Appeal No. 2005-2739 Page 7
Application No. 09/966,893
doubts the truth and accuracy of any statement in the supporting disclosure and to back
up assertions of its own with acceptable evidence or reasoning which is inconsistent with
the contested statement.” Id. at 224, 169 USPQ at 370.
In a nutshell, the examiner argues that “[t]he amount of experimentation to search
for any pharmaceutical composition comprising any polypeptide of any structure and
function which can be used to treat any patient having any lysosomal storage disorder
. . . without harming the patient is enormous and undue.” Examiner’s Answer, page 9.
According to the examiner, “[s]uch experimentation entails determining whether a
particular disease is a lysosomal storage disorder disease, determining the etiology of
the disease, searching and screening for any protein of any structure and function, and
determining whether any pharmaceutical composition comprising the protein would be
useful in treating the patient having any lysosomal storage disorder without harming the
patient.” Id., pages 9-10.
Nevertheless, we agree with appellants that the examiner has not established that
practicing the full scope of the claims would have required undue experimentation.
Appellants point out that “practice of the claims does not entail determining whether a
particular disease is a lysosomal storage disorder and determining the etiology of the
disease” as “[t]his information is known and is provided in Table 1” (Appeal Brief, page
10), wherein particular proteins “are clearly associated with the lysosomal storage
disorder they can be used to treat” (id.). Moreover, appellants argue that “[m]any of the
proteins encompassed within the claimed compositions, produced by a means other than
insect cell production, have already been used or are being tested in clinical trials to treat
lysosomal storage disorders.” Id., page 9. Finally, appellants argue that the examiner
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