In summary, all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products should be examined using the Guidance. The new procedure set forth in the Guidance will assist examiners in determining whether a claim reflects a significant difference from what exists in nature and thus is eligible, or whether a claim is effectively drawn to something that is naturally occurring, like the claims found ineligible by the Supreme Court in Myriad. A full explanation of the new procedure and multiple examples of its application are set forth in the Guidance.
The Myriad/Mayo guidelines include an example of a Brazilian Cherry Tree found in the Amazon that discuss the patent eligibility of a purified amazonic acid, the example read as follows:
Background: The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon basin region of Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in treating breast cancer, however, to be effective, a patient must eat 30 pounds of the leaves per day for at least four weeks. Many have tried and failed to isolate the cancer-fighting chemical from the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has named it amazonic acid. The purified amazonic acid is structurally identical to the amazonic acid in the leaves, but a patient only needs to eat one teaspoon of the purified acid to get the same effects as 30 pounds of the leaves. Applicant has discovered that amazonic acid is useful to treat colon cancer as well as breast cancer, and applicant has also created a derivative of amazonic acid in the laboratory (called 5-methyl amazonic acid), which is structurally different from amazonic acid and is functionally different, because it stimulates the growth of hair in addition to treating cancer.
Composition vs. Method Claims, Each Reciting A Natural Product
Claim 1. Purified amazonic acid.
Claim 2. Purified 5-methyl amazonic acid.
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1. Question 1: Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
2. Question 2: Does the claim recite or involve one or more judicial exceptions?
3. Question 3: Does the claim as a whole recite something significantly different than the judicial exception(s)?
Analysis of Claim 1: The answers to Questions 1-2 in the above analysis are both “yes”, because the claim is to a composition of matter, and because the claim recites a judicial exception, i.e., amazonic acid is a naturally occurring chemical found in the leaves of Amazonian cherry trees. The answer to Question 3 is “no”, because the claim as a whole does not recite something significantly different than the natural product, e.g., the claim does not include elements in addition to the judicial exception that add significantly more to the judicial exceptions, and also does not include features that demonstrate that the recited product is markedly different from what exists in nature.
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