Section 101 Examples
Example 18 (10): Food

This is an example provided by the U.S. Patent and Trademark Office for analyzing Section 101 patent subject matter eligibility issues. The example is one of the "Nature Based Product Examples" provided by the USPTO on December 16, 2014, and this example should be viewed in light of the introduction that was provided with it. The original PDF document is found here. The numbering of these examples is taken from Appendix 2 of the July 2015 Update on Subject Matter Eligibility.

The index for all of the examples provided by the Patent and Trademark Office is found on BitLaw's Section 101 Index.

Example 18 (10): Food

This example illustrates the difference between a nature-based product claim having multiple components that are unchanged because they are not combined (claim 1), and a nature-based product claim having multiple components that are changed by their combination (claim 2).


Goats are naturally occurring animals that produce milk to feed their young. Humans have consumed goat milk and products made from goat milk (e.g., cheese and yogurt) for centuries. One well- known method of making goat yogurt is to create a starter culture by mixing raw goat milk with bacteria, and then heating the starter culture to about 115 degrees Fahrenheit for several hours so that the bacteria can ferment the milk. The fermentation causes the conversion of lactose (milk sugar) in the goat milk into lactic acid, and this chemical change results in a physical change (the thickened consistency of the yogurt as compared to the goat milk). The lactic acid also makes the yogurt have a tangy flavor. Multiple species of bacteria are known as useful in making yogurt, including Streptococcus thermophilus (a naturally occurring bacterial species).

Applicant has discovered a new naturally occurring bacterial species that it named Lactobacillus alexandrinus. Goat milk yogurt made with L. alexandrinus has a pleasant tangy flavor. Neither S. thermophilus nor L. alexandrinus occur naturally in goat milk, and these bacteria do not occur together in nature. Applicant has also discovered that when mixed, S. thermophilus and L. alexandrinus have different properties than either bacteria has alone: (1) the mixed bacteria act synergistically to ferment goat milk at twice the speed than either bacteria can ferment by itself; and (2) the resultant goat yogurt is much lower in fat than either bacteria can produce when used by itself. Applicant discloses compositions comprising a goat milk starter comprising goat milk mixed with S. thermophilus and L. alexandrinus. Applicant also discloses kits for preparing goat milk yogurt. The kits comprise a separate packet of S. thermophilus, and a separate packet of L. alexandrinus, and may also comprise instructions for combining the two bacterial species with goat milk to make yogurt.


1. A kit for preparing goat milk yogurt comprising: Streptococcus thermophilus and Lactobacillus alexandrinus.
2. A yogurt starter culture comprising: goat milk mixed with Streptococcus thermophilus and Lactobacillus alexandrinus.

Analysis of Claims:

These claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. Because both claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES), and are nature-based products (goat milk and/or bacteria), the markedly different characteristics analysis is used to determine if the nature-based products are exceptions.

Claim 1: Ineligible.

As described in the specification, both S. thermophilus and L. alexandrinus are naturally occurring bacteria. There is no indication in the specification that the claimed bacteria have any characteristics (structural, functional, or otherwise) that are different from the naturally occurring bacteria. Because the bacterial species in the kit are not mixed, but instead are separate from each other, their inclusion in the same kit does not change their characteristics. Although the user of the kit may choose to mix the bacteria together at some time in the future, that mixture, which may or may not exist in the future is not a part of the claimed invention. In re Venezia, 530 F.2d 956, 958-59 (CCPA 1976). Thus, the bacterial species in the kit do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, the claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional features that could add significantly more to the exceptions (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.

Claim 2: Eligible.

As described in the specification, when S. thermophilus and L. alexandrinus are mixed, the two bacterial species have different characteristics than either species does on its own, e.g., they act together to ferment milk into a lower fat yogurt than either bacteria can produce when individually mixed with the milk. Thus, the mixture of the bacteria and milk has different functional characteristics (lower fat content) than the naturally occurring bacteria (or milk) by itself. These differences rise to the level of a marked difference, and accordingly the claimed starter culture is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.