Biosys v Ecogen Australia Pty Ltd
[1995] APO 51
•29 August 1995
official notice
decision of a delegate of the commissioner of patents
Application : No. 620833 in the name of Biosys
Title: Mass Production in Liquid Culture of Insect-Killing Nematodes
Action: Opposition by Ecogen Australia Pty Ltd under Section 59 of the Patents Act 1952.
Decision: Issued .
Abstract: Opposition succeeds on the grounds of non-compliance with section 40.
Applicant given the opportunity to amend.
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent Application No. 620833 by Biosys and Opposition thereto by Ecogen Australia Pty Ltd under Section 59 of the Patents Act 1952.
background
Patent application 620833 by Biosys was filed on 18 November 1988 under the provisions of the Patent Cooperation Treaty as PCT/US88/04124. The application claimed priority from US 123130 which was filed on 20 November 1987. The application was advertised accepted on 27 February 1992. On 27 May 1992 Ecogen Australia Pty Ltd (Ecogen) filed a notice of opposition.
As the application was filed before, but accepted after, the commencement of the Patents Act 1990, section 59 of the Patents Act 1952 and Chapter 5 of the Patents Regulations 1991 apply in relation to the opposition.
The serving of evidence was completed on 28 March 1994. On 27 April 1994 the applicant filed a voluntary request to amend the complete specification. These amendments were allowed on 23 November 1994.
A hearing to determine the opposition took place in Canberra on 16 May 1995. Biosys was represented by Dr J McL Emmerson QC instructed by Dr W Pickering patent attorney of F B Rice & Co. Ecogen was represented by Dr J McCann, patent attorney, of Spruson & Ferguson.
The specification
The patent specification is entitled "Mass Production in Liquid Culture of Insect-Killing Nematodes". The specification indicates that the invention relates to insect control employing biological agents for the benefit of agriculture, garden and household insects. In particular, it relates to large-scale production in liquid culture of insect parasitic nematodes using an improved nutrient medium and optimal culturing conditions.
Nematodes which are parasitic to insects are called entomogenous or entomopathogenic nematodes. These nematodes are an effective means of insect control. Of these the Order of greatest interest for insect control is the Order Rhabditida including the Steinernematid and Heterorhabditid Families. Nematodes within these families are symbiotic with species of bacteria. The growth of the nematodes is favoured in the presence of this associated symbiont, presumably because the symbiont serves as an easily assimilated food source.
The prior art methods of culturing nematodes are then described including the use of a solid phase matrix of plastic foam impregnated with homogenised animal tissue in which the nematodes are grown. It is stated that the problem with this method is that a scaled up version would require expensive automated equipment, would be difficult to maintain in an aseptic state, and would present difficulties in medium preparation and nematode harvesting. It is stated that a liquid, monoxenic process would avoid these limitations.
Liquid, monoxenic cultures grown in small drops of insect hemolymph are known. Axenic liquid cultures have been reported but are described as being limited in efficiency and requiring expensive nutritional additives.
The description then states that one of the greater difficulties in developing a liquid, monoxenic culture is in providing sufficient aeration for both the bacteria and the nematodes without exposing the nematodes to excessive shear forces. The prior art disclosure PCT Patent Application No. 86/01074 (PCT/AU85/00199, the Pace Application) is then discussed. It is stated that this application describes a process for large-scale culture of nematodes which addresses some of the problems associated with aeration requirements by control of the stirring rate. The Pace application also describes the use of a conventional liquid culture medium composed of ox kidney homogenate and yeast extract.
The discovery that led to the present application is then stated:
"It has been discovered that a critical component in a liquid, nutrient culture medium supportive of monoxenic nematode culture but controlled for oxygen demand, is the requirement of an emulsifier, such as egg yolk, which serves to facilitate the utilization of added oils or fats and that there have not been any previous reports of using an emulsifier to benefit liquid culture of entomogenous nematodes ..."
The objects of the invention are then described:
"It is, therefore, an object of the present invention to improve the production efficiency of entomogenous nematodes in liquid culture.
It is a further object of the invention to provide an improved liquid culture medium support of monoxenic culture but controlled for oxygen demand. This nutrient medium is easily prepared and is relatively inexpensive to produce as compared to presently available media.
Yet a further object of the invention provides a method to enhance bacterial and nematode development wherein the agitation rate is varied depending on the changing oxygen transfer requirements associated with each nematode developmental stage."
The invention is then described as providing a commercially inexpensive medium for culturing entomogenous nematodes in liquid culture wherein the essential nutrients are an emulsifier, such as egg yolk, a source of vitamins and minerals, such as that provided by yeast, a source of triglycerides, provided by an oil, and a source of protein, the medium having been sterilized and subsequently inoculated with bacteria symbiotic with the nematodes.
The description then gives examples of the various components. Egg yolk is a preferred emulsifier, part of which can be substituted by lecithin. The yeast source of vitamins and minerals may be that provided by yeast extract or yeast cells. A variety of triglyceride sources may be used, including vegetable oils and animal oils such as fish oil and lard. A preferred source of triglycerides is vegetable oil. The source of protein may be provided by protein extracts including dried animal organ extracts, fish meal, soy peptone and soy flour of which soy flour is preferred.
The specification ends with 18 claims of which claim 1 is the only independent composition claim:
"1. An emulsified liquid medium for culturing entomogenous nematodes in liquid culture, said medium comprising an emulsifier, a yeast source of vitamins and minerals, vegetable oil, and a source of protein, wherein said medium has been sterilised and subsequently inoculated with bacteria symbiotic with said nematodes."
Claims 2 to 6 further define components of the medium. Claim 7 defines a method of culturing nematodes:
"7. A method of culturing entomogenous nematodes in liquid medium comprising:-
i) inoculating the medium according to any one of claims 1 to 6 with a culture of entomogenous nematodes,
ii) agitating and aerating the medium during the reproductive cycle of the nematode culture, to provide sufficient dissolved oxygen for nematode growth, the medium also being maintained at a temperature suitable for nematode growth, and
iii) recovering the infective juveniles."
Claims 8 to 18 also define methods.
the grounds of opposition
The grounds of opposition as set out in the statement of grounds and particulars and relied upon at the hearing are:
"That the invention, so far as claimed in any claim, was published in Australia before the priority date of that claim.
The invention defined in at least claims 1, 7, 10 to 12, 14 and 15 of the opposed specification was published in Australia in International Patent Application No.PCT/AU85/00199 [the Pace application] on 26 February 1986."
"That the invention, so far as claimed in any claim, was, before the priority date of that claim, otherwise not novel in Australia."
Under this ground the opponent also relied upon the Pace application. Claims 1 to 15 were identified under this ground.
The ground of obviousness was listed in the Statement but not pursued at the hearing.
"That the complete specification does not comply with the requirements of Section 40 of the Act."
Many of the particularised instances under this ground were overcome by amendment prior to the hearing. At the hearing the opponent introduced further issues under this ground. In considering this ground I will follow the practice as set out in Cooper Industries Inc v Metal Manufactures Ltd (1994) AIPC 91-051 and address these problems in my decision.
evidence
The evidence consists of a number of declarations. I have summarised the evidence in support below. The other declarations were primarily concerned with the nature of the emulsion formed in both the prior art and the present application. I will refer to them in my decision where necessary.
Gary William Pace
The Pace application previously described the large-scale production in liquid culture of insect parasitic nematodes using substantially the same medium in essential function as that described in the Biosys application. The nutrient medium has not been improved.
The yields of Steinernema carpocapsae infectious juvenile nematodes in the Biosys application are substantially similar to those described in the examples of the Pace patent application.
The claims of the Biosys application do not achieve the objects stated in the description.
The nutrient media described in the Biosys application are not cheaper or easier to prepare than previously described media.
Material of an animal origin such as ox or pig kidney or chicken guts, inherently contain fats (i.e. sources of triglycerides), insoluble proteins as well as naturally occurring emulsifiers such as soluble proteins, phospholipids and cholesterol. The addition of a separate emulsifier in the Pace application would be redundant as it is already present. An Australian skilled person at the date of the Biosys application would have known that in a culture medium, as described in the Biosys application, a combination of a distinct protein source, triglyceride source and emulsifying source would, in essential function be equivalent to in a culture medium, as is described in the Pace patent application, a homogenized ox or pig kidney, or chicken guts component, all of which conveniently contain in combination, a protein source, a triglyceride source and natural emulsifiers.
novelty
The Citation
International Patent Application No. PCT/AU85/00199 (the Pace patent application) was published in Australia on 27 February 1986. The specification discloses the large scale production of entomopathogenic nematodes by a liquid culture method while maintaining critical conditions in such a way as to minimise shear forces while still allowing optimal agitation, gas exchange and nematode suspension.
The medium is described as preferably containing homogenized material of animal origin such as chicken guts or kidney of ox or pig. The medium composition should be adjusted to assist in stimulating the growth of the particular species of nematodes and its bacterial symbiont, to be cultured, and the progression of the nematode into the infective form.
An example describes a medium made up of ox kidney homogenate and yeast extract in deionised water. It is also stated that defined media, semidefined media and media based on different types of offal also support nematode growth and reproduction at varying yields.
Decision
The generally accepted test for anticipation is the "reverse infringement" test as set out in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235 where Aickin J 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 anticipation would, if the patent were valid, constitute an infringement."
Infringement of a claim occurs when each and every one of the essential integers of the claim have been taken (Rodi and Wienenberger AG v Henry Showell Ltd [1969] RPC 367).
It is common ground that the Pace citation discloses a liquid medium for culturing entomogenous nematodes in liquid culture, said medium comprising a yeast source of vitamins and minerals and a source of protein wherein said medium has been sterilised and subsequently inoculated with bacteria symbiotic with said nematodes.
There was some conflict in the evidence about the nature of an emulsion and whether the medium of the citation could be described as an "emulsified liquid medium". The experimental results described by Dr Friedman in his declaration for the applicant indicated that the ox kidney homogenate as described by Pace formed a layer of fat after five minutes centrifugation. Dr Selvan in a declaration for the opponent found that the medium of the opposed application separated after three minutes centrifugation. On this point I conclude that if the medium of the examples fall within the scope of the word "emulsified liquid medium" as used in claim 1, then this description is equally appropriate for the medium of Pace.
Counsel for the applicant submitted that there is no explicit disclosure in the citation of two of the features of the claim of the present application, that is, the addition of an emulsifier to form the emulsion and the presence of vegetable oil.
Dr Emmerson submitted that although the prior art contained ox kidney, there was no disclosure of the function or significance of the components. In particular it does not teach that it is necessary to have an emulsifier present or recognise the importance of emulsification.
I accept Dr Emmerson's submissions to the extent that the citation does not disclose the use of a substance that is a well-defined emulsifier that is known for this property and that it is the addition of a well-defined emulsifier that is the essence of the present invention. I do not agree however that the words
"... said medium comprising an emulsifier ..." in claim 1 serve to exclude media in which small amounts of an emulsifier are inherently within the mixture because of the presence of a component such as ox kidney, or that the importance of this emulsifier needs to be recognised in the disclosure. It may well be that the presence of a well-defined emulsifier is an essential feature of the invention described in the present application but this feature is not defined claim 1. Thus I conclude that the citation implicitly discloses the presence of an emulsifier in the medium as defined by claim 1.
On the issue of the presence of a vegetable oil Dr McCann submitted that although the presence of a triglyceride was an essential feature, the nature of the source of the triglyceride was not an essential feature but rather an arbitrary limitation provided to avoid anticipation and which could not give rise to novelty.
Dr Emmerson submitted that from the language of the claim it was clear that the nature of the oil was an essential feature. He referred to the rules of construction as set out in Decor Corp v Dart Industries (13 IPR 385) and stated that where the claims are clear there is no need to go to the body of the specification itself.
The issue of determining essential features was discussed in Catnic Components v Hill and Smith Ltd, [1982] RPC 183 at page 228:
"... I think that one can venture upon the following generalisations on the question of essentiality. (1) If that feature of the claim which is under consideration is in fact essential to the working of the claimed invention, then it must be an essential feature of the claim. (2) If the feature is not in fact essential to the working of the claimed invention, the applicant for a patent may nevertheless have made it an essential feature of the claim, that is to say, he may by the terms of the claim as properly construed have clearly limited his claim to a subject matter having that particular feature. If so, that feature will be an essential feature of the claim and anyone who makes a product or carries out a process which has all the features of the claim except that particular feature will not infringe the claim. But (3), all claims are not perfectly framed. Sometimes a draftsman may include some feature in a claim, either explicitly or by implication, which is not in fact essential to the working of the claimed invention and which the applicant has not by the terms of his specification and claim clearly indicated as a feature which he regards as an essential feature of his monopoly. In such a case an alleged infringer may be held to have infringed the claim notwithstanding that his product or process does not incorporate the feature in question or substitutes some equivalent for it. (4) The fact that a claim incorporates a particular feature does not alone suffice to make that feature an essential one. If this were not so, no feature of a claim could ever be inessential, but the speeches in Rodi and Wienenberger all assume that a claim may include an inessential feature"
Although I accept Dr Emmerson's point regarding the construction of claim 1 in that the scope of the claim is clearly limited to a medium comprising vegetable oil, it seems to me that it is impossible to determine whether a feature defined in a claim is essential or inessential solely by considering the claim without reference to the description ("... by the terms of his specification and claims ...").
In the specification as filed claim 1 was directed to a medium comprising "... a source of triglycerides ..." with no limitation as to the type of source. Amendments were filed prior to acceptance to limit the source to a vegetable oil. In the description in its present form animal oils, such as fish oil and lard, are also listed as possible triglyceride sources. While it is not clear from the description whether the particular nature of the source of triglycerides is essential to the working of the invention, it is clear that the source of triglycerides is something discrete, that is, a well-defined fat or oil which is added to the medium. Although the actual nature of added oil or fat is not important it is not contemplated that the fat or oil is, for example, provided by ox liver. In the claims the applicant has chosen to limit this essential feature to vegetable oil.
As vegetable oil is not disclosed in the Pace application I find that claim 1 is novel in the light of that document. Claims 2 to 6 are dependent on claim 1 and are similarly novel. Claims 7 to 18 define method using a medium according to any one of claims 1 to 6 and are also novel.
section 40
Most of the problems identified under the ground of Section 40 in the Statement of Grounds and Particulars have been overcome by amendment. The following issues were identified by the opponent at the hearing:
Claim 1 is not fairly based because it fails to achieve the objects of the invention.
The description states that the objects of the invention are to improve the production efficiency of entomogenous nematodes in liquid culture, to provide an improved liquid culture medium support of monoxenic culture but controlled for oxygen demand and that the nutrient medium be relatively inexpensive to produce as compared to presently available media. The opponent asserts that the medium is not an improvement when compared to the medium disclosed in the Pace declaration and that the yields of nematodes are substantially the same.
In a recent decision of the Supreme Court of NSW (Pracdes v Stanilite Electronics, unreported, 17 February 1995, No 3324/85) Windeyer J. considered the question of whether a claim which did not achieve a promise of the invention was fairly based:
"Inutility should not be confused with false basing. The claim is referable to the invention disclosed and is limited to it. It thus complies with s40(2) of the Patents Act."
It seems to me that the question of whether the invention as claimed achieves the objects of the invention is a question of utility and is not one that can be addressed in an opposition proceeding.
The scope of the claims of the opposed application is too wide since what is claimed is substantially equivalent with what has been disclosed previously and consequently cannot form part of the consideration given to the public for the monopoly which would be obtained if the claims were granted.
This objection seems to relate to a lack of novelty or inventiveness rather than to a non-compliance with section 40. The relevant test for a speculative claim is not whether the claim includes the prior art but whether the ambit of the claim is indeterminate and the field claimed largely unexplored (Esau's Application, (1932) 49 RPC 85).
In the present application I have found that an essential feature of the invention disclosed in the specification is that a well-defined emulsifier be added to the medium. This feature is not present in claims 1, 3 to 5 and 7 to 17 (the other claims include egg yolk in the medium). For this reason these claims are not fairly based on the description.
The scope of the claims of the opposed application is too wide since what is claimed are media and methods for liquid culturing of any entomogenous nematode whereas only a single strain of nematode culture and bacterial symbiont are disclosed in the examples and there is no evidence that the claimed media and methods would work for other strains.
The description discloses a medium for culturing nematodes. The applicant is entitled to claim the medium per se. They are also claiming a method of using this medium for culturing any entomogenous nematode based on the reasonable prediction that the medium can be so used. As it is the medium itself that is the alleged invention I cannot see how such a method claim travels beyond the scope of the disclosure. If the applicant is wrong, and the medium is not useful for other strains, then that is a question of utility which cannot be considered in these proceedings.
The description states that "dissolved oxygen must be maintained over approximately 32 mmHg throughout most of the process, but must be higher than 40 mmHg and preferably 80 mmHg when adults are developing and laying their eggs". Method claims 7 and 8 do not have this limitation.
Claim 7 defines that the medium be agitated and aerated during the reproductive cycle of the nematode culture "to provide sufficient dissolved oxygen for nematode growth". Claim 8 similarly defines that the medium be agitated. Claim 9 claims the method of claim 7 or 8 wherein the dissolved oxygen is maintained "at [over] approximately 32 mmHg, except for whilst adults are developing and laying eggs at which time the dissolved oxygen is maintained at 40 mmHg or higher". (It was conceded by the applicant at the hearing that the word "over" should be inserted before "approximately 32 mmHg".)
If the limits in the description are taken to be implicit in the wording of claims 7 and 8 then claim 9 is redundant. A preferable construction is that the level of oxygen in claims 7 and 8 is not so limited in which case the phrase "sufficient dissolved oxygen for nematode growth" includes amounts outside those defined in the description. As a result claims 7 and 8 are inconsistent with the description and not fairly based (Mond Nickel Co. Ltd's Application, (1948) RPC 123).
Claim 9 defines a method wherein the dissolved oxygen is maintained "at approximately 32 mmHg" whereas in the description the level is "over approximately 32 mmHg".
The applicant concedes that this was an error and will file appropriate amendments.
I conclude that claims 1, 3 to 5, and 7 to 17 are not fairly based because they omit an essential feature of the described invention and that claims 7 to 9 are not fairly based because they are inconsistent with the description.
conclusion
All of the claims are novel in the light of the Pace application for the reasons set out above.
Claims 1, 3 to 5, and 7 to 17 do not comply with section 40 because they are not fairly based on the matter described in the specification.
I allow the applicant 60 days from the date of this decision to propose relevant amendments to overcome these deficiencies.
costs
In actions before the Commissioner costs normally follow the event. In this case the opponent was not successful on the grounds of novelty. I did, however, find that the specification did not comply with Section 40. Although the major deficiency was not in the statement of grounds and particulars the two minor deficiencies had either been particularised or were introduced by amendment. On balance I think that it is appropriate for the parties to bear their own costs.
Vivienne Thom
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : F B Rice & Co
Patent attorneys for the opponent : Spruson & Ferguson
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