Much Ado About Preemption

" Much Ado About Preemption ," 50 Hous. L. Rev. 563 (2012) Abstract Preemption has emerged as the leading contender for conceptual grounding of the patentable subject matter doctrine's exclusion of abstract ideas and natural phenomena from patentability. Despite the Supreme Court?s frequent use of preemption rhetoric, however, the concept cannot provide a satisfactory explanation of the Court's patentable subject matter jurisprudence or a sound theoretical basis for the doctrine. Patentable subject matter jurisprudence has two distinct threads, one concerned with overly broad impact on downstream innovation and the other based on per se exclusion of abstract ideas and natural phenomena from patentability. Most of the Court's patentable subject matter decisions apply a per se exclusion analysis. While preemption is conceptually related to the downstream impact thread, the term is misleading even in that context. When preemption rhetoric is employed in the majority of cases, which are based on per se exclusion, it leads to confusion and incoherence. This Article disentangles the preemption rhetoric from the per se exclusion analysis in the Supreme Court's cases. Per se exclusion analysis necessarily involves two steps: identifying the per se excluded elements in a claim and applying some rule to determine whether additional claim limitations render the claim patentable. The Article identifies these two steps within the Supreme Court's cases and seeks to prepare the ground for coherent theoretical analysis. Preemption rhetoric is a distraction from important questions that must be answered to give patentable subject matter doctrine a firm theoretical grounding. First, what are the normative bases of the per se exclusions? As the discussion of the cases shows, failing to answer this question leads to seemingly arbitrary (or result-driven) identification of the per se excluded elements in a claim. Second, what rules should be used to determine whether a particular claim incorporating per se excluded elements along with other limitations is patentable subject matter? The current muddle in patentable subject matter analysis is due largely to failure to moor these second-step rules to the normative basis for per se exclusion.

"Much Ado About Preemption," 50 *Hous. L. Rev.* 563 (2012)

									Abstract

Preemption has emerged as the leading contender for conceptual grounding of the patentable subject matter doctrine's exclusion of abstract ideas and natural phenomena from patentability. Despite the Supreme Court?s frequent use of preemption rhetoric, however, the concept cannot provide a satisfactory explanation of the Court's patentable subject matter jurisprudence or a sound theoretical basis for the doctrine. Patentable subject matter jurisprudence has two distinct threads, one concerned with overly broad impact on downstream innovation and the other based on per se exclusion of abstract ideas and natural phenomena from patentability. Most of the Court's patentable subject matter decisions apply a per se exclusion analysis. While preemption is conceptually related to the downstream impact thread, the term is misleading even in that context. When preemption rhetoric is employed in the majority of cases, which are based on per se exclusion, it leads to confusion and incoherence. This Article disentangles the preemption rhetoric from the per se exclusion analysis in the Supreme Court's cases. Per se exclusion analysis necessarily involves two steps: identifying the per se excluded elements in a claim and applying some rule to determine whether additional claim limitations render the claim patentable. The Article identifies these two steps within the Supreme Court's cases and seeks to prepare the ground for coherent theoretical analysis. Preemption rhetoric is a distraction from important questions that must be answered to give patentable subject matter doctrine a firm theoretical grounding. First, what are the normative bases of the per se exclusions? As the discussion of the cases shows, failing to answer this question leads to seemingly arbitrary (or result-driven) identification of the per se excluded elements in a claim. Second, what rules should be used to determine whether a particular claim incorporating per se excluded elements along with other limitations is patentable subject matter? The current muddle in patentable subject matter analysis is due largely to failure to moor these second-step rules to the normative basis for per se exclusion.

Katherine J. Strandburg, Much Ado About Preemption, 50 Hous. L. Rev. 563 (2012)

Mayo Collaborative Servs. v. Prometheus Labs., Inc.

Am. Wood-Paper Co. v. Fibre Disintegrating Co.

rule to determine whether additional claim limitations render the claim patentable. The Article identifies these two steps within the Supreme Court's cases and seeks to prepare the ground for coherent theoretical analysis. Preemption rhetoric is a distraction from important questions that must be answered to give patentable subject matter doctrine a firm theoretical grounding. First, what are the normative bases of the per se exclusions? As the discussion of the cases shows, failing to answer this question leads to seemingly arbitrary (or result-driven) identification of the per se excluded elements in a claim. Second, what rules should be used to determine whether a particular claim incorporating per se excluded elements along with other limitations is patentable subject matter? The current muddle in patentable subject matter analysis is due largely to failure to moor these second-step rules to the normative basis for per se exclusion. In recent opinions focused on business methods and medical diagnostics, the Supreme Court has called a halt to the seemingly unlimited expansion of patentable subject matter overseen by the Federal Circuit at the turn of the This Article contends that the preemption rhetoric is a red herring. A sole focus on broad downstream impact is unsatisfactory, both as a theoretical matter and as an explanation of the Supreme Court's patentable subject matter jurisprudence. Most of the Court's patentable subject matter decisions rely, instead, on the fact that the claims at issue incorporate subject matter that is deemed per se excluded from patentability. Their outcomes turn, not on overbreadth, but on determining whether the inventor's application of per se unpatentable elements is sufficiently inventive to traverse the boundary between unpatentable and patentable terrain. Current doctrinal and theoretical shortcomings and confusion are exacerbated by attempts to shoehorn this type of analysis into a misunderstood preemption mold. The doctrine of patentable subject matter is the law's way of delineating the type of thing that cannot be claimed in a patent, no matter how new or useful it might be. Supreme Court case law, beginning in the mid-nineteenth century, has defined the boundary of patentable subject matter primarily by the exclusion of "abstract ideas" and "natural phenomena." The precise and deeply held deontological and utilitarian moral commitments to protecting the public domain" and that the preemption test is misleading in its focus on claim scope and in its neglect of the requirement that patentable subject matter be sufficiently creative). 4. Recent cases list a trilogy of exclusions for "laws of nature, natural phenomena, and abstract ideas." Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980); Mayo, 132 S. Ct. at 1293 (quoting Diamond v. Diehr, 450 U.S. 175, 185 (1981)); Bilski, 130 S. Ct. at 3253 (Stevens, J., concurring) (same). In other cases, the nature-related exclusions are also described as "natural products" and "scientific principle [s]." E.g., Chakrabarty, 447 U.S. at 311 (natural products); Am. Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11 (1931) (same); Diehr, 450 U.S. at 200 (Stevens, J., dissenting) (scientific principles); Parker v. Flook, 437 U.S. 584, 592 (1978) (same). Whether these are separate grounds for exclusion or simply different terms for a common issue has never been clear. Here I use the shorthand term "natural phenomena" to refer to all of these concepts, except where it is necessary to distinguish them. Similarly, the Court has sometimes referred to "mental processes," "abstract intellectual concepts," and simply "idea[s]" as unpatentable without distinguishing them from "abstract ideas." E.g., Bilski, 130 S. Ct. at 3258 (Breyer, J., concurring) (quoting Benson, 409 U.S. at 67); Flook, 437 U.S. at 589 (quoting Benson, 409 U.S. at 67); Benson, 409 U.S. at 67; Rubber-Tip Pencil Co. v. Howard, 87 U.S. (20 Wall.) 498, 507 (1874). Here I use the term "abstract ideas," except where more specificity is required. The patent statute is of little help in understanding these exclusions, since it says little about patentable subject matter, except to direct that a patent is available for "any new and useful process, machine, manufacture, or composition of matter," that otherwise meets the requirements of patentability, 35 U.S.C. § 101-a formulation that has changed little since the enactment of the first patent statute in 1790. Compare 35 U.S.C. § 101 (2006), with Act of Apr. 10, 1790 (Patent Act of 1790), ch.7, § 1, 1 Stat. 109, 110 (repealed 1793) (limiting patent availability to "any useful art, manufacture, engine, machine, or device, or any improvement therein not before known or used"). Only "process" is defined in the statute and it is tautologically defined to mean "process, art, or method" along with any new use of a "process, machine, manufacture, composition of matter, or material." 35 U.S.C. § 100(b) (2006). Perhaps unsurprisingly, the doctrine of reasons for these exclusions have been left murky, however, frustrating their implementation and often leading to incoherence in courts' reasoning about whether claims are too abstract or too "natural" to be patentable. In the latter part of the twentieth century, the Court of Appeals for the Federal Circuit, which is responsible for virtually all appellate review of patent issues, responded to the doctrine's difficulties by nearly eliminating the boundaries of patentable subject matter. The Federal Circuit's test set a very low bar, asking only whether a claimed invention produced a "useful, concrete, and tangible result" (and emphasizing usefulness). 5 Several commentators similarly advocate the marginalization, or complete abandonment, of the patentable subject matter limitation, arguing that the more manageable doctrines of novelty, 6 nonobviousness, 7 claim definiteness, enablement, and written description 8 are sufficient to winnow out undesirable patent claims. 9 In the wake of the Supreme Court's recent reaffirmation of patentable subject matter limits, the doctrine is in need of firmer theoretical grounding. As Rebecca Eisenberg recently noted, "patentable subject matter doctrine suffers from a lack of clarity not only as to what the applicable rules are, but also as to what those rules are supposed to accomplish." 10 "Preemption" has emerged as the leading contender for an organizing principle. Preemption was first invoked as a rationale for patentable subject matter exclusion in the case of Gottschalk v. Benson in 1972. 11 It has been mentioned in nearly every Supreme Court opinion on the topic since. 12 patentable subject matter has not focused on interpreting these statutory terms, except in the most formalistic sense. 5 Despite the ubiquity of preemption rhetoric, the concept will not bear the weight of patentable subject matter doctrine. As I will argue, it is of little use in assessing a claim's potential to control or preclude downstream innovation. Moreover, breadth of impact on downstream innovation has not been the primary issue at stake in most of the Supreme Court's patentable subject matter cases. Indeed, Benson was arguably the last Supreme Court case in which broad downstream impact was at the heart of the analysis. 13 Moreover, Benson's reference to preemption was specific to its context, in which the downstream impact of the claims at issue was essentially coextensive with the downstream impact of the underlying algorithm. 14 The emphasis on preemption distracts from analysis of more pertinent theoretical and policy questions: What justifies the per se exclusion of natural phenomena and abstract ideas from patentable subject matter? What can the theoretical inquiry tell us about the proper bounds of such exclusions? Is there theoretical justification for additional exclusions, perhaps for business methods, software, tax methods, or some other category? Or are some of the existing per se exclusions no longer justified? In light of the justifications for per se exclusions, what should an inventor be required to do to move a claim across the boundary from unpatentable to patentable terrain? This Article begins to untangle these issues by making the case that "preemption" has been over-emphasized and mischaracterized. Per se exclusions, and their theoretical justifications, deserve more attention. This Article lays the groundwork for further theoretical analysis of these questions. In a follow-on article, I will argue that at least some per se exclusions, including notably the exclusion of natural phenomena, are best understood primarily as policy choices between alternative innovation regimes or institutions, rather than as philosophical necessities or moral imperatives. Such an institutional grounding for patentable subject matter doctrine may provide a path forward in dealing with both current and emerging technologies, as well as a theoretical 13. As discussed, infra, Bilski's holding also may have been based on broad downstream impact, though the opinion is not clear on this point. See Bilski, 130 S. Ct. at 3231 (discussing that to allow a patent on risk hedging would "pre-empt the use of this approach in all fields, and would effectively grant a monopoly over an abstract idea"). In any event, the focus of the opinion was on the boundaries of the per se exclusion for abstract ideas. Id. 14. See Benson, 409 U.S. at 71-72 (reasoning that to allow a patent on an algorithm by itself would wholly preempt its use in the field). MUCH ADO ABOUT PREEMPTION 569 basis for deciding when a claim has crossed into patentability. 15 Part II of this Article identifies the two major threadsbreadth of downstream impact and per se unpatentabilitywithin the Supreme Court's patentable subject matter case law and delineates their distinct analytical frameworks. Part III focuses on the Court's analysis of per se patentable subject matter exclusions, demonstrating their prominence in the case law and attempting to disentangle them from the preemption rhetoric. Part IV illustrates the framework presented here by applying it to the case of DNA patents. Part V concludes. The Supreme Court's articulated reasons for patentable subject matter exclusions consist of two main threads. 16 One thread is concerned with upstream claims that have overly broad effects on downstream innovation. 17 The second thread concerns itself with marking out realms of subject matter that are per se unpatentable. This unpatentable territory is identified in the 15. For discussions of institutional aspects of patentable subject matter, see John M. Golden 16. Any analysis of the Supreme Court's patentable subject matter case law confronts a long-standing debate about which, if any, of the older cases cited as authority are "really about" patentable subject matter. Because the current statutory divisions in patentability analysis, not to mention the current requirements for patent claiming, were not always in place, commentators dispute whether pre-1952 Act cases frequently cited for patentable subject matter propositions are better understood as addressed to other aspects of patent doctrine, such as definiteness and scope of claims, enablement, and obviousness. See Golden, supra note 2, at 1075-76. I intend to skirt this debate here, because my interest is in parsing the Court's reasons for drawing the line between the patentable and the unpatentable. Whether these reasons are sound and whether patentable subject matter is the best doctrinal hook for the expressed concerns is left to another day. 17. See, e.g., Benson, 409 U.S. at 68, 71-72 ("Here the 'process' claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure binary conversion."); Dolbear v. Am. Bell Tel. Co., 126 U.S. 1, 538-39 (1888); O'Reilly v. Morse, 56 U.S. (15 How.) 62, 113 (1853) (noting that the broad claiming language at issue would allow the patentee to "avail himself of new discoveries in the properties and powers of electro-magnetism which scientific men might bring to light"). HOUSTON LAW REVIEW [50:2 case law as "laws of nature, physical phenomena, and abstract ideas." 18 In Bilski v. Kappos, four concurring justices argued that business methods also reside in presumptively unpatentable terrain. The downstream impact rationale asks whether a claim's limitations sufficiently cabin its potential effects on downstream innovation. Often, the analysis focuses on claim scope overbreadth. The per se unpatentable subject matter analysis, on the other hand, considers whether the inventor has contributed a sufficient inventive concept, over and above the per se unpatentable elements. 20 In its 1972 opinion in Benson, the Court implemented the downstream impact rationale with a reference to "preemption." 21 As discussed below, however, the Court's later references to preemption have not in fact focused the inquiry on the breadth of a claim's effects on downstream innovation and often are made in the context of a per se exclusion analysis. 22 The deployment of preemption as a one-size-fits-all rubric for assessing whether a claim's limitations are sufficient to bring it within the realm of patentable subject matter is thus the source of considerable confusion. The earliest opinion usually cited in patentable subject matter cases is Le Roy v. Tatham, which involved a patent on the 18. Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) MUCH ADO ABOUT PREEMPTION 571 use of wrought lead rather than cast lead in pipe manufacture. 23 Le Roy contains traces of both of the threads woven into the Court's later discussions. 24 The opinion asserts, essentially as self-evident, that abstract "principles" and natural "powers" are unpatentable: A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right. Nor can an exclusive right exist to a new power, should one be discovered in addition to those already known. Through the agency of machinery a new steam power may be said to have been generated. But no one can appropriate this power exclusively to himself, under the patent laws. The same may be said of electricity, and of any other power in nature, which is alike open to all, and may be applied to useful purposes by the use of machinery. Later, the opinion expresses concerns about the effects on downstream inventors of patents that broadly claim the "results" of a process, foreshadowing the broad downstream impact rationale: A patent is not good for an effect, or the result of a certain process, as that would prohibit all other persons from making the same thing by any means whatsoever. This, by creating monopolies, would discourage arts and manufactures, against the avowed policy of the patent laws. To round things out, Le Roy also explains how per se unpatentable subject matter can be applied in a patentable manner, stating that "the invention is not in discovering [natural powers], but in applying them to useful objects" and that "[a] new property discovered in matter, when practically applied in the construction of a useful article of commerce or manufacture, is patentable." 27 In later opinions, these threads are also intertwined, often more or less willy-nilly, and not generally recognized as distinct. 28 23. Le Roy, 55 U.S. at 167-68. 24. Id. at 187. 25. Id. at 175. 26. Id. 27. Id. Anticlimactically, the case was resolved on the comparatively boring basis of construing the scope of the claimed invention to be confined to the machinery used in the process, leaving generations of patent lawyers to speculate as to how "[t]he question whether the newly developed property of lead, used in the formation of pipes, might have been patented, if claimed as developed, without the invention of machinery" might have been resolved. Chiang identifies these two approaches with the abstract idea and law of nature exclusions and the natural product and natural phenomenon exclusions, respectively. Id. at 1356, 1376, 1381. While I agree with Chiang about the rough contours of the two threads of patentable subject matter discussion and about much in his larger analysis, I do not believe that these two rationales can be allocated in any sensible way among the traditional patentable subject matter exclusions. Dreyfuss and Evans make a similar distinction between "whether" questions about whether inventions in a particular field should be patented and "how" questions about how inventions should be claimed (the preemption questions), but argue that courts focus on the "how" questions. Dreyfuss & Evans, supra note 2, at 1356-57. The two threads I identify here are essentially Dreyfuss and Evans's "whether" and "how" questions. Though I agree with them that the case law provides few answers as to why natural phenomena, abstract ideas, and so forth should be per se unpatentable, I do not agree that concerns about broad downstream impact drive the Court's analysis in most cases. Id. at 1354-55. I discuss this point further below. See infra Part III. Alan L. Durham, Natural Laws and Inevitable Infringement, 93 MINN. L. REV. 933, 957-58 (2009), distinguishes between patentable subject matter and claim breadth and critiques various justifications for the unpatentability of natural laws and natural phenomena, advocating a patentable subject matter doctrine based on avoiding human mental activity. Richard S. Gruner, In Search of the Undiscovered Country: The Challenge of Describing Patentable Subject Matter, 23 SANTA CLARA COMPUTER & HIGH TECH. L.J. 395, 439 (2007), argues for a three-pronged patentable subject matter test derived in part from case law, in which two of the prongs, ("useful design . . . described in sufficient detail to be presently evaluated and implemented by users" and "no special characteristics of . . . the field of the advance that specially justify the withholding of patent rights") correspond in some respects to the primary threads identified here, while the third ("Use of the advance entails immediately transferable utility . . . .") is similar to the "practical use" strand described below. Id. (requiring the use of an advance to immediately transfer utility is essentially requiring the advance to have a practical use). 30. Dreyfuss & Evans, supra note 2, at 1356-60 (arguing for a patentable subject matter analysis based explicitly on potential impact on downstream innovation); Lemley et al., supra note 2, at 1317 (arguing that the abstract ideas exclusion should focus on "whether the scope of the patentee's claims is commensurate with the invention's practical, real-world contribution, rather than asserting coverage over general ideas unmoored to a specific application" and proposing a factor-based test). Collins, who parses the ambiguities of the term "abstract idea." 31 Collins identifies four distinct ways in which a claim might be directed to an abstract idea. 32 Two of these ways can be associated with concerns about downstream innovation. 33 First, a claim may be deemed abstract because its scope encompasses a wide swath of claim embodiments. 34 The connection with downstream innovation in this case is the concern that the inventor has been awarded rights over many embodiments that he or she did not invent, imposing unwarranted constraints on those who later invent them. 35 Second, and distinctly, a claim may be deemed abstract because the use of its embodiments is necessary to a wide swath of downstream innovation. 36 As Collins points out, this concern may arise even when a claim is limited to a narrow scope of embodiments. 37 Collins identifies two other ways in which a claim might be deemed to encompass an abstract idea. First, a claim may be directed to mental processes. 38 Second, the claim's embodiments may be "insufficiently tangible." 39 These, like "natural phenomena," are examples of potentially per se unpatentable categories, 40 which are not premised on broad downstream impact. 1. The Overbroad Downstream Impact Thread. Though mentioned in passing in Le Roy, 41 the downstream impact rationale for the traditional patentable subject matter exclusions gets its most definitive statement in O'Reilly v. Morse, where the Court invalidated Morse's broad claim to "the use of the motive power of the electric or galvanic current, which I call electromagnetism, however developed, for marking or printing intelligible characters, signs, or letters, at any distances." 42 If this claim can be maintained, it matters not by what process or machinery the result is accomplished. For aught that we now know some future inventor, in the onward march of science, may discover a mode of writing or printing at a distance by means of the electric or galvanic current, without using any part of the process or combination set forth in the plaintiff's specification. His invention may be less complicated-less liable to get out of order-less expensive in construction, and in its operation. But yet if it is covered by this patent the inventor could not use it, nor the public have the benefit of it without the permission of this patentee. . . . The court is of opinion that the claim is too broad, and not warranted by law. As Collins also discusses, Morse is based on a determination that the claim is overbroad in the number of embodiments it encompasses. 44 Overbreadth of this sort is a matter of claim drafting, rather than of any fundamental incompatibility between Morse's invention and the patent system. The Court specifically holds that Morse is the inventor of the telegraph, which clearly is a patentable technology. 45 The opinion does not disturb or criticize Morse's narrower claims to that technology. The broadest claim is invalidated because the Court determines that its scope potentially encompasses so many later-developed embodiments that the patentee's reward of exclusive rights is out of line with his contribution to the technology. 47 Notably, the dissent in Morse articulates essentially what are still the two most common rebuttals to the argument for patentable subject matter exclusion based on overbroad downstream impact. One rebuttal argues that improvement patents will adequately divide returns between the pioneer and later inventors: The reason given for thus confining the franchise of the inventor of an art to his machines and parts of machinery is, that it would retard the progress of improvement, if those who . . . can devise an improvement in it, should not be allowed to pirate it. . . . An improvement in a known art is as much the subject of a patent as the art itself; so, also, is an MUCH ADO ABOUT PREEMPTION 575 improvement on a known machine. Yet, if the original machine be patented, the patentee of an improvement will not have a right to use the original. This doctrine has not been found to retard the progress of invention in the case of machines; and I can see no reason why a contrary one should be applied to an art. . . . The court, by deciding that this claim is too broad, virtually decides that such an inventor of an improvement may pirate the art he improves, because it is contrary to public policy to restrain the progress of invention. The second rebuttal argument asserts that a patentee is entitled to claim the full scope of what he has invented: What is meant by a claim being to [sic] broad? The patent law and judicial decisions may be searched in vain for a provision or decision that a patent may be impugned for claiming no more than the patentee invented or discovered. It is only when he claims something before known and used, something as new which is not new, either by mistake or intentionally, that his patent is affected. The dissent's argument that an inventor is entitled to a patent on the full scope of his invention, even when the invention is very general, essentially carried the day thirty years later in Dolbear v. American Bell Telephone Co., which concerned Alexander Graham Bell's patent on the telephone. 50 Considering Bell's claim to "[t]he method of, and apparatus for, transmitting vocal or other sounds telegraphically, as herein described, by causing electrical undulations, similar in form to the vibrations of the air accompanying the said vocal or other sounds, substantially as set forth," the Court was unconvinced by an argument that "the claim, if given this broad construction, is virtually 'a claim for speech transmission by transmitting it; or, in other words, for all such doing of a thing as is provable by doing it.'" 51 Emphasizing that Bell had discovered a particular way of transmitting speech "by changing the intensity of a continuous current so as to make it correspond exactly with the changes in the density of air caused by sonorous vibrations," and that this discovery "astonished the scientific world," the Court upheld the broad claim. 52 As the opinion put it, "[s]urely a patent for such a A comparison of Morse with Dolbear illustrates two things about the overbroad claim scope strand of the overbroad downstream impact thread. First, unless a claim is drafted so broadly that it encompasses more than the inventor can describe and enable or is drafted so vaguely that one cannot determine whether or not a particular instantiation is within its scope, it is very difficult to make a rational determination as to when a claim is broad enough to be "too broad." 54 Second, and relatedly, the claim scope rationale is unlikely to bite in cases in which the claims meet the modern requirements of definiteness, enablement, and written description. 55 In light of the foregoing points, it perhaps should not be surprising that it was nearly a hundred years before the downstream impact rationale again played an important role in a Supreme Court patentable subject matter opinion. 56 In Gottschalk v. Benson, the Court denied patentability to "a method for converting binary-coded decimal (BCD) numerals into pure binary numerals" that was foundational to the then-nascent computer industry. 57 The result in Benson is a relatively straightforward application of a subject matter exclusion based on overbroad downstream impact due to the wide range of potential uses of the claimed technology. Thus, as the Court noted: [T]he "process" claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure binary The claims in Benson thus differed from those in Morse with respect to the type of concerns about overly broad downstream impact they raised. Morse was concerned with the potential number of downstream embodiments encompassed by the claim, while Benson is concerned primarily with the number of potential downstream uses of the claimed algorithm, rather than the number of potential embodiments. 59 The BCD conversion algorithm was basic to the use of computers, 60 which, as general purpose tools, are inputs to wide swaths of downstream innovation. If the use of the algorithm were necessary to the use of computers (or even necessary to a large number of uses of computers), a claim to the BCD conversion algorithm would indubitably have granted extremely broad downstream control over innovation. Unfortunately, the Benson opinion conflated the two types of downstream impact concerns, by citing Morse without commenting on the distinction. It also conflated the downstream impact rationale with per se exclusion by equating "[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts" with "basic tools of scientific and technological work." 61 The idea that patents on basic tools can have broad impacts on innovation has been widely discussed by commentators, particularly in the context of the debate over whether there should be a research exemption to patent infringement liability. 62 Not all "[p]henomena of nature, though 58. Id. 59. This distinction is one way to solve the puzzle of the Court's utter lack of interest in the distinction between Claim 8, which is limited to implementing the algorithm using a "reentrant shift register" and Claim 13, which could be infringed using pencil and paper. just discovered, mental processes, and abstract intellectual concepts" have sweeping downstream impact, however, and the Court's language has led to confusion, as this Article explains. The conflation between downstream impact and per se exclusion was exacerbated by the Court's cryptic "nutshell" explaining its ruling: It is conceded that one may not patent an idea. But in practical effect that would be the result if the formula for converting BCD numerals to pure binary numerals were patented in this case. The mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly preempt the mathematical formula and in practical effect would be a patent on the algorithm itself. This nutshell makes sense within the downstream impact rationale. If the BCD conversion algorithm has sweeping downstream implications for innovation because of its many potential uses in digital computers, then Benson's claims to the use of the algorithm in digital computers would result in essentially the same downstream implications as a claim to the algorithm itself, and thus "wholly pre-empt the mathematical formula." 64 Unfortunately, the discussion in the Benson opinion is sufficiently opaque that the nutshell may also be read to apply a per se exclusion of abstract ideas, thus entangling per se exclusion with "preemption." The Benson opinion's conflation of the per se exclusion and overbroad downstream impact threads bears major responsibility for the confused way in which preemption has entered the patentable subject matter analysis, as will be explained in the next section. Scholarly commentary has also tended to gloss over these distinctions. Thus, most discussions of the preemption rationale focus solely on claim scope overbreadth. Many scholars have argued that, because patent law provides other doctrines, such as enablement, written description, definiteness, and utility for cabining attempts to claim more broadly than warranted by the effect on innovations of patenting basic tools); Katherine J. scope of one's invention, the patentable subject matter requirement should play only a modest role, 65 while some have argued that it is entirely unnecessary. 66 For example, Lemley and his coauthors, in Life After Bilski, see only a limited role for patentable subject matter doctrine, primarily where the disclosure doctrines are inadequate because they need to be satisfied only at the time of patenting. 67 Their proposed implementation of the preemption rationale focuses on ensuring that patentees do not obtain rights over vast swaths of technology that they did not foresee by considering (1) the "generativ[ity]" of the claimed invention; (2) the prevalence of cumulative innovation in the relevant industry; (3) the pace of innovation in the relevant industry; (4) the fit between the scope of enablement and the breadth of the claim; and (5) the importance of the patentee's advance over the prior art. 68 Most versions of the overbreadth argument effectively assume that broad effects on downstream innovation come only from claims encompassing a large number of embodiments. This assumption motivates the argument that the statutory claim scope and disclosure doctrines-written description, enablement, utility, and claim definiteness-have rendered patentable subject matter constraints unnecessary. 69 As noted, broad downstream effects can come not only from a claim's large number of potential embodiments, but also from a wide range of downstream uses. A recent article by Dreyfuss and Evans recognizes the distinction between claim scope overbreadth and impact on downstream uses and develops an approach to patentable subject matter doctrine that encompasses both types of downstream uses. They argue that patentable subject matter doctrine most properly concerns itself with the stage in the development of a technology at 65. See supra note 3. 66. See supra note 3. 67. Lemley et al., supra note 2, at 1330-31, 1339. 68. Id. at 1339-41. Lemley and his coauthors limit their discussion to the "abstract ideas" exclusion, but it seems likely they would apply the same rationale to the exclusion of natural phenomena. Indeed, one coauthor has argued in earlier work that there should be no limits on patentable subject matter beyond those provided by other patent law doctrines. Risch, supra note 9, at 592, 596-98 (arguing that subject matter concerns are at bottom patentability concerns). Another coauthor, Ted Sichelman, has argued explicitly that the factors suggested in Life after Bilski should control the patentability of claims involving natural phenomena. See Sichelman, supra note 2, at 9-13 (applying a five-factor test to a patent claim involving natural phenomenon protection). 69. See Sichelman, supra note 2, at 6 (identifying but disagreeing with the view that novelty and nonobviousness serve as "gatekeepers" for patents of questionable validity due to abstract subject matter). which patenting is appropriate: 70 "The issue, in short, is timing. Patent claims cannot be made too early in the development of a field because there is a danger of preemption: exclusive rights may preempt others from competing and thereby diminish the vibrancy of the marketplace or the vigor of the creative environment." 71 Dreyfuss and Evans argue that "there will be situations where even very narrow patents block off too much, especially in areas (like computer science and genetic diagnostics) where applications flow easily from basic discoveries." 72 What matters, in other words, is not the scope of a claim, but the size of the downstream innovation "prospect" the claim controls. 73 Recognizing this distinction breaks the presumed connection between overbroad downstream impact and scope of claim embodiments and thus explains why an overbreadth-based patentable subject matter limitation is not duplicative of patent law's scope doctrines. It is also, as already discussed, a much better reading of Benson's concern with patents on "basic tools of scientific and technological work." 74 Dreyfuss and Evans take a further step toward a better theorized downstream impact thread when they suggest that the potential downstream impact of a claim should be judged by the degree to which it can be invented around. 75 They apply this insight to explain why claims to genetic material might be overbroad, even if they are limited to specific embodiments. 76 As Dreyfuss and Evans recognize, however, the concept of inventing around is dependent upon the level of granularity at which one views an innovative prospect and therefore on the 70. Dreyfuss & Evans, supra note 2, at 1357-61. Dreyfuss and Evans use the term "preemption" to mean the downstream impact of a claim. See id. at 1355-59 (discussing preemption as the ability of a patent to prevent competition and development). Though this is a very reasonable way to try to make sense of and build on the case law, I do not adopt that approach in this Article because I believe that the term is so thoroughly infected with confusion. I recognize, of course, that the term may be so completely woven into the precedent as to be unavoidable in legal argument. 71. Id. at 1356-58. Implicit in their argument is a rejection of any contention that patent incentives are particularly important in nascent technologies. For a contrary perspective, see Ted Sichelman, supra note 2, at 13-14 which notes that incentives to invent are provided by patent protection. Dreyfuss and Evans explicitly adopt the Merges and Nelson argument that downstream innovative progress is better produced by competition to make use of upstream context of a particular downstream innovation. 77 In the genetic context, for example, Dreyfuss and Evans explain that it may be impossible to invent around gene patents in the diagnostic context while entirely possible to do so in the context of therapeutic uses. 78 Because of such complexities in determining whether a downstream innovation prospect is too broad, Dreyfuss and Evans argue that the analysis should incorporate other "clues" including, for example, the identity of the inventor, particularly if she happens to be an academic or a user innovator. Even with the Dreyfuss and Evans improvements, downstream impact alone is not a satisfactory basis for patentable subject matter doctrine. First, as Sichelman argues in Funk Forward, patentable subject matter exclusions based entirely on concerns about downstream innovation are questionable in principle essentially because they do not account for the importance of incentivizing the invention of broad upstream technologies. 80 After all, he argues, the requirements of novelty and nonobviousness are intended to screen out claims to advances that would have been made during the patent term even without the patent incentive. 81 It thus seems ill-advised to exclude from patentability precisely those inventions that are most important for downstream innovation. 82 One type of response to arguments such as Sichelman's (which Sichelman recognizes) 83 is that patentable subject matter exclusion is a necessary corrective to the erroneous issuance of invalid patent claims that grant very broad downstream rights. 84 That response does not adequately counter the contention that patents are needed to incentivize the invention, disclosure, and dissemination of nonobvious upstream technology. While a patentable subject matter exclusion might avoid the erroneous award of patents over obvious broad upstream technology, it 77. Id. at 1371-72. 78. Id. Peter Lee recognizes a similar issue in arguing that whether a particular technology functions as infrastructure can change over time. See Lee, supra note 15, at 74-75, 86, 89 ("Patented technologies themselves can rapidly attain infrastructural status as inventive communities come to rely on them as enablers of downstream invention."). 79 simultaneously reduces the patent system's ability to incentivize the development of nonobvious broad upstream technology. Errors in both directions are likely to inflict high social costs, yet nothing internal either to the downstream impact thread or to the corrective argument permits one to determine which costs will be higher. Failure to account for incentives to invent upstream technology is a general weakness of the downstream impact rationale that deserves more theoretical attention. 85 In any event, while the downstream impact rationale can justify the unpatentability of some natural phenomena and abstract ideas, it is not an adequate explanation for their wholesale exclusion, nor can it make sense of the Supreme Court's patentable subject matter jurisprudence. Court's patentable subject matter decisions rest on the per se exclusion of natural phenomena and abstract ideas rather than on the broad downstream reach of the claims at issue. To demonstrate this, one must show, first, that there are categories of subject matter that are excluded from patentability per se, without reference to their downstream impact on innovation and second, that the Court's application of those categories to particular claims is not simply equivalent to asking whether the claims at issue have overbroad downstream impact. As to the first point, the rule that natural phenomena and abstract ideas are per se unpatentable, without regard for their downstream impact, is so deeply rooted in the case law as to be almost invisible. From Le Roy v. Tatham through Mayo v. Prometheus, the Supreme Court repeatedly simply states, categorically, that natural phenomena and abstract ideas are unpatentable. 86 The Court declares the unpatentability of the potentially mundane "new mineral discovered in the earth" and "new plant found in the wild," as well as of Einstein's "celebrated law that E=mc 2 " and Newton's "law of gravity." 87 While Benson's algorithm undoubtedly cut a very wide swath, 85. BRETT FRISCHMANN, INFRASTRUCTURE: THE SOCIAL VALUE OF SHARED RESOURCES ch.XII (2012), takes a step in this direction by conceptualizing patentable subject matter as a doctrine defining a set of "intellectual infrastructure" that, like other infrastructure, often is not best provided by the standard market approach. MUCH ADO ABOUT PREEMPTION 583 the equally unpatentable algorithm for calculating an alarm limit for hydrocarbon processing in Parker v. Flook certainly cut a smaller one, 88 and the claims to methods of hedging risk in commodities trading considered in Bilski v. Kappos varied in the amount of downstream innovation they would have controlled. 89 It is hard to conclude that the claim to a combination of bacteria for inoculating seeds deemed unpatentable in Funk Bros. v. Kalo necessarily had broader downstream implications than the claim to a genetically modified oil-eating bacterium held patentable in Diamond v. Chakrabarty. 90 In its most recent, unanimous, treatment of patentable subject matter, Mayo v. Prometheus, the Court reaffirmed the per se approach and explicitly rejected an argument that only natural phenomena with broad downstream impact should be unpatentable. 91 The natural phenomenon at issue in Mayo was the correlation between the blood level of a drug metabolite and the medical outcome. The claims were premised on the patentees' statistical analysis of clinical observations, which they used to determine numerical metabolite level thresholds correlated with toxicity and efficacy of the drug. 93 The Court specifically acknowledged that "[t]he laws of nature at issue here are narrow laws that may have limited applications," yet treated them as per se unpatentable. 94 Recognizing that prior "cases have not distinguished among different laws of nature according to whether or not the principles they embody are sufficiently narrow," the Court declined to "draw distinctions 88. Compare Benson, 409 U.S. at 64-65, 68, 71-72 (noting that the claim to the BCD algorithm was "so abstract and sweeping as to cover both known and unknown uses"), with Flook, 437 U.S. at 585-86, 589-92, 594 (rejecting a claim that recites a step using an algorithm for updating a temperature alarm-limit value). 89. among laws of nature based on whether or not they will interfere significantly with innovation in other fields now or in the future." 95 An analysis of whether particular claims incorporating per se excluded elements are patentable is logically distinct from an inquiry into overbroad downstream impact. By definition, the rule defining a per se excluded category of inventions is independent of any particular claim. Therefore, whether a particular claim incorporating a per se excluded element meets the patentable subject matter requirement must be determined by applying an additional rule. In other words, as an analytical matter, a per se exclusion approach to patentable subject matter doctrine must provide two types of rules: (1) rules for identifying the per se excluded material in a patent claim; and (2) rules for determining whether the additional claim limitations move the claim into patentable territory. To see this, it may help to imagine a box of per se unpatentable items. The first set of rules defines which items go in the box. When one of these per se unpatentable items is used in a claim, it remains a per se excluded item. One can sensibly say, for example, that the elements of a particular claim include an unpatentable scientific principle and an unpatentable mental process. 96 The per se unpatentability of these elements alone cannot tell a court how to determine whether the claim as a whole is patentable, however. To determine whether the claim is patentable, some second rule must be applied. The analysis of overbroad downstream impact, by contrast, involves only one rule, which might be stated as: "If the claim as a whole encompasses an overly broad swath of downstream innovation potential, the claim is unpatentable." Morse and Dolbear conduct the analysis in exactly this way. 98 Morse, for example, had patented both overbroad and appropriately limited claims, as assessed by the above rule. 99 Downstream impact 95. Id. at 1303. 96. See id. at 1298-99 (2012). 97. This is emphatically not to say that a per se exclusion analysis is necessarily or should be a "point of novelty" analysis. One can imagine any number of forms for the second rule, some of which would have nothing to do with whether the per se excluded element is novel. "Point of novelty" is one example of the second type of rule. As we shall see, the courts have considered a number of such rules. 98. analysis may be conducted in several stages for convenience or clarity; for example, by determining that an independent claim is overbroad and then comparing dependent claims to it to see how much they restrict the downstream impacts on innovation. Nonetheless, the crucial point is that an analysis of overbroad downstream impact, such as that in Morse, Dolbear, and Benson, involves only one question and hence only one rule. One could, in principle, formally cast overbroad downstream impact analysis into something that looks like the two-step per se framework. First, one could define a per se excluded category composed of elements with broad downstream impact. Given a claim containing such an element, as well as other limitations, one could then employ a "second rule" that asked, "Does this claim, with the additional limitations, still have overly broad downstream impact?" But this purported two-step process is effectively just a way of applying the single downstream impact rule. In any event, the per se exclusion thread of the Supreme Court's patentable subject matter opinions does not apply a test that is equivalent to a downstream impact rule. To begin with, the per se unpatentable categories defined with the case law include elements that do not have the kind of broad downstream impact envisioned by the Court's distinction between Morse and Dolbear. In addition, as discussed in detail in Part III, the second stage rules applied in the Court's per se exclusion cases do not turn on downstream impact. The fact that courts applying per se patentable subject matter exclusions necessarily are applying a two-stage framework may not always be immediately evident. There are several particular situations in which the two-step analysis may not need to be spelled out explicitly. For example, the entire claim may be made up of per se excluded material, so that it is unnecessary to apply the second rule explicitly, whatever it may be. Alternatively, the second rule might be trivial to apply. For example, the second rule could be "the addition of any further limitations that are not themselves per se unpatentable renders the claim patentable." The Federal Circuit's useful, concrete, and tangible result test functioned essentially in this way. 100 In sum, the Supreme Court's case law contains two distinct threads of patentable subject matter analysis, one based on overbroad downstream impact and the other on per se exclusion. These two threads are not redundant. As discussed in more detail in Part III.B, the Court treats natural phenomena and abstract ideas as per se unpatentable, regardless of the downstream scope of the specific phenomenon or idea at issue in a given case. To illuminate the Supreme Court's per se exclusion jurisprudence, we must first disentangle it from the preemption rhetoric. Subpart A takes up that task, describing how preemption has invaded patentable subject matter analysis since Benson and arguing that preemption is not a useful lodestar for either thread of patentable subject matter analysis. Subpart B reviews the major patentable subject matter opinions to illustrate the Court's application of the twostep per se exclusion framework and, in particular, to disentangle the rules that the Court has actually applied in the second stage of the analysis from the preemption rhetoric. For the per se exclusion thread of patentable subject matter doctrine to make normative sense, both the rule for defining the per se exclusion and the rule for determining the patentability of a claim incorporating excluded material should arise from some rationale for the per se exclusion. Unfortunately, most of the case law discussion of patentable subject matter is devoted to the second stage of the analysis: determining when a patent claim involving per se excluded material traverses the boundary from unpatentable to patentable. 101 MUCH ADO ABOUT PREEMPTION 587 is usually absent or perfunctory and frequently mixes distinct concerns. 102 The lack of theoretical justification for the per se exclusions makes it difficult to make normative sense of the case law and is a major theoretical gap, which has been only partially addressed by scholars. Indeed, most discussion of per se exclusion has focused on specific controversial topics, such as the patentability of business methods. 103 This Part attempts to clear the underbrush so as to motivate more general theoretical consideration of per se patentable subject matter exclusions. As discussed above, Benson is an excellent example of patentable subject matter exclusion based on overbroad impact of downstream uses of the claimed invention. Unfortunately, Benson's main legacy has been to conflate the downstream impact and per se exclusion frameworks, leading to the current preemption muddle. The confusion stems primarily from Benson's nutshell, which I repeat here: It is conceded that one may not patent an idea. But in practical effect that would be the result if the formula for converting BCD numerals to pure binary numerals were patented in this case. The mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly pre-empt 102. See, e.g., Bilski the mathematical formula and in practical effect would be a patent on the algorithm itself. As explained earlier, this nutshell is sensibly understood as part of a downstream impact analysis. The fact that claims to digital computer implementation of the BCD conversion algorithm wholly preempt the algorithm is important to the analysis only because it helps the Court to evaluate the potential downstream impacts of the claims at issue: preemption implies that if the algorithm has broad downstream impacts, the claim's downstream implications are equally broad. 105 However, it is also possible, in the context of Benson's rather opaque discussion, to read the nutshell as describing a per se exclusion analysis. In that reading, the nutshell appears to imply the following two rules: (1) abstract ideas are excluded from patentability per se. (The BCD conversion formula is an abstract idea and hence is unpatentable); (2) to determine whether claims incorporating an abstract idea are patentable, consider whether the claims wholly preempt the idea. The Court's rhetoric in later opinions often sounds as though it has adopted those rules. Reference to preemption thus has become a routine part of the second step of the patentable subject matter analysis of claims involving phenomena of nature and abstract ideas. 106 As a purely formal matter, preemption could be a workable rule for the second stage of a per se exclusion analysis. Normatively, however, the preemption rule has been given no justification and, in fact, makes little sense. As a result, courts that have taken the rule seriously have found it nearly impossible to apply in a rational manner. The preemption references have their roots in Benson's very particular context, which involved an algorithm with an extremely broad sweep of downstream uses and claims that had a virtually coextensive downstream impact. 107 As a general rule, however, preemption of a natural phenomena or abstract idea is not a good test for determining whether a claim has overbroad downstream impact. On the one hand, a claim that wholly preempts a natural phenomenon of minor importance will itself have minor impact. On the other hand, while a claim that wholly preempts a very broad abstract idea or natural phenomena will certainly have broad downstream impact, preemption cannot take the analysis any farther. If a claim is limited so that it does not wholly preempt a broadly sweeping idea or phenomenon, the claim may or may not still sweep too broadly downstream. Consider, for example, a hypothetical claim similar to Benson's except that it is limited to use of the BCD conversion algorithm in computers used in law schools. Does such a claim "wholly preempt" access to the algorithm? Under any ordinary meaning of the phrase, it certainly does not. Though those of us at law schools would miss our access to the algorithm, the number of downstream uses remaining accessible to the public is vast, so the algorithm is not wholly preempted. In fact, only a tiny portion of its downstream impact is affected. On the other hand, it may well be (we hope!) that the claim's downstream effects remain unacceptably broad. Presence or absence of preemption simply cannot tell us the answer, because preemption is the wrong question. To assess whether the overbroad downstream impact thread of patentable subject matter exclusion should apply, we must ask directly whether the hypothetical claim itself has unacceptably broad downstream impact. Attempts to shoehorn analysis of overbroad downstream impact into preemption terms have led to highly artificial (and unexplained) corollaries to the supposed preemption rule, which state that limitations to particular fields of use and additions of "post-solution activity" cannot render claims incorporating abstract ideas or natural phenomena patentable. 108 As implementations of the overbroad downstream impact rationale, these corollaries may be either wrong or right in a given instance. It all depends on the particular context and, in particular, on the breadth of downstream impact of the underlying natural phenomenon or abstract idea. At the other extreme, as the Court recognizes in Mayo, if an abstract idea or natural phenomenon has relatively narrow downstream impact on innovation, even a claim that wholly preempts it will have similarly narrow downstream effects. 109 life of its own in the case law, but the field of use and postsolution activity corollaries have moved across town and set up shop on their own as well. The result is often a preemption analysis that is thrice removed from the issue at hand: Should this claim (which incorporates some per se unpatentable elements) be deemed patentable? Defenders of the preemption rule might argue that the downstream impact and per se exclusion rationales are not as distinct as I have made them appear. Suppose that the Court has adopted a per se exclusion of natural phenomena and abstract ideas because it believes they are likely to have broad impacts on downstream innovation, but does not believe courts can effectively conduct a downstream impact analysis of each claim (or believes that conducting such an analysis would be too costly). Indeed, the Court suggests something like this in Mayo, where it states that "even a narrow law of nature (such as the one before us) can inhibit future research" to some extent and asserts, in light of this possibility, that a "bright-line prohibition against patenting laws of nature, mathematical formulas and the like" is needed as a "proxy for the underlying 'building-block' concern" because "[c]ourts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature." 110 If this is a convincing rationale for a per se exclusion of natural phenomena and abstract ideas, a preemption rule, which asks how much the claim has limited the downstream impact of the natural phenomenon or abstract idea, makes some sense as a second step. But note that by adopting such an analysis one simultaneously assumes two things: (1) one can say nothing about the relative downstream impact of various natural phenomena and abstract ideas, so must assume the downstream impact is the same; and (2) one nonetheless can effectively compare the downstream impact of a patent claim incorporating a natural phenomenon or abstract idea to the downstream impact of that phenomenon or idea in isolation so as to determine whether the claim preempts it. These are strong assumptions and, to me, implausible as a general matter. If a preemption rule is applied as the second step in evaluating a claim containing elements that are per se excluded on some other basis, the results are even more peculiar. In such cases, preemption is simply orthogonal to the underlying rationale for the exclusion, whereas the optimal rule for the second part of a per se exclusion analysis would be tightly tied to 110. Mayo, 132 S. Ct. at 1303. MUCH ADO ABOUT PREEMPTION 591 the rationale for the exclusion. Suppose, for example, that the rationale for the per se exclusion of abstract ideas from patentability were that patents should not intrude on the autonomy of human thought. Once we determine that a claim incorporates a particular mental process, the second rule should help us determine whether the additional limitations have sufficiently reduced the claim's intrusion on autonomous thought. Whether the claim wholly preempts the downstream innovative uses of the mental process is beside the point. Similarly, if the rationale for a per se exclusion is that natural products should be left in an unpatentable public domain in order to encourage widespread attempts to find their practical applications (which would then be patentable), the second part of the analysis likely should depend on whether the claim is to a practical application of the natural product. The fact that a claim covering the use of a particular natural substance as a cancer drug might wholly preempt the substance's downstream effects on innovation (if curing cancer is the substance's only practical use) is irrelevant. With this background discussion in mind, the next section turns back to the case law applying per se exclusions and interrogates the Court's analysis. It is convenient to discuss the Supreme Court's approach to applying per se patentable subject matter exclusions by considering relevant cases in chronological order. American Fruit Growers, Inc. v. Brogdex Co. 111 is a good starting point. In that 111. Am. Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11-12 (1931). An earlier series of cases deals with the distinction between a patentable "art" or process and the unpatentable "function of a machine, or the effect produced by it on the material subjected to the action of the machine." Corning v. Burden, 56 U.S. (15 How.) 252, 267-68 (1853); see also Sarnoff, supra note 2, at 66-67 (noting that pure method patents were ineligible for patent protection until the late nineteenth century). Though of some relevance to patentable subject matter discussion, these cases are primarily concerned with the acceptable scope of process claims and not of direct relevance to this discussion. See Risch, supra note 9, at 600-05 (revealing that the Court often rejected the patentee's process claims because they recited more than what the patentee actually invented or described in the patent application). Other early cases often cited for their statements of the per se unpatentability of natural phenomena and abstract ideas are more concerned with issues of novelty than of patentable subject matter. See, e.g., Am. Wood-Paper Co. v. Fibre Disintegrating Co., 90 U.S. (23 Wall.) 566, 603-04 (1874) (rejecting patent for want of novelty); Rubber-Tip Pencil Co. v. Howard, 87 U.S. (20 Wall.) 498, 505, 507 (1874) (holding that the patent although useful was not new). See Christopher Beauchamp, Pure Thoughts of Judge Hand: A Historical Note on the Patenting of Nature (2012), http://www.law.nyu.edu/ecm_dlv3/groups/public/@nyu_law_website__engelberg_center_on _innovation_law_and_policy/documents/documents/ecm_pro_071307.pdf; Jon M. case, the inventor developed a means for applying borax to citrus fruit rinds as a preservative and the claim at issue was to the treated fruit. 112 The issue in the case is framed as the definition of "manufacture" in the patent statute, but the Court's reasoning is of interest for present purposes. 113 The Court assumes without discussion, as had the appellate court, that the fruit at issue is a per se unpatentable natural product. 114 The appellate court had analyzed the patentability issue by asking whether the final product was itself a product of nature, concluding: "The product is a combination of the natural fruit and a boric compound carried by the rind or skin in an amount sufficient to render the fruit resistant to decay. The complete article is not found in nature and is thus an article of manufacture." 115 In essence, the appellate court applied this second-step rule: a claim is excluded from patentable subject matter only if the claim as a whole, with all of its limitations, is in the per se excluded category. Because the treated article was not itself a natural product, the claim was patentable. 116 Though in agreement as to the per se exclusion of the "natural fruit," 117 the Supreme Court reversed by applying a different rule to the second stage of the analysis: Addition of borax to the rind of natural fruit does not produce from the raw material an article for use which possesses a new or distinctive form, quality, or property. The added substance only protects the natural article against deterioration by inhibiting development of extraneous spores upon the rind. There is no change in the name, appearance, or general character of the fruit. It remains a fresh orange fit only for the same beneficial uses as theretofore. The Supreme Court's second-step rule thus was that the patentee's addition to the natural product must transform it sufficiently to imbue the claimed product with a distinctive character or use. 119 Though the precise scope of the Court's rule is not entirely clear, the Court seemed to require a change that affected the "beneficial uses" of the product before patentability would be conferred. 120 (Why longer shelf life is not a beneficial use was not explained. 121 ) Funk Bros. Seed Co. v. Kalo Inoculant Co. involved claims to "[a]n inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria." 122 The inoculant could be applied to seeds of a variety of plant species, so as to enhance their capacity for nitrogen fixation. 123 The bacteria in question were already used separately by farmers for this purpose. 124 The novel aspect of the invention was the selection of bacteria that could be combined in a single inoculant for use with a variety of types of seeds. 125 The difficulty in selecting appropriate bacterial strands was that they tended to inhibit one another's nitrogen-fixing capacity. 126 In analyzing patent eligibility, the Court presumed the per se unpatentability of the "state of inhibition or non-inhibition in the bacteria," which it deemed the "handiwork of nature." 127 It then considered whether the patentee's contribution was sufficient to confer patentability. 128 The appellate court had found the inventor's contribution sufficient because his "new and different composition of noninhibitive strains . . . contributed utility and economy to the manufacture and distribution of commercial inoculants." 129 The Court rejected this approach, which might be characterized as a rule of practical improvement bearing some similarity to the Brogdex rule. 130 Instead, the Court applied a rule that required that the inventor's contribution be "inventive," over and above whatever creativity was involved in the discovery of the natural phenomenon: The aggregation of select strains of the several species into one product is an application of [a] newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. . . . The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. . . . The application of this newly-discovered natural principle to the problem of packaging of inoculants may well have been an important commercial advance. But once nature's secret . . . was discovered, the state of the art made the production of a mixed inoculant a simple step. . . . That is to say, there is no invention here unless the discovery that certain strains of the several species of these bacteria are non-inhibitive and may thus be safely mixed is invention. But we cannot so hold without allowing a patent to issue on one of the ancient secrets of nature now disclosed. All that remains, therefore, are advantages of the mixed inoculants themselves. They are not enough. In summary, the Court in Funk Bros. first identified a per se excluded natural phenomenon in the claims and then, as a second step, applied a rule requiring that the inventor's practical application of that natural phenomenon must itself be inventive, even if the inventor himself had discovered the natural phenomenon at issue. 132 Parker v. Flook involved claims to a method for computing an "alarm limit" in a process for the catalytic conversion of hydrocarbons. 133 The method, which was computer-implemented, incorporated a mathematical formula. 134 Adjudicators at every level who considered patent eligibility were in agreement that the formula was per se unpatentable but, in analyzing the MUCH ADO ABOUT PREEMPTION 595 patentability of the claims incorporating the formula, they applied different approaches to the second step of the patentable subject matter analysis. 135 The patent examiner and the Board of Patent Appeals and Interferences (BPAI) employed a "point of novelty" rule, denying the claims because the per se unpatentable mathematic formula was the only difference between the claimed invention and the prior art. 136 The Court of Custom Claims and Patent Appeals (CCPA), which reviewed patent denials prior to the establishment of the Federal Circuit, applied a version of preemption analysis that found no preemption "since the mere solution of the algorithm would not constitute infringement of the claims" and reversed. 137 Note that, unlike Benson's nutshell, the CCPA's preemption rule did not assess the extent to which the claims preempted the downstream impact of the algorithm. 138 The Supreme Court explicitly rejected the CCPA's preemption rule, which had defined preemption such that simply adding any specific, practical limitation would render a claim patentable ("respondent incorrectly assumes that if a process application implements a principle in some specific fashion, it automatically falls within the patentable subject matter of § 101"). 139 Interestingly, the Court also, in a footnote, questioned the rationale behind preemption analysis, stating that "it is not entirely clear why a process claim is any more or less patentable because the specific end use contemplated is the only one for which the algorithm has any practical application." 140 The Court also rejected a rule at the opposite extreme under which any claim incorporating per se excluded material would be unpatentable ("respondent [incorrectly] assumes that the fatal objection to his application is the fact that one of its components-the mathematical formula-consists of unpatentable subject matter"). 141 Instead, the Court reiterated its Funk Bros. rule for determining the subject matter eligibility of a claim incorporating a per se excluded element, 142 important points. First, it is not enough simply to apply an abstract idea in a practical way: The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula; the Pythagorean theorem would not have been patentable, or partially patentable, because a patent application contained a final step indicating that the formula, when solved, could be usefully applied to existing surveying techniques. 143 Note that the Court's consideration of post-solution activity here was not related to how much the activity or the resulting claim preempted use of the unpatentable idea. The Pythagorean Theorem would not be wholly (or even significantly) preempted by a claim to its application in surveying. 145 The problem the Court identified was with "conventional or obvious" applications, using "existing surveying techniques," that could be devised by a "competent draftsman." 146 This leads to the second point, which was that the discovery or conception of the per se unpatentable abstract idea itself does not "count" at the second stage, when evaluating how the claim applies it. "If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end." 147 Hence, "the novelty of the mathematical algorithm is not a determining factor at all." 148 The Court's third point was that, for the claim to be patentable, its application of the per se unpatentable element must involve an inventive concept: "Even though a phenomenon of nature or mathematical formula may be well known, an inventive application of the principle may be patented. Conversely, the discovery of such a phenomenon cannot support a patent unless there is some other inventive concept in its application." 149 In the discussion that follows, I will refer to the second-stage rule laid out in Funk Bros. and Flook as the "inventive concept rule." Diamond v. Chakrabarty concerned the patent eligibility of a bacterium that had been genetically engineered so as to be capable of breaking down the components of crude oil. 150 (Its intended use was to clean up oil spills. 151 ) The Chakrabarty opinion is known for its quotation of a statement from the Senate Report accompanying the 1952 Patent Act that patentable subject matter extends to "anything under the sun that is made by man" 152 and its determinations that living things generally, and genetically modified organisms in particular, are not excluded from patentable subject matter per se. 153 The relevant part of the decision for our purposes, however, is the opinion's approach to the per se exclusion for natural phenomena. 154 While the Court spent considerable time discussing the "broad construction" of § 101 of the Patent Act (hence the "anything under the sun that is made by man" quote), that discussion was animated by the central question in the casewhether there is a per se exclusion for living things-and seems to have had little to do with the Court's application of the per se exclusion for natural phenomena. 155 In considering the natural phenomena exclusion, the Court first explained that its discussion of the broad scope of the statute, "is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable." 156 (The Court cited its prior cases from Flook back to Le Roy and quoted Funk Bros. at some length on this point. 157 ) The opinion then turned to the patentability of Chakrabarty's genetically engineered bacteria in light of the natural phenomena exclusion. 158 On that question, the Court's analysis was brief, and based primarily on distinguishing Chakrabarty's invention from the unpatentable claims in Funk Bros.: Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature's handiwork, but his own; accordingly it is patentable subject matter under § 101. 159 Nothing in this brief section of the opinion is inconsistent with a routine application of the second-stage inventive concept rule expressed in Funk Bros. and Flook. 160 While the Court did not evaluate Chakrabarty's inventive concept explicitly, its description of his inventive activity suggests that it was in no way conventional, routine, or obvious. As the Court described it, "Chakrabarty discovered a process by which four different plasmids [subcellular components of naturally-occurring bacteria], capable of degrading four different oil components, could be transferred to and maintained stably in a single Pseudomonas bacterium, which itself has no capacity for degrading oil." 161 Notably, in describing Chakrabarty's work, the Court distinguished between Chakrabarty's earlier research, in which he "discovered that plasmids control the oil degradation abilities of certain bacteria" and "discovered plasmids capable of degrading camphor and octane, two components of crude oil" and the work underlying the patent, which required him to invent a process for combining the natural plasmids he had discovered into a single, viable bacterium. 162 The earlier research investigated the properties of naturally occurring bacteria; the later work devised an inventive means of using that knowledge to create something new. 163 The Chakrabarty analysis of the natural phenomena exclusion fits comfortably with the second-stage inventive concept rule. In Diamond v. Diehr, however, the Court did not apply the inventive concept rule. 164 Diehr considered the patentability of a "process for curing synthetic rubber which includes in several of its steps the use of a mathematical formula and a programmed digital 159. Id. at 310. 160. Id. at 309. Indeed, the dissent, which focused on the question of the per se patentability of living things, did not dispute this aspect of the majority's analysis. See MUCH ADO ABOUT PREEMPTION 599 computer." 165 The formula involved was a well-known equation for calculating cure time using the even more well-known Arrhenius law. 166 According to the majority, the patentee's contribution "reside [d] in the process of constantly measuring the actual temperature inside the mold. These temperature measurements are then automatically fed into a computer which repeatedly recalculates the cure time by use of the Arrhenius equation." 167 The claims were not limited to any particular method of measuring the temperature. 168 The patent examiner had rejected the claims by "determin[ing] that those steps in respondents' claims that are carried out by a computer under control of a stored program constituted nonstatutory subject matter under this Court's decision in Gottschalk v. Benson." 169 Thus, the examiner's definition of the per se exclusion differed from the majority's. The examiner applied a per se exclusion of computer-implemented steps despite Benson's explicit statement that it did "not so hold" and its plea for Congress to decide that question. 170 Moreover, the rule the examiner applied to determine whether Diehr claimed a patentable application of the excluded computer-implemented steps was not the "inventive concept" rule the Supreme Court had adopted in its earlier opinions. 171 Rather than asking whether the application of the per se unpatentable subject matter embodied in the claims was merely conventional, the examiner asked the subtly different question of whether the remaining steps themselves were conventional and necessary to the claimed process. 172 According to the examiner, "[t]he remaining stepsinstalling rubber in the press and the subsequent closing of the press-were conventional and necessary to the process and cannot be the basis of patentability The CCPA reversed, not[ing] that a claim drawn to subject matter otherwise statutory does not become nonstatutory because a computer is involved. The respondents' claims were not directed to a mathematical algorithm or an improved method of calculation but rather recited an improved process for molding rubber articles by solving a practical problem which had arisen in the molding of rubber products. The CCPA's first point both rejected the examiner's definition of the per se exclusion and reiterated Flook's rejection of a second-stage rule that any claim incorporating patentable subject matter is unpatentable. 175 The second point emphasized both the tangibility of the claimed process and the practical usefulness of the patentee's invention. 176 The CCPA did not consider whether the claimed application of the unpatentable equation involved an inventive concept. 177 The Supreme Court began its analysis by returning to an old debate about the patentability of processes that are not limited to or characterized by implementation on particular machines. 178 Quoting Cochrane v. Deener, the Court stated: That a process may be patentable, irrespective of the particular form of the instrumentalities used, cannot be disputed. . . . A process is a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing. If new and useful, it is just as patentable as is a piece of machinery. The patentability of a physical process for molding rubber was, of course, not in dispute in 1981. 180 The question at issue, which the Court answered in the affirmative, was whether Diehr's claims, in which physical details of the rubber molding process did not play an important role, should be viewed as directed to such an "industrial process." 181 174. Id The Court then turned to the impact on patent eligibility of the claims' incorporation of "a mathematical equation and a programmed digital computer." 182 After reaffirming the per se unpatentability of "laws of nature, natural phenomena, and abstract ideas," the Court also reaffirmed that mathematical algorithms and formulae are included within the per se exclusion. 183 The Court then defined the per se unpatentable element of Diehr's claims as the "well-known mathematical equation" rather than the entirety of the computer-implemented steps. 184 In assessing the patentability of the application of this per se unpatentable equation, Diehr famously did not apply the "inventive concept" rule established in the earlier cases. 185 The opinion sets out less of a substantive explication of the Court's rationale for not applying that rule than may at first appear, however, because much of what the opinion says is in agreement with Funk Bros. and Flook. Like those earlier opinions, Diehr rejected a second-stage rule that would find any claim that merely incorporated a law of nature or abstract idea unpatentable. 186 Much of Diehr's remaining discussion focuses on a straw man point of novelty rule, which would "dissect the claims into old and new elements and then . . . ignore the presence of the old elements in the analysis," failing to consider the claims "as a whole." 187 Perhaps less apparently, Flook and Diehr also are essentially in agreement that "[t]he 'novelty' of any element or steps in a process . . . is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." 189 While Flook instructs the patentable subject matter analyst to treat newly discovered natural phenomena or abstract ideas as "well known," the real point of Flook's "inventive concept" rule is that only the inventor's activities over and above the discovery of the per se unpatentable subject matter count. 190 In other words, the rule would obtain precisely the same results if it were stated as "determine whether the claim reflects an inventive concept in the application of the unpatentable natural phenomenon or abstract idea, independent of whether the unpatentable element is new or old." Indeed, the opinion's lengthy discussion of the impact of presuming that a per se unpatentable mathematical algorithm is old was utterly irrelevant to Diehr's patent claims; 191 both the Arrhenius law and the equation using it to calculate curing times during rubber molding were, in fact, well known. 192 Therefore, any impact on the patentable subject matter question of the novelty (or lack thereof) of particular claim elements was truly neither here nor there for the claims at issue. 193 Finally, both Flook and Diehr maintained that patentable subject matter must be assessed separately from novelty and nonobviousness under the other sections of the Patent Act. 194 Diehr stated that "[t]he question . . . of whether a particular invention is novel is 'wholly apart from whether the invention falls into a category of statutory subject matter,'" while Flook opined that "[t]he obligation to determine what type of discovery is sought to be patented must precede the determination of whether that discovery is, in fact, new or obvious." 195 n.12 (rejecting petitioner's argument for applying the point of novelty rule and claiming it to be a misinterpretation of the Court's holding in Flook). 189. Diehr, 450 U.S. at 188-89; see also Flook, 437 U.S. at 591 ("[T]he novelty of the mathematical algorithm is not a determining factor at all."). 190. See Flook, 437 U.S. at 591-92, 594 ("Even though a phenomenon of nature or mathematical formula may be well known, an inventive application of the principle may be patented. Conversely, the discovery of such a phenomenon cannot support a patent unless there is some other inventive concept in its application."). The difference between the inventive concept rule and the Diehr approach thus came down to what second-stage rule to apply in considering the claims "as a whole" to assess their patent eligibility in light of their incorporation of a well-known mathematical equation. The inventive concept approach would have asked whether Diehr's application of the well-known equation for calculating cure time in the claimed computerized process was conventional. Diehr did not ask that question. 196 Instead, the Court relied on the following reasoning: [Diehr and his co-applicant] seek patent protection for a process of curing synthetic rubber. Their process admittedly employs a well-known mathematical equation, but they 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. These include installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly recalculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time. Obviously, one does not need a "computer" to cure natural or synthetic rubber, but if the computer use incorporated in the process patent significantly lessens the possibility of "overcuring" or "undercuring," the process as a whole does not thereby become unpatentable subject matter. In summarizing its approach at the end of the opinion, the Court concluded: We view respondents' claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula. . . . [W]hen a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e.g., transforming or reducing an article to a different state or thing), then the claim satisfies the requirements of § 101. Because we do not view respondents' claims as an attempt to patent a mathematical formula, but rather to be drawn to an industrial process for the molding of rubber products, we affirm the judgment . . . . The second-stage rule that the Court eventually applied in Diehr thus seems to have been that a claim incorporating a mathematical formula is patentable subject matter if the claim as a whole is drawn to a process that "perform[s] a function which the patent laws were designed to protect;" in other words, an "industrial process." 199 The Court did not expound in detail the characteristics of a "function which the patent laws were designed to protect," but emphasized two aspects: (1) such a function should be "useful;" and (2) "transforming or reducing an article to a different state or thing" is a core example of such a function. 200 The Court thus essentially, though without saying as much, applied a version of a technological arts requirement. 201 Though the "function which the patent laws were designed to protect" rule is the gist of the Diehr analysis, the opinion did not avoid getting caught up in the preemption tangle. It noted the fact that Benson's algorithm was applicable only in a digital computer and referred to Flook's lack of disclosure of how to determine the various variables needed in his algorithm, apparently to suggest the comparative specificity of the Diehr claims. 202 It also repeated the preemption corollaries that the unpatentability of a mathematical formula "cannot be circumvented by attempting to limit the use of the formula to a particular technological environment" or by adding "insignificant postsolution activity" to the process. 203 Finally, it maintained that Diehr's claims did not "pre-empt" the use of the well-known equation for calculating rubber curing time. 204 This discussion in Diehr is notable mostly for the way in which it illustrates the baroque character of the preemption rule. It is trivially evident, without resorting to any preemption epicycles, that the claims at issue in Diehr do not have overbroad downstream effects in the sense of either Morse or Benson. Overbroad downstream impact was not the issue in Diehr; the patentability of claims involving computer calculations was. Of course, Diehr's claims did not preempt the rubber curing formula because one can continue to cure rubber without updating the curing time based on the internal temperature. 206 But is this really the point? Suppose one accepted the dissent's characterization of the unpatentable algorithm encompassed by the claim as a "method of programming a digital computer in order to calculate-promptly and repeatedly-the correct curing time in a familiar process." 207 In that case, Diehr's claims would have wholly preempted the algorithm in much the same way as Benson's claims preempted the BCD conversion algorithm. (What other application is there for a calculation of when to open the mold?) Nonetheless, it cannot seriously be maintained that this preemption indicates that Diehr's claims would have broad downstream effects on innovation. Diehr raises one more important, but inadequately appreciated point. The inventive concept test of Funk Bros. and Flook was designed to deal with claims incorporating natural phenomena and abstract ideas newly discovered by the patent applicant. 208 In such cases, the distinction between the inventive concept test for patentable subject matter and the statutory inquiry into novelty and nonobviousness matters. Under § 102 and § 103, Bond's discovery of the non-inhibition properties of the bacteria in Funk Bros. would not have been included within the prior art and thus might have assisted him in demonstrating the nonobviousness of his claims. 209 The inventive concept test, however, asks whether Bond contributed some unconventional, inventive concept over and above the discovery of those natural properties. Bond's claims failed that test. 210 For claims involving well-known natural phenomena and abstract ideas, however, the inventive concept test is subsumed within the statutory novelty and obviousness inquiries. In the algorithm that had "no substantial practical application except in connection with a digital computer"). 206. Id. at 187. 207. Id. at 212-15 (Stevens, J., dissenting). 208. See Parker v. Flook, 437 U.S. 584, 593-94 (1978) (emphasizing that discoveries of phenomena of nature or mathematical formulas are unpatentable "unless there is some other inventive concept in [their] application"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131-32 (1948) (stating that a mixed inoculant was "no more than the discovery of some handiwork of nature and hence is not patentable"). 209. See 35 U.S.C. § § 102-03 (2006). 210. See Funk Bros., 333 U.S. at 130-31 ("If there is to be invention from discovery, it must come from the application of the law nature to a new and useful end."). majority opinion in Diehr, once the per se unpatentable mathematical algorithm was defined to be the well-known rubber curing equation, the debate over whether to employ "practical application" or "industrial process" or "inventive concept" as the second part of the patentable subject matter analysis was moot. The end result of the overall patentability inquiry, which would have included analysis under § 102 and § 103, would have been unaffected by the choice of second-stage rule. Those who argue that patentable subject matter analysis is unnecessary in light of the novelty and nonobviousness requirements are thus correct if: (1) the patentable subject matter framework is one of per se exclusion; (2) the per se exclusion is well defined so there is no debate as to its boundaries; (3) the rule for the second step of the analysis is "inventive concept" (or one of a few others, such as "practical application"); and (4) the per se unpatentable element of a particular claim is within the prior art that will be considered for novelty and nonobviousness. These conditions often do not hold, however. In Diehr, given the majority's definition of the per se unpatentable algorithm, applying the inventive concept rule would not have made any difference. If the dissent's approach to that first step had been adopted, however, the end of the story would have been different. The real issue in Diehr was the disagreement between the majority and dissent about how to define the per se unpatentable mathematical algorithm exclusion. While the majority took the unpatentable element to be the equation for calculating curing time, the dissent regarded the claims' entire "method of programming a digital computer in order to calculate-promptly and repeatedly-the correct curing time in a familiar process" as the per se unpatentable algorithm at issue. 211 Of course, nothing could be more conventional than to apply an algorithm for computing rubber curing time by opening the mold at the appropriate time, so the dissent would have applied the inventive concept rule and denied patentability. Since the unpatentable algorithm, as defined by the dissent, was not previously known, however, it would not have come in to the obviousness analysis. Thus the inventive concept analysis and the obviousness analysis might well have reached different conclusions. Compare Diehr, at 187-88 (majority opinion) (discussing the equation for calculating curing time itself as the unpatentable element), with id. at 212-13, 216 (Stevens, J., dissenting) (discussing the entire process of calculating the correct curing time as the unpatentable element). In the eyes of many, a major take-away point from the Court's complex set of opinions in Bilski v. Kappos was the centrality of preemption analysis, 212 as reflected in Justice Breyer's articulation of four points of agreement among the justices. Point one of the four states that "the Court has long held that '[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable' under § 101, since allowing individuals to patent these fundamental principles would 'wholly pre-empt' the public's access to the 'basic tools of scientific and technological work.'" 213 This blessing of the preemption rationale for the per se exclusion of abstract ideas and natural phenomena was unfortunate (as became apparent soon afterward when the Court considered Mayo v. Prometheus). 214 In fact, preemption had little to do with the questions truly at issue in Bilski itself, which centered around defining the boundaries of the per se abstract ideas exclusion. 215 In Bilski, the Supreme Court reviewed the Federal Circuit's application of the second-stage "machine-or-transformation-ofmatter" analysis, which the Federal Circuit had christened the "sole test" for patentable subject matter in its en banc opinion below. 216 Bilski involved claims to methods of hedging risk in commodity trading in the energy market. 217 Virtually everyonethe PTO, nearly every Federal Circuit judge (the only holdout was Judge Newman), and all nine Supreme Court justicesagreed that Bilski's claims were directed to unpatentable subject matter. They disagreed only as to the rationale for the unpatentability of the claims. 219 The disagreement focused on different ways of defining per se unpatentable abstract ideas, rather than on the second part of the patentable subject matter analysis. 220 As discussed in more detail below, the Court majority rejected a number of proposed first-stage tests for defining a per se excluded abstract idea, but did not provide a clear replacement, other than to refer to its precedents on the abstract idea exclusion. 221 Near the end of a many-page opinion, the Bilski majority simply concluded, bolstered only by the assertion "[h]edging is a fundamental economic practice," that "[t]he concept of hedging . . . is an unpatentable abstract idea, just like the algorithms at issue in Benson and Flook." 222 Having devoted nearly its entire opinion to discussing and rejecting various potential definitions of per se unpatentable abstract ideas, the Court in the end appeared to base its holding largely on a Benson-esque overbreadth analysis. 223 The Court first opined that two of the claims were so general as to amount to patenting of "[t]he concept of hedging" itself and hence unpatentable: "Allowing petitioners to patent risk hedging would pre-empt use of this approach in all fields, and would effectively preempt the use of the formula in all fields and noting that the patent examiner rejected the claims for being only a manipulation of an abstract idea and not limited to a practical application); id. at 3257 (Stevens, J., concurring) (opining that the claims were not directed to a "'process' within the meaning of § 101" and that business method patents are, and have always been, per se unpatentable); In re Bilski, 545 F.3d at 963-66 (holding that the process claims failed to "transform any article to a different state or thing"); id. at 966 (Dyk, J., concurring) (writing separately to emphasize the longstanding view that "processes not involving manufactures, machines, or compositions" are unpatentable); id. at 998 (Mayer, J., dissenting) (concluding that the claims were unpatentable on the grounds of per se exclusion for business method patents); id. at 1011 (Rader, J., dissenting) (concluding that claims were barred based on a per se exclusion of claims drawn to abstract ideas); Ex Parte Bilski, 2006 WL 5738364, at *27, *29-30 (noting that the claims at issue do not transform physical matter and were written so broadly that they preempted "any and every way to perform the steps"). 220. See Bilski, 130 S. Ct. at 3224, 3231 (Kennedy, J., opinion of the court) (focusing on per se exclusion of subject matter as the basis for rejecting petitioners' claims); id. at 3232 (Stevens, J., concurring); id. at 3257-58 (Breyer, J., concurring); In re Bilski, 545 F.3d at 963-64, 966; id. at 966 (Dyk, J., concurring); id. at 998 (Mayer, J., dissenting); id. at 1010-11 (Rader, J., dissenting); Ex parte Bilski, 2006 MUCH ADO ABOUT PREEMPTION 609 grant a monopoly over an abstract idea." 224 There is probably little disagreement that the concept of hedging, like the BCD conversion algorithm in Benson, is involved in a large swath of downstream uses. 225 Because the Court characterized those two claims as entirely commensurate with claims to the concept itself, the use of preemption here is, for once, consistent with its original usage in Benson. The Court devoted only a single paragraph to its analysis of the remaining, more limited, claims, which it described only as "broad examples of how hedging can be used in commodities and energy markets." 227 In concluding that those claims also were unpatentable, the Court alluded to the preemption corollaries concerning field-of-use limitations and token postsolution activity 228 'token postsolution components.'" 230 "In other words, the Court artificially limits petitioners' claims to hedging, and then concludes that hedging is an abstract idea rather than a term that describes a category of processes including petitioners' claims." 231 The implication was that, because the majority did not define a workable per se exclusion rule so that it could apply an appropriate two-step analysis, the majority punted instead by mischaracterizing the breadth of Bilski's claims and then rejecting them as overbroad. 232 Given the fact that the majority's focus throughout the opinion was on how to approach the per se exclusion question and that it eventually threw up its hands and simply referred to precedent, this accusation has something of the ring of truth. In any event, in light of the way the preemption analysis fits into the opinion as a whole, it seems likely that the majority justices were convinced that the claims were unpatentable for reasons that had nothing to do with the purported preemption analysis. (Indeed, the word is barely used in the opinion: twice by the majority; twice by the fourjustice concurrence, and once in the list of "points" in Justice Breyer's concurrence. 234 ) Though Justice Breyer's concurrence has highlighted "preemption" for those seeking clarity from Bilski, the preemption discussion in the majority opinion has the look of window dressing to cover a failed effort to define the boundaries of the per se exclusion for abstract ideas, despite agreement that the claims at issue fell within the boundaries. 235 In Mayo v. Prometheus, a unanimous Supreme Court resoundingly reaffirmed the inventive concept approach that it 230. The Federal Circuit had held that the claims passed its machine-or-transformation test based on the physicality of the "administering" and "determining" steps. 238 The Federal Circuit then purported to apply a preemption analysis to determine whether the claims impermissibly preempted the natural phenomenon (the correlation between metabolite and medical condition) upon which they relied. 239 Notably, however, the Federal Circuit's analysis did not really focus on whether the claims preempted downstream uses of the specific correlations at issue. 240 In fact, the Federal Circuit's analysis was much more consistent with a direct evaluation of potential downstream impact. The analysis relied heavily on the fact that the claims were limited by reciting "specific treatment steps" and involved a "particular application[:] the treatment of a specific disease by administering specific drugs and measuring specific metabolites." 241 The court also argued implicitly that there was room to design around the claims by stating that "[o]ther drugs might be administered to optimize the therapeutic efficacy of the claimed treatment." 242 These features of the claims were irrelevant to assessing the extent to which they preempt specific 236. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294 (suggesting that the "inventive concept" test is "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself"); supra note 164 and accompanying text (noting that the Court did not apply the "inventive concept" test in Diehr). 237 correlations between particular metabolite levels and patients' reactions to particular drugs. 243 Instead, they relate to the relatively narrow downstream impact of the claims overall. 244 In fact, the Federal Circuit's patentable subject matter analysis did not depend in any significant way on the fact that the claims involved a natural phenomenon. Essentially the same questions could have been asked about any claim. The Supreme Court's analysis in Mayo departed radically from the Federal Circuit's approach. Rather than focus on overbroad downstream impact or deploy the machine-ortransformation inquiry, the Court analyzed whether the inventor had added anything to the natural correlations other than "wellunderstood, routine, conventional activity already engaged in by the scientific community." 245 Because the claimed application of the per se unpatentable natural correlations would have been routine for the medical community, the claims were unpatentable. 246 Thus, the Court employed the second-stage inventive concept test that it had adopted in Funk Bros. and Flook. 247 After conducting this clean inventive concept analysis, the Court unfortunately muddied the waters by discussing its earlier cases without parsing the distinct aspects of patentable subject matter at issue in each. 248 For example, the opinion somewhat implausibly interpreted Diehr as having implicitly conducted an inventive concept analysis and determined that the steps in the industrial molding process over and above the equation for 243. See id. at 1355-57 (noting the specific relationship between the correlation and the particular drugs recited in the claims). 244. See id. at 1355-58 (interpreting the claims at issue as "specific treatment steps, not just the correlations themselves" that comprise "particular methods of treatment," which could be designed around simply by administering different drugs MUCH ADO ABOUT PREEMPTION 613 curing time added enough to have "transformed the process into an inventive application of the formula." 249 The confusion was exacerbated by the Court's attempt to wedge the Mayo claims into a preemption rubric, 250 forcing the opinion to contend with the relative narrowness of the natural correlations involved, as has already been discussed. Apparently, the Court itself was unconvinced by this discussion, as it felt the need to say that "[w]e need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them." 251 By this point, the Court's discomfort should be understandable. The preemption rubric simply doesn't fit with the inventive concept rule that the Court applies in cases involving newly discovered natural phenomena. To summarize, the Supreme Court's cases mostly have been concerned with how to apply a per se exemption for natural phenomena and abstract ideas and not with the overbreadth concerns suggested by the preemption rubric. With the possible exception of Bilski, every opinion involving a natural phenomenon or abstract idea that was discovered by the inventor has employed (or been consistent with) the inventive concept test established in Funk Bros. and reaffirmed in Mayo. 252 Brogdex, in which the natural product was the well-known orange, emphasized the degree to which the claimed product had beneficial uses different from those of the natural product, 253 while Diehr, in which the mathematical equation at issue was well known, emphasized that the claims were drawn to a "function which the patent laws were designed to protect." 254 Preemption analysis was not central to any of the Court's determinations of how to apply per se patentable subject matter exclusions, nor, as we have seen, has it been particularly useful as a tool for analyzing potential overbroad downstream impact. Instead, the preemption rubric has served mainly to muddy the water and to distract from more pertinent questions. This Article leaves all the hard questions open. While I plan to tackle some of them in follow-on work, the remainder of this Part provides a brief illustration of the potential payoff from the analytical framework suggested here. The illustration concerns whether DNA sequences are patentable subject matter, which is the subject of the Federal Circuit's opinions in Association for Molecular Pathology (AMP) v. USPTO. 255 AMP, which may well be headed for Supreme Court consideration, involves claims by Myriad Genetics to DNA sequences for mutations relating to breast cancer. 256 Analysis of whether DNA sequences should be unpatentable subject matter generally proceeds by assuming that the per se exclusion for products of nature applies to genes within a natural organism (such as a human being) and then focusing on whether claimed DNA sequences, which are either extracted from nature or artificially constructed, are sufficiently different from natural DNA to be patentable. 257 This is fine as far as it goes, but the analysis begs the usual questions. First, what is the scope of the per se exclusion and what is its rationale? The answer to this question, which is usually not addressed, has determinative consequences for the bottom-line outcome of the inquiry. Second, given the rationale for the per se exclusion, what second-stage rule should be used to determine the patentability of various types of DNA claims? At least three potential rationales for per se excluding genetic materials from patentable subject matter have been advanced. Some have argued that DNA patents interfere with human autonomy. 258 I set this rationale aside for purposes of this discussion, though a per se exclusion based on human autonomy concerns could in principle be developed along the same framework as any other per se exclusion. More often, it is argued that DNA sequences fall within the traditional per se exclusion for natural products. 259 Two distinct approaches to the natural product exclusion have at least some support in the case law. Dana Irwin, in a useful discussion of these issues, notes that natural phenomena have been defined alternatively as (1) that which exists in nature outside of human control; and (2) that which is the subject of scientific inquiry. 260 She argues that, during the nineteenth century, technology was defined, consistent with Enlightenment thinking, by mastery or control over nature. 261 Consistent with this way of thinking, per se exclusions from patentable subject matter represented "aspects of nature that had not yet been brought under human control," in the form of discoveries that had not yet been applied and "unembodied innovations that remained within an inventor's mind." 262 Many patentable subject matter cases describe natural phenomena and abstract ideas as pre-existing human intervention in a kind of commons, where they are available to all of humanity's use. 263 Judge Rader of the Federal Circuit echoed this perspective in his dissent in In re Bilski: "Natural laws and phenomena can never qualify for patent protection because they cannot be invented at all. After all, God or Allah or Jahveh or Vishnu or the Great Spirit provided these laws entities control over something as personal and basic to who we are as our genes.") (statement of Anthony D. Romero, Executive Director, ACLU). In fact, an argument of this sort was originally made in the AMP case, based on the First Amendment. ("The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none."). and phenomena as humanity's common heritage." 264 Under this rationale for per se exclusion, the second-stage rule for evaluating a patent claim incorporating a natural product would set out the requisite degree and type of human intervention. This type of approach is exemplified by Brogdex, discussed earlier, in which the Court focused on whether the patentee's interventions had produced new characteristics or "beneficial uses" for the treated fruit. 265 The purified product of nature doctrine, as set out by Learned Hand, has been the standard basis for DNA patentability. That doctrine also reflects the mastery of nature rationale. Hand opined that the patentability of an isolated natural product depends upon whether the patentee was "the first to make it available for any use [such that] it became for every practical purpose a new thing commercially and therapeutically." Hand's opinion thus employs a second-step test of human intervention and control focused on practical use. Eventually, Irwin argues, technology came to be viewed less as mastery over nature than as applied science. 266 Patentable subject matter doctrine thus evolved to emphasize the distinction between science and technology, and exclusions were redefined in terms of keeping the basic results of open science in the public domain. 267 1853). Thus, Morse argues that the patentees' ability to make free use of scientific advances, while keeping his own advances secret, is part of the problem with an overbroad claim: [W]hile he shuts the door against inventions of other persons, the patentee would be able to avail himself of new discoveries in the properties and powers of electro-magnetism which scientific men might bring to light . . . . New discoveries in physical science may enable him to combine it with new agents and new elements, and by that means attain the object in a manner superior to the present process and altogether different from it. And if he can secure the exclusive use by his present patent he may vary it with every new discovery and development of the science, and need place no description of the new manner, process, or machinery, upon the records of the patent office. And when his patent expires, the public must apply to him to learn what it is. (1) isolated full gene sequences; (2) short sequences isolated from the full gene; and (3) cDNA sequences produced in the laboratory to include only the active or "coding" sections of human DNA sequences. 270 The court upheld the subject matter patentability of all three types, over a dissent by Judge Bryson with regard to the full and short isolated DNA sequence claims. Judge Lourie, in his opinion for the court, applied a mastery of nature approach. In his view, cDNA molecules were almost trivially patentable because they were the result of such significant human intervention. 271 His analysis for the other two types of claims more discloses the second-stage rule that he applied to determine whether claims incorporating per se excluded material are patentable. 272 Judge Lourie defined the per se exclusion according to the chemical structure of the DNA molecules. 273 His emphasis on DNA as a chemical entity led him to adopt a second-stage rule that essentially any change in 274 While the isolated molecules covered by the full gene claims might have the same genetic code as naturally occurring DNA, their chemical structure is changed by the isolation process. 275 Shorter DNA fragments also are obviously different in chemical structure from their equivalents within the body. 276 Because "[c]reating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort," Judge Lourie deemed the claims to both full DNA sequences and short DNA sequences to be patentable. 277 Judge Moore concurred with Judge Lourie, both in the result and in applying a control of nature approach, but she applied a somewhat different second-stage rule to evaluate whether the claims reflect sufficient human intervention. Rather than basing her test on minor changes in chemical structure as indicators of human intervention, 279 she requires a greater degree of control, 280 and like Judge Hand, emphasizes the degree to which human intervention has resulted in new practical uses for the sequences. 281 Because using a short DNA sequence "as a primer or probe to determine whether a patient has a mutation is a new and important utility substantially different from the role of that DNA as it occurs in nature," Judge Moore easily found that claims to isolated short DNA sequences are patentable. 282 She had more difficulty with the claims to isolated full gene 274. Id. at 1327-29 ("[Genes] in their isolated states are different molecules from DNA that exists in the body."). 275. Id. at 1328 ("[I]solated DNA [is left with] a distinctive chemical identity as compared to native DNA."); id. at 1350-51 (Bryson, J., concurring in part and dissenting in part) (arguing that the majority elevates form over substance because although the BRCA genes were isolated, the BRCA sequence itself is the same as that found in nature). 276. See id. at 1328 (majority opinion). 277. Id. at 1333. 278. Compare id. at 1327-28 (emphasizing the chemical distinction between isolated and native DNA.), with id. at 1341-42 (Moore, J., concurring in part) (focusing on the added utility of the isolated claimed sequences). 279. Compare id. at 1327-29 (majority opinion) (proclaiming that the claimed isolated DNAs "constitute an a fortiori situation" based on the differences in structure, character, and use when compared to simply purified native DNA), with id. at 1342-43 (Moore, J., concurring in part) (arguing that "[i]t is not the chemical change alone, but that change combined with the different and beneficial utility" that renders the isolated DNAs patentable). 280. See id. at 1342-43 (Moore, J., concurring in part). 281. See id. at 1341-43 (emphasizing that the DNA products recited in the claims "are not naturally produced without the intervention of man" and describing the new utility characteristic of the claimed products). 282. Id. at 1342. MUCH ADO ABOUT PREEMPTION 619 sequences, however, concluding that an "isolated full length gene does not clearly have a new utility and appears to simply serve the same ends devised by nature, namely to act as a gene encoding a protein sequence." 283 Nonetheless, Judge Moore ruled these claims patentable, not because of the degree of human intervention involved, but because of the reliance interests that the PTO's practice of granting such claims over many years has produced. 284 Judge Bryson's dissenting approach differs in many respects from the approaches of Judges Lourie and Moore. His opinion is notable in that it separately applies more than one test for patentable subject matter analysis, grounded in different rationales. 285 Like the other judges, he defines the per se excluded category to encompass only naturally occurring DNA. 286 Unlike the others, however, he believes that distinctions between naturally occurring DNA and the claimed isolated DNA sequences should be judged according to the "conventional nomenclature" of the relevant scientific field, which is genetics, rather than chemistry. 287 In analyzing the cDNA and full gene sequence claims, Judge Bryson applies the control of nature paradigm. 288 Thus, he would uphold the patentability of cDNA as a "human-made invention," based on differences in structure and utility from naturally occurring DNA, but would find the isolated full gene sequences unpatentable based on his view that the relevant comparison is to the genetic sequence, in terms of which the inventions are claimed. 289 From Judge Bryson's genetics-based perspective, the full gene claims do not reflect any more human intervention than "snapping a leaf from a tree." 290 While Judge Bryson did not consider defining the per se exclusion by the realm of scientific activity, 291 the Supreme Court's inventive concept test, reaffirmed in Mayo, applies to the analysis of gene patents. 292 Applying the inventive concept test to the isolated DNA sequences, he would have ruled those claims unpatentable because the isolation of DNA requires nothing more for genetic science than conventional, routine activity analogous to the way in which the "isolation of interesting compounds is a mainstay of the chemist's art." 293 Because he takes the need for an inventive concept seriously, Judge Bryson generally focused much more than the other judges on the scientific activity surrounding DNA isolation. 294 He thus distinguished Myriad's unpatentable scientific discovery of the DNA sequences relevant to breast cancer from the application of the discoveries. 295 Finally, Judge Bryson undertook a downstream impact analysis of the claims to short fragments of the natural gene sequences. 296 His analysis did not depend on the downstream impact of particular DNA sequences, but, as in Morse, on the impact on downstream innovation that would result from the "breathtaking[ ]" number of embodiments covered by the claims. 297 He would have found the short fragment claims unpatentable, pointing out that the inventors could have claimed their inventions more narrowly to avoid the overbreadth issue. 298 This brief consideration of the DNA patent eligibility question illustrates the way in which different rationales for per se exclusion and different second-stage tests for moving a claim Pathology, 689 F.3d at 1350-53 (focusing on the genetic differences between natural DNA and the claimed DNA rather than the preservation of the scientific tools). 292. Compare Ass'n for Molecular Pathology, 689 F.3d at 1326-31 (majority opinion) (reading Mayo as a preemption analysis and concluding that the claimed DNA molecules, unlike the method claims in Mayo, are compositions of matter and do not preempt a law of nature), and id. at 1340-41 (Moore, J., concurring in part), with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294 (2012) (reaffirming the inventive concept test and finding the process claims unpatentable on the basis that there is no inventive step and the patent might "disproportionately [tie] up the use of the underlying natural laws, inhibiting their use in the making of further discoveries"), and Ass'n for Molecular Pathology, 689 F.3d at 1348-55 (Bryson, J., concurring in part and dissenting in part) (finding a lack of inventive concept beyond the chemical distinctions incidental to the isolation process). MUCH ADO ABOUT PREEMPTION 621 into patentable terrain can lead to different outcomes. It also illustrates that both threads of patentable subject matter analysis may apply in a single case. Thus, a DNA claim might be unpatentable both because it reflects insufficient human intervention or inventive activity and because its downstream impact is unacceptably broad. The analysis also suggests a possible explanation of the difference in views between the Federal Circuit and many genetic scientists, who find the patentability of DNA sequences highly objectionable. 299 From the scientists' perspective, all three types of DNA sequences at issue in AMP are routinely produced as a result of conventional scientific activity for which patents are unnecessary. 300 Their normative rationale for the unpatentability of DNA sequences may be based not so much on whether a sequence is in the natural realm, untouched by human intervention, but on its role in scientific activity, for which patents are not the relevant innovation system. Patentable subject matter doctrine should further society's goals for the patent system. 301 Patentable subject matter doctrine thus has a pragmatic purpose: to promote innovation while respecting other values that are important to us. Determining subject matter eligibility should not be either a matter of arcane philosophical distinctions or a sort of Rube Goldberg experience of applying meaningless and unrelated "tests" in the hope that a result will pop out at the end. This Article attempts to facilitate a systematic theoretical inquiry that remains grounded in pragmatic concerns by laying out a consistent framework for patentable subject matter doctrine. The framework first disentangles two threads of patentable subject matter analysis, separating concerns about overbroad impacts on downstream innovation from per se exclusions on other grounds. The framework next describes the two steps that must be taken to apply per se patentable subject matter exclusions to particular claims. Determining the rationale for a per se exclusion is logically prior to answering questions about how it should be applied. Focusing solely on the second-stage rule of application or failing to distinguish the two parts of the analysis, as courts have tended to do, is a recipe for confused analysis, as is illustrated by the current confused rhetoric about preemption. Because different per se exclusions may have different rationales, it is unlikely that a single rule for assessing patentability of claims incorporating per se excluded elements will produce logically consistent and normatively desirable results. The failure of the Federal Circuit's attempt to require a "machine-or-transformation-of-matter" test in all patentable subject matter cases illustrates this difficulty. The ultimate goal of this Article's analysis is to provide a foundation for further theoretical inquiry. In a follow-on article, I will consider whether per se patentable subject matter exclusions are best understood by focusing on the availability of alternative innovation institutions. Any per se exclusion is almost inevitably both under-and overbroad. If per se exclusions are conceptualized at the level of the individual claim, the advantages and disadvantages of the exclusion are likely to vary so much between claims that it is hard to avoid making laundry list arguments, which may quickly become result-oriented and even contradictory. 303 Conceptualizing per se exclusions at the institutional level, thus allowing comparison with the patent system as a means for incentivizing innovation, may be a more promising approach. 302. See supra text accompanying notes 237-243. 303. The concurring opinion of the four justices in Bilksi is somewhat infected with this problem in its discussion of policy justifications for excluding business method patents, which include, for example, both an argument that business methods do not need patent incentives for invention because they can be practiced in secrecy and an argument that business methods do not need patent incentives for disclosure because they are practiced publicly. Bilski v. Kappos, 130 S. Ct. 3218, 3254-55 (2010) (Stevens, J., concurring). Presumably each of these concerns applies to some business method patents, but listing them will not convince skeptics that they should be the subject of a per se exclusion. II. RE-READING THE SUPREME COURT'S PATENTABLE SUBJECT MATTER JURISPRUDENCE ...................................... 569 A. The Intertwined Threads of Overbroad Downstream Impact and Per Se Exclusion .................. 570 1. The Overbroad Downstream Impact Thread ......... 573 2. The Per Se Exclusion Thread ................................ 582 III. DISENTANGLING PER SE EXCLUSION ANALYSIS. .................. 586 A. The Preemption Muddle ................................................ 587 B. The Supreme Court's Two-Step Per Se Exclusion Analysis ........................................................ 591 IV. DNA PATENTS: AN ILLUSTRATION OF THE PER SE EXCLUSION FRAMEWORK ...................................................... 614 V. CONCLUSION ......................................................................... 621 I. INTRODUCTION 21. Benson, 409 U.S. at 68, 71-72. 22. See infra Part III.A. 1/2/2013 4:18 PM Id. at 177. 28. See e.g., Bilski v. Kappos, 130 S. Ct. 3218, 3231 (2010); Gottschalk v. Benson, , Inc., 132 S. Ct. 1289, 1302 (2012). The opinion nonetheless adopts from earlier precedent a muddled approach to preemption that mixes rationales. See id. at 1294 (warning against "upholding patents that claim processes that too broadly preempt the use of a natural law"). 29. For example, in The Rules and Standards of Patentable Subject Matter, 75. See Dreyfuss & Evans, supra note 2, at 1360-61 (discussing the ability to invent around as a "way to grapple with preemption" and "as a clue to patentability"). 76. Id. at 1359, 1365-67. 83. Id. at 7-8. 84. See Eisenberg, supra note 13, at 41-42. 94. Id. at 1301-03, 1305. HOUSTON LAW REVIEW [50:2 99. Morse, 56 U.S. at 101, 112-13 (invalidating the broad claim to any use of 2012] MUCH ADO ABOUT PREEMPTION 585 109. See Mayo, 132 S. Ct. at 1303. 172. Diehr, 450 U.S. at 180-81. 173. Id. (internal quotation omitted). 179. Id. at 182-83 (quoting Cochrane v. Deener, 94 U.S. 780, 787-88 (1876)). 180. Id. at 184 & n.8. 181. See id. at 179-80 n.5, 191-93. 188 182. 187. See Diehr, 450 U.S. at 188-89. 188. See Flook, 437 U.S. at 594 (rejecting the point of novelty rule and supporting the decision that a patent claim must be considered as a whole); Diehr, 450 U.S. at 188-89 & 253. Am. Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11-14 (1931). 254. Diamond v. Diehr, 450 U.S.175, 187, 192 (1981).

The doctrine of patentable subject matter is the law's way of delineating the type of thing that cannot be claimed in a patent, no matter how new or useful it might be. Supreme Court case law, beginning in the mid-nineteenth century, has defined the boundary of patentable subject matter primarily by the exclusion of "abstract ideas" and "natural phenomena."

The precise and deeply held deontological and utilitarian moral commitments to protecting the public domain" and that the preemption test is misleading in its focus on claim scope and in its neglect of the requirement that patentable subject matter be sufficiently creative).

MUCH ADO ABOUT PREEMPTION 569 basis for deciding when a claim has crossed into patentability. 15 Part II of this Article identifies the two major threadsbreadth of downstream impact and per se unpatentabilitywithin the Supreme Court's patentable subject matter case law and delineates their distinct analytical frameworks. Part III focuses on the Court's analysis of per se patentable subject matter exclusions, demonstrating their prominence in the case law and attempting to disentangle them from the preemption rhetoric. Part IV illustrates the framework presented here by applying it to the case of DNA patents. Part V concludes.

II. RE-READING THE SUPREME COURT'S PATENTABLE SUBJECT MATTER JURISPRUDENCE

HOUSTON LAW REVIEW [50:2 case law as "laws of nature, physical phenomena, and abstract ideas." 18 In Bilski v. Kappos, four concurring justices argued that business methods also reside in presumptively unpatentable terrain.

A. The Intertwined Threads of Overbroad Downstream Impact and Per Se Exclusion

The earliest opinion usually cited in patentable subject matter cases is Le Roy v. Tatham, which involved a patent on the 18. Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)

MUCH ADO ABOUT PREEMPTION 571 use of wrought lead rather than cast lead in pipe manufacture. 23 Le Roy contains traces of both of the threads woven into the Court's later discussions. 24 The opinion asserts, essentially as self-evident, that abstract "principles" and natural "powers" are unpatentable:

A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right. Nor can an exclusive right exist to a new power, should one be discovered in addition to those already known. Through the agency of machinery a new steam power may be said to have been generated. But no one can appropriate this power exclusively to himself, under the patent laws. The same may be said of electricity, and of any other power in nature, which is alike open to all, and may be applied to useful purposes by the use of machinery.

Later, the opinion expresses concerns about the effects on downstream inventors of patents that broadly claim the "results" of a process, foreshadowing the broad downstream impact rationale:

A patent is not good for an effect, or the result of a certain process, as that would prohibit all other persons from making the same thing by any means whatsoever. This, by creating monopolies, would discourage arts and manufactures, against the avowed policy of the patent laws.

30. Dreyfuss & Evans, supra note 2, at 1356-60 (arguing for a patentable subject matter analysis based explicitly on potential impact on downstream innovation); Lemley et al., supra note 2, at 1317 (arguing that the abstract ideas exclusion should focus on "whether the scope of the patentee's claims is commensurate with the invention's practical, real-world contribution, rather than asserting coverage over general ideas unmoored to a specific application" and proposing a factor-based test).

. . . The court is of opinion that the claim is too broad, and not warranted by law.

As Collins also discusses, Morse is based on a determination that the claim is overbroad in the number of embodiments it encompasses. 44 Overbreadth of this sort is a matter of claim drafting, rather than of any fundamental incompatibility between Morse's invention and the patent system. The Court specifically holds that Morse is the inventor of the telegraph, which clearly is a patentable technology. 45 The opinion does not disturb or criticize Morse's narrower claims to that technology.

The broadest claim is invalidated because the Court determines that its scope potentially encompasses so many later-developed embodiments that the patentee's reward of exclusive rights is out of line with his contribution to the technology. 47 Notably, the dissent in Morse articulates essentially what are still the two most common rebuttals to the argument for patentable subject matter exclusion based on overbroad downstream impact. One rebuttal argues that improvement patents will adequately divide returns between the pioneer and later inventors:

The reason given for thus confining the franchise of the inventor of an art to his machines and parts of machinery is, that it would retard the progress of improvement, if those who . . . can devise an improvement in it, should not be allowed to pirate it. . . . An improvement in a known art is as much the subject of a patent as the art itself; so, also, is an

MUCH ADO ABOUT PREEMPTION 575 improvement on a known machine. Yet, if the original machine be patented, the patentee of an improvement will not have a right to use the original. This doctrine has not been found to retard the progress of invention in the case of machines; and I can see no reason why a contrary one should be applied to an art.

. . . The court, by deciding that this claim is too broad, virtually decides that such an inventor of an improvement may pirate the art he improves, because it is contrary to public policy to restrain the progress of invention.

The second rebuttal argument asserts that a patentee is entitled to claim the full scope of what he has invented:

What is meant by a claim being to [sic] broad? The patent law and judicial decisions may be searched in vain for a provision or decision that a patent may be impugned for claiming no more than the patentee invented or discovered.

It is only when he claims something before known and used, something as new which is not new, either by mistake or intentionally, that his patent is affected.

It is conceded that one may not patent an idea. But in practical effect that would be the result if the formula for converting BCD numerals to pure binary numerals were patented in this case. The mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly preempt the mathematical formula and in practical effect would be a patent on the algorithm itself.

Scholarly commentary has also tended to gloss over these distinctions. Thus, most discussions of the preemption rationale focus solely on claim scope overbreadth. Many scholars have argued that, because patent law provides other doctrines, such as enablement, written description, definiteness, and utility for cabining attempts to claim more broadly than warranted by the effect on innovations of patenting basic tools); Katherine J.

context of a particular downstream innovation. 77 In the genetic context, for example, Dreyfuss and Evans explain that it may be impossible to invent around gene patents in the diagnostic context while entirely possible to do so in the context of therapeutic uses. 78 Because of such complexities in determining whether a downstream innovation prospect is too broad, Dreyfuss and Evans argue that the analysis should incorporate other "clues" including, for example, the identity of the inventor, particularly if she happens to be an academic or a user innovator.

Even with the Dreyfuss and Evans improvements, downstream impact alone is not a satisfactory basis for patentable subject matter doctrine. First, as Sichelman argues in Funk Forward, patentable subject matter exclusions based entirely on concerns about downstream innovation are questionable in principle essentially because they do not account for the importance of incentivizing the invention of broad upstream technologies. 80 After all, he argues, the requirements of novelty and nonobviousness are intended to screen out claims to advances that would have been made during the patent term even without the patent incentive.

The Per Se Exclusion Thread. Many of the Supreme

Court's patentable subject matter decisions rest on the per se exclusion of natural phenomena and abstract ideas rather than on the broad downstream reach of the claims at issue. To demonstrate this, one must show, first, that there are categories of subject matter that are excluded from patentability per se, without reference to their downstream impact on innovation and second, that the Court's application of those categories to particular claims is not simply equivalent to asking whether the claims at issue have overbroad downstream impact.

To see this, it may help to imagine a box of per se unpatentable items. The first set of rules defines which items go in the box. When one of these per se unpatentable items is used in a claim, it remains a per se excluded item. One can sensibly say, for example, that the elements of a particular claim include an unpatentable scientific principle and an unpatentable mental process. 96 The per se unpatentability of these elements alone cannot tell a court how to determine whether the claim as a whole is patentable, however. To determine whether the claim is patentable, some second rule must be applied.

III. DISENTANGLING PER SE EXCLUSION ANALYSIS.

To illuminate the Supreme Court's per se exclusion jurisprudence, we must first disentangle it from the preemption rhetoric. Subpart A takes up that task, describing how preemption has invaded patentable subject matter analysis since Benson and arguing that preemption is not a useful lodestar for either thread of patentable subject matter analysis. Subpart B reviews the major patentable subject matter opinions to illustrate the Court's application of the twostep per se exclusion framework and, in particular, to disentangle the rules that the Court has actually applied in the second stage of the analysis from the preemption rhetoric.

For the per se exclusion thread of patentable subject matter doctrine to make normative sense, both the rule for defining the per se exclusion and the rule for determining the patentability of a claim incorporating excluded material should arise from some rationale for the per se exclusion. Unfortunately, most of the case law discussion of patentable subject matter is devoted to the second stage of the analysis: determining when a patent claim involving per se excluded material traverses the boundary from unpatentable to patentable. 101

MUCH ADO ABOUT PREEMPTION 587 is usually absent or perfunctory and frequently mixes distinct concerns. 102 The lack of theoretical justification for the per se exclusions makes it difficult to make normative sense of the case law and is a major theoretical gap, which has been only partially addressed by scholars. Indeed, most discussion of per se exclusion has focused on specific controversial topics, such as the patentability of business methods. 103 This Part attempts to clear the underbrush so as to motivate more general theoretical consideration of per se patentable subject matter exclusions.

As discussed above, Benson is an excellent example of patentable subject matter exclusion based on overbroad impact of downstream uses of the claimed invention. Unfortunately, Benson's main legacy has been to conflate the downstream impact and per se exclusion frameworks, leading to the current preemption muddle. The confusion stems primarily from Benson's nutshell, which I repeat here:

It is conceded that one may not patent an idea. But in practical effect that would be the result if the formula for converting BCD numerals to pure binary numerals were patented in this case. The mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly pre-empt 102. See, e.g., Bilski the mathematical formula and in practical effect would be a patent on the algorithm itself.

As explained earlier, this nutshell is sensibly understood as part of a downstream impact analysis. The fact that claims to digital computer implementation of the BCD conversion algorithm wholly preempt the algorithm is important to the analysis only because it helps the Court to evaluate the potential downstream impacts of the claims at issue: preemption implies that if the algorithm has broad downstream impacts, the claim's downstream implications are equally broad. 105 However, it is also possible, in the context of Benson's rather opaque discussion, to read the nutshell as describing a per se exclusion analysis. In that reading, the nutshell appears to imply the following two rules:

(1) abstract ideas are excluded from patentability per se.

(The BCD conversion formula is an abstract idea and hence is unpatentable);

(2) to determine whether claims incorporating an abstract idea are patentable, consider whether the claims wholly preempt the idea.

The Court's rhetoric in later opinions often sounds as though it has adopted those rules. Reference to preemption thus has become a routine part of the second step of the patentable subject matter analysis of claims involving phenomena of nature and abstract ideas. 106 As a purely formal matter, preemption could be a workable rule for the second stage of a per se exclusion analysis. Normatively, however, the preemption rule has been given no justification and, in fact, makes little sense. As a result, courts that have taken the rule seriously have found it nearly impossible to apply in a rational manner.

If a preemption rule is applied as the second step in evaluating a claim containing elements that are per se excluded on some other basis, the results are even more peculiar. In such cases, preemption is simply orthogonal to the underlying rationale for the exclusion, whereas the optimal rule for the second part of a per se exclusion analysis would be tightly tied to 110. Mayo, 132 S. Ct. at 1303.

MUCH ADO ABOUT PREEMPTION 591 the rationale for the exclusion. Suppose, for example, that the rationale for the per se exclusion of abstract ideas from patentability were that patents should not intrude on the autonomy of human thought. Once we determine that a claim incorporates a particular mental process, the second rule should help us determine whether the additional limitations have sufficiently reduced the claim's intrusion on autonomous thought. Whether the claim wholly preempts the downstream innovative uses of the mental process is beside the point.

B. The Supreme Court's Two-Step Per Se Exclusion Analysis

The aggregation of select strains of the several species into one product is an application of [a] newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. . . . The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning.

. . . The application of this newly-discovered natural principle to the problem of packaging of inoculants may well have been an important commercial advance. But once nature's secret . . . was discovered, the state of the art made the production of a mixed inoculant a simple step. . . . That is to say, there is no invention here unless the discovery that certain strains of the several species of these bacteria are non-inhibitive and may thus be safely mixed is invention. But we cannot so hold without allowing a patent to issue on one of the ancient secrets of nature now disclosed. All that remains, therefore, are advantages of the mixed inoculants themselves. They are not enough.

In summary, the Court in Funk Bros. first identified a per se excluded natural phenomenon in the claims and then, as a second step, applied a rule requiring that the inventor's practical application of that natural phenomenon must itself be inventive, even if the inventor himself had discovered the natural phenomenon at issue. 132 Parker v. Flook involved claims to a method for computing an "alarm limit" in a process for the catalytic conversion of hydrocarbons. 133 The method, which was computer-implemented, incorporated a mathematical formula. 134 Adjudicators at every level who considered patent eligibility were in agreement that the formula was per se unpatentable but, in analyzing the

The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula; the Pythagorean theorem would not have been patentable, or partially patentable, because a patent application contained a final step indicating that the formula, when solved, could be usefully applied to existing surveying techniques. 143 Note that the Court's consideration of post-solution activity here was not related to how much the activity or the resulting claim preempted use of the unpatentable idea.

Diamond v. Chakrabarty concerned the patent eligibility of a bacterium that had been genetically engineered so as to be capable of breaking down the components of crude oil. 150 (Its intended use was to clean up oil spills.

In Diamond v. Diehr, however, the Court did not apply the inventive concept rule. 164 Diehr considered the patentability of a "process for curing synthetic rubber which includes in several of its steps the use of a mathematical formula and a programmed digital 159. Id. at 310. 160. Id. at 309. Indeed, the dissent, which focused on the question of the per se patentability of living things, did not dispute this aspect of the majority's analysis. See

The CCPA's first point both rejected the examiner's definition of the per se exclusion and reiterated Flook's rejection of a second-stage rule that any claim incorporating patentable subject matter is unpatentable. 175 The second point emphasized both the tangibility of the claimed process and the practical usefulness of the patentee's invention. 176 The CCPA did not consider whether the claimed application of the unpatentable equation involved an inventive concept. 177 The Supreme Court began its analysis by returning to an old debate about the patentability of processes that are not limited to or characterized by implementation on particular machines. 178 Quoting Cochrane v. Deener, the Court stated:

That a process may be patentable, irrespective of the particular form of the instrumentalities used, cannot be disputed. . . . A process is a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing. If new and useful, it is just as patentable as is a piece of machinery.

The patentability of a physical process for molding rubber was, of course, not in dispute in 1981. 180 The question at issue, which the Court answered in the affirmative, was whether Diehr's claims, in which physical details of the rubber molding process did not play an important role, should be viewed as directed to such an "industrial process." 181 174. Id

The Court then turned to the impact on patent eligibility of the claims' incorporation of "a mathematical equation and a programmed digital computer."

189 While Flook instructs the patentable subject matter analyst to treat newly discovered natural phenomena or abstract ideas as "well known," the real point of Flook's "inventive concept" rule is that only the inventor's activities over and above the discovery of the per se unpatentable subject matter count. 190 In other words, the rule would obtain precisely the same results if it were stated as "determine whether the claim reflects an inventive concept in the application of the unpatentable natural phenomenon or abstract idea, independent of whether the unpatentable element is new or old."

Indeed, the opinion's lengthy discussion of the impact of presuming that a per se unpatentable mathematical algorithm is old was utterly irrelevant to Diehr's patent claims;

191 both the Arrhenius law and the equation using it to calculate curing times during rubber molding were, in fact, well known. 192 Therefore, any impact on the patentable subject matter question of the novelty (or lack thereof) of particular claim elements was truly neither here nor there for the claims at issue. 193 Finally, both Flook and Diehr maintained that patentable subject matter must be assessed separately from novelty and nonobviousness under the other sections of the Patent Act.

194 Diehr stated that "[t]he question . . . of whether a particular invention is novel is 'wholly apart from whether the invention falls into a category of statutory subject matter,'" while Flook opined that "[t]he obligation to determine what type of discovery is sought to be patented must precede the determination of whether that discovery is, in fact, new or obvious." 195 n.12 (rejecting petitioner's argument for applying the point of novelty rule and claiming it to be a misinterpretation of the Court's holding in Flook).

189. Diehr, 450 U.S. at 188-89; see also Flook, 437 U.S. at 591 ("[T]he novelty of the mathematical algorithm is not a determining factor at all.").

190. See Flook, 437 U.S. at 591-92, 594 ("Even though a phenomenon of nature or mathematical formula may be well known, an inventive application of the principle may be patented. Conversely, the discovery of such a phenomenon cannot support a patent unless there is some other inventive concept in its application.").

The difference between the inventive concept rule and the Diehr approach thus came down to what second-stage rule to apply in considering the claims "as a whole" to assess their patent eligibility in light of their incorporation of a well-known mathematical equation. The inventive concept approach would have asked whether Diehr's application of the well-known equation for calculating cure time in the claimed computerized process was conventional. Diehr did not ask that question.

196 Instead, the Court relied on the following reasoning:

In summarizing its approach at the end of the opinion, the Court concluded:

206. Id. at 187. 207. Id. at 212-15 (Stevens, J., dissenting). 208. See Parker v. Flook, 437 U.S. 584, 593-94 (1978) (emphasizing that discoveries of phenomena of nature or mathematical formulas are unpatentable "unless there is some other inventive concept in [their] application"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131-32 (1948) (stating that a mixed inoculant was "no more than the discovery of some handiwork of nature and hence is not patentable").

209. See 35 U.S.C. § § 102-03 (2006). 210. See Funk Bros., 333 U.S. at 130-31 ("If there is to be invention from discovery, it must come from the application of the law nature to a new and useful end."). majority opinion in Diehr, once the per se unpatentable mathematical algorithm was defined to be the well-known rubber curing equation, the debate over whether to employ "practical application" or "industrial process" or "inventive concept" as the second part of the patentable subject matter analysis was moot. The end result of the overall patentability inquiry, which would have included analysis under § 102 and § 103, would have been unaffected by the choice of second-stage rule.

Those who argue that patentable subject matter analysis is unnecessary in light of the novelty and nonobviousness requirements are thus correct if: (1) the patentable subject matter framework is one of per se exclusion; (2) the per se exclusion is well defined so there is no debate as to its boundaries; (3) the rule for the second step of the analysis is "inventive concept" (or one of a few others, such as "practical application"); and (4) the per se unpatentable element of a particular claim is within the prior art that will be considered for novelty and nonobviousness. These conditions often do not hold, however.

Compare Diehr, at 187-88 (majority opinion) (discussing the equation for calculating curing time itself as the unpatentable element), with id. at 212-13, 216 (Stevens, J., dissenting) (discussing the entire process of calculating the correct curing time as the unpatentable element).

MUCH ADO ABOUT PREEMPTION 609 grant a monopoly over an abstract idea." 224 There is probably little disagreement that the concept of hedging, like the BCD conversion algorithm in Benson, is involved in a large swath of downstream uses. 225 Because the Court characterized those two claims as entirely commensurate with claims to the concept itself, the use of preemption here is, for once, consistent with its original usage in Benson.

237 correlations between particular metabolite levels and patients' reactions to particular drugs. 243 Instead, they relate to the relatively narrow downstream impact of the claims overall. 244 In fact, the Federal Circuit's patentable subject matter analysis did not depend in any significant way on the fact that the claims involved a natural phenomenon. Essentially the same questions could have been asked about any claim.

244. See id. at 1355-58 (interpreting the claims at issue as "specific treatment steps, not just the correlations themselves" that comprise "particular methods of treatment," which could be designed around simply by administering different drugs

IV. DNA PATENTS: AN ILLUSTRATION OF THE PER SE EXCLUSION FRAMEWORK

This Article leaves all the hard questions open. While I plan to tackle some of them in follow-on work, the remainder of this Part provides a brief illustration of the potential payoff from the analytical framework suggested here. The illustration concerns whether DNA sequences are patentable subject matter, which is the subject of the Federal Circuit's opinions in Association for Molecular Pathology (AMP) v. USPTO.

Eventually, Irwin argues, technology came to be viewed less as mastery over nature than as applied science. 266 Patentable subject matter doctrine thus evolved to emphasize the distinction between science and technology, and exclusions were redefined in terms of keeping the basic results of open science in the public domain. 267 1853). Thus, Morse argues that the patentees' ability to make free use of scientific advances, while keeping his own advances secret, is part of the problem with an overbroad claim:

Judge Lourie, in his opinion for the court, applied a mastery of nature approach. In his view, cDNA molecules were almost trivially patentable because they were the result of such significant human intervention.

275. Id. at 1328 ("[I]solated DNA [is left with] a distinctive chemical identity as compared to native DNA."); id. at 1350-51 (Bryson, J., concurring in part and dissenting in part) (arguing that the majority elevates form over substance because although the BRCA genes were isolated, the BRCA sequence itself is the same as that found in nature).

276. See id. at 1328 (majority opinion). 277. Id. at 1333. 278. Compare id. at 1327-28 (emphasizing the chemical distinction between isolated and native DNA.), with id. at 1341-42 (Moore, J., concurring in part) (focusing on the added utility of the isolated claimed sequences).

Patentable subject matter doctrine should further society's goals for the patent system. 301 Patentable subject matter doctrine thus has a pragmatic purpose: to promote innovation while respecting other values that are important to us. Determining subject matter eligibility should not be either a matter of arcane philosophical distinctions or a sort of Rube Goldberg experience of applying meaningless and unrelated "tests" in the hope that a result will pop out at the end.

Because different per se exclusions may have different rationales, it is unlikely that a single rule for assessing patentability of claims incorporating per se excluded elements will produce logically consistent and normatively desirable results. The failure of the Federal Circuit's attempt to require a "machine-or-transformation-of-matter" test in all patentable subject matter cases illustrates this difficulty.

21. Benson, 409 U.S. at 68, 71-72. 22. See infra Part III.A. 1/2/2013 4:18 PM

Id. at 177. 28. See e.g., Bilski v. Kappos, 130 S. Ct. 3218, 3231 (2010); Gottschalk v. Benson, , Inc., 132 S. Ct. 1289, 1302 (2012). The opinion nonetheless adopts from earlier precedent a muddled approach to preemption that mixes rationales. See id. at 1294 (warning against "upholding patents that claim processes that too broadly preempt the use of a natural law"). 29. For example, in The Rules and Standards of Patentable Subject Matter,

75. See Dreyfuss & Evans, supra note 2, at 1360-61 (discussing the ability to invent around as a "way to grapple with preemption" and "as a clue to patentability"). 76. Id. at 1359, 1365-67.

83. Id. at 7-8. 84. See Eisenberg, supra note 13, at 41-42.

94. Id. at 1301-03, 1305. HOUSTON LAW REVIEW [50:2

99. Morse, 56 U.S. at 101, 112-13 (invalidating the broad claim to any use of 2012] MUCH ADO ABOUT PREEMPTION 585

109. See Mayo, 132 S. Ct. at 1303.

172. Diehr, 450 U.S. at 180-81. 173. Id. (internal quotation omitted).

179. Id. at 182-83 (quoting Cochrane v. Deener, 94 U.S. 780, 787-88 (1876)). 180. Id. at 184 & n.8. 181. See id. at 179-80 n.5, 191-93.

188 182. 187. See Diehr, 450 U.S. at 188-89. 188. See Flook, 437 U.S. at 594 (rejecting the point of novelty rule and supporting the decision that a patent claim must be considered as a whole); Diehr, 450 U.S. at 188-89 &

253. Am. Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11-14 (1931). 254. Diamond v. Diehr, 450 U.S.175, 187, 192 (1981).