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July 05, 2012


I would have liked the memo to say: "Because the Supreme Court said so, a claim directed to simply administering a man-made drug that does not recite other steps or elements directed to use of a natural principle, such as a naturally occurring correlation, would be directed to eligible subject matter.  Further, a claim that recites a novel drug or a new use of an existing drug, in combination with a natural principle, would be sufficiently specific to be eligible because the claim would amount to significantly more than the natural principle itself."

Without the random exemption by the Court, it seems to me that once a drug is administered to a subject the natural principle of its action upon the subject puts it within this analysis. Sure, perhaps you can treat a disease with other drugs, but you can also perhaps diagnose a disease with other biomarkers, clinical symptoms, etc. Nobody gets a claim to a method of diagnosing a disease in a patient comprising detecting a threshold amount of any physiological, genetic, or biochemical marker in a sample from the patient, wherein the marker indicates a likelihood of disease. The definintion of the scope of a "natural principle" seems to shift depending on the nature of the process being claimed.

This memo only highlights the buckshot reasoning of the Mayo opinion. I guess the PTO had to fashion some type of workable analysis though. Next on the chopping block, isolated DNAs.


These interim guidelines show the mischief created by the nebulous opinion written in Mayo in terms of what medical diagnostic methods will pass muster under 35 USC 101. Some of the examples provided are helpful, but others are not. Until we get some articulation from at least the Federal Circuit as to what will pass must, medical diagnostic methods are currently in the "Twilight Zone."

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