Appeal No. 1997-3537
Application No. 08/395,867
appellant's brief (Paper No. 8, filed December 16, 1996) for the appellant's arguments
thereagainst.
BACKGROUND
As explained by Karjalainen (p. 302):
Abstract Background. Cow's milk has been implicated as a possible
trigger of the autoimmune response that destroys pancreatic beta cells in
genetically susceptible hosts, thus causing diabetes mellitus. Studies in
animals have suggested that bovine serum albumin (BSA) is the milk protein
responsible, and an albumin peptide containing 17 amino acids (ABBOS)
may be the reactive epitope. Antibodies to this peptide react with p69, a
beta-cell surface protein that may represent the target antigen for milk-
induced beta-cell--specific immunity.
Indeed, all of the diabetic patients studied by Karjalainen had elevated levels of anti-BSA
antibodies (but not of antibodies to other milk proteins), the bulk of which were specific for
ABBOS (abstract, p. 302; p. 303, c. 2, para. 4).
THE INVENTION
The claimed invention is directed to processes for enzymatically hydrolyzing BSA
(claims 6 and 11), in particular its 17 amino acid ABBOS portion (claims 2-5, 10 and 12-
14), in infant milk formula such that antibodies produced by an infant ingesting the
hydrolyzed milk formula will be reactive with an altered, i.e., hydrolyzed, ABBOS epitope
and, consequently, will not attack the p69 protein of the infant's pancreatic beta cells
(claims 2-5, 10 and 14); and, to sealed containers of infant milk formula containing
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