Propionibacterium P-63 for use in direct fed microbials for...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Specially adapted for ruminant animal

Reexamination Certificate

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C424S442000, C424S093100, C424S093300, C424S093400, C424S093440, C424S093450, C426S002000, C426S053000, C426S061000, C426S807000, C435S179000, C435S262500

Reexamination Certificate

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06455063

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a process for improving the utilization of feedstuffs by ruminants, especially during the transition from a roughage diet to a feedlot diet, and more particularly to a process for administering to a ruminant a feed additive composition which includes
Propionibacteria jensenii
strain P-63, preferably in combination with a lactic acid producing bacteria for improving the production from, and feed conversion efficiency of, a high grain or concentrate feedlot diet. The composition also may be used to reduce scours in swine.
2. Technology Description
Acute indigestion resulting from the transition from a predominantly roughage diet to a feedlot diet could be fatal to ruminants. The purpose of a feedlot operation is to fatten a ruminant, such as beef cattle, for sale or slaughter. The most common and efficient method of fattening ruminants is to feed them a high grain or high energy concentrate diet. However. this abrupt conversion from a roughage or pasture diet of plant food, mainly cellulose, to a feedlot diet predominantly composed of grains and starches can cause decreased production to feedlot cattle and even death from acidosis. Similar diet transitions can result in a decrease in milk production for dairy cows as well as death.
As discussed in
Diseases of Feedlot Cattle
, Second Edition, Lea & Febiger, p 292-293 (1971), acute indigestion in cattle is caused by sudden consumption of large amounts of grain, green corn, green apples or other easily fermentable feeds. During a roughage diet, cellulosic bacteria predominates in ruminal microflora. Volatile fatty acids are usually formed in the following proportions: acetic, 67%; propionic, 19%; and butyric, 14%. These acids constitute an important nutrient from cellulose digestion. However, during the fattening process at the feedlot, cattle are placed on a high grain diet. On a high grain diet the ruminal microflora ferment the new feed and produce 100 or more milli-moles per liter of lactic acid resulting in the rumen becoming immobilized. A large portion of the lactic acid accumulated may be the D(−) isomer which is an unavailable energy source for the ruminant and thus builds up in the rumen. Absorption of the acid into the blood lowers the blood pH and diminishes the content of bicarbonate and glucose bringing about acidosis. Compensation for the acidic condition occurs by excretion of carbonic acid through rapid respiration and by excretion of hydrogen ions through urine. Affected cattle may survive through compensation, however, severe acidosis is fatal. Additionally, the increase in acidity of the rumen damages the mucosa which may result in necrosis of the epithelium which enables bacteria such as
Spherophorus necrophorus
to enter the veins and be conveyed to the liver where liver abscesses may form in surviving animals.
Lactic acid and products containing lactic acid have been found to enhance gains in the starting period of cattle (first 28 days) and reduce liver abscesses when given prior to the transition from a roughage diet to a feedlot diet. Various strains of
Lactobacillus acidophilus
have been isolated which restore and stabilize the internal microbial balance of animals. Manfredi et al, U.S. Pat. No. 4,980,164, is such a strain of
Lactobacillus acidophilus
which has been isolated for enhancing feed conversion efficiency. The
Lactobacillus acidophilus
strain of the Manfredi et al patent has been designated strain BT1386 and received accession number ATCC No. 53545 from the American Type Culture Collection in Rockville, Md. Strain ATCC 53545 demonstrates a greater propensity to adhere to the epithelial cells of some animals which would increase the bacteria cultures' ability to survive. initiate and maintain a population within an animal intestine. Thus, the primary mode of action as previously understood relative to
Lactobacillus acidophilus
occurs post-ruminally.
Another strain of
Lactobacillus acidophilus
isolated for restoring and stabilizing the internal microbial balance of animals is disclosed in Herman et al, U.S. Pat. No. 5,256,425. The
Lactobacillus acidophilus
strain of the Herman et al patent has been designated strain BT1389 and received accession number ATCC No. 55221 from the American Type Culture Collection in Rockville, Md. Strain ATCC 55221 is a further improvement on strain ATCC 53545 in that it is easily identified and quantified due to its resistance to antibiotics such as erythromycin and streptomycin.
The above-mentioned strains of
Lactobacillus acidophilus
are perfectly good lactic acid producing organisms. However, more than a lactic acid producing organism is needed to improve the utilization of feedstuffs by ruminants, especially during the transition from a roughage diet to a feedlot diet. The problem with the increase of D-lactate in the rumen must also be resolved in order to facilitate the transition of ruminants from a roughage diet to a feedlot diet.
Administration of bacteria to cattle is also problem due to the extreme sensitivity of organisms like
Lactobacillus acidophilus
which are difficult to maintain in a viable state at ambient temperatures. Also, lactic acid is corrosive to feedlot and feedmill equipment and metallic components
U.S. Pat. Nos. 5,534,271 and 5,529,793 suggest that both a lactic acid producing culture as well as a lactate utilizing bacterial culture be combined with a typical animal feedlot diet to assist in the transition of a ruminant diet from roughage to feedlot while minimizing the risk of acidosis. These patents list several classes of materials from each of the producing and utilizing categories which may be selected for combination with the animal feedstock. Unfortunately, these patents; do not give much guidance as to which of these specific cultures should be selected in order to gain efficacious results. The only lactate utilizing cultures which are specifically enabled by the examples are Propionibacterium P-5, Propionibacterium P-42 and Propionibacterium P-99 and the only lactic acid producing cultures enabled by the examples are
Lactobacillus acidophilus
ATCC 53545 and
Lactobacillus acidophilus
strain LA45. The reference fails to disclose or suggest that amongst the thousands of permutations possible presented by their proposed combination of cultures, that synergistic results can occur by selecting a very specific strain of lactate utilizing culture not specifically enabled in these patents. The inventors of the instant invention have discovered such a specific lactate utilizing culture, namely Propionibacterium P-63.
Despite the above teachings, there still exists a need in the art for a direct fed microbial for ruminants having a specifically defined lactic acid utilizing culture which, when combined with lactic acid producing cultures, can demonstrate unexpected results in terms of efficacy against acidosis.
In addition, there exists a need in the art for a direct fed microbial which may reduce scours in swine and companion animals as the above technology has been more specifically directed against treatment of acidosis in ruminants.
BRIEF SUMMARY OF THE INVENTION
In accordance with the present invention a novel direct fed microbial for ruminants having a specifically defined lactic acid utilizing culture which, when used alone as a direct fed microbial or combined with lactic acid producing cultures, can demonstrate unexpected results in terms of resistance against acidosis is provided. More specifically, the lactic acid utilizing culture composes Propionibacterium P-63. This increased resistance can enable the ruminant to be superior producers of milk, if dairy ruminants, or experience greater weight gain, if beef ruminants. This culture may also be used to reduce scours in swine.
A first embodiment of the present invention comprises a ruminant direct fed microbial composition of matter comprising an acidosis inhibiting effective amount of Propionibacterium P-63. In most embodiments, the microbial compositio

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