T 1079/08 – A Medical Error

What is the correct ground for rejection when the claimed subject-matter does not achieve the alleged technical effect? Lack of inventive step? It really depends on the claim wording.

In the present case the Examining Division (ED) rejected the application for lack of inventive step. Claim 1 under consideration was directed at the use of the metabolites of venlafaxine for the preparation of a medicament for the treatment of various diseases.

[2] The ED rejected the application for lack of inventive step merely by finding that the technical effect underlying the invention had not been credibly achieved.

The ED arrived at this conclusion by considering that document D5 comparing the monoamine uptake inhibition activity of venlafaxine with that of its metabolites represented the closest prior art and by defining the technical problem to be solved as the provision of alternative uses for the known metabolites of venlafaxine. The ED found that this problem was not credibly solved, since there was no evidence provided showing that the metabolites were effective for the treatment of the diseases listed in claims 1 and 5.

[3] However, claims 1 and 5 then pending had the format of a second medical use Swiss-type claim. The Board observes that the use of the metabolites of venlafaxine for the preparation of a medicament for the treatment of the diseases listed in then pending independent claims 1 and 5 is the solution proposed by the application and the purpose of preparing a medicament for the treatment of the diseases indicated in then claims 1 and 5 is a technical feature defining the subject-matter claimed. Accordingly, being technical features of the use claims said preparation of a medicament for treating the listed diseases does not form part of the technical problem to be solved, but is the solution thereof.

[4] Actually, the ED rejected the application only because the prepared medicament was not shown to be suitable for the treatment of the diseases listed in then independent claims 1 and 5, i.e. because it was not shown that the technical effect underlying the claimed use was achieved.

In decision G 1/03 [2.5] the Enlarged Board of Appeal indicated that a lack of reproducibility of the claimed invention is relevant under the requirements of sufficiency of disclosure if the technical effect is a technical feature of the claim, since then it is a feature characterising the subject-matter claimed.

Hence the ED rejected the application under A 56 for reasons relevant to the matter of sufficiency of disclosure pursuant to A 83.

The same considerations and conclusions apply to the new format of present claims 1 and 5, i.e. purpose related product claims pursuant to A 54(5).

[5] The application was refused by the ED for lack of inventive step on the basis of reasons relevant to the matter of sufficiency of disclosure pursuant to A 83. However, the issue of sufficiency of disclosure had never been addressed during the examining proceedings before the first instance, although compliance with A 83 is normally a prerequisite to assess inventive step on a proper basis. In reply to the communication of the Board, the Appellant made some submissions with respect to the requirement of sufficiency of disclosure, but requested the case to be remitted back to the ED for consideration of that issue.

[6] In order to have the essential issue of sufficiency of disclosure under A 83 be considered by two instances, the Board considers it appropriate to exercise the power conferred to it by A 111(1) to remit the case to the ED for further prosecution.

[7] When resuming examination proceedings the first instance should take into account that in the decision under appeal, it arrived at the conclusion that the subject-matter of the main request lacked inventive step (A 56) merely by finding that the technical problem underlying the application had not been credibly solved without reformulating the problem in a less ambitious way and without assessing obviousness of the claimed solution to that reformulated problem in the light of the cited prior art.

However, A 56 requires that “an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art”. Thus, when it comes to the issue of inventive step pursuant to A 56 the ED should assess obviousness vis-à-vis the state of the art (see T 278/00 and T 87/08).

To read the whole decision, please click here.

A similar decision is discussed here.