Appeal No. 1997-2509
Application No. 08/230,982
Thus, it is the examiner’s position that (Answer, page 6):
the person of ordinary skill in the art confronted with the problem of
stabilizing IL-11, whose structure was known at the time the invention was
made, as shown by Paul et al., and therefore its amino acid residues, and in
view of the Manning and Wang reviews, that teach the various factors and
troublesome amino acid residues that influence protein stability, and
generally disclose some of the techniques that existed in the art of stabilizing
proteins at the time the invention was made, would consider the stabilization
of such a protein by reviewing existing methods of stabilizing proteins from
the same class of proteins, i.e.[,] cytokines. In view of all of the secondary
references disclosing not only requisite amounts but also the same
ingredients that are now of conventional use in the art, i.e.[,] glycine,
histidine, and phosphate buffers for markedly significant effect in stabilizing
the cytokine claimed herein, it would have been obvious to one of ordinary
skill in the art to stabilize IL-11 with glycine and histidine or phosphate buffer.
To optimize amounts of ingredients shown by these references for the
cytokine of interest here would have been within the skill of the ordinary
person in the art and this is indicated by the reference[s] themselves.
In contrast, the appellant argues the examiner has not established a prima facie
case of obviousness because the prior art fails to disclose or suggest the problem of
stabilizing a protein as basic and as insoluble as IL-11 and does not disclose a
reasonable expectation of success of stabilizing such protein. Brief, page 3. Appellant
argues there is no expectation of success because IL-11 does not show any structural
similarity with the proteins of the cited references. Brief, page 6.
Appellant also argues that the examiner’s logic fails because proteins classified by
their function (such as interleukins) are not structurally related, and interleukin-11 is not
structurally related to any known protein, citing Minasian as evidence of this proposition.
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