PTAB Finds that Psilocybin Formulation Is Not a Product of Nature; Further Prosecution Leads to Issued Patent

In a notable decision, the Patent Trial and Appeal Board affirmed the §101 rejection of claims directed to various compositions that included psychedelic mushroom compounds, finding the claims to be ineligible for patenting.¹ This decision and the application’s subsequent file history provide useful guidance on patent eligibility for compositions involving naturally occurring ingredients.

The Technology

The case centered on claims for compositions containing various amounts of three key components:

• psilocybin/psilocin (compounds found in Psilocybe cubensis and other psychedelic mushrooms)
• erinacines/hericenones (compounds from Hericium erinaceus, also known as the Lion’s Mane mushroom)
• niacin (vitamin B3)

Turtle Bear Holdings’ composition was created for the repair and improvement of neurological function by providing synergistic effects on neuronal growth.

The § 101 Rejection

The examiner rejected the claims under 35 U.S.C. §101, arguing they were directed to a natural phenomenon (e.g., product of nature). For ease of reference, Step 2A of the USPTO’s 2019 Revised Subject Matter Eligibility Guidance flowchart is provided below.

Under Step 2A Prong 1 of the analysis, the examiner noted that the components set forth in the claims were naturally occurring ingredients. Specifically, psilocybin and psilocin are naturally found in Psilocybe mushrooms, erinacine and hericenone are naturally found in Hericium mushrooms, and niacin (vitamin B3) is naturally found in mushrooms. Because the claimed composition simply contained a combined mixture of elements which are individually present in nature, the examiner concluded that the claims recited a product of nature, a judicially recognized exception to subject matter eligibility.

Under Step 2A Prong 2, the examiner stated there was no integration because functionally each individual component still retained its individual equivalent structure and individual related function, and there was no functional change in the characteristics of the components individually, or as a whole, as no transformation nor anything additional was recited in the claims to demonstrate a practical application.

Under Step B, the examiner found that the claimed compositions as a whole failed to recite something significantly more or markedly different from the components as they occur in nature individually.

The Board’s Analysis

The Board affirmed that all claims were invalid under 35 U.S.C. §101 for reciting patent-ineligible subject matter.

Under Step 2A Prong 1, the Board noted that because the claimed invention recited nature-based product limitations, the markedly different characteristics (MDC) analysis should be used to determine if the nature-based product limitation is a product of nature exception. Referring to Myriad, the Board found there was no indication on the record that mixing the nature-based ingredients in the claims resulted in a transformation of the products or that the mixtures had properties not possessed by the products in nature. Further, the Board was not persuaded that the claimed compositions were patent eligible simply because they were the result of a mixture of different nature-based products which themselves are not found together in nature. Hence, the Board concluded that under Step 2A Prong 1 the claims recited a judicial exception (i.e. a product of nature).

Under Step 2A Prong 2, the Board found that the specific milligram quantities of the nature-based components recited in the claims were insufficient to integrate the judicial exception into a practical application.

Under Step B, the Board found that the claims did not recite any specific limitation beyond the judicial exception that is not “well understood, routine, conventional” in the field. Relatedly, the Board referred to Funk Brothers, where mixing different bacterial strains wasn’t enough to confer patent eligibility without changing the bacteria themselves.

Continued Prosecution Post-Appeal

Following the Board’s decision, Turtle Bear Holdings filed a Request for Continued Examination (RCE). After filing new claims (directed to pharmaceutical formulations or dosages of instead of compositions), submitting expert declarations from the inventor, conducting examiner interviews, and emphasizing that the claimed formulations or dosages (i) showed markedly different characteristics that are not observed with the individual components themselves and (ii) integrated the judicial exception into a practical application, Turtle Bear Holdings successfully obtained an issued patent (U.S. 11,590,120).

Key Takeaways for Practitioners

This case highlights challenges which may be encountered when pursuing patents on natural products, even when the invention involves combining individual natural ingredients in unique ways or in specific quantities.  Having expert declarations or other evidence showing that the claimed products exhibit markedly different characteristics that are not observed with the individual components themselves, and presenting claims that specify practical applications of the combination of natural elements, can be helpful in establishing patent eligibility.

PERA Implications

Under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140), the composition claims that were found ineligible by the Board would likely have been considered to meet the patent eligibility requirement (e.g. pursuant to §§101(a), (b)(2)(A)).

Related Reading

As noted above, the Board was not persuaded that the claimed compositions were patent eligible just because they recited mixtures of different nature-based products that are not found together in nature. Compare this result with the Board’s conclusion in Ex parte Murty, where the Board found the requirements of Step 2A Prong 1 were not met (thus establishing patent eligibility), because there was no evidence that the specifically claimed combination of ingredients, as distinguished from the individual ingredients, existed in nature.

¹ Ex parte Stamets (Appeal 2020-006595; November 25, 2020)