Diagnostics Need Not Apply

ideas themselves are un-patentable "as they are the basic tools of scientific and technological work,"58 useful applications of these tools may be patent-eligible. A claim to a process that uses a natural law must "also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to 55 See supra notes 38-39 and accompanying text. 56 Mayo, 1 32 S. Ct. at 1 296-97. 57 Id. at 1 293. 58 Id. at 1 293 (citing Gottschalk v. Benson, 409 U.S. 63, 67 ( 1 972)). 2015] DIA GNOSTICS NEED NOT APPLY 267 significantly more than a patent upon the natural law itself."59 To count as a patent-eligible application, the claim "must do more than simply state the law of nature while adding the words 'apply it."'60 If all inventions make use of natural phenomena, laws of nature, and abstract ideas, it might seem that the real work of distinguishing patentable applications from un-patentable "laws of nature" must occur at step two of the analysis. But a close reading of the Mayo opinion suggests the opposite: one must understand the scope of the exclusions at step one in order to figure out what is left in the claims that might be sufficient to confer patent eligibility. In the case of diagnostic methods, the Court's broad understanding of what belongs in the category of "natural laws" prevents the Court from recognizing diagnosis as a form of applied technology at all. The Court concludes that the other elements of the Mayo claim do not "add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws" because the steps of administering thiopurine drugs to a patient and measuring metabolite levels in tissue samples were "well-understood, routine, conventional activity previously engaged in by researchers in the field." Some commentators have criticized this analysis as improperly conflating the requirements of patentable subject matter on one hand and the requirements of novelty and nonobviousness on the other hand,61 and some lower court decision have read the decision as limiting patent eligibility to "inventive applications" of natural laws, 62 although the PTO reads the decision more narrowly. 63 Understanding the opinion as requiring an "inventive application" 59 Id. at 1 294. 60 Id. 61 Jeff Lefstin traces this conflation to the opinion of Justice Douglas in Funk v. Kala, 333 U.S. 1 27 ( 1 948). Jeffrey A Lefstin, Inventive Application: A History, 67 FLA. L. REV. 565, 623-3 1 (20 1 5). 62 Ariosa Diagnostics v. Sequenom. 788 F.3d 1 37 1 , 1 377 (Fed. Cir. 20 1 5) ("Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cftDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cftDNA in maternal plasma or serum."); id. at 1 379 (agreeing that the invention "combined and utilized man­ made tools of biotechnology in a new way that revolutionized prenatal care," but noting "that the Supreme Court instructs that "groundbreaking, innovative, or even bril l iant discovery does not by itself satisfy the § 1 0 1 inquiry" (citing Myriad Genetics, 1 33 S. Ct. at 2 1 1 7)). But cf Genetic Technologies, Ltd. v. Agilent Technologies, Inc., 24 F. Supp. 3d 922, 929 (N.D. Cal. 201 4) (noting in response to argument that non-excluded claim elements consisted of "known prior art techniques" that "Agilent's arguments conflate the analysis of patent eligible subject matter under § I 0 I with analysis of novelty and non­ obviousness under §§ I 02 and 1 03 "). 63 U.S.P.T.O., 20 1 4 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 746 1 8, 74624 (Dec. 1 6, 20 1 4) ("A claim directed to a judicial exception must be analyzed to determine whether the elements of the claim, considered both individually and as an ordered 268 B. U. J. SCI. & TECH L. [Vol. 2 1.2 of the natural laws suggests that perhaps a more innovative diagnostic method could prove patent-eligible in a future case. But the Court stops short of resting its determination of patent ineligibility on the fact that other claim steps were too conventional: 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. For here, as we have said, the steps add nothing of significance to the natural laws themselves. 64 This is the essential problem for diagnostic method claims under the Court's analysis: because the Court codes the heart of the diagnostic method the determination of when it is appropriate to modify treatment for a particular patient as belonging to the realm of natural laws, it does not recognize any application of those laws (whether "inventive" or "conventional") in the claim at all. 65 Despite the very specific criteria set forth in the final "wherein" clauses in the claim for determining when it is appropriate to adjust the drug dosage, the Court sees that language as reciting an excluded natural law rather than an application. 66 The Court thus concludes that the claim merely recites natural laws followed by a general instruction to "apply it" in some unspecified way: [T]he 'wherein' clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient . . . (rather like Einstein telling linear accelerator operators about his basic law and then trusting them to use it where relevant). 67 The Einstein analogy seems fundamentally confused. The insight that e=mc2 provides only the most basic starting point for "linear accelerator operators" who would need considerably more help to translate this insight into practical applications; indeed, the obvious magnitude of the remaining work and the varie1{' of applications that subsequent innovators might pursue is what makes e=mc a compelling example of the distinction between "natural laws" and applications of those laws.68 By contrast, the . Mayo claim explains exactly how to apply the recited correlations in the treatment of patients. 69 There is no combination, are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself . . . Individual elements viewed on their own may not appear to add significantly more to the claim, but when combined may amount to significantly more than