Prometheus – What are We to Make of All This?

By Charles Gorenstein
March 27, 2012

The Prometheus decision reflects that Supreme Court is obviously concerned about the possibility that a patent claim might preempt a law of nature and thereby broadly restrict use and application of the underlying principles.  Perhaps the concern is heightened by the fact that the claimed method relates to treatment of disease, and the prospect of preempting such treatment is troubling.  The reasoning set forth in the opinion, however, is anything but helpful.

The court dismisses a suggestion that virtually any step beyond a law of nature should transform an unpatentable law of nature into a potentially patentable application, sufficient to satisfy §101 whereby patentability could be determined under applicable novelty and obviousness analyses pursuant to 35 U.S.C. §102 and 103, saying that such an approach would render the “law of nature” exception to §101 a “dead letter.” The court, never the less, decides the status of the claimed subject matter under §101 under a point of novelty approach, leaving the reader to puzzle about which part of the opinion should be considered as determinative of what is proper under the law.

The opinion includes an extended comparison of the claims in the present case to the claimed subject matter in the Diehr and Flook decisions.  The court noted that the claimed process in Diehr, a process of curing rubber based on the Arrhennius equation that expressed a law of nature, was deemed statutory because “nowhere [was it] suggested that all these steps, or at least the combination of these steps [otherwise recited in the claim] were in context obvious.”  The process claimed in Flook related to a method for monitoring certain parameters of a process, using an apparently novel mathematical algorithm to calculate certain current alarm limits, and then adjusting the system/process to reflect new limit values.  That method was deemed to be nonstatutory because, “putting the formula to the side, there was no ‘inventive concept’ in the application of the formula.  The additional activity was deemed to be “conventional and obvious” and, thus, could not transform an unprotectable law of nature into a statutory process.

The court, thus, engaged in and based its decision on an analysis that it expressly described as inappropriate for the situation.  What we are to make of that remains to be seen.  It has long been accepted that methods of treatment of disease are statutory methods eligible for patent protection.

The exemplary claim discussed in the Prometheus decision recited:

 A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. [emphasis supplied]

Suppose the claim had recited:

A method of treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug . . .

Conventionally, such a method of treatment would be considered to be statutory. Would the court have declared such a claim to now be ineligible under §101?   That appears to be a prevalent fear, perhaps with good reason.

The court dismissed the recited step of “administering a drug” as not really a method step at all, but merely a reference “to the relevant audience, namely doctors, who treat patients with certain diseases with [the recited] drugs.”  The basis for this is not clear, to say the least.  It is doubtful that this unusual variation in lexicography can be found in the underlying patent disclosure.  Must we now be concerned that words of a claim – consistently held to always have meaning; otherwise they would not be in the claim – might be ignored when inconsistent with a desired result or ruling?

Maybe the problem with the claims before the Prometheus court was that they were too specific, and might have passed under the §101 radar if the method had been recited more broadly.  Suppose the claim in issue had read:

A method for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder;

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, and

(c) increasing or decreasing the amount of said drug subsequently administered to said subject to maintain an efficacious level of 6-thioguanine in said subject.

Would the claim have been considered to be nonstatutory?  Would the question have even been raised?  From this perspective, (and setting aside considerations of novelty or obviousness) one might conclude that, rather than claiming some methods with reference to anything that looks like a law of nature in a claim, thus raising the specter of §101, it may be better to claim some methods more broadly so as to avoid such issues – maybe obtaining broader claim scope in any event.

What this all means is anything but clear. For the moment, it would seem that the Prometheus decision is just one more in a long series that will not resolve the question of what is or is not statutory subject matter.

The Author

Charles Gorenstein

Charles Gorenstein

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 3 Comments comments.

  1. EG March 27, 2012 8:29 am

    “The reasoning set forth in the opinion, however, is anything but helpful.”

    I completely agree, Charles. As I’ve repeatedly said, I could do just as well using a Ouija board relative to the nonsensical, illogical, conflcting, and confusing reasoning used in Breyer’s opinion. As I’ve noted in my two posts on this blog, the “law of nature” approach used by Breyer is not the way to go and is fatally flawed logically. You could say Prometheus’ claimed method is too “abstract” in view of Bilski under 35 USC 101, or is potentially “indefinite” under 35 USC 112, 2nd paragraph. But Prometheus’s claimed method isn’t a “law of nature” issue.

    BTW, the claim you propose is very similar to Claims 1 and 13 of related U.S. Pat No. 6,987,097 that Steve Hansen kindly pointed out on Gene’s post. If your proposed claim, as well as Claims 1 and 13 of the ‘097 patent, can’t past muster under 35 USC 101, I don’t know what method or process claim would.

  2. Alan Stewart March 27, 2012 9:29 am

    Charles:

    Good follow up question. I wonder how far SCOTUS and the FedCir will permit laws of nature to be imputed or referenced in claims, particularly in the biotech world. I see your proposed claim language in your last example as being over the threshold for further examination of novelty and obviousness. Your question about whether this Court would based on this decision is an interesting one.

    I am a lowly mechanical arts patent practitioner and I can see any number of mechanical interaction references we make in claims that could be seen implicitly as reciting a law of nature, as defined by Newton. If an organism responds to stimulus, which this decision sees as being a law of nature, is that so different from the interaction of moving parts?

    ars

  3. Mark Guttag March 27, 2012 5:45 pm

    Charles,

    Thank you for your analysis. I think it is dead on.

    Basically with respect to the phrase “administering a drug” in Claim 1, the Supreme Court has held in Prometheus:

    1. That the phrase “administering a drug” does not mean “administering a drug”; instead, the phrase “administering a drug” simply refers to “the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs.” And here I always thought that “administering a drug” meant to inject a drug into someone, feed a person a drug, etc. I wonder if there is a single published dictionary or on-line dictionary that has a definition of the term “administering” that corresponds to the Supreme Courts’ definition of this term.

    2. “Administering a drug” is an abstract idea. So, according to the Supreme Court, injecting a drug into someone, feeding a person a drug, etc. is merely an “abstract idea.” I am thankful for the Supreme Court letting us know about this new application of the Harold Hill’s “Think Method,” i.e. “If you want to play the minuet in G, you have to think the minuet in G.” Thanks to the Supreme Court’s decision we now all know that all we have to do to receive the benefits of a drug is to have someone “think” about administering the drug to us. I don’t know how the drug companies will stay in business once this bit of Supreme Court wisdom is widely known.

    Mark

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