T 0298/20 - Specific for sufficiency, specific for inventive step

Key points

• The claim is a second medical use claim.
• "D6 (points 1 and 3) is a draft of the guidelines proposed by a group of experts consulted by the FAO and the WHO for evaluating the use of therapeutic probiotics in food. In the first paragraph of point 3.1, D6 underlines the importance of identifying probiotic strains because, according to the available evidence, the effect of probiotics on health is strain specific. "
• For sufficiency: "It follows from D6 and D7 that on the filing date it was generally accepted that the health benefit provided by a probiotic was strain specific. Only in exceptional cases had it been observed that the effect of a strain was common to the whole species. There is no experimental evidence on file that the health benefits obtained by the administration of L. acidophilus NCFM and B. lactis Bi-07 [as used in the examples] can also be obtained with other strains of the species L. acidophilus and B. lactis [as encompassed by the claim]."
• " Therefore, the Board has serious doubts that, on the filing date, the skilled person could carry out the invention of claim 1 without undue burden. As a consequence, the ground for opposition of Article 100(b) EPC precludes the maintenance of the patent as granted."
• Turning to inventive step of AR-3 where the claim is limited to the specific strains that were tested, " the subject-matter of claim 1 differed from D2 at least in the combination of bacterial strains that were administered to children. In claim 1, it was a combination of L. acidophilus NCFM and B. lactis Bi-07, while in D2 it was a combination of L. rhamnosus GG or L. delbrueckii bulgaricus and B. lactis Bb-12."
• "the results of the clinical study in the patent (see Tables 2 and 3 and paragraph [0097]) demonstrate that the administration of the bacterial strains in claim 1 prevents or reduces flu-like symptoms in children affected by respiratory tract infections. Therefore, the objective technical problems is, as proposed by the patent proprietor, the provision of a probiotic composition for reducing or preventing flu-like symptoms in a child affected by a respiratory tract infection."
• 'As concluded for sufficiency of disclosure of the main request (point 5.2 above), on the priority date, it was generally accepted by the scientific community that the beneficial effects of probiotics on human health were strain dependent. The fact that L. acidophilus NCFM and B. lactis Bi-07 were known probiotics did not provide the skilled person with a reasonable expectation that they would have an effect on the flu-like symptoms of children affected by respiratory tract infections. Neither of the two strains had been disclosed to have such an effect."

EPO 

The link to the decision is provided after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t200298eu1