12 October 2022

T 2136/19 - Computer-implemented, so no medical method

Key points

  • In T 0944/15 of 2021, Board 3.4.01 found a computer-implemented method to be  an unallowable medical method under Article 53(c) EPC.
  • The Board: " Claim 1 of the main request is directed to a data processing method "to be executed by a computer". All the method steps recited in claim 1 are explicitly defined as being carried out at or by a digital processor of a computer. These steps are limited to receiving some data at the processor (for example, receiving image data such as data defining an x-ray image) and to determining, by the processor, some data on the basis of other data (for example, calculating directional distances on the basis of position data)." 
  • " The Board acknowledges that the three-dimensional position data may well be acquired by palpating the patient's anatomy, thus by a step of a surgical nature; however, by virtue of the amendment above, the step of acquiring the position data itself is not part of the claimed method." 
  • " claim 1 does not recite any method step defining or encompassing a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy (G 1/07, points 3.2.5 and 4.1 of the Reasons). The same applies to the dependent claims. The claimed method is strictly limited to a purely "passive" data processing method which is carried out entirely and exclusively within a computer without causing any effect on the patient's body as a result." 
  • " It is irrelevant that the claimed method may be performed after or even iteratively during a surgical intervention on the body, as described in the description. In any event, there would be no functional link between the claimed method and any effects of a surgical or therapeutic nature that would occur during this intervention. Therefore, in the absence of such a functional link, the claimed method as such does not qualify as a method for treatment of the human or animal body within the meaning of Article 53(c) EPC (with regard to the requirement of a "functional link", see G 1/07, point 4.3.2 of the Reasons)." 
  • " It follows that the subject-matter of claims 1-10 of the main request does not fall under the exception to patentability of Article 53(c) EPC. The same applies to the subject-matter of independent claim 11, which relates to a computer program directed to the method of claim 1, to a program storage medium on which this program is stored and to a computer running or configured with this program." 
  • The application has the title: "METHOD FOR ASSISTING THE POSITIONING OF A MEDICAL STRUCTURE ON THE BASIS OF TWO-DIMENSIONAL IMAGE DATA"
  • To cite the Board in T 944/15: " in the light of the disclosure of the invention, the skilled person cannot conceive of the invention without the steps of initiating the monitoring [of the patient during radiation therapy] and using the result [in the therapy, e.g. stopping the radiation exposure], which create a functional link to the method of treatment.”
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.



5. Exception to patentability

5.1 Claim 1 of the main request is directed to a data processing method "to be executed by a computer". All the method steps recited in claim 1 are explicitly defined as being carried out at or by a digital processor of a computer. These steps are limited to receiving some data at the processor (for example, receiving image data such as data defining an x-ray image) and to determining, by the processor, some data on the basis of other data (for example, calculating directional distances on the basis of position data).

5.2 In particular, the step of "acquiring, by the computer, three-dimensional position data comprising position information describing the position of the base point (3) and the reference point (4) in three-dimensional anatomical space, in particular relative to the first medical structure (1)", which the examining division had identified as encompassing the surgical step of using a navigated pointer to palpate the patient's anatomy (point 12.3 of the decision under appeal), has been replaced with the step of "receiving, at the processor," this three-dimensional position data.

The Board acknowledges that the three-dimensional position data may well be acquired by palpating the patient's anatomy, thus by a step of a surgical nature; however, by virtue of the amendment above, the step of acquiring the position data itself is not part of the claimed method.

It is also true, as pointed out by the examining division, that the claimed method is for "assisting" the positioning of the first medical structure relative to the second medical structure; however, as explained in the description, this assistance is only achieved by ultimately providing the surgeon with the correspondence information determined in the last method step (page 7 of the description of the main request, antepenultimate paragraph: "Any or all of this information can also be indicated to a surgeon so as to assist the latter in positioning the first medical structure relative to the second medical structure."; page 9, third paragraph: "Lastly (...) calculated and compared (...)"; emphasis added by the Board). This correspondence information enables a surgeon to "verify the correct position of the second medical structure with respect to the first medical structure" and, if needed, to move them relative to each other (page 10, first three lines); however, positioning the first or second medical structures is not a step of the claimed data processing method.

5.3 More generally, claim 1 does not recite any method step defining or encompassing a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy (G 1/07, points 3.2.5 and 4.1 of the Reasons). The same applies to the dependent claims. The claimed method is strictly limited to a purely "passive" data processing method which is carried out entirely and exclusively within a computer without causing any effect on the patient's body as a result. It is irrelevant that the claimed method may be performed after or even iteratively during a surgical intervention on the body, as described in the description. In any event, there would be no functional link between the claimed method and any effects of a surgical or therapeutic nature that would occur during this intervention. Therefore, in the absence of such a functional link, the claimed method as such does not qualify as a method for treatment of the human or animal body within the meaning of Article 53(c) EPC (with regard to the requirement of a "functional link", see G 1/07, point 4.3.2 of the Reasons).

5.4 It follows that the subject-matter of claims 1-10 of the main request does not fall under the exception to patentability of Article 53(c) EPC. The same applies to the subject-matter of independent claim 11, which relates to a computer program directed to the method of claim 1, to a program storage medium on which this program is stored and to a computer running or configured with this program.

6. It appears from the above considerations that the main request overcomes all the objections on which the decision under appeal was based.

7. Remittal to the examining division

The grounds on which the decision under appeal was based have been reviewed by the Board in view of the respective requirements of the EPC; however, the examining division did not deal with other requirements of the EPC, in particular those in relation to novelty and inventive step, since no search at all has been carried out yet.

For these reasons, and in view of the primary object of the appeal proceedings being to review the decision under appeal in a judicial manner (Article 12(2) RPBA 2020), the Board holds that special reasons within the meaning of Article 11 RPBA 2020 are present for remitting the case to the examining division for further prosecution, in accordance with Article 111(1) EPC.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The case is remitted to the examining division for further prosecution.

1 comment:

  1. T 944/15 is very controversial, in particular because it held that "computer program" claims can infringe Art. 53(c). Despite its controversial character, it has not been mentioned in the laast update of the Guidelines. I find it unlikely that many examination/opposition division will follow its findings. Its a one-off decision, in my view.

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