Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Hydrolases
Reexamination Certificate
1995-02-28
2001-08-14
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
Hydrolases
C424S094650, C426S530000, C426S590000, C426S656000, C426S801000
Reexamination Certificate
active
06274141
ABSTRACT:
This invention pertains to a method and apparatus for enabling the immune system of an infant to distinguish between the ABBOS amino acid section of bovine serum albumin and the p69 amino acid section of insulin producing betacells.
In another respect the invention pertains to a method and dietary composition for reducing the risk that an infant will develop diabetes.
In a further respect, the invention relates to a method and apparatus for cleaving protein-to-protein bonds in bovine serum albumin to reduce the similarity between the bovine serum albumin and pancreatic beta cells to minimize the likelihood that an infant will develop bovine serum albumin antibodies which will attack and kill the pancreatic beta cells.
In a still another respect, the invention relates to a method and formulation for hydrolyzing protein-to-protein bonds in bovine serum albumin in a nutritional formulation which is administered to infants until “gut closure” occurs.
Bovine serum albumin (BSA) is one of the proteins contained in cow's milk. BSA includes a short, seventeen amino-acid section called ABBOS. Digestive enzymes in the small intestine of an adult break down ABBOS, and other portions of the BSA molecule, into amino acids or into chains of two or three amino acids. In contrast, the intestines of infants have fewer enzymes and typically allow large protein chains like BSA to pass directly into the bloodstream. When infants are from three to twelve months of age, “gut closure” occurs. When gut closure occurs, the infant develops additional enzymes which break down protein enzymes and prevent the passage of large protein chains directly into the bloodstream.
Anti-BSA antibodies exist in the very great majority, if not all, of children who drink cow's milk. Each anti-BSA antibody reacts to a particular section of the BSA molecule. Some of the anti-BSA antibodies react specifically to a short, 17 amino-acid section of the BSA molecule. This section is called ABBOS. Anti-BSA antibodies which react to the ABBOS section are also called anti-ABBOS antibodies. Consequently, an anti-ABBOS antibody is, by definition, an anti-BSA antibody. And, if an antiABBOS antibody is present, there likely are other anti-BSA antibodies present which are not anti-ABBOS antibodies.
Before gut closure occurs in an infant, the infant can develop antibodies which react to the ABBOS amino acid section of the BSA. The production of such ABBOS antibodies by an infant can be a problem because ABBOS is similar to a p69 amino acid section of insulin-producing beta cells. Beta cells are produced by the pancreas. The similarity between the ABBOS amino acid section and the p69 amino acid section causes antibodies to attack and destroy the beta cells, resulting in diabetes. Children with diabetes have been shown to have higher levels of antibodies against BSA. Further, apparently only children who are prone to develop diabetes are able to make anti-ABBOS antibodies, which are unusually rare in the population at large. Children with diabetes therefore appear to have immune systems which better identify ABBOS and produce antibodies which attack ABBOS.
It is believed that the p69 amino acid section of the insulin-producing beta cells appears only during times of stress, such as a viral infection. Further, it is also believed that more than one viral infection is required for the ABBOS antibodies to kill a sufficient number of beta cells to cause diabetes.
The entire problem of ABBOS antibodies attacking an infant's beta cells can be avoided if the immune system of the baby “sees” the p69 amino acid before it sees ABBOS and before it develops antibodies to ABBOS. Immediately after birth, the immune system of an infant has a general idea of which cells are part of the body, and are not be attacked, and which cells are foreign, and should be attacked. But the infant's immune system has to learn to identify specific foreign cells “on the fly”. Accordingly, if the immune system of the infant views the p69 protein on a insulin-producing beta cell before it views ABBOS, then the immune system learns that the p69 protein is part of the infant's “in-house” processing system, and, the immune system will not subsequently attack the p69 protein. The production by the infant's beta cells of the p69 protein prior to the introduction of ABBOS into the infant's system cannot, of course, be guaranteed, which is why it is possible for ABBOS antibodies to be developed which subsequently attack p69 protein which it later first appears on the infant's beta cells.
BSA is found in cow's milk, in milk-like infant formulas based on non-fat cow milk (e.g., GERBER, SIMILAC, and CARNATION FOLLOW-UP infant formulas, and in whey predominant formulations (e.g., ENFIMIL, SMA infant formulas. As used herein, the term “milk formula” indicates cow's milk, a mother's breast milk, and milk-like infant formulas which contain BSA. The term “milk formula” also includes any other infant formula which is shown to include a peptide which can, in at least some infants, produce an antibody which attacks an amino acid section of insulin-producing beta cells. Further, it is important that manufactured milk formulations for infants have the proper proportions of protein, carbohydrates, and other nutritional components so that an infant's health is not adversely affected by ingesting the milk formulation. The components of nutritionally balanced manufactured infant milk formulations such as SIMILAC (Trademark), ENFAMIL (Trademark), and ISOMIL (Trademark) are well known in the art and will not be recited here.
The development by the infant's body of an antibody which attacks both a first protein and a second protein similar to the first protein is termed molecular mimicry. The development of a vaccine for smallpox exploited a case of molecular mimicry. When, in the late 18th century, smallpox was killing many people, another disease, cowpox, was common. Cowpox infected dairy cows and milkmaids. A cow infected with cowpox formed blisters on its udder. When their hands broke the blisters, milkmaids were infected with cowpox. The disease, however, was normally a mild one, and the milkmaids would fully recover. People who had cowpox would not get smallpox. As a result, in 1976 the English doctor Edward Jenner intentionally infected a boy with cowpox and then exposed the boy to smallpox. The boy did not contract smallpox. The development by the body of antibodies to cowpox is beneficial because these bodies then attack and destroy smallpox. The development by an infant's body of ABBOS antibodies is not, however, beneficial because the antibodies may attack and destroy insulin-producing beta cells.
Diabetes is one of the leading causes of death in the United States. Approximately 11 million Americans have diabetes, and about half of them do not know they are diabetic. Accordingly, it would be highly desirable to produce a method and apparatus for reducing the likelihood that an infant will, on ingesting a milk formula or other food product, develop antibodies which can attack insulin producing beta cells or other desirable living cells which the body produces and utilizes during its normal metabolic and physiological processes.
Therefore, it is a principal object of the invention to provide a method and apparatus for preventing the production by the immune system of antibodies harmful to desirable living cells in the body of an animal.
A further object of the invention is to provide a method and apparatus for altering the ABBOS on BSA in a milk formula to reduce the risk that ABBOS antibodies produced by an infant will attack insulin producing beta cells.
Another object of the invention is to provide a method and apparatus for altering protein-to-protein bonds of polypeptides in bovine serum albumin.
Briefly, I have discovered an article of manufacture for use in altering the appearance to the immune system of an infant of protein sections of bovine serum albumin. The article of manufacture includes a sealed container
Boatwright Doyle W.
Nissle P.C. Tod R.
Witz Jean C.
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