Interference 103,781
Inc. v. Monsanto Co., 243 F.3d 1316, 1332, 58 USPQ2d 1030, 1043
(Fed. Cir. 2001)(Paper No. 125):
“In order to establish an actual reduction to practice,
the inventor must prove that: (1) he constructed an
embodiment or performed a process that met all the
limitations of the interference count; and (2) he
determined that the invention would work for its intended
purpose.” Cooper v. Goldfarb, 154 F.3d 1321, 1327,
47 USPQ2d 1896, 1901 (Fed. Cir. 1998). In certain cases,
determining that the invention works for its intended
purpose will require testing. See Mahurkar v. C.R. Bard,
Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir.
1996). “[W]hen testing is necessary to establish utility,
there must be recognition and appreciation that the tests
were successful for reduction to practice to occur.”
Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 594-95,
44 USPQ2d 1610, 1615 (Fed. Cir. 1997).
To satisfy all the limitations of any claim designated as
corresponding to Count 2, the claimed synthetic Bt gene or
synthetic Bt gene made in accordance with a method claim
designated as corresponding to Count 2, must (1) encode a Bt
insecticidal protein, and (2) show enhanced expression in a plant
transformed thereby relative to the native Bt gene from which the
synthetic or modified Bt gene was derived. We conclude that all
the synthetic Bt genes or methods for designing synthetic Bt
genes or modifying native Bt genes of the claims designated as
corresponding to Count 2 require that the synthetic Bt gene
encode a Bt insecticidal protein. Moreover, we conclude that all
the claimed synthetic Bt genes or methods for designing synthetic
Bt genes or modifying native Bt genes designated as corresponding
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