Saturday, 23 April 2011

T 1744/08 – Wrong Base

The present decision deals with the refusal of a patent application. The Examining Division (ED) found the claims on file to lack inventive step.

Claim 1 reads as follows:
A process for preparing submicron sized particles of a pharmaceutically active compound comprising the steps of:
  • providing a multiphase system having an organic phase and an aqueous phase, the organic phase containing a pharmaceutically active compound dissolved in a water immiscible solvent; and
  • sonicating the multiphase system to evaporate a portion of the water immiscible solvent of the organic phase to cause precipitation of particles of the pharmaceutically active compound having an average effective particle size of less than 2 μm in the aqueous phase and wherein the sonicating step is effective to remove nearly all the water immiscible solvent in the system.
The decision contains an interesting statement on inventive step and sufficiency of disclosure:

[2] The refusal of the main request and of all auxiliary requests was based on the conclusion that there was no evidence in the original application that the sonicating step was able to remove nearly all the water immiscible solvent in the system. The ED concluded therefrom that there was lack of inventive step […]. If, however, the sonicating step is not able to remove nearly all the water immiscible solvent in the system, then the process as a whole cannot be carried out, as the said solvent removal step is an essential part of the process as claimed. As a consequence, the refusal is factually based on insufficiency of disclosure (A 83) rather than lack of inventive step (A 56).

When I first read this, I thought the Board had got it wrong. Absence of evidence for the technical effect should concern inventive step (as it is not established that a problem is indeed solved) rather than sufficiency of disclosure (which corresponds to the requirement that the skilled person has to be able to carry out the invention, which may be possible irrespective of whether there is evidence for the alleged effect).

Nevertheless, there are some exceptions to this reasoning. In a recent post, we have seen that claims directed at further therapeutic applications contain the latter as functional features, so that if no evidence for the therapeutic effect is given, one of the features is not described, and an A 83 objection appears to be justified.

The present case shows yet another exception. After some thinking, I believe the reasoning of the Board to be correct because the effect has been incorporated into the claim. In such a case, the skilled person trying to carry out the claimed subject-matter does not know how to get there, and an A 83 objection seems appropriate.

Having said this, I think the situation would be different if the effect had been asserted in the application – without there being any evidence that it was indeed obtained – but was not a feature of any of the claims. Then, as far as I can see, an A 56 objection would be more appropriate than an A 83 objection.

To read the whole decision, click here.

To have a look at the file wrapper, click here.


pat-agoni-a said...

I agree with your analysis of the case. It seems that the approach followed is something like this:

A perpetual motion machine claimed as such in the claims would be insufficiently disclosed (apart form possibly not being able of industrial applicability).

On the other hand, claiming a machine that is disclosed to be a perpetual motion machine in the description would lack inventiveness, as an arbitrary collection of parts.

Myshkin said...

The analysis is confirmed by the Enlarged Board in G 1/03, point 2.5.2:
"If a claim comprises non-working embodiments, this may have different consequences, depending on the circumstances.

Either there is a large number of conceivable alternatives and the specification contains sufficient information on the relevant criteria for finding appropriate alternatives over the claimed range with reasonable effort. (...)

If this is not the case and there is lack of reproducibility of the claimed invention, this may become relevant under the requirements of inventive step or sufficiency of disclosure. If an effect is expressed in a claim, there is lack of sufficient disclosure. Otherwise, ie if the effect is not expressed in a claim but is part of the problem to be solved, there is a problem of inventive step (T 939/92, OJ EPO 1996, 309)."

Maybe the wording of the EBA is slightly inaccurate. If the effect is expressed in the claim, the scope of the claim does not comprise (non-working) embodiments not achieving this effect.