TalexMedical LLC v. Becon Medical Ltd

1. Case Identification

• Case #: IPR2020-00030
• Patent #: 8,852,277
• Filed: October 9, 2019
• Petitioner(s): TalexMedical, LLC
• Patent Owner(s): Becon Medical Ltd and Henry Stephenson Byrd, MD.
• Challenged Claims: 1, 2, 9, 10, and 16

2. Patent Overview

• Title: Ear Molding Device for Correcting Misshaped Ears
• Brief Description: The ’277 patent discloses a molding system for non-surgically correcting misshaped ears. The system includes a cradle (comprising a base and a cover) that houses an ear molding device designed to retain and reshape the helix and helical rim of an ear.

3. Grounds for Unpatentability

Ground 1: Obviousness over Osman, Yotsuyanagi, and Gault - Claims 1, 10, and 16 are obvious over Osman in view of Yotsuyanagi and further in view of Gault.

• Prior Art Relied Upon: Osman (WO 81/02515), Yotsuyanagi (a 1993 article in "Plastic Surgery"), and Gault (UK Application No. 9517764.8).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the combination of references teaches every element of independent claim 1. Osman was alleged to teach the claimed "cradle," disclosing a protective ear device with a base plate and a releasably attachable cover that defines a compartment. Yotsuyanagi was asserted to teach the "ear molding device," which comprises a splint with a "brace" portion that supports a "scaphal mold" portion. Petitioner contended that Gault, which describes fitting a splint into the scaphoid fossa (scaphal area), confirms that a person of ordinary skill in the art (POSITA) would understand Yotsuyanagi's splint to be a scaphal mold positioned in the scaphal area, as claimed. Dependent claim 10's "vertical wall" was argued to be taught by the structure of Osman’s cap, and dependent claim 16's "arc-shaped semi-cylindrical extension" was allegedly disclosed by the shape of the Yotsuyanagi splint.
  • Motivation to Combine: A POSITA would combine the Yotsuyanagi splint with the Osman protective cover to address the known problem of patient compliance, particularly with infants who might dislodge the splint. Petitioner asserted that protecting a corrective splint was a known need, and Gault explicitly teaches including a protective cover for this purpose. A POSITA would look to known protective devices like Osman to ensure the splint remained in place for the duration of treatment. Gault would have been used to better understand the terminology and background of non-surgical splinting techniques like Yotsuyanagi.
  • Expectation of Success: Petitioner contended a POSITA would have a reasonable expectation of success because combining the components was a simple mechanical integration. Placing a known splint (Yotsuyanagi) under a known protective cover (Osman) involved predictable steps to achieve the desired, predictable result of protecting the splint.

Ground 2: Obviousness over Osman, Yotsuyanagi, Gault, and Voorhees - Claims 2 and 9 are obvious over Osman in view of Yotsuyanagi and Gault, and further in view of Voorhees.

• Prior Art Relied Upon: Osman (WO 81/02515), Yotsuyanagi (1993 article), Gault (UK Application), and Voorhees (Patent 5,749,099).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds upon Ground 1 to address dependent claims 2 and 9. Petitioner argued that Voorhees teaches the additional limitation of claim 2: an "adhesive backing" for securing the base section to the periauricular skin. Voorhees discloses a fluid-tight ear protector that uses a double-sided, pressure-sensitive adhesive to affix the device to the skin around the ear. For claim 9, which recites a "kit" containing the system components, Petitioner asserted that packaging related medical components as a kit was a well-known and obvious commercial practice. Gault was also cited as teaching the provision of a kit including a molding device and a protective cover.
  • Motivation to Combine: A POSITA, having already been motivated to combine the Osman cover with the Yotsuyanagi splint, would be further motivated to incorporate the adhesive taught by Voorhees to more securely affix the protective cover to the patient's skin. This would further ensure that the cover and the underlying splint remain in place, enhancing the overall efficacy of the treatment. The motivation to create a kit (claim 9) stemmed from the common-sense practice of conveniently packaging all necessary components for a treatment together for commercial sale.
  • Expectation of Success: Petitioner asserted a high expectation of success, as applying a known adhesive from an ear protection device (Voorhees) to another ear protection device (Osman) was a straightforward application of a known technique to improve adherence, a predictable and desirable outcome.

4. Key Claim Construction Positions

• Petitioner highlighted the district court's construction of the term "scaphal mold" in co-pending litigation. The court construed the term to mean a "mold at the end of the one or more braces that is positionable in the scaphal area." Petitioner argued this broad, positional construction—rather than a more limiting structural one—supports its obviousness argument, as it encompasses any prior art mold or splint placed in the scaphal area of the ear, such as the one disclosed in Yotsuyanagi.

5. Arguments Regarding Discretionary Denial

• §314(a) / §315(b): Petitioner argued against discretionary denial based on the parallel district court proceeding, stating that the petition was timely filed and the litigation was not in its final stages, with no trial date set.
• §325(d): Petitioner argued that denial would be improper because the primary prior art references (Osman, Yotsuyanagi '93, Voorhees) were never considered by the examiner during prosecution of the ’277 patent. Petitioner specifically distinguished the 1993 Yotsuyanagi reference from a different, 2004 Yotsuyanagi reference submitted in an IDS, arguing the 1993 reference was not cumulative because it contained essential figures and explanations of the splint's application that the 2004 reference lacked.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1, 2, 9, 10, and 16 of the ’277 patent as unpatentable.