Abbott Laboratories v. Miracor Medical SA

1. Case Identification

• Case #: IPR2025-00115
• Patent #: 11,674,517
• Filed: November 26, 2024
• Petitioner(s): Abbott Laboratories
• Patent Owner(s): Miracor Medical SA
• Challenged Claims: 1-4, 10-11, 14-15, 17, 21-22, 24, 26, 28-30, 32-33, and 35

2. Patent Overview

• Title: System for Assisting Blood Circulation
• Brief Description: The ’517 patent relates to a system for assisting heart circulation using a heart assist pump device, described as an intravasal rotary pump, with a magnetically driven rotor. The system is designed to be deliverable to the heart, with an inflow tube insertable into a ventricle.

3. Grounds for Unpatentability

Ground 1: Obviousness over Wampler-169 - All Challenged Claims 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, which discloses a "sealless rotary blood pump," teaches all limitations of the challenged claims. Wampler-169's left ventricular assist device (LVAD) is a heart assist pump with an inflow tube inserted into the left ventricle. Its magnetically driven rotor (impeller) contains permanent magnets and is driven by a surrounding electromagnetic stator (a second magnetic device). The rotor is suspended within its housing by hydrodynamic bearings created by blood flow, keeping it spaced apart from the housing walls. The system includes a radial outflow port and is operated by an external controller that regulates pump speed. Petitioner asserted that these features directly map to the limitations of independent claims 1 and 21 and the additional limitations of the dependent claims.

Ground 2: Obviousness over Bourque-2001 and Wampler-169 - Claims 1-4, 10-11, 14-15, 17, 21-22, 24, 26, 28-30, 32-33, and 35 are obvious over Bourque-2001 in view of Wampler-169.

• Prior Art Relied Upon: Bourque-2001 (a 2001 article in ASAIO Journal) and Wampler-169 (’169 application).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that Bourque-2001 discloses the "HeartMate III," a centrifugal LVAD with a magnetically levitated rotor, an inflow subassembly, and an external controller, teaching most claim limitations. Bourque-2001’s rotor is magnetically driven, rotates within a housing, and is connected to an external control unit.
  • Motivation to Combine: Petitioner argued that a person of ordinary skill in the art (POSITA) would combine Wampler-169 with Bourque-2001 to improve Bourque-2001’s design. Bourque-2001 taught that its inflow subassembly included a "flow-restrictive elbow fitting." Wampler-169 taught a more compact and efficient design where the inflow tube itself serves as the inflow cannula, eliminating the need for a separate, restrictive elbow. A POSITA would combine these teachings to improve blood flow, reduce the number of components (which Bourque-2001 identified as a source of "clinical troubles"), and lower infection risk by enabling a better anatomical fit near the heart's apex, as taught by Wampler-169.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because modifying the inflow cannula was a known and "not complex" technique. Both references describe centrifugal pumps for the same purpose, making the integration of Wampler-169's superior inflow design into Bourque-2001's system a predictable improvement.

Ground 3: Obviousness over Schima and Akamatsu-1999 - Claims 1-4, 10, 14-15, 17, 21-22, and other claims are obvious over Schima in view of Akamatsu-1999.

• Prior Art Relied Upon: Schima (Application # 2003/0124007) and Akamatsu-1999 (a 1999 article in J Artif Organs).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Schima discloses a compact rotary blood pump with nearly all the core mechanical features of the claimed invention, including a magnetically driven rotor with magnets, an inflow tube, a surrounding housing, a radial outflow, and a drive system comprising a second magnetic device. Schima also teaches using hydrodynamic forces from blood flow to achieve "contact-free journaling" of the rotor, spacing it from the housing.
  • Motivation to Combine: While Schima focused on pump design, it was silent on implantation and external control. Akamatsu-1999, which discloses an implantable centrifugal LVAD, supplied these missing elements. Akamatsu-1999 explicitly taught implanting a pump by inserting its inlet port into the left ventricle and using an external controller to regulate its operation. A POSITA would combine Schima’s advantageous pump design with Akamatsu-1999’s established and complementary teachings on implantation and control to create a complete, functional LVAD system.
  • Expectation of Success: The combination involved applying routine and well-understood techniques. The use of external controllers and the described method of implanting LVADs were common at the time, ensuring a high expectation of success in implementing Schima’s pump as a fully functional, implanted heart-assist system.
• Additional Grounds: Petitioner asserted an additional obviousness challenge based on Akamatsu-1999 as a single reference but relied on similar arguments for mapping pump components.

4. Key Claim Construction Positions

• "magneto coupling": Petitioner argued this term should be construed as "a transfer of torque from one rotating permanent magnetic component to another rotating permanent magnetic component via a magnetic field." This construction distinguishes it from stator-based drives, which use a stationary electromagnet.
• "spaced apart...by the blood flowing": Petitioner contended this phrase refers to a "hydrodynamic bearing," where the fluid film created by the rotor’s rotation provides the spacing force. This contrasts with a magnetic bearing, which uses repulsive magnetic forces for suspension.

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under §325(d), stating the primary references (Wampler-169, Bourque-2001, Akamatsu-1999, and Schima) were not cited or substantively considered by the Examiner during prosecution of the ’517 patent.
• Petitioner argued against discretionary denial under Fintiv factors, asserting that: (1) it intends to file a motion to stay the parallel district court litigation; (2) no trial date is set, and the median time-to-trial in the district is over 53 months; (3) investment in the parallel litigation is minimal as it is in early stages; and (4) the petition presents particularly compelling merits.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-4, 10-11, 14-15, 17, 21-22, 24, 26, 28-30, 32-33, and 35 of Patent 11,674,517 as unpatentable.