Is "Effective" Language in U.S. Claims Definite?
Last week, in BASF v. Johnson Matthey, the Federal Circuit addressed the issue of whether the phrase “effective to catalyze” rendered claims indefinite under 35 U.S.C. §112. Given the prevalence of “effective” language in U.S. claims (for example, “effective amount”), it’s worth taking a look at what happened in BASF to see what, if any, lessons can be learned.
By way of background, in Nautilus v. Biosig Instruments (2014), the U.S. Supreme Court ruled that a claim is indefinite under 35 U.S.C. §112 when the claim fails “to inform, with reasonable certainty, those skilled in the art about the scope of the invention” when read in light of the specification and prosecution history. Reasonable certainty does not require absolute or mathematical precision.
In BASF, the claims were directed to a two-layer structure, with each layer containing a material “effective to catalyze.” The district court (Delaware) ruled that the claims were indefinite under 35 U.S.C. §112.
On appeal, defendant Johnson Matthey focused on the catalytic materials, arguing that the effective-to-catalyze language was functional and that there were no “objective boundaries on (1) what amount of effectiveness is required, or (2) how to measure the effectiveness.” However, the Federal Circuit focused on the claimed two-layer structure, not the catalytic materials in the layers, despite the fact that the “effective” language related to the catalytic materials.
Initially, the Federal Circuit ruled that “[n]othing inherent in the standard of ‘reasonable certainty’ precludes a relevant skilled artisan from understanding with reasonable certainty what compositions perform a particular function. Not surprisingly, we have long held that nothing in the law precludes, for indefiniteness, ‘defining a particular claim term by its function.’”
Lesson No. 1: “Effective” language in claims is not per se indefinite after Nautilus. But this is really not surprising, particularly in view of the prevalence of such language in U.S. claims.
The Federal Circuit went on to state that “[w]hat is needed is a context-specific inquiry into whether particular functional language actually provides the required reasonable certainty.” In BASF, the context-specific inquiry focused on the novel two-layer structure. The Federal Circuit ruled that the invention related to the two-layer structure, not to selection of particular catalysts or materials, and that the patent informed the public that “any catalysts can be used as long as they play their claimed role in the claimed architecture.”
Based on this analysis, the Federal Circuit reversed the district court’s ruling of invalidity for indefiniteness.
In BASF, the context (two-layer structure) was not directly related to the “effective” language in the claims. But what would happen if the context were directly related to “effective” language – for example, a claimed directed to treating a disease using an effective amount of a drug? Would Johnson Matthey’s arguments be more effective in such a case if there were no objective boundaries on (1) what amount of effectiveness is required to treat the disease, or (2) how to measure the effectiveness in treating the disease?
Lesson No. 2: Don’t necessarily assume “effective” language is definite: In BASF, the district court was persuaded that “effective” language was indefinite. Perhaps, given the appropriate facts, the Federal Circuit would be persuaded as well. The bottom line is that “effective” language in claims should be examined to determine if it is definite, particularly where the language is directly related to the context of the invention.