MIT suing Still River Systems in patent dispute

MedCity News

The Mass. Institute of Technology files suit against Still River Systems Inc., demanding rights to the company’s patented particle accelerator technology.

The Mass. Institute of Technology is suing Still River Systems Inc. for rights to the company’s technology.

The school filed a complaint Dec. 17 in the U.S. District Court for Massachusetts alleging that the Littleton, Mass.-based radiation-therapy developer incorrectly left an MIT researcher out of a patent granted to the company’s founder and CTO, Kenneth Gall, in June.

MIT demanded that it be named as an owner or co-owner of patent 7,728,311, “Charged Particle Radiation Therapy,” because of its rights to the work of MIT Plasma Science and Fusion Center research engineer Timothy Antaya, whom the school alleges to have conceived one or more of the inventions in the patent, according to the court documents.

In the fall of 2002, Gall approached Antaya because he could not find anyone else who could develop a “synchrocyclotron for a single-room proton beam radio therapy treatment center,” ’ a modified cyclotron, or particle accelerator ’ according to court documents. In July 2004, Gall entered into an agreement with MIT for Still River to sponsor Antaya’s research, to allow the MIT scientist to “develop a working synchrocyclotron for certain medical applications,” so that the company could determine whether a commercially-viable synchrocyclotron with its specifications “was even possible,” according to court documents.

From that time through Febrary 2005, Antaya sent Gall at least four memos about his progress in developing a device that could be mounted for patient treatment. MIT alleges that Gall’s patent includes material from Antaya’s messages, including figures included in the memos.

MIT lawyers sent a letter to Still River in September 2010 demanding that Antaya be named as an inventor on Gall’s patent, but the company refused, according to court documents.

Still River‘s Monarch-250 proton beam radiotherapy device, which is still in development, has technology that includes “a cyclotron [and] proton beam delivery system,” according to the company’s website. Gall “originated the design principles of the Monarch-250 PBRT System and founded Still River Systems in 2004,” according to his bio on the site.
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Research joins forces with industry in the fight against cancer

The Geneva-based Application of Detectors and Accelerators to Medicine (A.D.A.M. SA) has recently completed the first unit of an innovative linear accelerator for hadron therapy applications. The design of the new unit is based on pioneering studies carried out by the TERA Foundation a few years ago. Assembled at CERN in the framework of a partnership agreement with the company, this first module is now ready to leave Switzerland for Rome, where it will undergo some important performance tests.

The first unit of LIGHT was unveiled on 20 November. The ceremony was attended by Sergio Bertolucci, CERN Director for Research, Rolf Heuer, CERN Director-General, Alberto Colussi, Director of ADAM SA, President Carlo Lamprecht and Domenico Campi, ADAM SA Board Members, and Ugo Amaldi, President of the TERA Foundation.

The Linac for Image-Guided Hadron Therapy (LIGHT) is the innovative linear accelerator designed by A.D.A.M. SA to revolutionise hadron therapy facilities by simplifying the infrastructure and making them profitable from an industrial point of view, while ensuring better beam quality. “Today proton beams for advanced cancer radiation treatment are produced either by cyclotrons, which need an energy selection system to adjust the beam energy to the value required by the specific treatment, or complex synchrotrons. When Ugo Amaldi told me that, according to studies carried out by the TERA Foundation, proton beams for hadron therapy could be produced by a 16-metre-long linear accelerator, I decided to accept the challenge to bring the project forward and to industrialise this research,” explains Alberto Colussi, director and founder of A.D.A.M. SA, established in December 2007. Requiring only a few milliseconds to change energy and with its 200 Hz repetition rate, the LIGHT accelerator allows a "multi-painting" treatment of moving organs.

A.D.A.M. SA took the original ideas of the TERA Foundation and adapted them to the needs of a modern medical centre. “Given the dimensions and the modularity of the LIGHT system, the new centres will be designed to house equipment which will be much less bulky,” confirms Colussi. In addition, the innovative concept developed by A.D.A.M. SA includes the absence of rotating gantries, the heavy devices used to direct the beam exactly to the target. “We have replaced the gantry with a mobile bed of novel design that allows operators to adjust the position of the patient to the needs of the treatment. This will reduce the costs compared to a traditional hadron therapy facility, allowing a larger number to be constructed,” adds Colussi.

LIGHT has its roots in fundamental research but it is now ready to be developed on an industrial level and will eventually be opened up to the worldwide market. “Working in collaboration with CERN has been very exciting: here there are no limits to the imagination, while in industry it is always necessary to deal with profit,” says Colussi.

Once all the tests with radiofrequency at CERN have been completed, the first unit of LIGHT will be heading to Rome, where it will undergo performance tests. If all goes well, A.D.A.M. SA plans to retail the first industrially produced LIGHT modules within two years.

The First Unit of LIGHT is designed for a 30 MeV injected proton beam produced by either a linac or a cyclotron, and its energy gain is 12 MeV. Since the LIGHT concept is a modular one, the output energy of three similar units is 65 MeV, used to treat eye tumours.

The output energy can be increased by adding other units. In a typical 230 MeV installation, corresponding to an 18m long medical linac, the radiofrequency (RF) power sources are each physically positioned along its length. The accelerating modules are longer as the beam progresses down the linac, because of the increasing beam velocity.

To accelerate protons by 200 MeV in less than twenty metres, the chosen frequency is 3GHz, which is standard for electron linacs but has never been used before for protons.

The RF power pulses produced by the klystron are transmitted through a waveguide. The beam energy modulation needed to correctly cover the target tumour depth is obtained electronically by changing the peak RF power applied to the accelerating modules. The pulsed klystron-modulators provide this change of RF power in a few milliseconds.

The First Unit equipment is computer-controlled from two desk-top computers connected to the control system.

by Francesco Poppi

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Hitachi, Hokkaido University to Develop New Proton Therapy Treatment System

September 23, 2010

Hokkaido University and Hitachi, Ltd. have announced that they have concluded an agreement to jointly develop a new type of proton beam therapy(PBT) system for cancer treatment by combining with the world-leading Japanese advanced medical technology. The proposed system was awarded for a grant under the Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST Program), a national project sponsored by the Japanese government. In line with the agreement, Hitachi will deliver this therapy system to Hokkaido University.

The FIRST Program is a major Japanese government initiative to incubate the world leading science and technology to establish future Japanese technical backbone. Only 30 "Core Researchers and Projects" were awarded for the grants out of 565 applications throughout Japan in March 2010 by the Council for Science and Technology Policy. Hokkaido University's "Sustainable Development of Molecular-Tracking Radiotherapy System" project, applied by Professor Hiroki Shirato, Department of Radiation Medicine, Graduate School of Medicine was awarded for this FIRST grant*, as the only application accepted in the field of radiation therapy. The proposed system is expected to advance radiation cancer therapy in Japan. Hokkaido University and Hitachi will combine real-time moving tumor tracking technology and spot scanning irradiation technology for the first time in the world to develop a compact and high-performance PBT system that can precisely target the respiratory moving tumors. The new facility will be constructed adjacent to the Hokkaido University Hospital with ground breaking in the fiscal year 2011 and completion in March 2014. After the completion, this new facility will start patient treatment as a part of, Hokkaido University Hospital.

PBT is an advanced type of cancer radiotherapy. Protons, the atomic nucleus of hydrogen, are accelerated to high speed and its energy is concentrated on tumors. PBT allows patients to continue the normal life during the treatment by its superb characteristics that almost no pain is associated with treatment and damage to the body's functions or form is limited to the minimal level. It has thus attracted attention as a cutting-edge therapy for treating cancer whilst maintaining patients' quality of life (QOL). Because of its superb characteristics of dose concentration to a small spot, PBT can focus easily to the cancers that do not move like brain tumors, but the treatment to the tumors in the body trunk such as lung and liver which moves in accordance with the respiration needs special care, and the combination of PBT with real time tracking to target the tumor location is desired.

Hokkaido University has focused on the development of technologies to concentrate irradiation dose to tumor locations, which is one of the most important technologies for the radiation therapy for more than half a century. Professor Shirato has successfully developed real-time moving tumor tracking technology that automatically identifies the location of a gold marker inserted in the proximity of a moving tumor with X-ray fluoroscopic images and irradiates only when the tumor comes to the anticipated marker position. He has also developed the world's first 4D(four-dimensional) X-ray radiation therapy system employing this technology. These breakthroughs enabled the accurately targeted X-ray radiation therapy to the respiratory moving tumors by the real time images.

Through its power systems business, Hitachi has developed PBT system based on its vast technologies and know-how related to accelerators, irradiation and control system. In May 2008, Hitachi's first spot scanning irradiation technology that can concentrate irradiation dose to the tumor shape has started patient treatment at the University of Texas M. D. Anderson Proton Therapy Center in the U. S., one of the world's largest hospitals specializing in cancer treatment. This marked the first clinical application of spot scanning irradiation technology in a general hospital.

Hokkaido University and Hitachi entered into a comprehensive academia-industry collaboration agreement in April 2003 and since then have been conducting various joint researches. In the medical field, in particular, they have been jointly developing new molecular imaging technology for assessing and diagnosing the radioresistance of cells that are critical in radiation therapy. This research trajectory followed selection of the technology in fiscal 2006 as a Future Drug Discovery and Medical Care Innovation Program as part of a major national project funded by the Special Coordination Fund for Promoting Science and Technology of the Ministry of Education, Culture, Sports, Science and Technology, which is expected to last for 10 years.

Under the FIRST Program, Hokkaido University and Hitachi will develop a PBT system that can accurately irradiate respiratory moving tumors by combining for the first time in the world the real-time moving tumor tracking technology accumulated by Hokkaido University in X-ray treatment and the spot scanning irradiation technology Hitachi was first to deliver to a general hospital. Because protons boast superior dose distribution to X-rays, the combination of real-time moving tumor tracking technology and spot scanning irradiation technology should yield more precise irradiation by drawing on the advantages of both technologies. It is highly demanded that this system will enable outstanding cancer treatment in terms of QOL with greatly enhanced safety. Development work also aims to popularize PBT worldwide by reducing the size of and simplifying accelerators and irradiation systems, to create a system that is internationally competitive.

Hokkaido University and Hitachi will combine their respective outstanding technologies, knowledge and experience in the medical and engineering fields, to contribute to cutting-edge radiation cancer therapy that maintains excellent QOL for patients through the development of this PBT system.
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