T 0395/18 - Administering through the mother

 Key points

• Claim 1 is directed to: “1. A composition comprising a non-digestible oligosaccharide for use in decreasing or preventing an allergic reaction in a mammalian subject [i.e. a baby], wherein the composition is administered to a lactating, postpartum female [i.e. the baby's mother] who is breast-feeding the mammalian subject [baby] and wherein the non-digestible oligosaccharide comprises galacto-oligosaccharide.”
• The Board has no comments on the second medical use claim format for this claim wherein the active substance is supplied to the mother and the recited therapeutic effect occurs in the baby. “Claim 1 is drafted in the format foreseen by Article 54(5) EPC. Accordingly, attaining the claimed therapeutic effect is a functional technical feature characterising the claim.”
• The critical issue is sufficiency of disclosure. The Board admits the opponent's new submissions after the preliminary opinion. “The preliminary opinion given by the board in its communication is based essentially on facts and arguments presented by the parties in writing. Nonetheless, the communication crystallised for the first time what the board itself had deduced to be the essential elements of the lengthy arguments presented by the parties when discussing sufficiency of disclosure. In particular, the communication drew attention to some paragraphs of the opposed patent discussing the principle underlying the claimed invention which convey the impression that, at the filing date, the skilled person would have assumed any galacto-, fructo- or acidic oligosaccharide to be suitable, individually, to induce the alleged therapeutic effect (paragraphs [0032], [0033], [0092] and [0102]). Furthermore, the communication drew attention to the results of the tests described in paragraph [0102] of the patent. It also clearly put the burden of proof regarding sufficiency on the respondent [opponent], thus contradicting the position taken by the opposition division.”
• On the substance of sufficiency, the Board finds that handbook D13, submitted by patentee, throws doubt on the alleged effect. “The mixed results throw serious doubts as to whether the claimed therapeutic treatment can be carried out, all the more so when considering that the principle underlying the invention - to administer oligosaccharides to a lactating mother in order to achieve a pharmacological effect in a child - departs considerably and constitutes a radical development from the teachings in the common general knowledge reflected in D13, which teaches administering the oligosaccharides directly to the child.” 
• AR-7 wherein the composition "comprises galacto-oligosaccharide, fructo-oligosaccharide and acidic oligosaccharide" is found to be sufficiently disclosed.

EPO T 0395/18 - link

decision text omitted.