Interference 105,004 Paper 18
DeBoer v. Gordon
having successfully expressing a heterologous protein in the milk
of a transgenic animal as of 1986. (JE005, Strijker declaration
at 3, ¶7.) We conclude that the technical development of the
field of the inventions was at an early stage in 1986.
Consistently, Dr. Meade states that it was unknown whether a
promoter from one species could effectively drive expression of a
protein coding sequence from a second species in the mammary
gland of a third species. (JE005 at 3–4, ¶9.) Dr. Strijker’s
testimony is also consistent: as of 1986, “it had not been
determined which, if any promoters, were suitable for the task,
and what if any other regulatory sequences might be required to
achieve expression in milk.” (JE007 at 3, ¶7.) We conclude from
these statements that as of 1986, there was little empirical
evidence relating to the efficacy of promoters taken from one
species used in another. Thus, there was, as of the critical
date, little if any basis for predicting the results of linking
different regulatory sequences to other protein coding sequences.
Particularly relevant to the status of the WAP promoter, Dr.
Meade states that whey acid protein is specific to rodents, and
is not normally present in the milk of ruminants. (JE007
at 3, ¶7.) Moreover, Dr. Meade states that there was no evidence
that the WAP promoter would function in bovines (id.), and that,
in 1986, he thought it would have been more likely that a milk
promoter from a ruminant would facilitate expression of
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