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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