DCT

3:25-cv-02198

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., 08/25/2025
Venue Allegations: Plaintiff alleges venue is proper in the Southern District of California because Defendant's principal place of business is in Carlsbad, California, within the district, and because Defendant conducts substantial business and has committed the alleged acts of infringement in the district.
Core Dispute: Plaintiff alleges that Defendant’s Intelect® Focus Shockwave medical device infringes two patents related to apparatus and methods for applying therapeutic acoustic shock waves.
Technical Context: The technology involves extracorporeal shockwave therapy (ESWT), which uses acoustic pressure waves to stimulate tissue healing, treat pain, and address other medical conditions.
Key Procedural History: The complaint alleges that Plaintiff put Defendant on notice of U.S. Patent No. 8,535,249 via letters dated February 7, 2020, and February 21, 2025. The parties subsequently spoke in March 2025 but did not resolve the dispute. This pre-suit history forms the basis for Plaintiff's willful infringement allegations.

Case Timeline

Date	Event
2003-02-19	’249 Patent - Earliest Priority Date
2005-05-04	’995 Patent - Earliest Priority Date
2010-11-30	’995 Patent - Issue Date
2013-09-17	’249 Patent - Issue Date
2020-02-07	Plaintiff sends first notice letter to Defendant regarding the ’249 Patent
2025-02-21	Plaintiff sends second notice letter to Defendant
2025-03-XX	Parties speak but do not resolve dispute
2025-08-25	Complaint Filing Date

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 notes that prior art shockwave therapy devices were limited. "Focused" systems concentrate high energy in a very small area, requiring precise targeting and potentially causing pain, while "radial" systems treat larger areas but lose energy density too quickly to be effective in deeper tissue (Compl. ¶25; ’249 Patent, col. 2:1-24).
The Patented Solution: The invention is an apparatus designed to generate acoustic waves with specific characteristics—"plane, nearly plane, convergent off target or divergent"—that are distinct from the tightly focused waves of prior art devices (’249 Patent, Abstract). By using geometries like a parabolic reflector (in contrast to a traditional ellipsoidal reflector), the apparatus can deliver therapeutic energy over a larger area at a specific depth without concentrating it into a painful, high-intensity focal point (’249 Patent, col. 3:40-49; Fig. 2). This allows for treatment that is both effective and less likely to cause tissue damage.
Technical Importance: This approach enabled the treatment of larger tissue areas and surface conditions with lower-energy, non-damaging shock waves, expanding the therapeutic applications beyond high-energy uses like disintegrating kidney stones (Compl. ¶27; ’249 Patent, col. 3:6-15).

Key Claims at a Glance

The complaint asserts independent Claims 1 and 20 (Compl. ¶28).
Claim 1 (Apparatus):
- An apparatus for generating pressure pulse/shock waves comprising:
- a pressure pulse/shock wave (PP/SW) source;
- a housing enclosing the source;
- an exit window from which wave fronts emanate;
- wherein the wave fronts have "plane, nearly plane, convergent off target or divergent characteristics"; and
- wherein the apparatus is shaped to provide waves with a power density between approximately 0.01 mJ/mm² and 1.0 mJ/mm² to "stimulate a living tissue while avoiding tissue damage."
Claim 20 (Therapeutic Device):
- A therapeutic device for administering a shock wave comprising:
- a housing;
- a shock wave source in the housing;
- a "wave directing and shaping structure" for causing a planar shock wave to be emitted;
- a structure for coupling the wave to the subject; and
- wherein the device is shaped to provide a planar shock wave with a power density between approximately 0.01 mJ/mm² and 1.0 mJ/mm² to "stimulate the living tissue while avoiding tissue damage."
The complaint does not explicitly reserve the right to assert other claims.

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 explains that early uses of ESWT were based on a "mechanistic model" where high-energy waves created "micro lesions" to trigger repair (’995 Patent, col. 2:38-44). This approach was associated with pain and tissue damage, such as hemorrhaging, limiting its application (’995 Patent, col. 3:11-24).
The Patented Solution: The invention recites a method of stimulating tissue by applying acoustic shock waves "in the absence of a focal point impinging the substance" and in a manner that avoids creating "cavitation bubbles" or "cellular hemorrhaging" (’995 Patent, Abstract; col. 23:35-40). The core concept is to use lower-energy, non-focused (or off-target) waves to trigger a beneficial biological response (e.g., release of growth factors) rather than a mechanical, destructive one (’995 Patent, col. 4:25-36).
Technical Importance: This methodological shift reframed ESWT from a quasi-surgical tool into a non-invasive regenerative therapy, enabling treatment of a wider range of conditions with significantly reduced pain and side effects (Compl. ¶67; ’995 Patent, col. 4:5-11).

Key Claims at a Glance

The complaint asserts independent Claim 1 and dependent Claim 3 (Compl. ¶69).
Claim 1 (Method):
- A method of stimulating a cellular substance by:
- activating a shock wave generator to emit pressure pulses or shock waves with an energy density between 0.00001 mJ/mm² and 1.0 mJ/mm²; and
- subjecting the substance to these waves "in the absence of a focal point impinging the substance";
- thereby "stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging."
The complaint also asserts Claim 3, which specifies that the treated organ can be skin (Compl. ¶79).

III. The Accused Instrumentality

Product Identification

Defendant's "Intelect® Focus Shockwave" device, also referred to as the "IFS Device" (Compl. ¶4).

Functionality and Market Context

The IFS Device is marketed for Extracorporeal Shock Wave Therapy (ESWT) to treat conditions such as chronic proximal plantar fasciitis (Compl. ¶7). The complaint cites Defendant's marketing materials, which state that the device "electromagnetically generates an extracorporeal shock wave" that is "focused through a lens and transmitted into the tissue" (Compl. ¶7). The complaint includes an image of the IFS Device showing its main console and handpiece applicator (Compl. p. 4, ¶8).
According to materials cited in the complaint, the IFS Device operates at an energy range of 0.01 - 0.55mJ/mm² and is promoted as a "non-invasive treatment option" with "no known significant adverse effects" (Compl. p. 13, ¶43).

IV. Analysis of Infringement Allegations

’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...	The IFS Device is an apparatus that generates extracorporeal shock waves for ESWT.	¶31	col. 3:40-41
a pressure pulse/shock wave (PP/SW) source	The IFS Device includes an applicator, referred to as the F-SW handpiece, which serves as the PP/SW source.	¶35, ¶40	col. 3:42
a housing enclosing said PP/SW source	The IFS Device includes a main console housing that encloses the applicator when not in use. A visual of the housing is provided in the complaint (Compl. p. 11, ¶37).	¶37	col. 3:43
an exit window from which shock wave fronts of waves generated by said PP/SW source emanate...	The F-SW handpiece includes a "coupling diaphragm" that functions as an exit window from which the shock waves emanate. The complaint provides a diagram of the handpiece from the operating manual (Compl. p. 12, ¶39).	¶39	col. 3:44
wherein said shock wave fronts have plane, nearly plane, convergent off target or divergent characteristics...	The complaint alleges, upon information and belief, that the shock waves generated by the IFS Device have these characteristics.	¶41	col. 3:46-48
wherein the apparatus is shaped and dimensioned to provide the shock wave fronts having a power density... in the range of approximately 0.01 mJ/mm² up to 1.0 mJ/mm² to stimulate a living tissue while avoiding tissue damage.	Defendant's marketing materials state the IFS Device has an "Enhanced Energy" range of 0.01 - 0.55mJ/mm² and is a "Non-invasive" treatment with "no known significant adverse effects." A screenshot of these specifications is provided (Compl. p. 13, ¶43).	¶42-43	col. 5:1-3

’995 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
The method of stimulating a cellular substance wherein the cellular substance is a tissue having cells...	The IFS Device is used as instructed by Defendant to perform a method of stimulating human tissue (a cellular substance) for therapeutic purposes.	¶72, ¶74	col. 23:7-10
activating an acoustic shock wave generator or source to emit pressure pulses or acoustic shock waves... having a low energy density in the range of 0.00001 mJ/mm² up to 1.0 mJ/mm²...	The IFS Device is an activatable shock wave generator that, according to Defendant's own materials, emits shock waves with an energy density of 0.01 mJ/mm² to 0.55 mJ/mm², a range that falls within that required by the claim.	¶76	col. 23:14-20
subjecting the cellular substance to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the substance...	The complaint alleges on information and belief that the device performs this step.	¶77	col. 23:35-37
...stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging...	The complaint alleges this step is met because Defendant advertises the treatment as "Non-invasive and no known significant adverse effects," suggesting the absence of cellular hemorrhaging.	¶77, ¶43	col. 23:37-40

Identified Points of Contention:
- Scope Questions: The central dispute for both patents appears to hinge on the nature of the waves generated by the accused "Intelect Focus Shockwave" device.
  - For the ’249 Patent, a key question is whether the device's "focused" waves can meet the claim limitation of "plane, nearly plane, convergent off target or divergent characteristics." The complaint alleges this on information and belief (Compl. ¶41), raising the question of whether a device designed to be focused can infringe a claim directed at non-focused or off-target waves.
  - For the ’995 Patent, the critical question is whether the accused method can be performed "in the absence of a focal point impinging the substance." The product's name creates a direct tension with this claim language.
- Technical Questions: What is the specific nature of the wave propagation from the IFS Device? Does its "focus" constitute a "localized geometric focal volume" as contemplated by the patents, or is it a broader "focal zone" with lower peak energy? Does the device's operation, when used as instructed, cause the "cavitation bubbles" or "cellular hemorrhaging" that the ’995 Patent method claims to avoid?

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 conflict for the ’995 Patent. Defendant's product is named the "Intelect Focus Shockwave," yet the claim requires the "absence" of an impinging focal point. The case may turn on whether this is a strict geometric limitation or a functional one tied to the biological effect. Practitioners may focus on this term because its construction could resolve the infringement question for the method patent.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader (Functional) Interpretation: The claim language itself links the "absence of a focal point" to the functional result of "stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging" (’995 Patent, col. 23:37-40). This could support an argument that any application of shockwaves, regardless of geometry, that avoids these negative effects meets the claim.
- Evidence for a Narrower (Geometric) Interpretation: The patent abstract distinguishes the invention by stating the substance is "positioned within a path of the emitted shock waves and away from a geometric focal volume or point" (’995 Patent, Abstract). This suggests a purely spatial requirement that the geometric focus must not be located within the treated tissue.
The Term: "convergent off target" (’249 Patent, Claim 1)
Context and Importance: This term provides Plaintiff a potential path to prove infringement even if the accused device generates convergent, or focused, waves. The definition of "off target" will be critical. Practitioners may focus on this term as it directly addresses the potential mismatch between a "focus" device and a patent directed at non-focused waves.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification's overall goal is to enable treatment of larger areas and avoid the pain and precision required by prior art high-energy focused devices (’249 Patent, col. 3:9-15). This context could support a reading where "off target" includes any application where the focal point is not precisely and damagingly concentrated on the tissue.
- Evidence for a Narrower Interpretation: Figure 11 of the patent explicitly depicts a scenario where the focal point (X) is located a distance (X₁) beyond the substance being treated (100) (’249 Patent, col. 8:14-22). This could support a narrower definition requiring intentional and significant displacement of the geometric focus from the treated tissue.

VI. Other Allegations

Indirect Infringement: The complaint alleges inducement of infringement for both patents. It asserts Defendant encourages and instructs customers to use the IFS Device in an infringing manner through its marketing, training, and operating manuals (Compl. ¶29, ¶70). For the ’995 method patent, the complaint asserts that knowledge of the patent is established at least as of the filing of the complaint itself (Compl. ¶70, fn. 1).
Willful Infringement: The willfulness allegation is based on alleged pre-suit knowledge of the ’249 Patent from notice letters sent in February 2020 and February 2025 (Compl. ¶9, ¶11, ¶60). The complaint alleges that despite this knowledge, Defendant continued its infringing activities, making the infringement willful (Compl. ¶60).

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

A core issue will be one of definitional scope: Will the claim terms "in the absence of a focal point impinging the substance" (’995 Patent) and "convergent off target" (’249 Patent) be interpreted geometrically (based on the location of a focal point) or functionally (based on the resulting biological effect, such as the absence of cavitation)? The resolution of this question will be critical in determining whether a product named "Focus Shockwave" can infringe these claims.
A key evidentiary question will be one of technical operation: Does the accused device’s "focus" create a high-energy "localized geometric focal point" of the type the patents sought to avoid, or is it a broader, lower-energy "focal zone" that achieves the therapeutic stimulation without causing the cellular damage the patents describe? This factual dispute will likely depend on competing expert analyses of the device's acoustic physics and bio-effects.