Appeal No. 1998-1719
Application No. 08/442,603
viewed by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1039, 228 USPQ
685, 687 (Fed. Cir. 1986).
Here, even though the references relied on by the examiner do not teach
Appellants’ modification to the translation start site in the pGB20 plasmid,
Appellants have admitted that this modification was known in the art to provide
optimal translation in mammalian cells. Since the prior art as a whole must be
considered in determining the obviousness of a claimed invention, I conclude that
the references relied on by the examiner, viewed as they would have been viewed
by one of ordinary skill, support a prima facie case of obviousness.
“When prima facie obviousness is established and evidence is submitted in
rebuttal, the decision-maker must start over.” In re Rinehart, 531 F.2d 1048, 1052,
189 USPQ 143, 147 (CCPA 1976). “If a prima facie case is made in the first
instance, and if the applicant comes forward with reasonable rebuttal, whether
buttressed by experiment, prior art references, or argument, the entire merits of the
matter are to be reweighed.” In re Hedges, 783 F.2d at 1039,
228 USPQ at 686.
Here, Appellants have provided evidence that the claimed host cells
unexpectedly secrete the recombinant glucocerebrosidase enzyme. In a
declaration under 37 CFR § 1.132, applicant Gary Barsomian states that
[g]lucocerebrosidase is known to be a lysosomal enzyme which, like
other lysosomal enzymes, is targeted to lysosomes within
mammalian cells. This means that one skilled in the art would
normally expect such an enzyme to be retained within the cell once
expressed, and not secreted into the medium in any significant
amounts. Accordingly, it was unexpected to discover that
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