December 13, 2022Update by Grace Kim and Sara Pistilli, PharmD.
On December 6, 2022, the Patent Trial and Appeal Board (PTAB) overturned a rejection of a claim to a plant extract based on patent ineligible subject matter (Appeal 2022-001062). Claim 1 of the application US 15/521,212 (the 212 Application) is directed towards:
Claim 1. An extract from a resin of a plant of genus Boswellia, wherein limonene content, linalool content, and thujone content are each less than 20 ppm in the extract and estragol content is less than 100 ppm in the extract, wherein the limonene content, linalool content, thujone content and estragol content are each calculated based on the dry weight of the extract.
The 212 Application claimed an extract from the resin of a plant of the genus Boswellia and related products and uses. Claim 1 recited “the content of limonene, linalool, and thujone as less than 20 ppm and the estragol content as less than 100 ppm.” The Examiner determined that the extract claimed was patent ineligible subject matter, stating that “the extract comprised the same components found in the plant and had the same activity and characteristics as the compounds found in the plant.” (Appeal Decision p. 3) The Examiner concluded that the claims do not recite additional elements that amount to significantly more than a product of nature, thus deeming the claimed composition as patent ineligible.
The Appellant explained that some normally occurring compounds in the Boswellia extract are known as neurotoxins or carcinogens. The claimed extract, however, had reduced amounts of these unwanted compounds making the extract physically different than the naturally occurring resin. The lower levels of unwanted compounds also made the claimed extract more tolerable and less toxic, thus making the claimed extract have different characteristics. Based on these two arguments, the Appellant concluded the claimed extract should be considered patent eligible subject matter.
The PTAB used the two-step framework created by the Supreme Court in Alice Corp. v. CLS Bank Int’l (573 U.S. 208, 216 (2014)) and Mayo Collaborative Services v. Prometheus Labs., Inc. (566 U.S. 66, 75–77 (2012)) and instructed by the USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”). The PTAB concluded that contrary to the Examiner’s conclusion for Step 2A of the Guidance, the extract claimed was markedly different from the naturally occurring resin due to the change in composition and function. This conclusion hinged on the PTAB’s analysis that the claimed extract was composed of different amounts of components compared to the naturally occurring resin. Notably, the PTAB specifically pointed out an example in the Guidance, Example 44, which showed that a mixture of two compounds resulting in a different composition despite retaining each compound’s individual properties would be deemed patent eligible. The PTAB held, “[w]hile we agree with the Examiner that the individual components retain their separate properties and the composition has the same use as prior extracts, there are differences in the composition and its properties when compared to the natural product.” (Appeal Decision p. 6)
The PTAB also distinguished the 212 Application from isolated DNA segments in Myriad, stating that in Myriad, the claims were directed to patent ineligible subject matter “because the isolated DNA was not significantly different from the naturally occurring DNA” but the present case presents “a composition that comprises several different compounds in amounts different from the naturally occurring resin.” (Appeal Decision p. 6)
In the Final rejection of the 212 Application, the Examiner also rejected the claims as being obvious over Gokaraju et al. (US 2011/0159120) and Majeed et al. (US 2007/0231345).
Gokaraju disclosed a dietary supplement consisting of two Boswellia serrata extracts. (Gokaraju ¶ 001). Similarly, Majeed disclosed the use of a Boswellia serrata extract. (Majeed ¶ 0011). The Examiner stated that because the 212 Application, Gokaraju and Majeed are all directed towards Boswellia serrata extracts, the claimed composition would be inherently the same as in Gokaraju and Majeed. The Examiner further took the position that reducing the levels of undesirable compounds, as claimed in the 212 Application, would be a matter of routine experimentation. (Appeal Decision p. 7)
The PTAB rejected the Examiner’s logic by stating that inherency is not properly established solely because each of the claimed extracts are sourced from Boswellia serrata. (Appeal Br. 8) The PTAB explained that the differences in extraction processes used by Gokaraju (Gokaraju ¶ 0042), a person normally skilled in the art would understand the claimed extract differed from the extract produced in Gokaraju. Finally, the PTAB concluded that there was no motivation or reasoning for a person skilled in the art to reduce the levels of limonene, linalool, thujone, and estragol, absent reading the 212 Application, and the Examiner did not show that reducing the undesirable components in Boswellia-based extracts was known in the art.
As in the case of the 212 Application, even if the individual compounds in a composition have the same properties as they have in a natural product, and the composition has the same use as prior extracts, if the claimed composition has different amounts of the compounds and results in markedly different properties than the natural product, the composition is patent eligible under 35 U.S.C. §101. Moreover, for rejections based on inherency, if the compositions or extracts produced by different methods would be different, the compositions or extracts are not inherently the same. Further, when the Examiner makes an obviousness rejection based on “matter of routine experimentation,” Applicants should consider whether the Examiner has shown that the reason for such modification or experimentation was known in the art.