Embody Inc v. LifeNet Health

1. Case Identification

• Case #: IPR2025-00249
• Patent #: 11,318,227
• Filed: December 4, 2024
• Petitioner(s): Embody, Inc. and Zimmer Biomet Holdings, Inc.
• Patent Owner(s): LifeNet Health
• Challenged Claims: 1-8

2. Patent Overview

• Title: Method of Treating Tissue Defect
• Brief Description: The ’227 patent relates to methods for treating tissue defects, such as in tendons, ligaments, or nerves, by implanting a scaffold comprising crosslinked, collagen-containing fibers. The patent’s asserted novelty centers on the structural alignment of these fibers, which results in a Fast Fourier Transform (FFT) analysis showing major adjacent peaks approximately 180° apart.

3. Grounds for Unpatentability

Ground 1: Obviousness of Claims 1-6 over Huang2 in view of Kuo

• Prior Art Relied Upon: Huang2 (a 2011 journal article on anisotropic collagen-containing nanofibers) and Kuo (Application # US 2011/0293685).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Huang2 discloses an electrospun scaffold made of crosslinked PCL/collagen fibers that are highly aligned (“anisotropic”). Huang2’s own FFT analysis of these fibers shows a single major peak at approximately 90° within the standard 0-180° reporting range. Petitioner asserted that a person of ordinary skill in the art (POSITA) would understand that the inherent symmetry of an FFT analysis means a second major peak must exist at 270°, thus satisfying the “180° apart” claim limitation. While Huang2 discloses using its scaffold for skin wound healing, Kuo was cited for its express teaching of using similar aligned collagen/PCL scaffolds for the specific purpose of repairing tendon, ligament, and nerve defects.
  • Motivation to Combine: A POSITA would combine Huang2 and Kuo because both references operate in the same field of tissue engineering and aim to solve the same problem: creating scaffolds that mimic the native tissue microenvironment to promote healing. A POSITA would have been motivated to apply the structurally superior aligned-fiber scaffold taught by Huang2 to the specific, clinically important applications of tendon, ligament, and nerve repair explicitly detailed in Kuo.
  • Expectation of Success: Since both references successfully created stable scaffolds of aligned collagen-blend fibers, a POSITA would have had a high expectation of success in using the scaffold from Huang2 for the methods taught by Kuo, especially as aligned fibers are known to be critical for tendon, ligament, and nerve tissue structure.

Ground 2: Obviousness of Claims 1-6 over Lee in view of Kuo

• Prior Art Relied Upon: Lee (Application # US 2010/0331980) and Kuo (Application # US 2011/0293685).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Lee discloses every element of the challenged claims except for the specific application to tendon, ligament, or nerve repair. Lee teaches a method of treating muscle tissue defects by implanting a scaffold of crosslinked, collagen-containing fibers that are explicitly described as aligned. Although Lee does not provide an FFT analysis, Petitioner’s expert performed an FFT analysis on the SEM images published in Lee, demonstrating that the aligned fibers produce major peaks at approximately 90° and 270°, thereby meeting the “180° apart” limitation. The combination with Kuo supplies the teaching of applying such scaffolds to repair tendons, ligaments, and nerves.
  • Motivation to Combine: A POSITA would combine Lee and Kuo to extend the use of Lee’s proven scaffold from muscle repair to the repair of anatomically and structurally similar tissues like tendons and ligaments, as taught by Kuo. Both references emphasize the desirability of using aligned fibers to mimic native tissue, providing a clear rationale for applying Lee’s technology to the indications described in Kuo.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success, as muscle, tendon, and ligament tissues are all known to be composed of aligned collagen fibers that require strength along the axis of alignment. Applying a scaffold effective for muscle repair to these other tissues would have been a predictable and logical step.

Ground 3: Anticipation of Claims 7 and 8 by Huang2

• Prior Art Relied Upon: Huang2 (a 2011 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Huang2 anticipates claims 7 and 8, which are directed to a method of cell culture. Huang2 explicitly discloses every element of these claims by describing a study where it placed cells (specifically fibroblasts, as recited in dependent claim 8) onto a scaffold comprising aligned fibers. As established in Ground 1, the FFT analysis of these fibers in Huang2 demonstrates major peaks 180° apart. Huang2 further describes growing these cells in suitable culture conditions for up to seven days to evaluate cell behavior, thus meeting the final limitation of the claims.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial would be inappropriate.
• Fintiv Factors: Petitioner contended that the parallel district court case is in its infancy, with no scheduling order yet issued. Therefore, a stay of the litigation is likely, and the Board’s Final Written Decision would precede any potential trial date.
• 35 U.S.C. §325(d): Petitioner asserted that the grounds rely on new, non-cumulative prior art references (Huang2, Lee, and Kuo) that were not before the examiner during the original prosecution of the ’227 patent or its parent application. This new art, Petitioner argued, is material and strongly favors institution.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-8 of Patent 11,318,227 as unpatentable.