DCT
2:18-cv-01914
Tissue Regeneration Tech LLC v. Male Performance Medical Partnership LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Tissue Regeneration Technologies, LLC (Georgia) and General Patent, LLC (Georgia)
- Defendant: Male Performance Medical Partnership, LLC (Wyoming), et al.
- Plaintiff’s Counsel: Weide & Miller, Ltd.
- Case Identification: 2:18-cv-01914, D. Nev., 10/04/2018
- Venue Allegations: Venue is alleged to be proper in the District of Nevada because Defendants conduct continuous business in the state, have purposefully availed themselves of the state’s laws, solicit customers in Nevada, and advertise their services within the district.
- Core Dispute: Plaintiffs allege that Defendants' "SwissWave" shockwave therapy services, used for treating erectile dysfunction and Peyronie's disease, infringe patents covering specific shockwave therapy apparatus and methods.
- Technical Context: The technology is Extracorporeal Shock Wave Technology (ESWT), which applies acoustic pressure waves to biological tissue to stimulate healing and regeneration, expanding its use beyond traditional applications like breaking up kidney stones.
- Key Procedural History: Plaintiff Tissue Regeneration Technologies, LLC is the exclusive licensee of the patents-in-suit, which are owned by co-plaintiff General Patent, LLC.
Case Timeline
| Date | Event |
|---|---|
| 2003-02-19 | Earliest Priority Date for U.S. Patent 8,535,249 |
| 2004-10-22 | Earliest Priority Date for U.S. Patent 7,841,995 |
| 2008-01-01 | Plaintiff TRT began marketing and sales operations |
| 2010-11-30 | U.S. Patent 7841995 Issued |
| 2013-09-17 | U.S. Patent 8535249 Issued |
| 2018-10-04 | Complaint Filed |
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"
- 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 describes a need for shockwave therapy devices that can treat a variety of tissue types and conditions beyond what was possible with existing technology. Conventional focused shockwave systems concentrate high energy in a small, deep focal point, which is effective for breaking stones but can be too intense or spatially limited for other tissues. Conversely, radial systems treat superficial areas but lack the energy density for deeper tissue treatment (’249 Patent, col. 2:5-24).
- The Patented Solution: The invention is an apparatus designed to generate a wider variety of acoustic wave types, including planar, nearly planar, divergent, or "convergent off target" waves ('249 Patent, Abstract). By using components like a parabolic reflector, the apparatus can deliver therapeutic energy over a larger area without a high-intensity, potentially damaging focal point impinging directly on the tissue, thereby enabling the stimulation of tissue regeneration while minimizing pain and side effects ('249 Patent, col. 3:25-40).
- Technical Importance: This approach expanded the application of shockwave therapy to larger or more sensitive biological surfaces, such as skin or organs, by providing a method to control energy delivery over a broader area with less intensity than traditional focused systems (Compl. ¶¶ 21, 24).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 20 (Compl. ¶ 80).
- Independent Claim 1 recites an apparatus for generating pressure pulse/shock waves, comprising:
- A pressure pulse/shock wave source, a housing, and an exit window.
- The apparatus generates shock wave fronts having "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.
- This power density is specified as sufficient "to stimulate a living tissue while avoiding tissue damage."
- Independent Claim 20 recites a therapeutic device for administering a shock wave, comprising:
- A housing, a shock wave source, and wave directing/shaping structure.
- The structure is for "causing a planar shock wave to be emitted" and transferred to living tissue.
- The device is "shaped and dimensioned" to provide a planar shock wave with a power density sufficient "to stimulate the living tissue while avoiding tissue damage."
- The complaint alleges infringement of "one or more claims... including at least Claims 1 and 20," reserving the right to assert other claims (Compl. ¶ 80).
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.
The Invention Explained
- Problem Addressed: The patent's background explains that the understanding and application of ESWT was largely limited to its mechanical, destructive effects, such as for disintegrating kidney stones. There was a need for methods that could harness the biological, rather than purely mechanical, effects of shockwaves for therapeutic purposes (’995 Patent, col. 1:22-34).
- The Patented Solution: The invention is a method for stimulating cellular substances (i.e., tissue) by applying acoustic shock waves in a way that avoids a high-energy focal point. The method involves subjecting tissue to waves—which can be convergent, divergent, or planar—"in the absence of a focal point impinging the substance" ('995 Patent, Claim 1). This approach is based on the discovery that lower-energy, non-destructive shockwaves can trigger a biological healing response, including the release of growth factors and neovascularization, without causing the cavitation and hemorrhaging associated with traditional high-energy focused waves ('995 Patent, col. 4:26-44; Compl. ¶¶ 26, 99).
- Technical Importance: This method established a framework for using shockwave energy to promote tissue regeneration across a wide range of medical fields, shifting the focus from mechanical destruction to biological stimulation (Compl. ¶¶ 23, 26).
Key Claims at a Glance
- The complaint asserts claims 1 and 3 (Compl. ¶ 105).
- Independent Claim 1 recites a method of stimulating a cellular substance, comprising the steps of:
- Activating an acoustic shock wave generator to emit pressure pulses or shock waves with a low energy density (0.00001 mJ/mm² to 1.0 mJ/mm²).
- Subjecting the cellular substance to these waves "in the absence of a focal point impinging the substance."
- The subjection stimulates a cellular response without creating cavitation bubbles or causing the sensation of cellular hemorrhaging.
- The complaint also asserts dependent claim 3, which adds the step of administering medicaments before, during, or after the shockwave treatment (Compl. ¶ 105).
III. The Accused Instrumentality
Product Identification
- The Storz D-Actor 100 device, which is branded, marketed, and used by Defendants under the trade name "SwissWave" as part of a franchised treatment protocol for erectile dysfunction (ED) and Peyronie's disease (PD) (Compl. ¶¶ 1, 37, 101).
Functionality and Market Context
- The SwissWave protocol is marketed as a procedure that "uses pulsed-energy waves to open and repair blood vessels and increase blood flow to [the] penis" (Compl. ¶ 101). Defendants license the SwissWave brand, provide the Storz D-Actor 100 device, and supply instructional and marketing materials to a network of physician and non-physician franchisees (Compl. ¶¶ 101-104). The complaint includes a marketing image of the SwissWave-branded device, showing a control unit and a handheld applicator. (Compl. p. 9).
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 accused Storz D-Actor 100 device, branded as the SwissWave device, is an apparatus that generates pressure pulse/shock waves. | ¶80, ¶87 | col. 3:41-43 |
| wherein the shock wave fronts have plane, nearly plane, convergent off target or divergent characteristics | The complaint alleges that the Accused Products generate waves with these characteristics, thereby infringing the claim. | ¶80 | col. 3:44-47 |
| 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 | The complaint alleges that the Accused Products are designed to operate within this specific power density range to achieve therapeutic stimulation without causing tissue damage. | ¶79 | col. 15:5-12 |
'995 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of stimulating a cellular substance, which is a tissue having cells | Defendants' "SwissWave Protocol" is a method for stimulating penile tissue to treat ED and PD. | ¶100, ¶101 | col. 12:25-30 |
| 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 to 1.0 mJ/mm² | The SwissWave method utilizes the Storz D-Actor 100 device to emit pulsed-energy waves for therapeutic treatment. | ¶101, ¶105 | col. 20:5-10 |
| subjecting the cellular substance to the... waves... in the absence of a focal point impinging the substance stimulating a cellular response in the absence of creating cavitation bubbles | The complaint alleges the SwissWave method infringes by subjecting tissue to waves in this manner. | ¶105 | col. 20:26-38 |
- Identified Points of Contention:
- Factual Contradiction: A central dispute for the '995 patent will likely arise from the "absence of a focal point" limitation. The complaint alleges infringement of this claim while simultaneously quoting Defendants' marketing material, which states that for the treatment to work, "the WAVE MUST BE FOCUSED to one millimeter" (Compl. ¶ 49(g)). This raises the question of whether the accused SwissWave protocol actually operates with or without a focal point impinging on the tissue, creating a direct factual conflict between the patent's requirements and the Defendants' own description of their service.
- Scope and Technical Evidence: For the '249 patent, a key question will be whether the accused Storz D-Actor 100 device is in fact capable of generating waves with the specific "plane, nearly plane, convergent off target or divergent characteristics" as claimed. The complaint's allegations are conclusory, suggesting that infringement will turn on technical evidence of the device's actual operational modes and wave properties.
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: The construction of this term is critical, as it appears to be directly contradicted by Defendants' marketing claims. Practitioners may focus on this term because the infringement determination for the '995 method patent may hinge on whether the "focus" described by Defendants qualifies as a "focal point" precluded by the claim.
- Intrinsic Evidence for a Broader Interpretation: The patent repeatedly contrasts its method with prior art that causes "cavitation bubbles" and "cellular hemorrhaging," which are associated with high-energy focused waves ('995 Patent, col. 20:30-38). This context may support an interpretation where "focal point" means a high-intensity, tissue-destructive focal point, potentially allowing for lower-energy forms of wave convergence that do not cause such effects.
- Intrinsic Evidence for a Narrower Interpretation: The claim language is plain and unconditional. The specification and figures explicitly describe positioning the target tissue away from any "localized geometric focal volume or point" ('995 Patent, col. 20:31-33, Figs. 11-12). This could support a strict interpretation that prohibits any geometric convergence of wave energy onto the treated tissue.
The Term: "convergent off target" ('249 Patent, Claim 1)
- Context and Importance: This term helps define the scope of the apparatus claimed in the '249 patent. Infringement will depend on whether the accused device can be shown to generate waves meeting this specific definition.
- Intrinsic Evidence for a Broader Interpretation: The specification describes "convergent off target" in functional terms as a way to create a "convergent but diffused or far-sighted focused wave treatment," spreading the energy to insure "less tissue trauma" ('249 Patent, col. 13:6-14). This suggests the term could cover a range of wave patterns that converge but lack a sharp, high-intensity focus.
- Intrinsic Evidence for a Narrower Interpretation: The patent's figures provide specific geometric examples of "convergent off target" waves, showing the target tissue placed either before the focal point (pre-convergence) or after it (post-convergence) ('249 Patent, Figs. 11, 12). This may support a narrower construction requiring a specific spatial relationship between the wave source, the focal point, and the target tissue.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants induce infringement of both patents. For the '249 apparatus patent, inducement is based on Defendants allegedly encouraging and instructing customers to use the device in an infringing manner (Compl. ¶ 81). For the '995 method patent, inducement is based on Defendants licensing the "SwissWave Protocol," training operators, and providing instructional materials on how to perform the patented method (Compl. ¶¶ 101, 106).
- Willful Infringement: While the complaint does not use the term "willful," it pleads the basis for post-suit willfulness by alleging that Defendants continue their infringing activities despite knowledge of the patents acquired "as early as the date of service of this Complaint" (Compl. ¶¶ 81, 106).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of factual contradiction: Does the accused "SwissWave" protocol operate "in the absence of a focal point impinging" on the tissue, as required by the '995 patent, or does it, as Defendants' own marketing material states, require a wave that is "FOCUSED to one millimeter"? Resolving how the accused system actually functions versus how it is advertised will be central to the method patent infringement claim.
- A key evidentiary question will be one of technical capability: Can the Storz D-Actor 100 apparatus, as used in the SwissWave protocol, be proven to generate the specific "convergent off target" or other non-standard wave fronts recited in the '249 patent? The complaint's conclusory allegations suggest this will require detailed technical evidence and expert testimony on the device's operational physics.