Appeal No. 1996-1801
Application 08/142,049
(e.g., col. 3, lines 17-21). In Anthony, the biological tissue was successively hermetically enclosed by
at least two enclosures to form a multi-enclosure package, which package and all of the contents
thereof were then sterilized by radiation (e.g., col. 2, lines 29-32; col. 3, lines 55-57; col. 5, lines 27-
32; and col. 8, lines 13-19).
Based on the objective evidence in the combined teachings of Falciani, Anthony and
Bacehowski, we find that one of ordinary skill in this art would have recognized that irradiation of
enclosed biological material with gamma radiation, including material surrounded by multi-enclosures, as
well as the irradiation of a multi-enclosure package prior to insertion of the biological material, is a result
effective step in a sterilization method comprising preparing, enclosing, transporting and storing sterilized
biological material, which irradiation step can be performed at various points in the process. 3
Accordingly, we find that, prima facie, one of ordinary skill in this art would have been
motivated to irradiate the final package containing the biological material with gamma radiation, whether
that package was for storage or for shipping, with the reasonable expectation of sterilizing each of the
enclosures constituting the package and the biological material contained therein in order to obtain the
desired level of sterilization to meet the conditions that the final package would encounter. Thus, prima
facie, one of ordinary skill in this art following the combined teachings of Falciani, Anthony and
Bacehowski would have arrived at the claimed method encompassed by appealed claim 1. In re
Gorman, 933 F.2d 982, 986-87, 18 USPQ2d 1885, 1888-89 (Fed. Cir. 1991) (“The extent to which
such suggestion [to select elements of various teachings in order to form the claimed invention] must be
explicit in, or may be fairly inferred from, the references, is decided on the facts of each case, in light of
3It is axiomatic that in evaluating the teachings of a reference, we must consider the specific teachings
thereof and the inferences one of ordinary skill in this art would have reasonably been expected to draw
therefrom. In re Fritch, 972 F.2d 1260, 1264-65, 23 USPQ2d 1780, 1782-83 (Fed. Cir. 1992); In
re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Thus, the definition of a term or
the meaning of a phrase in a reference must be construed within the context of the reference as
interpreted by one of ordinary skill in this art. See In re Salem, 553 F.2d 676, 682-83, 193
USPQ 513, 518 (CCPA 1977). In evaluating the relevance of the various teachings of the reference,
we must presume skill on the part of those of ordinary skill in this art. See In re Sovish, 769 F.2d 738,
743, 226 USPQ 771, 774 (Fed. Cir. 1985).
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