BitLaw

Example 29: Diagnosing and Treating Julitiss

This hypothetical example illustrates the application of the significantly more analysis to diagnostic and treatment claims using a hypothetical disease. Claims 1 and 7 are eligible in Step 2A, because they are not directed to any judicial exception. Claim 2 is ineligible, because it is directed to a judicial exception that could be termed either a law of nature or an abstract idea, and the recited additional elements do not amount to significantly more than the exception. Claims 3-6 are directed to the same exception, but are eligible in Step 2B because they recite specific and unconventional reagents and/or treatments that amount to significantly more than the exception.

Background

“Julitis” is an autoimmune disease affecting more than 17 million people in North America, which develops when the immune system mistakes normal skin cells for pathogens. Julitis causes chronic inflammation of the skin that results in an itchy and extremely painful rash on the face, hands, and feet. Conventionally, julitis is diagnosed by a physical examination of the characteristic rash. However, because the rash caused by julitis looks similar to rashes caused by rosacea, doctors often misdiagnosed people as having rosacea when they actually had julitis.

Applicant has discovered that the presence of a protein known as “JUL-1” in a person’s body is indicative that the person has julitis. All julitis patients have JUL-1 in their plasma, skin, hair and nails, but this protein is not found in persons who do not have julitis (e.g., patients with rosacea). Applicant discloses detecting JUL-1 by routine and conventional methods such as (i) physical biopsies of skin, hair or nails, or (ii) immunoassays in which a sample from a patient (e.g., a plasma or skin sample) is contacted with an antibody to the protein being detected, and then binding between the antibody and the protein is detected using a laboratory technique such as fluoroscopy. In particular, applicant 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). Prior to applicant’s invention, and at the time the application was filed, the use of porcine antibodies in veterinary therapeutics was known to most scientists in the field, but these antibodies were not routinely or conventionally used to detect human proteins such as JUL-1.

Prior 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. Because rosacea treatments (e.g., antibiotics) are not effective against julitis, julitis patients who were misdiagnosed as having rosacea also did not respond well to the treatments they were given. Some anti-TNF antibodies are naturally occurring in patients with other autoimmune diseases such as lupus. Applicant has successfully treated julitis patients (even those who are non-responsive to anti-TNF antibodies) with topical vitamin D. Prior to applicant’s invention, and at the time the application was filed, vitamin D was commonly used as an oral supplement to maintain bone health (e.g., in fortified dairy products), but doctors were not commonly or routinely administering topical vitamin D to patients with julitis or other diseases.

Claims

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.

Analysis

Claim 1: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claim recites steps of obtaining a plasma sample from a patient (step a) and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody (step b). These steps do not recite or describe any recognized exception. See, e.g., Mayo Collaborative Svcs. v. Prometheus Labs., 566 U.S.   , 132 S. Ct. 1289, 1297 (2012) (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”). Accordingly, the claim is not directed to an exception (Step 2A: NO), and is eligible.

Note that although nature-based product limitations are recited in the claim (e.g., the plasma sample and JUL-1), analysis of the claim as a whole indicates that the claim is focused on a process of detecting whether JUL-1 is present in a plasma sample, and is not focused on the products per se. Thus, there is no need to perform the markedly different characteristics analysis on the recited nature-based product limitations. In addition, note that because the analysis of this claim ends with eligibility at Step 2A, the Step 2B analysis does not need to be performed. Thus, the examiner would not need to evaluate the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance, indicating that the claim is not directed to any judicial exception.

Claim 2: Ineligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. In step c, the 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). Thus, the claim is directed to at least one exception (Step 2A: YES), which may be termed a law of nature, an abstract idea, or both. Note that although the claim recites several nature-based product limitations (e.g., the plasma sample and JUL-1), the claim as a whole is focused on a process of detecting whether JUL-1 is present in a plasma sample, and is not focused on the products per se. Thus, there is no need to perform the markedly different characteristics analysis on the recited nature-based product limitations.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the law of nature, the claim recites additional steps of obtaining a plasma sample from a human patient (step a), and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody (step b). Obtaining a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. Further, the step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., a mere data gathering step necessary to use the correlation. 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. 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. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).

Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike 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. Even when viewed as a combination, the additional elements fail to transform the exception into a patent- eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself (Step 2B: NO). The claim is not eligible.

A rejection of claim 2 should identify step c as an exception by pointing to it in the claim and explaining why it is an exception, e.g., that the recited correlation is a law of nature because it is a consequence of a natural process in the body, and/or that the critical thinking step is an abstract idea similar to those found by the courts to be an exception. The rejection should also identify the additional elements in the claim and explain why they do not amount to significantly more, in this case, because they merely add data gathering and well-understood, routine and conventional activities that do not impose meaningful limits on the law of nature.

Claim 3: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES). Because claim 3 recites the same correlation and critical thinking step (step c) as claim 2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a judicial exception (Step 2A: YES). Although this claim recites several nature-based product limitations (the plasma sample, JUL-1, and the antibody), there is no need to perform the markedly different characteristics analysis on them, for the reasons discussed above for claim 2.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the exception, the claim recites additional steps of obtaining a plasma sample from a human patient (step a), and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with a porcine anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody (step b). The additional element of obtaining a plasma sample (step a) does not by itself add significantly more, for the reasons discussed above for claim 2. Step b, however, also requires detecting using a porcine anti-JUL-1 antibody. Prior to applicant’s invention, and at 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. Whether taken alone or as a combination with the other additional elements, the recitation of detecting JUL-1 using a porcine anti-JUL-1 antibody yields a claim as a whole that amounts to significantly more than the exception itself (Step 2B: YES). The claim is eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance indicating that the correlation and critical thinking step (step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites additional limitations that when considered as a combination are unconventional steps that are more than a mere instruction to “apply” the exception using well-understood, routine or conventional techniques in the field.

Claim 4: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES). Because claim 4 recites the same correlation and critical thinking step (step c) as claim 2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a judicial exception (Step 2A: YES). Although this claim recites several nature-based product limitations (the plasma sample, JUL-1, and the antibody), there is no need to perform the markedly different characteristics analysis on them, for the reasons discussed above for claim 2.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the exception, the claim recites the additional elements of obtaining a plasma sample from a human patient (step a) and detecting the presence of JUL-1 in the sample by contacting the plasma sample with antibody mAb-D33 and detecting resultant binding between the antibody and JUL-1 (step b). The additional element of obtaining a plasma sample (step a) does not add significantly more by itself, for the reasons discussed above for claim 2. Step b, however, requires detecting using a specific anti-JUL-1 antibody (mAb-D33). Prior to applicant’s invention, and at 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. Whether taken alone or as a combination with the other additional elements, the recitation of detecting JUL-1 using mAb-D33 yields a claim as a whole that amounts to significantly more than the exception itself (Step 2B: YES). The claim is eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance indicating that the correlation and critical thinking step (step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites additional limitations that when considered as a combination are unconventional steps that are more than a mere instruction to “apply” the exception using well-understood, routine or conventional techniques in the field.

Claim 5: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES). Because claim 5 recites the same correlation and critical thinking step (step c) as claim 2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a judicial exception (Step 2A: YES). Although the claim recites several nature-based product limitations (the plasma sample, JUL-1, and vitamin D), there is no need to perform the markedly different characteristics analysis on them, for the reasons discussed above for claim 2.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the exception, the claim recites the additional elements of obtaining a plasma sample from a human patient (step a) and detecting the presence of JUL-1 in the sample (step b). When considered individually, steps a and b by themselves do not add significantly more to the exception for the reasons discussed above for claim 2 (e.g., step b in this claim is recited at an even higher level of generality than in claim 2, that encompasses any protein detection method, whether or not it uses antibodies). However, this 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. Whether taken alone or as a combination with the other additional elements, the recitation of administering topical vitamin D yields a claim as a whole that amounts to significantly more than the exception itself (Step 2B: YES). The claim is thus eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance indicating that the correlation and critical thinking step (step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites additional limitations that when considered as a combination are unconventional steps that are more than a mere instruction to “apply” the exception using well-understood, routine or conventional techniques in the field.

Claim 6: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES). Because claim 6 recites the same correlation and critical thinking step (step c) as claim 2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a judicial exception (Step 2A: YES). Although the claim recites several nature-based product limitations (the plasma sample, JUL-1, and the anti-TNF antibodies), there is no need to perform the markedly different characteristics analysis on them, for the reasons discussed above for claim 2.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the exception, the claim recites the same additional elements of obtaining a plasma sample from a human patient (step a) and detecting the presence of JUL-1 in the sample (step b) as claim 5. When considered individually, steps a and b do not by themselves add significantly more to the exception for the reasons discussed above for claims 2 and 5. This claim further recites an additional element of administering an effective amount of anti-TNF antibodies to the diagnosed patient (step d). Prior to applicant’s invention, and at the time the application was filed, however, administering these antibodies to treat a patient diagnosed with julitis was well-understood, routine and conventional activity engaged in by doctors in the field. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining, detecting, and administering steps does not automatically confer eligibility on a claim directed to an exception (see, e.g., Alice Corp., 134 S.Ct. at 2358-59).

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”). Thus, the administration of anti-TNF antibodies, when considered as a combination with the other additional elements, yields a claim as a whole that amounts to significantly more than the exception itself (Step 2B: YES). The claim is eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance indicating that the correlation and critical thinking step (step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites additional limitations that when considered as a combination are a meaningful way of applying the exception that is more than a mere instruction to “apply” the exception.

Claim 7: Eligible.

The claim recites at least one step or act, e.g., administering an effective amount of anti-TNF antibodies to a patient suffering from julitis. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. Although the claim recites a nature-based product limitation (the anti-TNF antibodies), analysis of the claim as a whole indicates that the claim is focused on a process of practically applying the product to treat a particular disease (julitis), and not on the product per se. Accordingly, it is not necessary to perform the markedly different characteristics analysis on the antibodies. The recited step of administering antibodies to a patient suffering from julitis does not recite or describe any recognized exception. See, e.g., Mayo, 132 S. Ct. at 1297 (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”). Thus, the claim is not directed to an exception (Step 2A: NO). The claim is eligible.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis does not need to be performed. Thus, the examiner would not need to evaluate the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance, indicating that the claim is not directed to any judicial exception.