MPEP 2105
Patent Eligible Subject Matter — Living Subject Matter

This is the Ninth Edition of the MPEP, Revision 08.2017, Last Revised in Januay 2018

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2105    Patent Eligible Subject Matter — Living Subject Matter [R-08.2017]

I.    INTRODUCTION

Prior to 1980, it was widely believed that living subject matter was not eligible for patenting, either because such subject matter did not fall within a statutory category, or because it was a judicial exception to patent eligibility. However, the decision of the Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), made it clear that the question of whether an invention embraces living matter is irrelevant to the issue of patent eligibility. Note, however, that Congress has excluded claims directed to or encompassing a human organism from eligibility. See The Leahy-Smith America Invents Act (AIA), Pub. L. 112-29, sec. 33(a), 125 Stat. 284 (September 16, 2011).

II.    LIVING SUBJECT MATTER MAY BE PATENT ELIGIBLE

A.    Living Subject Matter May Be Directed To A Statutory Category

In Chakrabarty, the Supreme Court held that a claim to a genetically engineered bacterium was directed to at least one of the four statutory categories, because the bacterium was a "manufacture" and/or a "composition of matter." In its opinion, the Court stated that "Congress plainly contemplated that the patent laws would be given wide scope" because it chose to draft 35 U.S.C. 101 using "such expansive terms as ‘manufacture’ and ‘composition of matter,’ modified by the comprehensive ‘any.’" 447 U.S. at 308, 206 USPQ at 197. The Court also determined that the distinction between living and inanimate things was not relevant for subject matter eligibility. 447 U.S. at 313, 206 USPQ at 199. Thus, the Court held that living subject matter with markedly different characteristics from any found in nature, such as the claimed bacterium produced by genetic engineering, is not excluded from patent protection by 35 U.S.C. 101. 447 U.S. at 310, 206 USPQ at 197.

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. In Ex parte Allen, 2 USPQ2d 1425 (Bd. Pat. App. & Inter. 1987), the Board decided that a non-naturally occurring polyploid Pacific coast oyster could have been the proper subject of a patent under 35 U.S.C. 101 if all the criteria for patentability were satisfied. Shortly after the Allen decision, the Commissioner of Patents and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) stating that the Patent and Trademark Office "now considers nonnaturally occurring, non-human multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.

With respect to 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 (35 U.S.C. 161 - 164 ) and the Plant Variety Protection Act (7 U.S.C. 2321 et. seq.). J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’ l, Inc., 534 U.S. 124, 143-46, 122 S.Ct. 593, 605-06, 60 USPQ2d 1865, 1874 (2001) (The scope of coverage of 35 U.S.C. 101 is not limited by the Plant Patent Act or the Plant Variety Protection Act; each statute can be regarded as effective because of its different requirements and protections).

See MPEP § 2106.03 for a discussion of the categories of statutory subject matter.

B.    Living Subject Matter May Be Eligible for Patent Protection

The Supreme Court in Chakrabarty held a claim to a genetically engineered bacterium eligible, because the claimed bacterium was not a "product of nature" exception. As the Court explained, the modified bacterium was patentable because the patent claim was not to a "hitherto unknown natural phenomenon," but instead had "markedly different characteristics from any found in nature," due to the additional plasmids and resultant capacity for degrading oil. 447 U.S. at 309-10, 206 USPQ at 197.

Subsequent judicial decisions have made clear that the Supreme Court’s decision in Chakrabarty is "central" to the eligibility inquiry with respect to nature-based products. See, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013). For example, the Federal Circuit has indicated that "discoveries that possess ‘markedly different characteristics from any found in nature,’ … are eligible for patent protection." In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1336, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ2d at 197). In Roslin, the claimed invention was a live-born clone of a pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and goats. An embodiment of the claimed invention was the famous Dolly the Sheep, which the court stated was "the first mammal ever cloned from an adult somatic cell." Despite acknowledging that the method used to create the claimed clones "constituted a breakthrough in scientific discovery", the court relied on Chakrabarty in holding the claims ineligible because "Dolly herself is an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature.’" Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671.

See MPEP § 2106.04 for a discussion of the judicial exceptions in general, MPEP § 2106.04(b), subsection II for a discussion of products of nature, and MPEP § 2106.04(c) for a discussion of the markedly different characteristics analysis that examiners should use to determine whether a nature-based product such as living subject matter is eligible for patent protection.

III.    HUMAN ORGANISMS ARE NONSTATUTORY SUBJECT MATTER

Congress has excluded claims directed to or encompassing a human organism from patentability. The Leahy-Smith America Invents Act (AIA), Public Law 112-29, 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:

[T]he 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.

157 Cong. Rec. E1177-04 (testimony of Representative Dave Weldon previously presented in connection with the Consolidated Appropriations Act, 2004, Public Law 108-199, 634, 118 Stat. 3, 101, and later resubmitted with regard to the AIA; see 149 Cong. Rec. E2417-01). Thus, section 33(a) of the AIA codifies existing Office policy that human organisms are not patent-eligible subject matter.

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 nonstatutory subject matter. Form paragraph 7.04.03 should be used; see MPEP § 706.03(a). 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.