MPEP 2105

2105 Patentable Subject Matter — Living Subject Matter

35 U.S.C. 101 defines Inventions which are patentable

According to 35 U.S.C. 101 :

"Whoever invents or discovers any new and useful process,machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title.

• 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.

The use of the comprehensive term "any" in 35 U.S.C 101 may encompass 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. Therefore, the relevant distinction is not between living and inanimate things, but between products of nature, whether living or not, and human made inventions. This determination was made in the US Supreme Court Case Diamond v Chakrabarty wherein the Court held that microorganisms produced by genetic engineering are not excluded from patent protection.

The tests set forth by the Court for determining the patentability of Living Subject matter are:

(A) “The laws of nature, physical phenomena and abstract ideas” are not patentable subject matter.

(B) A “non-naturally occurring manufacture or composition of matter — a product of human ingenuity—having a distinctive name, character, [and] use” is patentable subject matter.

(C) “[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 E=mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of... nature,free to all men and reserved exclusively to none.’”

(D) “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” [emphasis added] is a“manufacture” under 35 U.S.C. 101.

Patentability of Animals:

Following the reasoning in Chakrabarty, the Board of Patent Appeals and Interferences determined that animals are patentable subject matter under 35 U.S.C.101. The Commissioner of Patents and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) that the Patent and Trademark Office would now consider non naturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.

Patentability of Human organism:

The Leahy-Smith America Invents Act (AIA), Public Law112-29, sec. 33(a), 125 Stat. 284, states:

Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.

The legislative history of the AIA includes the following statement, which sheds light on the meaning of this provision:

"The U.S. Patent Office has already issued patents on genes, stems cells, animals with human genes,and a host of non-biologic products used by humans,but it has not issued patents on claims directed to human organisms, including human embryos and fetuses. My amendment would not affect the former,but would simply affirm the latter."

If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human organism, then a rejection under 35 U.S.C. 101 and AIA sec.33(a)must be made indicating that the claimed invention is directed to a human organism and is therefore non-statutory subject matter. Furthermore, the claimed invention must be examined with regard to all issues pertinent to patentability, and any applicable rejections under 35 U.S.C. 102, 103, or 112 must also be made.

Patentability of Plant Subject Matter

The Supreme Court held that patentable subject matter under 35 U.S.C. 101 includes newly developed plant breeds, even though plant protection is also available under the Plant Patent Act and the Plant Variety Protection Act. The work of the plant breeder ‘in aid of nature’ is a patentable invention.