The Federal Circuit, in Nestle USA v. Steuben Foods, vacated a decision by the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) for an unreasonably broad interpretation of the term “aseptic.” Notably, where the patent refers to “FDA level of aseptic” for aseptic packaging, the proper interpretation should be focused on FDA regulations specifically on aseptic packaging, and not to “any applicable United States FDA standard.”
Petitioner Nestle petitioned for IPR of claims 18-20 of U.S. Patent No. 6,945,013, owned by Respondent Steuben Foods. The claims cover methods for automatically aseptically bottling aseptically sterilized foodstuffs. Respondent argued that “FDA level of aseptic” must include all FDA standards, with which the PTAB agreed. As a result, the PTAB held that claims 18-20 were not obvious. Petitioner then appealed to the Federal Circuit.
The Court, reviewing de novo, held that the specification explicitly defined the term and that the broadest reasonable interpretation must be bound by this explicit definition. The specification defined “aseptic” as the United States “FDA level of aseptic.” Furthermore, the specification noted that prior art systems failed to provide aseptic filler complying with FDA standards “for labeling a packaged product as ‘aseptic.’” That is, according to the specification, the term “aseptic” must be focused on aseptic packaging, and not on aseptic foods in general.
The PTAB’s definition would require anything “aseptically” packaged to have a hydrogen peroxide residue of less than 0.5 parts per million (ppm). However, the Court noted that embodiments that required less than 0.5 ppm of hydrogen peroxide used express language to that effect, and that the FDA’s residue standard applied regardless of whether foodstuffs were aseptically packaged. Because the patent at issue was focused on aseptic packaging, the Court noted that regulations that applied to foods that are not aseptically packaged should not be considered. Thus, the Court held that the proper interpretation of “aseptic,” relying on FDA regulations toward aseptic packaging, as directed toward microorganism reduction features, and not toward hydrogen peroxide residue.
As is becoming a trend, the Federal Circuit is willing to cabin in unreasonably broad interpretations of claim terms by the PTAB if the application has supporting intrinsic evidence. In particular, when the specification has a specific definition of a term, courts will rely on that definition and the context of the specification for reasonable interpretation of the term. For elements of a claim that are crucial to patentability and can afford to be narrowly construed, including a definition in the specification can obviate a lot of hassle during prosecution. While this case is nonprecedential, it evinces that the Federal Circuit will rely on the context of the specification to interpret claim terms, and patent prosecutors may be able to take advantage of this shift during drafting and prosecution of patent applications.