Tuesday, 1 September 2015

T 943/13 - Not obvious as a food supplement



The opposition division revoked the following second medical use claim:

"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."

I understand that document D12 appears to disclose a soluble dietary fibre for use in the treatment or reduction of the incidence of muscle wasting which contains the required oligosaccharides. However, D12 does not disclose that the oligosaccharide prevents muscle wasting. On this basis the board finds the claim inventive. 

To be a bit pedantic, claim 1 does not actually say that it is the oligosaccharides that prevent the muscle wasting, but from the description this is clearly the purpose of including them. 

The board also devotes an interesting discussion to the sufficiency of this broad claim.



Reasons for the Decision
(...)

2. Sufficiency - Article 100(b) EPC

2.1 Claim 1 is a second medical use claim referring to 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 to 10 anhydromonose units.

It was a matter of dispute between the parties whether the claimed therapeutic effect of treating or reducing the incidence of muscle wasting and/or chronic muscle wasting and/or sarcopenia could be obtained with dietary fibres as defined in claim 1.

In its decision, the opposition division reasoned that this issue represented an inventive-step rather than an insufficiency objection (point 3.3 of the decision). In the board's view, this is not correct. If a therapeutic effect is cited in a second medical use claim, this effect constitutes a functional feature of this claim. Consequently, for the invention as defined by the claim to be sufficiently disclosed, the skilled person must be able to put this feature into practice, i.e. to obtain the claimed therapeutic effect. The question as to whether the therapeutic effect as defined in claim 1 is achievable is therefore a matter of sufficiency of disclosure (see, e.g., T 433/05, point 28).

2.2 The first aspect of the opponent's insufficiency objection was the question as to what extent the therapeutic effect was demonstrated in the opposed patent. In this respect, the opponent argued that the only experimental data of the patent were found in example 1. This example compared the respective muscle mass of tumour-bearing mice with tumour-bearing mice fed GOS. However, the overall documentation was poor and the results inconclusive, in particular in view of the subsequently published study D17 (and in the same way D18 and D19), which reached the exact opposite conclusion to example 1. D17 had more probative value than the evidence referred to by the proprietor, namely example 1 of the patent and D24, and therefore, in line with decisions T 219/01 and T 1685/10, sufficiency should be denied.

To decide on the opponent's objection, it is necessary to compare D17 (an analysis of D18 and D19 is not needed since the relevant content thereof is identical to that of D17) with example 1 of the patent and D24 as regards their probative value on the question of whether muscle wasting can be treated or reduced by galactooligosaccharides (which are the oligosaccharides used in example 1 of the patent, D17 to D19 and D24).

2.2.1 The opponent's evidence: D17
(...)

2.2.2 The proprietor's evidence: example 1 of the patent and D24
(...)

2.2.3 In view of the above, the board considers it more credible than not that galactooligosaccharides as covered by the definition of dietary fibres in claim 1 lead to the claimed therapeutic effect of a reduction or treatment of muscle wasting. The opponent's first insufficiency argument must thus fail.

2.3 According to the opponent's second insufficiency argument, and in line with the decision of the opposition division, it was not plausible that the therapeutic effect of claim 1 was obtained for oligosaccharides other than galactooligosaccharides, even if one accepted the therapeutic effect in view of example 1 and D24.

However, the burden of proof to show that oligosaccharides other than galactooligosaccharides do not provide the claimed therapeutic effect is on the opponent. In the absence of any experimental evidence, the opponent's argument is nothing more than an unsubstantiated allegation, and as such cannot lead to a finding of insufficiency of disclosure.

2.4 According to the opponent's third insufficiency argument, and again in line with the opposition division's decision, it is not plausible that the therapeutic effect on muscle wasting in cancer is likewise observed in sarcopenia, since the latter has a very different biochemical mechanism.

2.4.1 The opponent argued in particular that according to D9, galactooligosaccharides led to a protective effect against the development of certain types of tumours in rats and that by way of this mechanism the galactooligosaccharides indirectly led to a reduction in muscle loss in cancer cachexia. The same could not apply to the non-cancer related muscle wasting in sarcopenia.

The board accepts that less development of tumours, as observed in D9, may indirectly reduce muscle loss. This does not however exclude the possibility that treatment with galactooligosaccharides in addition directly reduces muscle loss in patients with cancer cachexia and that the same also occurs in patients suffering from sarcopenia. In this respect, the board does not share the opposition division's view that D15 confirms that muscle wasting in cancer cachexia and sarcopenia is based on distinct physiological phenomena. In fact, D15 (penultimate and last paragraph of the left-hand column of page 907) rather points to the contrary by stating that all atrophic conditions including muscle wasting associated with cancer and muscle wasting associated with sarcopenia share the commonality of an imbalance in the protein system, resulting in reduced protein synthesis and increased protein breakdown/proteolysis, which in turn results in reduced muscle mass and muscle fibre size.

2.4.2 Therefore, no insufficiency arises for the different types of muscle wasting covered by claim 1.

3. Novelty

3.1 According to the opponent's only novelty attack, the subject-matter of claim 1 lacks novelty over D12.

3.2 D12 discloses the use of a composition for preventing muscle loss, the composition comprising (i) a protein source which includes at least about 50 wt% of whey protein, (ii) a lipid source having an omega 3:6 fatty acid ratio of about 5:1 to about 10:1, (iii) a carbohydrate source and (iv) a balanced macronutrient profile comprising at least vitamin E and vitamin C (page 2, line 25 to page 3, line 10).

The prevention of muscle loss is attributed in D12 to the whey protein present in this composition (page 3, lines 16 to 21 and page 4, line 28 to page 5, line 4).

Dietary fibres as defined in claim 1 are disclosed in D12 only as one of various optional further components. Specifically, on page 9, lines 19 to 30 of D12, prebiotic fibres such as Raftilose**(®), a fructooligosaccharide with a degree of polymerisation of 3 to 7, are mentioned. However, D12 does not disclose the Raftilose in the context of the prevention of muscle loss. On the contrary, all that is disclosed in D12 is the following:

"A prebiotic fiber is a fiber which beneficially affects the host by stimulating growth and/or activity of bacteria in the colon which have the potential to improve host health" (page 9, lines 20 to 22).

"The soluble, prebiotic fibres are reported to promote the growth of Bifidobacteria in the gastrointestinal tract and, in certain circumstances prevent or decrease the growth of pathogens such as Chostridiae. Further, promoting the growth of Bifidobacteria is reported to have various other beneficial effects. Also, during fermentation of the fibres in the colon, short chain fatty acids are produced. These fatty acids are a fuel for intestinal cells" (page 9, line 31 to page 10, line 4).

Hence, the subject-matter of claim 1 (and by the same token of claims 2 to 11) is novel over D12.

3.3 Incidentally, it is noted that nowhere does D12 disclose the compositions of claims 12 to 15, in particular the type and amount of further components as required by these claims. Therefore, also the subject-matter of these claims is novel over D12.

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 (page 3, lines 16 to 21 and page 4, line 28 to page 5, line 4). 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.

(...)Order
For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The patent is maintained unamended.

This decision T 0943/13 (pdf) has European Case Law Identifier: ECLI:EP:BA:2015:T094313.20150625. The file wrapper can be found herePhoto "cookies and whiskey 2" by Jim Lukach obtained via Flickr under CC BY 2.0 license (no changes made).

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