Medtronic Inc v. Teleflex Life Sciences Ltd

1. Case Identification

• Case #: IPR2020-01342
• Patent #: 8,142,413
• Filed: July 30, 2020
• Petitioner(s): Medtronic, Inc., and Medtronic Vascular, Inc.
• Patent Owner(s): Teleflex Innovations S.À.R.L.
• Challenged Claims: 1-2, 4-5, and 7-14

2. Patent Overview

• Title: Coaxial Guide Catheter for Interventional Cardiology Procedures
• Brief Description: The ’413 patent discloses a method and apparatus for providing backup support during interventional cardiology procedures. The system uses a "coaxial guide catheter" (also known as a "child" or extension catheter) that is inserted through a "standard guide catheter" ("mother" catheter) and extends deeper into a coronary artery to prevent the guide catheter from dislodging from the artery's ostium. The invention focuses on a coaxial catheter design comprising a long, substantially rigid pushrod coupled to a short, flexible distal tubular structure.

3. Grounds for Unpatentability

Ground 1: Obviousness over Kontos and Adams - Claims 1-2, 4-5, 7-12, and 14 are obvious over Kontos in view of Adams and/or the knowledge of a POSITA.

• Prior Art Relied Upon: Kontos (Patent 5,439,445) and Adams (Application # 2004/0010280).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Kontos discloses the core of the claimed invention: a "mother-and-child" support catheter assembly for providing backup support. Kontos’s device includes a short, flexible tubular body (the claimed "flexible tip portion") coupled to a long manipulation wire (the claimed "substantially rigid portion"). This assembly is inserted through a guide catheter to extend into a coronary artery. Petitioner contended that Adams, which discloses a similar catheter system, provides any missing details. For example, Adams teaches using a guide catheter with a circular cross-section, attaching a hemostatic valve, and sizing the catheter lumens to accommodate various interventional devices (stents, balloon catheters, etc.). Petitioner mapped how specific limitations in dependent claims, such as adding a side opening (claim 4) or reinforcing the catheter (claims 11-12), are also taught or made obvious by Adams.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine the teachings of Kontos and Adams to achieve predictable improvements. For example, a POSITA would modify the Kontos device to include a hemostatic valve as taught by Adams and general knowledge to prevent blood loss. A POSITA would also be motivated to incorporate Adams’s teachings on side openings to create a smoother transition for interventional devices, reducing the risk of snagging, and to modify catheter dimensions to accommodate a wider range of tools, a common goal in the field.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success in combining these elements. The proposed modifications involved the application of known techniques (e.g., adding standard components like valves, changing catheter shapes) to a known type of device to achieve well-understood and predictable results, such as improved safety, device compatibility, and smoother operation.

Ground 2: Obviousness over Kontos, Adams, and Takahashi - Claim 13 is obvious over Kontos in view of Adams and Takahashi.

• Prior Art Relied Upon: Kontos (Patent 5,439,445), Adams (Application # 2004/0010280), and Takahashi (a 2004 journal article titled "New Method to Increase a Backup Support of a 6 French Guiding Coronary Catheter").
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addresses dependent claim 13, which requires the inner diameter of the coaxial catheter's lumen to be "not more than one French smaller" than the inner diameter of the guide catheter. While Kontos and Adams provide the foundational catheter system, Petitioner argued that Takahashi explicitly teaches this specific dimensional relationship. Takahashi describes a "five-in-six" system—inserting a 5 French catheter into a 6 French catheter—to improve backup support, which meets the "not-more-than-one French" limitation.
  • Motivation to Combine: A POSITA would be motivated to modify the Kontos/Adams catheter system to incorporate the specific sizing taught by Takahashi to achieve Takahashi’s stated benefit of improved backup support. This modification directly addresses the problem of providing robust anchoring for the guide catheter, which is the central purpose of both the ’413 patent and the prior art references.
  • Expectation of Success: Implementing the specific size differential taught by Takahashi in the Kontos/Adams system was a simple design choice. A POSITA would have expected it to work predictably, as appropriately sized catheters were ubiquitous, and Takahashi had already demonstrated the success of this "five-in-six" approach.

4. Key Claim Construction Positions

• "interventional cardiology device(s)": Petitioner argued that this term, based on its plain meaning and usage, requires the catheter to be adapted to pass at least one (for singular "device") or two (for plural "devices") types of instruments from the exemplary list (e.g., guidewires, balloon catheters), but not necessarily all of them. This counters a potential argument that the claims require compatibility with all enumerated device types.
• "standard guide catheter": Petitioner contended this term does not refer to a catheter with specific, narrow parameters but means "one of a variety of catheters used to guide devices or smaller catheters from the site of insertion into the coronary vasculature."
• "placed in a branch artery": Citing the patent’s specification and figures, Petitioner argued that this phrase includes placement within the ostium of a coronary artery, where it branches from a larger artery like the aorta.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise its discretion to deny institution under §314(a) based on the Fintiv factors. The key reasons asserted were that the parallel district court litigation had been stayed pending the outcome of related IPRs, the IPR petition was filed diligently after the Patent Owner first asserted the ’413 patent, and the IPR challenges a broader set of claims than those asserted in the litigation.
• Petitioner also argued against denial under §325(d), noting that the primary reference, Kontos, and the proposed combinations were never considered by the Examiner during the original prosecution of the ’413 patent.

6. Relief Requested

• Petitioner requested that the Board institute an inter partes review and cancel claims 1-2, 4-5, and 7-14 of the ’413 patent as unpatentable.