Athlomics Pty Ltd
[2009] APO 20
•26 October 2009
ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 2003275800 in the name of ATHLOMICS PTY LTD.
Title : Status Determination.
Action : Hearing in respect to objections during examination.
Decision : Issued 26 October 2009.
Abstract
Much of the applicant’s defence of the application was in respect to the invention as defined in claim 1. The applicant’s attorneys indicated that suitable corresponding amendments would be made to the other independent claims once claim 1 was found acceptable.
Claim 1 was found to be novel and inventive.
Several other claims were found to lack novelty and lack an inventive step.
Broad consensus was reached at the hearing as to how the claims could be amended to make them ready for acceptance.
Under paragraph 142(2)(e) and sub-regulation 13.4 of the Patents Act and Regulations, the applicant has until 25 November 2009 to obtain acceptance of the application.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent application 2003275800 by ATHLOMICS PTY LTD, and objections raised during examination.
BACKGROUND
Genomics Research Partners Pty Ltd filed patent application 2003275800 as a PCT application on 14 November 2003. The application claims priority from an Australian provisional application, 2002952696, filed on 14 November 2002. Application 2003275800 is now proceeding in the name of Athlomics Pty Ltd (“Athlomics”).
The Patent Office has issued three reports during examination of the application. In the latest report, dated 24 July 2009, an objection of lack of inventive step was maintained. Furthermore, because of the nature of the remaining objection, it was suggested that the applicant consider making further representations at a hearing.
On 24 August 2009, Athlomics responded with further submissions in reply and a proposed amendment to a passage of claim 1 of the application. The amendment and submissions did not appear to address all the outstanding issues though. The other independent claims, at least, of the application were not similarly amended or addressed.
On 4 September 2009, the Patent Office issued a hearing notice allowing the mandatory time of at least 10 days of notice of a hearing (Patent Regulation 22.23(1)).
The hearing was held in Canberra on 15 September 2009. Mr Alistair Smith and Dr Victor Argaet, patent attorneys of Davies Collison Cave, represented Athlomics.
THE SPECIFICATION
The specification states the present invention relates to determining the status of a subject, in particular for determining the ability of a subject such as a human, horse or camel to compete in a sporting and/or racing event by evaluating, for example, molecules obtained from blood of the subject.
Conventional means for determining the condition of a subject are initially discussed in the specification. Blood profile tests and clinical appraisals are stated to have limited value because of minimal correlation between results and the condition of the animal.
The use of genetic information is also acknowledged. One example uses calibrated gene expression profiles. When a subject is suspected of having a condition, a test is performed to obtain a specific profile which is then analysed. The collected profile is compared to a predetermined profile to determine if the condition has been correctly identified. This example is said to suffer the drawback that a preliminary diagnosis is required to allow the correct test to be performed. A second example allows users to perform DNA genetic profiling to determine the susceptibility of a subject to a condition. The subject is profiled to determine the presence of predetermined genes which in turn indicate the susceptibility of a subject to a respective condition. Again, this requires specific tests for specific conditions, and only allows the susceptibility of a subject to be determined.
The specification, in its currently proposed form, concludes with 37 claims. The independent claims in their currently proposed amended form are recited below.
1. A method of determining the status of a subject, the method being performed using a system including at least one end station coupled to a base station via a communications network, the method including:
a) Obtaining subject data from cells in a biological sample obtained from the subject, the subject data being obtained from a single test and including respective values for each of a plurality of parameters, individual parameters being representative of the level, abundance or functional activity of a gene expression product in the cells, the parameter values being indicative of the current biological status of the subject;
b) In the base station;
i) Receiving the subject data from the end station via the communications network;
ii) Comparing the subject data to predetermined data, the predetermined data including for each of a plurality of conditions:
(1) Values for at least some of the parameters; and,
(2) An indication of the condition;
iii) Determining the status of the subject in accordance with the results of the comparison, the status indicating at least one of the presence, absence or degree of more than one of the conditions; and,
iv) Transferring an indication of the subject status to the end station via the communications network.
22. Apparatus for determining the status of a subject, the apparatus including a processing system adapted to:
a) Receive subject data from an end station via a communications network, the subject data being obtained from cells in a biological sample obtained from the subject and being obtained from a single test and including respective values for each of a plurality of parameters, individual parameters being representative of the level, abundance or functional activity of a gene expression product in the cells, the parameter values being indicative of the current biological status of the subject;
b) Compare the subject data to predetermined data, the predetermined data including for each of a plurality of conditions:
i) A range of values for at least some of the parameters; and,
ii) An indication of the condition;
c) Determine the status of the subject in accordance with the results of the comparison, the status indicating at least one of the presence, absence or degree of one or more of the conditions; and,
d) Transfer an indication of the status of the subject to the end station via the communications network.
25.A method of allowing a user to determine the status of a subject using a base station, the method including causing the base station to:
a) Receive subject data from the user via a communications network, the subject data being obtained from cells in a biological sample obtained from the subject and being obtained from a single test and including respective values for each of a plurality of parameters, individual parameters being representative of the level, abundance or functional activity of a gene expression product in the cells, the parameter values being indicative of the current biological status of the subject;
b) Compare the subject data to predetermined data, the predetermined data including for each of a plurality of conditions:
i) Values for at least some of the parameters; and,
ii) An indication of the condition; and,
c) Determine the status of the subject in accordance with the results of the comparison, the status indicating the presence and/or absence of the one or more conditions; and,
d) Transfer an indication of the status of the subject to the user via the communications network.
28. A base station for determining the status of a subject, the base station including:
a) A store method for storing predetermined data, the predetermined data including for each of a plurality of conditions:
i)Values for at least some of the parameters; and,
ii) An indication of the condition; and,
b) A processing system, the processing system being adapted to:
i) Receive subject data from the user via a communications network, the subject data being obtained from cells in a biological sample obtained from the subject, being obtained from a single test, and including respective values for each of a plurality of parameters, individual parameters being representative of the level, abundance or functional activity of a gene expression product in the cells, the parameter values being indicative of the current biological status of the subject;
ii)Compare the subject data to the predetermined data;
iii) Determine the status of the subject in accordance with the results of the comparison; and,
iv) Output an indication of the status of the subject to the user via the communications network.
36.An end station adapted to determine the status of a subject, the end station including a processor adapted to:
a) Determine subject data from cells in a biological sample obtained from the subject, the subject data being obtained from a single test and including the subject data (sic) including respective values for each of a plurality of parameters, individual parameters being representative of the level, abundance or functional activity of a gene expression product in the cells, the parameter values being indicative of the current biological status of the subject;
b) Transfer the subject data to a base station via a communications network, the base station being adapted to:
i)Compare the subject data to predetermined data for one or more individuals, the predetermined data including:
(1) One or more parameter values for the respective individual; and,
(2) An indication of the status of each individual; and,
ii) Determine the status of the subject in accordance with the results of the comparison; and,
c) Receive an indication of the status of the subject via the communications network.
Athlomics proposed the version of claim 1 as quoted above in response to the third report. The other independent claims quoted above are proposed amendments arising from the second examination report.
THE EXAMINER’S REPORTS
During examination, the examiner has reported against the claimed invention on the grounds of lack of inventive step and lack of fair basis. In the most recent examination report (the third report) the ground of lack of inventive step remained outstanding. The examiner’s third report maintains the objection of lack of inventive step based on US Patent Application 2002/0059030 by Otworth et al, published 16 May 2002. The thrust of that report is the lack of inventive step in analysing for a plurality of conditions based on a single test.
PRELIMINARY MATTERS FOR THE HEARING
On 11 September, Mr Smith filed written submissions. These submissions largely contend that the present application relates to determining the status of a subject. The status indicates the presence, absence or degree of a plurality of conditions based on an analysis of a single test using a biological sample obtained from the subject. Mr Smith further outlined in the submissions that US 2002/0059030 is generally concerned with traditional medical testing procedures in which the required testing is determined based on a preliminary diagnosis before any testing is carried out. That is, the condition to be diagnosed is first selected, based on a medical assessment, then a test kit is chosen based on the pre-selected condition, the test kit including a cartridge adapted specifically for a pre-selected test related to the condition. The subsequent analysis therefore only relates to the pre-selected condition.
The day prior to the hearing (that is, 14 September) the Patent Office sent a facsimile to Athlomics’ attorney firm. The facsimile indicated what appeared to be the pertinent issues about US 2002/0059030 that appeared to leave an inventive step objection still outstanding. The reason for sending the facsimile was to better focus the hearing on those issues.
APPLICABLE LAW
Section 18 of the Patents Act is the pertinent section in respect to the present application. Relevant parts of subsection (1) appear below.
(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) ………………….: and
(b) when compared with the prior art base as it existed before the priority date of that claim:
(i) is novel; and
(ii) involves an inventive step; and …….DISCUSSION
While the examiner’s third report maintained an inventive step objection only, I am going to first consider novelty as that subject was discussed in respect to US 2002/0059030 at the hearing.
NOVELTY
In referring to several earlier decisions in respect to novelty, the Bristol-Myers Squibb Company v FH Faulding & Co Ltd decision, (2000) 46 IPR 553 at 576, states that what the authorities contemplate is that a prior publication, if it is to destroy novelty, must give a direction or make a recommendation or suggestion which will result, if the skilled reader follows it, in the claimed invention.
I will apply this test to the present case.
At the hearing Mr Smith submitted the claimed invention, the subject of the present application, concerns a single test to be performed on a subject to allow identification of a plurality of conditions. These conditions may be unknown before the test is performed. The test involves a sample taken from a subject. A gene expression of the sample provides the subject data which includes values for each of a number of parameters which are the gene expression products. The subject data is compared with predetermined data at a base station. The predetermined data typically comprises a plurality of signatures representative of different conditions or their severity. The comparison then identifies the condition(s) the subject may have.
Mr Smith submitted that US 2002/0059030 had some level of pre-diagnosis of an individual which is used to determine a likely condition the individual may have. This allows a particular test cartridge to be selected. The analysis thus would only indicate the presence or otherwise of one condition, that is, the one the subject is thought likely to have.
US 2002/0059030 relates to the processing of remotely collected electronic information characterizing properties of biological entities. An integrated system is provided in which biological sample characterization may be achieved using one or more sample data collection devices, or sensors, in conjunction with a centralized remote data analyzer.
Paragraph [0037] of US 2002/0059030 appears to be most closely pertinent against the claimed invention. That paragraph indicates the invention, the subject of US 2002/0059030, provides a method of pre-screening a subject prior to committing to or arranging for bringing the subject and the test provider together. A set of sample characterizations, or test, is determined to be administered to the subject. The test allows for the detection of some number of specific constituents contained within a sample of bodily fluids obtained from the subject. The test for each of these specific constituents is considered to be an assay and these multiple assays may be housed within a portable cartridge. A kit may be provided for the subject and the kit includes a selected cartridge or a set of multiple cartridges related to a desired test. Electronic data related to the predetermined test at the local site is transmitted to a central data facility for processing and then transmitted back or sent on to third parties.
Most of the aspects of claim 1 of the present application appear to be covered in the above description. There is the question though of whether US 2002/0059030 discloses a single test being used to indicate the presence, absence or degree of more than one condition.
As far as I can tell, the meaning of “single test” is not explained in the descriptive part of the present specification. From reading the specification as a whole and from Mr Smith’s submissions, it appears the meaning is intended to convey the following. The alleged invention obtains subject data from a gene expression from one sample taken from the subject. That subject data is then compared with the predetermined data. There appears to be nothing in the claims to preclude this test preceding or being preceded by a further form of analysis.
There was some suggestion at the hearing in reference to US 2002/0059030 that preliminary diagnosis, or pre-screening, or pre-selection of tests amounted to more than one test being performed. On the other hand, such preliminary activity may equally be considered to be merely an assessment of whether a test or what test is to be performed. In the context of the specification I think a single test means the taking of one sample from the subject and obtaining the requisite subject data therefrom for analysis.
The phrase, “gene expression product in the cells” also appears to require some discussion. This phrase appears to define any product derived from any bodily fluids or tissue such as blood, skin, membranes, saliva, etc. Claim 6 of the present application for instance defines the gene expression parameters being representative of the level or abundance of a molecule selected from one or more of about 20 broad-ranging items. Similarly the determination of an unlimited number of conditions, known or unknown, from a single test may appear to be speculative. While such phrases are extremely broad in scope, they are just two of many constituents of claim 1. This claim has an abundance of other features that set the boundaries of the claimed monopoly.
Paragraph [0037] of US 2002/0059030 describes a method of pre-screening a subject. The test is described as allowing for the detection of a number of specific constituents. Mr Smith submitted there may be multiple constituents detected and multiple cartridges but US 2002/0059030 still only supports the determination of only one condition for each test. Paragraph [0075] of the US document, for example, discusses the ability to use a remote testing kit for a variety of different types of testing and that such ability is dependent on the nature of the cartridge used. One embodiment is a sensor array which includes a plurality of chemically sensitive particles, each of the particles including receptors specific for the desired task. For example, a sensor array cartridge for use in medical testing for diabetes may include a number of particles that are sensitive to sugars. In this case, the sensor array, for all its multiple receptors, still only determines one condition, that being diabetes.
I am not aware of any disclosure in the US document that supports a single test determining multiple conditions. Consequently I regard claim 1 as novel.
At the hearing Mr Smith accepted that much of his defence of the application was on the basis of claim 1 of the application. Mr Smith and Dr Argaet indicated Athlomics had proposed amendments to claim 1 first and would make suitable corresponding amendments to the other independent claims once claim 1 was found acceptable.
Claims 22 and 25 at present define the determination of the presence, absence or degree of one or more conditions. These claims clearly include a single test determining only one condition within their scope.
Claims 28 and 36 at present merely define the determination of the status of the subject in accordance with the results of the comparison between the subject data and the predetermined data.
US 2002/0059030 has such disclosures in at least the paragraphs already referred to above. Furthermore, the features claimed in the present application of obtaining the subject data of parameter values from a gene expression product from a sample, and the transmission capability over a communications network between the point of sampling and a central data facility, for comparing and analysing the subject data with the data in the central facility, are also disclosed in the above referenced places in US 2002/0059030.
I conclude that at least the present claims 22, 25, 28 and 36 are not novel over US 2002/0059030.
Since Mr Smith and Dr Argaet indicated at the hearing that they would make suitable corresponding amendments to these claims along the lines of claim 1 if that claim was found acceptable, I have not gone further to closely assess the novelty of the claims dependent on claims 22, 25, 28 and 36.
INVENTIVE STEP
The next consideration is that of inventive step, the subject of the examiner’s reports.
Under subsection 7(2) of the Patents Act, an invention is taken to have an inventive step unless it would have been obvious to a person skilled in the art in light of the common general knowledge in the patent area before the priority date of the claims. Under subsections 7(2) and 7(3) the common general knowledge may be considered either on its own, or together with prior art information which the skilled person could, before the priority date of the claim, be reasonably expected to have ascertained, understood and regarded as relevant.
Wellcome Foundation Ltd v VR Laboratories (Aust.) Pty Ltd, (1981) 148 CLR 262 at 280, states the question is whether the invention would have been obvious to a hypothetical skilled addressee armed with the common general knowledge at the priority date. Also from that decision at page 286, an appropriate test is whether a person skilled in the relevant field, and faced with the same problem, would have taken as a matter of routine whatever steps might have led from the prior art to the invention.
The High Court in Aktiebolaget Hassle v Alphapharm Pty Limited, (2002) 56 IPR 129 at [50]-[53], appears to approve of the Wellcome (supra) test. In discussing what was meant by a matter of routine the High Court noted and accepted an affinity with the approach in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd, (1970) 87 RPC 157, of whether the person skilled in the art would directly be led as a matter of course to try what was claimed in the expectation that it might well produce a useful alternative. In Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [No. 2] (2007) 235 ALR 202, general principles regarded to be of continuing relevance, at [50]-[52], were that “obvious” means “very plain”, a scintilla of invention remains sufficient to support the validity of a patent, there must be some difficulty overcome, some barrier to be crossed, and an invention must be beyond the skill of the calling.
In the present case, the problem of the prior art has been expressed in various ways during prosecution of the application. The first two pages of the present specification broadly appear to suggest the existing problem is of the limitations of blood profiling, clinical appraisals, and presupposition of conditions to determine the appropriate tests to be performed. The examiner’s second report suggests the problem is to avoid the need to physically submit collected samples for analysis. The latter appears to be derived from, or at least is in a similar vein to, the applicant’s response to the examiner’s first report. In that response, Athlomics indicated the problem to be addressed is to provide a mechanism by which gene expression or similar analysis can be performed whilst the security of predetermined data is maintained. Still further, in a response dated 28 October 2008 to an EPO examination report on the EP equivalent application, the problems to be addressed are stated as the time-consuming nature, expense and difficulty of collecting signatures of the predetermined data, and the maintaining of the security of such data.
Against this background, it is clear there are multiple facets of the invention. From pages 51, 66 and 67 of the specification for example, persons to whom the specification would be addressed appear to include biotechnologists, medical practitioners, pathologists and animal trainers. Additionally, given the communications environment and the data security aspect of the alleged invention enabling remote diagnostics to occur, network communications engineers and data security specialists would also appear to be relevant persons. The person skilled in the art to whom the specification is addressed would seem to be a team of people as identified above.
In respect to claim 1 of the application, others may assert that the ability to test remotely for multiple conditions with a single test had been a long felt need or a highly desirable objective in the medical field and therefore an obvious step. At the hearing Mr Smith also suggested this was another problem to overcome. If this was a long felt need or highly desirable objective then one would presume many in the field would have turned their minds to finding a solution. The Joseph Lucas (Batteries) Limited v Gaedor Limited decision, [1978] RPC 297 at 358 appears to be pertinent.
“…the question of obviousness is probably best tested, if this be possible, by the guidance given by contemporaneous events. …. If an invention has resulted in the solution of a problem which has been troubling industry …. then the suggestion after the event that the step was obvious inevitably rings a little hollow.”
Others may also assert that the need in the medical field has been met for example by routine blood testing simultaneously for cancers, heart disease, high cholesterol, etc, or by sending sample parts from one blood sample to multiple analytical laboratories.
On the other hand, firstly, there is no documentary evidence, before the priority date of the application, of such alleged prior art before me. Secondly there is no evidence before me of whether that was common general knowledge at the priority date of the application. Thirdly, such alleged prior art is well short of disclosing the method of implementation defined in claim 1 of the application.
In claim 1, the method of achieving the single test for multiple conditions is by sampling a subject, obtaining subject data from a single test from the sample in the form of parameters representative of gene expression products, and comparing the subject data, sent via a communications network, with predetermined data in a base station to indicate the presence, absence or degree of more than one condition. The latter indication is achieved, according to claim 1, by the predetermined data including, for each of a plurality of conditions, values for at least some of the parameters and an indication of the condition.
Similarly it may also be asserted that a sufficiently large database of historical, statistically adequate predetermined data inherently enhances the prospect of identifying a significant number of conditions in the subject data in a single test. The collection of sufficient predetermined data for that objective may also seem an obvious solution. In the specification, the last paragraph on page 44 discusses the solution in this way. To consider this though would be to engage in the ‘ex post facto’ analysis often warned against. See for example Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd, (1980) 144 CLR 253.
The requirement from the Wellcome (supra) and Hassle (supra) cases though is that the step from the prior art to the claimed invention must be a matter of routine for the person skilled in the art and that such person would directly be led as a matter of course to try what was claimed in the expectation that it might well produce a useful alternative. Faced with any of the problems of the prior art as put above, I am unconvinced a person skilled in the present art would as a matter of routine have come up, from US 2002/0059030, with the enabling method as claimed in claim 1. I have insufficient evidence before me to establish the solution provided in claim 1 was an obvious one to the person skilled in the art at the priority date of the application. I conclude claim 1 has an inventive step on the available evidence before me.
On the other hand, claims 22 and 25 include a single test determining only one condition within their scope. Furthermore, claims 28 and 36 merely define the determination of the status of the subject in accordance with the results of the comparison between the subject data and the predetermined data. Similarly to the findings for novelty, I conclude that at least claims 22, 25, 28 and 36 do not have an inventive step over US 2002/0059030.
In view of the above-mentioned indications made by Mr Smith and Dr Argaet in respect to these claims, I have not gone further to closely assess the inventiveness of the claims dependent on claims 22, 25, 28 and 36.
DECISION
Claims 22, 25, 28 and 36 are found to lack novelty over US 2002/0059030.
Claims 22, 25, 28 and 36 are found to lack an inventive step over US 2002/0059030.
As mentioned earlier, in respect to these independent claims, Mr Smith and Dr Argaet agreed to amend them to more closely align with claim 1. At the hearing, I indicated that claims 22, 25, 28 and 36 did not define the feature of the status indicating the presence, absence or degree of more than one of the conditions. On the other hand, the subject may only have one condition. After some discussion, it was concluded a more accurate reflection of the invention appeared to be that, additionally to what is defined at part (b)(ii) of claim 1, the subject data is compared for each of a plurality of conditions to predetermined data. Part b(iii) would then appear to correctly define the status indication of one or more conditions in a subject as appropriate. Mr Smith and Dr Argaet agreed such an amendment of part (b)(ii) would be appropriate along with similar amendment on this point to the other independent claims.
Mr Smith and Dr Argaet also agreed to bring claim 36 in line with claim 1 in respect to the predetermined data including, for each of a plurality of conditions, values for at least some of the parameters and an indication of the condition. While claim 28 includes these features, they are defined at the beginning of the claim. A consequence of this is that the expression “the parameters” in part (a)(i) does not have a clear antecedent while the expression “a plurality of parameters” in part (b)(i) does not clearly indicate whether these parameters are additional to or exemplary of the earlier mentioned parameters.
There is currently a postponement of acceptance in place under subsection 49(3). Athlomics indicated in its response to the examiner’s third report that the withdrawal of the requested postponement of acceptance will be completed once the remaining objections are overcome.
Once the above points are addressed the application would appear to be in order for acceptance. Under paragraph 142(2)(e) and sub-regulation 13.4(1)(a) of the Patents Act and Regulations, the final date for acceptance is 25 November 2009. Athlomics has until that date to obtain acceptance of the application.
M. G. Kraefft
Delegate of the Commissioner of Patents26 October 2009
Patent attorneys for the applicant : Davies Collison Cave, Brisbane
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