T 2186/14 09-05-2019

Reasons for the Decision

1. The appeal is admissible.

2. Subject-matter of the application

Claim 1 relates to a delivery device for delivering a substance into a nasal airway of a subject (Figure 2). The device comprises a nosepiece unit having an outlet unit with a nozzle and a substance supply unit. The delivery device is configured such that at least 30 % of the dose is deposited in an upper posterior region of the nasal airway.

3. Article 84 EPC

3.1 Article 84 EPC requires that the claims define the matter for which protection is sought in a clear and concise manner and that the claims be supported by the description. These requirements ensure that the public is not left in any doubt as to the subject-matter covered by a claim.

3.2 Claim 1 includes a functional feature, namely, that the delivery device is configured such that at least 30 % of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the nasal airway which is posterior of the nasal valve and above the inferior meatus.

3.3 While, in general, a functional feature defining a technical result can be permissible in a claim, in the present case, the skilled person would have been left in doubt regarding how the feature "configured such that at least 30 % of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the nasal airway" could be reduced to practice. In fact, the claim does not specify any structural technical feature of the delivery device which provides for the deposition of at least 30 % of the dose in the upper posterior region of the nasal airway.

3.4 Furthermore, the Board holds that the deposition of the substance depends not only on the configuration of the device but also on factors which do not relate to the delivery device. The amount of substance deposited in a specific region of the nose depends, for instance, on the anatomy of the patient, on the type of substance and how it is delivered (e.g. liquid aerosol, dry powder, liquid jet...), and on how the device is used, i.e. at which angle or how far the nosepiece is inserted into the nose.

Hence, there is no direct and unique link between the device and the claimed result. Therefore, the functional definition cannot be used to define the subject-matter covered by the claim.

3.5 The appellant considered the definition in terms of the result to be achieved to be allowable because the result could be easily verified by an observation. It referred to example 2 of the description of the present application which disclosed a routine measurement of the deposition (page 27, last paragraph, to page 32, third paragraph). With the method described in this example, it would have been possible for the skilled person to verify whether any given administration device would fall under the scope of the claim or not.

The Board observes that example 2 relates to a study comparing the deposition achieved by a conventional nasal spray administration system with that achieved by a delivery device according to the invention. To evaluate the deposition, a labelled test solution was administered to some patients, and the nasal cavity was imaged by a camera. The deposition as obtained by the two administration systems is illustrated in Figures 12(a) and 12(b), respectively. As shown in table II, with the device according to the invention, 32 % of the dose is deposited in the upper posterior region of the nasal cavity, whereas the conventional device only provides for a deposition of 11 % in that region.

However, in this example, a specific test setting was employed, e.g. the aerosol was administered with the subjects sitting in the upright position (page 28, last paragraph, to page 29, first paragraph). There is no reason to believe that with a different test setting, e.g. the subjects leaning forward or backward during the administration, or with a different test solution, equal results would be achieved with the same device. Hence, since the desired result is influenced by factors not related to the claimed device, it is not possible to define the device by this result.

3.6 The appellant argued that it would have been clear to the skilled person that the device had to be used properly, e.g. properly inserted into the nose, and that if the device was used properly, the deposition did not depend on how it was used.

The Board does not concur with this view. Even among the ways of normal use of a nasal administration device there is a certain degree of freedom for how the device is used. This unavoidably has an impact on the result. For instance, for the amount of the deposition in a certain region of the nasal cavity, it surely matters how far the device is inserted into the nose and under which angle. In other words, it is inevitable that different results will be achieved from using the same device in a different (but still proper) way.

Furthermore, the deposition also depends on the anatomy of the subject, e.g. whether a child or an adult.

3.7 The appellant referred to the case underlying decision T 68/85 and to the ashtray example, both mentioned in the Guidelines for Examination (F-IV, 4.10).

Decision T 68/85 states that the claimed features may be expressed in structural or functional terms, the latter if, from an objective point of view, the features cannot otherwise be defined more precisely without unduly restricting the scope of the claim, and if the functional features provide instructions which would have been sufficiently clear for the skilled person to reduce them to practice without undue burden. However, this decision also found that an applicant cannot simply define a technical feature as it wishes. Rather, the objectively most precise form must be chosen (T 68/85, Reasons, 8.4.2).

The Board agrees with the appellant that the extent of protection should not be unduly limited. Nevertheless, the claim must clearly define the subject-matter for which protection is sought, and it must be possible to determine from the definition of the subject-matter whether any given device falls under the scope of the claim. In the Board's view, this is not the case for claim 1, as explained above.

The example referred to by the appellant concerns an ashtray in which a smouldering cigarette end is automatically extinguished due to the shape and relative dimensions of the ashtray. The latter may vary considerably in a manner difficult to define whilst still providing the desired effect. As long as a claim specifies the construction and shape of the ashtray as clearly as possible, it may define the relative dimensions by reference to the result to be achieved, provided that the specification includes adequate directions to enable the reader to determine the required dimensions by routine test procedures.

In this example, it is clear which structural features have to be appropriately designed to achieve the desired effect. The relative dimensions of the ashtray may vary but will always be such that a cigarette is automatically extinguished.

However, in the present case, the specific structural features which have to be appropriately designed are not clear from the wording of the claim. The only structural features included in the claim are a nosepiece unit comprising a nozzle and a substance supply unit. Apart from this, no indication is given as to how the device has to be configured so as to provide for the deposition of at least 30 % of the dose in the upper posterior region of the nasal airway.

3.8 In conclusion, claim 1 does not meet the provisions of Article 84 EPC.