Zusammenfassung von EPC2000 Art 054 für die Entscheidung T0558/20 vom 20.04.2023

In T 558/20 the board had to decide on the proper assessment of novelty under Art. 54(5) EPC, in particular when a claim defines a combined surgical and therapeutic method. The invention concerned a bone regenerative material for use in a method of treating a patient suffering from a degenerative bone condition that can be characterized by a loss of bone mineral density. The method comprised surgical steps of forming a void in a localized area of intact bone and filling it with the bone regenerative material. In its decision, the opposition division came to the conclusion that claim 1 of the granted patent could not benefit from the novelty exception in Art. 54(5) EPC; the claim had to be interpreted as being directed to a material suitable to be used in the method defined in the claim. The claim thus lacked novelty over the prior art. The board stated that Art. 54(5) EPC did not, as such, define any criteria to be applied for assessing whether a claim drafted according to the wording of the article was novel or not. It held that novelty of the claim over the prior art must be assessed in the usual way, i. e. by comparing the features of the claim, the nature of the substance or composition as well as the use and method steps, with the disclosure of the prior art. In the present case, the opposition division had first examined whether the specific use of the substance or composition defined in the claim was already known or not. If the use was already known, the claim could not benefit from the novelty exception. The board's approach by contrast meant reading the claim as it was drafted, assuring that the method fell under Art. 53(c) EPC, then considering the use and method features as limiting and assessing whether the specific use defined by them was already known from the prior art. This, in the board's view is aligned with Art. 54(5) EPC and follows its logic. The respondent argued that the therapeutic use defined in the claim, i. e. the use of the bone grafting materials defined therein for the treatment of degenerative bone conditions, was already known as such. The board however held that the claim defined a method for treating a patient suffering from a degenerative bone disease comprising two steps, firstly creating a void in an intact bone, and secondly filling the void with bone regenerative material. This was the "specific use in a method" referred to in Art. 54(5) EPC, and this use needed to be compared with the prior art. The surgical step was clearly a part of the therapeutic method. Without it, the bone grafting material could not deploy its therapeutic activity. The method defined in the present claim had to be assessed as a whole. The respondent's approach to mentally split the method into different parts, associate to some of them an effect of the substance or composition defined in the claim as opposed to others, and ignore the ones, which were not considered associated in this way was not valid in the present case because the surgical step was an integral part of the therapeutic method in which the substance was used. In view of Art. 53(c) EPC, referring to both therapeutic and surgical methods individually the board had some doubts whether, in general, such an approach was at all justified, but this was not decisive here. Thus, the surgical method steps could not be ignored when assessing novelty of the claim. The opposition division had also held auxiliary request 2 to lack novelty, since the method steps therein did not provide a "new technical teaching", a terminology taken from the Enlarged Board's decision G 2/08, which implied that for establishing novelty a new technical teaching was required. The board held that, as set out above, in a claim drafted according to Art. 54(5) EPC the method steps had to be taken into account when deciding on novelty. In the present case, requiring additional surgical steps clearly provided a new technical teaching compared to the prior art, because additional physical actions had to be undertaken. It disclosed forming a channel and using this channel as an access to form a void greater than the channel in the bone, whereas in the prior art, a hole was drilled, but nothing more. The method defined in the claim was thus not just verbally different from the prior art, but differed in tangible, physical method steps and thus novel.