Section 101 Examples
Example 15 (7): Nucleic Acids

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, and this example should be viewed in light of the introduction that was provided with it. 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.

The index for all of the examples provided by the Patent and Trademark Office is found on BitLaw's Section 101 Index.

Example 15 (7): Nucleic Acids

This example illustrates that changes in genetic information/structure (claims 2 and 4), or physical structure (claim 3), as compared to a product’s natural counterpart can demonstrate markedly different characteristics.

Background:

Virginia nightshade is a naturally occurring plant that grows wild in the Shenandoah Valley of Virginia. When damaged, the leaves of Virginia nightshade produce a hormone called Protein W, which activates chemical defenses against herbivores. Protein W is naturally encoded by Gene W, which is part of chromosome 3 in Virginia nightshade and has the nucleic acid sequence disclosed as SEQ ID NO: 1. The specification also discloses substitution modifications of Gene W, e.g., nucleic acids having one or more nucleotide bases that are substituted with different bases relative to SEQ ID NO: 1. For example, one of the disclosed modifications changes a naturally occurring adenine to a guanine, e.g., the first nine nucleotides are “TAC GGG AAA” in naturally occurring Gene L and “TAC GGG AAG” in the modified nucleic acid. Some of the modifications are silent, meaning that no change occurs in the encoded protein. It is known in the art that some silent modifications affect characteristics of nucleic acid such as transcription rate and splicing, and that some do not. No substitution modifications of Gene W are known to occur in nature. The modified nucleic acids have 90% or greater identity to SEQ ID NO: 1. The specification discloses labeling the nucleic acids, e.g., with a fluorescent or radioactive label.

The specification discloses vectors comprising SEQ ID NO: 1 and a heterologous nucleic acid. The specification defines “heterologous” nucleic acid sequences as nucleic acid sequences that do not naturally occur in Virginia nightshade, e.g., sequences from other plants, bacteria, viruses, or other organisms. Disclosed heterologous nucleic acids include plant viral vectors such as tobacco mosaic virus, and viral promoters such as the cauliflower mosaic virus (CaMV) 35S promoter. The viral promoters cause different expression of Gene W as compared to its natural expression levels in Virginia nightshade, e.g., Gene W is expressed all the time (constitutively) as opposed to only in response to leaf damage.

Claims:

1. Isolated nucleic acid comprising SEQ ID NO: 1.
2. Isolated nucleic acid comprising a sequence that has at least 90% identity to SEQ ID NO: 1 and contains at least one substitution modification relative to SEQ ID NO: 1.
3. The isolated nucleic acid of claim 1, further comprising a fluorescent label attached to the nucleic acid.
4. A vector comprising the nucleic acid of claim 1 and a heterologous nucleic acid sequence.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. Because all of the claims are directed to a statutory category, e.g. a composition of matter (Step 1: YES), and are nature-based products (a nucleic acid), the markedly different characteristics analysis is used to determine if the nature-based products are exceptions.

Claim 1: Ineligible.

The claimed nucleic acid has a different structural characteristic than naturally occurring Gene W, because the chemical bonds at each end were severed in order to isolate it from the chromosome on which it occurs in nature, but has the same nucleotide sequence as the natural gene. The claimed nucleic acid has no different functional characteristics, i.e., it encodes the same protein as the natural gene. Under the holding of Myriad, this isolated but otherwise unchanged nucleic acid is not eligible because it is not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally occurring Gene W. In other words, the claimed nucleic acid is different, but not markedly different, from its natural counterpart in its natural state (Gene W on chromosome 3), 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 claim is limited to nucleic acids in which the nucleotide sequence has been changed to contain at least one non-naturally occurring substitution modification relative to SEQ ID NO: 1. All of the claimed nucleic acids have different structural characteristics than the naturally occurring nucleic acid, e.g., one or more nucleotides have been changed relative to the natural sequence. Some of the claimed nucleic acids may have different functional characteristics, e.g., they may encode a different protein than the natural gene. Because the structural differences between the claimed nucleic acids and their natural counterparts are enough to ensure that the claim is not improperly tying up the future use of naturally occurring Gene W, they rise to the level of a marked difference, and so the claimed nucleic acids are not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Claim 3: Eligible.

The claim is limited to a molecule that includes a nucleic acid and a fluorescent label, which combination does not occur in nature as a single molecule. The claimed molecule thus has different structural characteristics than the naturally occurring nucleic acid and label (single molecule vs. two separate molecules). It also has different functional characteristics (the labeled nucleic acid is now fluorescent, whereas the natural gene is not). These differences rise to the level of a marked difference, and so the claimed molecule 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.

Claim 4: Eligible.

The claim is limited to vectors comprising a non-natural combination of Gene W (SEQ ID NO: 1) with a sequence from another organism, and thus does not read on the naturally occurring chromosome in Virginia nightshade. This non-natural combination results in the vectors having a different genetic structure and sequence than the naturally occurring nucleic acids, i.e., different structural characteristics. Some of the claimed vectors may have different functional characteristics, depending on the selected heterologous sequence. These differences rise to the level of a marked difference, and so the claimed vector 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.