Metabolite's broadest method claim has two steps: First, assay a body fluid to determine its homocysteine level. Second, correlate the homocysteine level to a vitamin deficiency. It reads as follows:
13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
In 2006, the Supreme Court almost took the time to reject this claim under Section 101, but decided that the issue had not been properly raised on appeal. Dissenting from the last minute denial of certiorari were Justices Breyer, Stevens and Souter. In a dissenting opinion drafted by Justice Breyer, the three would have held the invention as claimed an unpatentable "law of nature." The same anti-preemption theme of Bilski also runs through the Breyer opinion. The courts are concerned with the potential (but unidentified) problems of having a patent that
There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a "natural phenomenon." . . . .
Claim 13 . . . tells the user to use any test at all. Indeed, to use virtually any natural phenomenon for virtually any useful purpose could well involve the use of empirical information obtained through an unpatented means that might have involved transforming matter.
I thought it would be interesting to attempt to apply the Bilski decision to Claim 13 to judge its patentability.
Bilski offers two avenues for showing that a claimed process is patentable. First, the process will be patentable if it is tied to a particular machine or apparatus. Alternatively, the process will be patentable if it "transforms a particular article into a different state or thing." According to the court, "particular article" does not necessarily need to be physical, but it must at least be "representative of physical objects or substances."
Machine: Metabolite's Claim 13 easily fails the first prong of the machine-transformation test because the claimed method is not tied to any particular machine.
Transformation: The "correlating" step could be performed in a human mind and consequently cannot serve as the basis for finding patentable subject matter. As the court noted in Bilski – a process step that "may be performed entirely in the human mind is obviously not tied to any machine and does not transform any article into a different state or thing."
The "assay" step could follow the same analysis – if it is possible to "assay a body fluid for an elevated level of total homocysteine" only using the human mind then no there is no credible transformation. The mental step potential may be true if, for example, the body fluid's homocysteine level is visually apparent. [Interesting timing issues here, at the time of the invention, the assay involved extensive lab work, but later-invented technology has dramatically changed the process.]
Assuming that "assaying a body fluid for an elevated level of total homocysteine" cannot be done in the mind, we must then ask whether the claim requires a transformation of a particular physical object or substance or at least transformation of a particular article that is "representative of physical objects or substances." Perhaps the best physically related transformation involves transforming the "body fluid" into an indication of elevated homocysteine level and then into an indication of vitamin deficiency. Under Abele, both homocysteine level and vitamin deficiency do represent physical substances – consequently their 'creation' may be "sufficient to render that … process patent-eligible." [Of course, this analysis may apply a loose definition of 'transformation.']
- What do you think: [SURVEY: DOES CLAIM 13 PRESENT PATENTABLE SUBJECT MATTER]. I'll post results on Thursday or Friday. [See ongoing results here]
- Want more on Bilski: Professors Merges (UC Berkeley), Duffy (GWU), and Lichtman (USC) discuss Bilski on Professor Lichtman's new radio show - the www.ipcolloquium.com (Free CLE)