Subject Matter Eligibility Under 35 Usc 101.
Subject Matter Eligibility under 35 U.S.C. §101
1. Introduction
35 U.S.C. §101 defines patentable subject matter in the United 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."
Key Point: §101 sets threshold eligibility for a patent. It is the first hurdle before examining novelty (§102), non-obviousness (§103), or enablement (§112).
Non-eligible categories (“judicial exceptions”):
Laws of nature
Natural phenomena
Abstract ideas
These are not patentable even if new and useful.
2. Framework for §101 Eligibility
The courts have developed a two-step test (Alice/Mayo framework) to determine patent eligibility:
Step 1: Determine if the claim is directed to a law of nature, natural phenomenon, or abstract idea.
Step 2: Examine whether the claim includes an “inventive concept” that transforms it into patent-eligible subject matter.
3. Landmark Case Laws
Case 1: Diamond v. Chakrabarty (1980)
Facts: Ananda Chakrabarty genetically engineered a bacterium that could break down crude oil.
Issue: Is a genetically modified living organism patentable?
Judgment: Supreme Court ruled yes.
Reasoning: The bacterium was man-made, not a natural phenomenon.
Principle: §101 allows patenting human-made inventions, including living organisms.
Case 2: Mayo Collaborative Services v. Prometheus Laboratories (2012)
Facts: Prometheus patented a method to determine drug dosage based on metabolite levels in the blood.
Issue: Can a process that applies a law of nature be patented?
Judgment: Supreme Court invalidated the patent.
Reasoning: The process simply applied a natural correlation. No inventive concept beyond the natural law.
Principle: Application of a natural law must include inventive steps; mere observation is not enough.
Case 3: Alice Corp. v. CLS Bank International (2014)
Facts: Alice Corp patented a method for mitigating settlement risk in financial transactions using a computer.
Issue: Are computer-implemented abstract ideas patentable?
Judgment: Supreme Court ruled no.
Reasoning: The claim was an abstract idea, and using a generic computer does not make it patentable.
Principle: Software patents must do more than implement an abstract idea on a generic computer.
Case 4: Association for Molecular Pathology v. Myriad Genetics (2013)
Facts: Myriad Genetics claimed patents on isolated DNA sequences linked to breast cancer (BRCA1/BRCA2 genes).
Issue: Are naturally occurring DNA sequences patentable?
Judgment: Supreme Court held that naturally occurring DNA cannot be patented, but cDNA (synthetic DNA) can be.
Reasoning: Isolated DNA is a product of nature, whereas cDNA is man-made.
Principle: Natural products are excluded, synthetic modifications may qualify.
Case 5: Bilski v. Kappos (2010)
Facts: Bilski patented a method for hedging risk in energy trading.
Issue: Are business methods patentable under §101?
Judgment: Supreme Court rejected the patent.
Reasoning: Abstract business methods are not patentable, even if practical.
Principle: Business methods must show technological innovation to qualify.
Case 6: Enfish, LLC v. Microsoft Corp. (2016)
Facts: Enfish patented a self-referential database structure.
Issue: Are software-related inventions abstract ideas under §101?
Judgment: Federal Circuit ruled in favor of Enfish.
Reasoning: Claims focused on specific improvement to computer functionality, not an abstract idea.
Principle: Technological improvements are patent-eligible even if software-based.
Case 7: Ariosa Diagnostics, Inc. v. Sequenom, Inc. (2015)
Facts: Sequenom patented methods for detecting fetal DNA in maternal blood.
Issue: Does applying a natural phenomenon (cell-free fetal DNA) constitute a patentable invention?
Judgment: Federal Circuit invalidated the patent.
Reasoning: The claimed method was based on a natural phenomenon and steps were conventional.
Principle: Application of natural phenomena must include novel, inventive steps.
Case 8: DDR Holdings, LLC v. Hotels.com (2014)
Facts: DDR Holdings patented a method to retain website visitors by combining content from different sources.
Issue: Is this patent eligible under §101?
Judgment: Federal Circuit upheld eligibility.
Reasoning: The claim solved a technical problem specific to the Internet, not an abstract idea.
Principle: Patents addressing technical challenges or improving technology are often §101-eligible.
4. Key Takeaways from §101 Case Law
Patentable subject matter is broad, but judicial exceptions are strictly enforced.
Laws of nature, natural phenomena, and abstract ideas are not eligible, unless transformed by inventive steps.
Technological improvements (software, biotech) are often patentable.
Abstract ideas in business, finance, or generic computer use are generally excluded.
US Supreme Court and Federal Circuit cases form a hierarchy for interpreting §101.
5. Practical Impact
Patent Drafting: Must clearly highlight inventive concept and technical improvements.
Software & AI Patents: Focus on practical, technical solutions, not generic implementation.
Biotechnology & Genetics: Distinguish natural products vs man-made modifications.
Medical Diagnostics: Mere discovery of correlations is not patentable; methods must be inventive.
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