BTL Industries Inc v. InMode Ltd

1. Case Identification

• Case #: IPR2024-00703
• Patent #: 8,961,511
• Filed: April 10, 2024
• Petitioner(s): BTL Industries, Inc.
• Patent Owner(s): InMode Ltd.
• Challenged Claims: 1-58

2. Patent Overview

• Title: Method for Remodeling Tissue
• Brief Description: The ’511 patent discloses methods for tightening female genital tissue, including the vulva, introitus, and vagina, by applying radiant energy. The method involves heating collagen-rich target tissue beneath the mucosal epithelium to cause tissue remodeling and contraction, while simultaneously cooling the surface epithelium to prevent damage.

3. Grounds for Unpatentability

Ground 1: Obviousness over Edwards, Mosher, and Ingle - Claims 1-58 are obvious over Edwards in view of Mosher and Ingle.

• Prior Art Relied Upon: Edwards (Patent 6,463,331), Mosher (Application # 2004/0193238), and Ingle (Patent 6,216,704).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Edwards taught the foundational method of remodeling female urogenital tissue using radiofrequency (RF) energy to tighten the vaginal wall for therapeutic benefit. However, Edwards lacked specific operational parameters. Mosher and Ingle remedied this by teaching specific details for such treatments, including heating collagenous tissue to specific temperatures (e.g., 60-80°C) to cause shrinkage and remodeling, applying cooling to the surface epithelium to prevent damage, and using feedback controls to monitor temperature. For example, independent claim 1’s requirement of heating target tissue underlying an epithelium of female genital tissue was met by Edwards’s general disclosure, with Mosher and Ingle providing the known techniques for heating underlying collagenous structures (lamina propria, fascia) through the vaginal wall while cooling the surface.
  • Motivation to Combine: Petitioner asserted a person of ordinary skill in the art (POSITA) would combine these references to achieve a predictable result. A POSITA starting with Edwards's general method for vaginal remodeling would have looked to analogous art like Mosher and Ingle for specific, known techniques to implement the treatment safely and effectively. Mosher and Ingle provided the necessary details on treatment temperatures, cooling protocols, and the physiological mechanisms of collagen denaturation required to optimize the method taught by Edwards.
  • Expectation of Success: Success was expected because all three references relate to the non-invasive treatment of female urogenital conditions using radiant energy and rely on the same well-understood thermal dynamic principles for remodeling collagen-rich tissue. Applying the specific parameters from Mosher and Ingle to Edwards's method was a straightforward application of known techniques to achieve the predictable result of tissue tightening.

Ground 2: Obviousness over Edwards, Mosher, Ingle, and Ollivier - Claims 43-58 are obvious over the combination of Edwards, Mosher, and Ingle in view of Ollivier.

• Prior Art Relied Upon: Edwards (Patent 6,463,331), Mosher (Application # 2004/0193238), Ingle (Patent 6,216,704), and Ollivier (a 2000 Salon.com article).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the combination in Ground 1. Petitioner argued that claims 43 and 51, which recite heating specific external genital areas (the vulval vestibule and labia minora), were obvious with the addition of Ollivier. Ollivier explicitly taught cosmetic treatments for the vulva and labia, such as "Designer Laser Vaginoplasty," to "aesthetically modify" the labia. The base combination of Edwards, Mosher, and Ingle already taught the underlying RF heating and cooling technology for remodeling collagenous tissue.
  • Motivation to Combine: A POSITA, aware of the cosmetic procedures for the vulva and labia described in Ollivier, would have been motivated to apply the more advanced and known RF energy treatment methods from the primary combination (Edwards, Mosher, Ingle) to perform these cosmetic enhancements. The motivation was to use a known, effective tissue-tightening technique on a known area of the body (vulva) for a known purpose (cosmetic enhancement).
  • Expectation of Success: A POSITA would have had a reasonable expectation of success because the vulvar tissues recited in the claims comprise a similar mucosal epithelium and underlying collagen-rich layers as the vaginal tissue treated by the primary references. Therefore, applying the known RF technology to this anatomically similar area would be expected to yield predictable cosmetic tightening results.

4. Key Claim Construction Positions

• Petitioner argued that no terms required express construction and that the claims were unpatentable under their plain and ordinary meaning, as well as under constructions previously adopted by the Board in prior, settled IPRs involving the ’511 patent.
• "target tissue": Petitioner contended that under the Board’s prior preliminary construction—“tissue immediately beneath the mucosal epithelium...exclusive of deeper tissues, such as the endopelvic fascia”—the prior art satisfied the claims. It was noted that since the claims use the transition "comprising," prior art that also treats deeper tissues is not excluded.
• "heating": Petitioner relied on the Board’s prior construction of “raising the temperature of target tissue to no more than about 80 degrees C.” Mosher and Ingle were cited as explicitly teaching heating within this temperature range.
• "heating a portion of the vagina circumferentially around its wall from 1 o’clock to 11 o’clock" (Claim 35): Petitioner adopted the Board's prior broad construction of "heating at least one contact site in the 300 degree arc," arguing that Edwards’s teaching of treating the anterior and posterior vaginal walls inherently met this limitation.

5. Arguments Regarding Discretionary Denial

• Petitioner argued strongly against discretionary denial.
• Fintiv Factors: Petitioner asserted that the parallel district court litigation was in its earliest stages, with no answer filed or trial date set, and that the median time to trial far exceeds the deadline for a Final Written Decision (FWD). It also noted that the IPR petition challenges all 58 claims, whereas the district court complaint only mentions four, mitigating concerns of overlapping issues.
• General Plastic Factors: Petitioner emphasized that it was not a serial petitioner, this being its first IPR against the ’511 patent. The prior IPRs were filed by an unrelated party and were terminated by settlement before an FWD, meaning the Board has not previously completed a review on the merits.
• §325(d) Factors: Petitioner argued denial was inappropriate because the primary reference (Edwards) and one secondary reference (Ollivier) were not before the Examiner during prosecution. Furthermore, because the prior IPRs settled, deference to a prior Board decision on the merits was not a relevant factor; instead, the Board's prior institution decision suggests the merits are strong.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-58 of Patent 8,961,511 as unpatentable.