T 0250/23 - Second medical use of bacteria

Key points

• This decision illustrates establihsed case law that bacteria are substances or compositions in the sense of Art. 54(4) and (5).
• Claim 1 in this case:   "Eubacterium hallii or relatives having at least 98% sequence identity with the 16S rRNA sequence of Eubacterium hallii, and/or Alcaligenes faecalis or relatives having at least 98% sequence identity with the 16S rRNA sequence of Alcaligenes faecalis, for use in preventing and/or treating insulin resistance and/or insulin resistance-related complications selected from metabolic syndrome, dyslipidemia, type 2 diabetes mellitus, and insulin resistance in endocrine diseases such as in obese subjects with type 1 diabetes mellitus, Cushing's disease and lipodystrophy syndromes"."
• The Board, on novelty: "As regards D6, it is uncontested that this document does not explicitly disclose the use of Eubacterium hallii in preventing or treating insulin resistance. Instead, this bacterium is described as a butyrate-producing bacterium in the context of energy metabolism. The only specific activity of butyrate-producing bacteria referred to in this document is that they are related to higher gut metabolic activity leading to overweight. In conclusion, there is not even an implicit disclosure concerning insulin resistance in D6."
  
  
• On inventive step:
  "D2 is a scientific publication which addresses a wide range of beneficial effects on human health that butyrate has. In the paragraph headed "Obesity and insulin resistance" D2 discloses, based on a referenced publication, that dietary supplementation with butyrate can prevent and treat diet-induced obesity and insulin resistance in mouse models. The conclusion presented is that butyrate may have a potential application in the prevention and treatment of metabolic syndrome in humans. " 
• " In the following, an inventive-step analysis is carried out based on the teaching of D2 that calls for butyrate as the active component."
• "the paragraph in D2 that specifically mentions insulin resistance is restricted to oral administration of butyrate as such. How far the active substance to be administered can be modified is a question to address under obviousness."
• "the problem to be solved is to provide prevention or treatment of insulin resistance and/or insulin resistance-related complications"
• "  Starting from the closest prior art, the skilled person would have had to decide not to administer a palatable formula of butyrate. Then, they would have had to choose not to modulate the intestinal flora (e.g. by modifying the lumen pH) but to administer butyrate-producing bacteria. Finally, they would have had not to select the specific butyrate-producing bacteria mentioned in D2 - which are stated to represent the most important groups of butyrate producers in the human intestine - but to look for other butyrate-producing bacteria."" 
• " D2 itself does not mention the use of micro-organisms for managing insulin resistance, and the only micro-organisms mentioned in D2 are not the ones of claim 1. The skilled person would have had no motivation to turn to D3 or D4, which mention Eubacterium hallii among other bacteria. To do all this starting from the closest prior art is considered to encompass more than routine measures."" 
• The claim is held inventive.

EPO 

The link to the decision can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t230250eu1