Appeal No. 1998-0370
Application No. 08/568,410
218 USPQ 385, 388 (Fed. Cir. 1983); In re Okuzawa, 537 F.2d 545, 548, 190 USPQ 464,
466 (CCPA 1976).
Claim 1 requires the composition to contain ingredients which are “Generally
Regarded As Safe” (GRAS). In order to determine the limitations of GRAS, we look to the
specification. The specification refers to United States Code of Federal Regulations, Title
21 Section 173.315. (Specification, page 2, lines 17-23). Section 173.315 provides
regulations for substances to be used in washing or to assist in the lye peeling of fruits and
vegetables. Section 173.315 does not provide an exhaustive list of GRAS ingredients.
Section 173.315 does not expressly provide a definition for GRAS or refer to a specific
section of the United States Code of Federal Regulations for a definition.4 Since the
specification does not provide a definition for GRAS, we will use the plain and ordinary
meaning for the phrase, that is, the composition contains only ingredients that will not harm
humans. See In re Paulsen, 30 F.3d 1475, 1479, 31 USPQ2d 1671, 1674 (Fed. Cir.
1994) (when interpreting a claim, words of the claim are generally given their ordinary and
accustomed meaning, unless it appears from the specification or the file history that the
words were used differently by the inventor.) In sum, our construction of the subject
matter defined by Appellants’ claim 1 is that the claimed subject matter is directed to a
4 We note that 21 CFR § 182.1 describes “substances that are generally recognized as safe.”
This section does not provide an exhaustive list of substances generally recognized as safe.
Specifically this section states: “ it is impracticable to list all substances that are generally recognized
as safe for their intended use.”
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