MPEP 2105: Difference between revisions

2105 Patentable Subject Matter — Living Subject Matter

The test set down for patentable subject matter in this area is whether the living matter is the result of human intervention. This determination was made in the US Supreme Case Diamond v Chakrabarty wherein the Court held that microorganisms produced by genetic engineering are not excluded from patent protection.

• The term "manufacture" in 35 U.S.C. § 101 in accordance with its dictionary definition means "the production of articles for use from raw materials prepared by giving to these materials new forms, qualities, properties, or combinations whether by hand labor or by machinery."
• By using such expansive terms as "manufacture" and "composition of matter," modified by the comprehensive "any," Congress plainly contemplated that the patent laws would be given wide scope.
• This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable.
  • Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.
• Congress recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.
  • Genetically engineered living organisms fall under human-made inventions
  • A nonnaturally occurring manufacture or composition of matter — a product of human ingenuity —having a distinctive name, character, and use is patentable subject matter.
• The production of articles for use from raw materials prepared by giving to these materials new forms, qualities, properties, or combinations whether by hand labor or by machinery is a "manufacture" under 35 U.S.C. 101.
• Patentable subject matter under 35 U.S.C. 101 includes newly developed plant breeds.
• The Board of Patent Appeals and Interferences has also determined that animals are patentable subject matter under 35 U.S.C. 101 if all the criteria for patentability were satisfied.
  • The Patent and Trademark Office now considers nonnaturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.
  • If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter.