101 Rejections Under the Guidelines: Mayo and Myriad “Go Viral”

This is a guest post from Hans Sauer, Deputy General Counsel, Intellectual Property for BIO.

“Recently, I set out to find real-world examples of recent rejections under the USPTO Guidance, to do my own sampling rather than rely on reported anecdotes. In just two hours of not very systematic searching, I was able to identify dozens of cases that have these new rejections, and I have attached some of the more interesting ones for you. [These can be found at the end of this post.] I focused mainly on applications with product claims, and pulled up method claims only incidentally.

“As expected, these new “product of nature” rejections go far beyond nucleic acid claims. Interesting examples include multipart vaccine preparations, industrial enzymes, organic crop protection products, a pharmaceutical composition and method of treatment involving an anticancer molecule from a marine sponge, and even a method for washing laundry. We’re also now seeing rejections of monoclonal antibody claims, which is something we were worried would happen. Perusing the attached rejections only takes a half hour; it’s a quick way to get an impression of what’s going on.”

Scanned from a Xerox multifunction device

Scanned from a Xerox multifunction device[1]

Scanned from a Xerox multifunction device[2]

Scanned from a Xerox multifunction device[3]


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One Response to 101 Rejections Under the Guidelines: Mayo and Myriad “Go Viral”

  1. Paul Cole says:

    There is an interesting inconsistency between Mayo and Myriad/Chakrabarty.

    If you read Myriad/Chakrabarty you will find reference to the Hartranft opinion which is key to understanding those cases. the take-away message from Hartranft is that human activity on its own does not suffice for eligibility but human activity accompanied by new utility does.

    Applying that reasoning to Mayo, the limits specified are not a mere expression of a law of nature but are the key to new utility for the test, turning it from a laboratory curiosity to a medically useful procedure opening the way to the safe administration of the thiopurine drugs.

    We could all wish that the claim had been differently drafted, but the Supremes seemed to have lost sight of what should have been a just outcome. Arguably this was furst rate research of practical value, and ought not to have been denied protection on a technicality.

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