Appeal No. 2004-0250 Page 9
Application No. 09/226,412
Turning to the second difference noted by appellants, i.e., the percent weight
crystalline parameter required by the Jensen claims, we note the present specification
states that monomeric insulin analogs which form part of this invention are those
described in U.S. Patent 5,504,188 (Baker). See, specification, page 21, line 25. The
title of Baker is “Preparation of Stable Zinc Insulin Analog Crystals.” Baker describes
preparation of crystalline insulin analogs including crystalline Lyspro. Thus, one of
ordinary skill in the art would have found it obvious to use crystalline monomeric insulin
analogs in the method set forth in claims 30, 50, and 59 of this application. The use of
crystalline Lyspro as the sole monomeric insulin analog in the present invention would
have been understood by one skilled in the art to result in 100% by weight of the
particles being crystalline. Thus, the at least 50% by weight limitation would have been
obvious.
The last difference between the respective claims appellants point to is the molar
ratio parameter required by the Jensen claims. Jensen requires that the molar ratio of
insulin to enhancer be between about 9:1 and 1:9. As set forth above, the present
specification states that surfactants may be used in the monomeric insulin analog
formulations administered by claims 30, 50, and 59. In describing that surfactants may
be used, appellants did not set forth any finite amounts in which those surfactants
should be present. Under these circumstances, appellants have left it to the skill of the
art to determine an appropriate amount of surfactant to be used in implementing this
embodiment of the present invention. It should also be kept in mind that Chance
describes the use of surfactants as enhancers in formulating monomeric insulin analog
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