Section 101 Examples
Example 13 (5): Genetically Modified Bacterium
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. 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.
This example should be viewed in light of the introduction that was provided with it.
Index to USPTO's Section 101 Examples
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Example 13 (5): Genetically Modified Bacterium
This example illustrates that a naturally occurring product that is unchanged from its natural state does not have markedly different characteristics (claim 1), but that changes in biological function between a claimed product and its natural counterpart can demonstrate markedly different characteristics (claim 2).
Stable energy-generating plasmids that provide hydrocarbon degradative pathways exist within certain bacteria in nature. Different plasmids provide the ability to degrade different hydrocarbons, e.g., one plasmid provides the ability to degrade camphor, and a different plasmid provides the ability to degrade octane. Pseudomonas bacteria are naturally occurring bacteria. Naturally occurring Pseudomonas bacteria containing one stable energy-generating plasmid and capable of degrading a single type of hydrocarbon are known. There are no known Pseudomonas bacteria in nature that contain more than one stable energy-generating plasmid. In the specification, applicant discloses genetically modifying a Pseudomonas bacterium to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium.
1. A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.
2. A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.
Analysis of Claims:
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. Because both claims are directed to a statutory category, e.g., a manufacture or composition of matter (Step 1: YES), and are nature-based products (plasmid or bacterium), the markedly different characteristics analysis is used to determine if the nature-based products are exceptions.
Claim 1: Ineligible.
Based on the limited background information, there is no indication that the claimed plasmid has any characteristics (structural, functional, or otherwise) that are different from naturally occurring energy-generating plasmids. Because there is no difference between the claimed and naturally occurring plasmid, the claimed plasmid does not have markedly different characteristics, 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 bacterium has a different functional characteristic from naturally occurring Pseudomonas bacteria, i.e., it is able to degrade at least two different hydrocarbons as compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. The claimed bacterium also has a different structural characteristic, i.e., it was genetically modified to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium. The different functional and structural characteristics rise to the level of a marked difference, and accordingly the claimed bacterium 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.
The bacterium of claim 2 was held to be patent-eligible subject matter in Diamond v. Chakrabarty, 447 U.S. 303 (1980). Recently, the Supreme Court looked back to this claim as an example of a nature-based product that is patent-eligible because it has markedly different characteristics than naturally occurring bacteria, as explained in Myriad, 133 S. Ct. at 2116-17:
In Chakrabarty, scientists added four plasmids to a bacterium, which enabled it to break down various components of crude oil. 447 U. S., at 305, 100 S. Ct. 2204, 65 L. Ed. 2d 144, and n. 1. The Court held that the modified bacterium was patentable. It explained that the patent claim was “not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter--a product of human ingenuity ‘having a distinctive name, character [and] use.’” Id., at 309-310, 100 S. Ct. 2204, 65 L. Ed. 2d 144 (quoting Hartranft v. Wiegmann, 121 U. S. 609, 615, 7 S. Ct. 1240, 30 L. Ed. 1012 (1887); alteration in original). The Chakrabarty bacterium was new “with markedly different characteristics from any found in nature,” 447 U. S., at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the additional plasmids and resultant “capacity for degrading oil.”