I figure if I post 2 patents per day for the next year, we might get through
all the human milk component patents.  Although maybe not, since researchers
keep adding more patents... I believe this patent was filed in 1987 (and
still on file) called "Dietary compositions and methods using bile
salt-activated lipse."  # 4944944
Inventor:  Tang et al.   Assignee:  Oklahoma Medical Research Foundation.
Interesting that this patent was filed in 1987 and they mention genetic
engineering of this enzyme.  According to a Cornell web site, the food
industry has genetically engineered a variety of enzymes commercially since
1985.  Valerie W. McClain, IBCLC

"Milk bile salt-activated lipase has been found only in the milk of certain
species, namely humans, gorillas and recently cats and dogs. [Freed, et al.,
Biochim. Biophys. Acta, 878:209-215 (1986)]. Milk bile salt-activated lipase
is not produced by cows, horses, rats, rabbits, goats, pigs or Rhesus
monkeys. [Blackberg, et al., FEBS Lett. 112:51-54 (1980); Freudenberg,
Experientia 22:317 (1966)].

Although milk bile salt-activated lipase and its isozyme pancreatic
carboxylesterase have been the subject of considerable study, the
physiological significance of these enzymes heretofore has remained unknown.
The present invention is based on the discovery that bile salt-activated
lipase plays a major rate-limiting role in growth. Accordingly, the present
invention is directed to supplementation of dietary compositions, such as
infant formulas, with milk bile salt-activated lipase or pancreatic
carboxylesterase. Also, pathological conditions involving pancreatic
dysfunction, such as cystic fibrosis, may be treated by administering these
enzymes to the subject in conjunction with the ingestion of fats.

In accordance with the present invention, a dietary base from a first source
is selected. The composition of the base, the balance of protein,
carbohydrates, vitamins, etc., will be designed to supply the nutritional
needs of the subject who will consume it. Among these other ingredients, the
base contains fats or triglycerides. The source of the fat also may vary
according to the intended purpose of the composition and the subject
involved. For example, when the composition is an infant formula, the fat
usually will be milk fat.

The nutritional base of this invention is poor in bile salt-activated lipase
("BAL") in that insufficient amounts of the enzyme are present to permit
optimum hydrolysis of the fats in the intestines when exposed to bile salts.
Indeed, most bases will contain no bile salt-activated lipase.

An important application of the present invention is a fortified infant
formula for human infants. Thus, in this embodiment the preferred nutritional
base usually will comprise cow's milk, which does not contain BAL. Preferred
nutritional bases for this application include commercially prepared cow's
milk and commercially prepared infant formulas comprising cow's milk.
Suitable formulas include those marketed under the names Enfamil.RTM. by
Mead-Johnson & Company (Evansville, Ind.) and Similac.RTM. by Ross
Laboratories (Columbus, Ohio).

It will be appreciated that in many instances the preferred nutritional base
will contain no milk, such as where the composition is an infant formula for
an infant who does not tolerate milk well. In such cases, preferred
nutritional bases include milk-free infant formulas which usually contain soy
protein. These include ProSobee.RTM. marketed by Mead-Johnson & Company and
Isomil.RTM. marketed by Ross Laboratories.

Having selected a suitable nutritional base for the composition, bile
salt-activated lipase next is prepared. Milk BAL or pancreatic
carboxylesterase may be used. As will later appear, the enzyme may be
purified from natural sources or it may be produced by genetic engineering.
When the amino acid sequences of these enzymes or their function fragments
have been identified, synthetic BAL or its active fragments may be
constructed artificially. It will be understood that through these various
technologies, enzymes may be produced which are functionally similar but not
structurally identical."



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