Appeal No. 1996-1801
Application 08/142,049
The examiner has rejected appealed claims 1, 4, 5, 8, 9, 13, 16, 17 and 19 under 35 U.S.C. §
103 as being unpatentable over Falciani in view of Anthony and Bacehowski. The
examiner has also rejected appealed claims 14 and 15 under 35 U.S.C. § 103 as being unpatentable
over Falciani in view of Anthony and Bacehowski as applied to claim 13, and further in view of
Pomerantz and Anderson. We affirm.
Rather than reiterate the respective positions advanced by the examiner and appellant, we refer
to the examiner’s answer and to appellant’s brief for a complete exposition thereof.
Opinion
We have carefully reviewed the record on this appeal and based thereon find ourselves in
agreement with the examiner that the claimed sterilization method encompassed by appealed claim 1
would have been obvious over the combined teachings of Falciani, Anthony and Bacehowski, and that
the claimed sterilization method encompassed by appealed claim 14 would have been obvious over the
combined teachings of Falciani, Anthony, Bacehowski, Pomerantz and Anderson, to one of ordinary
skill in this art at the time the claimed invention was made. We agree with the position advanced on
appeal by the examiner, including the response to appellant’s arguments in the brief, adding the
following for emphasis.
We find from the combined teachings of Falciani, Anthony and Bacehowski that it was known
in the art to employ a multi-enclosure package, which can be inserted into a shipping package, to
maintain the sterility of various biological materials under various levels of contamination, wherein the
various enclosures surrounding such materials can be peeled away as necessary to maintain the desired
level of sterilization of the surface of the presented outer enclosure of the package in the area in which
the package is to be placed. See, e.g., Bacehowski, col. 7, lines 17-33. Each of Falciani, Anthony
and Bacehowski utilize gamma radiation to sterilize a multi-enclosure package, with only Bacehowski
performing the sterilization step prior to filing the multi-layer container 10 with a biological solution (col.
6, lines 46-49). In Falciani, the pharmaceutical product was sterilized via “ã-rays” “in bag 1” which
was hermetically sealed (col. 2, lines 41-44; emphasis supplied), prior to insertion of “bag 1” into
further hermetically sealed enclosures and encasing the resulting multi-enclosure package for shipping
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