DCT
2:23-cv-08583
InMode Ltd v. BTL Industries Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: InMode Ltd. (Israel)
- Defendant: BTL Industries, Inc. d/b/a BTL Aesthetics (Delaware)
- Plaintiff’s Counsel: Venable LLP
- Case Identification: 2:23-cv-08583, C.D. Cal., 05/31/2024
- Venue Allegations: Plaintiff alleges venue is proper in the Central District of California because Defendant BTL operates a "regular and established place of business" in the form of its "Body Boutique" in Beverly Hills, from which it conducts sales, demonstrations, and training for the accused products.
- Core Dispute: Plaintiff alleges that Defendant’s radiofrequency-based vaginal rejuvenation products infringe a patent related to methods for non-invasively remodeling and tightening genital tissue.
- Technical Context: The technology addresses the market for non-surgical aesthetic procedures, using controlled thermal energy to remodel collagen and tighten tissue without invasive surgery.
- Key Procedural History: The complaint alleges that the patent-in-suit was previously owned by Viveve, Inc., which acquired it from the original inventor. Viveve previously asserted the patent in a lawsuit against a competitor, ThermiGen, LLC, which settled. Plaintiff InMode alleges it later acquired the patent from Viveve and that this history establishes Defendant's pre-suit knowledge of the patent.
Case Timeline
| Date | Event |
|---|---|
| 2006-02-07 | U.S. Patent No. 8,961,511 Priority Date |
| 2015-02-24 | U.S. Patent No. 8,961,511 Issue Date |
| 2017-01-01 | Accused UltraFemme 360 Product Launch (approx. date) |
| 2018-06-04 | Prior litigation involving '511 Patent settled |
| 2022-01-01 | Accused EmFemme 360 Product Launch (approx. date) |
| 2024-05-31 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,961,511, Vaginal Remodeling Device And Methods, issued February 24, 2015
The Invention Explained
- Problem Addressed: The patent addresses the need for a non-invasive alternative to surgical procedures for treating vaginal tissue looseness, which can result from childbirth. Surgical options are described as unpopular due to risks of scarring and the invasive nature of the procedures in a sensitive area (’511 Patent, col. 2:7-16).
- The Patented Solution: The invention is a method and apparatus for remodeling genital tissue by applying radiant energy (such as radiofrequency) to heat the underlying, collagen-rich target tissue (the lamina propria and muscularis) while simultaneously cooling the outer epithelial surface (’511 Patent, Abstract). This process is designed to create a "reverse thermal gradient," which safely delivers therapeutic heat to denature existing collagen and stimulate new collagen growth, resulting in tissue tightening, without damaging the surface epithelium (’511 Patent, col. 4:8-13; col. 2:25-40). The device includes a treatment tip, shown in Figure 1, with an energy delivery element and an internal cooling mechanism (’511 Patent, Fig. 1; col. 6:1-14).
- Technical Importance: The described technology offers a method to achieve therapeutic tissue tightening for cosmetic and functional purposes without the risks, recovery time, and potential for counterproductive scarring associated with traditional surgery (’511 Patent, col. 2:17-21).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 35, among others (Compl. ¶7).
- Independent Claim 1 recites a method for remodeling genital tissue, with the key elements including:
- heating the target tissue
- remodeling the therapeutic zone of the target tissue
- wherein the heating includes heating a portion of the vagina "extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus"
- Independent Claim 35 recites a method for remodeling genital tissue, with the key elements including:
- heating the target tissue
- remodeling the therapeutic zone of the target tissue
- wherein the heating includes heating a portion of the vagina "circumferentially around its wall from 1 o'clock to 11 o'clock, wherein the aspect closest to the urethra is at 12 o'clock"
- The complaint notes that its infringement allegations pertain to "at least" the asserted claims, reserving the right to assert others (Compl. ¶7, ¶61).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant BTL's UltraFemme 360 and EmFemme 360 products and the corresponding treatment methods (Compl. ¶11, ¶55).
Functionality and Market Context
- The Accused Products are used to perform "non-invasive, radiofrequency vaginal rejuvenation treatments" (Compl. ¶56). They are marketed as devices that "homogeneously deliver[] volumetric heating throughout the treated area" for a "fast and uniform treatment" (Compl. ¶56).
- The complaint cites marketing materials describing the UltraFemme 360 as a "radiofrequency skin-tightening device" that functions by "heat[ing] the vaginal introitus and canal" to "stimulate new collagen formation" (Compl. ¶57).
- BTL sells these products to third-party healthcare providers and offers demonstrations and training, including at its "Body Boutique" locations (Compl. ¶13, ¶16). A screenshot from Defendant's website shows a search for healthcare providers in the Central District of California offering the accused treatments (Compl. p. 3).
IV. Analysis of Infringement Allegations
The complaint references an external claim chart (Exhibit 23) that was not filed with the complaint; therefore, the following infringement theory is constructed from the narrative allegations in the complaint body (Compl. ¶61).
'511 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for remodeling a therapeutic zone within a target tissue... comprising... heating the target tissue, and remodeling the therapeutic zone of target tissue... | The Accused Products perform "radiofrequency vaginal rejuvenation treatments" that "homogeneously deliver[] volumetric heating" to "stimulate 'new collagen formation.'" | ¶56, ¶57 | col. 15:46-57 |
| wherein the heating includes heating a portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus. | The Accused Products are alleged to "heat[] the vaginal introitus and canal." The complaint does not provide specific allegations regarding the precise depth of treatment. | ¶57 | col. 15:53-57 |
'511 Patent Infringement Allegations
| Claim Element (from Independent Claim 35) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for remodeling a therapeutic zone within a target tissue... comprising... heating the target tissue, and remodeling the therapeutic zone of target tissue... | The Accused Products perform "radiofrequency vaginal rejuvenation treatments" that "homogeneously deliver[] volumetric heating" to "stimulate 'new collagen formation.'" | ¶56, ¶57 | col. 17:11-21 |
| wherein the heating includes heating a portion of the vagina circumferentially around its wall from 1 o'clock to 11 o'clock... | The Accused Products are alleged to deliver "volumetric heating throughout the treated area" for a "uniform treatment." The complaint does not specify the exact circumferential treatment area. | ¶56 | col. 17:16-21 |
Identified Points of Contention
- Evidentiary Questions: The complaint's allegations are general. A central issue will be whether Plaintiff can produce evidence that the Accused Products, in actual use, heat tissue within the specific dimensional and positional boundaries required by claims 1 and 35 (e.g., "1 cm to 3.5 cm" deep and the "1 o'clock to 11 o'clock" circumference).
- Technical Questions: The ’511 Patent specification heavily emphasizes a "reverse thermal gradient" created by simultaneous surface cooling to protect the epithelium. The complaint does not allege that the Accused Products perform any surface cooling. The absence of this feature, while not an explicit limitation of the asserted independent claims, may create a dispute over whether the Accused Products function in a manner consistent with the patented invention.
V. Key Claim Terms for Construction
"heating the target tissue"
- Context and Importance: This term defines the core action of the patented method. The dispute will likely focus on whether the general "volumetric heating" alleged to be performed by the accused devices (Compl. ¶56) is the same as the "heating" disclosed in the patent. Practitioners may focus on this term because its construction could either narrow the claims to the patent’s specific "reverse thermal gradient" mechanism or allow them to cover a broader range of thermal treatments.
- Intrinsic Evidence for a Broader Interpretation: The term itself is straightforward. The patent describes the goal as heating the target tissue to a therapeutic temperature (e.g., between 45°C and 80°C) to cause remodeling (’511 Patent, col. 4:24-30). This could support an interpretation covering any method that achieves this result.
- Intrinsic Evidence for a Narrower Interpretation: The specification consistently describes the "heating" in the context of simultaneous surface cooling to create a "reverse thermal gradient" (’511 Patent, Abstract; col. 4:8-13). A party could argue that this context limits the scope of "heating" to methods that incorporate this protective cooling mechanism, which is framed as a key aspect of the invention.
"a location from 1 cm to 3.5 cm in from the introitus"
- Context and Importance: This specific dimensional limitation in claim 1 provides a clear boundary that Plaintiff's infringement proof must meet. Its construction is critical because the complaint's allegations are vague, referring only to heating the "canal" (Compl. ¶57).
- Intrinsic Evidence for a Broader Interpretation: The claim recites a range, which could be interpreted to mean that infringement occurs if any part of the treatment falls within these boundaries.
- Intrinsic Evidence for a Narrower Interpretation: The specification states that this length is "well adapted to treating the lower aspect of the vagina" and is "appropriate for providing the treatment tip access [to] the lower portion of a gently unfolded vagina" (’511 Patent, col. 4:30-35; col. 7:14-16). This may support an argument that the claim requires this specific anatomical region to be the intended and primary target of the heating, not merely an incidental area.
VI. Other Allegations
Indirect Infringement
The complaint alleges both induced and contributory infringement.
- Inducement: Allegations are based on Defendant knowingly providing "literature, instructional videos, training guides, user manuals" and conducting "demonstrations and clinical trainings" that allegedly instruct and encourage healthcare providers to use the Accused Products in an infringing manner (Compl. ¶71-72).
- Contributory Infringement: Allegations are based on the sale of the Accused Products and associated "consumables," which are asserted to be material parts of the invention, specially adapted for infringement, and not staple articles of commerce with substantial non-infringing uses (Compl. ¶75-77).
Willful Infringement
Willfulness is alleged based on pre-suit knowledge of the ’511 Patent. The complaint asserts that Defendant, as a competitor in the aesthetic healthcare market, knew or should have known of the patent because of a prior, publicly-settled lawsuit where the patent's previous owner (Viveve, Inc.) asserted it against another competitor (ThermiGen, LLC) (Compl. ¶62-63, ¶67).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof: Can the plaintiff demonstrate, through technical evidence, that the accused BTL products actually operate within the specific quantitative boundaries recited in the asserted claims (e.g., the "1 cm to 3.5 cm" depth of Claim 1), or will the general allegations of heating the "vaginal canal" fail to meet the claim limitations?
- The case may also turn on a question of claim scope: Will the term "heating the target tissue" be construed broadly, or will it be implicitly limited by the patent's detailed disclosure of a "reverse thermal gradient" created by active surface cooling—a feature not alleged to be present in the accused devices? The answer will significantly impact the infringement analysis.
- A key question for willfulness and enhanced damages will be one of notice: Does a competitor’s prior, settled litigation over a patent constitute sufficient pre-suit knowledge to support a finding of willful infringement, or will the defendant be able to argue it was reasonably unaware of the patent's relevance to its products?