UlThera Inc v. dermaFocus LLC

1. Case Identification

• Case #: IPR2016-01459
• Patent #: 6,113,559
• Filed: July 19, 2016
• Petitioner(s): Ulthera, Inc.
• Patent Owner(s): Dermafocus LLC
• Challenged Claims: 1-18

2. Patent Overview

• Title: Method for Rejuvenating Human Skin Using Ultrasound Energy
• Brief Description: The ’559 patent discloses methods for rejuvenating skin and reducing wrinkles by applying focused ultrasound energy to the dermis layer. The applied energy is intended to either heat the dermis to a specific temperature range (hyperthermia) to denature proteins or induce cavitation to mechanically stimulate a biological response, leading to the formation of new tissue.

3. Grounds for Unpatentability

Ground 1: Claims 1-7 and 12-16 are obvious over Knowlton in view of the Technomed patent.

• Prior Art Relied Upon: Knowlton (International Publication No. WO 96/34568) and Technomed patent (French Patent No. 2,672,486).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the combination of Knowlton and the Technomed patent taught all limitations of these claims. Knowlton disclosed a method for treating skin wrinkles by delivering energy, including ultrasound, to heat and denature collagen in the dermis. Knowlton further taught heating the dermis to temperatures (e.g., 60° to 80° C) that overlap with and render obvious the range claimed in the ’559 patent (47° to 75° C). While Knowlton taught the general concept, it did not specify operational parameters like power levels. The Technomed patent supplied this missing element by describing a focused ultrasound device for treating superficial varicose veins—structures located in or near the dermis. The Technomed patent disclosed using power levels (100 W/cm² to 2 kW/cm²) that fully encompass the range recited in dependent claim 6 (500 W/cm² to 1500 W/cm²), rendering it obvious.
  • Motivation to Combine: Petitioner contended a person of ordinary skill in the art (POSITA) would combine these references to achieve a predictable and effective result. Both references describe using ultrasound energy to treat tissue beneath the skin surface to improve its appearance. A POSITA seeking to implement Knowlton's general method for wrinkle treatment would have looked to analogous arts, such as the Technomed patent's disclosure on treating nearby tissue (varicose veins), for specific, clinically effective operational parameters like power levels and details on focused ultrasound systems. The similar treatment locations (the dermis or immediately adjacent tissue) and shared goal of aesthetic improvement provided a clear motivation to integrate Technomed's specific teachings into Knowlton's broader framework.
  • Expectation of Success: A POSITA would have had a high expectation of success because both references use the same energy source (ultrasound) to achieve thermal effects in similar anatomical locations. Applying the known effective power levels from the Technomed patent to the wrinkle-treatment application described in Knowlton was presented as a straightforward application of established principles.

Ground 2: Claims 8-11 and 17-18 are obvious over Knowlton and the Technomed patent in view of Technomed PCT.

• Prior Art Relied Upon: Knowlton (WO 96/34568), Technomed patent (French Patent No. 2,672,486), and Technomed PCT (International Publication No. WO 93/12742).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addressed claims requiring the additional step of inducing "cavitation" or "mechanically disrupting" tissue with a "shock wave." Petitioner argued that while Knowlton and the Technomed patent primarily focused on thermal effects (hyperthermia), Technomed PCT explicitly taught using focused ultrasound to create both thermal and cavitation effects. Technomed PCT described how cavitation—the formation and collapse of microscopic bubbles—becomes predominant at certain energy thresholds and results in the destruction of neighboring tissue. Petitioner asserted this process inherently involves mechanical disruption and the creation of a shock wave upon bubble collapse, directly mapping to the limitations of claims 17 and 18. This effect, when applied to the dermis as taught by the base combination, would satisfy the limitations of claims 8-11.
  • Motivation to Combine: Petitioner argued a POSITA would have been motivated to add the teachings of Technomed PCT for several reasons. First, Knowlton itself suggested that energy causing "physical destruction" of collagen tissue was a viable treatment path, opening the door for non-thermal methods. Second, Technomed PCT, which shares inventors with the Technomed patent, explicitly taught the benefits of combining hyperthermia and cavitation to create a "reinforced" destructive treatment. A POSITA seeking to enhance the effectiveness of the thermal treatment taught by Knowlton and the Technomed patent would have been motivated to incorporate the cavitation techniques from Technomed PCT to achieve this synergistic effect. The common subject matter (ultrasound treatment of tissue near the skin) and shared inventors between the Technomed references would further prompt a POSITA to consider their teachings together.
  • Expectation of Success: The expectation of success was argued to be high. Technomed PCT provided a known mechanism for non-invasively destroying tissue beneath the skin. A POSITA would have reasonably expected that applying this known cavitation technique to the dermis, the target location in Knowlton, would successfully induce the desired mechanical disruption for skin rejuvenation.

4. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 1-18 of the ’559 patent as unpatentable.