I was finishing up my recent comment on the reexamination proceedings involving the Baltimore et al. patent, when a fragment of one of the Office Actions caught my eye and stuck in my mind. The Examiner is trying to explain why inherent anticipation does not require recognition by the art of the underlying mechanism of action involved in, say, prior art reporting the bioactivity of a drug:

Similarly, theoretical mechanisms or rules of natural law that are recited in a claim, that themselves are not patentable, do not need to be recognized by one of ordinary skill in the art for a finding of inherency. A person of ordinary skill does not need to recognize that a method or structure behaves according to a law of nature in order to fully and effectively practice the method or structure. …EMI Group North America, Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342 (Fed. Cir. Sept. 21, 2001).
The EMI Court used the following hypothetical example to clarify this principle:
Humans lit fires for thousands of years before realizing that oxygen is necessary to create and maintain a flame. The first person to discover the necessity of making a fire by lighting a flame in the presence of oxygen could not have obtained a valid patent claim for “a method of making a fire by lighting a flame in the presence of oxygen.” …[U]nderstanding this law of nature would not give the discoverer a right to exclude others from practicing the prior art of making fires.

I think that this is an example of the hoary maxim: “That which literally infringes if later in time anticipates if earlier than the date of the invention”. Making fires would infringe a claim to lighting a flame in the presence of oxygen, but making fires preceded the discovery of oxygen’s role in flames and so would inherently anticipate the hypothetical claim the court discussed above.

Where the panel In re Bilski “went bad” happens early in the exhaustive opinion. In re Bilski, 545 F.3d 943 (Fed. Cir. 2008). Like Justice Breyer in his Lab. Corp. of Amer. Holdings dissent, the Fed. Cir. panel was struggling to define a “natural phenomena” or a “fundamental principle” in order to decide if the claims before them were unpatentable subject matter (along with “laws of nature and abstract ideas”. See Diamond v. Diehr, 450 U.S. 175 (1981)). Justice Breyer admitted that this has never been easy:

I concede that the category of non-patentable “phenomena of nature’ like the categories of “mental processes” and “abstract intellectual concepts,” is not easy to define. See Flook, …98 S. Ct. 2511 (“The line between a patentable ‘process’ and an unpatentable ‘principle’ is not always clear”)[Lab. Corps. of Amer. V. Metabolite Labs., 126 S. Ct. 2921, 2926 (2006)].

The Federal Circuit in Bilski saw the “line” but simply jumped over it, and then spent pages explaining why their legal short-cut was completely justified by precedent. Let’s review how they cut this corner:

The Court in Diehr thus drew a distinction between those claims that “seek to pre-empt the use of” a fundamental principle, on the one hand, and claims that seek only to foreclose others from using a particular application of the fundamental principle, on the other… Patents, by definition, grant the power to exclude others from practicing that which the patent claims. Diehr can be understood to suggest that whether or not a claim is drawn only to a fundamental principle is essentially an inquiry into the scope of that exclusion, i.e., whether the effect of allowing the claim would be to allow patentee to pre-empt substantially all uses of that fundamental principle. If so, the claim is not drawn to patent-eligible subject matter.

A few paragraphs later, the panel also admits that this inquiry can be difficult to resolve;

Unfortunately, this inquiry is hardly straightforward. How does one determine whether a given claim would pre-empt all uses of a fundamental principle?

Yes, that is the question, but it is never answered. In the next paragraph, one sentence later, the panel lays the issue to rest, with the dreaded test:

The Supreme Court, however, has enunciated a definitive test to determine whether a process claim is tailored narrowly enough to encompass only a particular principle rather than to pre-empt the principle itself. A claimed process is surely patent-eligible under s. 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.

This is a handy test, but it does not do justice to our obligation to wrestle with the larger questions and concepts we have been discussing. Let’s go back to the Ariad reexamination, which is much more interesting than the Fed. Cir. opinion that invalidated the claims based on insufficient description in the specification. I submit that the quote from the reexamination I presented above provides a workable test for deciding whether or not a process claim “pre-empt[s] the principle itself”. How about a test like this:

Claims are drawn to unpatentable natural phenomena would always be inherently or explicitly anticipated by fundamental natural phenomena.

Not elegant, but let’s test it out. In his Lab. Corps. dissent, Justice Breyer concedes that “many a patentable invention rests upon its inventor’s knowledge of natural phenomena; many ‘process’ patents seek to make abstract intellectual concepts workably concrete; and all conscious human action involves a mental process.”

Darn right! But two paragraphs later, the Justice starts out his opinion with “[t]here can be little doubt that the correlation between homcysteine and vitamin deficiency set forth in claim 13 is a “natural phenomenon.” No doubt? The claim in question must be a lot like the hypothetical claim discussed by the Ariad Examiner; allow it to stand, and we won’t be able to light a fire. Here is claim 13 of the Lab. Corps. patent:

A method for detecting a deficiency of cobalamine or folate in warm-blooded animals comprising the steps of:
Assaying a bodily fluid for an elevated level of total homocysteine; and
Correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamine or folate.

Well, this looks like a diagnostic assay that is a “product of human ingenuity” carried out by “the hand of man”, not like any universal or fundamental principle of nature. So what manifest law of nature, abstract idea or fundamental principle inherently anticipates this claim? It is a law of nature that animal blood has homocysteine in it. So a hypothetical unpatentable claim would be “Human blood comprising homocysteine”. But this “claim” would not anticipate claim 13 if it was prior art. Also, issuance of claim 14 would not permit patentee to collect a royalty from any person, simply because their blood must contain some homocysteine. Taking this analysis a bit further, let’s consider a claim to a natural internal relationship: “Human blood that comprises x amount of homocysteine and y amount of cobalamine.” This claim would not anticipate claim 13 either, and claim 13 could not be read to prohibit a person from having blood containing both substances. (This is why my proposed test is not circular; the claim is a constant and you test various principles or phenomena against it.)

Justice Breyer, I respectfully submit that nature may contain correlations but it does not analyze, much less correlate, anything. Nature doesn’t care if your homocysteine is low or high and what the consequences may befall you if it is too high or too low. Just like nature doesn’t care what your PSA level is, even though it
is certainly a natural phenomenon that men have PSA in their blood. But a claim: “Human blood containing PSA” does not anticipate a claim to a method of detecting prostate cancer by assaying blood for PSA and correlating an elevated PSA level to the presence of prostate cancer.” Good thing those patents have expired; they yielded workable life-saving tests before they faced invalidation.

The “human factor” is strangely absent from Bilski, but it is in almost every paragraph of Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), which affirmed the patentability of a “human-made microorganism” and effectively founded the biotech industry. The Justices spent a paragraph discussing precedent holding that “laws of nature, physical phenomena, and abstract ideas have been held not patentable….Such discoveries are ‘manifestations of … nature, free to all men and reserved exclusively to none.’”

But in 1980, these Justices took a different road than the one mapped in Justice Breyer’s dissent. In the next paragraph, they conclude that “[j]udged in this light, respondent’s micro-organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomena, but to a non-naturally occurring manufacture or composition of matter – a product of human ingenuity ‘having a distinctive name, character [and] use.”…His discovery is not nature’s handiwork, but his own; accordingly it is patentable under s. 101. I think it is no accident that Chakrabarty is not cited once in the main Bilski opinion, but it cited in both Newman’s and Rader’s dissents (“Natural laws and phenomena can never qualify for patent protection because they cannot be invented at all” 545 F.3d at 1013).

Of course I am aware that Chakrabarty addresses patentability of a composition of matter, not a process, but I submit that my test applies to both. Try it out. To close, I quote from Dennis v. Pitner, 106 F.2d 142 (7th Cir.1939). cert. denied 308 U.S. 606. The claims in suit were to an “extract of cube root” with a statement of intended use of it as an insecticide. Today, this would be considered a claim for a new use of a known compound. The court rebuffed the defendant’s argument that the claim was simply the “revelation of an existing law of nature”. In the formal language of the day, the court proceeded:

The discoveries that a cube root would act as an insecticide, that copper and iron when properly mixed in predetermined proportions [WARF v. Breon, 85 F.2d 166] would increase the red corpuscles in the human blood…necessitated the co-acting of two or more things. The insecticide needed the breath of an insect upon which the powdered cube root could act before it became an effective insecticide. The copper and iron mixture needed contact with the human blood before a change in red corpuscle count occurred. Seldom is there any discovery of a new phenomenon of an old chemical product that does not call for the old product’s contact with a material to which it must be applied by human agencies before the phenomenon occurs. In all such cases the discoverer is well outside of the rule which excludes the issuance of patents to those who have merely discovered a law or principle of nature or fundamental truth.

If a process carried out by “human agencies” is deemed somehow injurious to society (read “commerce”), Congress can, and has, legislated so as to protect the interested public. (We will consider patents on methods of conducting surgery in the future.) Please consider that precious few patent attorneys are even asked to write claims on fundamental principles of nature these days. They just don’t come along that often anymore. Cold fusion, anyone?