Bio-Rad Laboratories, Inc. - [2019] APO 26

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Bio-Rad Laboratories, Inc. [2019] APO 26

Patent Application: 2017203982

Title:System and Method for Producing Statistically Valid Assay Means and Ranges for Quality Control Materials

Patent Applicant:                   Bio-Rad Laboratories, Inc.
Delegate:  M. G. Kraefft
Decision Date:  7 June 2019
Hearing Date:  14 March 2019, in Melbourne; further submissions filed 23 May 2019.

Catchwords: PATENTS – section 45 – examiner’s objection – whether invention is a manner of manufacture – establishing statistically valid assay mean and assay range for quality control material lot – computation of variability estimate – based on historical test results – whether there is physically observable effect of less test sampling required if variability estimate computed from other aspects beyond historical test results – test results from current test sampling not used for variability estimate – claimed invention is a manner of manufacture – whether claims supported by matter disclosed – compliance with section 40 – application to be accepted.

Representation: Patent attorneys for the applicant: Mr Jeremy Robinson and Mr Nick Mountford, Griffith Hack.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2017203982

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: 7 June 2019
DECISION
The claimed invention, as proposed to be amended, is for a manner of manufacture and also complies with section 40.
I direct that the application be accepted.
REASONS FOR DECISION
BACKGROUND

Bio-Rad Laboratories, Inc. (“the applicant”) filed patent application 2017203982 (“the current application”) on 13 June 2017. The application is a divisional application based on application 2016200387 (“the parent application”). The parent application in turn is a divisional application based on application 2012236746. The latter application is based on a US application filed 29 March 2011 (“the priority date”).
The parent application was the subject of a decision, Bio-Rad Laboratories, Inc., [2017] APO 38 (“the first decision”), in respect to an examiner’s objection being maintained on the ground that the invention defined by the claims was not in respect of a manner of manufacture. In that decision, the delegate found that the claims of the parent application were not directed to a manner of manufacture. On the other hand, the delegate was not convinced that the problem was not a definitional one and therefore allowed the applicant an opportunity to amend the specification. After amendment and further examination reports, the parent application was accepted and proceeded to grant.
The current application was the subject of an examination report dated 27 June 2018. In that report, the examiner maintained an objection from the first report on the parent application noting that the claims of the current application were identical to the ones that formed the basis of the parent application’s report. The examiner therefore concluded that claims 1-19 of the current application did not define a manner of manufacture. The examiner further referred to the above-mentioned first decision in support.
The applicant subsequently requested to be heard. Together with filing written submissions prior to the hearing, the applicant also filed a statement of proposed amendments to the description and claims of the specification.
Following the hearing, a further issue relating to Section 40 of the Patents Act 1990 was identified. At the invitation of the Patent Office, the applicant filed further submissions addressing that issue.
SPECIFICATION
The alleged invention has application in the field of automated testing machines. More specifically, the field of application relates to such machines for conducting tests such as measuring a patient’s cholesterol levels or blood sugar levels, testing for the presence of drugs in a subject’s blood or urine, or measuring other aspects of a patient’s blood chemistry.
The specification mentions the desirability that the testing machines be qualified periodically to maintain confidence that the machines are operating properly. Paragraphs [4] to [8] of the first decision, with reference to the specification, provide further background in respect to the qualification processes. These processes involve sampling machine-testing samples, also called quality control materials, against known characteristics, and computing statistically valid means and ranges for particular sampled lots such that confidence levels of proper machine operation are within specified tolerances.
The specification, as proposed to be amended, concludes with 19 claims. Claims 1, 13 and 15 are independent claims. These claims may be found at Annex A at the end of this decision.
It may be noted that these claims are identical to proposed claims filed in respect to the parent application following the issuing of the first decision. A subsequent further examination report in that case, maintaining the objection of a lack of a manner of manufacture, resulted in the applicant further proposing amendments which led to acceptance of the parent application. By re-introducing the former proposed claims for the parent application into the specification of the current application, the applicant is essentially suggesting that the former proposed claims should have been accepted. In essence then, while the present matter arises from the sole examination report on the current application, which report refers to the reports on the parent application, it is the third examination report on the parent application which is of direct relevance to the current specification, as proposed to be amended.
APPLICABLE LAW
The 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”). Amendments to Sections 7, 40 and 49 of the Act apply to the present case as a consequence of Schedule 1, items 55(1)(d) and 55(4)(a), and Schedule 6, item 133(7)(d), of the Raising the Bar Act. The application was filed after 15 April 2013.
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; and …
Some conjecture also occurred in this case in respect to compliance with section 40. Relevant to this case, sub-section 40(3) provides that:-
(3)The claim or claims must be clear and succinct and supported by matter disclosed in the specification.
The standard of proof that applies is the balance of probabilities (subsection 49(1)). I must accept the 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.
CASE LAW
In National Research Development Corporation v Commissioner of Patents (“NRDC”), [1959] HCA 67, (1959) 102 CLR 252, the High Court provided a statement of the law in regard to manner of manufacture. At page 275, “… 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 page 276, the High Court further observed that what is meant by a “product” in relation to a process is only something in which a new and useful effect may be observed. More specifically:-
“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”.
In 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:-
“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.”
The High Court though was not laying down a precise formulation that can be applied unthinkingly. In D’Arcy v Myriad Genetics Inc (“Myriad”), [2015] HCA 35, at [23]:-
“This Court in NRDC did not prescribe a well-defined pathway for the development of the concept of ‘manner of manufacture’ in its application to unimagined technologies with unimagined characteristics and implications. Rather, it authorised a case-by-case methodology.”
That case-by-case approach must have regard to the substance of the claimed invention, not simply the form of the claim. The point was made succinctly in the Myriad case by Gageler and Nettle JJ. 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.”
In Commissioner of Patents v RPL Central Pty Ltd (“RPL”), [2015] FCAFC 177, the Full Court of the Federal Court stated the same thing in the context of an invention that was in substance a scheme. 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.”
Moreover 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”.
In Grant v Commissioner of Patents, [2006] FCAFC 120, the Full Court of the Federal Court ruled out some fields of endeavour in a generic sense. At [47]:-
“It has long been accepted that ‘intellectual information’, a mathematical algorithm, mere working directions and a scheme without effect are not patentable.”
THE FIRST DECISION
As mentioned above, in the first decision, the delegate found that the claims of the parent application were not directed to a manner of manufacture. On the other hand, the delegate was not convinced that the problem was not a definitional one and therefore allowed the applicant an opportunity to amend the specification. Paragraph [35] of the first decision appears to be most relevant to the present case. An extract appears below:-
“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.” (emphasis in original).
In respect to section 40, the delegate further stated as follows:-
“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.”
EXAMINATION REPORTS
First Report – Current Application
While the claims, as proposed to be amended, are different from those the subject of this first report, it would nonetheless appear helpful to outline the objection from that report in this case.
The relevant content of the report is as follows:-
“Objection item 1 of Examiner Report No 1 dated 28 March 2017 issued on parent application 2016200387 is being maintained as your present claims are identical to the ones that formed the basis for said report. Claims 1-19 therefore do not define a manner of manufacture within the meaning of Section 18(1)(a) of the Patents Act 1990.
Further reference is also made to the detailed arguments presented in this regard in subsequent Examiner Reports dated 5 October 2017 and 9 February 2018 and also Hearing Decision dated 13 June 2017 (sic) issued on said parent application 2016200387. These need to be considered if you decide to amend the claims in order to overcome this objection.”
Third Report – Parent Application
As mentioned earlier, this examination report is of direct relevance to the current specification, as proposed to be amended. The relevant content reads as follows:-
“Objection item 2 of the previous report is essentially still being maintained and hence Claims 1-19 do not define a manner of manufacture within the meaning of Section 18(1)(a) for the reasons set out in the hearing decision issued for the present application on 24 July 2017.
Amended independent claims do not exclude from their scope a computation of the variability estimate that relies only in part on historical data. The claims define the calculation of the variability estimate to be ‘from the historical test results’ and, whilst this means that historical data is used, the word ‘from’ does not guarantee that other data does not form part of the calculation. The addition of the last feature ‘wherein the variability estimate is computed independently of the test results from the testing of the samples of the particular lot of the quality control material’ doesn’t change this point as it does not explicitly exclude other data (e.g. testing data in addition to the data from testing of the samples of the particular lot of the quality control material). The hearing decision was quite clear at [35] that the claim had to be limited to ‘determination of variability in totality from historical data’. As suggested in the previous report such a restriction in scope might be achieved with the inclusion of a word to the effect of ‘exclusively’ or ‘only’, in relation to this claim feature.” (emphasis in original)
The report also raises the above-mentioned section 40 issue as follows:-
“In light of my above objection claims are not fully supported as discussed in objection item 3 of the previous report.”
SUBMISSIONS
After initially discussing the nature of the invention, as described and claimed in the specification in the light of the described problems identified by the inventors, the applicant cited a number of authorities on manner of manufacture. Relevant to the present matter, the applicant principally relied on the law from NRDC of the sufficiency of there being a physically observable effect and that the more efficient methods of establishing statistically valid assay means and ranges in the present case provided such an effect. The applicant also submitted the NRDC decision was more to the point of the present matter than the Research Affiliates or RPL decisions. In reference to the latter, the applicant stated the present invention’s effect was not in computer operations and not about improvements in computer technology. Rather it was about generating an outcome with a physically observable effect outside the computer. The applicant noted that in NRDC that effect was the absence of weeds. In the current application it was the absence of sample testing, or at least a reduced amount of sample testing.
In respect to the invention as claimed, the applicant focused its submissions on claim 1 with the understanding that its arguments were equally applicable to the remaining independent claims. The applicant accepted the remainder of the claims would stand or fall consistent with the outcome for claim 1.
The applicant noted the primary issue in the present case centred on the claimed method of computation of the variability estimate. In the parent application, as accepted, the variability estimate is calculated exclusively from the one or more historical test results. In the claims, as proposed to be amended in the current application, the variability estimate is computed from the one or more historical test results and computed independently of the test results from the testing of the samples of the particular, or current, lot of the quality control material.
The applicant indicated the proposed amendments appropriately defined the substance of the invention. The applicant noted that prior art methods did not utilise historical test results and instead relied upon current test results. To calculate the variability, a large number of tests were required, a number much larger than that required to calculate a mean. The applicant subsequently noted that the proposed claims include the requirement that the variability estimate is computed independently of the current test results, as indicated above. The applicant submitted that, therefore, it is clear from the claims that the variability estimate is not calculated from current measurements.
The applicant referred to the specification, as originally filed (page 9 lines 3-18), to indicate how an avoidance of reliance on large numbers of current test results was not detrimental in computing the variability estimate. The specification states that embodiments of the invention exploit two observations to dramatically reduce the number of tests that must be performed to establish statistically valid means and ranges for new quality control material lots. Firstly, a sample mean may be estimated using a relatively small number of samples, as compared with the number of samples required to estimate the sample variability with similar confidence. Secondly, it has been realised that while the mean test result expected from a particular quality control material varies between lots, resulting in the need to reassign means and ranges for each new lot, the variability of the test results tends to remain relatively stable between lots. Thus, the use of the historical test results to compute the variability estimate without reliance on the current tests leads to the reduced amount of quality control material used without significant adverse effects on the accuracy of the variability estimate. The applicant stressed that this is the material advantage, or the artificially created state of affairs, that is the result of the invention as claimed.
With reference to [35] of the first decision, the applicant noted that the delegate’s adverse finding was essentially based on a claim interpretation allowing a variability estimate to be obtained from historical test results in full or in part. While the natural way to alleviate the adverse finding may have been to delete the phrase “in part”, leaving the variability estimate to be obtained fully or only or exclusively from the historical test results, the applicant noted that the delegate did not have other intermediate alternatives before him. The applicant submitted that if the delegate had been presented with the claims as presently proposed then, on the basis of the first decision, he would have found those claims defined a manner of manufacture.

In respect to the support issue under section 40, the applicant initially referred to a disclosure from page 12 of the specification, as filed, which discusses adjustment of variability estimates based on the mean calculated from tests of current test samples. In addressing, in subsequent submissions, an issue around the claims including, within their scope, other unspecified inputs contributing to the computation of the variability estimate, the applicant referred to the Federal Court of Australia decision in Encompass Corporation Pty Ltd v InfoTrack Pty Ltd, [2018] FCA 421. From [170] of that decision, the applicant indicated that the support requirement picked up two concepts. Firstly, there must be a basis in the description for each claim. Secondly, the scope of the claims must not be broader than is justified by the extent of the description, drawings or contributions to the art.
The applicant submitted that, on reading the description, the contribution to the art is in utilising historical test results, rather than current test results, when calculating a variability from which can be calculated a range of test result values. The applicant noted this contribution was consistent with the claimed invention. Moreover, the applicant stressed that it should be clear that the contribution to the art is not in the calculation of a variability estimate as such. That is merely an outcome. Thus, the applicant put the general principle as one where using historical test results avoids the need to make further tests of samples of a particular lot of quality control material for computing the variability estimate. The benefit is that substantially fewer tests are necessary to compute a range of test result values.
The applicant further indicated that the use or otherwise of other inputs in calculating the variability estimate is unrelated to the contribution to the art and not relevant to the claims. The applicant stressed that the claims simply need to define calculating a range of test values using historical test results rather than tests on the current lot.
DISCUSSION
Sub-section 18(1) - Manner of Manufacture
The applicant accepted that the first decision may be said to be highly persuasive in the present matter. As indicated above, much of the present matter would appear to turn on the delegate’s statements at [35] of the first decision.
In that paragraph the delegate stated that one would expect the applicant’s described physical phenomena to manifest themselves in proportion to the extent to which one avails oneself of historical test results. In the current application, the proposed claims similarly define the computation of a variability estimate from one or more historical test results. Thus, a first aspect of the substance of the presently claimed invention resides in the use of stored or obtainable historical test results from a database in computing the variability estimate. It is noteworthy from the delegate’s statement that he appeared to accept that at least some proportionate use of the historical test results would create the requisite physically observable effects. In the same paragraph though, the delegate was concerned with the vagueness of the claim of the parent application in allowing a variability estimate to be obtained from historical test results in full or in part, and thus the described effects not necessarily being produced by the claim. Specifically, the claim appeared not to be limited to less measurements being made for determination of variability.
From the above, one may conclude the delegate was clearly not satisfied if the historical test results played no part in the computation of the variability estimate. In respect to a reliance on the historical test results in part, it would appear, also from the delegate’s statements, that the delegate was concerned with the ambiguous nature of the “in part” definition in the claim before him in not necessarily leading to observability of the described effect, rather than the use of historical test results in part inherently meaning there was an absence of a physically observable effect.
To avoid the above ambiguity, the proposed claims of the current application go further from those before the delegate in the parent application. Specifically, the claims further define the variability estimate being computed independently of the test results from current test samples. This defines a second aspect of the substance of the claimed invention.
It is fair to say that the first and second aspects of the substance of the claimed invention leave the computation of the variability estimate open as to whether one or more other aspects, beyond the historical test results, contribute input to that computation, as claimed. That is, it may be said that the claimed calculation of the variability estimate exclusively from the one or more historical test results in the parent case is somewhat narrower than the proposed claims of the current application. In this respect, the applicant submitted that there was no question in NRDC about how much of the chemical, or whether enough of the chemical, had been sprayed to produce the physically observable effect of less weeds, or whether any other method or element assisted in that regard. The claims passed on the basis that they defined the chemical being used in the field. In the same way in the present case, the applicant argued that the claims clearly define the computation of the variability estimate from one or more historical test results and that the variability estimate is computed independently of the test results from current test samples. The applicant indicated that this is sufficient to render the observability of less test samples being required than with prior methods.
The specification, at page 9 lines 7-10 as filed, mentions the realisation that, while the mean test result expected from a particular quality control material varies between lots, the variability of the test results tends to remain relatively stable between lots. Embodiments of the invention take advantage of this realisation by using a database of historical test results to establish the assay ranges. Thus, relatively few new tests must be performed to establish the assay means and ranges for a new lot of quality control material (page 9 lines 11-16 of the specification).
The claims of the current application, as proposed to be amended, clearly define the testing of samples of a new or current lot of quality control material. The claims also define the computing of a mean of the test results produced from such testing. On the other hand, the claims also define the variability estimate being computed independently of the test results from current test sampling. Clearly, no more current test sampling is required in the present claims than that to compute the mean.
An interpretation of the claims may be that the limitation of the use of the current tests is only in respect to the computational features of the claims, and that there is not necessarily a limitation to less testing being done on a particular lot than would have been done previously. That is, the claims may include within their scope surplus test sampling of the particular lot beyond that required and, arguably then, the above-mentioned material advantage does not manifest itself. On the other hand, one could also say that the claims define a physical sequence whereby, in ordinary use, in context, the sequence involves test sampling sufficient to deal with the computational features of the claims. In this case, that means no more test sampling than that required to compute a statistically valid mean. Alternatively, an outcome that less testing is required, as distinct from less testing being done, of itself may be said to provide the requisite material advantage.
As indicated earlier, the specification discusses concerns in respect to the previous requirement for a significantly larger number of current tests to compute a variability estimate compared to the number required to compute a mean, with similar confidence. That requirement is not the case with the presently claimed invention.
The effect of the first and second aspects of the substance of the claimed invention is the avoidance of a reliance on the traditional method of using test results from current test samples, a much larger number of which had previously been required, to calculate, with reasonable degrees of confidence, the variability estimate, compared to the number of tests required to calculate a mean. In essence, the claimed invention relies on already stored historical test results, rather than requiring test results from large numbers of current test samples, for computing the variability estimate. Specifically on the latter point, as claimed, the variability estimate is computed independently of the test results from current test samples. There may be other inputs or aspects, beyond the historical test results, within the scope of the claims to compute the variability estimate. The extent to which those other aspects may impact on the efficiency of obtaining data for computing the variability estimate would appear to be by the way. Crucially, test results from current test samples are specifically not used for computing the variability estimate in the claimed invention. I find the consequent reduced amount of current test sampling required to compute a variability estimate and establish a statistically valid assay range in this case is a physically observable effect within the meaning of that phrase as described in NRDC.
I conclude the claims of the current application, as proposed to be amended, are for a manner of manufacture.
Sub-section 40(3) – Whether Claims Supported by Matter Disclosed in Specification
At [35] of the first decision, the delegate also commented that the claimed breadth in the parent application appeared to create a section 40 issue in that the claims did not appear fully supported by the disclosure of the specification. The delegate indicated that the specification only discusses determination of variability in totality from historical data.
In the above-outlined third report on the parent application, the examiner objected to the claims on the grounds of lack of a manner of manufacture on the basis that the claims did not exclude computation of the variability estimate that relied only in part on historical data. Moreover, with reference to the delegate’s comments in respect to section 40 at [35] of the first decision, the examiner appeared to indicate that the only remedy to overcome the manner of manufacture objection was to claim the determination of the variability estimate in totality from historical data. I have found above that such a restriction is not necessary in this case to provide the requisite manner of manufacture. Whether claims to something broader than reliance totally on the historical data leads to a contravention of section 40 is a different matter to which I now turn.
The delegate’s statements at [35] in the first decision suggest that anything less, in the claims, than determining the variability estimate in totality from the historical test results may contravene section 40, although the delegate did not appear to indicate a concluded view on the point.
The specification presents a number of embodiments in respect to computing a variability estimate. Pages 10 and 11 of the specification, as filed, describe a within-instrument computation of the variability estimate. Within-instrument variability will arise because repeated tests on a single testing machine will vary somewhat. The specification indicates that the within-instrument variability is estimated using summations of historical data from qualification tests performed on prior lots of particular quality control material, across multiple testing machines, which likely reside in multiple laboratories. For computing a within-instrument variability, it is generally assumed that all results from a particular laboratory are obtained using the same instrument.
Pages 11 and 12 describe a between-instrument computation of the variability estimate. Between-instrument variability will arise because tests performed using different testing machines of the same make and model will vary. The between-instrument variability is also estimated using historical data from qualification tests performed on prior lots of particular quality control material, across multiple testing machines, which likely reside in multiple laboratories. Each particular testing machine may produce results that differ from results obtained from other machines of like make and model.
In both of the above computations, there appear to be no other described inputs than the historical test results from prior lots of quality control material. On the other hand, the context of these passages does not seem to suggest the exclusion of other data sources beyond the historical test results. The comments of Lord Hoffmann in Biogen Inc. v Medeva Plc, [1996] UKHL 18, [1997] RPC 1, appear pertinent. At [63]:-
“… the specification must enable the invention to be performed to the full extent of the monopoly claimed. If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms. The patentee need not show that he has proved its application in every individual instance. On the other hand, if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them.”
The principle inferred from the specification, for example page 9 lines 11-16 as filed, is that using historical test results avoids the need to make further tests of samples of a current lot, the latter being the case in the past, to compute the variability estimate and in turn the assay ranges. This may also be said to be where the technical contribution to the art lies in this case.
In Generics (UK) Ltd v H Lundbeck A/S, [2009] UKHL 12; [2009] RPC 13, Lord Neuberger at [97] drew a connection between the allowed extent of the patent monopoly and the technical contribution to the art as follows. Quoting with approval from an EPO Boards of Appeal decision, Fuel Oils/Exxon, (T409/91) [1994] OJ EPO 653:-
“… there is a ‘general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified’.” (emphasis in original)
The use of the historical test results, and not the test results from current test samples, in computing the variability estimate are also features of the claims, as proposed to be amended. Thus, the claims would appear to comply with the above legal principle. Lord Neuberger’s quote though from Fuel Oils/Exxon continues as follows:-
“This means that the definitions in the claims 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.”
In the present description, there would also appear to be allowance for other data sources to contribute to the determination of the variability estimate. Page 9 lines 16 and 17 of the specification as filed states that, in some embodiments, the estimates of variability may be further adjusted based on the newly-established assay mean.
The following example is indicative. Pages 12 and 13 of the specification describe the adjustment of variability estimates. The specification notes an observation that the within-instrument variability varies as a function of the mean test result for the particular quality control material of interest. The mean test result will vary as a function of the concentration of the analyte in the quality control material, which varies between lots. In one hypothetical scenario, a first lot of the particular quality control material may produce slightly higher mean test results than a second lot, and the results may also vary more within a particular testing instrument for the first lot than for the second. That is, in this hypothetical example, within-instrument variability is positively correlated with the mean test result. Because the estimate of the mean computed for a new lot of quality control material may differ from the average of the means from prior lots, it may be desirable to adjust the variability estimates in accordance with the observed relationship of variability and mean. Thus, a further or an overall variability estimate may be computed from the historical test results and from the computed mean from the tests of current test samples. This embodiment is reflected in claim 8 of the current application. That claim may be found at Annex B.
The specification thus clearly contemplates something other than just the historical test results exclusively influencing the variability estimate. In a general sense then, it may be said that the specification discloses that further data may be used to compute the variability estimate, although more test sampling of the current, particular lot is not contemplated.
It may be that the breadth of the claims is open in respect to the nature of such further data. On the other hand, the background discussion in the present specification suggests that the qualifying of testing machines, the gathering of data and the use of data in the present field of automated testing machines, and by example in the field of medical testing devices, would have been ubiquitous at the relevant time. As such, in the light of the present description, the nature of the additional data, the sourcing of the data and its use in contributing to the variability estimate would not appear to have presented an undue burden to the relevant person skilled in the art at the relevant time in performing the invention across the full, claimed scope.
In respect to claim 8, it may be argued that the use of the computed mean from tests of current test samples is contrary to the definition of claim 1, to which claim 8 is appended, where the variability estimate is computed independently of the test results from the current test sampling. In reconciling claims 1 and 8 when reading the claims as a whole, it would appear that claim 1 has effect when understood that the variability estimate is computed independently of the test results directly from the current test sampling.
In any case, it remains that no further test samples are required to determine the variability estimate beyond those taken to calculate the mean. In the last sentence of [35] of the first decision, the delegate essentially noted the same requirement in discussing the support issue.
I conclude the claims, as proposed to be amended, comply with section 40.
CONCLUSION
I have concluded that the claimed invention, as proposed to be amended, is for a manner of manufacture and also complies with section 40.
I direct that the application be accepted.
M. G. Kraefft
Delegate of the Commissioner of Patents
Annex A
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;
computing, from one or more historical test results, obtained from a database of historical test results, a variability estimate that is an estimate of the variability of test results, wherein the one or more historical test results are obtained from tests performed on one or more prior lots 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, 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,
wherein the variability estimate is computed independently of the test results from the testing of the samples of the particular lot of the quality control material.
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;
compute from the historical test results a variability estimate that is an estimate of the variability of test results;
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,
wherein the variability estimate is computed independently of the test results from the testing of the samples of the particular lot of the quality control material.
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 from the historical test results a variability estimate that is an estimate of the variability of test results, wherein the variability estimate is computed independently of the test results from the testing of the samples of the particular lot of the quality of (sic) 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.
Annex B
8. The method of claim 1 or claim 2, including the step of adjusting the variability estimate computed from the historical test results in dependence on an observed relationship between the mean and the variability of test results.