Because the Federal Circuit says it can’t, that’s why! In Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017), the panel held patent-ineligible claims to a method of assessing a test subject’s risk of having cardiovascular disease (CVD) by comparing levels of a marker MPO in a sample from the subject with levels from control subjects diagnosed as not having the disease wherein elevated levels of MPO in the test subject over the control subjects’ MPO levels “is indicative of the extent of the test subject’s risk of having cardiovascular disease”. In that decision, the panel found that the method claims are directed to a patent-ineligible natural law ‘that blood MPO levels correlate with CVD, “holding that the claimed method ‘starts and ends’ with observation of ‘naturally occurring phenomena’, as in Ariosa….” The panel jumped right to Step 2B of the Mayo/Alice test and found that the claims “recited no further inventive concept sufficient to transform the nature of the claims into a patent eligible application of the natural law.”
In this case, “Cleveland Clinic II,” (Appeal 2018-1218 (Fed. Cir., April 1, 2019) the Clinic appealed the 101 rejection of claims that did not recite a diagnostic conclusion:
- A method of detecting elevated MPO mass in a patient sample comprising;
- obtaining a sample from a human patient having [CVD]; and
- detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPRO in said plasma samples and said anti-MPO antibodies.
These claims were designed to track Example 29 – Claim 1 of the May 4, 2016 PTO Guidance on patent-eligible subject matter:
- A method of detection JUL-1 [a marker for the autoimmune disease “julitis”], said method comprising:
- obtaining a plasma sample from a human patient; and
- 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.
In Endo v. Teva, Appeal 2017-1240 (Fed. Cir., March 19, 2019), a Fed. Cir. panel of Judges Stoll, Wallach and Clevenger unanimously found patent-eligible claims to a method of treating pain with oxymorphone, based on the inventor’s discovery that there was a significant correlation between plasma AUC for the drug and a patient’s degree of renal impairment (U.S. Pat. No. 8,808,737). As Judge Stoll wrote:
“[U.S. Pat. No. 8,808,737] relates to his discovery that patients with renal impairment in need of pain relief can be treated in a new different way than other patients. Specifically, the inventor discovered than patients with moderately or severely impaired kidney function [as measured by creatinine clearance levels] need less oxymorphone than usual to achieve a similar level of pain management” [emphasis added].
The claim is not a model of elegant drafting, but it got the job done:
- A method of treating pain in a renally impaired patient, comprising the steps of:
- Providing a solid oral controlled release dosage form, comprising:
- About 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient and
- A controlled release matrix;
- Measuring a creatinine clearance rate of the patient and determining it to be [within one of four ranges representing renal impairment from healthy control to severe renal impairment; and
- Orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief;
Wherein after said administration to said patient the average AUC of oxymorphone over a 12-hour period is less than about 21 ng hr/ml. [emphasis added].
The Examiner in Appeal no. 2017-003416 (Mar. 1, 2019) had rejected this claim as directed to a natural product:
“18. An in vitro culture comprising a substantially pure, replenishable population of synchronous primate trophoblast cells, wherein the synchronous primate trophoblast express chorionic gonadotropin, are predominantly chorionic gonadotropin (CG-B) positive, and are derived directly in vitro from undifferentiated primate embryonic cells exposed to a trophoblast inducing factor selected from the group consisting of [four factors] without passing through an embryoid body stage.”
A trophoblast is a cell which is a precursor of the cells which participate in the formation of the placenta. At the blastocyst stage, the outer cells of the blastocyst become committed to participate in the development of the placenta. The Examiner argued that all of the process steps in this product-by-process claim should be ignored because the claimed cells were not markedly different from the cells as they occur in nature, citing Chakrabarty. Going on to Step 2B of the Mayo/Alice analysis, the Examiner found no other elements that would amount to significantly more than the natural product itself.
In earlier posts, I discussed at least one group of claims directed to the difficulties in claiming manipulations of “big data.” In ex parte Hazokaki, Appeal 2018-003293 (PTAB, Feb. 5, 2019), the Examiner and the Board were confronted with claims to a four-step method of formulating a skin-lightening composition, with six sub-steps reciting how to construct a database of “stored instances” created by generating gene differential expression profiles of, e.g., the wild type of a human skin cells and the skin cells after treatment with different “peturbagens” (skin lightening agents). Claim 1 reads as follows:
- A method of formulating a skin lightening composition, comprising:
- Constructing a database for use in identifying connections between peturbagens as genes associated with skin tone comprising:
- Providing a gene expression profile for a control human cell, wherein the control cell is from a human cell line selected from the group consisting of [w, x, y and z];
- Generating a skin expression profile for a human cell exposed to a peturbagen, wherein the cell is form the same cell line as the control cell line;
- Identifying genes differentially expressed in response to the peturbagen by comparing the gene expression profiles of (a)(i) and (a)(ii);
- Creating an ordered list comprising identifiers representing the differentially expressed genes, wherein the identifiers are ordered according to the differential expression of the genes;
- Storing the ordered list as an instance on a non-transitory computer readable medium, wherein the instance includes metadata identifying the cell line from the selection in (a)(i),
- Constructing a database of stored instances by repeating (a)(i)-(a)(v), wherein the at least one peturbagen of step (a)(ii) is different….for each instance,
- Querying the database to identify at least one putative skin lightening agent; and
- Confirming that the putative skin active agent provides skin pigmentation modifying efficacy using in vitro assays or clinical methods;
- Mixing the putative skin active agent with a dermatologically acceptable carrier to provide a skin lightening composition.