Medtronic CoreValve LLC v. Speyside Medical LLC

1. Case Identification

• Case #: IPR2021-00244
• Patent #: 9,603,708
• Filed: January 20, 2021
• Petitioner(s): Medtronic Corevalve LLC and Medtronic, Inc.
• Patent Owner(s): Speyside Medical, LLC
• Challenged Claims: 21-22

2. Patent Overview

• Title: Delivery Catheter for Cardiovascular Prosthetic Implant and Associated Method
• Brief Description: The ’708 patent discloses a method and device for the minimally invasive, transluminal deployment of a cardiovascular prosthetic implant. The invention focuses on combining a small delivery catheter (18 French or less in diameter) with a natural tissue valve whose leaflets have a thickness of at least about 0.011 inches.

3. Grounds for Unpatentability

Ground 1: Obviousness over Salahieh in view of Sands - Claims 21-22 are obvious over Salahieh in view of Sands.

• Prior Art Relied Upon: Salahieh (Patent 7,381,219) and Sands (an article titled "An Anatomical Comparison of Human, Pig, Calf, and Sheep Aortic Valves" published in Nov. 1969).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Salahieh disclosed all elements of the challenged claims except for the specific leaflet thickness. Salahieh taught a system for endovascularly deploying a prosthetic heart valve made from "biologic tissues, e.g. porcine valve leaflets," using a delivery catheter with a diameter of "no more than 17 french," which is less than the claimed 18 French. Sands, a study on donor valves, disclosed that optimal porcine aortic valve heterografts have leaflet thicknesses between 0.0276 and 0.0315 inches, satisfying the claimed limitation of "at least about 0.011 inches."
  • Motivation to Combine: A POSITA would combine these references to optimize the valve in Salahieh for human implantation. Since Salahieh taught using porcine leaflets but did not specify their thickness, a POSITA would have consulted the known art, such as Sands, to determine the optimal, functionally durable thickness for such leaflets, which was a known design parameter.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because both references related to porcine valves for human use, and applying a known optimal thickness to a valve system was a predictable and straightforward design choice.

Ground 2: Obviousness over Leonhardt in view of Sands - Claims 21-22 are obvious over Leonhardt in view of Sands.

• Prior Art Relied Upon: Leonhardt (Patent 5,957,949) and Sands (Nov. 1969 article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Leonhardt disclosed a system for percutaneously delivering an artificial heart valve comprising a biological porcine valve. The system used a deployment catheter with a diameter ranging from 12 to 20 French, which overlaps with and teaches the claimed "18 French or less" limitation. Like Salahieh, Leonhardt did not specify the leaflet thickness. Sands provided the missing element by teaching that suitable porcine valve leaflets have a thickness well above 0.011 inches.
  • Motivation to Combine: The motivation was similar to Ground 1. A POSITA implementing Leonhardt's system would need to select a porcine valve with appropriate characteristics. Sands provided the necessary, well-known data on optimal leaflet thickness to ensure the durability of the valve, making it an obvious reference to consult for this missing design parameter.
  • Expectation of Success: Success was expected because Leonhardt already taught using porcine valves for catheter-based delivery, and Sands merely provided a known, optimal dimension for the leaflets of such valves to ensure their function and durability.

Ground 3: Obviousness over Grube in view of Nguyen - Claims 21-22 are obvious over Grube in view of Nguyen.

• Prior Art Relied Upon: Grube (a 2007 journal article) and Nguyen (Application # 2006/0259136).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground was argued under the Patent Owner's broader claim construction where "natural tissue" includes pericardium. Petitioner argued Grube disclosed the clinical use of the third-generation CoreValve device, which was delivered percutaneously using an 18-French catheter. The valve was a bioprosthesis made from porcine pericardial tissue. Grube did not specify the leaflet thickness. Nguyen, which is assigned to CoreValve and described the same device, explicitly taught that the leaflets are formed from porcine pericardium and have a preferred thickness between 0.012 and 0.014 inches, meeting the claim limitation.
  • Motivation to Combine: A POSITA would immediately understand that Grube and Nguyen described the same CoreValve system. Grube discussed the clinical outcomes of the device, while Nguyen provided the underlying design and manufacturing details. Therefore, a POSITA would combine their teachings as a matter of course to get a complete picture of the device, including the specific leaflet thickness taught in Nguyen.
  • Expectation of Success: The expectation of success was exceptionally high, as the references were directed to the very same commercial product.

Ground 4: Obviousness over Salahieh in view of Nguyen - Claims 21-22 are obvious over Salahieh in view of Nguyen.

• Prior Art Relied Upon: Salahieh (Patent 7,381,219) and Nguyen (Application # 2006/0259136).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground also relied on the broader claim construction. Salahieh taught a delivery system using a sub-18 French catheter for a valve made of biologic tissues, including bovine or equine pericardium. Nguyen taught that pericardial leaflets with a thickness of 0.012-0.014 inches advantageously allow for a "smaller delivery profile."
  • Motivation to Combine: A POSITA would combine the references to create an improved, more compact delivery system. A POSITA would be motivated to apply Nguyen's teachings on optimal pericardial leaflet thickness to Salahieh's system to achieve the known benefit of better compressibility and a smaller profile, which is particularly advantageous for the small-diameter catheter taught by Salahieh.
  • Expectation of Success: Success was expected because combining a known material thickness (from Nguyen) that enables compaction with a small-bore delivery system (from Salahieh) was a predictable application of known technologies to achieve an expected result.

4. Key Claim Construction Positions

• Petitioner argued that the key disputed term, “natural tissue valve comprising a leaflets having a thickness of at least about 0.011 inches,” should be construed narrowly to require leaflets harvested from a natural mammalian donor valve.
• However, to preemptively address the Patent Owner’s anticipated broader construction (which includes leaflets formed from other biological tissue like pericardium), Petitioner presented invalidity grounds under both interpretations. Grounds 1 and 2 addressed the narrow construction, while Grounds 3 and 4 addressed the broader construction.

5. Arguments Regarding Discretionary Denial

• §325(d) (Same or Substantially Same Art/Arguments): Petitioner argued against denial, stating that the art and arguments were new and non-cumulative. Specifically, the Examiner never considered Grube, Nguyen, Leonhardt, or Sands during prosecution. While the Examiner considered other art for small catheters, it never considered any reference or combination that taught both a catheter of 18 French or less and a natural tissue valve with leaflets at least 0.011 inches thick.
• §314(a) (Fintiv Factors): Petitioner argued against discretionary denial based on a co-pending district court case. It asserted that the court case was in its early stages, with a trial date more than three months after the projected Final Written Decision (FWD) in the IPR. Furthermore, no substantive orders or claim construction had occurred in the litigation, and Petitioner intended to seek a stay pending the IPR outcome.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 21 and 22 of the ’708 patent as unpatentable.