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2105 Patentable subject matter - living subject matter

MPEP SECTION SUMMARY This section covers living subject matter, providing examples of what can be and cannot be patentable. For example, new minerals discovered in the earth are not patentable, but microorganisms produced by genetic engineering can be patented. In addition, it gives specifics on how no patent may issue on a claim directed to or encompassing a human organism, which was added in the America Invents Act (AIA).

  Section Frequency Chart

I. INTRODUCTION

Diamond v. Chakrabarty held that microorganisms produced by genetic engineering are not excluded from patent protection by 35 U.S.C. 101.

It is clear from Chakrabarty and subsequent judicial decisions that the question of whether or not an invention embraces living matter is irrelevant to the issue of patentability.

Congress has excluded claims directed to or encompassing a human organism from patentability.

II. LIVING SUBJECT MATTER MAY BE PATENTABLE

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.”

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.

• 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 and the Plant Variety Protection Act.

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.

The laws of nature, physical phenomena and abstract ideas are not patentable; some examples of these nonpatentable ideas include:

• new minerals discovered in the earth
  
• new plants found in the wild
  
• the law of gravity

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) states:

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

 

» 2106  Patent Subject Matter Eligibility