T1624/21

23.03.2023

Standard of proof for assessment of novelty



The applicant's appeal lies from the decision of the examining division to refuse European patent application No. 17 159 000.3. The title of the application is "14-3-3 eta antibodies and uses thereof for the diagnosis and treatment of arthritis".

The examining division considered that the subject-matter of claim 1 was not novel.

Claim 1 reads as follows:

"1. An anti-14-3-3 eta antibody, wherein said antibody is capable of specifically binding to an epitope located between positions 142 to 158 of the human 14-3-3 eta protein, the epitope is represented by the amino acid sequence KKNSVVEASEAAYKEAF (SEQ ID NO:24)."

In the decision under appeal, the examining division considered that the claimed antibody was not novel over those disclosed in documents D6 and D7. In its view, the appellant's arguments in support of novelty of the claimed subject-matter did "not help the instant authority to ascertain with the absolute certainty required for novelty criteria assessment under Article 52(1) and 54 EPC whether the anti-14-3-3 eta isoform protein antibodies disclosed in the prior art documents at hand, i.e. D6 and D7 are binding the epitope contained in the claim". Since the antibody of the claim was only defined by a linear epitope to which it bound, the examining division considered that "the applicants did not discharged [sic] themselves from the burden to provide the necessary evidences [sic] that mAb 6A12 and the antibody disclosed in D7 do not bind to the claimed epitope or at least to part of it, ...".

The board does not agree with the examining division's conclusion and reasoning for the following reasons:

It is a question of fact whether or not an antibody which is disclosed in a cited document binds to a particular antigen or epitope. According to established case law of the boards of appeal, the applicable standard of proof to assess whether a specific statement of fact is true or not is the balance of probabilities. According to this standard, the EPO shall base its decision on facts that are more likely to be true than not true. This standard of proof also applies to facts relevant to the assessment of novelty. Absolute certainty, as stipulated by the examining division, is not required.

For the case in hand, this means that the examining division should have assessed whether it was more likely or not that the 14-3-3 antibody disclosed in document D6 and the 14-3-3 eta antibody disclosed in document D7 bind to an epitope located between amino acids 142 to 158 of the human 14-3-3 eta protein. The examining division did not conduct such an assessment in the decision under appeal. Thus, for this reason alone, the decision under appeal must be set aside.

The case is remitted to the examining division for further prosecution.