Interference 105,004 Paper 18
DeBoer v. Gordon
that it was not known which sequences were required for promoter
activity; nor was their location known. (Id. at 2–3.)
23. Dr. Strijker testified that he is unaware of anyone
having successfully expressed a heterologous protein in the milk
of a transgenic animal as of 1986. (Id. at 3, ¶7.)
24. Dr. Strijker also testified that 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.” (Id.)
25. Dr. Strijker states that Campbell & Rosen (JE009),
published in 1984, reports that the WAP promoter had a “very
unusual TATA box,” as well as a CAAT sequence. (JE005 at 4, ¶9.)
26. Review of Campbell and Rosen confirms Dr. Strijker’s
characterization: an upstream sequence, TTTAAAT, is described as
“an unusual ‘TATA box,’ and another upstream sequence, CAAAGTCT,
is described as “similar to the ‘CAAT’ box.” Both sequences were
located in the upstream portions of both mouse and rat WAP genes.
(JE009 at 8694.)
27. Dr. Strijker states that he would have inferred from
the unusual TATA box structure that the WAP promoter was
“inherently extremely weak, and/or that the WAP promoter was
regulated in a manner not yet known and probably requiring one or
more additional sequences besides the TATA box and the CAAT
region.” (Id.) (JE005 at 4, ¶9.)
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