The USPTO has put out some helpful examples for the life sciences which can be found at http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf
The examples should be used in conjunction with the 2014 Interim Guidance on Subject Matter Eligibility.
To give you just a flavor for the examples, the PTO has a section on vaccines and how one goes about the analysis for nature based products..
One example is the following. “1. A vaccine comprising live attenuated Pigeon flu virus”.
The live attenuated virus is a nature-based product that must be compared to its naturally occurring counterpart. In this instance, the closest natural counterpart is the naturally occurring Pigeon flue virus from which the live attenuated virus was mutated. Since no mutations of this gene are known to occur in nature, under the holding in Myriad, this structural difference is a markedly different characteristic, because it causes the claimed virus to have a nucleotide sequence that is different from anything found in nature.
But contrast this to the next claim:
“2. A vaccine comprising: Peptide F; and a pharmaceutically acceptable carrier”.
In this case, assume that peptide F is a naturally occurring peptide produced by the Piegeon flu virus. Here again, the recited mixture of Peptide F and water is a nature baed product that must be compared to its closest naturally occurring counterpart. Because peptide F and water do not occur together in nature, there is no naturally occurring counterpart mixture for comparison, and so the claimed mixture is compared to its naturally occurring compoents, i.e., peptide F and water. Peptide F is naturally occurring and water is naturally occurring so neither would be eligible as claimed on their own. While the mixture is novel and does not occur in nature, there is no indication that mixing these components changes the structure, function, or other properties of the peptide or water. The calimed mixture as a whole does not display markedly different characteristics compared to the naturally occurring counterparts. Accordingly, each components is a “product of nature” judicial exception. Next, the claim as a whole is analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Mixing the peptide with a carrier such as water does not markedly change the characteristics of either component, because each component continues to have the same properties in the mixture as it had alone. In addition, using a carrier in a peptide vaccine was well-understood, routine & conventional prior to the invention and at the time of filing the application, so the mixing of the peptide and carrier, when recited at this high level of generality, does not meaningfully limit the claim. Thus, the claim as a whole does not amount to significantly more than each product of nature” by itself and does not qualify as eligible subject matter.
But suppose the claim recited “A vaccine comprising: peptide F; and a pharmaceutically acceptable carrier selected form the group consisting of a cream, emulsion, gel, liposome, nanoparticle, or ointment”. Here, the claimed cream for example, has different structural and physical characteristics than its naturally occurring components. For example, oil droplets are small, uniform in size, and homogenously dispersed in the water, which causes the resultant cream to have a semi-solid and non-flowable form at room temperature as compared to just oil and water, which are both flowable liquids at room temperature in nature. The cream’s changed form and adherence are marked differences in structural and physical characteristics as compared to the natural counterparts, and thus the cream is not a “product of nature” exception. One would not even need to go to the step of determining whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. There is no exception in this case.
The PTO has another interesting section on diagnostic claims.
Suppose that you discover the presence of a protein known as “UL-1” in a persons body that is indicative that the person has julitis. You first claim s the following:
“1. A method of detecting UL-1 in a patient, said method comprising: obtaining a plasma sample form a human patient; and b. detecting whether UL-1 is present in the plasma sample by contacting the plasma sample with an anti-UL-1 antibody and detecting binding between UL-1 and the antibody.”
Your second claim is the following:
“2. A method of diagnosing julitis in a patient, said method comprising: a. obtaining a plasma sample from a human patient; b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with a porcine anti-JUL-1 antibody and detecting binding between JUL-1 and the procaine antibody; and c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.”
The first claim is eligible and the second is ineligible. But the second claim is actually eligible! . Both of the claims are directed to a process, which is one of the statutory categories of invention. However, claim 1 is not directed to any judicial exception. It differs from Mayo above in that the claim only recites steps of obtaining a plasma sample from a patient and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody. This is different from claim 2 which is directed to making a correlation or relationship between the presence of JUL-1 in a patient’s plasma and the presence of julitis in the patient. This limitation sets forth a judicial exception because this type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by Mayo above. This additional step could be performed by a human using mental steps which are activities that have been found to constitute abstract ideas, which is a judicial exception (they may alternatively be called “law of nature”). So for claim 2, you would need to move on with the analysis and ask whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Obtaining a sample in order to perform tests is well-understood and detecting whether JUL-1 is present in the plasma sample merely instructs a scientist to use any detection technique with any generic anti-JUL-1 antibody. This claim would not withstand challenge.
The above is just a flavor and one should look at the examples. However, what strikes me most about the above is the strange consequence of Mayo analysis where claim 2 actually recites more than claim 1, albeit the judicial exeption which is the so called abstract idea of making a comparison, above but is itself found ineligible over claim 1.