PTO To Biotech Examiners – We’ll Get Back To You!

On March 21, 2012, Andrew H Hirschfield, Associate Commissioner for Patent Examination Policy, sent a short memo to the Patent Examining Corps to inform them about the decision in Prometheus v. Mayo. The “preliminary guidance” that was provided included a statement that mainly this decision did not affect the PTO’s Bilski guidelines re patenting “abstract ideas” (so keep calm software/business method Groups).

The memo described the unpatentable laws of nature at issue as “the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage with prove ineffective or cause harm.” The memo noted that “the claimed processes [the “invention as a whole”] are likewise not patent eligible unless they have additional features that provide practical assurance that the processes are genuine applications of these laws rather than drafting efforts designed to monopolize the correlations. [The Court found that] the additional steps in the claimed processes here are not themselves natural laws, but neither are they sufficient to transform the nature of the claims.”

The memo directs Examiners to continue to use the interim Bilski guidelines, while evaluating the claim to be sure that it does not “[amount] to a monopoly on the law of nature, natural phenomena, or abstract idea itself. In addition…a claim that includes [one of the three patent-ineligible categories] should include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than [one of the categories] with conventional steps specified at a high level of generality appended thereto. [Emphasis in original].

Of course, at this stage, the Office can offer no guidance as to  when a claim amounts to significantly more than one of the patent ineligible categories;  specifically  how to draft claims with additional steps specified at the appropriately low level generality. Perhaps the most important statements are the opening sentences of paragraphs 4 and 5:

“In this case, the claims inform a relevant audience about certain laws of nature…. the decision rested upon an examination of the particular claims in light of the Court’s precedents….”[Emphasis added.]

This appears to be a hint that the PTO would like to limit the decision to its facts – or at least to a narrow technical area –  but, unfortunately I, and I suspect, most of the readers of this Blog are members of the “relevant audience” and will be required to somehow avoid drafting such “particular claims”.

Click HERE to read the short memo.

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