AI for surgical planning
While the application of artificial intelligence is incredibly broad, it has found particular success in the field of image analysis including image classification and object recognition. This application of AI has particular significance in preoperative planning, where patient scans can be analysed to improve diagnosis and optimise procedures.
Examples of such applications include the detection of polyps from colonoscopy procedures, as well as powering intraoperative augmented reality systems, identifying anatomical landmarks in real-time to improve surgical outcomes.
Transcatheter aortic valve implantation (TAVI) is a procedure performed on patients with severe aortic stenosis who are often deemed to have a high risk of mortality from standard surgical aortic valve replacement. TAVI is a relatively new surgical procedure, however, the number of TAVI procedures is rapidly rising in the UK, from under 2000 in 2013/14 to over 7500 in 2022/23. Additionally, the relative number of urgent cases is rising, from 17% in 2016/17 to 25% in 2022/23. While TAVI procedures are relatively common, the 30-day mortality rate is 1.3% overall and 3.1% for urgent cases. With the large increase in procedures and significant mortality rate, there is a clear need for improved surgical planning to ensure that as this procedure becomes more common the associated complications are reduced.
DASI Simulations, based in Dublin, Ohio, have developed a surgical planning software which leverages AI to improve the planning of TAVI surgery.
The DASI system not only provides a computational model of a patient’s heart from CT angiogram images by identifying and measuring cardiac structures, but in addition, the system can provide interactive simulations results, predicting surgical outcomes across a range of scenarios.
This is an extremely powerful tool for surgeons given that the TAVI procedure requires decisions on the optimal valve type, size and position, all of which can be investigated using the DASI system.
DASI Simulations was founded as a start-up in 2019 in collaboration with Ohio State University. Through rapid development of their products, they have gained FDA approval for both their Precision TAVI (simulating surgical outcomes) and DASI Dimensions (measuring cardiac structures) software, as well as being used in over 80 hospitals in the US.
DASI have 4 published patent families, with the earliest filing being in June 2021. Given their Ohio base and the large market size, it is no surprise that DASI filed their first applications in the US.
In order to pursue protection abroad, they subsequently filed corresponding PCT applications. At the time of writing, 3 of the 4 PCT applications have entered the national/regional phase. In all three of these cases, DASI have entered the national/regional phase in Australia, Europe and Japan, following a typical patent filing strategy that targets the major healthcare markets. National phases have also been entered in Canda and India, although not for every application.
The prosecution of these applications in the US offers some insight into the strategy adopted by DASI. One application (US2022392642A1) faced a series of challenges at the USPTO, with the first office action rejecting the claims due to non-patentable subject matter, lack of sufficiency and clarity, and obviousness. A series of amendments to the independent claims was made in a single response, successfully overcoming all rejections, such that a notice of allowance was issued less than 5 months after the first office action. Another application (US2024050157A1) proceeded to grant in the US within 8 months of filing, without any substantive amendments required. Several other US applications remain under prosecution.
Decisive factors in DASI’s patent strategy of pursuing patent protection domestically and abroad are likely to be the rapid increase in TAVI procedures, as well as the fast-moving nature of AI related systems. Securing IP protection and building an international portfolio will enable DASI to deliver on the promise of their technology as their business grows.
For those operating in the AI & MedTech sector, there is significant opportunity to leverage AI for image analysis, allowing the generation of accurate patient-specific models. As shown by DASI Simulations, these models can then be used to further support surgeons by providing prediction capabilities. This is of particular relevance in relatively new procedures such as TAVI surgery.
Regarding patent strategy, due to the fast-paced nature of the industry, gaining rapid patent protection can be key to establishing one’s position in the market. It is also important to consider geographical scope, to ensure that the business’s interests are protected in markets of interest. In this regard, the strategy of filing a PCT application can be very effective, as it allows for more time to test the product and assess the market before having to commit to a definitive list of countries for protection. However, a challenge of building an international patent portfolio is that patentability rules vary from country-to-country. This is particularly the case for AI-based inventions, where there can be significant variations in how different patent offices assess these types of invention. Accordingly, when drafting a patent application, it is important to have an eye to the different jurisdictions in which the application may eventually be prosecuted, to ensure that it is fit for purpose across the jurisdictions of interest. As such, applicants must carefully balance patentability requirements with considerations around drafting and prosecution and a potential desire for rapid grant, to obtain a commercially valuable protection.
"The MedTech industry has an extremely fast-paced nature, gaining rapid patent protection can be key to establishing one’s position in the market."
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Joe Egelstaff - Patent Technical Assistant
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