Abbott Laboratories v. Miracor Medical SA

1. Case Identification

• Case Number: 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 of a Heart
• Brief Description: The ’356 patent relates to a method for assisting blood circulation using a heart assist pump device, such as a Left Ventricular Assist Device (LVAD). The system features a magnetically driven rotor positioned outside the heart's ventricle to pump blood from an inflow tube.

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, discloses all limitations of the challenged claims. It teaches a complete, implantable LVAD system with an inflow tube inserted into the left ventricle, a magnetically driven impeller (rotor) positioned outside the ventricle, a housing, and an external controller. Wampler-169 allegedly discloses the use of hydrodynamic bearings, where the rotor is suspended by a fluid film ("by the blood flowing"), and an electromagnetic stator that drives permanent magnets embedded in the impeller, which Petitioner contended meets the "magneto coupling" limitation under the Patent Owner's litigation theory.
  • Key Aspects: This ground asserted that a single prior art reference taught a nearly identical architecture to what is claimed, including the specific method of implantation, rotor suspension via hydrodynamic action, and external control.

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 (Bourque et al., HeartMate III: Pump Design for a Centrifugal LVAD, ASAIO Journal 2001) and Wampler-169.
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Bourque-2001 discloses a magnetically levitated centrifugal LVAD (the HeartMate III) that meets most claim limitations, including a magnetically driven rotor, external controller, and placement outside the ventricle. Petitioner argued that Bourque-2001's inflow subassembly, which features a flow-restrictive "elbow," is the primary element not expressly meeting certain limitations related to an axially aligned inflow tube. Wampler-169 was introduced to supply the teaching of an axially aligned inflow tube that also serves as the inflow cannula, eliminating the need for a separate, inefficient elbow component.
  • Motivation to Combine: A POSITA would combine these references to improve the design of the Bourque-2001 pump. Bourque-2001 itself acknowledged that its peripheral hardware, including the inflow elbow, caused clinical problems and that the elbow was flow-restrictive. Wampler-169 expressly taught an improved design that achieved a 90-degree redirection of blood flow "without the necessity of a flow-restrictive elbow fitting," providing a clear solution to a known problem and improving anatomic compatibility.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because combining the components was an arrangement of known elements (Bourque's pump and Wampler's inflow cannula) to achieve a predictable result (improved blood flow and reduced infection risk). The technique of implanting a cannula at the cardiac apex, as taught by Wampler-169, was well-known in the art.

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 (Akamatsu et al., Development of Terumo implantable left ventricular assist system, J Artif Organs 1999).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Schima discloses a compact centrifugal blood pump with a magnetically driven rotor, hydrodynamic suspension ("contact-free journaling"), and a magnetic drive system. However, Schima is silent on the specific implantation method and external control configuration. Akamatsu-1999 was used to supply these missing elements, as it explicitly teaches an implantable LVAD system with an inflow port inserted into the left ventricle and an external controller used to regulate pump operation.
  • Motivation to Combine: A POSITA would be motivated to combine the references because their teachings were complementary. Schima focused on an advantageous pump design, while Akamatsu-1999 focused on the implantation and control of such a pump. A POSITA would have sought to use Schima's superior pump hardware with Akamatsu-1999's established and effective implantation and control methodology to create an optimized, functional system.
  • Expectation of Success: There would be a high expectation of success as the combination involved implementing a known pump type (Schima) using a standard, well-documented implantation and control strategy (Akamatsu-1999). External controllers and ventricular cannulation were routine for LVADs at the time.

• Additional Grounds: Petitioner asserted an additional obviousness challenge based on Akamatsu-1999 as a primary reference, but this ground relied on similar arguments regarding the known components of centrifugal LVADs.

4. Key Claim Construction Positions

• "magneto coupling": Petitioner argued this term, in the context of the ’356 patent and contemporaneous art, refers to a specific drive type where torque is transferred from one set of rotating permanent magnets to another set of rotating permanent magnets. This construction was asserted to distinguish it from a stator-based drive, where a stationary electromagnet (stator) creates a rotating magnetic field to drive the rotor. Petitioner contended the Patent Owner improperly conflates these distinct drive types in parallel litigation.
• "by the blood flowing": Petitioner argued this phrase describes rotor suspension via a hydrodynamic bearing, where the rotor's rotation generates a fluid film of blood that creates pressure and forces the rotor to remain spaced from the housing. This was contrasted with a magnetic bearing, which uses magnetic repulsion to suspend the rotor. Petitioner asserted this construction is required by the patent's own description and that the Patent Owner's contrary interpretation in litigation would render the claim language meaningless.

5. Arguments Regarding Discretionary Denial

• §325(d) (Same or Substantially the Same Art): Petitioner argued denial is unwarranted because the primary references (Wampler-169, Bourque-2001, Akamatsu-1999) were not cited or considered by the Examiner during prosecution of the ’356 patent. While a German-language version of Schima was cited in an IDS, it was not relied upon by the Examiner, and the petition presented it in new combinations with detailed expert testimony not previously available.
• §314(a) (Fintiv Factors): Petitioner argued against discretionary denial under Fintiv because the parallel district court litigation was in its earliest stages with no trial date set, minimal party investment, and Petitioner intended to request a stay. Further, Petitioner contended the merits of the IPR were particularly strong, as the prior art disclosed nearly identical architectures to solve the same problem addressed by the ’356 patent.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-7, 10, and 12-13 of the ’356 patent as unpatentable.