Therapy implies the curing of a disease or malfunction of the body and covers prophylactic treatment, e.g. immunisation against a certain disease (see T 19/86) or the removal of plaque (see T 290/86). A method for therapeutic purposes concerning the functioning of an apparatus associated with a living human or animal body is not excluded from patentability if no functional relationship exists between the steps related to the apparatus and the therapeutic effect of the apparatus on the body (see T 245/87).
As clinical trials have a therapeutic aspect for the human subjects undergoing them, an objection under Art. 53(c) should be raised if a claim includes a step relating to a method of treatment of the human body by therapy (see G-II, 4.2.2).