Board Applies Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Rejects a Method of Predicting a Response to Treatment as Unpatentable Subject Matter under 35 U.S.C. § 101

July 23, 2012 – Blog Post

In Ex parte Potts (Case No. 2011-004700, in Application Serial No. 11/690,745, decision issued July 17, 2012), the Board rejected as unpatentable subject matter a claimed method for predicting the outcome of a clinical treatment based on measured correlations between treatments and responses, because the claims at issue sought only to patent a “law of nature.”

A.     In its recent decision of Mayo Collaborative Servs. v. Prometheus Labs., Inc. the United States Supreme Court affirmed that "laws of nature, natural phenomena, and abstract ideas" are not patentable.  132 S. Ct. 1289, 1293 (U.S. 2012) (quoting Diamond v. Diehr, 450 U.S. 175, 185, 101 S. Ct. 1048, 67 L. Ed. 2d 155 (1981)).  This longstanding rule addressed a concern that granting patents to ideas and phenomena of nature could inhibit or foreclose future innovations related thereto.  Id. at 1293, 1301-02.  Such ideas and laws are unpatentable under Section 101 regardless of their breadth or impact, because courts and judges are not institutionally well suited to making the judgments needed to distinguish among different principles of nature.  Id. at 1303.

Mayo Collaborative addresses the subject-matter patentability of process claims that include laws of nature as limitations.  From the outset the Court made it crystal clear that “to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.’”  Id. at 1294.  As a general rule, a process that focuses on the use of a natural law must also contain other elements or a combination of elements, i.e., an “inventive concept,” to ensure that the patent amounts to significantly more than the natural law itself.  Id. (see Parker v. Flook, 437 U.S. 584, 594 (1978)).  Merely limiting the natural law to a particular technological environment, or adding an insignificant post-solution activity, will not suffice.  Id. (see Diamond v. Diehr, 450 U.S. 175, 191-92).

What constitutes a “significant” inventive concept—for the purpose of rendering a process relying upon a law of nature patentable under Section 101—is the focus of the unanimous opinion in Mayo Collaborative.  132 S. Ct. at 1297.  Purely “conventional or obvious” limitations are normally not sufficient to transform an unpatentable law of nature into patent-eligible subject matter.  Id. at 1298 (see Flook, 437 U.S. at 590; see also Bilski, 130 S. Ct. 3218, 3255 (2010)).  In the words of Justice Breyer, “simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.”  Id. at 1300.  Moreover, the claimed process must limit its scope to avoid covering both known and unknown uses, because allowing the applicants to patent unknown uses would preempt applications in other fields.  Id. at 1301.

Applying these principles to Prometheus Labs’ process, the Court held that the steps of “administering” a drug to a subject and “determining” the level of a key metabolite in the subject, wherein an indicated need to adjust the dose was directly tied to a measured level of the metabolite, was not patentable under Section 101.  Id. at 1297.  The “administering” step was insufficient because it merely refers to the relevant audience—namely, doctors who treat patients with certain diseases using the drug.  Id.  As explained in Bilski, the “prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’”  130 S. Ct. at 3225.  The “determining” step did not provide a significant inventive concept because the methods for determining metabolite levels were well known, and purely “conventional or obvious” steps are not normally sufficient.  Id. at 1297-98.

B.      A similar fate befell the claims at issue in Ex parte Potts under the Board’s application of Mayo Collaborative.  Representative Claim 54 is drawn to the following method for evaluating the likelihood of a clinical response:

54.    A method for evaluating the likelihood of a clinical response for an individual to a treatment for a disease or condition, said method comprising:

a)      providing a primary self organizing map (SOM) constructed using a plurality of data sets of measurements obtained from a plurality of individuals, said plurality of individuals each having undergone a treatment for a disease or condition, said individuals each having a clinical response to said treatment;

b)      preparing a secondary SOM using a distinct labeling set, said distinct labeling set encompassing one or more of said clinical responses of said plurality of individuals to said treatment, said secondary SOM including a sample data set obtained from a sample of an individual in need of evaluation; and

c)      visually displaying a result from said secondary SOM that reveals the extent of similarity between the data sets of measurements of the distinct labeling set and said sample data set of said individual in need of evaluation;

         whereby a medical practitioner can use said result to evaluate the likelihood of a clinical response for said individual in need of evaluation to said treatment.

Op. at 2. 

The Board summarized the process steps as: (1) applying an algorithm to data relating to the results of patient treatment; (2) visually displaying the result; and (3) determining, based on the result, whether a patient in need of treatment will likely respond to treatment.  Op. at 6.  The Board determined as a finding of fact that, prior to the date of the applicants’ claimed invention, it was recognized in the relevant art that various algorithms could be used to manipulate data sets in order to predict whether a patient would respond to a particular treatment regimen.  Op. at 5 (FF 6).  The issue then was whether the steps of “applying” the algorithm (law of nature), “visually displaying” the result, and making a “determination” as to whether a patient was likely to respond to treatment constituted a sufficient “inventive concept” above and beyond the algorithm itself.

The Board held that the claims at issue fail to evince a sufficient inventive concept, because the recited process does not involve the transformation of an article into a different state or thing.  Op. at 6 (citing Diehr, 450 U.S. at 184).  Instead, according to the Board, the applicants’ claims were attempting to merely “apply” the natural law (algorithm) describing the relationship between patient-specific data and prior clinical responses in order to predict the benefit of medical treatment.  Op. at 6.  The opinion reiterates that to transform such a nonpatentable phenomenon, process, or concept into a patent-eligible application, one must do more than simply state the phenomenon, process, or concept while adding the words “apply it.”  Op. at 5 (quoting Mayo Collaborative, 132 S. Ct. at 1294).

Citing to a recent decision by the U.S. District Court for the District of Columbia, the Board applied the machine or transformation test and concluded that the transformation prong was not satisfied.  Op. at 6-7.  In the words of the Board, “Applicants’ claims are ‘more akin to a manual reorganization to treatment options.  This does not satisfy the transformation prong of the [machine or transformation] test.”  Id. (citing SmartGene, Inc. v. Advanced Biological Labs, SA, 2012 WL 1059611, at *17 (D.D.C., March 30, 2012)).  Cf. Mayo Collaborative, 132 S. Ct. at 1303 (“[I]n stating that the ‘machine or transformation’ test is an ‘important and useful clue’ to patentability, we have neither said nor implied that the test trumps the ‘law of nature’ exclusion.” (citing Bilski, 130 S. Ct. 3218)).

The Board also rested its decision on the conclusion that the recited process steps (i.e., the “manipulation” of data sets) were merely “conventional or obvious.”  Op. at 7-8.  It found that, at the time of the applicants’ invention, the manipulation of data sets to allow doctors to predict patient responses to treatment was known in the art, as was the manipulation of so-called “self-organizing maps (SOMs).”  Id.  As explained by the Board:

Thus, the notion that patient data relating to a clinical response to treatment can be manipulated to allow a medical practitioner to predict whether another patient, i.e., one in need of treatment, will respond to a particular treatment was “‘well known,’ to the point where, putting the formula to the side, there was no ‘inventive concept’ in the claimed application of the formula.”  Mayo, 132 S.Ct. at 1299, citing Parker v. Flook, 95 U.S. 594.  Accordingly, we are not persuaded by Appellants’ contention that “[t]he claimed methods rely on mathematical manipulations and presentations of data but do not seek to patent the mathematical formulae underlying those manipulations and presentations” (Reply Br. 6).  A “basic mathematical equation, like a law of nature, . . . [is] not patentable.” Mayo, 132 S.Ct. at 1299.  The “prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’” Id. at 1297, citing Bilski v. Kappos, 130 S.Ct. 3218, 3230 (2010); see also Parker v. Flook, 95 U.S. at 595 n. 18 (“a claim for an improved method of calculation, even when tied to a specific end use, is unpatentable subject matter under § 101”).

Op. at 8. 

Finally, the Board rejected the applicants’ reliance on the case of In re Abele, 684 F.2d 902 (CCPA 1982), because the process of improving a CAT scan image that was claimed in Abele satisfied the “transformation” prong of the machine-or-transformation test.  Op. at 9. 

The Board rejected the claimed methods under Section 101 as being directed to non-statutory subject matter.

For additional information regarding the Office’s application of the Supreme Court’s decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. readers are directed to the 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving the Laws of Nature, which was published by the Deputy Commissioner for Patent Examination Policy on July 3, 2012.