Commonwealth Scientific and Industrial Research Organisation v Bio-care Technology Pty Ltd and Ecoscience Corporation

OFFICIAL NOTICE

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application : No. 666888 in the name of Commonwealth Scientific and Industrial Research Organisation

Title: Insect Pest Control

Action: Oppositions under Section 59 by
Bio-care Technology Pty Ltd
&
Ecoscience Corporation

Decision: Issued

Abstract

The issue of whether a “micro-organism is not reasonably available to a person skilled in the relevant art in the patent area” as per paragraph 41(2)(c) of the Act was considered. The purpose of this provision in the Act was discussed.
Specific preferred fungal isolates were only available from the applicant. It was decided that exclusive control over access to microorganisms by an individual or entity meant that the microorganisms were not ‘reasonably available’. The specification as filed does not adequately identify the isolates. There can be no valid claim defined by reference to the isolates, since it would not be possible to determine the scope of the claim, whether the claim is novel or inventive or whether the claim is infringed or not.
The majority of claims of the application to methods of controlling termites were found invalid for want novelty or lack of an inventive step.
The prophylactic treatment of an uninfested structure and the prophylactic treatment of soil surrounding a structure with conidia of Metarhizium anisopliae are novel and non-obvious as the applicants were the first to realise the repellency of conidia to termites.
Applicant allowed 60 days to propose amendments to overcome the issues raised in the decision.
Costs awarded against the applicant.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 666888
in the name of Commonwealth Scientific and Industrial Research Organisation
and oppositions thereto by Bio-care Technology Pty Ltd and Ecoscience Corporation.

BACKGROUND

Patent application number 29365/92 in the name of Commonwealth Scientific and Industrial Research Organisation (CSIRO) was filed under the provisions of the Patent Cooperation Treaty on 23 November 1992 claiming priority from Australian Provisional application PK 9664 filed 22 November 1991. The application was advertised accepted on 29 February 1996.

On 29 May 1996 two notices of opposition were lodged, one in the name of Bio-care Technology Pty Ltd (Biocare) and the other by Ecoscience Corporation (Ecoscience). On 29 August 1996 each opponent served its Statement of Grounds and Particulars on the applicant. Each opponent served separate evidence-in-support of their opposition as well as separate evidence-in-reply. All evidentiary stages, including the applicant’s evidence-in-answer, were completed in relation to both oppositions in December 1997.

The oppositions were heard simultaneously in Canberra on 30 and 31 July 1998. Both opponents were represented by Katrina Howard of Counsel. Ms Howard was assisted by Ann Kurts (Patent Attorney from Griffith Hack, Sydney) for Bio-care Technology Pty Ltd and John McCann (Patent Attorney from Spruson & Ferguson, Sydney) for Ecoscience Corporation. The applicant was represented by David Yates S.C. of Counsel instructed by John Slattery (Patent Attorney from Davies Collison Cave, Melbourne).

EVIDENCE

Evidence-in-support of the Biocare opposition consists of Statutory Declarations by:

Andrew Charles Rath; Ann Kurts; Ngaire Petit-Young; Kevin Griffin; Deborah Stumm; and John Lawrence Rodwell.

Evidence-in-support of the Ecoscience opposition consists of Statutory Declarations by:

John Francis McCann; Dudley Edwin Pinnock; and John Francis McCann.

Evidence-in-answer to the Biocare opposition consists of a Statutory Declaration by Richard James Milner.

Evidence-in-answer to the Ecoscience opposition consists of a Statutory Declaration by Richard James Milner.

Evidence-in-reply in the Biocare opposition consists of a Statutory Declaration by Andrew Charles Rath.

Evidence-in-reply in the Ecoscience opposition consists of Statutory Declarations by:

John Francis McCann; Dudley Edwin Pinnock; and David W Miller.

In addition, under Subregulation 5.11 (1) I have also had regard to Australian Patent 607166 (81386/87), published as accepted 28 February 1991. This is the Australian family equivalent of US 5,418,164 which was tendered in evidence in the Ecoscience opposition. US 5,418,164 was not published prior to the earliest priority date, whereas 607166 was.

Pursuant to the provisions of Paragraph 5.11 (2) (c) I gave both the applicant and Ecoscience 28 days to give evidence or make representations with respect to the document. The applicant provided written submissions on 21 September 1998.

THE SPECIFICATION

The specification states that “this invention relates to the use of fungus, particularly Metarhizium anisopliae, for control of termites and other pest insects.” It also indicates that the fungus, Metarhizium anisopliae, is a known pathogenic fungus which infects a wide range of insects.

As background to the current invention the specification discloses that:

“Termite infestations have previously been controlled by the use of highly toxic chemicals such as arsenic and organochlorine based compounds. With the increase in awareness of the dangers of these chemicals it is now desirable to develop other effective means to control termites and other pest insects.”

“whilst it is known that Metarhizium anisopliae has the ability to infect pests such as termites and subsequently infect previously healthy termites, the effective use of this fungus in the field has not been achieved. One reason for this is that it has been observed that healthy termites avoid infected termites which have died. . . . . . . Thus, whilst the fungus has previously been used in the laboratory to infect termites over a short period of time in a confined area, it has not been reported to be at all effective for use in the field.”

The specification outlines one of the major difficulties to be overcome in the successful field control of termites on pages 6 and 7:

“Another difficulty to overcome with developing an effective method for the control of termites in field applications relates to the observed nature of healthy termites to avoid Metarhizium anisopliae. In some instances at has been observed that after a nest has been treated with fungus that it has been possible for the treated portion of the nest to be sealed off by the termites and regular functioning of the colony to occur in the untreated portion of the nest.

Applicant has found that whilst there could be several mechanisms for this observation surprisingly it is the volatiles from the conidia which are thought to be an important component.”

The stated object of the present invention is to:

“overcome or alleviate at least one of the difficulties associated with effectively controlling termites in the field”.

The four major aspects of the invention as described in the accepted specification are as follows:

i) A method for selecting fungal species or strains suitable for controlling termites;
ii) A method of harvesting conidia from the growth medium in the presence of a water wetting agent to reduce dust generated during the preparation phase;
iii) A method of storing conidia with clay to alleviate loss of viability during storage;
iv) A method of controlling termites in the field by use of Metarhizium anisopliae conidia or formulations thereof. This may be achieved by either one or a combination of:
a) “Prophylactic treatment” :- comprising treating an uninfested area or structure with Metarhizium anisopliae conidia or formulations thereof such that termites will avoid said area or structure.
b) “Curative treatment” :- comprising treating an infested area or structure with Metarhizium anisopliae conidia or formulations thereof such that the treatment will result in substantial colony mortality.

The term “conidia” as used in the specification refers to the spores of the fungus. Botanically speaking a spore is a minute reproductive body characteristic of flowerless plants. More specifically in relation to the current invention conidia are unicellular asexual reproductive bodies occurring in certain fungi.

The independent claims which define the invention, as accepted, are as follows:

A method of controlling termites, in field applications, said method comprising applying to an area or structure an effective amount of conidia of a select strain of Metarhizium anisopliae or formulations thereof.
A method of controlling termites in field applications, said method comprising applying to an uninfested structure, a prophylactic effective amount of conidia of a select strain of Metarhizium anisopliae or formulations thereof, such that said structure will not suffer damage from termites.
A method of controlling termites in field applications, said method comprising applying a prophylactic effective amount of conidia of a select strain of Metarhizium anisopliae or formulations thereof to the soil surrounding a structure to be protected from termite infestation.
A method of controlling termites in field applications, said method comprising treating an infested area or structure with a curative effective amount of conidia of a select strain of Metarhizium anisopliae or formulations thereof, such that the treatment will result in substantial termite colony mortality, said treatment comprising distribution of said conidia or formulations thereof substantially throughout said infested area or structure.

12.A termite prophylactic formulation or a termite field curative formulation comprising a suspension of conidia of a select strain of Metarhizium anisopliae; in an aqueous solution of a water wetting agent.
13.A termite prophylactic formulation or a termite field curative formulation comprising conidia of a select strain of Metarhizium anisopliae and an acceptable carrier, as a powder.
17.A termite prophylactic formulation or a termite field curative formulation comprising conidia of a select strain of Metarhizium anisopliae and an acceptable carrier, as a bait.

Pertinently, there are also dependent claims to methods which involve the use of specific preferred isolates of Metarhizium anisopliae referred to by CSIRO specific designations FI610, FI535 & FI726.

Other dependent claims variously contain the additional preferred features listed below:

The amount of conidia used in the method is such that the concentration of conidia on the surface of said structure is at least 10⁸ spores per cm³.
The amount of conidia applied to the soil is such that the concentration of conidia is at least 10⁸ spores per gram of soil.
The termites being treated are of the genera Copotermes, Nasutitermes, Neotermes or Mastotermes.

It is also worthy of note that a method for selecting fungal species, a method of harvesting conidia in the presence of a water wetting agent, and a method of storing conidia with clay do not form part of the claimed invention, even though these are described as major aspects of the invention.

The concepts of an “epizootic model” for infection of termites and the repellency of conidia to termites form an important background in relation to the current invention. These two issues were the subject of significant submissions from both counsel at the hearing.

I understand an “epizootic” to be a process whereby a large scale fungal infection is induced in a colony of termites via the initial ‘dosing’ of a small number of termites which are used as the initiating source for the large scale infestation. Generally, this process entails the application (dosing) of the infectious fungus (eg Metarhizium anisopliae) to a discreet number of termites, being some small percentage of the total number of termites resident in a colony or mound. The treated termites are used as infectious carriers to initiate the spread of the ‘disease’ throughout the termite colony to establish a wide scale infection.

In many ways a successful epizootic is an extremely clever model which, if successful, is designed to bring about substantial termite colony mortality with minimal amounts of infectious agent and labour. As mentioned earlier, the specification asserts that it is known that Metarhizium anisopliae has the ability to infect pests such as termites and subsequently infect previously healthy termites, however, the effective use of this fungus in the field has not been achieved.

Submissions from Mr Yates for the applicant also highlighted the fact that there have been some difficulties in transferring apparently successful laboratory results using Metarhizium anisopliae to the field. He indicated such difficulties could be related to the different conditions, such as temperature and ambient moisture, between the laboratory and the termite colony. Mr Yates also stressed the point that a successful laboratory experiment will not necessarily transfer to the field with the same degree of success, if any at all, given the behavioural characteristics of termite colonies.

Both counsel made reference to various documents which exhibited the use of the “epizootic model” for infection of termite colonies. The abstract from exhibit JFM-2 (Hanel & Watson - full citation below) is a representative summary of ways in which epizootics can be performed. The abstract is as follows:

“The insect-pathogenic fungus Metarhizium anisopliae caused heavy mortality in laboratory groups of the Australian termite Nasutitermes exitiosus (Hill) to which infected workers had been added. Conidia of Metarhizium anisopliae started an epizootic when introduced into field colonies of N. exitiosus near Canberra, irrespective of whether the termites were treated by dusting or spraying in the mound itself, or dusting in nearby feeding sites. In some cases the disease persisted for at least 15 weeks, and by this time few healthy termites could be found in almost half the treated colonies. Samples of workers taken from treated colonies showed high levels of contamination by Metarhizium, irrespective of the state of the colony, but the factors that inhibited the completion of fungal development in the nest are unknown.”

Mr Yates for the applicant specifically emphasised the point in the last sentence of the above abstract, that “the factors which inhibited the completion of fungal development in the nest are unknown.” He submitted that the limited success of field trials may be attributed to several factors, not the least of which might be that others in the field had not been in possession of the knowledge that conidia of Metarhizium anisopliae are repellent to termites. Mr Yates stated that the fact that conidia of Metarhizium anisopliae are repellent to termites was first realised by the current applicant.

Ms Howard for the opponents submitted that the claim by Dr Milner in evidence on behalf of the applicant (para 4 of both Milner declarations) that the ‘realisation that termites can detect and avoid pure conidia of Metarhizium was critical to the present invention’ must be viewed with some scepticism given the statement at the bottom of page 6 of the specification regarding “the observed nature of healthy termites to avoid Metarhizium anisopliae”.

On this point, Mr Yates took care to highlight the difference between the observed nature of healthy termites to avoid Metarhizium anisopliae as referred to at page 6 of the specification and the realisation that termites can detect and avoid conidia of the fungus. Specifically, he submitted it is not permissible, nor logical, to equate the observation that healthy termites avoid Metarhizium with the knowledge that it is the volatiles from conidia which are the important component in the repellency. For instance he stated, it is one thing to know that termites avoid Metarhizium, it is a different matter altogether to specifically identify what causes the repellency. Mr Yates further stated that it was not previously known what the cause of the observed behaviour was and there was nothing to suggest the conidia, as opposed to for instance the mycelia of the fungus, were in fact critical to the observed behaviour.

I must agree with Mr Yates for the applicant. I believe the knowledge that healthy termites avoid Metarhizium is not equivalent to a position where one can say that termites are able to detect volatiles from conidia and hence avoid the fungus.

DECISION

Construction of the Complete Specification and Section 40 matters

i) Not clear what the invention is
Ms Howard, for the opponents argued that the specification offends s.40(2)(a) because:

It is not plain from a reading of the whole specification what the invention is.
The abstract describes a particular invention said to be provided by the specification and the specification then describes ‘five aspects’ of the invention only two of which are claimed.
After reading the specification, especially the background art, one is left wondering what is the invention.

Mr Yates for the applicant submitted that:

The specification makes the nature of the invention sufficiently clear.
The abstract is not to be taken into account in construing the nature of the invention, this is specifically excluded by Regulation 3.4(8).
The fact that only two of the five described aspects are claimed, is not relevant, as it is for the applicant to decide which aspects of their invention they choose to claim.

I agree with Ms Howard that the specification is in some superficial respects contradictory or slightly misleading and in other respects only provides the reader with the most basic information regarding the alleged invention and how to perform it.

On balance, however, I can not agree with Ms Howard for the opponents that the specification does not clearly state what the invention is. As indicated by Mr Yates the abstract is not to be taken into account in construing the nature of the invention and it is for the applicant to decide which aspects of the alleged invention they choose to claim.

ii) Insufficient description of preferred isolates - FI610, FI535 & FI726

Ms Howard made the following submissions:

There was insufficient information in the specification to enable a person skilled in the art to carry out all embodiments of the alleged invention, citing Biogen v Medeva (1996) 36 IPR 438 at 459. Specifically, claim 2 refers to isolates FI610, FI535 & FI726 and mixtures thereof. It is unclear what these isolates are.
The specification does not identify a commercial source for obtaining the isolates.
A person skilled in the art could not reasonably be expected to perform the invention (as encompassed by the claims) without first having a sample of an isolate. The specification states that the characterisation of Metarhizium anisopliae is difficult, however, no characteristics of the specific isolates are given.
Such isolates were, and still are, not freely available. CSIRO were not willing to provide a sample of the isolates to Biocare without Biocare entering into a license agreement.
Hence, in accordance with Patent Office practice (Manual of Practice and Procedure Vol. 2, para 6.3.5) the specification is to be taken to comply with paragraph s.40(2)(a) if, and only if, the deposit requirements are satisfied. There has been no deposit and section 40(2)(a) is not complied with.

Mr Yates submitted that the points raised by Ms Howard ignore what is actually said in the legislation. He indicated that regard must be had to what is actually stated in Section 41, that is:

“Where . . . a person skilled in the relevant art in the patent area could not reasonably be expected to perform the invention without having a sample of the micro-organism before starting to perform the invention; and the micro-organism is not reasonably available to a person skilled in the relevant art in the patent area; the specification is to be taken to comply with paragraph 40(2)(a) . . if, and only if, the deposit requirements are satisfied in relation to the micro-organism.”

Mr Yates placed particular emphasis on the phrases highlighted above. He also submitted that:

A sample of the preferred isolates was not necessary as the specification discloses a method for selection of appropriate fungal strains, which can be used to obtain the isolates. Specifically, example 1 of the specification provides adequate description of how the specific strains are selected.
The correct test to be applied was not whether the strains were freely available, as argued by Ms Howard, but as set down in Section 41, whether the strains were reasonably available.

The two crucial issues which I need to consider are: a) whether the person skilled in the art could not reasonably be expected to perform the invention without having a sample of the specific isolates; and then b) whether the isolates are reasonably available.

a) could not reasonably be expected to perform the invention without having a sample of the preferred isolates

The specification, as filed, indicated that the isolate designations FI610, FI535, FI726, and other isolates referred to in the same manner are those used by the CSIRO, with no indication of where one might obtain a sample of the isolates. The specification as accepted, on page 5, indicates that the preferred isolates referred to as FI610, FI535, FI726, and others are held in the CSIRO Pathogen Culture Collection. Relevantly, the specification as filed did not have any such indication. Neither the specification as filed or as accepted provides specific identifying characteristics of the three preferred isolates, nor other isolates referred to in a similar way.

Dr Rath declares that:

“It is unclear what isolates FI535, FI610 and FI726 are. In my opinion a person skilled in this art could not obtain or know whether they had a sample of one of the isolates FI610, FI726 and FI535 on the basis of the disclosures of the specification.”

This is not specifically contested by Dr Milner, for the applicant, in his evidence-in-answer in the Biocare opposition.

In the Ecoscience opposition, Dr Pinnock declares that:

“In my opinion it would be impossible to isolate similar strains without more information regarding the source of these isolates. In addition, the characteristics of the strains listed in the opposed application are not provided in detail. Consequently, a person skilled in fungal microbiology and entomology could not isolate strains with the properties of those strain listed in the opposed application.”

Dr Milner, for the applicant, in his evidence-in-answer rebuts the statements of Dr Pinnock by stating that:

“It is clear from the disclosure in the present specification that the strains which are used are strains which have been selected in accordance with the bioassay disclosed in the present specification.”

Dr Milner further indicates, in response to paragraphs 173 to 175 of the Pinnock declaration, that:

“neither the individual ‘select’ strains, nor the method of selection of those strains, form part of the invention claimed.”

Firstly in contrast to the statements of Dr Milner, the preferred isolates do form part of the claimed invention. Thus the identification of the isolates is clearly apposite to the issue of infringement of the claims which specifically recite the isolates.

Secondly, I believe the statements of Dr Rath and Dr Pinnock to be more persuasive than those of Dr Milner for the applicant on this point. Both Dr Rath and Dr Pinnock are suitably qualified and experienced in the area of insect pathogenic fungi to give testimony as to the adequacy of the description of the fungal isolates. On balance, I do not believe, as has been put by the applicant, that there is sufficient information in the specification to allow a skilled person to unambiguously produce and/or identify the three preferred isolates via the general selection method set out in the specification.

In the absence of some specific characterisation of the preferred isolates or more specific criteria for selecting said isolates via the selection method described in the specification, I believe that a person skilled in the art could not reasonably be expected to perform the invention, in relation to isolates FI535, FI610 and FI726, without having a sample of the isolates.

b) whether the isolates are reasonably available

Ms Howard for the opponents made reference to the Patent Office - Manual of Practice and Procedure indicating that since the preferred isolates were a) not available from a commercial source, b) not freely available and c) since there had been no deposit under the Budapest Treaty the requirements of paragraph 40(2)(a) were not complied with.

Ms Howard pointed to Exhibit ACR-42 to support her proposition that the isolates were not freely (ie unconditionally) available. I agree with Ms Howard that the information in exhibit ACR-42 does indicate that the isolates are not freely available.

Mr Yates argued that reliance on ACR-42 was erroneous as that all that exhibit does is to show that it is not the practice of CSIRO to provide samples of the isolates without written protection. Mr Yates further submitted the criteria used by Ms Howard were not relevant and that the correct test is that stated in the legislation itself, whether the isolates are “reasonably available”. I agree with Mr Yates on both points.

I do not consider the section of the manual referred to by Ms Howard to provide any legal authority in relation to the issue of reasonable availability as set down in Section 41(2). I am not aware of any judicial or other consideration of Section 41(2) of the Act. The matter of whether the preferred isolates are reasonably available, or not, is one to be decided by reference to the wording and intent of the legislation and the facts of the case at hand.

Section 41 of the Act is an adjunct to Section 40 and is specifically concerned with specifications, and their sufficiency, that relate to inventions which are microorganisms per se or involve the use, modification or cultivation of a microorganism.

Subsection 41(2) relates to compliance with paragraph 40(2)(a) and is as follows:

“Where:

(a)an invention involves the use, modification or cultivation of a microorganism, other than the micro-organism mentioned in subsection (1); and
(b)a person skilled in the relevant art in the patent area could not reasonably be expected to perform the invention without having a sample of the micro-organism before starting to perform the invention; and
(c)the micro-organism is not reasonably available to a person skilled in the relevant art in the patent area;

the specification is to be taken to comply with paragraph 40(2)(a), so far as it requires a description of the micro-organism, if, and only if, the deposit requirements are satisfied in relation to the micro-organism.”

From my reading of the Act the intent of Section 41 is to maintain the “quid pro quo” in the patent system whereby a patentee is granted rights contingent upon disclosure to the public of their invention and how to put that invention into practice. The provision has its origin in the difficulties which can be associated with completely and unequivocally describing a microorganism in written form and issues of repeatability in relation to inventions involving microorganisms. In some, but not all, instances these issues can only be addressed by reference to a sample of the microorganism itself.

If an invention involving a microorganism can be fully described, and is repeatable, normal patent procedure applies. Otherwise, the invention is only fully described if the deposit requirements are met.

Section 41 exists to ensure an overriding purpose of the Act is met, that in return for the exclusive right, the patentee provides information sufficient for a person skilled in the art to be able to perform the invention. More specifically it is directed at ensuring access to microorganisms for inventions which involve microorganisms per se or their use, modification or cultivation. This would allow the public to conduct appropriate experimentation during the currency of patent proceedings and to make use of the invention following the cessation of any patent rights.

Obviously the ideal solution to the problem of adequately describing a microorganism and reliably repeating the invention comes in the form of a deposit under the Budapest Treaty, which is the “deposit requirements” referred to at the end of paragraph 41(2). In this context it is pertinent at this point to note there are instances where a microorganism is not freely (ie unconditionally) available but is regarded as being reasonably available under the provisions of the Act. The Budapest Treaty and subregulation 3.25 make specific provision for conditional access to samples of microorganisms during the currency of a patent application. The treaty also contains provisions for access to deposits after the expiration of any rights.

The term “reasonably available” as referred to in Section 41 of the Act must be construed in light of the issues I have outlined above. The term itself clearly alludes to the notion of equitable access to a microorganism which either itself, or by its use, is the subject of a patent application. When the overriding intent of the Patents Act is considered, I take the term to encompass equitable and/or impartial access to the microorganism for appropriate experimental use during the prosecution of an application. I also take the term to include conditional access during prosecution of matters relating to the validity of the grant itself as well as access after the cessation of patent rights, if any.

It is against this background that I will consider whether the preferred isolates are reasonably available. I need to consider a situation where access to a microorganism is exclusively controlled by one individual or entity and whether this falls within the meaning of the term “reasonably available”.

Clearly, a microorganism would be reasonably available if it can be independently found or obtained without fetter. However a microorganism would not, in my opinion, be reasonably available where there is a sole supplier who could arbitrarily apply conditions to the supply of the microorganism. It would be open to this sole supplier to apply whatever conditions they desired for access or indeed deny access to the microorganism at their discretion. Further, there is no guarantee that the conditions of access even if reasonable at a certain time won’t change over time or that a sole supplier would not discontinue providing the microorganism, for example after the life of the patent.

From the information before me CSIRO are the sole source for the preferred isolates and can place whatever conditions they wish upon their release. There is nothing to suggest that CSIRO is required to, nor will continue to, make the isolates available in the future either conditionally or unconditionally, during the currency of the application nor after the expiration of any rights in this invention. Hence, I can only conclude that the isolates are not reasonably available.

In conclusion, given the lack of characterising information in the specification a person skilled in the relevant art could not reasonably be expected to perform the invention, in respect of preferred isolates FI535, FI610 and FI726, without having a sample of the isolates. The isolates are not reasonably available in the patent area. The specification as filed and as accepted does not adequately identify the isolates. It follows that there can be no valid claim defined by reference to the specific isolates, since it would not be possible to determine the scope of the claim, whether the claim is novel or inventive or whether the claim is being infringed or not.

It follows that the other isolates referred to by the CSIRO-specific alpha-numeric designations on page 5 of the specification are also inadequately identified in the specification. In the absence of specific characterisation of the isolates in the specification, I believe that a person skilled in the art could not reasonably be expected to specifically identify these isolates.

I have determined that the preferred isolates FI535, FI610 and FI726, which currently form part of the claimed invention, and other similarly referenced isolates are inadequately identified in the specification. This raises the issue of the sufficiency of the description in general terms and whether there is a best method of performance of the invention as a whole, when not limited to the preferred isolates.

It is pertinent to note that the specification does not assert the isolates FI535, FI610 and FI726 nor other similarly referenced isolates as essential to the invention, merely as preferred. The invention in its broadest form is defined by the use of a “select strain” of Metarhizium anisoplae. Use of a “select strain” of Metarhizium anisoplae is an essential feature of the invention.

The term “select strain” as it stands is ambiguous in the claims when read in isolation, in that, it has no clear context nor criteria for the “selection”. However, it is possible to resolve the apparent ambiguity in the claims by reference to the body of the specification. From the specification, as a whole, it is apparent from the way in which the term is used that “select strain” refers to a strain selected via the method enunciated on pages 4 and 5 of the specification.

In relation to the meaning of the term Dr Pinnock, in the Ecoscience opposition, states:

“I assume that the term ‘select’ in claims 1,3,5,8,12,13 and 17 means a single or limited number of strains chosen by bioassay, a routine and well known approach and would apparently include previously described strains.”

“Furthermore, neither the claim nor the specification discloses what characteristics are selected for other than the strain having at least some ability to kill termites.”

I agree with Dr Pinnock the specification does not explicitly state specific characteristics or properties that might be said to be essential to the selection of specific strains of the fungus. In the absence of the characteristics I believe it is appropriate to adopt the purposive position as stated by Dr Pinnock of “the strain having at least some ability to kill termites” as the characteristic being selected for. Support for this can also be found on page 13 of the specification itself where it is stated that:

“To select those strains best suited for biocontrol of termites, each isolate strain was subjected to the following bioassay. . . . . .From a library of over 100 isolates tested, using this bioassay, some 9 isolates have been found to possess high virulence for both Nasutitermes and Coptotermes spp.”

Evidence from both the applicant and the opponents indicates that the “selection” method described in the current specification involves procedures, that a person skilled in the art would be able to follow to “select” fungal strains as described and defined in the specification.

The specification describes and exemplifies a process for the identification of “select strains” of Metarhizium anisoplae which is essential to the invention. The examples include the specific isolates referred to by the CSIRO-specific designations, eg FI535, FI610 etc but this is not problematic. It is clear from the specification, that strains have been identified according to the selection method of the invention and are thus “select strains”. It is not necessary, in the broad form of the invention to know with exactness what those isolates are, only that they are “select strains”. The best method of selecting the strains has been provided in the specification and hence the specification contains a best method of performance and sufficiently describes the invention.

Fair Basis

Ms Howard referred me to the principle of “real and reasonably clear disclosure” of what is claimed as per Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 (which concerned ‘internal fair basis’ as here) and CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 (which concerned fair basis of a complete specification on a provisional specification).

Ms Howard submitted that claims that are broad, indeterminate and are of a speculative nature will lack fair basis. According to these principles none of the claims is fairly based as set out below:

There is no real and reasonably clear disclosure of methods which do not use the isolates of Metarhizium anisopliae designated FI610, FI535 or FI726. No example of the use of other strains is given.
The results of one field experiment (example 8) have been used to support claims to “prophylactic” treatment (claims 3-7 and 11). Only one out of four treatments in that experiment prevented damage and even then few conidia survived. The claims are not limited to the particular treatment and are not fairly based.
Only one example (10) is given to support “curative” treatment (claims 8-11). This example is not sufficient to support the claims. The house had previously been treated for termites with Chlordane and it is not clear whether the single treatment with conidia was effective.
Apart from claim 11 the claims are to methods of controlling all termites, however, only species of Coptotermes, Nasutitermes, Neotermes have been exemplified, hence the claims are too wide.

Mr Yates for the applicant submitted that:

The arguments of counsel for the opponent proceed on the basis that an applicant can’t claim anything that is not exemplified. That is not the test to be applied.
The correct test to be applied is are the claims fairly based. Specifically the question of fair basis has been dealt with in CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 281-2.
The methods of termite control disclosed are effective regardless of genus. The applicant is not required to test all genera of termites.

It is apparent to me that the alleged fair basis deficiencies highlighted by the opponents are based on a notion that an applicant for a patent can’t claim anything which they do not specifically exemplify. I cannot agree with such a submission. I know of no principle of law which requires such a stringent relationship between the exemplification of the invention and the breadth of the claims, as appears to be suggested here. I am also not aware of any requirement that a specification has to exemplify all that is claimed.

In support of this position I would point out that isolates other than FI610, FI535 or FI726 have been disclosed and even indicated to be pathogenic to some degree. Further that the general method of selecting fungi to identify the “select strains” of the invention has been described which is not limited to the preferred isolates. As put by Mr Yates for the applicant, evidence from both the applicant and the opponents indicates that the selection method to obtain select pathogenic fungi is common place in the art. Hence, a person skilled in the art would be able to practice the invention using fungal isolates other than those specifically identified in the application without any difficulty. Thus there is a real and reasonably clear disclosure as per CCOM decision (supra) and Leonardis v Sartas (No1) 35 IPR 23I in relation to “select strains” of Metarhizium anisopliae which form part of the current invention.

Novelty

The test for determining whether an invention lacks novelty is the " reverse infringement test" as set out in Meyers Taylor Pty Ltd v Vicarr Industries (1977) CLR 228 at page 225 where Aiken 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 has been said to occur where "each and every one of the essential integers of that claim have been taken" (Rodi and Wienenberger AG v Henry Showell Ltd (1969) RPC 367).

As a starting position, claims are to be given a purposive construction and it is to be assumed that all features of independent claims are essential (Catnic Components v Hill & Smith, [1982] RPC 183). The independent claims are reported earlier in the decision.

Relevant Documents

Hanel & Watson

Hanel H. & Watson J. A. L.: “Preliminary field tests on the use of Metarhizium anisopliae for the control of Nasutitermes exitiosus (Hill) (Isoptera: Termitidae)”

Bulletin of Entomological Research, 73, 305-313 (published 1983): Exhibit JFM-2 & ACR-4

Milner

Milner R. J.: “Recent progress with Metarhizium anisopliae for pest control in Australia”

Proceedings of the First Asia-Pacific Conference of Entomology (APCE) 1989: Exhibit ACR-6

Fernandes & Alves

Fernandes P. M. & Alves S. B.: “Control of Cornitermes cumulans (Kollar, 1832) (Iosptera: Termitidae) with Beauveria bassiana (Bals.) Vuill. and Metarhizium anisopliae (Metsch.) Sorok, under field conditions” An. Soc. Ent Brasil, 20(1), 1991: Exhibit ACR-5 & JFM-10

Vitharana

Vitharana S. L.: “Feasibility of biological control of the low-country IIVF wood termite (Glyptotermes dilatatus) of tea (Camelia sinensis) in Sri Lanka”

Proceedings of Regional Tea (Scientific) Conference, Colombo, Sri Lanka, 1988: Exhibit JFM-1

FR 1 533 177

French Patent 1 533 177 (issued 1968): Exhibit JFM-8 [Translation provided JFM-9]

Hanel

Hanel H.: “A bioassay for measuring the virulence of the insect pathogenic fungus Metarhizium anisopliae (Metsch.) Sorok. (fungi imperfecti) against the termite Nasutitermes exitiosus (Hill) (Isoptera: Termitidae)” Z. agnew Ent., 92, 9-18 (published 1981): Exhibit ACR-8.

Lai

P.Y. Lai et al: “Pathogenicity of Entomophagous Fungi to Coptotermes formosanus” Journal of invertebrate pathology 39, 1-5 (1982) Exhibit ACR-11.

Consideration of the claims

Claim 1 is to a method of controlling termites by applying to an area or structure an effective amount of conidia of a select strain of Metarhizium anisopliae or formulations thereof. The Hanel & Watson publication discloses, in a first experiment, testing the transmission of Metarhizium anisopliae in the laboratory. A small number of dead worker termites (5 to 20) which had previously been treated with conidia of the fungus, and on which mycelium had developed, were added to test groups of 50 healthy termites. Cumulative mortality in the healthy termites was measured and corrected for mortality in the controls. The following statement is made in relation to the results exhibited:

“Clearly, the conidia that developed on the inoculating termites infected virtually all the healthy workers.”

I consider that a strain identified as effective in infecting termites via the method of the first experiment in Hanel & Watson to be a “select strain” as used in the claims of the current specification.

The second experiment is directed at measuring “The effect of treating termites in mounds”. The effect in mounds was measured as follows:

“Eight apparently healthy mounds (A-H) were selected, and termites in seven of them (A-G) were treated with conidia; three were sprayed with a suspension, three were dusted with a mixture of conidia and talc, and one was dusted with conidia alone. It was impossible to estimate the amount of conidia that actually contacted termites, but the dose ranged from 0.05 to 0.30 g of conidia per mound. The viability of the conidia was high; the assay showed 98% germination in 14 hours. Termites in the eighth mound were treated with a spray of water, and served as a control. Termite samples were taken weekly over a period of 15 weeks.”

Two points emerged from the measurement of corrected mortality in the experiment. Firstly, Metarhizium anisopliae persisted for 15 weeks in at least some mounds, but its incidence declined progressively. Secondly mortality in the bioassays of samples found to contain Metarhizium anisopliae was high initially but, like the incidence of Metarhizium anisopliae, decreased as the experiment proceeded.

It is clear that this publication discloses killing of termites and it is necessary to determine if this falls within the meaning of the term “control” as used in the claim.

The term “control” is used in all the independent method claims of the accepted specification. There is no definition of this term in the specification. The Compact Oxford English Dictionary, New Edition, 1991 lists, among others, the following plain English meaning for “control”:

‘To exercise restraint or direction upon the free action of; to hold sway over; exercise power or authority over; to dominate, command.’

Both counsel for the opponents and applicant were in agreement that the term “controlling” in the claims does not directly equate to ‘killing’ of termites. This is supported by the evidence of Rath at paragraph 16 of his 12/12/97 declaration in the Bio-care opposition and that of Dr Milner for the applicant at paragraph 20 of his declaration in the Ecoscience opposition.

Mr Yates submitted that “controlling” is ‘keeping termites below a damaging level by repelling or killing’. This meaning is supported by the evidence of Dr Rath (para. 17 12/12/97 declaration) where he states “control” means ‘keeping the level of infestation at any location below a damaging infestation level’. From the specification as a whole and a consideration of the statements from the declarants, I believe the term “controlling” in the claims would be ascribed the following meaning by a person skilled in the art in this particular field: “exercising restraint upon the free action to keep the level of infestation below a damaging level”. The ‘restraint’ may be achieved either through killing and/or through repelling.

I think it is pertinent to state that the terms ‘control’ and ‘killing’ are not synonymous. However, I believe killing of termites to be a means of control as per the use of that term in the claims. Indeed claim 8 to a curative method clearly indicates killing as the means of ‘control’. Producing ‘substantial mortality’ in a termite colony is one way in which the infestation is kept below a damaging level, particularly where the mortality is so extensive as to render the colony or mound non-functional. Control may also be effected by repelling termites with or without killing.

Given the above I consider the killing of termites described in the Hanel & Watson article to fall within the meaning of the term “control” as it is used in the claims.

I also consider the amount of conidia used in the Hanel & Watson publication to be an “effective amount” since it was effective in a curative method for controlling termites.

Hence, I believe claim 1 is rendered not novel since all the features of the claim have been disclosed in the Hanel & Watson article.

The abstract of the Fernandes & Alves publication discloses:

“Under field conditions Cornitermes cumulans nests (Kollar, 1832) were sprayed with 5 g of conidia from 2 isolates of Beauveria bassina and Metarhizium anisopliae. After 10 days, the fungi caused 100% nest mortality. The fungi sporulated on the cadavers and were effective in controlling this species of termite.”

In the ‘Materials and Methods’ section of the publication it discloses that isolates of B. bassiana and M. anisoplae used were preselected, in laboratory biotests, for virulence to C. cumulans. I consider the strains of M. anisoplae used to be “select strains” as referred to in the claims of the opposed application. The document discloses the spraying of infested tree stumps with conidia of the fungus via a central hole in the stump which crossed the ‘cellulose centre’. Results showed that both Beauveria bassina and Metarhizium anisopliae caused 100% nest mortality 10 days after treatment in two test locations.

This document discloses, control of termites in a field application, by applying to an infested tree stump (structure) an effective amount of conidia of a select strain of Metarhizium anisopliae or a formulation thereof. As for the Hanel and Watson article above, this renders claim 1 not novel since all of the features of the claim have been disclosed.

The Vitharana publication discloses results of tests designed to measure the effectiveness of nematode Heterorhabditis sp. and separately four strains of Metarhizium anisopliae as biological controls for Glyptotermes dilatatus (more commonly the wood termite of tea). The first section in relation to the effectiveness of the nematode is not pertinent to the current application.

The second section, involving four specific fungal strains of Metarhizium anisopliae, firstly discloses a test to gauge the relative efficacy of the strains on termites in the laboratory. Of the four strains tested, two were found to have high cumulative death tolls in the observation period of up to 5 days. However the other two strains did not have significant differences to the untreated control experiments during the observation period, but, did produce 100% mortality at 10 days from introduction of the fungus.

The two most efficacious strains identified in the bio-assay above were used in a field trial where a mature tea field, severely infested with termites, was treated with a suspension of the two strains. The treatment was replicated 20 times and randomly selected bushes were sampled at 3 and 4 weeks from treatment. Colony mortality was ‘estimated’ based on the debris found inside the galleries of the dissected bushes, which was examined for cadaver or head capsules of soldiers. Results indicated that large colonies were severely affected by the fungus and that substantial colony mortality resulted.

The two highly efficacious strains identified are to my mind “select strains”. This document discloses the control of termite infestation by application of a conidial suspension of the ‘select strains’ to an infested tea field. Claim 1 of the opposed application is not novel since the necessary steps are taken in the prior document. Here I have taken the tea field to fall within the meaning of “area or structure” as set out in the claim. I believe the amount of conidia used to be an “effective amount” as required by the claim since the results showed a sufficient amount of control in the infested area.

FR 1 533 177 discloses a method for the preparation of fungal insecticides, especially for the destruction of insects, such as termites, which travel underground. It discloses a process whereby an entomophagous fungi, such as Beauveria or Metarrhizium, is cultured in the presence of a bait. The intention being to produce a bait containing infectious particles (conidia) of the fungus such that when insects are drawn to the bait they become infected and subsequently die due to the action of the fungus. The patent also discloses the preparation of a dry product, rich in spores (conidia) which is formed by drying and milling of the fermentation culture. The dry product can be used for dusting or more notably diluted in water for injecting into the soil.

FR 1 533 177 discloses the use of fungi known to be entomophagous to termites (select strain) to effect control of termites in the field by applying infectious particles (conidia) of M. anisopliae to an area or structure. This teaches the features of claim 1 and the claim is not novel.

Claim 2 is dependent upon claim 1 wherein the strain of Metarhizium anisopliae used is selected from isolates FI610, FI535, FI726 or mixtures thereof. As I have indicated above in relation to the sufficiency of the description, isolates FI610, FI535, FI726 are inadequately described and it is not clear what these isolates in fact are. It follows that in the absence of knowing what the isolates are it is not possible for me to determine whether the use of these specific isolates is disclosed in the prior documents.

Claims 2, 9, 16 and 19 are all defined by reference to isolates FI610, FI535, FI726 which are inadequately described. I will not consider these claims further under the headings of novelty or inventive step.

Claim 3 is to a ‘prophylactic’ method characterised by, among other features, the application of a prophylactic effective amount of conidia to an uninfested structure. That is application of conidia to a structure devoid of termite infestation. Such a method is not fairly taught or suggested by any of the cited documents. The use of conidia of Metarhizium anisopliae disclosed in the cited documents involved the infection of termites by application of conidia to termites themselves or to nests or mounds of termites. The use of conidia was clearly directed at effecting contact with termites to induce infection and subsequently death. Nowhere is it suggested that conidia be applied to an uninfested structure, ie a structure devoid of termite infestation. Thus claim 3 is novel when compared to the cited documents. Claim 4 which is dependent upon claim 3 is similarly novel.

Claim 5 is also to a prophylactic method characterised, inter alia, by the application of a prophylactic effective amount of conidia to the soil surrounding a structure to be protected. The term “surrounding” as used in this claim, to my mind, indicates completely surrounding or encircling the structure to be protected. This is explicit in the term itself. This meaning is also appropriate when one considers the intended purpose of the claim, which is to effect prophylaxis. Hence, the term “surrounding” in this claim means totally surrounding, with no gaps or voids which are untreated. Regions of soil which are not treated with conidia would provide an avenue for termites to attack and infest the structure to be protected, in contradiction to the aim of preventing such an infestation.

There is only one document relevant to this claim, FR 1 533 177, the paragraph which bridges pages 6 and 7 of the patent states:

“The advantage of using fungi for introduction in the soil lies in the fact that these not only attack the insects as is the case with the termites and envelop them in mycelium which produces infectious conidiae, but [also] that these types of fungi, as multiple tests have shown, propagate in the neighbouring soil and can remain there. This method thus achieves the enrichment of the soil by the species that are noxious to the insects . . . ”

Further on page 8 of the patent it is stated that:

“The fourth and last stage has consisted in obtaining an insecticide mixture that is easily transportable and capable of being utilised either in the dry state by dusting termite development sites that lie chiefly in humid places or dissolved in water so as to proceed by way of injection into the soil, above all in places that can serve as departure points for the infestation of buildings.” (emphasis added)

The document discloses the application of a conidial suspension into the soil in places that can serve as departure points for the infestation of buildings. The places referred to in the patent, prima facie, relate to specific areas of soil as opposed to the entirety of soil which encompasses the building. There is no explicit disclosure of treating the entirety of the soil surrounding a building. I do not consider that the disclosure in FR 1 533 177 contains clear and unmistakable directions to apply conidia of Metarhizium anisopliae to the soil surrounding a structure to be protected. Hence this claim is novel.

Claim 6 is dependent upon claim 5 and is novel in the same way as claim 5.

Claim 7 is dependent on any one of claims 3 to 6 and is also novel.

Claim 8 is to a curative method comprising treating an infested area or structure with a curative effective amount of conidia of a select strain of Metarhizium anisopliae, such that the treatment will result in substantial colony mortality, comprising distribution of said conidia substantially throughout an infested area or structure. The Hanel & Watson article does not explicitly mention application of conidia substantially throughout an infested area or structure. For instance, it is stated that mounds were sprayed with a suspension, dusted with a mixture of conidia and talc or dusted with conidia alone. This is not the application of conidia substantially throughout the mound (structure) as required by the claim. Claim 8 is novel over this disclosure. Similarly dependent claim 10 is novel. I will deal with claim 8 further under the heading of inventive step.

Similarly, the Fernandes & Alves article discloses the application of conidia by spraying into a central hole which crosses the cellulose barrier of the infested tree stump. This is not sufficient in my opinion to establish that the application of conidia occurs substantially throughout the structure. Hence, claim 8 is novel over this disclosure.

FR 1533 177 does not explicitly disclose the application of conidia substantially throughout an area or structure. It could be argued that it is implicit in the document that the application of the conidia is, or could be, substantially throughout the area being treated, but, this is not stated in the document nor is it reasonably inferrable from the information provided. Claim 8 is novel over this disclosure. I will deal with this issue further under the heading of inventive step.

The Vitharana document discloses killing termites by treating an infested tea field by repeated spraying with an aqueous suspension of conidia. It is apposite to consider the term “area or structure” in claim 8. Neither term “area” or “structure” is specifically defined in the specification. The phrase “area or structure” as a collective concept is described in the specification in the following manner:

“The term ‘area or structure’ as used herein the description and claims includes but is not limited to the following: buildings, trees, gardens, earth and termite mounds.”

Given that trees, gardens and earth are clearly included in the scope of the term “area or structure”, I believe it is appropriate to consider an infested tea field as falling within the scope of the term “area” as it used in the claim.

The repeated application of an aqueous suspension of the conidia described in the Vitharana document would in my opinion be regarded as “distribution of the conidia substantially throughout the infested area”. Substantial termite mortality was reported which is as set out in the claim which also equates to the use of a “curative effective amount” as required by the claim. Hence since all features have been disclosed claim 8 is not novel.

It follows that claim 10, which is appended to claim 8, is not novel in light of the Vitharana publication since the action of “pumping or blowing” the conidia into the infested area is a common procedure and does not materially affect the working of the invention.

Claim 11 is dependent upon any one of claims 1 to 10 but is limited to methods of controlling four specific genera of termite, namely, Copotermes, Nasutitermes, Neotermes or Mastotermes. The Hanel & Watson article clearly discloses the genera Nasutitermes. The restriction to the four genera recited in this claim does not materially affect the working of the invention, hence, the claim (when not appended to claim 3) is not novel in the same manner as claim 1 above.

Claim 12 is to a prophylactic formulation of conidia of a select strain of Metarhizium anisopliae in an aqueous solution of a water wetting agent. The Hanel (1981) and Lai (1982) publications both disclose aqueous conidial formulations of pathogenic strains (ie select strains) of Metarhizium anisopliae which contain a wetting agent. These disclosures independently render claim 12 of the application not novel.

Claim 13 is clearly not novel as a formulation of conidia and talc is disclosed in the Hanel & Watson publication and FR 1 533 177 which discloses powder formulations.

Claims 14 is to “A formulation according to claim 12 or 13 wherein the concentration of conidia in said formulation is such that in use when the formulation is applied to a structure the concentration of conidia on the surface area to be treated is at least 10⁸ spores per cm³.” The specific concentration recited in this claim does not materially affect the working of the invention and hence this claim is also not novel, in the same way as claims 12 and 13.

Claim 15 is dependent on any one of claims 12 or 13 wherein the concentration of conidia in the formulation is such that when the formulation is applied to the soil the concentration of conidia is at least 10⁸ spores per gram of soil. In the same way as claim 14 this claim is not novel.

Claim 17 is to a formulation of conidia of Metarhizium anisopliae as a bait.

The Milner publication talks generally about the use of Metarhizium anisopliae and its pathogenicity against a range of pests, particularly soil inhabiting beetle larvae. Under the heading of ‘FIELD APPLICATION - Termites’ the following introductory paragraph appears:

“A different application problem is posed by termites. In this case the fungus can be applied to feeding sites, in attractive baits or occasionally directly to the colony. Whatever method is used, the aim is to ensure that the fungus is carried back and sets up an epizootic within the colony. If this is effective in destroying the queen then the colony will not survive.”

Dr Milner further discloses:

“The two stage process was developed in by Pinnock to produce 4.36x1016 conidia after the mycelium from 10,000-12,000 litres of liquid medium was mixed with 12 tons of bran. To promote sporulation this bran was incubated in plasticlined sacs for 5 days and then used as a bait for A. tasmaniae control (Bartlett and Jaronski, 1978).”

Formulation claim 17 and dependent claim 18 are not novel in light of the disclosures in Milner, and FR 1 533 177 which both disclose bait formulations.

Other documents

Ko W. H. and Fujii J. K. & Kanegawa K. M.: “The Nature of soil pernicious to Coptotermes formosanus” Journal of Invertebrate Pathology 39, 38-40 (1982): Exhibit JFM-24 & ACR-21

This document shows the noxious effects of specific soil borne bacteria, namely E. coronata or M. anisopliae, on Coptotermes formosanus, but, I do not think the disclosure deprives the current claims of novelty. The results are only from laboratory tests and there are no field results reported in the document. The discussion section only postulates that the pernicious nature of the soil samples may be one of the factors in preventing termite establishment in the area containing the soil. This does not disclose the essential features of the present claims.

US 5 418 164 & AU 607 166

United States Patent 5 418 164 was published on May 23, 1995. This date is subsequent to both the filing date 23 November 1992 and the priority date 22 November 1991 for the present application. I did not have regard to the document.

Australian Patent 607 166 is the Australian family equivalent of US patent 5,418,164. As indicated at the beginning of this decision I utilised the provisions of regulation 5.11(1) to inform myself of the document.

The document is generally directed at agents to combat pests as well as plant protection agents utilising carrier-free cell granulates of one or more microorganisms which are suitable for combating pests or for treating plants. The specification discloses and claims an agent which contains at least one carrier-free cell granulate containing organisms for combating pests (or for treating plants) with are bead shaped and have a diameter of 0.05 to 2.0 mm formed from fungi or bacteria which are capable of mycelium formation. There is a claim to a process of combating pests in that at least one carrier-free cell granulate of the invention is applied to pests or their environment. On page 5 of the document a preferred embodiment of the invention is described wherein the cell granulates contain an increased amount of permanent stages of microorganisms (ie conidia) on the surface.

More specifically an agent containing a carrier-free cell granulate of Metarhizium anisopliae is described and claimed. Carrier-free cell granulates of two specific strains of Metarhizium anisopliae are described in the examples and there is also a claim to an agent containing these two strains in the form of carrier-free cell granulate. The specification contains no specific disclosure in relation to the actual control of termites in the field.

Notwithstanding the claim in this patent to a process of combating pests, which includes termites, I do not consider the disclosure in this patent to be sufficiently enabling in relation to the control of termites per se. The disclosure is not such that it deprives the method claims of the opposed specification of novelty. In General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1972) RPC 457 at 485:

"To anticipate the patentee's claim the prior publication must contain clear and unmistakable 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."

In particular, I do not think that the document contains “clear and unmistakable directions” of methods of control of termites as defined in the current application. No direct relationship between conidia of Metarhizium anisopliae, or for that matter even Metarhizium anisopliae itself, and its pathogenic affects on termites is disclosed. No examples are given of the control, at any level, of termites or termite colonies.

Formulation claims 13 and 17 of the present application are novel since they involve the use of an acceptable carrier, whereas the cell granulates disclosed in 607 166 are carrier-free.

Inventive Step

According to subsections 7(2) and 7(3) of the Patents Act, a claimed invention will lack an inventive step if it is obvious in the light of:

(a) common general knowledge; or
(b) common general knowledge considered together with information in a single document or through doing a single act, provided that the document or act could reasonably be expected to have been ascertained, understood and regarded as relevant to work in the relevant art in the patent area by the person skilled in the art.

Considering the second of these criteria, I think there is no doubt that the various documents I have considered under the heading of novelty above were in the public domain before the priority date of the claims and would be "understood" and "regarded as relevant" by the person skilled in the art.

The general test to be applied in determining obviousness is whether the invention would have been obvious to a non-inventive worker equipped with the common general knowledge in the trade as at the priority date (The Wellcome Foundation Limited v. V R Laboratories (Aust) Pty Ltd ( 1980-1981) 148 CLR 262 at 270). It was also stated in the Wellcome case, supra, at 286 that:

"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."

The likelihood of success necessary to render a routine investigation obvious was considered in Beecham Group Ltd’s (Amoxycillin) Application [1980] RPC 261 at 290:

“It is clearly established that, for a particular step or process to be obvious .... it is not necessary to establish that its success is clearly predictable: Johns-Manville Corporation’s Patent [1967] RPC 479 at 494. It will suffice if it is shown that it would appear to anyone skilled in the art but lacking in inventive capacity that to try the step or process would be worthwhile: Technograph Printed Circuits Ltd v. Mills & Rockley (Electronics) Ltd [1972] RPC 346 per Lord Reid at 355 and 356; Johns-Manville, supra, per Lord Diplock LJ at 493 and 494; Tetra Molelectric Ltd v. Japan Imports Ltd [1976] RPC 541 at 581, 583-4.”

From a reading of the specification I believe the ‘problem’ which the present invention seeks to address is to “overcome or alleviate at least one of the difficulties associated with effectively controlling termites in the field using conidia of Metarhizium anisopliae”.

The method of claim 1 involves the control of termites by applying to an area or structure an effective amount of a select strain of conidia of Metarhizium anisopliae. It is agreed by all parties that Metarhizium anisopliae, and more particularly conidia thereof, are known to kill termites. This is part of the common general knowledge. It has also been asserted by the applicant that the method of selecting the strains which constitute the “select strains” of the invention involves common place steps which would be able to be performed by those skilled in the art and that is there nothing inventive required to be performed in the selection of strains of the invention. It has also previously been known that conidia Metarhizium anisopliae are applied to an area or structure infested by termites in order to kill the termites.

From the information before me I believe that the method defined in claim 1 is such that anyone skilled in the art (lacking in inventive capacity) would definitely consider it as being worthwhile in attempting to solve the problem I have outlined above. Hence claim 1 lacks an inventive step in light of the common general knowledge.

Claim 3 is to a prophylactic method wherein conidia of Metarhizium anisopliae are applied to an uninfested structure. As I have indicated above I consider this aspect of the invention to be novel in light of the documents raised in the oppositions. Further I have not been provided with any evidence which would lead me to believe that application of conidia of Metarhizium anisopliae to an uninfested structure is common general knowledge. Nor do I believe that any of the documents raised in the oppositions would be read in conjunction with the common general knowledge to deprive this claim of inventive merit. Nothing from what had gone before would, in my opinion lead the skilled worker to consider the prophylactic method of this claim in the control of termites worth trying. In contradiction to the method of this claim the common general knowledge clearly indicates the application of conidia of Metarhizium anisopliae to the termites themselves or to the immediate environs in order to effect an infection of the termites. Nowhere has the prophylactic use, to repel termites from an uninfected structure been postulated.

From my reading of the specification and the evidence that has been provided, the current applicant was the first to recognise the repellent nature of conidia of Metarhizium anisopliae. While in the past observations had been made that healthy termites were able to detect and avoid the fungus, there had been a distinct lack of information and understanding as to the cause or causes of the observed avoidance phenomenon. The common general knowledge clearly indicated the effectiveness of the conidia in killing termites in the laboratory and there has also been reports of varied degrees of success in the field in inducing epizootics in termite colonies. However nothing has been shown to me which teaches or fairly suggests the application of conidia to uninfested structures as a prophylactic measure. Hence, claim 3 is not obvious and hence inventive. Claim 4 which is appended to claim 3 is similarly inventive.

Claim 5 is to a prophylactic method which is characterised by the application of conidia of a select strain of Metarhizium anisopliae to the soil surrounding a structure to be protected from termite infestation. The only document which specifically discloses the application of conidia to the soil in the vicinity of a building or structure, not being a termite mound, is FR patent 1533177. The patent discloses injection of conidial suspensions into the soil in places which serve as departure points for the infestation of buildings. The document does not specifically disclose application of formulations of conidia of Metarhizium anisopliae to the soil completely surrounding structures which would be attacked by termites in order to effect prophylaxis.

What is disclosed in the prior patent is the application of conidia, known to be infectious to termites, to soil in places which serve as departure points for buildings. The application of the conidia to the soil is directed at inducing infection of the termites which come into contact with the conidia. The infected termites then travel into the building and it is hoped produce a more widespread infection within the termites resident in the building. The patent is primarily concerned with inducing infection in termites which will be carried to the building sought to be treated.

I consider that the notional addressee when faced with the problem I have outlined above and in possession of this patent document and the common general knowledge would not have regarded the process defined in claim 5 as worth trying. In the absence of the knowledge that conidia are repellent to termites, per se, there would be nothing to suggest to the skilled addressee that application of conidia to the soil surrounding a structure would be a useful prophylactic measure. The application of conidia to the soil in the patent document in that it seeks to attract and infect termites teaches away from the prophylactic method of the present claim. Further, the patent clearly relates to a situation where termites ultimately travel into the building whereas the prophylactic method of the current claim is directly aimed at preventing any infestation of the structure to be protected. Claim 5 is non-obvious in light of the disclosure in FR 1 533 177.

Claims 6 and 7 which are appended to claims 5 and 3 to 6 respectively are similarly non-obvious.

Claim 8 is to a curative method wherein a curative effective amount of conidia of Metarhizium anisopliae is distributed substantially throughout an area or structure such that substantial termite colony mortality results. I have indicated above under the heading of novelty that this claim is not novel in light of the specific method disclosed in Vitharana. There remains the issue of whether the method of claim 8 is inventive.

Essentially the difference between this claim and the prior art documents such as Hanel & Watson and Fernandes & Alves resides in the application of conidia substantially throughout an area or structure. Having identified the repellency of conidia to termites the applicant has seen the necessity for distribution of the conidia throughout the entire structure or area in order to effect successful control, ie a curative method. Mr Yates for the applicant stressed the previous efforts of researchers to induce epizootics in the field and the limited degrees of success exhibited therein. He also pointed to the distinction that killing of termites cannot, and should not, be regarded as equivalent to control of termites.

I agree with Mr Yates that controlling and killing are not equivalent, but, as I have indicated above killing is one means of control. As to any lack of success with field trial using epizootics I do not believe that this conclusively teaches away from the present invention. Nothing in the common general knowledge has been shown which would indicate that conidia can’t successfully kill termites in the field where the conidia are applied to the whole colony.

I cannot see any invention in the method of claim 8. Given the common general knowledge that conidia of Metarhizium anisopliae can be used to kill termites it appears obvious to me that a person skilled in the art would regard the application of the conidia substantially throughout a structure as definitely worth trying. Notwithstanding the attempts of others to induce successful epizootics and the varying levels of success observed therein, I consider that application of conidia of Metarhizium anisopliae substantially throughout an area or structure to be obvious. Hence, Claim 8 lacks an inventive step.

Claim 10 involves the process of claim 8 where the distribution of conidia is effected via pumping or blowing. I consider pumping or blowing to be common general knowledge and hence claim 10 also lacks an inventive step.

Claim 11, other than when it is appended to claim 3, lacks an inventive step since I consider that there is nothing inventive in the restricted genera defined in the claim.

Formulation claims 12, 13 and 17 are all characterised by a select strain of Metarhizium anisopliae together with some form of acceptable carrier. In the absence of any indication that there is invention in the “select strain” or in the association of the select strain with the well known carriers I consider these claims all lack an inventive step. Similarly for claims 14, 15 and 18.

Manner of Manufacture

Ms Howard for the opponents submitted that the invention was not a manner of manufacture since it is clear on the face of the specification, particularly pages 2-3, that there is no invention or inventive step in what is claimed. She stated that it is clear that claim 1 encompasses the prior art, that there was nothing new in the preventative and curative treatments of claims 3 and 8 and that the formulation claims are not inventive. She indicated that the alleged invention in the current application did not pass the threshold test as set down in NV Philips Gloeilampenfabrieken v. Mirabella Pty Limited (1995) 183 CLR 655

Ms Howard also made reference to Commissioner of Patents v Microcell (1959) 102 CLR 232, where the High Court considered an application for a patent relating to the use of reinforced plastics for rocket projectors. The Full Court unanimously held that the application was not directed to a new manner of manufacture, the reasons (at page 251) being as follows:

"We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter for a patent, and the position cannot be affected either by the fact that nobody thought of doing the thing before, or by the fact that, when somebody did think of doing it, it was found to be a good thing to do."

I can not agree with Ms Howard’s submissions. I believe that on a fair reading of the specification it is not apparent on the face of the document that there is nothing which might be considered inventive. Indeed, the problems indicated in the specification and those in referenced articles do highlight some areas for further development of successful control of termites in the field. I also consider that the specification discloses more than “the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable” as per Commissioner of Patents v Microcell (supra). As I have indicated under the headings of novelty and inventive step I believe the applicant was the first to disclose the property of conidia being repellent to termites. Hence, I do not consider the invention not to be a manner of manufacture based solely on the specification itself.

CONCLUSION

The oppositions have been successful on several grounds:

The specification as filed and as accepted does not adequately identify the isolates referred to as FI535, FI610 and FI726 on page 5 of the specification. The lack of information in the specification as filed in relation to these specific isolates cannot be overcome by amendment. Hence, there can be no valid claim defined by reference to the specific isolates. Therefore, claims 2, 9, 16 and 19 are not valid.
Claims 1, 8, 10, 11(in part), 12 to 15, 17 and 18 are not novel in light of various cited documents.
Claims 1, 8, 10, 11(in part), 12 to 15, 17 and 18 lack an inventive step.

Claims 3 and 5 {and dependent claims 4, 6, 7 and 11(in part)} are novel and inventive. None of the documents raised by the opponents discloses nor proposes the prophylactic methods of the invention as defined in claims 3 or 5.

There is patentable subject matter in the opposed specification in respect of the prophylactic methods defined in independent claims 3 and 5. I allow the applicant 60 days from the date of this decision to propose amendments to restrict the claimed invention to such methods.

COSTS

In actions before the Commissioner, costs normally follow the event and I have no reason to vary this practice. Both opponents have been variously successful in relation to substantive grounds of opposition to the grant of the present application. Hence I award costs in accordance with Schedule 8 of the Patents Regulations in relation to each opposition against the applicant, CSIRO.

V. J. Portelli

Delegate of the Commissioner of Patents

Patent attorneys for the applicant      : Davies Collison Cave, Melbourne
Patent attorneys for the opponents     : Griffith Hack, Sydney
for Bio-care Technology Pty Ltd
  Spruson & Ferguson, Sydney
   for Ecoscience Corporation

[1999] APO 21

24 March 1999