Section 101 Examples
Example 11 (3): Amazonic Acid, Pharmaceutical Compositions, & Methods of Treatment

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 11 (3): Amazonic Acid, Pharmaceutical Compositions, & Methods of Treatment

This example illustrates the application of the markedly different characteristics analysis to single- element product claims (claims 1, 2 and 3) and to a product-by-process claim (claim 4). It also demonstrates that changes in chemical structure (claims 2 and 3), physical form (claim 5), or chemical/physical properties (claim 6), as compared to a product’s natural counterpart can demonstrate markedly different characteristics. Additionally, this example provides samples of claimed processes that when viewed as a whole are not directed to a nature-based product, and thus are not subjected to the markedly different characteristics analysis in order to determine that the claim is not directed to an exception (claims 7 and 8).

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 and colon cancers. 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 and functionally identical to the amazonic acid in the leaves. Applicant has created two derivatives of amazonic acid in the laboratory. The first derivative (called 5-methyl amazonic acid), is structurally different from amazonic acid because a hydrogen has been replaced with a methyl group, and is functionally different because it stimulates the growth of hair in addition to treating cancer. The second derivative (called deoxyamazonic acid), was created by removing a hydroxyl group from amazonic acid and replacing it with a hydrogen. Applicant has not identified any functional difference between deoxyamazonic acid and amazonic acid.

Amazonic acid is absorbed through the lining of the human stomach and is rapidly metabolized by the body. It is also insoluble in water. Applicants disclose an example of a solid pharmaceutical composition demonstrating that when a core of amazonic acid is enveloped by a layer of a natural polymeric material, the resulting manufacture does not release the amazonic acid until it reaches the colon. This colonic release greatly improves the bioavailability of amazonic acid, and is particularly advantageous in the treatment of colon cancer. The specification defines “natural polymeric material” as being a naturally occurring polymer that is not easily digestible by human enzymes, so that it passes through most of the human digestive system intact until it reaches the colon. Specific disclosed examples are shellac and inulin. Applicants disclose an example of an aqueous composition, in which they were able to achieve a stable solution of amazonic acid in water by including a solubilizing agent in the solution. The solubilizing agent can be a naturally occurring product such as a sugar or polyol, or it can be a non- naturally occurring product such as a polysorbate surfactant.

Claims:

1. Purified amazonic acid.
2. Purified 5-methyl amazonic acid.
3. Deoxyamazonic acid.
4. A composition comprising an acid produced by a process which comprises: providing amazonic acid; and replacing the hydroxyl group of the amazonic acid with a hydrogen.
5. A pharmaceutical composition comprising: a core comprising amazonic acid; and a layer of natural polymeric material enveloping the core.
6. A stable aqueous composition comprising: amazonic acid; and a solubilizing agent.
7. A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.
8. A method of treating breast or colon cancer, comprising: administering an effective amount of purified amazonic acid to a patient suffering from breast or colon cancer.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All of the claims are directed to a statutory category, e.g., a composition of matter or process (Step 1: YES). Because claims 1-6 are nature-based products (e.g., amazonic acid, 5-methyl amazonic acid, or deoxyamazonic acid), the markedly different characteristics analysis is used to determine if the nature- based products are exceptions. Although claims 7-8 recite nature-based products (amazonic acid), a full eligibility analysis of these claims is not needed because the claims clearly do not seek to tie up all practical uses of the nature-based products.

Claim 1: Ineligible.

Although applicant has discovered that amazonic acid naturally occurs in the leaves of the Amazonian cherry tree, this discovery does not, by itself, render amazonic acid patent eligible. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. , 133 S. Ct. 2107, 2117 (2013) (“Myriad”). Instead, the claimed acid is analyzed to determine if separating the acid from its surrounding material in the leaf has resulted in the purified amazonic acid having markedly different characteristics from its naturally occurring counterpart. Based on the limited background information, there is no indication that purified amazonic acid has any characteristics (structural, functional, or otherwise) that are different from naturally occurring amazonic acid. The claim therefore encompasses amazonic acid that is structurally and functionally identical to naturally occurring amazonic acid. Because there is no difference between the claimed and naturally occurring acid, the claimed acid does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. 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 exception (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.

The claimed 5-methyl amazonic acid has a different structural characteristic than amazonic acid (its chemical structure is different due to the addition of the 5-methyl group). Because 5- methyl amazonic acid is a unique molecule that is distinct from, and does not prevent others from using, naturally occurring amazonic acid, its different structural characteristic rises to the level of a marked difference. Accordingly, the claimed 5-methyl amazonic acid is not a “product of nature” exception. This conclusion is bolstered by the fact that the different structural characteristic has resulted in a different functional characteristic (the stimulation of hair growth). Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Claim 3: Eligible.

The claimed deoxyamazonic acid has a different structural characteristic from amazonic acid (its chemical structure is different due to the removal of a hydroxyl group). Based on the limited background information, this change in structure has not resulted in any different functional characteristics. However, because deoxyamazonic acid is a unique molecule that is distinct from, and does not prevent others from using, naturally occurring amazonic acid, its different structural characteristic rises to the level of a marked difference. Accordingly, the claimed deoxyamazonic acid 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.

Claim 4: Eligible.

During examination, a product-by-process claim is not limited to manipulations of the recited steps, but instead is only limited to the structure implied by the steps. In this case, the specification describes that removing a hydroxyl group from amazonic acid and replacing it with a hydrogen results in deoxyamazonic acid. Thus, the acid produced by the claimed process steps is deoxyamazonic acid. As explained with respect to claim 3, deoxyamazonic acid has markedly different characteristics than naturally occurring amazonic acid, and 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.

Claim 5: Eligible.

The claim is limited to a particular pharmaceutical composition having two naturally occurring substances physically joined together into a non-natural structure (core of amazonic acid surrounded by a layer of natural polymeric material). The claimed composition thus is structurally different from the naturally occurring substances, and this structural difference results in the claimed composition having different functional characteristics in vivo (e.g., amazonic acid is not released until the composition reaches the colon, due to the relative indigestibility of the natural polymeric material, thus increasing the bioavailability of the amazonic acid) than the naturally occurring substances by themselves. These different structural and functional characteristics rise to the level of a marked difference, and accordingly the claimed composition 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.

Claim 6: Eligible.

In nature, amazonic acid is insoluble in water. As explained in the specification, however, when amazonic acid is combined with a solubilizing agent, it becomes soluble in water and forms a stable solution. This changed property (solubility) between amazonic acid as a part of the claimed stable aqueous composition and amazonic acid in nature is a marked difference. Accordingly, the claimed composition has markedly different characteristics, and 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.

Claim 7: Eligible.

Although the claim recites a nature-based product (amazonic acid), analysis of the claim as a whole indicates that the claim is focused on a process of practically applying the product to treat a particular disease (colon cancer), and not on the product per se. Thus, it is not necessary to apply the markedly different characteristics analysis in order to conclude that the claim is not directed to an exception (Step 2A: NO). The claim qualifies as eligible subject matter.

Claim 8: Eligible.

Although the claim recites a nature-based product (amazonic acid), analysis of the claim as a whole indicates that the claim is focused on a process of practically applying the product to treat a particular disease (breast or colon cancer), and not on the product per se. Thus, it is not necessary to apply the markedly different characteristics analysis in order to conclude that the claim is not directed to an exception (Step 2A: NO). The claim qualifies as eligible subject matter.