[author: Antoinette F. Konski]

The USPTO has just issued guidelines for its patent examining corps to assist them in determining whether a process claim is patent-eligible in light of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (“Prometheus”) decision. A copy of the guidance document (“Guidance Document”) is attached. [2012_interim_guidance] The examiners are advised to follow the Guidance Document in examining process claims in which a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a “natural principle” in the Guidance Document) is a limiting element or step. The revised procedure is effective as of its date of issuance, July 3, 2012.

Three Essential Inquiries

The Guidance Document sets forth three essential inquiries for examiners for determining patent-eligibility of process claims. The inquiries are to be applied after determining what the applicant believed was invented and determining the broadest reasonable interpretation of the claimed invention. The following three inquiries are to be applied to the claim as a whole.

1.  Is a Process Claimed?

The initial inquiry is easy to apply – is the claim a process or method? If yes, then move to Inquiry #2.

2.  Does the Claim Focus on a Law of Nature, a Natural Phenomenon, or Naturally Occurring Relation or Correlation?

The process or method claim is then examined to determine if it uses a natural principle, a natural phenomenon, or naturally occurring relation or correlation in a manner that is a limiting feature of the claim. A natural principle is defined as the handiwork of nature and occurs without the hand of man, e.g., the disinfecting property of sunlight is a natural principle. A correlation that occurs naturally when a man-made product such as a drug, interacts with a naturally occurring substance, such as blood, is also provided as an example of a natural principle. A claim that recites a correlation used to make a diagnosis is an additional example of a claim that focuses on a natural principle.

If the claim focuses on a natural principle that is a limitation of the claim, then examiners are advised to analyze the claim under the third inquiry. If the claim focuses on an abstract idea (such as steps that can be performed entirely in one’s mind, methods of controlling human activity, or mere plans for performing an action) the examiner is to analyze the claim under the 2010 Interim Bilski Guidance for patent-eligibility. A copy of the Bilski Guidance is attached. [bilski_guidance_27jul2010]

3.  Practical Application and Preemption

A process or method claim (inquiry # 1) that focuses on a natural principle, law of nature or naturally occurring relation or correlation (inquiry # 2) will be patent-eligible if the claim includes additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that there is a practical application of the principle to ensure that the claim amounts to significantly more than the natural principle itself. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on claim scope. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry.

Examiners are advised that it is not necessary that every element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies, relies on, or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.

A claim that does not include a natural principle as a limitation does not raise an issue under the law of natural exception. The administration of a man-made drug that does not recite other steps or elements directed to the use of a natural principle, such as a naturally occurring correlation is provided as an example of claim that is patent-eligible. A claim that recites a novel drug or a new use of an existing drug, in combination with a natural principle, is another example of a patent-eligible claim.

The Guidance Document provides 9 factors to assist examiners in analyzing the “additional features” in the claim to determine whether the claim recites a patent-eligible practical application of a natural principle. Several of the factors are relevant to personalized medicine inventions. These factors include:

• Appending conventional steps, specified at a high level of generality, to a natural principle does not make the claim patent-eligible;
• Steps that amount to instructions that are well-understood, routine, conventional activity, previously engaged in by those in the field add nothing specific to the natural principle that would render it patent-eligible;
• A claim that covers known and unknown uses of a natural principle and can be performed through any existing or future-devised machinery, or even without any apparatus, would lack features that are sufficient for eligibility; and
• Complete absence of a machine-or-transformation in a claim signals the likelihood that the claim is directed to a natural principle and has not been instantiated (e.g., is disembodied or can be performed entirely in one’s mind).

A mere statement of a general concept (natural principle) that would effectively monopolize that concept/principle would not be patent-eligibile. This can be contrasted with a tangible implementation containing claim elements or steps that are recited with specificity such that all substantial applications of the principle is not covered. Such specificity may be achieved with observable and verifiable steps, for example, rather than subjective or imperceptible steps.

Application of the Principles

The Guidance Document provides two examples of the application of the three inquiries. The first is to the claim adjudicated in Diamond v. Diehr, 450 U.S. 175 (1981) and used by the U.S. Supreme Court in the recent Prometheus decision as an example of a patent-eligible claim. The second is to the claim in Prometheus, and determined be patent-eligible. A proper response to a rejection under 35 U.S.C. 101 for failure to claim patent-eligible subject matter is an amendment adding additional steps/features or amending existing steps/features that integrate the natural principle into the process. Applicants may also provide arguments why the additional steps add something more to the claim than merely describing the natural principle. A showing that the steps are not routine, well-known or conventional could be persuasive.

Claim Examples

The Guidance Document provides an example of a claim set and its analysis under the three inquires that is relevant to diagnostic and treatment claims that are typical of inventions in personalized medicine. The claims in the set are directed to determining the increased likelihood of having or developing rheumatoid arthritis in a patient. For purposes of the example, it is assumed that the anti-IgM antibody XYZ does not occur in nature and is novel and non-obvious. Assays M and N can be used for comparing the anti-IgM antibody to a control sample, but are not routinely used together. The claims are:

1. A method of determining the increased likelihood of having or developing rheumatoid arthritis in a patient, comprising the steps of:

obtaining a serum sample from a patient;

contacting the serum sample with an anti-IgM antibody; and

determining that the patient has rheumatoid arthritis or an increased likelihood of developing rheumatoid arthritis based upon the increased binding of the anti-IgM antibody to IgM rheumatoid factor in the serum sample.

 2. The method of claim 1 further comprising:

providing a positive control sample; and

contacting the positive control sample with an anti-IgM antibody,

wherein the step of determining that the patient has rheumatoid arthritis or increased likelihood of developing rheumatoid arthritis comprises a step of comparing the anti-IgM antibody in the serum sample to the positive control sample.

3. The method of claim 1 or 2, wherein the anti-IgM antibody is antibody XYZ.

4. The method of claim 2, wherein the step of comparing the anti-IgM antibody to the positive control sample includes performing assay M and then performing assay N.

Inquiry #1

All claims are process claims.  Proceed to Inquiry #2.

Inquiry #2

All claims include the limitation of the correlation between rheumatoid arthritis and the rheumatoid factor IgM, which is a natural principle/law of nature. Proceed to inquiry #3.

Inquiry #3

All four claims are interpreted to integrate the law of nature into the recited process steps. Claims 1 and 2 are not deemed to be patent-eligible because the additional steps recited in the claims are insufficient to ensure that the claim amounts to significantly more than the natural principle itself. Claims 3 and 4, in contrast, do contain “something more” and therefore are patent-eligible. The additional step of using the anti-IgM antibody, especially one not known in the field, integrates the law of nature as it is used to express the principle and is also sufficient to limit the application of the law of nature. While it is not necessary that the antibody be novel and non-obvious, this additional fact is emphasized because the claim would not cover substantially all practical applications of the correlation. Claim 4 is found to be patent-eligible because the additional step of comparing the anti-IgM antibody to the positive control sample includes performing assay M and then performing assay N, which integrates the correlation into the process because the use of the control sample facilitates testing for the correlation. This step additionally uses assays M and N, which are not routinely used together so the claim is not deemed to cover substantially all practical applications of testing for the correlation. It is additionally noted that for the purpose of the example, use of the assays together is not well-known, routine or conventional, but the analysis of novelty and non-obviousness is yet to be determined.

Patenting Personalized Medicine

Patent claims in personalized medicine typically fall into two types. The first type is predicting, diagnosing or monitoring a disease or condition by analyzing a patient sample for a genetic or protein marker or metabolite that has been correlated to the prediction, diagnosis or progression of the disease. The second type is a “test-and-treat” claim, wherein a drug or therapy is administered to a patient that has been identified as in need of the drug or therapy after use of a diagnostic test or method.  

After Prometheus and consistent with the USPTO initial statement regarding Prometheus (see my March 25th, posting), diagnostic-type claims without “something more” were not going to pass the revised standard for patent-eligibility. The question remained then, what more is need to satisfy the post-Prometheus standard?

Consistent with my March 25th wish list (thank you USPTO!) the Guidance Document provided examples and indicated that diagnostic claims that use novel and non-obvious tools to perform the methods would continue to be patent-eligible after Prometheus. Using any known tool in a conventional manner (exemplified as a generic anti-IgM antibody in the example) does not confer patent-eligibility. Whether or not use of an intermediate tool (such as an antibody that has a specified affinity for the IgM rheumatoid factor) is an open question, although based on the suggestion in the Guidance Document, if the use of the antibody is novel and confers unexpected results to the method (as an indication of non-obviousness) then patent-eligibility is at least arguable under the proffered analysis.

With respect to test-and-treat claims, the Guidance Document indicates that if the treatment (i.e., drug) or use of the drug is new, then the treatment claim is patent-eligible, even when combined with a natural principle. The Guidance Document suggests that adding an administration step to a diagnostic method claim would not amount to a patent-eligible claim because it arguably would be appending conventional steps, specified at a high level of generality, to a natural principle. The addition of a more narrow application of the drug or therapy, would be necessary to render the claim patent-eligible.

Finally, the USPTO cautioned that while the principles of the Guideline Document are to applied from July 3rd going forward, comprehensive guidance will likely be necessary after the Federal Circuit addresses additional patent-eligibility issues in the recently remanded cases, Assn. for Molecular Pathology v. Myriad Genetics and WildTangent v. Ultramercial. Stay tuned.