| Review and Analysis of Lab. Corp. of Am. Holdings | | | | (citing State Street Bank & Trust Co. v. Signature |
| v. Metabolite Labs., Inc., No. 04-607 , SUPREME | | | | Financial Group, Inc., 149 F.3d 1368, 1373 (CA Fed |
| COURT OF THE UNITED STATES, 2006 U.S. | | | | 1998)). [*20] |
| LEXIS 4893; 74 U.S.L.W. 4431; 79 USPQ2d 1065; | | | | In my view, however, the cases to which |
| 19 Fla. L. Weekly Fed. S 311, Decided June 22, | | | | respondents refer do not support their claim. |
| 2006 | | | | Neither Cochrane nor Gottschalk can help them |
| I. SUMMARY | | | | because the process described in claim 13 is not a |
| This case has to do with "correlation" claims, | | | | process for transforming blood or any other |
| particularly for medical technology, but applicable | | | | matter. Claim 13's process instructs the user to |
| to other technologies as well. In addition, it | | | | (1) obtain test results and (2) think about them. |
| provides useful guidance on how the Supreme | | | | Why should it matter if the test results |
| Court will receive the Court of Appeals for the | | | | themselves were obtained through an unpatented |
| Federal Circuit's "useful, concrete, and tangible | | | | procedure that involved the transformation of |
| result" test for compliance with 35 USC 101. | | | | blood? Claim 13 is indifferent to that fact, for it |
| II. FACTS | | | | tells the user to use any test at all. Indeed, to use |
| In this case, the Supreme Court granted cert., | | | | virtually any natural phenomenon for virtually any |
| and then dismissed (a "DIG"; Dismissal for | | | | useful purpose could well involve the use of |
| Improvident Grant of Certiori). The Supreme | | | | empirical information obtained through an |
| Court concluded that the issue raised in the | | | | unpatented means that might have involved |
| appellant's brief had not been argued in the courts | | | | transforming matter. Neither Cochrane nor |
| below (district court and Federal Circuit), and | | | | Gottschalk suggests that that fact renders the |
| therefore was not entitled to consideration. The | | | | phenomenon patentable. See Cochrane, supra, at |
| issue raised by the appellants in their brief to the | | | | 785, 24 L. Ed. 139, 1877 Dec. Comm'r Pat. 242 |
| Supreme Court was whether claim 13 met the 35 | | | | (upholding process for improving quality of flour |
| USC 101 requirement for statutory subject | | | | by removing impurities with blasts of air); |
| matter, and did not claim merely a law of nature. | | | | Gottschalk, supra, at 71-73, 93 S. Ct. 253, 34 L. |
| Although the Supremes DIG'd this case, the Chief | | | | Ed. 2d 273 (rejecting process for converting |
| Justice did not participate, and there was a three | | | | numerals to binary form through mathematical |
| Justice dissent (Justices Breyer, Stevens and | | | | formula). |
| Souter). The dissent's opinion explains why it | | | | Neither does the Federal Circuit's decision in [*21] |
| dissents, but more importantly, explains why on | | | | State Street Bank help respondents. That case |
| the merits it would have held claim 13 invalid. Since | | | | does say that a process is patentable if it |
| the views of the other 5 justices on the merits | | | | produces a "useful, concrete, and tangible result." |
| are unknown, it may be that the opinion of the | | | | 149 F.3d at 1373. But this Court has never made |
| dissent, on the merits, is a majority view of the | | | | such a statement and, if taken literally, the |
| Court! Hence, it is instructive to review the claim | | | | statement would cover instances where this |
| at issue, and the reasons why the dissent would | | | | Court has held the contrary. The Court, for |
| have found this claim unpatentable. Claim 13 reads | | | | example, has invalidated a claim to the use of |
| as follows: | | | | electromagnetic current for transmitting |
| A method for detecting a deficiency of cobalamin | | | | messages over long distances even though it |
| or folate in warm-blooded animals comprising the | | | | produces a result that seems "useful, concrete, |
| steps of:assaying a body fluid for an elevated | | | | and tangible." Morse, supra, at 116, 56 U.S. 62, 14 |
| level of total homocysteine; andcorrelating an | | | | L. Ed. 601. Similarly the Court has invalidated a |
| elevated level of total homocysteine in said body | | | | patent setting forth a system for triggering alarm |
| fluid with a deficiency of cobalamin or folate. | | | | limits in connection with catalytic conversion |
| Both parties construed "correlating" to read upon | | | | despite a similar utility, concreteness, and |
| the mental impression of a doctor recognizing that | | | | tangibility. Flook, supra. And the Court has |
| the level identified by the assay was "an elevated | | | | invalidated a patent setting forth a process that |
| level of total homocysteine" compared to a | | | | transforms, for computer-programming purposes, |
| normal level of total homocysteine. It was also | | | | decimal figures into binary figures -- even though |
| established that, since the normal level of total | | | | the result would seem useful, concrete, and at |
| homocysteine was well known, any doctor seeing | | | | least arguably (within the computer's wiring |
| a result of an assay for total homocysteine would | | | | system) tangible. Gottschalk, supra. |
| immediately recognize if that level was an | | | | Even were I to assume (purely for argument's |
| elevated level. Under those facts, the dissent | | | | sake) that claim 13 meets certain general |
| opined on whether claim 13 was 35 USC 101 | | | | definitions of [*22] process patentability, however, |
| statutory subject matter as follows: | | | | it still fails the one at issue here: the requirement |
| I turn to the merits. The researchers who | | | | that it not amount to a simple natural correlation, |
| obtained the present patent found that an | | | | i.e., a "natural phenomenon." See Flook, supra, at |
| elevated level of homocysteine in a warm-blooded | | | | 588, n. 9, 98 S. Ct. 2522, 57 L. Ed. 2d 451 (even |
| animal is correlated with folate and cobalamin | | | | assuming patent for improved catalytic converter |
| deficiencies. As construed by the Federal Circuit, | | | | system meets broad statutory definition of |
| claim 13 provides those researchers with control | | | | patentable "process," it is invalid under natural |
| over doctors' efforts to use that correlation to | | | | phenomenon doctrine); Diehr, 450 U.S., at 184-185, |
| diagnose vitamin deficiencies in a patient. Does the | | | | 101 S. Ct. 1048, 67 L. Ed. 2d 155 (explaining that, |
| law permit such protection or does claim 13, in the | | | | even if a patent meets all other requirements, it |
| circumstances, amount to an invalid effort to | | | | must meet the natural phenomena requirement |
| patent a "phenomenon of nature"? | | | | as well). |
| I concede that the category of non-patentable | | | | At most, respondents have simply described the |
| "phenomena of nature," like the categories of | | | | natural law at issue in the abstract patent |
| "mental processes," and "abstract intellectual | | | | language of a "process." But they cannot avoid |
| concepts," is not easy to define. See Flook, supra, | | | | the fact that the process is no more than an |
| at 589, 98 S. Ct. 2522, 57 L. Ed. 2d 451 ("The line | | | | instruction to read some numbers in light of |
| between a patentable 'process' and an [*17] | | | | medical knowledge. Cf. id., at 192, 101 S. Ct. 1048, |
| unpatentable 'principle' is not always clear"); cf. | | | | 67 L. Ed. 2d 155 (warning against "allowing a |
| Nichols, 45 F.2d at 122 ("We are as aware as | | | | competent draftsman to evade the recognized |
| anyone that the line [between copyrighted | | | | limitations on the type of subject matter eligible |
| material and non-copyrightable ideas], wherever it | | | | for patent protection"). One might, of course, |
| is drawn, will seem arbitrary"). After all, many a | | | | reduce the "process" to a series of steps, e.g., |
| patentable invention rests upon its inventor's | | | | Step 1: gather data; Step 2: read a number; Step |
| knowledge of natural phenomena; many "process" | | | | 3: compare the number with the norm; Step 4: |
| patents seek to make abstract intellectual | | | | act accordingly. But one can reduce any process |
| concepts workably concrete; and all conscious | | | | [*23] to a series of steps. The question is what |
| human action involves a mental process. See | | | | those steps embody. And here, aside from the |
| generally 1 Chisum 1.03, at 78-295. Nor can one | | | | unpatented test, they embody only the |
| easily use such abstract categories directly to | | | | correlation between homocysteine and vitamin |
| distinguish instances of likely beneficial, from likely | | | | deficiency that the researchers uncovered. In my |
| harmful, forms of protection. Cf. FTC, To | | | | view, that correlation is an unpatentable "natural |
| Promote Innovation: The Proper Balance of | | | | phenomenon," and I can find nothing in claim 13 |
| Competition and Patent Law and Policy, ch. 3, p. 1 | | | | that adds anything more of significance. |
| (Oct. 2003) (hereinafter FTC) (collecting evidence | | | | III. ANALYSIS |
| that "issues of fixed cost recovery, alternative | | | | A. Merits of the dissent's analysis |
| appropriability mechanisms, and relationships | | | | I disagree with the dissent on the merits because |
| between initial and follow-on innovation" vary by | | | | their conclusion that claim 13 fails 35 USC 101 is |
| industry); Burk & Lemley, Policy Levers in Patent | | | | directed to only the "correlating" step, and not to |
| Law, 89 Va. L. Rev. 1575, 1577-1589 (2003) | | | | the claim as a whole. More specifically, the dissent |
| ("Recent evidence has demonstrated that this | | | | failed to recognize that "assaying" is a physical |
| complex relationship [between patents and | | | | mechanical process, and therefore any claim |
| innovation] is . . . industry-specific [*18] at each | | | | including a step of "assaying", regardless of what |
| stage of the patent process"). | | | | else the claim recites, meets the requirements for |
| But this case is not at the boundary. It does not | | | | statutory subject matter. That being said, there |
| require us to consider the precise scope of the | | | | are important guidelines provided by dissent that |
| "natural phenomenon" doctrine or any other | | | | are of great significance in predicting how the |
| difficult issue. In my view, claim 13 is invalid no | | | | court would handle other cases relating to 35 USC |
| matter how narrowly one reasonably interprets | | | | 101. |
| that doctrine. | | | | B. Guidance on the Future of the "useful, |
| There can be little doubt that the correlation | | | | concrete, and tangible result" Test |
| between homocysteine and vitamin deficiency set | | | | The dissent impugns the State Street Bank |
| forth in claim 13 is a "natural phenomenon." That is | | | | decision's "useful, concrete, and tangible result" by |
| what the petitioners argue. It is what the Solicitor | | | | noting that it is inconsistent with Morse, Flook, and |
| General has told us. Brief for United States as | | | | Gottschalk, and by noting that the "useful, |
| Amicus Curiae 19 (filed Dec. 23, 2005) ("The | | | | concrete, and tangible result" test is not Supreme |
| natural relationship between elevated | | | | Court precedent. The dissent represents the |
| homocysteine and deficiencies in the B vitamins is | | | | opinion of three members of the Court on the |
| an unpatentable 'principle in natural philosophy or | | | | "useful, concrete, and tangible result" test, and the |
| physical science'") (quoting Morse, 15 How., at 116, | | | | opinion of the other five members of the Court is |
| 56 U.S. 62, 14 L. Ed. 601)). Indeed, it is close to | | | | not currently known. Thus, the odds are that the |
| what the respondents concede. Brief for | | | | Supreme Court would not affirm that the "useful, |
| Respondents 31 ("The correlation between total | | | | concrete, and tangible result" test is an |
| homocysteine and deficiencies in cobalamin and | | | | appropriate test for 35 USC 101 statutory subject |
| folate that the inventors discovered could be | | | | matter. |
| considered, standing alone, a 'natural phenomenon' | | | | C. Mental "correlation" Limitations |
| in the literal sense: It is an observable aspect of | | | | Where does this leave "correlation" limitations |
| biochemistry in at least some human populations"). | | | | where the correlation is one of mental impression? |
| The respondents argue, however, that [*19] the | | | | In limbo. However, it would be wise to include |
| correlation is nonetheless patentable because claim | | | | alternative claims including limitations other than a |
| 13 packages it in the form of a "process" for | | | | mere mental impression correlation. For example, |
| detecting vitamin deficiency, with discrete testing | | | | alternatives to claim 13 might have included |
| and correlating steps. They point to this Court's | | | | printing or displaying (1) the result of the assay |
| statements that a "process is not unpatentable | | | | for total homocysteine and (2) a normal range for |
| simply because it contains a law of nature," Flook, | | | | total homocysteine. Since most medical tests |
| 437 U.S., at 590, 98 S. Ct. 2522, 57 L. Ed. 2d 451; | | | | display a normal range along with any test results, |
| see also Gottschalk, 409 U.S., at 67, 93 S. Ct. 253, | | | | such a backup claim could have mooted the 35 |
| 34 L. Ed. 2d 273, and that "an application of a law | | | | USC 101 challenge of this case. Moreover, details |
| of nature . . . to a known . . . process may well be | | | | of the process of assaying could have been |
| deserving of patent protection." Diehr, 450 U.S., at | | | | claimed. |
| 187, 101 S. Ct. 1048, 67 L. Ed. 2d 155. They add | | | | D. Were the Right Issues Raised at the Trial |
| that claim 13 is a patentable "application of a law | | | | Level? |
| of nature" because, considered as a whole, it (1) | | | | Finally, it is not clear that the patent infringement |
| "entails a physical transformation of matter," | | | | defendant argued the right issue at the trial level. |
| namely, the alteration of a blood sample during | | | | Specifically, it is not clear that the defendant |
| whatever test is used, Brief for Respondents 33 | | | | argued that claim 13 was invalid due to anticipation |
| (citing Cochrane v. Deener, 94 U.S. 780, 788, 24 | | | | or obviousness on the theory (1) that the |
| L. Ed. 139, 1877 Dec. Comm'r Pat. 242 (1877); | | | | assaying step was well known, and (2) that the |
| Gottschalk, supra, at 70, 93 S. Ct. 253, 34 L. Ed. | | | | step of correlating was not a distinguishing |
| 2d 273), and because it (2) "produces a 'useful, | | | | limitation since it only required a mental impression. |
| concrete, and tangible result,'" namely, detection | | | | If it had, the outcome at the trial level might have |
| of a vitamin deficiency, Brief for Respondents 36 | | | | been different. |