Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.
821 F.3d 1359
| Fed. Cir. | 2016Background
- Illumina owns U.S. Patent No. 7,566,537 directed to a sequencing-by-synthesis (SBS) method using nucleotides labeled via a cleavable linker and having a 2′ or 3′ protecting group that "comprises an azido group." Claim 1 recites a protecting group attached via the 2′ or 3′ oxygen that can be modified or removed to expose a 3′-OH.
- IBS petitioned for inter partes review (IPR) challenging claims 1–6 and 8 as obvious under 35 U.S.C. § 103 based on combinations of prior art: Tsien or Ju (teach SBS and 3′-OH protecting groups but not azido) combined with Zavgorodny (teaches azidomethyl as a cleavable protecting group).
- The Board instituted review but in its Final Written Decision found IBS failed to prove obviousness by a preponderance, mainly reasoning that an ordinary artisan would not have been motivated to combine the references given evidence that azidomethyl deprotection yields were not "quantitative."
- Key technical dispute: Tsien and Ju require "quantitative" (near-100%) deblocking for SBS; Loubinoux and Greene & Wuts in the record report only 60–80% or potentially lower yields for azidomethyl deprotection, undermining the contention that azidomethyl would meet Tsien/Ju criteria.
- The Board excluded IBS’s reply brief and accompanying expert declaration as improperly raising new arguments and new evidence in reply in violation of 37 C.F.R. § 42.23(b) (and possibly § 42.6(a)(3)).
- The Federal Circuit affirmed: it rejected IBS’s challenge, holding that substantial evidence supports the Board’s finding that IBS failed to show motivation to combine (and thus obviousness), and that the Board did not abuse discretion in excluding the reply materials.
Issues
| Issue | Plaintiff's Argument (IBS) | Defendant's Argument (Illumina) | Held |
|---|---|---|---|
| Whether claims are obvious over Tsien/Ju combined with Zavgorodny | An ordinary artisan would be motivated to combine because both concern SBS and would have chosen azidomethyl as a suitable protecting group; reasonable expectation of success exists | Azidomethyl would not meet the quantitative deblocking criterion taught in Tsien/Ju; prior art (Loubinoux, Greene & Wuts) shows low deprotection yields, so no motivation to combine | Affirmed: substantial evidence supports Board finding that IBS failed to show motivation to combine; claims not proven obvious |
| Whether the Board improperly required "quantitative" deblocking to satisfy claim scope | IBS: claims do not require quantitative cleavage so Board erred if it used that standard | Illumina: argued that petitioner’s own petition relied on meeting Tsien/Ju quantitative criterion as the reason to combine; prior art undermines that rationale | Court: agreed Board improperly conflated reasonable expectation-of-success inquiry with claim scope, but nonetheless found Board’s factual finding (no motivation to combine) supported by substantial evidence |
| Whether the Board abused discretion by excluding IBS’s reply brief and expert declaration | IBS: reply argued obviousness-to-modify conditions; expert evidence showed such modifications would be within skill of ordinary artisan | Illumina: reply raised a new theory and new evidence for the first time in reply, violating IPR rules that require the initial petition to present the case | Affirmed: Board did not abuse discretion in refusing to consider reply and declaration because they raised new arguments/evidence beyond the petition |
| Standard of review and sufficiency of the record | IBS: Board misapplied law/fact in assessing reasonable expectation and motivation | Illumina: record (Loubinoux, Greene & Wuts, petition framing) provides substantial evidence for Board findings | Court: reviewed legal issues de novo as appropriate but applied substantial-evidence review to factual findings and found them supported; affirmed |
Key Cases Cited
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (explains "obvious to try" and requirement of reasonable expectation of success in obviousness analysis)
- In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) (standard for reviewing Board factual findings under substantial evidence)
- Par Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186 (Fed. Cir. 2014) (motivation to combine and reasonable expectation of success are factual questions)
- Allergan, Inc. v. Apotex Inc., 754 F.3d 952 (Fed. Cir. 2014) (failure to consider claim scope in reasonable-expectation analysis is legal error)
- Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342 (Fed. Cir. 2012) (petition must show motivation to combine and reasonable expectation of success to prevail on obviousness)