T 0694/23 - Statistical significance as shown in the examples

Key points

• Claim 1: "A method for predicting whether a cancer patient with a solid tumor is responsive to treatment with chemotherapy comprising the steps: ..."
• "The sole distinguishing feature between the method described in D2 and the one being claimed is that D2 only suggests that a correlation exists between TIL densities at the invasive margin of liver metastasis and the time to progression under chemotherapy, but considers that, due to the small patient cohorts in the study, these conclusions are not statistically significant."
• So far, this does not identify a feature of the claim; it discusses the teaching of D2.
• "In contrast, the patent shows that the correlation underlying the method as claimed is statistically significant, at least for colorectal cancer, which is what is assessed in the Examples of the patent. "
• This describes the content of the patent application, in particular, the examples. It does not define a feature of the claim.
• "The technical effect underlying this difference is that the (statistical) robustness of the method for predicting whether a cancer patient is responsive to chemotherapy treatment is achieved."
• I assume that 'this difference' refers to the information contained in the examples of the patent. It is unusual to treat that information as a distinguishing feature (outside the scope of second medical use claims)
• Admittedly, the Board finds the claim to be obvious, even with the statistical significance as the difference.
• "Starting from the disclosure of document D2 and faced with the technical problem identified above, the skilled person would have been motivated to confirm D2's prediction and the correlation between the cell densities and the response to chemotherapy. For this, it had simply to follow D2's explicit suggestion and increase the number of samples in order to arrive, with a reasonable expectation of success, at a statistically significant correlation and thus at the method of claim 1. The claimed subject-matter thus lacks an inventive step from D2 alone."
• The claim is not a second medical use claim but a normal method claim and, hence, does not benefit from the 'it works' functional feature that is read into second medical use claims as a matter of law. The claim does not explicitly recite statistical significance either. 

EPO 

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

https://www.epo.org/en/boards-of-appeal/decisions/t230694eu1