WAKE UP THE WORD WAS "PROCESS" not PATENT> IF IT DID NOT MEET FDA REG'S, THEY DEFINITELY WOULD NOT APPROVE! END OF STORY! So what we have here is: A U.S. PATENT! FDA Approval! So as far as the U.S. market is concerned, Licensing clinics in hospitals and let the cash flow. $$$$$$$$$$$$$$$$$$$$$$$$$$