Federal Circuit IP
Restem, LLC v. Jadi Cell, LLC.
CAFC No. 2023-2054, Decided March 4, 2025
(MOORE, SCHALL, TARANTO)
Background:
- Restem filed an IPR petition challenging the validity of claims 1–15 of Jadi Cell’s ‘176 patent.
- The PTAB ruled in favor of Jadi Cell, LLC, holding that Restem failed to prove unpatentability.
- Prior art (Majore) did not inherently anticipate the claimed stem cells.
- The obviousness arguments were insufficient to invalidate the claims.
- 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:
- Claim construction: no error in PTAB’s construction.
- “placing” step: the spec. does not uniformly require “isolation” or “specific placement.” Adding these would improperly narrow the claims. No implicit construction.
- “isolated cell:” one or more cell v. a cell population – although the definition states “a cell,” the prosecution history supports “a cell population” construction.
- Inherent Anticipation: affirm, prior art Majore did not inherently anticipate.
- Restem: steps are similar, so the same product naturally follows.
- Cir: Here, the issue is validity, and the focus should be on the claimed product.
- 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.
- In determining infringement, the focus is on both the process and the product.
- 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.
- Restem failed to provide testing evidence
- 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.
- Obviousness: affirmed.
Takeaways:
- Inherent anticipation requires necessity, not mere possibility. When arguing “same result naturally follows a similar process,” provide testing evidence.
- Courts may rely on the Examiner’s characterization to narrow the claim scope. Consider add a comment.