In re: Roslin Inst. (Edinburgh), No. 13-1407 (Fed. Cir. 2014)Annotate this Case
In 1996, Campbell and Ian successfully produced the first mammal ever cloned from an adult somatic cell: Dolly the Sheep. Known as somatic cell nuclear transfer, the process involves removing the nucleus of a somatic cell and implanting that nucleus into an enucleated (i.e., without a nucleus) oocyte. A somatic cell is any body cell other than gametes (egg or sperm). An oocyte is an egg cell prior to maturation and a nucleus is the organelle that holds a cell’s genetic material (DNA). Often called “adult” cells, somatic cells are differentiated, i.e., they are specialized to perform specific functions. Liver, heart, and muscle cells are differentiated, somatic cells. To create Dolly, Campbell and Wilmut fused the nucleus of an adult, somatic mammary cell with an enucleated oocyte. The obtained the 258 patent for the process. The Patent and Trademark Office rejected their claims to the cloned animals, set forth in the 233 application, “Quiescent Cell Populations for Nuclear Transfer.’ In 2013, the Patent Trial and Appeal Board affirmed the rejection, finding that the claimed subject matter was ineligible for patent protection under 35 U.S.C. 101 because it constituted a natural phenomenon that did not possess “markedly different characteristics than any found in nature” and that the subject matter was anticipated by and obvious in light of prior art (35 U.S.C. 102 and 103) because the clones were indistinguishable from clones produced through prior cloning methods, i.e., embryotic nuclear transfer and in vitro fertilization. The Federal Circuit affirmed, citing Section 101.