Medical Infomatics Claim Construction

In a recent IPR appeal at the Federal Circuit, the Court reviewed the Board's claim construction de novo and found that the Board improperly added an element to their Broadest Reasonable Interpretation (BRI) of the claim terms. Because the Board improperly added a limitation, they reached an incorrect conclusion that the claim distinguished the prior art.

Patentee wins before the PTAB are rare, and as seen in this case are vulnerable on appeal with regard to claim construction issues. The patent related to tracking patient information on wearable medical treatment devices. The claims required consideration of "patient compliance data." The Board construed this to mean "data indicating whether a patient has followed instructions for use." Following this construction, the PTAB then found the prior art lacking because it was not clear that the prior art device actually provided instructions to the user. From the opinion:

[The initial construction has] no specific requirement relating to the instructions for use. The Board did not take issue with [Petitioner] showings that [the prior art] disclosed playing an audio message requesting that the patient press a button and storing information about button presses . Instead, it required more: evidence that the reference disclosed a system for “assur[ing] that every, or indeed any, recorded button push was performed in response to an instruction.”

Once it was determined that the Board added a limitation, the next step was to decide whether the added limitation was part of the proper construction. This was a relatively simple question since case law makes clear that 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. See SiRF Tech., Inc. v. Int’l Trade Com’n., 601 F.3d 1319, 1330 (2010).