2.1 Patent-Eligible Subject Matter & Statutory Categories
Key Takeaways
- 35 U.S.C. § 101 defines four statutory categories of invention: process, machine, manufacture, and composition of matter.
- Section 101 acts as a threshold gateway requirement; an invention must fit at least one statutory category before evaluating novelty (§ 102), nonobviousness (§ 103), and disclosure (§ 112).
- Under Diamond v. Chakrabarty, patentable subject matter includes 'anything under the sun that is made by man,' provided it is non-naturally occurring.
- Under Myriad Genetics, naturally occurring, isolated genomic DNA is ineligible for patenting, whereas lab-synthesized cDNA is patent-eligible because it does not exist in nature.
- Congress bars claims directed to or encompassing human organisms and inventions useful solely in atomic weapons; AIA § 14 instead treats tax strategies as insufficient to distinguish a claimed invention from the prior art, not as a blanket patent ban.
2.1 Patent-Eligible Subject Matter & Statutory Categories
To obtain a patent in the United States, an invention must first clear the threshold gateway requirement established by 35 U.S.C. § 101. Section 101 sets forth the statutory criteria for patent eligibility, defining what types of discoveries Congress intended to protect.
The Statutory Language & Gateway Role of § 101
The statutory text of 35 U.S.C. § 101 states:
"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title."
On the Patent Bar exam, it is vital to understand that § 101 operates as an initial threshold gatekeeper. Passing § 101 eligibility examination does not mean an invention is patentable. The claimed invention must still satisfy all other statutory requirements under Title 35:
- Novelty under 35 U.S.C. § 102
- Nonobviousness under 35 U.S.C. § 103
- Written Description, Enablement, and Definiteness under 35 U.S.C. § 112
If a claim fails under § 101, the examiner issues a subject matter eligibility rejection regardless of how novel, nonobvious, or well-described the invention may be.
The Four Statutory Categories (MPEP § 2106.03)
An invention must fall squarely into at least one of the four statutory categories enumerated in § 101. If a claim does not fall into at least one category, it is non-statutory and must be rejected under § 101.
| Statutory Category | MPEP Definition | Practical Examples |
|---|---|---|
| Process | An act, operation, or series of steps performed upon subject matter to produce a practical result; includes chemical processes, manufacturing methods, and physical step sequences. | A method for refining crude petroleum; a process for annealing steel alloys; a step-by-step chemical synthesis protocol. |
| Machine | A concrete entity consisting of an assembly of parts, mechanical elements, electrical circuits, or structural devices operating together. | An internal combustion engine; a computerized CT scanner apparatus; a mechanical sorting device. |
| Manufacture | An article or item produced from raw or prepared materials by giving these materials new forms, qualities, properties, or combinations. | A molded plastic bottle; an optical fiber cable; a synthetic ceramic substrate; an integrated circuit chip. |
| Composition of Matter | All chemical compositions, compounds, biological mixtures, synthetic molecules, and composite materials consisting of two or more substances. | A novel pharmaceutical molecule; a synthetic polymer blend; a bio-engineered recombinant plasmid; a metallic alloy. |
Key Distinction: Products vs. Processes
- Products encompass machines, manufactures, and compositions of matter. A product claim covers a physical structure or chemical entity regardless of how it is made (unless drafted as a product-by-process claim).
- Processes cover actions, activities, or methods. A process claim requires active steps executed over time.
Human-Made Inventions vs. Naturally Occurring Matter
The boundary between patent-eligible subject matter and ineligible natural phenomena has been drawn by landmark Supreme Court jurisprudence.
The Diamond v. Chakrabarty Landmark Rule
In Diamond v. Chakrabarty, 447 U.S. 303 (1980), the Supreme Court evaluated a patent claim directed to a genetically engineered bacterium capable of breaking down crude oil components. The Court held that Congress intended § 101 to cover "anything under the sun that is made by man."
- Because the micro-organism was human-engineered and possessed markedly different characteristics from any naturally occurring bacterium, it constituted a patent-eligible manufacture or composition of matter.
- Naturally occurring live organisms (such as wild bacteria or un-modified plants) remain ineligible.
Isolated DNA vs. cDNA: Myriad Genetics
In Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), the Supreme Court clarified the limits of biological patenting:
- Genomic DNA (Ineligible): Isolating a naturally occurring DNA segment (such as the BRCA1 or BRCA2 breast cancer genes) from surrounding chromosomal material does not render it patent-eligible. Even though isolation requires laboratory technique, the genetic sequence itself is a product of nature.
- Complementary DNA / cDNA (Eligible): Synthetically created cDNA, which contains only protein-coding exons and omits non-coding introns, is patent-eligible. Because cDNA does not occur naturally in the genome, it is a synthetic creation made by human intervention.
| Biological Subject Matter | Patent Status under 35 U.S.C. § 101 | Governing Precedent |
|---|---|---|
| Native genomic DNA sequence | Ineligible (Product of Nature) | Myriad Genetics (2013) |
| Isolated human chromosome segment | Ineligible (Product of Nature) | Myriad Genetics (2013) |
| Synthetic cDNA (exons only) | Eligible (Human-made composition) | Myriad Genetics (2013) |
| Genetically modified bacterium | Eligible (Markedly different characteristics) | Chakrabarty (1980) |
| Recombinant vector / plasmid | Eligible (Man-made DNA construct) | MPEP § 2106.04(b) |
Physical Transformation & Machine-or-Transformation
Historically, the Federal Circuit applied the Machine-or-Transformation Test as the exclusive test for process eligibility under § 101. Under this test, a process is statutory if:
- It is tied to a particular machine or apparatus; OR
- It transforms a specific article into a different state or thing.
In Bilski v. Kappos, 561 U.S. 593 (2010), the Supreme Court held that while the machine-or-transformation test is not the sole test for patent eligibility, it remains an important useful clue or investigative tool for assessing process claims under § 101.
Statutory Exclusions & Congressional Prohibitions
Beyond judicial exceptions, Congress has explicitly carved out certain subject matter from patentability by statute:
- Human Organisms Prohibition (AIA § 33(a)): Under Section 33(a) of the Leahy-Smith America Invents Act (AIA), no patent may issue on a claim directed to or encompassing a human organism at any stage of development (including fetuses, embryos, or cloned human beings).
- Tax Strategies (AIA § 14): AIA Section 14 deems a strategy for reducing, avoiding, or deferring tax liability insufficient to differentiate a claimed invention from the prior art. It is a prior-art/nonobviousness rule rather than a categorical § 101 exclusion of every claim that also uses tax-related technology.
- Nuclear Weapons & Special Nuclear Material (42 U.S.C. § 2181): Under the Atomic Energy Act of 1954, no patent shall be granted for any invention or discovery useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon.
An applicant files a patent application containing a claim directed to a 'method of treating industrial wastewater comprising flowing wastewater through a settling chamber, adding a synthetic flocculant polymer, and filtering precipitate through a porous membrane.' Under 35 U.S.C. § 101 and MPEP § 2106.03, into which statutory category does this claim fall?
A biotechnology company isolates a naturally occurring gene sequence (BRCA3) from human blood samples and also synthesizes a complementary DNA (cDNA) strand containing only coding exons of BRCA3. Based on Association for Molecular Pathology v. Myriad Genetics, Inc., how should an USPTO examiner evaluate these claims under 35 U.S.C. § 101?
Under Section 33(a) of the Leahy-Smith America Invents Act (AIA), which of the following subject matters is strictly prohibited from receiving a U.S. patent?
Which statement correctly describes the legal relationship between 35 U.S.C. § 101 subject matter eligibility and the requirements of 35 U.S.C. §§ 102, 103, and 112?