling device with a positioning device.
  • Coupling the signal to the target pathway structure using the coupling device.
• The complaint reserves the right to assert additional claims (Compl. ¶61).

III. The Accused Instrumentality

Product Identification

The Accused Products include the ActiPatch Therapy Trial, ActiPatch Knee Pain Therapy Kit, HealFast Crescent Patch, HealFast Square Patch, and the HealFast Pet Patch Loop (Compl. ¶34).

Functionality and Market Context

The complaint alleges these products are wearable devices that employ "pulsed shortwave therapy technology that uses low power pulsed electromagnetic fields" for therapeutic purposes (Compl. ¶33). A chart reproduced in the complaint from Defendant's 510(K) regulatory filing compares the accused "Actipatch" device to the "IVIVI Torino II," a product from the patents' original owner (Compl. ¶30). This chart, offered as visual evidence, indicates that technical features such as "carrier frequency, burst duration, burst frequency, energy deposited, and power required" are allegedly the same between the two devices (Compl. ¶¶30-31). The complaint alleges these are commercially significant products that compete with Plaintiff's own offerings (Compl. ¶46).

IV. Analysis of Infringement Allegations

The complaint references external claim chart exhibits (Exhibits C and D) that were not provided with the filed document; therefore, the infringement allegations are summarized below in prose based on the complaint's narrative.

’574 Patent Infringement Allegations

The complaint alleges that Defendant's acts of making, using, and selling the Accused Products directly infringe at least Claim 1 of the ’574 Patent (Compl. ¶36). The infringement theory appears to rely on the argument that the Accused Products embody the claimed method. The complaint alleges that Defendant's instructions encourage users to combine the PEMF devices with items like braces, which may be intended to meet the "combining...with a therapeutic device" limitation (Compl. ¶55). The allegation that the Accused Products employ identical technical parameters to the predicate device, as shown in the 510(K) filing, is presented as evidence that they meet the claim limitations related to configuring, choosing, and generating the specific waveform (Compl. ¶¶30-31).

’490 Patent Infringement Allegations

The complaint asserts that Defendant's activities also directly infringe at least Claim 1 of the ’490 Patent (Compl. ¶61). The narrative suggests that the Accused Products, as sold, are self-contained units that meet the "integrating at least one coupling device with a positioning device" limitation (Compl. ¶¶78, 81). As with the ʼ574 Patent, the complaint relies on the 510(K) filing to support the allegation that the products meet the technical limitations concerning the mathematically configured waveform (Compl. ¶30).

Identified Points of Contention

• Scope Questions: A central dispute may arise from the subtle but critical differences between the claims of the two patents. The litigation will likely explore whether the Accused Products and their instructed use constitute "combining" an inductive apparatus with a therapeutic device (’574 Patent), "integrating" a coupling device with a positioning device (’490 Patent), or neither.
• Technical Questions: A key evidentiary question is whether Plaintiff can prove that the Accused Products generate a waveform that is specifically "configur[ed] according to a mathematical model" and chosen to "satisfy a signal to noise ratio model." The complaint's primary evidence for this is a comparison to a predicate device in a regulatory filing, raising the question of whether this is sufficient to establish that this specific, complex method step is performed.

V. Key Claim Terms for Construction

The Term: "combining ... with a therapeutic device" (’574 Patent, Claim 1)

• Context and Importance: The definition of "combining" is critical for distinguishing the scope of the ʼ574 Patent from the ʼ490 Patent. Practitioners may focus on this term to determine if it requires two separate articles being brought together or if it can read on a pre-assembled product.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification depicts embodiments where coils are integrated into items like a sock or shoe, which could be characterized as a form of "combining" the coil technology with the therapeutic function of the footwear (’574 Patent, FIGs. 8A, 8B).
  • Evidence for a Narrower Interpretation: The claim's use of "combining...with" suggests an action performed on two distinct items. The specification also discusses using the invention "adjunctively with" or "conjunctively with" other standard therapies, potentially supporting a construction that requires separate components (’574 Patent, col. 14:16-19).

The Term: "integrating at least one coupling device with a positioning device" (’490 Patent, Claim 1)

• Context and Importance: This term is the core of the ʼ490 Patent's asserted novelty over the related ʼ574 Patent. Its construction will determine the degree of physical unity required between the signal generator (coupling device) and the wearable item (positioning device).
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification discusses incorporating coils into garments using temporary means like Velcro, which may support a broader definition of "integrating" that does not require permanent bonding (’490 Patent, col. 6:15-20).
  • Evidence for a Narrower Interpretation: The abstract states the coupling device is an "integral portion of a positioning device," suggesting they are manufactured as a single, inseparable unit (’490 Patent, Abstract). Figure 2, showing coils inside the fabric of a bra, may support a narrower construction requiring the coil to be embedded (’490 Patent, FIG. 2).

The Term: "configuring ... according to a mathematical model" (Both patents, Claim 1)

• Context and Importance: This limitation defines the technical core of the claimed invention. The dispute will likely center on what level of scientific rigor and what specific type of analysis is required to meet this "mathematical model" requirement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification describes the concept of an SNR model generally, which could support a construction covering any design process that systematically considers signal strength relative to biological noise (’574 Patent, col. 7:46-65).
  • Evidence for a Narrower Interpretation: The specification provides detailed equations and numerical examples based on the binding kinetics of Calcium to Calmodulin (Ca²⁺/CaM), which a court could see as defining the required type of model, thereby narrowing the claim scope (’574 Patent, col. 8:1-29).

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement for both patents. The factual basis for inducement is Defendant's alleged creation and distribution of "websites, advertisements...FAQ sheets, brochures, User Guides and Instruction Sheets" that instruct and encourage customers to use the Accused Products in an infringing manner, such as by combining the PEMF device with a brace (Compl. ¶¶55, 81).

Willful Infringement

Willfulness is alleged based on both pre-suit and post-suit knowledge of the patents (Compl. ¶¶44, 70). The complaint alleges pre-suit knowledge based on Defendant’s 2016 510(K) filing, which referenced a product made by the patents’ original owner as a predicate device (Compl. ¶30). It also alleges constructive notice through Plaintiff's patent markings and alleges Defendant's general awareness of the inventor's foundational work in the field (Compl. ¶¶29, 31).

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

• A core issue will be one of definitional scope: can the terms "combining" (from the ’574 Patent) and "integrating" (from the ’490 Patent) be construed in a way that allows the same accused activity—the sale and instructed use of the ActiPatch products—to infringe both patents, or will their definitions prove to be mutually exclusive?
• A key evidentiary question will be one of technical proof: can Plaintiff demonstrate that the accused ActiPatch devices utilize a signal that was specifically "configur[ed] according to a mathematical model" that satisfies an "SNR model"? The case may depend on whether the comparison made in a 2016 regulatory filing is sufficient factual support for this highly technical claim limitation, or if more direct evidence of the Defendant's design process is required.
• A third central question relates to willfulness: does Defendant's 510(K) submission, which cited the patent owner's product as a predicate device nearly two and a half years before the complaint was filed, establish pre-suit knowledge of the specific patents-in-suit sufficient to support a claim for willful infringement?