Appeal No. 2001-0733 Page 8
Application No. 09/095,429
evidence to counter the teachings of Ardelt. See Examiner’s Answer, page 21-
22. But, even though Mosimann teaches that the pyroglutamic acid residue is
present in the active site, and Ardelt suggests that enzymatic activity may be
related to cytotoxicity, the combination demonstrates that, at most, it may have
been obvious to try to produce the claimed recombinant protein.
The declarations of Dr. Youle and Dr. Ardelt, see Paper No. 8, establish
the unpredictability of the art. The Ardelt declaration states that from the crystal
structure as reported by Mosimann, it was not clear what the role of the
pyroglutamyl residue in catalysis is, and thus it was not predictable that the
pyroglutamyl residue was required for enzymatic and cytotoxic activity. See
Ardelt declaration, ¶ 2-5. In addition, Ardelt avers that the examiner has over
simplified the issues involved, because the ordinary artisan would have also
considered the ability of the enzyme to enter the cell, and its resistance to
ribonuclease inhibitor. See Ardelt declaratiion at ¶ 6, Youle declaration at ¶ 3.
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