T 1069/11 – A New Use

In this examination appeal case, the Board dismissed the main request because there were too many independent claims, in violation of the requirements of R 43(2).

Claim 1 of the first auxiliary request read:

1. Stent for use in prevention of restenoses of a wall (3) of a blood vessel having atheromatous plaque consisting of a multilayer braided framework (13) wherein the framework, devoid of any cover layer, comprises a plurality of stabilized layers (14, 15, 16) of biocompatible metal wires (17), which are interlaced, forming a lattice, a plurality of wires (17) of a given layer (14, 15, 16) being integrated in the lattice of at least one of the adjacent layers; characterized in that:

the mechanical characteristics of the stent are so that, when deployed in the vessel, an outermost layer (14) is able to rest against the vessel wall (3) and the other layers are able to extending [sic] substantially along cylindrical surfaces distinct from the outermost layer (14), so as to form a multi-layer mat so designed that the combined effect of the various layers locally affects the haemodynamic of a flow of blood passing along said mat, the flow of blood being deviated towards an inner face of an innermost layer and and [sic] provoking a drop of the pressure exerted on the vessel wall, thus preventing the growth of plaques on said vessel wall and promoting the growth of a new layer of endothelial cells.

The Board found this claim to lack novelty:

[3.1] D1 discloses a stent consisting of a multilayer braided framework (6) wherein the framework, devoid of any cover layer, comprises a plurality of stabilised layers (8, 10, 12) of biocompatible metal wires (14), which are interlaced, forming a lattice, a plurality of wires of a given layer being integrated in the lattice of at least one of the adjacent layers (abstract).

[3.2] It is true that D1 does not disclose that, once the stent is deployed in the vessel, its outermost layer rests against the vessel wall and the other layers extend substantially along cylindrical surfaces distinct from the outermost layer, so as to form a multi-layer mat so designed that the combined effect of the various layers locally affects the haemodynamic of a flow of blood passing along said mat, the flow of blood being deviated towards an inner face of an innermost layer and provoking a drop of the pressure exerted on the vessel wall, thus preventing the growth of plaques on said vessel wall and promoting the growth of a new layer of endothelial cells.

[3.2.1] However, claim 1 is directed to a stent as such. Therefore, these features, which relate to the stent while in use, must be construed as meaning merely that the stent is suitable for realising them once deployed.

[3.2.2] The appellant submitted that they are the result of mechanical characteristics of the claimed stent which are not disclosed in D1. However, it could not indicate which specific mechanical characteristic or characteristics distinguished it from the prior-art stent.

[3.2.3] Nor does the application in suit give any indication as to what this characteristic or these characteristics may be. On the contrary, a comparison of Figure 3 and paragraphs [0028] to [0030] of the application in suit and Figure 2 and paragraphs [0017] to [0019] of D1 reveals that the geometry, materials and materials treatment of the stent disclosed as a preferred embodiment in the present application are the same as those of the stent disclosed in D1.

As a matter of fact, the applicant itself acknowledged that the claimed invention is based on the discovery of a completely different field of application of the same structure known from D1 […].

[3.2.4] Since no difference in terms of mechanical characteristics can be seen between the stent of claim 1 and the stent known from D1, the latter stent must necessarily be intrinsically suitable for satisfying the requirements set out in the characterising portion of claim 1 of auxiliary request 1.

[3.3] The appellant submitted that novelty of the subject-matter of claim 1 should be acknowledged also on the basis of its medical indication, i.e. the fact that the stent is “for use in prevention of restenoses of a wall of a blood vessel having atheromatous plaque”.

[3.3.1] The only provisions of the EPC which foresee that the novelty of a product can be acknowledged on the basis of its medical indication are A 54(4) and (5).

According to A 54(4), it is possible to acknowledge the novelty of a “… substance or composition, comprised in the state of the art, for use in a method referred to in A 53(c), provided that its use for any such method is not comprised in the state of the art” (emphasis added).

According to A 54(5), it is also possible to acknowledge the novelty of a “… substance or composition referred to in paragraph 4 for any specific use in a method referred to in A 53(c), provided that such use is not comprised in the state of the art” (emphasis added).

A 53(c), to which both A 54(5) and A 54(5) refer, provides that European patents are not to be granted in respect of “methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods” (emphasis added).

[3.3.2] It can thus be seen from the text of those articles that there is an explicit difference between the wording chosen by the legislator for A 53(c) and the wording of A 54(5) and (5). First of all, as a consequence of the use of the expression “in particular”, A 53(c) in itself indicates that products are not limited to substances or compositions. Moreover, whereas A 53(c) mentions products, in particular substances or compositions, A 54(5) and A 54(5) only mention substances or compositions.

The legislator has thus made a distinction between products that can qualify as substances or compositions, and which are patentable within the framework of A 54(5) and (5), and other products, which do not fall under the exceptions provided by those provisions (see also T 1099/09 [3.3]).

[3.3.3] This finding is not at variance with decision G 2/08, which deals with the patentability of substances and compositions that are already known as medicaments (see questions referred to the Enlarged Board of Appeal under I.1.2 of the Summary of Facts and Submissions and the corresponding answers in the Order) and does not consider the patentability of products which do not qualify as substances or compositions.

[3.3.4] Nor does the passage of the travaux préparatoires of the EPC 1973 cited by the appellant (BR/ 219 e/72 ico/PA/gc, §30, second paragraph) suggest a different interpretation of the provisions of A 54(5) and (5). It is true that that passage states that the patentability of medical equipment should not be prejudged. However, it does not stipulate that said patentability can be acknowledged on the basis of the medical indication of those devices.

[3.3.5] Accordingly, the novelty of the product of claim 1 can be acknowledged on the basis of its medical indication only if that product qualifies as a substance or a composition. However, the claimed product is a stent consisting of a multilayer braided framework devoid of any cover layer. Accordingly it is a finished product having a certain shape and certain dimensions and which does not comprise any active ingredient. Hence, the claimed stent does not qualify as a substance or a composition.

[3.3.6] Decision T 227/91 does not contain any hint to the contrary. That decision is concerned with Swiss-type claims and, though it states that medicaments are expended in the process of use and have only a once-and-for-all utility (point [5.2] of the Reasons), fails to define all the conditions necessary for a product to qualify as a medicament, let alone a substance or a composition.

[3.4] Therefore, the provisions of A 54(5) and (5) do not apply to the claimed stent. Accordingly, its novelty cannot be acknowledged on the basis of its medical indication (use in the prevention of restenoses in a blood vessel having atheromatous plaque) either.

[3.5] Therefore, the subject-matter of claim 1 of auxiliary request 1 lacks novelty with respect to D1.

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