Subject Matter Eligibility Guidance -- Example on Diagnosing and Treating Julitis

by McDonnell Boehnen Hulbert & Berghoff LLP
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Last week, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101.  In addition to a memorandum on subject matter eligibility determinations that was issued to the patent examining corps, an updated list of court decisions (Supreme Court and Federal Circuit) addressing subject matter eligibility, and an updated index of eligibility examples, that guidance provided six additional life sciences examples numbered 28-33 (33 being the total number of examples that the Office has issued to date).

One of the more interesting of the six new life sciences examples is Example 29, which includes seven claims directed to the detection of a hypothetical protein, JUL-1, and the diagnosis and/or treatment of a hypothetical autoimmune disease, julitis.  According to the example, julitis develops when the immune system of a person having the disease mistakes normal skin cells for pathogens, which causes chronic inflammation of the skin that results in an itchy and extremely painful rash on the face, hands, and feet.  The example also indicates that while julitis is conventionally diagnosed by a physical examination of the characteristic rash, patients are often misdiagnosed as having rosacea since the rash caused by julitis looks similar to rashes caused by rosacea.

In the example, applicant has discovered that julitis patients have JUL-1 in their plasma, skin, hair and nails, while individuals who do not have julitis (or who have rosacea instead) do not.  Applicant also discloses detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody named "mAb-D33" that was created by applicant).  The example notes that at the time applicant's application was filed, porcine antibodies were not routinely or conventionally used to detect human proteins such as JUL-1.  The example also notes that at the time applicant's application was filed, julitis was conventionally treated with anti-tumor necrosis factor (TNF) antibodies, but for unknown reasons, some patients did not respond well to this conventional treatment.  The example further notes that applicant has successfully treated julitis patients (even those who are non-responsive to anti-TNF antibodies) with topical vitamin D, which at the time applicant's application was filed, was not commonly or routinely administered to patients with julitis.

The seven claims presented in example 29 are 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;
    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.

3.  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 porcine antibody; and
    c.  diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

4.  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 antibody mAb-D33 and detecting binding between JUL-1 and antibody mAb-D33; and
    c.  diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

5.  A method of diagnosing and treating 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;
    c.  diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected; and
    d.  administering an effective amount of topical vitamin D to the diagnosed patient.

6.  A method of diagnosing and treating 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;
    c.  diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected; and
    d.  administering an effective amount of anti-tumor necrosis factor (TNF) antibodies to the diagnosed patient.

7.  A method of treating a patient with julitis, the method comprising administering an effective amount of anti-TNF antibodies to a patient suffering from julitis.

According to the example, all but claim 2 are considered to be patent eligible.

In analyzing the claims presented in example 29, the Office explains that claim 1 is eligible because steps (a) and (b) of the claim "do not recite or describe any recognized exception" (the example cites Mayo Collaborative Services v. Prometheus Laboratories, Inc. in support of this determination, which the example indicates stands for the proposition that the recited steps of administering a drug to a patient and determining the resultant level of 6-thioguanine in the patient "are not themselves natural laws").  As a result, the analysis of this claim ends with Step 2A of analytic framework set forth in the Interim Guidance (i.e., determining whether the claim is directed to a judicial exception), and the example notes that there is no need to proceed with Step 2B of the analytic framework (i.e., determining whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception).

With respect to claim 2, the example explains that:

[T]he claim recites diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected, which describes 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 the Supreme Court in Mayo).  Additionally, step c could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams).

As a result, claim 2 is found to be directed to "at least one exception."  As for Step 2B of the analytic framework, the example explains that the claim's step of "[o]btaining a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics," and that the claim's step of "[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," and further, that:

When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant's invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein.

According to the example, consideration of the additional elements as a combination does not save claim 2 because "[u]nlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not invoke any of the considerations that courts have identified as providing significantly more than an exception."  Finding that claim 2 claim as a whole does not amount to significantly more than the exception itself, the Office determines that this claim is not eligible.

The example next explains that claim 3, which differs from claim 2 in that the detecting step utilizes a porcine anti-JUL-1 antibody, is eligible because:

[A]t the time the application was filed, the use of porcine antibodies in veterinary therapeutics was known to most scientists in the field.  But significantly, there is no evidence that porcine antibodies were routinely or conventionally used to detect human proteins such as JUL-1.  Thus, the claim's recitation of detecting JUL-1 using a porcine antibody is an unconventional step that is more than a mere instruction to "apply" the correlation and critical thinking step (the exception) using well-understood, routine or conventional techniques in the field.

Similarly, claim 4, which differs from claims 2 and 3 in that the antibody mAb-D33 is utilized in the detecting step, is found to be eligible because:

[A]t the time the application was filed, antibody mAb-D33 was not routinely or conventionally used to detect human proteins such as JUL-1.  Thus, the claim's recitation of detecting JUL-1 using mAb-D33 is an unconventional step that is more than a mere instruction to "apply" the correlation and critical thinking step (the exception) using well-understood, routine or conventional techniques in the field.

Claim 5 differs from claim 2 in that claim 5 is directed to a method of diagnosing and treating julitis, the detecting step of claim 5 encompasses any technique for detecting whether JUL-1 is present in the plasma sample, and claim 5 adds an additional step of administering an effective amount of topical vitamin D to the diagnosed patient.  Unlike claim 2, however, the example finds claim 5 to be eligible.  The example explains that claim 5 is eligible because:

[T]his claim further recites an additional element of administering an effective amount of topical vitamin D to the diagnosed patient (step d).  Vitamin D was known to doctors, and was routinely and conventionally used as an oral supplement to maintain bone health prior to applicant's invention, and at the time the application was filed.  However, mere knowledge of vitamin D or its use in other ways to treat other medical conditions does not make the administration of topical vitamin D to treat julitis a conventional step that those in this field would routinely practice.  The evaluation turns on whether the use of topical vitamin D was widely prevalent in the field at the time the invention was made and the application was filed.  Because it was not, the recitation of administering topical vitamin D is an unconventional step that is more than a mere instruction to "apply" the correlation and critical thinking step (the exception) using well-understood, routine or conventional techniques in the field.

Claim 6, which differs from claim 5 in that an effective amount of anti-tumor necrosis factor (TNF) antibodies –- rather than an effective amount of topical vitamin D –- is administered to the diagnosed patient, is also found to be eligible in example 29.  Although the example explains in analyzing claim 6 that "[p]rior to applicant's invention, and at the time the application was filed, julitis was conventionally treated with anti-tumor necrosis factor (TNF) antibodies, but for unknown reasons, some patients do not respond well to this conventional treatment," the example states that:

When the additional elements are viewed as a combination, however, the additional elements (steps a, b and d) amount to a claim as a whole that adds meaningful limits on the use of the exception (the correlation and critical thinking step).  The totality of these steps including the recitation of a particular treatment (administration of an effective amount of anti-TNF antibodies) in step d integrate the exception into the diagnostic and treatment process, and amount to more than merely diagnosing a patient with julitis and instructing a doctor to generically "treat it."  Further, the combination of steps, which is not routine and conventional, ensures that patients who have julitis will be accurately diagnosed (due to the detection of JUL-1 in their plasma) and properly treated with anti-TNF antibodies, as opposed to being misdiagnosed as having rosacea as was previously commonplace.  See Diamond v. Diehr, 450 U.S. 175, 188 (1981) ("a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made").

Finally, in determining that claim 7, which is directed to treating a patient with julitis by administering an effective amount of anti-TNF antibodies to the patient, is eligible, the example explains that "[t]he recited step of administering antibodies to a patient suffering from julitis does not recite or describe any recognized exception" (the example again cites Mayo Collaborative Services v. Prometheus Laboratories, Inc. in support of this determination, which the example indicates stands for the proposition that the recited steps of administering a drug to a patient and determining the resultant level of 6-thioguanine in the patient "are not themselves natural laws").  As with claim 1, the analysis of claim 7 ends with Step 2A of analytic framework, and the example notes that there is no need to proceed with Step 2B.

Patent Docs will provide summaries of other life sciences examples in subsequent posts.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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