T 1197/02 12-07-2006

Reasons for the Decision

1. The appeal is admissible.

2. Method claims (Article 52(4) EPC)

2.1 In its opinion G 1/04 (OJ EPO 2006, 334) the Enlarged Board of Appeal stated, inter alia, as follows:

"1. In order that the subject-matter of a claim relating to a diagnostic method practised on the human or animal body falls under the prohibition of Article 52(4) EPC, the claim is to include the features relating to:

(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,

(ii) the preceding steps which are constitutive for making that diagnosis, and

(iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.

2. [...]

3. In a diagnostic method under Article 52(4) EPC, the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion "practised on the human or animal body.

4. Article 52(4) EPC does not require a specific type and intensity of interaction with the human or animal body; a preceding step of a technical nature thus satisfies the criterion "practised on the human or animal body" if its performance implies any interaction with the human or animal body, necessitating the presence of the latter."

More specifically, as also results from the point 5 in the opinion G 1/04, those preceding steps which are constitutive for making the diagnosis are:

a) the examination phase involving the collection of data,

b) the comparison of these data with standard values, and

c) the finding of any significant deviation, i.e. a symptom, during the comparison, ...

2.2 The criterion "practised on the human or animal body" is to be considered only in respect of method steps which are of a technical nature (points 6.4.1 and 6.4.4 of G 1/04). Thus it neither applies to the deductive decision phase, nor to the above mentioned steps b) and c) which consist in comparing the data collected in the examination phase with standard values and in finding a significant deviation resulting from the comparison. These activities are principally of a non-technical nature and normally not practised on the human or animal body.

It results therefrom that in most cases only step a) which refers to the examination phase and involves the collection of data can actually be of a technical nature and, therefore, concerned with the criterion "practised on the human or animal body".

Additional, intermediate steps which concern for example the adjustment or preparation of the apparatus with which the collection of data will be performed may be introduced into a method claim for completeness. However, since these additional features are not part of one of the steps a) to c)mentioned above, which are necessary for making the diagnosis, they are to be ignored when assessing the diagnostic character of the method. The issue of whether or not these intermediate features are of a technical nature and practised on the human or animal body is, therefore, irrelevant for this question. Thus, contrary to the appellant's submission, it is not correct to require that all the steps pertaining to a claim to a diagnostic method, which are of a technical nature or are using technical means, fulfil the criterion "practised on the human or animal body" in order to exclude the method from patentability.

2.3 In the present method claim 1 according to the main request, the steps identified (a) to (e) are all claimed as part of the examination phase for collecting data by sequentially measuring contrast thresholds values in a plurality of previously determined zones which are presented successively to the visual field of the subject to be tested. However, step (a) which relates to generating and displaying a pattern having suitable characteristics has to be regarded as an additional step within the meaning of section 2.2 above, and, consequently, can be left aside when determining the diagnostic character of the claimed method. The remaining steps ((b), (c), (d), (e)) are of technical nature and require the presence of the subject for observing the patterns.

The step (h) represents the comparison of the collected thresholds with standard values exhibited by subjects of normal vision and, implicitly, the finding of any significant deviation resulting from the comparison, i.e. the symptom. These activities are not technical by nature and, therefore, need not be practised on the human body.

Intermediate steps (f) and (g) of calculating the mean of the logarithm of the threshold values to determine the zone which produces the highest threshold value and ranking the threshold values, respectively, represent a preliminary processing, with computing means, of the data collected in steps (a) to (e), in order to make a valid and efficient comparison with standard values. Although they are of a technical nature, these intermediate steps are not part of the comparison per se and thus are of no relevance for making the diagnosis. As a consequence, they are not to be considered, for the question whether or not the claim refers to a diagnostic method in the sense of Article 52(4) EPC.

The deductive medical decision phase, i.e. the diagnosis for curative purposes stricto sensu, is easily identified at the beginning of claim 1 by the provision of "a method of assessing the presence of glaucomatous damage to the visual system of a subject".

It results therefrom that the method claim 1 according to the main request includes all the features of a diagnostic method practised on the human or animal body as defined in the opinion G 1/04. Such a method is prohibited by Article 52(4) EPC.

2.4 The amendments made to the method claims according to the first to fourth auxiliary requests, by addition or deletion of features, do not change the above conclusion since the diagnosis, i.e. the deductive medical decision phase, and all the preceding steps which are constitutive for making the diagnosis, including the interaction with the human body during the data collection phase, are still present in all the method claims according to these requests.

Therefore the subject-matter of all these method claims also define a diagnostic method within the meaning of the opinion G 1/04 and are excluded from the patentability by Article 52(4) EPC. Consequently the main request and the auxiliary requests 1 to 4 are not allowable.

3. Apparatus claims (Article 123(2) EPC).

With respect to the application as filed the claims to the apparatus according to the fifth auxiliary request were amended as follows:

3.1 Claim 1

The features of the preamble of claim 1 are based on the features of the original claim 8, supplemented by features drawn up from the description as filed, see page 3, lines 22-24, page 4, lines 25-26 and page 9, lines 29-30.

A further specification of the modulation frequency range of the contrast is deemed not to be necessary since the technique and frequencies to be applied for observing a frequency-doubled pattern of the grating is well known from the closest prior art document D7 (US-A-5065767).

The features of the characterising portion of claim 1 are based on the features of original claims 10 and 9, respectively, supplemented by features taken from the description as filed, see page 9, lines 7-9. The selected zones are shown in Figures 1(b) and 1(d). The means for masking the pattern are supported by the paragraph on page 10, lines 14-17. A sequential presentation of the pattern and subsequent determination of the threshold values is supported by the passage on page 9, lines 26-29.

3.2 Dependent claims 2 to 6

The features of claim 10 are based on features from the original claim 10.

The features of claim 11 are supported by the description as filed, page 10, lines 22-27.

The features of claims 12 and 13 are based on the features of original claims 11 and 12, respectively.

The features of claim 14 are supported by the description as filed, page 5, lines 10-14.

3.3 It results therefrom that all the amendments made to the apparatus claims are clear and supported by the application as filed. Moreover, their subject-matter does not extend beyond the content of the application as filed, in agreement with the requirements of Article 123(2) EPC. Therefore, the apparatus claims according to the fifth auxiliary request are formally acceptable.

4. Remittal

Since the claims at issue, now restricted to the apparatus for performing the method, were greatly modified, in particular by the incorporation of features (means to mask the pattern) possibly not having been searched, the Board finds it appropriate to remit the case to the examining division for further prosecution on the substantive issues on the basis of claims 1 to 6 of the fifth auxiliary request filed at the oral proceedings.