Bio-Rad Laboratories, Inc.
[2017] APO 38
•24 July 2017
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Bio-Rad Laboratories, Inc. [2017] APO 38
Patent Application: 2016200387
Title:System and method for producing statistically valid assay means and ranges for quality control materials
Patent Applicant: Bio-Rad Laboratories, Inc.
Delegate: Ed Knock
Decision Date: 24 July 2017
Hearing Date: Written submissions filed on 13 June 2017
Catchwords: PATENTS – Examiner’s objection – manner of manufacture – method of calculating assay mean and assay range for a quality control material lot - elements of conventional computer technology employed in method – substance of the invention lies in a mathematical algorithm – advance over prior art is to use historical data to calculate assay range – claimed invention is not a manner of manufacture and is not fully supported – opportunity to amend and file further submissions, upon filing of which the application to be remitted for further examination consideration
Representation: Patent attorney for the applicant: Griffith Hack
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2016200387
Title:System and method for producing statistically valid assay means and ranges for quality control materials
Patent Applicant: Bio-Rad Laboratories, Inc.
Date of Decision: 24 July 2017
DECISION
The invention as claimed in claims 1 to 19 is not a manner of manufacture.
However, as there appears to be a realistic possibility of amendment to the specification to overcome the deficiencies found by this decision, the applicant is allowed two (2) months to file amendments and any supporting submissions, which are to be dealt with under the normal patent examining procedures applying to responses to a patent examiner’s report.
REASONS FOR DECISION
Background
1. Patent application 2016200387 is a divisional application of parent application 2012236746 (now lapsed) by Bio-Rad Laboratories, Inc. (the applicant). Application 2012236746 originated as International Application PCT/US2012/030709 filed under the PCT on 27 March 2012. International publication of PCT/US2012/030709 occurred on 4 October 2012 and the application entered the national phase in Australia on 23 September 2013 as application 2012236746. The earliest priority date claimed for this family of applications is 29 March 2011.
2. The applicant requested examination of the parent application upon entry into the national phase on 23 September 2013, and a first adverse examination report was issued on 23 January 2015. The only objections raised in this report were that the invention defined by the claims was not in respect of a manner of manufacture within the meaning of section 18(1)(a) of the Patents Act 1990, and that the claims lacked novelty and an inventive step under sections 18(1)(b)(i) and (ii). This examination report was responded to by the applicant with some submissions and a first set of proposed amendments under section 104 of the Patents Act 1990 filed on 29 October 2015. Shortly thereafter a second adverse examination report was issued, whose only objection was to maintain the previous manner of manufacture objection. In response to this second report the applicant filed another response on 18 January 2016 which consisted of more submissions and a second set of proposed amendments to the description and claims. The examiner subsequently issued a third report on 20 January 2016 which continued to maintain a manner of manufacture objection in respect to the latest version of the claims.
3. On 22 January 2016 the present application, 2016200387, was filed as a divisional application of application 2012236746, whereupon the latter application lapsed the following day as a result of the failure to gain acceptance in the prescribed time of 12 months. The claims of this divisional application are the claims which had been proposed in the applicant’s first statement of proposed amendments in respect to the parent application. A first adverse examination report in relation to the divisional application 2016200387 was issued on 28 March 2017, essentially maintaining the manner of manufacture line of objections which had been raised against the parent application. No other objections were taken in the first report. The response of the applicant to this adverse report was to request, on 26 May 2017, to be heard in relation to this matter. The applicant was heard by means of written submissions which were subsequently filed on 13 June 2017.
The specification
4. The present invention has particular application in the field of medical testing, such as measuring various aspects of blood chemistry, for instance, cholesterol or blood sugar levels, and testing for drugs in blood or urine. According to the specification, these days such tests can be performed at rates up to thousands per hour. The specification continues:
“In a typical test, a sample such as a quantity of a patient’s blood is reacted with a reagent, and the resulting product studied to determine the presence or amount of a particular analyte in the sample. The reagent may be specifically designed for the performance of the particular test.
Because important medical decisions may be made on the basis of the test results, it is highly desirable that the testing machines be qualified periodically to maintain confidence that the machines are operating properly, or to try to detect when the machines are not operating properly. In fact, U.S. government regulations require such periodic validation. By regulation, each testing machine must be qualified at least once per day for any day that patient testing is performed.
Qualification may involve testing a sample having known characteristics, and checking whether the machine produces a test result that agrees with the known characteristics. If so, the machine may be assumed to be operating properly, and if not, the operation of the machine may be suspect.”
5. This “qualification” procedure thus requires a testing sample (also referred to as “quality control material”) to have known characteristics. The specification further indicates that “very large” numbers of these quality control materials are required to meet the demand for them. They are made in “lots” which are tested at their time of manufacture. This testing is referred to in the specification by the expression “characterizing.” Determining the characteristics of a particular lot for any given parameter requires that some samples of material from the lot be themselves subjected to testing by a testing instrument which, in the words of the specification, is “operating properly,” with the purpose of arriving at a mean value and a statistical variability for the lot as a whole. The mean values and variabilities are known as “assay means and ranges.” All of this is, I gather from the specification, known in the prior art.
6. As to be expected, and as pointed out by the specification, statistical uncertainties arise in relation to the measured values obtained from testing, among which are ones that give rise to the so-called “variabilities.” The description exemplifies several statistical uncertainties:
· a “standard error of the mean,” arising from using sampling to determine the mean
· “within-instrument” variability, which is the situation of repeated tests on a single machine giving different results
· “between-instrument” variability, which is the situation of machines of the same type giving different results
· “between-laboratory” variability, which is the situation of different laboratories giving different results for the same machine.
7. The specification provides mathematical formulæ for calculating these uncertainties. These formulæ are well known in the field of statistics. The “variabilities” are simply derived from the standard deviations of the particular data sets used. The description outlines various mathematical techniques, such as regression analysis, to perform correlations and adjustments to the data to further refine the variability outcome. The ultimate specification of the assay range will have a probability associated with it dependent on the number of standard deviations either side of the mean it is desired that the assay range should encompass.
8. Testing for a mean value, it would appear from the description, can be achieved with an amount of characterizing tests which is tolerable from a costs point of view. However, this appears not to be the case where variability is concerned. To overcome this problem, the invention proposes that the large number of events required to arrive at statistically useful results for variability for a sample of a new lot of quality control material be obtained by accessing “historical results” - that is, results obtained from qualification testing on prior lots of quality control material - and calculating a variability estimate that is an estimate of the variability of the historical test results. In other words, historic test results are to be extrapolated to the new quality control material. According to the description, such historical results are routinely accumulated in a database by the quality control material manufacturer, although none is explicitly identified in the description. In order to correct for inaccuracies resulting from the use of historical data, the description identifies several mathematical computations that may be carried to enhance the values of the assay means and ranges which are obtained.
9. The specification concludes with nineteen claims of which three (1, 13 and 15) are independent. The independent claims read as follows:
“1. A method of establishing a statistically valid assay mean and assay range for a particular lot of a quality control material, the method comprising:
testing, on a medical testing machine, a number of samples from the particular lot of the quality control material;
computing a mean of the test results;
accessing, from a computer storage device, a database of historical test results obtained from tests performed on prior lots of the quality control material;
computing, using a computer system specially programmed to do so, at least in part from the historical test results a variability estimate that is an estimate of the variability of test results obtained from tests performed on at least one prior lot of the quality control material;
specifying a target probability with which a new qualification test result performed on a sample of the new lot of quality control material will fall within the assay range; and
computing, using the specially-programmed computer system, based at least in part on the mean and the variability estimate, a range of test result values within which a result from a qualification test of a sample from the particular lot of the quality control material is expected to fall, with the target probability.”
“13. A system for establishing a statistically valid assay mean and assay range for a particular lot of a quality control material, the system comprising:
a medical testing machine on which a number of samples from the particular lot of the quality control material are tested, to produce a number of test results;
a processor;
a database holding historical test results obtained from tests performed on prior lots of the quality control material; and
a memory readable by the processor, the memory holding processor instructions that when executed by the processor cause the system to
receive the number of test results from the medical testing machine;
compute a mean of the test results;
access the database of historical test results obtained from tests performed on prior lots of the quality control material;
compute at least in part from the historical test results a variability estimate that is an estimate of the variability of test results obtained from tests performed on at least one prior lot of the quality control material;
receive a specification of a target probability with which a new qualification test result performed on a sample of the new lot of quality control material will fall within the assay range; and
compute, based at least in part on the mean and the variability estimate, a range of test result values within which a result from a qualification test of a sample from the particular lot of the quality control material is expected to fall, with the target probability.”
“15. An assay mean and range assignment system for establishing a statistically
valid assay mean and assay range for a particular lot of a quality control material, the system comprising:
a medical testing machine on which a number of samples from a new lot of the quality control material are tested, to produce a number of test results;
a database holding historical test results obtained from tests performed on prior lots of a quality control material;
a mean determination module that receives the number of test results obtained from tests on the new lot of the quality control material and computes a mean of the test results;
a variability estimation module that computes at least in part from the historical test results a variability estimate that is an estimate of the variability of test results obtained from tests performed on at least one prior lot of the quality control material; and
a range establishment module that establishes, based at least in part on the mean and the variability estimate, a range of test result values within which a result from a qualification test of a sample from the new lot of the quality control material is expected to fall, with a target probability.”
Applicable Law
10. The statute applying to this matter is the Patents Act 1990 as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012. Of particular note in this regard is that subsection 49(1) requires that in order to accept a patent request the Commissioner be satisfied on the balance of probabilities that the requirements of the Act specified therein are met. These requirements include relevant provisions of section 40 and section 18, and more specifically for the purposes of this decision, paragraph (a) of subsection (1) of section 18.
11. 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; …
12. 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. At page 275 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”.
13. In similar vein, when discussing the “vendible product” proposition put forward by Morton J in Re G.E.C’s Application (1942) 60 RPC 1, the High Court in NRDC upheld the validity of a patent for the use of previously unknown properties of a known chemical to effect a new purpose. At page 277 it said:
“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.”
However in D’Arcy v Myriad Genetics Inc [2015] HCA 35 [Myriad], the High Court noted the difficulty in that specific case, related to the patentability of an isolated nucleic acid coding for a mutant or polymorphic polypeptide, of engaging with the criterion of “an artificially created state of affairs”. 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.”
In Grant v Commissioner of Patents [2006] FCAFC 120 [Grant], the Full Court of the Federal Court affirmed at [14] that business, commercial and financial schemes as such have never been considered patentable. Moreover at [16], the court stated as follows:
“Patents have also been refused for methods of calculation, theoretical schemes, including business schemes and abstract plans, such as:
· systems for arrangement of known things, such as a plan relating to the layout of houses in a row or terrace so as to prevent overlooking (Re ESP’s Application (1944) 62 RPC 87);
· an arrangement of buoys for navigational purposes (Re W’s Application (1914) 31 RPC 141);
· a system of business even though its implementation involved the use of a printed envelope with a particular arrangement of words (Re Johnson’s Application for a Patent (1901) 19 RPC 56 at 56); and
· a method of preventing the fraudulent re-use of sales book dockets and books used in that connection (Re Brown (1899) 5 ALR 81).”
It went on to say at [47] that it has long been accepted that “intellectual information”, a mathematical algorithm, mere working directions and a scheme without effect are not patentable.
The court in Grant found that a method of protecting an asset including steps of establishing a trust, making a gift to the trust, making a loan from the trust and securing the loan was not a manner of manufacture. The court observed at [26] that:
“The fact that a method may be called a business method does not prevent it being properly the subject of letters patent; see Catuity [Welcome Real-time SA v Catuity Inc [2001] FCA 445] at [125]–[126]”
but went on to find at [30] that Mr Grant’s method:
“does not produce any artificial state of affairs, in the sense of a concrete, tangible, physical, or observable effect.”
Two other recent decisions of the courts on manner of manufacture are those of the Full Court of the Federal Court on the patentability of computer-enabled business method inventions in Commissioner of Patents v RPL Central Pty Ltd (2015) 328 ALR 458; (2015) 115 IPR 461 [RPL Central] and Research Affiliates LLC v Commissioner of Patents (2014) 227 FCR 378 [Research Affiliates]. Relevant considerations for patentability of such inventions distilled from those decisions were surveyed in Aristocrat Technologies Australia Pty Limited [2016] APO 49 [Aristocrat]. The delegate of the Commissioner in that case stated at [35]:
“I conclude that it is relevant to consider a range of matters. Without seeking to be exhaustive, these include:
·there must be more than an abstract idea, mere scheme or mere intellectual information;
·is the contribution of the claimed invention technical in nature;
·does the invention solve a technical problem within the computer or outside the computer;
·does the invention result in improvement in the functioning of the computer, irrespective of the data being processed;
·does the application of the method produce a practical and useful result;
·can it be broadly described as an improvement in computer technology;
·does the method merely require generic computer implementation;
·is the computer merely an intermediary or tool for performing the method while adding nothing of substance to the idea;
·is there ingenuity in the way in which the computer is utilised;
·does the invention involve steps that are foreign to the normal use of computers; and
·does the invention lie in the generation, presentation or arrangement of intellectual information.”
In Research Affiliates the Full Court indicated the proper pathway to be taken in matters such as these. It stated:
“115. The High Court (in NRDC at 277) spoke in terms of a separate result achieved by the claimed method that has its own economic utility consisting in the improvement. By this reasoning, the High Court directed attention to the subject matter to which the claimed method was directed, which needed to exhibit the required characteristics of a manner of manufacture to be patentable. Here, that subject matter is truly the scheme, the idea, the index. As set out in the specification it may be, and in the claimed method it is, implemented in a computer, but the ingenuity of the inventors, the end result of which is the invention, is directed to the idea, which is not patentable. That method does not have an artificial effect falling squarely within the true concept of what must be produced by a process if it is to be held patentable (NRDC at 277).
116. The approach to be taken to deciding whether a claimed method or product is
properly the subject of letters patent must be flexible and must allow for new technologies presently unknown. The principles should be applied irrespective of the area of human endeavour and invention under consideration. However, that is not to say that any and every claimed method or process is properly the subject of a patent. Examples of exceptions have been identified, such as abstract ideas and mere schemes. There is no formula to be mechanically applied. It is a question of understanding what has been the work of, the output of, and the result of, human ingenuity, and to apply the principles that have been developed and explained so well in NRDC.117. In the context of the claim, the significance lies in the content of the data rather than any specific effect generated by the computer. The computer-implementation is an essential integer of the claimed process. That is, of course, important. It is of particular importance in the assessment of, for example, novelty and infringement. However, in examining whether a claimed invention is properly the subject of letters patent, it is necessary to look not only at the integers of that claimed invention but also at the substance of that invention.
118. The claimed method in this case clearly involves what may well be an inventive idea, but it is an abstract idea. The specification makes it apparent that any inventive step arises in the creation of the index as information and as a scheme. There is no suggestion in the specification or the claims that any part of the inventive step lies in the computer implementation. Rather, it is apparent that the scheme is merely implemented in a computer and a standard computer at that. It is no part of the claimed method that there is an improvement in what might broadly be called ‘computer technology.’”
Finally, in the most recent decision in this area the Full Court of the Federal Court considered a computer implemented method and system for automatic collection of evidence of skills and knowledge in RPL Central (supra), and concluded that the claimed invention was to a scheme or a business method that was not properly the subject of letter patents. In its decision the Full Court made several observations pertinent to the present matter. It was observed 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.”
And further:
“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.”
Examiner’s objection
21. As stated at [3], above, the present claims are identical to the amended claims which were filed in respect of the first examination report on the parent application 2012236746 of the present divisional application. The resultant second adverse report directed to those amended claims comprises a single objection which reads as follows (emphases in the original text):
‘“Objection 1 of the previous report is maintained. Claims 1-19 are considered not to be a manner of manufacture because they do not result in a material effect or advantage such that they can be considered patentable subject matter within the principles expressed by the High Court in NRDC [1959] HCA 67.
Your comments submitted in your reply have been given careful consideration, but are found not to be persuasive.
In your submission, at page 1, you have stated that "Accordingly, it should be appreciated that in the context of the patent specification, each of the tests on a medical testing machine results in chemical changed in order to measure a property of the quality control material to obtain a test result. At least this step of the method results in a ‘material effect’ in the chemical changes involved in the testing".
However, I consider the employment of the computer as claimed is still considered to be characterised solely by the information (data) processed. The material advantage as claimed does not bring about an improvement in what might broadly be called "computer technology". There is, for example, no new or surprising effect in using the computer.
The recent decision of the Full Court in Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150, at para 100, the Full Federal Court found that “the distinction between a mere “modern and efficient tool by which to perform the method of the claimed invention (being a method of performing an aspect of a business)” which could be performed without use of a computer and would not be patentable, and an invention where “the method as ‘tied to a machine’ and which would be patentable, such as in IBM 2, CCOM and Catuity.”
In the Full Court decision of Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150, the alleged invention of an abstract idea was also required to be programmed in a particular way to carry out in the computer. However as mentioned in the Full Court decision, the mere use of the computer to carry out an abstract idea is not patentable.
As was the case in the Research Affiliates decision, the present alleged invention uses a standard computer system to carry out the abstract idea of testing various samples and determining the range result within which the result would fall with the target probability. Therefore, the substance of your application is just comparing the test results and determining the range within which the results of the test would fall. From reading your specification as a whole it is clear that this is merely implemented by using standard computer system i.e. the computer operates in the normal or expected way. Moreover, there is no part of the claimed method/system which results in improvement in what might broadly be called “computer technology. Merely implementing a non-patentable scheme into a computer does not make the application patentable. The computer is merely used for storing and comparing purposes.
See the para [117] of the Research Affiliates decision, which stated that “In the
context of the claim, the significance lies in the content of the data rather than any specific effect generated by the computer. The computer-implementation is an essential integer of the claimed process. That is, of course, important. It is of particular importance in the assessment of, for example, novelty and infringement. However, in examining whether a claimed invention is properly the subject of letters patent, it is necessary to look not only at the integers of that claimed invention but also at the substance of that invention.”And at paragraph [118]: “The claimed method in this case clearly involves what may well be an inventive idea, but it is an abstract idea. The specification makes it apparent that any inventive step arises in the creation of the index as information and as a scheme. There is no suggestion in the specification or the claims that any part of the inventive step lies in the computer implementation.
Rather, it is apparent that the scheme is merely implemented in a computer and a standard computer at that. It is no part of the claimed method that there is an improvement in what might broadly be called “computer technology.”
Therefore, the application is not for a manner of manufacture”’
22. The first report of the present application likewise consists of, as already noted at [3], above, just a single manner of manufacture objection. This examination was performed by a different examiner to that of the parent. He stated (emphases in the text):
“Claims 1-19 do not define a manner of manufacture within the meaning of Section 18(1)(a) of the Patents Act 1990. From reading your application as a whole the substance of the alleged invention is a scheme for statically [sic statistically] validating assay mean and assay range for a particular lot of a quality control material based on historical data.
Key factors to considering patentable subject matter identified by the Full Court in Commissioner of Patents v RPL Central Pty Ltd [2015] FCAFC 177 at [099] include whether the contribution of the invention ‘solves a technical problem within the computer or outside the computer or whether it results in an improvement in the functioning of the computer, irrespective of the data being processed.’
The present invention solves the problem of statistical validation of published assay means and ranges for quality control materials. This is not a problem of technical nature.
Given the generic description of the computer implementation in your application, I do not consider that your application involves more than a generic utilisation of well-known functions of a computer, including the particular arrangement/combination of functions, and therefore does not involve any invention or ingenuity in any program or operation of a computer, or implementation by a computer to operate the method. Consequently, as per Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150 and Commissioner of Patents v RPL Central Pty Ltd [2015] FCAFC 177 the alleged invention is not a manner of manufacture.
Further reference is also made to the detailed arguments presented in this regard in Examiner Reports dated 11 November 2015 (relating to same claims as your present application) and 20 January 2016 (relating to somewhat narrower claims) issued on parent application 2012236746.”
Applicant’s submissions
23. The applicant stated at the outset that it would direct its submissions to claim 1, and that the arguments presented in respect to claim 1 applied equally to the remaining claims of the application.
24. The applicant submitted that the examiner’s report on the present application (see [22], above) asserted that the substance of the claimed invention is nothing more than a mere scheme, and that the implementation of the scheme on a computer is insufficient to confer patentability. The applicant disagreed with this position. It noted firstly, and correctly, that the information which the invention extracts from the data – a mean and range - “is grounded in the context of a real-world need to be able to rely on medical tests.” It further noted, also correctly, that the problem solved by the invention lay in reducing the amount of data required to be gathered, and thus the number of samples needing to be “characterised,” to ensure the statistically validity of mean and range figures extracted from the data.
25. The applicant also disagreed with the report’s identification of the substance of the invention as being a scheme for “statistically validating assay mean and assay range for a particular lot of a quality control material based on historical data.” I agree with the applicant on this: as the applicant states, the invention is about generating means and ranges which are statistically valid.
26. In relation to the second report issued in respect of the parent application (see [21], above), the applicant disputes the examiner’s assessment that the substance of the invention lies in “comparing the test results and determining the range within which the results of the test would fall.” The applicant goes on to say that “It is in fact difficult to know exactly what is intended by this statement.” Once again, I think that there is some force to the applicant’s criticism in this regard. I surmise that “test results” refers to individual test results, and the “comparing” refers to the statistical analysis of a set of test results which is at the heart of the present invention, but I accept that this may not really be conveyed by the wording adopted in the report.
27. The applicant presented an outline of the case-law applying to manner of manufacture issues in regard to inventions of the present genre, and stated:
“48. The key point made by the Full Court in RPL Central cited above is that implementing a ‘business method’ (being ‘not, per se, patentable’) within a computer being used for its ‘well-known and understood functions’ is insufficient to confer patentability. However, this reasoning begins with the assumption that the ‘non-computer’ components of the claimed invention are inherently non-patentable for not meeting the traditional requirements for a manner of manufacture. This is not the case in the present invention…
52. The significance of the invention corresponds to a ‘remarkable advantage’. A result, in the sense of ‘statistically valid means and ranges for new quality control material lot,’ is obtained with much reduced effort, cost, time, and resource consumption. These are ‘physical phenomen[a] in which the effect…may be observed’…
54. 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…
56. We submit, in view of our submissions herein, that when considering the factors set out in Aristocrat, there is clearly more than an abstract idea, mere scheme or mere intellectual information. Additionally, the contribution of the claimed invention is technical in nature and solves a technical problem outside the computer implementation. The application of the method produces, as detailed herein, a practical and useful result. The invention also does not lie in the generation, presentation, or arrangement of intellectual information.”
Consideration
28. For the purposes of considering whether the invention defined by the claims of the present application is directed to a manner of manufacture, I will follow the approach taken by the applicant and focus my consideration of this matter on claim 1. Then I think it is clear from Research Affiliates (supra) and RPL Central (supra), which both employed similar claiming schemes to the present application, that the fates of claims 2 to 19 will be tied to whatever fate befalls claim 1.
29. The law on manner of manufacture as it currently stands is encapsulated by this passage from RPL Central:
“It is not a question of stating precise guidelines [for what does or does not constitute a manner of manufacture] but of deciding, in each case, whether the claimed invention, as a matter of substance not form, is properly the subject of a patent.”
and this from Research Affiliates:
“However, in examining whether a claimed invention is properly the subject of letters patent, it is necessary to look not only at the integers of that claimed invention but also at the substance of that invention.”
30. In my view, the substance of the presently claimed invention - as that notion is to be understood from Research Affiliates and RPL Central - is a mathematical algorithm for, firstly, calculating an assay mean of test result values for a number of samples of a lot of quality control material, and, secondly, for calculating an assay range for this lot of quality control material. An element of this algorithm is the exploitation of historical test results to predictively calculate, with a specified target probability, a range of test result values within which a result from a qualification test of a sample from the particular lot of the quality control material is expected to fall.
31. Claim 1 also defines other subject matter which is only peripheral to the inventive algorithm. This additional subject matter relates to features which, while they assist in enabling the implementation of the algorithm at the core of the invention, clearly have a role which, from the reading of the specification, is subordinate to the algorithm in the overall inventive concept, and in accordance with Research Affiliates (supra) and RPL Central (supra) are conceptually disassociated from the substance of the invention. This other subject matter is:
· Using conventional computational means to compute the assay mean and the assay range by application of the algorithm defined by claim 1; and
· Generating test result data by:
(i) Testing a number of samples of a quality control material lot on a medical testing machine; and
(ii) Accessing, from a computer storage device, a database of historical test results obtained from tests performed on prior lots of the quality control material.
32. Dealing firstly with the computational aspects of claim 1, I observe that the applicant opted not to rely on these in arguing that its invention was a manner of manufacture. However it took this approach on the basis that “once the substance of the invention is correctly identified, it is no longer necessary to consider any technical improvement in computing technology.” While this does not quite concede that there is no such technical improvement, I have nonetheless reached the conclusion that this is, in fact, the case. The computational steps broadly defined by the claim (computing a mean of test results, computing a variability estimate from historical test results and computing a range of test result values within a specified probability) do not appear, if recourse is had to the preferred embodiment, to involve any more than straightforward mathematical operations. Indeed, these steps bear a strong resemblance to the computational embellishments at issue in Grant (supra), Research Affiliates (supra) and RPL Central (supra). Furthermore, the tenor of the present description itself is that there is nothing to the computational characteristics of the described invention, as evidenced by the use of the expression “may” to refer to every item of computer hardware and software employed in an “exemplary computer system 500 in which embodiments of the present invention may be implemented.” In the terms of Aristocrat (supra), the computer is merely an intermediary or tool for performing the method while adding nothing of substance to the idea.
33. As regards the obtaining of test result data, both of the techniques (i) and (ii) (that is, of testing and accessing) referred to at [31], above, are standard techniques for obtaining test result data where it is desired to analyse test result data of a specified type. In the present case that specified type happens to be medical quality control material. The need to acquire such data is a logical consequence of the purpose of carrying out an analysis of that particular variety of data in accordance with the algorithm referred to at [30], above.
34. According to the applicant, the mathematical algorithm of the invention bestows a “remarkable advantage,” in that certain desired statistical values, namely assay means and assay ranges, may be calculated with much reduced effort, cost, time, and resource consumption. In referring to a “remarkable advantage” the applicant is alluding to the use of that expression in NRDC (supra). Although I have a slight sense that there might be a little overstatement here, I am prepared to accept the correctness of that assertion, and agree that as a consequence of reduced effort, cost, time, and resource consumption the present invention is potentially economically beneficial. This is even though it seems likely that the statistical “short cut” involved in using historical data could be a cause of inaccuracy.
35. The applicant then goes on to assert that “reduced effort, cost, time and resource consumption” are “physical phenomena in which the effect … may be observed” - once again employing phraseology from NRDC. And once again, I agree with this assertion, or at least its broad thrust. In any given circumstance one would expect these physical phenomena to manifest themselves in proportion to the extent to which one avails oneself of historical test results. However, the claim suffers from vagueness in this regard, allowing a variability estimate to be obtained from historical test results in full or in part. As a result, I am not satisfied that the described effect is necessarily produced by the claim. The claim, in its breadth, appears not to be limited to less measurements being made for determination of variability. Such an issue also appears to create a section 40 issue in that the claims do not appear fully supported by the disclosure of the specification. In this regard the specification only discusses determination of variability in totality from historical data. No measurements are made for the purpose of working out variability beyond those taken to calculate the mean.
36. In respect to physical effect, the court in Grant (supra) at [32] stated:
“32 A physical effect in the sense of a concrete effect or phenomenon or manifestation or transformation is required. In NRDC, an artificial effect was physically created on the land. In Catuity and CCOM as in State Street and AT&T, there was a component that was physically affected or a change in state or information in a part of a machine. These can all be regarded as physical effects. By contrast, the alleged invention is a mere scheme, an abstract idea, mere intellectual information, which has never been held to be patentable, despite the existence of such schemes over many years of the development of the principles that apply to manner of manufacture. There is no physical consequence at all.”
Grant concluded by saying, at [47]:
“It has long been accepted that ‘intellectual information’, a mathematical algorithm, mere working directions and a scheme without effect are not patentable. This claim is ‘intellectual information,’ mere working directions and a scheme. It is necessary that there be some ‘useful product’, some physical phenomenon or effect resulting from the working of a method for it to be properly the subject of letters patent. That is missing in this case.”
In my view a similar assessment holds in regard to the present application. This is notwithstanding the likelihood that the inventors have used considerable ingenuity in devising their algorithm, which is based upon the idea of using historical data for a portion of its calculations.
36. The decisions in Research Affiliates (supra) and RPL Central (supra) are, as the applicant has observed at [48] of its submissions (quoted at [27], above), of only limited help for the purposes of determining the present matter. Both cases involved mere schemes which were found by the courts to only amount to abstract ideas which were not patentable subject matter. The focus of each decision was whether the various computational steps that were defined by the claims, and that served to implement the schemes, were sufficient to elevate the resultant method claims to being a manner of manufacture. In light of the applicant in the present matter having eschewed availing itself of that line of argument (appropriately, in my view), there seems little need to address further the findings in Research Affiliates and RPL Central, beyond that which I have already done.
37. However, I note that at [56] of its submissions (quoted at [27], above) the applicant has briefly made reference to a few of the “range of matters” set down in Aristocrat and detailed in [18], above. These matters have, as remarked in [18], been sourced from Research Affiliates and RPL Central. In Todd Martin [2017] APO 33 at [47], the hearing officer made the following comments regarding the “range of matters” set down in Aristocrat:
“47. With this list of points, the delegate in the Aristocrat case was not intending to indicate a list of conditions, for computer-implemented cases, to be met to define a manner of manufacture. That is evident from the delegate’s statement that the list was not intended to be exhaustive. Moreover, it would appear improper to find there was a manner of manufacture simply on the basis that one or more points could be answered in favour. In the present case for example, it may be that at least the fifth dot-point, regarding whether the application of the method produces a practical and useful result, is satisfied. On the other hand, that consideration on its own would be insufficient in the present case. Conversely it would also appear improper to find there was no manner of manufacture simply on the basis that one or more points could not be answered favourably. Rather than these points being seen as conditions to be met, they should be seen as relevant matters to consider, as the delegate stated at [35]. The substance and contribution of the claimed invention in each case should be considered on its merits overall and various points under the law would appear to have varying degrees of relevance depending on the case.”
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.
Conclusion
39. I find that the claims of this application for a patent are not directed to a manner of manufacture. However, I am not convinced that the problem is not a definitional one (such as has been referred to at [35], above), which might be satisfactorily addressed by appropriate amendment. Therefore I will provide a period of two (2) months from the date of this decision to file amendments and any supporting submissions. In addition, noting my comments in [35], above, in relation to section 40, it would appear advisable that the applicant’s amendments/submissions address the issue of full support. In the event that such amendments and/or submissions are filed, the response will be dealt with in the normal manner of such responses to an examiner’s report.
Ed Knock
Delegate of the Commissioner of Patents
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