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USPTO Issues New Myriad Guidance

December 17, 2014
On Tuesday, December 16 the United States Patent and Trademark Office issued a revised guidance on subject matter eligibility under § 101 in light of recent Supreme Court Decisions in Alice v. CLS Bank, Mayo, and Myriad.

These new guidelines are a response to extensive feedback provided from industry leaders and inventors over the last several months. (BIO provided both initial and supplemental comments on the Office’s March Subject Matter Eligibility Guidance). Public comments on the revised guidance will be accepted until March 16, 2015.

Donald Zuhn, founder of Patent Docs provided a beneficial breakdown of what changes the Office has highlighted.

Some notable revisions:

  • The test for determining whether a claim is directed to a “product of nature” exception is separated from the analysis of whether the claim includes significantly more than the exception.

  • The different analysis focuses on characteristics that include a product’s structure, function, and/or other properties as compared to its naturally occurring counterpart in its natural state.

The guidance maintained a two part framework for analyzing whether a patent claim covers specific eligible subject matter, keeping with the outline the Supreme Court established in the Mayo case.

  • Patent examiners should determine whether the claim is directed to a process, machine, manufacture, or composition of matter.

  • If the claim is directed to a statutory category of invention, then examiners must determine whether the claim is directed to a law of nature, or an abstract idea.

The USPTO has provided examples of nature based products to illustrate the analysis outlined in the Interim Guidance.

Right now it is uncertain how these revisions will impact patent claim examinations. A study on patent applications released this summer by BIO and Bloomberg BNA found that roughly 40% of reviewed claims similar to the ones under scrutiny in Mayo and Myriad received a Section 101 rejection.

As of December 16, at least some of these claims would be patentable under the USPTO’s revised guidance – a positive development for biotechnology innovators. Ironically, one day later the U.S. Court of Appeals for the Federal Circuit issued a harsh decision that may require the USPTO to rethink some of its revisions and effectively undo some of its hard work.

Only this much is certain: it will be a long time before we see more stability in this area of patent law.