Commonwealth Scientific and Industrial Research Organisation v Monsanto Technology LLC - [2007] APO 15

ABSTRACTS OF DECISIONS

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application : No. 738153 in the name of Monsanto Technology LLC

Title: Methods for the production of stably-transformed, fertile wheat employing Agrobacterium-mediated transformation and compositions derived therefrom

Action: Opposition under s.59 of the Patents Act 1990 by Commonwealth Scientific and Industrial Research Organisation

Decision: Issued 20 April 2007.
Abstract

The invention relates to fertile, stably-transformed transgenic wheat produced by Agrobacterium-mediated transformation.

The opposition was partially successful on the grounds of novelty and clarity, with claims 1, 2, 7, 8, 13, 15, 41, 47, 52 to 54 and 58 lacking novelty and claims 34 to 36 and 49 to 51 lacking clarity.

However the opposition was unsuccessful on all other grounds.

Costs were awarded against the applicant.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 738153 by Monsanto Technology LLC; opposition under s.59 of the Patents Act 1990, by Commonwealth Scientific and Industrial Research Organisation.

BACKGROUND

Patent application 738153 (34028/97) was filed as a PCT application (WO 1997/048814) on 20 June 1997, claiming priority from US 08/667,188, which was filed on 21 June 1996. Following examination 738153 was advertised as accepted on 13 September 2001.
A notice of opposition was filed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO, the opponent) on 12 December 2001. The opponent filed their statement of grounds and particulars on 12 March 2002. The statement was subsequently amended on 2 June 2005 to incorporate documents filed as further evidence. Service of evidence in support was completed on 23 October 2002. Evidence in answer was completed on 20 October 2004 and evidence in reply on 6 June 2005.
On 22 May 2003, prior to completion of evidence in answer, the applicant filed a request to amend the specification under section 104. The amendments were allowed on 20 May 2004.
Two rounds of further evidence were filed by the opponent on 2 June 2005 and 6 April 2006. Evidence in reply to the first round of further evidence was filed on 9 December 2005.
The substantive hearing was held in Canberra on 28 February 2007. The applicant was represented by David Myers and John McCann of Spruson & Ferguson, Sydney. The opponent was represented by John Slattery of Davies Collison Cave, Melbourne, assisted by Dr Rob De Feyter of CSIRO.

EVIDENCE

The opponent filed the following evidence as evidence in support, evidence in reply and further evidence.

Evidence in support

·       Statutory Declaration of John Michael Slattery, patent attorney of Davies Collison Cave, made 13 June 2002, together with exhibits JMS-1 to 45.
·       Statutory Declaration of Richard Ian Scott Brettell, Principal Research Scientist at CSIRO Division of Plant Industry, made 30 August 2002, together with exhibits RB-1 to 13 (Brettell #1).
·       Statutory Declaration of Christopher Michael Ford, Senior Research Fellow in the Department of Plant Science, University of Adelaide, made 6 September 2002, together with exhibits A and B.
·       Statutory Declaration of Ute Baumann, Postdoctoral Research Fellow at the Waite Agricultural Research Institute, made 11 September 2002, together with exhibits A and B.
·       Statutory Declaration of Margaret Anne Pallotta, Higher Education Officer in the Department of Plant Science, University of Adelaide, made 12 September 2002, together with exhibits A and B.
·       Statutory Declaration of Rachel Anita Burton, Senior Research Fellow in the Department of Plant Science, University of Adelaide, made 27 September 2002, together with exhibits A and B.
·       Statutory Declaration of Philip John Larkin, Senior Principal Research Scientist at CSIRO, Division of Plant Industry, made 17 October 2002, together with exhibit PJL-1.

Evidence in Reply

·       Statutory Declaration of Richard Ian Scott Brettell, made 14 May 2004, together with exhibits RB-14 to 17 (Brettell #2).
·       Statutory Declaration of Anthony J Pryor, Post Retirement Fellow at the CSIRO, made 19 May 2005, together with exhibits A to C.
·       Statutory Declaration of Philip John Larkin, made 26 May 2005, together with exhibits PJL-2 to 7 (Larkin #2).

Further evidence

·       Statutory Declaration of John Michael Slattery, made 1 June 2005, together with exhibits JMS-46 to 48 (Slattery #2).
·       Statutory Declaration of Robert Thomas Furbank, Senior Principal Research Scientist at CSIRO Division of Plant Industry, made 19 May 2005, together with exhibits RF-A and B.
·       Statutory Declaration of Julie Anne Chitty, Senior Technical Officer at CSIRO Division of Plant Industry, made 19 May 2005, together with exhibit JC-A.
·       Statutory Declaration of Robert Thomas Furbank, made 23 March 2006 (Furbank #2).
·       Statutory Declaration of Richard Ian Scott Brettell, made 27 March 2006 (Brettell #3).

The applicant filed the following evidence as evidence in answer and evidence in response to further evidence.

Evidence in Answer

·Statutory Declaration of Robert James Henry, Professor of Plant Conservation Molecular Genetics and Director, Centre of Plant Conservation Genetics, Southern Cross University, made 13 October 2004, together with exhibits RJH-1 to 11 (Henry #1).
·Statutory Declaration of Joyce Ellen Fry, Consultant for Gene Improvement and Transformation Technology Development and Application in Plants and former employee of Monsanto LLC, made 14 October 2004, together with exhibits JEF-1 to 10 (Fry #1).

Evidence in response to further evidence

·Statutory Declaration of Robert James Henry, made 9 November 2005 (Henry #2).
·Statutory Declaration of Joyce Ellen Fry, made 8 December 2005 (Fry #2).

SPECIFICATION

The specification is directed to methods of producing stably-transformed fertile wheat by Agrobacterium-mediated transformation. Agrobacterium-mediated transformation has been widely used in dicots and represents an efficient means of stably introducing foreign genetic material into plants. However, even into the 1990s Agrobacterium-mediated transformation of cereals had been problematic with few credible accounts of successful stable transformation.
The specification explains that prior to the applicant’s invention direct DNA transfer into isolated protoplasts and micro-projectile bombardment were the two methods of choice for transformation of wheat. Although there had been some reports of successful Agrobacterium-mediated transformation of monocots such as rice and maize there were no convincing reports of use of Agrobacterium-mediated methods for the successful generation of stable, fertile wheat plants.
The method disclosed in the specification involves incubation of regenerable wheat tissue with Agrobacterium strains containing foreign DNA of interest followed by regeneration of plants from the transformed tissue. The specification discloses that each of the steps of the method and features such as the starting materials used, tissue culture conditions and media, Agrobacterium strains and vectors and plant regeneration methods are all well known but that the invention lies in knowing that these steps can be combined to produce stable, fertile transgenic wheat. In particular the specification explains that the method can be applied to freshly isolated and precultured embryos, embryonic callus and suspension cells. There are 4 examples in the specification relating to preparation of starting material, engineering of Agrobacterium strains, inoculation of explant tissue and regeneration and testing of transgenic plants.

THE CLAIMS

The specification ends with 59 claims with the following 6 independent claims. The first 4 independent claims relate to wheat plants per se where the plants have been produced by inoculating precultured immature embryos or callus tissue with Agrobacterium and then regenerating transgenic plants. The remaining 2 independent claims related to methods for producing transgenic wheat plant by Agrobacterium-mediated transformation of precultured immature embryos or callus.
The independent claims are as follows:
1.“A fertile transgenic wheat plant, the genome of which has been altered through the genomic introduction of a pre-selected genetic component, said component comprising an exogenous gene positioned under the control of one or more pre-selected genetic control elements, the plant prepared by a process comprising:
i.Preparing a DNA composition in vitro, which composition includes the genetic component one desires to introduce into the genome of a wheat plant:
ii.Introducing said DNA composition into recipient wheat cells by Agrobacterium transformation;
iii.Regenerating wheat plants from said cells which have received said genetic component; and
iv.Identifying a fertile, transgenic wheat plant whose genome has been altered through the stable introduction of said genetic component, and wherein said recipient cells comprise an immature embryo isolated from an immature caryopsis and then precultured prior to inoculation, or a callus tissue.

8.A fertile, transgenic wheat plant, the genetic complement of which has been altered through the addition of a DNA composition comprising a pre-selected functional genetic element that includes a transgene selected from the group consisting of an nptII gene, a bla gene, a nptI gene, a dhfr gene, a aphIV gene, a aaaC3 gene, a aaaC4 gene and a GUS gene, wherein said functional genetic element confers on said wheat plant a phenotypic trait that is not found in the parentage of said plant, wherein said DNA composition was added using Agrobacterium transformation of recipient cells comprising an immature embryo isolated from an immature caryopsis and then precultured prior to inoculation, or a callus tissue.

20.A fertile, transgenic wheat plant, the genome of which has been altered through the genomic introduction of a pre-selected genetic component, said component comprising an exogenous gene positioned under the control of one or more pre-selected genetic control elements, substantially as hereinbefore described with reference to any one of the Examples.

21.A fertile, transgenic wheat plant, the genetic complement of which has been altered through the addition of a DNA composition comprising a pre-selected functional genetic element, substantially as hereinbefore described with reference to any one of the Examples.

25.A method for producing a fertile transgenic wheat plant, comprising the steps of:
i.Establishing a regenerable culture from a wheat plant to be transformed, wherein said culture comprises an immature embryo isolated from an immature caryopsis and then precultured prior to inoculation, or a callus tissue;
ii.Introducing a DNA composition comprising a genetic component one desires to introduce into the genome of said wheat plant, by Agrobacterium transformation;
iii.Identifying or selecting a transformed cell line;
iv.Regenerating a fertile transgenic wheat plant therefrom, wherein said DNA is transmitted though a complete sexual cycle of said transgenic plant to its progeny, wherein said progeny comprises a selectable or screenable marker gene, and wherein said marker gene is chromosomally integrated.

41.A method for producing a transgenic wheat plant, comprising the steps of
i.Establishing a culture from a wheat plant to be transformed, wherein said culture comprises an immature embryo isolated from an immature caryopsis and then precultured prior to inoculation, or a callus tissue;
ii.Transforming said culture with an Agrobacterium comprising a DNA composition comprising a genetic component one desires to introduce into the genome of said wheat plant;
iii.Identifying or selecting a transformed cell line; and
iv.Regenerating a transgenic wheat plant therefrom.
The remaining dependent claims, claims 2-7, 9-19, 22-24, 26-40 and 42-59 relate to progeny of the transgenic wheat plants and use of a detergent during transformation, or further define the immature embryos and callus tissue used as starting material.

THE DECISION

Construction Issues

Before discussing the grounds of the opposition it is necessary to resolve a key construction issue concerning the scope of the expression “embryos precultured prior to inoculation” as used in each of the independent claims. This expression was only present in a single dependent claim at acceptance but was introduced into each of the independent claims with the amendments of 20 May 2004. It has since emerged as a key issue in the opposition.
The opponent submitted that no definition or description of the time or conditions for preculture was provided in the opposed application. Given this, it was unclear whether there was any distinction between embryos temporarily placed on or in culture media prior to inoculation and embryos precultured prior to inoculation. If there was a distinction, the specification did not provide sufficient information for the skilled person to understand where that distinction lay.
This issue is highly relevant to the novelty and inventive step of the claims.
The principles of construction are well settled. In considering the definition of terms used in claims in Sachtler GmbH & Co KG V re Miller Pty Ltd [2005] FCA 788, Bennett J restated the following points:
·Terms in the claim which are unclear may be defined or clarified by reference to the body of the specification.
·It is legitimate to refer to the rest of the specification to explain the background to the claims, to ascertain the meaning of technical terms and to resolve ambiguities in the construction of the claims. Where the language of the claim is obscure or doubtful the doubt is sometimes resolved by referring to words in the body of the document to explain it.
·A patent should be given a purposive construction. However, that does not involve extending or going beyond the definition of the technical matter for which the patentee seeks protection in the claims. The question is always what the person skilled in the art would have understood the patentee to be using the language of the claim to mean. For this purpose, the language chosen is usually of critical importance.
“Culture” is a term routinely used in plant science and in the art of plant transformation, where it is used to describe the process of growing cells or tissues under controlled conditions in the laboratory. This understanding is consistent with the way in which the term is used by both partie’s experts in their various declarations when referring to plant materials used for transformation.
This construction is also consistent with the preculture described in the specification. “Preculture” or “pre-treatment” is used in the specification to describe growing embryos in or on culture media under controlled conditions prior to inoculation with Agrobacterium.
Example 5 describes three conditions for preparing embryos, the first two of which involve standard culture media and culture periods of 1 to 6 and 1 day respectively. Embryos prepared according to the first two conditions are described as “precultured immature embryos (cultured on medium 1 to 6 days)”, on page 29. Although all of these embryos are described as “cultured”, there will be significant developmental differences between embryos pre-cultured for 1 day and embryos pre-cultured for 6 days. At 1 day there will be little visible change to the embryo, although embryo tissues will have begun to change in response to the culture conditions, whereas at 6 days visible callus will have started to form in regions of the embryos. The changes seen in cultured embryos are discussed at page 30 of the specification, which describes the development of “callusing areas on the embryos pre-cultured for 3 d or longer”.
This is consistent with the way in which preculture is understood in the art where it is used to describe tissues grown under controlled conditions for periods ranging from a day to weeks and months.
The remaining condition described in example 5 provides the distinction between freshly isolated and precultured embryos. Embryos prepared according to the third condition are maintained in a medium similar to that used for the first two conditions but for only 1 to 3 hours. These embryos are described as “temporarily maintained in the liquid pre-culture medium” (page 29) and “freshly isolated” (table 6). There will have been little change to the embryo tissue during this short period in culture media and the embryos will remain in much the same state as when first isolated. This contrasts with precultured embryos where tissues in the embryos have developed or grown over the time spent in culture.
Thus the specification uses “preculture” in the same way as it used in the art and provides an example that distinguishes between freshly isolated and precultured embryos in terms of the period of time over which embryos are exposed to culture conditions.
There is also nothing in the specification to suggest that “preculture” should be restricted to any specific duration of culture. Table 7 shows successful transformation of freshly isolated embryos and embryos cultured for 1, 3, 5 and 6 days prior to inoculation, with only a slight advantage to precultured embryos over freshly isolated embryos and no trend in respect of advantages with increasing or decreasing periods of culture. Thus, although there is some slight advantage to precultured embryos there is no suggestion that this advantage is restricted to embryos cultured for any specific period of time.
In summary, I am satisfied that the specification distinguishes between freshly isolated embryos and embryos precultured prior to inoculation, with freshly isolated embryos being those that are maintained in culture media for a period of only a few hours prior to inoculation and precultured embryos being those that are cultured for longer periods, in the order of 1 to 6 days. I am also satisfied that the terms “cultured” and “precultured” are used in a way that is consistent with the way the terms are understood in the art.
At the hearing the opponent also submitted that even if the specification did distinguish between precultured and freshly isolated embryos, this distinction could not be regarded as a feature of the invention because there were no advantages demonstrated for preculture over fresh isolation or short term culture. However, as discussed above, table 7 shows some small advantage to precultured embryos, with precultured embryos having a simple average transformation efficiency of 2.25% for 6 experiments, in comparison to a simple average of 1.12% for 6 experiments using freshly isolated embryos. As such, although results vary significantly between experiments, an advantage is suggested for precultured embryos.
In addition, precultured embryos provide a further advantage in terms of increasing the range of tissues capable of transformation with Agrobacterium. As disclosed at page 22 of the specification, this contrasts with maize where work done by Ishida et al (JMS-29) demonstrated that only freshly cultured embryos were suitable for transformation.
Therefore, I am satisfied that the specification distinguishes between freshly isolated embryos and precultured embryos both in terms of preculture times and conditions and in terms of advantages of preculture over fresh isolation.

NOVELTY

Although the applicant listed 46 documents in their statement of grounds and particulars, at the hearing they restricted their detailed submissions on novelty to only the following 5 documents and oral disclosures made by Dr Brettell.
·Hood E.E. et al (1994) Plant Physiology Suppl., 104(1):114 (Abstract 607)
·EP 709462 (MONSANTO COMPANY) published 1 May 1996, with an earliest priority date of 26 October 1994
·EP 586355 (MONSANTO COMPANY) published 9 March 1994, with an earliest priority date of 19 August 1992.
·AU 57356/86 (CIBA-GEIGY AG) published 20 November 1986, with an earliest priority date of 13 May 1985.
·AU 80893/87 (CIBA-GEIGY AG) published 12 May 1988, with an earliest priority date of 7 November 1986.

I too have restricted my detailed discussion to these documents and oral disclosures, as none of the remaining documents clearly disclose the generation of stable, fertile transgenic wheat plants using Agrobacterium mediated transformation of precultured immature embryos or callus.

The law of novelty

The basic test for novelty is the “reverse infringement” test as stated in General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd, (1972) RPC 457 at pages 485, 486:
“If carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim”.
In applying this test regard must be given to the level of disclosure in the prior publication. As stated in Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR at 517:
“It is well accepted that the prior art must disclose all features of the invention embodied in the patent in suit and must do so in clear, unequivocal and unmistakeable terms. The prior art must enable the notionally skilled addressee at once to perceive and understand and be able practically to apply the discovery without the necessity of making further experiments. Whatever is essential to the invention must be read out of or gleaned from the prior publication.”
In Nicaro Holdings, Gummow J also referred to the speech of Lord Reid in C. Van Der Lely N.V. v Bamfords Limited (1963) RPC 61 and 71-72 where Lord Reid reaffirmed the principle set down by Lord Westbury in Hills v Evans [1862] 4 De G, F & J 288; 45 ER 1195 in relation to the level of disclosure necessary to anticipate a claimed invention:
"a person of ordinary knowledge of the subject would at once perceive and understand and be able practically to apply the discovery without the necessity of making further experiments".
Accordingly the alleged anticipation must not only disclose all of the integers of the claim, it must also provide sufficient detail to enable the skilled addressee to combine those integers to produce the invention without the need for further experimentation.

Oral disclosures made by Dr Brettells

Dr Brettells is a Principal Research Scientist at CSIRO Division of Plant Industry. From 1991 to 1996 Dr Brettell was actively involved a collaborative project between the CSIRO and the Grains Research and Development Corporation (GRDC) to develop methods for the transformation of cereal crops, including wheat. In the period between December 1995 and June 1996, prior to the earliest priority date of the opposed application, Dr Brettell gave the following presentations on current advancements in transformation of wheat and barley:
·12-13 December 1995, Cronulla, New South Wales
Presentation at a meeting organised by GRDC to review the current state of play in transformation of cereal crops in Australia and to identify future directions and priorities.
·17 May 1996, CSIRO Plant Industry, Canberra
Staff talk entitled “Cereal Transformation for Improved Grain Quality and Disease Resistance.”
·3 June 1996, WAITE Agricultural Research Institute, Adelaide
Presentation as part of WAITE plant science seminars entitled “Gene Transfer in Wheat: A Real Transformation?”
In each of these disclosures Dr Brettell spoke about successful generation of transgenic wheat via Agrobacterium-mediated transformation.
In their evidence, and at the hearing, the applicant submitted that Dr Brettell’s disclosures could not be regarded as public disclosures because attendees at the meetings would have understood that presentations and discussions at the meeting were to be regarded as confidential. If this was correct then Dr Brettell’s disclosures would not form part of the prior art base for the purpose of novelty.
Although it might be argued that the Cronulla meeting was an “invitation only” meeting, and therefore restricted to a small group of researchers working on cereal transformation in Australia, there is no evidence that attendees at this meeting were aware of any clear duty of confidentiality. There is also no evidence that either of the other two meetings were restricted to invitees only. To the contrary, RB-6, which is a copy of the “Yellow Sheet” advertising the particular series of Canberra-based CSIRO staff seminars including Dr Brettell’s presentation, clearly states “All Welcome”. In addition, RB-8, which is the notice for the WAITE seminars, confirms that the WAITE presentation was part of a general seminar series organised by the Department of Plant Science at the University of Adelaide.
As such, I am satisfied that it is appropriate to regard Dr Brettell’s presentations as part of the prior art base for novelty and to move on to consider the content and extent of Dr Brettell’s presentations.
In their submissions the applicant also argued that Dr Brettell’s presentations were not enabling disclosures because they lacked essential information, and because they did not confirm stable, heritable integration of transgenes in the progeny of transformed plants.
In his first declaration the applicant’s expert Dr Henry argued that Dr Brettell’s presentation notes from the Cronulla, Canberra and WAITE meetings failed to provide many important details of methodologies and materials necessary for successful wheat transformation. In particular Dr Henry submitted that Dr Brettell failed to disclose information about Agrobacterium strains used, culture conditions, plant regeneration methods and conditions, and specific tissues used or how these were prepared.
However, these submissions are refuted by evidence provided by Dr Brettell in his first declaration; exhibits RB-4 and RB-8, which are copies of overheads presented at the talks; and in declarations made by 4 of the attendees at the WAITE seminar. This evidence confirms that, in his talks and in discussions at the meeting Dr Brettell disclosed details of the plasmids, promoters and Agrobacterium strain used, that his methods were similar to those used in dicots, that timentin was used to control Agrobacterium overgrowth and that actively dividing embryo cultures were used as starting material.
RB-8 provides a detailed plasmid map of the vector used for wheat transformation, including identification of the maize ubiquitin promoter driving expression of a transgene, use of the bar gene for selection and use of the gus gene. RB-8 also lists promoters, Agrobacterium strain, means of controlling Agrobacterium growth and actively dividing cultures capable of efficient regeneration as reasons for success with transformation. Notes taken by four attendees at the WAITE seminar confirm that during his talk Dr Brettell elaborated on each of these features. In particular notes taken by Baumann and Pallotta confirm that Dr Brettell disclosed the particular Agrobacterium strain used, that the methods were similar to those used for dicots, that timentin was used to control Agrobacterium overgrowth factors and that “embryo derived” and “embryo” cultures were used as starting material. One of the overheads in RB-4 also confirms that transgenic wheat plants had been produced from embryo derived cultures and that the transgenic nature of the plants had “been confirmed by PAT assay as well as gel blot hybridisation (Southern) analysis”.
Dr Brettell’s overhead in RB-4 also makes the point that one of the key features behind his success was “belief in the method”. This is a particularly telling point. At the priority date of the application it was still widely believed that monocots, and in particular cereals, were not easy to stably transform with Agrobacterium and that special conditions would need to be developed if cereals such as wheat were ever to be successfully and efficiently transformed using Agrobacterium. Dr Brettell demonstrated that this was not the case and that the methods routinely used in dicots were suitable for wheat, with some specific alterations such as the use of timentin, cultured embryos and the plasmid construct illustrated in RB-8. Once the specific alterations were identified the skilled person could then adapt the methods used in dicots to suit a monocot such as wheat. A similar approach is also reflected in the opposed specification, which explains that standard and well known vectors, Agrobacterium strains, culture and inoculation procedures can be used in the method of the invention.
As such I am satisfied that Dr Brettell’s presentations provided sufficient information for the skilled person to successfully repeat Agrobacterium-mediated transformation to produce stable transgenic wheat.
In particular, I am satisfied that Dr Brettell disclosed the use of precultured immature embryos as starting material. This is confirmed in Dr Brettell’s first declaration, an overhead from the WAITE meeting and notes made by Ms Pallotta at the WAITE meeting. Although, Dr Brettell appears to have only broadly described “cultured embryos” with no specific duration of culture disclosed, I am satisfied that this broad description is consistent with the precultured embryos defined in the claims. There is nothing in the specification, and no evidence from the applicant to suggest that a specific period of culture is essential or particularly advantageous. In particular, table 7, which discloses transformation efficiencies for particular stages of culture, does not provide evidence of consistent advantages to any particular period of culture. Given this, I am satisfied that any reference to cultured embryos is consistent with the precultured embryos as currently defined in the claims.
The applicant also argued that that Dr Brettell’s presentations would not have been sufficient to convince the skilled person that transgenic wheat had actually been produced. It was submitted that in the absence of southern blot evidence the skilled person would regard Dr Brettell’s regenerated wheat plants as examples of mutant “escapes” rather than transgenic plant resulting from successful transformation.
However, this argument is at odds with declarations made by 4 of the opponent’s experts, each of whom was actively involved in the field of cereal transformation at the priority date of the opposed application and each of whom was convinced that Dr Brettell had disclosed successful transformation of wheat using Agrobacterium. Ford, Pallotta, Bauman and Burton all attended Dr Brettell’s WAITE presentation and each state the following in their declarations:
“I consider that this presentation by Richard Brettell was a clear disclosure of the production of transformed wheat by Agrobacterium-mediated transformation using embryos at the right stage (immature embryos) as starting material.”
As such, I am satisfied that the opponent has established that Dr Brettell’s disclosure was accepted as a credible account of the production of transformed wheat by Agrobacterium-mediated transformation.
In summary, I am satisfied that the Brettell presentations form part of the prior art base for novelty and that Dr Brettell provided clear and unmistakeable directions to produce fertile, transgenic wheat by a process comprising preparing embryo cultures from immature wheat embryos, inoculating the cultures and then regenerating stable, fertile transgenic wheat plants. Thus, independent claims 1, 8 and 41 of novelty.
Claims 2, 15 and 52-54, which are dependent on 1, 8 or 41, also lack novelty. These claims include the added feature of a screenable or selectable gene, more specifically a bla or gus gene, or two transgenes on a single DNA segment. The construct disclosed by Dr Brettell in RB-8 included both the bla and gus genes on a single vector.
Claims 7, 13 and 47, which are also dependent on 1, 8 or 41, lack novelty. The claims include the feature that the immature embryo is isolated from a caryopsis at least 2 days after anthesis. Although there was no evidence that Dr Brettell provided specific details of when the embryos were isolated, the opponent provided evidence to show that wheat embryos used in tissue culture are generally isolated 12 to 14 days after anthesis. This was also confirmed in a number of the citations provided by the opponent, for example JMS-19, where embryos used in transformation and culture were isolated 12 to 14 days after anthesis. As such I am satisfied that the skilled person would have appreciated that Dr Brettell’s embryos would have been isolated at least 2 days after anthesis.
Claim 58, which is dependent on claim 41 also lacks novelty. This claims recites a transgenic wheat plant produced by the method of claim 41.
However, I have no evidence that the remaining claims dependent on claims 1, 8 and 41 lack novelty.
Claims 3-5, 9-11 and 43-45 specify pre-culture periods of at least 24 hours. I have no evidence that Dr Brettell disclosed a specific duration of culture or that the skilled person would have understood the period of culture to be at least 24 hours. The only evidence that I have relates to RB-13, which is a manuscript prepared by Dr Brettell’s group and relating to Agrobacterium-mediated transformation of barley. This manuscript discloses overnight culture of immature barley embryos prior to inoculation. Although this is obviously not wheat, the manuscript also states that similar work has been done in wheat. As such, the only evidence that I have suggests that Dr Brettell’s method did not include culture of embryos for at least 24 hours prior to inoculation.
Claims 6, 12 and 46 specify that the starting material is callus, rather than immature embryos. This is distinguished from Dr Brettell’s method where cultured immature embryos were used.
Claims 16 to 19 and 48 to 51 specify that a surfactant is used to aid transformation. The opponent did not provide any evidence to suggest that Dr Brettell used a surfactant, nor did they provide evidence to suggest that the skilled person would have necessarily used a surfactant if repeating Dr Brettell’s wheat transformation. In addition, although there is some evidence that surfactants such as Tween had occasionally been used for dicots there is nothing to suggest that they would have been a routine addition when inoculating monocots such as wheat. Given this I have no evidence that Dr Brettell used a surfactant in his methods, or that a surfactant would have been included as a matter of course when repeating Dr Brettell’s methods.
Claims 14 and 56 disclose the use of the nptII gene as a transgene. This is in contrast to Dr Brettell’s methods where the gus and bla transgenes are used.
Claim 42 defines use of the Agrobacterium strain c58. Although I have evidence that Dr Brettell disclosed the specific strain that he used, I have no evidence that this was the c58 strain define in claim 42, nor have I any evidence that the skilled person would have understood that this was the strain of choice.
Claims 22-24 and 59 define progeny, seeds and cells of transgenic wheat plants. Although there is evidence that Dr Brettell intended to obtain these from his transformed plants, at the hearing the opponent revealed that at the time of the presentation Dr Brettell’s plants were not yet mature enough to breed and as such he had not yet obtained progeny or seeds from these plants. In addition, the opponent failed to provide any evidence that Dr Brettell had isolated cells from his plants at the time of the presentations.
Similarly, with respect to independent claim 25 and its dependent claims, this claim includes the feature of obtaining progeny from transgenic wheat prepared by Agrobacterium-mediated transformation. As discussed in the preceding paragraph, Dr Brettell had not obtained progeny from his transgenic wheat at the time of his presentations. Thus claims 25-39 and 57 the Brettell presentations do not deprive these claims of novelty.
Claims 20, 21 and 40 are omnibus claims referring to the examples in the specification. Although I am satisfied that Dr Brettell’s methods and transgenic wheat fall within the scope of the independent claims, I have no evidence that the methods used by Dr Brettell were the same as those used by the applicant. In particular, as discussed above, I have no evidence that the culture conditions and Agrobacterium strain used by Dr Brettell were the same as those used by the applicant.
In conclusion, I am satisfied that Dr Brettell’s presentations deprive claims 1, 2, 7, 8, 13, 15, 41, 47, 52 to 54 and 58 of novelty. However, the opponent has failed to provide evidence to support a lack of novelty for the remaining claims.

Hood et al

Hood et al represents the abstract for a poster presented at the annual meeting of the American Society of Plant Physiology in Portland, Oregon in 1994. The abstract discloses transformation of wheat embryos using Agrobacterium and regeneration of transgenic plants from the transformed tissue.
Hood et al was provided as part of further evidence in association with two statutory declarations made by Ms Chitty and Dr Furbank, both of whom attended the Portland meeting and spoke with Dr Hood during the poster session. Information in the Chitty and Furbank declaration relates to their attendance at the Portland meeting, including additional information provided through discussions with Dr Hood at the meeting
The opponent submitted that the Hood abstract deprived the claims of novelty either on its own, or in association with more detailed information provided by Hood to Ms Chitty and Dr Furbank at the poster session in Portland.
Superficially the method described in the Hood abstract appears very similar to that defined in the claims. The abstract discloses transgenic wheat produced by transforming immature wheat embryos using Agrobacterium. Following Agrobacterium inoculation plantlets were regenerated from cultured tissue and then tested for expression of the gus transgene.
However, when regarded on its own I am not satisfied that the Hood abstract provides sufficient information to enable the skilled person to produce transgenic wheat as defined in the claims. The level of detail in the abstract is typical of conference abstracts, whose primary goal is to stimulate interest and encourage conference participants to seek out further details at poster sessions. Although the abstract provides details of some crucial features such as Agrobacterium strains, wheat cultivars used, selection procedures and PCR and dot blot analysis of transgenic plants; it does not provide other details necessary to repeat the transformation. In particular it does not provide details of the Agrobacterium vectors used, explant culture or procedures for inoculation and co-cultivation of explant tissue and Agrobacterium.
As such, I do not believe that the Hood abstract can be regarded as an enabling disclosure for Agrobacterium-mediated transformation of wheat as claimed.
With respect to the additional information provided by Dr Hood to Chitty and Furbank at the meeting in Portland, this information does not form part of the prior art base for novelty at the priority date of the opposed application. Prior to 2001 the prior art base did not include information made publicly available through doing an act outside the patent area. As such this additional information is not relevant to the novelty of the claims. Although the opponent also suggested that Chitty and Furbank repeated this information to Dr Brettell on their return to work in Canberra, they did not provide any evidence of the content of these discussions or suggest that they could be regarded as public disclosures.
Thus, I am not satisfied that Hood et al deprives the claims of novelty.

EP 709462

EP 709462 is entitled “Rapid and Efficient Regeneration of Transgenic Plants” and focuses on transformation of wheat immature embryos and callus. The basic steps of the invention as described at page 3 of the citation are to: isolate regenerable tissue such as embryos or callus; introduce foreign DNA via micro-projectile bombardment, Agrobacterium transformation, electroporation or protoplast-facilitated gene delivery; and then regenerate transgenic plants. The citation then discloses bombardment as the preferred method for introduction of foreign DNA and provides 3 specific examples, each of which relates to micro-projectile bombardment. As such, although the citation may broadly disclose each of the steps of the claimed method, it does not provide clear directions to use Agrobacterium for introduction of foreign DNA. In contrast it suggests that bombardment is the preferred method.

At the hearing the opponent submitted that the citation provided sufficient detail for the skilled person to introduce foreign DNA using any of the four methods disclosed at page 3. In particular the specification provided a reference to Chan et al 1993 (JMS-22) which discloses successful Agrobacterium-mediated transformation of immature rice embryos. Thus, the opponent argued, the citation provides not only the direction to use Agrobacterium-mediated transformation but also the detailed information necessary to carry out this procedure.
However, Chan et al relates to rice transformation, not wheat. Although rice and wheat are both cereals, they are not closely related and the methods used for transformation and culture of rice are not the same as those used for wheat. Thus, it would require more than routine trial and error for the skilled person to modify the methods described in Chan et al to suit Agrobacterium-mediated transformation of wheat.
Given this, I am not satisfied that the citation provides sufficient information or clear directions to use Agrobacterium to transform wheat. Thus, I do not believe that the citation deprives the claims of novelty.

EP 586355

EP 586355 is entitled “Method for Transforming Monocotyledonous Plants” and discloses transformation of the Gramineae family, which includes corn wheat. In a similar fashion to EP 709462 it describes an invention involving delivering foreign DNA to immature embryos and callus of monocots. At page 3 it states that foreign DNA may be delivered by any transformation means but that electroporation and microprojectile bombardment are preferred. Of the six examples, five related to transformation of corn using microprojectile bombardment. The sixth example relates to transformation of wheat using micro-projectile bombardment.
As such EP 586355 suffers from similar deficiencies to EP 709462 in that it does not provide sufficient information or clear directions to use Agrobacterium to transform wheat. Given this, I am not satisfied that the citation deprives the claims of novelty.

AU 57356/86

AU 57356/86 relates to Agrobacterium-mediated transformation of plant material and includes wheat as one of the plants suitable for transformation. However, all of the examples provided relate to dicots rather than monocots and there is no suggestion that cultured immature wheat embryos or callus might be suitable tissues for Agrobacterium-mediated transformation of wheat.
As such the citation does not provide clear and unmistakeable directions to produce transgenic wheat as claim. Given this, I am not satisfied that the citation deprives the claims of novelty.

AU 80893/87

AU 80893/87 is more specific than AU 57356/96 in that it is at least limited to Agrobacterium-mediated transformation of monocots, with wheat and maize being the subjects of the examples. However, rather than disclosing precultured immature embryos and callus as starting materials, the citation discloses protoplasts, wounded whole plants and tissue and plant growth zones such as plant and stem sheathes as starting material. Agrobacterium is preferably introduced to these tissues by direct injection.
In addition, the citation does not disclose the generation of whole transgenic plants from this process or stable inheritance of transgenes.
As such there are fundamental differences between the methods disclosed in the citation and those defined in the claims of the plant. Given this, I am not satisfied that the citation deprives the claims of novelty.

Other citations

In addition to the prior art discussed above the opponent raised a number of other citations, most of which are non-patent journal articles relating to the transformation of monocots. Most notable among these citations are articles by Hiei et al 1994 (JMS-23), Dong et al 1996 (JMS-24), Rashid et al 1996 (JMS-25) and Chan et al 1993 (JMS-22), relating to transgenic rice and Ishida et al 1996 (JMS-29) relating to transgenic maize. As agreed by both parties’ experts these citations, in particular Hiei et al, represent information that changed the landscape for transformation of cereals. These were the first citations to conclusively demonstrate successful and reasonably efficient generation of fertile transgenic cereals using Agrobacterium. Prior to these reports there had been few if any credible reports of successful generation of transgenic cereals and it was generally accepted that monocots were recalcitrant to Agrobacterium transformation.
However, despite the fact that these citations are relevant to the general field of transformation of cereals, none of the citations disclose fertile, transgenic wheat produced by Agrobacterium-mediated transformation of precultured embryos or callus. Citations such as Heie et al and Ishida et al, which disclose Agrobacterium-mediated transformation of precultured embryos or callus, relate to rice or maize, rather than wheat, and citations that relate to wheat disclose micro-projectile bombardment, transformation of tissues other than callus or embryos, or fail to disclose the production of stable, fertile plants. As such, none of the citations clearly discloses all of the features of the claims.
Given this, I am not satisfied that any of the citations deprive the claims of novelty.

Summary

In summary, I am satisfied that claims 1, 2, 7, 8, 13, 15, 41, 47, 52 to 54 and 58 lack novelty in light of the information disclosed by Dr Brettell at the Cronulla, Canberra and Waite meetings.
However, I am not satisfied that any of the remaining documents provided sufficient information, or clear and unmistakeable directions to the invention as claims. Thus, I am not satisfied that any of the remaining citations deprive the claims of novelty.

INVENTIVE STEP

In their submissions at the hearing the opponent focused on a lack of inventive step in light of common general knowledge in the art alone, or in combination with any one of the five documents discussed in detail above or either of the following documents:
· AU 45134/93 (JAPAN TOBACCO INC.) 31 January 1994, with an earliest priority date of 6 July 1993.
· AU 75460/94 (JAPAN TOBACCO INC.) 22 March 1995, with an earliest priority date of 1 September 1994.
I too have restricted my detailed discussion to this prior art. I am satisfied that these are the most relevant documents among the citations exhibited by the opponent. All disclose the production of transgenic wheat.
I have not discussed the Brettell presentations because I do not believe that the skilled person could have reasonably been expected to have ascertained the information disclosed in these presentations. The disclosures were made before restricted audiences at an invitation only meeting and at departmental seminars. At the hearing neither party provided inventive step submissions on the Brettell presentations.

The law of inventive step

The “problem-solution” approach set out by Aickin J in WellcomeFoundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 typifies one of the basic tests for inventive step or obviousness.
"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 High Court in Aktiebolaget Hassle v Alphapharm Pty Limited [2002] HCA 59 at 53 when expanding on the “problem-solution” approach also affirmed the test set out by Graham J in Olin Mathieson v Biorex [1970] RPC 157 at page 187:
“Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of the relevant prior art [.......] directly be led as a matter of course to try [a particular thing] in the expectation that it might well produce a useful result?”
The Court in Alphapharm also noted with approval the test set out in Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd (1979-80) 144 CLR 253, at page:
“In the case of a combination patent the invention will lie in the selection of integers, a process which will necessarily involve rejection of other possible integers. The prior existence of publications revealing those integers, as separate items, and other possible integers does not itself make an alleged invention obvious. It is the selection of integers out of, perhaps many possibilities, which must be shown to be obvious.”
Accordingly there must be a motivation for the skilled person to apply what is disclosed in a relevant prior art document or what is common knowledge in the art with the expectation that it will produce the claimed result.

Common general knowledge in the art

The opponent submitted that each of the steps of the applicant’s method for producing transgenic wheat was part of the common general knowledge at the priority date of the application. In his first declaration, the opponent’s expert Dr Larkin explains that the following were well known prior to 21 June 1996, the priority date of the application:
·Techniques for introducing foreign DNA into plants, including Agrobacterium-mediated transformation of plant cells and tissues;
·Use of plant embryos and callus for genetic transformation;
·DNA compositions for use in Agrobacterium-mediated transformation;
·Techniques for regeneration of transformed plant cells and tissues;
·Techniques for growth of transgenic plants, and the progeny of transgenic plants.
I am satisfied that this is an accurate account of the state of the art at this time, particularly with respect to dicots. However, it does not necessarily follow that it would have been obvious to the skilled person to combine these steps to produce transgenic wheat.
At the priority date of the application although Agrobacterium-mediated transformation of many dicot species was routinely practised the same could not be said for transformation of monocots. Even into the 1990s it was still widely accepted that monocots were intractable to Agrobacterium-mediated transformation. A 1995 review article co-authored by Dr Brettell (JMS-44) observes that “cereals have shown a notable reluctance to submit to transformation by Agrobacterium”. This same review, although encouraging further work on transformation of small grain cereals such as wheat, and disclosing successful Agrobacterium-mediated transformation of japonica rice and maize in the previous year, confirms that transformation of cereals was still in its infancy at this time.
Articles such as this paint a picture of an art where there a strong desire to develop reproducible and efficient methods for Agrobacterium-mediated transformation of small grain cereals, but also an understanding that much work still needed to be done and that methods that worked in one species of cereal, or even one specific cultivar could not necessarily be routinely applied to another.
This is understanding is reflected in a number of articles published at this time, including Hiei et al 1994 (JMS-23), which was one of the first confirmed reports of successful Agrobacterium-mediated transformation of rice, and was described by Mr Slattery as the article “that changed the whole ball game” in the monocot transformation world. This article, although confirming similarity with methods used in dicots, does not go beyond suggesting that the method may be suitable for other japonica rice cultivars and even within rice stresses the importance of choosing the correct combination of vectors and strains.
As such, I am not satisfied that it would have been a matter of routine for the skilled person to combine or manipulate the steps outlined above in such a way as to achieve Agrobacterium-mediated transformation of wheat. In particular, I am not satisfied that the skilled person would have expected that Agrobacterium-mediated transformation methods that were routine in dicots could be married with standard tissue culture and plant regeneration methods for wheat to produce stable, fertile transgenic wheat.
Given this, I am not satisfied that the opponent has established that the claims lack an inventive step in light of common general knowledge in the art.

Hood et al

The opponent submitted that even if Hood et al did not deprive the claims of novelty, it would have been a matter of routine for the skilled person to fill in the gaps in Hood et al to arrive at a successful protocol of the transformation of wheat.
However, this conclusion ignores the lack of information in the art at the time about appropriate Agrobacterium vectors, suitable target tissues and inocultation and co-culture procedures. Although successful transformation protocols, such as that disclosed by the applicant and claimed in the opposed application have now shown that standard vectors, tissues and inoculation procedures will work with wheat, this was not known at the priority date of the application. In contrast, previous problems had led to a general expectation that choice of vectors, identification of suitable tissues and manipulation of inoculation and co-culture conditions were important factors in success with monocots.
Given this, I am not satisfied that the skilled person would have been able to fill in the gaps in Hood et al as a matter of routine. Thus, I am not satisfied that the opponent has established that Hood et al deprives the claims of an inventive step.

EP 709462 and EP 586355

As discussed in relation to novelty, both of these citations specifically deal with transformation of wheat. Although both identify micro-projectile bombardment as the preferred means of transformation and exemplify only micro-projectile bombardment, both also suggest that any other transformation method is suitable. In particular, EP 709462 refers to Chan et al, which discloses Agrobacterium-mediated transformation of rice, as an example of another suitable transformation method.
At the hearing the opponent submitted that the direct reference in Chan et al, when considered in combination with the teachings in the EP 709462 would motivate the skilled person to apply the methods taught in Chen et al to the transformation of wheat.
However, this approach fails to take into account the general expectation in the art that methods that work in one cereal cannot necessarily be routinely transferred to another and that selection of appropriate strains, vectors, explant tissues and inoculation conditions is likely to be pivotal to success. Given this, I am not satisfied that the skilled person would be motivated to try Agrobacterium-mediated transformation of wheat. In contrast, I believe the skilled person would restrict themselves to using the micro-projectile bombardments methods explicitly disclosed in each of the citations.
As such I am not satisfied that the claims lack an inventive step in light of either citation.

AU 57356/86

Although AU 57356/86 includes wheat among the list of plants that can be transformed using Agrobacterium, the examples are restricted to transformation of dicots and there are no specific details of how the exemplified protocols might be modified to suit monocots.
Given the expectation in the art at the priority date that dicot methods could not be routinely transferred to monocots and the lack of understanding of what sorts of modifications would be required in applying dicot methods to monocots, I am not satisfied that the disclosure in the citation would provide any motivation to the skilled person to try Agrobacterium-mediated transformation of wheat. I am also not satisfied that the skilled person would know how to modify the methods in the citation to work in wheat.
As such I am not satisfied that the claims lack an inventive step in light of the citation.

AU 80893/87

In contrast to the previous patent citations AU 80893/87 does disclose Agrobacberium-mediated transformation of wheat. However, rather than disclosing embryos or callus as starting materials, the citation only exemplifies targeted inoculation of wounded wheat seedlings. In addition the citation also does not disclose regeneration of transgenic plants from infected tissue.
As such, even if the skilled person were to consider this as a potential method for producing transgenic plants, they would use the fresh, wounded tissue disclosed in the citation rather than the cultured embryonic tissue used in the applicant’s methods. They would appreciate the fundamental differences between the two types of tissues and understand that in an unpredictable art such as plant transformation success with a specific type of tissue in a particular plant does not necessarily predict success with different tissue in the same plant.
Given this, I am not satisfied that the citation deprives the claims of an inventive step.

AU 45134/93 and AU 75460/94

These citations disclose Agrobacterium-mediated transformation of corn and rice. AU 45134/93 exemplifies transformation of callus tissue from rice and maize, whereas AU 75460/94 exemplifies transformation of rice and maize immature embryos. As such, both citations are relevant to the field of Agrobacterium-mediated transformation of cereals.
However, as discussed previously, at the priority date of the opposed application there was an expectation that modifications would be required before methods that had worked in one cereal could be successfully applied to another. At this time the scope and nature of any such modifications was also unclear. In particular, it should be remembered that wheat is not a close relative of either corn or maize, and that in contrast to the diploid genomes of corn and rice, most wheat cultivars have a complex hexaploid genome.
Although the applicant’s work and work of others in the field after the priority date of the opposed application have since revealed that in many cases only minor modifications were required and that these modifications may have been of a routine nature, this was not known or expected at the priority date. Given this, I am not satisfied that the disclosures in the citations would have motivated the skilled person to try the same or similar protocols in wheat with an expectation that stable transgenic wheat would result.
As such, I am not satisfied that the claims lack an inventive step in light of either citation.

Other citations

As mentioned in relation to novelty, the opponent raised a number of other citations disclosing transformation of monocots and including journal articles relating to successful Agrobacterium-mediated transformation of rice and maize. Although these citations raised expectations in the art that other cereals such as wheat could be transformed by Agrobacterium, I am not satisfied that the skilled person would consider that any of these citations provided a method that could be routinely applied or adapted to a range of cereals extending beyond the specific cereal disclosed in the citation.
This conclusion is borne out by statements made in citations such as Hiei et al 1994 (JMS-23), Chan et al 1993 (JMS-22) and Ishida et al 1996 (JMS-29) to the effect that Agrobacterium-mediated transformation is still regarded as “difficult” in monocots and that although there is some expectation that the same methods can be successfully applied to similar cultivars of the same species modifications will still be required when adapting this methods to different or “difficult” cultivars or other monocot species.
Given this, I am not satisfied that any of remaining citations particularised by the opponent in their evidence are sufficient to deprive the claims of an inventive step.

MANNER OF MANUFACTURE

The law of manner of manufacture

In Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232, at 249, the Court stated:
“Many valid patents are for new uses of old things. But it is not an inventive idea for which a monopoly can be claimed to take a substance which is known and used for making various articles, and make out if it an article for which its known properties make it suitable, although it has not in fact been used to make that article before.”

It was also stated in British Celanese Ltd v Courtaulds Ltd 52 RPC 171, at pages 193-194:
“It is accepted as sound law that a mere placing side by side of old integers so that each performs its own proper function independently of any of the others is not a patentable combination, but that where the old integers when placed together have some working inter-relation producing a new or improved result then there is patentable subject-matter in the idea of the working inter-relation brought about by the collocation of the integers.”
Accordingly, there is a threshold for invention which requires that where there are known steps or known integers a patentable invention can only be one where these steps or integers are combined in such a way as to produce a new result.
At the hearing the opponent submitted that this threshold was not achieved by the claimed invention. That each of the steps of the claimed methods was known in the context of plant transformation and plant tissue culture and that the invention was simply a combination of these known steps in a way that achieved their expected goal: transformation of wheat. As acknowledged by the opponent in their submissions, this argument follows the same lines as the arguments put forward with respect to inventive step.
For the same reasons outlined in respect of inventive step, I do not believe that the invention represents nothing more than an obvious combination of known steps to achieve the expected result. Although the steps may have been known in the general context of plant transformation, they were not known in the context of cereal transformation. Nor would it have been obvious how these steps could be applied or modified to suit wheat.
Given this, I am satisfied that the invention meets the threshold set for manner of manufacture.

SECTION 40

The opponent submitted that claims 34 to 36 and 49 to 51 lack clarity because the claims recite “the transgenic wheat plant” of preceding claims, yet the preceding claims relate to methods for producing transgenic wheat, rather than transgenic wheat per se. I agree that this is the case and that the claims are incorrectly appended. At the hearing the applicant conceded that this was the case and confirmed that they would amend the claims to overcome this problem.
The opponent also made submissions on lack of clarity with respect to “precultured prior to inoculation”. However, I have already dealt with this issue under “construction issues” and concluded that I am satisfied that the meaning of “precultured prior to inoculation” would be clear to the skilled person in the context of the invention.
The opponent also submitted that the specification failed to provide a full and sufficient disclosure of immature embryos having been precultured prior to inoculation. However, the examples, in particular page 27 and table 7 disclose media and conditions for preculture as well as transformation efficiencies for precultured immature embryos.
Similarly, the opponent submitted that there was no disclosure of the use of surfactant in inoculation media, in particular an organosilicone-based surfactant. The use of surfactant is a feature of claims 16 to 19, 33 to 36 and 48 to 51. However, page 30 of the examples discloses transgene expression in immature embryos transformed with the organosilicone-based surfactant Silwet in inoculation media.
At the hearing the opponent made the point that the disclosure at page 30 only related to the detection of transgene expression in cultured tissue, with no evidence that this tissue could be regenerated to produce stable transgenic plants. However, there is nothing in the specification to suggest that stable transgenic plants could not be regenerated from Silwet treated embryos using the regeneration methods described in other examples.
At the hearing the opponent also referred to a later paper published by the inventors where Silwet was shown to have toxic effects on plant tissue when used at concentrations similar to those recited in some of the claims. Thus, they submitted there was evidence that there was insufficient information in the specification to produce transgenic plants from Silwet treated embryos. In response to this, Dr Myers confirmed that even though higher concentrations of Silwet were shown to be toxic to most embryos, not all embryos were killed and those that did survive showed higher transformation efficiencies.
As such, I am satisfied that the specification meets the requirements for full description of the invention as it relates to the use of a surfactant in inoculation medium.
The opponent also submitted that there was a lack of fair basis for the features of embryos precultured prior to inoculation and use of a surfactant in the inoculation medium. In order for a claim to be fairly based, the claims must be consistent with what the specification as a whole describes as the invention.
I am satisfied that it is clear from not only the introductory portions of the specification but also the examples that these two features are important features of the invention. There are a number of clear statements in the general description of the invention to confirm that the use of precultured immature embryos as starting material is a preferred embodiment of the invention. There are also general statements to support the use of surfactant in inoculation media and substantiation of this with a discussion of the use of Silwet in the examples.
As such, I am satisfied that the invention as claimed is consistent with the invention as described in the specification and that the claims are fairly based.
In summary, the opponent provided submissions on clarity, fair basis and full description. Although I am satisfied that claims 34 to 36 and 49 to 51 lack clarity, I have no clear evidence that the opponent has established that there are any further problems with clarity, fair basis or full description.

CONCLUSION

The opposition was partially successful on the grounds of novelty and clarity but was unsuccessful on all other grounds.
With respect to novelty, I am satisfied that the Brettell presentations form part of the prior art base for novelty and that the information disclosed in these presentations, particularly the WAITE presentation, was sufficient to enable the skilled person to produce fertile, transgenic wheat by Agrobacterium-mediated transformation. As a consequence, the Brettell presentations deprive claims 1, 2, 7, 8, 13, 15, 41, 47, 52 to 54 and 58 of novelty.
However, the opponent failed to provide evidence to support a lack of novelty for the remaining claims in light of the Brettell disclosures. The opponent also failed to provide evidence to support a lack of novelty with respect to any of the remaining citations or to support a lack of inventive step with respect to any of the citations, Brettell included.
The opponent also provided submissions on manner of manufacture, clarity, fair basis and full description. With respect to clarity, I am satisfied that claims 34 to 36 and 49 to 51 lack clarity. The claims recite “the transgenic wheat plant” of preceding claims, yet the preceding claims relate to methods for producing transgenic wheat. However the opponent has failed to provide me with evidence that the opposed specification failed to meet the requirements for the remaining grounds of manner of manufacture, fair basis and full description.
Given that there is clearly patentable subject matter remaining in the application I give the applicant 60 days to provide amendments to resolve the lack of novelty for claims 1, 2, 7, 8, 13, 15, 41, 47, 52 to 54 and 58 and the lack of clarity for claims 34 to 36 to 49 to 51.

COSTS

36. The normal practice is that costs follow the event. In the current circumstances I see no reason to deviate from this practice and I believe that it is appropriate to award costs against the applicant.

TERRY MOORE

Delegate of the Commissioner of Patents

20 April 2007

Patent attorneys for the applicant : Spruson and Ferguson, Sydney
Patent attorneys for the opponent : Davies, Collison, Cave, Melbourne