Intellectual Property Office of New Zealand - Patents Decisions
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Intellectual Property Office of New Zealand - Trade MarksLast Updated: 14 October 2008
P22/2004
IN THE INTELLECTUAL
PROPERTY OFFICE OF
NEW
ZEALAND
IN THE MATTER of the Patents Act 1953
AND
IN THE MATTER of an application for Letters Patent No 501687 in the name of APIMED MEDICAL HONEY LIMITED
Applicant
AND
IN THE MATTER of opposition to said application under section 21 by HONEY NEW ZEALAND (INTERNATIONAL) LIMITED
Opponent
Hearing: 17 November 2004
T Mahood for the Applicant
No appearance by the Opponent
The Opponent made written submissions on costs
Decision
BACKGROUND
Patent application 501687 was filed on 8 January 2001, claiming priority from provisional applications 501687 and 501748 filed on 9 December 1999 and 13 December 1999, respectively.
The notice of acceptance issued on 29 July 2002, acceptance being published in Patent Office Journal 1478 of 30 August 2002.
Notice of opposition was filed on 24 December 2002, first amended notice of opposition and statement of case were filed on 27 February 2003. A second amended notice of opposition and first amended statement of case were filed on 21 July 2003. A third amended notice of opposition and second amended statement of case were filed on 25 September 2003. Grounds (b), (d), (e) - both limbs, and (f) of section 21(1) were pleaded by the opponent.
The applicant’s counterstatement was filed on 3 June 2003, with an amended counterstatement being filed on 3 May 2004. All grounds pleaded were denied by the applicant.
On 3 November 2004 the opponent withdrew from the opposition proceedings.
LOCUS STANDI
The applicant did not challenge the standing of the opponent. I accept that the opponent has locus standi.
PRIORITY DATES
Since all of the documents cited have accession dates before the earliest date to which the claims could be entitled, the actual priority date is not an issue.
EVIDENCE
In support of the opposition, affidavits of:
In support of the application, statutory declarations of:
NATURE OF THE INVENTION
The invention relates to the use of honey in medical dressings.
The opening paragraphs describe the field of invention:
TECHNICAL FIELD
The present invention is directed to the use of honey in medical dressings. Preferred embodiments modify honey with a viscosity increasing agent, resulting in a range of possible compositions including ointments and salves, self-adhesive gels such as for use on mouth ulcers and pustules, and pliable or flexible sheets which can be used as a wound covering.
Alternatively the invention may be viewed as an improvement on prior art “moist wound dressings” by incorporating honey in the gel to potentially confer to such dressings antibacterial properties, anti-inflammatory properties, debriding qualities, and promotion of growth of wound tissue.
BACKGROUND ART
The use of honey in treating wounds have [sic] been long known, with such use being recorded in 4,000 year old Sumerian clay tablets. There are continuing records of its use throughout history, with an increasing number of medical reports near the beginning of this century. Recently the anti-bacterial properties of honey and its potential use as a wound dressing has [sic] attracted greater attention.
Recent international medical literature record [sic] honey as being effective as a dressing for wounds, burns and skin ulcers. Recorded observations include that inflammation, swelling and pain are quickly reduced, that sloughing of necrotic tissue occurs without the need for debridement, and that growth of tissues to repair the wound is stimulated. As a consequence, healing occurs rapidly with minimal scarring, and often without any necessity for skin grafting.
Work by the inventor and others has helped to establish that the effectiveness has been due primarily to anti-microbial properties of honey. Healing processes will not usually occur unless infection is cleared from a lesion, and investigations involving swabbing wounds dressed with honey has shown that infecting bacteria are rapidly cleared.
In this respect honey appears superior to the expensive modern hydrocolloid wound dressings which are favoured in the art as a moist dressing. Although tissue re-growth in the healing process is enhance by a moist environment, and deformity is reduced if the re-growth is not forced down by a dry scab forming on the surface, moist conditions also favour the growth of infecting bacteria. The difficulty facing the prior art is that anti-biotics are ineffective in this situation while antiseptics cause tissue damage and thus slow the healing process. In contrast, honey causes no tissue damage and appears to actually promote the healing process.
While there is a need for moist dressings within the art, investigations involving honey as wound dressings have focussed primarily on unmodified honeys. As mentioned above, dressing wounds with honey has been the most prevalent form of investigation, essentially attempting to maintain raw honey in contact with a wound as part of a moist dressing. However, while such methods may be useful for investigative trials, the techniques can be relatively time consuming to apply and maintain, and may be impractical in a number of situations.
A primary cause of this is the relatively fluid nature of most honeys - i.e. honey is runny at body temperature. Due to this fluidity, especially at body temperature, localising honey to the desired area may be difficult. Difficulties may be less for an incapacitated person in a hospital bed, though these difficulties generally preclude its use as a simple wound dressing on an active person.
Containment of unmodified honey is thus a problem, and no simple practical solution has been proposed. The soaking of absorbent materials, such as gauzes, in a dressing to be applied over a wound and then held in place by a further covering is a possibility though tends to be messy and would be difficult to apply except in a clinical situation. Even then applying such a dressing can be relatively time consuming and require the use of an excessive number of relatively expensive sterilised coverings.
Another problem is that many wounds exude moisture and this causes the problem of further dilution of the honey exacerbating containment problems, especially where there is pressure on the dressing causing the diluted honey to be squeezed out. This dilution of the honey may also introduce other considerations such as a potential reduction in anti-bacterial activity due to dilution.
Accordingly, while the anti-bacterial properties of honey have been acknowledged, there are a number of practical problems to be overcome before honey can find widespread use as a practical dressing for wounds and other medical uses.
Similarly there are a number of problems associated with prior art ‘moist’ wound dressings, such as of the alginate type. The moist environment provided by these types of dressings favours the growth of micro-organisms and accordingly they cannot be used on infected wounds, even though this may otherwise be the preferred choice of dressing. The use of many antibiotics have [sic] also failed to keep unwanted microbial growth in check when ‘moist-type’ dressings are used in certain situations of this type. Accordingly, medicine cannot always make use of the full potential of moist prior-art dressing types.
Reference will be made throughout the specification to the anti-microbial properties of honey. It has been acknowledged that this is known in the art and a number of publications survey these properties. It is anticipated that a skilled addressee of the art would be familiar with the teachings of these publications insofar that many honeys possess anti-microbial properties, with some exhibiting more activity than others. Consequently, this document shall not seek to establish that certain honeys do possess anti-microbial properties, nor shall it seek to set out a specific list comparing the properties of all honeys which may or may not have been publicly documented. Again it will be relied upon that anti-microbial properties associated with honey have been established in the prior art. By way of reference, some relevant documents which address this are given:
− Molan, P.C. (1992) The antibacterial activity of honey. 1. The nature of the antibacterial activity. Bee World 73 (1): 5-28.
− Molan, P.C. (1992) The antibacterial activity of honey. 2. Variation in the potency of the antibacterial activity. Bee World 73 (2): 59-76.
− Willix, D.J.; Molan, P.C.; Harfoot, C.J. (1992) A comparison of the sensitivity of wound-infecting species of bacteria to the antibacterial activity of manuka honey and other honey. Journal of Applied Bacteriology 73: 388-394.
− Cooper, R.A.; Molan, P.C. (1999) The use of honey as an antiseptic in managing Pseudomonas infection. Journal of Wound Care 8 (4): 161-164.
− Cooper, R.A.; Molan, P.C.; Harding K.G. (1999) Antibacterial activity of honey against strains of Staphylococcus aureus from infected wounds. Journal of the Royal Society of Medicine 92: 283-285.
A number of publications describe the large amount of variation in potency of antibacterial activity between different honeys. The variation can be as much as one-hundred-fold, and is due to varying levels of antibacterial factors in honey additional to the sugar content and acidity in which there is little variation.
A patent document of some interest is US 5,177,065 by Silvetti. This document references the manufacture of wound dressings incorporating high levels of mono-saccharides. In this document, it is the osmotic properties of concentrated sugar solution which are ascribed as providing any bacteriostatic effect. Consequently, the described invention of Silvetti, and claims, concentrate on film-like compositions based on individual mono-saccharides or mono-saccharide blends.
A very brief reference to honey is made in the prior art discussion of Silvetti, though only in terms of dismissing honey as a folk medicine which would appear to have no useful anti-bacterial effect in a wound healing preparation, such as the subject of that specification. Accordingly, while this document is of some interest, it teaches away from the use of honey in a wound covering form or composition, and instead teaches towards the use of predominantly monosaccharide solutions.
Accordingly, it is an object of the present invention to address the problems associated with the prior art, or at least to provide the public with a useful choice. It also appears from the prior art that the use of honey in a medicinal sense is useful though difficulties associated with its use prevent its full potential from being realised, and hence the present invention also seeks to address this.
Further aspects and advantages of the present invention will become apparent from the ensuing description which is given by way of example only.
The claims are as follows:
All claims contain the integers of claim 1.
THE LAW
The applicant submitted that the burden of proof in opposition proceedings lies with the opponent. As stated in Saxpack Foods v Watties Canneries, unreported. M454/87, 11 July 1988, by Ongley J:
I approach the proceedings upon the basis that the purpose of opposition proceedings is to clear the register of patents which are manifestly untenable. It is not to provide a method of disposing of truly contentious cases.
The applicant also submitted that if there is any conflict of credible expert opinion, the Commissioner should not refuse the grant of a patent unless the conflict is clearly resolved in the opponent’s favour. In support the applicant drew on Beecham Group Limited v Bristol Myers Company (No2) [1979] NZLR 629 at 634, quoting from Lord Diplock in General Electric Company’s Application [1964] RPC 413:
The right principle is that if on the face of the written evidence filed there appears to be a bona fide conflict of fact or credible expert opinion upon a question on the answer to which the existence or non-existence of the ground for refusal specified in s.14(1)(e) [equivalent to New Zealand section 21(1)(e)] depends, the Comptroller should not exercise his jurisdiction to refuse the grant unless, after cross-examination of the witness if he thinks fit to order it, the conflict is clearly resolved in favour of the party opposing the grant.
The applicant noted that the benefit of any doubt must be given to the applicant as in ex parte Swift [19621 RPC 37, 46:
[T]he function of the Comptroller-General and of the Tribunal under s.6 of the Act of 1949 is not to decide finally whether an alleged manner of new manufacture is actually patentable. Rather, their function is only to refuse to allow applications to proceed which on no reasonable view could be said to be within the ambit of the Act ... Thus if one goes back to s.2 of the Statute of 1623, it will be seen that from the very beginning it is for the High Court to determine actual patentability.
The applicant pointed out that the Swift approach was approved by the Court of Appeal in Pharmac (CA 56/99, 17 December 1999), at paragraph 15.
PRIOR PUBLICATION – section 21(1)(b)
Section 21(1)(b) states:
That the invention, so far as claimed in any claim of the complete specification, has been published in New Zealand before the priority date of the claim —
(i) In any specification filed in pursuance of an application for a patent made in New Zealand and dated within 50 years next before the date of filing of the applicant’s complete specification:
(ii) In any other document (not being a document of any class described in subsection (1) of section 59 of this Act)
The usual test for prior publication is that set forth in the judgment of the English Court of Appeal by Sachs LJ in The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited and Others [1972] RPC 457, 485 to 486:
If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor’s publication will inevitably result in something being made or done which, if the patentee’s patent were valid, would constitute an infringement of the patentee’s claim, this circumstance demonstrates that the patentee’s claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented ... A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
This dictum has been applied and followed by the Court of Appeal of New Zealand in Beecham Group Limited’s (New Zealand/Amoxycillin) Application [1982] FSR 181.
The integers of the claims include:
− a medical composition for dressing wounds comprising the combination of:
−
− one or more honeys and
− one or more gelling agents,
− the amount of gelling agent in the composition is such that the resulting composition is in the form of a formable and/or pliable solid that can be readily moulded to fit the wound to which it is to be applied, and
− at least 50% (by weight) of the composition is honey.
United States Patent Specification 5980875
The document was available from the Intellectual Property Office of New Zealand (“the office”) as of 23 November 1999. Honey is, or the actives from honey are, mixed with a base or bases chosen particularly from oils, gelling agents and emulsifiers to produce compositions for therapeutic, cosmetic and nutritional purposes including hair growth promotion, hair loss prevention, and wound healing. Honey is said to have known antibacterial properties, wound and ulcer healing capacity, antitumour activity and metastatic effects. The document notes the problems associated with the topical use of honey which make it inconvenient to use. The stickiness, thinning and liquefaction of honey are major restrictions to its use in topical applications. The document notes the existing need for honey-based treatments having physical characteristics conducive to topical application.
The formulation of the invention described in the specification has as active ingredient honey or a honey related product. The formulation may take the form of a cream, gel, ointment, paste, lotion or the like. The formulation is said to have reduced stickiness and a consistency that allows small and large doses to be applied topically without liquefaction.
For topical application the formulation can take the form of a cream, lotion, shampoo, spray, soap, gel, dressing or other acceptable form including aerosol. The formulation can be a liquid or semi-solid.
There is no description of a medical composition which includes more than 50% (by weight) of honey, the honey being combined with a gelling agent to produce a formable and/or pliable solid, that can be readily moulded to fit a wound to which it is to be applied. Thus in terms of the test in the General Tire case the document does not anticipate the presently claimed invention.
The applicant pointed out that the opponent, in paragraph 5.2 of its statement of case, failed to point out where in the document is disclosed a medical composition which comprises a formable and/or pliable solid. The applicant said that the opponent only made vague and generalised comments that the applicant’s claim 1 is anticipated by the document.
The applicant also pointed out that the opponent’s witness, Dr Porter, did not depose that the citation disclosed a formable and/or pliable solid composition, particularly at paragraph 38 of his affidavit where he analysed the cited document.
The applicant stated that the citation disclosed what it says can, at best, be classified as flowing gels. Professor Molan, in support of the application, deposed, at paragraph 141.2 if his declaration, that upon becoming aware of the citation he conducted a series of experiments and concluded that it was not possible to produce a honey composition with a formable or pliable solid consistency using the methods described in the cited document without significantly decreasing the honey content to levels significantly less than 50% and to a level which at best seriously impaired the honey’s efficacy as an anti-microbial agent and medicament. This evidence of Professor Molan went uncontested by the opponent.
This document does not prior publish the applicant’s claimed invention.
United States Patent Specification 4671267
The document was available from the office as of 27 October 1987. The document discloses a member useful in treating sprains, muscle aches, orthopaedic and skin injuries such as burns and other wounds. The members are said to make use of pliable, self-sustaining, moisture-sorbing gels including a humectant such as glycerin entrapped within a synthetic resin polymer matrix. The polymer matrix is described as containing acrylic acid or acrylamide monomer units. The members are useful for heat and cold treatments of injuries.
There is no mention of the use of honey. The applicant pointed out that the deponent in support of the opposition, Dr Porter, does not mention honey in his discussion of this document at paragraph 39 of his affidavit.
There is no mention of a composition that is in the form of a formable and/or pliable solid that can be readily moulded to fit the wound to which it is to be applied. There is no indication that the gel itself has to be formable and/or pliable such that it can be readily moulded to fit the wound to which it is to be applied. It is the member itself, containing the gel, that is wrapped around the injury.
The document does not plant the flag at the precise destination as required by the test in the General Tire case.
This document does not prior publish the applicant’s claimed invention
The ground of prior publication is not made out.
PRIOR USE - section 21(1)(d)
Section 21(1)(d) states:
That the invention, so far as claimed in any claim of the complete specification, was used in New Zealand before the priority date of that claim
The applicant drew attention to the Office Practice Note, published in Patent Office Journal No 1287 in July 1986, page 714, as to what an opponent must do to prove this ground:
To succeed on this ground, an opponent must first establish that the alleged instance(s) of prior use was (were) not secret use(s) of the invention, as claimed. See the decision of the House of Lords in Bristol-Myers (Johnson’s) Application [1975] RPC 127, at 157, for a discussion on what constitutes public use, as opposed to secret use. The opponent must also establish, by evidence,
(a) what was used
(b) where it was used
(c) by whom it was used
(d) the date it was used
(e) where apparatus still extant may be inspected.
The opponent alleged prior use in its second amended statement of case. The allegations related to alleged disclosures made by the inventor, Professor Molan. These allegations were denied by the applicant.
As the opponent has not led any evidence in support of the allegations and particularly has failed to meet the requirements of the practice note, the ground cannot be made out.
The ground of prior use is not made out.
OBVIOUSNESS - section 21(1)(e)
Section 21(1)(e) reads:
That the invention, so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step having regard to matter published as mentioned in paragraph (b) of this subsection, or having regard to what was used in New Zealand before the priority date of the applicant’s claim
The ground of obviousness has two limbs, one being based on prior publication, the other being based on prior use. Both limbs are raised in these proceedings. IPONZ Office Practice Note No 33 published in Patent Office Journal No 1367 of April 1993, page 492, explained this as follows:
This ground has two separate distinct limbs, (a) obviousness and clear lack of inventive step, having regard to what has been published in New Zealand, before the priority date of a claim under attack, and (b) obviousness and clear lack of inventive step, having regard to what has been used in New Zealand, before the priority date of a claim under attack. It is not permissible to combine the two separate limbs. Note the use of the disjunctive “or” in the [section of the Act].
Since no evidence is provided in support of the ground of prior use the limb of obviousness having regard to what has been used in New Zealand before the priority date of the claim cannot be pursued.
The applicant pointed out that, from Beecham Group Ltd v Bristol-Myers Co (No 2) [1980] 1 NZLR 192 at 232, obviousness should be judged from the viewpoint of a ‘notional’ person possessing the following characteristics:
The applicant pointed out that the usual test for obviousness was that set out by Oliver J in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59 at 73, and followed in New Zealand by Tompkins J in Smale v North Sails Ltd [1991] 3 NZLR 19 at 42 and Gault J in Ancare v Cyanamid [2000] 3 NZLR 299 at 309:
There are, we think, four steps, which require to be taken in answering the jury question. The first is to identify the inventive concept embodied in the patent in suit. Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question. The third step is to identify what, if any, differences exist between the matter cited as being “known or used” and the alleged invention. Finally the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.
The applicant also drew on Lucas v Peterson (Fisher J, High Court Auckland, CP6/99, 9 May 2003) where, starting with the four stage analysis set out in Windsurfing, above, Fisher J went on to disclose, at paragraph 69, a series of supplementary principles to help determine the question of obviousness as follows:
(a) Where the invention is the combination of features all of which were individually known, the Court must avoid the danger of concentrating on the integers rather than the whole concept: Wood v Gowshall [1937] 54 RPC 37; Smale, supra, at p 43; Sabaf SpA v Meneghetti SpA [2002] EWCA Civ 976; [2003] RPC 264, 278 at para 40.
(b) The Court must also avoid the danger of falling into ex post facto analysis. It must put out of its mind developments since the invention and view the question of obviousness from the perspective of persons skilled in the art immediately before the priority date: Non-drip Measure Co Ltd v Strangers Ltd [1943] 60 RPC 135, 142; Technograph Printed Circuits Ltd v Mills and Rockley (Electronics) Ltd [1972] RPC 346, 362. The warning against being wise after the event is of special importance in a field, such as the present one, where it is easy to imagine that one is skilled in the art after a relatively brief period looking at a few drawings: Fichera & Anor v Flogates Ltd & Anor [1983] FSR 198.
(c) There is no inventive step if a known article is applied to a new and analogous purpose: Morgan & Co v Windover & Co (1890) 7 RPC 131, 134 (HL); Smale v North Sails, supra, at 43.
(d) Similarly, there is no inventive step if known features are brought together into a single whole in which the component parts continue to “do their own thing”: International Paint Co Ltd’s Application [1982] RPC 247 at 275. Thus there is no invention if “however juxtaposed to the other ingredients of the mixture or parts of the article, each part performs its own function and would do so even in the absence of the other parts.”(ibid). The converse is true if the collocation of features produces a new or improved function by virtue of the novel relationship established between the known features.
(e) Obviousness relates to the technical subject matter claimed to be inventive, and not to its commercial worth; Windsurfing, supra, at 72.
(f) The mere fact that the claim is merely to an improvement to a product already on the market does not preclude an inventive step: Hickman v Andrews [1983] RPC 147 at 189.
(g) In the end, it is impossible to avoid the conclusion that the distinction between novelty and obviousness is a question of degree rather than classification, at least in a case of the present kind.
The applicant pointed out that although the opponent has attempted to mosaic numerous documents it provides no evidence that the documents are capable of being read together and thus mosaiced.
The only expert evidence in support of the opposition is from that of Dr Porter who limits his analysis of obviousness by way of publications to US patent specifications 5980875, 4671267 and 5336501.
The applicant questioned the status of Dr Porter as a person ‘skilled in the art’. It stated that until 2002/2003, well after any priority date to which the claims could be entitled, Dr Porter’s training and research were restricted to plant physiology and working with essential and other plant oils. Dr Porter only began investigating the use of honey as a medicament in wound care in 2003.
The applicant submitted that Dr Porter had no experience with the efficacy or otherwise of antibiotics in wound care at any priority date of the claims and is not qualified to comment on the state of the art at such a date, or what would or would not have been obvious to the notionally skilled addressee at such time. The applicant added that even at the time of providing his declaration Dr Porter had very limited experience in wound dressings and limited practical experience with honey, each of which was gained after any priority date.
The applicant submitted that, to the very limited extent that Dr Porter’s evidence can be considered that of one ‘skilled in the art’, his evidence relies heavily upon ex post facto reasoning consequent on his experience being gained after any priority date.
I accept that Dr Porter’s evidence can only be of limited assistance to me.
I note the submissions of the applicant that its experts all have experience in the relevant fields, experience that was gained well before any priority date and I note the applicant’s comments in its submissions that they are still active in those fields.
On balance the evidence of the applicant’s experts is preferred.
The approach to the question of obviousness from Windsurfing can be summarised as:
Step one: the inventive concept of the invention as claimed
There are said to be a number of limitations inherent in the use of flowable honey as a medicament in wound care. Limitations include:
The applicant’s claimed invention, the medical composition for dressing wounds comprising a combination of honey and gelling agent in the form of a formable and/or pliable solid that can be readily moulded to fit the wound to which it is to be applied wherein at least 50% (by weight) of the composition is honey, is said to overcome these limitations while ensuring that the honey content of the medical composition remains efficacious by retaining the level of activity. That is, the benefits of using honey as a medicament in wound care are not diminished by the method of application or manufacture of the dressing.
Step two: the identified cited published matter
United States Patent Specifications 5980875 and 4671267
These are discussed under ‘Prior publication’ above.
United States Patent Specification 4948575
The document was available from the office as of 13 November 1990. This document discloses a dimensionally stable alginate hydrogel foam which is capable of absorbing significant wound exudate without appreciable swelling. The wound dressing is formed in the wound cavity or on the wound surface from a reactive composition that foams as it gels.
United States Patent Specification 5674524
The document was available from the office as of 30 October 1997. The specification discloses an alginate dressing comprising a fibrous alginate layer needle punched to a non-alginate backing web so that fibres from the alginate layer penetrate into and are interlocked with the backing web. The dressing has improved absorbency and long term stability when used in the treatment of wounds.
United States Patent Specification 5735812
The document was available from the office as of 22 April 1998. This citation describes a water soluble wound dressing material containing alginate ester and a humectant. The material is normally produced in the form of soft, comfortable, wound-friendly films. The material could also contain medicaments and antiseptics.
United States Patent Specification 5238685
The document was available from the office as of 4 October 1993. The document discloses a wound dressing comprising a backing layer which is preferably a semi-permeable material, and a wound contact pad. The wound contact pad comprises a mixed salt alginate preferably in the form of fibres. The mixed salt alginate has first and second cations. The first cation (which may be calcium) is capable of forming an insoluble alginate salt and the second cation (which may be sodium) is capable of forming a soluble alginate salt. The backing layer may include antimicrobial agents, anaesthetics and pharmaceutical agents.
United States Patent Specification 5470576
The document was available from the office as of 20 December 1995. The
specification discloses a wound dressing comprising an absorbent
pad impregnated
with an alginate for promoting wound healing and which on contact with the skin
exhibits haemostatic properties.
The absorbent pad is soft and
pliant.
United States Patent Specification 5336501
The document was available from the office as of 30 August 1994. This document discloses cross-linked hydrogels, water-containing gels. The gels are cross-linked using cross-linking chemicals and heat. The heat used in the examples in the citation is 100oC for 20 minutes. The heat and water would significantly impair the efficacy any honey present. It is noted that the document does not mention honey.
Only the first two and last documents were considered in the evidence of the opponent so attention is directed solely to these documents.
Step 3: the differences between the cited publications and the invention claimed in claim 1
The claimed composition is a form of honey dressing not previously reported and with the advantages over existing wound dressings, which may have contained honey, as referred to above. Particularly there is a medical composition for dressing wounds comprising the combination of one or more honeys and one or more gelling agents, the amount of gelling agent in the composition being such that the resulting composition is in the form of a formable and/or pliable solid that can be readily moulded to fit the wound to which it is to be applied, and there is a high content of honey, i.e. greater than 50% by weight of the composition.
Step 4: do the differences constitute steps which would have been clearly obvious to a “normally skilled but unimaginative addressee” with a knowledge of the use of honey in wound care at the relevant date or do they require any degree of invention.
As stated by the applicant there were a number of practical difficulties in producing a medical composition capable of overcoming the problems associated with the use of honey in wound dressings as mentioned above. One such problem was that honey must be present at a concentration of greater than 30%, and preferably greater than 50%. The UMF (Unique Manuka Factor (Registered Trade Mark)) activity of honey has to be greater than 10 for honey to work efficaciously. To help achieve this the honey must be diluted as little as possible.
Another problem is that honey cannot be excessively heated during production of a medical composition because heating denatures several important bioactives in honey. The most important bioactive is the enzyme responsible for hydrogen peroxide production, hydrogen peroxide being important to the medical properties of honey.
A further problem is the low water activity level of honey. Because of this low water activity level one cannot form a formable and/or pliable solid simply by adding a gelling agent to honey.
Yet again, additional water cannot be added to honey or honey combined with an aqueous base (present in prior art gels) because
The opponent’s basic position is, to me, that the invention is the obvious mixing of honey with suitable gels. This does not take into account the difficulties discussed above. As the applicant pointed out in submissions the evidence of Dr Porter does not provide evidence of how honey might be combined with the prior art acknowledged in the specification of the subject application; does not state why he believes such a combination is obvious given the problems associated with the lack of free water in honey; or say how he would overcome these problems to arrive at the invention given the disclosures in the prior art. Instead what Dr Porter gives is an ex post facto analysis of the objects of the invention.
Professor Molan, on the other hand, described the process by which he arrived at the invention claimed in his declaration at paragraphs 21 to 31. There he described his initial attempts to incorporate honey into various types of gels used in wound dressings. He described the reasons why most common gel types, continuous gels, which he investigated were unsuitable, namely that honey can be flushed from them by exudates; the aqueous base of all continuous gels dilutes the honey; and the presence of water removes from the honey one of its most important bioactives, the hydrogen peroxide.
Professor Molan deposed that at the time he began developing the invention the state of the art was to attempt to introduce honey into an existing matrix or substrate and Professor Molan initially began along the same lines. He discontinued this approach because of the problems associated with the presence of water in the known types of gels. It was then that Professor Molan changed his attention to viewing honey itself as the dressing, a concept he said was diametrically opposed to the prevalent dogma. This in itself, the applicant submitted, demonstrates an inventive step, something that would not be clearly obvious to the “normally skilled but unimaginative addressee”.
Professor Molan deposed that he encountered numerous problems simply by adding an existing gelling agent to honey. The low water activity prevented the gel from becoming hydrated and forming a gel unless additional water was added giving rise to the problems associated with water noted above, and producing a product that failed to meet the objects of the invention.
He tried numerous gelling agents but the result was a paste, not a gel.
After a significant amount of trial and error he thought of attempting to release water from the sugar molecules using heat, thus temporarily increasing the water activity of the honey and enabling the gelling agent to become hydrated. Heating, though, can result in loss of enzyme from the honey thereby reducing its efficacy as a medicament and again not meeting the objects of the invention.
Eventually Professor Molan discovered that heating honey to 60oC for a period short enough to avoid significant loss of enzyme activity in the honey achieved sufficient hydration of sodium alginate to create a viscoelastic mixture with the ideal properties for a honey wound dressing whilst retaining the efficacy of the honey.
I repeat paragraphs 21 to 31 of Professor Molan’s declaration where he described how he arrived at his invention:
THE INVENTIVE PROCESS
21 After considering the ways of overcoming these problems I eventually came up with the idea of gelling the honey in a solid form. I was familiar with the many types of gels used in wound dressings, and initially tried incorporating honey into them.
22 One type of gel I investigated was continuous gels. However, I discovered these are unsuitable because:
22.1 The honey can be flushed from them by exudate in a similar manner to the absorbent pads (mentioned in paragraph 14 above).
22.2 More importantly, the aqueous base of all continuous gels dilutes the honey.
22.3 Apart from the dilution decreasing the effectiveness of the various bioactive components of honey (due to a decrease in concentration), the presence of water removes from honey one of the most important bioactive components, hydrogen peroxide. To explain, there is only a trace quantity of hydrogen peroxide in honey until the honey is diluted with water. When honey is diluted the enzyme producing hydrogen peroxide becomes active. However, the enzyme then soon loses activity and the hydrogen peroxide breaks down, so after 24 - 48 hours there is no longer any detectable hydrogen peroxide present. [Reference].
22.4 The enzyme involved in producing hydrogen peroxide is also inactivated by heating honey [Reference].
22.5 Hydrogen peroxide, as well as contributing to the antibacterial activity of honey, is a chemokine known to stimulate cellular activity at levels which are found in honey [reference]. It is also known to activate:
21.5.1 Angiogenesis (growth of new blood vessels, which is a rate-limiting step in wound healing);
21.5.2 The growth of fibroblasts (the cells which fill in a wound);
21.5.3 Nuclear transcription factors which are believed to be involved in the stimulation of the immune response by honey; and
21.5.4 Tissue proteases (by its oxidant action) which is believed to be the mechanism by which honey stimulates rapid autolytic debridement of wounds.
22.6 If the production of hydrogen peroxide is triggered during the manufacturing process, then, unless the dressing is applied within 24 hours, the beneficial effects are significantly reduced.
22.7 Similar problems occur when excessive heating takes place during the manufacturing process. Heating denatures the enzyme that produces the hydrogen peroxide, and significantly reduces the efficacy of honey as a result.
23 These experiments showed me that if I was to solidify honey for use as a medical composition I would have to do it without the addition of water (either directly or by the use of aqueous gel bases) and without heating the honey thereby inactivating the enzyme responsible for producing hydrogen peroxide.
24 I set about devising a way of solidifying honey which would be non-sticky to handle yet flexible enough to conform to wound contours and sufficiently plastic to be easily formed into various shapes and sizes both in situ in a wound and during the manufacturing processes, whereby the honey would not be washed away from the wound surface, and the honey was not diluted, or its enzymes deactivated.
25 The state of the art at the time was that everyone added honey to an existing matrix or substrate. I did not follow the dogma prevalent in the field at the time, and which is still common practice, by adding honey (as a medication) to a gel dressing although this clearly would have been the obvious starting point. The reason I did not take this approach was to avoid diluting the honey with the aqueous base (water component) of existing types of gels.
26 My idea was that honey itself would be the dressing (i.e. completely the opposite of the prevalent dogma). I therefore used honey as the substrate, and added a relatively small portion of solid gelling agent(s) to that.
27 During my investigations I tried the various commonly used viscosity-increasing agents with a view to solidifying honey with these. However, after much experimentation I found that due to honey’s composition (the sugar molecules tying up water molecules) it has a very low water activity. This low water activity prevented the gelling agents used from being hydrated (and thus forming a gel) when mixed with honey unless additional water was added.
28 I tried numerous gelling agents but the results were always similar. The honey / gelling agent mixture would form a paste, but not a gel that achieved my objectives, or that could be used practically as a wound dressing.
29 After a significant amount of time and trial and error, I eventually thought of trying to release water form the sugar molecules within honey by heating to see if I could get hydration of the viscosity-increasing agent sodium alginate (which is normally used as a cold-setting agent in the preparation of foods). After trying a range of temperatures I found that by heating honey to 60oC (for a period short enough to avoid significant loss of enzyme activity in honey) I could achieve sufficient hydration of the sodium alginate to create a viscoelastic mixture with the ideal properties for a honey wound dressing.
30 I found that by varying the proportions of honey and sodium alginate a material could be produced that was either a putty that could be moulded into wound cavities, or a firm rubbery solid which could be rolled into sheets and easily cut to the size and shape required. Honey in this form:
3.1 Is non-messy to handle;
3.2 Can absorb relatively large quantities of exudate without washing away; and
30.3 Is not flushed out by wound exudates, because it becomes a viscous liquid rather than being a continuous gel.
31 Honey in this form can also be impregnated into or adhered onto a gauze dressing, while still retaining its advantageous characteristics.
Professor Molan deposed that US 5336501 simply disclosed another form of hydrogel which retained the problems associated with water and honey, that is the premature activation of the enzyme and premature production of hydrogen peroxide. The heat and its duration used in US 5336501, i.e. 100oC for 20 minutes, to cross-link the gel to increase its viscosity would significantly impair the antimicrobial and medicinal properties of honey.
Regarding US 4671267 Professor Molan pointed out that the document does not mention honey and hence does not contemplate or solve the problems referred to above. On the invention disclosed in this US document Professor Molan deposed:
The evidence of Professor Molan was supported by the declaration of Dr Yoon that the invention is counterintuitive. Dr Yoon also pointed out that, in his own experiments, Dr Porter had failed to increase the viscosity of honey using barley β-glucan. Dr Yoon trialed Dr Porter’s β-glucan in an attempt to solidify honey. Like Dr Porter she was unsuccessful. She queried Dr Porter on this and his response in a facsimile, below, was a clear statement that he had failed to solidify honey:
... While there was significant stiffening of both honeys with 6+%, the mixtures did not form the firm gels obtained with the water, and the manuka honey was noticably [sic] more “granular”. It appeared that although the material dispersed completely in water and gelled at 70oC, neither dispersion or gelling was adequate at this temperature.
From these results it is obvious that incorporating the material into honey is not straightforward ... It is also obvious that it will require exploration of more adventurous methods of incorporation to determine if there is a method that will give you the effects you require ... [emphasis added]
Perhaps it is worthwhile looking at more drastic methods to ensure complete dispersion in the honey - eg 100oC or more ...
... It is rare to obtain simple solutions with material is [sic] such early stages of development, so it looks as though you will have to explore the full range of options available to you or even invent some more. [emphasis added]
These statements of Dr Porter indicate the inventiveness of the invention claimed in the subject application. They also appear to contradict Dr Porter’s own statements in his affidavit that the invention is obvious and that he would have rapidly arrived at the same combination of properties and roles of dressings as claimed in the subject application.
Deponent Betts attests to the practical benefits of the applicant’s wound dressing over dressings that were available prior to those of the applicant.
The evidence in support of the application was not rebutted by the opponent as no evidence in reply was filed.
I have come to the conclusion that obviousness has not been proved.
The ground is not made out.
NOT AN INVENTION - section 21(1)(f)
Section 21(1)(f) states:
That the subject of any claim of the complete specification is not an invention within the meaning of this Act
The definition of invention, Section 2(1), reads:
“Invention” means any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies and any new method or process of testing applicable to the improvement or control of manufacture; and includes an alleged invention
The applicant referred to the United Kingdom Court of Appeal decision in Sabaf SpA v Meneghetti SpA [2002] EWCA Civ 976; [2003] RPC 264 at paragraph 43 where it was held:
A mere collocation is no more than a species of obviousness judged by the statutory test. In our judgment there is no separate law of collocation.
The invention claimed has not been shown to have been prior published, nor prior used, nor has it been shown to my satisfaction that the applicant’s invention is obvious and clearly does not involve any inventive step based on prior publication. There is nothing to suggest that the product claimed does not fall within the definition of invention under section 2(1).
The ground is not made out.
DECISION
I find that none of the grounds has been made out. I dismiss the opposition, and I direct that the patent be sealed.
COSTS
Both parties sought an award of costs, or such relief as the Commissioner may deem fit. The opponent filed written submissions on costs. The withdrawal per se of the opponent, its views expressed in the submissions that the product claimed is prior used by a substantial portion of the industry and the applicant will have to commence a class action against a number of separate parties in an attempt to defend the patent from alleged infringement, and that the courts would be a more appropriate venue for determining the validity of the patent can have little or no effect on the award of costs. The award of costs must relate to the circumstances of the present opposition proceedings. In addition, the applicant is entitled to be heard.
Pursuant to section 95(1) I award $3300-00 to the applicant by way of costs based on the schedule of costs and direct that the opponent pay this sum to the applicant.
Dated this 29th day of November 2004
_____________________________
A Hazlewood
Assistant Commissioner of
Patents
James & Wells for the Applicant
Pipers for the Opponent
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