While sufficiently ambiguous to escape harm in this instance, it is generally not good practice to characterize “the invention” as relating to any particular embodiment. It did, after all, take an appeal to the Federal Circuit to overturn a district court’s conclusions here to the contrary.
Background / Facts: The patents being asserted here cover a sterile, pharmaceutically effective budesonide product, which is used to treat asthma in children. The claims recite a pharmaceutically acceptable suspension consisting of a “micronized powder” composition, which the district court construed as requiring heat sterilization due to the patent specification’s perceived disavowal of any other type of sterilized micronized powder compositions.
Issue(s): Whether the patent specification’s statements that refer to “the invention” as associated with a particular form of dry heat sterilization constitute a disavowal of any other type of sterilized micronized powder compositions.
Holding(s): No. “There is no dispute that the patent refers only to dry heat sterilization as the preferred method of achieving the claimed ‘micronized powder composition’ and criticizes, often sharply, other forms of sterilization. Nonetheless, ‘[m]ere criticism of a particular embodiment encompassed in the plain meaning of a claim term is not sufficient to rise to the level of clear disavowal.’… ‘It is likewise not enough that the only embodiments, or all of the embodiments, contain a particular limitation.’” In this particular case, “[the] statements with respect to ‘the invention’ are ambiguous at best, given the three distinct types of inventions (processes, products, and methods of use) described in the specification. … At most, the specification is confusing with respect to whether it limits only the disclosed process to a specific form of sterilization or both the process and the disclosed product to a specific form of sterilization. However, that confusion leaves available an interpretation of the patent that the products, as opposed to the processes, are not limited to any particular form of sterilization. Accordingly, we cannot conclude that [the patentee] disclaimed non-heat sterilized micronized powder compositions based on the specification.”