Affidavit of Dr. Cook



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, Albert W. Cook, M.D., Prof. of Neurosurgery At State University of New York, Downstate Medical Center, an American citizen residing at 516 Center Island, Oyster Bay, Long Island, New York declare:

I was born July 23, 1922, in Ridgewood, New York City.

In 1944, I received a B.A. degree with pre-medical education from Dartmouth College.

In 1946, I received an M.D. degree from Long Island College of Medicine (which later became part of Downstate Medical Center of the State University of New York).

During 1946-1947, I was an intern at Brooklyn Hospital.

From 1947-1949, I was a resident physician in neurosurgery as a Lt. JG., USN Medical Corps at the U.S. Naval Hospital, St. Albans, N.Y.

From 1949-1950, I did additional general surgery residency training at St. Johns Episcopal Hospital, Brooklyn.

From 1950-1953, I did neurosurgery residency training Long Island College Hospital and at Kings County Hospital of Downstate Medical Center, State University of New York.

In 1953, I was appointed as an Assistant Professor in the Dept. of Neurosurgery, Downstate Medical Center, State University of New York.

In 1959, I was appointed as a Full Professor and Chairman of the Dept. of Neurosurgery, Downstate Medical Center, State University of New York.

In 1977, I was appointed Director of the Dept. of Neuroscience, Long Island College Hospital.

In 1987, I was appointed Director of New York Pain Center of Long Island College Hospital.

I have known Dr. Omura professionally and personally for about 10 years. I am familiar with Dr. Omura's clinical research, including his work on basic electrical parameters for safe and effective electro-therapy, non-invasive measurement of blood pressure and relative blood flow at different parts of the body, including brain circulation, as well as his work on the Bi-Digital O-Ring Test. Dr. Omura was also interested in our clinical applications of electrical stimulation of the spinal cord for patients who have pain or who have motor dysfunctions, and I was the first one to discover that electrical stimulation of the spinal cord improves motor function in some diseases often considered to be difficult to treat or incurable, such as multiple sclerosis. Because of our mutual interest, we have been participating in each other's teaching programs. He has even served in our department as an Attending Physician at the Neuroscience Dept. of Long Island College Hospital, where I have been Director. Since I have become Director of New York Pain Center, he has been helping us there as a consultant.

In treating many medical problems of pain or symptoms resulting from circulatory disturbances, in addition to his non-invasive measurement of blood pressure and blood flow at different parts of the body, such as the brain or lower extremities, his non-invasive Bi-Digital O-Ring Test diagnostic method, as well as imaging method of internal organs, malignant tumors, and localization of specific bacteria and viruses have become extremely important clinical tools. As a professor of neurosurgery, many people think that I will mainly be involved in neurosurgery, but I have come to the realization that surgery is not always the best solution for each patient, although in certain conditions surgery may be absolutely indicated. We are often accustomed to admit patients and do intensive laboratory tests, which are frequently expensive, time-consuming and sometimes traumatic to patients, even with risk to life in some cases. By witnessing many clinical cases demonstrated for diagnosis and treatment in front of physicians and dentists during his periodically given seminars and workshops, accredited by the New York State Boards of Medicine & Dentistry, I am firmly convinced of the clinical importance of the Bi-Digital O-Ring Test, as well as its applications for localizing and imaging identical substances in the patient's body as reference control substances. Following are some examples:

1) One of my patients, an approximately 75-year-old gentleman, was complaining of severe pain at one side of the back of the neck. However, the x-rays of the cervical vertebrae did not show any abnormalities. When Dr. Omura examined him with the Bi-digital O-Ring Test, the exact site of abnormality in the vertebra was localized, and it was suggested that we repeat tomography of the neck about every 2 mm around this localized abnormal area. This time, the x-rays showed narrowing of the neural canals in the exact location he indicated.

2) We had one elderly woman patient who had severe intractable pain and very cold temperature in one hand. Our hospital's vascular department evaluated the circulation at the radial and ulnar arteries near the wrist, which indicated that the circulation was within normal limits, but no treatment alleviated the pain. She even wanted to die rather than continuously suffer from the severe pain, and she was therefore considered for possible surgery. When Dr. Omura examined her with the Bi-Digital O-Ring Test, he found the abnormality to be located nearer the hand than the area they had been measuring. When he measured blood pressure and blood flow of the lower wrist and of each finger, there was significant reduction in both parameters. The Bi-Digital O-Ring Test indicated that there was severe irritation between the 6th and 8th cervical nerves. When he gave acupuncture para-vertebrally in the affected neck area corresponding to the 5th and 7th cervical vertebrae, her pain in the hand almost immediately disappeared, with return of blood pressure and blood flow to normal levels at the fingers and lower wrist.

3) In early 1988, a Canadian anesthesiologist brought his l4-year-old daughter, who had been suffering from severe spastic paralysis of both the upper and lower extremities since shortly after birth, to the periodic acupuncture & electro-therapy seminar & workshop (accredited by the New York State Boards for Medicine & Dentistry) of which I am Co-Chairman with Dr. Omura. When this patient was brought in, her neck was severely twisted to the right and her pupils could hardly be seen, as the eyes were rolled upwards. The anesthesiologist explained that, in spite of all attempts by leading neurologists, rehabilitation medicine specialists, and physio-therapists from various universities in the United States and Canada, very little progress had been made. He even brought the daughter to the People's Republic of China in November of 1987, hoping that the best acupuncturists or Qi-gong masters in China attending the World Congress on Acupuncture & Natural Medicine would be able to help her. However, none of them were able to improve the condition.

The disappointed anesthesiologist fortunately met Dr. Omura, who was one of the main invited speakers of the Congress, the night before they were leaving, and he asked Dr. Omura to help. Dr. Omura immediately examined her in his hotel room, and the Bi-Digital O-Ring Test indicated a sub-clinical infection of alpha-streptococcus and cytomegalo-virus in the entire motor area. Blood pressure and blood flow to the entire brain was reduced due to spasticity of both the right and left vertebral arteries. The location and diameter of the narrowed vertebral arteries were imaged by the Bi-Digital O-Ring Test. Dr. Omura suggested to the anesthesiologist that he would be happy to examine and treat the child free of charge during his forthcoming seminar and workshop in New York, provided that the daughter would be treated with amoxycillin for her alpha-streptococcus infection for about 2 weeks to eliminate treatable bacterial infection. Dr. Omura examined the child in front of the doctors at the seminar & workshop in New York and essentially confirmed the findings, with the exception of the alpha-streptococcus, which had been treated with antibiotics. When he gave acupuncture at the narrowed vertebral arteries at the transverse foramen of the 6th cervical vertebra at both sides of the neck, blood pressure and blood flow measured non-invasively at the supra-orbital arteries increased significantly toward normal, with relaxation of the spastic muscles at the lower extremities within a few minutes after treatment. However, there was no effect in the upper extremities, neck or eyes. During the 2nd day of the conference, Dr. Omura examined the daughter and repeated the same acupuncture treatment, which further improved the brain circulation, but there were no further significant changes except that the lower extremities were somewhat more relaxed and stretched. At this point, he applied aluminum foil surface electrodes with electro-conductive jelly to the front of the entire motor area, as well as to the posterior part of the entire motor area, then gave safe (about 1 pulse/second) electrical stimulation sufficient to produce muscle contraction of the scalp but without creating pain. Spasticity of all of the patient's extremities disappeared, the head came to normal position and the rolled pupils also came to normal position. The anesthesiologist father claimed that this was like a miracle, since all the previous treatment had failed to produce such a dramatic result. I understand that this relaxation of the muscles resumed to the previous state within a few days, but the anesthesiologist had strong hope for the first time in the child's life that there was a possibility that the condition could be significantly improved. All of the doctors attending the meeting witnessed the efficacy of the Bi-Digital O-Ring Test in diagnosis and dramatic results of treatment based on the Test results.

4) Using the Bi-Digital O-Ring Test Molecular Identification Method, without opening the skull or any other part of the body, utilizing the reference control substance, one can localize specific bacteria or viruses or malignant tumors of specific internal organs and select potentially effective medications for them which are not harmful to normal tissue or major internal organs, including the thymus gland.

5) In order to localize changes in the neuro-transmitters in the brain, standard neuro-chemical methods require a sample of tissue. Therefore, it is quite difficult to repeat measurement of changes before and after certain treatments in living humans for medical and ethical reasons. However, using Dr. Omura's Bi-Digital O-Ring Test Molecular Identification Method, detailed structure of the serotinergic system in a slice of human brain can be accomplished in less than three hours with better accuracy than standard neuro-chemical analysis done with multiple slices of brain tissue, which takes at least a few weeks to make complete mapping by competent scientists and technicians. For the past 2 years, Dr. Omura has successfully applied similar techniques with living humans by placing a white latex swimming cap (an electrical insulator but which is permeable to an electro-magnetic field from different brain tissues, as the skull is transparent to an electro-magnetic field) on the patient's head. Then he is able to map the neuro-transmitters on the surface of the swimming cap. Similarly, on this cap placed on the patient's head, possible subclinical infections from various bacteria and viruses in the brain are also localized and mapped. Using this technique, he has successfully diagnosed many clinical problems involving intra-cranial diseases. Also, the effects of drugs or certain treatments, such as acupuncture, on brain circulation, as well as neuro-transmitters, before and after treatment, was non-invasively demonstrated for the first time in living humans.

6) Dr. Omura has been using the Bi-Digital O-Ring Test successfully on individuals who have no fingers or hands, on individuals who are paralyzed or on infants, animals, or others who cannot communicate their thoughts, using the Bi-Digital O-Ring Test and its imaging methods indirectly through a third person. This is done by connecting the abnormal electrical information to the third person through an electro-conductive probe, which could be a simple copper wire. This is known as the "Indirect Bi-Digital O-Ring Test Method." Therefore, I understand that even veterinarians have begun using it.

7) In September, 1987, he was an invited speaker of the Pain Symposium at Modena University in Italy. After the Symposium, when he demonstrated this method at the University of Pavia, Italy, Professor Nappi, a leading neurologist and Editor in Chief of the journal, Functional Neurology, asked him to be an Editorial Board Member of the journal. Since March, 1988, Dr. Omura is serving as an Editorial Board Member of that journal. In addition, he has been serving on the International Advisory Board of the Scandinavian Journal of Acupuncture & Electro-Therapy, as well as being an Editorial Board Member of Alternative Medicine. He has been Editor in Chief of Acupuncture & Electro-Therapeutics, The International Journal, published by Pergamon Press, since 1974. During 1980-1986, he also served as an Editorial Consultant to The Journal of Electrocardiolgy. These honors to serve on editorial boards are only given to individuals with outstanding international reputations as researchers. Dr. Omura is currently serving as Director of Medical Research, Heart Disease Research Foundation; Adjunct Professor of Pharmacology, Chicago Medical School; Visiting Research Professor, Dept. of Electrical Engineering, Manhattan College; and President of the International College of Acupuncture & Electro-Therapeutic, which is permanently chartered as an educational and research organization by the University of the State of New York, State Education Dept. He also serves as a member of the New York State Board for Medicine as one of the 2 physician representatives from Manhattan. His background in basic and clinical medicine, as well as physics and engineering, is impeccable.

I consider the Bi-Digital O-Ring Test to be a significant contribution for both basic and clinical medicine. I have witnessed many clinical situations where standard laboratory tests failed to localize hidden medical problems due to limitations of present standard laboratory procedures, where the Bi-Digital O-Ring Test often provided a simple, quick and accurate diagnosis non-invasively, as well as serving in selection of effective treatment and evaluation of therapeutic effects of any treatment, without depending upon expensive, bulky instruments or time-consuming, invasive tests.

All this data is in support of Dr. Omura's patent application concerning the Bi-Digital O-Ring Test for the imaging and diagnosing of internal organs of patients.



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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