In Re Huai-Hung Kao
639 F.3d 1057
| Fed. Cir. | 2011Background
- Endo seeks review of Board decisions affirming obviousness re three oxidephone-controlled-release opioid applications: '432, '859, and '740.
- Board relied on Maloney references, with substitutions of oxymorphone for oxycodone and a Paddle vs Basket dissolution-rate comparison to teach the claimed dissolution profiles.
- For the '432 Application, the Board found the dissolution-rate overlap supported by a correlation that lacked substantial evidence.
- The Board affirmed obviousness for the '859 Application based on Maloney teaching a 5–100 mg oxymorphone controlled-release formulation with 12-hour release and additional elements (hydrophobic/hydrophilic materials).
- For the '740 Application, the Board rejected claim 21 as obvious over Maloney in view of Reitberg, emphasizing a correlation between renal impairment and bioavailability.
- The Federal Circuit vacates the '432 decision and remands, but affirms '859 and '740.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Obviousness of '432 claims | Endo argues Board relied on improper facts regarding dissolution rates. | Office contends substitution and correlation yield obviousness. | Vacated and remanded for proper analysis. |
| Waiver and separate consideration of claim 20 | Endo separately argued claim 20. | Office waived separate consideration under 37 C.F.R. §41.37. | Waiver accepted; claim 20 treated with claim 1 on remand. |
| Obviousness of '859 claims (food effect, 12-hour effectiveness, hydrophobic material) | Maloney lacks explicit disclosures of claimed limitations; evidence shows nonobviousness. | Maloney inherently discloses limitations; secondary considerations insufficient. | Substantial evidence supports Board; however, on appeal the court sustains Board on primary grounds but notes nexus issues; remand directed for secondary considerations assessment. |
| Obviousness of '740 claim 21 | Ahdieh argues correlation between renal impairment and bioavailability was not known; nexus required. | King Pharmaceuticals and Ngai show informing steps lack sufficient functional relationship to invention. | Claim 21 rejected as obvious; affirmed for '740; issues limited by record on remand as appropriate. |
Key Cases Cited
- In re Kotzab, 217 F.3d 1365 (Fed. Cir. 2000) (obviousness as a question of law based on underlying facts)
- In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) (standard for substantial evidence in factual findings)
- KSR Intern. Co. v. Teleflex, Inc., 550 U.S. 398 (S. Ct. 2007) (flexible, common-sense approach to obviousness)
- Merck & Co. v. Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986) (non-enablement and reasonable expectation standard for obviousness)
- King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267 (Fed. Cir. 2010) (informing steps lack functional relationship with administering step)
- Ngai, 367 F.3d 1336 (Fed. Cir. 2004) (informing a patient about benefits does not render unpatentable)
- Ormco Corp., 463 F.3d 1299 (Fed. Cir. 2006) (nexus required between secondary considerations and claimed invention)
- In re Greenfield, 571 F.2d 1185 (CCPA 1978) (evidence of secondary considerations may establish commensurateness)