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December 17, 2010


Medical treatment patents 6,355,623 and 6,680,302 were flogged to death by the district court using §101. Resurrection came at the CAFC under Bilski, applying the solitary machine-or-transformation (m-o-t) test of the time. The Supreme Court found m-o-t merely "a useful and important clue," and so vacated and remanded the Prometheus v. Mayo case where '623 and '302 had been so buffeted. Remand was a revisit, but with eyes wide open to a "liberal encouragement".

Prometheus Lab v. Mayo Collaborative (CAFC 2008-1403) precedential

The issue again before us is whether Prometheus's method claims meet the requirements of § 101. The text of the statute provides that:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title.

35 U.S.C. § 101. The Supreme Court has consistently construed § 101 broadly. Most recently, in Bilski, the Court stated that by choosing expansive terms to specify four independent patent-eligible categories of inventions or discoveries--processes, machines, manufactures, and compositions of matter--and by modifying those terms with the comprehensive "any," Congress plainly contemplated that § 101 would be given wide scope. 130 S. Ct. at 3225 (quoting Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980)). "Congress took this permissive approach to patent eligibility to ensure that 'ingenuity should receive a liberal encouragement.'" Id. (quoting 5 Writings of Thomas Jefferson 75-76 (H. Washington ed. 1871)).

Yet, it is equally well-established that § 101, while broad, is not unlimited. "The Court's precedents provide three specific exceptions to § 101's broad patent-eligibility principles: 'laws of nature, physical phenomena, and abstract ideas.'" Id. (quoting Chakrabarty, 447 U.S. at 309). Although not compelled by the statutory text, the Court has held that "these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years," id. (citing Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174-75 (1853)), and "[t]he concepts covered by these exceptions are 'part of the storehouse of knowledge of all men . . . free to all men and reserved exclusively to none,'" id. (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)); see also Benson, 409 U.S. at 67 ("Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.").

The Supreme Court has also established that while a law of nature, natural phenomenon, or abstract idea cannot be patented, "an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." Bilski, 130 S. Ct. at 3230 (quoting Diehr, 450 U.S. at 188). In making this determination, the Court has made clear that a claim must be considered as a whole; it is "inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis." Id. (quoting Diehr, 450 U.S. at 188). Nonetheless, a scientific principle cannot be made patentable by limiting its use to a particular technological environment or by adding insignificant post-solution activity. Diehr, 450 U.S. at 191-92.

In light of the Supreme Court's decision in Bilski, patent eligibility in this case turns on whether Prometheus's asserted claims are drawn to a natural phenomenon, the patenting of which would entirely preempt its use as in Benson or Flook, or whether the claims are drawn only to a particular application of that phenomenon as in Diehr. Bilski, 130 S. Ct. at 3230. We conclude they are drawn to the latter.

Remand from SCOTUS was for the CAFC to repent m-o-t as a solitary sacred cow, and declare other cattle as possibly chattel to patentability under 101.

The Supreme Court's decision in Bilski did not undermine our preemption analysis of Prometheus's claims and it rejected the machine-or-transformation test only as a definitive test. The Court merely stated that "[t]he Court of Appeals incorrectly concluded that this Court has endorsed the machine-or-transformation test as the exclusive test." 130 S. Ct. at 3226 (emphasis added).

The (legal) treatment of the (medical) treatment -

As before, we again hold that Prometheus's asserted method claims recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and thus do not wholly preempt all uses of the recited correlations. As discussed below, the claims recite specific treatment steps, not just the correlations themselves. And the steps involve a particular application of the natural correlations: the treatment of a specific disease by administering specific drugs and measuring specific metabolites. As such, and contrary to Mayo's assertions, the claims do not preempt all uses of the natural correlations; they utilize them in a series of specific steps. See Diehr, 450 U.S. at 187 ("Their process admittedly employs a well-known mathematical equation, but they do not seek to preempt the use of that equation. Rather, they seek only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process."). The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment. Other drugs might be administered to optimize the therapeutic efficacy of the claimed treatment.

As Prometheus points out, quite literally every transformation of physical matter can be described as occurring according to natural processes and natural law. Transformations operate by natural principles. The transformation here, however, is the result of the physical administration of a drug to a subject to transform - i.e., treat - the subject, which is itself not a natural process. "It is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter." Bilski, 545 F.3d at 962. The administering step, therefore, is not merely data-gathering but a significant transformative element of Prometheus's claimed methods of treatment that is "sufficiently definite to confine the patent monopoly within rather definite bounds." Benson, 409 U.S. at 70.

A further requirement for patent-eligibility is ensuring that the involvement of the transformation in Prometheus's claimed process is "not merely insignificant extrasolution activity." Flook, 437 U.S. at 590.

Not all of the asserted claims, however, contain the administering step. That omission, which occurs in claims 46 and 53 of the '623 patent, does not diminish the patentability of the claimed methods because we also hold that the determining step, which is present in each of the asserted claims, is transformative and central to the claimed methods.

The key to patentability were action steps, beyond observance.

Given the integral involvement of the administering and determining steps in Prometheus's therapeutic methods, this case is easily distinguishable from prior cases that found asserted method claims to be unpatentable for claiming data-gathering steps and a fundamental principle.

We agree with the district court that the final "wherein" clauses are mental steps and thus not patent-eligible per se. However, although they alone are not patent-eligible, the claims are not simply to the mental steps. A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus's claimed methods as a whole. The data that the administering and determining steps provide for use in the mental steps are obtained by steps well within the realm of patentable subject matter; the addition of the mental steps to the claimed methods thus does not remove the prior two steps from that realm. No claim in the Prometheus patents claims only mental steps. Therefore, contrary to Mayo's assertions, a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that requires such steps.

As we explained in Bilski,

[I]t is inappropriate to determine the patent eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter. After all, even though a fundamental principle itself is not patent-eligible, processes incorporating a fundamental principle may be patent-eligible. Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under § 101.

545 F.3d at 958 (citations omitted). Such is the case here.

Reversed and remanded.

Posted by Patent Hawk at December 17, 2010 12:54 PM | § 101


This will be the death of 6000.

Posted by: Pedantic Pete at December 17, 2010 3:58 PM

Pedantic Pete,

Well and adroitly stated.

Posted by: EG at December 18, 2010 10:07 AM

Lulz idk about that, I agree with what the court said, apparently Mayo didn't bother to argue the abstract idea preemption which I espoused as an argument. If they don't argue it, they don't deserve to win.

Posted by: 6000 at December 20, 2010 6:25 AM

I am sure that there is a corollary to "bad facts make bad law."

Until overruled by en banc or the Supremes though, this is law.

Posted by: Pedantic Pete at December 20, 2010 7:32 AM

Am I the only one bothered by the fact that the "transformation" CAFC points to in the "determining" step lies in actions explicitly NOT recited in the independent claim?

Maybe it is just me ...

Posted by: Patrick at December 20, 2010 2:46 PM

The outcome of the Classen patent litigation should add further nuance to this line of cases.

Posted by: patent litigation at December 20, 2010 3:44 PM

Patent Litigation,

I agree. In fact, it presents an opportunity for the CAFC to at least try to keep SCOTUS off its back ... but I really think we'll see a Bilski 2.0 if they uphold the Classen claim.

Posted by: Patrick at December 21, 2010 1:14 PM