Do Not Delete 1/2/2013 1:59 PM ARTICLE PROMETHEUS LABORATORIES, MENTAL STEPS, AND PRINTED MATTER Kevin Emerson Collins∗ ABSTRACT This article identifies connections between the Supreme Court’s recent opinion in Mayo Collaborative Services v. Prometheus Laboratories and two doctrines that federal appellate courts have used to curb the reach of patent protection: the historical mental steps doctrine and the contemporary printed matter doctrine. These connections suggest a new way of thinking about what the Court is doing in its Prometheus Laboratories opinion. On its rhetorical surface, the opinion clearly addresses the role that “laws of nature” have long played in restricting the reach of patentable subject matter. However, beneath its laws-of-nature rhetoric, Prometheus Laboratories can also be construed as a case that explores the impact of the unpatentability of the human mind on the reach of patent protection. The Court’s Prometheus Laboratories opinion resonates strongly with both historical limits on the patentability of newly invented mental processes (mental steps) and contemporary limits on the patentability of information that is meaningful to the human mind (printed matter). TABLE OF CONTENTS I. INTRODUCTION...................................................................... 392 II. PROMETHEUS LABORATORIES AND THE HISTORICAL MENTAL STEPS DOCTRINE .................................................... 397 ∗ Professor of Law, Washington University School of Law. kecollins@wulaw.wustl.edu. I thank the presenters and fellows at the University of Houston’s 2012 Santa Fe conference for their useful comments. 391 Do Not Delete 392 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 A. Substitute Exclusions .................................................... 398 1. The Claims ............................................................. 398 2. The Doctrinal Analyses. ......................................... 402 3. The Substantive Limits on Patentable Subject Matter. ....................................................... 409 B. Disrupting the Status Quo: The Mental Steps Doctrine Revived ........................................................... 411 1. In re Musgrave....................................................... 411 2. Diamond v. Diehr................................................... 416 III. PROMETHEUS LABORATORIES AND THE CONTEMPORARY PRINTED MATTER DOCTRINE ................................................ 420 A. The Contemporary Core of the Printed Matter Doctrine ......................................................................... 421 B. Complementary Exclusions ........................................... 427 C. Continuity with the Status Quo: Erasing the Arbitrary Statutory Divide............................................ 430 IV. CONCLUSION ......................................................................... 434 I. INTRODUCTION On its rhetorical surface, the U.S. Supreme Court opinion in Mayo Collaborative Services v. Prometheus Laboratories clearly addresses the role that “laws of nature” have long played in restricting the reach of patentable subject matter 1 under § 101 of the Patent Act. The Court invalidates a claim to a medical diagnostic method, reasoning that the claim is an unpatentable attempt to privatize a newly discovered law of nature in the abstract rather than a patentable description of an inventive application of the law of nature.2 Given this conceptual framework, the opinion, for the most part, cites and discusses only the Court’s own cases addressing the patentability of laws of nature.3 This Article offers a different perspective on the Court’s Prometheus Laboratories opinion that is not focused solely on the exclusion of laws of nature from patentable subject matter. It identifies strong and multi-stranded connections between 1. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1292 (2012). 2. Id. at 1294. 3. See id. at 1293, 1298–301 (citing, e.g., Diamond v. Diehr, 450 U.S. 175 (1981); Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v. Benson, 409 U.S. 63 (1972); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948); O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1853)). Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 393 the Court’s Prometheus Laboratories opinion and two doctrines that federal appellate courts have used to curb the reach of patent protection: the historical mental steps doctrine of the Court of Customs and Patent Appeals (CCPA) and the contemporary printed matter doctrine of the Court of Appeals for the Federal Circuit (CAFC).4 The goal of drawing these connections is to suggest a different way of thinking about the law that the Court has created in its Prometheus Laboratories opinion. The connections demonstrate that, underneath its rhetorical surface, the Court’s Prometheus Laboratories opinion resonates strongly with both historical limits on the patentability of mental processes (mental steps) and contemporary limits on the patentability of information that is meaningful to the human mind (printed matter). Perhaps this resonance is significant. Perhaps it would make sense to understand Prometheus Laboratories as a case that is as much about the human mind as a limit on patent protection as it is about laws of nature as a limit on patent protection. The mental steps doctrine was a facet of the doctrine of patentable subject matter that the CCPA employed to curtail the patentability of method claims reciting processes that were mental in the sense that they could be performed entirely by a human mind.5 More specifically, it employed a point-of-novelty analysis to restrict the patentability of mental processes. A method claim reciting a mental process was not categorically excluded from patentable subject matter. Rather, it was beyond patentable subject matter only if a mental-process limitation was the claim’s sole point of novelty.6 The mental steps doctrine was relatively short lived. The CCPA first clearly articulated the 7 mental steps doctrine in its 1951 case In re Abrams, but it had abandoned the doctrine by 1970 in the course of its struggle with the patentability of computer software.8 The CAFC never revived 4. The CCPA was a precursor to the CAFC that heard patent applicants’ appeals when the Patent and Trademark Office (PTO) rejected their applications. The CCPA was dissolved, and the CAFC was founded, in 1982. 5. Diehr, 450 U.S. at 195–96 (1980) (Stevens, J., dissenting) (discussing the principles of the “mental steps doctrine”). 6. Id.; see also infra notes 57–70 (explaining point-of-novelty analysis). 7. In re Abrams, 188 F.2d 165, 169 (C.C.P.A. 1951). Although Abrams articulates the authoritative formulation of the mental steps doctrine, the CCPA’s application of the mental steps doctrine to the Abrams claim is problematic. See infra text accompanying notes 57–78. 8. In re Musgrave, 431 F.2d 882, 894–95 (C.C.P.A. 1970). Signs of the CCPA’s skepticism towards the mental steps doctrine can be seen in earlier, pre-Musgrave cases. See, e.g., In re Prater, 415 F.2d 1378, 1385, 1387 (C.C.P.A. 1968), superseded by 415 F.2d 1393 (C.C.P.A. 1969). Do Not Delete 394 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 the doctrine, and it does not consider the doctrine to be good law today.9 The Court’s opinion in Prometheus Laboratories and the mental steps doctrine of Abrams are connected on two distinct levels. First, the two impose very similar limits on the patentability of medical diagnostic claims like those at issue in Prometheus Laboratories. The two are rough substitutes in the area of medical diagnostics in the sense that the restrictions on patentability articulated in Prometheus Laboratories and the mental steps doctrine have considerable substantive redundancy. Despite being decided over sixty years apart and being drawn to inventions in different technological fields, the claims at issue in Prometheus Laboratories and Abrams both describe diagnostic methods that follow the identical template. They are both determine-and-infer claims: they describe the acts of determining a first fact and inferring a second fact through a mental syllogism that is enabled by a newly discovered, natural correlation (a “law of nature” in the Court’s terminology in Prometheus 10 Abrams and Prometheus Laboratories also Laboratories). employ parallel doctrinal analyses. In Prometheus Laboratories, the Court employs what this Article refers to as a bracket-anddistinguish analysis to identify unpatentable claims to laws of nature. It conceptually brackets off any laws of nature that are wound up with the claimed subject matter and invalidates any claims in which there is nothing that distinguishes the remaining, unbracketed subject matter from conventional technology.11 The bracket-and-distinguish analysis of Prometheus Laboratories does for laws of nature precisely what the point-ofnovelty analysis of Abrams does for mental processes: the distinction between a claim and the prior art cannot reside solely in a feature of the claimed invention that, standing alone, is not patentable subject matter. In determine-and-infer claims, the two distinct kinds of unpatentable subject matter are compounded in the same step: the inference step is a mental process that employs a law of nature as a factual premise. Prometheus Laboratories is thus a rough substitute for Abrams in the area of diagnostic method claims: it is doing much of the very work to limit the reach of the patent regime that used to be done by the mental steps doctrine. 9. In re Bilski, 545 F.3d 943, 960–61 (Fed. Cir. 2008) (en banc), aff’d on other grounds sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010). 10. See infra Section II.A.1. 11. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1297 (2012); see also infra notes 44–48 (explaining bracket-and-distinguish analysis). Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 395 Second, Prometheus Laboratories and the mental steps doctrine are connected in the sense that Prometheus Laboratories removes all precedent that precludes a full revitalization of the mental steps doctrine in the CAFC in the future. The CAFC never revisited the CCPA’s abandonment of the mental steps doctrine because it interpreted the Supreme Court’s reasoning in Diamond v. Diehr to forbid a point-of-novelty analysis as a 12 methodology for identifying patentable subject matter. By adopting and defending the bracket-and-distinguish analysis in Prometheus Laboratories—the functional equivalent of a point-ofnovelty analysis—the Supreme Court has in effect, if not in express language, repudiated its earlier position in Diehr, undermined the CAFC’s position on the mental steps doctrine, and cleared the way for the doctrine’s revival. The cases at the contemporary core of the CAFC’s printed matter doctrine involve claims with limitations that recite information with content that is meaningful to the human 13 mind. More specifically, they employ a point-of-novelty analysis to invalidate claims for a lack of novelty under § 102 or nonobviousness under § 103 when the only difference between a claimed invention and the prior art resides in the content of the claimed information.14 For example, a claim to the combination of an old kit of chemicals and a set of printed instructions conveying a newly discovered method of using the chemicals is not patentable under the printed matter doctrine.15 Similarly, a twostep method of giving known drugs to a patient and informing the patient of the most effective way to ingest the drugs is not a patentable invention when the information conveyed to the patient is the only point of novelty.16 In both situations, the distinction between the claimed invention and the prior art resides in the content of the information, i.e., in the meaning that the information has to a human interpreter. The printed matter doctrine and Prometheus Laboratories are complementary in the sense that they place distinct limits on the reach of the patent regime that work together to achieve a single goal: they prevent the discovery of a law of nature from ever being a patentable event in and of itself. The discovery of a 12. Diamond v. Diehr, 450 U.S. 175, 188–89 (1981); In re Bilski, 545 F.3d at 958. 13. See, e.g., In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004). 14. See In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (nonobviousness); In re Ngai, 367 F.3d at 1338–39 (novelty); see also DONALD S. CHISUM, CHISUM ON PATENTS § 1.02[4][e], at 1–42 (2012). 15. In re Ngai, 367 F.3d at 1339. 16. King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010). Do Not Delete 396 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 law of nature is nothing more than the creation of a new type of factual knowledge about the world. In turn, factual knowledge per se exists in two distinct manifestations: it exists as mental states within human minds, e.g., mental states of “understanding” or “comprehending” the law of nature, and as extra-mental information that is meaningful to human minds. To prevent the raw factual knowledge that constitutes the discovery of a law of nature from being a patentable entity, a two-pronged restriction on patent protection is needed. The printed matter doctrine uses a point-of-novelty analysis to restrict the patentability of the extra-mental information that conveys or disseminates factual knowledge. Prometheus Laboratories then picks up where the printed matter doctrine leaves off. It uses the bracket-and-distinguish analysis to restrict the patentability of the manifestations of factual knowledge of a law of nature that exist within human minds. If it is simply the mental comprehension of a newly discovered law of nature that distinguishes a claimed process from the prior art, Prometheus Laboratories holds that the process is not patentable subject matter. The complementarity of Prometheus Laboratories and the printed matter doctrine suggests a new way of understanding the relationship between Prometheus Laboratories and contemporary CAFC law. The conventional narrative emphasizes the break that Prometheus Laboratories makes from the immediate past: the Supreme Court retreated from its opinion in Diamond v. Diehr and thus upset thirty years of the status quo in the CAFC on the patentability of laws of nature.17 The dovetail connection between the core of the CAFC’s contemporary printed matter doctrine and Prometheus Laboratories inverts this narrative and highlights a strand of continuity. To see this continuity, however, the patent community must look at the Patent Act holistically, breaking down the distinct, statutorily defined doctrinal silos that traditionally structure patent scholarship. It must not categorically isolate invalidity under § 101 (the statutory provision at issue in Prometheus Laboratories and the mental steps doctrine)18 from invalidity under §§ 102 and 103 (the 17. See, e.g., Bernard Chao, Moderating Mayo, 107 NW. L. REV. COLLOQUY 82, 88–89 (2012), http://www.law.northwestern.edu/lawreview/colloquy/2012/12/LRColl2012n12 Chao.pdf. Similarly, Prometheus Laboratories also upends the CAFC’s longstanding refusal to recognize the mental steps doctrine as a limit on patentable subject matter. See infra text accompanying notes 147–55. 18. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293–94 (2012) (discussing problems with patentability under section 101 of the Patent Act); see also In re Abrams, 188 F.2d 165, 165 (C.C.P.A. 1951) (rejecting patent claim based on 35 Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 397 statutory provisions at issue in the contemporary core of the printed matter doctrine).19 Viewed at close range, the two groups of connections drawn in this Article tell two divergent stories. The connections between Prometheus Laboratories and the historical mental steps doctrine tell a story of both substantive redundancy—the two doctrines invalidate similar, if not identical, sets of diagnostic method claims—and inversion of the CAFC’s pre-Prometheus status quo. In contrast, the connections between Prometheus Laboratories and the contemporary printed matter doctrine tell a story of both substantive complementarity—the two doctrines invalidate distinct sets of claims to achieve a unified goal—and continuity with the CAFC’s pre-Prometheus status quo. Viewed more broadly, however, the two groups of connections both point to the same line of future inquiry. Prometheus Laboratories is intimately wound up with cases in which lower courts restrict the reach of patent protection into the processes that comprise human minds and the extra-mental information that is meaningful to human minds. Thus, perhaps it would be productive to understand Prometheus Laboratories as a case that is as much about the unpatentability of the human mind as it is about the unpatentability of laws of nature. This Article proceeds in three parts. Part II identifies connections between Prometheus Laboratories and the mental steps doctrine of Abrams. Part III discusses the connections between Prometheus Laboratories and the contemporary core of the printed matter doctrine. Part IV concludes. II. PROMETHEUS LABORATORIES AND THE HISTORICAL MENTAL STEPS DOCTRINE This Part examines two types of links between Prometheus Laboratories and Abrams––the case in which the CCPA first clearly articulated the mental steps doctrine. Section II.A highlights the substantive redundancy of the exclusions from patentable subject matter effectuated by Prometheus Laboratories and Abrams in the area of medical diagnostics. Section II.B argues that Prometheus Laboratories clears the way for the revival of Abrams in the CAFC. U.S.C.A § 31, which has been recodified as 35 U.S.C. § 101). 19. See King Pharm., 616 F.3d at 1274, 1278, 1283 (discussing the issues in the case as related to section 102 of the Patent Act); In re Gulack, 703 F.2d at 1385 (discussing the issues in the case as related to section 103 of the Patent Act). Do Not Delete 398 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 A. Substitute Exclusions Prometheus Laboratories and Abrams have striking similarities on two dimensions. First, Section II.A.1 demonstrates that the claims at issue in the two cases follow the identical template: they both describe mental processes that are enabled by knowledge of newly discovered laws of nature. Second, Section II.A.2 illustrates that the doctrinal analyses employed in the two cases—namely the bracket-and-distinguish and point-of-novelty analyses—have parallel structures. Section II.A.3 then examines the exclusions from patentable subject matter that Prometheus Laboratories and Abrams generate. Although one focuses on laws of nature and the other focuses on mental processes, both draw the same outer boundary for patentable subject matter when claims describe diagnostic processes that involve mental acts of reasoning that employ newly discovered laws of nature as factual premises. 1. The Claims. The patent claims at issue in Prometheus Laboratories describe a medical diagnostic method.20 More specifically, they describe a method through which a doctor can determine whether there is a need to adjust the dosage of thiopurine drugs taken by patients who have autoimmune 21 diseases. Upon ingestion of a thiopurine drug, a patient’s body breaks the drug down into metabolites, including 6-TG.22 (Patients metabolize thiopurine drugs differently, so two patients taking the same dosage of a thiopurine drug may have significantly different levels of the metabolites in their blood. 23) Even before the researchers’ work, a general correlation between the levels of the metabolites in a patient’s body and the likely clinical outcome for the patient was already known. Too much of the metabolite leads to concerns about safety and toxicity, whereas too little of the metabolite leads to concerns about inefficacy.24 The inventors quantified this correlation. They identified specific upper and lower thresholds for 6-TG that, if surpassed, lead to the safety and inefficacy concerns, respectively.25 Based on their discovery, the researchers filed for, and received, patent protection for a method of diagnosing whether a patient was taking an optimal amount of a 20. 21. 22. 23. 24. 25. Prometheus Labs., 132 S. Ct. at 1294. Id. at 1295. Id. Id. Id. Id. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 399 thiopurine drug.26 The Court took the following claim to be representative: A method of optimizing therapeutic efficacy for treatment of an [autoimmune] disorder, comprising: (a) administering a [thiopurine] drug . . . to a subject having said . . . disorder; and (b) determining the level of [6-TG] in said subject . . . wherein the level of [6-TG] less than about 230 pmol per 8 8x10 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of [6-TG] greater than about 400 pmol 8 per 8x10 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said 27 subject. The “wherein” clauses describe the mental step in which a doctor comes to understand the need to adjust the drug dosage; no post-understanding action on the part of the doctor, such as an actual adjustment to the amount of the drug administered, is 28 required for infringement. As the Court summarized the claims, they “tell a treating doctor to measure metabolite levels and to consider the resulting measurements in light of the statistical 29 relationships they describe.” Abrams arose from an invention in the field of petroleum 30 prospecting. It is often difficult to discern where oil is located below the ground based on an inspection of the visible surface of the ground. Drilling boreholes in a random fashion is possible, but it is wasteful. The Abrams claims describe a method of determining if boreholes are in the vicinity of a petroleum deposit even though they do not directly tap into a deposit.31 The factual premises that underlie the claims is that petroleum deposits create “gaseous emanations in and about the area of their location” and that these emanations can be detected by measuring the rate at which air pressure rises in a sealed-off borehole.32 The CCPA took a six-step method as representative: 26. 27. 28. 29. 30. 31. 32. Id. Id. Id. at 1296. Id. at 1302. In re Abrams, 188 F.2d 165, 165 (C.C.P.A. 1951). Id. at 165–66. Id. Do Not Delete 400 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 (1) sinking a number of boreholes . . . , (2) sealing off each of said boreholes from the atmosphere . . . , (3) reducing the pressure in said borehole[s] . . . , (4) measuring the rate of pressure rise . . . , (5) [standardizing the data gathered on] the rate of pressure rise . . . at a standard reference pressure . . . , and (6) comparing the rates determined in step 5 for different boreholes to detect anomalies which are indicative of the 33 presence of [petroleum] deposits. The Abrams claims do not require subsequent drilling in the vicinity of a borehole with an elevated rate of pressure rise for infringement.34 The claim can be infringed simply by coming to an understanding that certain boreholes have characteristics that are indicative of the presence of petroleum deposits in the area.35 That is, to paraphrase the above description from Prometheus Laboratories, the claims “tell [an oil prospector] to measure [the rates of pressure rise] and to consider the resulting measurements in light of the statistical relationships they 36 describe.” The claims at issue in Prometheus Laboratories and Abrams share a number of characteristics. Both describe methods for ascertaining some fact that cannot be readily perceived through direct observation. Although the label “diagnostic method” is often used to imply a method in the medical arts, the Abrams claim is just as much of a diagnostic method as the Prometheus Laboratories claim is. The Abrams claim simply diagnoses the earth’s geology rather than a patient’s heath. Additionally, both claims build on natural correlations or laws of nature. In Prometheus Laboratories, the law of nature is in part the correlation between the facts that (i) the patient’s metabolite level is above a certain threshold and (ii) a patient is taking so much of a thiopurine drug that 37 he has an elevated risk of suffering adverse side effects. In Abrams, the law of nature is the correlation between the facts that (i) there are unusually high gaseous emanations in a 33. Id. at 165. 34. Id. at 166. 35. Id. (stating that flow rate as a characteristic must be merely “compared to detect anomalies which are indicative of the presence of [petroleum] deposits”). 36. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1302 (2012). 37. Id. at 1295. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 401 borehole and (ii) there is a higher probability of a petroleum deposit being near the borehole.38 The CCPA does not identify the Abrams correlation as a law of nature, but it clearly is just as natural and just as law-like as the Prometheus Laboratories correlation, if not more so.39 Both claims also put the correlations to practical use in the 40 same way: they are determine-and-infer claims. They initially describe (in one or more steps) the worldly, extra-mental, or 41 physical act of determining a first fact about an individual. Both claims then describe a mental syllogism that employs the first fact about the individual and the law of nature as premises to infer a second fact about the individual as a conclusion. In generic form, the claimed syllogism is as follows: Premise 1: An individual has property X. Premise 2: In general, individuals who have property X are more likely than usual to have property Y. Conclusion: Said individual is more likely than usual to 42 have property Y. The common template becomes yet clearer when the Abrams claim is redrafted in the exact format of the Prometheus Laboratories claim with the inference in a “wherein” clause: (1) sinking a number of boreholes . . . (2) determining the rate of pressure rise in said boreholes . . . at a standard reference pressure . . . wherein an anomalously high rate of pressure rise indicates 43 a likelihood of petroleum deposits in the vicinity. 38. In re Abrams, 188 F.2d at 165–66. It is unclear from the Abrams opinion whether this correlation was discovered by the patent applicant. 39. The Prometheus Laboratories correlation was held to be natural despite the fact that thiopurine drugs are man-made pharmaceuticals. Prometheus Labs., 132 S. Ct. at 1296–97. Therefore, the man-made nature of the boreholes does not preclude the Abrams correlation from being a law of nature. 40. For a more detailed explanation of the nature of the claimed logical inference, see generally Kevin Emerson Collins, Propertizing Thought, 60 SMU L. REV. 317 (2007). 41. The term “individual” does not refer only to a human. It refers to a token rather than a type, or a particular individual rather than a class of entities. For example, any given borehole is an “individual” in Abrams. 42. The determine-and-infer template challenges the perception that Prometheus Laboratories is a case with significant implications for biomedical diagnostics in particular. See, e.g., Asher Hodes, Diagnosing Patentable Subject Matter, 26 BERKELEY TECH. L.J. 225, 230–40 (2011); Brent Kendall et al., Top Court Decision Stirs Alarm in Biotech, WALL ST. J., Mar. 21, 2012, at A1. Prometheus in fact addresses the patentability of determine-and-infer claims in all technological arts, not only the biomedical arts. Cf. Collins, supra note 40, at 342–44 (noting that the determine-and-infer template can be used to draft a diagnostic claim in any art). 43. This claim is slightly broader than the actual Abrams claim because the single, Do Not Delete 402 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 The determine-and-infer template that underlies the claims in Prometheus Laboratories and Abrams demonstrates that the two cases result from two confrontations, over sixty years apart, with the exact same challenge to the reach of patentable subject matter. However, courts deciding the two cases identified different problems in need of a solution. As explored in the following Section, the doctrine deployed in Prometheus Laboratories queries whether the claims impermissibly describe newly discovered laws of nature in the abstract, whereas the doctrine articulated in Abrams probes whether the claims are, in effect, unpatentable claims to purely mental processes. 2. The Doctrinal Analyses. In Prometheus Laboratories, the Supreme Court employs a bracket-and-distinguish analysis to draw the boundary between categorically unpatentable claims to newly discovered laws of nature per se and potentially patentable claims to applications of those laws. As its name suggests, the bracket-anddistinguish analysis involves two steps. First, the Court identifies the laws of nature at issue and conceptually brackets them off from the remainder of the claimed subject matter.44 Second, the Court compares the portion of the claimed subject matter that remains outside of the brackets to the technology that was conventional at the time of the invention.45 The claim does not describe patentable subject matter if “the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.”46 In other words, “[p]urely ‘conventional or obvious’ ‘[pre]solution activity’ is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”47 In contrast, if the claim recites in addition to the natural law “other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself,” then the claim describes a patentable application of a law of nature.48 generally formulated step (2) replaces a number of more particularized steps. 44. Prometheus Labs., 132 S. Ct. at 1297. The precedent from which Prometheus Laboratories draws the bracket-and-distinguish analysis brackets the law of nature by treating it as part of the prior art. Parker v. Flook, 437 U.S. 584, 591–92 (1978); infra note 136 and accompanying text. In contrast, Prometheus Laboratories brackets off the law of nature without indicating that it should be part of the prior art. However, this difference appears to be more semantic than substantive. 45. Prometheus Labs., 132 S. Ct. at 1298. 46. Id. at 1294. 47. Id. at 1298 (second alteration in original) (quoting Flook, 437 U.S. at 590). 48. Id. at 1294 (quoting Flook, 437 U.S. at 594). Prometheus Laboratories also Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 403 The Court holds that the Prometheus Laboratories claims 49 fall on the unpatentable side of the boundary. The Court identifies the correlation “between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will . . . cause harm” as a law of nature, and finds nothing in the claimed subject matter beyond the law of 50 nature that makes the claim eligible for patent protection. The “administering” and “determining” steps recite conventional processes that were well-known in the prior art at the time of the invention. The “administering” step was old because “doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone” discovered the correlations.51 Similarly, the “determining” step lacked novelty at that time, as “methods for determining metabolite levels were well known in the art.”52 The mental wherein step was concededly new, but the Court attributes its novelty entirely to the newly discovered laws of nature: it is nothing more than “a suggestion that [a doctor] should take [the laws of nature] into account when 53 treating his patient.” Finally, recognizing that, in theory, an “inventive concept” could come from the combination of steps that individually were conventional, the Court noted that the combination of the steps “adds nothing . . . that is not already present when the steps are considered separately.”54 In summary, the court explained its ruling as follows: To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond 55 the sum of their parts taken separately. discusses the dynamic costs of the claims at issue—that is, the social costs that follow from the effects the claims will have on future inventors who seek to use the claimed subject matter as an input into further innovation. Id. (“At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”). It is possible that the existence of significant dynamic costs will be a second prong of a conjunctive test for the identification of impermissible claims to laws of nature. However, in order to draw out the connections between Prometheus Laboratories and the mental steps and printed matter doctrines, this Article does not dwell on the dynamic-cost issue. 49. For a discussion of the claims at issue in Prometheus Laboratories, see supra Section II.A.1. 50. Prometheus Labs., 132 S. Ct. at 1296–97. 51. Id. at 1297. 52. Id. at 1297–98. 53. Id. at 1297. 54. Id. at 1298. 55. Id. Do Not Delete 404 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 Reinforcing the Court’s position that it is the conventionality of the claimed subject matter (other than the law of nature) that led to the claims being labeled as unpatentable subject matter, the Court left open for future cases the following question: “We 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.”56 In Abrams, the CCPA uses a point-of-novelty analysis to draw the boundary between categorically unpatentable claims to purely mental processes and potentially patentable claims to 57 processes that happen to include some mental steps. Abrams lays out this analysis in the form of three rules suggested by the appellant. The first rule deals with the simple limiting case: “[i]f all the steps of a method claim are purely mental,” the claim is 58 not patentable subject matter. The second and third rules deal with mixed claims that embody both “positive and physical steps”—i.e., extra-mental steps—in addition to purely mental 59 steps. The second rule holds that mixed claims are not patentable subject matter if “the alleged novelty or advance over the art” required for patentability under what are now the novelty and nonobviousness provisions “resides [even in part] in one or more of the so-called mental steps.”60 The third rule states the implicit negative corollary of the second rule: mixed claims are patentable subject matter if “the novelty or advance over the art” required for patentability can be found “in one or more of the positive and physical steps” without reference to any mental steps.61 When the third rule applies, the mental steps “are incidental parts of the [claimed] process which are essential to [only] define, qualify or limit its scope” and not to demonstrate 62 that a patentable advance over the prior art has occurred. A fourth, implicit rule not mentioned in Abrams is that claims comprised of only extra-mental steps are never barred by the 63 mental steps doctrine. The CCPA affirmed the PTO’s rejection of the Abrams claims for failure to describe patentable subject matter under the 64 mental steps doctrine. The first two steps are extra-mental 56. 57. 58. 59. 60. 61. 62. 63. 64. Id. at 1302. In re Abrams, 188 F.2d 165, 167 (C.C.P.A. 1951). Id. at 166. Id. Id. Id. Id. Id. at 166–67. For a discussion of the claims at issue in Abrams, see supra Section II.A.1. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 405 steps that lack novelty, whether taken individually or collectively.65 The PTO identified the last two steps as purely mental steps, and the CCPA seems to have concurred.66 The dispute therefore centered on the third “reducing” and fourth “measuring” steps, which are also clearly extra-mental steps that cannot be performed by a mind alone.67 The patent applicant argued that these steps embodied “differences in procedure over the acknowledged prior art.”68 While apparently conceding the novelty of these steps, the PTO concluded that they did not bring the claim within the bounds of patentable subject matter because “these steps . . . are without significance in the absence of the [mental] calculation steps” in steps five and six.69 Without fully explaining its reasoning, the CCPA agreed with the PTO’s conclusion, noting that “it seems to us that [the claims] are eliminated from the applicability of appellant’s proposed rule 3, 70 and fall within No. 2.” Although it clearly states the basic rules of the mental steps doctrine, Abrams may involve an incorrect application of those rules to the claims at issue. Assuming that the “reducing” and “measuring” steps are novel in relation to the prior art and that the CCPA adopted the PTO’s reasoning, the CCPA’s reasoning in 71 Abrams is unsound. The PTO stated that the advance over the prior art cannot reside in extra-mental steps whose sole utility is the production of data that, in turn, is useful as only an input into a subsequent, unclaimed mental activity.72 This interpretation of the mental steps doctrine is untenable. It would undermine the patentability of a large number of conventionally 65. In re Abrams, 188 F.2d at 167, 169. 66. Id. at 165, 167. But cf. id. at 167–68 (noting that the patent applicant argued the fifth step was not a mental step). 67. Id. at 167–70. 68. Id. at 167. 69. Id. This point is made clearly in Commissioner of Patents’ brief in Abrams: As stated by the Board of Appeals in its decision (R. 40) “the steps defined in the claims on appeal without the mental steps would render the process meaningless.” The sole function served by the manipulative or physical steps in the claims is that of deriving certain numerical data. This data is completely without utility in the absence of mental operations thereon. . . . [The mental steps] consist[ ] of calculating and comparing operations to render the derived figures useful. Brief for the Commissioner of Patents at 4, In re Abrams, 188 F.2d 165 (C.C.P.A. 1951) (No. 5723). 70. In re Abrams, 188 F.2d at 170. 71. It is possible that the CCPA determined that these steps were old in the art, making the applicability of Rule 2 a clear-cut issue. However, the CCPA never rebuts the patent applicant’s argument that these steps represent an advance over the prior art. 72. In re Abrams, 188 F.2d at 167. Do Not Delete 406 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 patentable diagnostic technologies. For example, assume that an inventor invents a chemical that turns blue in the presence of human blood. In addition to a product claim, the inventor may seek a method claim of diagnosing whether a stain is a blood stain comprising applying the chemical to a stain. To the extent that the chemical itself is novel and nonobvious, the method claim should be patentable, too. However, under the PTO’s reasoning in Abrams, the method claim would not be patentable subject matter under the mental steps doctrine. Despite the fact that it recites only extra-mental steps, those steps are “without significance in the absence of the [mental] calculation steps” that translate the blue color into a “diagnosis” that the stain is a blood stain.73 To avoid turning the mental steps doctrine into a radically overbroad exclusion from patentable subject matter, it is important to make a clean distinction between limitations reciting mental steps and limitations reciting extra-mental steps that yield useful factual data. Under a normatively acceptable version of the mental steps doctrine, only the former cannot be considered when assessing whether the claim as a whole contains an advance over the prior art. Assuming that the “reducing” and “measuring” steps are novel in relation to the prior art, the CCPA should have undertaken something akin to a nonobviousness analysis as part 74 of the mental steps doctrine. It should have queried whether the combination of the four extra-mental steps represents enough of an advance over the prior art to be patentable: was the method of sinking a number of boreholes, sealing off the boreholes from the atmosphere, reducing the pressure in the boreholes, and measuring the rate of temperature rise in the boreholes nonobvious? If it was not, then the CCPA reached the correct conclusion (albeit, perhaps, by the wrong route) as Rule 2 of the mental steps doctrine should govern.75 If it was, however, then 76 Rule 3 should govern, as the patent applicant argued that it did. A truncated version of the claimed method in which the mental steps are excised would be a patentable advance over the prior 73. Id. 74. A literal reference to nonobviousness in Abrams would be anachronism. The nonobviousness requirement was first codified in the Patent Act in 1952, the year after Abrams was decided. Patent Act of 1952, Pub. L. No. 593-950, 66 Stat. 792 (codified as amended at 35 U.S.C. § 103 (2006)). However, the nonobviousness requirement roughly codified the pre-1952 judicial interpretation of the Patent Act that mandated more than novelty for an invention to be patentable. Graham v. John Deere Co., 383 U.S. 1, 12–16 (1966). 75. In re Abrams, 188 F.2d at 166. 76. Id. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 407 art, meaning that the mental steps recited in the claim are either superfluous or “incidental parts of the [claimed] process which are essential to [only] define, qualify or limit its scope.”77 When mental steps are appended to an otherwise patentable claim, they merely restrict the scope of that patentable claim, and they do not give the patent applicant any additional increment of 78 undeserved protection. The CCPA never refined the mental steps doctrine to a point where it developed enough precision in its formulation to squarely address the issue, but under the common rules of the nonobviousness doctrine, it would seem that mental steps can be considered in an indirect manner in assessing the 79 Although the mental-step nonobviousness of the claim. limitations cannot be relied upon to distinguish a claim from the prior art, mental processes can be used to demonstrate that the claimed, extra-mental steps produce “unexpected results” and are thus nonobvious.80 To the extent that the Abrams correlation was 81 newly discovered, the novel combination in Abrams of the extra-mental steps—sinking, sealing, reducing and measuring—seems to produce the unexpected result of allowing an oil prospector to locate oil deposits. More broadly, the novel combination of extra-mental steps has value (i.e., generating data that can be used in a mental process) that was not understood before the date of the invention, and the inventor identified that value. The invocation of unexpected results is a common mode of reasoning used to support nonobviousness,82 and there is no reason to conclude that it should not apply to diagnostic claims as well. In sum, the restriction on the patentability of laws of nature articulated in Prometheus Laboratories and the mental steps 77. Id. 78. See Collins, supra note 40, at 331, 335. 79. This is not the only aspect of the mental steps doctrine that remained unclear or unrefined throughout the decades during which the CCPA used the doctrine. See, e.g., infra notes 101–03 and accompanying text. The lack of refinement of the mental steps doctrine by the CCPA in the 1950s and 1960s, however, should not be taken to imply that the doctrine is inherently unclear. 80. See, e.g., In re Huai-Hung Kao, 639 F.3d 1057, 1067–69, 1073–74 (Fed. Cir. 2011) (“On remand, the Board, in considering the evidence of unexpected results, should determine whether there is a nexus between the unexpected [results] and aspects of the claimed invention not already present in the prior art.”). 81. See supra note 38. 82. See Dan L. Burk, The Problem of Process in Biotechnology, 43 HOUS. L. REV. 561, 577 (2006) (“[U]nexpected or surprising results from a known method are a hallmark of nonobviousness.”). Do Not Delete 408 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 doctrine of Abrams both follow the same two-step procedure.83 First, a court identifies a phenomenon that is, standing alone, unpatentable subject matter and extracts it from the claimed subject matter. Where Prometheus Laboratories brackets off laws of nature, Abrams removes mental processes.84 Second, a court examines what remains after the extraction in light of the prior art. If what is left over after the extraction of a law of nature is merely conventional activity, Prometheus Laboratories holds that the claim does not describe patentable subject matter.85 Inversely, if there is an “inventive concept” in the remains, the claim does describe patentable subject matter.86 If what is left over after the extraction of mental processes does not constitute a novel or nonobvious advance over the prior art, Abrams holds that the claim does not describe patentable subject matter.87 Again, inversely, if there is a patentable advance over the prior art in the extra-mental remains of a claimed invention, the claim describes patentable subject matter.88 However, there are two points at which the Prometheus Laboratories and Abrams analyses may diverge in identifying a patentable advance over the prior art. First, it is possible that the two analyses will use different baselines. Prometheus Laboratories references conventional technology, whereas 89 Abrams uses the prior art as the baseline. Over time, the reference to conventional technology may simply come to mean the prior art, but a sui generis definition of conventional technology is also conceivable. Second, it is possible that Prometheus Laboratories and Abrams will employ different standards for determining how much of an advance is needed over this baseline in the remaining, unbracketed portion of the claimed invention to constitute a patentable invention. The mental steps doctrine seems to bootstrap the pre-existing and well-developed novelty and nonobviousness doctrines into the analysis of patentable subject matter.90 It is as of yet unclear 83. Cf. Diamond v. Diehr, 450 U.S. 175, 204 n.22 (1981) (Stevens, J., dissenting) (noting the similarity between the bracket-and-distinguish analysis of Flook and the mental steps doctrine). 84. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1297 (2012); In re Abrams, 188 F.2d 165, 168 (C.C.P.A. 1951). 85. Prometheus Labs., 132 S. Ct. at 1305. 86. Id. at 1294 (quoting Parker v. Flook, 437 U.S. 584, 594 (1978)). 87. In re Abrams, 188 F.2d at 166, 170. 88. Id. at 166. 89. Prometheus Labs., 132 S. Ct. at 1294, 1298; In re Abrams, 188 F.2d at 167–69. 90. But cf. supra text accompanying notes 79–82 (noting that the role of nonobviousness in the mental steps doctrine was never fully clarified). Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 409 whether the bracket-and-distinguish analysis of Prometheus Laboratories also bootstraps in §§ 102 and 103 in this manner, or whether there is a sui generis standard that must be developed to demonstrate an “inventive concept.” Prometheus Laboratories does make several references to the “obvious” nature of the claim (apart from the law of nature), but it is not explicit on this point.91 3. The Substantive Limits on Patentable Subject Matter. The similarity of both the claims and the doctrinal analyses in Prometheus Laboratories and Abrams means that the doctrines announced in the two cases are to some degree redundant in the substantive limits that they place on the reach of patentable subject matter. Prometheus Laboratories and Abrams are likely to reach the same conclusion on the patentability of diagnostic methods that take the form of determine-and-infer claims. In determine-and-infer claims, the unpatentable subject matters that are targeted in Prometheus Laboratories and Abrams are compounded into a single step: the inference step is a mental process that employs a law of nature as a factual premise.92 Therefore, the inference step cannot be used to demonstrate the distinction between a claim and the prior art under either the point-of-novelty analysis of the mental steps doctrine (because it is a mental process) or the bracket-and-distinguish analysis of Prometheus Laboratories (because its novelty resides in the use of a newly discovered law of nature as a factual premise). For this reason, the Prometheus Laboratories claims would be invalid under the mental steps doctrine articulated in Abrams, and the Abrams claims would be invalid under the laws-of-nature doctrine articulated in Prometheus Laboratories.93 Prometheus Laboratories is thus now doing some of the very work that used to be performed by the mental steps doctrine. However, Prometheus Laboratories and the mental steps doctrine are unlikely to be perfect substitutes. They are likely to yield different results in cases not involving claims like the Abrams and Prometheus Laboratories claims with limitations 91. Prometheus Labs., 132 S. Ct. at 1298–99, 1303–04. 92. See supra text accompanying notes 40–43. 93. See Prometheus Labs., 132 S. Ct. at 1294, 1297 (“If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process had additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.”); In re Abrams, 188 F.2d at 166–67 (explaining that any patentable aspect of the claim must “advance over prior art” and that advance must reside “in the physical [rather than the mental] steps set forth in the claims”). Do Not Delete 410 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 that describe mental processes that are enabled by knowledge of a newly discovered law of nature. Many claims to tangible products and methods of using those products are premised on newly discovered laws of nature, but they do not recite mental processes as limitations.94 For example, consider the claim to a combination of naturally occurring bacteria in Funk Brothers 95 Seed Co. v. Kalo Inoculant Co. If the bracket-and-distinguish analysis of Prometheus Laboratories were to govern the Funk Brothers claims, there would be serious questions about whether a claim recites patentable subject matter, but the mental steps doctrine would not place the patentability of the Funk Brothers claims in doubt. Inversely, determine-and-infer claims may build upon knowledge of newly discovered correlations that are social constructs rather than laws of nature. For example, assume an enterprising marketing firm discovers that consumers who use Apple iPhones are more likely to make high-end purchases than consumers who use Android phones. 96 This marketing firm could attempt to patent the two-step diagnostic method of determining whether a customer who walks into a retail store is using an Apple or Android phone and understanding a need to pitch more high-end products to the customer if the customer is using an Apple phone. If Prometheus Laboratories is really about the patentability of laws of nature, then its bracket-and-distinguish analysis would not impact the patentability of this hypothetical claim despite the fact that it follows the determine-and-infer template to the letter. However, the claim would be invalid under the mental steps doctrine. The precise nature of the divergence between Prometheus Laboratories and the mental steps doctrine will, of course, depend on how Prometheus Laboratories is construed in future cases. However, in the area of diagnostic method claims that follow the determine-and-infer template and that employ laws of nature as factual premises, Prometheus Laboratories is more or less a substitute for Abrams. Prometheus Laboratories is now doing much of the very work to limit the reach of the patent regime that used to be done by the mental steps doctrine. 94. See Phillip McGarrigle & Vern Norviel, Laws of Nature and the Business of Biotechnology, 24 SANTA CLARA COMPUTER & HIGH TECH. L.J. 275, 285 (2007). 95. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948). 96. Cf. Dana Mattioli, On Orbitz, Mac Users Steered to Pricier Hotels, WALL ST. J., June 26, 2012, at A1 (noting a correlation between Mac users and people who are likely to purchase more expensive hotel bookings). Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 411 B. Disrupting the Status Quo: The Mental Steps Doctrine Revived Over the last forty years, the CCPA and CAFC have relied on two cases to conclude that the mental steps doctrine is no longer a viable facet of the doctrine of patentable subject matter. Section II.B.1 considers the CCPA’s initial rejection of the mental steps doctrine in In re Musgrave.97 From shortly after the opinion was issued, however, the CCPA’s holding in Musgrave has been recognized as unsound on many levels, and it has not been relied upon to justify the demise of the mental steps doctrine in the long run. Section II.B.2 turns to the real reason why the mental steps doctrine remained unused in the CCPA and CAFC after Musgrave: its point-of-novelty analysis was viewed an impermissible technique for drawing the limits of patentable subject matter. Beginning with Musgrave itself, the CCPA reasoned that the § 101 analysis of patentable subject matter could not be informed by the distinction between any part of a claimed invention and the prior art.98 The Supreme Court seemed to affirm this position with its reasoning in Diamond 99 v. Diehr, and for the last thirty years, the CAFC has justified its rejection of the mental steps doctrine by citing Diehr. However, the Supreme Court’s adoption of the bracket-anddistinguish analysis in Prometheus Laboratories has undermined the authority of the relevant passages from Diehr and has thus removed the only valid, binding precedent that stands in the way of a revitalization of the mental steps doctrine in the CAFC. 1. In re Musgrave. Musgrave was one of a series of cases to reach the CCPA during the late 1960s and early 1970s in which the PTO had relied on the mental steps doctrine to reject claims 100 The claimed invention in to computer-software inventions. Musgrave was a method of correcting seismographic data from an “expanded-spread” of detectors to account for the hyperbolic nature of the wave front being measured.101 The PTO’s argument, derived from its examination guidelines for the patentability of 97. See In re Musgrave, 431 F.2d 882, 889 (C.C.P.A. 1970). 98. Id. at 885–86, 889–90. 99. Diamond v. Diehr, 450 U.S. 175, 187–188 (1981). 100. For discussion of these cases, see Pamela Samuelson, Benson Revisited: The Case Against Patent Protection for Algorithms and Other Computer Program-Related Inventions, 39 EMORY L.J. 1025, 1032–48 (1990). These CCPA opinions were all written before the Supreme Court issued its opinion in Benson and shifted the conceptual frame for the patentable subject matter analysis from mental processes to algorithms. 101. In re Musgrave, 431 F.2d at 884 (emphasis omitted). Do Not Delete 412 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 computer programs, was that software is analogous to a mental process in that the logical operations performed by computers were processes that could also be performed in the human mind.102 The PTO therefore reasoned the mental steps doctrine of Abrams should curtail the extent to which programmed computers were patentable subject matter.103 In the first batch of cases, the CCPA rejected the analogy and reversed the PTO’s rejections of the computer-invention claims.104 It distinguished Abrams and concluded that the mental steps doctrine did not apply to either apparatus claims or method claims limited to machine execution of their steps.105 In Musgrave, the CCPA changed course. It directly undermined the unpatentability of mental processes, holding that even mental processes per se were patentable subject matter and that even Rule 1 of Abrams was not good law.106 The CCPA justified its sweeping holding in Musgrave with three distinct lines of argument. First, the CCPA stated that it “need not be encumbered in [its] reasoning by the ‘Rules’ of Abrams” that had structured the PTO’s opinion below “for the reason that they have never enjoyed the approval of this court.”107 Second, the CCPA noted that the text of § 101 made no mention of mental processes being excluded from patentable subject matter.108 Third, the CCPA implied that the 102. Examination of Patent Applications on Computer Programs: Notice of Issuance of Guidelines, 33 Fed. Reg. 15,609 (Oct. 22, 1968). 103. See In re Musgrave, 431 F.2d at 885–88 (summarizing the Patent Office’s ruling in favor of adopting Rule 2 of Abrams). 104. Samuelson, supra note 100, at 1041–42. 105. See id. at 1046–47. In In re Mahony and In re Bernhart, the CCPA held directly that the mental steps doctrine did not invalidate apparatus claims or process claims that were limited to machine execution. In re Mahony, 421 F.2d 742, 744–747 (C.C.P.A. 1970); In re Bernhart, 417 F.2d 1395, 1399–1401 (C.C.P.A. 1969). In In re Prater, the CCPA upheld apparatus claims but invalidated method claims for overbreadth under Section 112, paragraph 2 because the claims were broad enough to be infringed by either machine or pencil-and-paper performance of the claimed method. In re Prater, 415 F.2d 1393, 1401–06 (C.C.P.A. 1969). The CCPA’s reasoning on the method claims in Prater was a bit odd, and it did not rely on the mental steps doctrine. The patent applicants argued on appeal that their method claims were limited to machine execution of the method, but the claims were broad enough to encompass mental execution when read objectively in light of the specification. The CCPA invalidated the method claims because they reached beyond that which the applicant subjectively regarded as his invention. Id. at 1404–05. In an earlier Prater opinion that was vacated after the grant of a petition for rehearing, the CCPA criticized Abrams at length. In re Prater 415 F.2d 1378, 1381–87 (C.C.P.A. 1968), superseded by 415 F.2d 1393 (C.C.P.A. 1969). 106. In re Musgrave, 431 F.2d at 888–93. As a secondary line of reasoning, Musgrave also included a targeted attack on the point-of-novelty analysis of the mental steps doctrine. Id. at 893. 107. Id. at 889. 108. Id. at 890. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 413 exclusion of mental processes from patentable subject matter was unnecessary because there was another restriction on the reach of patentable subject matter that could do the needed work: the technological arts test.109 “All that is necessary, in our view, to make a sequence of operational steps a statutory ‘process’ within 35 U.S.C. § 101 is that it be in the technological arts so as to be in consonance with the Constitutional purpose to promote the progress of ‘useful arts.’”110 In sum, the CCPA stated: We cannot agree with the [PTO] board that these claims (all the steps of which can be carried out by the disclosed apparatus) are directed to non-statutory processes merely because some or all of the steps therein can also be carried out in or with the aid of the human mind or because it may be necessary for one performing the processes to 111 think. The CCPA’s holding in Musgrave—that mental processes are not a limit on the reach of patentable subject matter—is suspect on many levels. In part, the problems follow from a conflict with the Supreme Court’s subsequent interpretation of § 101. Only two years after Musgrave, Gottschalk v. Benson—the Court’s first in a trilogy of cases addressing the patentability of software inventions—included “mental processes” in its list of exclusions from patentable subject matter.112 Additionally, the technological arts test adopted in Musgrave to replace the mental steps doctrine was short lived. It has never been embraced by the 109. Id. at 893. 110. See id. In keeping with the spirit of the technological arts test, Musgrave conceded that some types of mental processes might not be patentable subject matter. It reasoned that whether mental processes were excluded from patentable subject matter might be contingent on how “mental” is interpreted: “If so construed as to encompass only steps incapable of being performed by a machine or apparatus, it might lead to a correct result. . . . If . . . construed . . . so as to encompass steps performable by apparatus, as well as mentally, then [even] the [first] “Rule” [of Abrams] is unsound . . . .” Id. at 890. Thus, mental steps that described “peculiarly human mental activities” such as aesthetic or moral judgments might not be patentable subject matter, but mental steps that were analytical and deterministic were patentable subject matter. Id. at 889 n.4 (quoting Robert I. Coulter, The Field of the Statutory Useful Arts, Part I, 34 J. PAT. OFF. SOC’Y 417, 426 (1952)). In the alternative, Musgrave also suggested that this restriction on the reach of the patent regime could be accomplished through indefiniteness doctrine rather than patentable subject matter. Id. at 893. 111. Id. 112. Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012); Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 127 (2006) (Breyer, J., dissenting) (dissenting from the dismissal of certiorari as improvidently granted); Parker v. Flook, 437 U.S. 584, 589 (1978). Do Not Delete 414 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 Supreme Court or the CAFC.113 An embrace of Musgrave’s rejection of mental processes as a limit on patentable subject matter is difficult given the ensuing rejection of Musgrave’s embrace of the technological arts test. Interestingly, even the CCPA itself did not seem to accept its own reasoning in Musgrave at face value. In its subsequent opinions, the CCPA recognized that Musgrave had purported to abandon the mental steps doctrine, but taking the posture of an argument in the alternative, the CCPA, continued to analyze claims under the mental steps doctrine nonetheless.114 In part, however, Musgrave is also problematic even when taken on its own terms. For example, the assertion that the CCPA had never sanctioned the mental steps doctrine in Abrams 115 in the first place is highly questionable. The only reason offered in Abrams for rejecting the patent applicant’s claims was that they fell under the appellant’s proposed second rule—i.e., in a claim reciting both mental and extra-mental steps, the distinction between the claim and the prior art required for patentability lies in the mental steps.116 But for the CCPA’s adoption of the first and second rules, Abrams is a conclusory statement of a holding without any supporting rationale at all. The CCPA’s conclusion in Abrams that mental processes are not patentable subject matter could not be stated more explicitly in the opinion: “Citation of authority in support of the principle that claims to mental concepts which constitute the very substance of an alleged invention are not patentable is unnecessary. It is selfevident that thought is not patentable.”117 The Musgrave panel may legitimately have disagreed with this conclusion and thought little of its precedential basis, but it is disingenuous to conclude that Abrams did not hold that mental processes are not 113. In re Bilski, 545 F.3d 943, 960 (Fed. Cir. 2008) (en banc), aff’d on other grounds sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010). 114. In In re Foster, the CCPA does seem to treat the technological arts test as binding. See In re Foster, 438 F.2d 1011, 1014–15 (C.C.P.A. 1971) (holding that it is not important whether a claim contains mental steps or not if it is within the technological arts). However, in its next opinion on computer software in In re Benson, the CCPA was already backtracking. In re Benson, 441 F.2d 682, 686–87 (C.C.P.A. 1971), rev’d sub nom. Gottschalk v. Benson, 409 U.S. 63 (1972). 115. Musgrave oddly relies on an earlier CCPA opinion that had been withdrawn to support its critique of Abrams. In re Musgrave, 431 F.2d at 888–89 (relying on In re Prater, 415 F.2d 1393, 1385–87, superseded by 415 F.2d 1393 (C.C.P.A. 1969)). 116. In re Abrams, 188 F.2d 165, 166, 170 (C.C.P.A. 1951). 117. Id. at 168. This assertion echoes the patent treatises of the day: “[P]atent protection is allowed only to exclude others from exercising their hands, not to exclude them from using their brains.” EMERSON STRINGHAM, OUTLINE OF PATENT LAW AND GUIDE TO DIGESTS § 1210, at 143 (1937). Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 415 patentable.118 Furthermore, a number of CCPA opinions after Abrams relied on one or more of the first two rules articulated in Abrams that establish the exclusion from patentable subject matter, and Musgrave cannot explain these cases away without an en banc opinion.119 Taking a step back, the CCPA’s holding in Musgrave should not bind the CAFC today because the claims at issue in Musgrave presented a poor vehicle for assessing the costs and benefits of the mental steps doctrine. Musgrave was a case about the patentability of computer programs that performed complex 120 The PTO had conscripted the mental steps calculations. doctrine into the fight over the patentability of computer software—a fight that it lost as computer-related and software inventions eventually became routinely patentable.121 However, the mental steps doctrine suffered collateral damage in this fight. Rather than holding more narrowly that the mental steps doctrine did not govern the patentability of machine-executed processes (as it had done in earlier cases), Musgrave rejected the mental steps doctrine in its entirety.122 It threw out the baby (the application of the mental steps doctrine to claims that recite steps that can be performed by the human mind) with the bathwater (the application of the mental steps doctrine to claims that recite the machine execution of operations that are analogous the operations that can be performed by the human mind).123 In deciding Musgrave, the CCPA could not have assessed the impact of its decision on the patentability of claims like the Abrams and Prometheus Laboratories determine-andinfer claims in which the advance over the prior art lies in human, mental reasoning rather than in software. 118. See In re Abrams, 188 F.2d at 166, 169–70 (citing earlier court language that purely mental acts are not proper subject matter for protection under the patent statutes without excluding all mental processes). 119. In re Venner, 262 F.2d 91, 95 (C.C.P.A. 1958); In re Lundberg, 197 F.2d 336, 339 (C.C.P.A. 1952); In re Shao Wen Yuan, 188 F.2d 377, 380–81 (C.C.P.A. 1951). 120. In re Musgrave, 431 F.2d at 882–84. 121. See Randall M. Whitmeyer, A Plea for Due Processes: Defining the Proper Scope of Patent Protection for Computer Software, 85 NW. U. L. REV. 1103, 1105 (1991) (“It is estimated that there are currently ‘thousands’ of program-related United States patents, an increasing number of which cover ‘pure’ software.” (footnotes omitted)). 122. In re Musgrave, 431 F.2d at 889. The PTO construed the Musgrave claims broadly so as to encompass both computer execution and human execution of mathematical steps, and it then rejected the claims under the second rule of Abrams. Id. at 888–89. In previous cases, the CCPA had handled this issue by saying that the mental steps doctrine did not govern method claims limited to machine execution of their steps. See supra note 105. 123. See In re Musgrave, 431 F.2d at 893 (declaring the technological arts test to be the sole test of patentability). Do Not Delete 416 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 2. Diamond v. Diehr. Although Musgrave has never explicitly been overruled, its broad holding—that mental processes per se are patentable subject matter—has had little impact on the development of the doctrine of patentable subject matter over the last forty years. Even in the immediate aftermath of its Musgrave opinion and before Benson, the CCPA was already hedging its bets in its subsequent cases involving 124 It cited Musgrave for the computer-related inventions. proposition that mental processes are patentable subject matter but then offered alternative reasons why the particular claims at issue could not be patented.125 The CAFC has, over the years, invalidated a number of claims on the basis that they are in 126 effect claims to mental processes in the abstract, and it has expressly recognized the infirmity of Musgrave’s broad holding.127 The reason why the mental steps doctrine was not picked up again by the courts after Musgrave was a narrower objection to the doctrine: its point-of-novelty analysis was thought to employ an impermissible methodology for drawing the boundary of 128 patentable subject matter. The crux of this position was that the § 101 analysis of patentable subject matter could not be informed by the distinction between any part of a claimed invention and the prior art.129 Distinction from the prior art was to be assessed under only the separate statutory command of 130 § 102 (novelty) and § 103 (nonobviousness). The roots of this understanding of § 101 can also be traced to Musgrave. In addition to its broad conclusion that Rule 1 of Abrams was not good law, Musgrave reasoned that the second and third rules of Abrams—those that implemented the point-of131 novelty analysis in particular—were “logically unsound.” It reasoned that any given claimed invention should never be patentable subject matter under Rule 3 on an earlier date—when 124. See In re Foster, 438 F.2d 1011, 1014–16 (C.C.P.A. 1971). 125. Id. at 1014–16; In re Benson, 441 F.2d 682, 686–87 (C.C.P.A. 1971), rev’d sub nom. Gottschalk v. Benson, 409 U.S. 63 (1972). 126. See, e.g., In re Comiskey, 554 F.3d 967, 981–82 (Fed. Cir. 2009); In re Grams, 888 F.2d 835, 840–41 (Fed. Cir. 1989). 127. In re Comiskey, 554 F.3d at 978 n.11; see also In re Bilski, 545 F.3d 943, 960 (Fed. Cir. 2008) (en banc) (rejecting the use of the technological arts test set forth in Musgrave), aff’d on other grounds sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010). 128. See Diamond v. Diehr, 450 U.S. 175, 188–91 (1981) (Stevens, J., dissenting) (tracing the history of the mental steps process and the court opinions that discontinued the process). 129. Id. 130. In re Bergy, 596 F.2d 952, 962–63 (C.C.P.A. 1979), aff’d sub nom. Diamond v. Chakrabarty, 447 U.S. 303 (1980). 131. In re Musgrave, 431 F.2d 882, 889–90 (C.C.P.A. 1970). Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 417 the non-mental steps represented an advance over the prior art— and then unpatentable subject matter under Rule 2 on a later date—after the non-mental steps had become conventional.132 In the CCPA’s view, allowing the “identical process” to be “first within and later without the categories of statutory subject matter, depending on such extraneous factors” as the state of the 133 prior art “would be an absurd result.” Parker v. Flook, the Supreme Court’s second case of its trilogy of cases addressing computer-related inventions, seemed to reject the Musgrave position that the distinction between certain limitations of a claim and the prior art was irrelevant to 134 the patentable subject matter analysis. Flook involved a claim to a method of updating an alarm limit using a specified formula.135 The Court employed a variant of the bracket-anddistinguish analysis that animates Prometheus Laboratories in which it identified the formula as a law of nature, treated the formula as part of the prior art, and then looked for something 136 that could distinguish the claimed invention from the prior art. Because the claimed method contained no “patentable invention” or “inventive concept” once the formula was bracketed off from the rest of the claimed subject matter, the Court concluded that the claim did not describe patentable subject matter.137 132. Id. at 889. 133. Id. Why this result would be logically absurd is unclear. It is an even mildly curious result if and only if one fetishizes the claim, equates the claimed subject matter with the invention, and steadfastly refuses to take into account what an inventor has actually given to society in order to merit the claim. See Oskar Liivak, Rescuing the Invention from the Cult of the Claim, 42 SETON HALL L. REV. 1, 6–8 (2012). 134. Parker v. Flook, 437 U.S. 584, 593–94 (1978). 135. Id. at 585. 136. Id. at 592–94. The motivating assumption for treating the law of nature as part of the prior art was that the discovery of a law of nature “reveals a relationship that has always existed.” Id. at 593 n.15. 137. Id. at 594. The bracket-and-distinguish analysis in Flook is a close cousin to, if not identical with, the point-of-novelty analysis of the mental steps doctrine. See supra Section II.A.2. Interestingly, despite the prominence of the mental steps doctrine and its point-of-novelty analysis in the early cases addressing the patentability of computer software under Section 101, see supra note 105, the Supreme Court’s Flook opinion does not mention the mental steps doctrine as a source of support for the bracket-anddistinguish analysis that it uses to enforce Section 101. It cites instead a number of its own precedents on the patentability of laws of nature, including Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). Flook therefore marks a transition from the mental steps doctrine of Abrams to the laws of nature doctrine of Funk Brothers as the principal doctrine for limiting the patentability of computer software under section 101—a doctrinal shift that, oddly, is not accompanied by a significant shift in the substantive limit that distinguishes the software claims that could and could not be patented. The transition, however, was not seamless. The Flook proceedings in the PTO and the CCPA were a gap during which a point of novelty approach was used in a freefloating manner without express reliance on either Abrams or Funk Brothers. The Do Not Delete 418 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 The CCPA was not very receptive of the Supreme Court’s reasoning in Flook, and it stuck to its guns on its refusal to intermingle the analyses of patentable subject matter and 138 patentable distinction from the prior art. In fact, in In re Bergy, the CCPA went out of its way to take the Supreme Court to the woodshed for its Flook analysis.139 Bergy asserted that it is “universally accepted” that novelty and statutory subject matter “are separate and distinct” requirements for patentability that are “wholly apart” from one another.140 It noted that “[t]erms like . . . ‘inventive concept’ no longer have any useful place in deciding questions under the 1952 [Patent] Act” and under § 101 in particular, despite the fact that the Supreme Court had used 141 precisely this term in its reasoning in Flook the year before. In sum, the CCPA asserted that: “Prior art is irrelevant to the determination of statutory subject matter under § 101.”142 In Diamond v. Diehr, the Supreme Court’s final case in its trilogy on the status of software-related inventions as patentable subject matter, the CCPA’s position from Musgrave and Bergy seemed to have prevailed.143 Certain passages in Diehr clearly reject a comingling of the analyses of patentable subject matter and the distinction between a claimed invention and the prior art: “The ‘novelty’ of any element or steps in a process [under § 102], or even of the process itself, is of no relevance in determining whether the examiner and board of appeals at PTO employed a point-of-novelty analysis in rejecting the Flook claims. In re Flook, 559 F.2d 21, 22 (C.C.P.A. 1977), rev’d sub nom. Flook, 437 U.S. at 584. To support this methodology for identifying patentable subject matter, they relied the CCPA’s opinion in In re Christensen. Id. at 22–23 (referencing In re Christensen, 478 F.2d 1392, 1394–95 (C.C.P.A. 1973), overruled by In re Taner, 681 F.2d 787 (C.C.P.A. 1982)). In re Christensen was the first CCPA opinion addressing the patentability of software to issue after the Supreme Court’s decision in Benson. Relying solely on Benson, expressly disavowing any reliance on the mental steps doctrine, and thus writing on something of a blank canvas, Christensen concluded that “a method claim in which the point of novelty is a mathematical equation” was not patentable subject matter. In re Christensen, 478 F.2d at 1394. In its Flook brief before CCPA, the PTO again relied solely on Benson and Christensen to support its rejection. Brief for the Commissioner of Patents and Trademarks at 4–5, In re Flook, 559 F.2d 21 (C.C.P.A. 1977) (No. 77-512). The CCPA distinguished Christensen, rejected the point-of-novelty analysis, and upheld the claims. In re Flook, 559 F.2d at 23. The first mention of Funk Brothers et al. in the Flook proceedings as a source for the bracket-and-distinguish analysis occurred at the eleventh hour in the PTO’s petition for certiorari. Petition for a Writ of Certiorari to the United States Court of Customs and Patent Appeals at 15–20, Parker v. Flook, 437 U.S. 584 (1978) (No. 77-642). 138. In re Bergy, 596 F.2d 952, 959–67 (C.C.P.A. 1979), aff’d sub nom. Diamond v. Chakrabarty, 447 U.S. 303 (1980). 139. Id. at 959–64. 140. Id. at 960–61 (emphasis in original). 141. Id. at 962. 142. Id. at 962–63 (emphasis in original). 143. Diamond v. Diehr, 450 U.S. 175, 188–89 (1981). Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 419 subject matter of a claim falls within the [§ ] 101 categories of possibly patentable subject matter.”144 Other passages preclude a point-of-novelty analysis insofar as they require examination of claims “as a whole” and forbid “dissect[ing] the claims into old and new elements and then . . . ignor[ing] the presence of the old elements in the analysis.”145 These passages on their face seem to reject both the bracket-and-distinguish analysis of Flook and the point-of-novelty analysis of the mental steps doctrine.146 For the last thirty years, the CAFC has grounded its refusal to employ the mental steps doctrine on its interpretation of Diehr 147 rather than its interpretation of Musgrave. The CAFC has invalidated claims that recite both mental and extra-mental steps for lack of patentable subject matter on the basis that, viewed as a whole, they in effect claimed mental processes because the extra-mental steps were merely data-gathering steps.148 In so doing, however, it has never expressly relied on the novelty, conventionality, or prior-art status of the extra-mental 149 steps to justify its holding. Musgrave may have been the immediate cause of the CAFC’s initial abandonment of the mental steps doctrine, but, in the long term, it was Diehr that was responsible for the doctrine’s continued disuse. Prometheus Laboratories changes the outlook for the future of the mental steps doctrine. Prometheus Laboratories does not openly acknowledge that it is contradicting or overruling any aspect of Diehr, but it does severely undermine the very passages from Diehr upon which the CAFC has relied in its refusal to 150 reconsider the mental steps doctrine. It draws heavily from Flook to explain the bracket-and-distinguish analysis that is 151 difficult to square with this language from Diehr. It dissects the claim into a newly discovered law of nature and the remainder of 144. Id. 145. Id. at 188. 146. See id. at 195–201 (Stevens, J., dissenting). 147. For a recent en banc opinion affirming this interpretation of Diehr, see In re Bilski, 545 F.3d 943, 958 (Fed. Cir. 2008) (en banc), aff’d on other grounds sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010). 148. See supra note 126. 149. See In re Bilski, 545 F.3d at 958. 150. Compare Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1297 (2012) (dissecting the claim into a newly discovered law of nature and three steps, then concluding that such steps are unpatentable due to their lack of novelty), with Diehr, 450 U.S. at 188–89 (“The ‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the [Section] 101 categories of possibly patentable subject matter.”). 151. See supra text accompanying notes 135–146 (describing the conflict between Flook and Diehr). Do Not Delete 420 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 the claim, and compares the remaining steps to the prior art, concluding that the claim is not patentable subject matter because the remaining steps lack novelty.152 It fails to cite the language from Diehr prohibiting the dissection of a claim into components and the comparison of a subset of the components to the prior art.153 It expressly notes that there may be redundancy between the novelty and statutory subject matter inquiries: “We recognize that, in evaluating the significance of additional steps, the [§ ] 101 patent-eligibility inquiry and, say, the [§ ] 102 novelty 154 inquiry might sometimes overlap.” Prometheus Laboratories also reinterprets the holding in Diehr in a manner that makes it consistent with the bracket-and-distinguish analysis that the Court employed in Flook. Emphasizing a point on which Diehr was silent, Prometheus Laboratories suggests the claim at issue in Diehr described patentable subject matter because Diehr “nowhere suggested that all these steps [other than the law of nature], or at least the combination of those steps, were in context obvious, already in use, or purely conventional.”155 In sum, given its elevation of Flook and its concomitant demotion of Diehr, Prometheus Laboratories severely undercuts the precedent upon which the CAFC has relied for the last thirty years in its refusal to employ the mental steps doctrine. The CAFC now has no valid justification for refusing to revitalize the mental steps doctrine. III. PROMETHEUS LABORATORIES AND THE CONTEMPORARY PRINTED MATTER DOCTRINE This Part draws connections between Prometheus Laboratories and the printed matter doctrine of the CAFC. Section III.A identifies the contemporary core of the printed matter doctrine. Section III.B argues that Prometheus Laboratories dovetails with the contemporary core of printed matter doctrine, creating a complementary restriction on the reach of the patent regime. Working together, Prometheus Laboratories and the printed matter doctrine prevent the discovery of a law of nature from being an event that, in and of itself, triggers the availability of patent protection. Section III.C 152. See supra Section II.A.2 (describing the bracket-and-distinguish analysis of Prometheus Laboratories). 153. But cf. Prometheus Labs., 132 S. Ct. at 1304 (citing the “as a whole” language from Diehr to support a description of the Sections 102 and 103 analyses of a claim in relation to the prior art). 154. Id. 155. Id. at 1299. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 421 discusses the shift in perspective that is needed to see Prometheus Laboratories as a continuation, rather than a disruption, of the pre-Prometheus status quo in the CAFC. The statutory distinction between the grounding of the doctrine of patentable subject matter (and thus both Prometheus Laboratories and the mental steps doctrine) in § 101 and the grounding of the contemporary core of the printed matter doctrine in §§ 102 and 103 must be recognized as arbitrary and without significance. A. The Contemporary Core of the Printed Matter Doctrine The printed matter doctrine curtails the patentability of information that is intelligible or meaningful to the human mind.156 More precisely, it uses a point-of-novelty analysis to invalidate patent claims in which a limitation specifying the “content” of information must be considered in order to demonstrate a novel and nonobvious advance over the prior art under §§ 102 and 103 of the Patent Act, respectively.157 The printed matter doctrine has a long history that reaches back into patent opinions from the early twentieth century,158 and it has evolved significantly during this time.159 All printed matter 156. If the information has not been recorded on a tangible substrate, then it is not patentable subject matter without any reference to the printed matter doctrine. In re Nuijten, 500 F.3d 1346, 1353 (Fed. Cir. 2007) (invalidating “signal” claims under Section 101). 157. In re Gulack, 703 F.2d 1381, 1386 (Fed. Cir. 1983); CHISUM, supra note 14, § 1.02[4][e], at 1–36 (equating “printed matter” with “informational content” in the CAFC’s application of the printed matter doctrine). Some printed matter cases are decided under the auspices of the patentable subject matter doctrine of Section 101. See generally infra Section III.C (discussing the arbitrariness of the statutory divide between Section 101, on the one hand, and Sections 102 and 103, on the other hand, in printed matter cases). 158. For a historical overview, see generally Morton C. Jacobs, Patentability of Printed Matter: Critique and Proposal, 18 GEO. WASH. L. REV. 475 (1950). 159. For example, some early printed matter cases state that the advance over the prior art cannot reside in an “arrangement of printed matter” rather than in the “content” of printed matter. See, e.g., In re Lockert, 65 F.2d 159, 160 (C.C.P.A. 1933); In re Russell, 48 F.2d 668, 669 (C.C.P.A. 1931); Flood v. Coe, 31 F. Supp. 348, 349 (D.D.C. 1940). For a case in which the doctrine’s focus expands from arrangements of printed matter to also encompass the content of printed matter, see In re Sterling, 70 F.2d 910, 912 (C.C.P.A. 1934) (noting that the printed matter doctrine had previously governed “arrangement of printed matter” and that it should also logically govern “the substance of language of that which is printed”). A rule that prohibits novelty from residing entirely in the arrangement of printed matter may in some instances create a broader exclusion from the patent regime than a rule that prohibits novelty in the informational content of printed matter. See Kevin Emerson Collins, Semiotics 101: Taking the Printed Matter Doctrine Seriously, 85 IND. L.J. 1379, 1424–27 (2010) (discussing the patentability of a new system of indexing printed matter with old contents). Do Not Delete 422 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 opinions therefore cannot easily be reconciled.160 Taking a reductionist approach, this Article examines only what it identifies as the coherent, contemporary core of the CAFC’s printed matter cases. It considers only printed matter cases in which claims describe a combination of already-known objects or processes, and information that conveys newly discovered knowledge to human minds.161 Two recent CAFC cases applying the printed matter doctrine nicely illustrate the coherent core of the contemporary printed 162 163 matter doctrine: In re Ngai and King Pharmaceuticals. In Ngai, an inventor had discovered a new use for an existing set of chemicals, and he had sought a “kit” claim to the prior-art group of chemicals in combination with written instructions on how to use the chemicals in the new manner.164 The CAFC relied on the printed matter doctrine to invalidate the claim for lack of novelty.165 Only the content of the information conveyed by the printed matter to a human reader distinguished the claim from the prior art as a factual matter, and any advance in the content of this printed matter could not be considered in assessing whether the claim described a novel invention under § 102.166 In King Pharmaceuticals, the CAFC extended the printed matter doctrine from product claims to method claims and from the content of printed matter to the content of spoken matter.167 The patents at issue arose from “the unexpected finding that administration of metaxalone”—a known drug—“with food increases both the rate and extent of absorption via the oral dosage form in human 168 subjects.” One family of claims described a two-step method of, first, “administering” metaxalone to patients with food and, second, letting the patient know about the increase in bioavailability of 160. Some printed matter cases are not easily generalized because the claims involved are downright quirky. See, e.g., In re Jie Xiao, 462 F. App’x 947, 951 (Fed. Cir. 2011) (rejecting claims to combination locks employing meaningless wildcard symbols); In re Miller, 418 F.2d 1392, 1396 (C.C.P.A. 1969) (assessing the patentability of measuring cups with false quantity indications printed on them). 161. For an extended discussion of the restriction of the printed matter doctrine to information that is intelligible to the human mind, see Collins, supra note 159, at 1417– 31. See also In re Lowry, 32 F.3d 1579, 1583 (Fed. Cir. 1994) (quoting In re Bernhart, 417 F.2d 1395, 1399 (C.C.P.A. 1969)); In re Jones, 373 F.2d 1007, 1012–14 (C.C.P.A. 1967) (holding “code disks” patentable under the printed matter doctrine because they are cogs in a machine, not human-readable texts). 162. In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004). 163. King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1278–80 (Fed. Cir. 2010). 164. In re Ngai, 367 F.3d at 1337–38. 165. Id. at 1339. 166. Id. 167. King Pharm., 616 F.3d at 1278–79. 168. Id. at 1270. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 423 metaxalone that occurs when the drug is consumed with food.169 Some claims in this family described a method of informing the patient in which “the metaxalone is from a container with printed labeling advising” of the increased bioavailability, and others more broadly described the step of “informing” the patient of the increased bioavailability.170 The CAFC invalidated these claims under the printed matter doctrine of § 102 and its point-of-novelty analysis.171 Despite the fact that the informing steps were novel as a factual matter, the court held that “[t]he ‘informing’ limitation adds no novelty to the method” as a legal matter because § 102 novelty cannot reside in the content of information, i.e., the meaning that the information has to a human mind.172 Given that the remainder of the claim (i.e., the step of administering of metaxalone to a patient with food) was anticipated by the prior art under the inherency doctrine, the claim was anticipated and invalid.173 The printed matter doctrine has a misleadingly narrow name in that it restricts the patentability of all humanintelligible information, regardless of whether the information is printed matter. The printed matter doctrine is technologically neutral, meaning that it curtails the patentability of all information that is intelligible to only a human mind, including information in the form of audio tapes,174 e-books,175 and (as in King Pharmaceuticals) speech.176 The mental steps and printed matter doctrines are close cousins on a doctrinal level because they employ the same pointof-novelty analysis.177 The point-of-novelty analysis in the printed matter doctrine predates both Abrams and its three rules of the 169. Id. at 1270–71. Another family of claims described one-step methods of “administering” metaxalone to patients with food and thereby increasing the drug’s bioavailability. Id. The CAFC invalidated the one-step methods under the inherency doctrine because they were anticipated by the prior art. Id. at 1275–77. 170. Id. at 1271. 171. Id. at 1279–80. 172. Id. at 1278. 173. Id. at 1276. For another recent case that uses the printed matter doctrine to invalidate claims following the template of the King Pharmaceuticals claims, see In re Huai-Hung Kao, 639 F.3d 1057, 1072–73 (Fed. Cir. 2011). See also In re J-Med Pharm., Inc., 471 F. App’x 900, 900 (Fed. Cir. 2012) (issuing a summary affirmance of the PTO’s rejection of claims to a combination of decongestants and administration instructions); AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1063–65 (Fed. Cir. 2010) (affirming the PTO’s rejection of claims to a combination of a corticosteroid and administration instructions). 174. Ex parte Carver, 227 U.S.P.Q. (BNA) 465, 467 (B.P.A.I. 1985). 175. See infra note 193. 176. King Pharm., 616 F.3d at 1278. 177. In re Gulack, 703 F.2d 1381, 1385 & n.8 (Fed. Cir. 1983) (printed matter); In re Abrams, 188 F.2d 165, 166 (C.C.P.A. 1951) (mental steps). Do Not Delete 424 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 mental steps doctrine.178 Nonetheless, the PTO has used Abrams to clarify the printed matter doctrine, stating that “the second and third rules mentioned in In re Abrams . . . are equally applicable to printed matter as they are to mental steps, since both are nonstatutory.”179 The printed matter doctrine now mirrors Abrams’s three rules. First, if a claim provides only printed-matter limitations, the claim does not describe patentable subject matter.180 Second, if a claim describes both conventionally patentable subject matter and printed-matter limitations and the latter are needed to demonstrate the novelty or nonobviousness of the claimed subject matter, the claim is not a patentable advance over the prior art because the content of 181 the printed matter cannot be given “patentable weight.” Third, if a claim describes both conventionally patentable subject matter and printed-matter limitations and the former is sufficient to demonstrate novelty and nonobviousness, the claim is patentable.182 In fact, the second and third rules first articulated in Abrams have arguably reached a greater refinement in the printed matter doctrine than they did in the mental steps doctrine. The role of nonobviousness in rules two and three has been explored in significant depth in printed matter cases (through the “patentable weight” analysis in nonobviousness cases),183 but it was never addressed in a mental steps case.184 An important historical exception to the restriction on patentability set forth in the printed matter doctrine is the cooperative-relation exception. If the printed matter has a cooperative relationship with the underlying substrate, then the content of printed matter can be considered in assessing whether the invention presented a patentable advance over the prior art.185 Older cases elaborating the cooperative-relation exception often involved a structural relationship between the printed matter and 178. In re Sterling, 70 F.2d 910, 912 (C.C.P.A. 1934). Cf. supra Section II.A.2 (discussing the three rules of Abrams). 179. Ex parte Jenny, 130 U.S.P.Q. (BNA) 318, 320 (P.O.B.A. 1961). CCPA approved of the PTO’s reasoning in In re Jones, 373 F.2d 1007, 1013–14 (C.C.P.A.1967). 180. This is the gist of the cases in which the printed matter doctrine is applied as a facet of Section 101. See infra notes 218–19 and accompanying text. 181. In re Miller, 418 F.2d 1392, 1396 (C.C.P.A. 1969). But see infra text accompanying notes 185–203 (discussing the cooperative-relation exception to the printed matter doctrine). 182. Jenny, 130 U.S.P.Q. at 320. 183. See infra notes 181–82 and accompanying text. 184. See supra text accompanying notes 74–82. 185. See Jacobs, supra note 158, at 477–78. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 425 the substrate.186 For example, many of the printed matter cases from the first half of the twentieth century involved claims to tickets of various kinds.187 The formal arrangement of the information on these tickets allowed the tickets to be torn or punched in ways that were not previously possible, allowing tickettakers to divide up or obliterate the bits of information on the 188 tickets more easily than was possible in the prior art. Despite the fact that these claims described printed matter at their points of novelty, the courts often upheld these claims because the advance over the prior art resided in the “cooperative relationship between the printed indicia and the structural features” of the tickets.189 In more recent cases, the structural-relation exception to the printed matter doctrine has evolved into a functional-relation exception: so long as the content of the printed matter has a functional relationship to the underlying substrate, that content can be considered in assessing the novelty and nonobviousness of the invention. Thus, the informational content of human-readable printed matter could be considered to assess patentability in claims to sets of measuring spoons with false textual indications of the size of the spoon that facilitated the preparation of half- or doublerecipes.190 Similarly, a claim to a circular band imprinted with a looping series of numbers that had no beginning or end could rely on the numbers to create a distinction from the prior art because the looping nature of the substrate (the band) and the numbers 191 displayed a functional relationship. Although it has played an important role in many historical printed matter cases, the cooperative-relation exception has not played a significant role in limiting the reach of the printed matter doctrine in the cases at the doctrine’s contemporary 192 core. When claims have limitations that describe information that has newly discovered knowledge as its contents (as opposed to limitations that describe a new manner of conveying information that has already-known knowledge as its contents), patent owners’ arguments that the cooperative-relation exception 186. See, e.g., Flood v. Coe, 31 F. Supp. 348, 349 (D.D.C. 1940). 187. Collins, supra note 159, at 1393–94 (describing the ticket-tearing cases). 188. Flood, 31 F. Supp. at 348–49. 189. Id. at 349; see also Jacobs, supra note 158, at 485 (“[I]f the meaning of the language is of no significance, and the novelty lies in the useful manner of arranging the printed matter on a sheet, it is a manufacture.”). 190. In re Miller, 418 F.2d 1392, 1395–96 (C.C.P.A. 1969). 191. In re Gulack, 703 F.2d 1381, 1386 (Fed. Cir. 1983). 192. See King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010) (rejecting the argument that the relationship between the informing limitation and the method was functional). Do Not Delete 426 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 should preserve the validity of their claims have never carried the day.193 In King Pharmaceuticals, the patent owner argued that there was a functional relationship between the content of the information conveyed to the patient and the administering of metaxalone to a patient because “the ‘informing’ limitation increases the likelihood that the patient will take metaxalone 194 with food, thereby increasing the efficiency of the method.” The CAFC rejected this argument, holding that the printed matter doctrine precluded the content of the oral or written information from being considered when assessing the legal novelty of the claim under § 102.195 A yet more recent CAFC case on the printed matter doctrine, AstraZeneca LP v. Apotex, Inc., adds another twist to the cooperative-relation argument made in King Pharmaceuticals.196 Like King Pharmaceuticals, AstraZeneca involved a claim to a combination of an already-known drug and printed instructions conveying knowledge about how to use the drug in a more effective manner.197 However, in AstraZeneca, the drug could not be legally sold without the claimed printed matter because the FDA approved the drug for sale on the condition that the printed matter appeared on the label.198 Invoking the functionalrelation exception, the patent owner argued that the drug-plus-label claim was valid under the printed matter doctrine because the claimed combination “is a new and useful patentable kit that did not exist in the prior art—‘a nebulized budesonide product that can be [legally sold and] safely and effectively administered oncedaily.’”199 The CAFC rejected this argument, concluding that the informational content of the printed matter could not establish the 193. The one exception is the PTO’s policy for dealing with software-on-disk claims or Beauregard claims. The PTO rejects claims to songs or e-books encoded on computer disks as “nonfunctional descriptive material” but it allows claims to most software programs encoded on disks by labeling the software as “functional descriptive material.” Examination Guidelines for Computer-Related Inventions, 61 Fed. Reg. 7478, 7481 (Feb. 28, 1996). Through this policy, the PTO is arguably reaching the correct final result on patentability. However, this outcome cannot be explained in a conceptually coherent manner with the cooperative-relation exception. Rather, the outcome should be explained by the fact that software-on-disk claims do not encode information that is intelligible to only the human mind. The distinction the PTO is attempting to make is a distinction between human-readable information, on the one hand, and information in the form of stimuli or signals encoded that causes a machine to act in a pre-determined manner, on the other hand. Collins, supra note 159, at 1421–24. 194. King Pharm., 616 F.3d at 1279. 195. Id. The CAFC also considered and rejected the same functional-relation argument in In re Huai-Hung Kao, 639 F.3d 1057, 1072–73 (Fed. Cir. 2011). 196. AstraZeneca LP v. Apotex, Inc., 623 F. Supp. 2d 579, 590–91 (D.N.J. 2009), aff’d, 633 F.3d 1042 (Fed. Cir. 2010). 197. Id. at 584. 198. Id. at 590–91. 199. Id. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 427 legal novelty of the claimed combination despite the existence of this functional relationship between the drug and the content of the printed matter.200 In sum, the CAFC has been very stingy with the cooperative-relation exception to the printed matter doctrine when a claim describes an old product or method in combination with information that has newly discovered knowledge about how to use the product as its content. As the CAFC has noted, if it were to adopt a broader interpretation of the cooperative-relation exception, then “anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.”201 Almost thirty years ago, one commentator extrapolated from the existence of the functional-relation exception to the printed matter doctrine and predicted that patent applicants would pursue claims like the Ngai, King Pharmaceuticals, and AstraZeneca claims that describe a combination of an old product plus new instructions on how to use the product.202 He understood that patent applicants would defend the nonobviousness of such claims by alleging a functional relationship between the “intellectual content of the imprinted matter” and “the particular substrate on which it is imprinted”: Instructions for carving a turkey could be etched on the blade (or handle) of a knife. Instructions for throwing a curve (or spitter) could be printed on the cover of a baseball, and pharmacists could print the doctor’s instructions on the 203 surface of tablets and pills . . . . As the cases discussed above demonstrate, however, this argument has not to date been palatable to the CAFC, and the cooperative-relation exception has not played an important role in limiting the core of the contemporary printed matter doctrine. The CAFC has not allowed the functional-relation exception to preserve the patentability of claims to combinations of old objects and human-readable information that conveys the knowledge required to engage in new methods of using those objects. B. Complementary Exclusions The relationship between Prometheus Laboratories and the mental steps doctrine was one of (partial) redundancy: either facet of patent law could be called upon to invalidate the Prometheus Laboratories claims and other determine-and-infer 200. 201. 202. 203. Id. at 591. In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004). Alton D. Rollins, Printed Matter, 65 J. PAT. OFF. SOC’Y 467, 469–70 (1983). Id. at 470. Do Not Delete 428 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 claims in which a mental act of reasoning employs a newly discovered law of nature as a premise.204 The relationship between Prometheus Laboratories and the printed matter doctrine is different. The printed matter doctrine cannot do the work that Prometheus Laboratories does. The core of the CAFC’s contemporary printed matter doctrine would not invalidate the Prometheus Laboratories claims because those claims do not have limitations describing the informational contents of texts, speech, or diagrams.205 Rather, Prometheus Laboratories complements or dovetails the printed matter doctrine. Each of the two doctrines invalidates a distinct set of claims, but they work together to effectuate a unified policy goal: they prevent the discovery of a law of nature from ever being patentable, in and of itself. The printed matter doctrine is not targeted specifically at 206 laws of nature. It invalidates claims with limitations that describe the contents of human-readable information even if those contents are not a law of nature.207 Yet, many of the cases at the contemporary core of the printed matter doctrine do involve laws of nature. For example, the King Pharmaceuticals claims are premised on a newly discovered correlation that mirrors the correlation at issue in Prometheus Laboratories. In Prometheus Laboratories, the newly discovered law of nature was the correlation between (1) a patient who is taking a thiopurine drug having a metabolite level above a certain threshold and (2) the patient having an increased likelihood of suffering adverse side effects from the thiopurine drug.208 In King Pharmaceuticals, the newly discovered correlation was between (1) a patient who is taking metaxalone having ingested the drug with food and (2) the patient enjoying greater bioavailability of 209 the metaxalone. Given that the Prometheus Laboratories correlation is a law of nature, it is difficult to understand how the 204. See supra Section II.A.3 (describing the substantive redundancy of Prometheus Laboratories and the mental steps doctrine in the area of medical diagnostics). 205. For a discussion of the claims at issue in Prometheus Laboratories, see supra Section II.A.1. 206. See Collins, supra note 159, at 1380 (defining the printed matter doctrine as one that governs “information recorded in [a] substrate or medium” which reaches claims such as those involving printed matter describing new uses for old machines (quoting CHISUM, supra note 14, § 1.02[4], at 1–25)). 207. See, e.g., In re Jie Xiao, 462 F. App’x 947, 951 (Fed. Cir. 2011) (rejecting claims to combination locks employing meaningless wildcard symbols). The irrelevance of whether informational content is a law of nature under the printed matter doctrine parallels the irrelevance of whether a mental process is enabled by a law of nature under the mental steps doctrine. See supra text accompanying note 96. 208. See supra text accompanying notes 20–25. 209. See supra text accompanying note 168. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 429 King Pharmaceuticals correlation could not be a law of nature, too.210 King Pharmaceuticals and Prometheus Laboratories enforce complementary limits on the reach of patent protection. Each excludes a different type of claim in which the discovery of a law of nature masquerades as a patentable invention. The discovery of a law of nature is nothing more than the creation of a new type of previously nonexistent factual knowledge about the world. Factual knowledge per se, in turn, exists in two forms: it exists as mental states within human minds and as extra-mental 211 information that is meaningful to human minds. To prevent the raw factual knowledge that constitutes the discovery of a law of nature from itself being a patentable entity, a two-pronged restriction on patent protection is needed. The printed matter doctrine uses a point-of-novelty analysis to restrict the patentability the extra-mental information that conveys or disseminates a newly discovered law of nature. For example, in King Pharmaceuticals, the “informing” step describes the extramental codification of information (a label) or speech act that is needed to transmit knowledge from one mind to another. Prometheus Laboratories then picks up where the printed matter doctrine leaves off. It uses the bracket-and-distinguish analysis to restrict the patentability of the form of factual knowledge of a law of nature that exists within human minds. If it is simply the mental comprehension of a newly discovered law of nature that distinguishes a claimed process from the prior art, Prometheus Laboratories holds that the process is not patentable subject matter.212 Because the bracket-and-distinguish analysis of Prometheus Laboratories mirrors the point-of-novelty analysis of the printed 213 matter doctrine, Prometheus Laboratories meshes seamlessly with the core of the CAFC’s contemporary printed matter 210. Other cases at the core of the contemporary printed matter doctrine also involve information with factual content that is readily classified as a law of nature. See, e.g., In re Huai-Hung Kao, 639 F.3d 1057, 1072–73 (Fed. Cir. 2011); AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1063–65 (Fed. Cir. 2010); In re Ngai, 367 F.3d 1336, 1337–38 (Fed. Cir. 2004). 211. Cf. JAEGWON KIM, PHILOSOPHY OF MIND 25 (2d ed. 2006) (describing the philosophical understanding of human knowledge); ROBERT CUMMINS, MEANING AND MENTAL REPRESENTATION 2 (1989) (discussing the process of understanding extra-mental representations). 212. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1297 (2012); supra text accompanying notes 49–56. 213. See supra Section II.A.2 (illustrating the parallel between the bracket-anddistinguish analysis of Prometheus and the point-of-novelty analysis of the mental steps doctrine). Do Not Delete 430 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 doctrine to achieve a single policy goal. The discovery of a law of nature cannot, in and of itself, yield a patentable invention because factual knowledge per se cannot differentiate a claim from the prior art, regardless of whether the factual knowledge exists as a mental state of comprehension or as the contents an extra-mental codification of information that is meaningful to a human mind. C. Continuity with the Status Quo: Erasing the Arbitrary Statutory Divide One reason why the complementarity of Prometheus Laboratories and the contemporary core of the CAFC’s printed matter doctrine has to date been overlooked is that the two facets of patent law are conventionally understood to be grounded in different statutory provisions of the Patent Act.214 Prometheus Laboratories is a § 101 case that limits the reach of patentable subject matter, whereas the contemporary core of the printed matter doctrine is grounded in both the novelty provision of § 102 215 and the closely allied nonobviousness provision of § 103. This statutory divide, however, is arbitrary.216 The conventional classification system within patent law that separates Prometheus Laboratories and the printed matter doctrine into hermetically sealed boxes needs to be reconsidered. The arbitrariness of the statutory divide is evident within the printed matter doctrine itself because, beyond the doctrine’s contemporary core, there is an internal split in its own statutory 217 grounding. Two different types of printed matter cases are associated with two different statutes in the Patent Act, despite the fact that the two types of cases use identical reasoning. When 214. Another reason is that the Supreme Court precedent suggests that the laws-ofnature exclusion is in part about preventing the privatization of something “that has always existed” rather than something that was invented by mankind. See Parker v. Flook 437 U.S. 584, 593 n.15 (1978) (“The underlying notion [behind the prohibition on patenting a law of nature] is that [a law of nature] reveals a relationship that has always existed.”). In contrast, the labels and speech at issue in printed matter cases are clearly artifacts of human ingenuity, and the printed matter doctrine governs informational content about both natural and man-made systems. 215. See Prometheus Labs., 132 S. Ct. at 1293–94 (explaining that Section 101 of the Patent Act is the basic principle against which the claim is to be measured); Collins, supra note 159, at 1402–03 (noting that printed matter claims “are analyzed under either the novelty provisions in section 102 or the nonobviousness provisions in section 103”). 216. Neither the exclusion of laws of nature from patentable subject matter nor the printed matter doctrine is codified in the express language of the Patent Act. Both are creatures of judicial interpretation. See 35 U.S.C. §§ 101, 102, 103 (2006). 217. Andrew Chin, Gene Probes as Unpatentable Printed Material, 20 FED. CIR. B.J. 527, 532–33 (2010–2011). Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 431 brought to bear on claims to printed matter per se in many older cases, the printed matter doctrine is classified as a facet of the § 101 doctrine of patentable subject matter.218 For example, although they have physical materiality, books are not within the statutory meaning of “manufactures” in § 101.219 In the core of its contemporary applications, however, the printed matter doctrine has been used to scrutinize the patentability of claims to traditionally patentable objects and methods that include printed-matter limitations.220 In these cases, the claim is presumed to describe patentable subject matter, and the limit on the reach of patent protection attributable to the printed matter doctrine is categorized as part of either the novelty provision of 221 § 102 or the nonobviousness provision of § 103. Here, the pointof-novelty analysis means that the content of the printed matter cannot be considered when determining whether a claimed invention constitutes a patentable advance over the prior art. The newness of the instructions may make the claimed subject matter, taken as a whole, new as a purely factual matter, but the claimed subject matter is not novel as a legal matter because the advance over the prior art resides solely in the content of the printed matter. The statutory division of the printed matter doctrine between § 101, on the one hand, and §§ 102 and 103, on the other, has deep historical roots, but it does not affect the substance of the analysis.222 The printed matter doctrine draws the same boundary around the inventions that can be patented in both its § 101 applications and its §§ 102 and 103 applications. The § 101 cases simply apply the general printed-matter rule when the only limitation on the scope of a claim is the content of the printed matter: the advance over the prior art, if it exists, must by definition reside in the content of the printed matter, and the claim is per se invalid. 218. Id. at 532. 219. CHISUM, supra note 14, § 1.02[4], at 1–24 (“Under traditional doctrine, ‘printed matter’ by itself did not constitute a ‘manufacture’ . . . .”); cf. In re Chatfield, 545 F.2d 152, 157 (C.C.P.A. 1976) (“Some inventions, however meritorious, do not constitute patentable subject matter, e.g., printed matter . . . .”). The PTO’s distinction between functional and nonfunctional descriptive material in Beauregard claims illustrates a contemporary use of the printed matter doctrine as a facet of the Section 101 doctrine of patentable subject matter. See supra note 193. 220. See supra Section III.A (identifying the core of the contemporary printed matter doctrine in CAFC cases). 221. See, e.g., In re Ngai, 367 F.3d 1336, 1338–39 (Fed. Cir. 2004) (novelty); In re Gulack, 703 F.2d 1381, 1385, 1386 (Fed. Cir. 1983) (nonobviousness). 222. See In re Sterling, 70 F.2d 910, 912 (C.C.P.A. 1934) (using the same reasoning to affirm printed-matter rejections based both on a lack of novelty and on an absence of patentable subject matter). Do Not Delete 432 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 The arbitrariness of the statutory divide can also be seen in a juxtaposition of the proceedings in King Pharmaceuticals and Prometheus Laboratories. In both proceedings, the courts considered arguments that the case should be decided under the other statutory provision. The district court in King Pharmaceuticals invalidated the “informing” claims for lack of patentable subject matter under § 101, relying on the bracket-and-distinguish analysis of Flook to support its conclusion: “[T]he discovery of . . . a phenomenon [of nature] cannot support a patent [under § 101] unless there is 223 some other inventive concept in its application.” The CAFC reversed the district court on this doctrinal point, holding that the Supreme Court has mandated “a [§ ] 101 patentability analysis [that] is directed to the claim as a whole, not individual 224 limitations.” However, the CAFC upheld the district court’s judgment of invalidity by invoking the printed matter doctrine and applying it as part of the novelty analysis of § 102.225 Not only did King Pharmaceuticals start out as a § 101 case in the district court and end up as a § 102 case in the CAFC, it may be that the return leg of a round trip lies in the near future. After Prometheus Laboratories and its elevation of Flook over Diehr, it is unclear that the CAFC’s rejection of the district court’s classification of the invalidity determination as a § 101 issue is correct. The district court’s argument may someday carry the day, and King Pharmaceuticals may present a § 101 issue.226 Inversely, the Solicitor General’s amicus brief in Prometheus Laboratories extrapolated from King Pharmaceuticals and urged the Court to view the case as raising a § 102 issue of novelty and inherency rather than as a § 101 issue of patentable subject 223. King Pharm., Inc. v. Eon Labs, Inc., 593 F. Supp. 2d 501, 512 (E.D.N.Y. 2009) (quoting Parker v. Flook, 437 U.S. 584, 594 (1978) (first and second alterations in original)), aff’d on other grounds, 616 F.3d 1267 (Fed. Cir. 2010). 224. King Pharm., 616 F.3d at 1277. Technically, the CAFC cited Flook, not Diehr, to support the “claim as a whole” approach to Section 101. Id. However, this interpretation of Flook is highly influenced by the Court’s subsequent opinion in Diehr. See supra text accompanying notes 147–49 (discussing the CAFC’s interpretation of Diehr before Prometheus Laboratories). Furthermore, the CAFC also cited its own decision in In re Bilski to support its “claim as a whole” principle. King Pharm., 616 F.3d at 1277. The cited passage of In re Bilski, in turn, relies on Diehr, not Flook. In re Bilski, 545 F.3d 943, 958 (Fed. Cir. 2008) (en banc), aff’d on other grounds sub nom. Bilski v. Kappos, 130 S. Ct. 3218 (2010). 225. King Pharm., 616 F.3d at 1278–79. 226. In fact, the Supreme Court suggested as much toward the end of its Prometheus Laboratories opinion when it noted in response to an argument by the Solicitor General that the analysis of distinction from the prior art under Section 103 needed to examine the claim “as a whole.” See infra text accompanying notes 233–35. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 433 matter.227 Interestingly, the Solicitor General’s views cite the CAFC’s printed matter doctrine for support, but they in fact sound much more like the CCPA’s mental steps doctrine (implemented 228 through §§ 102 and 103 rather than § 101). The Solicitor General noted that the “administering” and “determining” steps existed in the prior art.229 Yet, like the CAFC, the Solicitor General interpreted the Supreme Court’s opinion in Diehr to overrule Flook and forbid consideration of the distinction of any part of the claim from the prior art as part of the analysis of patentable subject matter.230 After opining that the claims did recite patentable subject matter, the brief concluded that the claims were likely to be invalid under a point of novelty analysis rooted in either § 102 or § 103: A patent applicant cannot . . . avoid a rejection under Section 102 or 103 merely by appending a purely mental step or inference to a process that is otherwise known in (or obvious in light of) the prior art. . . . Because the “wherein” clauses of respondent’s claims do not recite any physical step to be performed by a doctor (or anyone else), they add no patentable weight to the “administering” and 231 “determining” steps. To defend a point-of-novelty analysis for a “mental step or inference,” the Solicitor General cited not to the historical mental steps doctrine of the CCPA, but to the contemporary printed matter doctrine of the CAFC.232 The Supreme Court went out of its way in Prometheus Laboratories to comment on and reject the Solicitor General’s 227. Brief for the United States as Amicus Curiae Supporting Neither Party at 11, Mayo Collaborative Servs. V. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (No. 101150). For a similar analysis offered immediately after the issuance of King Pharmaceuticals and a year before the Supreme Court even accepted certiorari in Prometheus Laboratories, see Kevin Emerson Collins, An Initial Comment on King Pharmaceuticals: The Printed Matter Doctrine as a Structural Doctrine and Its Implications for Prometheus Laboratories, 2010 PATENTLY-O PAT. L.J. 111, 116 (2010), http://www.patentlyo.com/lawjournal/2010/08/collins-printed-matter.html. 228. See Brief for the United States as Amicus Curiae Supporting Neither Party, supra note 227, at 28–29 (using the printed matter doctrine for support); cf. Collins, supra note 159, at 1396–97 (comparing the patentable weight approach with the mental steps doctrine). 229. Brief for the United States as Amicus Curiae Supporting Neither Party, supra note 227, at 27. 230. Id. at 16–17. 231. Id. at 27, 28–29; see also id. at 26 (“[The] claimed process differs from the prior art only with respect to the mental inference a doctor may draw after the ‘administering’ and ‘determining’ steps have been completed. Although that similarity to the prior art is irrelevant to the Section 101 inquiry, it would likely warrant invalidation of the claims under 35 U.S.C. 102 or 103.” (citation omitted)). 232. Id. at 29 & n.9 (citing In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004); King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1278 (2010)). Do Not Delete 434 1/2/2013 1:59 PM HOUSTON LAW REVIEW [50:2 proposal.233 The Court made space within § 101 for its bracket-anddistinguish analysis by noting that the Solicitor General’s proposal “would make the ‘law of nature’ exception to [§ ] 101 patentability a 234 dead letter.” Additionally, the Court questioned whether a pointof-novelty analysis could be employed under the auspices of the novelty and nonobviousness analyses, noting that “[§§ ] 102 and 103 say nothing about treating laws of nature as if they were part of the prior art when applying those sections.”235 Thus, whether the printed matter doctrine will remain an artifact of §§ 102 and 103, or whether it will be forced to migrate back to its historical origins as an artifact of § 101 patentable subject matter, is now an open question. IV. CONCLUSION The reasoning that animates the Supreme Court’s opinion in Prometheus Laboratories draws from the Court’s own precedents addressing the exclusion of laws of nature from patentable subject matter. This Article contextualizes Prometheus Laboratories within two different bodies of patent law that have, to date, been addressed by only lower courts: the historical mental steps doctrine of the CCPA and the contemporary printed matter doctrine of the CAFC. The connections between Prometheus Laboratories and the mental steps doctrine tell a story of partial redundancy and disruption of the status quo. In contrast, the connections between Prometheus Laboratories and the printed matter doctrine tell a more easily overlooked story of complementarity and continuity with the status quo. More broadly, however, the strength and multi-stranded nature of both sets of connections raises the possibility of looking past the lawsof-nature rhetoric that animates the Supreme Court’s Prometheus Laboratories opinion. Perhaps it makes sense to 233. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1303–04 (2012). However, the Court did not go out of its way to point out the conflict between its bracket-and-extract analysis for laws of nature employed in Prometheus Laboratories and the passages in Diehr that both the CAFC and the Solicitor General had interpreted to prohibit such an analysis. See id. at 1304 (“We recognize that, in evaluating the significance of additional steps, the [Section] 101 patent-eligibility inquiry and, say, the [Section] 102 novelty inquiry might sometimes overlap.”). 234. Id. at 1303. 235. Id. at 1304; cf. Brian J. McNamara, Patent Protection of Computer Hardware and Software, 12 WAKE FOREST J. BUS. & INTELL. PROP. L. 137, 169 (2012) (referring to the Court’s recognition in Prometheus Laboratories that Sections 101 and 102 overlap). To further confuse the issue, the Court cited its language from its opinion on Section 101 in Diehr that a claim must be considered “as a whole” to support the proposition that Sections 102 and 103 must consider the claim as a whole. Prometheus Labs., 132 S. Ct. at 1304. Do Not Delete 2012] 1/2/2013 1:59 PM PROMETHEUS LABORATORIES 435 reconceptualize Prometheus Laboratories as a case about the limits on the patent regime that follow from the unpatentability of mental processes (mental steps) and information that is intelligible to humans (printed matter). That is, perhaps Prometheus Laboratories can be best explained by focusing on the unpatentability of the human mind.