Triple Null Trouble – APO Finds CSIRO’s High Amylose Wheat Claims Unsupported

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

Introduction

The Australian Patent Office (APO) upheld an opposition by Urrbrae Foods Pty Ltd against CSIRO’s patent application number AU2017292900 (the Application) directed to high amylose wheat.  While grounds of manner of manufacture and entitlement failed, the Delegate found the claims lacked support and the opposition was successful on that ground.  CSIRO was given two months to amend, and costs were awarded against it.  No amendments have been filed.  Instead, CSIRO has filed an appeal of the decision in the Federal Court.

Background

The application, entitled “High amylose wheat – III” relates to high amylose wheat plants and methods of producing them.  The invention concerns wheat grains having null mutations in all three SSIIa genes (A, B and D genomes), leading to increased amylose content (≥45%) and higher dietary fibre fractions such as β-glucan, arabinoxylan, cellulose and fructan.  These traits are purported to improve nutritional value and human health outcomes.

The application contained 28 claims at acceptance.  Claim 1, as the only independent claim, reads as follows:

Wheat grain of the species Triticum aestivum, the grain comprising

i.       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 content,

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,

iv.      a β-glucan content,

v.       an arabinoxylan content,

vi.      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.

Dependent claims are directed to flour, food products, methods of producing the wheat, and uses in human nutrition.

Urrbrae initially opposed the application on the grounds of entitlement, manner of manufacture, novelty, inventive step, utility and support.  At the hearing, however, Urrbrae pressed only the grounds of manner of manufacture, support and entitlement.

Key Issues

Lack of Support

The central issue in the case concerned whether the claimed invention—wheat grains exhibiting high amylose and fibre content—was enabled and supported across the full scope of the claims, or whether the disclosure only enabled and supported claims to wheat grains from specific genetic backgrounds.

Urrbrae argued that the CSIRO’s technical contribution was confined to grains developed from the Sunco genetic background.  The specification itself, via the worked examples, highlighted Sunco as uniquely successful in achieving the claimed characteristics of the wheat, while grains from other genetic backgrounds such as EGA-Hume and Westonia lines either failed to achieve the claimed characteristics or achieved inconsistent results.  Urrbrae submitted that this demonstrated that the invention could not be performed across its full breadth, and that the claims therefore extended beyond what was enabled or supported by the specification.

In contrast, the CSIRO argued that the invention lay not simply in the generation of the claimed grain lines from one genetic background, but in the method of generating, screening, and selecting suitable lines.  CSIRO maintained that the specification provided sufficient guidance to enable the skilled person to reproduce the invention across different wheat cultivars, without undue experimentation, and that it was unnecessary to exemplify every possible genetic background.  CSIRO characterised Urrbae’s objection as being that, a priori, it is not possible to generate only wheat grain with the required characteristics.

The Delegate agreed in part with Urrbrae, finding that while the specification clearly enabled production of grains meeting the claimed parameters in Sunco and Westonia backgrounds, it provided no guiding principle for extending those results to other genetic lines such as EGA-Hume.  The Delegate noted that, 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.  The Delegate referred to 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, as being apt in this case.  The Delegate found that the specification recognises that the genetic background of the wheat is important to achieving the claimed results, but there is no further elucidation of any associated principle that would support a technical contribution to the art of the scope claimed.  Determination of whether wheat grains from any particular genetic background will afford the claimed results effectively left the skilled person to conduct a trial-and-error research project where the outcome is uncertain.  As such, the Delegate found that the technical contribution was limited to the success demonstrated in the Sunco and Westonia genetic lines, and the broader claims were not supported to the extent that they encompassed other wheat grains from other genetic backgrounds.

Manner of Manufacture

Urrbrae argued that the invention did not constitute a manner of manufacture under s 18(1)(a) of the Patents Act 1990, contending that (i) the claims lacked inventive character on the face of the specification, and (ii) not everything within the claims was the result of human action.

Lack of Inventive Character

Urrbrae submitted that 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.  Urrbrae argued that the invention was no more than the use of a known property (increased amylose content) of a known article (triple null wheat) 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.

CSIRO 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. CSIRO 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.

The Delegate was not persuaded that the specification on its face reveals an absence of the requisite quality of inventiveness, stating that 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.  The Delegate stated that it was not apparent on the face of the specification that the claimed invention would be arrived at without invention.

Result of Human Action

Urrbrae argued that the claimed wheat plants were not the result of human action, since the specification allowed for the possibility of naturally occurring mutations and natural crossing or self-fertilisation of grain lines.  On that basis, Urrbrae submitted that the claims could capture plants arising without human intervention.

CSIRO responded that there was no evidence that triple-null wheat plants—those with mutations in all three SSIIa genes and exhibiting the claimed composition—occur naturally.  The specification, particularly Example 4 and its breeding schematics, demonstrated extensive human involvement through controlled crossing, backcrossing, and selection to achieve the desired phenotype.

The Delegate noted that even if natural mutations are theoretically possible, that does not mean they exist in practice.  There was no evidence that any naturally occurring plants fell within the scope of the claims.

The Delegate held that the claimed invention was clearly the product of deliberate human breeding and selection, not a spontaneous natural occurrence.  A mere possibility of natural existence does not meet the balance of probabilities threshold.  Accordingly, the ground that the claims were not the result of human action was not made out.

Lack of Entitlement

Urrbrae alleged the invention was first made by Dr Colin Jenner, whose ‘Cross III’ wheat achieved amylose contents of up to 55%.  However, the Delegate found that there was no persuasive evidence that CSIRO derived its invention from Dr Jenner.  Whilst no evidence was filed by the named inventor, which the Delegate noted would have been the best evidence, internal CSIRO documentation showed the inventive concept was developed independently of Dr Jenner.  The entitlement ground therefore failed.

Outcome

The opposition succeeded on the ground of lack of support.  The grounds of manner of manufacture and entitlement were rejected.  CSIRO was given two months to file amendments to narrow the claims to align with its demonstrated contribution to the art. Costs were awarded against CSIRO.  CSIRO has not filed any amendments.  Instead, CSIRO has filed an appeal with the Federal Court.

Implications

This decision demonstrates the APO’s strict application of post-Raising the Bar support requirements in the agricultural biotech space.  Broad claims encompassing wheat grains from all genetic lines were not allowed due to a lack of consistent experimental evidence that established a principle of general application.  This finding emphasises the importance, in biotechnology and plant breeding cases, of articulating a clear principle or rationale for why an invention should be expected to work across its claimed scope, particularly when results vary across genetic backgrounds.  Without this, patent applicants risk having their monopoly confined to specific examples rather than the broader class of products they intended to protect.

The decision also confirms that plant breeding inventions remain patentable in Australia where they involve deliberate human intervention, even if some mutations could theoretically occur in nature.  However, patentees should ensure their specifications clearly describe the inventive human contribution, particularly where the invention builds on naturally occurring traits or known breeding systems.

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