In Re Bimeda Research & Development Ltd.
724 F.3d 1320
| Fed. Cir. | 2013Background
- The '400 patent claims a method of preventing bovine mastitis by sealing the teat canal with a seal formulation that creates a physical barrier without using antibiotics.
- PTO ordered ex parte reexamination based on prior art showing teat seals that combined physical barriers with antiinfectives (e.g., antibiotics, acriflavine).
- Bimeda canceled original claims and added new claims; independent claims 18 and 26 (expressly antiinfective-free / no bacterial action) were allowed.
- Claim 32 expressly claimed a teat seal that is "acriflavine-free" (negative limitation); examiner rejected claims 32–39 under 35 U.S.C. § 112, ¶1 for lack of written description.
- The Board affirmed, finding the specification did not show possession of a formulation that specifically excludes the species acriflavine while permitting other antiinfectives (no "blaze marks").
- Federal Circuit affirmed: substantial evidence supports the Board’s finding that the specification conveys a non-antibiotic invention and thus does not support a claim excluding only acriflavine but allowing antibiotics or other antiinfectives.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether claim 32 (an "acriflavine-free" teat seal) meets § 112 written description | Specification broadly teaches antiinfective-free seals; omission of acriflavine from an example shows inventor intended acriflavine-free embodiments | Specification emphasizes a non-antibiotic invention and does not disclose excluding one species while permitting others; no guidance to target acriflavine | Affirmed: claim 32 lacks written description support; substantial evidence supports Board |
| Whether a genus disclosure supports a negative claim excluding one species of that genus | Bimeda: broad genus disclosure + example without acriflavine supports negative species exclusion | PTO/Board: genus disclosure alone insufficient; must have guidance toward excluding that particular species | Affirmed: genus disclosure insufficient without "blaze marks" to show possession of species exclusion |
| Whether Example 1 (no acriflavine) demonstrates possession of an acriflavine-free formulation that permits other antiinfectives | Bimeda: Example 1’s lack of acriflavine shows acriflavine-free embodiment | Board: Example 1 shows a formulation wholly free of antiinfectives (non-antibiotic); it does not disclose embodiments that exclude only acriflavine | Affirmed: Example 1 consistent with antiinfective-free disclosure, not the claimed dual-natured formulation |
| Standard of review for written description factual findings | Bimeda: challenges Board’s factual findings | PTO/Board: factual findings reviewed for substantial evidence | Court: applies substantial-evidence review and affirms Board’s factual findings |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir.) (en banc) (written description is a question of fact reviewed for substantial evidence)
- Gartside v. Harrison, 203 F.3d 1305 (Fed. Cir. 2000) (standard for written description review)
- In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967) (genus disclosure insufficient to support claims to specific species absent guidance)
- In re Hiniker Co., 150 F.3d 1362 (Fed. Cir. 1998) ("The name of the game is the claim"—claims govern scope)
- In re Jolley, 308 F.3d 1317 (Fed. Cir. 2002) (written description determined on facts of each case)
- Consol. Edison Co. v. NLRB, 305 U.S. 197 (Sup. Ct.) (definition of substantial evidence)