Friday, 24 September 2010

T 1002/09 – Improving Gut Feelings

Claim 1 of the main request before the Board read:

1. A liquid nutritional composition for use in promoting gut health in an elderly patient comprising a protein source, a source of digestible carbohydrates and a source of dietary fibre, characterised in that it has an energy density of 1.3-1.8 kcal/ml and dietary fibre in an amount of more than 2.5g/100ml.

In its assessment of novelty, the Board is confronted with the need to qualify this claim: is it a claim directed to a first medical application or not? The qualification of the indication of use (“for use in promoting gut health in an elderly patent”) will prove decisive:

[3.1] As in Claim 1 of the main request before the examining division (ED) the liquid nutritional composition according to Claim 1 is characterised in that it has an energy density of 1.3- 1.8 kcal/ml and dietary fibre in an amount of more than 2.5 g/100ml. The board shares the view of the ED that such a composition is novel over the prior art cited in the examining procedure in particular with respect to D3 and D5.

[3.1.1] D3 discloses a nutritional composition for elderly patients. In one embodiment, the composition comprises a protein source, a carbohydrate and a lipid source wherein the carbohydrate source includes a source of dietary fibre having a soluble fibre to insoluble fibre ratio of about 1:4 to 4:1 (Claim 2). D3 recommends that the level of fibre should be low with levels of between 0.8 and 1.5 g/100 ml […]. A higher fibre content, let alone in combination with the energy density required in Claim 1, is not disclosed in D3.

[3.1.2] D5 relates to a nutritional composition, suitable for enteral administration, comprising dietary fibre, characterised in that it contains 5-120 g of fibre per daily dosage of the composition, and the fibre consists of 15-50 wt.% of soluble non-starch polysaccharides, 15-45 wt.% of insoluble non-starch polysaccharides, and 8-70 wt.% of oligosaccharides and/or resistant starch (Claim 1). D5 discloses that fibre plays an important role not only in the nutrition of healthy people but also of hospital patients or persons with constipation or with diarrhoea […]. However, very little guidance is given as to the actual composition of such a nutritional composition. As far as fibre content is concerned, this may vary between 0.5 and 12 g/l00 ml with 1 to 2 g/ l00 ml being disclosed in Example 2.

The only guidance on energy content suggests a fibre content of 0.5-l2 g/100 ml at an energy content of 2 kcal/ml (derived from Claims 7 and 9). The combination of an energy density of 1.3- 1.8 kcal/ml with an amount of dietary fibre of more than 2.5 g/100ml is not clearly and unambiguously derivable from this document.

[3.1.3] The board therefore notes that novelty of the claimed composition is given irrespective of the technical meaning of the wording “for use in promoting gut health in an elderly patient”.

[3.2] In order to assess whether the feature in Claim 1 “… for use in promoting gut health in an elderly patient” has merely a descriptive character or represents a further technical feature with the result that Claim 1 has to be considered as a claim in accordance with a first medical indication in analogy to A 54(4), the relevant question to be answered is whether the intended use represents a treatment by therapy in the sense of A 53(c). Considering that malnutrition is a cause of digestive and gastro-intestinal disorders, associated with gut discomfort and pain, the invention aims at providing a nutritional composition to regulate gut motility and improve digestive tract health. In the board’s judgment, alleviation of pain and suffering by promoting gut health in applying measures which regulate gut flora and improve intestinal transit are therefore therapeutic measures (at least in the sense of prophylaxis) for preventing malfunctions or illness of the human body. This view is in line with the definition given for therapy in the case law of the boards of appeal where it is stated that therapy “clearly relates to the treatment of a disease in general or to a curative treatment in the narrow sense as well as the alleviation of the symptoms of pain and suffering” (e.g. T 144/83 [3]).

As regards the reference “in an elderly patient” this implies a clear limitation of the therapy to this demographic group. It is only plausible that different age groups have different needs concerning the nutrition (e.g. due to a change in the metabolism with age). Thus, in analogy to A 54(4) (“first medical use of a known compound”) Claim 1 is directed to a purpose-related product.

If you wish to download the whole decision, please click here.