Abbott Laboratories v. Miracor Medical SA

1. Case Identification

• Case #: IPR2025-00096
• Patent #: 11,351,356
• Filed: November 5, 2024
• Petitioner(s): Abbott Laboratories
• Patent Owner(s): Miracor Medical SA
• Challenged Claims: 1-7, 10, and 12-13

2. Patent Overview

• Title: Method for Assisting Blood Circulation
• Brief Description: The ’356 patent relates to a method for assisting heart circulation using a heart assist pump device with a magnetically driven rotor. The device features an inflow tube inserted into a heart ventricle, while the pump body containing the rotor is positioned outside the ventricle.

3. Grounds for Unpatentability

Ground 1: Obviousness over Wampler-169 - Claims 1-7, 10, and 12-13 are obvious over Wampler-169.

• Prior Art Relied Upon: Wampler-169 (Application # 2002/0102169).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Wampler-169, a single reference disclosing a Left Ventricular Assist Device (LVAD), teaches all limitations of the challenged claims. Wampler-169’s pump features an inflow tube inserted into the left ventricle, with the main pump body external to the heart. It discloses an impeller (the “magnetically driven rotor”) with embedded permanent magnets (the “first magnetic device”) that is driven by a circular electromagnetic stator (the “second magnetic device”). The rotor is suspended by hydrodynamic forces generated by blood flow, which Petitioner contended meets the limitation of the rotor remaining spaced apart from the housing “by the blood flowing.” Wampler-169 also disclosed an external controller for regulating pump operation.
  • Motivation to Combine (for §103 grounds): Not applicable (single reference ground).
  • Expectation of Success (for §103 grounds): Not applicable (single reference ground).

Ground 2: Obviousness over Bourque-2001 and Wampler-169 - Claims 1-7, 10, and 12-13 are obvious over Bourque-2001 in view of Wampler-169.

• Prior Art Relied Upon: Bourque-2001 (a July 2001 article in the ASAIO Journal) and Wampler-169 (Application # 2002/0102169).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted Bourque-2001, which describes the HeartMate III LVAD, discloses a centrifugal pump with a magnetically levitated rotor, an external controller, and an inflow subassembly inserted into the heart. For any limitations not fully disclosed by Bourque-2001, such as an axially aligned inflow tube without a flow-restrictive bend, Petitioner relied on the teachings of Wampler-169.
  • Motivation to Combine (for §103 grounds): A POSITA would combine the teachings to improve the design of the HeartMate III pump disclosed in Bourque-2001. Bourque-2001 itself acknowledged that its inflow path included a “sharp bend” or “elbow” that was flow-restrictive. Wampler-169 taught a more efficient centrifugal pump design that achieved a 90-degree redirection of blood flow without a flow-restrictive elbow by using an axially aligned inflow tube, which also served as the inflow cannula. A POSITA would have incorporated Wampler-169’s superior inflow design to eliminate the restrictive elbow in Bourque-2001, thereby improving blood flow and reducing clinical complications.
  • Expectation of Success (for §103 grounds): A POSITA would have a reasonable expectation of success in making this modification, as it involved combining known design elements for their intended purposes to achieve a predictable improvement in pump performance and anatomic compatibility.

Ground 3: Obviousness over Schima and Akamatsu-1999 - Claims 1-7, 10, and 12-13 are obvious over Schima in view of Akamatsu-1999.

• Prior Art Relied Upon: Schima (Application # 2003/0124007) and Akamatsu-1999 (a March 1999 article in the J Artif Organs journal).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner contended that Schima discloses a rotary blood pump with all the key mechanical features claimed: a magnetically driven rotor with magnets, an external drive motor creating a magnetic field via magneto coupling, and hydrodynamic stabilization of the rotor. However, Schima is silent on the specific implantation method and control system. Akamatsu-1999, which describes an implantable centrifugal LVAD, supplied these missing elements by teaching the implantation of the pump with its inlet port inserted into the left ventricle and the use of an external controller to regulate pump operation.
  • Motivation to Combine (for §103 grounds): A POSITA would combine the references because their teachings were complementary. It would have been obvious to apply Akamatsu-1999’s well-established implantation and control techniques to Schima’s advantageous pump design. This would allow a POSITA to implement Schima's pump as a functional LVAD system to solve the same problem addressed by Akamatsu-1999: providing circulatory support.
  • Expectation of Success (for §103 grounds): Success was expected because implanting an LVAD’s inflow tube into the ventricle and regulating its function with an external controller were standard, well-known techniques in the field at the time.

• Additional Grounds: Petitioner asserted an additional obviousness challenge based on Akamatsu-1999 as a single reference but relied on similar principles.

4. Key Claim Construction Positions

• “magneto coupling”: Petitioner argued this term refers to the transfer of torque between two rotating permanent magnetic components. This construction was used to distinguish it from a stator drive, where a stationary electromagnet generates a rotating magnetic field to drive a rotor, a configuration disclosed in some prior art.
• “remains entirely spaced apart from the surrounding rotor housing by the blood flowing”: Petitioner argued this phrase requires a “hydrodynamic bearing,” where the rotor is suspended by a fluid film generated by the pump’s rotation. This was contrasted with a “magnetic bearing,” where suspension is achieved through repulsive magnetic forces, a different technology also present in the prior art.

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under both §325(d) and §314(a) (Fintiv).
• §325(d): Denial was argued to be improper because the primary references asserted in the petition (Wampler-169, Bourque-2001, Akamatsu-1999, and Schima) were not cited or substantively considered by the Examiner during the original prosecution of the ’356 patent.
• §314(a) (Fintiv): Petitioner argued the Fintiv factors weigh against denial. Key reasons included that there is no trial date in the parallel litigation, the median time-to-trial is over 53 months (ensuring an FWD would issue long before trial), and investment in the litigation has been minimal as it is in the early stages of discovery. Petitioner also contended the merits of the petition are particularly strong.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-7, 10, and 12-13 of Patent 11,351,356 as unpatentable.