Appeal No. 2006-2451 Page 9
Application No. 09/988,150
Appellants compare their rabbit nasal mucosa data (specification, page 6, Example 1) to
Smith’s rat intestinal data (specification, page 3, lines 11-14). Appellants have not
addressed whether the calculated improvement in delivery could be attributed to
species differences (rabbit versus rat) in transport rates, rather than being a property of
the tissues, alone.
In addition, Smith utilized bovine growth hormone (bGH) in their oral delivery
studies, which is a 191 amino acid protein. Specification, page 3, lines 8-14; page 1,
line 28. Appellants, in contrast, used insulin, which contains a total of 51 amino acids.
Id., page 13, Table 2; page 1, line 16. The protein type (growth hormone versus insulin)
and size (191 amino acids versus 51 amino acids) could account for the transport
differences. During oral argument, Appellants argued that the specification states that
once a threshold is reached of about 51 amino acids, the size of the protein should not
matter. Id., page 1, lines 12-17. We do not find this argument persuasive because
Appellants own data summarized in Table 1 on page 12 of the application shows that
the net transport rate across the nasal mucosa varied, depending on the protein utilized.
For example, insulin + antibody had a net rate of about 68.32, while BSA + antibody had
a net rate of about 9. Appellants also acknowledge in the specification that “there are
appreciable differences for the same peptide from species to species, even from
individual to individual of the same species.” Id., page 1, lines 17-20.
In sum, we do not find the evidence of “unexpected results” as presented in this
appeal to be adequate to rebut the case of prima facie obviousness. The rejection of
claim 11 is affirmed. Claims 12, 13, and 15-19 fall with claim 11 since separate reasons
for their patentability were not presented. Since our explanation as to why the results
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