PTAB Finds That Base Oil + Essential Oil Formulation is Not a Natural Product

The Patent Trial and Appeal Board (PTAB) reversed the § 101 rejection of claims directed to a formulation that includes an essential oil in an oil base containing fatty acids, and found the claims to be eligible for patenting.¹ This decision provides helpful insights on how the U.S. Patent and Trademark Office evaluates claims involving products of nature under 35 U.S.C § 101.

The Technology

The case involved Joyce Ma’s formulation of an essential oil dispersed in a base mixture of oils having fatty acids. The fatty acids were present in amounts sufficient to mimic the fatty acid composition of a human cell membrane or sebum (a substance produced by the skin). The formulation was created to improve the penetration or absorption of substances applied to tissues and/or otherwise improve the functioning of the body.

For example, in order to mimic the oleic acid (fatty acid) 30.8% concentration present in human sebum, the patent application described selectively combining different oils (e.g. emu oil, coconut oil) which contain oleic acid in the appropriate ratio in order to achieve the desired oleic acid concentration.

The resulting base oil mixture, by virtue of its resulting fatty acid composition, could for example facilitate and/or improve permeability of the formulation and its components into a target location of the body.

The § 101 Rejection

The examiner rejected the claims under 35 U.S.C. § 101, arguing they were directed to a product of nature. According to the Step 2A Prong 1 analysis, the examiner found the claims to read on a natural product, particularly the compositions of a cell membrane or a sebum of a mammalian cell.

According to the Step 2A Prong 2 analysis, the examiner found that the judicial exception was not integrated into a practical application, because the claimed mixture of fatty acids was not markedly different from its naturally occurring counterpart. Here, the examiner relied upon the claim clause “wherein the fatty acids are in amounts that render a fatty acid composition of the base composition substantially identical to a fatty acid composition of a cell membrane or a sebum of a human cell.”

Under the Step 2B analysis, the examiner concluded that the claims did not include additional elements sufficient to amount to significantly more than the judicial exception, because the addition of an essential oil from a natural plant did not alter the fatty acid composition recited in the claims.

The Board’s Analysis

The PTAB reversed, disagreeing with various aspects of the § 101 rejection.

Under the Step 2A Prong 1 analysis, the Board stated that even if the claimed fatty acids in the oil of the base are substantially identical to the fatty acids in a cell membrane or in human sebum, it remained true that the claimed base is a mixture of selected oils, and not a cell membrane or sebum. Hence, the claimed formulation is not a product of nature.

Further, the Board noted that the claimed mixture of oils resulted in a fatty acid composition conferring functional properties different from those of any of the individual oils themselves.

In sum, the Board resolved the patent eligibility question under Step 2A Prong 1 by finding that the claimed formulation was not directed to a product of nature, without needing to complete an analysis that fully addressed Step 2A Prong 2 or Step 2B. The logical path of the Board’s reasoning can be further understood with reference to the USPTO’s 2019 Revised Subject Matter Eligibility Guidance flowchart excerpted below.

As a side note, although the examiner raised the markedly different characteristics (MDC) question, the Board seemed to implicitly put the burden of proof on the examiner to show that the claimed formulation lacked markedly different characteristics as compared to a product of nature. The Board concluded that because the examiner had not provided such evidence, the claims were eligible for patenting.

Key Takeaways for Patent Practitioners

This decision highlights several important points to consider when pursuing claims involving a product of nature:

1. If the invention involves approximating or artificially replicating a feature present in a naturally occurring material, make sure to thoroughly explain this throughout the specification, drawing sharp distinctions between the synthetic or man-made formulation and the product of nature themselves, while emphasizing that the former contains a specific subcomponent that is intended to mimic a specific subcomponent of the latter
2. When claiming combinations of natural products, make sure to fully flesh out the unique properties conferred by the combination as a whole
3. Even in crowded fields like therapeutic formulations, innovative combinations of elements with clear technical descriptions regarding the conceptual underpinnings of the combinations and their desired effects can help establish patent eligibility

PERA Implications

Although the Board found that the claims met the requirements for §101 eligibility, under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140) there is a good chance this case would not have made it to the Board, because the examiner would likely have concluded that the formulation claims met the patent eligibility requirement (e.g. pursuant to §§ 101(a), (b)(2)(A),(b)(2)(B)).

¹ Ex parte Ma (Appeal 2023-002362; May 30, 2023)