DCT
2:25-cv-08484
Softwave Tissue Regeneration Tech LLC v. Moon Pool LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: SoftWave Tissue Regeneration Technologies, LLC (Ohio)
- Defendant: Moon Pool, LLC, d/b/a Launch Medical (California)
- Plaintiff’s Counsel: Insight, PLC
- Case Identification: 2:25-cv-08484, C.D. Cal., 09/08/2025
- Venue Allegations: Venue is based on Defendant allegedly conducting continuous business in the Central District of California, including making, using, selling, and advertising the accused products within the district.
- Core Dispute: Plaintiff alleges that Defendant’s "The Phoenix" acoustic wave therapy device infringes three patents related to therapeutic methods and apparatuses that use pressure pulses or shock waves to stimulate biological tissue.
- Technical Context: The technology involves the medical application of extracorporeal shock wave therapy (ESWT), where acoustic waves are directed at tissue to stimulate healing, treat erectile dysfunction, and address other conditions.
- Key Procedural History: The complaint states that the parties were previously involved in a lawsuit concerning the same patents (the "Original Litigation"), which was dismissed following a settlement agreement. Plaintiff alleges Defendant breached the settlement, leading to this re-filed action and forming the basis for allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2003-02-19 | Earliest Priority Date ('249 Patent) |
| 2004-10-22 | Earliest Priority Date ('995 Patent) |
| 2005-06-17 | Earliest Priority Date ('127 Patent) |
| 2009-10-13 | U.S. Patent No. 7,601,127 Issued |
| 2010-11-30 | U.S. Patent No. 7,841,995 Issued |
| 2013-09-17 | U.S. Patent No. 8,535,249 Issued |
| 2025-09-08 | Complaint Filing Date |
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 is directed at methods for treating medical conditions such as infertility and impotence ('127 Patent, Abstract). The implicit problem is how to apply therapeutic energy to sensitive genital tissue to stimulate a healing response without causing damage from excessive energy concentration.
- The Patented Solution: The invention is a method of applying acoustic shock waves with specific physical characteristics (e.g., pressure, duration, energy density) to genital tissue. A central element of the solution is that the waves are applied "in the absence of a focal point impinging the genital tissue," thereby distributing the energy to stimulate a cellular response while avoiding the cellular hemorrhaging associated with focused-wave therapies ('127 Patent, col. 20:26-40). The method uses waves that are described as convergent, divergent, planar, or near planar to achieve this therapeutic effect ('127 Patent, col. 20:30-33).
- Technical Importance: This approach suggests a method for harnessing the biological stimulation effects of shockwave therapy for sensitive applications while mitigating the risk of tissue damage inherent in high-energy, focused applications like lithotripsy.
Key Claims at a Glance
- The complaint asserts independent Claim 1 and dependent Claims 3 and 7 (Compl. ¶18).
- Independent Claim 1 contains three primary method steps:
- Activating an acoustic shock wave generator to emit pressure pulses with specified physical parameters (e.g., energy density, pressure amplitude, rise times) directed toward genital tissue.
- Subjecting the genital tissue to these waves "in the absence of a focal point impinging the genital tissue" to stimulate a cellular response without creating cavitation bubbles.
- Stimulating the tissue where it is positioned in the path of the emitted waves "removed from any focal point."
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’s background section describes limitations of prior art shock wave devices: focused systems treat a very small area, requiring extensive scanning and potentially causing damage, while radial systems lack the energy density to treat deeper tissue ('249 Patent, col. 2:16-20). The problem is the lack of an apparatus that can effectively treat a larger tissue area with sufficient, but safe, energy density.
- The Patented Solution: The invention is an apparatus designed to generate acoustic pressure pulses with specific, controlled wave fronts that are not tightly focused. The solution lies in the physical construction of the device, which includes a pressure pulse/shock wave (PP/SW) source, a housing, and an "exit window" from which waves emanate ('249 Patent, Abstract). By controlling the geometry of the source and optional reflectors or lenses, the apparatus can produce waves that are planar, divergent, or "convergent off target," allowing therapeutic energy to be delivered over a broader area without a damaging focal point ('249 Patent, col. 3:41-50).
- Technical Importance: The invention provides a device architecture for delivering therapeutic shock waves that balances the need for sufficient energy penetration with the goal of treating larger surface areas safely, moving beyond the limitations of purely focused or purely radial systems.
Key Claims at a Glance
- The complaint asserts independent Claims 1 and 20 (Compl. ¶84).
- Independent Claim 1 recites an apparatus comprising:
- A pressure pulse/shock wave (PP/SW) source.
- A housing that encloses the source.
- An exit window from which wave fronts emanate, where the apparatus is shaped to provide shock waves with plane, nearly plane, convergent off target, or divergent characteristics within a specified power density range (0.01 mJ/mm² to 1.0 mJ/mm²).
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 methods for stimulating cellular substances, including tissues and organs in mammals, using acoustic shock waves. The methods cover the use of both focused and non-focused waves at various energy levels to treat a wide range of conditions by stimulating a biological response without creating cavitation bubbles or cellular hemorrhaging (Compl. ¶¶104, 109, 112).
- Asserted Claims: At least independent Claim 1 and dependent Claim 3 (Compl. ¶107).
- Accused Features: The complaint alleges that Defendant's promotion and its customers' use of the Phoenix device to treat erectile dysfunction and Peyronie's Disease constitutes practicing the claimed methods of stimulating tissue (Compl. ¶¶106-107, 114).
III. The Accused Instrumentality
Product Identification
- The accused product is "The Phoenix," a device formerly known as "The Rocket" (Compl. ¶12).
Functionality and Market Context
- The Phoenix is marketed as a home-use device that employs "Acoustic Wave Therapy" or "Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)" to treat erectile dysfunction and Peyronie's Disease (Compl. ¶¶10, 15-16). The complaint alleges the device functions by generating "powerful, targeted sound waves" or "acoustic shock waves" that are emitted from the device's tip to stimulate genital tissue (Compl. ¶¶14, 45, 60). It is sold as part of a kit that includes the device, a power adapter, a stainless steel tip, lubricant, and a topical numbing cream (Compl. ¶12). A screenshot of the kit's contents is provided in the complaint, highlighting the inclusion of lubricant and numbing cream (Compl. p. 20). The device is further described as having a "patented guidance system" with "blue pacing lights" to guide the user on speed and placement (Compl. p. 6).
IV. Analysis of Infringement Allegations
'127 Patent 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...impotence diagnosed patient... | The Phoenix device is advertised and utilized to provide a method of stimulation for patients with erectile dysfunction (ED), which is a form of impotence. | ¶50 | col. 19:65-67 |
| activating an acoustic shock wave generator or source to emit pressure pulses...directed toward the genital tissue... | The Phoenix device is activated to generate and emit acoustic shock waves, which are directed to the genital tissue to perform treatments. | ¶¶52-54 | col. 20:1-7 |
| subjecting the genital tissue...to the...acoustic shock waves...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 device allegedly emits unfocused, divergent, or planar shock waves that are directed to the genital region, thereby avoiding a focal point within the tissue to prevent damage. | ¶¶60-61, 64 | col. 20:26-33 |
| stimulating said tissue, organ or body wherein the tissue...is positioned within a path of the emitted shock waves removed from any focal point of the emitted acoustic shock wave. | The Phoenix is used such that the genital tissue is positioned in the path of emitted shock waves that are removed from any focal point. | ¶63 | col. 20:47-51 |
- Identified Points of Contention:
- Scope Questions: A central question will be whether the acoustic waves generated by The Phoenix truly operate "in the absence of a focal point impinging the genital tissue." The defense may argue that the waves have focusing characteristics that fall outside the patent’s claimed scope, even if they are marketed as "gentle" or for home use.
- Technical Questions: The complaint alleges on "information and belief" that the device operates within specific physical parameters (e.g., pressure above 0.1 MPa, rise times below 100 ns) required by the claim (Compl. ¶57). A key factual dispute will be whether discovery and expert analysis confirm that the accused device actually generates waves with these precise and technical characteristics.
'249 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| Apparatus for generating pressure pulse/shock waves comprising: | The Phoenix is an apparatus advertised as an Acoustic Wave Therapy device for generating extracorporeal shock waves. | ¶87 | col. 3:41-43 |
| a pressure pulse/shock wave (PP/SW) source; | The complaint alleges the applicator tip of the Phoenix device is the PP/SW source. The complaint includes a visual depicting the applicator as the source (Compl. p. 25). | ¶91 | col. 3:44-45 |
| a housing enclosing said PP/SW source; | The body of the Phoenix device is alleged to be the housing that encloses the applicator/source. A visual in the complaint encircles the device's body to illustrate this element (Compl. p. 25). | ¶93 | col. 3:45-46 |
| an exit window from which shock wave fronts of waves generated by said PP/SW source emanate, wherein said shock wave fronts have plane, nearly plane, convergent off target or divergent characteristics... | The tip of the applicator serves as the "exit window" from which shock waves emanate, and the complaint alleges on information and belief that these waves have the claimed characteristics. | ¶¶95-96 | col. 3:46-50 |
| wherein the waves have a power density in the range of approximately 0.01 mJ/mm2 up to 1.0 mJ/mm2 to stimulate a living tissue... | The complaint alleges on information and belief that the apparatus is shaped and dimensioned to provide shock waves within this specified power density range to be both therapeutic and non-damaging. | ¶97 | col. 4:5-9 |
- Identified Points of Contention:
- Scope Questions: Does the tip of the Phoenix applicator constitute an "exit window" as the term is used in the patent, or is it merely the terminal end of the device? The construction of this structural term may be critical.
- Technical Questions: Similar to the '127 patent, the complaint relies on "information and belief" to allege that the device produces waves with the specific power density and wave front characteristics required by the claim (Compl. ¶¶96-97). The actual physical output of the device will be a central factual question for the court.
V. Key Claim Terms for Construction
The Term: "in the absence of a focal point impinging the...tissue" ('127 Patent, Claim 1)
- Context and Importance: This negative limitation is the core of the asserted method claim, distinguishing it from prior art focused-wave therapies like lithotripsy. The entire infringement theory for the '127 patent hinges on proving that the accused method meets this "absence of a focal point" requirement. Practitioners may focus on this term because it defines the boundary between infringing and non-infringing energy application.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The shared specification defines "divergent waves" as "all waves which are not focused and are not plane or nearly plane" ('249 Patent, col. 6:8-10). This could support a broad interpretation where any wave that is not actively focused onto the tissue meets the "absence" requirement.
- Evidence for a Narrower Interpretation: The specification's discussion of specific embodiments, such as those using parabolic reflectors to create "planar" waves, could be used to argue that the invention is limited to specific, engineered non-focused wave types, not just any wave that happens to be unfocused ('249 Patent, col. 8:56-9:12).
The Term: "exit window" ('249 Patent, Claim 1)
- Context and Importance: This is a key structural element of the claimed apparatus. The complaint identifies the applicator tip as the "exit window" (Compl. ¶95). The viability of the infringement claim for the '249 patent may depend on whether this component part of the accused device meets the definition of the claimed structural element.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract describes it as the component "from which wave fronts of waves generated by said PP/SW source emanate." This functional description could support reading the term on any surface of the device from which the therapeutic energy is emitted toward the patient.
- Evidence for a Narrower Interpretation: The specification refers to the exit window in the context of a "water cushion or any other kind of exit window for the acoustical energy" ('249 Patent, col. 10:25-27) and shows it as a distinct component (e.g., element 17 in figures). This may support an argument that the "exit window" must be a structurally distinct component, such as a membrane or lens, rather than simply the end of the applicator housing.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement against Defendant based on its "online instruction videos and an easy-to-read instruction manual" which allegedly instruct and encourage customers to use the Phoenix device in a manner that directly infringes the asserted method claims (Compl. ¶¶15, 71-74).
- Willful Infringement: The complaint alleges willful infringement based on Defendant’s knowledge of the patents-in-suit since at least the filing of the "Original Litigation" (Compl. ¶77). Plaintiff asserts that Defendant's continued infringement despite this prior notice constitutes willful and deliberate conduct.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical proof: Can Plaintiff produce evidence beyond "information and belief" to demonstrate that the accused Phoenix device, a consumer-grade product, actually generates acoustic waves meeting the precise and narrow technical parameters (e.g., pressure amplitude, energy density, rise times) required by the patent claims?
- A second central question will be one of definitional scope: Can the claim limitation "in the absence of a focal point impinging the...tissue" be construed to read on the accused device's operation, or will Defendant demonstrate that its "unfocused" waves are technically distinct from the specific non-focused wave characteristics disclosed and claimed in the patents?
- Finally, a key legal question will be the impact of prior litigation: How will the court treat the allegations stemming from the prior, settled lawsuit? This history provides a strong basis for Plaintiff’s willfulness claim but may also introduce issues of estoppel or impact claim construction arguments based on positions taken in the earlier case.