In the post myriad/Prometheus decision of Perkinelmer, Inc. v. Intema Limited, the Federal Court struck down claims directed to a screening method to estimate the risk of fetal Down’s syndrome. The Court reiterated that the key distinction for analysis is between claims that recite ineligible subject matter, and no more, and claims to specific inventive applications of that subject matter. Unlike the former, the later do not risk the broad preemption of “the basic tools of scientific and technological work”. For a process claim to cover a patentable application of, for example, a natural law, it must ‘contain other elements or a combination of elements, something referred to as an ‘inventive concept‘ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.’
The Court reviewed the Mayo decision which was a diagnostic assay involving two steps: “administering” a thiopurine compound to a patient and determining the level of 6-thioguanine”, a metabolite of thiopurine, in the patient. The claims contained two “wherein” clauses which did not dictate any step in the process, but disclosed the metabolite concentration range necessary for effective treatment – the purported discovery embodied in the claims. This correlation, i.e., that an effective does of thiopruine produces a certain range of metabolite concentrations, was the result of the natural metabolic process. The claims in dispute thus were drawn to a law of nature and needed to “add enough to their statement of the correlation to allow the processes they describe to qualify as a patent-eligible processes that apply the natural laws” which they failed to do. The Supreme Court emphasized the “inventive concept” requirement section 101, stating that “simply appending conventional steps, specified at a high level of generality, to the laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable. (compare the claims of Diehr which were patent-eligible because of the way the additional steps of the prcoess integrated the [ineligible] equation into the process as a whole” and the Diehr court “nowwhere suggested that all these steps, or at least the combination of those steps, were in context obvious, already in use, or purely conventional”.
The Court also reviewed the Myriad decision of the Federal Court which were directed to screening methods for cancer predisposing mutations in human gene sequences. The Court there struck down similar claims. For example, one claim, contained the sole step of “analyzing” a human gene sequence to identify a certain mutation. Another required the single step of “comparing” a gene sequence form a sample of a tumor with a sequence from a non-tumor sample to identify a certain mutation with a “wherein” clause stating that a specific difference between the two sequences identified the mutation of concern. The claims were not over an application of the mental process of comparing. Rather, the steps of comparing two DNA sequences was the entire process that was claimed.
Similarly, in the current case (Perkinemer) the claims were directed to analytical methods to determine the risk of fetal Down’s syndrome. One claim, for example, required two “measuring” steps; a screening marker from the first trimester of pregrancy is observed; then, a marker from the second trimester is observed. The claim then contains a “determining” step in which the risk of Down’s syndrome is calculated by comparing both screening marker measurements with known statistical information. The Court pointed out that the “measuring” steps were insufificient to make the claims patent eligible since they merely tell the users of the process to measure the screening markers through whatever known method they wish. In fact, the patent stated “the inividual measurements are obtained through known methods…Any markers which are effective at each particular stage may be selected”. Nor was the “determining” step sufficient because the statistical information mentioned in this step was well-understood, conventional information.
The Court further pointed out that the claims which were held patentabble in Myriad supported the Courts decision. The claims which were held patentable in Myriad were directed to “comparing” the growth rates of two sets of host cells that had been altered with a cancer-causing human gene – one set was treated with the potential therapeutic and the other was untreated. If the growth rate of the treated cells was slower than the untreated cells, the treatment was effective. The comparison was an ineligible mental step. But the host cells did not occur naturally; they were man made and thus were themselves patetent-eligible subject matter. So, according to the panel, their inclusion in the process made the claims patent eligible despite the reference to an otherwise ineligible mental step. In contrast, the current case (Perkinelmer v. Intema) included no patent-eligible subject matter along with the ineligible concepts. They include only “conventional steps, specified at a high level of generality”.