Opinion ID: 867144
Heading Depth: 3
Heading Rank: 5

Heading: Mayo v. Prometheus

Text: The Supreme Court’s most recent guidance regarding patent eligibility drew heavily on the foregoing precedents in applying the “laws of nature” exception to claims covering medical diagnostic methods. The claims in Mayo recited methods for optimizing thiopurine administration in a patient based on a natural correlation between the therapeutic efficacy of a particular dose of a thiopurine and the resulting concentration of thiopurine metabolites in the patient’s blood. Too little metabolite and the dose was insufficient; too much suggested that the dose should be reduced to avoid toxicity. Mayo, 132 S. Ct. at 1294–95. Accordingly, the claims recited the specific steps of administering the thiopurine drug and determining the resulting metabolite concentration in the patient’s blood, wherein a concentration above or below predefined thresholds indicated a need to adjust the drug dose. See id. at 1295 (claim 1). The Supreme Court held that those claims failed the § 101 test for subject-matter eligibility. The Court began its analysis by noting that the claims “set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Id. at 1296. Therefore, the question was “whether the claims do significantly more than simply describe these natural relations”; did they “add enough” to the natural law to render the claimed processes patent eligible? Id. at 1297. Examining the other limitations, the Court concluded that the “administering” and “determining” steps were insufficiently limiting or inventive to confer patent eligibility: “Anyone who wants to make use of these [natural] laws must first administer a thiopurine drug and measure the resulting metabolite concentrations, and so the combination amounts to nothing significantly more than an instruction to doctors to apply the CLS BANK INTERNATIONAL v. ALICE CORPORATION 15 applicable laws when treating their patients.” Id. at 1298. Because these additional steps were mere “routine, conventional activity previously engaged in by scientists who work in the field,” the Court concluded that they did not transform the law of nature into a patent-eligible application of that law. Id. C. An Integrated Approach to § 101 Several common themes that run through the Su- preme Court’s decisions should frame our analysis in this and other § 101 cases. First and foremost is an abiding concern that patents should not be allowed to preempt the fundamental tools of discovery—those must remain “free to all . . . and reserved exclusively to none.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). Preemption features prominently in the Supreme Court’s recent § 101 decisions, see Mayo, 132 S. Ct. at 1301 (“The Court has repeatedly emphasized . . . a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature.”); Bilski, 130 S. Ct. at 3231 (concluding that the disputed claims “would pre-empt [risk hedging] in all fields, and would effectively grant a monopoly over an abstract idea”); Diehr, 450 U.S. at 187 (“Their process admittedly employs a well-known mathematical equation, but they do not seek to pre-empt the use of that equation.”); Benson, 409 U.S. at 72 (“[I]f the judgment below is affirmed, the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself.”), and traces back to the earliest judicial decisions addressing subject-matter eligibility, see, e.g., O’Reilly v. Morse, 56 U.S. 62, 113 (1853) (rejecting a claim that would have broadly conferred “a monopoly” in the use of electromagnetism, “however developed, for the purpose of printing at a distance”). Guarding against the wholesale preemption of 16 CLS BANK INTERNATIONAL v. ALICE CORPORATION fundamental principles should be our primary aim in applying the common law exceptions to § 101. To be clear, the proper focus is not preemption per se, for some measure of preemption is intrinsic in the statutory right granted with every patent to exclude competitors, for a limited time, from practicing the claimed invention. See 35 U.S.C. § 154. Rather, the animating concern is that claims should not be coextensive with a natural law, natural phenomenon, or abstract idea; a patent-eligible claim must include one or more substantive limitations that, in the words of the Supreme Court, add “significantly more” to the basic principle, with the result that the claim covers significantly less. See Mayo 132 S. Ct. at 1294. Thus, broad claims do not necessarily raise § 101 preemption concerns, and seemingly narrower claims are not necessarily exempt. What matters is whether a claim threatens to subsume the full scope of a fundamental concept, and when those concerns arise, we must look for meaningful limitations that prevent the claim as a whole from covering the concept’s every practical application. See id. at 1302 (“The laws of nature at issue here are narrow laws that may have limited applications, but the patent claims that embody them nonetheless implicate this concern.”). Next, the cases repeatedly caution against overly formalistic approaches to subject-matter eligibility that invite manipulation by patent applicants. Allowing the determination of patent eligibility to “depend simply on the draftsman’s art . . . would ill serve the principles underlying the prohibition against patents for ‘ideas’ or phenomena of nature.” Flook, 437 U.S. at 593. Thus, claim drafting strategies that attempt to circumvent the basic exceptions to § 101 using, for example, highly stylized language, hollow field-of-use limitations, or the recitation of token post-solution activity should not be credited. See Bilski, 130 S. Ct. at 3230 (“[T]he prohibition CLS BANK INTERNATIONAL v. ALICE CORPORATION 17 against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity.’” (quoting Diehr, 450 U.S. at 191– 92)); Flook, 437 U.S. at 590 (rejecting such an approach as “exalt[ing] form over substance”). The Supreme Court’s precedents require that we look past such devices when analyzing a claim to consider its true practical effect with respect to the purpose of § 101—preserving the “basic tools” of scientific discovery for common use. Finally, the cases urge a flexible, claim-by-claim approach to subject-matter eligibility that avoids rigid line drawing. Bright-line rules may be simple to apply, but they are often impractical and counterproductive when applied to § 101. Such rules risk becoming outdated in the face of continual advances in technology—they risk “freez[ing] process patents to old technologies, leaving no room for the revelations of the new, onrushing technology.” Benson, 409 U.S. at 71. Stringent eligibility formulas may also lead to misplaced focus, requiring courts to “pose questions of such intricacy and refinement that they risk obscuring the larger object of securing patents for valuable inventions without transgressing the public domain.” Bilski, 130 S. Ct. at 3227. Accordingly, the Supreme Court has rejected calls for a categorical exclusion of so-called business method claims and has held that the formulaic “machine-or-transformation” test cannot be the exclusive means for determining the patent eligibility of process claims. Id. at 3227–29. What is needed is a flexible, pragmatic approach that can adapt and account for unanticipated technological advances while remaining true to the core principles underlying the fundamental exceptions to § 101. With these basic principles in mind, the following analysis should apply in determining whether a computer-implemented claim recites patent-eligible subject 18 CLS BANK INTERNATIONAL v. ALICE CORPORATION matter under § 101 or falls into the common law exception for abstract ideas. The first question is whether the claimed invention fits within one of the four statutory classes set out in § 101. Assuming that condition is met, the analysis turns to the judicial exceptions to subject-matter eligibility. A preliminary question in applying the exceptions to such claims is whether the claim raises § 101 abstractness concerns at all. Does the claim pose any risk of preempting an abstract idea? In most cases, the answer plainly will be no. Cf. Honeywell Inc. v. Sperry Rand Corp., No. 4-67-cv-138, 180 USPQ 673, 1973 WL 903 (D. Minn. Oct. 19, 1973) (early computer hardware patents). Where bona fide § 101 concerns arise, however, it is important at the outset to identify and define whatever fundamental concept appears wrapped up in the claim so that the subsequent analytical steps can proceed on a consistent footing. Section 101 is concerned as much with preserving narrow “basic tools” as it is with abstract concepts that have far-reaching implications—for example, risk hedging or transmitting information at a distance using electricity—and the breadth of acceptable exclusion may vary accordingly. See Mayo, 132 S. Ct. at 1302–03. In short, one cannot meaningfully evaluate whether a claim preempts an abstract idea until the idea supposedly at risk of preemption has been unambiguously identified. Although not required, conducting a claim construction analysis before addressing § 101 may be especially helpful in this regard by facilitating a full understanding of what each claim entails. See Bancorp, 687 F.3d at 1273–74. The § 101 inquiry next proceeds to the requisite preemption analysis. With the pertinent abstract idea identified, the balance of the claim can be evaluated to determine whether it contains additional substantive CLS BANK INTERNATIONAL v. ALICE CORPORATION 19 limitations that narrow, confine, or otherwise tie down the claim so that, in practical terms, it does not cover the full abstract idea itself. See Mayo, 132 S. Ct. at 1300 (discussing a patent-eligible process claim that involved a law of nature but included additional steps “that confined the claims to a particular, useful application of the principle”); Bilski, 130 S. Ct. at 3231 (rejecting claims that “add [too little] to the underlying abstract principle”); Diehr, 450 U.S. at 187 (“[T]hey do not seek to pre-empt the use of that equation. Rather, they seek only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process.”). The requirement for substantive claim limitations beyond the mere recitation of a disembodied fundamental concept has “sometimes” been referred to as an “inventive concept.” See Mayo, 132 S. Ct. at 1294 (citing Flook, 437 U.S. at 594). We do not read the Court’s occasional use of that language in the § 101 context as imposing a requirement that such limitations must necessarily exhibit “inventiveness” in the same sense as that term more commonly applies to two of the statutory requirements for patentability, i.e., novelty and nonobviousness. See 35 U.S.C. §§ 102, 103. The phrase “inventive concept” originated with Flook, yet the Court began its discussion of § 101 in that case by stating that the question of patenteligible subject matter “does not involve the familiar issues of novelty and obviousness that routinely arise under §§ 102 and 103.” 437 U.S. at 588. The Court has since reiterated that those separate inquiries do not bear on the question of subject-matter eligibility under § 101. Diehr, 450 U.S. at 188–89 (“The ‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.”); id. at 191 (“A rejection on either of these [anticipation or obviousness] grounds does not affect the determination that respondents’ claims recited subject 20 CLS BANK INTERNATIONAL v. ALICE CORPORATION matter which was eligible for patent protection under § 101.”); see also Mayo, 132 S. Ct. at 1298–1300, 1302 (holding was consistent with Diehr and Flook and did not “depart from case law precedent”). An “inventive concept” in the § 101 context refers to a genuine human contribution to the claimed subject matter. “The underlying notion is that a scientific principle . . . reveals a relationship that has always existed.” Flook, 437 U.S. at 593 n.15. From that perspective, a person cannot truly “invent” an abstract idea or scientific truth. He or she can discover it, but not invent it. Accordingly, an “inventive concept” under § 101—in contrast to whatever fundamental concept is also represented in the claim—must be “a product of human ingenuity.” See Chakrabarty, 447 U.S. at 309. In addition, that human contribution must represent more than a trivial appendix to the underlying abstract idea. The § 101 preemption analysis centers on the practical, real-world effects of the claim. See, e.g., Mayo, 132 S. Ct. at 1294 (“[A] process that focuses upon the use of a natural law [must] also contain other elements . . . sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.”); Bilski, 130 S. Ct. at 3231 (rejecting claims that would “effectively grant a monopoly over an abstract idea”); Benson, 409 U.S. at 71–72 (“[T]he patent . . . in practical effect would be a patent on the algorithm itself.”). Limitations that represent a human contribution but are merely tangential, routine, well-understood, or conventional, or in practice fail to narrow the claim relative to the fundamental principle therein, cannot confer patent eligibility. For example, the “administering” and “determining” steps in Mayo might have appeared to be concrete limitations representing true human contributions to the CLS BANK INTERNATIONAL v. ALICE CORPORATION 21 claimed methods; it is difficult to see how giving a particular man-made drug to a patient or drawing and testing blood could be considered purely abstract or preordained. Yet the Court held that those steps failed to render the claims patent eligible because, as a practical matter, they were necessary to every practical use of what it found to be a natural law and therefore were not truly limiting. Mayo, 132 S. Ct. at 1298 (“Anyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations . . . .”); see also Benson, 409 U.S. at 71 (noting that the “mathematical formula involved here has no substantial practical application except in connection with a digital computer”). Also in Mayo, the Court instructed that the added steps, apart from the natural law itself, must amount to more than “well-understood, routine, conventional activity previously engaged in by researchers in the field.” 132 S. Ct. at 1294. Similarly, token or trivial limitations, see Diehr, 450 U.S. at 191–92 (stating that “insignificant post-solution activity will not transform an unpatentable principle into a patentable process”), or vague limitations cast in “highly general language,” Mayo, 132 S. Ct. at 1302, have failed to satisfy § 101. Finally, bare field-of-use limitations cannot rescue a claim from patent ineligibility where the claim as written still effectively preempts all uses of a fundamental concept within the stated field. Bilski, 130 S. Ct. at 3230 (discussing Flook and Diehr). Whether a particular claim satisfies the § 101 standard will vary based on the balance of factors at play in each case, and the fact that there is no easy bright-line test simply emphasizes the need for the PTO and the courts to apply the flexible analysis above to the facts at hand. Thus, the Supreme Court used the language “routine” and “conventional” in Mayo to indicate what qualities added to a natural law do not create patent-eligible subject matter. See Mayo, 132 S. Ct. at 1298. We do not 22 CLS BANK INTERNATIONAL v. ALICE CORPORATION therefore understand that language to be confused with novelty or nonobviousness analyses, which consider whether particular steps or physical components together constitute a new or nonobvious invention. Analyzing patent eligibility, in contrast, considers whether steps combined with a natural law or abstract idea are so insignificant, conventional, or routine as to yield a claim that effectively covers the natural law or abstract idea itself. Two other considerations are worth noting with respect to the § 101 analysis. First, some have argued that because § 101 is a “threshold test,” Bilski, 130 S. Ct. at 3225, district courts must always consider subject-matter eligibility first among all possible bases for finding invalidity. That is not correct. District courts are rightly entrusted with great discretion to control their dockets and the conduct of proceedings before them, including the order of issues presented during litigation. See, e.g., Amado v. Microsoft Corp., 517 F.3d 1353, 1358 (Fed. Cir. 2008) (“District courts . . . are afforded broad discretion to control and manage their dockets, including the authority to decide the order in which they hear and decide issues pending before them.”). In addition, district courts may exercise their discretion to begin elsewhere when they perceive that another section of the Patent Act might provide a clearer and more expeditious path to resolving a dispute. See MySpace, Inc. v. GraphOn Corp., 672 F.3d 1250, 1258–62 (Fed. Cir. 2012); Dennis Crouch & Robert P. Merges, Operating Efficiently Post-Bilski by Ordering Patent Doctrine Decision-Making, 25 Berkeley Tech. L.J. 1673 (2010). Second, it bears remembering that all issued patent claims receive a statutory presumption of validity. 35 U.S.C. § 282; Microsoft Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238 (2011). And, as with obviousness and enablement, that presumption applies when § 101 is raised as a basis CLS BANK INTERNATIONAL v. ALICE CORPORATION 23 for invalidity in district court proceedings. See OSRAM Sylvania, Inc. v. Am. Induction Techs., Inc., 701 F.3d 698, 706 (Fed. Cir. 2012) (obviousness); Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195 (Fed. Cir. 1999) (enablement).