Affidavit of Dr. Shimotsuura



Ref. Application of: Y. Omura, M.D., SC.D.

Serial No. 06/785,495

Filed: October 8, 1985


Examiner: John Hanley

Primary Examiner: William E. Kamm

Group Art Unit: 335


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


I, Yasuhiro Shimotsuura, M.D., a Japanese citizen residing at No. 67, Asahimachi, Kurume City, Fukuoka Prefecture, Japan, declare:

That I graduated from Fukuoka University, School of Medicine, and received an M.D. degree in 1979, and entered postgraduate residency training in the program at the Dept. of Neurosurgery at Fukuoka University during 1979 and 1980. In 1981, I entered the postgraduate residency program of the Dept. ot Medicine of Kurume University, Kurume City, Japan. Since then, I have been specializing in gastro-intestinal diseases and related problems. Currently, I am group leader of the Digestive Organ Research Section of the 2nd Division of the Dept. of Medicine, Kurume University, where I am engaged in research.

That I have read and understand the specifications of the above—identified application;

That in order to prove that Dr. Omura's Bi-Digital O-Ring Test, as claimed and described in the above application, as well as in his lectures and publications, is a simple, non—invasive, clinically very useful diagnostic and screening test, I conducted the following experiment:

I am an internist specializing in gastro-intestinal diseases and related medical problems at the 2nd Division of the Dept. of Medicine, Kurume University, Kuyume City, Fukuoka, Kyushu, Japan. Our Department of Medicine annually examines employees of the Bridgestone Tire Company (the largest automobile tire manufacturer in Japan) who are over 40 years old for stomach cancer, the most prevalent form of cancer in Japan. According to Dr. Omura's lectures given in Tokyo, as well as his publications, including his book Practice of Bi-Digital O-Ring Test (published by Ido No Nippon Sha, Tokyo & Yokosuka, in 1986, in Japanese), Dr. Omura claims that, if the Bi-Digital O-Ring Test of the thymus gland is extremely abnormal (the thymus gland is the only exception in the body where an extreme abnormal finding is +4 and occasionally -4, and a normal finding is between -l and -3), and the thymus gland is significantly hypofunctioning, (+3 or +4), most of these people have either: (l) chronic infections; (2) allergies; or (3) malignant tumors.

After attending his 2-day seminar and workshop in the summer of 1985 in Tokyo, I had difficulty believing his incredibly simple diagnostic methods. To confirm or disprove the method, I first practiced it with family members but could not obtain consistent results upon repeating it, as I did not remember the exact procedure, since it appeared to be so simple when I saw his demonstrations from a distance and I missed details. Therefore, I attended his seminar and workshop for a second time in March, 1986, in Tokyo. There, in the presence of about 450 doctors in a Tokyo auditorium, without knowing any medical history or the chief complaint of the patient, Dr. Omura accurately imaged half of the stomach and duodenum connected to the cut end of the stomach of a middle—aged male patient brought in by a very skeptical cancer specialist who was also attending the 2-day seminar & workshop organized by the Medical Core (the well—known medical conference organizer of important medical topics in Japan) and Ido-No-Nipponsha (the largest publisher specializing in the combination of Western medicine and Oriental medicine in Japan). Just like most of the other participants, in spite of all my previous doubts of the validity of the Bi-Digital O-Ring Test, I felt that when used properly, it could be an incredibly simple but powerful early diagnostic or screening test. I realized that my initial inconsistent results were due to incorrect application of the test methods resulting from a superficial and distorted understanding of the process. I also realized that I had to find out where I made a mistake in my actual procedure of carrying out the Bi-Digital O-Ring Test. When I mentioned my inconsistent results to Dr. Omura and invited him to give a lecture and demonstration with patients at my medical school, he was kind enough to visit the institute and give lectures and successful demonstrations on diagnosis and imaging of the normal and abnormal internal organs of our patients. He also observed my procedure with patients and pointed out the following common mistakes by beginners:

(1) Improper selection of the most sensitive compatible fingers between the subject and examiner for the Bi-Digital O-Ring Test.

(2) Improper direction of pulling (ideally, one should pull in opposite directions in a straight line).

(3) When pulling the O-Ring of the patient, the examiner also must make completely closed O-Rings.

(4) The examiner is not measuring the exact force applied or changes in absolute magnitude of the force before and during the testing of internal organs. What it is necessary to detect is whether there are changes before and during the testing of internal organs.

(5) Phantom effect: Even when probing stimulation is removed, the effect remains for a few seconds, and if the next test is given during this time duration, the result often becomes inconsistent: therefore, before repeating the test, one must wait for about 4-6 seconds, depending on the individual, to insure accuracy.

(6) The test results become unreliable if it is done in the presence of an undesirable electro-magnetic field, including the field coming from a television set.

Dr. Omura's lectures and demonstrations provided us with essential background in neuroanatomy, electro-physiology, electro-magnetic fields, and resonance phenomena between 2 identical oscillators, including identical cell structures and neurotransmitters, all required for the understanding of the basic mechanisms of the Bi-Digital O-Ring Test. After he taught us the correct procedure, not only myself, but even my wife was able to do it, and we began to appreciate the implications of the Bi-Digital O-Ring Test, although it was still too drastic a concept for me to believe fully until I tested many patients myself.

In order to find out whether Dr. Omura's claims were valid or not, I examined only the thymus glands of 1000 randomly selected workers over 40 years old at the Bridgestone Tire Company, using the Bi-Digital O-Ring Test by applying minute mechanical stimulation with a round-tipped insulator at the thymus gland representation area located at the lower part of the manubrium bone at I each side of the midline. I tried several different forces ranging from 0.01 grams to 10 grams/square millimeter on the same individual, and the differences in response between these lesser or greater forces were insignificant. However, most of the study was done using a force of less than 1 gram/square millimeter.

Of all the 1000 workers examined, 109 had an abnormal Bi-Digital O-Ring Test result which showed extreme hypofunctioning of the thymus gland (between +3 and +4). Since adenocarcinoma of the stomach is the most common cancer in Japan, all of these 109 subjects were asked to hold a microscopic slide of adenocarcinoma of the stomach. Thirty of the subjects, holding the slide in one hand, without use of any other stimulation showed a significant response of weakening of the Bi-Digital O-Ring (-3 or -4) of the other hand, which indicated that they may have adenocarcinoma of the stomach or a pre-cancerous condition. Twelve of these 30 subjects agreed to go through a standard stomach cancer examination, either by insertion of a gastro-camera or by an x-ray, with barium swallowing. Three of these 12 were found to have a distinctive adenocarcinoma of the stomach, and another 3 were found to have atypical cells in the stomach, which have been found in many cases to change later to adenocarcinoma. I can say nothing definitive of the remaining 18 subjects, since they could not come for standard tests. However, when checking the previous annual examination results of 1000 workers in the same company, I saw that an average of 6 cancers per year had been found through standard testing. I re-evaluated the available results of previous years' x-ray films and pictures by gastro-camera of these 12 workers, and among the 3 newly confirmed cancer subjects I found x-rays of one patient had shown suspicious shadows of cancer that had, at the time of last year's annual examination, gone undetected.

Many of my associates in the medical school have been very impressed with these findings, as this test appears to be more accurate than the commonly used standard cancer screening tests with x-rays after barium swallowing or by gastro-camera, and the diagnostic screening can be done with a minimal requirement of time, expense, and discomfort for the patient. In fact, when I examined them, it took less than one minute per subject, and I was able to screen all of the 1000 workers in less than 3 days. Stomach x-rays with barium swallowing or gastro-camera studies require much more time and manpower, as well as discomfort for the patient, and considerable expense.

In spite of these encouraging results, indicating that the Bi-Digita1 O-Ring Test is more reliable than the standard western medical tests and can be used as one of the simplest, quickest mass screening methods ever known, I wanted to study it further. I randomly examined 150 patients over 40 years old who were visiting our clinic regardless of their medical problem, most with no known problems of the stomach. After finding each patient's most sensitive O-Ring made by two different fingers with its strength compatible with my own, I asked each patient to hold a microscopic slide of an adenocarcinoma of the stomach with the cover glass of the slide facing his palm, and then performed the Bi-Digita1 O-Ring Test on his other hand. Before testing patients, the slide was cleaned with alcohol and wrapped with tissue paper, in order not to contaminate the slide with bacteria or virus, and the wrapping tissue paper was changed before the testing of each patient. Twenty-nine patients showed a positive response to the slide, indicating that they may have an adenocarcinoma or a precancerous state of the stomach. Among these 29 patients, l2 were confirmed to have an adenocarcinoma of the stomach using standard tests. None of these were previously suspected of having any malignant tumors.

These findings clearly demonstrate that the Bi-Digital O-Ring Test can be used as the simplest, quickest, most inexpensive non-invasive diagnostic test method available thus far. It is particularly suitable for quick, efficient screening of large groups for early diagnosis. The early detection of stomach cancer, the most prevalent type of cancer in Japan, is essential for saving the lives of many productive and active people.

I will be presenting a preliminary report of these findings during the 1st Symposium on the Bi-Digital O-Ring Test, to be held in Tokyo during August 22-23, 1987. The meeting has been organized by the Japan Bi-Digital O-Ring Test Association, five of whose seven advisors are currently professors and chairmen of departments in 5 different medical schools, while 2 are former deans of major medical schools, including the medical school of the University of Tokyo (equivalent of Harvard University in the U.S.A.) The detailed results, analysis, and further study will be presented during the 3rd Annual International Symposium on Acupuncture & Electro-Therapeutics at Columbia University, New York City, during October 8-11, 1987, as well as at the Annual Scientific Meeting of the Japan Mass Screening Diagnosis Association to be held in the late fall, 1987. Basic research on the neuroanatomical and neurophysiological mechanisms of the Bi-Digital O-Ring Test is being conducted by Prof. C. Takeshige, chairman of the 2nd Department of Physiology, and his associates at the School of Medicine, Showa University, Tokyo. He and his associates have electrically stimulated certain areas of the cerebral motor cortex of animals to create similar conditions of keeping the O-Ring closed in humans, while giving mechanical stimulation on the animal's skin above the normal or abnormal internal organ. By destroying different parts of the nerve pathways to the central nervous system, they are now clarifying some of the basic neuroanatomical mechanisms of the Bi-Digital O-Ring Test. Professor N. Tani and his associates of the Josai Dental College, Saitama, Japan, are also confirming Dr. Omura's findings, through frequency spectral analysis of EEG changes generated either by tactile stimulation or very weak light beam stimulation of various parts of the human body. The results of these two groups of scientists will also be presented not only in the scientific meetings of their specialties, but also at the 1st Symposium on the Bi-Digital O-Ring Test in Tokyo as well as at the 3rd Annual International Symposium on Acupuncture & E1ectro-Therapeutics at Columbia University in October, 1987. Mr. Katsumata, a physicist in Japan, published basic experimental evidence supporting Dr. Omura's concept of roles of electro-magnetic fields emitted from different molecules in the Bi-Digital O-Ring Test, in the article entitled "Fundamental Research on the O-Ring Test," in the official journal of the Japan Bi-Digital O-Ring Test Association, Resonance, 1:Nos.3 & 4, 14-19, 1987. Some of Prof. Tani's group's research appears as an 8 page report in the same issue.

As many cancers have not, in the past, been detected sufficiently early, I believe that the Bi-Digital O-Ring Test will save 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.

Valid XHTML 1.1!