The patent relates to a transcutaneous modulated power link for a medical implant, in particular for a hearing aid acting on the middle ear.
Brief outline of the case
The opposition was rejected and the opponent appealed.
The OD considered that the independent method claim was not to be considered as a therapeutic method and that the device claims were novel and inventive over the prior art cited by the opponent.
The board decides that the method claims as granted infringed Art 53(c). The same applied to AR 1-5.
The patent was thus revoked.
The claim at stake
The granted claim related to a method of providing a control signal for application to a mechanical actuator (23) of an implantable hearing device (100), whereby an audio signal was received, converted in a modulated electrical signal, said signal being transmitted and demodulated so that it could be applied to the mechanical actuator.
The opponent’s point of view
For the opponent, as long as the claimed subject-matter incorporates one step of a therapeutic nature, it falls under the exclusion from patentability of Art 53(c). The actuation of the mechanical actuator directly affects the human body, in order to improve or restore hearing.
The opponent referred to T 789/96 which related to a pacemaker. The method at stake in T 789/96 was not considered of therapeutic nature, as its purpose was to save energy.
The board’s decision
For the board, the method of claim 1 is directed at alleviating, removing or lessening the symptoms of a disorder or malfunction of the human body. This is confirmed in description as originally filed.
The claimed invention aims at assisting users suffering from a loss of hearing due to a malfunctioning middle ear. The actuator is intended to act directly on a part of the inner ear, e.g. the stapes, or directly onto the oval window of the cochlea.
Contrary to the view expressed by the OD, the board considered that the claimed method implies some interaction between the mechanical actuator and the body of the carrier. a direct functional link between the claimed combination of features and the effect produced on the body by the mechanical actuator.
The board considered the effect resulting from the claimed method as a therapeutic effect, since it is directly aimed at improving the hearing of users suffering from a malfunctioning middle ear.
A different finding would deprive the claimed method of its purpose, that is, to assist users who suffer from a loss of hearing. It would also directly affect the analysis of inventive step in that it would deprive the claimed subject-matter of any clearly identifiable technical effect.
The board saw more parallels between the present case and the case underlying decision T 1021/98. The method at stake in T 1021/98 related to a method of operating a pacemaker having a direct effect on heart tissue. Against this background, the essential point was that the claimed method provided an effect on the body and the effect qualified as a therapeutic one.
Comments
The present decision merely confirms that any method having an effect on the body is to be qualified as a therapeutic method, if it has for effect to overcome an ailment of the human or animal body.
Although the method did not claim the action of the actuator on the inner ear of a patient, this was necessarily the case, as otherwise there would not have been any improvement of the hearing.
The present decision merely confirms that any method having an effect on the body is to be qualified as a therapeutic method, if it has for effect to overcome an ailment of the human or animal body.
Although the method did not claim the action of the actuator on the inner ear of a patient, this was necessarily the case, as otherwise there would not have been any improvement of the hearing.
Although relating to the manufacture of a knee prothesis, which a priori has nothing medical, the method claim in T 1005/98 infringed Art 53(c), at the time Art 52(4). The claimed method absolutely necessitated a surgical step. The surgical step was not claimed but could not be ignored when applying the method.
In the present case, the method implies that the actuator is connected to any suitable part of the user’s hearing system such as the stapes, or directly to the oval window of the cochlea by way of a prosthetic stapes. In this respect, it can also be considered that the present method necessarily implies a surgical step like in T 1005/98.
Although the method was not patentable, it is somehow surprising that the proprietor did not file in reply to the opposition an AR in which the method claims were deleted. In the annex to the summons, the OD considered that the objections of lack of IS against the device claims were not convincing.
Filing only device claims in reply to the appeal would most probably would have been considered as an amendment and hence not admitted.
On the procedure
In view of the decision of the board, the method claims should never have been granted.
https://www.epo.org/en/boards-of-appeal/decisions/t190825eu1
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