Latest US patent guidelines could ‘muddy the waters’

The US Patent and Trademark Office (USPTO) has issued new guidance for determining what claims are eligible for patenting, with one lawyer saying it could “muddy the waters”.

The guidance, called 2014 Interim Guidance on Patent Subject Matter Eligibility, has been issued in light of US Supreme Court decisions including Association for Molecular Pathology v Myriad Genetics, and Mayo Collaborative Services v Prometheus Laboratories.

Both cases raised questions surrounding patent claims and subject matter.

It is the third round of guidance published by the USPTO following releases in June and March this year.

Published on December 16 in a notice on the US Federal Register website, the latest measures, although not legally binding, will be effective immediately and apply to all pending and newly filed applications.

Under the new guidelines, the examiner will have to determine whether an application contains exceptions to patent-eligible subject matter including laws of nature, natural phenomena and abstract ideas.

If an application does contain an exception, examiners are then instructed to apply a two-step test.

If part one identifies an abstract idea, part two is then considered. This includes looking at eligibility claims that may be enough to qualify as “significantly more” than an initial claim, including improvements to another technology or technical field, and the application of an abstract idea with, or by use of, a particular machine.

Noel Day, partner at law firm Honigman Miller Schwartz and Cohn, said the new guidance was “more permissive” than the court decisions but still “muddies the waters” slightly.

“An important part of the analysis for many biotech or pharmaceutical inventions is whether a nature-based product has markedly different characteristics compared to its naturally occurring counterpart,” she said.

Kevin Noonan, partner at law firm McDonnell Boehnen Hulbert & Berghoff, told LSIPR that the new guidelines were not as narrow as the last set of guidelines.

“On the downside, this guidance goes the other way in being very generic and just reciting the varied and conflicting Supreme Court (as well as Federal Circuit) precedent in this area,” Noonan said.

“The USPTO as an administrative agency should use its expertise to take a position not inconsistent with the Supreme Court but that provides some ‘real world’ outlook on what should and should not be patent-eligible.”

But Noonan warned that the guidance could yet change again.

The Federal Register’s notice outlining the guidance announced a 90-day written comment period and encouraged the public to submit comments.

The USPTO also said it plans to host a public outreach forum on the guidelines in January.

“The dark cloud in this silver lining is that this is a work in progress according to the guidance and thus there is not a great deal of certainty here,” Noonan said.

In a statement, the USPTO said it would continue to solicit stakeholder feedback as it further refines the guidance.