In a recent Federal Circuit opinion, Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc. (Dec. 2020), the patentee, Bracco, claimed a synthetic hormone formulation that includes "a surfactant/solubilizer" which the specification explained "may reduce interfacial tension or aid in solubilization … . Surfactants/solubilizers include … amino acids". Maia's product included amino acids that did not act as surfactants and solubilizers.
Two of Maia's arguments are of particular interest. The first of these is that the specification's usage pattern for the slash ("/") indicates an intended meaning of "and", because it is consistently used in connection with elements that perform multiple functions. Bracco countered that in each case, the slash could also be taken to mean "or". The court ultimately relied on the doctrine of claim differentiation to decide that the intended meaning of the slash was "and/or". Patent practitioners should accordingly take note that slashes often create ambiguity, and should either avoid their use or take care to specify the intended meaning in the specification.
The second of Maia's notable arguments was that the lower court's construction of a surfactant as an excipient that "may" reduce interfacial tension is meaningless, because every excipient "may" or "may not" reduce interfacial tension. The court acknowledged that, standing alone, the term "may" is ambiguous. However, in context, the court interpreted "may" to indicate some inherent measure of likelihood. Thus the term "may" was found to include those excipients that reduce interfacial tension, or are capable of reducing interfacing tension, but to exclude those excipients that can never reduce interfacial tension.
This case thus presents another important take-home lesson for patent practitioners, most of whom have been trained to use the term "may" liberally as a way of making their disclosures nonlimiting. The term "may" can be limiting on the scope of the disclosure and claims, potentially excluding those elements incapable of the described characteristic. Practitioners that continue to use "may" in their specifications should consider whether to provide further clarification that those characteristics are truly optional or are a required theoretical capability of those elements.
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