Appeal 2007-1161
Application 09/954,166
terminus of the variable regions of the heavy chain and the light chain”
(Answer 6).
19. “[T]he fusion proteins retain binding activity” (Answer 6). See, e.g.,
Harris, p. 14.
20. “[T]he binding domains can include cell surface receptors (see [Harris]
entire document, particularly pages 6-8, page 12, lines 15-19 and page 13,
lines 7-16 and Figures 2, 6, 8 and 9)” (Answer 6).
Level of Skill
21. As summarized below, the evidence of record establishes that the
technical skill of the ordinary skilled worker at the time the invention was
made was high.
22. Each of Dal Porto, Chang, and Harris teach engineering of complexes of
various types of fusion proteins.
23. Dal Porto describes heavy chain immunoglobulin grafted with MHC
domains (Dal Porto, p. 6673. col. 2).
24. Chang discloses a dimeric fusion protein complex, where each fusion
protein comprises an extracellular TCR domain fused to a coiled coil domain
of leucine zippers (Chang, p. 11408).
25. Harris teaches various types of extracellular domains fused to light and
heavy immunoglobulin chains (Harris, p. 6-7), similar in structure to Dal
Porto’s molecule.
26. Thus, the skilled worker had the technical skill and knowledge to
prepare fusion proteins, including the knowledge to select a receptor type
(e.g., MHC or TCR) and a polypeptide to fuse it to (e.g., coiled coil,
immunoglobulin light chain; immunoglobulin heavy chain),
7
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