Affidavit of Dr. Muteki



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, Takesuke Muteki, M.D., Ph.D., Prof. & Chairman, Dept. of Anesthesiology, Kururme University, a Japanese citizen residing at Araki 561-4, Araki-cho, Kurume City, Fukuoka-ken, Japan declare:

I was born June 21, 1929 in Fukuoka City, Japan.

In April of 1954 I received an M.D. from the School of Medicine, Kurume University.

In August 1958, I received a Ph.D. from the Postgraduate Divisions of Surgery and Pharmacology of the Kyushu University.

In 1965, I became a board certified Anesthesiologist.

During the period 1955-1959, I was a resident physician at the Department of Surgery, Kyushu University.

From 1959-1960, I was a postdoctoral research fellow at the Dept. of Anesthesiology, Baylor College of Medicine, Houston, Texas.

During 1961-1962, I was an Anesthesiologist-Surgeon at the Dept. of Surgery, Kurume University.

In February of 1962, I was appointed as an Assistant Professor of Anesthesiology and Director of the Central Anesthesiology Section of the Kurume University.

From 1967-1968, I was a visiting Professor of Anesthesiology at the Free University of West Berlin in West Germany.

In June of 1968, I was appointed as Full Professor and Chairman of the Dept. of Anesthesiology, Kurume University.

In April 1970, I was also appointed as Director of Emergency Medicine of the University Hospital of the Kurume University. Currently, I am serving as a representative of the following professional medical associations:
  • Japanese Association of Anesthesiology
  • Japanese Association of Surgery
  • Japanese Association of Circulatory Regulation
  • Artificial Respiration Research Society
  • Japanese Society of Medical Instrumentation
  • Other professional medical organizations
Since 1987, I have been advisor to the Japan Bi-Digital O-Ring Test Association, as one of 8 advisors to the association, most of whom are currently professors and some former deans of major medical schools in Japan.

I have known Dr. Omura for many years through his important original research works. Our close association with Dr. Omura began about 2-and-a-half years ago when he gave seminars and clinical demonstration on the use of the Bi-Digital O-Ring Test for diagnosis and imaging of various internal organs at the Dept. of Medicine, as well as the Dept. of Emergency Critical Care Medicine of Kurume University. Without knowing any history or chief complaint of the patient, he was able to diagnose specific cancers of specific internal organs and their locations, as well as diagnose the cause of intractable pain resulting from viral infection, and provided very useful clinical solutions for treatment. Since then, in our medical school, we started clinical evaluation of the Bi-Digital O-Ring Test with several interested physicians from various specialties. To our surprise, we obtained rather impressive results, some of which are listed below:

1) In screening of a thousand workers from Bridgestone Tire Company for cancer of the stomach (adeno-carcinoma), the total number of detections of pathologically confirmed cancers, utilizing the Bi-Digital O-Ring Test with a microscopic slide of adeno-carcinoma of the stomach, was about 2 times greater than that of standard procedures, consisting of taking barium x-rays of the stomach and gastroscopic examination of the stomach. (This screening was accomplished with the initiative of my associates, particularly Dr. Shimotsuura, a specialist in the G.I. system in internal medicine.) Among the workers showing positive response in the Bi-Digital O-Ring Test for adeno-carcinoma of the stomach, biopsies through gastroscopy detected and histologically confirmed more cancers than shown by barium x-rays or by routine gastroscopic examination of the stomach, which sometimes missed early stages of cancer. The time required for screening a thousand people took only a few days (only about 1 minute per individual), expenses were minimal, and no discomfort to the patient was created, while standard methods require considerable expense, time, manpower, with discomfort to the patient. Therefore, we believe that the Bi-Digital O-Ring Test will be an ideal mass screening method for adeno-carcinoma of the stomach.

2) In our subsequent studies we examined 196 patients (114 males and 82 females with average age of 57.2 years) who visited our hospital for a variety of reasons. We suspected that patients had adenocarcinoma of the stomach if they showed the following 3 specific Bi-Digita1 O-Ring Test results: 1) Thymus gland hypofunction; 2) Significant response to microscopic slide of a specific gastric cancer (adenocarcinoma); 3) Stomach abnormality. In those who showed positive response, we imaged the stomach and localized the cancer positive area by the use of the Bi-Digital O-Ring Test imaging method. We found that 21 out of 196 randomly selected patients showed positive response to adeno-carcinoma of the stomach ranging from slight response (-1) to strong response (-4). In 5 out of 21 patients whose stomachs we examined using standard X-Rays, gastroscopy and biopsies, we confirmed adeno-carcinoma of the stomach by microscopic examination of the biopsied stomach tissue taken during gastroscopic examination of a strong Bi-Digital O-Ring Test positive area (between -3 response and -4 response). Three out of these 5 patients had no chief complaint indicative of stomach problems. Among them, we had one male subject who had no gastro-intestinal symptoms but showed strong Bi-Digital O-Ring Test response for the microscopic slide of adeno-carcinoma of the stomach, indicating a possibility of the individual having adeno-carcinoma of the stomach. Although gastroscopy revealed no sign of cancer other than a slight abnormality in the small area of the mucous membrane of the stomach, biopsies were taken from five locations in the stomach during the first gastroscopic examination, and no malignancy was found. Since the Bi-Digital O-Ring Test with microscopic slide of adeno-carcinoma still showed marked Bi-Digital O-Ring weakening response, a similar biopsy was repeated a total of 6 times in a period of 4 months out of which only 2 biopsies in the last examination revealed adeno-carcinoma of the stomach. Shortly after that, a gastroectomy was performed and a small area of cancer tissue with a diameter of less than 5mm. in area was confirmed in the excised stomach. Details of these clinical studies have been already published in 1987.

3) About 70 cases of chlamydia trachomatis were detected in our emergency crtitical care medicine clinic by the Bi-Digital O-Ring Test, using chlamydia antibodies as the control reference substance. About 80% of these were confirmed by standard laboratory tests performed at the university hospital. Many of the remaining 20% may partially be due to improper collection of test specimens. The clinical implications of these findings give further supporting evidence for the validity and accuracy of the Bi-Digital O-Ring Test results.

4) In our emergency critical care medicine department alone, an average of 1 patient per 3 or 4 weeks who had swallowed an insecticide known as paraquoto (a very long-acting organophosphate) for the purpose of committing suicide was brought in. Every one of these patients died within 2 days after ingestion of the chemical, regardless of our efforts using every known treatment, if the serum concentration of the chemical was over 2 ppm. During ]uly, 1988, while Dr. Omura was visiting our medical school as an invited speaker, my close associates, Dr. Shinozaki, an Assistant Professor in our department, as well as Dr. Shimotsuura, discussed this serious problem with him. On ]uly 27, although we had no such patients, since all previous patients had died, we used one of the internists as a simulated patient, holding a fatal dose of the chemical in a container in his hand. With Dr. Omura, we evaluated all the medications recommended in the medical text books. As we long suspected, the Bi-Digital OŚRing Test indicated that the currently recommended and widely used drugs had no significant beneficial effects. Therefore, using the internist, we evaluated about 50 different drugs and injectable forms of medication and intravenous amino acid solutions. This simple screening test with the Bi-Digital O-Ring Test for selecting potentially effective drugs indicated that one particular intravenous (i.v.) fluid containing only certain amino acids(commercially available as "aminoleban") could reverse a weakened O-Ring response of -4, when 10 cc of insecticide (fatal dose) was held in the subjects hand, to an excellent normal +4 response. Other i.v. amino acid solutions which included arginine had no beneficial effect. This test was repeatedly reproduced, using other doctors as simulated patients.

Shortly after Dr. Omura left our medical school, one 51-year-old female patient who took a fatal dose (extremely high blood concentration of 35 ppm) of the insecticide was brought to our university intensive care unit of the emergency critical care medicine department. Since such patients always need continuous i.v. fluids, we gave intravenous administration of "aminoleban", and the patient lived 9 days after ingestion of the fatal dose of insecticide. During the first day, 2500 cc of "aminoleban" was given intravenously. Within the first 5 hours, the blood concentration of insecticide diminished from 35 to only 5 ppm. By the end of 2 days, this had reduced to 0.8-1 ppm. We never previously succeeded in keeping such a patient alive more than 2 days when the blood concentration of the insecticide was more than 2 ppm, and nobody with a concentration of 35 ppm had previously survived more than one day. Therefore, when we accumulate more cases of this kind, we are intending to report on the clinical significance of the Bi-Digital O-Ring Test for emergency medicine during the next scientific meeting of emergency medicine.

5) My close associate, Dr. Shimotsuura, with the help of engineers and computer specialists, recently constructed an electromechanical instrument which can objectively measure change in the Bi-Digital O-Ring Test response. Using this prototype instrument with computographic display, some of the skeptical scientists who either never did research or have been doing it improperly can now be convinced of the simplicity and validity of the Test. Although the instrument is very heavy and bulky and impossible for one person to carry, it was demonstrated during the 2nd Annual Symposium on the Bi-Digital O-Ring Test, sponsored by the Japan Bi-Digital O-Ring Association. Many of the participants had first hand experience to further convince themselves of the clinical usefulness of the Test, in spite of its apparent deceivingly simple procedure, which somewhat resembles the historical stage before use of the reflex hammer was gradually accepted by the medical profession.

6) About 2 years ago, one of the Japanese companies constructed an instrument to measure changes in pinching force during the Bi-Digital O-Ring Test, without use of a human examiner, using an electro-mechanical transducer and computer display system, based on different principles than those of Dr. Shimotsura's measuring device. The instrument was demonstrated during one of the symposiums in Tokyo, on the Bi-Digital O-Ring Test, and it was able to obtain similar information as that obtained with a human examiner. Recently, we were informed that this measuring device for change of force during the Bi-Digital O-Ring Test is now under consideration by the Japanese patent office.

7) In Japan, because of Dr. Omura's book, entitled Practice of the Bi-Digital O-Ring Test, (first edition was published in March, 1986), along with a video teaching guide on the correct practice of the Bi-Digital O-Ring Test, this method is rapidly permeating the medical profession. Already the 4th edition of his Japanese book has been published from Ido-no-Nippon-sha, Tokyo & Yokosuka, Japan, which means that more than 10,000 copies have been sold since the first edition was published. Useful books are often shared by their associates, so the actual number of individuals who have read his book should be much more than 10,000. The book has recommendations from Prof. Hideo Yamamura, Former Professor & Chairman of the Anesthesiology Dept., Tokyo University, and Former Dean of Tokyo University; Prof. Chifuyu Takeshige, Professor & Chairman of the Physiology Dept. and Dean of the School of Medicine, Showa University; and Prof. Gong-Bai Chen, Director of the Institute of Neurology, Shanghai Medical University, People's Republic of China; and others. For the 2nd Annual Symposium on the Bi-Digital O-Ring, held during July 30-31, 1988, at the Great Auditorium of the Meiji Seika, Tokyo, Prof. Takeshige served as the President of the Symposium. Many researchers from all over Japan presented many important papers on original research with the Bi-Digital O-Ring Test after Dr. Omura's special lecture and demonstration. Besides this annual symposium, on the average of 4 times a year the Japan Bi-Digital O-Ring Test Association organizes research and study meetings in Tokyo and they publish its official journal ("Kyomei" which means "Resonance").

Based on these findings, I strongly urge approval of Dr. Omura's application concerning the Bi-Digital O-Ring Test. I believe that this method is not only a simple, quick, relatively accurate, economical way of screening for various diseases in early stages, but it also has great possibilities of saving many lives.



The undersigned declarant declares 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.





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