DCT
5:19-cv-00257
Endonovo Therap Inc v. KVP Intl Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Endonovo Therapeutics, Inc. (Delaware)
- Defendant: KVP International, Inc. (California); Orthocor Medical, Inc. (Delaware); Caerus Corp. (Minnesota)
- Plaintiff’s Counsel: Manning & Kass, Ellrod, Ramirez, Trester LLP
- Case Identification: 5:19-cv-00257, C.D. Cal., 02/07/2019
- Venue Allegations: Venue is alleged based on Defendants residing in the district, committing acts of infringement within the district, and having a regular and established place of business there.
- Core Dispute: Plaintiff alleges that Defendants’ Pulsed Electromagnetic Field (PEMF) therapy products for humans and animals infringe four patents related to electromagnetic medical therapies.
- Technical Context: The technology at issue is Pulsed Electromagnetic Field (PEMF) therapy, which uses electromagnetic fields to treat medical conditions such as pain, inflammation, and degenerative joint disease.
- Key Procedural History: The complaint alleges that the patents-in-suit, invented by PEMF pioneer Dr. Arthur Pilla, were assigned through a series of corporate acquisitions, culminating in their acquisition by Plaintiff Endonovo on December 22, 2017. The complaint also alleges Defendants had pre-suit knowledge of the patents, asserting that KVP's website references Dr. Pilla's research and that Defendant Orthocor’s own patenting efforts were limited by Dr. Pilla’s patents as prior art.
Case Timeline
| Date | Event |
|---|---|
| 2003-12-05 | ’385 Patent Priority Date |
| 2004-04-26 | ’574 and ’490 Patents Priority Date |
| 2010-06-22 | ’574 Patent Issue Date |
| 2010-07-20 | ’490 Patent Issue Date |
| 2010-10-29 | ’096 Patent Priority Date |
| 2015-02-24 | ’385 Patent Issue Date |
| 2016-01-01 | Caerus Corp. acquires Orthocor Medical, Inc. (approximate date) |
| 2017-05-23 | ’096 Patent Issue Date |
| 2017-10-01 | KVP allegedly begins marketing infringing "Cura" product line (approximate date) |
| 2017-12-22 | Endonovo acquires the patents-in-suit |
| 2019-02-07 | 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”
The Invention Explained
- Problem Addressed: Prior art electromagnetic therapy devices were not lightweight, portable, or optimally configured for specific biological effects, limiting their clinical utility and effectiveness (ʼ574 Patent, col. 3:5-18).
- The Patented Solution: The invention describes a method for therapeutic treatment using a lightweight, portable induction apparatus, such as a coil, integrated into a therapeutic device like a wrap or bandage. The core of the solution is configuring the electromagnetic waveform according to a mathematical "signal to noise ratio" model to ensure the signal is detectable by the target biological pathway (e.g., molecules or cells) above its natural background activity, thereby optimizing the therapeutic effect (ʼ574 Patent, Abstract; col. 10:35-60).
- Technical Importance: This approach enabled the development of portable and targeted PEMF therapies by modeling the signal to maximize its impact on a specific biological mechanism (Compl. ¶¶3-4).
Key Claims at a Glance
- The complaint asserts method claims, including independent Claim 1 (Compl. ¶¶66, 70).
- Claim 1 requires the steps of:
- Combining at least one inductive apparatus with a therapeutic device, wherein said therapeutic device is positioned in proximity to a target pathway structure.
- Configuring at least one waveform according to a mathematical model having at least one waveform parameter, said at least one waveform to be coupled to said target pathway structure.
- Choosing a value of said at least one waveform parameter to satisfy a signal to noise ratio model, so that said at least waveform is configured to be detectable in said target pathway structure above background activity in said target pathway structure.
- Generating an electromagnetic signal from said configured at least one waveform.
- Coupling said electromagnetic signal to said target pathway structure using said at least one inductive apparatus device thereby providing treatment.
- The complaint reserves the right to assert other claims (Compl. ¶66).
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”
The Invention Explained
- Problem Addressed: The patent addresses the need for convenient, inconspicuous, and effective PEMF therapy devices that can be easily integrated into daily life and various therapeutic garments without cumbersome separate components ('490 Patent, col. 3:8-33).
- The Patented Solution: The invention is an electromagnetic treatment apparatus where the signal-generating component (the "coupling device," such as a coil) is an integral part of the "positioning device" (such as a garment, brace, or dressing). The apparatus includes a means for configuring the electromagnetic waveform based on a mathematical model to ensure the signal effectively interacts with the target biological pathway ('490 Patent, Abstract; col. 17:18-37). Figure 2 of the patent shows coils integrated into a brassiere.
- Technical Importance: This integration of the treatment coil directly into wearable items created self-contained and user-friendly therapeutic products (Compl. ¶¶94, 96).
Key Claims at a Glance
- The complaint asserts apparatus and method claims, including independent apparatus Claim 41 and independent method Claim 1 (Compl. ¶¶89, 93, 95).
- Claim 41 requires:
- A waveform configuration means for configuring at least one waveform to be coupled to a target pathway structure according to a mathematical model having at least one waveform parameter capable of being chosen to satisfy a Signal to Noise Ratio model.
- At least one coupling device connected to said waveform configuration means for generating an electromagnetic signal.
- A positioning device wherein said at least one coupling device is integral to said positioning device.
- The complaint reserves the right to assert other claims (Compl. ¶89).
U.S. Patent No. 8,961,385 - “Devices and Method for Treatment of Degenerative Joint Diseases with Electromagnetic Fields”
Technology Synopsis
The patent describes a method for treating degenerative joint disease using a lightweight, wearable pulsed EMF therapy device. The invention specifies particular parameters for the treatment regime, including bursts of electromagnetic signals with defined peak amplitudes (<200 milliGauss), durations (0.5-50 msec), interburst intervals, and specific treatment on-times and off-times (Compl. ¶118; ’385 Patent, Abstract).
Asserted Claims
The complaint asserts method claims, reciting elements of what appears to be Claim 1 (Compl. ¶118).
Accused Features
The accused products are alleged to infringe by employing a method of positioning a flexible coil applicator adjacent to a joint and applying a timed system of EMF pulses based on the specific timed intervals and treatment regimes disclosed in the patent (Compl. ¶119).
U.S. Patent No. 9,656,096 - “Methods and Apparatus for Electromagnetic Enhancement of Biochemical Signaling Pathways for Therapeutics and Prophylaxis in Plants, Animals and Humans”
Technology Synopsis
The patent discloses a device for accelerating the binding of cytosolic ions to a corresponding buffer (e.g., calcium to calmodulin) to modulate biochemical signaling pathways for tissue repair and growth. The device comprises a flexible coil applicator and a signal generator configured to apply signals with specific parameters (e.g., peak electric field, pulse duration, burst duration, carrier waves) that are mathematically related to the "ion bound time" of the target pathway (Compl. ¶141; ’096 Patent, Abstract).
Asserted Claims
The complaint asserts device claims, reciting elements of what appears to be Claim 1 (Compl. ¶141).
Accused Features
The accused products are alleged to be devices that function to accelerate cytosolic ion binding to modulate biochemical signaling pathways, incorporating a flexible coil applicator and a signal generator that applies an electromagnetic signal with the claimed parameters (Compl. ¶141).
III. The Accused Instrumentality
Product Identification
The accused products include the "KVP Cura" line (including the KVP Cura Patch), the "OrthoCor Active System," the "EMbrace Relief System," the "EMpower Device," and the "EMbrace L'il Back System" (Compl. ¶¶69, 92, 117, 140).
Functionality and Market Context
The accused products are therapeutic devices, including wearable braces, wraps, and attachable patches for both humans and animals, that utilize PEMF technology to reduce pain and increase blood flow (Compl. ¶¶50, 54, 61). The complaint alleges that some products, like the KVP Cura Patch, are designed to attach to various garments, while others incorporate the PEMF technology directly into the device (Compl. ¶¶51, 92). An advertisement for the "KVP Cura Patch" shows the patch being applied to a dog's leg using a wrap (Compl. p. 8). Photos of the "OrthoCor Active System" show a back brace and a knee brace, each with PEMF modules attached (Compl. p. 10). Another visual shows the "EMpower Device" coupled with a back bracer for use on a dog as part of the "EMbrace L'il Back System" (Compl. p. 12). The complaint alleges Defendant Orthocor supplies PEMF components to Defendant KVP for its products (Compl. ¶53).
IV. Analysis of Infringement Allegations
’574 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| Combining at least one inductive apparatus with a therapeutic device, wherein said therapeutic device is positioned in proximity to a target pathway structure | The accused products combine an inductive apparatus (a PEMF patch or unit) with a therapeutic device (a brace, wrap, or garment) that is positioned near the body location requiring therapy. | ¶71 | col. 10:35-41 |
| Configuring at least one waveform according to a mathematical model having at least one waveform parameter... | The PEMF technology in the accused products allegedly generates an electromagnetic signal based on a waveform that is necessarily configured according to a model to be effective. | ¶71 | col. 10:42-46 |
| Choosing a value of said at least one waveform parameter to satisfy a signal to noise ratio model... | The signal is allegedly configured to satisfy signal-to-noise ratios so that the waveform is detectable at the target location, which is alleged to be a requirement for the technology's therapeutic effect. | ¶71 | col. 10:47-53 |
| Generating an electromagnetic signal from said configured at least one waveform | The inductive device in the accused products generates the electromagnetic signal. | ¶71 | col. 10:54-56 |
| Coupling said electromagnetic signal to said target pathway structure using said at least one inductive apparatus device thereby providing treatment | The generated signal is coupled to the target body area to provide treatment. | ¶71 | col. 10:57-60 |
- Identified Points of Contention:
- Evidentiary Question: The complaint alleges that the accused products meet the "configuring...according to a mathematical model" and "satisfy a signal to noise ratio model" limitations because this is how the PEMF technology "must work to be effective" (Compl. ¶71). This raises the evidentiary question of what direct proof Plaintiff will offer that Defendants' products are in fact designed and configured based on such specific mathematical and SNR models, rather than on more general principles of timed pulse delivery.
’490 Patent Infringement Allegations
| Claim Element (from Independent Claim 41) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a waveform configuration means for configuring at least one waveform... according to a mathematical model... to satisfy a Signal to Noise Ratio model | The accused products allegedly use PEMF therapy that comprises a means for configuring a waveform parameter to satisfy a signal-to-noise ratio, ensuring the signal is detectable by the target body area. | ¶94 | col. 17:18-28 |
| at least one coupling device connected to said waveform configuration means... for generating an electromagnetic signal... and for coupling said... signal to said target pathway structure | The products comprise a connecting means, such as a brace or patch, that couples the generated signal from the PEMF device to the target area requiring therapy. | ¶94 | col. 17:29-34 |
| a positioning device wherein said at least one coupling device is integral to said positioning device | The brace, garment, or patch serves as the positioning device, and the PEMF generator/coil (the coupling device) is allegedly integral to it, whether built-in or attached. | ¶¶94, 96 | col. 17:35-37 |
- Identified Points of Contention:
- Scope Question: A primary point of contention may be the scope of the term "integral". The complaint alleges infringement by products where the PEMF device is a detachable "patch" that attaches with Velcro, as well as by products where the technology is built in (Compl. ¶¶92, 96). This raises the question of whether a component designed to be attached and detached can be considered "integral" to the positioning device, a term that may suggest a more permanent, unitary construction.
V. Key Claim Terms for Construction
- The Term: "configuring... according to a mathematical model... to satisfy a signal to noise ratio model" (from claims of the '574 and '490 patents)
- Context and Importance: This phrase represents the core technical novelty of the inventions. Its construction will be critical to determining whether the accused products, which deliver timed electromagnetic pulses, practice the claimed invention. Practitioners may focus on whether this requires a complex, target-specific calculation or can be satisfied by more general signal design principles.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the purpose of the SNR model as ensuring the induced power is "sufficiently above background thermal noise power," a general concept applicable to any effective signal ('490 Patent, col. 8:1-3).
- Evidence for a Narrower Interpretation: The specification provides detailed mathematical equations and specific examples of modeling the Ca²⁺/Calmodulin pathway, which could support a narrower construction requiring a specific, complex biophysical simulation ('490 Patent, col. 7:55-col. 8:67).
- The Term: "integral" (from claims of the '490 patent)
- Context and Importance: The definition of this term will be central to whether the '490 patent reads on accused products that use a detachable PEMF component, such as the "KVP Cura Patch," which attaches to a garment via Velcro (Compl. ¶¶8, 51).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not provide an explicit definition of "integral," which could allow for a construction meaning "designed to function as a single unit," potentially covering components that are attachable but intended for combined use (Compl. ¶96).
- Evidence for a Narrower Interpretation: The patent's figures depict embodiments where the coils are permanently integrated or woven into the fabric of the positioning device, which may support a narrower construction requiring a one-piece, non-detachable assembly ('490 Patent, Fig. 2).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants induce infringement by providing advertisements, FAQ sheets, user guides, and instruction sheets that instruct and encourage customers to combine and use the accused products in ways that practice the patented methods (Compl. ¶¶82-83, 107-108).
- Willful Infringement: Willfulness is alleged based on Defendants' purported knowledge of Dr. Pilla's foundational research and the patents-in-suit. The complaint alleges KVP's own website states its "time treatment" approach is based on Dr. Pilla's research and that Orthocor's ability to obtain its own patents was limited by Dr. Pilla's patents serving as prior art (Compl. ¶¶44-46, 74).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof: What evidence will be presented to demonstrate that the accused products' simple, timed-pulse waveforms are "configured according to a mathematical model" that satisfies a "signal to noise ratio model," as required by the claims, versus being based on general therapeutic parameters?
- A key legal question will be one of definitional scope: Can the term "integral," as used in the ’490 Patent, be construed to cover a PEMF device that is designed to be detachably affixed to a garment, or is its scope limited to devices of unitary, single-piece construction?
- A central factual question will be one of knowledge and intent: Do the allegations that Defendants were aware of Dr. Pilla’s research and were constrained by his patents as prior art provide a sufficient basis to support the claims for willful and indirect infringement?