Akzo Nobel N.V. v the Dow Chemical Company
[2002] APO 3
•16 January 2002
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 701986 in the name of AKZO NOBEL N.V.
Title: Microbiological degradation of alkylene amine acetates
Action: Opposition under Section 59 of the Patents Act 1990 by THE DOW CHEMICAL COMPANY
Decision: Issued .
Abstract
The invention relates to a process for the microbiological degradation of alkylene amine acetates under alkaline conditions using microorganisms in activated sludge. At the hearing the opposition's arguments were based on the grounds of: novelty, inventive step, fair basis, full description, and clarity.
The opposition failed on all grounds. Costs were awarded against the opponent.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 701986 by Akzo Nobel N.V. and opposition under S.59 by The Dow Chemical Company
BACKGROUND
Patent Application 701986 by Akzo Nobel N.V. (Akzo) was filed on 13 June 1996 (under the provisions of the PCT treaty) with a priority date of 6 July 1995. Acceptance of the application was advertised on 11 February 1999. The Dow Chemical Company (Dow) filed a notice of opposition on 10 May 1999 and a statement of grounds and particulars on 10 August 1999.
The hearing was held on 22 & 23 May 2001. The opponent was represented by Dr Neil Ireland patent attorney, accompanied by Dr Damian Slizys both of Phillips Ormonde & Fitzpatrick, Melbourne. The applicant was represented by Mr Barry Hess of Counsel, and Ms Carmela Monger of Griffith Hack, Melbourne.
THE SPECIFICATION
The application describes a process of degrading alkylene amine acetates in waste water by contacting these with activated sludge under alkaline conditions. Described alkylene amine acetates include ethylene diamine tetraacetic acid (EDTA) and propylene diamine tetraacetic acid (PDTA).
The specification indicates that the process is generally intended to take place in a water treatment plant, in particular a waste water treatment plant employing an activated sludge system.
The process is said to be characterised in that alkylene amine acetate-containing waste is degraded by contacting it, at a pH above 8.0 and below 9.5, with activated sludge containing a wide range of microorganisms, in the absence of specific carrier materials.
There is only 1 independent claim:
Claim 1 defines:
"A process for the microbiological degradation of alkylene amine acetates under alkaline conditions using microorganisms present in activated sludge, characterised in that alkylene amine acetate-containing waste is degraded by contacting it, at a pH above 8.0 and below 9.5, with activated sludge containing a wide range of microorganisms, in the absence of carrier materials."
STATEMENT OF GROUNDS AND PARTICULARS
Dow's opposition under Section 59 referred to the following:
(a) Inventive step
(b) Novelty
(c) Manner of Manufacture
(d) Fair basis
(e) Clarity
(f) Full description
Dow’s grounds were supported by particulars. During the hearing there was some questioning, by counsel acting for the applicant, on whether some matters were properly particularised but in the end no objection was raised. The opponent did not to pursue the ground of manner of manufacture at the hearing.
EXPERTS AND EVIDENCE
Professor Bruce Anderson
Currently Associate Professor and ICI Research fellow in environmental Biotechnology at RMIT University since 1995. He has experience in fermentation and bioremediation, including a number of activated sludge processes. Has acted as a consultant on several waste water treatment projects. Professor Anderson's evidence consisted of:
(i) Statutory Declaration, dated 9 February 2000, and exhibit BNA-1 to BNA-15 filed in evidence in support.
(ii) Statutory Declaration, dated 9 February 2001, filed in evidence in reply
Professor Paul Greenfield
Professor of Chemical Engineering University of Sydney.
He has taught industrial waste water treatment and published a number of papers relating to waste water treatment. Professor Greenfield's evidence consisted of:
(i) Statutory declaration, dated 3 November 2000, and exhibit PFG-1 filed in evidence in answer
Dr Cornelus van Ginkel
The inventor of the Akzo application. He has published a number of papers on biodegradability.
Dr van Ginkel's evidence consisted of:
(i) Statutory declaration, dated 30 October 2000, and exhibit CGG-1 filed in evidence in answer.
Prior Art documents cited in this decision:
Exhibit BNA-6 Belly et al, "Degradation of ethylenediaminetetraacetic acid by microbial populations from an aerated lagoon.", Applied Microbiology Vol. 29 No 6
p 787-794 June 1975. (Henceforth referred to as Belly et al)
Exhibit BNA-8 Yonezawa et al, "Biodegradation of EDTA by activated sludge and its effect on activated sludge", Bulletin of the National Research Inst. for pollution and resources Vol. 6 No 4 p15-22 (1977) [Verified translation] (Henceforth referred to as Yonezawa et al)
Exhibit BNA-10 Russian Patent No 525627 (Stepenova et al) published 25 August 1976
"Process for purifying waste waters containing heavy metal complexonates" [Verified translation] (Henceforth referred to as the Stepenova patent]
Exhibit BNA-11 United States Patent 5252483 (Lauff et al) published October 12 1993
"Degradation of ferric chelates by a pure culture of Agrobacterium sp."
(Henceforth referred to as the Lauff patent)
Exhibit BNA-15 Gschwind, "Biodegradation of EDTA in a model wastewater",
Journal Das Gas Und Wasserfach Vol. 133, No 10 p 546-549, October 1992 [Verified translation] (Henceforth referred to as Gschwind)
DECISION
Scope of terms in the claims:
Several issues in this decision require a determination of the scope of the claims.
As noted earlier, claim 1 defines:
"A process for the microbiological degradation of alkylene amine acetates under alkaline conditions using microorganisms present in activated sludge, characterised in that alkylene amine acetate-containing waste is degraded by contacting it, at a pH above 8.0 and below 9.5, with activated sludge containing a wide range of microorganisms, in the absence of carrier materials."
Activated sludge
Much debate at the hearing concerned the scope of the term "activated sludge" a term which both sides appear to accept is a well understood in the art. In the Akzo specification no definition of activated sludge is given, it is simply indicated that the activated sludge is sourced from water treatment plants.
Professor Anderson defines activated sludge in terms of an activated sludge process:
"Activated sludge systems operate as continuous culture processes where an incoming biodegradable effluent is mixed with recycled, concentrated biomass containing desirable microbial communities capable of breaking down the organic compounds present.
In that context "activated sludge" is a concentrated biomass of microorganisms previously activated to breakdown under aerobic conditions, organic compounds present in an influent liquid"
Professor Anderson subsequently takes this definition of activated sludge out of the context of an activated sludge process and applies it to material produced or used in other processes. In particular Professor Anderson argues that lagoons and ponds may be systems analogous to activated sludge processes and the biomass found there might be classed as activated sludge:
"While a lagoon process is generally not considered an activated sludge process per se, material isolated from a lagoon could be classified as activated sludge. An activated sludge process is typically one in which a portion of the biomass (between 0% and 100%) is returned to the degradation chamber. The amount returned will vary depending on a number of variables such as sludge age, balance between new and old biomass and the like. In this regard therefore, a pond system in which a certain amounts of biomass settles can be seen as analogous to such a process. As such the material isolated may be classified as activated sludge."
Professor Anderson's views are not supported by Professor Greenfield:
" …Pond biomass is not activated sludge, though some of the organisms present in both activated sludge are likely to be identical. Activated sludge has undergone biological selection to generate an ecosystem that has both the ability to degrade a specific waste water and to separate from the liquid in a secondary clarifier or other separation device.
Simply because it may be possible to classify a material as being in some way equivalent to another does not indicate that the person skilled in the art would refer to the two materials in the same terms. No evidence has been provided indicate that workers in the field refer to material in a lagoon or a pond as activated sludge. I conclude on the basis of the evidence before me that the term "activated sludge" is understood by the person skilled in the art to refer to material produced by an activated sludge process.
It therefore follows that the activated sludge defined in claim 1 must derive from an activated sludge process.
Carriers
In the evidence provided by Professor Anderson, he raises the issue of whether the claims are clearly restricted to artificial carrier materials, or whether they include within their scope the use of natural carriers.
There is little discussion in the body of the Akzo specification on this point, but I think it is pertinent that carriers are described in terms of "special carrier materials" or "specific carrier materials" which suggest materials not inherently present in the microbiological process. This is also consistent with the statement in the Akzo application that:
"the use of carrier materials as applied by Gschwind is objectionable because of the amount of solid waste formed, which needs to be treated as chemical waste, may well be increased. Moreover, it is not possible to use carrier materials just like that in "conventional," activated sludge based treatment plants."
The carriers in the Gschwind reference were artificial beads. In addition, I note that Professor Anderson describes flocs as "acting as natural carriers" and this choice of words suggests to me that the term "carriers" by itself is normally taken to refer to artificial materials. For these reasons I consider the word carrier, as used in the claims, to be understood by the person skilled in the art, to refer to artificial materials used to attach and retain microorganisms.
Activated sludge process
Another issue of importance to the opposition is whether the process for degrading alkylene amine acetates defined by the claims is entirely restricted to an activated sludge process. The term "activated sludge process" is not used in the claims and the claimed process lacks the features that Professor Anderson describes as characterising an activated sludge process such as being a continuous process and a process requiring recycling of the activated sludge. The specification indicates that the examples show how EDTA and PDTA can be degraded in activated sludge based waste water plants but also states:
"However, it is equally possible to practice the invention in plants operated on the same or similar principle, variants which will be obvious to the skilled person."
For these reasons I consider that, while the process claimed requires the use "activated sludge" to degrade the alkylene amine acetates, the claimed process is not required to be an activated sludge process.
Novelty
A test for determining whether an invention lacks novelty is the "reverse infringement test" as set out in Meyers Taylor Pty Ltd v Viccar Industries (1977) 137 CLR 228 at page 235 where Judge Aickin stated:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged invention would if the patent were valid, constitute an infringement."
Infringement is said to occur where "each and every one of the essential features of that claim have been taken" (Rodi and Wienenberger AG v. Henry Showell Ltd (1969) RPC 367
In this case there appears to be no suggestion that any of the features of claim 1 are not essential features.
Belly et al
This document is a study on the mechanism of degradation of EDTA in the environment using organisms taken an aerated lagoon receiving EDTA containing waste. The organisms were placed in a flask with culture medium and the ferric salt of EDTA or other ethylene amine acetate salts. The opponent conceded that an aerated lagoon is not considered an example of an activated sludge process. For the reasons given earlier, I therefore conclude that the material isolated from the aerated lagoon would not be considered activated sludge by the person skilled in the art and so the citation lacks an essential feature of the claim.
There was also debate by the parties on whether the Belly et al article provided directions to degrade EDTA at a pH that was above pH 8.0 and below 9.5, but this matter does not need to be pursued. As the feature of "activated sludge" is not disclosed in Belly et al, the claimed invention is novel over Belly et al.
The Stepenova patent
This patent teaches a process for purifying waste waters with respect to heavy metal salts of EDTA, referred to as "heavy metal complexonates". The process involves treatment of the waste water with caustic soda to remove metals as metal hydroxides after which the precipitated hydroxides are removed and the filtrate is diluted with water to achieve a pH of 8-9 and subjected to biological purification using aerobic organisms. The biological or microbial treatment is thus performed at the recommended pH of the Akzo's claimed invention. After treatment for 48 hours the waste water is said to contain very low levels of EDTA.
I have found that the term activated sludge is restricted to biomass produced using an activated sludge system. The opponent does not argue that the Stepenova patent discloses biomass produced by an activated sludge process and I can discover no directions in the patent to use an activated sludge process. As the process disclosed in the Stepenova patent lacks the feature of "activated sludge" the claimed invention is novel over the Stepenova patent.
There were other documents raised in the evidence that were relied upon by the opponent for inventive step rather than novelty. Nevertheless I have considered them under the ground of novelty (particularly Gschwind which is the closest of the remaining documents) and I find that none of them teach the process of the claimed invention and so all claims are novel over each of the documents discussed under inventive step.
Inventive step
Subsections 7(2) and 7(3) of the Patents Act of 1990, when read in the light of the definition of "prior art base" provided in schedule 1 of the Act, relevantly indicate that a claimed invention will lack an inventive step when compared with the prior art base, if it is obvious in the light of:
common general knowledge existing in the art before the priority date considered alone; or
common general knowledge when considered with information in a single document, provided that document could be reasonably be expected to have been ascertained, understood and regarded as relevant to work in the relevant art in the patent area before the priority date by the person skilled in the art
A frequently used approach by the courts and the Patent Office to the determination of inventive is the so called "problem/solution" approach.
"…the test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have lead from the prior art to the invention whether they be the steps of the inventor or not' per Aickin J in Wellcome v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at 286"
This involves identifying from the specification one or more problems existing in the prior art that were addressed by the invention. The Akzo specification describes the invention as relating to the degradation of alkylene amine acetates using microorganisms found in activated sludge. After referring to a number of earlier publications that describe the degradation of these types of compounds the Akzo specification states:
"So far, the microbiological degradation of alkylene amine acetates has been shown only in model experiments using conditions which are neither common or attractive in actual practice. Despite the favourable process/performance ratio of, say EDTA and PDTA (ie. as agents in industrial applications that use these compounds), a tendency can even be noted to develop new alternatives which often perform less successfully, because alkylene amine acetates are assumed not to be biodegradable." (The comments in italics are my own)
In the light of this discussion, the problem appears to be to develop a process of biological degradation of EDTA and other alkylene amine acetates that is suitable to be used commercially in a wastewater treatment plants.
The person skilled in the art
The problem is concerned with microbiological degradation of pollutants in waste water being treated in plants. The examples in the Akzo application show the process being performed in a model system for plants using an activated sludge process. This suggests that the person skilled in the art would include engineers, perhaps microbiologists and plant operators in waste water plants. The opponent has described the art generally as being concerned with bioremediation and/or waste water treatment, and suggested the relevant skilled addressees could be an individual or a team of research and development scientists or engineers and/or production scientists/engineers. This characterisation sounds overly broad and vague and there is little evidence to support this view. I will view the person skilled in the art as being one or more of the group of engineers, plant operators, and microbiologists.
Common general knowledge
Dr van Ginkel does not live, or claim to be familiar with the art, in Australia. The opponent has not submitted or provided evidence to suggest that workers in Australia would have the same knowledge of this art as workers overseas. I therefore do not have regard to Dr van Ginkel's evidence for purposes of determining common general knowledge. Professor Anderson and Professor Greenfield are well qualified to give evidence on the common general knowledge in Australia.
None of the documents relied upon to support the allegation of a lack of inventive step were asserted by the opponent to be common general knowledge in the art. One of these documents, Belly et al, appears to me to have been reasonably well known overseas, since it was cited in three of the four other documents in the evidence that provide teaching on the microbial degradation of EDTA. However neither of the Australian experts claimed to have had prior knowledge of any of the documents in question and overall I consider there is insufficient evidence to show that some or all of the disclosure of Belly et al or any of the other documents had become common general knowledge in Australia at the relevant date.
Professor Greenfield has little to say on the common general knowledge of workers in the art, although some of his comments on Professor Anderson's evidence are helpful in this regard. Since 1994, Professor Anderson has been in involved in the production of a journal for the Australian Water and Wastewater Association titled "Water". Because of this and earlier work in the field of waste water, I would expect that he had a reasonably thorough knowledge of the state of the art in Australia at the priority date. Professor Anderson made a number of assertions on common general knowledge in the art. Having considered the evidence I accept the following to be common general knowledge in Australia at the relevant date:
It was well known in Australia that biological treatment of wastewater could be performed using a number of different processes including continuous flow processes such as conventional activated sludge plants, or processes using pool or lagoon processes where (as described in Professor Anderson’s evidence) no attempt is made to maintain a particular flow rate or to ensure complete mixing.
It is well known in Australia that microorganisms and in particular bacteria can be used in the degradation or bioremediation of chemical pollutants.
Is it well known to use or design activated sludge systems to degrade pollutants, including those molecules known to be difficult to biodegrade such as EDTA? There is little information provided on this matter. Professor Anderson states that microorganisms have been used in Australia in a number of waste treatment systems to degrade chemical pollutants. Professor Anderson provides the following examples of waste water treatment systems used in Australia that dealt with chemical pollution:
(i) Various lagooning systems for the treatment of wool scouring process effluents where the contaminants of concern are nonylphenylethoxylate surfactants
(ii) A large effluent digestion plant to deal with waste waters from the flour production facility at Altona, Victoria
(iii) A biological waste treatment system for fermentation and treatment of chemical waste waters near Newcastle, NSW
Professor Anderson does not explicitly identify any of these systems as using activated sludge or as dealing with recalcitrant pollutants. I therefore cannot assume that these exemplified systems use activated sludge to break down recalcitrant molecules and that generally, it is well known how to design activated sludge processes to deal with more unusual pollutants.
Are the documents in question relevant for the purposes of inventive step?
The opponent does not argue that the claimed invention lacks an inventive step over common general knowledge alone, but rather the combination of common general knowledge and a prior published document. I therefore need to consider whether the documents put forward by the opponent would meet the requirements that they would be found by the person skilled in the art and ascertained and regarded as relevant. The documents are:
(i) Belly et al, "Degradation of ethylenediaminetetraacetic acid by microbial populations from an
aerated lagoon"
(ii) Yonezawa et al, "Biodegradation of EDTA by activated sludge and its effect on activated
sludge"
(iii) Russian Patent No 525627 (Stepenova et al)
(iv) United States Patent 5252483 (Lauff et al)
(v) Gschwind, "Biodegradation of EDTA in a model wastewater"
Each of these documents are concerned with biodegradation of one or more alkylene amine acetates in aqueous systems and so would be considered relevant documents. I consider that the person skilled in the art would search standard patent and non patent literature sources. A keyword search on EDTA (the most common alkylene amine acetate) and likely search terms such as effluent/waste water/ activated sludge/ biodegraded would be likely to find the documents. The Lauff patent, which would be easily found by this means, cites and briefly discusses the Stepanova patent and the Belly et al article and so would alert the searcher to the existence of relevant older art. The applicant while asserting that the documents did not form part of the body of common general knowledge in Australia, does not dispute the fact that they would be ascertained. The fact that several of the documents are in a foreign language does not prevent them from being translated and understood. For all these reasons I conclude that the documents would be ascertained, understood and regarded as relevant. I will now consider each in turn.
Belly et al
Belly et al, discloses that degradation of EDTA is possible by organisms taken from an aerated lagoon. Optimum degradation was observed to have occurred at pH of 7-8, but some degradation appears to have been found to have occurred in the range of pH 5-9 although few details were given on degradation outside the range of pH 7-8. I have found that activated sludge was not used in the process described in this study. The question is therefore whether the teaching of Belly et a,l would lead to a process using activated sludge according to the claimed invention. The opponent's submissions in this matter are directed at an "activated sludge process" and this appear to be the only process using activated sludge that was common general knowledge in Australia at the relevant date.
The opponent argued that the disclosure of Belly et al, would encourage the person skilled in the art to develop an activated sludge process, and cited Professor Greenfield's statement that:
"The fact that EDTA was degraded in a pond or other biological system provides some encouragement that EDTA could be degraded in an activated sludge process, but provides no confidence that, for specified inlet levels, very low effluent levels could be reliably achieved."
Although the experts did not consider this point, it appears to me that the teaching of Belly et al, may be more likely to direct the person skilled in the art to develop or optimise a lagoon system.
This impression is strengthened by other statements provided by Professor Greenfield:
"Pond degradation simply confirms the biodegradability over very long residence times. It is not possible to design an activated sludge process knowing only that a material was degraded in an aerated pond."
Professor Anderson does not discuss the conversion of pond processes to activated sludge processes in much detail. He discusses briefly and in quite general terms, the setting up of activated sludge processes and he appears to consider such a process was routine:
"As Professor Greenfield would know when designing /commissioning a treatment plant (activated sludge or otherwise) there are a number of variables that would routinely be varied. Indeed a skilled addressee has a matrix of possible parameters that will be varied in order to achieve the desired result within the design constraints of the plant (such as input material, required throughput, desired effluent etc). As the claimed pH (8.0 to 9.5) is close to the Belly optimal pH of 7-8 and within the disclosed range of 5.0-9.0, I consider a skilled addressee on reading the Belly reference would have tried the claimed pH."
I accept that was well known in Australia at the relevant date to operate conventional activated sludge plants that deal with sewage. However the evidence before me includes an article by Gschwind which reports that EDTA is not degraded in municipal treatment plants that deal with biological treatment of waste water, indicating that a conventional activated sludge plant would not degrade EDTA. This also indicates that conventional procedures could not be used. There is little expert evidence on what was generally known about setting up of activated sludge processes to degrade less conventional molecules or to degrade products that are more difficult to biodegrade. Some evidence provided by the opponent suggests that development of this type of facility is not routine. In particular the article by Yonezawa et al, concerns an attempt to develop an activated sludge process to degrade EDTA. The group concerned acknowledged the earlier work of Belly et al and therefore, I presume, understood the article's findings and considered them when trying to set up an activated sludge process. Nevertheless Yonezawa et al, report negative findings in their study of the suitability of the activated sludge process for degrading EDTA. Of course this work was early (1977) and not performed by an Australian group. But in the absence of evidence of differences in the common general knowledge possessed by Australian workers in this field at the priority date, I consider that this evidence certainly suggests that the successful achievement of an activated sludge process to degrade EDTA was not routine at the priority date. In any case, the opponent has not provided the evidence to convince me that at the priority date it was simply a matter of routine steps to develop an activated sludge process that fell within the scope of the claims.
Furthermore the other documents put forward by the opponent also acknowledge the Belly et al, article which therefore appears to have been widely read by workers in the field overseas. The problem of EDTA contamination of water appears to have been well known from at least the time of Belly et al's publication. Various attempts appear to have been made to biodegrade EDTA so the lack of development does not appear to be simply because there was an unfelt need in the art. Activated sludge plants were well known prior to the Belly et al article. Yet no successful activated sludge process for degrading EDTA is reported over the 20 year period between the publication of the Belly et al article and the priority date of the Akzo application. This lack of success suggests to me there was some significant barrier, whether the barrier was technical (ie the development was not routine) or perhaps some significant prejudice in the art that had to be overcome before success could be achieved.
For these reasons the claimed invention has not been shown to lack an inventive step over Belly et al.
Yonezawa et al
The Yonezawa publication is a study on the acclimation of activated sludge to EDTA containing synthetic wastewater and the biodegradability of EDTA. The objective of the study is to learn whether EDTA can be treated by the activated sludge method.
This study begins by referring to other workers who had reported EDTA as being recalcitrant to biological degradation and the work of Belly et al that found that EDTA is biodegraded by organisms found in an aerated lagoon.
The study used a batch process where activated sludge and culture medium in a reaction vessel was treated with synthetic waste water containing EDTA. The pH of this process is not reported,
The reported findings of the Yonezawa et al study included:
Acclimation of activated sludge to EDTA did not occur.
The greater the EDTA concentration, the smaller the EDTA degradation rate constant became, and the EDTA degradation rate constant of non-acclimated activated sludge was greater than that of acclimated sludge.
Dr Ginkel notes, in his evidence, that acclimatisation to EDTA did not occur and states (and this is not refuted by Professor Anderson) that the degradation rates observed in the batch cultures used in Yonezawa et al, are too low to result in detectable removal in continuous or semi-continuous activated sludge systems maintained at hydraulic retention times of 8-48 hours.
Although the study does not discuss the significance of its findings with regard to the objective of determining whether EDTA can be treated by an activated sludge method, in my view the significance of the findings is that they suggest that an activated sludge process is not a practical method to degrade EDTA.
In this matter the opponent relied less on the findings of the Yonezawa article itself, and more on the evidence from the applicant. Of significance to the opponent was that Dr Ginkel had determined, having regard to the components of the culture medium used in Yonezawa et al, that Yonezawa ran their activated sludge process at a pH of 6.5. This conclusion appears to have been accepted by Professor Greenfield who states that low pH may have caused the low degradation rates.
"It is apparent from Figures 1-2 in Exhibit BNA-8 that although there is biodegradation of EDTA under the specified conditions, this biodegradation is far from complete. The relatively low rates of degradation are probably a function of low pH."
It is not apparent whether the experts were attempting to explain the Yonezawa process in the light of the subsequent success of the Akzo process or in isolation from it. Certainly Professor Greenfield does not appear to consider that the Yonezawa, article directs the person skilled in the art toward the claimed invention:
"I consider it is not possible to specify the design and operating conditions of an activated sludge process to treat EDTA containing waste on the basis of Exhibit BNA-8."
Professor Anderson indicates in his 2nd declaration, filed during evidence in reply, that he accepts the accuracy of the Ginkel calculations and that it would have been obvious to raise the pH to the values used in the Akzo application in order to obtain improved degradation of EDTA. In my opinion, the statements relied upon by the opponent are of dubious value because they may have been based on analysing the disclosure of the Yonezawa publication in the light of the subsequent solution provided in the Akzo application. In this regard, I note that Professor Anderson, in his first declaration and prior to having read Dr Ginkel's evidence, states that Yonezawa et al, did not clearly disclose the pH of their process. It is my view that this earlier conclusion of Professor Anderson is more likely to be the conclusion reached by the person skilled in the art on reading Yonezawa et al, before the priority date of the Akzo application.
I have rejected the idea that Yonezawa et al, provides a teaching on pH for their activated sludge process. It does not appear to me that Yonezawa et al, contains any suggestion that the failure of the activated sludge to acclimate and the slow degradation rates obtained were pH related. I think the conclusions of Yonezawa et al tend to confirm the earlier reports cited therein, evaluating EDTA as a compound that is difficult to degrade by microorganisms. Yonezawa et al, in effect teaches away from using an activated sludge process to degrade EDTA in a commercial waste water system.
The Stepenova patent
As previously discussed under the ground of novelty, this patent teaches a process for purifying industrial waste waters with respect to heavy metal salts of EDTA. The EDTA is degraded using aerobic organisms apparently at a pH of 8-9, a pH that is within the scope of the claimed invention.
There is no evidence before me that the degradation of EDTA was likely to have been performed in an activated sludge plant or some other process containing activated sludge. The opponent’s only argument for a lack of inventive step was on the basis that the term "activated sludge" was broad enough to include any microbiological material used in the purification of waste water. I have found that "activated sludge" must be given a narrower meaning, so this argument fails.
A patent claiming to have produced a microbial process that effectively degraded EDTA from industrial effluent would offer some encouragement for the person skilled in the art to try to develop some sort of waste water system based on it's teaching. However this patent provides exceedingly little detail on the nature of their system and it is not clear in the light of the evidence provided that an activated sludge process would be considered. Even if such a process was considered, there is insufficient evidence to conclude that the design and implementation of an activated sludge process would be a matter of routine steps.
For these reasons I consider that the claimed invention has an inventive step over the Stepenova patent.
The Lauff patent
This document describes the use of a pure culture of Agrobacterium species to degrade aminopolycarboxylic acids such as EDTA.
This species of Agrobacterium was isolated from sludge in a treatment facility receiving industrial waste containing the ferric chelate of EDTA, and thus is an organism present in activated sludge.
However the method in the Lauff patent differs from that claimed in the Akzo application:
(i) it does not contact the EDTA containing waste with activated sludge
(ii) it does not employ a wide range of organisms
(iii) it uses a pH below 8 and reports that at pH >8.1 EDTA degradation stops
Professor Anderson considers the Akzo application suggests the use of individual organisms to degrade EDTA. He refers to the following passage near the beginning of the application, where there is a discussion on how to keep biodegradation activity sufficiently high if the supply of alkylene amine acetates is irregular:
"Alternatively, an individually enriched and/or grown culture of alkylene amine acetate converting microorganisms can be used in the activated sludge."
An "individually enriched" culture is not equivalent to a culture of an individual microorganism. Furthermore in the Akzo application, the cultured organisms are added to active sludge that would already contain a variety of microorganisms, even if the alkylene amine acetate degrading activity of the sludge has decreased. In contrast in the Lauff patent, the degradation of EDTA was said to be inhibited by the presence of other organisms and accordingly the presence of other organisms in the media containing the Agrobacterium is not preferred.
I therefore consider that the US patent teaches away from using an activated sludge process, or any process involving a range of microorganisms and also teaches away from degrading EDTA at a pH above 8.
The claimed invention therefore possesses an inventive step over the disclosure of the Lauff patent.
Gschwind
The Gschwind article teaches a microbial process of degrading EDTA under continuous conditions using carrier material in a laboratory fermenting unit equipped to enable temperature, pH and oxygen regulation. The optimal pH for an efficient EDTA degradation under aerobic conditions is between 9 and 9.5 which is within the scope of the claims of the Akzo application. The carrier material was inoculated with a mixed population of microorganisms that were separated from activated sludge by passage through a column.
Gschwind's process differs only in two respects from Akzo's claimed invention:
(1) The degradation of EDTA is not performed by microorganisms actually in activated sludge.
(2) The process of degrading EDTA relies on carrier materials.
The carrier material used was a polymer product made from polyurethane foam flakes and activated charcoal.
Attempts to enrich the culture used in this fermenter by using these microorganisms without the carrier present failed. On this point Gschwind concludes that the results reported confirm the superiority of immobilised bacteria in the degradation of substances that are hard to degrade.
Professor Anderson states, without elaboration, that the use of a carrier was because of the "continuous nature of the process". An activated sludge plant is also a continuous system, and so this might imply than an activated sludge process would also require carriers.
Professor Anderson elsewhere suggests that he does not know why the carrier is required in Gschwind. In his declaration at evidence in reply he states:
"I consider Professor Greenfield's comment as to why the carrier material was used "probably because the carrier had an absorptive impact on the dissolved EDTA concentration, thereby reducing its inhibitory effect, and also because it allows very slow growing cells to remain in the reaction" to be speculative. The carrier may bind the organisms, bind the EDTA or do a combination of these. Without further experimentation it is simply impossible to tell.
……..I consider that the skilled addressee would consider that it would be possible to adjust other process parameters in this process to achieve this desired result other than through the use of a carrier."
Elsewhere in his earlier declaration, Professor Anderson refers generally to the use and benefits of carriers in continuous systems:
"A consequence of the flow requirements of the process is however that microorganisms may be pushed out by the flow of the water to be contaminated. It was therefore well known that in a continuous flow process steps had to be taken to retain and/or recover biomass, and that it was advisable to have the microorganism immobilised on carrier to prevent it being removed during the process."
In this regard, Professor Greenfield states:
"The use of attached media or carrier materials is consistent with the available biodegradability information for EDTA and PDTA and is the approach that many professionals would have taken to solve the problem of low biodegradability. Successful attachment to a solid surface ensures that the solids residence time (SRT) of the active organism exceeds the critical value of SRT to avoid washout of the microorganisms, while still allowing the liquid residence time, and hence the volume of the liquid to be relatively low"
I am not convinced that the person skilled in the art on reading the Gschwind article would be likely to consider that EDTA could be suitably degraded in an activated sludge process without the use of artificial carriers, particularly as the reason the carrier makes the process successful appears not to be understood. The evidence appears to me to indicate that the carriers would be considered indispensable. The opponent further argues, that Gschwind also teaches a carrier-free process to degrade EDTA. This is based on an earlier step in the process, where prior to placing the active microorganisms in the fermenting unit with the artificial carrier, Gschwind describes an isolation or enrichment step where activated sludge is applied to column filled with sand, mature compost or active charcoal and EDTA degradation is monitored. However this isolation step is not described in Gschwind as being in itself a degradation process, nor do I find reason to conclude that the disclosure about this step would direct or suggest to the skilled addressee the use of this step as the basis for degrading EDTA in a practical waste water treatment process. Perhaps more importantly, the process of eluting the column would separate or disaggregate the microorganism from the activated sludge so the degradation that was measured in the eluted liquid would most likely not be from microorganisms still present in the form of activated sludge. Furthermore the sand etc used as the carrier material for the column is of course a "carrier" (even though not the same as the artificial beads used in Gshwind's degradation step), so the described process is not degradation in the absence of a carrier. Thus even if a degradation process is taught or suggested in the isolation step, it is degradation by free microorganisms in the presence of a carrier and thus falls outside the scope of the claimed invention.
Overall I consider that it is most likely that the person skilled in the art would be taught away from the claimed process, which uses activated sludge in a process without artificial carriers, by the disclosure of Gschwind.
Accordingly for all these reasons I find that all claims are inventive over Gschwind.
Fair basis
The opponent raised a number of concerns, of which three are worth considering in some detail.
1) The claims are not restricted to an activated sludge process, although the process described in the specification is directed at one in which waste is degraded by contacting it continuously during its stay in a reactor
2) The claims do not require the microorganisms to be present in flocs
3) The claims should be restricted to degradation of EDTA and PDTA
Not restricted to an activated sludge process
The opponent submits that the specification is clearly directed at an activated sludge process but that none of the features of an activated sludge process are included in the claims. Such features are said to include but not be limited to the following:
The continuous nature of the process
The waste is in continuous contact with activated sludge during its stay in the reactor
The hydraulic retention time of the waste water in the reactor
The recycle rate of the biomass back to the reactor
Level of mixed liquid suspended solids
Solids retention time
The opponent's argument here could be interpreted to be raising issues of sufficiency under the guise of fair basis. The supporting references to the evidence for this argument appear directed at sufficiency or enabling disclosure issues. In any case an argument that features allegedly needed to make the invention work must necessarily be in the claims for the claims to be fairly based was previously dismissed by Gummow J in Rehm v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at page 95:
"The circumstance that something is a requirement for the best method of performing an invention does not make it necessarily a requirement for all claims; likewise, the circumstance that material is part of the description of the invention does not mean that it must be included as an integer of each claim. Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification."
I think that the opponent's underlying argument is that the claims should be directed at an activated sludge process and not just a process using activated sludge. But that is not the correct question, which is rather, has the claimed process using activated sludge to degrade alkylene amine acetates been broadly described in the body of the specification?
The Akzo specification describes the invention in the following terms:
"The invention pertains to a process for the microbiological degradation of alkylene amine acetates under alkaline conditions, using microorganisms present in activated sludge.
…..The process disclosed in the opening paragraph is characterised in that alkylene amine acetate-containing waste is contacted, at a pH of 9 or less, with activated sludge containing a wide range of microorganisms, in the absence of specific carrier materials."
The specification then illustrates this process using a model system of an activated sludge based waste water treatment plant which demonstrated sludge induced degradation of PDTA and EDTA at a variety of pH levels but with best results at pH 8.5 and 9.0. There are no submissions before me on whether the model system which is described as "semi-continuous" would be considered by workers in the art as an "activated sludge process". As mentioned earlier, Professor Anderson describes an activated sludge process as a continuous system. It is therefore possible that this model system is one of the obvious variations that the claims are intended to encompass. I think it would be undesirable to needlessly require the claims to be framed in such a way that might result in the disclosed examples of the invention falling outside the scope of the claims.
Overall, I conclude that there is a real and reasonably clear disclosure of the claimed invention in the body of the specification.
The opponent, referred me to the test from Olin Corporation v Super Cartridge Co Pty Ltd & Anor. (1977) 14 ALR 149 citing the statement of Barwick CJ at page 152:
"…the question is a narrow one, namely whether the claim to the product being new, useful and inventive, that is to say, the claim as expressed, travels beyond the matter disclosed in the specification".
In my opinion, the circumstances of this opposition differ somewhat from those in Olin Corporation v Super Cartridge Co Pty Ltd & Anor (supra), as in that case the claims were directed to a product, not necessarily made by the inventive method, see for example p 161, where Gibbs J stated:
"But the question is whether the claims extend beyond the subject of the invention. In my opinion the inventive step lay in the manner of making the articles. The appellant was entitled to a monopoly in respect of an article which carried its invention into effect - that is, an article made in accordance with the process it discovered - but not in respect of an article which might possibly made by a process entirely different from that of the appellant."
In this instance the applicant is claiming (broadly) the process discovered, and the claims do not appear, to me, to go beyond the subject of the invention. I am therefore not persuaded by these arguments that the claims lack inventive step.
Does not require the use of flocs
The Akzo application refers to the use of flocs in a single passage on page 2:
"It has been found that waste water which contains alkylene amine acetates and optionally, other contaminants can be effectively purified at a pH of about 8-9, by making use of organisms in flocs, without the need to employ a special carrier material for the microorganisms."
The opponent succinctly argued that:
"Notwithstanding that this term has a meaning in the art, the claim does not implicitly include this terminology. The claim is therefore not fairly based"
There is little information before me on "flocs", but Professor Anderson does provide some relevant comments in his evidence:
"In conventional activated sludge systems the microorganisms form naturally into discrete flocs which then act as natural carriers to which further microorganisms can attach. Artificial carrier materials in the form of beads, plastic rings, etc have been used in high-rate systems to aid in the attachment and retention of biomass.
….Given that it is usual in conventional activated sludge processes to deliberately waste some biomass in order to control sludge age, the complete retention of biomass is normally not appropriate. If adequate retention of solids is achievable through the natural floc formation process artificial carriers or filtration processes are not necessary"
Professor Anderson's evidence suggests that flocs occur naturally and are perhaps known to have some functionality in retaining biomass in activated sludge processes. Elsewhere in the Akzo specification where the inventive process is described there is no mention of flocs, only the absence of carrier materials. The examples of the invention do not mention flocs or how biomass is retained, although they do describe sludge retention time. I think what is broadly disclosed is that carriers do not have to be used, and not that flocs must be used.
Furthermore simply because there is a discussion of a feature in the specification does not mean that there must be a corresponding feature in the claim. Such an argument was rejected by Gummow J at page 94 in Rehm v Websters Security Systems (International) Pty Ltd (supra):
'' I accept the submission of counsel for the applicant that when the question is one of fair basing of a claim upon matter disclosed either in the body of the specification or in a provisional specification, it is not appropriate and is, indeed, misleading to seek to isolate in the body of the specification or in the provisional specification "essential integers" which correspond with the essential integers in the claim in question. "
For these reasons I am not persuaded by the opponent's arguments on this matter.
Claiming the class of alkylene amine acetates.
For this issue the opponent has argued that the claims go beyond a sound prediction and so are not fairly based quoting Olin Mathieson v Biorex (1970) RPC 157 at 193:
"If it is possible for a patentee to make a sound prediction and to frame a claim which does not go beyond the limits within which the prediction remains sound, then he is entitled to do so. Of course, in doing so he takes the risk that a defendant may be able to show that his prediction is unsound or that some bodies falling within the words he has used have no utility or are old or obvious or that some promise he has made in his specification is false in a material respect; but if, when attacked, he survives this risk successfully, then his claim does not go beyond the consideration given by his disclosure, his claim is fairly based on such disclosure in these respects, and is valid."
Clearly it is up to the opponent to prove that the prediction made by the applicant that the whole class of alkylene amine acetates can be degraded by the inventive method is not a sound one. The opponent bases their arguments, on evidence provided by the applicant's own experts, including the inventor himself Dr van Ginkel:
"None of the references cited by the opponent disclose or even suggest the degradation of PDTA. Microorganisms capable of degrading an organic compound require a series of enzymes capable of converting this compound or compounds of central metabolic pathways. These enzymes often have a very narrow specificity. Enzymes with narrow substrate specificities unable to recognise a compounds (sic) with an additional carbon do exist. In addition the central metabolic pathways of C2 and C3 compounds differ. A person skilled in microbial physiology would therefore not consider it obvious that an EDTA degrading organisms is also capable of degrading PDTA."
And also Professor Greenfield:
"None of the references discloses or suggests degradation of PDTA. It is not possible to predict effective biodegradability in a waste water treatment plant for one compound on the basis that a similar but simpler, compound is biodegradable. This is because the addition of more complex groups to a simpler molecular structure tends to reduce biodegradability (e.g. because of increased hydrophobicity, polymer structure). Given that EDTA is clearly only slowly biodegradable, it is simply not possible to infer that a similar but more complex compound such as PDTA is also effectively biodegradable in a waste management system"
However the opponent's basis for their argument appears somewhat unsound. Although the references referred to by Professor Greenfield and Dr van Ginkel may not disclose the degradation of both EDTA and PDTA, the Akzo specification does so, both in the general discussion and the examples illustrating the invention. The applicant therefore has a much broader basis for making a prediction than the earlier work.
There are other reasons not to accept the opponent's arguments. Professor Anderson did not support the remarks of Dr van Ginkel that the bacterial enzymes concerned are likely to have a very narrow specificity:
"It is also true that many enzymes have broad substrate specificity. It will thus depend on the active site of the enzyme as to whether degradation occurs. This will depend on whether the enzyme attacks the pendant carboxylate groups or the carbon chain. For complete mineralisation the comments may be true but for degradation this is probably not the case."
Furthermore several of the documents tended in evidence suggest the prediction that the organisms concerned can deal with a class of compounds may be a reasonable prediction.
In Belly et al, lagoon microorganisms degraded a range of related alkylene amine acetate compounds under alkaline conditions:
"… then the present study indicates that in addition to EDTA, other intermediates such as ED3A, EDDA and EDMA can also be degraded by microorganisms in aerated lagoons, and is consistent with the findings that both the ethylene and acetate parts of the EDTA molecule are metabolised to similar extents."
In the Lauff patent a single microorganism isolated from activated sludge was claimed to be suitable for degrading ferric chelates of aminopolycarboxylic acids having two or more amine groups and three or more carboxylic acid groups at a neutral or slightly alkaline pH.
"For the purposes of this application the term "ferric chelates of aminopolycarboxylic acid"….include for example, ethylenediamine tetra acetic acid (EDTA), propylenediaminetetra acetic acid, and the like."
For these reasons I find that the opponent has not proven that the claims the degradation of the class of alkylene amine acetates are based on an unsound prediction. I also find the subject matter of the claims broadly disclosed. None of the other matters raised under fair basis appear to cover different issues of any significance. I therefore find all the claims of the Akzo application to be fairly based.
Clarity
The opponent raised a number of issues under clarity, most of which appear to be quite minor and/or which relate to details on the working of the invention which the person skilled in the art would either obtain from the body of the specification or supply from their own stock of knowledge. One such issue perhaps merits a brief discussion.
Claim 8 defines a process according to any of the proceeding claims in which alkylene amine acetate degrading microorganisms are added to the activated sludge prior to or at the time the effluent stream contacts the sludge. The opponent argues that it is unclear whether the microorganisms added represent all the microorganisms responsible for degrading the alkylene amine acetate or constitute an additional supply and that therefore claim 1 is also not clear.
Although the answer to this question is not apparent in the claim itself, where the claims are ambiguous or unclear it is permissible to refer to the description for an answer. On page 4 of the description the applicant discusses how to achieve efficient degradation if in conditions where the alkylene amine acetate degrading activity has become too low. In such circumstances suitable microorganisms can be introduced to the treatment plant before or at the moment the effluent is supplied to the plant. The microorganisms can be supplied in the form of sludge taken from a time when the activity of the microorganisms was higher, or from specially cultured microorganisms. It is thus apparent from this description that claim 8 refers to a situation where the alkylene amine acetate degrading activity of the sludge in the plant needs to be enhanced by the addition of more microorganisms. Claim 8 is therefore clear.
I therefore find the Akzo application not to be deficient on the ground of clarity.
Full description
The opponent argued that the description was deficient with regard to the activated sludge for the following reasons:
The specification does not teach the skilled addressee how identify suitable activated sludges for the performance of the invention.
It is not clear that the person skilled in the art would have access to the waste water sludges identified in the application
The level of disclosure on the microorganisms used is lower than the level of disclosure used to support a microorganism patent.
An appropriate test for full description, suggested by the opponent, was that described by Carr J in Patent Gesellschaft AG v Saudi Livestock Transport and Trading Company [1997] 95 FCA (18 February 1997):
"The specification contains a full description if it makes the nature of the invention plain to persons having reasonably competent knowledge of the subject and also makes it plain, to persons having reasonable skill, how to perform the invention"
None of the experts appear to have any serious concerns with the identity and accessibility of suitable activated sludge to perform the invention. Judging from Professor Anderson's assessment of the cited prior art, Professor Anderson appeared to consider that microorganisms sourced from a variety of locations could be used to degrade EDTA and PDTA in the pH range of the claims.
Unless the specification is manifestly deficient, this issue can only be assessed by reference to evidence from the person skilled in the art. I do not consider the description is deficient to this degree. The illustrations of the invention use a number of different activated sludges and suggest to me that a range of waste water plants contain activated sludge suitable for the performance of the invention. For these reasons the opponent's arguments on this matter must be dismissed.
The opponent also argued that there was insufficient teaching in the specification to allow a skilled addressee to run an activated sludge process.
Professor Anderson has expressed some doubts on this matter:
"In some respects, however I do not consider that the process described is elaborated in sufficient detail to allow a person skilled in the art to put the process necessarily into practice. In particular, I note that none of the examples give what I would consider an adequate description of the feedstreams of the alkylene amine acetate containing waste. Whilst the bottom of page 4 gives an example of the concentration range for efficient degradation there is no disclosure of other materials that can or cannot be present to achieve efficient degradation.
Furthermore, in all the examples of (sic) the non-EDTA carbon content (NPOC) of the waste water is not clearly described. In these examples only NPOC from the added EDTA and the final treated in NPOC are given. In addition the nitrogen and metal levels are not mentioned. This is particularly important as calcium levels are known to be necessary since adequate calcium is necessary for healthy microbes in the presence of EDTA and other strong complexing agents. It is therefore not clear whether additional materials are required in a waste stream for the efficient working of the process. While on their face I would therefore assume this is not necessary this is unclear and may not provide a skilled addressee with adequate teachings to effectively work the invention."
Professor Anderson also states in his declaration filed during evidence in reply that the Akzo specification does not provide adequate teaching to develop a waste water degradation plant because the operating conditions are not adequately specified.
Professor Greenfield does not agree that the information provided is insufficient:
"It is highly unusual to specify in great detail all the components of an actual waste water, because in practice they are rarely measured. Only when a completely synthetic waste water is used is such a specification feasible. On the basis of what is presented in the opposed application, I consider that a practitioner of ordinary skill in the field would be able to design an EDTA degrading activated sludge plant."
The evidence of the two Australian experts is in conflict on these issues of sufficiency of description. There is little other evidence before me on the requirements and steps involved in designing and setting up a commercial process of biodegrading recalcitrant pollutants likes those of the invention using activated sludge. The examples illustrating the invention are described in the Akzo application as being run in accordance with an OECD guideline and using a published testing method. These examples appear to me to provide a reasonable amount of detail on the running of what is described as an accepted model system for a waste water treatment plant.
In addition the model system itself is a process of degrading alkylene amine acetates with all the features of the claimed invention. For all these reasons, I consider that the Akzo specification has not been shown to have failed the requirement for a full description of the invention.
I therefore find that the specification fully describes the invention.
CONCLUSION
Dow has failed to establish any of their grounds of opposition to Akzo's application.
I direct that this application may be sealed after twenty eight days from the date of this decision.
If the Commissioner of Patents is served with a notice of appeal from this decision before that time, I direct that sealing not occur until the appeal has been decided or discontinued.
COSTS
As there are no other circumstances of sufficient weight, I will follow the normal practice and award costs in accordance with the event.
I therefore award costs in accordance with Schedule 8 against Dow.
Ross Osborne
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Griffith Hack, Melbourne.
Patent attorneys for the opponent : Phillips Ormonde & Fitzpatrick, Melbourne
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