Wireless capsule endoscopy
Overview
History
Wireless capsule endoscopy, also known as the capsule camera or video pill or Miniature ingestible Capsule or Capsule Endoscopy is a camera with the size and shape of pill used to visualize the gastrointestinal tract [1]. This device is being promoted as an alternative to an endoscopy and has become a valuable tool to gastroenterologists all over the world with sales over 135 million dollars per year with over half million Capsules already sold. The camera assists in detecting cancer, ulcer,Small Bowel and other types of internal Gastrointestinal or Digestive ailments.
Inventors
Currently there are two key patents. The main System patent 7039453 for Capsule Endoscopy System was issued based on long review by the US Patent Office [2] to Tarun Mullick,Ram Nair,Sudhir Dutta et el based on "First to Invent" criteria and not "First to File" issued to Gavriel Iddan and Doron Sturlesi. Their patent # 5604531 [3] has subsequently been changed with Key Claims 1,2,3 and 11 rejected by US Patent office in April,2006 based on an appeal by Olympus Corp. in 2003. [4] These claims for Capsule Endoscopy System are crucial as other claims 4 to 10 and 12 to 17 are dependent on them. Moreover,the US Patent laws give top priority to "First to Invent" and not "First to File" to protect the rights of small inventors.Currently Given Imaging Ltd. and Olympus Corp.are producing these products outlined in this system patent.According to these inventors,Tarun Mullick conceived CAPSULE ENDOSCOPY in 1985 and had developed it by 1989,but chose to wait for more features and finally filed a provisional patent followed by a complete 157 claims patents which the US Patent office reviewed carefully as "First to Invent" documents were examined by them over 5 years and complete System patent for Capsule Endoscopy was issued in 2006 at the same time to Tarun Mullick et el. while US Patent office rejected Iddan's 4 main claims relating to the system(Claims 1,2,3 and 11 have been rejected) in 2006.Olympus Corp.is trying to prove the invalidity of this patent by Iddan as they filed their patent after Tarun Mullick et el.
Patent Litigation
So now there are three patents and Law Judges/Jury will decide who the first inventors are and whose patent is basic and more powerful.Olympus Corp. has spent close to 3 million$ in legal battle and Given Imaging has spent close to 2 mil.$ and in the next 18 months,they may spend another 6 to 8 million dollars each.Both corporations could spend 16 to 20 million$ in total in 2007 and 2008.These estimates are based on Given Imaging statements on Aug.2,2007 that their 2007 litigation expenses for 2007 are likely to be 4 million$. An Israeli Patent attorney Dr.Michael Factor reported in a blog in 2006 that in Israel,if main claims are rejected on appeal,the patent becomes less effective based on a recent ruling by the Israel patent office that where an independent claim is disqualified,all the dependent claims are disqualified as well.Because of high stakes,this legal case could take 4 years to settle as the main inventor has not announced their legal moves.US District Judge James Knoll Gardner has ordered JURY TRIAL from November 3,2008 in Allentown,Pennsylvania in Eastern District Court of Pennsylvania [5] which is close to Olympus USA headquarters.Both companies(Given Imaging,Olympus Corp.) are gathering information and witnesses to defend that they are not infringing patents in the discovery phase and each spending close to 300,000 to 400,000$ per month in legal costs.At some point,MicroGizzmos 's CEO/Inventors Tarun Mullick ,Sudhir Dutta are going to file their lawsuit against Given Imaging and Olympus Corp.which could push the final verdict timing to 2010/2011.Details of this legal case 2:06-cv-02132 are available thru www.Pacer.com . US Judges in the past have imposed severe penalties for willful infringement of patents of small inventors by big companies and US Supreme Court has sided with the small inventors like Late Thomas Campana Jr. and David Stout of NTP,Inc. a patent holding company [6] . US Supreme Court refused to hear Research in Motion case and sent the case back to US District Court Judge James R.Spencer who issued stern warnings to RIM and RIM finally paid 612.5 million$ to NPT,Inc in Jan.2006.Nokia,Visto and Good Technology decided to license in 2005 fearing big penalties. For this reason,it is premature for readers to think that Iddan et el. has the first basic patent based on publicity by Given Imaging. The US patent law clearly states that "Patents are governed by "FIRST TO INVENT" principle and not "First to File" rule".This is why the US Patent office took 5 years 4 months to approve Patent#7039453 to Tarun Mullick et el as their claims are very broad.The provisional patent was filed in 1999 and approved on Feb.8,2000 but the 157 claims patent was filed on January 12,2001. The USPTO approved 17 claims out of 157 claims of Tarun Mullick et el.The other 140 claims have been refiled in July,2006 as they are for much larger functions pertaining to Endoscopy.Only the Judge and Jury will determine this in United States.Olympus Corp.is contesting in Eastern Dist.of Pennsylvania Court in Allentown that it also has a patent for Capsule Endoscope .Readers can examine the wordings of Patent# 6939292 [7] issued to Olympus corp.This patent was filed after Patent# 7039453.That is why ,it is premature to declare the first inventor of Capsule Endoscopy.
Current and Future Uses of Capsule Endoscopy
At the present time, the capsule camera is primarily used to visualize the small intestine. Whereas the upper gastrointestinal tract (esophagus, stomach, and duodenum) and the colon (large intestine) can be very adequately visualized with scopes (cameras placed at the ends of thin flexible tubes), the small intestine is very long (average 20-25 feet) and very convoluted. The capsule camera travels through the length of the small intestine in about 4 hours, and wirelessly transmits two images every second to a receiver carried by the patient. The images are of very good quality, comparable to those from scopes. The test carries a high sensitivity and specificity for detecting lesions. The main uses today are for detecting the cause of gastrointestinal bleeding, and for inflammatory bowel disease, such as Crohn's disease. Capsule Endoscopy is currently a favorite of many research Gastroenterologists for Small Bowel [8] .At DDW 2007,Olympus EndoCapsule was compared to Given Imaging PillCam [9] for picture quality in a study presented at this meeting.Olympus EndoCapsule picture quality [10] was deemed to be better.Click on Image quality on the Olympus website to see the high resolution image of EndoCapsule. EndoCapsule uses CCD chip and PillCam uses CMOS chip. Given Imaging is going to sell Colon Capsules or Pills in the second half of 2007 in Europe and possibly in the USA after FDA approval.At this meeting,new advanced Endoscopy Capsule concepts for Colon Screening were discussed.These concepts are part of 140 claims refiled by Tarun Mullick ,Sudhir Dutta et el with the US Patent Office. [11] The Capsule Endoscopy is going to be used for many more active procedures and functions like the Current Endoscopes very soon and Capsule Endoscopy is likely to become a first line procedure by Gastroenterologists to detect and treat Gastrointestinal problems based on many papers presented at DDW 2007 in May in Washington,DC.Stanford Univ.aeronautics dept. and many other Japanese co.like Sayaka [12] are also working on similar advancements. Sayaka Promo Video is interesting to watch for those unfamiliar with the Capsule Endoscopy .Stanford Univ.inventors have filed a patent in the US and Europe. In addition,its use is likely to spread to every country in the world.This June,2007,Capsule Endoscopy was approved in Japan with reimbursement from Oct.2007 due to the great efforts of Given Imaging.Given imaging website provides regular news releases on FDA approvals,worldwide acceptance and reimbursement and new studies worldwide supporting Capsule Endoscopy as an accepted diagnostic procedure.[13] , [14] Olympus corp. announced on Sept.21,2007 that they are launching their EndoCapsule in Oct.2007 in USA as a new technology which is going to grow rapidly for many applications.[15] Dr.Oz investigated Food Myths on Oprah show on sept.17,2007 using PillCam.This Capsule is now being used by researchers for all kinds of foods digestion in our body along with stress affect on our digestion system for London Cab drivers by Dr.Oz.[16]