TalexMedical LLC v. Becon Medical Ltd

1. Case Identification

• Case #: IPR2020-00028
• Patent #: 8,167,942
• Filed: October 9, 2019
• Petitioner(s): TalexMedical, LLC
• Patent Owner(s): Becon Medical Limited and Henry Stephenson Byrd, M.D.
• Challenged Claims: 1-7 and 9

2. Patent Overview

• Title: Ear Molding Device for Correcting Misshaped Ears
• Brief Description: The ’942 patent discloses a non-surgical splint for correcting misshaped ears in infants. The device comprises one or more "braces" supporting a "scaphal mold" constructed to retain and reshape the helix and helical rim of the ear over time.

3. Grounds for Unpatentability

Ground 1: Obviousness over Dancey in view of Gault - Claims 1-7 and 9 are obvious over Dancey in view of Gault.

• Prior Art Relied Upon: Dancey ("Acrylic Ear Splints for Treatment of Cryptotia," a 2005 journal article) and Gault (UK Patent Application Publication GB2304579, published 1997).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Dancey, which addresses the correction of cryptotia (an ear deformity), discloses all elements of the challenged claims. Dancey’s custom-made, two-part acrylic splint functions as the claimed "molding device." Petitioner asserted that one part of the splint, which fits over the ear, is a "scaphal mold," and the other part, positioned against the patient's head for support, is a "brace." This device is constructed to "retract the upper pole [of the ear] into an acceptable position," thereby retaining the helix and helical rim to maintain a correct anatomical shape as the ear grows. Gault, an earlier publication on ear splints, was used to provide context on the state of the art and confirm anatomical terminology, such as defining the "scaphoid fossa" as the area between the helix and antihelix, thereby confirming Dancey’s splint is placed in the claimed "scaphal area."
  • Motivation to Combine: Petitioner contended that a person of ordinary skill in the art (POSITA) would combine the teachings because both Dancey and Gault are directed to the same purpose of using non-surgical splints to correct ear deformities. A POSITA reviewing Dancey would have naturally looked to earlier references like Gault to better understand the background art, anatomical terminology, and fundamental principles of ear splinting.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success in applying the contextual knowledge from Gault to the specific splint design in Dancey, as both deal with the predictable mechanical process of splinting cartilage for cosmetic correction.

Ground 2: Obviousness over Yotsuyanagi in view of Gault - Claims 1 and 9 are obvious over Yotsuyanagi in view of Gault.

• Prior Art Relied Upon: Yotsuyanagi ("The Use of a Thermoplastic Splint for Treating Cryptotia," a 1993 journal article) and Gault (UK Patent Application Publication GB2304579).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Yotsuyanagi’s thermoplastic splint, which conforms to the ear's complex shape, teaches the limitations of claims 1 and 9. Using annotated figures, Petitioner identified the portion of the Yotsuyanagi splint placed in the scaphoid fossa as the "scaphal mold" and the portion fitting on the posterior of the ear as the "brace." This device is shown to retain the helix and helical rim to gradually correct the ear's shape over time. Claim 9’s additional limitations—an "arc-shaped semi-cylindrical extension" with "rounded edges"—were also alleged to be expressly shown in the figures of Yotsuyanagi. As in Ground 1, Gault was cited to provide established anatomical definitions and confirm that Yotsuyanagi's splint is positioned in the "scaphal area."
  • Motivation to Combine: The motivation was identical to that in Ground 1. Both Yotsuyanagi and Gault address the same problem of non-surgical ear correction. A POSITA would have used Gault's foundational teachings to better understand and interpret the specific splint application described in Yotsuyanagi.
  • Expectation of Success: The combination involved applying known splinting principles to achieve a predictable result, giving a POSITA a high expectation of success.

4. Key Claim Construction Positions

• "scaphal mold": Petitioner highlighted that in parallel district court litigation, the court construed this term to mean a “mold at the end of the one or more braces that is positionable in the scaphal area." Petitioner argued this construction is broad and defines the mold by its location rather than by a specific structure. This broad, positional definition was central to Petitioner's argument, as it allowed prior art devices like those in Dancey and Yotsuyanagi, which are placed in the same ear location for the same purpose, to fall within the scope of the claims.

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under §314(a) by stating this was its first petition challenging the ’942 patent, it was filed timely within the one-year statutory bar, and the co-pending district court litigation was in its early stages with no trial date set.
• Petitioner also argued against denial under §325(d), which considers whether the same or substantially the same prior art was previously presented to the PTO. Petitioner asserted that its primary references, Dancey and Yotsuyanagi, were not considered during the original prosecution. The examiner had relied on a different reference (Godley), which the applicant distinguished as a "pressure dressing." Therefore, Petitioner contended the grounds in the petition were not cumulative to the art previously considered by the examiner.

6. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 1-7 and 9 of Patent 8,167,942 as unpatentable.