Medical field 

In T 906/01 the alleged public prior use concerned the implantation of a correction device into a patient. There remained some doubt as to the I. Spinal System which was really implanted.

The board considered that a device having an investigational status, being implanted and tested within the restricted area of a hospital, under the responsibility of a surgeon operating within the framework of an investigator's agreement which included a confidentiality clause, had to be regarded as a prototype device. Usually the development and test phases of such products or devices were necessarily surrounded by secrecy as long as said products or devices had not been approved and commercialised (see T 818/93). Therefore, even without the production of more specific evidence on behalf of the respondent, the board was of the opinion that the clinical tests performed on the I. Spinal System by and under the responsibility of the surgeon, conferred on the operation as a whole an implicit obligation of confidentiality which had to be extended to the whole team involved in that operation. Therefore, neither the fact that the I. Spinal System was received and prepared by hospital staff, nor the fact that it was visible to the hospital staff during the operation, was sufficient to prove that the I. Spinal System was accessible to the public. Furthermore, it was assumed that the operating room was not accessible to persons other than the operation team, and that the device was implanted at least partly under the patient's skin and, therefore, not immediately visible from the outside.

The board followed the reasoning of T 152/03 that, in this field, there was a prima facie assumption that any person involved in a medical process was obliged to maintain confidentiality, given the need for patient confidentiality and the need to protect the development and testing of prototype devices, and that any evidence proving the contrary was important and had to be produced as soon as possible.

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