In general, “clones” which are identical genetic copies of a cell, cell part, or organism are nonstatutory subject matter under 35 U.S.C. § 101, unless the claims “describe clones that have markedly different characteristics from the donor animals of which they are copies.”
Background / Facts: The application on appeal here from rejection at the PTO is directed to the first mammal ever cloned from an adult somatic cell: Dolly the Sheep. The cloning method has already been patented and is not on appeal here. Instead, the present application claims the product of the cloning method—i.e., the clones themselves.
Issue(s): Whether “clones” which are identical genetic copies of a cell, cell part, or organism are statutory subject matter under 35 U.S.C. § 101.
Holding(s): No. “Dolly’s genetic identity to her donor parent renders her unpatentable.” Here, as in Myriad, the court found that the applicant “did not create or alter any of the genetic information” of its claimed clones, “[n]or did [the applicant] create or alter the genetic structure of [the] DNA” used to make its clones. “Instead, [the applicant’s] chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection.” Further, although probably dicta because the court noted that they were “unclaimed,” the court went on to state that any “differences in mitochondrial DNA, which originates from the donor oocyte rather than the donor nucleus” and any “phenotypic differences” that may result from “environmental factors” in a given organism “do not confer eligibility on their claimed subject matter” because they are generally “uninfluenced by [the applicant’s] efforts.” Nevertheless, the court did not completely close the door on clone claiming. “To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case. Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies.”