Ariosa Diagnostics v. Verinata Health, Inc.
805 F.3d 1359
| Fed. Cir. | 2015Background
- Verinata owns U.S. Patent No. 8,318,430 claiming a noninvasive prenatal testing method that counts indexed, amplified cell-free DNA sequences from pooled maternal samples to detect fetal aneuploidy (e.g., trisomy 21) without separating fetal from maternal DNA.
- Ariosa petitioned the PTAB for inter partes review challenging claims 1–30 as obvious in view of three prior-art references: Shoemaker (single fetal cells, cell isolation and PCR), Dhallan (cell-free fetal DNA, amplify and sequence, compute fetal fraction), and Binladen (indexed multiplexed sequencing of pooled samples across species).
- The PTAB instituted IPRs but ultimately upheld all claims, finding Ariosa failed to articulate how to combine the references or what a skilled artisan would have modified, and gave no weight to an Illumina product brochure (Exhibit 1010) submitted in reply.
- Ariosa appealed, arguing (1) the Board improperly ignored Exhibit 1010 as background evidence of routine indexing/multiplex sequencing available by 2008, and (2) the Board improperly disallowed reliance in reply on unpresented Dhallan embodiments that allegedly avoid restriction-enzyme–digestible primers and thus could be combined with Binladen.
- The Federal Circuit held the Board’s language suggested it may have wrongly refused to consider Exhibit 1010 as background art and that the Board failed to sufficiently articulate alternative, independent grounds for discounting that exhibit; because the record does not permit the court to resolve the issue, the court vacated and remanded for further consideration.
Issues
| Issue | Ariosa's Argument | Verinata's Argument | Held |
|---|---|---|---|
| Whether the PTAB properly excluded or gave no weight to Exhibit 1010 (Illumina brochure) as background evidence of routine indexing/multiplex sequencing available by Jan 2010 | Exhibit 1010 was presented in the Petition’s expert declarations to show routine background knowledge and should have been considered | Board treated Exhibit 1010 as improper new evidence raised in Reply and accorded it no weight | Federal Circuit: Board’s language could reflect an erroneous legal limitation; vacated and remanded because the Board didn’t adequately articulate a permissible reason for discounting Exhibit 1010 |
| Whether Ariosa may rely on reply-identified portions of Dhallan (embodiments avoiding restriction-enzyme–digestible primers) that were not specifically identified in the Petition | Those specific embodiments are encompassed by Dhallan and permit combination with Binladen’s tagging scheme | Board: Petition failed to identify those specific Dhallan passages; reliance in Reply is impermissibly new | Federal Circuit: No error in Board rejecting new, previously un‑identified Dhallan embodiments in Reply; Board acted reasonably under procedural rules |
| Whether the Petition adequately explained how to combine Dhallan, Binladen, and Shoemaker and provided a rational underpinning for obviousness | The Petition and expert declarations together supplied the motivation and background to combine the references and achieve claimed method | Board: Petition lacked an articulated reason with rational underpinning and didn’t explain necessary modifications for combination | Federal Circuit: Board reasonably found inadequacy in the Petition’s explanations; remand only to reassess in light of Exhibit 1010 and fuller articulation by parties as appropriate |
| Whether any error in the Board’s treatment of Exhibit 1010 was harmless | Ariosa: Exhibit 1010 could fill the explanatory gap and materially affect outcome | Verinata: Any consideration of Exhibit 1010 would not change the bottom-line because Petitions still lack adequate explanation | Federal Circuit: Cannot conclude non-prejudicial; remanded for Board to reassess under correct legal standard |
Key Cases Cited
- In re Kahn, 441 F.3d 977 (Fed. Cir.) (requirement for articulated reason with rational underpinning in obviousness analysis)
- Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir.) (standard of review and use of background art to show skilled artisan knowledge)
- PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186 (Fed. Cir.) (factual issues in obviousness analysis)
- Tri-Med, Inc. v. Stryker Corp., 608 F.3d 1333 (Fed. Cir.) (obviousness factual inquiries)
- DeSilva v. DiLeonardi, 181 F.3d 865 (Fed. Cir.) (brief must make arguments accessible)
- Bowman Transp., Inc. v. Arkansas-Best Freight Sys., 419 U.S. 281 (U.S.) (agency review may be affirmed if a proper path can reasonably be discerned)
- In re Chapman, 595 F.3d 1330 (Fed. Cir.) (harmless-error principles in agency rulings)
- In re Watts, 354 F.3d 1362 (Fed. Cir.) (harmless-error review)
- In re Lee, 277 F.3d 1338 (Fed. Cir.) (courts should not make agency factual/discretionary determinations)
- ICC v. Brotherhood of Locomotive Engineers, 482 U.S. 270 (U.S.) (courts must respect agency factfinding)
- SEC v. Chenery Corp., 332 U.S. 194 (U.S.) (courts cannot supply agency’s reasons for decision)