Broad Construction Of Process In Product-By-Process Claim Dooms Petitioner's Inherency Argument For Resulting Product

• Published date: 15 June 2023
• Subject Matter: Intellectual Property, Patent
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Mr Alexander M. Boyer, Amanda Murphy and Stacy Lewis

In Restem, LLC v. Jadi Cell, LLC, IPR2021-01535, Paper 42 (P.T.A.B. April 18, 2023), the Patent Trial and Appeal Board ("Board") issued a final written decision finding no challenged claims were shown to be unpatentable because the petitioner failed to demonstrate anticipation or obviousness by inherency.

Background

Jadi's U.S. Patent No. 9,803,176 ("the '176 patent") relates to an allogenic cell or stem cell population, including methods of "isolating, culturing, developing, or otherwise producing these cells." Restem, Paper 42 at *3. Restem challenged claims 1-15 of the patent, which recite product-by-process claims. In relevant part, independent claim 1 recites:

An isolated cell prepared by a process comprising:

placing a subepithelial layer of a mammalian umbilical cord tissue in direct contact with a growth substrate; and

culturing the subepithelial layer such that the isolated cell from the subepithelial layer is capable of self-renewal and culture expansion,

wherein the isolated cell expresses at least three cell markers selected from [a] group . . ., and

wherein the isolated cell does not express NANOG and at least five cell markers selected from [another] group . . . .

Restem asserted eight grounds of unpatentability, including anticipation and obviousness. These grounds all relied on prior art processes that Restem alleged inherently resulted in an isolated cell with the required cell markers.

Board Decision

During the proceeding, the parties disputed the meaning of the claimed phrases: "placing a sub-epithelial layer . . . in direct contact with a growth substrate" and "expresses/does not express."

Restem asserted that "placing a sub-epithelial layer . . . in direct contact with a growth substrate" means "direct contact with any material capable of being used to obtain explants." Id. at *18. Jadi argued for a narrower construction requiring "placing the exposed subepithelial layer of an umbilical cord interior side down such that the exposed subepithelial layer is in direct contact with the growth substrate." Id. (emphasis added). The Board found this construction supported by an embodiment in the specification but declined to adopt it. Id. at *21-23. The Board found that the narrower construction would have excluded other disclosed embodiments without clear disavowal of claim scope. Id. Instead, the Board held that "placing a sub-epithelial layer . . . in direct contact with a growth substrate" means "orienting umbilical cord tissue...