中国国际医疗器械设计与制造技术展览会(Medtec China)2021

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December 7-9 2022 | Suzhou lnternational Expo Centre B1-E1

How IP protection is enabling robotic surgery innovation

2022-08-31

Count Vicarious Surgical among a group of relatively young surgical robotics companies seeking to innovate and make a difference in a space that has been dominated by Intuitive. Vicarious’ technology uses proprietary human-like surgical robots combined with 3D visualization to transport surgeons inside the patient to perform minimally invasive surgery.

Vicarious Surgical CEO Adam Sachs announced on his latest earnings call that the Waltham, Massachusetts–based company has completed the design of its Beta 2 robotic surgery platform. It’s beginning the integration phase of the build, and the company has inked center of excellence agreements with the nationwide HCA Healthcare as well as University Hospitals in northern Ohio to further development.

IP protection is crucial for Vicarious Surgical success, said Carolina Säve, a patent attorney who joined Vicarious in January 2022 as its director of intellectual property.

“At the end of the day, the company’s value will depend on how strong the patent portfolio is and how much IP ownership we have been able to retain,” she said.

Säve — along with Greenberg Traurig shareholders Roman Fayerberg and Todd Basile — recently answered some questions from Medical Design & Outsourcing regarding what medtech insiders need to know about IP protection in the robotic surgery space.

How does Vicarious Surgical go about accomplishing its IP protection?

Säve: We have been working to align the IP strategy with the business strategy, which has allowed us to identify any gaps in the IP strategy. By having a strong line of communication between marketing, IP and R&D, we can align our goals and build a stronger patent portfolio. To build that strong portfolio, we also have to file early and often as we move forward in development, trying to capture each improvement as we move toward completing our system. The other component that has been important for us is ensuring we have ownership of our IP as we work with third parties in development agreements or the like. We consider IP ownership before entering into any agreement to avoid any disputes down the line. Similarly, we obtain inventor assignment signatures early on to maintain a clean line of ownership.

As we move toward manufacturing our system, we’re also instituting internal protocols of trade secrets on any parameters, fine-tuning of our system components, or the software running parts of our system.

What is particularly unique regarding IP protection in the medical robotics space?

Säve: Our robotic system includes many different technologies — mechanical, software, control systems, electrical, etc. — so our IP strategy also has to consider how we protect all of these different technologies, whether that is drafting a variety of patent claims for one component or considering other types of protection such as trade secrets. This also means fostering collaboration with different engineering teams and ensuring each technical team understands each other’s goals. For example, our mechanical and software teams need to see eye to eye.

We have also developed a new incentive program as another process for capturing the ideas of our engineers. This has allowed me to work closely with the engineers and also help foster collaboration between the different teams.

I suspect all the software involved presents some unique challenges?

Basile: It’s hard to protect something if you don’t understand it, and let’s face it, most folks aren’t software engineers. So yes, the software presents the additional challenge of figuring out what’s going on before determining how to protect it. I think the key here is to look at software as embodying a methodology that, at its essence, can be communicated by a flow chart: “If this, then that.” If you can work with your engineers to get to that point, the tech becomes more digestible and you can identify what’s valuable to protect.

The next challenge is deciding how best to protect various types of software employed in surgical robotics. Take, for example, autonomous navigation to a surgical site. Most navigation software will use sensors to detect certain trigger events, such as getting too close to an artery wall or nerve. A trigger event then causes the robot to take some action in response, such as stopping or turning away. Often competitors can reverse engineer this sort of functionality when it is based on nonproprietary sensors, so maybe you opt for patents in these cases. Conversely, when navigation relies on software-intensive computer vision, the machine learning approaches you used to train your computer vision, as well as the underlying data pool and resulting algorithms, likely are not outward-facing. Thus, you might opt for trade secret protections in these cases.

Last but not least, patent eligibility is always something you’ve got to consider when discussing software. The rule of thumb is that software must provide some technological innovation or improve other technologies to be patentable. For example, you can’t just automate processes on a generic computer that could otherwise be done by hand. Fortunately, with surgical robotics, much of the software is sensing- and controls-related, meaning your software improves the real-world functionality of a robot. Likewise, software that trains robot AI from a data pool is often considered transformative enough to be patent-eligible, especially since the result is making robots capable of doing technologically innovative things. So, while there are exceptions, patent eligibility is not as much of a concern when talking about robotics software.

What are the top questions that entrepreneurs starting surgical robotics companies need to ask as they start working with patent attorneys on an IP protection strategy?

Säve: Outside counsel should ensure that they understand the business goals and track how the goal changes as the development evolves. This can help identify gaps in IP strategy. Landscape searches are important early on as well to provide outside counsel with an understanding of the field, trends in the industry, what competitors are doing, identifying gaps/opportunities in the markets, and also seeing what areas to avoid.

Freedom to operate (FTO) searches are also important, both at different stages of development and for different system components. It is helpful to collaborate with outside counsel on an early design’s overall FTO. Then you can bring the analysis in-house as you use clearance search results for specific components during the development stages. As you begin to finalize the system, it is an opportunity to again collaborate with outside counsel on an overall FTO. It is often insufficient to rely on just one FTO: Your system will change, sometimes drastically, and it is important to capture these changes in this type of analysis. Collaboration with outside counsel for an overall system FTO is important to prevent any views of conflict of interest, while an in-house team can often handle that analysis as a tool during the development process.

Fayerberg: I agree that when starting to work with patent attorneys, it is important to find outside patent counsel who not only understand the technology but are also willing and able to understand the business goals and help craft the patent strategy accordingly. They should also look for attorneys with a strong record of helping young companies through different stages of growth. There are different considerations when working with emerging companies versus larger, more established companies. Obviously, budget is one of them. How do you build a valuable IP position with limited resources? For emerging companies, in my experience, the technology evolves rapidly and you want attorneys who understand that and can prepare patent applications that will cover not only the technology at the time of drafting but will remain valuable as the technology evolves. Also, entrepreneurs should look for attorneys who understand the industry and can help find valuable opportunities in the industry that is becoming crowded.

Basile: “What are my goals? What technologies should I be protecting? What protections make the most sense for each?”

Are there new legal trends that people in the surgical robotics space need to be aware of?

Säve: As we mentioned, software is very much a part of surgical robotics today, and with that comes the consideration of data collection and usage. The industry aims toward autonomy and real-time feedback during a surgical procedure. So what about all that data? Agreements now must include considerations of who owns the data that is collected, how is it being stored, who can use it, and how it can be used. For example, how can a company like Vicarious Surgical have access to that data for our systems to keep learning and improving using that data? There is also the consideration of privacy, given that this data includes patient identifying information. How is that information encrypted so that the data related to it can be used for machine learning? These will all be important factors that will shape how the future of surgical robotics might look.

Basile: For sure, data is an asset, and it can be quite valuable. Companies in this space are wise to consider data ownership and access as part of their overall IP and business strategy.

Fayerberg: On a fun note, one interesting trend that has been developing in patent law is whether a patent can be granted on an invention by an artificial intelligence — by itself without a human inventor. Recently, the Federal Circuit heard an appeal from a court decision that has barred an AI-generated invention from being patented. In contrast, the South African Patent Office has granted a patent for the same AI-generated inventions. I do not expect the current generation of medical robots to become inventors, but you never know.

Todd Basile is a registered patent attorney with more than 15 years of combined experience in the tech and legal industries. He helps technology companies protect and commercialize their innovations and brands across various industries including medtech, digital health, robotics and software. He can be reached at [email protected]

Roman Fayerberg is a registered patent attorney with more than 15 years of experience in patent and IP law. He advises clients on procurement and enforcement of IP rights, including domestic and international patents, with a focus on medtech, digital health, robotics and life science technologies. He can be reached at [email protected]

Carolina Säve is the Director of Intellectual Property at Vicarious Surgical, a surgical robotics company aimed at performing minimally invasive surgery with 3D visualization to increase procedure efficiency and improve patient outcomes. Carolina joined Vicarious Surgical from a national law firm at which she conducted patent prosecution, strategic portfolio development, and diligence for companies in cutting-edge advancements in automotive industry, medical devices, consumer products, and wireless communications. She can be reached at [email protected]

Article source: Medical Design and Outsourcing