Appeal No. 1999-1229
Application 08/543,975
oryzae, or by limiting the milk and dairy products in their diet to only those which had been
pre-hydrolyzed. Specification, pp. 1-2.
As indicated by the claims, the present invention is generally directed to a
composition for hydrolyzing lactose which comprises two different lactases which function
optimally within different pH ranges. In addition, the invention is directed to various
compositions which comprise a lactase derived from either Aspergillus oryzae or
Aspergillus niger and Kluyveromyces lactis. The lactase derived from K. lactis can be
enterically coated to prevent deactivation by the gastric enzymes of the stomach
environment.
DISCUSSION
The examiner’s conclusion of obviousness is said to be based on the teachings of
Barillas, Rosado, Medow, Gekas, Kan and Sipos.
To that end, we find that Barillas and Rosado disclose the administration of a
lactase derived either from the yeast K. lactis or from the fungus A. niger, to randomly-
selected children and to healthy and lactose-intolerant adults, respectively. The authors
quantify lactose absorption using a modified hydrogen breath analysis procedure.
According to the examiner, the authors note a difference in the activity of the two enzymes,
but she does not explain what the difference is, or its significance. Answer, p. 4.
Medow discloses that the co-administration of lactose and lactase-containing tablets
reduced the hydrogen breath secretion in 16 of 18 lactose-intolerant children by 89%.
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