Medtronic, Inc. v. Niazi Licensing Corporation

1. Case Identification

• Patent #: 6,638,268
• Filed: February 12, 2018
• Petitioner(s): Medtronic, Inc.
• Patent Owner(s): Niazi Licensing Corporation
• Challenged Claims: 1, 10-14, 18, 19, and 23-26

2. Patent Overview

• Title: Catheters for Introducing Pacing Leads
• Brief Description: The ’268 patent relates to methods and apparatus for placing an electrical lead into a lateral branch of a coronary sinus vein. The core technology involves a "double catheter" system, comprising an outer catheter and a slidably disposed inner catheter, designed to navigate the cardiac vasculature to deliver the lead.

3. Grounds for Unpatentability

Ground 1: Claims 12 and 24 are obvious over Auricchio in view of Randolph

• Prior Art Relied Upon: Auricchio (Patent 5,935,160) and Randolph (Patent 5,775,327).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Auricchio taught a method for placing a coronary pacing lead using a double catheter system comprising an outer guide catheter and an inner, pliable support catheter. This system taught most limitations of the challenged claims, including inserting the catheter system into the coronary sinus, advancing a guidewire, and advancing the inner catheter over the guidewire into a branch vein. However, Petitioner contended Auricchio did not explicitly disclose adjusting the catheter’s curvature. Randolph was introduced to teach this missing element, disclosing a guiding catheter for accessing the coronary sinus with a shapeable distal section, including hook-shaped curves, and control lines for deflecting the catheter after insertion.
  • Motivation to Combine: Petitioner asserted a person of ordinary skill in the art (POSITA) would have been motivated to combine the references because both relate to catheters for delivering devices into a branch vein of the coronary sinus. A POSITA would have considered Randolph's complementary teachings on steerable catheters when designing an improved delivery system for LV lead placement. Applying the known technique of a deflectable catheter from Randolph to Auricchio’s system would have been an obvious way to assist with navigating complex anatomy and locating the coronary sinus ostium.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success, as combining the two would involve the application of a known technique (steerable catheters) to improve a similar device (Auricchio’s catheter) to achieve more efficient lead placement.

Ground 2: Claims 13, 14, 18, 19, 23, 25, and 26 are obvious over Auricchio, Randolph, and Payne

• Prior Art Relied Upon: Auricchio (Patent 5,935,160), Randolph (Patent 5,775,327), and Payne (WO 99/49773).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds on the combination of Auricchio and Randolph to address claims requiring specific bend angles in the outer catheter's hook-shaped distal end (e.g., a first bend of 130°-180°, a second bend of 75°-100°). While Randolph taught hook-shaped catheters, it did not explicitly disclose these angle ranges. Petitioner argued Payne taught a delivery catheter system with a preformed, J-shaped distal end having multiple bends with angle ranges that overlap the claimed ranges (e.g., 95°-165° and 90°-160°). Petitioner asserted this overlap created a presumption of obviousness. For claims requiring a hemostatic valve, Payne was also cited for disclosing such a valve to prevent blood leakage.
  • Motivation to Combine: Petitioner argued a POSITA would have been motivated to incorporate Payne’s teachings because all three references address catheter systems for cardiac procedures. A POSITA seeking to optimize the catheter shape of the Auricchio/Randolph combination would have looked to known shapes like that in Payne, which was designed for navigating the heart. The use of pre-formed shapes to match anatomical pathways was a well-known design choice. Adding Payne's hemostatic valve was argued to be an obvious improvement to minimize blood loss, a common objective in such procedures.
  • Expectation of Success: The combination was presented as a predictable substitution of known elements. A POSITA would have expected success in modifying the shape of the Auricchio/Randolph catheter with the specific, known bend angles from Payne to create a catheter better suited for coronary sinus cannulation.

Ground 3: Claims 1 and 10 are obvious over Lurie and Ockuly

• Prior Art Relied Upon: Lurie (Patent 6,277,107) and Ockuly (Patent 5,833,673).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground challenges claims reciting a "double catheter" with a mechanism for changing the outer catheter's curvature. Petitioner argued Lurie disclosed an outer, resilient, hook-shaped guide catheter for cannulating the coronary sinus. Lurie itself suggested that its stiffness could be enhanced by inserting a dilator or shaped catheter. Ockuly was introduced as teaching a telescoping system with an inner guiding introducer that is longer than the outer one and can be extended from its distal end to form various curves and shapes. Petitioner argued that inserting Ockuly’s inner catheter into Lurie’s outer catheter would function as the claimed "mechanism for changing the curvature," satisfying the claim limitation.
  • Motivation to Combine: Petitioner asserted that Lurie's own disclosure—acknowledging the difficulty of coronary sinus access and suggesting the use of an inner catheter to enhance stiffness—would directly motivate a POSITA to look to references like Ockuly that taught advanced telescoping systems. Both references describe introducers for cardiac procedures, and combining them would be a simple substitution of Ockuly’s inner introducer for the basic "shaped catheter" suggested by Lurie. This would predictably improve Lurie's device by providing steerability and eliminating the need to exchange tools.
  • Expectation of Success: A POSITA would have reasonably expected that combining the systems would be successful, as it involved using a known telescoping technique (from Ockuly) to solve a problem expressly identified in the primary reference (Lurie).

• Additional Grounds: Petitioner asserted an obviousness challenge to claim 11 based on Auricchio alone. Petitioner also asserted an additional obviousness challenge to claims 1 and 10 based on the combination of Lurie, Ockuly, and Blanc (a 1998 article), where Blanc was used to explicitly teach the use of contrast media, a feature Petitioner argued was already obvious.

4. Key Claim Construction Positions

• "mechanism ... for changing the curvature": Petitioner argued this term in claims 1 and 23 is a means-plus-function term under §112, para. 6. The claimed function is "changing the curvature of the distal end of the outer catheter." Petitioner identified three corresponding structures from the specification: (1) a torque screw with a pull wire, (2) an inner guide, or (3) an inner guide combined with an obturator. This construction is central to the argument that the prior art's inner catheters (e.g., from Ockuly) meet the limitation.
• "sufficient stiffness to permit advancement...": Petitioner contended this phrase in the preamble of claim 24 is non-limiting. It was argued that the phrase merely states an intended use and is not necessary to give life, meaning, or vitality to the claim, as the body of the claim intrinsically sets forth the complete invention.

5. Relief Requested

• Petitioner requests institution of inter partes review and cancellation of claims 1, 10-14, 18, 19, and 23-26 of the ’268 patent as unpatentable.