DCT
1:19-cv-04844
Tissue Regeneration Tech LLC v. Anti Aging Group LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Tissue Regeneration Technologies, LLC (Ohio/Georgia) and General Patent, LLC (Georgia)
- Defendant: The Anti-Aging Group, L.L.C. (Florida) and Sexual MD Solutions LLC (Florida)
- Plaintiff’s Counsel: Cochran & Edwards, LLC; Insight PLC
- Case Identification: 1:19-cv-04844, N.D. Ga., 10/28/2019
- Venue Allegations: Venue is asserted based on a forum selection clause in a prior license agreement between the parties, which designated the U.S. District Court for the Northern District of Georgia for any related litigation.
- Core Dispute: Plaintiffs allege that Defendants’ “GAINSWave” medical procedure, which uses extracorporeal shock wave technology to treat erectile dysfunction, infringes a patent for therapeutically stimulating genital tissue.
- Technical Context: The technology involves the application of acoustic shock waves, a non-invasive energy-based treatment, to stimulate biological responses such as tissue regeneration and increased blood flow in reproductive organs.
- Key Procedural History: The parties were previously involved in litigation (GAINSWAVE I), which was resolved via a Settlement and License Agreement on September 17, 2018, granting Defendants a license to the patent-in-suit. Plaintiffs allege this license was terminated on September 29, 2019, due to Defendants' breach. The complaint highlights a "Covenant Not to Contest" clause from that agreement, which may estop Defendants from challenging the patent's validity, enforceability, or infringement.
Case Timeline
| Date | Event |
|---|---|
| 2004-10-22 | ’127 Patent Priority Date |
| 2009-10-13 | ’127 Patent Issue Date |
| 2018-07-20 | Defendants’ alleged first knowledge of patent (GAINSWAVE I) |
| 2018-09-17 | Parties enter into Settlement and License Agreement |
| 2019-05-28 | Alleged last royalty payment made by Defendants |
| 2019-08-28 | Plaintiffs provide formal notice of breach |
| 2019-09-29 | License Agreement terminated |
| 2019-10-28 | 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
- Issued: October 13, 2009
The Invention Explained
- Problem Addressed: The patent describes a need for new, non-invasive techniques to enhance reproductive potential and treat conditions like infertility and impotence, noting the risks and limitations of existing options such as fertility drugs, surgery, and other therapies. (’127 Patent, col. 1:30-col. 4:31).
- The Patented Solution: The invention is a method for stimulating genital or reproductive tissue by applying acoustic shock waves from a generator. The method is characterized by using waves that are specifically controlled to be non-destructive—for example, by using divergent or planar waves, or by positioning the tissue away from the focal point of focused waves—thereby stimulating a therapeutic cellular response without causing cavitation or hemorrhaging. (’127 Patent, Abstract; col. 11:1-12).
- Technical Importance: The technology proposes a method to achieve the therapeutic benefits of shockwave therapy (e.g., revascularization, nerve stimulation) for sensitive reproductive tissues while avoiding the tissue damage associated with high-energy, focused shockwave applications like lithotripsy. (’127 Patent, col. 9:26-44).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 3 and 7-9. (Compl. ¶52).
- Independent Claim 1 requires:
- A method for 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 specific physical parameters (e.g., amplitude above 0.1 MPa).
- Subjecting the tissue to these waves "in the absence of a focal point impinging the genital tissue or reproductive organ."
- This subjection stimulates a "cellular response in the absence of creating cavitation bubbles."
- The complaint's use of "at least" these claims reserves the right to assert additional claims. (Compl. ¶52).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the "GAINSWave® Treatment" or "GAINSWave Procedure," a medical method licensed and promoted by the Defendants. (Compl. ¶9, ¶51).
Functionality and Market Context
- The GAINSWave procedure is alleged to be a treatment for erectile dysfunction and Peyronie's Disease. (Compl. ¶9, ¶51).
- The complaint states that the procedure "utilizes high frequency, low-intensity soundwaves to improve blood flow to the penis, remove micro-plaque, and stimulate the growth of new blood vessels." (Compl. ¶51).
- Defendants are alleged to market, license, and provide training for this procedure to medical providers, who then perform it on patients. (Compl. ¶52).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
’127 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of stimulation of a genital tissue or reproductive organ of an infertility or impotence diagnosed patient... | The GAINSWave procedure is marketed to treat erectile dysfunction, which the patent defines as a form of impotence. | ¶9, ¶50, ¶51 | col. 19:65-67 |
| activating an acoustic shock wave generator or source to emit pressure pulses including... acoustic shock waves directed toward the genital tissue or reproductive organ... | The procedure "utilizes high frequency, low-intensity soundwaves" applied to the penis, which implies the activation of a shock wave generator. | ¶51 | col. 20:1-10 |
| subjecting the genital tissue, reproductive organ or the entire reproductive region of the body to the... shock waves... | The procedure applies soundwaves "to the penis" to "stimulate the growth of new blood vessels." | ¶51 | col. 20:25-30 |
| 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 evidenced by not experiencing the sensation of cellular hemorrhaging... | The complaint makes a general allegation that Defendants infringe the claims, which contain this limitation, but provides no specific facts on this element. | ¶52 | col. 20:30-45 |
Identified Points of Contention
- Technical Question: The complaint does not specify the operational parameters of the GAINSWave procedure, such as its energy density, wave profile (e.g., focused vs. unfocused), or whether it operates with a focal point. A central question will be whether the accused procedure, as actually performed, meets the specific physical and biological effect limitations of the claims. (Compl. ¶51).
- Scope Questions: A primary dispute may center on the negative limitations. What evidence shows the GAINSWave procedure operates "in the absence of a focal point impinging" the tissue and "in the absence of creating cavitation bubbles"? The complaint's conclusory allegation of infringement (Compl. ¶52) will require substantial factual support to prove these specific claim requirements are met.
V. Key Claim Terms for Construction
The Term: "in the absence of a focal point impinging the genital tissue or reproductive organ"
- Context and Importance: This negative limitation is critical for distinguishing the claimed method from conventional, high-energy shockwave therapies that deliberately focus energy to destroy targets (e.g., kidney stones). The infringement analysis hinges on whether the accused GAINSWave method satisfies this non-destructive criterion. Practitioners may focus on this term as it is a core feature defining the invention's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses achieving this by positioning tissue "pre-convergence inward of the geometric focal point," suggesting the use of a focused source could still fall within the claim if the focal point is deliberately placed outside the tissue. (’127 Patent, col. 11:1-3).
- Evidence for a Narrower Interpretation: The patent repeatedly contrasts the invention with focused-wave devices and highlights embodiments using "unfocused" waves that are "divergent, planar or near planar." (’127 Patent, col. 9:60-62). This could support an interpretation that the claim requires a truly unfocused wave source or a wave pattern that lacks a geometric focal point altogether.
The Term: "stimulating a cellular response in the absence of creating cavitation bubbles"
- Context and Importance: This limitation links the physical application of waves to a specific biological outcome. Infringement requires showing not only that waves were applied but that they caused a therapeutic response without the destructive side effect of cavitation. This will likely be a battle of expert testimony on the biophysics of the accused procedure.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the "cellular response" broadly as stimulating "the body's own natural healing capability" and activating "growth factors." (’127 Patent, col. 11:51-56, 11:44-46). This could be argued to cover any demonstrable therapeutic effect like the "growth of new blood vessels" alleged for GAINSWave. (Compl. ¶51).
- Evidence for a Narrower Interpretation: The patent explicitly ties the absence of cavitation to the patient "not experiencing the sensation of cellular hemorrhaging." (’127 Patent, col. 20:35-39). A defendant might argue that any evidence of pain, bruising, or micro-damage from the procedure proves cavitation occurred, thereby taking it outside the claim scope.
VI. Other Allegations
Indirect Infringement
- The complaint alleges induced infringement, stating that Defendants intentionally encourage and instruct their medical provider customers to use the GAINSWave procedure in an infringing manner through marketing, training, and licensing activities. (Compl. ¶52, ¶53).
Willful Infringement
- Willfulness is alleged based on Defendants' continued infringement after their license to the patent was terminated. The complaint asserts that Defendants had knowledge of the patent since at least July 20, 2018, from a prior lawsuit between the parties. (Compl. ¶53).
VII. Analyst’s Conclusion: Key Questions for the Case
- Contractual Estoppel: A threshold legal issue will be the enforceability and scope of the "Covenant Not to Contest" from the prior license agreement. The court's ruling on whether this provision estops Defendants from challenging the patent’s validity, enforceability, or infringement will fundamentally shape the landscape of the litigation and available defenses.
- Proof of Infringement: A central evidentiary question will be one of technical operation: can Plaintiffs produce evidence demonstrating that the GAINSWave procedure, as actually performed by third-party licensees, meets the specific negative limitations of Claim 1, namely operating "in the absence of a focal point impinging" the tissue and "in the absence of creating cavitation bubbles"?
- Specific Intent for Inducement: Should the case proceed on indirect infringement, a key question will be whether Plaintiffs can prove specific intent. This will require showing that Defendants' training and marketing materials not only promoted the GAINSWave procedure generally but specifically instructed or encouraged licensees to perform it in a manner that satisfies every limitation of the asserted claims.