Bio-Rad Laboratories, Inc.
[2018] APO 24
•28 March 2018
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Bio-Rad Laboratories, Inc. [2018] APO 24
Patent Application: 2012272906
Title:System and method for determining an optimum QC strategy for immediate release results
Patent Applicant: Bio-Rad Laboratories, Inc.
Delegate: R Subbarayan
Decision Date: 28 March 2018
Hearing Date: Written submissions filed on 9 November 2017
Catchwords: PATENTS – Method of determining an optimum Quality Control Strategy for medical testing devices - Examiner’s Objection – Manner of manufacture and lack of support – claimed invention not merely an algorithm performed using a standard computer – leads to an ‘artificial effect’ - contribution is technical in nature - claimed invention is a manner of manufacture – claimed invention does not extend beyond the contribution to the art – claims are supported - application to proceed to acceptance
Representation: Patent attorney for the applicant: Griffith Hack
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2012272906
Title:System and method for determining an optimum QC strategy for immediate release results
Patent Applicant: Bio-Rad Laboratories, Inc.
Date of Decision: 28 March 2018
DECISION
I find that the claimed invention, as proposed to be amended, is for a manner of manufacture. The claims are also supported by the description. I therefore direct that the application proceed to acceptance.
REASONS FOR DECISION
BACKGROUND
Application 2012272906 in the name of Bio-Rad Laboratories, Inc. (Applicant) was filed on 21 June 2012 as a PCT application (PCT/US2012/043582) and claims an earlier priority date of 23 June 2011. Examination was requested on 20 November 2015. On 29 April 2016 before any examination had taken place, the application filed a request for accelerated examination under the Global Patent Prosecution Highway Pilot Program together with proposed amendments to the specification to make the claims correspond with those found to be allowable by the US Patent Office.
A positive first examination report was issued on 15 September 2016, stating that while the application was in order for acceptance, it could not be accepted because there was a postponement of acceptance in place.
The applicant withdrew the postponement of acceptance on 17 November 2016 and requested acceptance of the application. However a second adverse examination report issued on 23 December 2016 introducing an objection that the claims do not define a manner of manufacture within the meaning of Section 18(1)(a) of the Patents Act 1990.
The applicant responded with submissions rebutting the examiners assessment.
A third adverse examination report was issued on 28 April 2017 maintaining the manner of manufacture objection.
The application responded with a request to be heard in this matter.
A fourth adverse examination report was issued on 15 September 2017 which maintained the manner of manufacture objection and also introduced a new objection that the claims lack support under subsection 40(3). A Hearing Notice was issued on 26 October 2017 advising the applicant that the matter would be heard based on written submissions and inviting the applicant to provide their written submission within 2 weeks.
The applicant’s written submissions were received on 9 November 2017 along with a set of proposed amendments to the description and claims. I have considered these proposed amendments and am of the view that they are allowable as they comply with the requirements of S102(1).
This decision is therefore based on the claims as proposed to be amended on 9 November 2017.
THE RELEVANT LAW
The examination of the present application is governed by the Patents Act 1990 (the Act) as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act). Although the application was made before 15 April 2013, the applicant did not request examination until 20 November 2015. Therefore amendments to sections 40 and 49 of the Act apply to the present case as a consequence of Schedule 1, items 55(1)(e) and 55(4)(b) of the Raising the Bar Act.
The standard of proof that applies to the examination of the present application is the balance of probabilities – I must accept the present application if satisfied on the balance of probabilities that the application complies with the Act. If I am not so satisfied, then I can refuse the application.
SPECIFICATION
The present application relates to optimising a testing regime for testing of diagnostic devices such as those used for testing the concentration of particular substances in blood or urine samples.
It is important to ensure that such diagnostic devices work properly and the results obtained are accurate or at least within a predetermined range or margin of error. To test a device for proper functioning and accuracy of the results obtained, the device is periodically tested using one or more reference samples for which the correct result is known. The specification refers to this testing procedure as a Quality Control (QC) event. The testing values obtained are verified against a set of predetermined QC criteria.
If the test results meet the QC criteria, the device is working properly and can be used to test patient samples. If on the other hand, the test results do not meet the QC criteria, the device is likely to have started malfunctioning at some point before or during the QC event. Two scenarios are likely.
Firstly “The malfunctioning may have started after testing the last patient sample, but before the QC event, in which case all the patient results will have been reported correctly”.[1] Secondly “the error can have occurred at any point in time before the QC event, and all the results reported for the patient samples tested following such failure may have been reported with an error greater than the acceptable margin of error”.[2]
[1] Specification as filed, at [0004]
[2] Specification as filed, at [0004]
One way to ensure that the test results are correct is to release the test results obtained after a successful QC event only after the following QC event is also successfully passed. The specification states that “The need for immediate release of test results often renders this option impractical, and another solution is therefore needed”.[3] Another way to decrease the number of erroneously reported test results is to increase the number of QC events and by testing more reference samples at each QC event however this comes at increased cost and decreased number of patient samples tested.
[3] Specification as filed, at [0005]
The specification distinguishes any erroneous results in the test results of the patient samples as either correctible errors or final errors. The erroneous results reported in patient samples that were tested between a previously passed QC event and a failed QC are referred to as correctible errors as the lab may retest these samples and inform patients of the new, correct results. If erroneous results were reported prior to the last QC pass, these results are referred to as final errors because the erroneous results are non-correctible and will be the final report from the lab.
This can be best understood with reference to Figure 1 of the specification that is reproduced below:
In this figure, 120 indicates QC intervals, vertical lines 111 indicate when a test result was obtained, 101 indicates a passed QC event and 102 indicates a failed QC event.
The first row shows four sets of test-results or QC intervals (120) where all the QC events are passed QC events. Therefore there is no systematic error present and all of the test results are correct.
The second row shows four QC intervals in which the last QC event is a failed QC event thereby indicating that a systematic error occurred somewhere in the fourth QC-interval. Results obtained after the systematic error are affected results (113) and are shown shifted relative to unaffected results that were obtained before the systematic error. Since the affected results occurred after the last passed QC-event they are correctible errors.
The third row shows four sets of QC intervals, where a systematic error occurred in the third QC-interval. The QC event following the systematic error was passed. The errors that occurred after the last passed QC event (103) are correctible errors (113) whereas errors that that occurred before the passed QC event are final errors (112).
The specification further states that “It is in the interest of any operator of diagnostic equipment to limit both the number of correctible and final errors. However, when there is a fixed amount of resources made available for quality control, the measures used to reduce the number of correctible errors may adversely affect the number of final errors and vice-versa. For example, if more reference samples are tested at each QC event, more patient samples must be tested between each QC event. While this shift may reduce the chance of a final error, it may increase the expected number of correctible errors after a QC failure. An approach for finding an appropriate balance is therefore needed”.[4]
[4] Specification as filed, at [0019]
The present application is therefore directed to providing a method for optimising a QC strategy for immediate release test results “that uses the minimal number of quality control tests while still obtaining the desired performance targets”.[5] The specification provides the summary of the invention in the following terms:
“The present invention proposes a method for optimizing a quality control strategy for immediate release results. 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 prespecified 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”.[6]
[5] Specification as filed, at [0017]
[6] Specification as filed, at [0007]
Overview of the Optimization Process
Figure 3 which is reproduced below is a flow chart that outlines the steps of the optimization process.
The optimization process begins by generating a number of candidate QC rules (310). Once a set of candidate rules is generated, the QC utilization rate is calculated for each QC rule (320), the QC utilization rate being the average number of reference samples tested at each QC event divided by the average number of patient samples tested between QC events. The rule with the lowest utilization rate is then selected as the optimal QC strategy (330).
The specification then provides a detailed description of each of these steps in the process.
Quality Control Rules
According to the specification different QC rules may be chosen. For example the QC rule could specify that the testing will comprise testing three different reference samples twice at each QC event and that “the QC event shall be deemed to have failed if the chi-squared test-statistic for the reference sample test results exceeds a predetermined number (a control limit)”.[7] According to my understanding, a chi-squared test is a technique used in Statistics to determine whether there is a significant association between two variables. The specification states that the chi-squared test-statistic for each test is determined by calculating the difference between the reference value and the expected value and dividing it by the standard deviation of the reference value and then calculating the sum of squares of these values as expressed in the mathematical formula
[7] Specification as filed, at [0033]
The specification mentions that other possible QC rules may only specify one or two different reference samples and furthermore it may test each sample only once or thrice and a threshold test-statistic may be calculated for each of these rules in the same way.
The specification further states that “the invention may be used with other tests, including but not limited to cumulative sum control chart (CUSUM), exponentially weighted moving average (EWMA) and Westgard Multirules”[8] and that “There are a number of other ways of defining QC rules, and the invention is not limited to the ones described in this application”.[9] I again understand these to be well known techniques used in statistical analysis.
[8] Specification as filed, at [0040]
[9] Specification as filed, at [0040]
Computing a control limit that meets the false rejection criteria
A QC event is deemed a pass if the relevant test-statistic is below a predetermined control limit or otherwise it is deemed a failure. The specification states that the control limit for a particular false rejection criteria may be determined using the principles of probability distribution. In particular where the chi-squared test is used, the control limit may be determined using the inverse of the chi-squared cumulative distribution function (CDF), the observed value of the test-statistic and the number of degrees of freedom (the number of reference samples tested). The specification states the inverse of the cumulative distribution function (CDF) may be calculated using proprietary software or by computer simulation. For example, the chi-squared cumulative distribution function (CDF) may be computed using the proprietary software MatLab from MathWorks.
Determining the maximum number of patient samples that can be tested between QC events while meeting the performance goals
The two separate performance criteria to be met are the maximum number of final errors (the final-max) and the maximum number of correctible errors (correctible-max) and both of these performance criteria may be met by adjusting the number of samples tested between QC events (the QC interval).
In an embodiment of the invention the largest QC-interval (correctible max) that meets the predetermined threshold for correctible results requirement is determined by selecting a QC interval such that the expected number of final errors is equal to the final-max requirement .
The specification provides a number of ways of calculating the expected number of correctible errors by applying principles of mathematical statistics. For example in one embodiment, the expected number of correctible errors may be calculated by integrating the product of the expected number of correctible errors for a systematic error of a particular size (NumCErr(SE)) and the likelihood of systematic errors that are of that particular size f (SE) :
In this formula, a normal distribution with a mean error value of zero and a standard deviation (σ) based on the overall stability of the system may be used for f(SE). In an embodiment of the invention the standard deviation is based on the sigma metric of the system (σm) and a system stability factor (PF). The specification states that the sigma metric of the test system (σm) is used as a measure of the performance of the system and measures the ratio of the quality specification to the test system imprecision and that the system stability factor (Pf) indicates the portion of system failures that result in a systematic error at least as large as the quality specification for the analyte.
Similarly the largest QC-interval (final max) that meets the predetermined threshold for final results requirement is determined by selecting a QC interval such that the expected number of correctible errors is equal to the correctible-max requirement . The specification again details methods of calculating these using similar principles.
Computing the QC utilization rate
The QC-utilization rate is then calculated by dividing the number of QC tests per QC event by the number of patient samples tested in each QC interval where the number of patient samples tested will be the smaller of the maximum QC interval size for the final-maximum requirement (N BF) and the maximum QC interval size for the correctible-maximum requirement (N BC)
Selecting the best QC-Rule
The QC rule with the lowest QC utilization rate will be the most efficient QC rule and this is therefore then chosen as the optimal QC strategy.
Implementing the optimization process
The specification then describes a system for implementing the quality control optimization process. The system includes an analyte measurement module and a computer system that has a processor, disk drives, system bus, monitor and other standard peripherals. In an embodiment, a sample is placed in the analyte measurement module and the analyte responses are measured and transferred into the computer system over the system bus. The computer then executes the instructions for implementing the methods of the quality control optimization process by means of suitable software programs. The results from the computer can then be displayed on the monitor or outputted through other communication means.
The Claims
The specification as filed ended with 26 claims. However the applicant filed an amended set of claims on 29 April 2017 and these claims were found to be allowable and formed the basis for all of the examiner’s four adverse reports. The independent claims of this claim set are as follows:
1. A method for optimizing a quality control strategy comprising:
generating, with a processor, a set of candidate quality control rules;
for each candidate rule:
computing a control limit that meets a false rejection criteria;
computing, using the control limit, a correctible maximum by calculating how many patient samples that can be tested between quality control events while keeping the number of correctible results with an error exceeding a predetermined threshold below a predetermined value;
computing, using the control limit, a final maximum by calculating how many patient samples that can be tested between quality control events while keeping the number of final results with an error exceeding a predetermined threshold below a predetermined value;
selecting a quality control interval size, the quality control interval size being a smallest value of the correctible maximum and the final maximum; and
computing a quality control utilization rate by dividing the number of reference samples tested at each quality control event by the quality control interval size; and
selecting a candidate quality control rule based on the quality control utilization rates of the set of candidate quality control rules.11. A method for optimizing a quality control strategy comprising:
generating, with a processor, a set of candidate quality control rules, wherein each rule is adapted for testing at least one reference sample having a reference value to obtain a test value, and computing a chi-squared test statistic based on the test value and reference value for each reference sample tested and determining whether the test statistic is greater than a control limit;
for each candidate rule, using the processor:
computing a control limit that meets a false rejection criteria using the inverse of the chi-squared cumulative probability distribution function;
computing, using the control limit, a correctible maximum by calculating how many patient samples that can be tested between quality control events while keeping the number of correctible results with an error exceeding a predetermined threshold below a predetermined value;
computing, using the control limit, a final maximum by calculating how many patient samples that can be tested between quality control events while keeping the number of final results with an error exceeding a predetermined threshold below a predetermined value;
selecting as a quality control interval size, a smallest value of the correctible maximum and the final maximum; and
computing a quality control utilization rate by dividing the number of reference samples tested at each quality control event by the quality control interval size; and
selecting the candidate rule having a lowest quality control utilization rate.12. A method for analyzing a quality control strategy, the method comprising:
receiving, with a processor, a quality control rule defining quality control events and specifying a control limit for determining whether a quality control event passes or fails;
receiving, with the processor, a number of patient samples tested between quality control events;
computing, by the processor, a first expected number of correctible errors when a quality control event fails, the first expected number computed based on the quality control rule and the number of patient samples tested between quality control events;
computing, by the processor, a second expected number of final errors that are not correctible when a quality control event fails, the second expected number computed based on the quality control rule and the number of patient samples tested between quality control events; and
outputting, by the processor, an assessment of the quality control rule, the assessment including the first expected number of correctible errors and the second expected number of final errors as separate values.23. A system for optimizing a quality control strategy comprising:
a processor configured to implement the method of any one of claims 1-24.24. A computer-readable storage medium storing a plurality of computer-readable instructions, which, when executed by a computing system, optimize a quality control strategy, the plurality of instructions comprising the method of any one of claims 1-22.
As noted earlier the applicant has proposed a new set of claims to replace the claims that were examined. The proposed claims include 12 claims of which independent claims 1, 10 and 12 are as follows:
1. A method for optimizing a quality control strategy comprising:
generating a set of candidate quality control rules, wherein each rule is adapted for testing at least one reference sample having a reference value to obtain a test value, and computing a test statistic based on the test value and reference value for each reference sample tested and determining whether the test statistic is greater than a control limit;
identifying a predetermined performance target for the candidate quality control rules comprising a maximum number of correctable errors equal to a first value and a maximum number of final errors equal to a second value;
for each candidate rule:
computing a control limit that meets a false rejection criteria;
computing, using the control limit, a correctible maximum by calculating how many patient samples that can be tested between quality control events while keeping the number of correctible errors below the first value;
computing, using the control limit, a final maximum by calculating how many patient samples that can be tested between quality control events while keeping the number of final errors below the second value;
selecting as a quality control interval size, a smallest value of the correctible maximum and the final maximum; and
computing a quality control utilization rate by dividing the number of reference samples tested at each quality control event by the quality control interval size; and
selecting the candidate rule having a lowest quality control utilization rate as the quality control strategy,
wherein the selected candidate rule uses a minimal number of quality control tests while meeting the performance target.10. A system for optimizing a quality control strategy comprising:
a computer system having a processor, the processor configured to:
generate a set of candidate quality control rules, wherein each rule is adapted for testing at least one reference sample having a reference value to obtain a test value, computing a test statistic based on the test value and reference value for each reference sample tested ,and determining whether the test statistic is greater than a control limit;
identify a predetermined performance target for the candidate quality control rules comprising a maximum number of correctable errors equal to a first value and a maximum number of final errors equal to a second value;
for each candidate rule:
compute a control limit that meets a false rejection criteria;
compute, using the control limit, a correctible maximum by calculating how many patient samples that can be tested between quality control events while keeping the number of correctible errors below the first value;
compute, using the control limit, a final maximum by calculating how many patient samples that can be tested between quality control events while keeping the number of final errors below the second value;
select as a quality control interval size, a smallest value of the correctible maximum and the final maximum; and
compute a quality control utilization rate by dividing the number of reference samples tested at each quality control event by the quality control interval size; and
select the candidate rule having a lowest quality control utilization rate as the quality
control strategy,
wherein the selected candidate rule uses a minimal number of quality control tests while meeting the performance target.12. A system for testing patient samples, comprising:
a testing apparatus comprising an analyte measurement module configured to measure analyte responses to patient samples and reference samples,
wherein the patient samples and reference samples are measured according to a quality control strategy determined according to the method of any one of claims 1 to 9.THE ALLOWABILITY OF THE AMENDMENTS
I have considered the proposed amendments filed on 9 November 2017 along with the applicant’s written submissions for the hearing and I am satisfied that they are allowable under the requirements of s102 of the Act.
THE LAW ON MANNER OF MANUFACTURE
Section 18 of the Patents Act 1990 provides that:
(1) Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; ...
As to what constitutes a manner of manufacture within the meaning of section 6 of the Statute of Monopolies, the decision of the High Court in National Research Development Corporation v Commissioner of Patents [1959] HCA 67, (1959) 102 CLR 252 [NRDC], is considered authoritative in this regard. The invention being addressed in that decision involved a process for eradicating weeds from a stretch of land by means of a selective herbicide. The court stated:
“The point is that a process, to fall within the limits of patentability which the context of the Statute of Monopolies has supplied, must be one that offers some advantage which is material, in the sense that the process belongs to a useful art as distinct from a fine art... that its value to the country is in the field of economic endeavour”. (at p276)
“Notwithstanding the use of the word "making", which but for the context might have been taken to indicate the narrow view that an article or material must result if a process is to be a "manufacture", the tenor of the passage seems to be that what is meant by a "product" in relation to a process is only something in which the new and useful effect may be observed. Sufficient authority has been cited to show that the "something" need not be a "thing" in the sense of an article; it may be any physical phenomenon in which the effect, be it creation or merely alteration, may be observed: a building (for example), a tract or stratum of land, an explosion, an electrical oscillation. It is, we think, only by understanding the word "product" as covering every end produced, and treating the word "vendible" as pointing only to the requirement of utility in practical affairs, that the language of Morton J.'s "rule" may be accepted as wide enough to convey the broad idea which the long line of decisions on the subject has shown to be comprehended by the Statute”. (at p276)
“The effect produced by the appellant’s method exhibits the two essential qualities upon which ‘product’ and ‘vendible’ seem designed to insist. It is a ‘product’ because it consists in an artificially created state of affairs, discernible by observing over a period the growth of weeds and crops respectively on sown land on which the method has been put into practice. And the significance of the product is economic; for it provides a remarkable advantage ... for one of the most elemental activities by which man has served his material needs, the cultivation of the soil for the production of its fruits”. (at p276)
In Grant v Commissioner of Patents [2006] FCAFC 120 [Grant], the Full Federal Court summarised as follows, their Honours’ reasoning in NRDC for concluding that the invention in that case was for a manner of manufacture:
·“The concept was not limited to the idea of making tangible goods by hand or machine (the everyday meaning of ‘manufacture’); rather the question was ‘[i]s this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?’ (269).
·The unresolved question was whether it is enough that a process produces a ‘useful result’ or whether it is necessary that ‘some physical thing is either brought into existence or so affected as the better to serve man’s purposes’ (270).
·The ambit of s 6 cannot be stated by precisely defining ‘manufacture’ (271).
·A process, to fall within s 6, must belong to a ‘useful art as distinct from a fine art’ (275), it must have an ‘industrial or commercial or trading character’ (275 citing Re Lenard’s Application (1954) 71 RPC 190, at 192).
·A product, in relation to a process, is ‘only something in which the new and useful effect may be observed’; that ‘"something" need not be a "thing" in the sense of an article; it may be any physical phenomenon in which the effect, be it creation or merely alteration, may be observed’ (276).
·Morton J’s ‘rule’ (the High Court’s inverted commas) may be accepted as long as ‘product’ is taken to cover ‘every end produced’ and ‘vendible’ as ‘pointing only to the requirement of utility in practical affairs’ (276).
·In the instant case, the method had as its end result an ‘artificial effect’ and thus was within the true concept of what must be produced by a process if it is to be held patentable (277).
·The effect of the method is a ‘product’ because it consists in ‘an artificially created state of affairs’ (explained in the context of the growth of weeds and crops on sown land on which a method had been put into practice) (277).
·If there is nothing that can properly be called a ‘product’ of the process ‘even an ingenious new departure would be outside the limits of patentability” (278).
In International Business Machines Corporation v Commissioner of Patents [1991] FCA 625; (1991) 33 FCR 218 (IBM), Burchett J held that the application of a mathematical formula in a computer program to achieve the production of an improved curve image, was a manner of manufacture. His Honour also pointed out (at 158):
"(I)t is not enough to take a narrow and confined look at the "product" produced by a method. Of course, if a method is regarded purely as the conception of an idea, it can always be said that the product of such a method is merely intellectual information. If, however, in practice the method results in a new machine or process or an old machine giving a new and improved result, that fact should in our view be regarded as the "product" or the result of using the method, and cannot be disregarded in considering whether the method is patentable or not."
More recently in D’Arcy v Myriad Genetics Inc [2015] HCA 35 [Myriad], the High Court noted the concept of an ‘artificially created state of affairs of economic significance’ as used in NRDC was not a precise verbal formula that could be applied in all situations: At [20]:
“The terminology of an ‘artificially created state of affairs of economic significance’ is to be understood in the context in which it was used in NRDC. It was not intended as a formula exhaustive of the concept of manner of manufacture. The Court made that point emphatically:
‘To attempt to place upon the idea the fetters of an exact verbal formula could never have been sound.’”Further in Myriad, an emphasis on considering the substance of the claimed invention over the form of the claims is apparent. At [94]:
“Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture. The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation.”
and at [144]:
"Whatever words have been used, the matter must be looked at as one of substance and effect must be given to the true nature of the claim."[10]
[10] Myriad at [144].
In Commissioner of Patents v RPL Central Pty Ltd[11] (RPL) the Full Court of the Federal Court again emphasized the need to look at the substance of the claimed invention in the context of an invention that was in substance a scheme. It was stated at [96]:
"A claimed invention must be examined to ascertain whether it is in substance a scheme or plan or whether it can broadly be described as an improvement in computer technology. The basis for the analysis starts with the fact that a business method, or mere scheme, is not, per se, patentable. The fact that it is a scheme or business method does not exclude it from properly being the subject of letters patent, but it must be more than that. There must be more than an abstract idea; it must involve the creation of an artificial state of affairs where the computer is integral to the invention, rather than a mere tool in which the invention is performed. Where the claimed invention is to a computerised business method, the invention must lie in that computerisation. It is not a patentable invention simply to 'put' a business method 'into' a computer to implement the business method using the computer for its well- known and understood functions.
and at [98]:
“It is not a question of stating precise guidelines but of deciding, in each case, whether the claimed invention, as a matter of substance not form, is properly the subject of a patent”.
[11] [2015] FCAFC 177; 115 IPR 461.
In Research Affiliates LLC v Commissioner of Patents, [2014] FCAFC 150, the Full Federal Court noted that the consistent approach in the UK decisions can be of assistance in the Australian context.
“In our opinion, it is more helpful to consider the analysis of the issue in the UK decisions which, with respect, provide a consistent approach. Despite being in the context of the statutory exclusion of computer programs “as such”, the UK decisions are of assistance in understanding the distinction to be drawn in the Australian context between an unpatentable business method and a claimed invention which may be patentable if the invention results in an “artificial effect”, within the understanding of that concept as explained in NRDC. [23]
Their Honours also noted at [36] that the test of a ‘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 an analysis of an ‘artificial effect’.
Examiner’s Manner of Manufacture Objection
The examiner’s objection in relation to manner of manufacture in the fourth report reads as follows:
After careful consideration of the reply of 23rd August 2017, it is maintained that claims 1 – 24 still do not define a manner of manufacture under section 18 (1)(a) of the Patents Act 1990.
With regard to your response and reading the specification as a whole, the substance of the alleged invention is simply a quality controlling strategy (a scheme). This is even evidenced by your response where it is stated that “the material effect or substance of the present invention is not in the computerisation but resides in the selection of a candidate rule that minimises the costs associated with Quality Control events”. This further exemplifies that the substance is within a scheme.
In Aerotel Ltd v Telco Holdings Ltd; Macrossan’s Application, [2006] EWCA Civ 1371; [2007] RPC 7, a four-step “technical effect” approach is outlined in respect to the question of excluded subject matter under UK law. At [40]:-
“(1) properly construe the claim
(2) identify the actual contribution;
(3) ask whether it falls solely within the excluded subject matter;
(4) check whether the actual or alleged contribution is actually technical
in nature.”**which was also cited in Todd Martin [2017] APO 33, (7 July 2017) and the approach is equally applicable in this instance.
Furthermore, applicant's assertions that the substance of the current application is not in the computerisation is similar to the approach in the Bio-Rad Laboratories, Inc. [2017] APO 38. This approach was rejected by the hearing officer, see [32].
Further at [38]:-
“The hearing officer in that case went on to assess where the balance of considerations lay, and I have done similarly in the present matter. In doing so I have impliedly rejected the applicant’s contention at [56] of its submissions (quoted at [27], above) that “the invention also does not lie in the generation, presentation, or arrangement of intellectual information.” Clearly it does, and no matter how ingenious, economically advantageous or useful the invention is, it still comes up against this barrier that, on the cases, it does not qualify as being a manner of manufacture”.The above paragraph again refutes your assertion that "the material effect resides in the selection of a candidate rule that minimises the costs associated with QC events while still providing sufficient testing to meet performance targets".
The present invention only solves the problem of statistical confirmation of erroneous test samples. This is not a problem of technical nature (see Aerotel above). The substance of present invention is a method including an algorithm for determining and outputting a range of test result values determined from earlier samples to compare whether a test sample falls within the range of error threshold. This process is an algorithm, performed using a standard computer system and consequently cannot be considered a manner of manufacture.
Note: The claims only define non-specific computational or mathematical calculations that is alleged to produce the specific outcome described in the description. However the inclusion of the specifics of the actual optimisation process may lead to the possibility of overcoming the current objections”.
Applicant’s submissions and Considerations
The applicant submitted that the present invention is not to be judged by the principles in Research Affiliates and RPL as the material effect of the invention lies outside of the computer.
We submit that the Report erroneously focuses on the computational features of the invention rather than the substance of the invention. The Report ignores any material effect of the claimed method outside of the computer implementation despite, as discussed, there clearly being an economically important benefit that constitutes an artificially created state of affairs.
The assertion in RPL Central that “[w]here the claimed invention is to a computerised business method, the invention must lie in that computerisation” is not applicable to the present invention, as it assumes that the substance of the invention is inherently non-patentable. It is thus not necessary to separately consider any technical improvement to computing technology, as the present invention is not analogous to those in Research Affiliates and RPL Central—the material effect is outside of the compute. [40]
They further submitted as follows:
In view of our discussion above, we submit that it is clear that the Report mischaracterises the invention. The independent claims simply do not define any “statistical confirmation of erroneous test samples”. Additionally, there are no steps of “determining and outputting a range of test result values determined from earlier samples to compare whether a test sample falls within the range of error threshold”. We therefore submit that the basis for the objection in the
Report is in error.The applicant also submitted that the substance of the invention is not “simply a quality controlling strategy (a scheme)” as stated by the examiner but “is instead a method for determining an optimal strategy which minimises the use of reference samples while meeting required performance targets to thereby achieve a material effect by minimising the number of reference samples used”.
I agree that the examiner appears to have over-simplified or mischaracterised the substance of the invention. It is incorrect to label the invention merely as the examiner has indicated above or as a mere quality control scheme. I also agree with the applicant’s submission that the invention is a method of determining an optimal strategy that uses a minimal number of reference samples. As discussed earlier, figure 3 of the specification provides an overview of the optimization process including the different steps in the method of optimization. When one looks at what is involved in this optimization process, it is quite clear that the invention lies in computing a QC utilisation rate for different QC rules so that the QC rule with the lowest QC utilisation rate can then be chosen as the QC strategy as it is this QC rule that uses a minimal number of reference samples for testing while still meeting the chosen performance targets of maximum permissible final errors and maximum permissible correctible errors.
The High Court in NRDC identified the qualities of an ‘artificially created state of affairs’ and the ‘economic significance’ as essential for being considered a manner of manufacture. The present invention clearly has economic significance as it enables the use of lesser number of reference samples and lesser number of tests in order to meet certain testing performance targets clearly leading to savings in time and costs. So the question that remains is does it lead to an ‘artificially created state of affairs’ or as the Full Court put it slightly differently in Grant, does it lead to a “concrete, tangible, physical or observable effect”.
In NRDC the creation of a weed-free tract of land was considered to be an artificially created state of affairs that could be physically observed. In the present case, the performance of the method of the invention results in identifying a QC strategy that requires the least number of testing of reference samples in order to meet certain chosen performance targets. Unlike in claim 12, where there is actual testing involved in the method, claims 1 and 10 only identify which is the best QC rule to be used for testing. So in that sense, there is no directly observable artificially created state of affairs by carrying out the method of claim 1 or by using the system of claim 10. However when this 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, in my view, ‘artificial effects’. Furthermore the contribution of the claimed invention is clearly technical in nature as it has application in the technology of medical diagnostic devices and their testing. In my view this invention is not dissimilar to IBM in that it involves the application of certain mathematical formulae in the creation of a new process that finds application in a field of technology. It is also clearly not a mere business scheme or business innovation. In my view these are sufficient to satisfy the requirements of an ‘artificially created state of affairs’ under the principles enunciated in NRDC.
The claimed invention is a manner of manufacture.
Examiner’s Lack of Support Objection under subsection 40(3)
The Law in relation to subsection 40(3)
Subsection 40(3) requires that the claim(s) must be supported by matter disclosed in the specification. In the UK where similar provisions apply, this has been interpreted as requiring that there must be a basis in the description for each claim and the scope of the claims must not be broader than is justified by the extent of the description, drawings, sequence listing and the contribution to the art. As noted in Generics (UK) Ltd v H Lundbeck A/S [2009] RPC 13 at [36]:
“… the definitions in the claims [i.e. the claimed invention] should essentially correspond to the scope of the invention as disclosed in the description. In other words, … the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art.”
While this does not mean that the claims should be restricted to the specific embodiments described, the scope of the claims must be properly supported by the matter disclosed in the body of the specification.
The provisions of s40(3) were considered in detail by a delegate of the Commissioner in CSR Building Products Limited v United States Gypsum Company [2015] APO 72, who having reviewed several recent UK and EPO decisions and having regard to the guidance they provided, formulated the following test in order to determine whether a claim is supported by the description.
(i)Construe the claims to determine the scope of the invention as claimed,
(ii)Construe the description to determine the technical contribution to the art, and
(iii)Decide whether the claims are supported by the technical contribution to the art.
The Examiner’s Objection
The examiner’s objection in relation to lack of support in the fourth report reads as follows:
“The invention defined by the claims lacks support under subsection 40(3) because it omits features that ensure that the stated benefits of the described invention are achieved.
In particular, I make reference to your response where you discuss that there is a particular material advantage achieved by the present invention. While this maybe so, and the invention may serve to minimise the QC utilization rate while meeting performance targets, the claims are not so limited. It appears that the claims do not contain the features that enable the benefits that are described at for example [17], [19], [27], [72] and [73] of the specification.
The claims simply optimise quality control by performing a range of calculations and “selecting a candidate rule based on a predetermined criterion”. There is nothing in this methodology that ensures the minimization of QC samples while meeting any particular performance criteria. Thus the claims travel beyond the disclosure of the specification. This issue is a primary cause of the manner of manufacture issue also raised in this report. This objection is analogous to that raised by the delegate at [35] in Biorad (ref).
I also consider the claims lack support as they encompass possibilities which cannot be readily predetermined or assessed on the basis of what has been disclosed. In particular, the claims seek to compute, using the control limit, both a “correctable maximum” and a “final maximum”. The specification at items A and B discuss particularly precise mathematical calculations that are designed to make these calculations. These particular calculations appear to represent the contribution to the art, there being no clear principle of general application to extend over the whole scope of the claim”.
Applicant’s Submissions and Considerations
In relation to the examiner’s contention that the claims are not limited to minimising the QC utilization rate while meeting performance targets the applicant has submitted as follows:
The Report states that “[w]hile this may be so, and the invention may serve to minimise the QC utilization rate while meeting performance targets, the claims are not so limited”. Although it is arguable that the claims considered by the Examiner in preparing the Report did in fact adequately limit the scope of the invention to minimising the QC utilization rate while meeting performance targets, we have proposed an amendment to the independent claims to expressly incorporate this feature (see integer (1.5)).
I do not see the need to go into the merits of this objection of the examiner, as the amendments proposed by the applicant clearly define that the QC rule having the lower QC utilization rule is selected and thereby overcome any concerns raised by the examiner.
In relation to the examiner’s contention that the claims travel beyond the disclosure and encompass possibilities which cannot be readily determined the applicant has submitted as follows:
We submit that the Report is in error. The Application makes it clear at paragraphs 48-69 that different calculation techniques can be utilised in calculating the largest QC-interval (correctible max) that meets the predetermined threshold for correctible results requirement and calculating the largest QC-interval (final max) that meets the predetermined threshold for final results requirement.
We submit that the contribution to the art is not in the specific algorithms disclosed but, rather, in the teaching that an optimal number of patient samples to be tested between QC events (i.e. QC-interval) is equal to the smallest of the interval that meets the correctible results requirement and the interval that meets the final results requirement for a given number of reference samples tested during a QC event.
Paragraphs 48-69 of the description do disclose different calculation techniques that can be used in calculating the largest QC intervals. The question is whether the contribution to the art is a specific one of these calculation techniques as mentioned in the examiner’s objection or is it the broad teaching that an optimal number of patient samples to be tested between QC events (i.e. QC-interval) is equal to the smallest of the interval that meets the correctible results requirement and the interval that meets the final results. There is clearly nothing on the face of the specification itself or in the prior art identified in the examination reports that would suggest that the concept of calculating the correctible max and the final max and using these to arrive at an optimum QC strategy that uses the minimum number of reference samples is known. In my view this could be considered a principle of general application. I am therefore satisfied the contribution to the art is as submitted by the applicant. Furthermore the specification provides at least one method of performing it and also guidance as to some of the other calculation techniques that could be used, thereby providing an enabling disclosure. It follows that the independent claims do not extend beyond the contribution to the art.
The proposed amended claims are supported by the body of the specification.
CONCLUSION
I have found that the claimed invention, as proposed to be amended on 9 November 2017, is for a manner of manufacture and is also supported by the disclosure in the body of the specification. I therefore direct that the application should be accepted.
R Subbarayan
Delegate of the Commissioner of Patents
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