2106.04(b) Laws of Nature, Natural Phenomena & Products of Nature
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I. LAWS OF NATURE AND NATURAL PHENOMENA, GENERALLY
The law of nature and natural phenomenon exceptions reflect the Supreme Court's view that the basic tools of scientific and technological work are not patentable, because the "manifestations of laws of nature" are "part of the storehouse of knowledge," "free to all men and reserved exclusively to none."
Thus, "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter".
The courts have identified the following concepts and products as examples of laws of nature or natural phenomena:
- i. isolated DNA, Ass’n for Molecular Pathology v. Myriad Genetics, Inc.;
- ii. a cloned farm animal such as a sheep, In re Roslin Institute (Edinburgh);
- iii. a correlation between variations in non-coding regions of DNA and allele presence in coding regions of DNA, Genetic Techs. Ltd. v. Merial LLC;
- iv. a correlation that is the consequence of how a certain compound is metabolized by the body, Mayo Collaborative Servs. v. Prometheus Labs.;
- v. a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True Health Diagnostics, LLC;
- vi. electromagnetism to transmit signals, O’Reilly v. Morse;
- vii. qualities of bacteria such as their ability to create a state of inhibition or non-inhibition in other bacteria, Funk Bros;
- viii. single-stranded DNA fragments known as "primers", University of Utah Research Foundation v. Ambry Genetics Corp;
- ix. the chemical principle underlying the union between fatty elements and water, Tilghman v. Proctor;
- x. the existence of cell-free fetal DNA (cffDNA) in maternal blood, Ariosa Diagnostics, Inc. v. Sequenom; and
- xi. the natural relationship between a patient’s CYP2D6 metabolizer genotype and the risk that the patient will suffer QTc prolongation after administration of a medication called iloperidone, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals.
The courts have also noted, however, that not every claim describing a natural ability or quality of a product, or describing a natural process, necessarily recites a law of nature or natural phenomenon.
- Thus, in a claimed method of treating cancer with chemotherapy, the cancer cells’ inability to survive chemotherapy is not considered to be a law of nature.
- Similarly, in a claimed method of treating headaches with aspirin, the human body’s natural response to aspirin is not considered to be a law of nature.
- These claims are accordingly eligible at Prong One unless they recite another exception, in which case they require further analysis in Prong Two (and Step 2B, if needed) to determine their eligibility.
- Similarly, a method of producing a new compound is not directed to the individual components’ ability to combine to form the new compound.
Even if a claim does recite a law of nature or natural phenomenon, it may still be eligible at any of Pathways A through C.
- For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not "directed to" that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype.
- This particular treatment step applied the natural relationship in a manner that integrated it into a practical application.
The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).
A claim that recites a law of nature or a natural phenomenon requires further analysis in Step 2A Prong Two to determine whether the claim integrates the exception into a practical application.
A claim that does not recite a law of nature or natural phenomenon is eligible at Pathway B (Step 2A: NO) unless the claim recites, and is directed to, another exception (such as an abstract idea, or a product of nature).
II. PRODUCTS OF NATURE
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature".
- For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts.
As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena.
Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.
- Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention.
- Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.
When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis to evaluate the nature-based product limitation and determine the answer to Step 2A.
- Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
- Examples of nature-based products include the isolated gene and cDNA sequences of Myriad, the cloned farm animals of Roslin, and the bacterium of Chakrabarty.
- As is evident from these examples, a nature-based product that is a living organism (e.g., a plant, an animal, a bacterium, etc.) is not excluded from patent protection merely because it is alive, and such a product is eligible for patenting if it satisfies the markedly different characteristics analysis.
It is important to keep in mind that under the broadest reasonable interpretation (BRI) of the claims, a nature-based product limitation may encompass both eligible and ineligible products.
- For example, a claim to a "cloned giraffe" may have a BRI encompassing cloned giraffes with markedly different characteristics, as well as cloned giraffes that lack markedly different characteristics and thus are products of nature.
Such a claim recites a product of nature, and thus requires further analysis in Prong Two.
- If the claim is ultimately rejected as failing to encompass an inventive concept (Step 2B: NO), it is a best practice for the examiner to point out the broadest reasonable interpretation and recommend an amendment, if possible, that would narrow the claim to those embodiments that are not directed to products of nature, or that are otherwise eligible.
For claims that recite a nature-based product limitation (which may or may not be a product of nature exception) but which are directed to inventions that clearly do not seek to tie up any judicial exception, examiners should consider whether the streamlined eligibility analysis discussed in MPEP § 2106.06 is appropriate.
- In such cases, it would not be necessary to conduct a markedly different characteristics analysis.
» 2106.04(c) The Markedly Different Characteristics Analysis
