Mayo v. Prometheus – Some Observations and Opinions

by Ryan Alley on March 23, 2012

in General

Case No. 10-1150 (S.Ct. – Breyer)

Usually I focus here on Federal Circuit decisions. Supreme Court cases are well-covered elsewhere and often lack definite ramifications until the Federal Circuit or USPTO starts applying them, Mayo v. Prometheus included. So, while I address the case, this post is mostly scattershot thoughts and impressions on the Supreme Court’s subject matter eligibility jurisprudence as reflected by Prometheus, without many practitioner suggestions. Consume at your own risk.


Other & Better Voices
Firstly, there is already some great blog commentary on Prometheus. Check out Professor Michael Risch’s post on the case. Risch was cited in the opinion and critiques several interesting aspects of the Court’s reasoning. Kevin Noonan also has a very thorough post at Patent Docs. Dennis Crouch has a couple timely Patently-O posts with a boatload of community comments. And there are several other posts and viewpoints floating around the blogosphere.

General Impact
I thought the opinion started out narrowly drawn to the specific diagnostic methods at issue and seemed fairly reasonable in its limited analysis of the same. Reading on, the reasoning and rebuttals began to feel much broader and problematic for several areas beyond medicine. Additionally, because this is a unanimous opinion, I suspect the Court’s logic and approach to § 101 will manage to find broader application.

Judicial Exception Test
The touchstone of the Court’s analysis is that laws of nature (and presumably either of the other two judicial exceptions) cannot be claimed without a meaningfully limiting application of the law. Laws of nature include any physical correlation/property/phenomenon/effect, regardless of how narrow the field or how contrived its occurrence. Once the law of nature is identified in the claim, the remaining elements, in order to satisfy § 101, cannot be as generic as “apply it,” nor can they be “well-understood, routine, conventional activity already engaged in by the scientific community” or “when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Here, the claimed administering step was both routine and too general, a mere audience-identifier required to observe the underlying law of nature – a thiopurine metabolite-drug effectiveness correlation. The opinion does not elaborate on what sort of step might have sufficed to limit the application of this law to a patent-eligible claim, except to agree that the rubber-curing process of Diehr possessed such sufficient application.

I think the Supreme Court’s test appears similar in some ways to the panel majority’s approach in Dealertrack, where the majority first extracted out a concept from the claim and then looked at the remainder of the claim to see if a specific enough application of this abstract idea was required by the claim. Consider any claim drafting lessons from that case?

Section 101 Policies
Around page 17, the opinion starts to get into some larger ideas and goals underlying the strict judicial exception test. Justice Breyer appears deeply concerned about the blocking effects of patents for future innovation. If a law of nature is discovered and all its applications generically claimed, nobody will be able to benefit from or improve upon the same. For example, Mayo’s infringing test is a blocked improvement over the asserted patent, and the asserted claims block “all processes that make use of the [claimed] correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.”

But some of Justice Breyer’s fears and examples look a little overstated. I’m not at all sure how much of an “improvement” Mayo’s test really was or whether measured metabolites could not be used in a different process in the future, as Justice Breyer asserts. Moreover, even if these examples are correct, why does the opinion not discuss cross-licensing as a potential solution to these problems? Further, the opinion’s concerns about over-claiming of a discovered law of nature blocking innovation are arguably already addressed by § 112. Where a patentee discovers a new law/property/correlation/effect/etc and generically over-claims every application of it, those claims will likely be invalid against future applications that were not enabled by the patentee, under § 112 (or maybe even the reverse doctrine of equivalents). For all the scholarship cited in the opinion, were none of the Merges’ articles identifying these solutions persuasive? This is perhaps the problem with having no dissent; nobody in a robe has neatly identified weaknesses in the opinion for us.

Workability and Avoidability of the Judicial Exception Test
A particular aspect of the policy concerns I think bears emphasizing is that the Court did not seem to care how specific or manufactured the discovered law was, but whether the claims clearly recited a limited application of the same. This is a red flag to me, because it puts applicants, examiners, and/or judges in the position of having to identify possible future applications of a discovered correlation in deciding if a claim monopolizes a new discovery. What if a short-sighted inventor discovers a very important and universal property but comprehends and discloses only a narrow aspect of the property and claims an application of that entire narrow aspect? To decide subject matter eligibility, does the inventor, Examiner, and/or judge have to figure out that the property is actually a much broader law such that the inventor has actually claimed only a narrow application of it? Do we just take the inventor’s disclosure as true on the entire extent of the law? Can applicants evade this rule by hiding the discovered property or phrasing it really broadly such that they seem to be claiming only a narrow aspect of it?

This aspect also seems to make opinion’s subject matter ineligibility stance easily translate to any other technology field where a discovered property/correlation/physical effect is incorporated into existing determination methods. I am thinking simulating, forecasting, and measuring methods are particularly susceptible. For example, the first person to discover that certain radioactive elements alter their decay rates based on impending solar flare activity might try to claim a method of predicting solar flares based on closely monitoring decay rates of these specific elements. Invalid claim due to claiming every application of the discovered property as stated, right? You can go on and on with examples like these – a method of predicting oil location based on a discovered vibration resonance in the oil detectable through conventional seismic monitoring; an updated method of calculating surface air temperatures that accounts for a discovered connection between monitoring atmospheric temperature and surface thermal radiation; a method of determining the likelihood of nuclear fuel damage based on a newly realized relationship between low-lying emergency power generators and high water conditions. . . anything that just generates a useful indication from conventional processes updated to account for a newly discovered law of nature. How much and what more do I have to add to such claims to save them? Recite them as machines? (Cybersource suggests even reciting a non-method will not work)

Down with M-o-T
The Supreme Court has now twice dismissed the machine-or-transformation test in favor of the judicial exception tests. The Prometheus opinion specifically finds the test inapplicable here because the recited “administering” step was merely audience-identifying and did not appropriately limit the use of the underlying metabolic correlation. How exactly, M-o-T is useable as a “clue” in the judicial exception test is not entirely clear.

No restraint on § 101
The opinion specifically declines to adopt the government’s position that § 101 issues should be reserved for claims that recite only laws of nature, instead plying §§ 102, 103, and 112 against claims reciting minimal applications of those laws. In the words of the Court, one cannot “substitute §§102, 103, and 112 inquiries for the better established inquiry under §101.” I cannot understand what is meant by “established.”

Increase in Trade Secret Activity
A possible result of rigorous adoption of the Prometheus analysis is that innovators will keep their basic discoveries of material properties, biological reactions, physical interactions, etc. as trade secrets instead of seeking patent protection over tweaks to existing processes based on these discoveries. That’s not to say that these discoveries will never be pursued or disclosed; rather, such disclosure will likely just be delayed until the innovator has a machine or limited process that exploits the property in a valuable way.

6 March 23, 2012 at 1:50 pm

“What if a short-sighted inventor discovers a very important and universal property but comprehends and discloses only a narrow aspect of the property and claims an application of that entire narrow aspect?”

Well I have some good news. “properties” aren’t judicially excepted subject matter so don’t worry your pretty little head about that.

“Do we just take the inventor’s disclosure as true on the entire extent of the law? ”

Are we talking about a property or a lawl? Perhaps a natural lawl?

“Can applicants evade this rule by hiding the discovered property or phrasing it really broadly such that they seem to be claiming only a narrow aspect of it?”

Certainly. Unless someone ciphers out what they’re doing. At which point they get busted. Usually it isn’t that hard to tell what they’re doing. And not only that, but as an added bonus when they try to evade the rule they usually end up just claiming what they actually invented. Which is what the whole debacle is about: getting them to only claim what they invented and nothing more. If they did that in the first place we wouldn’t even be having this conversation.

“This aspect also seems to make opinion’s subject matter ineligibility stance easily translate to any other technology field where a discovered property/correlation/physical effect is incorporated into existing determination methods.”

Physical effects? Pretty sure those aren’t exempt.

“I am thinking simulating, forecasting, and measuring methods are particularly susceptible. For example, the first person to discover that certain radioactive elements alter their decay rates based on impending solar flare activity might try to claim a method of predicting solar flares based on closely monitoring decay rates of these specific elements”

Meh, that 101 is easy to avoid.

“You can go on and on with examples like these – a method of predicting oil location based on a discovered vibration resonance in the oil detectable through conventional seismic monitoring; an updated method of calculating surface air temperatures that accounts for a discovered connection between monitoring atmospheric temperature and surface thermal radiation; a method of determining the likelihood of nuclear fuel damage based on a newly realized relationship between low-lying emergency power generators and high water conditions. . . anything that just generates a useful indication from conventional processes updated to account for a newly discovered law of nature.”

Indeed so, but in each of those cases it is like insanely easy to avoid the 101. You simply will have others trying to design around your specific invention… just as intended.

“How much and what more do I have to add to such claims to save them?”

Depends on the situation.

The one thing that I see that is kind of sort of bad about the abstract idea analysis is this: it makes patent drafting a tiny bit harder and so patent drafters will qq.

“How exactly, M-o-T is useable as a “clue” in the judicial exception test is not entirely clear.

If you have a solid mot chances are you won’t get a 101. Unless of course you’re blatantly trying to capture a judicial exception like Prom did.

“A possible result of rigorous adoption of the Prometheus analysis is that innovators will keep their basic discoveries of material properties, biological reactions, physical interactions, etc. as trade secrets instead of seeking patent protection over tweaks to existing processes based on these discoveries.”

Right because patent applications aren’t already chock full of those even when they aren’t used in claims. /facepalm.

Ryan Alley March 23, 2012 at 2:42 pm

6, thanks for your comments, as always. Just to clarify, when I say “effect” or “property” I mean something like the correlation that was the “natural law” in Prometheus. E.g., platinum has a property of being soluable in aqua regia, and this could be expressed as a law of nature (a la Prometheus) as a correlation between placing the platinum in aqua regia and observing the platinum dissolving.

“in each of those cases it is like insanely easy to avoid the 101. . . . it makes patent drafting a tiny bit harder and so patent drafters will qq”
6, like throwing in a machine, adding an implementation step, or claiming a machine configured to perform the determination? Doesn’t this look like the drafter’s tricks Breyers says shouldn’t get you around 101s? Or do you have to show other ways of exploiting the natural law aside from the claims? Sounds more like an argument than a drafting technique, right?

6 March 23, 2012 at 3:39 pm

“E.g., platinum has a property of being soluable in aqua regia”

So let’s draft a claim to that shall we?

The claim: A method comprising: Forming a solution by dissolving platinum in aqua regia.

^That is tots patent eligible bro. I 100% assure you of this. You will never draw a 101 from the office or the courts.

Don’t think that just because you can bs your way into thinking that platinum’s solubility “can be expressed as a natural lawl” that it is a natural lawl. I’m not even sure how you managed to tell yourself this. But in any event, even if such were the case the “Diehr rule”, shall we say, is going to apply to any decent claim directed to the traditional arts patentable.

” Doesn

Ryan Alley March 23, 2012 at 4:20 pm

6, my argument is directed toward methods of determining, measuring, or predicting. So keep the claims like Prometheus: “a method of determining if a material is platinum, the method comprising: introducing the material to aqua regina; measuring an amount of material solute in the aqua regina, wherein [Pt’s solubility value] indicates the material is platinum.” Still ok?

6 March 23, 2012 at 5:42 pm

Well Ryan if Pt’s solubility value did indicate the material is platinum in such a situation then we might have a good hypo, but since it doesn’t, 112 enablement for claiming something impossible and call it a day.

But even presuming it would work, and since I understand your desire to test out tard ways of drafting, I will say that this claim is probably fine over 101 at least due to the implicit step of having to form a solution to get an amount of solute which would make an indication about the material to even be in the AR in the first place. Which, btw, is a step that any decent examiner would insist on being made explicit using 112 due to the huge gap you introduced between the steps which until filled will also stop you from having an enabled functional method. And then you’re going to include the entirety of the method I drafted in your method as a substep anyway.

If however you don’t want to make that implicit step explicit you might find yourself on the recieving end of a 101 for attempting to to claim the abstract idea (as opposed to a natural lawl) that Pt’s solubility value indicates a material solute in AR is Pt. Indeed, I can pretty well assure you that you would.

It’s easy to draft up bad hypos to test out 101 Ryan, but it is a lot harder to draft up good hypos.

Since I’m the one doing all the pontificating, let’s have you pontificate for a moment, why do patent attorneys, as paranoid as they are, insist on trying to play with fire in this arena by trying to claim something which is not an invention when they could simply claim the invention? Are they simply confuzzled about what is an actual invention or have they simply bought so deeply into the farce that whatever poop they happen to squeeze out is an invention by virtue of their having squeezed it out? Because the attorneys I deal with don’t seem to be under any such delusions. I mean seriously, when I read Prom my mind immediately goes to thinking that “the invention”, if there is one, is the adjustment of dosages based on that little correlation they dreamed up. Yet, in the claim we see no adjustment of dosages. Is the lure to try to make people not even practicing inventions at all into infringers that strong? Is it the lust for power?

Ryan Alley March 23, 2012 at 7:01 pm

6, let’s say we make the dissolving step explicit. And let’s also say that Prometheus made with metabolite-forming explicit as well. Prometheus is now saved? I’m doubtful. The only way to make my hypo 101-worthy and consistent with Prometheus is to say there’s something distinct and insufficiently limiting about administering thioguanine to a patient versus dissolving platinum. But if you don’t like the hypo, what about my solar-flare detecting friend? How does he claim that method as a limited application of his discovered decay rate – solar flare activity correlation?

“Yet, in the claim we see no adjustment of dosages. Is the lure to try to make people not even practicing inventions at all into infringers that strong? Is it the lust for power?”
Lust for avoiding divided infringement maybe. Multiple, distinct health care providers may be running the test and setting the actual dosage. Maybe the Federal Circuit will fix this problem with Akamai? At any rate, I’m in your boat; a better case would have involved claims to an adjustment of dosages (and maybe even an administering of adjusted dose). But I also suspect such a step would have been Flook’ed by Breyer as insig. post-sol. activity.

6 March 27, 2012 at 3:53 pm

Hey sorry I was away there Ryan, was hitting the big boys and don’t have u faved on all comps.

“And let’s also say that Prometheus made with metabolite-forming explicit as well. ”

I’m not sure how making the metabolite-forming explicit would help matters. I’m presuming, in your claim, that nobody has ever formed such a suspension. In Prom the metabolite formation is as old as the administering step. Ain’t going to help brosensky.

“The only way to make my hypo 101-worthy and consistent with Prometheus is to say there’s something distinct and insufficiently limiting about administering thioguanine to a patient versus dissolving platinum.”

Nah bro.

You’re still looking at this FROM THE AR SE WRONG END. You’re looking at it from the end of “drafting a claim” UP FRONT. FIRST THING. Take a look instead to what happens at the END of the patent’s life, aka in a courtroom for infringers. Look at what the EFFECT of the claim as a whole is. Then work your way BACKWARDS instead of going from the drafting FORWARDS as you are currently doing.

“But if you don’t like the hypo, what about my solar-flare detecting friend? How does he claim that method as a limited application of his discovered decay rate – solar flare activity correlation?”

To be clear, I cannot comment on the validity of any apps before the office or issued patents.

No. 1 I never said that he ought be able to claim “that method” as a “limited application”. It appears he has some decent apparatus claims already. If we want to get right down to making the apparatus claims a bit better you could simply tell us what kind of detector you’re using. Then simply make it a method of using the specific detector. Although this is hard to say, because I wasn’t there when whomever drafted this thing abstracted out all of the “invention” in favor of just telling us about the “natural lawl” and then instructing [particle accelerator operatorslol] ahem, solar observers to use that principle to detect solar flares. I notice that they did at least give an exemplary embodiment of a detector. Perhaps if they’d have given the genus of that type of detector it would have been the perfect balance.

That is of course not to say that this application/patent is invalid because of course that is a question for a court.

However, the whole point to this type of caselawl is to prevent people from claiming the whole field, in a certain hypothetical and nonexistant case perhaps predicting solar flares using the change in a decay rate of a radioactive sample that interacts with at least one of a particle or a field and its correlation with the flux of the particle or field is such a field. If these hypothetical yet nonexistent people simply claimed one apparatus they came up with for doing this then it shouldn’t be a problem, indeed, they could just claim apparatuses without even mentioning that it was to be used to monitor solar activity. But as to methods, if they should claim only a specific method of using a specific apparatus then that should suffice. That leaves room for other people to make different/better detectors, and methods of detecting, aka to design around. Without this caselaw, the entire principle of predicting solar flares based on the criteria above may very well be preempt and nobody can draft around that patent to make other detectors etc to use this principle.

However, in certain cases it may have completely slipped some ta rds minds to include the invention along with the correlation etc. so then you have WD problems when you try to amend. Although I’m sure that none of this would relate to any pending applications or issued patents, only to hypothetical cases that don’t exist.

“But I also suspect such a step would have been Flook’ed by Breyer as insig. post-sol. activity.”

I don’t doubt it, but at least they would have had a better case.

6 March 23, 2012 at 3:40 pm

” Doesn’t this look like the drafter’s tricks Breyers says shouldn’t get you around 101s?”

Does the claim I just drafted above look like a drafter’s trick? No, it looks like a legit invention, a method of forming a solution. Wow that took all of like 5 seconds. Learn to draft those and you’ll be ripe as rain youngen.

NalBytes March 30, 2012 at 12:46 pm

This is a good analysis of the case without too much speculation or hysterics. So many other commentors have gone nuclear without waiting to see the how this plays out. But there is some cause for attention, maybe even, concern, as suggested here. I wonder if the best solution for the 101 mess might not be legislative? Perhaps the best way to invoke legislation would be for the courts to rigorously apply Prometheus?

Ryan Alley March 31, 2012 at 1:32 pm

Thanks for the comment NAL. I think everyone is justifiably concerned on this case, insofar as where it might lead. Some might be sensational, but I do not see “hysterics” (yet). Speaking of which, I saw a post on Gene Quinn’s site offering a positive take on the case. I am highly doubtful any statutory changes will be made to patentable subject matter.

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