Takeaway: A claim construction incorporating an industry standard that may differ depending on the application of the claimed invention is permissible and will not necessarily render a claim indefinite.

In its Decision, the Board denied a request for reconsideration of the Board’s Decision not to institute trial with regard to claims 20-23 of the ’468 patent (while instituting trial for claims 1-3, 7, and 9). Claims 20-23 had been challenged on two grounds of obviousness. Petitioner argued that “the Board’s decision not to institute was based upon a legally erroneous construction of the term ‘aseptic.’” Further, even using the Board’s construction of “aseptic,” Petitioner argued that the Board’s decision was based on erroneous factual findings. The Board denied Petitioner’s request.

The standard of review is abuse of discretion. See 37 C.F.R. § 42.71(c). “An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors.” Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004). “The party challenging the decision has the burden of showing a decision should be modified, and the request for rehearing must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71.

The Board first turned to claim construction of the term “aseptic,” as Petitioner contended “that the Board abused its discretion by misconstruing ‘aseptic,’ and by incorrectly applying the facts to this claim construction.” Specifically, Petitioner contended “that the Decision incorrectly concluded that ‘[i]f hydrogen peroxide is used as the sterilant, claim 20 requires compliance with the [FDA] standard level of residual hydrogen peroxide.’” Petitioner argued three reasons claim construction was in error: (1) there is no “FDA standard” for “aseptic;” (2) the FDA requirement of 0.5 ppm H2O2 (hydrogen peroxide) is not an “aseptic” standard; and (3) the Board’s construction renders the claims indefinite. The Board addressed each in turn.

First, the Board disagreed with Petitioner that an ordinary meaning of “aseptic” applied. Review of the specification “reveals that the ’468 patent adopted a special meaning of the term ‘aseptic,’ namely, to the FDA level of aseptic.” See Hormone Research, Inc. v. Genentech, Inc., 904 F.2d 1558, 1563 (Fed. Cir. 1990). Moreover, explicit requirements are described in the specification to meet “FDA aseptic standards.” Thus, Petitioner’s first argument was not persuasive. Similarly, Petitioner’s second argument was not persuasive because it was “premised on the interpretation that ‘aseptic’ is limited to its ordinary meaning of ‘free or freed from pathogenic microorganisms.’”

The Board last addressed indefiniteness, and notably stated that Patent Owner’s “assertion in the District Court case is not relevant to our inquiry here.” Specifically, Petitioner argued that “aseptic” incorporating “any applicable United States FDA standard creates an ambiguity that renders the claims indefinite.” The Board was not persuaded, and noted in a footnote that “[i]t has long been accepted that a standard may be included in a claim.” The Board also recognized that “FDA standards may differ depending on, for example, the type of foodstuff processed.” Thus, the Board was not persuaded that it had made an erroneous interpretation of law in construction.

Regarding Petitioner’s final argument that the Board abused its discretion by unreasonably applying the facts, the Board was also not persuaded. Petitioner argued that institution of claims 20-23 should proceed because the prior art taught a certain limitation, as “other Board proceedings have determined.” Noting that “Board decisions from other proceedings are not binding,” the Board stated that “the relevant inquiry is not whether the limitation was known in the art, determined to be known in another proceeding, or shown by Patent Owner” but whether “the Petition explained adequately how the construed claim is unpatentable.” See 37 C.F.R. §§ 42.104(b)(4)-(b)(5). On this, Petitioner acknowledged “that the Petition did not meet these requirements.”

Therefore, Petitioner’s request for rehearing was denied.

Nestlé Healthcare Nutrition, Inc. v. Steuben Foods, Inc., IPR2015-00249
Paper 37: Decision Denying Request for Rehearing
Dated: July 20, 2015
Patent: 6,481,468 B1
Before: Phillip J. Kauffman, Rama G. Elluru, and Beverly M. Bunting
Written by: Kauffman