DCT

2:22-cv-07810

SoftWave Tissue Regeneration Tech LLC v. DR HAR HARI S Khalsa DC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:22-cv-07810, C.D. Cal., 02/19/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the Central District of California because a co-defendant (Dr. Khalsa) acts as a spokesperson for the other defendants in California and maintains a regular, established place of business in the district. It is also alleged that Defendant StemWave’s terms and conditions select California law.
  • Core Dispute: Plaintiff alleges that Defendants’ sale and promotion of the "StemWave" shockwave therapy device and associated treatment methods infringe two patents related to therapeutic applications of acoustic pressure pulses.
  • Technical Context: The technology concerns the use of electro-hydraulic, electromagnetic, or piezoelectric devices to generate acoustic shock waves for medical treatments, such as promoting tissue regeneration and healing.
  • Key Procedural History: The complaint alleges that Plaintiff sent Defendants a notice letter on June 8, 2022, informing them of alleged infringement of one of the patents-in-suit, which may form the basis for a willfulness claim.

Case Timeline

Date Event
2003-02-19 '249 Patent Priority Date
2005-05-04 '995 Patent Priority Date
2010-11-30 U.S. Patent No. 7,841,995 Issues
2013-09-17 U.S. Patent No. 8,535,249 Issues
2022-04-27 StemWave announces exclusive distributorship of Modus F device
2022-05-01 StemWave begins distribution of the Accused Product
2022-06-08 Plaintiff sends notice letter to Defendants regarding the '995 Patent
2023-02-19 Amended Complaint Filed

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

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 that prior extracorporeal shock wave therapy (ESWT), used for applications like breaking up kidney stones, required high-energy, tightly focused waves. This approach could cause pain and tissue damage (e.g., hemorrhaging), limiting its utility for other therapeutic purposes, particularly on soft tissue. (’995 Patent, col. 2:10-15; col. 3:11-19).
  • The Patented Solution: The invention proposes a method of stimulating tissue using low-energy pressure pulses or shock waves that are deliberately unfocused (e.g., planar or divergent) or aimed so the focal point is not on the target tissue. This approach is designed to trigger a biological healing response, such as neovascularization and release of growth factors, without the destructive mechanical effects and pain associated with high-energy, focused ESWT. (’995 Patent, Abstract; col. 4:25-44).
  • Technical Importance: This method enabled the expansion of shock wave therapy to a wider range of conditions, including soft tissue regeneration and treatment of larger surface areas, often without requiring anesthesia. (’995 Patent, col. 3:45-53).

Key Claims at a Glance

  • The complaint asserts independent Claim 1 and dependent Claims 8 and 10. (Compl. ¶41).
  • The essential elements of independent Claim 1 include:
    • A method of stimulating a cellular substance (tissue) in a human or animal.
    • Activating an acoustic shock wave generator to emit pressure pulses or shock waves with a specified low energy density (0.00001 mJ/mm² to 1.0 mJ/mm²) and defined physical characteristics (e.g., amplitude, rise time, duration).
    • Subjecting the cellular substance to these waves "in the absence of a focal point impinging the substance," thereby stimulating a cellular response without creating cavitation bubbles or cellular hemorrhaging.
    • The emitted waves are described as convergent, divergent, planar, or near planar, and can be generated by electro-hydraulic, electromagnetic, piezoceramic, or ballistic sources.

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 addresses a gap between two types of existing shockwave devices. Tightly focused systems are effective for small, deep targets but are inefficient for larger areas. Conversely, radial systems treat large superficial areas but lack the energy density to be effective on deeper tissue. (’249 Patent, col. 2:1-20).
  • The Patented Solution: The invention is an apparatus designed to generate a wider variety of therapeutic waves. It uses a source and a housing with features like a generalized parabolic reflector or adjustable components to produce waves that are not just focused, but also planar, nearly planar, divergent, or "convergent off target." This versatility allows a single device to be adapted for different therapeutic needs. (’249 Patent, Abstract; col. 4:41-54).
  • Technical Importance: The invention provides for a more versatile shock wave apparatus that can bridge the performance gap between highly focused and purely radial systems, offering optimized treatment for a broader range of tissue types and depths. (’249 Patent, col. 3:1-21).

Key Claims at a Glance

  • The complaint asserts independent Claim 1. (Compl. ¶71).
  • The essential elements of independent Claim 1 include:
    • An apparatus for generating pressure pulse/shock waves.
    • A pressure pulse/shock wave (PP/SW) source.
    • A housing that encloses the PP/SW source.
    • An exit window from which shock waves emanate, where the waves have "plane, nearly plane, convergent off target or divergent characteristics."
    • The apparatus is shaped and dimensioned to provide waves with a power density between approximately 0.01 mJ/mm² and 1.0 mJ/mm² to stimulate living tissue while avoiding damage.

III. The Accused Instrumentality

Product Identification

The accused product is the Modus F shockwave device, branded and sold by Defendants as the "StemWave" device. (Compl. ¶13). The complaint includes a photograph of the Modus F device in its stand. (Compl. ¶13, p. 6).

Functionality and Market Context

The StemWave device is marketed as a "revolutionary new German technology" for therapeutic use, including treating musculoskeletal and orthopedic conditions, joint pain, and nerve injuries. (Compl. ¶14). It is described as using "Area Directed Technology (ADT)," which combines an electro-hydraulic system with an ellipsoidal reflector to generate "focused acoustic waves." (Compl. ¶15, ¶53). The complaint alleges that Defendant StemWave became the exclusive North American distributor for the Modus F device, manufactured by Inceler Medikal, as of April 2022, with distribution beginning May 1, 2022. (Compl. ¶15).

IV. Analysis of Infringement Allegations

'995 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a method of stimulating a cellular substance wherein the cellular substance is a tissue having cells... Defendants use and instruct others to use the Modus F device to treat human tissue, such as for arthritis in a toe. ¶43, ¶45 col. 23:8-11
activating an acoustic shock wave generator...to emit pressure pulses or acoustic shock waves...having a low energy density in the range of 0.00001 mJ/mm² to 1.0 mJ/mm²... The Modus F device is an activatable shockwave generator. A video shows a user setting the energy to 0.10 mJ, which is within the claimed range. The complaint alleges on information and belief that the device meets the specific pulse characteristics. ¶40, ¶47, ¶49, ¶50 col. 23:13-31
subjecting the cellular substance to convergent, divergent, planar or near planar acoustic shock waves...in the absence of a focal point impinging the substance stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging... The complaint alleges on information and belief that Defendants use and instruct how to use the Modus F device to subject human tissue to the specified waves "in the absences of a focal point impinging the substance" and without causing hemorrhaging. ¶52 col. 23:32-54

'249 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an apparatus for generating pressure pulse/shock waves comprising: a pressure pulse/shock wave (PP/SW) source; The Modus F is an apparatus that generates acoustic waves and includes an applicator that serves as the PP/SW source. The complaint includes a photo of the device with the applicator circled. ¶74, ¶77 col. 15:61-63
a housing enclosing said PP/SW source; and The Modus F device includes a housing that encloses the applicator/source. ¶79 col. 15:64-64
an exit window from which shock wave fronts...emanate, wherein said shock wave fronts have plane, nearly plane, convergent off target or divergent characteristics...[and] a power density in the range of approximately 0.01 mJ/mm2 up to 1.0 mJ/mm2... The applicator has an exit window. The complaint alleges on information and belief that the device is shaped and dimensioned to produce waves with the claimed characteristics and power density to be effective without causing tissue damage. ¶81, ¶83, ¶84 col. 15:65-16:8
  • Identified Points of Contention:
    • Scope Questions: A primary dispute for the '995 patent will likely concern the meaning of "in the absence of a focal point impinging the substance." The complaint cites Defendants' marketing material which explicitly refers to a "Focal Zone" and an "ellipsoidal reflector," which is a focusing component. (Compl. ¶19, ¶53). This creates a direct tension with the claim language. The resolution may depend on whether the "Focal Zone" of the accused device is functionally equivalent to the high-energy, destructive "focal point" the patent sought to avoid.
    • Technical Questions: For the '249 patent, a key question will be evidentiary: does the Modus F apparatus, as a matter of technical fact, generate waves with the specific "plane, nearly plane, convergent off target or divergent characteristics" required by the claim? The complaint alleges this on "information and belief," which suggests this will be a matter for expert discovery and testing. (Compl. ¶83). The complaint provides a screenshot from a demonstrative video showing the user interface of the accused device, which includes settings for "Target," "Freq," and "Energy." (Compl. ¶40, p. 14).

V. Key Claim Terms for Construction

  • The Term: "in the absence of a focal point impinging the substance" ('995 Patent, Claim 1)
  • Context and Importance: This term is the central point of contention for the '995 patent's method claim. The accused StemWave device is marketed as creating a "Focal Zone," seemingly contradicting this limitation. The entire infringement theory for this patent hinges on how this phrase is construed. Practitioners may focus on this term because its definition will likely be dispositive of infringement for Claim 1.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (i.e., any focus is a "focal point"): The specification distinguishes the invention from prior art that uses focused waves, stating that in certain applications, "focused shock waves are used to treat ischemic heart tissue for generating better blood supply by targeting the treated tissue in the focal point of the emitted wave pattern." (’995 Patent, col. 2:4-9). This could support an argument that any device intentionally creating a focus on or in the tissue falls outside the claim.
    • Evidence for a Narrower Interpretation (i.e., only a sharp, destructive focus is a "focal point"): The claim itself links the "absence of a focal point" to the functional result of "not experiencing the sensation of cellular hemorrhaging." (’995 Patent, col. 23:37-41). This suggests the "focal point" being avoided is the kind that causes tissue damage, not necessarily any and all geometric focusing. The specification also describes its goal as avoiding "disadvantageous effects of cavitation phenomena." (’995 Patent, col. 3:15-24). This may support an argument that a diffuse, low-energy "focal zone" that does not cause such effects still meets the "absence of a focal point" limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. For inducement, it pleads that Defendants provide instructional materials, marketing, and training (the "StemWave Procedure") that encourage and enable their customers to use the Modus F device in an infringing manner. (Compl. ¶¶ 36, 61, 72). A YouTube video by Dr. Khalsa demonstrating the procedure is cited as a specific example of such instruction. (Compl. ¶39). For contributory infringement of the '995 patent, the complaint alleges the device is a material part of the patented method and is not a staple good with substantial non-infringing uses. (Compl. ¶63).
  • Willful Infringement: Willfulness is alleged for the '995 patent based on alleged pre-suit knowledge. The complaint states that a notice letter was sent to Defendants on June 8, 2022, and that infringing activity continued thereafter. (Compl. ¶60). For the '249 patent, the willfulness allegation appears to be based on post-suit knowledge, starting from the date of service of the complaint. (Compl. ¶71, ¶72).

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

  • A core issue will be one of definitional scope: Can the '995 patent's claim limitation "in the absence of a focal point impinging the substance" be construed to read on a method using a device that Defendants' own marketing describes as creating a "Focal Zone" with an "ellipsoidal reflector"? The case may turn on whether the accused device's "focal zone" is functionally distinct from the sharp, high-energy "focal point" the patent contrasts itself with.
  • A key evidentiary question will be one of technical capability: Can Plaintiff produce evidence to substantiate its "information and belief" allegations that the accused Modus F apparatus is, in fact, "shaped and dimensioned" to produce the specific "plane, nearly plane, convergent off target or divergent" wave characteristics required by the '249 patent's claims?