PTAB

PGR2021-00024

Allergan, Inc. v. BTL Medical Technologies S.R.O.

Case #: PGR2021-00024
Patent #: 10,695,576
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: 1-30

Title: Aesthetic method of biological structure treatment by magnetic field
Brief Description: The ’576 patent relates to devices and methods for aesthetic muscle toning by applying time-varying magnetic fields to a patient's body, such as the abdomen or buttocks. The claims recite specific device components and broad operational parameter ranges for the magnetic fields.

Core Argument: Petitioner argued that the term "control unit" is a means-plus-function term under 35 U.S.C. § 112(f) because it is a generic nonce word that does not connote a specific structure to a person of ordinary skill in the art (POSITA). The petition contended that the ’576 patent specification fails to disclose the necessary corresponding structure, such as a specific algorithm or circuit diagram, required to perform the claimed functions (e.g., regulating energy, controlling treatment parameters). Instead, the specification provided only high-level black-box diagrams, rendering the claims indefinite.

Prior Art Relied Upon: Pop (a two-applicator magnetic stimulation device 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 disclosed nearly all elements of the independent claims, as it was a two-applicator magnetic stimulation device that operated within the claimed parameter ranges for magnetic flux density, impulse duration, and repetition rate to cause muscle contraction for pain relief. The primary element Pop allegedly lacked was a belt for securing the applicators. Porcari disclosed using an elastic belt to secure electrical stimulation electrodes to a patient’s abdomen for muscle toning.
- Motivation to Combine: A POSITA would combine Porcari’s belt with the Pop device because securing applicators with a belt was a well-known and obvious alternative to Pop's adjustable arms. Given the known interchangeability of electrical and magnetic stimulation techniques, a POSITA would look to the Porcari reference to improve Pop by allowing greater patient mobility and ensuring consistent applicator placement, a simple substitution of one known securing means for another.
- Expectation of Success: A POSITA would have a high expectation of success, as the combination would predictably result in a functional device that effectively secures the applicators during treatment.

Prior Art Relied Upon: Pop and Mo (Application # 2006/0187607).
Core Argument for this Ground:
- Prior Art Mapping: This ground addressed claims requiring modulation of the magnetic flux amplitude. Petitioner argued that Pop already allowed users to adjust the magnetic flux density. Mo taught a method for modulating stimulation amplitude in a trapezoidal pattern (ramping up, maintaining, and ramping down) to protect patients from the discomfort of sudden stimulation.
- Motivation to Combine: A POSITA would be motivated to incorporate Mo's ramp modulation into the Pop device to improve patient comfort, a known benefit of such techniques. As Pop already provided the ability to adjust intensity, implementing a specific, known modulation scheme like that in Mo would have been an obvious improvement.
- Expectation of Success: The combination would predictably result in a more comfortable patient experience without changing the device's fundamental muscle stimulation function.

Core Argument: Petitioner argued that, as an alternative to the obviousness grounds, the claims are invalid under 35 U.S.C. § 112(a). The specification allegedly failed to provide adequate written description or enablement because it presented numerous broad, interdependent parameter ranges (e.g., flux density, impulse duration, repetition rates) in isolation. It failed to disclose any specific combination of these parameters that would achieve the claimed muscle toning, thus not demonstrating possession of the invention and requiring undue experimentation for a POSITA to practice the full scope of the claims.
Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations of Pop, Porcari, and Mo in view of Errico (International Publication No. WO 2015/179571), which taught a billing system for a medical device, but relied on similar design modification theories.

"toning": Petitioner proposed construing "toning" and "toned" according to its plain meaning as confirmed in the patent: an enhanced visual appearance of a muscle caused by induced muscle contractions that strengthen, firm, volumize, or tighten the muscle. This construction was central to the argument that the prior art's known effects of muscle strengthening and firming fall within the scope of the claims.
"control unit": As detailed in Ground 1, Petitioner argued this is a means-plus-function term that is indefinite for lack of corresponding structure in the specification.

Petitioner’s arguments relied on the central technical contention that by the patent's priority date, a POSITA would have considered magnetic stimulation and electrical stimulation to be well-understood and interchangeable modalities for inducing muscle contraction. This interchangeability was crucial to the motivation to combine magnetic stimulation devices (like Pop) with features from electrical stimulation prior art (like Porcari's belt).

Petitioner argued that discretionary denial under Fintiv would be inappropriate. The petition was filed promptly (within months of patent issuance), and a parallel district court proceeding was stayed. Petitioner contended that a parallel ITC investigation would not resolve all issues, as it involved only 12 of the 30 challenged claims, and the ITC lacks the authority to invalidate claims. Furthermore, the parties in the litigation are not identical to the parties in the PGR.

Petitioner requested institution of a post-grant review and cancellation of claims 1-30 of Patent 10,695,576 as unpatentable under 35 U.S.C. § 103 and § 112.