23Jan 2015

{Time to Read: 4 minutes} USPTO Guidelines: Diving into Details by Silvia Salvadori, PhD.In my last article, I shared the highly-anticipated news that the  United States Patent and Trademark Office (USPTO) Guidelines were released. Now, let’s take a deeper look at the details in the guidelines. The most surprising and apparent difference between the old and the new guidelines is that the new guidelines seem to be much more flexible. The first (and biggest) difference is the absence of the twelve (12) factors, which previously had to be analyzed one-by-one. Rather, there is now a three-step analysis:

  • The first step is to determine whether a claim recites a process, a machine, a manufacture, or composition of matters.
  • If the answer is yes, the next step is to determine whether the claim is directed to a judicially recognized exception.
  • If so, the third step is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception.

According to the new three-step analysis, the claims now need to be “directed” to a judicial exception, rather than “involve” a judicial exception, as it was in the previous guidelines. This change is not unsubstantial, because the determination that a claim is “directed” to a judicial exception is narrower than before and requires the exception to be recited (e.g., described) in the claim. This is quite a change.
In order to determine whether the claims “directed” to the judicial exceptions are patentable, the USPTO provides a few examples: combinations of naturally occurring elements, pharmaceutical compositions and methods of treatment. The key is that if the claims recite a nature-based product limitation, the “markedly different characteristic analysis” is used to determine whether the claims are directed to a “product of nature” and is thus patent ineligible or not. Functional Differences:

  • Now “functional differences” cover not just the structure, but also the properties of resulting combinations of naturally occurring elements.


  • Under the new guidelines, a claim reciting gunpowder comprising an intimate finely-ground mixture of potassium nitrate, charcoal and sulfur is considered patent eligible. The resulting gunpowder combination not only has structural differences from each of the single components (because the final component is micronized), but also has different properties because the gunpowder combination is an explosive material, while the single elements, per se, are non-explosive.

Method of Treatment:

  • For example: a method of treatment for disease with naturally occurring compounds. Previously those type of claims were rejected as being unpatentable; now they are no longer considered as directed to judicial exceptions. In fact, although the claims might recite nature-based products, the claims as a whole are directed to method of practically applying the product to treat a particular disease and not on the product per se. Thus, it would not be necessary to apply the markedly different characteristic analysis in order to conclude that these type of claims are not directed to judicial exceptions. Accordingly, these claims now pass muster under these new guidelines. This is a victory for companies and universities.

If you have any questions about the new guidelines or need help understanding them, please contact me at silvia@salvadorilaw.com

Silvia Salvadori, PhDSilvia Salvadori, PhD.
(212) 897-1938