DCT

1:18-cv-03482

Tissue Regeneration Tech LLC v. Anti Aging Group LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-03482, N.D. Ga., 07/19/2018
  • Venue Allegations: Venue is alleged to be proper in the Northern District of Georgia because Defendants conduct business in the district, solicit customers in the district, and have committed the alleged acts of infringement in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ "GAINSWave" branded services, which use a Storz D-Actor 100 device for treating erectile dysfunction and Peyronie's disease, infringe three patents related to methods and apparatuses for applying acoustic shock wave therapy.
  • Technical Context: The technology involves Extracorporeal Shock Wave Therapy (ESWT), specifically the use of low-energy, unfocused or divergent acoustic waves to stimulate biological responses like tissue regeneration and neovascularization.
  • Key Procedural History: Plaintiff General Patent, LLC is the owner of the patents-in-suit and has granted an exclusive license to Plaintiff Tissue Regeneration Technologies, LLC, which includes the right to enforce the patents. The complaint includes parallel claims for false advertising under the Lanham Act.

Case Timeline

Date Event
2003-02-19 Priority Date for U.S. Patent No. 8,535,249
2004-10-22 Priority Date for U.S. Patent Nos. 7,601,127 and 7,841,995
2009-10-13 Issue Date for U.S. Patent No. 7,601,127
2010-11-30 Issue Date for U.S. Patent No. 7,841,995
2013-09-17 Issue Date for U.S. Patent No. 8,535,249
2018-07-19 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 Oct. 13, 2009

The Invention Explained

  • Problem Addressed: The patent describes the limitations and risks of existing treatments for infertility and impotence, such as the high costs of in-vitro fertilization (IVF), the health risks of multiple gestations from fertility drugs, and degenerative conditions resulting from aging (’127 Patent, col. 1:31-col. 2:67).
  • The Patented Solution: The invention proposes a method of using acoustic shock waves to stimulate genital or reproductive tissue. This stimulation is intended to trigger the body's natural healing mechanisms, regenerate tissue, and improve revascularization and blood flow, thereby treating conditions like impotence without invasive surgery or systemic drugs ('127 Patent, Abstract; col. 3:28-44). The method emphasizes avoiding a high-intensity focal point within the tissue to prevent damage ('127 Patent, col. 11:1-10).
  • Technical Importance: This approach represented a non-invasive method to address the underlying biological causes of certain reproductive health issues, such as poor vascularization, by stimulating the body's own regenerative capabilities ('127 Patent, col. 3:45-54).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 3 and 7-9 (Compl. ¶98).
  • Independent Claim 1 requires, in essence:
    • A method of stimulating genital or reproductive tissue in a patient diagnosed with infertility or impotence.
    • Activating an acoustic shock wave generator to emit pressure pulses or shock waves toward the tissue.
    • The waves must have a low energy density (0.000001 to 1.0 mJ/mm²).
    • The waves are applied "in the absence of a focal point impinging the genital tissue or reproductive organ" to stimulate a cellular response without causing cavitation or hemorrhaging.
    • The tissue is positioned away from any localized geometric focal volume of the emitted waves.

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 Sep. 17, 2013

The Invention Explained

  • Problem Addressed: The patent identifies a gap in existing shock wave technology. "Focused" systems, like those for breaking kidney stones, treat only a very small area and can be too intense, while "radial" systems treat a larger area but lack the energy density to be effective in deeper tissues (’249 Patent, col. 2:5-20).
  • The Patented Solution: The invention is an apparatus designed to generate pressure or shock waves that are neither highly focused nor merely superficial. It uses specific configurations, such as parabolic reflectors, to create waves that are "plane, nearly plane, convergent off target or divergent," allowing therapeutic energy to be delivered to a larger volume of tissue at a clinically effective depth without the destructive intensity of a tight focal point ('249 Patent, Abstract; col. 3:40-52).
  • Technical Importance: The technology provides a "middle ground" apparatus capable of treating broader areas of soft tissue more effectively than either existing focused or radial systems by controlling the geometry of the acoustic wave fronts ('249 Patent, col. 2:5-20).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 20 (Compl. ¶111).
  • Independent Claim 1 requires, in essence:
    • An apparatus for generating pressure/shock waves, comprising a source, a housing, and an exit window.
    • The apparatus generates wave fronts with "plane, nearly plane, convergent off target or divergent characteristics."
    • The apparatus is shaped and dimensioned to produce waves with a power density between 0.01 mJ/mm² and 1.0 mJ/mm² to stimulate living tissue while avoiding tissue damage.

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 Nov. 30, 2010.
  • Technology Synopsis: The patent addresses the need for a therapeutic method that can stimulate biological healing processes (such as neovascularization and release of growth factors) without the tissue destruction associated with high-energy, focused shock waves. The invention discloses methods and an apparatus for applying acoustic shock waves that are specifically characterized as divergent, near-planar, or convergent but positioned away from a focal point to treat a wide range of tissues and conditions in mammals (’995 Patent, Abstract; col. 3:24-4:54).
  • Asserted Claims: The complaint asserts independent claim 1 and dependent claim 3 (Compl. ¶135).
  • Accused Features: The GAINSWave procedure, which is alleged to involve stimulating tissue in a human by applying "high frequency, low intensity sound waves to improve blood flow to the penis," is accused of infringing the patented method (Compl. ¶¶125-126).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the "GAINSWave" branded medical procedure and the Storz D-Actor 100 device used to perform it (Compl. ¶16).

Functionality and Market Context

  • The GAINSWave procedure is a service marketed and licensed by the "GAINSWave Defendants" (e.g., The Anti-Aging Group) to medical providers. This procedure involves using the Storz D-Actor 100 device to apply "pulsating acoustic shockwaves" to the penis for the treatment of erectile dysfunction and Peyronie's disease (Compl. ¶¶16, 21(p), 40-42). The alleged therapeutic mechanism is the stimulation of "growth of new blood vessels" and the breakdown of scar tissue to improve blood flow (Compl. ¶¶19(e), 20(g)). The complaint alleges that Defendants market these services as "clinically proven" and supported by numerous clinical studies, and franchise the GAINSWave brand, protocols, and training to a network of providers (Compl. ¶¶19(a), 40, 92(b)).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Exhibits B, D, and F) that were not included with the filed pleading. As such, the infringement allegations are summarized below in prose based on the narrative provided in the complaint.

  • ’127 Patent Infringement Allegations
    The complaint alleges that the "Local Medical Practice Defendants" directly infringe the method claims of the ’127 Patent by performing the GAINSWave procedure (Compl. ¶105). The core of the allegation is that this procedure constitutes a method of stimulating genital tissue (the penis) with low-energy acoustic shock waves to treat impotence (erectile dysfunction), mapping directly onto the steps of asserted claim 1 (Compl. ¶88). The complaint further alleges that the "GAINSWAVE Defendants" (the franchisors) induce this infringement by actively and intentionally encouraging, training, and providing "clinically proven protocols" to their licensees on how to perform the patented method (Compl. ¶¶90, 92, 99). The marketing claims that the procedure works by improving blood flow and stimulating new vessel growth are cited as evidence that the accused method performs the claimed stimulation (Compl. ¶¶19(e), 21(p)).

  • ’249 Patent Infringement Allegations
    The complaint alleges that all Defendants infringe the apparatus claims of the ’249 Patent. The "GAINSWave Defendants" are accused of making, using, selling, and importing the infringing device (the Storz D-Actor 100), while the "Local Medical Practice Defendants" are accused of infringing by using it (Compl. ¶¶111, 118). The infringement theory is that the Storz D-Actor 100 is an apparatus for generating pressure/shock waves with the characteristics and energy densities recited in the claims (Compl. ¶110). Specifically, the complaint alleges the device generates waves with a power density between 0.01 mJ/mm² and 1.0 mJ/mm² to stimulate tissue, which falls within the scope of asserted claim 1.

V. Key Claim Terms for Construction

  • ’127 Patent

    • The Term: "in the absence of a focal point impinging the genital tissue" (from claim 1)
    • Context and Importance: This negative limitation is central to distinguishing the claimed method from prior art lithotripsy, which uses a high-energy focal point. The infringement analysis will depend on whether the acoustic field produced by the accused Storz D-Actor 100, a radial wave device, meets this "absence of a focal point" requirement. Practitioners may focus on this term because the definition will determine whether a radial pressure wave, which has a point of maximum intensity near the applicator but no geometric focus, falls within the claim scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification repeatedly contrasts the invention with high-energy focused waves that cause hemorrhaging and pain, suggesting the "absence of a focal point" means the absence of a destructive, high-energy concentration, not necessarily the complete absence of any pressure peak ('127 Patent, col. 11:1-10).
      • Evidence for a Narrower Interpretation: The patent's figures and detailed description extensively discuss focal points in the context of specific geometric reflectors (e.g., ellipsoids, paraboloids) ('127 Patent, Figs. 10-12). A party could argue the term is limited to this specific acoustic-optic context, potentially excluding the different physics of a radial wave generator.

  • ’249 Patent

    • The Term: "convergent off target or divergent characteristics" (from claim 1)
    • Context and Importance: This phrase defines the specific, non-focused nature of the waves generated by the claimed apparatus. The Plaintiffs characterize their own technology as "unfocused" (Compl. ¶23), aligning with this language. The dispute may turn on whether the waves produced by the accused Storz D-Actor 100, which are generated by a different physical mechanism, can be properly characterized as having "divergent characteristics" as understood in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a broad definition, stating that "divergent waves" are "all waves which are not focused and are not plane or nearly plane" and that a focused wave becomes divergent after passing the focal point ('249 Patent, col. 6:10-14). This could arguably encompass the expanding waves from a radial source.
      • Evidence for a Narrower Interpretation: The patent’s illustrations of divergent waves consistently show them as originating after passing through a geometric focal point created by a reflector ('249 Patent, Fig. 12, element 204). A party could argue that the term is limited to waves created by this specific "focused-then-diverged" pathway, which may not describe the operation of the accused device.

VI. Other Allegations

  • Indirect Infringement: The complaint makes detailed allegations of induced infringement against the "GAINSWAVE Defendants." It alleges these defendants provide their licensees with "clinically proven protocols," marketing materials, sales training, and two-day "medical training" seminars that actively instruct and encourage the performance of the infringing methods and use of the infringing device (Compl. ¶¶90, 92(b), 95-96, 99).
  • Willful Infringement: The complaint alleges knowledge of the patents-in-suit "as early as the date of service of this Complaint" for all asserted patents (Compl. ¶¶99, 112, 136). This pleading establishes a basis for post-suit willful infringement but does not contain allegations of pre-suit knowledge.

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

  • A key evidentiary question will be one of technical characterization: Do the pressure waves generated by the accused Storz D-Actor 100 device, which operates on a radial or ballistic principle, in fact possess the "divergent" or "near planar" characteristics and energy densities required by the apparatus claims, and is the GAINSWave method performed "in the absence of an impinging focal point" as required by the method claims?
  • A core issue will be one of definitional scope: Can claim terms such as "focal point" and "divergent characteristics," which are described in the patent specifications with reference to specific geometric reflectors like paraboloids, be construed broadly enough to encompass the different physical wave-generation mechanism of the accused radial device?
  • A third central question will concern induced infringement: Assuming the underlying procedures are found to be infringing, did the GAINSWAVE Defendants' franchise model—including their provision of training, marketing, and "proven protocols"—demonstrate the specific intent required to encourage their licensees to infringe the asserted patents?