“65. In the case of obviousness in view of the state of the art, a key question is generally “what problem was the patentee trying to solve?”
“In more concrete terms, the team would, I consider, be deemed to be already working within the adequately resourced R&D department of a manufacturer of contemporary surgical dressings which (if required) could rely upon a consultative combination with persons concerned with the in situ treatment of wounds with commercially available dressings - such as tissue viability nurses (TVNs) and specialist consultants. I do not therefore consider that the team should include alginate chemists, rheologists, epidemiologists, materials scientists, honey experts and so on. This is a technically simple patent and in this case pitching the notional addressee at the right technical level is important.”
“21. I will come later to analyse the judge’s reasoning, but first make it clear that a decision on obviousness does not require a conclusion as to whether or not the skilled person would be slightly, moderately or particularly interested in any document. The court has to adopt the mantle of the skilled person. That mantle will include the prejudices, preferences and attitudes that such persons had at the priority date. Thereafter the court has to decide whether the step or steps from the prior art to the invention were obvious. That decision has to be taken without the invention in mind and through the eyes of the skilled person. Of course any prior art document relied on must be deemed to be read properly and in that sense with interest. To conclude otherwise would deprive the public of their right to make anything which is an obvious modification of a published document. By obvious I mean that which would be obvious to the skilled person. The correct approach was set out by Oliver LJ inthe Windsurfing case. He said at page 74 line 20: ‘We agree, of course, that one must not assume that the skilled man, casting his experienced eye over Darby [the prior art], would at once be fired with knowledge that here was something which had a great commercial future which he must bend every effort to develop and improve, but he must at least be assumed to appreciate and understand the free-save concept taught by Darby and to consider, in the light of his knowledge and experience, whether it would work and how it will work.’” ‘We agree, of course, that one must not assume that the skilled man, casting his experienced eye over Darby [the prior art], would at once be fired with knowledge that here was something which had a great commercial future which he must bend every effort to develop and improve, but he must at least be assumed to appreciate and understand the free-save concept taught by Darby and to consider, in the light of his knowledge and experience, whether it would work and how it will work.’”
“The common general knowledge is the technical background of the notional man in the art against which the prior art must be considered. This is not limited to material he has memorised and has at the front of his mind. It includes all that material in the field he is working in which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art. This does not mean that everything on the shelf which is capable of being referred to without difficulty is common general knowledge nor does it mean that every word in a common text book is either. In the case of standard textbooks, it is likely that all or most of the main text will be common general knowledge. In many cases common general knowledge will include or be reflected in readily available trade literature which a man in the art would be expected to have at his elbow and regard as basic reliable information. In this case, for example, the general technical discussion of conductive polymers in the Cabot technical report was common general knowledge well before the priority date. So too would be the general teaching in the leading articles and textbooks on the subject.”
“49. In fact, though Molan’s cited article may not as such be an item of common general knowledge, by the priority date much of its contents in my view, was. For example, having in particular regard to the evidence of Professor White, the following I consider, formed part of the common general knowledge in the UK (in no particular order): (a) That honey had antibacterial/antimicrobial properties and that such properties had been the subject of clinical trial. (b) That a number of varieties of honey were commercially available and, being a natural product, its antibacterial activity may be expected not to be uniform, some honeys being more efficacious than others. (c) That a medical practitioner would normally prefer to use as pure a therapeutic product as he could obtain. This would equally (and automatically) apply to honey. Though its provenance was ‘natural’ and thus free of possible processing contaminants, honey might contain undesirable hive contaminants. (d) That if was thought prudent or necessary, decontamination could be effected by γ-irradiation (which was itself a well-known process for doing this in general pharmaceutical practice). (e) That one could apply liquid honey direct into an open wound and, if necessary, cover it in situ to stop it running out. (f) That the general rheological properties of natural honey were widely known - and not just to the skilled addressee. It is usually runny, it is non-uniform in taste appearance etc, it will crystallise over time, it can be returned to a liquid condition by putting the honey jar on a radiator, it absorbs water and also dissolves in it – and so on.”
“For present purposes, the physical attributes of these [Mrs Hampton’s] wound dressings must have been identical to those possessed by ALGIVON - because they were made in the same way. In both, the calcium alginate acts simply as a mechanical carrier for the honey. This is indeed a squeeze for Apimed.”
“Guidelines for practice Honey varies in consistency, from liquid to solid, with the glucose content crystallised. Solid honeys may be liquefied by warming and semi-solid honeys can often be liquefied by stirring. Heating above 37˚C should be avoided, as this may burn the patient and will destroy the enzyme that produces hydrogen peroxide. The honey should be spread evenly on the dressing pad rather than directly to the wound. The amount of honey required on a wound depends on the amount of exudation; the beneficial effects of honey on wound tissues will be reduced or lost if small quantities of honey become diluted by large amounts of exudate. Wounds with deep infection require greater amounts of honey to obtain an effective level of antibacterial activity by diffusion into the wound tissues. Dressing technique Typically, 30mL of honey is used on a 10cm x 10cm dressing. Dressing pads impregnated with honey (such as those produced by REG International, New Zealand) (Figs 1 and 2) are the most convenient way of applying honey to surface wounds. Occlusive or absorbent secondary dressings are needed to prevent honey oozing out from the wound dressings. (Fig 3). The frequency of dressing changes will also depend on how rapidly the honey is diluted by exudates. Daily dressing changes are usual, but up to three times daily may be necessary. Exudation should be reduced by the anti-inflammatory action of honey, so the frequency of dressing changes should decline as treatment progresses. Deep wounds (Figs 4-6) or abscesses are most easily filled by using honey packed in ‘squeeze-out’ tubes, now available commercially (Actimel) (Fig 7).”
“This paper has described the chemical and physical properties of honey and has shown how these may have a positive influence on wound healing. Honey is an ideal substance to use as a wound dressing material. Its fluidity, especially when warmed, allows it to be spread and makes honey dressings easy to apply and remove. The osmotic action resulting from honey’s high sugar content draws out wound fluid and thus dilutes the honey that is in contact with the wound bed, minimising adhesion or damage to the granulating surface of the wound when the dressing is removed. The high solubility of honey in water allows residual honey to be washed away by bathing. Although the clinical experiences detailed in this paper show positive results, more quality randomised controlled trials are needed to provide evidence to encourage the use of honey in wound care.”
“112. The nature of the dressings which Professor Molan used is not however revealed – though their source is. There is thus a missing element in the Windsurfing progression set out in para 103 above, item (3). The evidence is clear regarding alginate dressings at the time (as sodium or calcium alginate or a mixture thereof.); their availability was commercial and their use was common general knowledge. These dressings were not only widely available commercially in the UK (see above) but in cases of exudate being present, were actually the dressings of choice. There is evidence of this from Mr Gray T2/191-192, and 270 and from Professor White in White I, I/1/55-56 and T4/469. Mrs Hampton also gave evidence to the same effect about the use of alginate dressings, adding that she preferred the closer ‘weave’ of the alginates in order better to retain the honey. 113. I have no doubt that the skilled person reading Professor Molan’s article would at once and without hesitation, have in mind commercial sodium and calcium alginate dressings as being the dressings of choice to use in following his directions – assuming he did not go to REG Internat’l itself. In my judgment, all the independently defended claims of the Patent are therefore obvious in the light of the Molan article. 114. For the avoidance of doubt, the ‘fancy’ honeys which are now the subject of the proposed amendment to the Patent claims 11(a) to (c), cannot in my view afford patentable subject matter over and above the unamended claims; it was common general knowledge that different honeys offered different levels of efficacy - but they are all honeys.”
“The case under this head is put clearly and succinctly by Professor White: White I, I/1/130-131.The problem of retention and application of honey, he says, may obviously be solved by making the honey thicker by using any medical thickening agent –and (see above) many were available. That is, I consider, realistically the end of all the claims which are independently defended.”
“180. It is also particularly important to be wary of hindsight when considering an obviousness attack based upon the common general knowledge. The reason is straightforward. In attacking a patent, attention is focussed upon the particular development which is said to constitute the inventive step. With this development in mind it may be possible to mount an attack which is unencumbered by any detail which might point to non obviousness: Coflexip SA v Stolt Comex Seaway Ltd (CA) [2000] IP&T 1332 at [45]. It is all too easy after the event to identify aspects of the common general knowledge which can be combined together in such a way as to lead to the claimed invention. But once again this has the potential to lead the court astray. The question is whether it would have been obvious to the skilled but uninventive person to take those features, extract them from the context in which they appear and combine them together to produce the invention.”