Background

Cyberkinetics Neurotechnology Systems Inc. (CNS) was a research laboratory based in Foxborough, Massachusetts, in the United States of America (USA).  It was co-founded by John Donoghue, a neuroscientist with a pioneers’ desire to discover how thoughts in the brain are translated into action. CNS conducted clinical trials in bionics – or biomimicry, the application of biological methods and systems to design and engineering technology. The company’s main goals were to create innovative software products that could be utilized to improve the quality of life of severely motor-impaired people.

Invention

CNS’ industry-leading innovation was a remarkable brain-computer interface (BCI) called the BrainGate Neural Interface System (BrainGate).

BrainGate – and its successor, BrainGate2 – is a device that reads neuro-signals transmitted from the brain of a physically disabled person, allowing the user to control a point and click computer cursor and make choices by clicking an icon interface. The BCI device works via a sensor – smaller in size than a contact lens – which is surgically implanted onto the area of the disabled user’s motor cortex, the portion of the brain that is responsible for movement.

The sensor’s millimeters thin electrodes record electrical signals from the brain – thoughts which may relate to a simple desire to move up, down, left, or right, fast or slow. These signals or thoughts are transmitted to and interpreted by a “decoder” – computers and software that convert brain signals into useful commands for an external device. The external device – such as a standard computer desktop, a powered wheel chair, or a robotic arm – then carries out the instructions that the disabled users desire but cannot do themselves, such as turning on a light switch, driving a wheel chair, typing and sending an email, or making a phone call. All of this is done by the user simply thinking about the action. BrainGate interprets the thought into computer commands and the external device puts the instructions into action.

The BCI device demonstrated revolutionary results following clinical trials and it promises to radically improve the quality of life of paraplegics, quadriplegics and other physically disabled people.  The technology also aims to help people with lost limbs, brainstem stroke (where the victim cannot move or speak), and muscular dystrophy patients with their simplest day-to-day tasks and communication needs. Asked whether he desired to walk again, one paralyzed BrainGate candidate user simply replied: “No, I’d just like to be able to scratch my own nose.”

Research and Development

BrainGate’s research and development (R&D) is the culmination of a series of scientific investigations and clinical trials throughout the 1990s within major academic institutions in the USA including Brown University, Columbia University and Harvard University.  

Dr. Donoghue and his colleagues established CNS as a spin-off company to exploit the potential of the BrainGate technology that they had developed in various university labs.  CNS’ initial funding round benefited from a US$ 9 million investment led by Oxford Bioscience Partners – a venture capital firm that provides equity financing and management assistance to entrepreneurial-driven companies within the life sciences and healthcare sector.

CNS raised more than US $40 million for its R&D before becoming a public company following a reverse-merger in 2002 where it acquired Bionic Technologies Ltd, a company based in the state of Utah, USA, that developed multi-data acquisition systems for neuro-scientific research.

In 2004, the USA’s Food and Drug Administration (FDA) granted CNS the first of two Investigational Device Exemptions (IDEs) to apply laboratory tests from academic laboratories in clinical trials on human patients.  The pilot trials were established in hospitals in Rhode Island, Massachusetts, and in the state of Illinois for four participants with tetraplegia – decreased ability to use the arms and legs.

One such trial patient for the BrainGate device was a wheelchair-bound candidate who was paralyzed from the neck down. Using BrainGate technology attached to a motorized wheel chair, the patient was able to steer the chair by blowing into a sip-and-puff tube connected to his mouth. Moreover, by simply thinking his actions and thereby manipulating a computer cursor, BrainGate allowed the patient to open and read e-mails, play video games, grasp objects with a robotic arm, and operate television controls and lights switches. “Our ultimate goal is to develop the BrainGate System so that it can be linked to many useful devices,” explained Dr. Donoghue.

Despite its obvious promise, the BrainGate technology is cumbersome – with wireless transmission not yet available – and indeed many other obstacles remain to be overcome by its R&D team.  Brain implants, for instance, are particularly troublesome because the ability of the electrodes to detect brain signals deteriorates – for unknown reasons – after several months. The R&D process itself is challenging and potentially dangerous for the patients concerned. Having a permanent hole in the patient’s head places them at constant risk of infection while clinical studies require a thirteen month commitment from the subject.

Despite the challenges, researchers believe that the technology will be refined, miniaturized, and a fully implanted, wireless sensor that can emit signals to an external device will be developed in the not too distant future. CNS has already developed several industry leading technologies including: Bionic – a microchip used at the heart of its computers; the NeuroPort system – applied in human clinical trials to monitor brain activity; and, the Cerebus system – used for data acquisition and surgical training programs during research and testing.

Patents and Trademarks

Recognizing the need to protect its valuable technology, CNS sought international protection for its inventions and established an impressive portfolio of over 20 international patent applications filed through the Patent Cooperation Treaty (PCT) system. CNS also recognized the importance of having a strong brand name protected by trademarks, not only because it ensures the trust and loyalty of its current clients and patients but also because a good name results in greater future financial returns and attractiveness to new consumers and investors.

IP Management

In 2009, following successful clinical trials, recognizing the tremendous potential of the BrainGate brand, and seeking to raise funds while maximizing on the good will associated with the new technology, Dr. Donoghue and the CNS board sold off CNS and its intellectual property (IP) assets. CNS’ intellectual property rights (IPRs) including its patent portfolio, the BrainGate™ trademark and its domain name (www.cyberkinetics.com), were sold for almost one million dollars.

The assets were bought by Mr. Jeff Stible, who established a new company – BrainGate Co – which now owns all first generation technology from CNS (such as CNS’ brain implantable Bionic chip) as well as the IP emerging from BrainGate related research from academic institutions.  BrainGate Co. has exclusive rights to key patents surrounding neural interfaces and their use to control computers, prosthesis, and other devices.

Mr. Stible has consolidated and expanded CNS’ original IP assets, investing millions of dollars in the technology, while seeking to break into new areas of R&D including investigations into epilepsy – an affliction with three million sufferers in the USA and fifty million worldwide.

BrainGate Co. now holds several trademarks in the USA and in other countries including: BrainGate™, Cyberkinetics™, Neuroport®, Cerebus®, Bionics®, and the phrases “Turning Thoughts into Action” ® and “Wired for Thought”™.

The new company continues to maintain CNS’ domain name so that the website cannot be abused by cyber squatters and to ensure that it remains an asset free for potential use in the future.  It also maintains CNS as a “shell” company – a publicly held company with no or nominal assets – and continues to exploit marketing opportunities for the brand name recognition associated with CNS.

Meanwhile, Dr. Donoghue has established a separate company – BrainGate2 – that aims to continue the next generation of BrainGate technology including the development of a wireless brain implantable chip.

Business Results

In 2004, CNS’ BrainGate device won the “Best of what’s New” award from the science publication Popular Science, an award-winning American science magazine founded in 1872.

Thus far, five people — known as “participants” — have tested CNS’ Bionic implant and permission has been granted to study fourteen more participants. While the revenue potential for BrainGate technology is small at present (as it is still being developed), Mr. Stible hopes that once FDA approval has been given for the product, its commercialization potential will be enormous. “We know we’re still too early with this technology,” Mr. Stible said, “but we’re structuring the company in a certain way based on that knowledge.” As of 2010, Dr. Donohues’s new company – BrainGate2 – is recruiting more people in a research trial supported by the NIH and Massachusetts General Hospital.

Climbing Mount Probable

Dr. Donoghue and BrainGate technology developers are revolutionizing the lives of motor-impaired people around the world, helping them climb mount probable one hopeful thought at a time.  This case shows how IP can be a very valuable and tradable asset even for a company that has not yet begun to commercialize its product.

Source: WIPO