Method Of Treatment Inventive But Not Patentable -
Apparatus Patentable But Not Inventive

Wake Forest University Health Sciences v Smith & Nephew

 This patent related to dressing of wounds. A method was described that was said to be particularly effective for closing, over a period of time, large open wounds for which sutures might cause tearing and further tissue damage. The method involved sealing, for example with Vaseline, a cup (12) over the wound, positioning a polycellular screen or foam (10) over the wound within the cup, and sucking out air.

Of course a method of dressing a wound would not be patentable under Article 52(4) EPC (now Article 53(c)), but Wake Forest University Health Sciences succeeded in obtaining a patent for an apparatus for facilitating the healing of a wound. They sued Smith & Nephew for infringement, and the latter counterclaimed for invalidity. The counterclaim was only partially successful. The (lower) Patents Court had found claim 1 to be anticipated but found claim 4 and certain other claims to be valid. Smith & Nephew appealed. The Court of Appeal overruled the decision and found claim 4 to be obvious.

Of interest in the decision is the application of the “Windsurfing” approach to obviousness (as re-stated in Pozzoli v BDMO).

The dependent claim in question (claim 4) merely required that the cup or film placed over the wound should take the form of a flexible polymer sheet with adhesive to attach to the skin. Other claims were also considered on appeal which related to the on-off cycle of pumping (in words such as “wherein said vacuum means operates cyclically”).

It seems the Judge was somewhat impressed by the method and somewhat unimpressed by the principal prior art relied on, which was a Russian paper dating from 1986 published in a book distributed in the USSR. He saw significant differences between the described methods and he was sympathetic to the argument that this as a case of “anticipation or nothing” – i.e. he was satisfied that, provided claim 4 could be shown to be novel, he would find it to be inventive. He said: One has to be careful in approaching obviousness not to ignore the teaching and purpose of [the principal reference] unless the prior art can be said to point clearly to possible modification of the apparatus and he concluded that the skilled addressee would have no reason to modify that teaching by using adhesive polymer film. Accordingly, he decided that Claim 4 was not obvious.

The Court of Appeal said he should have properly applied the Pozzoli analysis, and had he done so he would have concluded that using an adhesive film was obvious (not least because the evidence showed that adhesive films were much more commonly available in operating rooms than films with no adhesive). 

Against the obviousness counter- attack, Wake Forest put up two defences which are often difficult to apply. One is that the principal prior art reference would not have been considered further by the person skilled in the art and the other is the “teaching away” argument. 

Wake Forest argued that the skilled person would have seen no reason to embark upon any development of the teaching of the Russian paper and that it would simply have been put aside and would not have been seen as any more worthy of consideration than other material, with no motivation to take it forward. Arguments focussed on the different purpose behind the prior art (wound cleaning) were not relevant. It is sufficient, in order to establish obviousness, that the use of an adhesive film is an obvious development of the apparatus for the methods and purposes envisaged.

The Judge sympathised with the argument that the prior art taught away from the invention of claim 4 because it used an easily removable polymer film. However, the Court of Appeal said the fact that a film sealed by Vaseline might be easily removable does not make it part of the teaching that an easily removable film must be used. There was insufficient evidence to cause the skilled team to “put [the Russian paper] in the bin.”

Ultimately, Wake Forest were hampered by being unable to claim their novel method of closing large wounds, and were limited by having to claim the apparatus. Unfortunately for them, the modified apparatus was obvious for other purposes.

Comment:

This case affirms the reformulated version of the “Windsurfing” test for obviousness laid down in Pozzoli v BDMO. The Court of Appeal did not adopt an EPO-style problem-solution approach.

The argument that a document should be set aside and given no further consideration for obviousness is not a easy argument to run. It can be used with effect in the EPO approach if it is not the “best starting point” for solving the objective technical problem. But one has to be prepared to consider, as here, the question “what if the reader to whom that document is addressed would wish to improve it for its own purposes?” There does not need to be a motivation or pointer to reach the ultimate result. If it is obvious to arrive at the result for its own purposes, it is nevertheless obvious even if it might be highly advantageous for other reasons.

Equally, it is a rare case in which the “teaching away” argument has force. It is not enough, as here, to say “the prior art teaches something different, so it teaches away.” The argument only has merit if the prior art positively teaches not to consider making the claimed modification or teaches that an element is so essential that to modify or replace it would be considered disadvantageous.