T 2128/09 – Only The Brave

This is another examination appeal.

Claim 1 of the main request before the Board read:

1. An in vitro process for an identification of inhibitors acting only on protein kinase C-related kinases (PRKs) selected from the group consisting of PRK1, PRK2 and PKNβ, said inhibitors allowing to selectively block the activity of the Androgen Receptor (AR) wherein said process comprises the steps of

• selecting an inhibitor to be tested for its protein kinase C-related kinase inhibitor capacity;
• providing at least two reactions involving at least one of said PRKs and at least the AR acted upon by at least one of said PRKs under physiological conditions, wherein said two reactions comprise the ligand-dependent activation of the AR by RhoA V14;
• adding distinguishable effective amounts of said inhibitor to be tested to said at least two reactions so as to obtain an inhibitor effect of said inhibitor on said PRKs; and
• measuring said measurable effect in dependency upon the distinguishable effective amounts of said inhibitor to be tested so as to ascertain an inhibitory effect of said inhibitor on said PRKs in said reaction. (my emphasis)

The Board found this invention to be insufficiently disclosed:

[1] The Board, exercising its power to examine whether a requirement of the EPC that the examining division regarded as having been met in the examination proceedings (see decision G 10/93), has examined whether the requirements of A 83 are complied with.

[2] Claim 1 refers to an in vitro process for identifying inhibitors acting only on PRKs selected from the group consisting of PRK1, PRK2 and PKNβ. The claimed process consists of the following steps:

• selecting a potential inhibitor,
• providing at least two reactions involving at least one of said PRKs and the androgen receptor (AR), wherein one reaction comprises the ligand-dependent activation of the AR by RhoA V14,
• adding distinguishable amounts of the potential inhibitor to the at least two reactions, and
• measuring an inhibitory affect of the tested, potential inhibitor.

Thus, claim 1, while containing steps that would allow the determination of whether or not a tested inhibitor indeed acts on PRKs selected from the group consisting of PRK1, PRK2 and PKNß, does not contain any step which would allow a skilled person to decide whether or not it acts on these PRKs only or also on other substances, such as other protein kinases.

[3] The appellant referred to Example 2 and argued that it disclosed a process according to claim 1 for identifying inhibitors acting only on PRKs selected from the group consisting of PRK1, PRK2 and PKNβ.

[4] The two substances, referred to as Ro31-8220 and HA 1077, which were tested for their inhibitory effect on PRK1 in the assay of Example 2 […], are acknowledged in the published application (see paragraph [0041] as having only a low specificity for PRKs and showing an inhibitory effect on a number of protein kinases.

[5] The Board seeing that Example 2 describes the steps of the process of claim 1, cannot find any hint in the description of this example that would assist a skilled person in defining the working steps, referred to in point (2) above, that are necessary to identify inhibitors acting only on PRKs selected from the group consisting of PRK1, PRK2 and PKNβ, which working steps are not present in claim 1.

[6] Therefore, the invention according to claim 1 is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Thus, the main request does not meet the requirements of A 83.

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