On March 4th, 2014, the United States Patent and Trademark Office (“USPTO”) issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as applied to patent-eligibility. See Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013) (“Myriad“) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012) (“Prometheus“). The Guidance supersedes the USPTO’s one page document issued the day the U.S. Supreme Court held that isolated DNA that is structurally no different from DNA in the human body, other than it is isolated from the human body, is not patent-eligible. (See the prior post of June 13, 2013.) In the Guidance, the USPTO advises examiners to apply the Myriad and Prometheus holdings to any subject matter that could be characterized as a judicial exception to patent-eligibility: a law of nature; a natural principle; a natural phenomena, or a natural product. If the claimed subject matter could fall within one of the judicial exceptions to patent-eligibility, examiners are instructed to evaluate the claimed subject matter, using the following factors, to determine if the claim recites something significantly different than the judicial exception(s).
Factors Weighing Toward Eligibility
The Guidance notes six factors that would indicate that the claimed subject matter is significantly different from a judicial exception and therefore weighted toward eligibility:
- the claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products;
- the claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception;
- the claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s);
- the claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s);
- the claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application; and
- the claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.
The Guidance indicates that in analyzing the claim using the above factors and that if, on balance the totality of the relevant factors weigh toward eligibility, the claim qualifies as eligible subject matter. If on the other hand, the factors weigh against eligibility, the claim should be rejected. The Guidance also notes that, the analysis as a whole is a factor based analysis, which requires consideration and subsequent weighing of multiple factors, and is to be applied similar to the Wands factor based analysis to evaluate whether undue experimentation is required to make and use a particular claimed invention, citing MPEP 2164.01(a).
The Guidance provides several examples applying the factors to subject matter that could be within the judicial exception(s). Today’s post will review the illustrative examples that relate in whole or part to compositions of matter. My March 7th post covers the Guidance examples that relate to processes.
Composition/Manufacture Claim Reciting a Natural Product
The hypothetical claims recite:
- A stable energy-generating plasmid, which provides a hydrocarbon degradation pathway.
- A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradation pathway.
In applying the six factors, the Guidance indicates that the first claim should rejected under Section 101, because the claim does not recite structural differences between the claimed plasmid and naturally occurring plasmids and therefore does not claim a plasmid that is markedly different from what exists in nature.
In contrast the second claim, in reciting the two energy-generating plasmids, recites something significantly different than naturally occurring bacteria. The claim is determined to be markedly different in that it is both structurally different (the genetic modification to include plasmids that are not found in naturally occurring Pseudomonas bacterium) and functionally different (it is able to degrade at least two different hydrocarbons as compared to naturally-occurring Pseudomonas bacterium).
Composition vs. Method Claims, Each Reciting a Natural Product
The hypothetical claims recite:
- Purified amazonic acid.
- Purified 5-methyl amazonic acid.
- A method of treating colon cancer, comprising administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.
The claimed amazonic acid is structurally identical to the amazonic acid in tree leaves from which it can be isolated. However, purification of the chemical is very difficult; only the inventor has successfully purified the amazonic acid. 5-methyl amazonic acid is a chemical derivative of the purified compound that was created in the laboratory. The 5-methyl amazonic acid is functionally different from the natural product in that it stimulates the growth of hair as well as treating cancer. While use of the tree leaves containing amazonic acid to treat breast cancer was known, its use for treating colon cancer was discovered by the inventor.
Claim 1 is not deemed patent-eligible because it is not structurally different from the compound as it exists in the tree leaves.
Claim 2 is deemed patent-eligible, because it is structurally different from the compound as it exists in the tree leaves, and the structural difference results in a functional difference. The Guidance notes that while a functional difference is not necessary to find a marked difference, the presence of the functional difference makes a stronger case for patent-eligibility.
The Guidance indicates that claim 3 is patent-eligibility because the claim satisfies factors 2 through 4 and 6, of the six factors. The claim elements of the particular dose and dosing schedule to the particular patient, is noted to limit the scope of the claim. In addition, prior usage of the tree leaves containing the compound was not for the treatment of the recited colon cancer.
Composition Claim Reciting Multiple Natural Products
The hypothetical claim recites:
- An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.
The Guidance indicates the claim should be rejected under Section 101 because the claim as a whole does not recite significantly different than the natural product; it was not altered in any way.
Compositions vs. Method Claims, Each Reciting Two Natural Products
The Guidance provides two exemplary claims:
- A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2.
- A method of amplifying a target DNA sequence comprising:
providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine;
heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other;
cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; and repeating steps (b) and (c) at least 20 times.
Claim 1 is deemed not to be patent-eligible because the isolated primes are are not structurally different from naturally occurring DNA.
Claim 2 is deemed patent-eligible, because the claim contains elements that narrow the scope of the claim and involve manipulation of the natural products.
Compositions and Their Use After Myriad and Prometheus
The U.S. Supreme Court’s Myriad decision created uncertainty as to how far the holding would be applied beyond isolated DNA. The USPTO, without direction from the Federal Circuit, has indicated that it would apply the Myriad holding to any naturally occurring product of nature, and that isolation of the product from nature is insufficient, in and of itself, to confer patent-eligibility. Thus, patent applicants should expect to have “isolated” or “purified” naturally occurring products that are not structurally different from their natural counterparts rejected for failing to satisfy Section 101. Applicants should consider, where possible, noting structural and functional distinctions between the claimed subject matter and the natural counterparts and how the claim elements would not preempt all possible uses of the technology.