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A recent Australian Patent Office decision, Bio-Rad Laboratories, Inc. [2018] APO 24 (28 March 2018), found a claimed invention relating to a method of determining an optimum Quality Control Strategy to result in an artificial effect, and the application was directed to proceed to acceptance.  Although there are no specific provisions which exclude computer implemented methods and business methods from patentability in the Patents Act, the courts have found some inventions lacking patentable subject matter, even when computing elements were involved.

This decision may provide some optimism to patentees with inventions relating to computer implemented methods and business methods.


Bio-Rad Laboratories, Inc (Applicant) filed Application 2012272906 on 21 June 2012 as a PCT application (PCT/US2012/043583) and a request for accelerated examination under the Global Patent Prosecution Highway Pilot Program. Amendments were proposed so that the specification corresponds with that found allowable by the US patent office.  A number of adverse examination reports were issued with the Examiner raising objections that the claims do not define a manner of manufacture with the meaning of Section 18(1)(a) of the Patents Act 1990 (The Act) (i.e. the application does not include patent eligible subject matter).

The claimed invention provides a regime for testing diagnostic devices.  These devices are periodically tested to ensure that they are functioning properly and that the results obtained are accurate.  These tests are also known as Quality Control (QC) events.  There was apparently a need for optimising a QC strategy for immediate release test results that used the minimal number of QC tests while still obtaining the desired performance targets.

As provided in the specification, an embodiment of the invention includes generating a set of candidate quality control rules and for each candidate rule, computing a maximum number of patient specimens that can be tested between quality control events while keeping the expected number of unacceptable results below a pre-specified maximum. Furthermore, a quality control utilization rate can be computed based on the number of patient specimens tested between each quality control event and the number of reference samples tested at each quality control event. The candidate rule with the best quality control utilization rate may be selected as the optimum quality control strategy.

The Law on Manner of Manufacture

It was reiterated that the authoritative decision as to what constitutes a manner of manufacture within the meaning of Section 6 of the Statute of Monopolies is the decision of the High Court in National Research Development Corporation v Commissioner of Patents [1959] HCA 67, (1959) 102 CLR 252 [NRDC].  In a more recent decision (Research Affiliates LLC v Commissioner of Patents, [2014] FCAFC 150), the Full Federal Court noted that it would be helpful to consider the approach of UK decisions, in particular in understanding the distinctions between an unpatentable business method and a patentable invention that results in an ‘artificial effect’ within the understanding of that concept as explained in NRDC. It was also mentioned that the test for “technical contribution” used in the UK decision Aerotel Ltd v Telco Holdings Ltd; Macrossan’s Application, [2006] EWCA Civ 1371; [2007] RPC 7(Aerotel) can be useful in determining whether there is an ‘artificial effect’.

Examiner’s Objections

The Examiner seemed to base the objections on the Aerotel four-step “technical effect” approach, as follows:

(1) properly construe the claim;

(2) identify the actual contribution;

(3) ask whether it falls solely within the excluded subject matter; and

(4) check whether the actual or alleged contribution is actually technical in nature.

Delegate’s Decision

However, in deciding to accept the patent application, the Delegate of the Commissioner of Patents found that the Examiner had over-simplified or mischaracterised the substance of the invention, and that it was incorrect of the Examiner to label the invention as a mere quality control scheme.

Instead of strictly following Aerotel, the Delegate instead stated that it was important to follow the High Court in NRDC and to identify the qualities of an ‘artificially created state of affairs’ and the ‘economic significance’ as essential factors to be considered.

The Delegate then found that, though there is no directly observable artificially created state of affairs by carrying out the claimed method, when the identified QC rule is put into effect during testing, the resulting reduction in the number of tests to be carried out and the reduction in the number of reference samples that are used are ‘artificial effects’. The contribution of the claimed invention was also found to be clearly technical in nature because its application was in the technology of medical diagnostic devices and their testing.


It appears that the Patent Office, at least in a Hearing before the Delegate, can still base their decisions on the ‘artificially created state of affairs’ test from NRDC, including where the ‘artificially created state of affairs’ is not directly observable, at least when the invention clearly has economic significance (Decision paragraph 56).