Office Practice Regarding Fertilized Eggs, Stem Cells, Organs and Tissues
June 20, 2006
The Patent Office takes the position that animals at any stage of development, from fertilized eggs on, are higher life forms and are thus not patentable subject matter under section 2 of the Patent Act. Totipotent stem cells, which have the same potential as fertilized eggs to develop into an entire animal, are considered to be equivalents of fertilized eggs and are thus higher life forms and are not patentable subject matter.
Embryonic, multipotent and pluripotent stem cells, which do not have the potential to develop into an entire animal, are patentable subject matter.
Further, the Office takes the position that organs and tissues are not compositions of matter for the purposes of the definition of invention under section 2 of the Patent Act and are therefore not patentable subject matter. Organs and tissues are created by complex processes, elements of which require no human intervention, and do not consist of ingredients or substances that have been combined or mixed together by a person.
Artificial organ-like or tissue-like structures, generated substantially through the hand-of-man by combining various cellular components and/or inert components, may be considered, on a case-by-case basis, to be compositions of matter and therefore patentable subject matter.
For the purposes of the foregoing, the following terminology taken from the National Institutes of Health Stem Cell Information website has been adopted:
Embryonic stem cells — Primitive (undifferentiated) cells derived from a 5-day preimplantation embryo that have the potential to become a wide variety of specialized cell types.
Multipotent — Ability of a single stem cell to develop into more than one cell type of the body.
Pluripotent — Ability of a single stem cell to give rise to all of the various cell types that make up the body. Pluripotent cells cannot make so-called "extra-embryonic" tissues such as the amnion, chorion, and other components of the placenta.
Totipotent — A totipotent stem cell can give rise to all the cell types that make up the body plus all of the cell types that make up the extraembryonic tissues such as the placenta.