Urrbrae Foods Pty Ltd v Commonwealth Scientific and Industrial Research Organisation [2025] APO 12

I award costs according to Schedule 8 against Commonwealth Scientific and Industrial Research Organisation.

1. Patent application 2017292900 (the application) was filed by Commonwealth Scientific and Industrial Research Organisation (CSIRO; the applicant) on 4 July 2017 under the provisions of the Patent Cooperation Treaty and claiming priority from AU 2016902643 which was filed on 5 July 2016. The application entered national phase on 21 December 2018 and following examination was advertised accepted on 23 December 2021.

1. Urrbrae Foods Pty Ltd (the opponent) filed a notice of opposition under section 59 of the Patents Act 1990 (the Act) on 23 March 2022. The statement of grounds and particulars as filed on 22 June 2022 and amended on 14 October 2022 identifies as grounds of opposition entitlement, manner of manufacture, novelty, inventive step, utility and support. At the hearing grounds of manner of manufacture, support and entitlement were pressed.

1. The applicant proposed post-acceptance amendments to the specification on 11 November 2022 which were allowed unopposed on 16 March 2023. This decision is in relation to the specification as amended.

1. The evidence filed during the evidentiary periods is summarised in the table below:

1. The application was filed after 15 April 2013 and therefore the amendments to the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act) apply to it. This includes section 60(3A) of the Act, which provides that the Commissioner may refuse an application if satisfied on the balance of probabilities that a ground of opposition exists. It is the opponent who carries the onus of proof.

1. At the outset, I note that in written submissions the applicant submitted that because section 40(2)(a) was not raised by the opponent the claims must be taken to be enabled across their full scope:

"...CSIRO observes that the sufficiency requirement is not, and has never been, in issue in relation to the Application. Accordingly, the Application does (and must be taken to) enable the invention to be performed across the full scope of the claims without undue burden."[1]

1. Such a conclusion could have consequences for the support ground (inasmuch as a lack of enabling disclosure is one way in which claims may exceed the technical contribution to the art and therefore lack support[2]). Accordingly, at the hearing I raised the possibility of considering sufficiency under section 60(3), which provides that the Commissioner may take into account any ground of opposition, whether or not it is relied upon by the opponent. This possibility was then the subject of some discussion at the hearing.

1. Ultimately, I find it unnecessary for the sufficiency ground to be raised (or considered) in order to make a finding on support. I do not consider that in the context of an opposition a decision not to raise or press a ground dictates a presumption of validity that flows through to other grounds. This is implicit in the existence of section 60(3) which expressly contemplates the raising of grounds not raised by the opponent, which in turn supports the opposition process achieving a result of avoiding the grant of invalid patents. Here, while it may be that certain findings would lead to both a lack of sufficiency and a lack of support, support is the ground that has been raised by the opponent, and the case run at the hearing was foreshadowed in the statement of grounds and particulars. This can be clearly distinguished from the examples raised by the applicant of various court proceedings where a patent has been assumed to comply with any grounds not pressed.[3] I do not consider that the choice not to oppose on the ground of sufficiency means that the support consideration is curtailed, and therefore I do not consider it necessary to consider the ground of sufficiency under section 60(3).

1. The specification is directed to high amylose wheat plants and method of producing the same. The specification ends with 26 figures and 28 claims.

1. Before construing the specification, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd:

"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date." [4]

1. It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:

"He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious."[5]

1. The hypothetical skilled person works in the field with which the invention is connected and is a non-inventive person or team likely to have a practical interest in the subject matter of the invention.[6]

1. Dr Carragher is the sole director and shareholder of the opponent and currently works as a consultant in applied food science research.[7] He indicates that while most of his career has been aquaculture and seafood, he has also worked in legume and cereal processing and has a "good understanding of general food science processes and practices."[8]

1. Among the annexures to Dr Carragher's first declaration is a partially redacted affidavit affirmed on 8 August 2019 by the late Colin Frederick Jenner (Jenner). Dr Jenner is described by Dr Carragher as "a respected cereal chemist who was mostly interested in understanding the processes involved in grain filling".[9] Dr Carragher states that Dr Jenner made this declaration because "he was aware that CSIRO had made the 900 application and wanted evidence to be available after his death of his development of high amylose wheat many years earlier."[10]

1. Dr Howitt is the leader of the Future Protein Mission at CSIRO and has over 26 years of research experience in the field of molecular biology in agricultural plants, including wheat.[11] In various roles within CSIRO since 2006, he has been a member of, and led, "research teams investigating mutants which modify grain composition in cereals, such as wheat". Notably, this includes the research team that produced the high amylose wheat lines forming the basis of the application.[12] I note that Dr Howitt confirmed that he complied with the Federal Court of Australia Expert Evidence Practice Note.[13]

1. The opponent submitted that the skilled person is a cereal chemist working with a plant breeding expert.[14] The applicant submitted that the skilled person has post-doctoral experience in respect of modifying cereal plants to improve their nutritional characteristics.[15] I agree that the skilled person or team would have experience with cereal plants and plant breeding and genetics, regardless of how that experience is attained.

1. I did not understand the opponent to challenge the relevance of Dr Howitt's experience, but the opponent did point to his lack of independence, accordingly characterising his evidence as "of little assistance."[16] Instead, the opponent submitted Dr Carragher's experience in cereal chemistry, grain filling and breeding (which I understand was derived substantially via his professional association with Dr Jenner) means that he is representative of the skilled person. I acknowledge that, as noted by the applicant, Dr Carragher's education and primary experience is not in relation to cereals, and the extent and nature of his experiences with Dr Jenner is not entirely clear, but I can accept that he is a person with "a practical interest in the subject matter" of the application.

1. I am satisfied that Drs Carragher and Howitt have backgrounds that enable them to understand the specification and provide evidence in relation to it, although neither could be said to be independent. As will become clear, this is not a case which turns heavily on the evidence of what the skilled person would have known or done, but where there is conflicting evidence I will, in the usual manner, decide which evidence should be given greater weight.

1. I note for completeness that the other declarants in this matter do not give evidence intended to be indicative of the perspective of the notional skilled person. Dr Bird, now retired, held various positions, including Research Group Leader, Principal Research Scientist and Senior Principal Research Scientist, within CSIRO's health sciences and nutrition groups between 1995 and 2019,[17] but his evidence is limited to his recollection of attending a Nutrition Society meeting regarding modified wheat. Mr Hyland is a registered patent attorney acting for the opponent in this matter, and in his declaration he exhibits documents from the file wrappers of related Japanese, US and European file wrappers, and notes comments made by the examiners in those jurisdictions.[18]

1. The specification explains, by way of background, that despite huge global consumption of wheat (with food produced from wheat grain supplying at least 20% of the food kilojoules for the global population) and increased awareness of the importance of starch functionality on end product quality, research on genetic variation in wheat and the impact thereof on starch characteristics lags behind that of other commercially important crops.[19]

1. The specification proceeds to set out various background information concerning wheat components:
   • Starch is the main carbohydrate in wheat grain and is made up amylose and amylopectin.
   • The ratio of amylose (an essentially linear polymer of α-1,4 linked glucose units) to amylopectin (a relatively highly branched polymer with α-1,6 glycosidic unit bonds liking linear chains of α-1,4 linked glucose units) appears to be a major determinant in both the health benefit of wheat grain/starch and the end quality of products comprising wheat starch.[20]
   • Dietary fibre, major components of which in wild-type wheat grain are oligosaccharides such as raffinose (about 1% by weight), fructans (about 1%), and cell wall polysaccharides (mainly cellulose, arabinoxylan and β-glucan, about 10%), is important for regulating blood glucose and insulin level and bowel health.[21]

1. The specification then discusses resistant starch (RS), starch or partially digested starch products that are not digested and absorbed in the small intestine, which is understood to have an important role in promoting intestinal health and protecting against various diseases. It is noted that foods comprising increased amylose have been found to have higher levels of RS and high amylose starches have been developed in maize and barley for use in foods that promote bowel health.[22] The beneficial effects of RS are explained[23] and it is said that since most processed starchy foods contain very little RS, incorporation of high amylose wheat grain into food products could contribute considerably to dietary RS intake.[24]

1. The specification then explains the synthesis of starch in plants:

"Starch is initially synthesized in plants in chloroplasts of photosynthesizing tissues such as leaves in the form of transitory starch. This is mobilized during subsequent dark periods to supply carbon for export to sink organs and energy metabolism or for storage in organs such as seeds or tubers. Synthesis and long-term storage of starch occurs in the amyloplasts of the storage organs, such as the endosperm of cereals, where the starch is deposited as semicrystalline granules up to 100µm in diameter. Granules contain both amylose and amylopectin, the former typically as amorphous material in the native starch granule while the latter is semicrystalline through stacking of the linear glucosidic chains. Granules also contain some of the proteins involved in starch biosynthesis."[25]

1. The specification goes on to discuss the enzymes involved in the synthesis of starch in the endosperm. As shown in Figure 1, reproduced below, ADP-glucose pyrophosphorylase (ADGP) catalyses synthesis of ADP-glucose from glucose-1-phosphate and ATP, before a set of starch synthases (SS) catalyse the transfer of glucose residues from ADP-glucose via α-1,4 linkages to elongate an α-glucan chain, and starch branching enzymes (SBE) form new α-1,6 linkages in α-polyglycans. Finally, starch debranching enzymes (DBE) remove some of the branch linkages.[26] Multiple isoforms of these enzymes are found in the endosperm of higher plants and the specific contribution of each isoform to starch biosynthesis is not known. This is particularly the case with respect to bread wheat (Triticum aestivum) which, being hexaploidy, has three sets of homologous chromosomes defining genomes A, B and D. According to the specification, hexaploidy has been considered a significant obstacle in the research and development of useful wheat variants, noting that knowledge is limited regarding how homologous genes interact, how their expression is regulated, and how the proteins produced by homologous genes work separately or together.[27]

1. The specification states that in maize, rice and wheat the enzymes starch synthase I (SSI), starch synthase IIa (SSIIa) and starch synthase IIIa (SSIIIa), and perhaps other starch synthases, are involved in amylopectin synthesis.[28] The effects of various mutations in these enzymes is then discussed, indicating that observations in one cereal species could not be simply extrapolated to another:[29]
   • An SSIIa mutant wheat plant entirely lacking the SSIIa protein (i.e. triple null, produced by crossing lines lacking the A, B and D genome specific forms of the protein) exhibited deformed starch granules and the starch had altered amylopectin structure. The starch had an increased amylose content (30-37% w/w) and a reduction in starch content. The source of this information is Yamamori et al. (2000) Theor Appl Genet 101:21-29 and the specification notes that there is no suggestion in this document that greater than 45% starch could be produced, which was substantiated by Konik-Rose et al. (2007) Theor Appl Genet 115:1053-1065[30] where a maximum of 43.98% amylose in the starch of a triple null ssIIa mutant was obtained.[31]
   • In barley a chemically induced null mutation in the SSIIa gene reduced the synthesis of amylopectin and raised the proportion of amylose in the starch to 65-70% w/w.
   • Japonica rice comprises an SSIIa mutation which reduces the SSIIa enzyme relative to Indica rice, but the level of amylose is not substantially elevated in Japonica rice, with a combination of mutations in the SBEIIb and SSIIIa genes having more impact on the proportion of amylose in rice.[32]

1. I note that the disclosures of all referenced publications, including Yamamori and Konik-Rose, are incorporated by reference into the application.[33]

1. Effects of the starch branching enzyme are discussed, with high amylose phenotypes of maize and rice having been generated by mutations in the SBEIIb gene (also known as the amylose extender gene), and further increases of amylose levels in maize being produced by also reducing SBEI activity.[34] In contrast, wheat with reduced SBEIIb alone did not yield increased amylose content, but the reduction of SBEIIa protein in endosperm was associated with increased relative amylose levels of more than 50%. It is suggested that "if it were desired to produce a high amylose wheat having at least 50% amylose, the SBEIIa gene is the gene that would be targeted in bread wheat."[35]

1. The background part of the specification concludes by posing the need for "improved high amylose wheat plants and for methods of producing same"[36], and the specification then states:

"The inventors have found, unexpectedly, that hexaploidy wheat grain with an amylose content of at least 45%, as a weight percentage of the total starch content of the grain, can be produced by combining mutations in the three SSIIa genes on the A, B and D genomes of the wheat by breeding and selection. ... At least two of the three mutations were null mutations, preferably all three. Since loss of function mutations in SSIIa are recessive, the phenotype was seen when the mutations were in the homozygous state. The inventors also found that the mutant ssIIa wheat grain had significantly increased levels of non-starch polysaccharides, particularly β-glucan, fructan, arabinoxylan and cellulose, each as a percentage of the grain weight. This yielded a substantial increase in total fibre content, as well as associated increases in protein content and other favourable phenotypes."[37]

"The present invention is based in part on the surprising observations made in the experiments described herein that hexaploidy wheat grain comprising null mutations in each of its three SSIIa genes can be produced which have an amylose content of at least 45% (w/w). This was unexpected on the basis of observations made by others that the level of amylose in triple null ssIIa hexaploidy wheat grain was less than 45% (Yamamori et al., 2000; Konik-Rose et al., 2007). ... Furthermore, the wheat grain has other desirable properties including increased total fibre content, based on increases in the fructan, β-glucan, arabinoxylan and cellulose contents, which provides for health benefits when the grain or products produced from the grain are used as food or feed."[38]

1. The specification explains that the invention also provides food ingredients comprising the grain, a process for producing a wheat plant capable of producing the grain, and a process of improving a parameter or parameters of metabolic health, bowel health or cardiovascular health by providing the grain or food product.[39] Specific properties of the wheat grain of the invention are then elaborated on, with the levels of starch and non-starch polysaccharides identified as "phenotypes associated with the reduction in SSIIa activity whilst the grain is developing in the wheat plant, the result of the mutations in the SSIIa genes."[40]

1. The specification states that the grain may be homozygous for a null mutation in each of the A, B and D genomes, and the null mutations may be, independently, a deletion, an insertion, a premature translation stop codon, a splice site mutation, and a non-conservative amino acid substitution.[41] It goes on to state that:

"In certain embodiments the grain further comprises a loss of function mutation in an endogenous gene which encodes a starch synthesis polypeptide, or a chimeric polynucleotide which encodes an RNA which reduces the expression of the endogenous gene which encodes the starch synthesis polypeptide, said starch synthesis polypeptide being selected from the group consisting of SSI, SSIIIa and SSIV, wherein said mutation is selected from the group consisting of a deletion mutation, an insertion mutation, a premature translation stop codon, a splice site mutation and a non-conservative amino acid substitution mutation. It is preferred that at least one, more than one, or all of the mutations are i) introduced mutations, ii) were induced in a parental wheat plant or seed by mutagenesis with a mutagenic agent such as a chemical agent, biological agent or irradiation, or iii) were introduced in order to modify the plant genome."[42]

1. It is explained that the wheat plants of the invention may be crossed with plants with more desirable genetic backgrounds, with the desired genetic background including consideration of various characteristics including agronomic yield.[43]

1. The description concludes with 12 examples. Example 4 describes the generation of triple null SSIIa mutant plants in different genetic backgrounds using three wheat lines: C57 (null for SSIIa-A), K79 (null for SSIIa-B) and T116 (null for SSIIa-D) in a series of crosses, backcrosses, intercrosses and progeny selections.[44] Figure 5, reproduced below, illustrates the process of production of triple null mutants (C57-K79-T116-Sunco BC3 F2) with the Sunco genetic background. Triple null mutant lines of the BC3 F8 lines were generated for EGA Hume, Sunco and Westonia genetic backgrounds, with the lines grown at the same time and under the same conditions.[45]

1. Example 5 describes the analysis of grain and starch parameters of 21 triple null mutants. It is identified in the specification that the Sunco mutant grain showed higher levels of amylose and non-starch polysaccharides than the EGA Hume and Westonia mutant grains.[46] This is reported in Table 6 of the specification, reproduced at Annex B.

1. Figures 10 and 14, reproduced below, show the starch and non-starch polysaccharide content of the triple null and wild-type wheat lines of the Sunco, Westonia and EGA Hume genetic backgrounds. The inventors suggest that the increased content of beta glucan and fructan in the mutant grains is attributable to "a diversion of carbon, coming into the grain as di-saccharides or mono-saccharides, from amylopectin" into these non-starch polysaccharides, relative to the wild type.[47]

1. The discussion of the results of the analysis is as follows:

"A number of starch properties have previously been reported to be modified in triple-null ssIIa hexaploid wheat including starch granule morphology, amylose content, amylopectin chain length distribution, crystallinity and starch gelatinization temperature, RVA and swelling power (Yamamori et al. 2000; Yamamori et al. 2006; Konik-Rose et al. 2007). The present study found that the genetic background of ssIIa null mutations had an effect on grain composition parameters including, to the surprise of the inventors, the amylose content in the starch which was increased above 45% in some lines. Three back-crossed populations were generated in different genetic backgrounds, using commercially grown wheat cultivars, and genotyped using DNA markers for the ssIIa null mutations. Four to eleven lines of the triple-null ssIIa mutants in each genetic background and five wild-type lines from each of the three breeding populations were selected and analysed.

Through the analysis of the seed weight and grain composition in each genetic background, three high amylose, high fibre, high AX and BG, and high fuctan lines were identified. These three lines were from crosses with the same genetic background, namely Sunco. Wheat lines containing about 60% amylose, more than 23% total fibre and more than 7% fructan were identified and selected. Such levels have never before been reported for hexaploid wheat and were entirely unexpected to the inventors. The increases were also observed on a per grain basis. These high amylose ssIIa null mutants also contained increased BG, AX and cellulose, demonstrating the correlation of these parameters. However, these three mutant lines also showed reduced starch content and seed weight, due to substantially reduced amylopectin synthesis."[48]

1. Example 6 describes combination of SSIIa mutations with other mutant wheats. In particular, the YDH7 line is described as having both the three mutated ssIIa genes and a hairpin RNA construct designated hp-SBEIIa (leading to reduced starch branching enzyme II activity in the endosperm).[49]

1. Example 7 describes analysis of starch granules and properties in triple null mutant grains. Example 8 describes production of bread and other food product using high amylose wheat. Example 9 reports in vitro measurements of glycaemic index of food prepared using YDH7 flour, with increased incorporation of this flour resulting in reduced glycaemic index. Example 10 reports an increase of resistant starch in YDH7 wheat grain.

1. Example 11 describes identification of additional mutations in each of the SSIIa genes in mutagenised wheat populations.

1. The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:

"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. ... While the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole ... It is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification ... terms in the claim which are unclear may be defined or clarified by reference to the body of the specification." [50]

1. The entire claim set is set out at Annex A. Claim 1 is the only independent claim:

Wheat grain of the species Triticum aestivum, the grain comprising

1. mutations in each of its SSIIa genes such that the grain is homozygous for a null mutation in its SSIIa-A gene, homozygous for a null mutation in its SSIIa-B gene and homozygous for a null mutation in its SSIIa-D gene,
2. a total starch content comprising an amylose content and an amylopectin content,
3. a fructan content which is increased relative to wild-type wheat grain on a weight basis, preferably between 3% and 12% of the grain weight,
4. a β-glucan content,
5. an arabinoxylan content,
6. a cellulose content,

the grain having a grain weight of between 25mg and 60mg, wherein the amylose content is between 45% and 70% on a weight basis of the total starch content of the grain as determined by iodine binding assay, wherein the amylopectin content on a weight basis is reduced relative to the wild-type wheat grain, wherein each of the β-glucan content, arabinoxylan content and cellulose content are increased relative to the wild-type grain on a weight basis, such that the sum of the fructan content, β-glucan content, arabinoxylan content and cellulose content is between 15% and 30% of the grain weight.

1. No lack of clarity in the claims has been identified by the opponent, but it is useful to discuss some of the features in claim 1.

"As used herein, the term 'grain' generally refers to mature, harvested seed (also called the kernel) of a plant but can also refer to grain after imbibition or germination, according to the context. Grain includes the mature kernels produced by growers for purposes other than growing further plants. Mature cereal grain such as wheat commonly has a moisture content of less than about 18-20%, typically about 8-10% moisture. ... The parts of the grain include the testa (seedcoat), the pericarp (fruitcoat), the aleurone layer, the starchy endosperm and the embryo (germ) which is made up of the scutellum, the plumule (shoot) and radicle (primary root). The combined testa, pericarp and aleurone layer are commonly referred to as the 'bran', which can be removed from the grain by milling, which may also comprise the germ. The scutellum is the region that secretes some of the enzymes involved in germination and absorbs the soluble sugars from the breakdown of starch in the endosperm for growth of the seedling after germination. The aleurone which surrounds the starchy endosperm also secretes enzymes during germination."[51]

1. I note that the specification indicates that the mutants in all three genetic backgrounds investigated had a lower grain weight (15-30% lower) than the wild-type lines, consistent with the lower production of starch associated with SSIIa mutations.[52]

1. A null mutation is a complete loss of function mutation; a null allele is one that does not encode or is not capable of leading to the production of any active enzyme.[53]

1. The specification indicates that starch from wild-type Triticum aestivum grain typically comprises 20-30% amylose and about 70-80% amylopectin as measured by an iodometric method.[54] That is, the claimed grain includes a higher level of amylose and correspondingly a lower level of amylopectin relative to wild type. The specification explains various methods of determining amylose content including the iodometric, or iodine binding, method referenced in the claim.[55]

Fructan, β-glucan, arabinoxylan and cellulose content

1. The content of each of fructan, β-glucan, arabinoxylan and cellulose defined in the claim is increased relative to the wild-type grain. The claim defines that the fructan content is preferably between 3% and 12% of the grain weight but the claim is not limited to this weight content (the specification reports that the content of fructan in wild-type grain is 0.6% to 2.6% by weight[56]). The increases in content are qualified by the requirement that the sum of fructan content, β-glucan content, arabinoxylan content and cellulose content is between 15 and 30% of the grain weight.

Correlation between amylose content and non-starch polysaccharide content

1. A subject of some discussion at the hearing was the question of whether the increase in content of each of the non-starch polysaccharides referenced in the claims is simply consequent upon the increase in amylose content.

1. As set out above, the specification explains the levels of non-starch polysaccharides by reference to the reduced SSIIa activity or the diversion of carbon from amylopectin to other polysaccharides. It is clear, however, even from a cursory inspection of Figures 10 and 14, set out previously, that there is not a direct relationship between levels of amylose and levels of each of the non-starch polysaccharides of interest. For example, it is apparent in the three highest amylose content Sunco triple mutants that the fructan content does not vary in direct proportion with amylose content.

1. In commenting on the defined parameters in the claim, Dr Carragher observed that "the data in the specification show that the outcomes are almost completely random."[57] In addition, Dr Carragher undertook a regression analysis of the data presented in the application and said that the analysis "appears to show a plausible correlation between fructan and amylose levels in SSIIa triple null wheat."[58] However, upon removing what he identified as three outlying lines with the highest amylose and fructan contents, he concluded "there is practically no correlation between amylose and fructan in the majority of the triple null lines tested by the applicant."[59] Instead, he stated that:

"The outlying 3 lines relied upon by the applicant in support of its claimed invention also give rise to another obvious conclusion - the high amylose and fructan in those lines is not due to the triple null status. Otherwise, all of the triple null lines would show similar results.

The fact that only 3 of the triple null lines produced the result claimed in the invention shows clearly that the SSII triple null status of the lines is not the, the sole or the primary reason for the outcome.

The data clearly show that there must be some other factor or mechanism at play unrelated to, or maybe combined with SSII triple null but that is only present in very few triple null lines. That added factor needs to be present in order to achieve the results relied upon by the applicant."[60]

1. This is consistent with Dr Carragher's discussion of the high amylose wheat variety produced by Dr Jenner:

"Dr Jenner said he thought the large variation of amylose and fructan in triple null variants meant there was little, if any, correlation between high amylose and high fructan and so there was another factor at play."[61]

1. At the hearing I understood the opponent's position to be that there is an association between high content of amylose and non-starch polysaccharides as defined in the claims, and that the triple null status is necessary but not sufficient to explain this - the correlation is imperfect, but the specification does not provide any further explanation of what is at work, that is, there is something else happening in the wheat, and not explained in the specification, to explain this. The opponent pointed to Dr Howitt's evidence, said to be consistent with this: "The data presented in the Application demonstrates that wheat lines having the high amylose phenotype necessarily require the triple null ssIIa genotype".[62] However, the opponent also referred to the specification, in passages I have referred to above, as suggesting that the claimed non-starch polysaccharide levels are inherent in triple null grain with claimed high amylose and adverted to an apparent dependence of the non-starch polysaccharide levels on the high amylose content. I take this to be aligned with the opponent's submission that the applicant did nothing to achieve the defined results regarding non-starch polysaccharides independent of seeking to increase the amylose content of the wheat in order.

1. The applicant submitted that the claim is to a wheat grain with a combination of parameters and that all the defined integers are relevant aspects of the invention, despite the opponent's attempt to "read away" the non-starch polysaccharide characteristics. In response to the position that the non-starch polysaccharide levels are simply consequent upon the high amylose level, the applicant pointed to the specification's reference to high amylose wheat with reduced SBEIIa activity: "[l]evels of non-starch polysaccharides such as fructans were not increased in wheat having reduced SBEII activity and increased (>50%) amylose in its starch".[63] That is, the applicant considers that the non-starch properties are not an inherent quality of high amylose wheat (although I note that the opponent's point was more specific to triple null grains with high amylose, rather than high amylose grain generally). The applicant also pointed to Dr Carragher's evidence referenced above concerning the lack of correlation between amylose and fructan in triple null wheat. Essentially, I understood the applicant's position to be that it is not appropriate to ignore aspects of the claim on the basis of an assertion that they are inherent characteristics.

1. Given the apparent lack of a directly proportional variation between amylose content and the content of other non-starch polysaccharides, and the evidence of Dr Carragher regarding the difference across the lines with the claimed amylose content demonstrated in the specification, I do not think there is sufficient evidence to conclude that the non-starch polysaccharide parameters defined in the claim merely and inevitably follow from the presence of the triple null status and amylose content. That is, I do not think it is safe to conclude that any triple null wheat having at least 45% amylose will inevitably also satisfy the other parameters of the claim.

1. Claims 2, 8 and 11 defines various further properties of the wheat grain of the claims to which they are appended, such as amylose content and starch characteristics.

1. Claim 3 specifies that the grain of claim 1 or 2 has a level and/or activity of SSIIa protein that is less than 5% of the wild-type grain, or which lacks one or more or all of the SSIIa-A, SSIIa-B and SSIIa-D proteins. Claim 4 specifies the nature of the null mutations. Claim 5 defines the grain of any of claims 1-4 that further comprises a loss of function mutation in an endogenous gene that encodes a starch synthesis polypeptide or a chimeric polynucleotide encoding an RNA that reduces the expression of a gene that encodes a starch synthesis polypeptide, wherein the starch synthesis polypeptide is SSI, SSIIIa or SSIV. Claim 6 specifies that the grain is homozygous for a null mutation in each of the SSIIIa-A, SSIIIa-B and SSIIIa-D genes.

1. Claim 7 provides that at least one of the mutations are introduced mutations, were introduced in a parental wheat plant or seed by mutagenesis, or were introduced to modify the plant genome. Claim 9 provides that the grain is non-transgenic.

1. Claim 10 defines the grain or any one of claims 3-9 wherein the SSIIa level and/or activity is determined by assaying the SSIIa level and/or activity in developing endosperm, or in harvested grain.

1. Claims 12-15 define specific sequences of the SSIIa genes.

1. Claim 16 defines male and female fertile wheat plants that produce, or are obtained from, the grain of any one of claims 1-15, and claim 17 defines the wheat plant of claim 16 which lacks all of SSIIa-A, SSIIa-B and SSIIa-D protein.

1. Claims 18 defines a flour or wheat bran produced from the grain of any of claims 1-15. Claims 19 and 20 define a food ingredient and claim 21 defines a food product comprising the grain of any of claims 1-15 or the flour or wheat bran of claim 18.

1. Claim 22 defines a composition comprising at least 10% by weight of the wheat grain of any of claim 1-15 or the flour or wheat bran of claim 18, and wheat grain having a level of amylose lower than 45% or flour, wholemeal, starch granules or starch obtained therefrom.

1. Claim 23 and 24 define processes of producing wheat grain and a wheat plant, respectively.

1. Claim 25 defines a process for screening wheat grain or a wheat plant comprising determining the amount or activity of SSIIa relative to wild-type wheat grain or wheat plant and selecting grain or a grain-producing plant.

1. Claim 26 defines a process for producing a food comprising adding a food ingredient according to claim 19 or 20 to another food ingredient and mixing the food ingredients.

1. Claim 27 defines a process for improving one or more parameters of metabolic, bowel or cardiovascular health, or preventing or reducing the severity or incidence of a metabolic, bowel or cardiovascular disease comprising providing the subject the grain of claims 1-15, food product of claim 21 or food product produced by the process of claim 26.

1. Claim 28 defines a process for producing starch comprising obtaining wheat grain according to any one of claims 1-15 and extracting starch from it.

1. Subsection 15(1) sets out the persons to whom a patent for an invention may be granted:

Subject to this Act, a patent for an invention may only be granted to a person who:

(b) would, on the grant of a patent for the invention, be entitled to have the patent assigned to the person; or

(c) derives title to the invention from the inventor or a person mentioned in paragraph (b); or

(d) is the legal representative of a deceased person mentioned in paragraph (a), (b) or (c).

1. That is, a patent may only be granted to the inventor, or a person who has acquired ownership via the inventor. Determining inventorship involves a two-part inquiry: determination of the inventive concept and identification of who had a material effect on that concept.[64]

1. The Full Court in Polwood Pty Ltd v Foxworth Pty Ltd explained how the inventive concept is to be determined:

"The invention or inventive concept of a patent or patent application should be discerned from the specification, the whole of the specification including the claims. The body of the specification describes the invention and should explain the inventive concepts involved. While the claims may claim less than the whole of the invention, they represent the patentee's description of the invention sought to be protected and for which the monopoly is claimed. The claims assist in understanding the invention and the inventive concept or concepts that gave rise to it. There may be only one invention but it may be the subject of more than one inventive concept or inventive contribution. The invention may consist of a combination of elements. It may be that different persons contributed to that combination."[65]

1. In addition, the Full Court in SARB explained that:

"[t]he question of entitlement is separate to, and distinct from, the question of patentability assessed by reference only to the patent claims. The inventive concept is discerned from the whole of the specification. This focusses attention on how the patent applicant chooses to describe its invention."[66]

1. Having identified the inventive concept, relevant principles in establishing inventorship include:
   • One criterion for inventorship may be to determine whether the person's contribution had a material effect on the invention.[67]
   • If the final concept of the invention would not have come about without a person's involvement, the person has entitlement.[68]
   • The fact that parties were in collaboration is relevant and can be a major consideration.[69]
   • Positing desiderata, or presenting an idea of a desirable outcome without any idea as to how that might be achieved, will not establish a claim to entitlement.[70]

1. Importantly, an inventor will not lack entitlement simply because another person independently arrived at the same invention. The 8th edition of Terrell on Patents in a passage cited with approval by the Full Court in Stack v Davies Shephard Pty Ltd[71] reads:

"A may have invented something; he made have made a few experiments with the invention, and then abandoned it (without publication). B may subsequently have invented the same thing, altogether independently of A. If B applies for letters patent he is at law the first inventor; but if it is shown that the process of invention was not carried on in B's mind at all, but that A communicated his ideas to B, although with the full intention of abandoning them, B will not be the first inventor."

1. Where a lack of entitlement is said to arise because the invention was communicated to the applicant, it was explained by Besanko J in Aspirating IP Limited v Vision Systems Limited that "it is necessary to determine whether the inventive concept was communicated to the applicant by the person alleged to be the true inventor".[72]

1. In the opponent's submission, the inventive concept was either conceived exclusively by Dr Jenner, or was derived jointly from Dr Jenner's concept as conveyed to CSIRO and CSIRO's conception.[73]

1. I understood the parties to be in substantial agreement with respect to the inventive concept being characterised as a triple null ssIIa wheat grain having the properties set out in claim 1, including an amylose content of at least 45%.[74] I note the applicant's emphasis that the inventive concept does not reside in the idea of such a grain, but is embodied in the grain itself.

1. As will become apparent, the present decision does not turn on the identification of the inventive concept. However, from an assessment of the entirety of the specification I think it is clear enough that the triple null wheat variant per se, and its general association with a higher amylose content, is admitted prior art and not part of how the applicant frames its invention. The specification as a whole and the claims are consistent with a conclusion that the inventive concept is embodied by a triple null ssIIa wheat grain having at least 45% amylose and increased levels of other non-starch polysaccharides as defined by the claims.

1. It is useful to set out the evidence in relation to the development of high amylose wheat lines by both the applicant and Dr Jenner.

1. The applicant has adduced evidence from Dr Howitt, who I note is not an inventor of the present application, regarding its development of the wheat plants described in the application. Dr Howitt states that he "conducted a detailed search and review of CSIRO internal business records relating to the Application, to which I have direct and complete access".[75] He similarly states that he accessed CSIRO records regarding the preparation and filing of the present application and associated provisional application.[76]

1. According to Dr Howitt, early work conducted by CSIRO relating to the SSIIa locus and corresponding protein was included in a 1999 provisional application and subsequently published by Dr Zhongyi Li (an inventor of the present application and leader of the CSIRO team that developed the plants described in the application) in Plant Physiology.[77]

1. CSIRO obtained three wheat cultivars with single null mutations in the SSIIa gene (C57, K79 and T116) as well as the triple null wheat line described in Yamamori in 2000.[78] Production of doubled haploid triple null wheat lines was undertaken between 2002 and 2003 and subsequently published as Konik-Rose in 2007.[79] Triple null lines with different genetic backgrounds were generated from late 2005 to 2007.[80] Grain from the eighth filial generation of the triple null wheat lines was harvested around December 2012 to January 2013 and analysed for various parameters in late 2014, showing an amylose content of at least 45% and increased total fibre content (with increases in fructan, β-glucan, arabinoxylan and cellulose contents).[81]

1. With respect to the preparation and filing of the present application, Dr Howitt states that Dr Li provided grain characterisation data for inclusion in a provisional application to CSIRO's IP Manager in March 2015, and a draft of the Examples for inclusion in a provisional application was provided to Dr Li in March 2016.[82] In April 2016 Dr Li provided a revised version of the grain characterisation data (recalculated to take into account the moisture content of the grain) and the provisional application was then filed on 5 July 2016, with no substantive changes made to the specification before the associated PCT application was filed on 4 July 2017.[83]

1. Turning to Dr Jenner's affidavit, he declares that:

"In August-September 2000 the Kanto 79 and Chousen 57 lines were crossed in the quarantine glasshouse and the F2 seeds from this cross were screened for SSIIa-double null types. In September 2001 the F2 SSIIa-double nulls were then crossed with Turkey 116. The F2 seeds from this cross (called RS0003) were screened for SSIIa-null types and the single, double and triple nulls were subsequently grown in a glasshouse for the production of bulk seed.

The harvested seeds were screened by microscopic examination for cracked starch granules, which is indicative of the SSIIa-null genotype. Starch from the endosperm of seeds with 80% or more cracked granules was analysed for total amylose using an iodine binding assay. The amylose content of pooled endosperms from SSIIa triple nulls was 39% (about 11% higher than normal wheat)...

In February-March 2003 the embryos from the seeds analysed above were planted in a greenhouse and a number of crosses were made between single, double and triple null SSIIa lines. One of these crosses (called Cross III) was made between an F2 plant from cross RS0003, a triple null, which also appeared null for a 90kDa (branching enzyme) protein and an SSIIa-double null (in the B and D genomes). The F2 progeny from this cross had severely shrivelled seeds with very little starch and all seeds were deficient in the SSIIa protein. A pooled sample of these seeds was tested and found to be 55% amylose using the iodine binding assay."[84]

1. Dr Jenner states that additional research involving researchers from various institutions (not CSIRO) has been undertaken, but that Cross III has never been crossed with any other material.[85]

1. I note also that the applicant pointed to Dr Jenner's identification in a 2001 business plan of CSIRO as a potential competitor: "Recent unsubstantiated information suggests that Morell's group at CSIRO Plant Industries may also be following a non transgenic pathway to develop a high amylose starch."[86]

1. The opponent referred to two broad opportunities for communication of the inventive concept from Dr Jenner to CSIRO which I will consider in turn.

1. The first of these is a 2006 meeting of the Adelaide Branch of the Nutrition Society of Australia where Dr Jenner gave a presentation titled 'Can cereals with novel starch improve health'. The slides of the presentation report an SGP-1 triple null wheat having 55% amylose as a percentage of starch and 3% total dietary fibre, although no details as to the preparation of the wheat are apparent from the slides.[87] Dr Bird did not recall seeing the slides or attending the presentation[88] but upon review of the slides commented as follows:

"I note that one of the Jenner Slides refers to CRIII wholemeal, which it states had an amylose content (as a % of starch) of 46% when cooked and 55% when uncooked. Values are also given for the rapidly digestible, slowly digestible and resistant starch content of the wheat. The methods used to produce these results are not disclosed, nor are any other properties of CRIII described or disclosed in any detail."[89]

"It is very unlikely that I communicated any information in the Jenner Slides or in relation to CR III to anyone at CSIRO, including because the Jenner Slides merely contain unremarkable information."[90]

1. Second, the opponent notes that in 2015[91] and 2016 Dr Jenner met with members of the CSIRO research team and in March 2016 Dr Carragher provided data regarding the Cross III wheat to an inventor of the present application.[92]

1. I note that Dr Howitt's evidence is, from his review of CSIRO's business records, that in the preparation and filing of the application "no information concerning any SGP-1 null wheat line alleged to have been developed by Mr Colin Jenner or the University of Adelaide, including any wheat line designated 'CRIII' or 'Cross III', was considered".[93]

1. The entitlement ground is most simply resolved by consideration of the nature of the opportunities identified by the opponent for communication between Dr Jenner and CSIRO.

1. The opponent submitted that in the absence of evidence from the inventors I cannot conclude that Dr Bird did not communicate Dr Jenner's work "to his colleagues who were interested in developing high amylose wheat based upon the absence of SSIIa."[94] In particular, the opponent pointed to a professional association between Dr Bird and named inventors.[95] The difficulty I have with this submission is that even if Dr Bird did communicate with his colleagues the content of Dr Jenner's 2006 presentation, CSIRO, as the opponent acknowledged, was already interested in developing high amylose wheat based on absence of SSIIa, having produced doubled haploid triple null wheat lines between 2002 and 2003. I also note that the presentation does not refer to the content of non-starch polysaccharides in the wheat. There is no evidence that any communication, even if it occurred, rose to the level that would support a conclusion that Dr Jenner is an inventor; there is no evidence of any impact on CSIRO's pre-existing research pathway or of any collaboration.

1. With respect to the second opportunity for communication identified by the opponent, regardless of what was communicated in those interactions, I have no reason to doubt the evidence of Dr Howitt that the data upon which the provisional application was based was provided to CSIRO's IP Manager in March 2015. That is, the invention embodying the inventive concept, being the triple null wheat grain with the claimed parameters, was complete at that point. As such there is no basis to conclude that any relevant contribution was made by Dr Jenner directly or via Dr Carragher in 2015 or 2016. I can accept the opponent's point that Dr Howitt's evidence to the effect that no information regarding the Cross III variant was considered in preparation of the application being based on review of business records, rather than direct experience, is not determinative of what the drafter/inventors were actually aware of. Accordingly, I accept that it is conceivable that, as the opponent noted at the hearing, CSIRO had the benefit of knowledge of the Cross III variant in drafting the claim parameters. However, I do not think this can be considered a material contribution to the inventive concept.

1. I note that the opponent suggested that, if I considered the evidence as to entitlement otherwise equivocal, the applicant's failure to call evidence from the inventors would allow me to more confidently infer that regard to the work of Dr Jenner was had. In response, the applicant referenced the opponent's failure to adduce evidence from Dr Rajinder Sharma (a plant breeding expert who made decisions with Dr Jenner regarding which lines to cross[96]). The applicant also noted that Dr Jenner, despite making his declaration in knowledge of the present application, made his declaration to provide evidence of his development of high amylose wheat,[97] and did not make a specific claim to entitlement to the invention in the present application.

1. Ultimately, evidence from a named inventor would of course be the best evidence regarding the conception of the invention, and it is not immediately apparent why such evidence was not adduced. However, in the present circumstances I do not consider the evidence equivocal such that it is necessary to draw inferences based on the failure of any given person to provide evidence. The onus in this matter is on the opponent to make out a case for lack of entitlement and the totality of the evidence does not establish that there was any relevant communication to CSIRO or any named inventor that calls entitlement into question.

1. For completeness, I note that the opponent, while not pressing the ground of inventive step, suggested at the hearing that failure of the entitlement ground on the basis that both CSIRO and Dr Jenner had arrived at the invention independently would be strong evidence of obviousness. It seems to me that this would depend on the extent to which the named inventors and Dr Jenner could be considered representative of a person lacking in inventive capacity, but it is a matter outside the scope of this opposition.

1. The opponent has not made out the ground of lack of entitlement.

1. It is a requirement of paragraph 18(1)(a) of the Act that an invention be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. In written submissions the opponent submitted that the invention claimed does not define a manner of manufacture for several reasons: that the claims lack inventive character on the face of the specification, that not everything within the claims is the result of human action, and that the claims involve an expansion of the concept of manner of manufacture. At the hearing, the opponent indicated that its manner of manufacture case was put on two bases: that the claims lack inventive character on the face of the specification, and that not everything within the claims is the result of human action.

1. There is a threshold of inventiveness on the face of the specification necessary for a claim to satisfy the manner of manufacture requirement. In NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd the majority of the High Court said:

"...if it is apparent on the face of the specification that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further" [98]

and confirmed the proposition[99] set out in Commissioner of Patents v Microcell Limited, where the High Court said:

"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".[100]

1. The threshold of inventiveness is assessed from what is apparent on the face of the specification. This form of manner of manufacture is a narrow one, and it is clear from the body of case law that it must be assessed on the basis of the face of the specification alone.[101] This form of manner of manufacture was not clearly particularised in the statement of grounds and particulars,[102] but given that it is a ground that should typically not require evidence and both parties made submissions in writing and orally, I have considered it.

1. Yamamori and Konik-Rose are both referenced in the specification and incorporated into the specification by reference, and as such I agree with the opponent that it is clear on the face of the specification that triple null mutants were known, and were known to exhibit higher amylose levels than wild-type grain. In particular, Konik-Rose, as noted previously, discloses an amylose content of 43.98% (but does not report the content of other non-starch polysaccharides defined in the present claims).

1. The opponent noted that the amylose content in Konik-Rose is very close to that defined in the claims and that Yamamori does not say that higher levels of amylose could not be obtained - indeed the opponent observed that Dr Jenner was very interested in Yamamori and in a 2001 proposal flagged the possibility of producing wheat cultivars with a starch amylose content of up to 45%.[103] As such, in the opponent's submission "there is no inventiveness in developing triple null grain with the intention of producing high amylose wheat plants, particularly where there is a need for improving high amylose wheat plants."[104] I also understood the opponent to put their case as the invention being no more than the use of a known property (increased amylose content) of a known article (triple null wheat)[105] for a new use for which that property makes it suitable, and the serendipitous discovery of other properties or characteristics of that wheat do not take it outside of this category.

1. The applicant responded that the prior art incorporated into the specification does not state that grain with the defined characteristics could be produced and that admissions that it was known that triple null wheat had a higher amylose content than wild type do not amount to an admission that grain with the combined claimed characteristics was known.[106] The applicant also pointed to the specification's reference to the SBEIIa gene as a more obvious target if seeking to produce wheat with at least 50% amylose.

1. On balance, I am not persuaded that the specification on its face reveals an absence of the requisite quality of inventiveness. While it may have been obvious to generate triple null wheat with an objective of increased amylose content, the specification makes no clear admission that a grain having an amylose content of 45% and the other parameters defined in the present claims was known or a desired result. To the contrary, that is presented as the invention. Moreover, the specification does not clearly suggest that the described approach would inevitably lead to each of the claimed parameters of the claimed invention and as noted above I do not believe it has been established that it would. In addition, I do not think silence in Yamamori as to the possibility of obtaining the claimed amylose content is to the point; obviousness on the face of a document requires more than a lack of explicit teaching away. It is not apparent to me on the face of the specification that the claimed invention would be arrived at without invention. For completeness, I note that I do not consider the reference to the SBEIIa gene as a desirable approach to modifying amylose content to impact on this consideration one way or the other. In line with the opponent's observation that more than one thing can be obvious (per Nichia Corporation v Arrow Electronics Australia Pty Ltd[107]), it seems reasonable that a specification may also on its face reveal a lack of invention (or not) in respect of multiple alleged inventions.

1. In addition, in Microcell a claim characterised as a self-propelled-rocket projector was refused on the basis that the specification disclosed that it was nothing more than the use of a known material (reinforced plastic material) for the purpose of which its known properties (relevantly, strength and lightness) made it suitable. Their Honours noted that "no new product is obtained, and there is no new method of manufacture suggested or an old one improved."[108] I do not see the present circumstances as relevantly analogous to this. While it is clear from the specification that triple null wheat was known to have a high amylose content relative to wild-type wheat, it is not apparent to me that it was known that the claimed amount of amylose could be obtained in combination with the other parameters of the claims - these are not known properties of the triple null mutation.

1. I note that opponent also submitted that "where there is no disclosure by the specification as to how to reliably produce the claimed characteristics, the claims lack the necessary quality of inventiveness".[109] However, the specification provides examples demonstrating obtention of embodiments of the claimed invention - in this regard the applicant pointed to Example 4 - and sufficient disclosure is a separate consideration to that of quality of inventiveness.

1. I am not satisfied that a lack of manner of manufacture on the face of the specification has been made out.

1. In D'Arcy v Myriad Genetics Inc[110] the plurality set out factors relevant to the characterisation of a claimed invention as a manner of manufacture. The first of these is: "Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action":[111]

"an invention is something which involves 'making'. It must reside in something. It may be a product. It may be a process. It may be an outcome which can be characterised, in the language of NRDC, as an 'artificially created state of affairs'. Whatever it is, it must be something brought about by human action."[112]

1. The second factor is: "Whether the invention as claimed has economic utility." The plurality in Myriad explained that when an invention falls within the existing concept of manner of manufacture, consideration of whether an invention satisfies these first two factors will usually suffice.[113] However, in some circumstances considerations of additional factors can be appropriate:

"When a new class of claim involves a significant new application or extension of the concept of 'manner of manufacture', other factors including factors connected directly or indirectly to the purpose of the Act may assume importance. They include:

1. Whether patentability would be consistent with the purposes of the Act and, in particular:

3.1 whether the invention as claimed, if patentable under s 18(1)(a), could give rise to a large new field of monopoly protection with potentially negative effects on innovation;

3.2 whether the invention as claimed, if patentable under s 18(1)(a), could, because of the content of the claims, have a chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee;

3.3 whether to accord patentability to the invention as claimed would involve the court in assessing important and conflicting public and private interests and purposes.

1. Whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability.

5. Relevantly to Australia's place in the international community of nations:

5.1 Australia's obligations under international law;

1. Whether to accord patentability to the class of invention as claimed would involve law-making of a kind which should be done by the legislature."[114]

1. While both parties made submissions directed to these additional factors, the anterior question is whether they are engaged. As set out above and subsequently applied in the Federal Court, this will only be the case where "the claims in question require an extension of the existing concept of manner of manufacture to a new class of case or are on the border."[115] In Grain Pool of Western Australia v Commonwealth it was confirmed that "there is no intrinsic impediment to the patentability of plant varieties"[116] and, as noted by the applicant, plant varieties characterised by phenotype have been found to constitute patentable subject matter in previous decisions of the Commissioner.[117] In these circumstances it seems to me this should not be considered a new class of claim involving an extension of the concept of manner of manufacture and consequently these additional factors are not engaged.[118]

1. I acknowledge the opponent's submission that the invention as claimed would give rise to a large new field of monopoly protection with negative effects on innovation and could have the effect of freezing research and innovation since not all triple null grains will have the claimed characteristics,[119] noting that in some years the Cross III grains have the claimed amylose levels and in others they do not. However, as I understand it, these undesirable outcomes flow from similar considerations to those that apply in relation to support, discussed further below, with the opponent particularly noting the lack of guidance as to how to predict whether or not a particular triple null grain will have the claimed characteristics. However, I do not think this drives a conclusion that the invention is at the margins of patentability; it is fair to say that in many biological systems the phenotype may be a function of many variables not all of which are readily controlled by a grower/breeder and such claims to plants and animals are well established. Similarly, claims to plants and animals that may include naturally occurring mutations are not new. In my view any defects in the claims are appropriately dealt with by the first two factors identified by the plurality in Myriad and the remaining requirements for patentability articulated in the Act.

1. As to the question of whether the invention is the product of human action, the opponent submitted that the specification makes clear that the starting mutations can be naturally occurring and they can be crossed naturally, for example:

"Mutant wheat plants having a mutation in a single SSIIa gene which can be combined by crossing of plants and selection of progeny having other SSIIa gene mutations to generate the wheat plants of the invention can be either synthetic, for example, by performing site-directed mutagenesis on the nucleic acid, or induced by mutagenic treatment, or may be naturally occurring, i.e. isolated from a natural source."[120]

"...high-throughput TILLING technology is ideal for the detection of natural polymorphisms. ... Plates containing arrayed ecotypic DNA can be screened rather than pools of DNA from mutagenized plants."[121]

"The wheat plants of the invention may be crossed with plants containing a more desirable genetic background, and therefore the invention includes the transfer of the reduced SSIIa trait to other genetic backgrounds. As used herein, 'crossing' or 'cross' refers to the process by which the pollen of a flower on one plant is applied (artificially or naturally) to the stigma of a flower of another plant."[122]

1. As such, in the opponent's submission the claims capture products which are not the result of human action, being merely the result of the crossing of naturally mutated grain lines, including by self-fertilisation.[123] At the hearing the opponent clarified that it was not suggested that a triple null mutation would be as common as wild-type wheat, but that it was nevertheless possible.

1. The applicant's position was that there is no admission in the specification that triple null plants (as opposed to wheat plants with a mutation in a single SSIIa gene) can be isolated from nature. To the contrary, Figures 5 and 7, the schematic of the crossing and back-crossing program described in Example 4, reveals the extent of human activity in the selective breeding program to get from the isolated single mutant lines to the BC3 F2 lines, with yet more intervention required to get to the BC3 F8 generation. I understood the applicant's submission to be that evidence of a triple null wheat with the claimed characteristics existing in nature would be necessary to make out this ground of opposition.

1. The applicant referred to somewhat analogous situations considered previously in the Patent Office, albeit in cases to which the Raising the Bar Act did not apply and where the onus was on the opponent to demonstrate that it was clear or practically certain that a granted patent would be invalid. In Cargill the specification described the genetic modification of canola plants and the claims related to canola plants producing seed having a defined oil fraction and the seed produced by those plants. In Sun Pharmaceutical Industries (Australia) Pty Ltd v Tasmanian Alkaloids Pty Ltd[124] and TPI Enterprises Ltd v Tasmanian Alkaloids Pty Ltd[125] the specification described production of high codeine poppies via mutagenesis of poppy seeds and screening of the progeny of plants grown from the mutagenised seed, and the claims defined poppy plants which would yield a poppy straw with a high codeine content. In each of these cases, as in the present case, there was no evidence to suggest that any naturally occurring plants did, in fact, fall within the scope of the claim. In these circumstances no lack of manner of manufacture was found - the opponents had not discharged their onus.

1. Even accepting the opponent's submission that the specification contemplates the possibility of a naturally occurring triple null mutants, there is no evidence to support the position that it is more likely than not that triple null mutant wheat strains producing grains with the defined parameters are in fact naturally occurring. I accept that the specification indicates that wheat plants containing single null mutations are naturally occurring, and that these mutations may be combined via breeding. However, that is not to say that such crosses giving rise to grain having the claimed parameters would or have occurred in nature, without human intervention, and I can see no reason to conclude that selective breeding such as described in the present application is inconsistent with the requirement that an invention be "brought about by human action". As such, I see no reason to depart from the approach in the cases mentioned above. A mere possibility that something may exist in nature does not satisfy the requirement of the standard of balance of probabilities that a tribunal feel "an actual persuasion of its occurrence or existence".[126] On balance, I am not satisfied that the opponent has established that the claims do not define the result of human action. There being no apparent dispute that the claimed invention has economic utility, the lack of manner of manufacture ground is not made out.

1. Subsection 40(3) as amended by the Raising the Bar Act requires that the claims must be supported by matter disclosed in the specification. The test for claim support in Australia[127] is as set out by Aldous J in Schering Biotech Corp's Application:

"...to decide whether the claims are supported by the description it is necessary to ascertain what is the invention which is specified in the claims and then compare that with the invention that has been described in the specification. Thereafter the court's task is to decide whether the invention in the claims is supported by the description. I do not believe that the mere mention in the specification of features appearing in the claim will necessarily be a sufficient support. The word 'support' means more than that and requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed."[128]

1. Put another way, the technical contribution to the art that arises from the disclosure of the specification must justify the monopoly claimed.[129] A claim will lack support if the body of the specification does not enable a claimed product to be made, or the claims define an invention materially different to the described invention.[130] Similarly, the technical contribution will be exceeded if the claims cover ways of achieving the desired result that owe nothing to the patent or any principle it discloses:

"Two classes of this are where the patent claims results which it does not enable, such as making a wider class of products when it enables only one and discloses no principle to enable others to be made, and where the patent claims every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention..."[131]

1. While there is a growing body of Australian case law concerning the law on support, it remains, in line with the guidance in the Explanatory Memorandum to the Raising the Bar Act, useful to have regard to decisions of the UK and members of the European Union.[132]

1. The applicant emphasised that a claim to a product is supported if one way of making it is disclosed, drawing on the UK House of Lords decision Generics (UK) Ltd v H. Lundbeck A/S[133] (while this decision related to sufficiency rather than support, support not being a ground of revocation in the UK, these grounds are often two sides of the same coin[134] and principles applied in the context of sufficiency in the UK have been applied to the ground of support in Australia[135]). As such, before considering the parties' submissions, it is helpful to understand the decision in Lundbeck. Lundbeck included a claim to a specific product, a single enantiomer, and a single method of making the enantiomer was described. Despite there potentially being other methods by which the enantiomer could be produced, a single method was sufficient to enable the claim to a specific compound; that compound was the patentee's technical contribution to the art.[136] However, it was acknowledged in Lundbeck that there may be difficulties in extrapolating this conclusion to classes or ranges of compounds:

"A single chemical compound is a product for the purposes of UK patent law... It is moreover a product of a special character, since it is a product which, simply as a chemical compound... can have only one embodiment... Statements of general principle relating to inventions with many embodiments may be irrelevant to an invention which consists of a single compound."[137]

"Where classes of compounds are claimed, difficult interlocking problems as to construction and sufficiency may arise..."[138]

1. The applicant directed my attention to Anan Kasei Co. Ltd v Neo Chemicals and Oxides Limited[139] where the Court of Appeal considered a claim to a class of products defined by their composition, physical characteristics, and performance in a test. Having considered both Lundbeck and Biogen Inc v Medeva plc[140], Floyd LJ observed that the conclusion in Lundbeck (that the technical contribution in the case of a claim to a single novel chemical compound is the compound) must also be true of a claim to a class of compounds - where each can be made by the application of a method disclosed in the specification no further methods need be disclosed. However, he noted that Biogen shows that a claim formally to a class of products may cover embodiments that owe nothing to the patentee's technical contribution, and in particular "[a] claim to a product defined by its function ... is capable of extending to subject matter which owes nothing to the patentee's contribution to the art."[141]

1. Floyd LJ went on to emphasise the relevance of evidence to this consideration: "The underlying rule ... is that the patentee cannot claim more than he had enabled. Whether he has claimed more than he has enabled is a question of fact which falls for decision on the evidence in the case."[142] He then said:

"Neo are undoubtedly correct that the specification enables only those structures which could be made by the skilled person by the methods disclosed in the specification, coupled with the common general knowledge. To establish that the claim offended against the Biogen principle as explained in Lundbeck, however, Neo had to go further. They had positively to establish that there were structures which were covered by the claims which could not be made with the benefit of that teaching."[143]

1. It is useful to also consider Lord Hoffman's comments in Biogen concerning claims to classes of products:

"...if the patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect. On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them."[144]

1. The opponent pointed to Jusand as an exemplary case where a product claim was directed to a class of products. In that case, which related to a safety system for use in a bore for mining (a product), it was found that the system as claimed was able to be constructed from a range of materials, but the specification showed only how to make it from steel. As such, the claims exceeded the technical contribution to the art:

"This would reward the patentee for something it has not done and it would prevent others of an inventive disposition from discovering how to make ingenious systems of anchor and impact reduction members from other materials including materials not yet known.

The [patentee] has conceived the ingenious idea of converting downward weight force into lateral braking force. That idea carries with it the need to solve a second problem - how to construct a system of anchor and impact reduction members which can withstand the enormous forces present during the impact event. It has solved that problem with the invention it discloses in the specification using steel.

However, the inventive and burdensome task of using other, possibly superior, materials lies in the inventive future. The [patentee] is not entitled to prevent others from using its insight to create inventions from materials other than steel when the only invention it has actually disclosed is one made from steel. If the selection and design of the Safety System in these other materials did not require inventive skill or undue burden, the answer would be different. However the short of the matter is that these endeavours do involve inventive skill and undue burden."[145]

1. The opponent also referred to the observations of Nicholas J in ToolGen regarding speculative claiming and plausibility in the context of support:

"...determining the patentee's technical contribution to the art is often not easy. While it has been suggested that the technical contribution may correspond with the inventive step, there will be situations in which this is not so including where, for example, the invention of the claim involves a very significant inventive step and yet, by reason of some deficiency in the disclosure of the specification, the public is deprived of its side of the patent bargain. Leaving aside what the UK authorities sometimes refer to as 'classical insufficiency' (broadly corresponding to the requirements of s 40(2)(a) of the Act), this may arise when the specification discloses how to perform the invention across the scope of the claims (eg. by using a known pharmaceutical compound in a new method of treatment) but not the basis upon which the invention of the claim might reasonably be expected to work (ie. by delivering the relevant therapeutic effect). The practice of claiming inventions that are not shown to have a sufficiently plausible or credible justification or support is sometimes referred to as speculative claiming."[146]

"It can be seen that the concept of plausibility has been developed in the UK authorities as a check on speculative claiming and to ensure that the patentee's monopoly is no more extensive than the contribution to the art made by the relevant disclosure."[147]

1. At the hearing the opponent submitted that the technical contribution in this case is the possibility of using Sunco wheat to make a grain with the parameters defined in the claims. The opponent pointed to the distinction drawn in the specification between Sunco grains (which work far better than the other lines) and every other type of grain, and the teaching in the specification that the genetic background is important:

"The present study found that the genetic background of ssIIa null mutations had an effect on grain composition parameters including, to the surprise of the inventors, the amylose content in the starch which was increased above 45% in some lines."[148]

"Through the analysis of the seed weight and grain composition in each genetic background, three high amylose, high fibre, high AX and BG, and high fructan lines were identified. These three lines were from crosses with the same genetic background, namely Sunco."[149]

1. As such, in the opponent's submission a claim broader than that is simply not supported, and nor is a person skilled in the art enabled to make something across the scope of the claim. That is, the worked examples themselves show that the invention does not work across its scope. The claims encompass grain with an EGA-Hume genetic background, but no EGA-Hume grains within the scope of the claims were produced. Moreover, the majority of the Westonia lines did not fall within the scope of the claims. In fact, in the majority of the grains lines exemplified (and the Yamamori grain which also bears the triple null genotype) the claimed characteristics were not achieved. In this regard, the opponent noted that there is no explanation of the results in the specification (that is, the difference in outcome for different genetic backgrounds), which is relevant as the skilled person is not given the information that would allow them to reliably and consistently make the invention work - that is, achieve the claimed characteristics. This is consistent with the evidence of Dr Carragher as to the missing factor in explaining the high levels of fructan and amylose in the claimed invention.

1. The opponent also pointed to the evidence of Dr Howitt who, when responding to the proposition that the data in the specification shows that the results are almost completely random, said:

"I disagree with this opinion. The Application demonstrates that a high proportion (~43%) of the wheat lines having the triple null ssIIa genotype have the claimed phenotype (see, Table 6 of the Application) and that the claimed phenotype can be obtained in wheat lines of different genetic backgrounds, e.g., Sunco and Westonia, using the methods described in the Application."[150]

The opponent's observation here was that Dr Howitt did not go so far as to say that he expected that the claimed phenotype could be achieved in the EGA Hume genetic background, or other non-Sunco or non-Westonia genetic backgrounds (that is, that the invention could be worked across the scope of the claims).

1. The opponent submitted that if a person were to generate an EGA-Hume (or some other genetic background) wheat that possessed the claimed characteristics, that would be within the scope of the claims, but the generation of that wheat line would not have been taught or disclosed by the specification in circumstances where the teaching of the specification is that the Sunco genetic background is important. As such, it is apparent the claims exceed the technical contribution to the art.

1. It is the opponent's position that the claims define a class of products, and the approach taken in Jusand, where a disclosure of how to achieve everything within the scope of the was lacking, is informative, and demonstrates the inappositeness of Lundbeck to the present case.

1. In the applicant's submission the invention is not simply the generation of the claimed grain lines. Instead, it involves a method of generation, screening and selection:

"CSIRO has invented a new product, and it has disclosed the principles by which the PSA can make that product, including generating, screening, selecting and identifying wheat grain with the claimed phenotypic characteristics defined by the claim."[151]

Viewed from this perspective, it is the applicant's submission that there is no evidence of an undue burden; there is no evidence that the work required is more than routine.

1. The applicant submitted that there is clearly an enabling disclosure that enables the invention to be performed across the scope of the claims, referring to Example 4, and pointed to the disclosure and description of multiple genetic backgrounds in the specification:

"The wheat plants of the invention may be crossed with plants containing a more desirable genetic background, and therefore the invention includes the transfer of the reduced SSIIa trait to other genetic backgrounds. ...

The desired genetic background of the wheat plant will include considerations of agronomic yield and other characteristics. ... For Australian use, one might want to cross the altered starch trait of the wheat plant of the invention into wheat cultivars such as Baxter, Kennedy, Janz, Frame, Rosella, Cadoux, Diamondbird or other commonly grown varieties."[152]

1. In the applicant's submission, the technical contribution is the product that can be made as a result of the disclosure, that is, the product as claimed, not limited to the Sunco genetic background. Specifically, there are worked examples of the claimed product in nine wheat lines, some with the Sunco genetic background, some with Westonia, such that there is no doubt that the claimed product can be made, and the principles by which it can be made have been disclosed. The applicant submitted that it is not required to exemplify the invention with every possible genetic background to satisfy the requirements of patentability, and characterised the opponent's objection as being that a priori it is not possible to generate only wheat grain with the required characteristics. However, in the applicant's submission that is not what is required, and the method does not end with generation. The method involves generation, screening and selection, and each of those steps is enabled. In this regard, Example 4 is not multiple experiments with varying levels of success, it is one experiment involving the steps of generation, screening and selecting. There is no evidence that if Example 4 were repeated the results would not be reproducible.

1. With respect to EGA-Hume, the applicant observed that those strains described in the specification do not fall within the scope of the claim. The existence of products not within the scope of the claim does not establish a lack of support. Moreover, Example 4 does not establish that the desired properties cannot be produced in wheat with an EGA-Hume background, only that they were not in the four wheat plants with the EGA-Hume background produced in Example 4. The applicant characterised the opponent's real objection as being that the claims could include wheat with the EGA-Hume background if it had the claimed characteristics, which I understood the applicant to accept. However, in its submission this does not lead to a lack of support. This would only be the case if that hypothetical grain could not be made using the body of the specification and the common general knowledge; that is, if it owed nothing to the technical contribution to the art. The applicant submitted that there is no evidence that there is a grain made using EGA-Hume (or any other background) that falls within the claims but cannot be made using the teaching of the specification, or owes nothing to the teaching of the specification. Such a conclusion could only be speculation.

1. As noted previously, the specification discloses that some, but not all, wheat strains with the triple null background exhibit the claimed parameters - this is apparent from both the results presented in the specification and the prior art incorporated by reference. The specification identifies the genetic background as relevant to whether these parameters are achieved: "the genetic background of ssIIa null mutations had an effect on grain composition parameters including, to the surprise of the inventors, the amylose content in the starch which was increased above 45% in some lines."[153]

1. In addition to the evidence from Drs Carragher and Howitt previously discussed on this point, Dr Jenner commented in relation to triple null strains he developed that "the amylose % of the material is not simply a function of genotype, but is modified by environmental and management conditions."[154] Indeed, the present application is not the first disclosure of unexplained amylose content differences in triple null strains, with Konik-Rose stating that:

"The difference in amylose contents between two types of triple null SSIIa lines (this work and Yamamori et al. 2000) could be the result of using either different genetic backgrounds or different analytical methods for amylose determination."[155]

1. The specification itself, to which I attach some weight, repeatedly references the Sunco line as distinct from the other two lines investigated (without elucidating the basis for this), for example:

"Comparing the triple-null mutant grain in the three genetic backgrounds, the Sunco grain contained significantly higher proportions of amylose than the other two null mutant grain samples."[156]

"The Sunco mutant grain contained significantly less starch than the ssIIa mutant grain in the other two genetic backgrounds."[157]

1. However, the specification provides no teaching, beyond the use of the Sunco line, and to a lesser extent the Westonia line, that leads the skilled person with some level of certainty towards the achievement of a wheat grain with all of the claimed parameters. The specification says nothing more than that the genetic background is important, the three most desirable lines were in the Sunco genetic background, and as noted above, that Sunco is statistically different from the other two lines investigated. There is no explanation for why this is, or may be, so, or what genetic backgrounds might expect similar (or any) levels of success in achieving both high amylose and the parameters concerning non-starch polysaccharides defined in the specification. As noted above, Dr Howitt says no more than that the specification shows that the claimed phenotype can be obtained in wheat with "different genetic backgrounds, e.g., Sunco and Westonia".[158]

1. While the specification lists a number of possible genetic backgrounds into which the triple null mutation could be introduced, it does not provide any indication that success in achieving the claimed phenotype is likely in those strains. In this regard the comments of Lord Hoffman in Biogen to the effect that where a patentee provides a new product with a beneficial effect but cannot demonstrate a common principle by which a beneficial effect will be shared by other products of the class, they will not be entitled to a claim to the entire class, [159] are apposite. It is recognised in the specification that the genetic background of the wheat is important to achieving the claimed results, but there is no further elucidation of any principle associated therewith that would support a technical contribution to the art of the scope claimed.

1. It is apparent from the specification that the Sunco line provides particularly favourable results, and the claimed parameters were also achievable in the Westonia line. While results within the scope of the claims were achieved less frequently in the Westonia line than in the Sunco line I have no evidence as to what level of success might be expected in this art, noting that at least some degree of variability must be expected in a biological system. As such, I am not in a position to find that the technical contribution does not extend to the claimed results in the Westonia line.

1. The specification does not show production of any wheat grain within the scope of the claims in the EGA-Hume line. While it may be conceivable that this could be achieved upon further work, or even repetition of the experiment disclosed in the specification, the specification provides no basis to expect that it would be obtainable. While the applicant noted that the opponent has not provided evidence of any grain of the EGA-Hume (or any other line) that falls within the scope of the claims and that owes nothing to the teaching of the specification, and I acknowledge that the evidence, beyond the specification itself, is limited such I find this consideration finely balanced, I do not consider it fatal to the opponent's case. As set out above, as I see it the fundamental issue is that determination of whether any particular genetic background will afford the claimed results is left to trial and error by the skilled person without the benefit of any guiding principle in the specification. In these circumstances I consider the technical contribution to the art to be limited to the obtention of the claimed parameters in the Sunco and Westonia wheat lines; the claims are not supported to the extent that they exceed this.

1. It follows that while I can accept that the specification discloses and enables the skilled person to undertake a breeding and selection program, the approach articulated by the applicant of generating, screening and selecting desired products (essentially reproducing the work reported in Example 4) without any basis for expecting to achieved the claimed phenotype in any given genetic background (other than Sunco and Westonia) seems to me essentially the setting of a research project. That is, a project involving trial and error where the outcome is uncertain - "research to find out which derivatives work",[160] rather than an enabling disclosure. The technical contribution, that is, what is enabled, is not in my view any wheat grain characterised by the defined parameters. While the possibility of achieving such a grain has been disclosed, this is not what the specification has put "at the disposal of the person skilled in the art"[161] - requiring the skilled person to essentially reproduce a research project in order to (perhaps) arrive at products with the claimed desirable properties cannot be considered to "fairly entitle the patentee to a monopoly" over any products with those desirable properties in circumstances where no principle to assist the skilled person in working towards success has been elaborated.

1. The present case is distinguished from the circumstances in Anan Kasei in that the opponent's complaint is not just that there may be other ways of making wheat grains with the claimed characteristics, but also that the method disclosed does not reliably result in the claimed wheat grains - this much is apparent on the face of the specification, where the significance of the genetic background is acknowledged. In contrast, in Anan Kasei I do not understand there to have been any argument that the method disclosed in the specification would not reliably lead to a product within the scope of the claims.[162] The present circumstances seem somewhat more akin to those in Jusand, where the invention was able to be constructed from a range of materials but the specification showed only how to make it from one.[163]

1. The opposition has been successful on the ground of support. I will allow the applicant an opportunity to propose amendments to overcome this finding.

1. It is usual in matters before the Commissioner that costs follow the event.

1. In this case, the applicant observed that the opposition run was confined relative to that articulated in the statement of grounds and particulars and sought costs thrown away with respect to the abandoned grounds. However, it is common (and desirable) for an opponent to refine their case prior to the hearing. In this case the evidence filed by both parties is, in the main, relevant to the grounds ultimately pressed by the opponent. I see no basis in the opponent's approach for departing from the usual approach to costs.

1. The opponent has been successful in their opposition; I will award costs according to Schedule 8 against the applicant.

1. Wheat grain of the species Triticum aestivum, the grain comprising

1. mutations in each of its SSIIa genes such that the grain is homozygous for a null mutation in its SSIIa-A gene, homozygous for a null mutation in its

SSIIa-B gene and homozygous for a null mutation in its SSIIa-D gene,

ii) a total starch content comprising an amylose content and an amylopectin

iii) a fructan content which is increased relative to wild-type wheat grain on a

weight basis, preferably between 3% and 12% of the grain weight,

the grain having a grain weight of between 25mg and 60mg, wherein the amylose content is between 45% and 70% on a weight basis of the total starch content of the grain as determined by iodine binding assay, wherein the amylopectin content on a weight basis is reduced relative to the wild-type wheat grain, wherein each of the β- glucan content, arabinoxylan content and cellulose content are increased relative to the wild-type wheat grain on a weight basis, such that the sum of the fructan content, β-glucan content, arabinoxylan content and cellulose content is between 15% and 30% of the grain weight.

1. The wheat grain of claim 1 which is further characterised by one or more or all of the features:

i) a starch content of between 30% and 70% of the grain weight,

1. the amylose content is between 45% and 65% of the total starch content of the grain as determined by iodine binding assay,
2. the starch content has a chain length distribution as determined by fluorescence-activated capillary electrophoresis (FACE) after debranching of the starch samples which is increased in the proportion of chain lengths of DP 7-10 and decreased in the proportion of chain lengths DP 11-24, relative to wild-type wheat starch,
3. the fructan content comprises fructan of DP 3-12 such that at least 50% of the fructan content is of DP 3-12,
4. the fructan content is increased by between 2-fold and 10-fold relative to the wild-type wheat grain on a weight basis,
5. the β-glucan content is increased by 1% or by 2% on an absolute basis, and/or is increased by between 2-fold and 7-fold relative to the wild-type wheat grain on a weight basis,

vii) the β-glucan content is between 1% and 4% of the grain weight,

viii) the arabinoxylan content is increased by between 1% and 5% on an absolute basis,

ix) the cellulose content is increased by between 1% and 5% on an absolute basis,

1. the grain has a germination rate which is between about 70% and about 100% relative to the wild-type wheat grain,

xi) the grain, when sown, gives rise to wheat plants which are male and female fertile.

1. The grain of claim 1 or claim 2, wherein the grain comprises a level and/or activity of SSIIa protein which is less than 5% of the level or activity of SSIIa protein in the wild-type wheat grain, or which lacks one or more or all of SSIIa-A protein, SSIIa-B protein and SSIIa-D protein.

1. The grain of any one of claims 1 to 3, wherein each null mutation is selected, independently, from the group consisting of a deletion mutation, an insertion mutation, a premature translation stop codon, a splice site mutation and a nonconservative amino acid substitution mutation, preferably wherein the grain comprises deletion mutations in each of two or three SSIIa genes.

1. The grain of any one of claims 1 to 4, which further comprises a loss of function mutation in an endogenous gene which encodes a starch synthesis polypeptide, or a chimeric polynucleotide which encodes an RNA which reduces the expression of the endogenous gene which encodes the starch synthesis polypeptide, said starch synthesis polypeptide being selected from the group consisting of SSI, SSIIIa and SSIV, wherein said mutation is selected from the group consisting of a deletion mutation, an insertion mutation, a premature translation stop codon, a splice site mutation and a non-conservative amino acid substitution mutation.

1. The grain of any one of claims 1 to 5, which is homozygous for a null mutation in its SSIIIa-A gene, homozygous for a null mutation in its SSIIIa-B gene and homozygous for a null mutation in its SSIIIa-D gene.

1. The grain of any one of claims 1 to 6, wherein at least one, more than one, or all of the mutations are i) introduced mutations, ii) were induced in a parental wheat plant or seed by mutagenesis with a mutagenic agent such as a chemical agent, biological agent or irradiation, or iii) were introduced in order to modify the plant genome.

1. The grain of any one of claims 1 to 7 having an amylose content of about 60% on a weight basis of the total starch content of the grain.

9. The grain of any one of claims 1 to 8, which is non-transgenic.

1. The grain of any one of claims 3 to 9, wherein the SSIIa level and/or activity is determined by assaying the SSIIa level and/or activity in developing endosperm, or by assaying the amount of SSIIa protein in harvested grain by immunological or other means.

1. The grain of any one of claims 1 to 10, wherein the starch granules of the grain and/or the starch of the grain is characterised by one or more of properties selected from the group consisting of:

ii) the starch characterised by a reduced glycaemic index (GI);

1. the starch granules having reduced birefringence when observed under polarized light;

v) the starch characterized by a reduced swelling volume;

vi) modified chain length distribution and/or branching frequency in the starch;

vii) the starch characterized by a reduced peak temperature of gelatinisation;

1. the starch characterized by a reduced peak viscosity;

1. reduced peak molecular weight of amylose as determined by size exclusion chromatography;

1. reduced proportion of A-type and/or B-type starch, and/or increased proportion of V-type crystalline starch;

each property being relative to wild-type wheat starch granules or wild-type wheat starch.

1. The grain of claim 1, wherein the _SSIIa-_A gene of the wheat grain comprises the nucleotide sequence set forth as SEQ ID NO: 52.

1. The grain of claim 1, wherein the _SSIIa-_B gene of the wheat grain comprises the nucleotide sequence set forth as SEQ ID NO: 53.

1. The grain of claim 1, wherein the _SSIIa-_D gene of the wheat grain comprises the nucleotide sequence set forth as SEQ ID NO: 54.

1. the _SSIIa-_A gene of the wheat grain comprises the nucleotide sequence set forth as SEQ ID NO: 52;
2. the _SSIIa-_B gene of the wheat grain comprises the nucleotide sequence set forth as SEQ ID NO: 53; and
3. the _SSIIa-_D gene of the wheat grain comprises the nucleotide sequence set forth as SEQ ID NO: 54.

1. A wheat plant, which produces, or is obtained from, the grain of any one of claims 1 to 15, wherein the wheat plant is male and female fertile.

17. The wheat plant of claim 16, which lacks all of SSIIa-A protein, SSIIa-B protein and

1. Flour produced from the grain of any one of claims 1 to 15, which is preferably wholemeal, or wheat bran produced from the grain of any one of claims 1 to 15.

1. A food ingredient that comprises the grain of any one of claims 1 to 15, and/or the flour, preferably the wholemeal, or wheat bran of claim 18, preferably at a level of at least 10% on a dry weight basis.

1. The food ingredient of claim 19, wherein the food ingredient is kibbled, cracked, parboiled, rolled, pearled, milled or ground grain or any combination of these.

1. A food product comprising a food ingredient at a level of at least 10% on a dry weight basis, wherein the food ingredient is wheat grain of any one of claims 1 to 15, and/or the flour, preferably the wholemeal, or the wheat bran of claim 18.

1. A composition comprising: (a) the wheat grain of any one of claims 1 to 15, and/or the flour, preferably the wholemeal, or wheat bran of claim 18, at a level of at least 10% by weight, and (b) wheat grain having a level of amylose lower than 45% (w/w) or flour, wholemeal, starch granules or starch obtained therefrom.

1. A process for producing wheat grain according to any one of claims 1 to 15, the process comprising harvesting wheat grain from a wheat plant according to claim 16 or claim 17, and optionally processing the grain to produce a food ingredient according to claim 19 or claim 20.

1. A process for producing a wheat plant that produces grain according to any one of claims 1 to 15, the process comprising: step (i) crossing two parental wheat plants each comprising a null mutation in each of one, two or three SSIIa genes selected from the group consisting of SSIIa-A, SSIIa-B and SSIIa-D, wherein the two parental plants together comprise null mutations in all three of SSIIa-A, SSIIa-B and SSIIa-D, or of mutagenising a parental plant comprising one or two of the null mutations; step (ii) screening plants or grain obtained from the cross or mutagenesis, or progeny plants or grain obtained therefrom, by analysing DNA, RNA, protein, starch granules or starch from the plants or grain, and step (iii) selecting a fertile wheat plant which comprises a null mutation in each of the SSIIa-A, SSIIa-B and SSIIa-D genes.

1. A process for screening wheat grain or a wheat plant, the method comprising: (i) determining the amount or activity of SSIIa relative to the amount or activity in wildtype wheat grain or a wild-type wheat plant and selecting grain, or a plant which produces grain, according to any one of claims 1 to 15.

26. A process for producing a food comprising the steps of: (i) adding a food ingredient

according to claim 19 or claim 20 to another food ingredient, and (ii) mixing the food ingredients, thereby producing the food.

1. A process for improving one or more parameters of metabolic health, bowel health or cardiovascular health in a subject in need thereof, or of preventing or reducing the severity or incidence of a metabolic disease such as diabetes, bowel disease or cardiovascular disease, the method comprising providing to the subject the grain of any one of claim 1 to 15, the food product of claim 21 or the food product produced by the process of claim 26.

28. A process for producing starch, comprising the steps of (i) obtaining wheat grain

according to any one of claims 1 to 15, and (ii) extracting starch from the grain,

[2] See, e.g., ToolGen Incorporated v Fisher (No 2) [2023] FCA 794 at [410] ('ToolGen').

[3] See, e.g., Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 540 at [352], Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents [2022] HCA 29 at [34]. I note that in Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC [2023] FCA 1119 at [259] Rofe J made a similar observation in the context of an appeal under section 60(4): "There is no challenge to the validity of any of the claims ... on the grounds of lack of novelty or inutility. Each claim ... is thus taken to disclose a new and useful product or method", but this is again distinguished from the present situation in that it did not limit the scope of the grounds that were pressed.

[4] [2013] FCA 214; 100 IPR 451 at [139].

[5] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70].

[15] Applicant's submissions at [6.3].

[18] These were referenced in the opponent's written submissions as relevant considerations in relation to manner of manufacture, and at the hearing as supportive of the opponent's support argument. I have not found them to be of assistance in considering the present grounds of opposition under Australian law and on the basis of the expert evidence provided.

[46] Specification, [0399], [0402], [0404], [0406], [0408].

[47] Specification, [0403], [0405].

[50] [2009] FCAFC 70; 81 IPR 228 at [118]- [120].

[55] Specification, [0269], [0368].

[64] See, e.g., Vehicle Monitoring Systems Pty Ltd v SARB Management Group Pty Ltd [2021] FCAFC 224 at [52] ('SARB'), [61]; Kafataris v Davis [2016] FCAFC 134 at [62].

[65] [2008] FCAFC 9 at [60] ('Polwood').

[68] Polwood at [53], JMVB Enterprises Pty Ltd v Camoflag Pty Ltd [2005] FCA 1474 at [132].

[71] [2001] FCA 501 at [19].

[72] [2010] FCA 1061 at [520].

[74] Opponent's submissions at [46], applicant's submissions at [9.9].

[86] Annexure A to Carragher #1 at p 31.

[91] I understand this to be in August or September 2015 based on the email from Mr Adler on 29 September 2015 Annexure A to Carragher #1 at pp 94-95) which states: "It was great to meet with you and talk over dinner a couple of weeks ago at the ABIC conference."

[92] Opponent's submissions at [55], Annexure A to Carragher #1 at pp 109-124.

[98] [1995] HCA 15; 183 CLR 655 at [9] ('NV Philips').

[100] [1959] HCA 71; 102 CLR 232 at 251 ('Microcell').

[101] See, e.g., Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; 235 CLR 173 at [106], AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 at [382]- [386], InterPharma Pty Ltd v Hospira, Inc (No 5) [2019] FCA 960 at [465].

[102] The passage identified by the opponent at the hearing as particularising this form of manner of manufacture follows particulars concerning human action and breeding technique and reads: "[t]he invention (other than in claim 8) is therefore not a manner of manufacture within the meaning of section 6 of the Statute of Monopolies and is therefore not a patentable invention under s. 18(1)(a)."

[103] Annexure A to Carragher #1 at p 27.

[104] Opponent's submissions at [42].

[105] Opponent's submissions at [41].

[106] Applicant's submissions at 8.26.

[107] [2019] FCAFC 2.

[109] Opponent's submissions at [42].

[110] [2015] HCA 35; 258 CLR 334 ('Myriad').

[115] Sequenom Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011 at [378].

[116] [2000] HCA 14; 202 CLR 479 at [46].

[117] Sun Pharmaceutical Industries (Australia) Pty Ltd v Tasmanian Alkaloids Pty Ltd [2018] APO 7, TPI Enterprises Ltd v Tasmanian Alkaloids Pty Ltd [2018] APO 8, Cargill Incorporated v Dow AgroSciences LLC [2016] APO 43 ('Cargill').

[119] Opponent's submissions at [32].

[123] Noting the indication in the specification at [235] that "[p]rocedures such as crossing wheat plants, self-fertilising wheat plants or marker-assisted selection are standard procedures and well known in the art."

[124] [2018] APO 7.

[125] [2018] APO 8.

[126] Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336 at 361.

[127] See, e.g., Calix Limited v Grenof Pty Ltd [2023] FCA 378 at [126] ('Calix').

[128] [1993] RPC 249 at 252-253.

[129] See, e.g., Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 at [530]- [533], ToolGen at [396].

[130] Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2023] FCAFC 178 at [222]- [224] ('Jusand'), ToolGen at [410], Calix at [128].

[131] Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 540 at [483] (not criticised on appeal).

[133] [2009] UKHL 12 ('Lundbeck').

[135] See, e.g., Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 540 at [489]- [491].

[139] [2019] EWCA Civ 1646 ('Anan Kasei').

[140] [1996] UKHL 18; [1997] RPC 1 ('Biogen').

[144] Biogen at 49 (with citations omitted).

[151] Applicant's submissions at [7.18].

[152] Specification, [0233]-[0234].

[159] Biogen at 49 (with citations omitted).

[160] See, e.g, American Home Products Corporation v Novartis Pharmaceuticals UK Ltd [2000] EWCA Civ 231; [2001] RPC 159 at [43]

[161] See TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1493 at [243]- [244] citing Fuel Oils/Exxon (T409/91) [1994] OJ EPO 653.