Appeal No. 1999-1256
Application No. 08/333,076
Thus, on this record, it appears that the full scope of claims 31 and 32
could only be practiced by those skilled in the art who carried out the very
considerable experimentation necessary to identify agents that promote
differentiation of embryonic stem cells into each of the different types of
possible differentiated cells.
Therefore, based on the factors set out in In re Wands, 858 F.2d 731, 737,
8 USPQ2d 1400, 1404 (Fed. Cir. 1988), and despite the high level of skill
in the art, we conclude that practicing the full scope of claims 31 and 32
would require undue experimentation. We therefore affirm the rejection of
claims 31 and 32 under 35 U.S.C. § 112, first paragraph.
Thus, as the decision itself makes clear, we applied the standard of enablement set out
in In re Wands and agreed with the examiner’s conclusion that undue experimentation
would have been required to practice the full scope of claims 31 and 32. The Wands
factors are an appropriate framework for analyzing enablement. See, e.g., Enzo
Biochem Inc. v. Calgene Inc., 188 F.3d 1362, __, 52 USPQ2d 1129, 1136 (Fed. Cir.
1999).
As for Appellants’ “analogous example,” we disagree that the instant claims are
analogous to an invention “directed to culture conditions for expression of recombinant
protein in a certain cell.” Such conditions would be expected to be similar regardless of
the specific heterologous protein being expressed by the cell. In the instant claims, by
contrast, the particular agent that is added to the differentiation culture medium
determines what type of cells the embryonic stem cells differentiate into: different
agents would be required to induce the embryonic stem cells to differentiate into each
type of differentiated cell (muscle cells, nerve cells, hematopoietic cells, skin cells, islet
cells, liver cells, etc.). Appellants’ example is therefore unhelpful to their case.
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