Avation Medical Inc v. EMKinetics Inc

1. Case Identification

• Case #: IPR2024-01375
• Patent #: 11,224,742
• Filed: September 3, 2024
• Petitioner(s): Avation Medical, Inc.
• Patent Owner(s): EMKinetics, Inc.
• Challenged Claims: 1-13

2. Patent Overview

• Title: Method of Treating Overactive Bladder or Incontinence
• Brief Description: The ’742 patent discloses methods for treating overactive bladder (OAB) or incontinence using non-invasive transdermal electrical stimulation. The core inventive concept purports to be the direct targeting and stimulation of a branch of the posterior tibial nerve (PTN), rather than the main nerve trunk.

3. Grounds for Unpatentability

Ground 1: Claims 1-13 are obvious over Svihra in view of Mann, Ponsford, and the knowledge of a POSA.

• Prior Art Relied Upon: Svihra (a 2002 journal article), Mann (Patent 6,941,171), and Ponsford (a 1988 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Svihra taught a method of treating OAB using non-invasive electrical stimulation applied via surface electrodes placed behind the ankle to target the PTN. Petitioner contended the only material difference between Svihra and independent claim 1 of the ’742 patent is the claim’s requirement to directly target and stimulate a branch of the PTN. The dependent claims were argued to add only conventional elements, such as using an electrode patch (claim 2) or detecting muscular response (claim 3).
  • Motivation to Combine: Petitioner argued a person of ordinary skill in the art (POSA) would combine Svihra’s method with the teachings of Mann and Ponsford. Mann taught that stimulating specific nerve branches emanating from the sacral nerve roots (which include the PTN and its branches) could offer advantages, such as avoiding the recruitment of unintended nerves. Ponsford taught specific and reliable techniques for directly targeting and stimulating PTN branches, such as the medial and lateral plantar nerves, by placing electrodes on the sole of the foot. Therefore, a POSA would have been motivated to modify Svihra’s method to target a PTN branch to achieve more selective stimulation and enhance patient convenience by using a more discrete electrode location.
  • Expectation of Success: A POSA would have had a high expectation of success because the prior art established that stimulating the PTN or its branches produced similar therapeutic effects. Ponsford confirmed that signals from stimulating the branches travel "upstream" to the PTN, and the modification involved merely relocating a known type of electrode to a known anatomical location using established techniques.

Ground 2: Claims 1-13 are obvious over Amarenco in view of Mann, Ponsford, and the knowledge of a POSA.

• Prior Art Relied Upon: Amarenco (a 2003 journal article), Mann (Patent 6,941,171), and Ponsford (a 1988 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner presented this ground as structurally similar to Ground 1. Amarenco, like Svihra, disclosed a non-invasive method for treating OAB symptoms by stimulating the PTN using a self-adhesive surface electrode placed on the skin behind the ankle. Petitioner asserted that this base teaching met all limitations of claim 1 except for the direct targeting of a PTN branch.
  • Motivation to Combine: The motivation arguments mirrored those in Ground 1. Petitioner argued a POSA would have been motivated to modify Amarenco’s established stimulation protocol by applying the specific branch-targeting techniques from Ponsford. The rationale, supported by Mann, was to gain the known advantages of more selective nerve stimulation. Petitioner noted that during prosecution of the ’742 patent, the examiner had already found a motivation to combine Amarenco with Mann to target a branch, but allowed the claims because the art of record allegedly failed to teach how to directly stimulate a branch. Petitioner contended that Ponsford, which was not before the examiner, provides this missing teaching.
  • Expectation of Success: The expectation of success was argued to be high and predictable for the same reasons articulated in Ground 1. The combination involved applying known techniques to a known process to achieve a predictable result.

4. Arguments Regarding Discretionary Denial

• §314(a) (Fintiv): Petitioner argued that discretionary denial under Fintiv would be inappropriate. It asserted that the parallel district court litigation is at a very early stage, with no trial date set and minimal investment by the parties. To further mitigate overlap, Petitioner stipulated that if the Board institutes trial, it will not pursue in the district court any invalidity ground raised or that could have been reasonably raised in this inter partes review (IPR).
• §325(d): Petitioner argued against denial under 35 U.S.C. §325(d), contending that its petition raises new art and arguments not previously before the U.S. Patent and Trademark Office. Specifically, neither Svihra nor Ponsford was cited or considered during prosecution. Petitioner asserted that the examiner materially erred in allowing the claims. The examiner’s sole reason for allowance was that the prior art of record did not disclose the "direct stimulation of a posterior tibial nerve branch." Petitioner argued that Ponsford explicitly teaches this limitation, meaning the examiner’s conclusion was based on an incomplete record, and this error warrants institution.

5. Relief Requested

• Petitioner requests institution of an IPR and cancellation of claims 1-13 of the ’742 patent as unpatentable.