I. Introduction

Two recent opinions by the United States Court of Appeals for the Federal Circuit illustrate the continuing broad limits for what qualifies as patentable subject matter under 35 U.S.C. § 1011 following the Supreme Court’s highly publicized opinion in Bilski v. Kappos.2 In Bilski, the Supreme Court rejected the “machine-or-transformation” test as the exclusive test for the patent-eligibility of a process and declined to adopt per se patentability exclusions on particular subject matter outside of its three well-established exceptions: (1) laws of nature; (2) physical phenomena; and (3) abstract ideas.3

Following Bilski, the Federal Circuit acknowledged in Prometheus Labs., Inc. v. Mayo Collaborative Services4 that while the machine-or-transformation test is not the definitive test, it is still a useful “investigative tool.” Addressing the laws-of-nature exception, the Federal Circuit held that transformations occurring in Prometheus’s personalized medicine claims indicated that the patents at issue recited patent-eligible applications of naturally occurring correlations rather than the natural correlations themselves.5 Additionally, the Federal Circuit’s opinion in Research Corp. Techs. v. Microsoft Corp.6 (RCT) addressed the abstract idea exception. Finding that RCT’s method of digital image halftoning was not “manifestly” abstract, the court held RCT’s claimed processes to be patent-eligible.7

II. Laws Of Nature

The Federal Circuit’s decision in Prometheus turned on whether the claimed methods were drawn to a law of nature or only a “particular application of naturally occurring correlations.”8 The personalized medicine patents included methods for optimizing the dosages of particular drugs to a patient’s individual metabolic biochemistry. Claim 1 of the ‘623 Patent recited:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8x10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.9

In a 2009 decision, the Federal Circuit had found the ‘623 Patent to pass the machine-or-transformation test.10 But the Supreme Court vacated this opinion and remanded the case for further consideration in light of Bilski.11 On remand, the Federal Circuit showed its willingness to still utilize the machine-or-transformation test as an “investigative tool” to determine the ultimate question of whether a claimed process is a patent-eligible application of a natural phenomena.12

First, the Prometheus court found that the “administering” step was transformative.13 “When administering a drug such as AZA or 6-MP, the human body necessarily undergoes a transformation.”14 “[T]he effect on the body after metabolizing the artificially administered drugs, is the entire purpose of administering these drugs.”15 Next, the court found that the “determining” step was transformative.16 Determining levels of the drug in a patient necessarily involves some form of manipulation to extract the metabolites from a bodily sample and determine their concentration.17 Further, the Federal Circuit found that these steps were “central” to the purpose of the claimed process rather than mere “data-gathering steps” or “insignificant extra-solution activity.”18

Interestingly, the Federal Circuit pointed to the specification of the patent and the preamble of the asserted claims to draw the conclusion that the disputed claims were not merely claiming the combination of natural correlations and data-gathering steps.19 Specifically, the court found that the purpose of the “claimed methods for optimizing efficacy and reducing toxicity of treatment regimes” was “made clear in the specification and the preambles of the asserted claims.”20

III. Abstract Ideas

The Federal Circuit’s decision in RCT turned on whether or not the claimed methods were drawn to an abstract idea.21 The patents at issue pertained to digital image halftoning, which involves the placement of dots in a formation that gives the viewer of a digital image the illusion of varying colors or shades of gray despite the limited number of pixel colors available.22 Claim 1 of the ‘310 Patent recited:

1. A method for the halftoning of gray scale images by utilizing a pixel-by-pixel comparison of the image against a blue noise mask in which the blue noise mask is comprised of a random nondeterministic, non-white noise single valued function which is designed to produce visually pleasing dot profiles when thresholded at any level of said gray scale images.23

According to the patent, the inventors’ blue noise mask “produces higher quality halftone images” than the prior art “while using less processor power and memory space.”24

Before analyzing the claims at issue in RCT, the Federal Circuit heeded the Supreme Court’s repeated emphasis regarding the breadth of patentable subject matter. “Congress plainly contemplated that the patent laws would be given wide scope.”25 “Therefore, the Supreme Court has ‘more than once cautioned that courts’ should not read into the patent laws limitations and conditions which the legislature has not expressed.”26 With this guidance in mind, the RCT decision announced a high threshold regarding what will be deemed abstract ideas. The Federal Circuit “will not presume to define ‘abstract’ beyond the recognition that this disqualifying characteristic should exhibit itself so manifestly as to override the broad statutory categories of eligible subject matter . . . .”27

The Federal Circuit then held that there was nothing abstract in the patents at issue.28 Pointing to the specification, the RCT court noted that “invention presents functional and palpable applications in the field of computer technology.”29 “Indeed, this court notes that inventions with specific applications or improvement to technologies in the marketplace are not likely to be so abstract that they override the statutory language and framework of the Patent Act.”30

IV. Conclusion

Prometheus and RCT illustrate the current thinking of the Federal Circuit with respect to the breadth of patentable subject matter under 35 U.S.C. § 101 following the Supreme Court’s decision in Bilski. Prometheus highlighted the Federal Circuit’s willingness to continue using the machine-or-transformation test as a useful tool to determine when personalized medicine claims are drawn to patent-eligible applications of natural correlations. Further, RCT set a high threshold for invalidating an invention as an abstract idea, requiring that the invention be “manifestly” abstract. Interestingly, both opinions looked to the specifications of the respective patents for justification that the claims were in fact drawn to patentable subject matter. These opinions suggest that the Federal Circuit will now review subject matter challenges with respect to the patent as a whole, potentially making it easier for method claims to survive the threshold test provided by Section 101’s eligibility requirements.