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Example 43: Treating Kidney Disease

This example illustrates the application of Revised Step 2A to treatment claims. The recited disease (Nephritic Autoimmune Syndrome Type 3) and biomarkers (C11 and C13) are hypothetical, but the recited treatments (glucocorticoids, non-steroidal agents, rapamycin, and plasmapheresis) are known treatments in the medical field. Claim 1 is ineligible because it recites a judicial exception (an abstract idea), and the claim as a whole does not integrate the exception into a practical application or provide an inventive concept. Claims 2-4 recite the same judicial exception as claim 1, but are eligible because the claim, including the recited treatment or prophylaxis steps, integrates the exception into a practical application. Claim 5 is eligible because it does not recite a judicial exception. This example also illustrates how process claims reciting nature-based product limitations are analyzed.

BACKGROUND

Nephritic Autoimmune Syndrome Type 3 (NAS-3) is an autoimmune disease that primarily affects the glomeruli, which are tufts of blood vessels in the kidneys that filter waste materials out of the bloodstream. It is known that NAS-3 is associated with the undesired formation of a protein complex (the membrane attack complex) in the person’s own glomeruli, thereby causing cell lysis and inflammation, and eventually chronic kidney disease or even kidney failure. More than two-thirds of people suffering from NAS-3 develop kidney failure within five years after their diagnosis.

Treatment of NAS-3 is complicated because the disease progresses rapidly, and some patients do not respond well to glucocorticoids (a class of steroids), which are the conventional first-line treatment. Many patients who are non-responsive to glucocorticoids often respond well to conventional second- line treatments, which include therapy with non-steroidal agents such as rapamycin. Rapamycin is a naturally occurring chemical isolated from bacteria, which has been in use as a therapeutic agent in humans since the early 1970s. Another conventional second-line treatment for some patients is a course of plasmapheresis, which is a filtration process that removes excess autoantibodies from the patient’s blood. Because these second-line treatments may have significant side effects such as bone marrow suppression and an increased risk of life-threatening infections, it is desirable to use them only when absolutely necessary, that is, when the patient is not responding to glucocorticoids. Unfortunately, by the time it usually becomes apparent that patients are not responding to glucocorticoids, the disease has often progressed to the point of causing irreversible kidney damage.

Applicant has now discovered and disclosed that the ratio between the levels of two proteins known as C11 and C13 in the blood of a patient with NAS-3 is indicative of patient response to glucocorticoids. In particular, applicant discloses that a high ratio (≥ 3:1) of C11 to C13 is indicative that the patient has a “non-responder phenotype,” which the specification defines as meaning that the patient will not respond, or is not responding, to glucocorticoids. Applicant discloses that calculation of this ratio in

patients diagnosed with NAS-3, and subsequently adjusting treatment in accordance with the calculation, contributes to optimal treatment and better clinical outcomes for patients with NAS-3.

CLAIMS

1. A treatment method comprising:

(a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non- responder phenotype;
(b) administering a treatment to the patient having a non-responder phenotype.

2. The method of claim 1, wherein the treatment is a non-steroidal agent capable of treating NAS-3.

3. The method of claim 1, wherein the treatment is rapamycin.

4. The method of claim 1, wherein the treatment is a course of plasmapheresis.

5. A treatment method comprising administering rapamycin to a patient identified as having Nephritic Autoimmune Syndrome Type 3 (NAS-3).

ANALYSIS

Claim 1 is ineligible.

Claim interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification’s definition of “non-responder phenotype” as meaning that the patient will not respond, or is not responding to glucocorticoids, and the plain meaning of the other terms, the broadest reasonable interpretation of claim 1 is a method of calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with NAS- 3 in order to identify the patient as having the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or greater and thus is not responding, or will not respond, to glucocorticoids), and administering a treatment to the patient having the non-responder phenotype. No particular treatment is required, i.e., the treatment can be glucocorticoids, other steroids, other therapeutic agents, kidney transplants, plasmapheresis, dialysis, palliative care, etc.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. The claim recites at least one step or act, including calculating a ratio. Thus, the claim is to a process, which is one of the statutory categories of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Limitation (a) in the claim recites several nature-based product limitations including C11, C13, and the blood sample, which raises the question of whether the markedly different characteristics analysis should be used to determine if the nature-based product limitations are product of nature exceptions. For a process claim, the general rule is that the claim is not subject to the markedly different analysis for nature-based products used in the process. MPEP 2106.04(c)(I)(C). While there is an exception to this general rule for process claims that are drafted in such a way that they are no different in substance than a product claim, claim 1 does not invoke this exception because review of this claim indicates that it is focused on a process of determining how much C11 and C13 is present in the blood sample and then treating a patient in accordance with that determination, and is not focused on the products per se. Thus, the general rule expressed in the MPEP applies, meaning that the markedly different characteristics analysis is not performed on the recited nature-based product limitations, and the claim is not considered to “recite” any products of nature for purposes of further eligibility analysis. However, the claim still must be reviewed to determine if it recites any other type of judicial exception.

Limitation (a) in the claim recites “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” which has a BRI that requires performing an arithmetic calculation (division) in order to obtain the ratio of C11 to C13 levels, and then using this ratio to identify whether the patient has the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or greater and thus is not responding, or will not respond, to glucocorticoids). This limitation therefore recites a mathematical calculation. The grouping of “mathematical concepts” in the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be practically performed in the human mind, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract ideas. In addition, limitation (a) describes a naturally occurring relationship between the ratio of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls within the mathematical concept and mental process groupings in the 2019 PEG, and a law of nature), and the analysis must therefore proceed to Step 2A Prong Two.

Although limitation (a) falls under several exceptions (e.g., a mathematical concept-type abstract idea, a mental process-type abstract idea, and a law of nature), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that limitation (a) aligns with at least one judicial exception, and to conduct further analysis based on that identification. See October 2019 Update at Section I.B n.7. For purposes of further discussion, this example identifies the recited exception as an abstract idea.

Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Besides the abstract idea, the claim recites the additional element of “administering a treatment to the patient having a non-responder phenotype” in limitation (b). Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Like the claims in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78 (2012), claim 1 here tells the relevant audience (doctors) about the mathematical concepts and at most adds a suggestion that the doctors take those laws into account when treating their patients. Limitation (b) thus fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, limitation (b) does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A: YES).

Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claim recites a single additional element in limitation (b), which does not require any particular application of the recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.

Practice note: A rejection of claim 1 should identify the exception by pointing to limitation (a) in the claim and explaining why it recites an abstract idea and/or a law of nature. The rejection should also explain that the claim as a whole, including the highly generic “treatment” step, does not integrate the exception into a practical application or amount to significantly more than the exception because it is at best the equivalent of merely adding the words “apply it” to the claim. The examiner could also include a citation to MPEP 2106.05(f), which provides a detailed explanation and examples of how courts have evaluated the “mere instructions to apply an exception” consideration.

While the analysis here identifies the recited exception as an abstract idea, it also explains that there are no bright lines between the types of exceptions, and that limitation (a) may also be identified as a law of nature. In the latter case, other than the explanation of why the limitation is a judicial exception, the analysis (and rejection) will be the same as previously described.

Claim 2 is eligible.

Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Claim 2 depends from claim 1, and adds a wherein clause specifying that the administered treatment is a non-steroidal agent capable of treating NAS-3. It is important to remember during claim interpretation that no limitations can be disregarded and the mere fact that the limitation appears in a “wherein” clause does not automatically mean that it is not given weight. In this case, when the wherein clause is considered in view of the specification, it is clear that the wherein clause has patentable weight because the claim requires that the treatment be an agent (e.g., a medicament) that is not a steroid and that has the function of being capable of treating NAS-3. No particular agent is required, so long as the agent is not a glucocorticoid or other steroid, and that it has the claimed function of treating NAS-3.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. The claim recites at least one step or act, including calculating a ratio. Thus, the claim is to a process, which is one of the statutory categories of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. Claim 2 depends from claim 1, and thus recites the same limitation (a). For the reasons discussed above for claim 1, this limitation recites an abstract idea, and the analysis must therefore proceed to Step 2A Prong Two.

Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG at Section III(A)(2).

Besides the abstract idea, the claim recites the additional element of “administering a treatment to the patient having a non-responder phenotype,” wherein “the treatment is a non-steroidal therapeutic agent capable of treating NAS-3.” Although the background of this example explains that non-steroidal therapeutic agents are a conventional second-line treatment for NAS-3, the Step 2A Prong Two analysis excludes consideration of whether a limitation is well-understood, routine, conventional activity (2019 PEG Section III(A)(2), 84 Fed. Reg. at 55). Thus, the following evaluation does not take into account whether or not the therapeutic agent is well-known. See October 2019 Update at Section III.D.

When this particular element is evaluated in the context of the claim as a whole, and under the broadest reasonable interpretation of this claim, it is evident that this limitation encompasses the administration of a “particular treatment or prophylaxis” under the 2019 PEG, i.e., the administration of a therapeutic agent that is capable of treating NAS-3 and that is not a steroid. For instance, this limitation has more than a nominal relationship to the judicial exception because it uses the recited abstract idea in a manner that imposes a meaningful limit on it, i.e., the abstract idea is used to identify the patient as being non- responsive to glucocorticoids, and the patient is then administered a treatment that is particular to that identified phenotype (i.e., a drug that is not a glucocorticoid or other steroid). See October 2019 Update at Section III.C, discussing how to evaluate the “particular treatment or prophylaxis” consideration in more detail. In this regard, the claim here is like those in Endo Pharms. Inc. v. Teva Pharms. USA Inc., 919 F.3d 1347 (Fed. Cir. 2019) and Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), both of which also used a judicial exception to identify patients in need of a particular treatment, and then administered the treatment to the identified patients. For instance, the Endo claims relied on a law of nature (the relationship between oxymorphone and patients with renal impairment) to identify a patient as requiring a particular treatment (a lower dosage of oxymorphone), and then administered that particular treatment to the patient. Just like the treatment step in Endo, the treatment limitation here integrates the recited judicial exception into a practical application, such that the claim is not directed to the judicial exception (Step 2A: NO). The claim is eligible.

Practice note: Although claim 2 is eligible, it may be unpatentable for other reasons, and thus it is important to practice compact prosecution by examining each claim for compliance with every statutory requirement for patentability in the initial review of the application. For instance, the examiner should evaluate whether the functionally- claimed genus of non-steroidal agents capable of treating NAS-3 is adequately supported by the written description. See MPEP 2163(II)(A)(3)(a).

Claim 3 is eligible.

Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Claim 3 depends from claim 1, and adds a wherein clause specifying that the administered treatment is rapamycin. It is important to remember during claim interpretation that no limitations can be disregarded and the mere fact that the limitation appears in a “wherein” clause does not automatically mean that it is not given weight. In this case, when the wherein clause is considered in view of the specification, it is clear that the wherein clause has patentable weight because the claim requires that the treatment be rapamycin. The claim does not require any particular dosage, mode of administration, or frequency of administration.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. The claim recites at least one step or act, including calculating a ratio. Thus, the claim is to a process, which is one of the statutory categories of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. Claim 3 depends from claim 1, and thus recites the same limitation (a). For the reasons discussed above for claim 1, this limitation recites an abstract idea, and the analysis must therefore proceed to Step 2A Prong Two. Note that while claim 3 recites an additional nature-based product limitation (the rapamycin in the administration step), analysis of the claim as a whole indicates that the claim remains focused on a process of determining how much C11 and C13 is present in the blood sample and then treating a patient in accordance with that determination, and is not focused on the products per se. Thus, the general rule in MPEP 2106.04(c)(I)(C) still applies, such that the claim is not considered to “recite” any products of nature for purposes of further eligibility analysis.

Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55.

Besides the abstract idea, the claim recites the additional element of “administering a treatment to the patient having a non-responder phenotype,” wherein “the treatment is rapamycin.” Although the background of this example explains that rapamycin is a conventional second-line treatment for NAS-3, the Step 2A Prong Two analysis excludes consideration of whether a limitation is well-understood, routine, conventional activity (2019 PEG Section III(A)(2), 84 Fed. Reg. at 55). Thus, the following evaluation does not take into account whether or not the rapamycin is well-known. See October 2019 Update at Section III.D.

When this particular element is evaluated in the context of the claim as a whole, and under the broadest reasonable interpretation of this claim, it is evident that this limitation encompasses the administration of a “particular treatment or prophylaxis” under the 2019 PEG, i.e., the administration of rapamycin. For instance, this limitation has more than a nominal relationship to the judicial exception because it uses the recited abstract idea in a manner that imposes a meaningful limit on it, i.e., the abstract idea is used to identify the patient as being non-responsive to glucocorticoids, and the patient is then administered a treatment that is particular to that identified phenotype (rapamycin is not a glucocorticoid). See October 2019 Update at Section III.C, discussing how to evaluate the “particular treatment or prophylaxis” consideration in more detail. As discussed above for claim 2, the claim here is like those in Endo, 919 F.3d 1347, and Vanda, 887 F.3d 1117, both of which also used a judicial exception to identify patients in need of particular treatment, and then administered the particular treatment to the identified patients. Like the treatment step in Endo, the treatment limitation here integrates the recited judicial exception into a practical application, such that the claim is not directed to the judicial exception (Step 2A: NO). The claim is eligible.

Practice note: The same claim interpretation must be used when evaluating the claim for compliance with all requirements for patentability (e.g., eligibility, definiteness, novelty, non-obviousness, written description, etc.). Although limitation (a) recites an abstract idea, it still imposes a limit on the claim scope and serves as a patentable distinction that cannot be ignored. Thus, for example, a reference disclosing administration of rapamycin to a patient identified as having NAS-3 would not anticipate claim 3 unless the reference also discloses calculation of the ratio of C11 to C13 levels in a blood sample from the patient.

Claim 4 is eligible.

Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Claim 4 depends from claim 1, and adds a wherein clause specifying that the administered treatment is a course of plasmapheresis. It is important to remember during claim interpretation that no limitations can be disregarded and the mere fact that the limitation appears in a “wherein” clause does not automatically mean that it is not given weight. In this case, when the wherein clause is considered in view of the specification, it is clear that the wherein clause has patentable weight because the claim requires that the treatment be a particular type of procedure, i.e., plasmapheresis. The claim does not require any specifics about the procedure, for instance, how many plasma exchanges are performed, how often they are performed, or how much of the patient’s blood volume is processed during each exchange.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. The claim recites at least one step or act, including calculating a ratio. Thus, the claim is to a process, which is one of the statutory categories of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. Claim 4 depends from claim 1, and thus recites the same limitation (a). For the reasons discussed above for claim 1, this limitation recites an abstract idea, and the analysis must therefore proceed to Step 2A Prong Two.

Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55.

Besides the abstract idea, the claim recites the additional element of “administering a treatment to the patient having a non-responder phenotype,” wherein “the treatment is plasmapheresis.” Although the background of this example explains that plasmapheresis is a conventional second-line treatment for NAS-3, the Step 2A Prong Two analysis excludes consideration of whether a limitation is well- understood, routine, conventional activity (2019 PEG Section III(A)(2), 84 Fed. Reg. at 55). Thus, the following evaluation does not take into account whether or not the plasmapheresis is well-known. See October 2019 Update at Section III.D.

Practice note: As illustrated by the analysis of this claim and described in the 2019 PEG, the “treatment” consideration encompasses the integration of any type of judicial exception into a practical application, including, e.g., the abstract idea recited in claim 4. This consideration also encompasses both treatment and prophylaxis limitations, including, e.g., the plasmapheresis limitation recited in claim 4. Examples of “treatment” and “prophylaxis” limitations include (but are not limited to) administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like.

When this particular element is evaluated in the context of the claim as a whole, and under the broadest reasonable interpretation of this claim, it is evident that this limitation encompasses the administration of a “particular treatment or prophylaxis” under the 2019 PEG, i.e., the administration of plasmapheresis (a therapeutic procedure). For instance, this limitation has more than a nominal relationship to the judicial exception because it uses the recited abstract idea in a manner that imposes a meaningful limit on it, i.e., the abstract idea is used to identify the patient as being non-responsive to glucocorticoids, and the patient is then administered a treatment that is particular to that identified phenotype (plasmapheresis does not involve administering glucocorticoids). See October 2019 Update at Section III.C, discussing how to evaluate the “particular treatment or prophylaxis” consideration in more detail. As discussed above for claim 2, the claim here is like those in Endo, 919 F.3d 1347, and Vanda, 887 F.3d 1117, both of which also used a judicial exception to identify patients in need of particular treatment, and then administered the particular treatment to the identified patients. Like the treatment step in Endo, the treatment limitation here integrates the recited judicial exception into a practical application, such that the claim is not directed to the judicial exception (Step 2A: NO). The claim is eligible.

Claim 5 is eligible.

Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of claim 5 is a method of administering rapamycin to a patient having NAS-3. The claim does not require any particular dosage, mode of administration, or frequency of administration.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. The claim recites at least one step or act, including administering rapamycin to a patient. Thus, the claim is to a process, which is one of the statutory categories of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. The administering step in the claim recites rapamycin, which is a nature-based product limitation, and thus raises the question of whether the markedly different characteristics analysis should be used to determine if the nature-based product limitation is a product of nature exception. For a process claim, the general rule is that the claim is not subject to the markedly different analysis for nature-based products used in the process. MPEP 2106.04(c)(I)(C). While there is an exception to this general rule for process claims that are drafted in such a way that they are no different in substance than a product claim, claim 5 does not invoke this exception because review of this claim indicates that it is focused on a process of administering rapamycin to a patient identified as having NAS-3, and is not focused on the products per se. Thus, the general rule expressed in the MPEP applies, meaning that the markedly different characteristics analysis is not performed on the recited nature-based product limitations, and the claim is not considered to “recite” any products of nature for purposes of further eligibility analysis. However, the claim still must be reviewed to determine if it recites any other type of judicial exception.

The recited step of administering rapamycin to a patient having NAS-3 does not set forth or describe any recognized exception. As explained by the courts, a method of treating cancer with chemotherapy is not directed to the cancer cells’ inability to survive chemotherapy, and a method of treating headaches with aspirin is not directed to the human body’s natural response to aspirin. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1049 (Fed. Cir. 2016), cited in MPEP 2106.04(b)(I); see also Mayo, 566 U.S. at 78 (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 administration step here is not a judicial exception. Because the claim does not recite a judicial exception, it cannot be directed to one (Step 2A: NO). The claim is eligible.

Practice note: Although claim 5 is eligible, it may be unpatentable for other reasons, and thus it is important to practice compact prosecution by examining each claim for compliance with every statutory requirement for patentability in the initial review of the application. For instance, the examiner should evaluate whether claim 5 is patentable over prior art. As explained in the background, administering rapamycin to a patient identified as having NAS-3 is a conventional treatment for NAS-3, and thus the claim is anticipated by a reference disclosing such administration. In addition, if applicant has stated, either in the specification or during prosecution, that administering rapamycin to a patient identified as having NAS-3 is a conventional treatment for NAS-3, the examiner may consider this statement to be applicant-admitted prior art, which may be relied upon for both an anticipation and obviousness determination. See MPEP 2129(I).