860 F.3d 1367
Fed. Cir.2017Background
- Stanford (Quake) and CUHK (Lo) developed competing prenatal tests using cell-free fetal DNA (cff-DNA) from maternal blood to detect fetal aneuploidy; Quake’s later-added claims in the ’018 patent expressly cover a random massively parallel sequencing (MPS) method.
- Lo’s random MPS method (filed 2007/2008) sequences mixed maternal/fetal DNA randomly, aligns fragments to a reference genome, and detects chromosomal dosage imbalances (e.g., trisomy 21).
- Quake’s original specification emphasized digital PCR and detection of predetermined target sequences, but also referenced use of Illumina MPS and language about “randomly fragmented genomic DNA.”
- The PTO declared three interferences; the PTAB found Stanford’s later-added claims lacked adequate written description support and credited CUHK expert Dr. Gabriel’s testimony that the specification supports targeted (not random) sequencing.
- Stanford sought review in district court under 35 U.S.C. §146; district court proceedings were stayed and later transferred after this court’s Biogen decision limiting §146 relief for interferences declared after Sept. 15, 2012.
- The Federal Circuit vacated and remanded the PTAB decisions because the Board relied on improper or insufficient evidence (post‑dating or platform-mismatched references) and failed to support key factual findings with substantial evidence.
Issues
| Issue | Stanford's Argument | CUHK's Argument | Held |
|---|---|---|---|
| Availability of §146 review | Biogen was wrongly decided; Stanford sought district court review of PTAB decisions | Biogen controls; §146 unavailable for interferences after 9/15/2012 | Court refuses to revisit Biogen; §146 remedy not available here |
| Use of district-court discovery in review | Evidence developed in district court materially affects PTAB record and should be considered | District-court proceedings lacked jurisdiction after Biogen and are a nullity; record is limited to the four corners before the PTAB | Court may not consider or remand based on the nullified district-court discovery; review confined to PTAB record |
| Written-description sufficiency for random MPS claims | The ’018 specification (Illumina reference, phrases like “randomly fragmented genomic DNA,” and discussion of alignment/software) discloses random MPS and supports later-added claims | Specification emphasizes digital/targeted detection; PTAB expert testimony shows skilled artisans would read the spec as targeting predetermined sequences | PTAB erred: it relied on improper evidence (post‑date or non‑Illumina platform references) and failed to cite substantial evidence; vacate and remand for PTAB to reassess whether the specification shows possession of random MPS as of the priority date |
| Remand scope / evidentiary guidance | (Stanford) PTAB should be required to consider full record or district-court evidence | (CUHK) PTAB record is adequate; district-court materials improper | Court vacates and remands; instructs PTAB to examine pre‑filing art‑related facts about Illumina and may consider whether later publications can be used only as evidence of the pre‑existing state of the art, not as new post‑filing facts |
Key Cases Cited
- Biogen MA, Inc. v. Japanese Found. for Cancer Research, 785 F.3d 648 (Fed. Cir.) (AIA bars §146 review for interferences declared after Sept. 15, 2012)
- In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) (review confined to the PTAB record / “four corners” rule)
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (written description standard: specification must show inventor possessed claimed invention)
- Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991) (written-description inquiry perspective of one of ordinary skill)
- SEC v. Chenery Corp., 332 U.S. 194 (1947) (reviewing court limited to the grounds the agency invoked)
- Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574 (1999) (subject-matter jurisdiction is threshold and cannot be waived)