Medtronic Inc v. Teleflex Life Sciences Ltd

1. Case Identification

• Case #: IPR2020-01344
• Patent #: RE46,116
• Filed: July 31, 2020
• Petitioner(s): Medtronic, Inc., and Medtronic Vascular, Inc.
• Patent Owner(s): Teleflex Innovations S.À.R.L.
• Challenged Claims: 25-55

2. Patent Overview

• Title: Coaxial Guide Catheter for Interventional Cardiology Procedures
• Brief Description: The ’116 patent describes a catheter system for interventional cardiology procedures, comprising an outer guide catheter and an inner guide extension catheter. The system is designed to provide enhanced "backup support" to prevent the guide catheter from dislodging from a coronary artery's ostium during a procedure.

3. Grounds for Unpatentability

Ground 1: Obviousness over Kontos and Ressemann - Claims 52-53 are obvious over Kontos in view of Ressemann and the knowledge of a POSITA.

• Prior Art Relied Upon: Kontos (Patent 5,439,445) and Ressemann (Patent 7,604,612).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Kontos disclosed a guide extension catheter (support catheter assembly 10) with a distal tubular structure and a proximal "substantially rigid segment" (wire 14), which is advanced through a guide catheter to provide support. However, Kontos did not explicitly teach a side opening for receiving a treatment catheter. Ressemann allegedly cured this deficiency by teaching an extension catheter with an angled side opening to facilitate the entry of therapeutic devices. The combination of Kontos's catheter structure with Ressemann's side opening allegedly rendered the method claims obvious.
  • Motivation to Combine: A POSITA would combine Ressemann's side opening with Kontos's catheter for several predictable benefits. These included: facilitating smoother entry of interventional devices compared to Kontos's flared funnel; allowing for a reduction in the guide catheter's outer diameter without a commensurate reduction in the entry point for the therapy catheter; enabling smoother passage through tortuous vasculature; and permitting easier re-entry into the guide catheter if the extension catheter was advanced beyond it.
  • Expectation of Success: Petitioner asserted that employing Ressemann's well-known side opening with the Kontos device was a simple substitution of a known element to obtain predictable results, requiring no invention.

Ground 2: Obviousness over Kontos, Ressemann, and Takahashi - Claims 25-40, 42, and 44-48 are obvious over Kontos in view of Ressemann, Takahashi, and the knowledge of a POSITA.

• Prior Art Relied Upon: Kontos (Patent 5,439,445), Ressemann (Patent 7,604,612), and Takahashi (a 2004 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the Kontos and Ressemann combination from Ground 1 to address additional claim limitations. Specifically, for claim 25's limitation requiring the extension catheter's inner diameter to be "not more than one French size smaller" than the guide catheter's lumen, Petitioner relied on Takahashi. Takahashi described a "five-in-six system" (a 5 French catheter inside a 6 French catheter) to increase backup support, thereby teaching the claimed dimensional relationship.
  • Motivation to Combine: A POSITA would combine the teachings of Takahashi with the Kontos-Ressemann catheter to achieve improved backup support, a recognized benefit of maintaining a close tolerance between the inner and outer catheters. The motivations for the Kontos and Ressemann combination remained the same as in Ground 1.
  • Expectation of Success: Petitioner contended that modifying catheter dimensions to achieve the claimed "not-more-than-one-French" differential was well within the ordinary skill of a POSITA, as appropriately sized catheters were ubiquitous in the art.

Ground 3: Obviousness over Root - Claims 25-55 are obvious over Root and the knowledge of a POSITA.

• Prior Art Relied Upon: Root (Application # 2007/0260219).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the challenged claims were not entitled to their earliest priority date of May 3, 2006, making Root (published in 2007 from a May 3, 2006 filing) valid prior art. Petitioner asserted that the Patent Owner admitted during prosecution that Root taught nearly every limitation of the claims. The key distinction was that the patent's original specification and Root only disclosed a side opening located within the substantially rigid segment of the catheter. The challenged claims, however, recite the side opening as a separate segment distinct from the rigid portion.
  • Motivation to Combine: A POSITA would modify Root to place the side opening in a non-rigid material outside of the substantially rigid segment. The motivation stemmed from a known problem with the Patent Owner's commercial product (GuideLiner), where the metal collar forming the side opening could damage stents during delivery. A POSITA would have sought to eliminate this risk by constructing the side opening from a softer material, a known and simple design modification.
  • Expectation of Success: Petitioner argued success was expected because side openings outside of rigid segments were known in the art, making the modification a routine design choice to solve a known problem.
• Additional Grounds: Petitioner asserted two additional obviousness challenges: Ground III argued claim 45 is obvious over Kontos, Ressemann, Takahashi, and Kataishi (Application # 2005/0015073) to teach a side opening with two inclined slopes. Ground V argued claims 45-46 are obvious over Kontos, Ressemann, Takahashi, and Root, using Root to teach the two-incline, more rigid side opening.

4. Key Claim Construction Positions

• "flexural modulus": Petitioner proposed this term had an established meaning by 2006 as "a measure of resistance ... to bending," or a measure of a device's rigidity. This construction was argued to be consistent with the ’116 patent's disclosure of a catheter with decreasing flexibility (and increasing flexural moduli) from the distal to proximal end.
• District Court Constructions: Petitioner agreed, for purposes of the IPR, with prior district court constructions for "substantially rigid" ("rigid enough to allow the device to be advanced within the guide catheter"), "side opening" (plain and ordinary meaning), and "lumen" ("the cavity of a tube").

5. Key Technical Contentions (Beyond Claim Construction)

• Priority Date Entitlement: A central contention was that the challenged claims are not entitled to the May 3, 2006 priority date. Petitioner argued the claims require a "segment defining a side opening" that is structurally separate and distinct from the "substantially rigid segment." However, all specifications in the priority chain allegedly disclose the side opening only within the substantially rigid segment. Petitioner asserted that this lack of written description support meant the effective filing date for these claims was no earlier than January 26, 2012, which rendered Root available as prior art.

6. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise discretionary denial under §314(a) based on the Fintiv factors. The core reasons were that the parallel district court litigation was stayed pending resolution of related IPRs, making a final written decision likely to issue before a trial. Petitioner also asserted it acted diligently, filing the petition five months after the Patent Owner asserted the ’116 patent, and that there was minimal overlap between the 30 claims challenged in the IPR and the single claim asserted in the district court.

7. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 25-55 of the ’116 patent as unpatentable.