The Trials and Tribulations of Patent Eligibility of Natural Products at the PTAB

March 8, 2018

      As patent prosecution practitioners, we often look for direction from the judges at the PTAB, particularly when agreement cannot be reached at the examining level. This is very evident when there is imprecise guidance as to what constitutes patent eligible subject matter for inventions including natural products following the Supreme Court’s decision in Myriad as well as the various iterations of PTO guidance and training materials. Here is a tale of two cases with two different panels (yet each panel interestingly includes one common APJ (New)) and each panel renders very different decisions.

      Ex parte Kies (Appeal 2017-002990, Application Serial no. 13/064,449, decision issued October 2, 2017) included a 101 rejection for this claim:

15. An oral dietary composition which retains or restores muscle health; protecting muscle against damage associated with oxidative stress or exercise; maintains muscle health during exercise; or promotes muscle recovery after exercise, comprising an effective amount of hydroxytyrosol and vitamin C, wherein said hydroxytyrosol is purified to be free of salidroside, and wherein said vitamin C is purified to be free of salidroside.

The argument for patent eligibility constituted:

 Appellants contend that the combination of hydroxytyrosol and vitamin C without the presence of salidroside does not occur in nature. Appeal Br. 8. Appellants point to the fact that the hydroxytyrosol and vitamin C have been purified to be free of salidroside and that this render the claims patentable.

Apparently, there was no evidence proffered (at least timely, see fn 6 in the decision) that the combination of natural products “is markedly different than what exists in nature.” The panel in Kies concluded:

We agree with the Examiner that the claims encompass patent ineligible subject matter. Both hydroxytyrosol and vitamin C are naturally occurring. Final Act. 3. While the combination of the two ingredients may not appear in nature, the combined product has not been shown to possess . . . properties other than what is found in nature.

      Now consider Ex parte McCausland (Appeal No. 2016-004128, Application Serial no. 11/415,837, decision issued September 5, 2017) in which a new 101 rejection was entered in the Examiner’s Answer against this claim:

1. A nutritional supplement, comprising: a liquid fruit component including at least an extract of at least one oligoproanthocyanidin-containing fruit, at least the extract including an oligoproanthocyanidin; and a transfer factor component dissolved in the liquid fruit component and including transfer factor, 

the transfer factor retaining an ability to elicit an immune response in the presence of the oligoproanthocyanidin.

      As in Kies, the Examiner’s position relied on the fact that the components were natural products and the lack of evidence showing that there were differences from the natural occurring material. This panel disagreed with the Examiner’s position:

We do not agree. Simply put, oligoproanthocyanidins are found in, and may be extracted from, plants, including certain fruits. . .

 . . .Transfer factor, on the other hand, is a signaling polypeptide produced in colostrum, a form of milk produced by the mammary glands of mammals (including humans) in late pregnancy. The Examiner points us to no naturally-occurring composition in which these plant- and animal-produced compounds are simultaneously found. 

This panel goes further to explain that

Put another way, absent evidence that these constituents co-exist in any naturally-occurring composition, any composition combining these constituents must necessarily be an artificially constructed one, and not a natural phenomenon excluded from patentability by Section 101. Rather, Appellants’ claims are directed to a patentable composition of matter, i.e., “a nonnaturally occurring manufacture or composition of matter—a product of human ingenuity ‘having a distinctive name, character [and] use.’”

Unlike Funk Bros., in which the various bacterial strains were all naturally associated with leguminous plants, here there is no natural connection whatsoever between the plantderived OCPs and the mammal-produced transfer factor. These elements do not combine in nature and the only way in which they can be combined is via the artifice of the inventor. That fact takes Appellants’ invention out of the realm of Section 101 and makes it an invention that is patent-eligible.

The panel’s reasoning and analysis in McCausland is more thorough when compared to Kies and this author thinks actually reaches the correct conclusion.