BIOENERGY, INC.’S RESEARCH AND PATENTING PROGRAM

(Licensed to Valen Labs, Inc. for Nutritional Applications)

I. BACKGROUND

Bioenergy’s patent strategy is clear. Bioenergy pursues an aggressive policy of obtaining patent protection on indications with the dual objectives of covering substantially all of the uses of ribose in broad indications with large patient or consumer populations. As of March 2005, Bioenergy holds 14 United States patents, one European patent, four Great Britain patents and eight United States provisional and utility patents still in prosecution. In addition, several patents have been allowed in other countries. Most of these have extensive foreign counterparts on file. The patent portfolio is summarized in detail on the following pages.

The biochemistry of ribose has been known for decades, having been elucidated through experiments with isolated cells or tissues. The founder of Bioenergy, Dr. John E. Foker was one of the first to begin to study the physiology of ribose in intact animals. His studies showed that hearts subjected to a global ischemic insult recovered ATP levels more quickly when ribose was administered i.v.

In the mid 1990s, Bioenergy began to investigate whether ribose might have a role in raising the energy levels of healthy people. Before this research was carried out, there was no expectation that healthy people would show an increase in energy by taking ribose. It was possible, even likely, that healthy people would already have a high basal level of ATP and ATP synthetic capacity that would not be increased on ribose ingestion. Bioenergy sponsored scientific, controlled studies at leading academic institutions in order to establish a firm scientific basis for the use of ribose in healthy people. The results of one study led to the first patent filing in 1998. Bioenergy has expanded its research into other areas and now owns an extensive patent portfolio, which allows it exclusive rights to sell ribose for the uses in its patent claims. Bioenergy passes on those rights to its customers and licensees.

Only BIOENERGY Ribose™ products can be sold for the uses claimed in Bioenergy patents.

II. BIOENERGY PATENTS AND PATENT APPLICATIONS

Bioenergy’s patents and patent applications can be divided into five groups: uses by healthy people, including sport uses; uses for healthy people under specific stress conditions; medical uses; methods for ex vivo use; and veterinary uses.

A. USES FOR SPORTS AND HEALTHY PEOPLE

U.S. Patents 6,159,942 and 6,534,480: COMPOSITIONS FOR INCREASING ENERGY IN VIVO
Filed PCT, designating all countries. Filed nationally in EPO, China, Canada, Japan. US cases issued, New Zealand case issued, others pending. Claims use of oral ribose for healthy people, horses, dogs and cats. Use in sports nutrition or general nutrition for increased energy associated with athletic activity, strenuous exercise or labor. Includes ribose alone or in combination with other ingredients, such as creatine and magnesium. Not limited to the delivery vehicle of oral dosage (e.g., drinks, bars, foods, tablets, and the like). PCT (including US) filings include claims related to increasing cellular ATP and purine nucleotide levels. This one-ingredient claim dominates any combination claim.

U.S. Patent 6,159,943: METHOD FOR REDUCING CRAMPING AND SORENESS
Filed PCT naming all treaty countries. Filed nationally in EPO, Australia, Canada and Japan. Issued in Great Britain. Use in sports nutrition or general nutrition for increased energy associated with athletic activity, strenuous exercise or labor. Includes ribose alone or in combination with other ingredients. This is in addition to the use to increase energy because of the timing of dosage.

U.S. Patent 6,429,198: COMPOSITIONS FOR IMPROVING ATHLETIC PERFORMANCE
Targets serious, competitive athlete, either human, horse or dog. This is differentiated from the ‘942 patent by the new finding that proper usage of ribose not only increases power, but prevents fatigue to a significant degree.

U.S. Patent 6,525,027: METHOD FOR INCREASING MUSCLE MASS AND DECREASING BODY FAT IN HUMANS
Weight-training exercise is defined as exercise using all the large muscles of the body. Targets body builders and those wishing to sculpt the body with diet and exercise. [Early results indicate that subcutaneous fat is selectively reduced.]

B. USES FOR HEALTHY PEOPLE UNDER STRESS CONDITIONS

U.S. Patent 6,159,942: (see above for details)
In addition to the conditions explicitly listed in the US patent, the PCT patent teaches that increased energy demand exists during strenuous labor and advanced age.

U.S. Patent 6,218,366: METHOD FOR RAISING THE HYPOXIC THRESHOLD
Bioenergy’s first research centered essentially on muscle, both cardiac and skeletal. This is an extension into the general body effects of hypoxia.

U.S. Patent 6,429,198: METHOD FOR TREATING ACUTE MOUNTAIN SICKNESS
Relieves headache and nausea due to altitude sickness. May ameliorate the serious symptoms of pulmonary and cerebral edema.

U.S. Patent 6,663,849: COMPOSITIONS FOR ENHANCING THE IMMUNE RESPONSE
Filed PCT, designating all treaty countries. The data is based on mouse in vivo data and cell culture of human lymphocytes. Shows ribose enhances proliferation, differentiation and oxidative burst of phagocytes.

U.S. Patent Pending: COMPOSITIONS TO REDUCE EXERCISE-INDUCED SWELLING OF JOINTS
The examples are humans, racehorses and greyhounds. Shows that ribose decreases joint swelling associated with exercise.
Bioenergy has the exclusive right to advertise and sell ribose for the use of healthy persons who are experiencing stresses such as heavy exercise, trauma, infection, burns, hypoxia, acute mountain sickness, and the like.

C. MEDICAL USES

U.S. Patent 6,339,716: METHOD FOR DETERMINING VIABILITY OF A MYOCARDIAL SEGMENT.
Great Britain Patent issued. PCT application filed nationally in EPO, Australia, Canada, China, Japan and Mexico. Medical diagnostic use with ribose to be given i.v. Claims cover all types of cardiac imaging, such as Thallium-201, Echo, PET, and the like.

U.S. Patent 4,605,644: RIBOSE AND ADENINE FOR RECOVERY FROM ISCHEMIA
Shows that ribose in association with adenine increases cardiac energy and functional recovery following ischemia.

U.S. Patent 4,719,201: USE OF RIBOSE FOR RECOVERY FROM ISCHEMIA
It was further discovered that ribose alone was sufficient to speed ischemic recovery in the heart.

U.S. Patent 4,824,660: METHOD FOR UNCOVERING HIBERNATING MYOCARDIUM
Improves thallium or other perfusion diagnostic imaging.

U.S. Patent 6,218,366: METHOD FOR RAISING THE HYPOXIC THRESHOLD
This medical use is directed at the subjects having one or more conditions resulting in muscle hypoxia or general tissue hypoxia.

U.S. Patent Pending: COMPOSITIONS FOR ENHANCING PHYSICAL REHABILITATION IN HUMANS AND METHODS OF USING THE SAME
Based on PRV filed 7-28-2000 and PRV filed 6-29-01 LOW DOSAGE RIBOSE FOR CARDIOVASCULAR DISEASE AND HYPERTENSION
A product is now in clinical trials for patients in with congestive heart failure and/or ischemic heart disease. Expanded uses will be claimed.
Low dosage ribose alone has been shown to be effective for treating patients with CHF and CAD.

U.S. Patent 6,663,859: COMPOSITIONS FOR ENHANCING THE IMMUNE RESPONSE
Data is based on in vivo mouse studies and cell culture of human lymphocytes.

U.S. Patent 6,703,370: USE OF RIBOSE TO TREAT FIBROMYALGIA
Issued in Great Britain. Ribose gives considerable, but not total, relief in patients with fibromyalgia. Based on quality of life assessment

U.S. Patent Pending: USE OF RIBOSE TO ENHANCE RECOVERY FROM ANESTHESIA AND TRAUMA
Patients receiving ribose feel less pain and more rapid return to health when ribose is given peri-anesthesia.

D. METHODS FOR EX VIVO USE

U.S. Patent 6,663,859: COMPOSITIONS FOR ENHANCING THE IMMUNE RESPONSE (see above for details)
Proliferation and differentiation of cultured cells. Autologous or donor blood can be treated to enhance immune response and transfused into a mammal. The broad definition includes stem cells support.

U.S. Patent 6,790,603: COMPOSITIONS FOR THE STORAGE OF PLATELETS
Allowed in the EPO. Composition claims for greatly improved platelet storage and enhanced function.

U.S. Patent Pending: COMPOSITION FOR THE STORAGE OF BLOOD AND BLOOD PRODUCTS
Blood or red blood cells stored in the presence of ribose remain functional for more than 60 days. Elimination of dextrose decreases problems of bacterial contamination Bioenergy has exclusive rights in the most effective platelet and blood preservation cocktails. Bioenergy also has exclusive rights in the use of ribose for cell culture.

E. VETERINARY USES
All of the patents and applications under the above categories also extend to veterinary use.
Bioenergy has exclusive rights to sell ribose for geriatric and racing animals and for sperm cell preservation.


 

 

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