In this decision, the European Patent Office did not grant a patent on the concept of presenting clinical statistics to help identify previous similar medical cases. It gives an concise summary of the test for assessing whether an invention falls into the “presentation of information” exclusion. Here are the practical takeaways of the decision T 1091/17 (Clinical statistics/PHILIPS) of 4.6.2020 of Technical Board of Appeal 3.5.05:
This European patent application relates to searching for case-based decision support in medical applications.
Case-based clinical decision support systems (CDSS) known from the prior art can assist physicians by identifying previous cases that have been diagnosed and treated, and are similar to the case under evaluation. According to the application, current case-based CDSS systems mostly present similar cases based on only image-based information and fail to incorporate patient medical history, which plays an important role in the diagnostic process. Moreover, previously known systems lack transparency as to why certain cases are retrieved.
Here is how the invention is defined in claim 1:
Claim 1 (main request)A method of searching cases in a database, said method comprising:
– a first step of performing similarity matching between an input case and cases in the database by using a first matching criterion that includes at least one image-based feature to identify a set of cases similar to said input case, the at least one image-based feature including at least one of a shape of a tumor, texture of the tumor, and size change of the tumor;
– calculating statistics on features associated with the set of similar cases, wherein the statistics describe non-image-based clinical information and wherein the features associated with the set of similar cases are image-based and/or non-image-based features;
– presenting the set of similar cases and the statistics to a user;
– receiving a user input including a second matching criterion that includes at least one non-image-based feature derived from clinical information and is based on said statistics, said clinical information including at least one of relevant previous or current diseases, lifestyle facts, genetic profiles, family medical history, a physician’s particular knowledge and information of the patient to be diagnosed or treated, weight, allergies, and vital statistics; and
– a second step of performing similarity matching between the input case and the set of similar cases by using said second matching criterion.
Is it technical?
The first-instance examining division had refused the patent application based on lack of inventive step.
The board of appeal based its inventive-step assessment on a document which disclosed an iterative method for querying medical images in a database in which initial queries are refined in subsequent iterations or interactive “loops”. The board agreed with the appellant that this document did not disclose calculating statistics on the basis of clinical information associated with the set of similar images, presenting these statistics to the user and receiving subsequent user input based on these statistics.
The appellant emphasized the fact that claim 1 presents the calculated statistics together with the set of similar cases. In the appellant’s view, the case law consistently distinguished between what is presented to the user (statistics) and how it is presented (together with the set of similar cases). Since, in this case, presenting the statistics together with the similar cases involved how the information is presented rather than what is presented, it was not a presentation of information as such.
Here’s how the board responded:
The board is aware of a few exceptional decisions of the boards of appeal (see T 1749/06, point 4.1.3, second sentence; T 651/12, page 16, first full sentence) expressing the view that the reference to “presentations of information” in Article 52(2)(d) EPC was meant to relate exclusively to the cognitive content of the presented information (“what is presented”) and not to the manner in which it is presented (“how it is presented”). Nevertheless, this view has not been adopted by the mainstream case law in the course of legal development (cf. G 3/08, Headnote 4). The predominant view in the case law is what T 1235/07 (see point 11) calls the “wider view”, according to which both what is presented and how it is presented are considered to be “presentations of information” (see T 1143/06, points 3.4, 3.5 and 5.4; T 1741/08, point 2.1.10; T 1214/09, point 4.8.1; T 1562/11, point 2.7, last paragraph; T 1802/13, page 10, first full paragraph).
This view has also been adopted by the European Patent Office for its practice (see Guidelines for Examination in the European Patent Office, November 2019 edition, G-II.3.7).
Therefore, the appellant’s argument that the distinguishing features do not relate to presentations of information does not convince the board.
The board also commented on the relevant test for identifying whether an invention relates to a presentation of information “as such”:
Irrespective of whether an invention relates to “what is presented” or “how it is presented”, the test suggested in the case law to judge whether a presentation of information might exceptionally (see T 1741/08, point 3.3, last paragraph) contribute to the technical character of the invention is to assess whether it credibly assists the user in performing a technical task by means of a continued and guided human-machine interaction process (see T 336/14, Headnote and T 1802/13, page 10, second full paragraph).
A prerequisite for this test is the proper formulation of the technical task performed by the user. The appellant referred in its written submissions to a “medical task”. This level of generality would not be sufficient since not every task performed in medicine is a technical task. Indeed an example given by the appellant (“if the statistics, e.g. show that seven out of eight retrieved cases belong to patients with cancer, then the user can derive that the case under evaluation might have something to do with cancer”) illustrates this point. The example implies that the alleged technical task is a diagnostic task. However, besides technical tasks carried out mainly in the examination phase involving the collection of data, diagnosis involves tasks of a predominantly non-technical nature such as the deductive decision phase, which is a purely intellectual exercise (see G 1/04, point 6.4.1). The “medical task” in the appellant’s example relates to the purely intellectual deductive decision phase and therefore cannot be accepted as a technical task.
The appellant then argued, in analogy to T 643/00 (see Catchword, second sentence), that searching and retrieving medical cases stored in a database was the relevant technical task. The board could accept this as a suitable formulation. The question to be answered then is whether the invention credibly assists the user in performing this technical task by means of a continued and guided human-machine interaction process.
Here the appellant argued that the presentation of the calculated statistics together with the set of similar cases assisted the user, typically a physician, in performing the technical task of searching for a medical case more efficiently and reliably. This provided helpful information to guide the physician in concentrating their search and thus obtaining the desired case more quickly, which was a technical effect. The appellant also argued that the mere fact that mental activities on the user’s part were involved did not necessarily render this effect non-technical.
But the board did not agree:
This argumentation relies heavily on the wording of T 643/00, point 17, but removes it from its proper context. The borrowed wording is preceded by the following text: “the functions/steps of processing the images in a specific format, i.e. a predetermined plural number of images in a side-by-side manner at a low level of resolution, and allowing selection and display of an image at higher resolutions [provide information to the the user in the form of a technical tool for an intellectual task he has to master]”. It is thus clear that the deciding board in T 643/00 did not give a carte blanche for deeming technical any information that supports a user in performing a technical task (see also T 1741/08, point 2.1.12, “not everything that supports a technical task has itself a technical character”). It made this statement for the very specific case of a particular display technique defined in terms of an objective technical criterion, namely image resolution. This has also been the common understanding in subsequent case law (see e.g. T 1741/08, point 2.1.13; T 336/14, point 1.2.6; T 581/14, point 16.19). The effect of image resolution on the user is an objective physiological effect which can qualify as a credible technical effect (see T 1442/16, point 1.8, last paragraph), unlike the effect of presenting clinical statistics in the case in hand, which relies on a chain broken by semantic or cognitive processing (see T 1741/08, point 2.1.6). Therefore, T 643/00 does not help the appellant’s case.
The appellant was not able to convince the board that the distinguishing features of claim 1 of the main request produced a technical effect. Therefore, claim 1 of the main request does not involve an inventive step (Article 56 EPC).
Also the auxiliary requests filed by the appellant did not change this assessment, so that the appeal was eventually dismissed.
- You can read the whole decision here: T 1091/17 (Clinical statistics/PHILIPS) of 4.6.2020
- Guidelines for Examination, G-II-3.7 (Presentations of information)