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5.6.8.1 General Principles – Assessing Manner of Manufacture

Date Published

Overview

Manner of manufacture, or patent-eligible subject matter requires asking: 'is this a proper subject of letters patent according to the principles which have been developed for the application of s6 of the Statute of Monopolies?'

The Courts have taken into consideration various principles when deciding whether or not a claimed invention is a manner of manufacture. There is agreement that:

  • There is no simple or universal principle to be applied – each case needs to be considered on its own merit; and

  • The claimed invention must, in substance, be a manner of manufacture (noting that the substance of a claimed invention will often be the same whether claimed as a product, method, or system).

Examiners should consult those parts of 5.6.8 Patentable Subject Matter (Manner of Manufacture) dealing with specific subject matter for more detailed assistance.

Note that in many situations, the circumstances which give rise to a manner of manufacture objection, or border upon doing so, will also give rise to an objection of lack of inventive step. Thus, examiners should always consider the possibility of raising an inventive step objection in tandem with a manner of manufacture objection.

Introduction

Schedule 1 defines "invention" as:

"any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention".

Subsection 18(1)(a) states:

"an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies."

A similar provision applies for innovation patents (s18(1A)(a)).

The definition of "invention" in schedule 1 therefore incorporates both the aspect of newness and the aspect of manner of manufacture, whereas s18(1)(a) and s18(1A)(a) omit reference to the aspect of newness.

Nevertheless, in the decision of the High Court in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd 32 IPR 449 (which was confirmed by Advanced Building Systems Pty Ltd and Anor v Ramset Fasteners (Aust) Pty Ltd (1998) 152 ALR 604; (1998) AIPC 91-40; 40 IPR 243), the majority of the High Court concluded that "newness" was imported into s.18(1)(a) to the extent that:

“the phrase “manner of manufacture within the meaning of section 6 of the Statute of Monopolies” in s 18(1)(a) should be understood as referring to a process which is a proper subject matter of letters patent according to traditional principles.”

Thus, the expression "manner of manufacture" under the 1990 Act has the same meaning and involves the same concepts as the expression "manner of new manufacture" under s35(1)(aa) of the 1952 Act.

In D’Arcy v Myriad Genetics Inc (2015) HCA 35 the majority stated:

“The legislative history of the requirement for patentability imposed by s18(1)(a) of the Act has been set out in previous decisions of this Court [40]. The question posed by the application of s 18(1)(a) may be framed as in NRDC [41]:

‘Is this a proper subject of letters patent according to the principles which have been developed for the application of s6 of the Statute of Monopolies?’

That question is to be answered according to a common law methodology under the rubric of ‘manner of manufacture’ as developed through the cases, but consistently with ‘a widening conception of the notion [which] has been a characteristic of the growth of patent law.’ [42] That widening conception is a necessary feature of the development of patent law in the 20th and 21st centuries as scientific discoveries inspire new technologies which may fall on or outside the boundaries of patentability set by the case law which predated their emergence.”

The scope of eligible subject matter, including products, methods and processes, is therefore defined by principles established by the Courts in relation to specific cases. For a list of some of these cases see 5.6.8.19 Annex A - History of Manner of Manufacture.

Assessing manner of manufacture

The assessment of whether an application defines patent eligible subject matter is considered with respect to each claim.

In general, the principles set out in D'Arcy v Myriad Genetics Inc (2015) HCA 35 (Myriad), Commissioner of Patents v RPL Central Pty Ltd (2015) FCAFC 177 (RPL), Research Affiliates LLC v Commissioner of Patents (2014) FCAFC 150 in particular, and other cases suggest that examiners can approach the examination of manner of manufacture as follows:

Construe the claim; (see 5.5 Construction of Specifications)

  1. identify the substance of the claimed invention;
  2. ask whether the substance of the claim lies within established principles of what does not constitute a patentable invention (for example, is the substance merely a scheme, plan, rules of gameplay, intellectual, or genetic information?); and
  3. if not, consider whether the substance of the claim otherwise lies outside of existing concepts of manner of manufacture and is to be treated as a “new class” of subject matter. (This leg of the approach will only be used in rare situations; see Is the claim for a "new class" of subject matter? below).

Construe the claim

The normal rules of construction apply when determining the scope of a claim for this purpose (see 5.5 Construction of Specifications). Examiners should however be very careful in considering broad or indefinite terms or adopting constructions suggested by the applicant that pre-empt a determination of the substance of the invention, for example, by taking an unduly broad or narrow construction of the claim.

Identify the substance of the claimed invention

In considering the substance of a claimed invention it will often not matter in what form the invention is claimed, the substance can be the same whether claimed as a product, method or system. However, each case needs to be considered on its particular facts. For example, if the substance of a claim is to a mere discovery, then this would not be patentable. However, if another claim is directed to an application of that discovery then the substance of that claim may be the application of the discovery and may in substance be a patentable invention (see 5.6.8.4 Discoveries, Ideas, Scientific Theories, Schemes and Plans).

When considering a combination claim, the substance of the invention can lie in an individual integer of the combination, or a collection of integers. In determining the substance, while it is legitimate to consider whether the individual integers are part of the state of the art, it is a mistake to determine the substance of the invention solely by excluding known integers and examiners must ultimately consider the claim as a whole.

In the vast majority of cases considered during examination, the substance of the claim is essentially the same as the subject matter of the claim. However, it cannot be assumed that this will always be the case.

The determination of the substance of the invention is part of the construction exercise. The enquiry seeks to arrive at ‘a characterisation of the invention claimed,’ rather than a determination of the scope of the claim. The construction task, for the purposes of determining the substance of the claimed invention, can have regard to the common general knowledge and the relevant prior art. In determining what the substance of the claimed invention is, examiners should consider and weigh up all the material before them; see 5.6.1.4 Balance of Probabilities.

Relevant factors to consider and weigh up may include:

  • The contribution to the art asserted by the specification;

  • The level of detail provided in the specification with regard to various aspects of the invention;

  • How does the invention work;

  • The form of words, breadth and emphasis of the claim;

  • What problem does the invention address;

  • What are the actual or alleged advantages of the invention; and

  • What does the invention add to the state of the art as at the priority date?

Examiners need to assess the substance of the claimed invention at every report stage. A determination is to be made whether the substance has altered as a result of any amendments and arguments to one that has traditionally been considered patentable. While no general rules can be given to assist in this determination, further guidance and examples are given in the discussions of specific subject matter categories.

Role of the state of the art

Consideration of what the state of the art was before the priority date is one of several factors that examiners should consider and weigh up when determining what the substance of a claimed invention is.

The state of the art, in conjunction with the specification, can provide a basis to understand objectively where the contribution lies (for example, the "inventiveness" or "ingenuity"). This is not the same as a determination of whether a claimed invention is lacking novelty or an inventive step under s18(b) which involve an assessment against the subject matter of the claim. Manner of manufacture is an assessment of the substance of the claimed invention, and identification of the contribution informs this consideration. Even if a claim lacks novelty and/or an inventive step, this does not mean that there is no substance to the claimed invention. Similarly, a modification to a business scheme may be considered inventive but lack a manner of manufacture.

Put another way, manner of manufacture assesses whether the contribution of the invention is directed to the "type" or "nature" of subject matter that should attract patent protection, whereas novelty and inventive step assess whether the contribution is "significant enough" or "whether the degree of contribution sufficiently advances the art" when compared to the prior art.

The state of the art incorporates at least the common general knowledge (Myriad at paragraph 39: “…the scientific background, presumably comprising common general knowledge, or at least relevant prior art”; RPL: “well-known … functions of a computer”). Care should be exercised in treating matters as part of the state of the art if they cannot be regarded as part of the common general knowledge.

Is the substance of the claim patentable in view of established principles?

In most cases where the issue arises, the substance of a claimed invention can be assessed against existing concepts of manner of manufacture that have been developed through case law. Consequently, the question will normally be whether the substance of the invention falls within an established category of ineligible subject matter (for example, the fine arts, discoveries, or schemes). If so, then the invention does not relate to patent eligible subject matter. How the assessment is made is dependent on the particular exclusion and specific guidance is provided in 5.6.8 Patentable Subject Matter (Manner of Manufacture).

Is the claim for a "new class" of subject matter?

If the substance of a claimed invention appears not to fall within established concepts of manner of manufacture and does not fall within established exceptions, it is considered to be a “new class” requiring special consideration as set out in Myriad at paragraph 28.

To decide whether a claim relates to a “new class”, the relevant consideration is whether the Courts have previously dealt with subject matter of that type and whether that subject matter has been excluded in the context of manner of manufacture.

In general, the Courts have indicated that, subject to other requirements and aside from particular exceptions, patents are available for products, methods of making, and using products and methods that otherwise result in a new and useful effect. Technical subject matter that has been previously considered by Courts without rejection includes:

  • recombinant or isolated proteins;

  • pharmaceuticals and other chemical substances;

  • methods of treatment;

  • methods of applying herbicides; and

  • applications of computer technology.

Where it is apparent that the substance of the invention lies in a new class of subject matter that is outside the established categories of patent eligible inventions, examiners should discuss the matter with their supervising examiner and Oppositions to determine the approach to be taken.

Objecting to Manner of Manufacture, Novelty, and Inventive Step

Key points (see below for further explanations):

  1. reservation of opinion for novelty and inventive step should only be considered when there is clearly no patentable subject matter in a specification.
  2. reservation of opinion for manner of manufacture is appropriate only in exceptional circumstances.
  3. a manner of manufacture objection should not be taken merely because a claim is not novel/not inventive, these are separate considerations.

Where the invention claimed is clearly not in respect of a manner of manufacture and it is not readily apparent what subject matter might reasonably be expected to be claimed, examiners should consider whether it is appropriate to restrict their report, for example, with respect to novelty and inventive step (see 3.3.4 Reserving Opinion and Restricting Search).

Where the substance of a claimed invention clearly falls within the realm of patentable subject matter but claim(s) are either plainly not novel or not inventive, a manner of manufacture objection will not be relevant.

In cases where a claim is not novel or clearly not inventive, the way in which the novelty and/or inventive step objection could potentially be overcome may be important to a conclusive determination of manner of manufacture. Examiners should not avoid a consideration of manner of manufacture simply because a novelty/inventive step objection is in place. However, where the current claims are not novel or not inventive but the examiner anticipates that amendments likely to be proposed would result in a manner of manufacture or Section 40 objection, this should be indicated in the examination report.

Relationship with older court decisions

The approach to assessing the substance of the invention, whereby the substance of the invention is considered to be the alleged or actual contribution to the relevant prior art is consistent with the law articulated by the High Court in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd 32 IPR 449 which provides for a threshold requirement that an “alleged” invention must possess the necessary quality of inventiveness (that is, be an “alleged invention”) on the face of the specification. Here, their honours in majority said that if the threshold is not met, then “one need go no further”. This does not stand for a principle that one cannot go further than the allegations of a specification in considering the substance of the invention. Such a principle would be inconsistent with the case law identified above.

Ethics and Social Policy

It is the role of Parliament to reflect community expectation in the development of legislation, for example, in exclusions from patentability. Where a claimed invention falls within an established class of patentable subject matter (as outlined above in Assessing manner of manufacture), it is not appropriate to exclude patentability on the basis of separate notions of ethics or social policy that are not reflected in the legislation (Anaesthetic Supplies Pty Limited v Rescare Limited (1994) AIPC 91-076; 28 IPR 383). Where the claimed subject matter relates to a “new class”, patentability is to be assessed according to the factors identified by the High Court in D’Arcy v Myriad Genetics Inc. (2015) HCA 35 (as described above in Is the claim for a "new class" of subject matter?).

Amended Reasons

Amended Reason Date Amended

Published for testing
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