## Facts

- Patent applicants sought claims directed to (1) a biologically pure culture of *Streptomyces vellosus* identified by deposit number NRRL 8037, capable of producing lincomycin, and (2) a man-made, genetically engineered bacterium capable of degrading multiple components of crude oil.
- In the *Bergy* application, the examiner allowed several process claims, but rejected an added claim to the biologically pure culture itself.
- The PTO conceded that all other patentability requirements were satisfied and that unappealed claims in each application had been allowed.
- The only rejections at issue were under 35 U.S.C. § 101, on the theory that living organisms are outside statutory subject matter.
- The C.C.P.A. had previously found similar claims patentable; the Supreme Court granted certiorari and remanded for reconsideration in light of *Parker v. Flook*.
- On remand, the C.C.P.A. reconsidered only the § 101 issue and heard the appeals together because they presented the same legal question.

## Issues

1. Whether a biologically pure culture of a microorganism and a genetically engineered bacterium are patentable “manufacture” or “composition of matter” under 35 U.S.C. § 101 despite being living organisms.
2. Whether *Parker v. Flook* requires a narrower interpretation of § 101 that excludes such claims.

## Decision

- The court reversed the PTO Board of Appeals.
- The court held that a biologically pure culture of *Streptomyces vellosus* is patentable subject matter under § 101 as a “manufacture” or “composition of matter.”
- The court held that a man-made, genetically engineered bacterium is likewise patentable subject matter under § 101.
- The court concluded that an invention’s being “alive” has no controlling legal significance under § 101.
- The court determined that *Flook* did not compel a different outcome because it addressed abstract mathematical subject matter rather than tangible compositions.

## Legal Principles

- Section 101’s categories (“process, machine, manufacture, or composition of matter”) are construed broadly, subject to the exclusions for laws of nature, natural phenomena, and abstract ideas.
- A claimed microorganism can qualify under § 101 when it is a product of human ingenuity (for example, isolated, characterized, and controlled in a claimed form with specific utility), rather than a claim to a naturally occurring organism as found in nature.
- Patent eligibility under § 101 does not turn on whether the claimed subject is animate or inanimate; the statutory inquiry focuses on whether the claim fits within a statutory category and avoids the judicial exclusions.
- *Parker v. Flook* addresses treatment of abstract mathematical subject matter in process claims and does not narrow § 101’s coverage of tangible manufactures or compositions.

## Conclusion

The C.C.P.A. held that man-made living microorganisms, including a biologically pure culture defined by identifying characteristics and specific utility, fall within § 101’s “manufacture” or “composition of matter,” and that *Flook* did not alter that result.


In re Bergy, 596 F.2d 952 (C.C.P.A. 1979)