Psychedelic Alpha reports
As reported by our Editor-at-Large Graham Pechenik over on Twitter, it appears that a years-long effort “across multiple applications [and] several appeals” has resulted in success for Paul Stamets.
US Patent 11,590,120, which covers combinations of psilocybin and lion’s mane extract, alone and with niacin, has been issued. This combination is colloquially referred to as the ‘Stamets Stack’, which is now the subject of a drug development push by Stamets’ MycoMedica Life Sciences, which secured $60m in funding last summer.
Stamets’ ’120 Patent issued from one of at least ten child applications that sprouted from a first provisional application filed on July 23, 2016. Stamets’ composition claims originally fared poorly with examiners, accruing “§ 101” rejections for being “patent ineligible” naturally-occurring products, as nothing more than a combination of compounds all naturally present in Psilocybe and lion’s mane mushrooms (failing the patent office’s “markedly different characteristics” test).
Stamets appealed these rejections to administrative patent judges several times; in each case, the examiner’s rejections were affirmed (“the claims merely recite a mixture of individual naturally-occurring components, and nothing else additionally”).
In the application leading to the ’120 Patent, Stamets ultimately persuaded the examiner that his claims were to more than natural products, by amending them to recite “pharmaceutical formulations” and “pharmaceutical dosage forms” (these “are not natural phenomena” and “distinguish the claims from a mere assembly of natural products”), and by submitting an affidavit demonstrating that the combination of compounds “provides a synergistic effect that is not expected based on what is known in the prior art,” and is thus “markedly different from the naturally occurring components.”
Subsequently, after six and a half years and four Requests for Continued Examination (RCEs), a patent with composition claims covering the “Stamets Stack” finally issued. Numerous other Stamets’ applications remain pending, including one with claims on the use of psilocybin or psilocin alone to reduce symptoms of depression or anxiety (in which Porta Sophia filed a third-party submission of prior art last May).