Affidavit of Dr. Tcherkezova



DECLARATION
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

Ref. application of: Y. Omura, M.D., ScD.
Serial No. 06/785,495Examiner: J. Hanley
Filed: October 8, 1985Group No. 335

For: Bi-Digital O-Ring Test for imaging and diagnosing internal organs of patients

DECLARATION

Hon. Commissioner of Patents and Trademarks
Washington, D.C. 20231

Sir:

I, Maja Tcherkezova, M.D., a member of the teaching faculty of the National Institute of Neurology, Sofia, Bulgaria, a Bulgarian citizen residing in Sofia 1 Gurco No. 50, Bulgaria, declare:

I was born May 16, 1953 in Sofia, the Capital of Bulgaria.

In 1978, I received an M.D. from the National Institute of Neurology, Psychiatry and Neurosurgery, Medical Academy, Sofia, Bulgaria.

Since 1978, I have specialized in the combined fields of neurology and psychiatry at the National Institute of Neurology, Psychiatry & Neurosurgery, Sofia, Bulgaria.

Since 1984, I have held the appointment of Head of the Acupuncture Section and Head of the Reflexology Section of the Medical Academy, which is the national postgraduate education center in Bulgaria.

Because of my medical specialties, I have known Dr. Omura's research work on non-invasive measurement of blood pressure and blood flow at different parts of the body for more than 10 years through his articles in journals and his chapters in books. However, my first meeting with Dr. Omura, as well as his work on the Bi-Digital O-Ring Test, was 5 years ago, when my country hosted the 1st World Congress on Acupuncture. At that time, Dr. Omura was the main invited speaker of the Congress, and, for the first time, we heard about the clinical usefulness of the Bi-Digital O-Ring Test. However, he did not describe details of the technique. After his talk, we had occasion to further discuss the relationship between brain circulation and blood chemistries before and after acupuncture or electrical stimulation, although he was hesitant to discuss details of the exact technique of the Bi-Digital O-Ring Test. However, for the past few years, he has been publishing extensively on various aspects of the Bi-Digital O-Ring Test, including its imaging techniques. We have been closely following most of his work through his English language publications. We have tried the Bi-Digital O-Ring diagnostic methods without any instructions or guidance from him. Still we found that the Bi-Digital O-Ring Test could provide simple, quick, but often accurate diagnostic information.

In the middle of May, 1988, we had our 1st National Acupuncture Congress, and Dr. Omura was again our main guest speaker of the Congress, representing North America because of his outstanding scientitic contributions in the field. During this meeting, his luggage, containing all his slides, did not arrive in time for his opening speech as the Plenary Lecturer. Since he had brought some essential instruments with him as hand baggage, we requested that he give a patient demonstration, combining Bi-Digital O-Ring Test evaluation of the patient and confirmation of normal and abnormal circulation at different parts of the body, including brain circulation, using his non-invasive blood pressure and blood flow measuring instruments, for which I understand that he received a U.S. patent in November of 1987, and a Japanese company is already manufacturing it. Also, most medical schools in Japan are using it now.

Our organizing committee of the Congress brought a 64-year-old housewife, who was the mother of the Vice Council of the Bulgarian Office of the Council General in Washington, D.C. She had been diagnosed as having Alzheimer's Disease, with typical loss of short-term as well as recent memory, and additional motor dysfunction. Her general movements were very slow, and she had very weak force in the hands and difficulty in even opening a door. Although Dr. Omura was hesitant to examine and treat her because of the well-known fact that there is no effective treatment for Alzheimer's Disease, the President of the Congress, Dr. Iliev, insisted that Dr. Omura should try to evaluate her, using the Bi-Digital O-Ring Test, and his instruments for non-invasive measurement of blood pressure and relative blood flow of the head. Based on the findings, Dr. Iliev suggested that Dr. Omura should demonstrate how he treats patients with manual acupuncture and electrical stimulation, even though we had been taught that there is no effective treatment.

According to the neurologist who brought this patient, starting 4 years ago, the patient had fainting and dizziness several times a year, lasting about 2 to 3 minutes each time. Since then, her short-term memory had rapidly deteriorated. She had been living with her husband and mother-in-law in the same house for the past few years, but she insisted that she was living only with her husband, and she didn't remember that the mother-in-law was also living there. She forgot everything that happened recently, and this created serious problems for the family members. She could speak English since she was young, and her ability to communicate in English had remained intact. About 4 or 5 years ago, before her dizziness had started, her blood pressure was very high, averaging 180/110 mm Hg. About 2 years ago, the blood pressure in her arms had become normal, and it was still normal upon current examination. However, in the 4 or 5 months previous to the Congress she had developed frequent urination. X-rays of the brain showed general atrophy. EEG spectral analysis showed abnormally high voltage alpha waves at the left frontal lobe of the occipital area. The Bi-Digital O-Ring Test of the fingers of the left hand indicated that she had abnormal irritation corresponding to the 6th & 7th cervical vertebrae and their corresponding 7th & 8th cervical nerves on the left side of the neck. The right hand evaluation indicated that there was abnormality at the lower half of the 6th & 7th cervical vertebrae and their corresponding 7th & 8th cervical nerves on the right side of the neck. Her latest blood sugar test, done a few days earlier, was 140 mg %, indicating mild hyperglycemia, and serum gammaglobulin was slightly elevated. Blood pressure of the arms at a sitting position was 120-130 mm Hg. Supra-orbital arterial blood pressure, measured by Dr. Omura was 60 mm Hg at the right side of the forehead and 80 mm Hg at the left side of the forehead, with markedly diminished relative blood flow at both sides of the brain.

Using the Bi-Digital O-Ring Test Molecular Identification Method, after placing a latex swimming cap on the patient's head, Dr. Omura's evaluation of the brain showed a striking increase in thromboxane B2 at both sides of the hippocampal area of the brain corresponding approximately to above the ear. According to Dr. Omura, the presence of thromboxane B2 indicated the presence of circulatory disturbance, which released thromboxane A2, a powerful vaso-constrictor which is unstable and has a half-life of about 30 seconds and, within a few minutes is converted to the stable less vaso-constrictive thromboxane B2. Short-term memory is formed at the hippocampus. Also, using monochronal antibodies of different viruses as reference control substances, he found cytomegalovirus and Epstein-Barr virus at both the left and right sides of the hippocampal area. With the Bi-Digital O-Ring Test, using monochronal antibodies of chlamydia, he also found a chlamydia-positive response in the entire brain, as well as in the genito-urinary area. By imaging the vertebral arteries, on the skin above them, he demonstrated that both the right and left vertebral arteries were extremely narrowed (about 1/3 of normal diameter, which is the equivalent of 1/9 of the normal cross sectional area of the arteries) by spastic constriction after the entry point of the vertebral arteries at the transverse foramen of the 6th cervical vertebra. After he gave manual acupuncture, the diameter of the vertebral arteries became normal size instead of one-third of normal size. Blood pressure of the right supra-orbital artery increased from 65 mm Hg to 90 mm Hg. Left supra-orbital arterial blood pressure increased from 80 mm Hg to 150 mm Hg, with significant increase in relative blood flow at both the right and left supra-orbital arteries and disappearance of thromboxane B2 from the hippocampal area. However, the patient's symptoms did not change at all. Dr. Omura then applied a pair of strips of aluminum foil electrodes, with suffident electro-conductive jelly, to cover the entire hippocampal and motor areas, to be located between 2 electrodes. After he gave sufficient electrical stimulation with his electrical pulse generator at 1 pulse per second to sufficiently induce strong muscle contraction of the scalp without creating any pain, the patient's memory rapidly improved, along with improved motor function and strength in the hands. After treatment, the patient could remember what her neurologist, Dr. Mitev, had told her. Before treatment, Dr. Mitev had repeatedly explained that the visitor was Dr. Omura from New York, but she forgot each time immediately afterwards. However, after non-invasive electrical stimulation of the motor and hippocampal areas of the brain, after improvement of brain circulation induced by acupuncture, when Dr. Mitev explained about Dr. Omura, the patient was able to remember most of what she had been told, she started moving more smoothly, and she was even able to open the door by herself. Although Dr. Omura warned that this effect would most likely disappear soon without repeated treatment, all of the participants who witnessed this remarkable result were extremely impressed by the extraordinary advantage of the Bi-Digital O-Ring Test in making diagnosis where the latest laboratory tests had failed to detect hidden factors causing rather common medical problems difficult to treat. Just as in most Western nations, in our country A1zheimer's diseases is getting to be a serious social problem profoundly affecting everyone surrounding the patient, emotionally, financially and socially.

Within the same day, the news had spread all over Bulgaria that A1zheimer's Disease, which is known to be incurable, had been improved significantly using treatment based on diagnosis made by the Bi-Digital O-Ring Test. Therefore, many doctors and their families wanted Dr. Omura to examine them, using the Bi-Digital O-Ring Test. Dr. Omura ended up examining the Governor of the Province, as well as many doctors and their families every day while he was there, until 3 A.M., and refused to accept any compensation. Because of this, we had a chance to closely observe his Bi-Digital O-Ring Test Diagnostic Method, and we were deeply impressed by its accuracy and simplicity. At the end of May, 1988, during the World Congress on Acupuncture, held in Prague, Czechoslovakia, organized by the Czechoslovakian Academy of Medicine and ICMART, we met him again. After his lecture there, he again demonstrated the Bi-Digital O-Ring Test Diagnostic Method and its imaging technique at the request of the participants and the Chairman of the session. During the Prague International Congress, I found that doctors in many other countries were also seriously interested in the clinical application of the Bi-Digital O-Ring Test. In fact, most of the participants stayed with Dr. Omura even until closing of Congress Hall about 2 hours after the meeting ended, when the custodian finally turned off the lights.

Based on the above experiences, I sincerely hope, for the sake of many hopelessly sick patients, you will promptly grant approval of Dr. Omura's application for the Bi-Digital O-Ring Test. For less developed countries like ours, with very limited financial resources, the Bi-Digital O-Ring Test and its imaging method is an ideal, simple, non-invasive and economical diagnostic method, with considerable accuracy. I will certainly be teaching this method to doctors coming to our Institute as one of the most simple and important diagnostic tools.

From the above result,

The undersigned delcarant delares further that all statements made herein of his own knowledge are true and that all statements made on information and belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the application or any patent issuing thereon.





Valid XHTML 1.1!