Miracor Medical SA v. Abbott Laboratories

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Miracor Medical SA (Belgium)
  • Defendant: Abbott Laboratories (Illinois) and Thoratec LLC (California/Delaware/Illinois)
  • Plaintiff’s Counsel: Barnes & Thornburg LLP
• Case Identification: 1:25-cv-00484, N.D. Ill., 01/15/2025
• Venue Allegations: Plaintiff alleges venue is proper because Defendants have a regular and established place of business in the district and have committed the alleged acts of infringement there.
• Core Dispute: Plaintiff alleges that Defendant’s HeartMate 3 Left Ventricular Assist Device/System (LVAD/LVAS) infringes two patents related to magnetically driven pumps for assisting heart performance.
• Technical Context: The technology concerns Left Ventricular Assist Devices, which are implantable mechanical pumps used to support circulation in patients with advanced heart failure.
• Key Procedural History: Plaintiff previously filed a suit against the same Defendants on November 27, 2023 (1:23-cv-16257), asserting six other patents from its portfolio. The current complaint asserts two patents that issued in October 2024, suggesting an ongoing dispute over Defendants' HeartMate 3 technology.

Case Timeline

Date	Event
2007-02-27	Priority Date for ’600 and ’007 Patents
2023-11-27	Prior lawsuit filed by Miracor against Abbott (1:23-cv-16257)
2024-10-01	U.S. Patent No. 12,104,600 Issues
2024-10-04	Alleged date of Abbott's knowledge of the ’600 Patent
2024-10-15	U.S. Patent No. 12,117,007 Issues
2024-11-02	Alleged date of Abbott's knowledge of the ’007 Patent
2025-01-15	Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 12,104,600 - Device to Assist the Performance of a Heart, issued October 1, 2024

The Invention Explained

• Problem Addressed: The patent describes the need for medical devices that can assist a failing heart but notes that conventional heart-lung machines often maintain a forced circulation without adapting to the heart's specific needs (Compl. Ex. 1, ’600 Patent, col. 1:40-49). A key challenge is minimizing mechanical stress on sensitive fluids like blood to prevent damage (Compl. Ex. 1, ’600 Patent, col. 2:28-32).
• The Patented Solution: The invention is an intravasal rotary pump designed to be less damaging to blood. Its central feature is a "magneto coupling" that creates a "completely impervious separation of the rotor from the drive wheel" (Compl. Ex. 1, ’600 Patent, col. 2:32-36). As depicted in Figure 2, a drive wheel (21) inside a catheter magnetically actuates an external rotor (18) that pumps blood, eliminating the need for certain seals and passages that could otherwise damage blood cells (Compl. Ex. 1, ’600 Patent, col. 4:56-65, Fig. 2).
• Technical Importance: The use of a magnetically coupled, contactless drive system represents an approach to reduce hemolysis (red blood cell damage), a significant concern in the design of blood pumps and ventricular assist devices (Compl. Ex. 1, ’600 Patent, col. 2:28-32).

Key Claims at a Glance

• The complaint asserts independent claims 1 (device) and 9 (method) (Compl. ¶¶25, 27).
• Exemplary independent claim 1 requires:
  • An inflow tube with a suction end for insertion into a heart ventricle.
  • A magnetically driven rotor with guide surfaces to create centrifugal flow.
  • A first magnetic device associated with the rotor.
  • A second magnetic device to rotate the rotor via a "magneto coupling."
  • A "first chamber" in fluid communication with the inflow tube, having a "substantially entirely planar" bottom wall.
  • A "second chamber" that surrounds and seals the second magnetic device from the rotor.
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 12,117,007 - Device to Assist the Performance of a Heart, issued October 15, 2024

The Invention Explained

• Problem Addressed: As a continuation of the same patent family, the ’007 Patent addresses the same technical problem as the ’600 Patent: the need for an adaptable and less-damaging method of assisting cardiac performance (Compl. Ex. 2, ’007 Patent, col. 1:31-49).
• The Patented Solution: The solution is also a rotary pump using a "magneto coupling" to achieve an "impervious separation" between the drive and the rotor, thereby reducing mechanical stress on blood (Compl. Ex. 2, ’007 Patent, col. 2:30-36). The core technology described in the specification is identical to that of the ’600 Patent (Compl. Ex. 2, ’007 Patent, Figs. 1-3).
• Technical Importance: The focus remains on improving the biocompatibility of ventricular assist devices by minimizing blood damage through a specific magnetically coupled design (Compl. Ex. 2, ’007 Patent, col. 2:28-32).

Key Claims at a Glance

• The complaint asserts independent claims 1 (device) and 13 (method) (Compl. ¶¶36, 38).
• Exemplary independent claim 1 requires:
  • An inflow tube with a suction end and a central axis.
  • A magnetically driven rotor and an associated first magnetic device, both axially aligned with the central axis.
  • A second magnetic device, also axially aligned, that is "axially spaced from the guide surfaces" of the rotor and rotates it via a magneto coupling.
  • A first chamber with a "substantially entirely planar" bottom wall.
  • A sealed second chamber surrounding the second magnetic device.
  • A "defined blood outflow path... in a direction that not aligned with the inflow tube and the central axis."
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

• Product Identification: The accused products are the "HeartMate 3" or "HeartMate 3 LVAD/LVAS" and its related components, including the LVAD blood pump, System Controller, System Monitor, and Touch Communication System (collectively, "Accused Products") (Compl. ¶13).
• Functionality and Market Context: The Accused Products comprise a Left Ventricular Assist System, a type of mechanical circulatory support device used to assist the heart's pumping function in patients with heart failure (Compl. ¶¶7, 13). The complaint alleges that Defendants provide extensive technical support and instructional materials for the use of these products (Compl. ¶14).
• Visual Evidence: No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that were not publicly filed with the pleading (Compl. ¶¶25, 36). The infringement allegations are therefore summarized based on the complaint's narrative.

• U.S. Patent No. 12,104,600 Infringement Allegations
  The complaint alleges that the HeartMate 3 system directly infringes at least claim 1 of the ’600 Patent by containing all of its required elements (Compl. ¶¶24-25). The infringement theory posits that the physical construction of the HeartMate 3 pump embodies the claimed inflow tube, magnetically driven rotor, dual magnetic devices forming a magneto coupling, and the specified first and second chambers (Compl. ¶¶25, 29).

• Identified Points of Contention:

  • Scope Questions: A central dispute may arise over the term "substantially entirely planar" as applied to the first chamber's bottom wall. The infringement analysis will question whether the corresponding surface within the HeartMate 3 pump, which may have functional contours or features, can be characterized as "planar" within the scope of the claim.
  • Technical Questions: The complaint's theory relies on the HeartMate 3's drive mechanism meeting the definition of a "magneto coupling" that separates a sealed drive component from the rotor. A key question for the court will be whether the specific architecture of the HeartMate 3 pump—a known magnetically levitated centrifugal-flow pump—matches the structural arrangement of the "first chamber" and "second chamber" as claimed in the patent.

• U.S. Patent No. 12,117,007 Infringement Allegations
  The complaint asserts that the Accused Products directly infringe at least claim 1 of the ’007 Patent (Compl. ¶¶35-36). This infringement theory is similar to the one for the ’600 patent but must also satisfy additional limitations in the ’007 patent's claims, such as the specific spatial relationships between components and the nature of the blood flow path (Compl. ¶36).

• Identified Points of Contention:

  • Scope Questions: Claim 1 of the ’007 patent requires the blood outflow path to be in "a direction that not aligned with the inflow tube and the central axis." The interpretation of "not aligned" will be critical. This suggests a centrifugal or mixed-flow design, and the parties may dispute whether the HeartMate 3's specific flow vector meets this limitation.
  • Technical Questions: Claim 1 also requires the second magnetic device (the drive) to be "axially spaced from the guide surfaces" of the rotor. The infringement analysis will depend on a detailed examination of the HeartMate 3's internal geometry to determine if its drive magnets are located in a position that is "axially spaced" from the rotor's pumping vanes, as that term is construed.

V. Key Claim Terms for Construction

• For the ’600 and ’007 Patents:

  • The Term: "magneto coupling"
  • Context and Importance: This term is foundational to the patent's described invention, which emphasizes an "impervious separation" between the drive and the rotor. The entire infringement case rests on whether the HeartMate 3's magnetically levitated drive system constitutes a "magneto coupling" as claimed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not appear to provide a special definition, which may support an argument that the term should be given its plain and ordinary meaning, potentially covering any system where one magnetic component drives another without physical contact.
    • Evidence for a Narrower Interpretation: The specification consistently describes a specific embodiment where an internal drive wheel (21) within a catheter drives an external rotor (18) ('600 Patent, col. 4:56-65; Fig. 2). A party could argue the term is implicitly limited to this particular catheter-based, inside-out configuration.

• For the ’007 Patent:

  • The Term: "a direction that not aligned with the inflow tube and the central axis"
  • Context and Importance: This limitation defines the fundamental fluid dynamic principle of the claimed pump, distinguishing it from a purely axial-flow design. Practitioners may focus on this term because the HeartMate 3 is known as a centrifugal-flow pump, and the question will be whether its specific flow path fits the claim's characterization.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party may argue that any flow path that is not perfectly parallel to the central axis, including any radial or tangential component, meets the "not aligned" limitation.
    • Evidence for a Narrower Interpretation: The patent links the rotor's "guide surfaces" to producing "centrifugal flow components" ('600 Patent, col. 3:40-45). A party could argue that "not aligned" requires a substantially radial or perpendicular outflow characteristic of a true centrifugal pump, potentially excluding mixed-flow designs.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. Inducement is based on allegations that Defendant provides instructional materials (manuals, videos, etc.) that guide medical professionals to use the HeartMate 3 in an infringing manner (Compl. ¶¶28, 39). Contributory infringement is based on allegations that the HeartMate 3 components are a material part of the invention, are not staple articles of commerce, and are especially designed to be used together in an infringing system (Compl. ¶¶29, 40).
• Willful Infringement: Willfulness is alleged for both patents based on Defendant’s alleged knowledge of the patents shortly after they issued. The complaint alleges knowledge of the ’600 patent as of October 4, 2024, and of the ’007 patent as of November 2, 2024, both dates preceding the filing of the lawsuit (Compl. ¶¶27, 38). The allegations also assert willful blindness for any period before direct knowledge was obtained.

VII. Analyst’s Conclusion: Key Questions for the Case

• A central issue will be one of structural and functional mapping: Does the physical architecture of the commercially successful HeartMate 3 pump—a compact, magnetically levitated device—actually align with the specific claim limitations derived from a patent describing a catheter-based system with an internal drive and external rotor? This will involve a detailed, technical comparison of structures like the "first chamber" with its "planar" bottom wall against the engineered surfaces of the accused device.
• The case will also turn on a question of claim construction and scope: Can the term "magneto coupling", which is rooted in the patent’s description of a specific catheter embodiment, be construed broadly enough to read on the sophisticated, fully-levitated rotor system of the HeartMate 3? The outcome of this definitional dispute may determine whether the patent can reach beyond its disclosed embodiment to cover a next-generation commercial product.