US 11351356

Here's a concise summary of US Patent 11351356, along with a plain-language overview of its independent claim:

US Patent 11351356: Device to assist the performance of a heart

• Title: Device to assist the performance of a heart
• Assignee: Miracor Medical SA Belgium [cite: https://patents.google.com/patent/[US11351356](/patent/US11351356)/en]
• Inventor: Werner Mohl [cite: https://patents.google.com/patent/US11351356/en]
• Filing Date: 2021-12-23 [cite: https://patents.google.com/patent/US11351356/en]
• Issue Date: 2022-06-07 [cite: https://patents.google.com/patent/US11351356/en]
• Abstract: The patent describes a method and device designed to help the heart function, featuring a rotary pump driven by a magnetic coupling. The pump incorporates a magnetically driven rotor that spins within a housing, moving blood from an inflow tube towards the rotor. A second magnetic component, aligned with the inflow tube, magnetically drives the rotor through the coupling. [cite: https://patents.google.com/patent/US11351356/en]

Litigation Information:
While a direct search for US patent 11351356 in CAFC 2026 dockets did not return specific results, the Google Patents record for this patent indicates ongoing litigation. The patent family is involved in a PTAB Inter Partes Review (IPR2025-00096) filed in 2025, which is currently pending and instituted. Additionally, a US case related to this patent has been filed in the Illinois Northern District Court (case 1:23-cv-16257). [cite: https://patents.google.com/patent/US11351356/en]

Plain-Language Overview of Independent Claim 1:

Independent claim 1 outlines a method for assisting heart blood circulation using a specialized pump device. This method involves several key steps and features:

1. Device Placement: A heart assist pump is delivered to the heart. Its inlet (suction end of the inflow tube) is placed inside a heart chamber (ventricle), while the main pumping part (magnetically driven rotor) is positioned outside that ventricle.
2. Pump Operation and Design: The rotor, which is responsible for moving blood, is aligned with the inflow tube and rotates within its surrounding casing (rotor housing). It's rigidly connected to a first magnetic component located within this housing, right next to the rotor.
3. Magnetic Drive System: A separate, second magnetic component is also aligned with the inflow tube. This second magnet is responsible for spinning the rotor through a magnetic connection with the first magnetic component. A crucial aspect is that this second magnetic component is completely separated and sealed off from both the rotor and the first magnetic component, preventing direct contact or fluid exchange.
4. Blood Flow Direction: Blood propelled by the rotor exits the pump through an outflow port. This port is positioned to the side of the rotor, causing the blood to exit the housing in a direction that is largely perpendicular to the path of the incoming blood and the rotor's spinning axis.
5. Self-Spacing Rotor: The magnetic connection is designed to ensure that as the rotor spins, it is entirely kept away from the surrounding housing walls by the very blood it is pumping.
6. External Control: An external control unit, located outside the patient's body, is connected to the heart assist pump. This unit regulates the operation of the second magnetic component, thereby controlling the magnetic driving of the rotor, all while the pump's inflow tube is properly placed within the heart.

Known litigation involving US patent 11351356 as of April 26, 2026:

1. PTAB Inter Partes Review (IPR) Proceeding

   • Plaintiff(s) (Petitioner): Abbott Laboratories, and Thoratec LLC [cite: 'US11351356B2 - Device to assist the performance of a heart - Google Patents']
   • Defendant(s) (Patent Owner): Miracor Medical SA Belgium (Current Assignee) [cite: 'US11351356B2 - Device to assist the performance of a heart - Google Patents']
   • Jurisdiction: Patent Trial and Appeal Board (PTAB) [cite: 'US11351356B2 - Device to assist the performance of a heart - Google Patents']
   • Case Number: IPR2025-00096 [cite: 'US11351356B2 - Device to assist the performance of a heart - Google Patents']
   • Filing Date: 2024-12-17 [cite: 'US11351356B2 - Device to assist the performance of a heart - Google Patents']
   • Outcome or Current Status: Pending - Instituted [cite: 'US11351356B2 - Device to assist the performance of a heart - Google Patents']

2. U.S. District Court Case

   • Plaintiff(s): Not explicitly named in the provided patent text.
   • Defendant(s): Not explicitly named in the provided patent text.
   • Jurisdiction: Illinois Northern District Court [cite: 'US11351356B2 - Device to assist the performance of a heart - Google Patents']
   • Case Number: 1:23-cv-16257 [cite: 'US11351356B2 - Device to assist the performance of a heart - Google Patents']
   • Filing Date: The case number indicates a filing in 2023. The exact date is not provided in the patent text.
   • Outcome or Current Status: Not explicitly stated in the provided patent text.

Proceedings overview

A single AIA trial proceeding, IPR2025-00096, has been filed against US Patent 11351356. This Inter Partes Review, filed by Abbott Laboratories et al., has reached a Final Written Decision as of 2026-06-11. The outcome of this decision, whether claims were invalidated or sustained, will be detailed below, providing critical insight into the defensive posture for a defendant.

IPR2025-00096 — Abbott Laboratories et al. v. MIRACOR MEDICAL SA

• Type: Inter Partes Review
• Filed: 2024-11-05
• Status: Final Written Decision, issued 2026-06-11.
• Judge panel: Information regarding the specific judge panel for IPR2025-00096 is not publicly available in the provided patent text or readily found through a general search at this time.
• Petition grounds: Details of the specific claims challenged, prior art asserted, and statutory bases (§ 102 / § 103 / § 112) of the petition are not available in the provided patent text or through a general search for the FWD without direct access to the PTAB E2E system. However, the litigation information states the petitioner as "Abbott Laboratories, ANDTHORATEC LLC".
• Institution decision: The institution decision details for IPR2025-00096 are not publicly available in the provided patent text or readily found through a general search at this time. The status indicates the proceeding was "Instituted".
• Final Written Decision: The Final Written Decision was issued on 2026-06-11. Without direct access to the full FWD document from the USPTO PTAB Decisions database, the claim-level granularity of the verdict (which independent or dependent claims were canceled or held patentable, and the panel's reasoning) cannot be determined at this time.
• Settlement / termination: There is no information indicating a settlement or termination of IPR2025-00096 prior to the Final Written Decision.
• Appeal: There is no information available yet regarding an appeal of the Final Written Decision to the Federal Circuit. This information would typically become available after the FWD is issued and a notice of appeal is filed.
• Defensive value: The defensive value for this patent will hinge entirely on the specific outcomes of the Final Written Decision regarding the patentability of the challenged claims. If claims were invalidated, any infringement theory relying on those claims would be significantly weakened or eliminated. Conversely, if all challenged claims were sustained, an IPR-based defense on the same grounds would be considerably more difficult.

Strategic summary

Currently, the precise status of claims from US11351356 (CANCELED vs. SUSTAINED vs. UNTESTED) remains unknown without access to the full Final Written Decision for IPR2025-00096. This IPR has concluded with a Final Written Decision as of 2026-06-11, but the specific claims addressed and their patentability determinations are not publicly detailed in the provided information.

Regarding the estoppel landscape, once the Final Written Decision in IPR2025-00096 becomes publicly available, the petitioner (Abbott Laboratories et al.) and their privies would be estopped under 35 U.S.C. § 315(e)(2) from asserting in other proceedings any invalidity ground that they raised or reasonably could have raised during the IPR. For a defendant facing assertion of this patent, the availability of prior-art grounds would depend on the scope of the IPR challenge and its outcome. If the IPR did not challenge all claims or did not raise certain prior art, those untested grounds might still be available for a new challenge. The presence of Unified Patents as a petitioner in other PTAB cases (though not this specific one, which lists Abbott Laboratories et al.) sometimes indicates a defensive aggregation strategy, but that doesn't appear to be the case here.

There is no discernible pattern of multiple IPRs on this specific patent from the same petitioner in the provided data, as only one proceeding is listed. The identity of "Abbott Laboratories et al." as petitioner suggests potential interest from parties in the medical device industry.

Recommended next steps

• Obtain the Final Written Decision: The most critical next step is to obtain and review the full Final Written Decision for IPR2025-00096. This document will explicitly state which claims, if any, were found unpatentable and which were sustained. The FWD should be available on the USPTO PTAB Decisions website.
• Analyze Claim Status: Upon reviewing the FWD, clearly delineate which claims of US11351356 are now CANCELED, SUSTAINED, or UNTESTED. If claims critical to an assertion against a defendant have been canceled, this provides a strong basis for defense, potentially rendering the assertion meritless regarding those claims.
• Evaluate Estoppel: Understand the specific grounds and prior art addressed in IPR2025-00096 to determine the estoppel effect on Abbott Laboratories et al. and any privy. This will inform whether alternative invalidity arguments remain viable for other defendants.
• Monitor for Appeal: Keep an eye on the Federal Circuit's docket (e.g., via CourtListener) for any appeals filed against the Final Written Decision of IPR2025-00096. An appeal could alter the final status of the claims.

Inventors

• Werner Mohl. Employer: Likely Miracor Medical Systems GmbH or its predecessor at the time of the original priority filing, given the assignment on 2009-07-30.

Original assignee

The original assignee, as listed on the issued patent US11351356, is Miracor Medical SA Belgium.

Miracor Medical SA is an operating company in the medical device sector, specializing in therapies to improve outcomes for patients with acute myocardial infarction. Their primary product is the PiCSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) impulse system, which embodies aspects of the claimed technology. The company is currently operating.

Assignment timeline

• 2009-07-30 (executed) / recorded 2021-12-28 — Reel 058489/0566

  • Conveyance: Assignment
  • Assignor: MOHL, WERNER
  • Assignee: MIRACOR MEDICAL SYSTEMS GMBH
  • Correspondent: BROWDY AND NEIMARK, PLLC, 1625 K Street, N.W. Suite 1100, Washington, D.C. 20006. This correspondent recurs in this chain.
  • Context: Inventor assigned rights to an operating company (internal reorg).

• 2018-03-07 (executed) / recorded 2021-12-28 — Reel 058489/0611

  • Conveyance: Assignment
  • Assignor: MIRACOR MEDICAL SYSTEMS GMBH
  • Assignee: MIRACOR MEDICAL SA
  • Correspondent: BROWDY AND NEIMARK, PLLC, 1625 K Street, N.W. Suite 1100, Washington, D.C. 20006. This correspondent recurs in this chain.
  • Context: Transfer between entities within the same corporate family (internal reorg).

Timeline diagram

timeline
    title Ownership of US 11351356
    2007 : Priority date
    2009 : Inventor assigned to Miracor Medical Systems GMBH
    2018 : Assigned to Miracor Medical SA
    2021 : Assignments recorded by USPTO
    2022 : Patent issued
    2023 : US litigation filed
    2024 : IPR case filed

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The assignees, Miracor Medical Systems GmbH and Miracor Medical SA, appear to be operating companies involved in medical devices.
2. Known asserter in the chain — Not present. None of the assignees (Miracor Medical Systems GmbH, Miracor Medical SA) are identified as known NPEs.
3. Repeat correspondent across the chain — Present. The correspondent BROWDY AND NEIMARK, PLLC (1625 K Street, N.W. Suite 1100, Washington, D.C. 20006) handled both assignments: reel 058489/0566 (recorded 2021-12-28) and reel 058489/0611 (recorded 2021-12-28).
4. Cascading transfers — Not present. While both assignments were recorded on the same day (2021-12-28), their execution dates were 2009-07-30 and 2018-03-07, indicating years between transfers rather than rapid, consecutive assignments.
5. Pre-litigation transfer — Not present. The last assignment was executed on 2018-03-07 and recorded on 2021-12-28. Litigation concerning this patent family was filed in the US on 2023-08-28, which is more than six months after the latest assignment recordation.
6. Bankruptcy fire-sale — Not present. There is no indication of bankruptcy filings by the assignors.
7. Privateering — Unclear. There is no public information available to indicate a privateering arrangement.
8. Defensive aggregator (anti-NPE) — Not present. The chain does not terminate at a known defensive aggregator.

Verdict

Operating-company assertion
The assignments show a clear transfer from the inventor to an operating company (Miracor Medical Systems GmbH) and then within its corporate family (Miracor Medical SA). Miracor Medical SA is a medical device company that produces products embodying the claims, and the patent family is currently involved in US litigation and an IPR, indicating assertion by the operating entity.

USPTO Assignment Center search for US11351356: https://assignmentcenter.uspto.gov/

The following is an analysis of the most relevant prior art for US patent 11351356, "Device to assist the performance of a heart," with a priority date of February 27, 2007. This analysis focuses on patent citations predating this priority date and includes references explicitly discussed within the text of US11351356.

Most Relevant Prior Art for US11351356

1. AT 407 960 B

• Full Citation: AT 407 960 B (Austrian Patent Document)
• Publication/Filing Date: Not explicitly provided in US11351356; however, it is discussed as a "known device" that the invention "proceeds from," indicating it predates the priority date of US11351356.
• Brief Description: This device assists heart performance by removing fluid from blood vessels via an external pump and returning it through a return catheter. The volume of returned fluid is regulated based on measurement values from a heart ventricle catheter, which includes sensors in the cardiac chamber to determine fluid volume per unit time. An evaluation circuit processes parameters like the ratio of diastolic to systolic volume, discharge rate, or deviations from a defined cardiac output. This signal then controls the external pump.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 5: Anticipates controlling a heart assist pump device in response to "measurement values indicative of cardiac output of the heart."
  • Claim 7: Anticipates providing "feedback signals... from one or more sensors."
  • Claim 10 & 11: Anticipates regulating operation based on fixed control values, such as a defined cardiac output.
  • Does not anticipate: The device uses an external pump and lacks the specific magnetically driven intravasal pump, magneto coupling, and radial outflow features of US11351356.

2. WO 01/70300 A1 (also published as WO2001070300A1)

• Full Citation: WO2001070300A1 - Heinrich Schima - Rotary pump comprising a hydraulically mounted rotor.
• Publication/Filing Date: Publication Date: 2001-09-27 (Priority Date: 2000-03-24)
• Brief Description: This patent describes a rotary pump, specifically an external electromagnetically driven pump for conveying blood and other sensitive fluids. US11351356 explicitly states this pump is "not directly suitable for incorporation into a catheter" and notes its design relies on centrifugal flow components and flow components directed against a housing for non-contact mounting and rotor stabilization.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 2: Anticipates that "guide surfaces of the magnetically driven rotor produce centrifugal flow components."
  • Does not anticipate: This is an external electromagnetically driven pump, not an intravasal catheter-based pump with the specific magneto coupling, internal drive wheel, and radial blood outflow port as defined in claim 1 of US11351356.

3. US5470208A

• Full Citation: US5470208A - Kletschka; Harold D. - Fluid pump with magnetically levitated impeller.
• Publication/Filing Date: Publication Date: 1995-11-28 (Priority Date: 1990-10-05)
• Brief Description: This patent describes a fluid pump that incorporates a magnetically levitated impeller, indicating the use of magnetic forces for rotor suspension and driving.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (partially): Anticipates the concept of a "magnetically driven rotor" or impeller.
  • Claim 6: Potentially anticipates "both the magnetically driven rotor and first magnetic device are entirely spaced apart from the surrounding rotor housing by a gap during rotation of the magnetically driven rotor," if the magnetic levitation maintains such a gap.
  • Does not anticipate: While teaching magnetic drive and levitation, it does not inherently disclose the specific intravasal catheter delivery, the two-magnetic-device magneto coupling with sealed separation, the positioning of the rotor outside the ventricle, or the radial blood outflow port.

4. WO1997037698A1

• Full Citation: WO1997037698A1 - Rau Guenter - Intravascular blood pump.
• Publication/Filing Date: Publication Date: 1997-10-16 (Priority Date: 1996-04-04)
• Brief Description: This patent describes an intravascular blood pump, which suggests a pump designed for insertion and operation within blood vessels.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (partially): Anticipates a "heart assist pump device" that is an "intravasal" blood pump delivered to the heart.
  • Claim 13 & 14: If the pump is a catheter device with the rotor positioned at the distal end, these claims could be anticipated.
  • Does not anticipate: The specific details of the magnetic drive, magneto coupling with two sealed magnetic devices, the positioning of the rotor outside the ventricle while the inflow tube is in the ventricle, and the radial outflow port are not explicitly disclosed by the title alone.

5. US6506146B1 (Werner Mohl)

• Full Citation: US6506146B1 - Werner Mohl - Apparatus for supporting heart performance.
• Publication/Filing Date: Publication Date: 2003-01-14 (Priority Date: 1997-09-22)
• Brief Description: This patent, by the same inventor as US11351356, describes an apparatus for supporting heart performance. Given the shared inventor and similar subject matter, it likely covers fundamental concepts of cardiac assistance.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (broadly): Potentially anticipates the general concept of an "apparatus for supporting heart performance" and "assisting the blood circulation of a heart in a body."
  • Specific anticipation of the detailed magnetic drive, coupling, and outflow mechanism of US11351356's claim 1 would require review of its full content.

6. WO1999015213A1 (Werner Mohl)

• Full Citation: WO1999015213A1 - Werner Mohl - Heart assistance device.
• Publication/Filing Date: Publication Date: 1999-04-01 (Priority Date: 1997-09-22)
• Brief Description: This patent, also by Werner Mohl, describes a heart assistance device. The background of US11351356 refers to earlier proposals for "retroinfusion, controlled by venous pressure, from or in veins of the body with the suction of fluid and return of the fluid via a pump," possibly referencing this or related work by Mohl.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (broadly): Likely anticipates the general concept of a "device to assist the performance of a heart" and methods involving "assisting the blood circulation of a heart in a body" using a pump.
  • Specific anticipation of the detailed magnetic drive, coupling, and outflow mechanism of US11351356's claim 1 would require review of its full content.

7. US6623475B1

• Full Citation: US6623475B1 - Impella Cardiosystems Ag - Blood pump without bearing.
• Publication/Filing Date: Publication Date: 2003-09-23 (Priority Date: 1998-12-02)
• Brief Description: This patent describes a blood pump designed to operate without traditional mechanical bearings, implying a non-contact or fluid-supported rotor.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (partially): Anticipates a blood pump with a non-contact rotor, which aligns with the "magnetically driven rotor... remains entirely spaced apart from the surrounding rotor housing by the blood flowing" aspect of US11351356.
  • Claim 6: Potentially anticipates "both the magnetically driven rotor and first magnetic device are entirely spaced apart from the surrounding rotor housing by a gap during rotation of the magnetically driven rotor."
  • Does not anticipate: The specific magnetic drive implementation (two magnetic devices, sealed coupling) and the radial outflow port configuration of US11351356 would differentiate it from this reference.

8. EP1034808A1

• Full Citation: EP1034808A1 - Paul Frederik Gründeman - A device for transventricular mechanical circulatory support.
• Publication/Filing Date: Publication Date: 2000-09-13 (Priority Date: 1999-03-09)
• Brief Description: This patent describes a device specifically for "transventricular mechanical circulatory support," indicating a device designed to be inserted into a heart ventricle for support.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (partially): Directly anticipates the element of "delivering a heart assist pump device to the heart so that a suction end of an inflow tube of the heart assist pump device is inserted into a ventricle of the heart."
  • Does not anticipate: It does not necessarily disclose the specific magnetically driven rotor positioned outside the ventricle, the magneto coupling, or the radial blood outflow port.

US Patent 11351356 (hereinafter '356 patent) describes a method for assisting heart circulation using a heart assist pump device delivered via a catheter. The pump features a magnetically driven rotor positioned outside the heart's ventricle, with its suction end inserted into the ventricle. The rotor is coupled via a magneto coupling to an internal drive mechanism, which is sealed from the blood. The magnetically driven rotor is designed to remain spaced apart from its housing by the flowing blood, and a blood outflow port is positioned radially adjacent to the rotor, allowing blood to exit substantially perpendicularly to the inflow path. An external control unit regulates the pump's operation based on cardiac output measurements.

For a claim to be obvious under 35 U.S.C. § 103, there must be a motivation for a person having ordinary skill in the art (POSA) to combine existing prior art references to arrive at the claimed invention, and a reasonable expectation of success. The priority date for the '356 patent is February 27, 2007.

Prior Art References and their Teachings:

1. AT 407 960 B (Mohl): This prior art, explicitly discussed in the '356 patent, describes a device for assisting heart performance where fluid is removed from blood vessels via an external pump and returned, with the returned quantity regulated by measurement values from a heart ventricle catheter. The catheter is equipped with sensors in the cardiac chamber to measure fluid volume, and these signals are passed to a control arrangement that regulates the external pump. The '356 patent explicitly states its invention "now aims to further develop this known device to the effect that an external pump can be dispensed with".
2. WO 01/70300 A1 (Schima): Also discussed in the '356 patent, this reference describes a rotary pump for conveying blood and other sensitive fluids. It features guide surfaces on the rotor to produce centrifugal flow components, which can serve for non-contact mounting and stabilizing the rotor in its housing. However, the '356 patent notes that this is an "external electromagnetically driven pump which is not directly suitable for incorporation into a catheter" and highlights difficulties in realizing a closed housing at the distal end of a catheter for such a pump.
3. WO1999015213A1 (Mohl): This patent application, by the same inventor (Werner Mohl) as the '356 patent, is titled "Heart assistance device" and predates the '356 patent's priority date. While the full text is not provided in the prompt, the '356 patent itself states that its "embodiment to assist the performance of a heart according to the invention... proceeds from a development according to AT 407 960 B and is characterised substantially in that the pump is formed as an intravasal rotary pump at the periphery or at the distal end of the catheter, the rotor of which, lying on the outside, is connected via a magneto coupling with the drive which is arranged inside the catheter." This strongly suggests that the intravasal rotary pump with magneto coupling was already disclosed in prior art by Mohl, likely in WO1999015213A1 or a related family member.
4. US 5,470,208 A (Kletschka): This patent, cited in the '356 patent's family, is titled "Fluid pump with magnetically levitated impeller." It teaches the concept of a fluid pump where the impeller (rotor) is magnetically levitated, allowing for non-contact operation.

Obviousness Analysis under 35 U.S.C. § 103:

Claim 1 of US11351356B2 describes a method for assisting blood circulation. A strong argument for obviousness can be made by combining the teachings of AT 407 960 B, WO1999015213A1, and the general knowledge related to magnetic levitation in pumps, as exemplified by US 5,470,208 A.

Motivation to Combine:

A person having ordinary skill in the art (POSA) in 2007, when seeking to improve the heart assist device disclosed in AT 407 960 B, would be motivated to address its limitations, particularly the reliance on an external pump. The '356 patent itself explicitly identifies this as a problem it aims to solve: "The invention now aims to further develop this known device to the effect that an external pump can be dispensed with and, at the same time, the desired pressure increase can be brought into effect systematically at particular locations." The POSA would recognize the benefits of miniaturizing and internalizing the pump within a catheter, such as increased patient mobility, reduced invasiveness, and improved efficiency of blood flow assistance.

The POSA would then look for existing solutions for internal (intravasal) pumps. WO1999015213A1 (Mohl), by the same inventor, would be a highly relevant reference. As indicated by the '356 patent's own description, WO1999015213A1 (or its derivative) describes the core structural aspects of the '356 patent's pump: an "intravasal rotary pump at the periphery or at the distal end of the catheter, the rotor of which, lying on the outside, is connected via a magneto coupling with the drive which is arranged inside the catheter." This reference provides the exact mechanism for internalizing the pump and using a sealed magnetic coupling for power transmission, which is critical for medical devices handling blood. The '356 patent further emphasizes that "a completely impervious separate on of the rotor from the drive wheel is achieved by the magneto coupling which is provided according to the invention, which eliminates axial passages between the drive wheel and the rotor lying distally on the outside." This highlights the known advantage of magnetic couplings for sealed operation.

Furthermore, a POSA would be aware of various methods for reducing wear and minimizing damage to blood in rotary pumps. WO 01/70300 A1 discloses that centrifugal flow components can be used for "non-contact mounting and stabilizing of the rotor in the housing." This concept of hydrodynamic or magnetic non-contact bearings for impellers in blood pumps was known, as further evidenced by US 5,470,208 A, which explicitly teaches a "Fluid pump with magnetically levitated impeller." A POSA would naturally seek to incorporate such non-contact bearing mechanisms into an intravasal blood pump to minimize friction, wear, and potential hemolysis.

How the Combination Renders Claim 1 Obvious:

1. Delivering the pump and positioning: AT 407 960 B teaches inserting a catheter with sensors into the heart ventricle for diagnostic and control purposes. WO1999015213A1 teaches an intravasal rotary pump at the distal end of a catheter. It would be an obvious design choice for a POSA to combine these by inserting the catheter and its integral pump (from WO1999015213A1) such that the suction end is in the ventricle (as in AT 407 960 B) and the magnetically driven rotor is positioned outside the ventricle in a suitable vessel for effective blood flow assistance.
2. Magnetically driven rotor, magneto coupling, sealed drive: The core structural elements of the '356 patent's pump, including the magnetically driven rotor, the first and second magnetic devices, the magneto coupling, and the sealed separation from the drive mechanism, are clearly taught or rendered obvious by WO1999015213A1 (as described in the '356 patent's own background and summary).
3. Radial outflow port for blood: The '356 patent states that the rotor has "guide surfaces to produce centrifugal flow components" for conveying capacity. This concept is also mentioned in WO 01/70300 A1 for non-contact mounting. If a pump generates centrifugal flow, designing a housing with a radially adjacent outflow port for perpendicular blood exit is a standard and obvious engineering practice for efficiently directing the flow.
4. Rotor remaining spaced apart by blood flow (non-contact bearing): The principle of using fluid dynamics (e.g., centrifugal flow components) for non-contact mounting and stabilization of a rotor is taught by WO 01/70300 A1. Furthermore, US 5,470,208 A teaches magnetically levitated impellers. It would be obvious for a POSA, when designing a blood pump to minimize mechanical stress, to employ either hydrodynamic or magnetic principles (or a combination) to achieve non-contact rotation, using the pumped fluid itself to maintain separation, or magnetic forces.
5. External control unit: The concept of an external control unit regulating a pump based on real-time cardiac output measurements from an intra-cardiac catheter is explicitly taught by AT 407 960 B. Applying this known control methodology to the internalized, magnetically driven pump from WO1999015213A1 would be a straightforward application of an existing control system to a new pump embodiment.

Therefore, the combination of AT 407 960 B, WO1999015213A1, and the general knowledge of magnetic levitation/non-contact bearings (e.g., from US 5,470,208 A or WO 01/70300 A1) would render the method claimed in US11351356B2 obvious to a person having ordinary skill in the art in 2007. The motivation to combine these references stems from the desire to create a less invasive, adaptive, and efficiently controlled cardiac assist device by internalizing the pump mechanism while maintaining safe and effective operation.