Axonics Modulation Technologies Inc v. Medtronic Inc

1. Case Identification

• Case #: IPR2020-00679
• Patent #: 8,626,314
• Filed: March 16, 2020
• Petitioner(s): Axonics Modulation Technologies, Inc.
• Patent Owner(s): Medtronic, Inc.
• Challenged Claims: 1, 2, 4, 7, 10-12, 14, 18-24

2. Patent Overview

• Title: Implantable Medical Electrical Lead
• Brief Description: The 8,626,314 patent is directed to an implantable medical electrical lead and methods for its implantation, particularly for stimulating sacral nerves. The invention describes a lead with a plurality of electrodes at its distal end and an anchoring mechanism comprising a plurality of tine elements located between the electrodes and the proximal end of the lead body to prevent migration.

3. Grounds for Unpatentability

Ground 1: Claims 1, 2, 4, 7, 10-12, 14, 18-24 are obvious over Young, Gerber, and Lindegren.

• Prior Art Relied Upon: Young (a 1995 journal article on trigeminal nerve stimulation), Gerber (Patent 6,055,456), and Lindegren (WO 98/20933).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Young taught a Medtronic tined lead for chronic pain treatment, comprising a single electrode and two sets of four tines to prevent dislodgement. To improve upon Young’s single-electrode design, a person of ordinary skill in the art (POSITA) would have looked to references like Gerber, which explicitly taught multi-electrode leads for sacral nerve stimulation with an anchoring mechanism located proximal to the electrodes. Gerber disclosed the exact positioning of the anchoring mechanism that was a key basis for allowance of the ’314 patent. Lindegren was cited for teaching a preferable manufacturing method where tines are mounted on a ring-shaped means, made of an elastic material like silicone rubber.
  • Motivation to Combine: A POSITA would combine these references because they are all in the analogous art of neurostimulation and address the common problem of lead migration. Young expressly suggested that its single-electrode lead could be improved by providing multiple stimulation sites. This would motivate a POSITA to incorporate the multiple electrodes taught by Gerber. To improve fixation and manufacturability, the POSITA would have found it obvious to use Lindegren’s ring-mounted tines on the combined Young/Gerber lead.
  • Expectation of Success: Success was expected because the combination involved replacing components with known alternatives to achieve predictable results, such as adding more electrodes for better stimulation flexibility and using a known tine configuration for reliable anchoring.

Ground 2: Claims 18, 20, and 21 are obvious over Young, Gerber, and Lindegren in view of Hauser.

• Prior Art Relied Upon: Young (a 1995 journal article), Gerber (Patent 6,055,456), Lindegren (WO 98/20933), and Hauser (Patent 5,052,407).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground supplemented the combination of Ground 1 with Hauser to more explicitly teach the method steps of claims 18, 20, and 21. Petitioner argued that to the extent Young did not fully detail the method of withdrawing an introducer to deploy fixation tines, Hauser provided the missing teaching. Hauser disclosed a non-invasive implantation method using a catheter (introducer) where proximal tines remain constrained within the catheter until it is withdrawn, at which point the tines deploy to anchor the lead.
  • Motivation to Combine: A POSITA, having conceived of the lead in Ground 1, would have been motivated to consult Hauser for established, simplified implantation methods. Hauser is in the same field, addresses problems of major surgery for lead placement, and describes similar techniques using a catheter and stylet. A POSITA would have found it a simple application of a known technique to use Hauser's method of introducer withdrawal to deploy the tines of the lead from the primary combination.
  • Expectation of Success: There was a high expectation of success in applying Hauser’s well-defined implantation and deployment method to the analogous lead structure of the primary combination.

Ground 3: Claims 1, 2, 4, 7, 10-12, 14, 18-24 are obvious over Gerber in view of Hauser and Akerstrom.

• Prior Art Relied Upon: Gerber (Patent 6,055,456), Hauser (Patent 5,052,407), and Akerstrom (Patent 4,407,303).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground presented an alternative combination starting with Gerber as the base reference. Gerber taught a multi-electrode lead for sacral nerve stimulation with a proximal anchoring mechanism that fixes by fibrosis. Petitioner argued a POSITA would replace Gerber’s generic anchoring mechanism with well-known tined anchors, as taught by Hauser, which disclosed multiple sets of tines for fixation. Furthermore, a POSITA would have arranged these tines using the design taught by Akerstrom. Akerstrom taught mounting anchoring loops (which function like tines) on separate, spaced-apart collars, which allows for a smaller profile during insertion and prevents overlapping.
  • Motivation to Combine: The motivation arose from improving Gerber’s lead. A POSITA would have considered tines (from Hauser) as a leading candidate for a fibrosis-based anchor. To optimize the tined anchor design for percutaneous delivery, a POSITA would have adopted Akerstrom’s collar-based arrangement. This arrangement makes the tines easily manufacturable and ensures they fold neatly without overlapping, which is advantageous for insertion through an introducer.
  • Expectation of Success: The combination was presented as a highly feasible and predictable modification, as it involved combining simple, known mechanical elements (tines, collars) to improve anchoring in a well-understood application.

4. Key Claim Construction Positions

• Petitioner argued that the claim term "a plurality of tine elements" requires a construction of "two or more structures that mount to the lead body, each structure comprising of multiple tines attached to the structure." This construction was based on the patent's consistent use of "plurality" to mean two or more and its description of tine elements as distinct structures. Petitioner asserted this construction is critical because it precludes interpreting the claims as covering a single, integrated tine structure, thereby aligning the claim scope with what is allegedly taught by the prior art combinations.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate. The petition asserted that the primary references relied upon—Young, Hauser, and Lindegren—were never considered by the Examiner during the original prosecution. While Gerber and Akerstrom were submitted in an Information Disclosure Statement (IDS), they were never substantively discussed or applied in a rejection. Therefore, the combinations of prior art and the associated arguments were presented as being new and not substantially the same as those previously before the U.S. Patent and Trademark Office.

6. Relief Requested

• Petitioner requests the institution of an inter partes review and the cancellation of claims 1, 2, 4, 7, 10-12, 14, and 18-24 of Patent 8,626,314 as unpatentable under 35 U.S.C. §103.