Docket No. 2016-1750
REYNA, MAYER, HUGHES
May 9, 2017
Brief Summary: PTAB’s incorporation of “any applicable United States FDA standard” into the term “aseptic” where “the specification twice defines the term ‘aseptic’ as the United States ‘FDA level of aseptic’” (“binding lexicography”) was erroneous; decision vacated and remanded.
Summary: Nestle appealed PTAB finding that claims 18-20 of US 6,945,013 relating to “‘method[s] for automatically aseptically bottling aseptically sterilized foodstuffs,’ where bottles are ‘aseptically disinfect[ed]’ ‘at a rate greater than 100 bottles per minute,’ and ‘aseptically fill[ed]…with aseptically sterilized foodstuffs’” were not obvious in view of the cited prior art. The PTAB construed “aseptic” to mean “aseptic to any applicable United States FDA standard, and in the absence of any such standard, aseptic assumes its ordinary meaning of free or freed from pathogenic microorganisms.” Based on this construction, the PTAB determined the claims would not have been obvious (no reasonable expectation of success). Nestle argued, and the FC panel agreed, that construction of “aseptic” to include “‘any applicable United States FDA standard’ rather than only FDA regulations governing ‘aseptic packaging’” is erroneous. The FC panel explained that PTAB claim constructions are reviewed de novo and its underlying factual determinations involving extrinsic evidence for substantial evidence” unless “the intrinsic record fully determines the proper construction” (Microsoft, FC 2015). And in an IPR the claims are construed according to their “broadest reasonable interpretation” that is legally correct (Cuozzo, US 2016; In re Skvorecz, FC 2009), unless the patentee “choose[s] to be his own lexicographer” (Vitronics, FC 1996; Martek Bio., FC 2009 (“When a patentee explicitly defines a claim term in the patent specification, the patentee’s definition controls.”)) “Here,”, the FC panel concluded, “the specification twice defines the term ‘aseptic’ as the United States ‘FDA level of aseptic’”, which is “binding lexicography”. “The question”, here, however, “is the scope of the phrase” (Markman, FC 1995). According to Steuben, the phrase “incorporates the full ‘panoply of FDA standards’”, similar to the PTAB’s conclusion, meaning that the final product has “a hydrogen peroxide residue of less than 0.5 ppm.” The FC panel disagreed because, e.g., “[w]here the patentee wished to claim embodiments requiring less than 0.5 ppm of hydrogen peroxide residue, it did so using express language” and “the scope of ‘aseptic’ cannot include regulations that apply to foods that are not aseptically packaged.” It found the FDA’s definitions of “aseptic processing and packaging” and “commercial sterility” in its regulations as “consistent with the specification, which itself describes certain microorganism reduction features of the invention immediately after defining the term ‘aseptic’.” Thus, it concluded the PTAB’s incorporation of “any applicable United States FDA standard” into “aseptic” was erroneous, and vacated and remanded the decision.