Composition-of-matter inventions – such as chemical formulas, mixtures, pharmaceutical compositions, and biochemical derivatives -are some of the most powerful forms of patent protection available. But they are also heavily scrutinized under 35 U.S.C. § 101, especially when they involve natural products or nature-based ingredients.
The USPTO’s guidance makes clear that a composition is patentable only if it is not “directed to” a product of nature, or, if it is nature-based, it must exhibit markedly different characteristics from its natural counterpart.
This article breaks down how the USPTO evaluates composition claims using three official examples.
1. What Is a Composition Patent?
A composition-of-matter patent protects chemical compounds, mixtures, formulations, and manufactured combinations of ingredients. Examples include:
Pharmaceuticals
Cosmetic formulations
Food and beverage compositions
Chemical mixtures
Material composites
Biochemical derivatives
However, simply discovering something in nature – like a leaf extract, fruit juice, or naturally occurring molecule – does not make it patentable. To be eligible, the claimed composition must reflect human ingenuity, not merely natural discovery.
2. The Legal Test: “Markedly Different Characteristics”
When a claim involves a nature-derived product, the USPTO asks:
Does the claimed composition have structural, functional, or physical characteristics that are markedly different from what exists in nature?
If yes, the claim is patent-eligible.
If no, the claim is treated as a product of nature and rejected under § 101.
Marked differences can arise from:
Structural change (new chemical structure)
Functional change (new properties or behaviors)
Physical or chemical differences (e.g., solubility, stability, delivery behavior)
New combinations that do not occur in nature
3. Example 1: Gunpowder & Fireworks — Patentable Compositions
Gunpowder Mixture (Eligible)
A claim combining three natural substances: potassium nitrate, charcoal, and sulfur. Although each component exists in nature, they do not occur together in a finely-ground ratio mixture.
Individually, none are explosive.
Together, they produce a new explosive property.
This is a markedly different characteristic, so the composition is patentable.
4. Example 2: Pomelo Juice — When Processing Natural Materials Becomes Patentable
Method of “Providing a Pomelo Fruit” (Not Eligible)
A claim that simply says “providing a pomelo fruit” is equivalent to claiming the fruit itself. There is no transformation or new characteristics.
Thus, the claim is directed to a natural product, and nothing in the claim adds “significantly more.” It is not patentable.
Beverage Composition With Added Preservative (Eligible)
Here, pomelo juice is mixed with a preservative – natural or synthetic – in an “effective amount” that allows the juice to last weeks instead of days.
Natural pomelo juice spoils within days.
The claimed composition spoils much more slowly.
Because the combination exhibits new functional characteristics (slower spoilage), it is markedly different and patent-eligible.
5. Example 3: Amazonic Acid & Pharmaceuticals – The Full Spectrum
Purified Natural Chemical (Not Eligible)
Applicant isolated “amazonic acid” from a plant. Even though purification required human effort, the purified molecule is identical to the molecule found in nature.
Under Myriad, purification alone does not create patentability. There are no markedly different characteristics, so the claim is ineligible.
Chemically Modified Derivatives (Eligible)
Two derivatives were created:
5-methyl amazonic acid: new structure + new function (hair growth + cancer treatment)
Deoxyamazonic acid: new structure, same function
Both molecules have non-natural chemical structures, making them distinct from natural amazonic acid. Structural difference alone can establish eligibility.
Product-By-Process Claim (Eligible)
A claim defining the molecule “as produced by a process removing a hydroxyl group” results in deoxyamazonic acid—again, a new chemical structure, so it is eligible.
Pharmaceutical Composition With Polymers (Eligible)
A drug core surrounded by a natural polymer coating that allows colon-specific release has new:
Structural characteristics
Functional behavior inside the body
Thus, it is markedly different from what exists in nature and is eligible.
Aqueous Solution With Solubilizing Agent (Eligible)
In nature, amazonic acid is insoluble in water. The claimed composition renders it soluble and stable: a new physical property. That change is enough to establish eligibility.
Treatment Methods (Eligible)
Claims reciting using amazonic acid to treat cancer qualify because they are directed to a practical application, not the natural product itself.
6. Key Takeaways for Inventors
Nature-based components can be patentable if:
They are part of a new mixture,
They are chemically modified,
They exhibit new properties or functions, or
They are incorporated into a manufactured structure or device.
Purely natural products, even if purified, are NOT patentable unless:
The claimed form has structural/functional differences from the natural form.
7. What This Means For Your Invention
If you’re developing:
a new formulation
a new food or beverage blend
a pharmaceutical composition
a cosmetic or topical treatment
a chemical derivative or modified molecule
a new delivery system
a new functional mixture of natural ingredients
You may very well be able to obtain a patent, even if the starting materials exist in nature.
The key is demonstrating human-created differences that give rise to new structure, function, or behavior.
Ready to move ahead with patent protection on your composition invention? Contact us at admin@legacypatents.com or click the link below, and we will help guide you!
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