SoftWave Tissue Regeneration Tech LLC v. Launch Medical Inc

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: 2:24-cv-02989, C.D. Cal., 06/12/2024
• Venue Allegations: Venue is based on Defendant’s status as a California limited liability company with its principal place of business within the Central District of California, where it is alleged to conduct business and commit acts of infringement.
• Core Dispute: Plaintiff alleges that Defendant’s "The Phoenix," a home-use acoustic wave therapy device for treating erectile dysfunction, infringes three patents related to methods and apparatuses for the therapeutic stimulation of biological tissue using pressure or shock waves.
• Technical Context: The technology at issue is extracorporeal shock wave therapy (ESWT), a non-invasive medical treatment that applies acoustic pressure waves to tissue to promote healing, regeneration, and other biological responses.
• Key Procedural History: This Amended Complaint follows an original complaint. The patents-in-suit were assigned to Plaintiff from General Patent, LLC. The complaint alleges Defendant had knowledge of the lead patent prior to the filing of the complaint and knowledge of the other two patents as of the filing of a prior complaint, which may form the basis for allegations of enhanced damages.

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 Nos. 7,601,127 and 7,841,995
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
2024-06-12	Amended 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"

• Patent Identification: 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 identifies the significant personal and financial costs associated with conventional treatments for infertility and impotence, such as fertility drugs and surgery, which carry risks of side effects and complications (’127 Patent, col. 1:46-65).
• The Patented Solution: The invention proposes a non-invasive method for treating these conditions by stimulating genital or reproductive tissue with acoustic shock waves. The method is designed to trigger a regenerative or healing response in the tissue by applying low-energy, unfocused (e.g., divergent or planar) waves, thereby avoiding the pain and tissue damage associated with high-energy, tightly focused shock wave therapies like lithotripsy (’127 Patent, Abstract; col. 4:50-57).
• Technical Importance: The technology offered a therapeutic approach aimed at addressing the underlying physiological causes of conditions like impotence, such as poor vascularization, rather than merely treating symptoms with drugs or invasive procedures (’127 Patent, col. 9:25-44).

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 3 and 7 (Compl. ¶33).
• Independent Claim 1 contains the following essential elements:
  • A method for stimulating genital or reproductive tissue in a patient diagnosed with infertility or impotence.
  • Activating an acoustic shock wave generator to emit low-energy pressure pulses toward the tissue.
  • Subjecting the tissue to these acoustic shock waves "in the absence of a focal point impinging the genital tissue" to stimulate a cellular response "in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging."
  • Stimulating the tissue while it is positioned in the path of the emitted shock waves but "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"

• Patent Identification: 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 describes the limitations of prior art shock wave devices: "focused" systems treat a very small area and are inefficient, while "radial" systems lack the energy density to effectively treat deeper tissues (’249 Patent, col. 2:16-24).
• The Patented Solution: The invention is an apparatus designed to generate shock waves with specific, therapeutically advantageous characteristics: plane, nearly plane, divergent, or "convergent off target." This design, which can utilize elements like a parabolic reflector, allows the apparatus to treat a larger surface area more uniformly than a focused device while still delivering sufficient energy to produce a therapeutic tissue reaction (’249 Patent, Abstract; col. 3:41-50).
• Technical Importance: The disclosed apparatus represents a technological bridge between focused and radial systems, aiming to provide a more efficient and versatile tool for applying shock wave therapy over larger or more superficial areas like skin (’249 Patent, col. 2:16-24).

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claim 20 (Compl. ¶72).
• Independent Claim 1 recites the following essential elements:
  • An apparatus for generating pressure pulse/shock waves.
  • A pressure pulse/shock wave (PP/SW) source.
  • A housing that encloses the 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 these waves with a power density sufficient to produce a tissue reaction 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"

• 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 addresses the problem that high-energy, focused shock waves can cause tissue damage and pain (’995 Patent, col. 2:40-49). It discloses methods of stimulating a wide range of biological substances (including organs like the skin) using low-energy, unfocused (divergent, planar) or off-target waves to trigger a healing response, such as neovascularization, without the damaging effects of conventional systems (’995 Patent, Abstract; col. 4:24-39).
• Asserted Claims: Independent claim 1 and dependent claim 3 are asserted (Compl. ¶94).
• Accused Features: The complaint accuses the method of using "The Phoenix" device to stimulate the skin for the treatment of conditions like erectile dysfunction, which allegedly involves activating a shock wave generator and subjecting the tissue to low-energy, non-focused shock waves as claimed (Compl. ¶¶93, 101).

III. The Accused Instrumentality

Product Identification

"The Phoenix," formerly known as "The Rocket," a device for home use (Compl. ¶7).

Functionality and Market Context

The Phoenix is marketed as a device that uses Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT), also referred to as Acoustic Wave Therapy, for the treatment of Erectile Dysfunction and Peyronie’s Disease (Compl. ¶¶7, 11). The complaint alleges the device works by generating "powerful sound waves" that create "micro-trauma to the blood vessels beneath the skin, fostering angiogenesis, the growth of new blood vessels" (Compl. ¶49). To guide its use, the device incorporates what is described as a "patented guidance system" with "blue pacing lights" to show the user where to apply the tip and at what speed (Compl. ¶12). The product is positioned as an affordable and private alternative to clinical shock wave treatments (Compl. ¶13). The complaint includes a visual from the Defendant's website illustrating how a user should perform the treatment. This visual depicts a diagram of the device being applied along the length of the penis (Compl. ¶44, p. 15).

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 infertility or impotence diagnosed patient...	The Phoenix is advertised as a device for treating Erectile Dysfunction (ED), a form of impotence (Compl. ¶2).	¶39	col. 20:1-4
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...	Use of the Phoenix involves activating it to generate acoustic shock waves, which are alleged on information and belief to operate within the claimed low energy density range to stimulate tissue while avoiding damage (Compl. ¶44).	¶¶41, 44	col. 20:5-20
subjecting the genital tissue...to the...acoustic shock waves...in the absence of a focal point impinging the genital tissue...stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging...	The shock waves are directed to genital tissue, and the complaint alleges on information and belief that they are unfocused, divergent, or planar to avoid a focal point and prevent harm, which is alleged to satisfy the "absence of cavitation" limitation (Compl. ¶¶50, 53).	¶¶49, 50, 53	col. 20:21-49
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 Phoenix allegedly uses Acoustic Wave Therapy (AWT) in a manner where the genital tissue is positioned in the path of the shock waves but away from any focal point (Compl. ¶52).	¶¶51, 52	col. 20:50-54

'249 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a pressure pulse/shock wave (PP/SW) source;	The Phoenix device includes an applicator which the complaint alleges is the PP/SW source. A visual in the complaint identifies the device's tip as the source (Compl. ¶79).	¶79	col. 16:4
a housing enclosing said PP/SW source;	The Phoenix includes a housing that encloses the applicator/source. The complaint provides a visual that highlights the entire device body as the housing (Compl. ¶81).	¶81	col. 16:5
an exit window from which shock wave fronts...emanate, wherein said shock wave fronts have plane, nearly plane, convergent off target or divergent characteristics wherein the apparatus is shaped and dimensioned to provide the shock wave fronts having a power density level to produce a tissue reaction...while avoiding tissue damage.	The complaint alleges the Phoenix applicator has an "exit window" from which waves emanate (Compl. ¶83). On information and belief, it is alleged that these waves have the claimed characteristics and are dimensioned to produce a tissue reaction at a power density that avoids damage (Compl. ¶¶84, 85).	¶¶83, 84, 85	col. 16:6-14

Identified Points of Contention

• Scope Questions: A central question for the ’127 patent is whether the "micro-trauma" that the accused product allegedly causes to foster angiogenesis (Compl. ¶49) can meet the claim limitation of "stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging." The complaint's own characterization of the product's mechanism may create a factual dispute over whether it practices this negative limitation.
• Technical Questions: For the ’249 patent, a key issue will be evidentiary. The complaint alleges "on information and belief" that the shock waves have the specific "plane, nearly plane, convergent off target or divergent characteristics" required by the claims (Compl. ¶84). Proving that the accused device generates waves with these precise physical properties, particularly the "convergent off target" characteristic, will likely require significant technical evidence and expert testimony.

V. Key Claim Terms for Construction

For the '127 Patent:

• The Term: "stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging"
• Context and Importance: The construction of this negative limitation is critical. The accused product is alleged to work by causing "micro-trauma," which suggests some level of tissue disruption. Whether this "micro-trauma" falls outside the scope of "cellular hemorrhaging" will be a central issue. Practitioners may focus on this term because it draws the line between a purely stimulative, non-damaging effect and a mechanism that relies on controlled injury.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (i.e., allowing for minor effects): The specification describes stimulating "growth factors" and activating a "natural healing capability" (’127 Patent, col. 11:55-63). A party could argue this language encompasses minor, controlled tissue effects that fall short of the significant "hemorrhaging" seen in high-energy applications, which the patent sought to avoid.
  • Evidence for a Narrower Interpretation (i.e., strictly non-disruptive): The specification repeatedly highlights that the method avoids the problems of prior art, including "pain and discomfort" and "localized hemorrhaging" (’127 Patent, col. 11:15-18). It states the treatment "effectively insures the tissue or organ does not have to experience the sensation of hemorrhaging" (’127 Patent, col. 11:5-8), supporting a construction that prohibits any mechanism based on causing tissue injury, however minor.

For the '249 Patent:

• The Term: "convergent off target"
• Context and Importance: This term is highly technical and specific. Infringement of this aspect of the claim depends entirely on whether the accused device can be proven to generate waves with this exact characteristic, as distinct from merely "divergent" or "planar" waves. The defense will likely argue the accused product is, at best, a simple divergent-wave device.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (i.e., any non-focal converging wave): The specification of the parent patent family explains this concept as a way to "insure less tissue trauma while insuring cellular stimulation" by, for example, using a "shifted far-sighted focal point" (’127 Patent, col. 13:6-12). This could support a reading that covers any wave that is generally converging in nature but whose peak energy is intentionally displaced from the tissue surface.
  • Evidence for a Narrower Interpretation (i.e., a specific pre-focus geometry): The patent figures shared across the family (e.g., ’127 Patent, Fig. 11) illustrate a very specific geometry where converging waves (202) impinge on a target (100) that is placed before the geometric focal point (20). A party could argue that "convergent off target" is strictly limited to this pre-focal point configuration and does not cover other types of unfocused or broadly divergent waves.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement for all three patents. The allegations are based on Defendant’s website, marketing materials, online instructional videos, and user manuals, which allegedly instruct and encourage customers to use The Phoenix device in a manner that directly infringes the asserted method claims (Compl. ¶¶61, 63, 73, 95). The complaint provides an image of the product kit, which includes "Detailed instructions" and a "Packet of topical numbing cream," to support these allegations (Compl. ¶58, p. 19).
• Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that Defendant had knowledge of the ’127 patent "prior to the filing of this Amended Complaint" (Compl. ¶62) and of the ’249 and ’995 patents "at least as early as the date of service of this Amended Complaint" (Compl. ¶¶73, 95). These allegations of knowledge, coupled with the request for attorneys' fees for an "exceptional case" (Compl. p. 30), lay the groundwork for a potential finding of willfulness.

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

• A key technical-factual question will be one of operational equivalence: Does the "micro-trauma" that "The Phoenix" device allegedly causes to promote healing (a form of controlled injury) constitute the same therapeutic action as the ’127 patent’s claimed method, which requires "stimulating a cellular response in the absence of...cellular hemorrhaging"?
• A central issue of claim construction and scope will be whether the wave characteristics of the accused device, which is marketed as delivering "targeted sound waves," can be read on the ’249 patent's claims requiring specific "plane, nearly plane, convergent off target or divergent" waves, particularly given the technical specificity of the "convergent off target" limitation.
• A primary evidentiary hurdle for the Plaintiff will be to prove, beyond its "information and belief" pleading, that the accused apparatus actually generates shock waves with the precise physical properties required by the claims of the ’249 apparatus patent.