DCT

2:25-cv-08484

Softwave Tissue Regeneration Tech LLC v. Moon Pool LLC

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-08484, C.D. Cal., 11/02/2025
  • Venue Allegations: Venue is alleged to be proper based on Defendants regularly conducting business, soliciting customers, and selling the accused products within the Central District of California.
  • Core Dispute: Plaintiff alleges that Defendants’ at-home acoustic wave therapy device infringes three patents related to methods and apparatuses for therapeutic pressure pulse/shock wave treatment for medical conditions, including impotence.
  • Technical Context: The technology involves the application of acoustic shock waves to biological tissue to stimulate healing, regeneration, and other therapeutic responses, particularly for treating erectile dysfunction and Peyronie's Disease.
  • Key Procedural History: The complaint states that this action follows a prior litigation between Plaintiff and Defendant Launch Medical, which was dismissed after a settlement agreement was reached. Plaintiff alleges Launch Medical failed to perform its obligations under that agreement, leading to the re-assertion of patent infringement claims.

Case Timeline

Date Event
2003-02-19 Earliest Priority Date for U.S. Patent No. 8,535,249
2004-10-22 Earliest Priority Date for U.S. Patent No. 7,841,995
2005-06-17 Earliest Priority Date for U.S. Patent No. 7,601,127
2009-10-13 U.S. Patent No. 7,601,127 Issues
2010-11-30 U.S. Patent No. 7,841,995 Issues
2013-09-17 U.S. Patent No. 8,535,249 Issues
2020-09-30 Plaintiff SoftWave TRT acquires rights to the Patents-in-Suit
2025-11-02 Complaint Filed

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

  • U.S. Patent No. 7,601,127, “Therapeutic Stimulation Of Genital Tissue Or Reproductive Organ Of An Infertility Or Impotence Diagnosed Patient,” Issued October 13, 2009

    • The Invention Explained:
      • Problem Addressed: The patent addresses the need for new techniques to enhance the reproductive potential of both males and females, correcting degenerative conditions that result from aging or disease, particularly infertility and impotence (’127 Patent, col. 4:29-34).
      • The Patented Solution: The invention proposes a non-invasive method of stimulating genital or reproductive tissue using acoustic shock waves (’127 Patent, col. 4:50-57). The method involves applying waves with specific physical characteristics (e.g., low energy density, specific pressure amplitudes and durations) to the target tissue without a localized focal point, which is intended to stimulate a cellular response and healing without causing cavitation or hemorrhaging (’127 Patent, col. 20:26-40). Key figures illustrate various wave patterns, such as convergent, planar, and divergent waves, that can be emitted by a generator (e.g., ’127 Patent, Figs. 1A-1C).
      • Technical Importance: This approach aimed to provide a therapeutic benefit by stimulating the body's natural healing capabilities at a cellular level, using lower energy levels than were typically used for destructive procedures like breaking kidney stones, thereby avoiding tissue damage (’127 Patent, col. 11:1-9).
    • Key Claims at a Glance:
      • The complaint asserts independent Claim 1 and dependent Claims 3 and 7 (Compl. ¶¶10, 26, 49).
      • Independent Claim 1 recites a method with the following essential steps:
        • Activating an acoustic shock wave generator to emit pressure pulses with specified physical parameters (energy density, pressure, duration, rise times).
        • Subjecting genital or reproductive tissue to these pulses, where the pulses are convergent, divergent, planar, or near planar and lack a focal point impinging the tissue.
        • Positioning the tissue away from any localized geometric focal volume of the emitted waves.
        • Stimulating the tissue, which is positioned in a path removed from any focal point of the emitted wave.
      • The complaint reserves the right to assert additional claims (Compl. ¶49).

  • 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,” Issued September 17, 2013

    • The Invention Explained:
      • Problem Addressed: The patent identifies a need for shock wave treatment devices that can effectively treat larger tissue areas, such as skin or tendons, which is difficult with traditional focused-beam systems that concentrate energy on a small point (’249 Patent, col. 1:11-15). Existing focused systems often require moving the device to cover a larger area, while radial systems may lack sufficient energy density for deeper tissues (’249 Patent, col. 2:7-22).
      • The Patented Solution: The invention is an apparatus for generating acoustic waves that are not tightly focused but are instead "plane, nearly plane, convergent off target or divergent" (’249 Patent, Abstract). This is achieved through specific reflector geometries, such as a "generalized paraboloid," which can compensate for disturbances and create a more uniform wave front over a larger area (’249 Patent, col. 6:46-59). The apparatus includes a shock wave source, a housing, and an exit window, and is dimensioned to produce waves with a power density sufficient to stimulate a tissue reaction while avoiding damage (’249 Patent, col. 16:1-9).
      • Technical Importance: The technology provided a way to apply therapeutic shock waves over a broader, more diffuse area, potentially reducing treatment time and improving outcomes for conditions affecting larger surface areas or volumes of tissue (’249 Patent, col. 3:11-17).
    • Key Claims at a Glance:
      • The complaint asserts independent Claims 1 and 20 (Compl. ¶¶91-92).
      • Independent Claim 1 recites an apparatus with the following essential elements:
        • A pressure pulse/shock wave (PP/SW) source.
        • A housing enclosing the source.
        • An exit window from which shock wave fronts emanate.
        • The apparatus is shaped and dimensioned to provide shock wave fronts having plane, nearly plane, convergent off target, or divergent characteristics.
        • The apparatus is further shaped to provide waves with a power density in a specified range (0.01 mJ/mm² to 1.0 mJ/mm²) to stimulate living tissue while avoiding damage.
      • The complaint reserves the right to assert additional claims (Compl. ¶92).

  • Multi-Patent Capsule:

    • Patent Identification: U.S. Patent No. 7,841,995, “Pressure Pulse/Shock Wave Therapy Methods And An Apparatus For Conducting The Therapeutic Methods,” Issued November 30, 2010.
    • Technology Synopsis: This patent describes a method for stimulating a "cellular substance" (e.g., tissue or an organ) by activating a shock wave generator and subjecting the substance to the emitted waves (’995 Patent, col. 4:24-34). The method is characterized by applying these waves in the absence of a focal point on the substance, which is intended to trigger a biological healing response without destroying tissue, distinguishing it from high-energy lithotripsy (’995 Patent, col. 2:40-44).
    • Asserted Claims: Independent Claim 1 and dependent Claim 3 (Compl. ¶119).
    • Accused Features: The complaint alleges that Defendants' promotion and customers' use of the Phoenix device to treat erectile dysfunction and Peyronie's Disease constitutes use of the claimed method (Compl. ¶¶118-119, 126).

III. The Accused Instrumentality

  • Product Identification: "The Phoenix," formerly known as "The Rocket" (the "Accused Product") (Compl. ¶11).
  • Functionality and Market Context:
    • The Accused Product is described as a home-use medical device that utilizes "Acoustic Wave Therapy" or "Li-ESWT (low-intensity extracorporeal shock wave therapy)" to treat erectile dysfunction (ED) and Peyronie's Disease (Compl. ¶¶11, 17, 26). The complaint alleges the device works by emitting "powerful, targeted sound waves" that "penetrate deep into the treated area, causing a favorable physiological response" (Compl. ¶59; p. 17). This process is alleged to cause "micro-trauma to the blood vessels beneath the skin, fostering angiogenesis, the growth of new blood vessels" (Compl. ¶65; p. 19).
    • The device is marketed as the "first home-use medical device to deliver the same Acoustic Wave technology found in doctor's offices" and features a "patented guidance system" with pacing lights to ensure proper technique (Compl. ¶¶11, 16, 19). The complaint highlights that the device is sold as part of a kit that includes lubricant and topical numbing cream (Compl. ¶15). A screenshot in the complaint shows the kit's contents, including the device, a stainless steel tip, a power adapter, lubricant, and numbing cream (Compl. ¶15; p. 6).

IV. Analysis of Infringement Allegations

  • U.S. Patent No. 7,601,127 Infringement Allegations
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
The method of stimulation of a genital tissue or reproductive organ of an infertility or impotence diagnosed patient comprising the steps of: The Phoenix device is advertised and used to treat impotence, specifically erectile dysfunction (ED) and Peyronie's Disease, which are pathological conditions diagnosed in patients. ¶¶55, 77 col. 20:65-67
activating an acoustic shock wave generator or source to emit pressure pulses...having a low energy density in the range of 0.000001 mJ/mm2 to 1.0 mJ/mm2; the pressure pulse being an acoustic pulse which includes several cycles of positive and negative pressure, wherein the pressure pulse has an amplitude of the positive part of such a cycle above 0.1 MPa and the time duration of the pressure pulse cycle is from a micro-second to about a second... The complaint alleges on information and belief that the Phoenix device is activated to generate acoustic shock waves and emits pressure pulses with these specific physical parameters to achieve the advertised therapeutic effect while avoiding tissue damage. ¶¶51, 53, 57, 60-62 col. 5:41-56
subjecting the genital tissue, reproductive organ or the entire reproductive region of the body to the convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the genital tissue or reproductive organ stimulating a cellular response in the absence of creating cavitation bubbles... The Phoenix is directed to the genital tissue and is alleged to emit unfocused waves that stimulate a cellular response (angiogenesis) without causing cavitation or hemorrhaging, a sensation which users are not intended to experience. ¶¶52, 64-66 col. 12:4-11
wherein the genital tissue or reproductive organ is positioned within a path of the emitted shock waves or pressure pulses and away from any localized geometric focal volume or point of the emitted shock waves... The complaint alleges on information and belief that the use of the Phoenix involves applying unfocused acoustic waves, meaning the target tissue is positioned away from any geometric focal point. This is supported by marketing materials describing the stimulation of new blood vessels. ¶¶66, 68, 70 col. 12:55-57
stimulating said tissue, organ or body wherein the tissue, organ or body is positioned within a path of the emitted shock waves removed from any focal point of the emitted acoustic shock wave. The device is alleged to stimulate tissue by causing micro-trauma that fosters angiogenesis, and this stimulation occurs in the path of the emitted waves, which are removed from any focal point. A visual depicts how to "Perform Treatments" by running the device along the tissue. ¶¶67-68; p. 17 col. 20:49-54

  • Identified Points of Contention:

    • Scope Questions: A central question may be whether the users of the Phoenix device meet the preamble requirement of being an "infertility or impotence diagnosed patient." The defense may argue that home-use purchasers are not formally diagnosed, while the plaintiff may argue the conditions the product treats (ED, Peyronie's Disease) are inherently diagnoses of impotence.
    • Technical Questions: The complaint's allegations regarding the specific physical parameters of the acoustic waves (e.g., energy density, pressure amplitude, pulse duration) are made "upon information and belief." A key point of contention will be whether the Phoenix device, when tested, actually operates within these claimed numerical ranges. The assertion that the device stimulates a cellular response "in the absence of creating cavitation bubbles" is a negative limitation that will likely require expert testimony and evidence regarding the device's mechanism of action.

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

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An apparatus for generating pressure pulse/shock waves comprising: The Phoenix is an apparatus advertised as an "Acoustic Wave Therapy device" that generates and uses sound waves to target a treatment area. ¶¶97-98 col. 1:16-19
a pressure pulse/shock wave (PP/SW) source; The complaint identifies the "applicator" of the Phoenix device as the PP/SW source. A visual in the complaint highlights this component with a yellow circle. ¶¶101-102; p. 27 col. 13:46-51
a housing enclosing said PP/SW source; The Phoenix device is alleged to have a housing that encloses the applicator (the PP/SW source). An image from the complaint is provided to show this housing. ¶¶103-104; p. 28 col. 13:46-51
an exit window from which shock wave fronts of waves generated by said PP/SW source emanate; The complaint alleges that the Phoenix includes an "exit window" in the applicator from which the shock waves emanate, citing instructions to apply pressure with the shaft and to use a "Heat Shield on the tip." ¶106 col. 13:51-54
wherein said shock wave fronts have plane, nearly plane, convergent off target or divergent characteristics... The complaint alleges on information and belief that the shock wave fronts produced by the Phoenix have these characteristics, consistent with an apparatus designed for treating a broader tissue area rather than a single focal point. ¶107 col. 1:4-9
wherein the apparatus is shaped and dimensioned to provide the shock wave fronts having a power density level...in the range of approximately 0.01 mJ/mm2 up to 1.0 mJ/mm2 to stimulate a living tissue while avoiding tissue damage. On information and belief, the complaint alleges the Phoenix is shaped and dimensioned to provide shock waves within this specific power density range, which is necessary to achieve the advertised therapeutic stimulation without causing the tissue damage associated with higher-energy devices. ¶108 col. 16:1-9
  • Identified Points of Contention:
    • Scope Questions: The interpretation of "convergent off target or divergent characteristics" will be critical. The parties may dispute the precise technical meaning of these terms and whether the wave pattern generated by the Phoenix meets that definition, as opposed to being purely radial or focused.
    • Technical Questions: As with the '127 Patent, the complaint's allegations regarding the specific power density are based on "information and belief." The actual measured output of the Phoenix device will be a central factual question. Whether the device is "shaped and dimensioned" to achieve this output, as the claim requires, suggests a question of design and intent that may be debated.

V. Key Claim Terms for Construction

  • For the ’127 Patent:

    • The Term: "an infertility or impotence diagnosed patient"
    • Context and Importance: This preamble term may limit the scope of the entire method claim. Its construction will be critical to determining whether the method is practiced by users of a direct-to-consumer device like the Phoenix, who may not have a formal medical diagnosis. Practitioners may focus on this term because it raises a threshold question of applicability before any technical analysis of the device's operation is even necessary.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification discusses "impotence" generally as a condition to be treated and defines it as an "abnormal physical or psychological state of a male characterized by inability to copulate" (’127 Patent, col. 5:56-60). This functional definition could be argued to apply to anyone purchasing a device for ED, regardless of a formal diagnosis.
      • Evidence for a Narrower Interpretation: The claim's use of the word "diagnosed" could be argued to require a formal assessment by a medical professional. The patent's context often refers to treatments administered by a "physician" in a clinical setting, which may support a narrower construction requiring professional medical involvement (’127 Patent, col. 9:16-19).

  • For the ’249 Patent:

    • The Term: "convergent off target or divergent characteristics"
    • Context and Importance: This phrase defines the core technical nature of the apparatus's output and distinguishes it from prior art focused-wave and purely radial-wave devices. The infringement analysis for the Phoenix will depend heavily on whether its emitted wave pattern falls within the scope of this technical description.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification explains that the goal is to treat larger tissue areas and that this can be achieved in multiple ways, including moving a focal point away from the tissue to create either a pre-focal convergent wave or a post-focal divergent wave (’249 Patent, Figs. 11-12). This suggests the term encompasses a range of unfocused or de-focused wave patterns.
      • Evidence for a Narrower Interpretation: The patent provides specific technical descriptions and figures for achieving these characteristics, such as using a "generalized paraboloid" reflector (’249 Patent, col. 6:46-59). A defendant might argue that the term should be limited to apparatuses that use these specific structures or principles, and not any device that simply produces a generally unfocused wave.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges Defendants induce infringement by instructing and encouraging customers to use the Phoenix in an infringing manner (Compl. ¶78). This is allegedly done through "online instruction videos and an easy-to-read instruction manual," as well as website content that explains how and why to use the device for treating ED and Peyronie's Disease (Compl. ¶¶19, 79).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the patents-in-suit. For Launch Medical, knowledge is alleged to stem from at least the filing of the "Original Litigation" (Compl. ¶84). For The Novus Center, knowledge is alleged based on a separate lawsuit where The Novus Center itself discussed Plaintiff's business and identified the ’127 Patent (Compl. ¶¶85, 111).

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

  • A core issue will be one of definitional scope: does the method claim limitation of treating a "diagnosed patient" in the '127 Patent read on the activities of an end-user of a direct-to-consumer product purchased without a formal medical consultation, and how will the court view the self-identification of conditions like ED?
  • A key evidentiary question will be one of technical compliance: can Plaintiff produce evidence, likely through expert testing and analysis, that the Phoenix device actually generates acoustic waves with the specific physical parameters (e.g., energy density, pressure amplitude, wave characteristics) recited in the claims of the '127 and '249 patents, or will there be a fundamental mismatch in technical operation?
  • A third central question concerns knowledge and intent: what evidence exists to show that Defendants, particularly after the failure of the prior settlement, knew of the patents and deliberately encouraged specific uses of the Phoenix that they knew or should have known were infringing, which will be central to the claims of induced and willful infringement?