Source: https://patentlyo.com/patent/2011/11/mayo-prometheus.html
Timestamp: 2019-04-26 05:44:40+00:00

Document:
The briefing continues in this patentable subject matter case pending before the US Supreme Court. (Read Professor Golden's discussion of the first round of merits briefs). In its newly filed merits brief, Prometheus attempts to refocus attention on the "concreteness" of its patented method of personalizing the dosage of a particular drug treatment. The refocus begins with the statement of the question presented. Download 2011-10-31_Prometheus Merits Brief.
Mayo, the petitioner challenging the patent, opened briefing with a question of whether a patent that "covers observed correlations between blood test results and patient health, so that the patent effectively preempts use of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve "transformations" of body chemistry." This language of Mayo's question is directly suggestive of the decisions of Benson and Flook — both of which held claimed methods to be unpatentable.
In its brief, Prometheus restates the question in a way that instead highlights the concrete and practical application language found in Diehr and Brenner v. Manson. Prometheus asks: "Whether the Federal Circuit correctly held that concrete methods for improving the treatment of patients suffering from autoimmune diseases by using individualized metabolite measurements to inform the calibration of the patient's dosages of synthetic thiopurines are patentable processes under 35 U.S.C. §101."
First, most of the claims begin with the administration of a thiopurine compound to a patient with an autoimmune disorder. As noted, the thiopurine converts within the body into metabolites that do not otherwise exist in nature.
Second, the patient's metabolite levels are determined. Because "metabolite levels are not detectable in raw human tissue," all methods for measuring their concentration require "significant chemical and physical alteration of blood or human tissue" and sophisticated laboratory equipment and machines. Some of the dependant claims, for example, specify the use of high pressure liquid chromatography (HPLC), which entails an intricate series of operations on the blood (including heating, centrifuging, separating, and adding various reagents), running the resulting solution through a computer-controlled chromatography instrument, calculating the peak height or peak area, and feeding those figures into an equation, which finally outputs the metabolite levels.
Third, the metabolite measurements are compared to the patents' reference levels, "warning" the physician about the potential efficacy or toxicity of the patient's dosage.
Several important points are hidden by the patentee's statement of its invention: First, although most of the patented claims do require administration of thiopurine some claims do not include that particular step. Second, although current technological methods of measuring metabolite levels apparently require the extraction of human tissue and the use of "sophisticated laboratory equipment," the broadest claims only require "determining" of the metabolite levels. Finally, it is likely important to recognize that the claimed method is about tweaking the dosage of thiopurine and at the time of the invention most of the individual elements of the claim were already well known: It was well known that thiopurine could be used to treat IBD; it was well known that that the body converted thiopurine to the claimed metabolite; it was known that individuals had varying responses to thiopurine; and it was known that dosage should be adjusted so that it would be both effective and nontoxic.
First, to be patent-eligible, a process must really be a process—a series of steps that involve physical action in the real world, as opposed to merely an idea or principle stated in the abstract. Second, that process must be described at a narrow and specific enough level of generality that it does not preempt abstract ideas or basic building blocks of science that go far beyond what the patentee actually invented: A process for using a telegraph is patentable; the basic idea that information might be transmitted at a distance by exploiting laws of electromagnetism is not.
A. Prometheus's patented methods describe concrete methods for improving treatment of seriously ill patients with specific synthetic drugs. These patents do not claim the "correlations" they employ in the abstract, but as part of specific physical processes employing drugs and machines. . . . As the Federal Circuit recognized, the patents-in-suit pass [the machine-or-transformation] test with flying colors and easily satisfy the requirements of §101. Mayo attempts to avoid that conclusion in three ways, none of which has merit. First, Mayo invites this Court to discard the two initial steps (administering the thiopurines and determining the resulting metabolite levels) because they were "well known" in the art. But this Court rejected that "point-of-novelty" approach over 30 years ago in Diehr and again recently in Bilski. Second, Mayo argues that those same two initial steps should be disregarded because, according to Mayo, they are not "central" to the patents' purpose. Mayo does this only by ignoring the Federal Circuit's settled construction that the claims are limited to patient treatment (a question not presented here) and that those two steps are essential to that purpose. Third, Mayo invites this Court to invent, out of whole cloth, a categorical rule that processes ending with the provision of useful information cannot be patentable—even if preceding steps involve machines and physical transformations. That argument also is inconsistent with Bilski, and it would impose an arbitrary and (in the information age) absurd limitation on patentability.
B. The patents-in-suit do not preempt natural phenomena in any relevant sense. Their "correlations" concern certain properties attending certain uses of non-natural thiopurine compounds, which would not exist but for the handiwork of man. A patent system that recognizes thiopurine compounds themselves as potentially patentable subject matter, allowing preemption of all uses of these compounds, cannot be concerned that a process patent may preempt some of their uses. . . .
C. Prometheus agrees with the United States that the Patent Act's express statutory criteria for patentability—under 35 U.S.C. §§102, 103, and 112—make expansive judicial lawmaking under §101, of the sort invited by Mayo's arguments, unnecessary. But the application of those provisions is not before the Court in this case, and presents difficult and fact-bound questions that the lower courts should address in the first instance on remand.
II. Mayo proposes to transform §101 into an invitation for ad hoc, case-by-case evaluation of whether granting a particular patent will promote or retard the progress of the useful arts. That would create an unadministrable morass for courts and patent examiners, doom any hope for consistent administration of the patent laws, and usurp Congress's authority to determine the appropriate scope of the patent laws.
III. Any change in the Court's §101 jurisprudence that permitted a ruling in Mayo's favor, on whatever grounds, would have drastic and unfortunate consequences. It would upend settled expectations by invalidating thousands of diagnostic and personalized treatment patents. And it would stifle investment and innovation in the nascent field of personalized medicine. Contrary to Mayo's understanding, government funding does not translate pure academic research into practical products that benefit patients, and doctors themselves cannot bring to bear the resources necessary to fuel innovation and commercialize inventions on a large scale. Mayo's contention that patents like these hinder medical care is also unpersuasive. The United States is the world leader in biotechnology and personalized medicine, in part because investors have committed billions of dollars in capital in reliance on the prospect of patents like these. Thousands have been issued, including many to Mayo itself. Mayo's short-sighted view would exchange long-term innovation (including cost reductions) for ephemeral savings. In any event, Congress already considered Mayo's invitation to broadly restrict patent protection for medical diagnostic and treatment methods—and chose to adopt a limited personal immunity for doctors instead.
Excellent and insightful site. Great info, thank you very much for sharing!
Simple, I do. That is why I agree with the government position that novelty should be handled under 102.
If you check the a few convo’s between Malcolm and I on this issue, he seems to agree that lack of novelty has to be established first under his approach. Here, Prometheus has admitted that everything in their claims is old but the mental steps. Everything. So is this a section 102 case, or can we decide the case on section 101 as well?
What I think is that if you frame the issue of patentability as a general issue under 101/102/103/112, and then ask whether the subject matter is patentable under the statutes taken as a whole, we wouldn’t have to get into whether we need to do section 102 before we do section 101. Somewhat, this is what the Stern brief actually argues.
Are you missing the point of”This is pure conflation from the get-go” with a comment like “the result is the same“?
Isn’t legal thinking of “the result is all that matters” the same as dust-kicking?
You know anon, I somewhat agree with the point that novelty should not be part of the section 101 analysis. However the brief does appear to handle that point deftly.
Regardless, if one moves the novelty analysis into section 102, as does the US government brief, the result is the same. It will be interesting to see just how the Supreme Court handles this section 101/102 issue.
HELLO! – 101 is not the novelty test. The courts should not indulge in such “whatever” comingling of the statute. The courts exist to serve clarity of law – not obfuscation. To buy into the crrp that this brief puts forth is to kick up the dust and operate in the murky cloud, rather than seek clarity.
This is pure conflation from the get-go. We have been through the wrangling about the need not to conflate, the need to actually present the legal arguments on 101 according to what 101 actually stands for and to avoid the intentional conflation of 101 and 102.
Lastly, I my “weasel” alarm went off with MM’s post of “As with Bilski… Sadly… What a debacle” – these sound like MM is laying the ground work for a (shudder) loss with the upcoming decision with his reference to shaming loss in Bilski, the shame clearly seen from his actions following the Bilski decision, his underground for months after that decision, the rise of the Diehrbots and the point-blank azz kicking he and Ned have recieved on these threads for their mistaken stand on what the law IS that has been going on for more than a year.
Although I have told you exactly how I feel. And as many times you have either ignored me or changed the Helm.
The design around Patent has now morphed. And that is not even my biggest complaint. My biggest is Mine has “EDGES” Kent does not. Kent works from the North! I work form the East and West! Just like Ruffles have ridges Potato Chips do not. And that is a complete difference, not a design difference. Because edges make it different. It allows means to be mounted if necessary. And because mine came first! And if you continue to say it didn’t Mine is different!
Thanks, Ned. As you anticipated, I agree with the brief fully. And I note that Prometheus’ response doesn’t begin to address the arguments raised in the brief. And I know why: it’s impossible to do so without revealing the incredibly poor hand that Prometheus is holding right now.
As with Bilski, we can only assume that the people “in charge” who are insisting that Prometheus press on with their unbelievable horseshxt are doing so only because they have so much additional horsexxxt in the pipeline (and so little else) that it’s impossible not to. Sadly, it won’t be Prometheus that ends up looking the fxxl but the Federal Circuit. What a debacle.
IBP, for Shilling purposes, you might want to tell him whether your analysis fits within the Diehr definition of claims as a whole.
Essentially, this requires that all elements be considered new as one cannot isolate old from new and only consider the new.
This is why I asked you to consider the government’s approach in my post below. A series of physical steps (all of which are old) that produces a useful result is patent eligible under 101. But, when you get to 102/103, where you look at differences between the prior art and the claimed elements, you can ignore mental steps that are “appended” (means added to the end of, I think) for novelty purposes.
The Shilling, actually the Diehr court said what it meant about “claim as a whole” in 101 sense. It said one could not look for a point of novelty, i.e., identify the only new feature being the program or the mental step, and then ignore the old steps. For 101 purposes, the old steps have to be considered.
This is why I think the approach of the government brief may be the correct approach, all things being considered.
Why don’t you try including some real analysis of this instead of just blather?
What exactly do you think “as a whole” means, within the context of a process claim?
A process is just this: a beginning, a middle, and an end–that IS the “whole” claim. Or, if you prefer, a start point, a journey, and an end point.
Consideration of the start point, the journey, and the end point IS consideration of the claim as a whole, and not focusing on any individual limitation in isolation, to the exclusion of others.
Completely contained within the first step can be a corporeal start, and an abstraction. Likewise, completely contained within the last step can be a concretion from the abstract to the corporeal, with a corporeal end.
The 3 phases are the beginning, middle, and end. The beginning is NOT the first step, but rather the beginning of the first step; likewise, the end is NOT the last step, but rather the end of the last step.
No claim step is treated in isolation, and the division between claim steps is totally eliminated for the purposes of my analysis.
Furthermore, the “corporeal” concepts of the beginning of the first step and the end of the last step, and the “abstract” concepts between those 2 points, are 2 species of the same genus of identity–corporeal being that which is not abstract, and abstract being that which is not corporeal. The identity in question is the nature of the characterization of the object upon which the claim is working at any particular instant, which is a continuous identity with a continuous, but varying, manifestation.
I enjoyed reading the bit about Marie Antoinette. It seemed she had a tin ear about public opinion, especially when she reported gives birth exactly 9 months after a certain Swedish count visits Versailles, spends lavishly at time of high national debt, parties when the people suffer, and openly champions the causes of the of the enemies of the Revolution.
All first ladies should take note.
Malcolm, if you haven’t read this brief yet, you should.
It obviously was written by Richard Stern who is of counsel to the firm signing the brief. It supports your views on Prometheus 100%. It also supports everything else I personally have been say on any number of topics for a good long time.
Either I have been channeling Richard, or he and I see eye to eye in general.
Is there anything else where we have had long running battles?
No reading required? The only people who didn’t read are the ones posting in re my comment. The petition was to end software patents. The response was “hur hur but quality” and had nothing to do with software patents. They made one reference to “software-related” patents but not “software patents” themselves.
The only one not reading is u “shilling” or “AI” or whatever reta rd name you want to call yourself.
Oh I read them and the bs response. Software-related inventions are not patents on software tardface. Which is what the petition is about.
I don’t think anyone said anything about demanding “quality patents” in the petition. They simply spouted off about them as a sound byte in the response. Learn to read yo.
Yes, Ned, because what you have to say is SOOO worthwhile.
And note: you surely cannot claim to ever attempt serious conversation, given your penchant for “cut and run,” non-answering of questions, and blatant, even obscene misrepresentations of law.
You want serious conversation? How about “taking that log out of your own eye” first? With the shear proclivity of your posts, that little bit of effort will indeed go quite a long way.
Will any such constructive steps happen?
Not. A. Chance. After all, these are the Shilling Grounds.
More like To-may-toh, po-tah-to – you are not comparing the same things.
Leave out “the sense” portion and deal with the actual claim. Trying to induce some mystical “sense of” the claim is a blatent overstep to the realm of the subjective. Not needed. Not desired.
The “point of novelty” is the entire claim, read as a whole.
Embrace what the full 101 scope of law is. Funny thing that – the constant repetition of the truth is (sadly) required to combat the constant repetition of the l_ies.
I’m not ignoring you Ned, I’m just busy and will try to get to this later.
I wrote that other piece quite some time ago, in some haste, and I might improve it a bit at this point–however, the idea that the last step must be an action performed on a corporeal object is in there, and necessarily occasions, at some point in the claim, an abstraction FROM that corporeal object. I conceived of that as happening in the first claim, and I’m not sure that is incorrect, I just don’t have time to think about it right now.
However much I agree with you that the claim must be treated as a whole, every process claim reveals a trajectory from a start point to an end point. Taking a look at that OVERALL trajectory in terms of a single dimension–the character of the object of the claim at any particular point in the trajectory–and seeing if the claim begins and ends at the same object character–IS treating the claim as a whole.
As a whole trajectory that is, in an overall sense.
Shilling, as always. You have nothing worthwhile to say. You do not even attempt serious conversation. All you do is troll.
6 continues to marginalize himself in his fawning to his would-be tech dirt friends.
He sees an “anti-software patent” post and jumps into the lemming herd on the march to the cliff edge.
No reading required. No thinking required.
I feel the same way after reading your posts.
We are being spammed with a vengeance.
If the latter, do you agree or disagree that all such functional claiming must also comply with the rule of construction of 112, p.6?
The same can be said about those seeking Prior User Rights, that cost the original Patentee a lot of money, but where the Prior User Right holder is not willing to pay but is willing to receive the benefits.
I will now step off of my soapbox and return you to the trainwreck in process.
IBP, see my post below at 7:50 pm.
Hence, does a Bear really poo on the side of the road and kick it in? Do you really think a falling Tree makes no noise? Do you really think they control and allow themselves to be penalized?
I do suggest that if they are going to play the Game, they play it in a more fair way.Locking me in the very Tower that took over is unfair! And then using dasterdly means yourselves has torn apart the very Fabric of which I came. FREEDOM from all is my Goal. You see I even have Goals. Why? Because I am a Human Being that you decided was not Human nor worthy.
lasted, the South had a hard time funding the war because there really was no national government that could impose its will on its member states.
The Euro experiment has once again shown history that there really cannot be fiscal union without political union with a strong national government running the finances.
The same can be said about military alliances (read Nato) that cost a lot of money, but where not all are willing to pay but all are willing to receive the benefits.
The qualities of numbers was one such cultural understanding. The first number that springs to mind with most crystals is 6. Most of us will have seen a common quartz crystal, each and every one has 6 sides. In cross-section they are hexagonal, at the molecular level they are hexagonal. As science slowly abandons the idea of particles of substance, in favour of energy waves and patterns, they are seen as hexagonal geometrised light-energy.
Another aspect of claim language that the “empty wagon” crowd just doesn’t seem to get. “In fact, § 112, ¶ 6, expressly authorizes a form” – “a”, not “the”, as in, there is more than one permissible way than just “means”.
not have the force and effect of law.
is these rejections that are appealable.
Ah, yes, the weasel clause. You just have to love the careful stepping around the APA.
In other words, it is not a 101 issue. It is a 102/103/112 issue.
Hmmm… – 6, are you sure you have actually read these links?
Thank you for the links. I have only read through the first one and I am not sure that you quite understand what the proposition is.
Anyone with any real world experience knows that you cannot inspect in quality. Post-work inspection only reveals (at best) the lack of quality in the first place.
In other words, and as has been harpooned as “mere yelling of DO YOUR JOB,” the call for quality patents is a call for the inspectors to DO YOUR JOB.
Inspection. The buck stops with the inspectors.
Never mind the destination, isn’t the train ride lovely?
Because secrecy is the aim of the patent system.
“Q: How do we determine if a process is patentable under 101?
At least IBP was upfront about his willingness to repeat a l_ie so often that it would appear to be the truth.
Careful IBP, becuase when you leave telltale signs of who is thinking what, it is easy to take out the underpinnings of the l_ie.
Diehr expressly says: claim as a whole – you may not divide the claim and analyze piece by piece in the Stevens mode.
Ned, it is sometimes asserted that a thread here is a “trainwreck”. But the Euro is a real trainwreck, as the UK has warned all along.
But boy was the ride fun, while it lasted.
Fun for the big banks in France, lending unfeasibly large sums south of the Alps, knowing all the while that the Government of Germany was effectively guarantor of all. Fun for voters south of the Alps, enjoying unfeasibly large pensions and buying nice German cars. Fun for German industry, exporting unfeasibly large numbers of nice cars, and unfeasibly large amounts of capital goods to China at prices set by a currency that is held low by all the underperforming Mediterranean waggons being dragged along by the German locomotive.
What next? Will Germany (which, by the way, was first to break the original Euro club rules that Germany imposed at the outset on the other club members)stay with its Mediterranean club or will it form a new club of law-abiding tax-paying nations north of the Alps?
If only democracies could arrange for responsible, intelligent and public-spirited persons to be minded to stand for election, and if only voters were intelligent enough to distinguish them from the trough-feeding scoundrels that have offered themselves for election in recent times. For those in government circles in China, it must be very educational, to watch such acts of self-destruction. It’s enough to put anybody off democracy.
The truth is I got the College participation, but I didn’t get that they were hired to design around. I didn’t know this… until I woke up. All this BS kept me from understanding the Algebra question.. as to just how much they were involved.
I suggest my next Idea free and clear… is built by a Technical College for me.. which will result in 10% spread around for all Technical College Scholarships. Allowing full Scholarship to as many as it affords. Although I know who I can get to build it right this minute, this is a better idea. This Patent Idea is HUGE! I will be willing to share it too.. But listen I’m getting really upset here. I am almost 60 tick tick tick tick.
If C gave T an Idea. And T showed S and that by way of SNEAKERY resulted in U+T making K+E+N+T. And they through no fault of their own are right in the middle.. Then leaving C out of the discussion will result in Circular Jerking which will result in a larger M+E+S+S.
Which to me is D+U+M+B!
My nickname for gene quinn. The full nickname is Eugenemus Decimus Quinnius.
Note it was one of the first few responses. Gathering thousands of sigs in a day and got a response before it even hit 25k.
New one is already up.
I seem to recall a leader that once replied similarly to a question put to her.
It would seem prudent for all who love the patent system to sign all petitions I just posted.
I’m pretty sure that Axel Foley would never have been created absent the intellectual property protection afforded by copyright.
Answer: absolutely nothing. It is just another red herring designed to obfuscate and divert attention from the real issue.
Prometheus’ merits brief is full of such red herrings.
What’s that saying? If you can’t dazzle them with logic, baffle them with b u l l s h i t ?
Fukin seriously. Kev constantly bemoans the end of inovation in BIO without patents on this or that biological specimen. How about some real mo fin’ useful arts sht going down in BIO? Let’s hear about some of that going on.
I had a BIO professor try to sign me up on his staff when I was a wee little thing just out of college to build him a special sensor the likes of which were unknown to this earth at the time (he was a formost expert in the field so I presume he wasn’t lying). Not that I wasn’t interested in the work, but I didn’t like the guy that much and didn’t want to work for him. Still, that would be something I’d be glad to give a patent for when he got it finished by someone else.
Been saying this for years. The correlations will be discovered with or without patents. Once the correlation is discovered, it is a matter of routine development to get a product (home brew test or kit) on the market. I said “routine,” I didn’t say cheap, although compared to an actual pharmaceutical or biological, it really is cheap. The technology utilized to actually determine the presence/absence/amount of the “marker” is really where it’s at. That technology VERY WELL might not be (or have been) developed without the existence of patents.
The only suspense in my mind is how the voting goes. I’m sure it won’t be 9-0, but I’ll be disappointed if it’s less than 8-1.
Some of the stories suggest that such a default would trigger bank failures generally, and would make lenders who still have liquidity, such as China, reluctant to lend any further into uncertainty.
Or we can just keep bailing out the banks forevah. Because that works so awesomely as everyone knows. What other scary things will happen if the banks take a 75% haircut? Will the politicians who represent the bankers start telling the poor and middle class that they need to start making “sacrifices”? LOL.
Greece should have defaulted months ago.
I’m talking about machines like cheap, hand-held devices for “instantly” measuring relevant clinical information, determining a “genetic fingerprint” and the like. Of course, merely because the data is obtained or processed by such a “hand-held” machine should not make the information or even the basic algorithms for running the computers in such devices (“if DNA sequence X present, turn on indicator light”) patent-worthy (but count on the USPTO to fxxx that up). It’s the novel machines themselves, the novel, non-obvious arrangement of their physical parts that’s critical. It’s THAT technology that will really assist in “personalized medicine” and it’s THAT technology that is appropriately promoted with our patent system.
Patenting the information itself will accomplish nothing beneficial (unless you’re a lawyer or otherwise invested in the patent-system in an extraordinary fashion). The information will be obtained without the patent system.
Malcolm, I don’t want to divert attention to much from the interesting topic at hand, but how do you feel about the pending Greek bankruptcy where the dept holders, such as most of the world’s big banks, would take a 75% haircut? Some of the stories suggest that such a default would trigger bank failures generally, and would make lenders who still have liquidity, such as China, reluctant to lend any further into uncertainty. The result might collapse the economies of Europe, and potentially here as well.
I know you railed against bailing out Wall Street. Are your views the the same now?
doctors themselves cannot bring to bear the resources necessary to fuel innovation and commercialize inventions on a large scale..
What does this have to do with Prometheus’ claimed invention??? The only novel “discovery” in Prometheus’ patent is a simple FACT, one that requires ZERO amount of “commercialization” in order for it to be immediately valuable to doctors. To infringe Prometheus’ claims, practitioners of the prior art (in this case, lab technicians reading results of blood tests) need not do anything different from what they’ve been doing for years EXCEPT to have read and understood the published, unpatentable information dislosed and dedicated to the public in Prometheus patent.
Mere publication of the unpatentable information is all that is necessary for doctors to practice Prometheus’ invention “on a large scale.” If Prometheus wanted to prevent that from happening, all they needed to do was keep their discovery secret. If Prometheus wanted to make money off the invention, they should have made a deal with a kit manufacturer to come up with some sort of “instant read” device and market it to doctors with the usual zeal that companies use to market their latest bxxshxt.
And, IBP, can you be just a bit more concise?
A machine, article or composition that has utility is patentable as such.
I understand Prometheus’s argument to be this: the process claimed is a series of physical steps. The result is useful. So where is the 101 problem?
The government agrees, but goes on to suggest that the problem here is that all the physical steps are old and the appreciation of the results of the physical steps, not being physical itself, cannot define over the prior art for novelty purposes.
Why is the government wrong?
Since the body has an existing pathway to produce the metabolite, this statement is almost certainly a lie.
In any event, this is not new. People have been administering drugs and gauging their effects on patients and thereby adjusting dosages for decades at least. Patent lawyers and judges are so busy playing their fun word games that they completely lost sight of reality.
Since it is obvious that greedy corporations and word-game-playing lawyers will corrupt any possible patent system, and since patents obviously have no value whatsoever, then patents must be eliminated. Completely. Forever.
The usual “but no one will ever create anything without patents” is the biggest lie in the industry. Obviously false, it is trivial to prove that such a statement is untrue. Claiming that the wheel and axel could never have been invented and therefore must not exist is hardly a valid reason for granting patents.
But but but these are medical method patent claims reeking of such failure. What do we do? Ban all medical method patents?
Prometheus should have cited Obama’s Memorandum from last Friday in support of that statement: link to patentdocs.org.
Experiments during which rocks containing crystal structures are put under pressure has demonstrated that electrical and chemical processes occur whereby light energy and other types of EM radiation can be triggered. It is thought that in the landscape such Earth energies can generate visible glows and moving light balls over areas where underground strata are under pressure, from reservoirs or fault lines for instance. UFO researchers have independently identified ‘window areas’ where sightings seem partic­ularly common and these appear to match locations with predicted geological attributes.
Several important points are hidden by the patentee’s statement of its invention: First, although most of the patented claims do require administration of thiopurine some claims do not include that particular step. Second, although current technological methods of measuring metabolite levels apparently require the extraction of human tissue and the use of “sophisticated laboratory equipment,” the broadest claims only require “determining” of the metabolite levels. Finally, it is likely important to recognize that the claimed method is about tweaking the dosage of thiopurine and at the time of the invention most of the individual elements of the claim were already well known: It was well known that thiopurine could be used to treat IBD; it was well known that that the body converted thiopurine to the claimed metabolite; it was known that individuals had varying responses to thiopurine; and it was known that dosage should be adjusted so that it would be both effective and nontoxic.
This is a beautifully written summary of the prior art. Well done!
Of course, this sort of weirdness is inherent to claims that smell so strongly of 101 failure.
The United States is the world leader in biotechnology and personalized medicine, in part because investors have committed billions of dollars in capital in reliance on the prospect of patents like these.
Maybe those investors should find some better lawyers to advise them because a lot of us practicing in the field have recognized the 101 issues raised by claims such as those of LabCorp, Prometheus, Classen and Myriad for a long, long time.
Completely untrue. Government-funded researchers are continually translating “pure academic research” into novel, practical products that benefit patients. And they file patents on them, too. All. The. Fracking. Time. They just don’t commercialize them.
And let’s face it: the last thing that most “inventors” in the area of “personalized medicine” want to do is commercialize a “practical product.” The “discoveries” in nearly all of these inventions (including the inventors on Prometheus patent) are pure, abstract information (i.e., “presence/level of X correlates with Y”) and it is that information alone that is of value to anyone. A claim to a “kit” to identify “the level of X”, for example, is going to be “worthless” because it’s trivial for the institutions to work around or design their own based on the well-known prior art methods of identifying the level of X (you know, the same old methods that are invariably listed in the boilerplate of such patents).
And a great deal of “personalized medicine” “discoveries” is are made simply by running programs through data (e.g., sequence data) that was produced by government-funded “pure academic research”. Why in the world does Prometheus believe that companies will stop engaging in such activities if they are not granted patents? It’s sweatless work and it’s getting easier to do all the time. The only real roadblocks that present themselves to researchers are those arising from these ridiculous patents that should never have been granted in the first place.
This is absolutely true, IMHO.
They don’t have to take any action that furthers the “stated goal” you tard. I swear to go d. People like you should be held back a grade until you learn some basics about the lawl you want to practice in lawlschool before you’re allowed to gradumacate.
Someone seems to be taking for granted that thiopurines are patent eligible.
But, even taking that for granted they are of course correct that such would in theory preempt all applications of using them. To be sure, a patent claiming a surely eligible product can do so. However, even with the product the question would still remain as to whether or not the way the applicant attempted to claim the product was permissible and made for patent eligible subject matter without stumbling into improper drafting such that they are just claiming an abstract idea. The issue, (just as it is with software as a matter of fact), is not in whether or not a computer or a thiopurine is patent eligible subject matter, but rather whether or not the manner in which the applicant chooses to claim it has been done properly or not. Like I have stated a hundred thousand times, the issue is drafting, and tards trying to capture abstractions by clever drafting instead of inventions.
Indeed, Eugene just posted a little article demonstrating exactly what is the matter. It is a fundamental misthinking on the parts of certain tards. Almost, if not entirely, a different patent world-view from that which is the proper patent world-view.
Except when you sue someone practicing the prior back because they are “thinking” a new thought about the result that the prior art provides. Which is exactly what Prometheus did.
COMPLETELY IRRELEVANT! “INVENTION” AS DISCLOSED IS WHOLLY INOPERATIVE!
What do chemical and biological patents have to do with THIS patent?
Mayo invites this Court to invent, out of whole cloth, a categorical rule that processes ending with the provision of useful information cannot be patentable—even if preceding steps involve machines and physical transformations.
I didn’t see that in Mayo’s brief. It’s certainly not necessary to fashion the rule that broadly and still find Prometheus’ claims (and any claims similar to Prometheus’ claims) invalid under 101.
One wonders how any chemical or biological patent is ever granted these days.
You might wonder that but I certainly don’t, nor do my clients.
Some of the dependant claims, for example, specify the use of high pressure liquid chromatography (HPLC), which entails an intricate series of operations on the blood (including heating, centrifuging, separating, and adding various reagents), running the resulting solution through a computer-controlled chromatography instrument, calculating the peak height or peak area, and feeding those figures into an equation, which finally outputs the metabolite levels.
Another pathetic joke. By biotech standards, HPLC is ancient history. I wouldn’t be surprised if there are a few high schools in the US with decent HPLC equipment.
Again, there is never any action taken that furthers the stated goal of maintaining the 6-TG level and thereby optimizing therapeutic efficacy—that is, therapeutic efficacy is never actually optimized.
The “invention” disclosed is wholly inoperative.
Hey now, it’s not out of “whole cloth”–I articulated the broader rule, of which their “categorical rule” is but a subset, a long time ago on patently-o, and re-stated it more than once on patently-including a year ago.
Not only that, but I provided detailed reasoning to support the broader rule, so it is demonstrably NOT made up out of “whole cloth” as Prometheus would have the court believe.
“You know, even in Flook, Stevens J. writing for the court favorably cited Tilghman v Proctor for the proposition that a “patentable ‘process'” is a “conception of the mind, seen only by [its] effects when being executed or performed”.
Q: How do we determine if a process is patentable under 101?
A: We divide process steps, or acts, into 2 categories: 1) tangibly (corporeally) manifested, and 2) intangibly (incorporeally) manifested, and then check to see that at least both the first and last steps of the process are of the tangibly-manifested, or corporeally-manifested, kind; if they are, the process satisfies 101–if they are not, the process does not satisfy 101.
Let’s consider 2 different process steps to illustrate the above: a) the act of REMOVING (as in removing material by machining), and b) the act of DETERMINING (as in determining which of 2 temperatures is greater).
REMOVING is a tangible step, while DETERMINING is an intangible step. A simple test to make this determination (ha!) could be something like considering the noun upon which the verb operates: “removing…material”, while “determining…relative magnitude”. Material is corporeal, whereas relative magnitude, or even just magnitude, is not.
I don’t think there are necessarily any hard grammatical rules here, the determination of tangible or intangible rests upon the context in which the verb is used. Precision in language is required–something in which all of us patent attorneys should be expert.
Really think about this construction, and you will see how it could work. AT LEAST BOTH THE FIRST AND LAST STEPS OF THE PROCESS MUST BE OF THE TANGIBLY-MANIFESTED, OR CORPOREALLY-MANIFESTED, KIND.
Intervening steps could be of either kind or both kinds, in any combination.
They could be “concrete” or “abstract”, it doesn’t matter, so long as any abstraction is included as a step–for instance, if you describe your coding, any manipulation of a resulting signifier is equivalent to manipulation of the signified, just maybe easier, or faster, etc..
BUT THE FINAL ACT MUST BE PERFORMED ON THE SIGNIFIED.
SIMILARLY, I THINK THAT THE FIRST ACT MUST BE PERFORMED ON THE SIGNIFIED, AND ANY SUBSEQUENT ABSTRACTION MUST NECESSARILY BE INCLUDED AS A STEP.
If the first and last steps are tangibly-manifested, the loop can be closed–it doesn’t matter if the signified is abstracted for a while during the process.
I said before that an ALGORITHM is not abstract when it includes a final step that includes a numerical solution that signifies an amplitude, a direction, a combination thereof, or a set thereof, of either a tangible object or a value on a standardized scale that is itself a signifier of an underlying physical phenomenon (e.g. temperature), and when the signified is acted upon automatically as a result of said numerical solution.
Physical action on an object would be required for non-abstraction, and there could be no decision-making step between the solution and the action–it would have to be automatic. Thus, the action would necessarily have to be incorporated into the algorithm as an essential step. That is why THE FINAL ACT MUST BE PERFORMED ON THE SIGNIFIED.
I think that the first act must also be performed on the signified to justify any subsequent abstraction, and to definitively establish the correspondence of any resultant signifier with the signified. For instance, if you need to know the dimensions of a block you will be machining, you will do something physical such as bringing a calibrated rod into contact with a relevant linear portion of the block, or bringing the stylus of a surface profiler into contact with the surface of the block. Any resulting number or set of numbers are then signifiers that have a defined relationship with the signified, which earns any manipulations of those numbers or sets of numbers a pass, provided that they are decoded back into a tangibly-manifested or corporally-manifested act. THUS, THE FIRST ACT MUST BE PERFORMED ON THE SIGNIFIED IN ORDER TO JUSTIFY INTERVENING STEPS THAT ARE PERFORMED ON ANY SIGNIFIER.
disorder is “inoperative” you tard? You’re aware that no specific utility need be fulfilled so long as some utility is. And I can assure you that some utility is provided by what I just recited. Even if you’re too dum to see it then please don’t be dum enough to not stfu.
Ah, yes, the obligatory “settled expectations” argument.
For the expectations to have been TRULY “settled”, any applicable agreements would include language to the effect that the agreement would continue notwithstanding any future finding of invalidity or unenforceability of any underlying patent.
Other than that, NOTHING is settled.
What a bunch of bunk–but the courts buy into it, nonetheless–hence the obligatory nature of the argument.
It is never used as the central reason for a decision, but it is sometimes useful to buttress a particular holding.
Dkt.45 at 194-95 (discussing 1995-1998 study period).
The USSC reads this as … the doctors determined that a dose that results in x should be thearpeutically effective and nontoxic so they decided to patent it and the usage thereof. This is that case, and Promethius loses.
Good news is, this case won’t take as long as Bilski did to come out.
Except that one way that I pointed out explicitly in the first thread on this topic.
I can’t wait for the USSC to hear the case and for them to jeer at Prom.
Why do I sense another multi-hundred thread trainwreck?
– “most of the individual elements of the claim were already well known” – most, but not all? most, but not in the actual combination claimed?
One wonders how any chemical or biological patent is ever granted these days. After all, the elements have been known since when? the action of molecular bonding has been known since when? Why not just whip oout that magic microscope, zoom into the desired level and exclaim – see, this acts just like it is known to do (at this level).
Is there any wonder why the good Professor is confused when attempting to teach 101 patent law? It must be confusing to not understand why one’s own viewpoint isn’t law.
Alas, as I have noted earlier today – this blog is indeed the Shilling Grounds.
Not surprising that the academic IANAE does not recall that which he does not want to recall. It only has been plastered onthese threads in response to those who find Bilski “confusing” – what was that phase? Bilski 4?, Bilski 24?, Bilski 34? something like that anyway. Perhaps you too won’t be confused if you actually read Bilski (and Diehr) with an open mind.
Back to the Tower with you Both!
“This case presents not a patentable-subject-matter issue, but a simple utility issue.
“Method steps require ACTIONS to have an effect in the real world. At some point, the “wave function” of abstracted steps MUST collapse into an ACTION step in order to avoid the fatal quality of abstraction. The claims never recite any ACTION that “optimizes therapeutic efficacy”.
There is never any action taken that furthers the stated goal of maintaining the 6-TG level and thereby optimizing therapeutic efficacy—that is, therapeutic efficacy is never optimized.
THE CLAIM FAILS 101 FOR A LACK OF UTILITY.
I feel better now, the dizziness is gone.
I didn’t realize Flook was inconsistent with Bilski. Neither did the court in Bilski, as I recall.
I’m going to work at analyzing their arguments within the framework of my own 101 paradigm, which I believe comports well with, and is justifiable, under existing law.
Wait, haven’t I done that already?
OK, I’ll weigh their arguments against my determinations, then.
Hey, we’ve all got to look at this from SOME starting point!
The court will choose its starting point, I choose my own. We’ll see whose determination is better for the patent regime as a whole.

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