There is no requirement for the specification to identify a particular measurement technique for ascertaining a claimed value or range of values as long as such an understanding is within the scope of knowledge possessed by one of ordinary skill in the art. Here, for example, an “average” clamping/coaptation pressure in the range “between and including 60 psi and 210 psi” was found to be sufficiently definite under 35 U.S.C. § 112(b) because one skilled in the art would understand “the underlying physics- and mathematics-based link between the average pressure and the midpoint of [a] clamping arm.” “If such an understanding of how to measure the claimed [values] was within the scope of knowledge possessed by one of ordinary skill in the art, there is no requirement for the specification to identify a particular measurement technique.” This would be a good case to consult and cite in response to an indefiniteness rejection for a claimed value or range of values being indeterminate.
Background / Facts: The patents being asserted here are directed to surgical instruments that use ultrasonic energy created by blades vibrating at high frequencies to cut tissue and blood vessels. The asserted claims recite or imply an “average” clamping/coaptation pressure in the range “between and including 60 psi and 210 psi,” which is described as providing improved blood vessel sealing over that conventionally achievable. Neither the claims nor the specification, however, specifically refer to any particular point on the clamping surface area at which to take the recited pressure measurements or identify a location at which the clamping force is to be measured.
Issue(s): Whether the specification (or claims) is required to identify a specific method one of ordinary skill in the art would use to measure the recited clamping/coaptation pressures.
Holding(s): No. “[I]n the context of the dispute here, the definiteness requirement of 35 U.S.C. § 112 mandates only that one skilled in the art must be able to understand which pressures are relevant to the claims and how those pressures can be measured, so to discern the scope of the claimed average pressure range with reasonable certainty. [] If such an understanding of how to measure the claimed average pressures was within the scope of knowledge possessed by one of ordinary skill in the art, there is no requirement for the specification to identify a particular measurement technique.” It is uncontested that one skilled in the art would understand “the underlying physics- and mathematics-based link between the average pressure and the midpoint of [a] clamping arm.” Thus, “evidence in the record demonstrates that because the specification and claims of the [] patent focused on average clamping and coaptation pressures, a skilled artisan would have possessed such an understanding and such knowledge.”