2020 Manual of Patent Examining Procedure 2105

Summary

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 ...