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On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products“&�Բ�����;, 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 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). My post reviews the �ҳܾ��岹�Գ���’s analysis of patent claims that could fall under the natural product exception to patent-eligibility. This post will review the �ҳܾ��岹�Գ���’s review of patent claims that could fall relate to a law of nature exception to patent-eligibility. Claims directed to abstract ideas are not analyzed using the principals of the Guidance. Examiners are directed to MPEP 2106(II) for analysis of claims involving abstract ideas.

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:

1. 1. 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;
2. 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;
3. 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);
4. 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);
5. 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
6. 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.

Factors Weighing Against Patent-Eligibility

The Guidance also lists six factors that would weigh against patent-eligibility:

1. the claim is a product claim reciting something that initially appears to be a natural product, that is not markedly different in structure from naturally occurring products;
2. the claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered;
3. the claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s);
4. the claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field;
5. the claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s); and
6. the claim recites elements/steps in addition to the judicial exception(s) that add nothing more than a mere field of use.

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).

Process Claim Involving a Natural Principle and Reciting Natural Products

The hypothetical claim recites:

1. A method for determining whether a human patient has degenerative disease X, comprising: obtaining a blood sample from a patient; determining whether misfolded protein ABC is present in the blood sample, wherein said determining is performed by contacting the blood sample with antibody XYZ and detecting whether binding occurs between misfolded protein ABC and antibody XYZ using flow cytometry, wherein antibody XYZ binds to an epitope that is present on misfolded protein ABC but not on normal protein ABC; and diagnosing the patient as having degenerative disease X if misfolded protein ABC was determined to be present in the blood sample.

Antibody XYZ is stated not to exist in nature, and is not purely conventional or routine in the art (it was newly created by the inventors).

The Guidelines indicate that the claim is patent-eligible, because the use of the novel antibody and detecting the resultant binding using flow cytometry in the claim narrow the scope of the claim, so that others are not foreclosed from using other means to detect the misfolded protein. The claim also was noted to do more than describe a natural principle with general instructions to apply it.

Process Claims Involving a Natural Principle

The hypothetical claims recite:

1. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to sunlight, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder.
2. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to a synthetic source of white light, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.
3. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: providing a white light source that emits white light; filtering the ultra-violet (UV) rays from the white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a predetermined period ranging from 30-60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Claims 1 and 2 are determined not to be patent-eligibility because exposing the patient to sunlight is not a meaningful limit on the claim scope, in that exposing the patient to sunlight forecloses others from using or applying sunlight. The claims also are no more than applying the natural principle and natural phenomenon.

Claim 3 however, is patent-eligible because the filtering and positioning steps meaningfully limit the claim to a particular application of the natural principle. The additional steps of the claim also are not well-understood, purely conventional or routine in the art of treating mood disorders.

Process Claim Reciting an Abstract Idea and a Natural Product

The hypothetical claim recites:

1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

This claim is copied from claim 1 of Myriad’s U.S. Patent No. 6,033,857, that was held to be ineligible by the U.S. Supreme Court. The Guidance indicates that because the claim recites an abstract idea, the claim should be analyzed using MPEP 2106(II) even though the claim also recites a natural product.

What Now for Applicants?

Applicants having pending claims directed to any natural product that are not structurally different from the natural counterpart should expect to see these claims rejected under Section 101 in view of the new Guidelines. However, while the Guidelines provide several examples to assist examiners with their analysis, the Guidelines are light on guidance on the degree of “markedly different” the claimed product must be to satisfy Section 101. Moreover, whether or not the courts would agree with the USPTO’s take on Myriad and Prometheus is an open question that only a judicial challenge can answer.