Unclaimed elements that are essential for operation of the claimed invention need not necessarily be claimed. Here, for example, information about how “patient compliance data” was obtained for the claimed recording of such information was found to be permissibly outside the scope of the claimed invention even though it was a necessary precondition. “[T]he fact that an unclaimed element may be necessary for a device to function as claimed does not, standing alone, allow courts to treat the unclaimed element as a claim limitation.” This would be a good case to consult and cite in response to a rejection or other requirement based on essential but unclaimed features.
Background / Facts: The patent on appeal here from inter partes review proceedings at the PTO is directed to wearable medical devices that can record and remotely communicate a patient’s medical information. The claims recite recording, among other medical information, “patient compliance data” in a storage unit, but make no mention about how the patient compliance data is obtained.
Issue(s): Whether the claims inherently include information about how the patient compliance data is obtained since this is an essential prerequisite to being able to store the patient compliance data.
Holding(s): No. “As we have previously made clear, the fact that an unclaimed element may be necessary for a device to function as claimed does not, standing alone, allow courts to treat the unclaimed element as a claim limitation. … The claimed concept of storing patient compliance data may be possible only if the patient is provided instructions with which he can comply. But this fact alone does not elevate the instructions or any information about them to the level of a claim limitation. The Board’s additional requirement that the device give the patient particular instructions or store particular information about the instructions given to the patient therefore finds no place in the ‘patient compliance data’ claim term.”