Ariosa Diagnostics, Inc. v. Sequenom, Inc.
788 F.3d 1371
| Fed. Cir. | 2015Background
- Drs. Lo and Wainscoat discovered cell-free fetal DNA (cffDNA) in maternal plasma/serum and claimed methods (U.S. Patent No. 6,258,540) for amplifying and detecting paternally inherited cffDNA to perform prenatal diagnosis (e.g., MaterniT21).
- The asserted claims are method claims: start with naturally occurring cffDNA from maternal plasma/serum, amplify (e.g., PCR), detect (e.g., gel/ probe), and optionally diagnose fetal traits.
- Defendants (Ariosa, Natera, Diagnostics Center) developed noninvasive prenatal tests and sought declaratory judgments of noninfringement; Sequenom counterclaimed. The district court granted summary judgment that the asserted claims are invalid under 35 U.S.C. § 101.
- The district court (and the Federal Circuit here) found the claims directed to a natural phenomenon (cffDNA) and that the claimed amplification/detection steps were well‑understood, routine, and conventional in 1997.
- Applying the Mayo two‑step framework, the court held the claims lacked an "inventive concept" sufficient to transform the natural phenomenon into patent‑eligible subject matter and affirmed invalidity; preemption concerns were inherent to the § 101 analysis.
Issues
| Issue | Sequenom's Argument | Ariosa's Argument | Held |
|---|---|---|---|
| Whether the asserted claims are directed to patent‑ineligible natural phenomena | Claims are patent‑eligible applications of the natural phenomenon (cffDNA) because they implement a novel, practical method | Claims are directed to the natural phenomenon of paternally inherited cffDNA | Held: Claims are directed to a natural phenomenon (cffDNA) and therefore fall under Mayo step 1 |
| Whether claim elements add an "inventive concept" beyond conventional steps (Mayo step 2) | The claimed combination of applying known techniques to maternal plasma was novel and meritorious; the invention lies in using discarded plasma for cffDNA detection | Amplification and detection steps (PCR, probes, sample prep) were well‑understood, routine, and conventional in 1997, so they do not supply an inventive concept | Held: The amplification/detection steps are conventional; no inventive concept transforms the claim into patent‑eligible subject matter |
| Preemption risk — do the claims improperly tie up future uses of cffDNA | Sequenom: claims are narrow, do not preempt all uses of cffDNA, and therefore are non‑preemptive | Ariosa: even without complete preemption, Mayo analysis controls; the claims risk preempting the natural phenomenon | Held: Preemption concerns are addressed by the § 101/Mayo analysis; absence of complete preemption does not save claims that fail Mayo |
| Role of "groundbreaking" discovery in § 101 analysis | Sequenom: the inventors’ discovery and commercial impact (MaterniT21) show a meaningful inventive contribution deserving patent protection | Ariosa: Novelty or utility of discovery does not satisfy § 101 if claims are directed to natural phenomena without inventive concept | Held: A groundbreaking discovery alone does not satisfy § 101; Myriad/Mayo control and invalidate these claims |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289 (2012) (two‑step test for laws of nature and need for an "inventive concept")
- Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (preemption is the concern underlying judicial exceptions to § 101)
- Ass’n for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013) (discovery of natural DNA sequences does not make them patentable)
- Diamond v. Diehr, 450 U.S. 175 (1981) (a new combination of known steps can be patentable if it integrates the principle into a patent‑eligible process)
- Parker v. Flook, 437 U.S. 584 (1978) (post‑solution activity that is purely conventional does not render a law of nature patentable)