- administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
- determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
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the steps of the claimed methods were commonly performed by medical professionals in evaluating, considering and constructing treatment options for a patient presenting a specific medical condition; and
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the claims consist of “well understood, routine, conventional activity already engaged in by the scientific community” and thus lack the “inventive concept” required to transform unpatentable abstract ideas into patentable applications.
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So as not to tie up too much future use of laws of nature and thus impede innovation by blocking others from developing future technologies, a claim will need to articulate specific steps, such as adding method of treating steps based on the diagnostic information, rather than simply detecting or considering natural phenomenon.
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To be patentable, a process must recite clear steps that go beyond those that are “obvious, already in use, or purely conventional”. In Prometheus, the Supreme Court found that the “administering” and “determining steps” recited in the claims were conventional and had already been practised by doctors prior to the patent having been filed. The “wherein” clauses were held to do little more that “simply tell a doctor about the relevant laws, at most adding a suggestion that he should take those laws into account when treating his patient”. If the claims had been drafted differently so that they included a further step whereby the doctor was then required to administer a particular dose of 6-thioguanine after making a determination of the metabolite levels, it is possible that the Supreme Court might have then found the claim sufficiently transformative and reached a different conclusion.
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In the ABL case, the claimed method aided in the selection of a treatment regimen for a patient based on three knowledge bases. Thus, recitation of a computer-implemented step in the method which adds nothing to the process that doctors do not already regularly engage in mentally when evaluating and treating patients will not be sufficient in itself to render a claim patentable.
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relationship between blood glucose levels and diabetes in a patient
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when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood
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use of the natural disinfecting properties of sunlight.
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a claim to diagnosing an infection that recites the step of correlating the presence of a certain bacterium in a person’s blood with a particular type of bacterial infection with the additional step of recording the diagnosis on a chart would not be patentable because the additional step of recording the diagnosis on a chart is extra-solution activity unrelated to the correlation.
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adding steps to a natural biological process that only recite well-understood, routine, conventional activity previously engaged by researchers in the field.
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a combination of steps that amounts to nothing significantly more than an instruction to doctor’s to apply applicable laws when treating their patients.
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a claim that covers known and unknown uses of a natural principle and which can be performed through any existing or future-devised machinery, or even without any apparatus lack features sufficient for patentability.
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additional limitations that are necessary for all practical applications of the natural principle, such that everyone practicing the natural principle would be required to perform those steps or every product that natural principle would be required to include those features.
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a machine or transformation that is merely nominally, insignificantly, or tangentially related to the steps or elements, e.g., data gathering or data storage would not show integration. For example, a machine that is simply incidental to execution of the method (using a computer as a counter balance weight and not as a processing device) rather than an object that implements the method or a transformation that involves only a change of position or location of an object rather than a change in state or thing does not show that these additional features integrate the natural principle into the invention as they are incidental to the claimed invention.
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A method comprising the steps of obtaining a sample form a patient, measuring a biomarker and determining the likelihood of developing arthritis will not meet the test for patentability
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The above method further comprising the use of a positive marker will also not meet the test
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A method which involves the use of a novel and non-obvious antibody to measure the biomarker will meet the test
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A method which that requires the biomarker to be measured using a combination of two assays that are “not routinely used together” will meet the test.
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Methods or processes that recite clear steps that go beyond those that are obvious, already in use or purely conventional will be patentable.
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Claim to a new drug or a new ways of using an existing drug will still be patentable. It remains to be confirmed in the Courts but it is at least arguable that a “new way of using an existing drug” which involves the identification of new treatment indications for a known drug and to new dosing regimens for a known drug would continue to be patentable.
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Steps of a method that are seen as requiring substantial computer programming and so could not simply by performed by human kind satisfy the criteria of patentable subject matter (per Ultramercial LLC v Hulu LLC Fed Cir 2011). Therefore, one strategy is to include “determining” steps that cannot be implemented with a paper and pencil analysis.
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Claims that recite particular steps that distinguish the invention from the mere application of a law of nature will remain patentable. For example, a claim based on treating a psychiatric behavioural disorder by treating the patient to a source of white light can be made patentable by reciting additional steps that of manipulating the light and positioning the patient for light exposure.
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Claims that incorporate an administration step (e.g. immunizing a patient) appear to move the claim from a principle to an application and therefore satisfies patentable subject matter (as per Classen v Biogen Idec Fed Cir 2011).
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Claims directed to a method of therapy rather than method of diagnosis would have more chance of meeting patent eligibility criteria. For example, a claim to a method of treating a patient with a particular dosage of drug (thiopurine) wherein the patient was previously diagnosed.
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Claims that include use of truly novel apparatus or method of analysis for data acquisition or a novel reagent (this can include an isolated DNA as recently affirmed by the Federal Circuit in Myriad in August this year), should still be patentable.