Federal Circuit IP

Restem, LLC v. Jadi Cell, LLC.

By Ziyu Ma Published March 19, 2025

CAFC No. 2023-2054, Decided March 4, 2025

(MOORE, SCHALL, TARANTO)

Background:

  1. Restem filed an IPR petition challenging the validity of claims 1–15 of Jadi Cell’s ‘176 patent.
  2. The PTAB ruled in favor of Jadi Cell, LLC, holding that Restem failed to prove unpatentability.
    1. Prior art (Majore) did not inherently anticipate the claimed stem cells.
    2. The obviousness arguments were insufficient to invalidate the claims.
  3. Restem appealed, arguing errors in claim construction, inherent anticipation, and obviousness.

Issue: whether a prior art describing a similar process inherently anticipates a product claimed by a product-by-process claim?

Holding: Affirmed. A product-by-process claim is not inherently anticipated by a reference that merely discloses the claimed process. The validity of a product-by-process claim depends on whether the prior art discloses the claimed product.

Federal Circuit Analysis:

  1. Claim construction: no error in PTAB’s construction.
    1. “placing” step: the spec. does not uniformly require “isolation” or “specific placement.” Adding these would improperly narrow the claims. No implicit construction.
    2. “isolated cell:” one or more cell v. a cell population – although the definition states “a cell,” the prosecution history supports “a cell population” construction.
  2. Inherent Anticipation: affirm, prior art Majore did not inherently anticipate.
    1. Restem: steps are similar, so the same product naturally follows.
    2. Cir: Here, the issue is validity, and the focus should be on the claimed product.
      1. In determining validity of a product-by-process claim, the focus is on the product, as an old product is not patentable even if made by a new process.
      2. In determining infringement, the focus is on both the process and the product.
    3. The prior art Majore disclosed a two-step procedure similar to claim 1, but the product of such a two-step procedure is not necessarily the same as the claimed cell that has the cell marker expression profile.
      1. Restem failed to provide testing evidence
      2. Expert testimony and other prior art: cell marker expression can depend on a variety of factors other than the two steps, such as cell-to-cell interaction.
    4. Obviousness: affirmed.

Takeaways:

  1. Inherent anticipation requires necessity, not mere possibility. When arguing “same result naturally follows a similar process,” provide testing evidence.
  2. Courts may rely on the Examiner’s characterization to narrow the claim scope. Consider add a comment.