356 F. Supp. 3d 925
N.D. Cal.2018Background
- Plaintiffs Illumina and Sequenom sued Ariosa and Roche alleging infringement of U.S. Pat. Nos. 9,580,751 ("'751") and 9,738,931 ("'931"), which claim methods of extracting cell-free maternal plasma/serum DNA, size-discriminating fragments (≤~500 bp in '751; ≤~300 bp in '931), removing larger fragments, and analyzing the resulting fraction to detect fetal genetic traits.
- Defendants moved for summary judgment under 35 U.S.C. § 101, arguing the asserted claims are directed to natural phenomena and lack an inventive concept; plaintiffs contended the claims recite a lab technique producing a non-natural, enriched fetal-DNA composition.
- The patents’ asserted novelty rests on the discovery that fetal cell-free DNA is, on average, shorter than maternal DNA and that selecting for smaller fragments enriches fetal DNA for downstream analysis.
- The PTO had rejected the applications as using conventional size-selection techniques; plaintiffs argued the resulting enriched fraction is not a naturally occurring composition and thus patent-eligible.
- The court framed the dispute under the Alice/Mayo two-step § 101 framework: (1) whether claims are directed to a patent-ineligible concept (natural phenomena), and (2) if so, whether claim elements provide an inventive concept beyond routine, conventional steps.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether claims are directed to patent-ineligible subject matter (natural phenomena) | Claims are directed to a laboratory method producing a non-natural, enriched fetal-DNA fraction useful for analysis | Claims merely begin with a natural sample and end with analysis of naturally occurring fetal DNA; thus directed to a natural phenomenon | Held directed to ineligible natural phenomena; claims claim results from testing naturally occurring fetal DNA |
| Whether the claims contain an "inventive concept" under Alice step two | The claimed combination and selection of ~300–500 bp cutoffs and dependent lab steps (PCR, electrophoresis, etc.) reflect human ingenuity and create a new useful composition/process | The steps (extraction, size discrimination, selective removal, analysis) are well‑understood, routine, conventional lab techniques and add nothing inventive | Held no inventive concept; the claimed steps are routine/conventional and do not transform the natural phenomenon into patent-eligible subject matter |
| Whether dependent claim limitations save eligibility | Dependent steps (amplification, chromatography, electrophoresis) render the claims transformative | Dependent steps are conventional laboratory techniques previously known in the field | Held dependent limitations insufficient to supply an inventive concept; they are conventional and do not change the outcome |
| Appropriateness of summary judgment on § 101 | Plaintiff contended factual disputes exist about whether steps were conventional | Defendants argued no genuine dispute; asked court to decide eligibility as a matter of law | Court granted summary judgment for defendants, finding no genuine factual dispute that would preclude § 101 ruling |
Key Cases Cited
- Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (2014) (establishes two‑step framework for § 101 analysis)
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) (natural laws/phenomena and routine steps do not confer patent eligibility)
- Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (naturally occurring DNA is not patentable)
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (claims directed to detecting naturally occurring fetal DNA held ineligible)
- Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016) (claims directed to detection of natural phenomena treated as ineligible)
- CellzDirect, Inc. v. Rapid Litig. Mgmt. Ltd., 827 F.3d 1042 (Fed. Cir. 2016) (distinguishes patent‑eligible new lab techniques from mere applications of natural discoveries)
- Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016) (guidance on framing what a claim is "directed to")
- Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) (fact questions may exist on whether elements were well‑understood, routine, conventional)
- Diamond v. Diehr, 450 U.S. 175 (1981) (novelty alone does not determine § 101 eligibility)