Allergan Inc v. BTL Medical Technologies SRO

1. Case Identification

• 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

2. Patent Overview

• Title: Aesthetic method of biological structure treatment by magnetic field
• Brief Description: The ’576 patent discloses devices for aesthetic muscle toning by applying time-varying magnetic fields to a patient’s body region, such as the abdomen or buttocks, using one or more applicators. The claims recite specific ranges for parameters like magnetic flux density, impulse duration, and pulse repetition rates.

3. Grounds for Unpatentability

Ground 1: Indefiniteness of "Control Unit" - Claims 1-22 and 24 are unpatentable under 35 U.S.C. §112(f)

• Core Argument: Petitioner argued that the term “control unit” is an indefinite means-plus-function term. The term "unit" is a generic nonce word that fails to connote a specific, well-known structure to a person of ordinary skill in the art (POSITA). The prefix "control" is merely descriptive of function and adds no structural definition. Petitioner asserted that the specification fails to disclose any corresponding structure, such as a specific circuit design or a step-by-step algorithm, for performing the numerous control functions recited in the claims. Instead, the specification provides only high-level black-box diagrams, which is insufficient to satisfy the requirements of §112(f).

Ground 2: Obviousness over Pop and Porcari - Claims 1-15, 23, 25-26, and 28-29 are obvious over Pop in view of Porcari

• Prior Art Relied Upon: Pop (the Remed Salus Talent Pop, a commercially available magnetic stimulation device sold starting in 2012) and Porcari (a 2002 journal article describing an electrical muscle stimulation study).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that the Pop device, used for relieving muscle pain via magnetic stimulation, disclosed nearly every element of the independent claims. Pop included two independently operable, cooled applicators and generated magnetic fields with parameters (e.g., impulse duration, repetition rate, flux density) falling within the claimed ranges. The primary element Pop lacked was a belt to secure the applicators to a patient; Pop instead used adjustable arms. Porcari, in the analogous field of electrical muscle stimulation for abdominal toning, explicitly taught securing electrodes to a patient’s abdomen using elastic straps.
  • Motivation to Combine: A POSITA seeking to apply the Pop device for muscle toning would have been motivated to replace its cumbersome adjustable arms with a simpler, more convenient method of securing the applicators. It would have been obvious to look to the analogous art of electrical stimulation, where Porcari taught using a belt for this exact purpose. This modification would predictably improve patient mobility and ensure consistent applicator placement during treatment.
  • Expectation of Success: Combining a known securing mechanism (a belt) with a known stimulation device (Pop) was a simple mechanical integration that would have yielded predictable results.

Ground 3: Obviousness over Pop and Mo - Claims 16-19 are obvious over Pop and Mo

• Prior Art Relied Upon: Pop (Remed Salus Talent Pop device) and Mo (Application # 2006/0187607).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground addressed claims requiring modulation of the magnetic field amplitude. Petitioner argued that Pop already disclosed the core device and that its manual mode allowed users to adjust the magnetic flux density (intensity). Mo taught a magnetic stimulation device that used "ramp modulation"—a gradual increase and decrease of stimulation amplitude in a trapezoidal envelope—to protect the patient from the discomfort of sudden stimulation.
  • Motivation to Combine: A POSITA would have been motivated to improve the patient comfort of the Pop device. Mo provided an explicit reason to modulate amplitude: to reduce the "impact of sudden stimulation." A POSITA would have recognized that implementing Mo's ramp modulation in the Pop device was a known solution to a known problem and would predictably make the treatment more appealing to patients.
  • Expectation of Success: Implementing a known ramp-up and ramp-down control scheme for stimulation amplitude was a well-understood technique with a high expectation of success for achieving the predictable result of enhanced patient comfort.

• Additional Grounds: Petitioner asserted that claims 20-22, 27, and 30 are obvious over Pop, Porcari, and Mo. Claim 24 was challenged as obvious over Pop, Porcari, and Errico (WO 2015/179571), which taught a billing system for stimulation services. Finally, Petitioner argued all claims (1-30) are invalid under 35 U.S.C. §112(a) for lack of sufficient written description and non-enablement, contending the specification fails to teach a POSITA how to select from the broad, interdependent parameter ranges to achieve the claimed muscle toning.

4. Key Claim Construction Positions

• "toning": Petitioner proposed this term be given its plain meaning as confirmed in the patent: an enhanced visual appearance of a body region or muscle caused by induced muscle contractions that strengthen, firm, volumize, or tighten the muscle. This construction was used to argue that prior art for "muscle strengthening" was directly relevant to the claimed invention.
• "control unit": As asserted in Ground 1, Petitioner argued this term should be construed as a means-plus-function term that is indefinite for lack of corresponding structure disclosed in the specification.

5. Key Technical Contentions (Beyond Claim Construction)

• Interchangeability of Stimulation Modalities: A central technical contention was that by the time of the invention, a POSITA would have understood that magnetic stimulation and electrical stimulation were two well-known and similar modalities for inducing muscle contraction. Petitioner argued that artisans would have considered techniques, parameters, and accessories (like belts) from both fields to be interchangeable, providing a strong basis for combining references from both arts.

6. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under Fintiv would be inappropriate. The petition was filed promptly, well within the nine-month statutory window for a post-grant review (PGR). A parallel district court case was stayed pending the outcome of a related ITC investigation. Furthermore, the ITC investigation would not resolve all 30 challenged claims, and unlike the PTAB, the ITC cannot invalidate claims. Therefore, institution would promote efficiency and serve the public interest in resolving questions of patent validity.

7. Relief Requested

• Petitioner requested institution of a post-grant review and cancellation of claims 1-30 of the ’576 patent as unpatentable.