Nature-Based Food Products May Be Eligible for Patenting Under 35 U.S.C. § 101

According to the U.S. Patent and Trademark Office’s 2014 Interim Guidance on Patent Subject Matter Eligibility (2014 IEG), there are several categories of nature‑based products which may be eligible for patenting, such as chemical mixtures, plant extracts, purified proteins, genetically modified bacteria, agricultural bacterial mixtures, nucleic acids, antibodies, biological cells, and foods.  In this example, we’ll take a closer look at how the Patent Office determines whether certain food products are eligible for patenting.

The Science of Yogurt

Traditionally, yogurt is made by mixing bacteria and milk together to create a culture.  The metabolic activity of the culture results in the production of lactic acid, and in turn, the lactic acid causes proteins within the milk to clump together, thickening the milk to form yogurt.

The Invention

In this example, the inventor has found a new naturally occurring species of bacteria called Lactobacillus alexandrinus.¹ The inventor has discovered that by mixing L. alexandrinus with milk and Streptococcus thermophilus (a naturally occurring bacterial species well known for making yogurt), the resulting culture produces a yogurt having a pleasant tangy flavor. The inventor has also discovered that the two mixed bacteria act synergistically to ferment milk at twice the speed than either bacteria can ferment by itself, and the resultant yogurt is much lower in fat than either bacteria can produce when used by itself.

Based on these discoveries, the inventor would like to patent two products. The product on the left is a kit that can be used for making yogurt. The kit includes a packet of S. thermophilus along with a separate packet of L. alexandrinus. The product on the right is a culture for making yogurt. The culture includes a mixture of the two bacteria along with milk.

According to 35 U.S.C. § 101, products of nature are not eligible for patenting.  So how can the inventor obtain a patent based on these discoveries?  The answer lies in the specific wording that is used for the claims which will be included in the patent application.

Claims in the Patent Application

The inventor files a patent application with the following two claims:

1. A kit for preparing milk yogurt comprising:

          Streptococcus thermophilus and Lactobacillus alexandrinus.

2. A yogurt starter culture comprising:

          milk mixed with Streptococcus thermophilus and Lactobacillus alexandrinus.

The Kit Is Not Eligible for Patenting, Whereas the Culture is Eligible

Under the USPTO’s 2014 IEG, the claims would be reviewed according to this flowchart.

Claim 1

Under Step 1 of the analysis, the kit claim is directed to a statutory category, specifically a composition of matter.  So, the answer to Step 1 is YES.

We know that the kit involves a nature-based product, because it includes bacteria that can be used in the production of food. Under Step 2A, the markedly different characteristics (MDC) test can be used to determine whether a nature-based product is a “product of nature” judicial exception. According to the USPTO guidelines, if the nature-based products as presented in the claim have markedly different characteristics as compared to any naturally occurring counterparts, there is no judicial exception and the claim is eligible (Step 2A: NO), whereas if the nature-based products do not have markedly different characteristics, then the claim is directed to the “product of nature” judicial exception (Step 2A: YES) and the analysis proceeds to Step 2B.

In this example, the claimed kit includes the two bacterial species, each in their own packet. Their presence in the kit does not markedly change their characteristics. Therefore, the answer to Step 2A is YES and we proceed to Step 2B. The kit claim does not recite any additional elements that could amount significantly more than the “product of nature” exception (Step 2B: NO), and therefore the claim does not pass the 35 U.S.C. § 101 test for subject matter eligibility.

Claim 2

As with the kit claim, under Step 1 of the analysis the culture claim is directed to a statutory category, namely a composition of matter. Again, the answer to Step 1 is YES.

According to the markedly different characteristics analysis (MDC) at Step 2A, we know that after mixing, the bacterial species promote faster fermentation and reduced fat yogurt, which are marked differences in terms of bacterial function and activity when compared to the bacteria in their natural state. Hence, the culture is not a “product of nature” judicial exception (Step 2A: NO) and the claim is eligible for patenting under 35 U.S.C. § 101.

Revised Guidance for Step 2A

In 2019, the USPTO published Revised Patent Subject Matter Eligibility Guidance (2019 PEG) to provide increased clarity, predictability, and consistency in how Section 101 is applied during patent examination. The 2019 PEG revised the procedure at Step 2A for determining whether a claim is directed to a judicial exception (e.g. product of nature) by using a two-prong inquiry.

In this food invention example, the outcome of the patent eligibility determination still remains the same following implementation of the 2019 PEG. This is because the Step 2A Prong 1 still applies the markedly different characteristics (MDC) test, and under Step 2A Prong 2, the kit claim does not recite any additional elements beyond the two bacterial species. If the kit claim did recite any additional elements, the question would be whether the additional elements operated to integrate the product of nature into a practical application.

¹ U.S. Patent and Trademark Office, ‘2014 Interim Guidance on Patent Subject Matter Eligibility,’ 79 Fed. Reg. 74618 (Dec. 16, 2014) [Nature Based Example 10, pp. 16-17; PDF]