Appeal No. 2003-1668 Page 7
Application No. 08/479,883
experimentation, which species among all those encompassed by the claimed
genus possess the disclosed utility.” Vaeck, 947 F.2d at 496, 20 USPQ2d at
1445 (footnote omitted). Whether the amount of experimentation required is
“undue” is determined by reference to the well-known Wands factors. See
Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
In this case, we agree with Appellants that the examiner has not shown
that practicing the full scope of the claims would have required undue
experimentation. First, the scope of the claims is not inordinately broad: claim
46 requires mutations in two out of thirty-eight specified amino acids, while claim
54 requires mutation of one of forty-six specified amino acids,2 and a second
mutation in one of the same thirty-eight amino acids recited in claim 46.
The examiner asserts that each of these mutations could substitute any
other amino acid for the naturally occurring one at each position. Examiner’s
Answer, page 8. The examiner’s position, however, does not take into account
the guidance provided by the specification. The specification states that the
mutation in the amino acids corresponding to site 1 should at least preserve, if
not enhance, binding with the variant’s receptor. See page 10. Thus, the
specification states, substitutions in site 1 should be with amino acids that are
closely related to the naturally occurring amino acid. See id.
2 Helices 1 and 2 of human growth hormone span amino acids 6-33 and 72-92, respectively.
Specification, page 15. Thus, the loop linking helices 1 and 2 apparently is made up of amino
acids 34-71; the C-terminal 2/3 of that loop therefore corresponds to amino acids 46-71. Helix 4
of human growth hormone spans amino acids 155-184. Specification, page 15. The C-terminal
1/2 of that helix therefore corresponds to amino acids 169-184. Thus, a total of forty-six “site 1”
amino acids are specified in claim 54.
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