Subject Matter Eligibility - May 2016 Update

By: Sandra King & Tom Powers  |   June 6, 2016

On May 4, 2016, the USPTO issued a memorandum to Examiners on the topic of “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” The memorandum addressed how examiners should formulate a subject matter eligibility rejection under 35 U.S.C. § 101 as well as how examiners should evaluate an applicant’s response to a § 101 rejection. The main purpose of the memorandum was to assist examiners in applying the 2014 Interim Guidance on Patent Subject Matter Eligibility as well as the July 2015 Update: Subject Matter Eligibility.

The memorandum directs the Examiner to identify the abstract idea (Step 2A) as it is recited in the claim and explain why it corresponds to a concept that the courts have identified as an abstract idea. If the Examiner determines that a claim is directed to a law of nature or a natural phenomenon (Step 2A), the rejection should identify the law of nature or natural phenomenon as recited in the claim and explain why it is considered a law of nature or natural phenomenon.

For the second part of the analysis (Step 2B), the memorandum directs the Examiner to identify in the rejection, the additional elements in the claim and explain why the elements taken individually and in combination do not amount to a claim as a whole that is significantly more than the exception in Step 2A. As an example, the memorandum states that, when the examiner has concluded that certain claim elements recite well-understood, routine, conventional activities in the relevant field, the rejection should explain why the courts have recognized the additional elements when taken both individually and as a combination to be well-understood, routine, or conventional activities.

Specific examples of application of the updated guidelines are summarized below:

Example 1: Addition of an additive to a natural product

A) Pomelo Juice and Vaccines

According to the PTO, there are two questions to be addressed in determining whether a composition is patent eligible. First, is the composition directed to a product of nature (Step 2A)? If the composition contains a nature-based product which does not have structural or functional differences from the closest natural counterpart, then the nature-based product is directed to a product of nature. Second, if the claim is directed to a natural product, do any recited features, or any combination of features, amount to “significantly more” than the product of nature (Step 2B)?

We first examine addition of an additive to a natural product, based on examples offered by the PTO. One simple example relates to pomelo juice. The disclosure teaches that a preservative causes pomelo juice to spoil much more slowly than pomelo juice by itself. The claim presented by the PTO is as follows:

1) A beverage composition comprising pomelo juice and an effective amount of an added preservative.

Based on the PTO’s analytical framework, the claim relates to a product of nature, where the product of nature is pomelo juice. The PTO indicates that the above claim is however, directed to something which is markedly different from the juice in nature, due to the slower spoiling in the presence of the preservative; therefore, the composition is not itself a product of nature under Step 2A of the PTO’s analytical framework.

In a similar vein, the PTO has presented analysis of the following composition claim relating to the natural product amazonic acid:

1) A stable aqueous composition comprising amazonic acid and a solubilizing agent.

In this case, amazonic acid is insoluble in water. However, the specification explains that addition of a solubilizing agent changes the properties of amazonic acid, making the compound soluble in water. The change in solubility is a marked difference from amazonic acid by itself, and the composition is patent-eligible under Step 2A of the PTO’s analytical framework. Again, patent eligibility is based on disclosure explaining how the additive changes the natural product, and not simply adding a limitation of a solubilizing agent as an additive.

Another similar example was presented in a claim to a vaccine comprising Peptide F, a peptide isolated from pigeon flu virus, in combination with an aluminum salt adjuvant:

1) A vaccine comprising:

a. Peptide F; and
b. an immuno-effective amount of an aluminum salt adjuvant.

According to the specification, Peptide F induces a weak immune response to pigeon flu virus (seroprotection rate of 30%) and the aluminum salt adjuvant induces no immune response. Together, Peptide F and the aluminum salt adjuvant induce a strong immune response to pigeon flu virus (seroprotection rate of 80%). The composition claimed is patent-eligible under Step 2A of the PTO’s analytical framework, because the combination of Peptide F and the adjuvant has markedly different properties from Peptide F alone. Again, however, patent eligibility is based on disclosure showing a specific change https://www.viagrasansordonnancefr.com/viagra-generique/ in properties.

In practice, overcoming a rejection of a composition containing a natural product under 35 § 101 may be more complicated than simply adding a preservative to a composition. The analysis presented by the PTO directly ties patent eligibility to a disclosure presenting data on rates of spoilage of pomelo juice and a combination of pomelo juice and a preservative, for example. In the absence of such data, an examiner may argue that addition of a preservative to pomelo juice does not lead to a marked structural or functional difference under Step 2A of the PTO analysis. The examiner may then be able to argue that addition of a preservative is well understood, routine, and conventional in the art, and does not add “significantly more” to the natural product recited in the patent claim. The result would be a determination that the claimed composition is not patent eligible under Step 2B of the PTO analysis.

Accordingly, if patentability may rest on addition of an additive which changes the properties of a natural product, then we recommend including comparative data between the natural product and the mixture of the natural product and the additive in the specification. This should aid in establishing that the composition is structurally or functionally different from the natural product, without requiring argument about whether the use of the additive is routine or conventional.

B) Use of a Particular Dosage Form

In the Subject Matter Eligibility Examples issued in May, 2016, the PTO provides several examples relating to particular dosage forms comprising a natural product. In one example, Peptide F vaccines are discussed in relation to these claims:

1) A vaccine comprising:

a. Peptide F; and
b. a pharmaceutically acceptable carrier.

2) A vaccine comprising:

a. Peptide F; and
b. a pharmaceutically acceptable carrier selected from the group consisting of a cream, emulsion, gel, liposome, nanoparticle, or ointment.

In the case of claim 1, Peptide F is a naturally occurring protein, and the carrier may be water. Even though the two do not occur together in nature, combining Peptide F and water does not materially change the properties of either the peptide or water. Therefore, Peptide F is a product of nature under Step 2A of the PTO’s analytical framework. Adding a carrier, such as water, is well-understood, routine, and conventional, and so the combination of Peptide F and a carrier does not amount to significantly more than Peptide F by itself, and the combination is not patent eligible under Step 2B of the PTO’s analytical framework.

In the case of claim 2, Peptide F is found in nature. However, the combination of Peptide F with a cream, emulsion, gel, liposome, nanoparticle, or ointment is not found in nature. Under Step 2A of the PTO’s analytical framework, the combination of Peptide F and the components of the carrier must be compared to the closest naturally occurring counterpart. Where the carrier is a cream based on cottonseed oil and water, the claimed cream has different structural and physical characteristics from its naturally occurring components, cottonseed oil and water. The cream contains oil droplets homogenously dispersed in the water, so that the cream has a semi-solid and non-flowable form. The cream is therefore different from either oil or water, which are each flowable liquids. Since the cream is semi-solid, it will adhere to a patient’s skin longer than either oil or water. “The cream’s changed form and adherence are marked differences in structural and physical characteristics as compared to the natural counterparts, and therefore the cream 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.”

Thus, under the PTO’s analysis, even if the active ingredient is unchanged from the natural material, e.g., there is no change in structure or activity of the active ingredient, if the active ingredient is administered in a structurally defined carrier, the composition may not be a product of nature. A similar PTO example is directed to sweetening agents, as shown in the claims below.

1) A dietary sweetener comprising:

a. 1-5 percent texiol; and
b. at least 90 percent water.

2) A dietary sweetener comprising:

a. 5 percent texiol;
b. water, fruit juice, or a combination of water and fruit juice; and
c. sufficient amounts of pectin to provide a solid gel.

In the case of claim 1, the claim is patent ineligible under the PTO analysis. The closest naturally occurring counterpart to the composition of claim 1 is a naturally occurring sweet texiol-water mixture in the sap of the Texas mint plant. Since both the claimed mixture and the naturally-occurring mixture have similar properties, the claimed mixture “does not display markedly different characteristics compared to the closest naturally occurring counterpart.” Therefore, even though the claimed mixture and the naturally occurring sweet texiol-water mixture have different percentages of water, the components of claim 1 are each considered to be products of nature under Step 2A of the PTO analysis. In the absence of evidence that mixing water and texiol in the stated amounts produces results which are not well-understood, routine and conventional in the field under Step 2B of the PTO analysis, claim 1 is not patentable.

In the case of claim 2, the claim is patent eligible under the PTO analysis. The closest naturally occurring counterparts to the claimed mixture are a naturally occurring water-pectin combination and a naturally occurring texiol-water combination. Mixing the two naturally occurring combinations causes the texiol to exhibit “changed properties as compared to naturally occurring texiol in the plant sap, in that the claimed texiol is present in a solid yet spreadable gel form and has improved organoleptic properties (e.g., a more pleasant mouthfeel).” Since the properties of the texiol are changed, the resulting combination is not a product of nature under Step 2A of the PTO analysis, and the composition is patent eligible.

In practice, this method of overcoming a rejection of a composition containing a natural product under 35 U.S.C. § 101 is frequently recommended by patent examiners. In cases where a composition lacks synergism between components, or where the activity of an active component is not materially enhanced by a specific additive, defining the structure of the dosage form or carrier may be the simplest way to establish that a claimed composition is not a product of nature under Step 2A of the PTO analysis. According to the PTO examining corps, suitable dosage forms which are not products of nature under Step 2A of the PTO analysis include tablets, capsules, transdermal patches, suppositories, creams, emulsions, gels, liposomes, nanoparticles, and ointments.

Example 2: Diagnostic Methods

In the Subject Matter Eligibility Examples issued in May, 2016, the PTO provides examples relating to diagnostic methods. One example relates to diagnosing julitis by detecting a specific protein called JUL-1, claimed as follows:

1) A method of detecting JUL-1 in a patient, said method comprising:

a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

2) A method of diagnosing julitis in a patient, said method comprising:

a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and
c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

According to the Supreme Court, the relationships between concentrations of certain metabolites in the blood and specific diagnostic outcomes are laws of nature and are not themselves patentable. Mayo Collaborative Svcs. V. Prometheus Labs, 132 S.Ct. 1289, 1297 (2012). However, steps of determining the level of a metabolite “are not themselves natural laws.” Id.

Since claim 1 above contains no specific step of drawing a correlation between levels of a metabolite and the presence of a disease, claim 1 is not directed to any correlation which might be a consequence of a natural law or an algorithm. Therefore, claim 1 is not directed to a judicial exception to patent eligibility under Step 2A of the PTO analysis, and claim 1 is therefore patent eligible.

Claim 2 has been determined to be patent ineligible by the PTO. Since claims 1 and 2 have identical steps (a) and (b), this result is counter-intuitive. However, the PTO analysis focuses on step (c) of claim 2, absent from claim 1. In this case, the diagnostic step is asserted to be based on a law of nature correlating the disease julitis with the presence of JUL-1. Alternatively, step (c) is viewed as an abstract idea, such as “diagnosing an abnormal condition by performing clinical tests and thinking about the results.” Thus, under step 2A of the PTO analysis, step (c), and hence the claim as a whole, is directed to a judicial exception.

According to the PTO, “[d]etecting 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. When recited at this high level of generality, there is no meaningful limitation…in this step that distinguishes it from…the routine and conventional techniques of detecting a protein using an antibody to that protein.” Therefore, the PTO concludes that steps (a) and (b), although patent eligible as a two-step process, do not add significantly more to a step (c) of diagnosing julitis, and the claim is patent ineligible under step 2B of the PTO analysis.

However, if claim 2 is amended to recite a specific anti-JUL-1 antibody which is not conventionally present in human serum, e.g.., a porcine antibody, the step of detecting JUL-1 with the antibody becomes an unconventional step that does add significantly more to the step (c) of diagnosing julitis, and the claim becomes patent eligible.

Based on this analysis, a patent application directed to diagnosis of a disease by detection of a protein or metabolite should include claims to detecting the target protein or metabolite with an immunological reagent, in addition to claims directed to diagnosis of the disease. Claims directed to diagnosis of the disease should include limitations directed to the structure of the immunochemical which distinguishes it from a similar reagent normally found in human plasma.