T 0943/13 - Second medical use and A56

EPO T 943/13

For the decision, click here. [C]

EPO Headnote
The causal relationship between the substance or composition on the one hand and the therapeutic effect achieved on the other hand is decisive for the assessment of inventive step of further-medical-use claims (see point 4.1.5).

Key points

• The claim is a second medical use claim (drafted as product for use in the treatment). A prior art composition D12 gives the same effect.  According to the Board, the objective technical problem is therefore " the provision of the claimed therapeutic effect by a different means", and not, as asserted by the opponent, "the provision of an alternative composition" .
• The Board states that "the board acknowledges that the objective technical problem might indeed be the provision of an alternative composition if claim 1 was a "normal" product claim directed to a substance or composition. However, claim 1 is formulated as a further medical use claim directed to a substance or composition for use in a therapeutic application"  and then finds that for that kind of claims, the objective technical problem is as formulated by the Board.
• As a comment, if the claim had been a product-as-such claim, the objective technical problem may still have not been the provision of alternative compositions (as such). Rather, since the composition was deemed to provide a technical effect, be it the same as D12, the objective technical problem would possibly be the provision of alternative solutions for obtaining that effect. In other words, in this context, alternative would not mean an arbitrary composition, but a composition that would provide the same technical (therapeutic) effect as D12. 

Summary of Facts and Submissions

II. The opposition division's decision was based inter alia on the patent as granted (main request), claims 1 and 12 to 15 of which read as follows:

"1. A soluble dietary fibre for use in the treatment or reduction of the incidence of muscle wasting and/or chronic muscle wasting and/or sarcopenia, the dietary fibre comprising at least 30 wt.% of oligosaccharides having a chain length of 3-10 anhydromonose units."

Reasons for the Decision

4. Inventive step

4.1 The opponent argued that the subject-matter of claim 1 lacked inventive step in view of D12 as the closest prior art.

4.1.1 Like the patent, D12 aims at reducing the incidence of muscle wasting. Consequently, this document can be considered to represent the closest prior art.

4.1.2 As set out above, the composition to be used according to claim 1 differs from the composition disclosed on page 2, line 25 to page 3, line 10 of D12, in that it contains a dietary fibre comprising at least 30 wt% of oligosaccharides having a chain length of 3 to 10 anhydromonose units.

4.1.3 As furthermore set out above when discussing sufficiency of disclosure, it is credible that the dietary fibres to be used according to claim 1 lead to the claimed therapeutic effect, i.e. the treatment or reduction of the incidence of muscle wasting and/or chronic muscle wasting and/or sarcopenia. The same effect is achieved in D12 by the whey protein [...]. The objective technical problem is therefore the provision of the claimed therapeutic effect by a different means.

4.1.4 There is no indication at all in D12 that this therapeutic effect can be achieved by the use of a dietary fibre as defined in claim 1. On the contrary, D12 discloses that it is the whey protein rather than the optional dietary fibres disclosed therein that is responsible for obtaining this effect (see the above-quoted passages on pages 3 to 5 of D12). Therefore, if anything, D12 teaches away from the claimed alternative. The subject-matter of claim 1 (and by the same token of claims 2 to 11) is thus inventive in view of D12.

4.1.5 The opponent argued that the objective technical problem was the provision of an alternative composition. The composition of D12 was known to prevent muscle wasting. In the absence of any particular effect, no motivation was needed to select the optional dietary fibres disclosed in D12 to arrive at the subject-matter of claim 1.

The board acknowledges that the objective technical problem might indeed be the provision of an alternative composition if claim 1 was a "normal" product claim directed to a substance or composition. However, claim 1 is formulated as a further medical use claim directed to a substance or composition for use in a therapeutic application. As set out in G 2/08 (point 5.10.9), non-obviousness of such a claim "is not derived from the substance or composition as such" (in the present case the oligosaccharide-containing soluble dietary fibre) "but from the purpose the claimed substance or composition is related to, namely from its intended therapeutic use" (in the present case the treatment or reduction of the incidence of muscle wasting and/or chronic muscle wasting and/or sarcopenia). In analogy to non-medical use claims, it is the causal relationship between the substance or composition on the one hand and the effect achieved therewith on the other hand that constitutes a functional feature of the claim (see G 2/88, point 10.3). This causal relationship constitutes the claim's contribution over the prior art. Accordingly, the inventive step of such a claim hinges on the question as to whether this causal relationship, and not just the substance or composition as defined in the claim, is obvious. Hence, in the present case, the objective technical problem is not just the addition of a further arbitrary substance (fibre) to the composition of D12, which already provides the therapeutic effect due to the presence of whey protein. On the contrary, the objective technical problem is the provision of this causal relationship, i.e. the achievement of the claimed therapeutic effect with a different means, namely the specified fibres of claim 1. It is this problem that has been used in the problem-and-solution approach above (see point 4.1.3).

4.2 In an alternative approach, the opponent used D15 as the closest prior art to attack the subject-matter of claim 1 under inventive step.

4.2.1 D15 is a review article on molecular mechanisms of muscle atrophy. It is thus in the same technical area as the opposed patent and therefore, as argued by the opponent, can be considered to represent the closest prior art.

D15 discloses that the transcription factor NF-kappaB induces muscle atrophy (last paragraph on the left-hand column of page 908), that salicylate can be used to treat NF-kappaB induced muscle atrophy and that high doses of salicylate are not well tolerated in humans (last paragraph of D15).

4.2.2 The subject-matter of claim 1 differs from D15 in that instead of salicylate, oligosaccharides having a chain length of 3 to 10 anhydromonose units are used to obtain the claimed therapeutic effect.

4.2.3 In the same way as for D12, the objective technical problem is the provision of an alternative means to obtain the claimed therapeutic effect.

4.2.4 There is no indication at all in D15 that this can be achieved by the dietary fibres as defined in claim 1.

The opponent argued in this respect that the use of dietary fibres as defined in claim 1 was obvious in view of D22. The opponent in particular explained that the skilled person learning from D15 that NF-kappaB induces muscle atrophy and that this could be treated by salicylate, of which high doses were not well tolerated by humans, would look for an alternative means to reduce the NF-kappaB level. From D22 (first paragraph on the left-hand column of page 799), the skilled person would be taught that butyrate inhibits the activity of NF-kappaB, and that butyrate levels in the gut could be influenced by dietary fibres (last paragraph of D22). Since it was known from e.g. D9 or D23 that oligosaccharides such as galactooligosaccharides led to an increased intestinal production of butyrate, it would have been obvious to use these galactooligosaccharides instead of the salicylate in D15 to treat NF-kappaB induced muscle atrophy.

The board does not agree. Firstly, the skilled person starting from D15 and looking for an alternative means to provide the claimed therapeutic effect would not have considered D22, since this document is not related at all to muscle wasting but focuses on drugs preventing excess inflammation in the gut (see e.g. the introductory paragraph on page 798). Secondly, even combining D15 with D22, the skilled person would not arrive at the claimed subject-matter since the dietary fibres in D22 are not as defined in claim 1. An additional step would be needed, namely to look into the further documents D9 or D23 and to select the fibres disclosed therein. These documents are however in a field completely different from muscle wasting, namely the effect of galactooligosaccharides on specific forms of cancer (D9) and the stimulation and growth of bifidobacteria in the colon (D23). There is no motivation at all in the two documents D9 and D23 to use the dietary fibres disclosed therein in order to obtain the claimed therapeutic effect. Therefore, arguing that the skilled person would combine the various aspects of D15, D22 and D9 or D23 in such a way as to arrive at the subject-matter of claim 1 is based on hindsight. The subject-matter of this claim is therefore inventive in view of D15 as the closest prior art.

4.3 The opponent furthermore argued that the subject-matter of claims 12 and 13 was not inventive in view of D12.

4.3.1 The food supplement and carbohydrate composition of these claims differ from the composition disclosed on pages 2 and 3 of D12 inter alia by the same feature as claim 1, namely the specific dietary fibres. Therefore, in the same way as for claim 1, the objective technical problem is the provision of an alternative means to achieve the claimed therapeutic effect and, for the reasons given above, the claimed alternative is not obvious. Therefore, the subject-matter of claims 12 and 13 is inventive in view of D12.

4.4 In the written proceedings, the opponent argued that the subject-matter of claims 12 and 13 was obvious in view of D9 as the closest prior art. As set out above, D9 is however in a technical area entirely different from that of the patent. Therefore, D9 cannot be considered to represent the closest prior art.

4.5 The opponent argued lastly that the subject-matter of claims 14 and 15 was obvious in view of D6 as the closest prior art

4.5.1 Like the opposed patent, D6 concerns nutritional compositions for the prevention and treatment of cachexia in cancer patients (page 1, lines 1 to 2 and page 7, lines 1 to 2). It stresses specifically the issue of muscle wasting (page 2, lines 1 to 3). Therefore, in line with the opponent's argument, D6 can be considered to represent the closest prior art.

D6 teaches the use of a composition comprising an oil blend containing omega-6 and omega-3 fatty acids, branched chain amino acids and an antioxidant component to prevent or treat cachexia and the muscle wasting associated therewith (page 4, lines 14 to 23 and claim 1 in conjunction with page 2, lines 1 to 3).

The supplement and composition of claims 14 and 15 differ from those of D6 inter alia in that dietary fibres of a specific chain length are present.

In the same way as for D12 and D15, the objective technical problem is the provision of an alternative means to provide the claimed therapeutic effect.

This problem is solved by the use of a dietary fibre as defined in claims 14 and 15 (by way of back-reference to claims 1 to 4).

The only place where a dietary fibre is disclosed in D6 is example IV (fructooligosaccharides FOS). However, there is no information in D6 why these fructooligosaccharides have been included in the composition of this example. In fact, what is disclosed in D6 to be effective to treat cachexia (and the muscle wasting linked to it) is the combination of the fatty acid blend, the nitrogen source and the antioxidant (see page 4, lines 14 to 23 and claim 1 of D6).

The skilled person looking for an alternative means to obtain the claimed therapeutic effect would thus not have had any motivation to use the fructooligosaccharides disclosed in D6, let alone fructooligosaccharides as covered by the definition of the dietary fibres in claims 14 and 15. Therefore, the subject-matter of these claims is inventive in view of D6.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is maintained unamended.