PGR2021-00020
Allergan Inc v. BTL Medical Technologies SRO
1. Case Identification
- Case #: PGR2021-00020
- Patent #: 10,695,575
- Filed: December 14, 2020
- Petitioner(s): Allergan, Inc., Allergan Limited, Allergan USA, Inc., Zeltiq Aesthetics, Inc., Zeltiq Ireland Unlimited Company, and Remed Co. Ltd.
- Patent Owner(s): BTL Medical Technologies S.R.O.
- Challenged Claims: 1-29
2. Patent Overview
- Title: Aesthetic method of biological structure treatment by magnetic field
- Brief Description: The ’575 patent describes methods and devices for aesthetic muscle toning using a time-varying magnetic field. The method involves applying two independently positionable applicators to a patient's body to generate magnetic impulses that cause muscle contractions, with claims reciting broad operational parameter ranges for magnetic flux density, impulse duration, and repetition rate.
3. Grounds for Unpatentability
Ground 1: Indefiniteness of Claim 13 under §112(f)
- Core Argument: Petitioner argued that claim 13 is indefinite because it recites a "control unit," which is a means-plus-function term under 35 U.S.C. §112(f), without disclosing corresponding structure in the specification. The term "unit" was asserted to be a nonce word, and the prefix "control" fails to impart any structural meaning. Petitioner contended the specification provides only a black-box diagram and functional descriptions (e.g., "regulating and/or adjusting") without disclosing any specific hardware, software, or algorithm necessary to perform the claimed function of controlling the discharge of energy to the magnetic coils. This failure to link the function to a specific structure renders the claim indefinite.
Ground 2: Claims 1-13, 16-20, and 22-23 are obvious over Pop in view of Porcari
- Prior Art Relied Upon: Pop (a two-applicator magnetic stimulation device publicly sold by Petitioner Remed Co. Ltd. since 2012) and Porcari (a 2002 journal article on electrical muscle stimulation).
- Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that Pop, a device used for pain relief via muscle stimulation, disclosed nearly all elements of the independent claims. Pop included two independently positionable applicators, each with a magnetic coil, an oil-based cooling system, and operated within the claimed parameter ranges for magnetic flux density, impulse duration, and repetition rate. The primary element Pop lacked was a belt for coupling the applicators to the patient. Porcari, which studied an electrical muscle stimulation device for abdominal toning, explicitly taught securing electrodes to the abdomen using straps.
- Motivation to Combine: A POSITA would combine Pop with the belt from Porcari to improve the device's ease of use and allow patients more freedom of movement during treatment. Petitioner argued that magnetic and electrical stimulation were well-understood, interchangeable modalities for achieving muscle contraction, making it obvious to apply a known attachment method from one modality (Porcari) to the other (Pop).
- Expectation of Success: A POSITA would have a high expectation of success, as adding a belt to secure the applicators is a simple, predictable mechanical modification.
Ground 3: Claims 14, 15, and 24-29 are obvious over Pop in view of Porcari and Anderson
- Prior Art Relied Upon: Pop, Porcari, and Anderson (Patent 8,834,547).
- Core Argument for this Ground:
- Prior Art Mapping: This ground addresses claims requiring the cooling of skin or adipose tissue to a specific temperature range (e.g., -2°C to 15°C) to increase a patient's apoptotic index (fat cell death). While Pop’s applicators were cooled and would provide some incidental skin cooling, Anderson explicitly disclosed a method and device for controlled cooling of a target body region to selectively disrupt lipid-rich cells and reduce subcutaneous fat.
- Motivation to Combine: A POSITA would be motivated to combine Anderson's targeted skin cooling with the muscle toning method of Pop/Porcari to achieve a superior, multi-modal aesthetic result. It was known that consumers desired both muscle toning and fat reduction, and combining these known treatments would have been an obvious way to satisfy that market demand.
- Expectation of Success: Success would be predictable, as the combination involves applying two known aesthetic treatments, each with its own well-understood mechanism of action, to the same treatment area.
Ground 4: Invalidity of All Claims (1-29) under §112(a)
Core Argument: As an alternative to its obviousness arguments, Petitioner argued that if the prior art failed to teach the claimed invention, then the patent's specification failed the written description and enablement requirements of 35 U.S.C. §112(a). The patent claimed extremely broad, multi-dimensional parameter ranges (e.g., magnetic flux density of 0.1-7 T; impulse duration of 3µs-3ms) but allegedly provided no working examples or guidance on how to select a specific combination of interdependent parameters that would actually achieve the claimed muscle toning. Petitioner argued that practicing the full scope of the claims would require undue experimentation, as many combinations at the low end of the claimed ranges would be physically incapable of inducing muscle contraction, let alone toning.
Additional Grounds: Petitioner asserted an additional obviousness challenge against claim 21 based on the combination of Pop, Porcari, and Errico (a reference teaching a touchscreen interface for a nerve stimulation device).
4. Key Claim Construction Positions
- "control unit" (claim 13): Petitioner argued this is an indefinite means-plus-function term lacking corresponding structure in the specification, as detailed in Ground 1.
- "toning" / "toned": Petitioner proposed this term be given its plain and ordinary meaning as confirmed in the patent: an enhanced visual appearance of a muscle caused by induced contractions that strengthen, firm, or volumize the muscle.
5. Arguments Regarding Discretionary Denial
- Petitioner argued that discretionary denial under Fintiv would be inappropriate. It contended that as a Post-Grant Review (PGR), which has a statutory nine-month filing window, the petition should be given different consideration than an inter partes review (IPR). The petition was filed promptly, only three months after the parallel ITC proceeding began. Petitioner also noted that the parallel district court case was stayed and that the ITC proceeding involved only 10 of the 29 challenged claims, meaning the PTAB was the only forum that could efficiently and completely address the patentability of all challenged claims.
6. Relief Requested
- Petitioner requests institution of post-grant review and cancellation of claims 1-29 of the ’575 patent as unpatentable.