Appeal No. 1997-3537
Application No. 08/395,867
BSA antibodies form against ABBOS and subsequently bind to p69, pancreatic beta-cell
surface proteins, causing the development of diabetes" (answer, p. 6).
According to the examiner,
[i]t would have been obvious ... to prepare an infant milk formula ... as
claimed since Thibault and Martinez clearly suggest using proteases to
reduce large peptides in infant milk (BSA)-containing foods, and Karjalainen
teaches that BSA is not desirable in infant milk formulae due to the presence
of ABBOS (a large peptide). ... [R]emoval [of ABBOS prior to infant
digestion] alters the appearance of BSA to an infant's immune system which
prevents the creation of antibodies against ABBOS so that the p69 amino
acid section is not affected. [Answer, para. bridging pp. 6-7.]
However, the examiner has not pointed out, and we do not find, where Karjalainen
discloses or suggests using enzymatically hydrolyzed BSA in milk formulas to prevent
onset of milk-induced diabetes. Rather, Karjalainen appears to suggest preventing
exposure to cow's milk early in life to prevent onset of milk-induced diabetes by analogy to
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a diabetes-prone rodent model.
Furthermore, to the extent the examiner relies on inherency to establish that "the
hypoallergenic milk formulation is basically the same as the milk formulation claimed"
(answer, p. 9), that reliance appears misplaced for several reasons. First, both Thibault
and Martinez use enzyme mixtures comprising trypsin and chymotrypsin. Karjalainen
6Karjalainen "suggests that an active, antigen-driven immune response against the BSA-derived
ABBOS peptide is a feature of the autoimmune response in patients with insulin-dependent diabetes. This
likens the disease in humans to that in diabetes-prone rodents, in which the prevention of exposure to cow's
milk early in life prevents the development of the disease." (p. 307, c. 1, ll. 1-7, footnote omitted, emphasis
added).
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