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8.90 Section 16(2) excludes methods of diagnosis practised on the human or animal body. Diagnosis includes methods identifying a disease state, but also includes methods identifying the absence of such a disease state (T 807/98 ST JUDE).
8.91 The process of diagnosis involves four steps leading towards identification of a condition (see G 01/04):
(1) The examination and collection of data;
(2) Comparison of the data with normal values;
(3) Recording any deviation from the norm; and finally,
(4) Attributing the deviation to a particular clinical picture.
8.92 This is a narrow interpretation – only methods comprising all four of these steps and which will lead to the identification of a clinical state will be excluded from industrial applicability. Such interpretation is consistent to that of the earlier decision T 385/86 BRUKER/Non-invasive measurement OJEPO 1988, 308 where a method of determining temperature and pH by magnetic resonance imaging that included a step of taking a sample, or determining internal temperature or pH, without leading to the identification of a pathological condition and thereby was not considered to be a method of diagnosis (see also Bio-Digital Sciences’ Application  RPC 668).
What does “practised on the body” involve?
8.93 Section 16(2) requires that a diagnostic method be carried out on a living human or animal body. Therefore, if the diagnostic method is not carried out on a living human or animal body, but on a dead body, for example to determine the cause of death, said method would not be objectionable (e.g. performing an autopsy).
8.94 The criterion “practiced on the human or animal body” is to be considered only in respect of method steps of a technical nature (G 01/04). Section 16(2) does not require a specific type and intensity of interaction with the human or animal body. The criterion “practiced on the human or animal body” is satisfied as long as the step of technical nature (usually the examination and data collection step) implies any interaction with the human or animal body, necessitating the presence of the latter.
8.95 When deciding whether a claim defines a method of diagnosis practised on the human or animal body, the Examiner may use a simplified test. First, the Examiner should consider whether the method includes a technical step, i.e. a measurement or examination step (explicitly or implicitly), and a deductive step of determining the disease or deriving a clinical picture (corresponding to steps (1) and (4) above). If this is the case, then the second question is whether the technical step is “practised on the body” – the simple test for this is whether the patient has to be present during this step. If the answer to both questions is “yes”, an objection should be made.
8.96 In this regard, the Enlarged Board of Appeal in G 01/04 also noted that:
“if … some or all of the method steps of a technical nature … are carried out by a device without implying any interaction with the human or animal body, for instance by using a specific software program, these steps may not be considered to satisfy the criterion ‘practised on the human or animal body’, because their performance does not necessitate the presence of the latter.”
8.97 Therefore, if a claim to a diagnostic method includes new and inventive technical steps that are all carried out separately from the body, for example, by being carrying out in vitro on a sample of tissue obtained from the body, it will be capable of industrial application. For example, in T 666/05 UNIVERSITY OF UTAH, claims defining methods for diagnosing a predisposition for breast cancer by detecting a mutation in the BRCA1 gene in a tissue sample from the subject was allowable since the technical steps of the claimed methods are performed on an in vitro tissue sample. Nonetheless, such claims should still be examined to determine whether they fall under the definition of a method of therapy or surgery.
8.98 Additional, intermediate steps which relate to, for example, the preparation or adjustment of a device for data collection, may be introduced into a diagnostic method claim for completeness. However, since these intermediate steps are not part of steps (1) to (4) as described above, which are necessary for making the diagnosis, they are ignored when assessing the diagnostic character of the method. Thus, even when the performance of such intermediate technical steps do not require the presence of the human or animal body, it would still not overcome a diagnostic method claim that was in the first place not allowable (see T 1197/02 THE AUSTRALIAN NATIONAL UNIVERSITY and T 143/04 BETH ISRAEL HOSPITAL ASSOCIATION).
Who performs the method?
8.99 The question of whether a claimed method is excluded under Section 1 (2) depends on whether it falls within the definition of a “method of diagnosis”, and whether it is “practised on the human or animal body”. It does not depend on who performs the method, or if a medical or veterinary practitioner is required.
8.100 In general, a method is “practised on the human or animal body” if it involves any interaction that requires the presence of the subject. Consequently, as long as the subject’s presence is required, it will be considered as being “practised in the human or animal body”.
8.101 In this regard, G 01/04 states that:
“… whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC should neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medicinal or nonmedicinal support staff, the patient himself or herself or an automated system.”
Identification of a condition and/or disease to be diagnosed
8.102 A diagnostic method requires a deductive step (4) that must involve the identification of a “condition”. For example, a method of measuring temperature using magnetic resonance would be allowable as there is no condition to be diagnosed (see T 385/86).
8.103 Notably the omission of such a step from the claim may overcome an objection under Section 16(2), but may result in a support objection under Section 25(5 (c) if an essential feature of the invention is not defined. For example, in decision T 143/04 the claims as originally filed were directed to a method of diagnosing Alzheimer’s disease. The Applicant amended the claims to include only the examination phase and remove the references to a comparison and diagnosis. However, the EPO Technical Board did not allow this amendment because the invention as filed is not an independent data collection method, but a method of diagnosis that included those data collection steps. In addition, it was held that as long as the method can be used to diagnose a disease, whether the method is reliable is an irrelevant consideration (paragraph 3.4 of T 143/04).
8.104 There may be cases where it is apparent from the description that a claimed method is in fact a method of diagnosis, even if the words of the claim do not specify a specific disease. For example, in T 125/02 AEROCRINE the measurement of nitrogen monoxide levels in exhaled air was used to identify “impaired respiratory function”; and the description indicated that the method allowed particular course of treatment to be selected, and so the claimed method was considered to encompass all the steps leading to a diagnosis.
8.105 In some cases, the method may be useful in diagnosing a disease but does not provide sufficient information in itself to enable a diagnosis. Thus, a method should not be considered a method of diagnosis if it merely determines the general health and wellbeing of an individual and is not intended to determine a pathological condition.
8.106 For example, methods such as fitness tests and the like would be considered patentable. Similarly, if a method is merely for data acquisition or processing and it only provides intermediate results that may be of diagnostic significance, it could be patentable as long as no actual diagnosis can be obtained. However, care must be taken in such cases since if the application indicates that the claimed method of data acquisition or processing is an integral part of a method of diagnosis, there may be support issues when the said data collection/processing method is claimed as an independent method (see paragraph 2 of T 143/04).
8.107 Examples of techniques that may be allowable include:
(i) Methods of imaging using CT scanning (see T 09/04 KONONKLIJKE PHILIPS ELECTRONICS);
(ii) Methods of measuring a parameter in a sample, such as blood glucose (T 330/03 ABBOTT LABORATORIES);
(iii) Methods of assessing tissue viability by measuring total haemoglobin, oxygen saturation and hydration (T 41/04 NATIONAL RESEARCH COUNCIL OF CANADA)
(iv) Methods of determining ear temperature (T 1255/06 EXERGEN CORPORATION);
(v) Methods of imaging an artery in a patient using magnetic resonance imaging (see T 663/02 PRINCE); and
(vi) Methods of detecting regional variations in oxygen uptake from the lungs (T 990/03 MEDI-PHYSICS INC.).
8.108 Although these are prima facie allowable methods, if the method encompasses attribution of the result to a clinical condition or disease, then it may still be considered a diagnostic method.