In Becton, Dickinson and Company v. Baxter Corporation Englewood, [2020-1937] (May 28, 2021), the Federal Circuit reversed that PTAB determination that certain claims of U.S. Patent No. 8,554,579 were not invalid as obvious.

The ’579 Patent is directed to systems for preparing patient-specific doses and a telepharmacy method in which data captured while following a protocol associated with each received drug order and specifying a set of steps to fill the drug order are provided to a remote site for review and approval by a pharmacist.

At issue was whether the art disclosed a verification step. Baxter successfully argued to the PTAB that the art taught that there may be a verification step, but not that there must be a verification step. The Federal Circuit concluded that the Board’s determination was not supported by substantial evidence. The Federal Circuit said that in the context of the prior art, “may” does not mean “occasionally,” but rather that one “may” choose to systematically check each step. Examining the reference, the Federal Circuit concluded that the purpose was to provide verification, and thus it satisfied the verification step.

Also at issue was whether the art disclosed the highlighting limitation, which requires “an interactive screen that includes prompts that can be highlighted by an operator to receive additional information relative to one particular step.” The Federal Circuit found that one of the references teaches highlighting in the pharmacy context, and said that the Board erred in looking to the reference as the only source a person of ordinary skill would consider for what “additional information might be relevant.” A person of ordinary skill is also a person of ordinary creativity, not an automaton.

Finally, the Federal Circuit said that Baxter does not meaningfully argue that the weak showing of secondary considerations here could overcome the showing of obviousness based on the prior art.