Softwave Tissue Regeneration Tech LLC v. Djo LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: SoftWave Tissue Regeneration Technologies, LLC (Ohio)
  • Defendant: DJO, LLC (Delaware)
  • Plaintiff's Counsel: Insight, PLC
• Case Identification: 3:25-cv-02198, S.D. Cal., 03/24/2026
• Venue Allegations: Plaintiff alleges venue is proper in the Southern District of California because Defendant's principal place of business is in Carlsbad, California, and it conducts continuous business, including the alleged infringing activities, within the district.
• Core Dispute: Plaintiff alleges that Defendant's Intelect® Focus Shockwave medical device, and its methods of use, infringe four U.S. patents related to extracorporeal shock wave therapy (ESWT) technology.
• Technical Context: The technology concerns apparatus and methods for applying acoustic pressure pulses or shock waves to biological tissue to stimulate therapeutic responses, such as tissue regeneration and pain treatment.
• Key Procedural History: The complaint states that Plaintiff notified Defendant of alleged infringement of U.S. Patent No. 8,535,249 via letters sent in February 2020 and February 2025. These communications may form the basis for allegations of pre-suit knowledge and willful infringement.

Case Timeline

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

U.S. Patent No. 8,535,249 - "Pressure Pulse/Shock Wave Apparatus For Generating Waves Having Plane, Nearly Plane, Convergent Off Target Or Divergent Characteristics"

The Invention Explained

• Problem Addressed: The patent's background section identifies limitations in prior art shock wave devices Compl. ¶27 It notes that conventional focused systems treat only a small area and can be painful, while radial (diverging) systems lack the energy density to treat deeper tissues effectively '249 Patent, col. 2:1-22
• The Patented Solution: The invention is an apparatus designed to generate a variety of unfocused or alternatively focused shock waves, including "plane, nearly plane, convergent off target or divergent" waves '249 Patent, abstract This allows the therapeutic energy to be delivered over a larger area without concentrating it at a single, high-intensity focal point, thereby stimulating tissue while avoiding damage '249 Patent, col. 3:45-53 The specification describes how different reflector geometries, such as a parabolic reflector, can be used to produce these desired wave characteristics '249 Patent, col. 4:51-56 '249 Patent, Fig. 2
• Technical Importance: This technology purports to enable less painful and more efficient treatment of larger tissue areas, expanding the use of shock wave therapy to orthopedic and soft-tissue applications beyond its original use in breaking up kidney stones '249 Patent, col. 2:35-51

Key Claims at a Glance

• The complaint asserts independent claims 1 and 20 Compl. ¶11 Compl. ¶45
• Independent Claim 1 includes the following essential elements:
  • An apparatus for generating pressure pulse/shock waves comprising:
  • A pressure pulse/shock wave (PP/SW) source;
  • A housing enclosing said PP/SW source;
  • An exit window from which shock wave fronts emanate;
  • Wherein the shock wave fronts have "plane, nearly plane, convergent off target or divergent characteristics";
  • Wherein the apparatus is shaped and dimensioned to provide shock wave fronts having a power density level to produce a tissue reaction; and
  • Wherein the waves have a power density in the range of approximately 0.01 mJ/mm² up to 1.0 mJ/mm² to stimulate living tissue while avoiding tissue damage.

U.S. Patent No. 7,841,995 - "Pressure Pulse/Shock Wave Therapy Methods And An Apparatus For Conducting The Therapeutic Methods"

The Invention Explained

• Problem Addressed: The patent describes a need for therapeutic methods that can stimulate biological healing processes in various tissues without the negative side effects, such as hemorrhaging, associated with high-energy, focused shock waves '995 Patent, col. 3:5-24
• The Patented Solution: The patent claims a method of stimulating a cellular substance by applying acoustic shock waves or pressure pulses "in the absence of a focal point impinging the substance" '995 Patent, col. 4:32-34 The goal is to stimulate a cellular response, such as growth factor release, without creating the "cavitation bubbles" that lead to tissue damage '995 Patent, abstract The method covers the use of various non-focused wave types (convergent, divergent, planar) to achieve this effect '995 Patent, claim 1
• Technical Importance: The invention provides a methodological framework for using lower-energy, unfocused shock waves to trigger biological healing responses, greatly expanding the potential applications of the technology to a wide range of soft-tissue and organ-related conditions '995 Patent, col. 3:25-33

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claim 3 Compl. ¶69
• Independent Claim 1 includes the following essential steps:
  • A method of stimulating a cellular substance, which is a tissue having cells, comprising the steps of:
  • treating the cellular substance;
  • activating an acoustic shock wave generator to emit pressure pulses or shock waves toward the substance with a low energy density (in the range of 0.00001 mJ/mm² up to 1.0 mJ/mm²); and
  • subjecting the substance to "convergent, divergent, planar or near planar" acoustic shock waves "in the absence of a focal point" to stimulate a cellular response "in the absence of creating cavitation bubbles."
• The complaint also asserts dependent claim 3, which specifies that the treated organ can be skin Compl. ¶79

U.S. Patent No. 7,601,127 - "Therapeutic Stimulation of Genital Tissue or Reproductive Organ of an Infertility or Impotence Diagnosed Patient"

• Technology Synopsis: This patent discloses a method for treating infertility or impotence by applying acoustic shock waves to genital or reproductive tissue "'127" Patent, abstract The described solution involves subjecting the tissue to convergent, divergent, or planar shock waves to stimulate a biological response, such as improving blood flow or nerve sensitivity, without a damaging focal point "'127" Patent, col. 4:38-44
• Asserted Claims: Independent claims 1 and 7 Compl. ¶88
• Accused Features: Plaintiff alleges that Defendant's IFS Device, when used with its "Urology Stand-off" accessory, is advertised and used by customers for treating conditions like erectile dysfunction, thereby practicing the claimed method Compl. ¶¶91, 105

U.S. Patent No. 8,529,451 - "Shockwave Coupling Adapter and Method of Use"

• Technology Synopsis: The patent describes a spacer or adapter designed for use with a focused shock wave applicator "'451" Patent, abstract The spacer is a fluid-filled membrane positioned between the applicator and the patient. Its purpose is to ensure the high-energy focal point of the shock wave occurs within the spacer itself, so that only a lower-energy, diverging wave pattern exits the spacer and contacts the patient's tissue, thus avoiding the pain and damage associated with a direct focal point impact "'451" Patent, col. 2:45-56
• Asserted Claims: Independent claim 1 Compl. ¶112
• Accused Features: The complaint identifies the "stand-off" accessories sold and used with the IFS Device as the claimed spacer, alleging they are used to position the applicator and modify the wave pattern in an infringing manner Compl. ¶¶115, 117 The complaint includes an image of the stand-off being applied to a patient's skin Compl. p. 29

III. The Accused Instrumentality

Product Identification

• The accused product is the "Intelect® Focus Shockwave" device, also referred to as the "IFS Device" Compl. ¶5

Functionality and Market Context

• The IFS Device is a medical system that electromagnetically generates and applies extracorporeal shock waves to a patient's tissue for therapeutic purposes Compl. ¶7 It consists of a main unit with a touch-screen interface and a handpiece applicator that delivers the waves Compl. ¶32 Compl. ¶35 The device is sold with accessories called "stand-offs" which are used to vary the penetration depth of the shock waves Compl. ¶115 The complaint alleges the device is marketed and sold in the U.S. for treating various conditions, including chronic proximal plantar fasciitis and urological indications such as erectile dysfunction Compl. ¶7 Compl. ¶91 The complaint includes a screenshot from a customer's website advertising the IFS Device for "Next Level ED Treatment" Compl. p. 23

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,535,249 Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A primary question may be whether the accused "Intelect® Focus Shockwave" device can generate waves with the claimed "convergent off target or divergent characteristics." The product's name suggests it produces a focused wave, creating a potential mismatch with the claim language. The plaintiff's case may depend on demonstrating that the device's operational use, especially with stand-offs, effectively moves the focal point away from the target tissue, thus meeting the "off target" limitation.
  • Technical Questions: What evidence does the complaint provide that the device's operation produces the specific wave geometries claimed (plane, nearly plane, etc.)? The complaint makes this allegation "upon information and belief," suggesting this will be a point of factual dispute requiring expert analysis of the device's actual output.

U.S. Patent No. 7,841,995 Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The central issue for this patent is the meaning of "in the absence of a focal point impinging the substance." Defendant may argue that a device named and designed to be a "Focus Shockwave" inherently creates a focal point that impinges the tissue. Plaintiff may counter that "impinging" in the context of the claim means causing the negative effects (cavitation, hemorrhaging) that the patent seeks to avoid, and that the low energy levels used by the IFS Device do not meet this functional definition of "impinging."
  • Technical Questions: What is the clinical and physical evidence that the IFS Device operates without "creating cavitation bubbles"? This is a negative limitation that will likely require expert testimony and empirical data to resolve.

V. Key Claim Terms for Construction

• For the "'249" and "'995" Patents:
  • The Term: "convergent off target" "'249" Patent and "in the absence of a focal point impinging the substance" "'995" Patent
  • Context and Importance: These related terms are at the heart of the dispute. The accused product is named the "Intelect® Focus Shockwave," creating an immediate tension with patent claims that require an unfocused or off-target effect. The viability of the infringement claims may depend entirely on whether the operational characteristics of the accused device can be construed as meeting these limitations, despite its name. Practitioners may focus on these terms because they directly address the potential mismatch between the product's branding and its alleged function.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specifications of both patents distinguish their inventions from prior art that caused pain and tissue damage due to high-energy focal points '249 Patent, col. 2:1-10 '995 Patent, col. 3:11-17 This context may support an interpretation that the "absence" of a focal point or an "off target" configuration is defined functionally by the avoidance of tissue damage, rather than by a strict geometric definition. The '249 patent specification explicitly describes an "off target" scenario where the focal point is placed beyond the tissue, so the tissue is only exposed to pre-focal, converging waves '249 Patent, col. 10:1-12
    • Evidence for a Narrower Interpretation: The plain language of the terms suggests a purely geometric meaning. A defendant may argue that if a geometric focal point is located within the treated tissue, the claims are not met, regardless of the energy level or biological effect. The patents' detailed discussions of specific reflector geometries (e.g., parabolic vs. ellipsoidal) to create specific wave types may support an argument that the claimed wave "characteristics" are tied to the fundamental design of the apparatus, not merely its adjustable settings '249 Patent, col. 4:30-56

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement for all four patents. The stated basis is that Defendant provides the IFS Device along with instructions, marketing materials, user manuals, and recommended clinical protocols that allegedly encourage and enable customers to use the device in an infringing manner Compl. ¶29 Compl. ¶70 Compl. ¶89 Compl. ¶113 The complaint asserts that Defendant's knowledge of the patents, at least from the date of service, is sufficient to establish the requisite intent for inducement Compl. ¶70, n.1
• Willful Infringement: The complaint alleges willful infringement of at least the "'249" patent. This allegation is based on Plaintiff having sent notice letters to Defendant in February 2020 and February 2025, thereby providing Defendant with pre-suit knowledge of the patent and its alleged infringement Compl. ¶9 Compl. ¶10 Compl. ¶11

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

• A core issue will be one of operational function versus product branding: Can a device marketed as a "Focus Shockwave" be shown to operate in a manner that is "convergent off target" or "in the absence of a focal point impinging the substance" as the patents require? The resolution will likely depend on whether the court adopts a strict geometric definition of "focal point" or a functional one tied to the avoidance of tissue damage as described in the patents.
• A second key question will be one of evidentiary proof for a negative limitation: What technical and clinical evidence can establish that the IFS Device, when used as instructed, stimulates a "cellular response in the absence of creating cavitation bubbles"? This will likely shift the focus from the device's mechanical design to the biological and physical effects it produces in tissue at its recommended energy settings.