On May 9, 2017, the U.S. Court of Appeals for the Federal Circuit issued a non-precedential decision in Nestle USA Inc. v. Steuben Foods, Inc. (2016-1750) illustrating that even when you win at inter partes review (IPR), you can lose.
The Federal Circuit panel consisted of Judges Reyna, Mayer, and Hughes. Judge Hughes delivered the panel’s opinion.
In a rare IPR affirming patentability, the Patent Trial and Appeal Board (the “Board”) found claims of US Patent No. 6,945,013 to be patentable that were directed to a “method for automatically aseptically bottling aseptically sterilized foodstuffs” in which bottles are “aseptically disinfected at a rate greater than 100 bottles per minute”. However, this unusual pro-patentee outcome was too much for the Federal Circuit. It ultimately vacated and remanded on claim construction grounds, thus highlighting the success of IPRs in achieving their goal of judicial economy.
The Board 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.” According to the patentee, this required anything “aseptically” packaged to satisfy the regulatory requirement of 21 C.F.R.§ 178.1005(d) that the final product have a hydrogen peroxide residue of less than 0.5 ppm.
The Board disagreed, noting that where “the patentee wished to claim embodiments requiring less than 0.5 ppm of hydrogen peroxide residue, it did so using express language”, selectively employing, as is its wont, claim differentiation as needed (or not) to invalidate a patent. Further, the Board stated that the scope of “aseptic” cannot include regulations that apply to foods that are not aseptically packaged, meaning an “FDA level of aseptic” must be confined to FDA regulations related to aseptic packaging per se. Admitting that the FDA does not define “aseptic” outright, the Federal Circuit insisted that “at the time of the application, it defined ‘aseptic processing and packaging’ as ‘the filling of a commercially sterilized cooled product into presterilized containers, followed by aseptic hermetical sealing, with a presterilized closure, in an atmosphere free of microorganisms.’” The Federal Circuit then linked this to another FDA definition of an unclaimed term for “commercial sterility” to arrive at its claim construction.
Perhaps most intriguing is that the Federal Circuit seized on a statement from the patent’s background to define a claim term. The background stated that the prior art systems failed to “provi[de] a high output aseptic filler that complies with the stringent United States FDA standards for labeling a packaged product”, which the Federal Circuit bootstrapped into “support” for its preferred claim construction. But obviously this statement in the background was not a definition in any sense of the word.