967 F.3d 1319
Fed. Cir.2020Background
- The patents (U.S. Pat. Nos. 9,580,751 and 9,738,931) claim methods to prepare a DNA fraction from maternal plasma/serum that is enriched for fetal cell-free DNA (cff‑DNA) by size‑discriminating and selectively removing fragments above ~300–500 base pairs, then analyzing the resulting fraction.
- The specifications acknowledge the natural phenomenon that cff‑DNA exists in maternal blood and disclose the inventors' discovery that fetal fragments tend to be shorter than maternal fragments (majority <~500 bp), which "forms the basis" of the invention.
- Roche moved for summary judgment in the Northern District of California that asserted claims were invalid under 35 U.S.C. § 101 as directed to an ineligible natural phenomenon; the district court granted judgment for Roche.
- The Federal Circuit (Majority opinion by Judge Lourie) reversed, holding the claims are directed to a patent‑eligible method of preparation that uses physical process steps to alter a sample composition (enrich fetal DNA), not merely to detect or claim the natural phenomenon itself.
- Judge Reyna dissented, arguing the patents claim only the natural discovery, rely on conventional techniques, lack an inventive concept under Alice/Mayo step two, and preempt use of the natural phenomenon.
Issues
| Issue | Plaintiff's Argument (Illumina) | Defendant's Argument (Roche) | Held |
|---|---|---|---|
| Whether the claims are "directed to" a natural phenomenon under Alice/Mayo step one | Claims are directed to a concrete method of preparing an enriched fetal‑DNA fraction (size discrimination + removal + analysis), not to the natural phenomenon itself | Claims merely exploit the natural fact that cff‑DNA is shorter than maternal DNA and therefore are directed to the natural phenomenon | Majority: Not directed to the natural phenomenon; claims are methods of preparation and thus pass step one (no need to reach step two) |
| Whether Ariosa/Myriad control (i.e., distinguishing detection/composition claims) | Myriad and Ariosa are distinguishable because those cases claimed the natural product or only detection; here the claim is a method that changes sample composition | Analogizes to Ariosa/Myriad: this is effectively an isolation/enrichment of a natural product and should be ineligible | Majority: Distinguishes Ariosa and Myriad — those were detection or composition claims; here the claimed process alters the mixture and yields a new fraction |
| Whether use of conventional techniques (centrifugation, electrophoresis, chromatography, nanotech) defeats eligibility (Alice/Mayo step two) | Conventionality is relevant to step two or to obviousness but does not make the claim directed to a natural phenomenon at step one; the process produces a different composition | The claimed steps are routine and conventional; adding them to a natural law does not supply an inventive concept | Majority: did not reach step two because claim not directed to a natural phenomenon; noted conventionality is a step‑two or separate statutory issue. Dissent: would find no inventive concept and hold claims ineligible |
| Preemption concern: do claims tie up the natural phenomenon? | Claims are limited to specific process steps for preparing an enriched fraction, not to all uses of the size correlation | Claims effectively preempt use of the size‑based enrichment because they cover methods to isolate/enrich cff‑DNA by size | Majority: did not find the claims to be directed to the phenomenon and therefore did not conclude unlawful preemption; Dissent: says claims broadly preempt use of the discovery |
Key Cases Cited
- Diamond v. Chakrabarty, 447 U.S. 303 (1980) (§ 101 construed broadly; patentable subject matter includes man‑made inventions)
- Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66 (2012) (laws of nature/natural phenomena not patentable; two‑step test and requirement that additional elements supply an "inventive concept")
- Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014) (defines the two‑part "directed to" framework for judicial exceptions)
- Diamond v. Diehr, 450 U.S. 175 (1981) (applications of laws of nature can be patentable when claims are directed to a process applying them)
- Parker v. Flook, 437 U.S. 584 (1978) (process itself, not merely a law of nature or algorithm, must be new and useful)
- Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013) (naturally occurring DNA segments are not patentable as compositions of matter; Court left open method claims for isolating DNA)
- Rapid Litig. Mgmt. Ltd. v. CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016) (claims exploiting a natural phenomenon via a new method of preservation held patent‑eligible)
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (claims to detecting cff‑DNA held ineligible as directed to a natural phenomenon)
- Roche Molecular Sys. v. Cepheid, 905 F.3d 1363 (Fed. Cir. 2018) (applying conventional techniques to a natural phenomenon does not supply an inventive concept)
- Athena Diagnostics, Inc. v. Mayo Collaborative Servs., 915 F.3d 743 (Fed. Cir. 2019) (diagnostic claims applying a natural law held ineligible)