Mayo v. Prometheus: Medical Methods and Patentable Subject Matter at the Supreme Court

Mayo v. Prometheus Labs., (on petition for writ of certiorari 2009)

The Mayo Clinic has filed a petition asking the Supreme Court to hear its case challenging the patentable subject matter of Prometheus Labs' patents that cover a method of optimizing the dosing of a drug. U.S. Patents 6,355,623 and 6,680,302.

The invention basically offers an iterative approach to dosing that involves three steps: (1) administer a drug to a subject; (2) then determine the level of drug in the subject; and (3) decide whether the next dose should be the same, higher, or lower. The decision on the next dose is made by comparing the the level of the drug in the subject against predetermined thresholds. Claim 1 of the '302 patent adds additional detail including identifying the active ingredient (6-thioguanine), the diagnosis (a GI disorder), and the predetermined thresholds (e.g., 230 pmol of drug per 8108 red blood cells). Claim 46 of the '623 is a broad claim in that it does not not require the administration step (step 1 from above).

Broad Functional Language: You'll note that the claims are written in broad functional language without tying the the claimed methods to any particular technology. Thus, the "administering" step could potentially be accomplished by any effective method (that has or will be invented) of getting the drug into the subject. Likewise, the patent offers potential methods of "determining the level" of drug in the body (e.g., liquid chromatography) but the claim is broadly written to seemingly cover any mechanism that fulfills that method.

Novelty Involves the Mental Step: Of course, the general iterative process is well known, what makes the Prometheus claims novel is that they identify the particular thresholds that are important (e.g., 230 pmol). In practice, the process of comparing the thresholds to the subject's drug level is done in the mind of a physician. As Mayo explains, this merely involves the physician's mental recognition of a natural correlation between metabolite levels and patient condition.

With these facts in mind, Mayo presents the following question: Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations.

The Federal Circuit held the method patentable under its Bilski test by finding that the required administration of the drug transformed an article into a different state or thing -- essentially creating a per se rule that a method requiring administration of a drug will be deemed patentable subject matter under Section 101. The court also held that the "determining the level" step was necessarily transformative since "those levels cannot be determined by mere inspection."

Chances for Supreme Court Review: The fact that Bilski - another Section 101 case - is already pending before the Supreme Court does not mean that the court will reject this case. Rather, the court has often granted certiorari in tandem. The Supreme Court has regularly used case clustering in the past when considering patent issues: Nonobviousness (John Deere (1966), Adams (1966), & Anderson's-Black Rock (1969)); Patentable subject matter (Flook (1978), Charkabarty (1980), Diehr (1980)); Prosecution history estoppel (Warner-Jenkinson (1995) & Festo (2000)).

The case also represents a growing trend of pitting patient advocates (who want cheaper access to medicine) against innovators (who create better medicine).

Notes & Documents:

• Read Mayo's Petition for Certiorari: MayoCertPet.pdf.
• Mayo is represented by Fish & Richardson (John Dragseth); Mayer Brown (Stephen Shapiro); and Professor Eugene Volokh (UCLA).
• Professor Collins discusses the Federal Circuit decision
  
• My initial discussion of the Federal Circuit decision

Claim 1 of the '302 patent: 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 a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder,

   wherein a level of 6-thioguanine less than about 230 pmol per 8108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

   wherein a level of 6-thioguanine greater than about 400 pmol per 8108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Comments

[BTP]

Can/did Mayo demonstrate that physician observations were used before the critical date of the patent? (I'm guessing not, else we would not be at this stage.)

[Malcolm Mooney]

"The case also represents a growing trend of pitting patient advocates (who want cheaper access to medicine) against innovators (who create better medicine)."

More accurately, "innovators who create 'new' medicine". There is no requirement in the PTO or at the FDA that a "new" medicine be "better" than existing therapies.

This is why you see so many ads on TV trying to persuade you that taking one of these new drugs will make you happier (buttheremaybesomesideeffectsmentionedifyoulistencarefully) and why massive amounts of money are spent by drug companies trying to persuade physicians to prescribe their new (but not necessarily "better") drugs to patients. These advertising costs, of course, are passed onto consumers.

But this case is not about a "new" medicine, but really about an allegedly new "way of thinking" about the effects of a previously known treatment protocol. In other words, the patentee published a scientific fact (in its patent application) and now apparently wishes to prevent others who learn of this fact from thinking about the fact and from acting rationally upon the fact.

As far as I can tell, there is little or no evidence suggesting that the "new" facts published by Prometheus would not have been recognized in due time. The "incentive" of a patent was not needed to promote this discovery but the existence of the patent certainly serves to impede exploitation of the discovery. Everyone knows that drugs are metabolized differently by different patients. It goes without saying that doctors and clinics will work with their patients to optimize dosages of old drugs. The only reasons doctors and clinics would not optimize dosages would be (1) patents preventing them from doing it; and (2) a desire to keep dosages high so they could prescribe more and earn money from sales or kickbacks. Nearly everybody agrees that the latter reason is amoral. More people are sympathetic to (1), however, usually because they have swallowed some industry line about how we'll all die if patents aren't available to encourage even trivial "discoveries".

[Malcolm Mooney]

It's a great brief, and it confirms my worst suspicions:

"As Prometheus’s expert testified, if the physician reads an email with the test results, it would not matter if she “crumples it up, throws it away, reads it, acts on it, doesn’t act
on it, any assumptions you want to come up with.”
C.A. App. A13557-613558; see also C.A. Supp. App.
A13805-13806. The physician infringes the moment
she recognizes the correlation."

Prometheus is quite literally claiming a human thought and not just any thought: it is claiming infringement by thinking about a fact that Prometheus itself PUBLISHED. It's as if someone spilled his glass of wine on your shirt and then accused you of stealing his drink.

[Hans Blix]

Can you hear that? It's the death rattle for all those companies that have built themselves around these "determine and infer" patents. What's compelling about this particular case is that Mayo has a bunch of these kind of patents under its control, and yet it is willing to sacrifice them all. Kind of tells you everything you need to know about these patents: they are so bad that even those who control them think they are invalid!

[anonymous]

Here's a solution:

let the claim in under 101 because it recites something in the real world (a physical administration of a the drug or a testing of the presence of a physical attribute)

but (for purposes of 102, 103) ignore anything that has no physical connection to real world utility.

Thinking about a correlation has no physical connection to the test or the administration of the drug. accordingly, ignore the thinking step for purposes of 102, 103 (unless you have telekinetic powers that trigger the administration)

It's the same as printed matter. Paper is 101 subject matter, but you ignore the printed matter on it for 102 and 103.

[Malcolm Mooney]

anonymous "let the claim in under 101 because it recites something in the real world (a physical administration of a the drug or a testing of the presence of a physical attribute)"

Note that even the Federal Circuit's Opinion didn't go that far. They require that the test for the presence of a physical attribute require "more than mere observation". My guess is that the Federal Circuit believes that such a requirement would suffice to make the claim sufficiently "transformative". I would argue, however, that such a transformation is often incidental to the purpose of the claim (as is the case here, where the purpose of the invention is to "optimize" an old therapy and poking a person to take a blood sample accomplishes achieves zero therapeutic effect).

[anonymous]

"Note that even the Federal Circuit's Opinion didn't go that far."

That's fine--it's the second half of my solution that's the key. Thinking about the previously unknown correlation has zero functional link to whatever is considered an allegedly non-abstract component/step and thus should be ignored for 102, 103.

[I admit that 102 might need amended for this]

Can we really not sink this claim with 102/103? My guess is that the infer step isn't novel, but that the defendant can't find decent prior art for this mental step, it being mental and all. (Finding solid disclosures for mental steps must present an institutional nightmare for the USPTO.)

Maybe, instead of cutting out the infer step entirely for 102/103 purposes (a la anonymous above), we should just permit some evidenciary wiggle room for mental steps. Maybe permit mental steps to be presumed non-novel from customs or typical thought processes within a discipline?

[6]

"Maybe, instead of cutting out the infer step entirely for 102/103 purposes (a la anonymous above), we should just permit some evidenciary wiggle room for mental steps. Maybe permit mental steps to be presumed non-novel from customs or typical thought processes within a discipline?"

I already take substantial liberties with them. In fact, one could say that my behavior regarding them is entirely innappropriate.

I mean, what's the attorney going to argue? But but but the reference makes no mention of thinking about x!

O rly? Is that right? Final.

[private sector]

6--

You public sector union hack. Another shining example of your personal ignorance and stupidity, and that of the public service in general.

An applicant is entitled to a patent if they make legally sufficient disclosure, and if you cannot adduce legally sufficient evidence to deny the patent.

Final? F-you. You are worse than useless, you are wasteful of everyone's time and money, including that of society at large.

What's the attorney going to argue? The attorney doesn't NEED to argue anything, merely presenting the facts of your actions is sufficient to demonstrate prima facie evidence of examiner error.

Final? O rly? Is that right? Appeal.

[Paul Cole]

Colitis is a very nasty disease. The effect of the patented method is to make acceptable treatments that were previously marginal because of toxicity and side effects, and thereby make practically available treatments that were not available before.

The invention is therefore important and deserving of protection. The impression you get from just reading the claim is misleading, and makes you think that this is just a trivial invention, whereas at least potentially it is important and valuable. In my submission there is genuine invention here, a real contribution to human knowledge, and it would be wrong to defeat this invention on a technicality. But perhaps it would be a good case for the Supreme Court because it is a worthwhile invention by an inventive entity with a significant academic and practical reputation.

[Phillies Sweep]

I didn't like the Federal Circuit's decision in this case, not because I think the policy arguments behind the decision were wrong - those arguments are absolutely right, much of the biotech industry is built up around finding these kinds of correlations, and Bilski as written is a death-knell for patents for many such inventions - but b/c this case was the wrong vehicle for reigning in Bilksi as it applies to such correlation claims. The only steps that this claim recites are administering a drug and determining its level. There's no utility in that. The utility comes from knowing the significance of the level and acting on that knowledge. Unfortunately, all that stuff at the end of the claim about what the level signifies isn't a method step, which is why I think the CAFC was wrong to say this claim meets 101. If the patentee had added another step, e.g. "and administering a second dose in accordance with the results of the determination", then I'd say the CAFC came to the right result on the 101 question. I fear that in choosing this case to try to limit the effects of Bilski on correlation inventions, the CAFC may have opened the door for another smack-down by the supremes.

[kd]

Did I miss something? I thought that medical methods were patentable, but not enforceable unless they were tied to a specific apparatus.

[EG]

In my opinion, the result in Prometheus that the claimed method is statutory subject matter under 35 USC 101 is correct (and wouldn't have been such an issue prior to Bilski). My problem with the case is the "mental gymnastics" that Judge Lourie went through to get to that result. This strained effort to apply the Bilski "machine or transformation" test to a medical dosage calibration claim just illustrates how "artificial" this test is.

[EG]

For my further views on Prometheus, see:

http://www.ipwatchdog.com/2009/09/21/cafc-method-for-calibrating-drug-dosage-is-transformative/id=6307/

[Snicket]

Why not knock these claims out with written description and/or enablement, following Univ. of Rochester v. Searle? Even the narrower claims overreach.

[6]

"Final? O rly? Is that right? Appeal."

I wish I had someone with enough balls. If only I could get the interesting appeals.

" and if you cannot adduce legally sufficient evidence to deny the patent."

Who's to say that I didn't? Huh? You? The attorney? If you do, your argument is going to sound like sht.

"Final? F-you. You are worse than useless, you are wasteful of everyone's time and money, including that of society at large."

Noooooo, surely not. Take it to the people who "make (interpretlol?) tha lawl" if you don't believe that I found your case legally anticipated/obvious.

"What's the attorney going to argue? The attorney doesn't NEED to argue anything, merely presenting the facts of your actions is sufficient to demonstrate prima facie evidence of examiner error."

Hah, yeah, keep on believin' that. I've got people that are better than you at arguing (from what I can see anyway) and I haven't heard a good one yet. Good luck finding the "facts of [my] actions" from my OA.

Plus, as far as I know Comisky never was overturned.

[MIchael L. Slonecker]

A constant source of frustration I experience when reading these purported 101 cases is that I believe facts matter, and most discussions proceed on a basis devoid of facts.

As best I have been able to determine, the patentee runs a business where blood test samples are sumbited for analysis by the patentee's lab, and the results of that analysis are provided to the attending physician to be used for adjusting as appropriate the dosage given a patient. Apparently the Mayo Clinic had been using the test services provided by the patentee, but has since decided to strike out on its own.

If i understand the method correctly, and I make no claim that I do, a physician administers a drug appropriate to a medical condition, withdraws a blood sample, sends it to the patentee's lab for analysis of certain markers that are present after the patient's system has broken down the drug into another form containing the markers, examines the blood sample to look for the presence of the markers and their quantitative value, and then reports such valus back to the physician for dosage adjustment.

What leaves a question in my mind is what happens between the time a blood sample is received by the lab and a report to the physician leaves the lab? What is it that the lab is actually doing? Likewise, why are the claims devoid (except in the case of one dependent claim...and even then identified in only the most general of term) of claim elements pertaining to whatever "pixie dust" is used to arrive at the results of the blood sample analysis?

Might someone be able to speak with authority and help clear up some of my confusion?

[Cass L. Singer]

re: "If i understand the method correctly, and I make no claim that I do, a physician administers a drug appropriate to a medical condition, withdraws a blood sample, sends it to the patentee's lab for analysis of certain markers that are present after the patient's system has broken down the drug into another form containing the markers, examines the blood sample to look for the presence of the markers and their quantitative value, and then reports such valus back to the physician for dosage adjustment."

IMHO, the fundamental 101 issue is that the claim does *not* recite that final step, the one necessary for real-world utility -- acutally administering another dose of the drug, adjusted in accordance with the lab results. Had it done so, the question presented on appeal would be moot; the modified claim clearly would cover all practical use of the correlation.

To put it another way, you haven't improved the care of the patient until you've given that adjusted second dose.

I have no overbreadth problem with the initial "administering" step, insofar as the method of adminstration was in fact irrelevant to the correlation being observed. The spec is required by statute to be directed to those skilled in the art, not to laymen or judges.

Even had the claim met 101, it would overwhelmingly appear to be obvious over art showing (a) the iterative process (notoriously old, I presume), and (b) the clinical utility of the drug itself *for the condition recited in the claim* (or obvious equivalent thereof). A new and unobvious use of a known drug would presumably meet 102/103.

[Malcolm Mooney]

Paul Cole: "The effect of the patented method is to ...make practically available treatments that were not available before."

Paul, are you asserting that nobody administered 6-TG to colitis patients prior to the filing date? That nobody adjusted dosages of 6-TG prior to the filing date?

If so, I believe you are mistaken. And because of that mistake, your conclusion is bogus.

The idea that a PATENT on a dosing regimen makes a treatment more "practically available" is absurd on its face.

[Malcolm Mooney]

"Paper is 101 subject matter, but you ignore the printed matter on it for 102 and 103."

Unless, of course the paper is computer-readable.

[Malcolm Mooney]

"I didn't like the Federal Circuit's decision in this case, not because I think the policy arguments behind the decision were wrong - those arguments are absolutely right, much of the biotech industry is built up around finding these kinds of correlations"

That's an incredibly weak policy argument. Much of *every* industry is built up around basic research and scientific discovery. That doesn't mean we should allow people to patent methods of thinking about newly discovered scientific facts.

[Actual Inventor]

Well, I just skimmed this patent and claims. And I don't have a medical or bio chemical specialty. But from what I see , we have a series of successive steps that when applied produce a certain result. So the patent is definitely for a process. The steps involve physical acts so its not a mental process that is being patented. The steps when taken as a whole are even tied to apparatus ( you can't draw blood without a needle). So what’s the problem in 101?

Maybe there are 112, 102 and 103 problems here. And I think you really need to be a SME in the field to determine that, especially for 112 and 103. But, according to SCOTUS precedent, current CAFC case law ( Bilski), the 1952 patent act, and the constitution of the Unites States of America, the invention seems to be solid patentable subject matter.

So far, it seems the only people against this patent are the flaming anti patent types and/or those who do not yet understand the the quantum nature of industrial and technological processes.

[Malcolm Mooney]

AI: "steps involve physical acts so its not a mental process that is being patented."

There is no court in the country that believes that the analysis under 101 is this shallow and stoopit, AI.

"So far, it seems the only people against this patent are the flaming anti patent types "

Like the Mayo clinic?

[Actual Inventor]

MM: "There is no court in the country that believes that the analysis under 101 is this shallow and stoopit, AI."

Every process begins with, and inherently maintains a thinking protocol ( mental steps). However when the thinking protocol is executed it is transformed into physical acts. This really should not be so difficult for you to comprehend. On and just a bit of advice, when you do not understand something, simply say so and ask for help,rather than lashing out with juvenile invectives.

[Actual Inventor]

MM: "So far, it seems the only people against this patent are the flaming anti patent types "

Like the Mayo clinic?"

Like Malcolm Mooney.

[Actual Inventor]

MM: "That doesn't mean we should allow people to patent methods of thinking about newly discovered scientific facts."

But we absolutely should, and are legally required to allow patents on novel, non obvious applications of newly discovered scientific facts.

[Hans Blix]

Actual Inventor said "So far, it seems the only people against this patent are the flaming anti patent types and/or those who do not yet understand the quantum nature of industrial and technological processes."

Well, I guess that includes Breyer, Stevens, and almost certainly Scalia (read the transcript of the oral argument in LabCorp v. Metabolite where Scalia slammed the patent). So, by my count there are three justices that think these "determine and infer" patents are bunk. And since Scalia is just about as far apart from Breyer and Stevens on the ideological spectrum as one could be, I'd say that it's a fair bet that cert will be granted, and that these patents will be killed.

[Malcolm Mooney]

I'd be curious to know what fraction of the peanut gallery believes (1) that patents should be granted on methods of thinking about newly discovered facts and (2) that the current law requires that patents be issued on methods of thinking about newly discovered facts.

I know that AI is in the minority, but I'm curious as to how few extreme Diehrbots like AI there actually are. I suspect that there are far fewer of them then the howling of the sockpuppets would suggest. I also suspect an Internet poll would over-represent the Diehrbots.

[Michael Brooks]

Dear Dr. Dermatologist, how do I appear be responding to the medicine?
On second thought, I read CAFC opinions and patents, so I might be inducing infringement under Mayo v. Prometheus – and so, don’t look at the charts based on my request. You see, the involuntary act of my body metabolizing, and the act of you, the dermatologist, reviewing (i.e., thinking about comparing results with thresholds as) indicators of my bodily function (at my request) is a process perhaps covered by one or more claims of a US patent.

Come closer and I’ll try to explain: Dr. Dermatologist, a patent claim may be patent-eligible by having at least one step tied to a natural transforming function of a biological apparatus (e.g., the human metabolic system). You’ll note that transformation implies a result – a result that may be of natural chemical processing, ie., my metabolism.
Also, a claim may be patent-eligible by having at least one step tied to a microprocessor (a machine of metals and oxides), a machine configured (by wiring and/or programming) to execute a step such as comparing results of previous steps. You’ll note: no final result or output is required to infringe such a claim (presuming such a claim was also found to be patentable and issue in a patent).
Having said this, please do not go away thinking a claim is made patent-eligible by having a step tied to a biological “machine” (human brain) or system of biological processors (a group or company of humans) transforming sensed inputs into a final expressed result by comparing results of previous steps.

You might think of it this way, chemical refineries, whether hardware or humans, allow for the patent eligibility of a process, patent-eligible information refineries require hardware without requiring output. Can I reschedule my treatment based the Supreme Court’s calendar?

[Actual Inventor]

MM Wrote:

"I'd be curious to know what fraction of the peanut gallery believes (1) that patents should be granted on methods of thinking about newly discovered facts and (2) that the current law requires that patents be issued on methods of thinking about newly discovered facts. I know that AI is in the minority, but I'm curious as to how few extreme Diehrbots like AI there actually are."

Malcolm, I have never stated that patents should be granted on "methods of thinking about...anything." And I have never stated that is what Diehr or any case law says. Are you so threatened that you have to resort to making fallacious statements and flat out lies?

Instead of using straw man tactics why can't you simply base your positions on the case law? Or if there is no current case law to support your beliefs then present some logical reason why your position is beneficial to our capitalist system and society at large. If you put away your sophomoric antics and present your thoughts in a more reasonable manner you may find more willing to be persuaded by your arguments, or at the very least respect what you have to say.

[Actual Inventor]

Hans Blix Wrote: "So, by my count there are three justices that think these "determine and infer" patents are bunk."

Hans, can you cite one patent issued for merely determining and inferring?

[Malcolm Mooney]

AI "Malcolm, I have never stated that patents should be granted on "methods of thinking about...anything."

And I never said that you did.

But you did say that we "absolutely should" "allow people to patent methods of thinking about newly discovered scientific facts."

Do you want to retract that statement, AI? It's a miserably stoopit statement so I would retract it if I were you.

[Malcolm Mooney]

AI: "I don't have a medical or bio chemical specialty."

AI: "can you cite one patent issued for merely determining and inferring?""

Just one? Pardon me, Hans:

5,693,470

1. A method of determining a predisposition to cancer comprising: testing a body sample of a human to ascertain the presence of a mutation in a gene identified as hMSH2 (human analog of bacterial MutS and Saccharomyces cerevisine MSH2) which affects hMSH2 expression or hMSH2 protein function, the presence of such a mutation indicating a predisposition to cancer.

I can do this all day. What a rube.

[Ned Heller]

The brief made the very good point that Benson and Flook were decided on preemption; and that Diehr did not overrule either, but looked to see whether the claim as a whole was directed to what we now know to be MOT - but only as a object of the claim. Accepting this as the law, and I have difficulty with it, the vice in the Fed. Cir.'s opinion is that it found satisfaction of the MOT by finding a transformation as a "input" to the claim, not its "object."

Depending on what happens in Bilski, the Supremes need to accept cert. here.

MM: just a note: the doctor involved in this dispute did not infringe the patent. Mayo did. The only way the doctor could have infringed the patent would be if he himself actually or legally performed all its steps.

Also I have a problem with the briefs quip about novelty. Prior metabolite levels may have be known and correlated in a publicly available database, but that does not mean there can be no invention in discovering a subrange which enormously enhanced therapeutic results.

Finally, I think the form of these claims has a lot to do with the European ban on patents on methods of treating patients medically. To actually claim the last step, administering the drug, would put these claims into forbidden territory in Europe.

[Noise above Law]

"Paper is 101 subject matter, but you ignore the printed matter on it for 102 and 103."

Unless, of course the paper is computer-readable.

Really Malcolm? really? Is it track shoe time again?

[S. Fielder]

Kudos to whomever it was who called out 6.

[6]

"Unless, of course the paper is computer-readable."

And unless the office in which your application resides /= 6's.

[Malcolm Mooney]

Ned: "MM: just a note: the doctor involved in this dispute did not infringe the patent. Mayo did. The only way the doctor could have infringed the patent would be if he himself actually or legally performed all its steps."

Technically true: Mayo infringes by encouraging its doctors to know facts and to think about lab results.

But the doctor is the entity most likely to practice the only "new" step disclosed by the patentee, i.e., thinking about the patentee's published "discovery".

"Prior metabolite levels may have be known and correlated in a publicly available database, but that does not mean there can be no invention in discovering a subrange which enormously enhanced therapeutic results."

The "subrange" doesn't "enhance the results", Ned. It's exactly this kind of slipperiness and sloppiness which justifies crushing these crappily drafted claims out of existence.

The point is that metabolite levels were previously known and correlated. Doctors looked at them. Doctors thought about them. What exactly did the doctors think? Difficult to say. That's why we don't allow people to patent thoughts, directly or indirectly.

[Malcolm Mooney]

Ned: " I think the form of these claims has a lot to do with the European ban on patents on methods of treating patients medically. To actually claim the last step, administering the drug, would put these claims into forbidden territory in Europe."

Speaking only for myself, when I am prosecuting applications in other jurisdictions, I work with foreign associates to rewrite the claims to accord with that jurisdictions laws. I suspect Prometheus does the same.

[Malcolm Mooney]

Ned: "Accepting this as the law, and I have difficulty with it, the vice in the Fed. Cir.'s opinion is that it found satisfaction of the MOT by finding a transformation as a "input" to the claim, not its "object."

True enough. The Fed. Cir. relied on Bilski to rescue this claim from the junk heap where it belongs, just as the Diehrbot's rely on the phrase "on an airplane" to rescue a method for telling someone that it's time to take a leak.

[Actual Inventor]

Malcolm lied: "But you did say that we "absolutely should" "allow people to patent methods of thinking about newly discovered scientific facts." Do you want to retract that statement, AI?

Malcolm, I did not make that statement. I am almost certain now you are deliberately lying for some form of demented self pleasure since anyone reading the blog can see exactly what I typed and in what context. But in the event you really think you are correct, I will cut and paste my exact statement below.

Actual Inventor posted on Oct 29, 2009 at 03:06 PM

"But we absolutely should, and are legally required to allow patents on novel, non obvious applications of newly discovered scientific facts."

I wont bother asking you to admit you lied or made a mistake. Because you do not have the courage and integrity to do so. You have consistently demonstrated that whenever you are intellectually backed into a corner you will lie or run away.

CASE CLOSED

[Malcolm Mooney]

AI: "Malcolm, I did not make that statement."

Was it a sockpuppet who posted under your name at Oct 29, 2009 at 03:06 PM?

"You have consistently demonstrated that whenever you are intellectually backed into a corner you will lie or run away."

The exact opposite is true. Who posted under your name at Oct 29, 2009 at 03:06 PM?

[Actual Inventor]

MM: AI: "can you cite one patent issued for merely determining and inferring?""

5,693,470

1. A method of determining a predisposition to cancer comprising: testing a body sample of a human to ascertain the presence of a mutation in a gene identified as hMSH2 (human analog of bacterial MutS and Saccharomyces cerevisine MSH2) which affects hMSH2 expression or hMSH2 protein function, the presence of such a mutation indicating a predisposition to cancer."

Why didn't you cite the prometheus patent we are discussing here. Are you tacitly conceding that prometheus is not a patent on a mere mental process?

I don't have time to look up this patent and read the spec, which is preferable to do since you are a notorious liar and game player. But just taking the claim as you typed it, anyone can plainly see there is more happening than the mere mental process of determining and inferring. For example, take the first step:

" A) Testing a body sample of a human to ascertain the presence of a mutation in a gene identified as hMSH2 ."

Unless the specification described some technique for looking into a human being with super microscopic x ray vision this step is clearly going to require a physical action and the use of technology. And as long as the claim does not preempt its statutory under 101. Move on to 102.

Next?

[Hans Blix]

Actual Inventor, you win. You never actually made the statement that Malcolm attributed to you. However, you did so effectively by asserting that patents like the ones at issue should be permitted. At their core, these patents seek to prevent people from making inferences about facts that they have elucidated using old methods. In this case, the drug was old. So were the methods for determining the metabolite levels. All you have left is the inference ("indicates a need"). If the claim included a further step of actually adjusting the dosage, then you wouldn't have a patent eligibility problem. You'd still have a problem enforcing the patent against anyone (due to the single actor problem that has been discussed on this blog many times), but at least you would have a valid patent.

[Actual Inventor]

Ned Heller Wrote: "The brief made the very good point that Benson and Flook were decided on preemption; and that Diehr did not overrule either, but looked to see whether the claim as a whole was directed to what we now know to be MOT - but only as a object of the claim."

Very good point indeed. I was waiting to see if any of the anti-patent bloggers would use this as a reason for rejecting the claim under 101. But only noticed the patent being attacked for having one or more mental steps. Typical of those that want the patent laws to regress back to the pre Flook era when dissection of claims allowed the unconstitutional banning of process and method patents. I believe one of the reasons they want to return to the pre Flook days is that preemption is far more difficult than dissection and often requires in depth subject matter expertise.

[Malcolm Mooney]

AI: "Typical of those that want the patent laws to regress back to the pre Flook era when dissection of claims allowed the unconstitutional banning of process and method patents."

Dissection of claims continues to be allowed to ban process and method claims. See discussion upthread re "other solutions".

By the way, AI, you did say we "absolutely should" "allow people to patent methods of thinking about newly discovered scientific facts" in your Oct 29, 2009 at 03:06 PM comment, did you not? Or was it someone else?

If it was you, please explain what you meant when you said that we "absolutely should" allow people to patent methods of thinking about newly discovered scientific facts. Did you mean that we "absolutely should" allow people to patent methods of thinking about newly discovered scientific facts? Or did you mean something else? I'm just reading what you (or someone who posted under name meant).

AI: "I was waiting to see if any of the anti-patent bloggers would use this as a reason for rejecting the claim under 101."

Since I know you can't read very well, AI, you should know that I argued the tangentiality of the allegedly "transforming" step in the previous threads on this topic. Many of the arguments in the petition mirror those that I and others have posted here and elsewhere. It's a compelling petition. More importantly, it's correct and may end up stinging you more than Bilski.

But this has nothing to do with being "anti-patent", although you and the other trolls never seem to be able to grasp this. It has to be with being anti CRAPPY patent. I understand that in certain circles there is no such as a crappy patent because, in those circles, patents make the world go around and without them civilization as we know it would dry up and die. But here on earth, there are many patent practitioners like myself who simply don't approve of every granted patent.

I'm very sorry for you (and others like you) if you can't digest this information. It must be difficult to be both that stoopit and that stubborn.

[Malcolm Mooney]

AI: "Why didn't you cite the prometheus patent we are discussing here."

I could have. Or I could have cited the issued claim in the LabCorp case. Or I could have cited many others.

"But just taking the claim as you typed it, anyone can plainly see there is more happening than the mere mental process of determining and inferring. For example, take the first step: Testing a body sample of a human to ascertain the presence of a mutation in a gene identified as hMSH2 ."

The problem, AI, is that taking human samples and sequencing human genes is old. That's why the patentee didn't claim a method of sequencing hMSH2. It was old. They couldn't do it. So they threw on a step of "thinking" about the result. Do you understand why this is a problem? Yesterday the lab worker sequenced hMSH2 and looked at the data. No infringement. This morning the patent issues and the patentee sends a copy to the lab worker who reads it. The lab worker sequences hMSH2 exactly as he did the day before. But now he infringes.

As I said, it's like spilling your glass of wine on somebody and accusing them of stealing your drink. It's simply wrong, the CAFC blew it in a vain (pun intended) attempt to fix the problems with Bilski, and now the Supremes are going to fix it for everyone, by which I mean you.

[anon]

MM, I agree with you about the other stuff, and I find I generally disagree with AI, but re:
"By the way, AI, you did say we "absolutely should" "allow people to patent methods of thinking about newly discovered scientific facts" in your Oct 29, 2009 at 03:06 PM comment, did you not?"

Maybe AI edited the post(although I didn't think that was enabled), or maybe you need a break from staring at the computer screen, cause what's coming up for me is:

MM: "That doesn't mean we should allow people to patent methods of thinking about newly discovered scientific facts."

But we absolutely should, and are legally required to allow patents on novel, non obvious applications of newly discovered scientific facts.

Posted by: Actual Inventor | Oct 29, 2009 at 03:06 PM

So unless your point is that you can take part of his response, and part of your response, and turn it into something any reasonable person would agree AI never actually suggested, you should really just concede the point to AI and continue arguing things that have merit (like that determine-and-infer methods shouldn't ultimately be patentable).

[Noise above Law]

""You have consistently demonstrated that whenever you are intellectually backed into a corner you will lie or run away."

The exact opposite is true."

Really Malcolm, really?

[Noise above Law]

Malcolm lies first - THEN runs away.

[Paul Cole]

Malcolm: This was apparently a family of drugs that were therapeutically beneficial but dangerous to administer, and therefore not used by many physicians. The patentees found how to administer them safely. I think you need to climb deeper into the matrix of fact than time permits to form a concluded opinion. But on the face of the document there was a significant discovery and a major benefit to patients. It is all too easy with hindsight to say that this is just a minor difference. But for the Mayo research, this drug would have remained just as it was. And if the prior art is good enough, then you can simply administer the drug as was done before and not make the measurements recommended by Mayo. But it seems that many physicians were reluctant to do that for fear of harmful toxicity and side effects.

This are however problems with the way in which the claim is drafted. If we look at it again, it reads:

"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 [entity 1:, the physician]; and

(b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder [entity 2: the test laboratory - is not the test carried out on a blood or tissue sample removed from the subject?],

wherein a level of 6-thioguanine less than about 230 pmol per 8108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein a level of 6-thioguanine greater than about 400 pmol per 8108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject [Does not entity 2 study the readings from the tissue sample? Are thense not communicated to the physician (entity 1)? Is not the drug dose then adjusted?]."

Assuming you are the Mayo clinic and you wish to licence other clinics to perform the same analysis, how does this claim help? It requires the physician [entity 1] over whom Mayo has no control. The claim specifies an operation performed by the physician whereas all that is needed is a reference to a sample from a patient to whom a given dose of the medicament has been administered. The laboratory [entity 2] carries out the test and evaluates the results (possibly implicit in the claim, but not explicitly made a technical feature) and arrives at a recommendation to maintain the existing dose or to give a revised dose (not explicitly a feature of the claim). There are therefore two entities involved, whereas it is always desirable to write a claim so that it is infringed by the activities of a single entity.

The claim is also at risk of alleging more than it actually achieves. Does the method "optimise" the dose (i.e. arrive at the very best possible dose) or merely evaluate whether it falls within a particular desirable range? "Optimise" is potentially restrictive word arguably falling into the "patent profanity" category. And it potentially raises all sorts of non-enablement issues since it purports to give the patient the very best dose, whereas all it perhaps does is to give a recommendation for an improved dose. Even if carried out iteratively, all it may achieve is to give a good dose for the drug, but perhaps not the very best dose.

If the claim were re-written to specify that it is a method of testing a tissue sample from a patient to whom the drug has been administered to determine whether for the specific patient it falls within a dosage range where a desirable combination of activity and adverse effects is obtained, it might have less problems, since methods of testing samples are usually considered good subject matter for a patent. Presentation is very important, especially in patent claims.

[Paul Cole]

I see in my previous comment I should have said Prometheus not Mayo since it is Promethius who has the patent and Mayo who are opposing. The arguments, however, remain the same.

[still lurking]

Two things:

1) Could 35 USC 287(c) somehow be interpreted so that infringement is simply not enforceable?

2) The Federal Circuit's holding that the "determining the level" step was necessarily transformative since "those levels cannot be determined by mere inspection" sounds incorrect to me.

Is it conceivable that the levels could be determined by fluorescence or something similar to a pH strip? These sound like they're determined by mere inspection. Or am I not going deep enough?

[Actual Inventor]

Hans Blix wrote: “At their core, these patents seek to prevent people from making inferences about facts that they have elucidated using old methods. In this case, the drug was old. So were the methods for determining the metabolite levels. All you have left is the inference ("indicates a need"). “

Hans, If indeed the invention as claimed is an “old” method(s) then what we have is a 102 issue not 101. To deny this patent under 101 for having old subject matter would be in effect to ressurect the point of novelty test in Flook that was over ruled in Diehr.

The proper and legal test is preemption, not point of novelty. Mayo points out in their brief citing Chakrabarty, “ In particular, a patent claim cannot preempt, either directly or by practical effect, a law of nature, natural phenomenon, or abstract scientific idea.”

The reason we have the preemption test as opposed to the point of novelty test is that a process patent is a constitutional right ratified by congress in the 1952 patent act as a separate and distinct category from the other classes. The point of novelty test uses dissection of the claims under 101 to deny constitutional rights to a certain class of inventors. However by surgically removing the mental, old, obvious, physical, non machine, or non transformation step you in effect mute an entire class of patents that every American inventor has a right to obtain. Preemption is not dissection but instead takes the claim as a whole. Diehr says, “where a claim recites a law of nature or biological principle, a court must look to whether the claim seeks protection for the phenomenon “in the abstract” or instead implements the phenomenon in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect.” Diamond v. Diehr, 450 U.S. 175, 191 (1981).”

Neither is preemption a swap of titles for the point of novelty test as some have implicitly asserted. If indeed preemption was simply point of novelty under another name why would Stevens, whom I believe wrote the Flook decision be a decenter in the Dier case just one year later?

I’ll tell you why, because Diehr does not allow him, and others with the same motive, to deny the constitutional rights of inventors to obtain patents on processes and methods not subjugated by the other classes.

Now, Mayo in their brief state, “ Prometheus’s claims are invalid because they preempt all uses of the natural correlation between patient metabolite levels and patient health.”

I am willing to concede if indeed Mayo can prove such a case. But let there be an honest debate about it with REAL subject matter experts to address the scientific facts regarding scope and preemption of any law of nature, or natural phenomenon. Specifically I want to see:

A) The law of nature or phenomenon identified

B) Proof no one can use or have access to said law of nature or natural phenomenon if the Prometheus’s claims are upheld as invalid

[Actual Inventor]

Correction in my post at Oct 30, 2009 at 09:23 AM The last sentence should read as follows:

B) Proof no one can use or have access to said law of nature or natural phenomenon if the Prometheus’s claims are upheld as valid

[Ray]

Thanks Paul Cole. It is way too easy for us to just scan these new technologies and not see how truly useful they are (and if you were suffering from colitis ....aaarrrrggghhh). And not to come up with a better way to write the claim so that the patent is both allowable and economically valuable. At this stage of the game, tho, can the claim be re-phrased? What would that take? ... RCE / CIP add new matter ... new claims ....

[6]

"To put it another way, you haven't improved the care of the patient"

I love when people use relative terms which are relative to a COMPLETELY DIFFERENT PROCESS.

You know why? 1 1 1 1 1 11 1 1 1 11 1 111111111111111111111

11111111111111111111111111111111111111111 1 1111 1 1 11

22222222222222222222222222222222222222222

22222222222222222222222222

nnnnnnnnnnnnnnnnn
d

[Malcolm Mooney]

AI: "Diehr says, “where a claim recites a law of nature or biological principle, a court must look to whether the claim seeks protection for the phenomenon “in the abstract” or instead implements the phenomenon in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect.” Diamond v. Diehr, 450 U.S. 175, 191 (1981).”

Were the patent laws designed to protect human thoughts? No. Claim fails under Diehr.

"But let there be an honest debate about it with REAL subject matter experts to address the scientific facts regarding scope and preemption of any law of nature, or natural phenomenon."

What makes you think that this didn't take place at the District Court?

[Malcolm Mooney]

Paul Cole: "This are however problems with the way in which the claim is drafted."

No kidding, Paul. Welcome to the table.

[Malcolm Mooney]

"Malcolm lies first - THEN runs away."

Troll seems to have difficulty comprehending the meaning of the words "lie", "first" and "run away". Keep working, troll. Your sockpuppets know what the helll you're talking about but nobody else does.

[Malcolm Mooney]

anon, I appreciate your helpful attempt to parse AI's Oct 29, 2009 at 03:06 PM comment where, I can see that, in one interpretation, he responded not in affirmation or denial of my statement "That doesn't mean we should allow people to patent methods of thinking about newly discovered scientific facts," but with a poorly punctuated non-sequitur.

Perhaps the troll can run it through the sentence analysis program that it used to determine that there isn't a separate written description requirement and tell us all what AI really meant.

But my response to AI's comment was perfectly reasonable (unless we agree that AI usually replies to comments with non-sequiturs). My first reaction, as you'll recall, was to ask him to retract the statement because, frankly, I found it ridiculous. Instead of clarifying what he meant, AI chose merely re-type his response and engage in name-calling. Waste of time.

[Malcolm Mooney]

Paul: "And if the prior art is good enough, then you can simply administer the drug as was done before and not make the measurements recommended by Mayo."

Prometheus is the patentee here. And again, unless I'm mistaken, people were measuring 6-TG metabolites in the prior art.

A proper claim would be written as follows:

1. A method of treating a patient with disease X, comprising:

administering a first dose of drug to said patient; and administering a second dose of drug to said patient when said metabolite Y in said subject is below level Z.

That's a real method claim, and not an algorithm. It recites actions or steps, none of which are human thoughts.

The reason Prometheus doesn't want this claim is because this claim could be proved to be inherently anticipated by looking at blood samples of patients who were treated with a varying dosage regimen before the patent filing. The inherent feature, of course, being the level of the metabolite.

But this claim should also work:

1. A method of treating a patient with disease X, comprising:

administering a first dose of drug to said patient; measuring a level of metabolite Y in said subject; administering said second dose of drug to said patient after said metabolite Y in said subject is below level Z.

Again, it might be inherently anticipated.

The reason the "thinking" limitation gets thrown into Prometheus claims is to avoid this risk of inherency. But look at how it avoids the inherency: it publishes a previously undisclosed fact that nobody can "prove" anyone was thinking before and puts that fact in the claim.

I suggested in a previous thread that if Mayo simply told its doctors to look at the test results and "do the right thing" then Prometheus should be out of luck because how could they know what the doctors are thinking? Or Mayo could find some other metabolite that's not recited in the claims but is correlated with the metabolites that are recited and have its doctors look at those metabolites instead. But the system is totally rigged in favor of patentees when it comes to these sorts of claims because discovery can get the doctors and force them to confess what they are thinking, but the PTO isn't every going to do anything like that for the doctors in the prior art.

A clever attorney could do a great deal of mischief with this paradigm. I submit that a great deal of mischief has already been done.

[MIchael L. Slonecker]

Mr. Mooney:

In response to Mr. Cole you remark:

"No kidding, Paul. Welcome to the table."

Is there a reason beyond your "view of your subject matter mastery" that compels you to constantly mock others who are apparently trying, with obvious sincerity, to present comments that they believe may contribute to the ongoing discussion?

Might I suggest you add the words "respect" and "collegiality" to your dictionary? They go a long way towards engendering useful and informative discussions, one of the primary reasons underlying why Mr. Crouch even created this blog?

[broje]

Even I have misgivings about the claim. Even with the problems regardign identifying a direct infringer, it is still perectly adequate to have a step regarding taking an action to cause administration of blah blah dose blah blah blah. That action could be making a diagnosis, administering the dose, whatever. And I would expect plenty of dependent claims to express all those options.

But if this claim goes through, you could pass 101 with this claim: drinking a cup of coffee; and evaluating taste of the coffee, wherein a good taste indicates a need to order another cup of the coffee, and a bad tastes indicates a need to order a cup of a different coffee. The potential for abuse of this claim format is astounding.

[Actual Inventor]

Hans Blix "Actual Inventor said "So far, it seems the only people against this patent are the flaming anti patent types and/or those who do not yet understand the quantum nature of industrial and technological processes."

Well, I guess that includes Breyer, Stevens, and almost certainly Scalia (read the transcript of the oral argument in LabCorp v. Metabolite where Scalia slammed the patent). "

Hans, I do not believe the dissenters, Breyer, Stevens, Scalia are anti-patent. The error in their dissent was using preemption as a method of dissection like Stevens did in Flook. As I elaborated on in my Oct 30, 2009 09:23 AM post, Preemption is not dissection. Its illogical to have preemption over rule and replace the point of novelty test because of dissection in Flook then go about using the new test exactly like the old one. Such an act is not a sign of judicial progress but a mere swapping of labels.

The reason for the dissenters error was do to a lack of understanding of the quantum nature of industrial and technological processes. While you can’t patent a thought you can patent a process. And yes there is an essential difference.

If this case is granted Cert. look for my amicus brief which will instruct the court exactly what processes are according to the science of quantum mechanics, quantum biology, and complex human information processing.

[Actual Inventor]

Broje wrote:

"you could pass 101 with this claim: drinking a cup of coffee; and evaluating taste of the coffee, wherein a good taste indicates a need to order another cup of the coffee, and a bad tastes indicates a need to order a cup of a different coffee.

But could such a claim pass 112, 102, and 103?

[Malcolm Mooney]

Here's one for AI:

1. A method for optimizing a selection of movies, comprising:
(1) breathing, wherein said breathing delivers oxygen to the brain to facilitate neuronal firing;
(2) accessing a list of a plurality of movies, wherein said list includes RINGMASTER (movie released on the date of filing);
(3) determining a most preferred movie, wherein said determining involves comparing the anticipated enjoyment from watching said movie to the anticipated enjoyment from watching RINGMASTER.

Patentable under 101?

[Paul Cole]

Does all this stuff really justify a trip to the Supreme Court?

The Mayo brief is strongly reminescent of the debate about pre-empting an algorithm. The right [to pre-empt an algorithm] is not an open or debatable question. It was fully discussed in [President] Jackson's time [or in any event a very long time ago] and denied not only by him but also by a vote of ... [the Supreme Court]. Do we really need to discuss it again?

There are two possible routes. The high profile one is to take this claim to the Supreme Court. The lower profile one is to take it to the USPTO and rewrite it so that it is less open to objection.

During the Second World War, posters in Britain used to ask: "Is your journey really necessary?" Not a bad question for the parties in the present case.

[6]

"The potential for abuse of this claim format is astounding."

And ... we have a winar!

"But could such a claim pass 112, 102, and 103? "

It could if I include a few trivial limitations, which, whilst narrowing the claim, are still outstandingly abusive.

[Malcolm Mooney]

AI: "But could such a claim pass 112, 102, and 103?"

But they absolutely should, and are legally required to be claimed in a single sentence.

[Paul Cole]

Just another thought for Malcolm Mooney.

If Mayo had some new and really good prior art, there would surely be a re-examination in progress. Presumably there is no new prior art that raises a substantial question of patentability. In these circumstances a certain amount of suspicion must apply to arguments that it was all known,implicit in what had been done before or obvious.

[6]

"Such an act is not a sign of judicial progress but a mere swapping of labels."

That happens to be a good thing in this case.

"The reason for the dissenters error was do [siclol] to a lack of understanding of the quantum nature of industrial and technological processes. While you can’t patent a thought you can patent a process. And yes there is an essential difference."

That's right there is a difference, but how does that have anything to do with the "quantum nature of industrial ... processes"? Do you even know what the word quantum means? Or are you using the term loosely as in "quantum leap" "quantum (made up bs sci fi term)"?

Is there a difference between a method that includes as one of its "steps" a thought, or "thinking about something" amongst some other non-thought steps and in a claim that merely recites "thinking about something"? Yes, there is a difference here as well, but it probably isn't one that should change the determination that the claim still covers thinking, even though it doesn't ONLY cover thinking.

IMO simply state that "thinking" is not a "step" in so far as patent law is concerned and thus is not available to assist the claim in distinguishing over the prior art. That is perfectly reasonable and all parties should be quite happy about not having the gov. controllin' on their thoughts.

[6]

"If this case is granted Cert. look for my amicus brief which will instruct the court exactly what processes are according to the science of quantum mechanics, quantum biology, and complex human information processing."

Oh dear je sus I can't wait for this lolfest. Please, hurry up and write it. I await it with baited breath.

[appealho]

baited breath - that is what happens when you eat the chum

[Malcolm Mooney]

Paul: "If Mayo had some new and really good prior art, there would surely be a re-examination in progress. Presumably there is no new prior art that raises a substantial question of patentability."

People choose litigation over re-examination all the time, for a variety of reasons. Mayo won at the District Court and they should have won at the Federal Circuit, but for a very poorly reasoned decision by the majority.

Paul: "In these circumstances a certain amount of suspicion must apply to arguments that it was all known,implicit in what had been done before or obvious."

You mean every time that someone chooses to litigate rather than file a re-exam, it means that "suspicions must apply" to their arguments about the state of the art? I think that's ridiculous.

[Malcolm Mooney]

"IMO simply state that "thinking" is not a "step" in so far as patent law is concerned and thus is not available to assist the claim in distinguishing over the prior art. That is perfectly reasonable"

Agreed. And it's also perfectly reasonble to apply the same restriction to "thinking" steps recited in computer-implemented method and composition claims.

[anonymous]

"Unless, of course the paper is computer-readable."

We don't need to re-hash that discussion, Malcolm. But there's at least a distinction between a paper form that isn't functionally tied to other components as opposed to a computer-readable medium that is functionally tied.

Your RINGMASTER hypo fits well into my analysis. if you let it in under 101, you get to ignore the RINGMASTER limitation for purposes of 102,103, like the writing on the paper in printed matter cases.

[6]

"But there's at least a distinction between a paper form that isn't functionally tied to other components as opposed to a computer-readable medium that is functionally tied."

Quick question, with the advent of reliable OCR, isn't any printout of source code technically able to be such a computer readable medium? Legitimate and serious question anon. Not even joking around.

[Malcolm Mooney]

anonymous "Your RINGMASTER hypo fits well into my analysis. if you let it in under 101, you get to ignore the RINGMASTER limitation for purposes of 102,103, like the writing on the paper in printed matter cases."

What other types of limitations are "like the writing on the paper in printed matter cases"? And how do you determine if something is "like the writing on the paper in printed matter cases"? And what about the last limitation in the claim? What doctrine is used to ignore that limitation? e.g.:

1. A method for optimizing a selection of movies, comprising:
(1) breathing, wherein said breathing delivers oxygen to the brain to facilitate neuronal firing; and
(2) determining a most preferred movie, wherein said determining involves ranking the anticipated enjoyment from watching a plurality of movies to the anticipated enjoyment from watching RINGMASTER.

Patentable under 101?

[anonymous]

"What other types of limitations are "like the writing on the paper in printed matter cases"?"

Claims that recite a type of information, where the information has functional nexus with the computer that displays the information, the transmitter sending the information or the receiver receiving the information. In those cases, the computer displays and the signal carries the information in the same way and the information is non-functional, like the printed matter. Treat it as non-functional descriptive matter.

"how do you determine if something is "like the writing on the paper in printed matter cases"?"

identify the components that allegedly recite statutory subject matter (e.g., the computer display or the signaling device) and determine whether the feature affects the function of these components -- that is, it is a non-functional descriptive feature?

"What doctrine is used to ignore that limitation?"

it's the RINGMASTER term/limitation you ignore, rather than the whole element

For instance, if someone claims "a big computer brain that sends a signal to a display device that, upon receiving the signal, displays RINGMASTER" you ignore RINGMASTER and treat it as a display of anything for 102, 103.

[Malcolm Mooney]

anonymous, how do you think your "descriptive matter doctrine" squares with Diehr (not sure that I care, but I know that others do).

I'm also not sure that you can read RINGMASTER out of my hypothetical claims. Seems like a necessary and functional feature in the final clause, no?

[Noise above Law]

Malcolm,

The term is not "descriptive matter doctrine". It is "Written Matter Doctrine". You know this well, even as you feign ignorance (your shield of persistent ignorance matches 6's - must be an employee discount thing at the Office).

We have been over this numerous times. Please don't abuse the new people to the site with the same stale crap that surfaces every four to five months.

In fact, the last time was nearly five months ago. And previous to that, there was an additional four months absence. It seems that you feel only safe enough to trot out the argument after you have run far enough away.

Guess what Malcolm, you will need to keep running, unless you can actually answer the challenge.

See:

http://www.patentlyo.com/patent/2009/06/bilski.html#comments

http://www.patentlyo.com/patent/2009/02/classen-v-biogen-request-for-rehearing/comments/page/2/#comments

[Noise above Law]

In fact, for those who want pincites to the gory details:

Track shoes and a pretty dress…

Running up that (Sam) hill… with apologies to Kate Bush.

Last time we were down this path (but definitely not the first time) we had, from the evening of June 2 to the afternoon of June 7, the following interplay (see comments,previously numbered but now identified by posting times of:

Jun 02, 2009 at 08:21 PM
Jun 02, 2009 at 09:00 PM
Jun 03, 2009 at 06:14 AM

***But Malcolm provided no response to my post, so…

Jun 03, 2009 at 03:51 PM
Jun 03, 2009 at 05:05 PM
Jun 03, 2009 at 06:11 PM

***Ever the smug smart-a$$ (but only when he thinks he cannot be shown up), and less than 24 hours later,

Jun 04, 2009 at 01:02 PM

***Of course, the so-called admitted defeat was ethereal. The challenge laid out (yet once again):

Jun 06, 2009 at 10:16 AM

***And thus we reach the moment of truth when Malcolm finally answers the challenge with all his honesty and integrity:

Jun 07, 2009 at 03:30 PM
Jun 07, 2009 at 04:39 PM

***So… after goading for the information and getting it, Malcolm’s answer to the challenge is…:

“What the sam hill are you talking about?”

So much for the bravado: “I would be glad to respond. I predict you are not up to the task, however."

To quote ME:
"Your prediction, like much of what you put up would be wrong.

You have run so many times and avoided the Printed Matter Doctrine challenge that it will take some time to find the original. I will find it and you will run again….

I will find it and you will run again…."

Running up that (sam) hill.

[anonymous]

"anonymous, how do you think your "descriptive matter doctrine" squares with Diehr (not sure that I care, but I know that others do)."

lol ... thanks for your recitation of other's interest, if not yours

diehr's claims recited functionally interrelated features for curing rubber. all of those available for 102/103.

now, if the Dieher claims recited further, "wherein the cured rubber forms a Richard Nixon mask," the Richard Nixon part would be ignored for 102/103.

[anonymous]

"I'm also not sure that you can read RINGMASTER out of my hypothetical claims. Seems like a necessary and functional feature in the final clause, no?"

no. the element recites a comparison of enjoyment values (I'm paraphrasing)

the content of the movies has no substantial functional affect on the comparing function

the comparing function is the same regardless of the inputs

[6]

"the comparing function is the same regardless of the inputs"

I see what you're trying to say, but that's not really true. It will depend specifically on what the user thinks about the content of RINGMASTER.

[Actual Inventor]

How the Preemption analysis is applied according to The Supreme Court of the United States.

STEP ONE: Read the claims as a whole.

Diehr says: “In determining the eligibility of respondents’ claimed process for patent protection under §101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The “novelty” of any element or steps in a process, or even of the <450 U.S. 189> process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter.12

_____

STEP TWO: Ask, if the claims when considered as a whole preempt a scientific principle or phenomenon of nature?

Diehr says: “We recognize, of course, that when a claim recites a mathematical formula (or scientific principle or phenomenon of nature), an inquiry must be made into whether the claim is seeking patent protection for that formula in the abstract.”

CAUTION! Do not mistake this as a pass to dissect claims into unpatentable subject matter. Diehr also says: “Similarly, in Parker v. Flook,supra,we stated, “A process is not unpatentable simply because it contains a law of nature or a mathematical algorithm.” 437 U.S.,at 590, 198 USPQ at 197 .”

__

STEP THREE: Asked, if the claims when considered as a whole are applied?

Diehr says: It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection. See, e.g., Funk Bros. Seed <450 U.S. 188> Co. v. Kalo Co., 333 U.S. 127, 76 USPQ 280 (1948);Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923); Cochrane v. Deener,94 U.S. 780 (1876); O’Reilly v. Morse,15 How. 62 (1853); andLe Roy v. Tatham, 14 How. 156 (1852).

[6]

"Asked, if the claims when considered as a whole are applied?"

Lol WUT?

I'm telling you, your brief is going to be a shtfest of lolin.

[curious]

IMHO, "administering" brings the claim within the ambit of 101; however, "indicates a need to" does not modify any of the steps and thus should not be given any patentable weight for 102 and 103 purposes.

[Actual Inventor]

Malcolm Mooney this is an intervention!

As you can see below your friends and supporters are reaching out to you. Its time to be honest and confront your pathological delusions. Stop lying, running, then rationalizing and projecting. Be a man, or woman, whatever the case may be, and own up to your mistakes, face your fears, and perhaps you will gain the self esteem you need and earn the respect you so desperately crave.

_____________
Hans Blix wrote : “Actual Inventor, you win. You never actually made the statement that Malcolm attributed to you.”

Posted by: Hans Blix | Oct 29, 2009 at 07:46 PM
____________

anon wrote: MM, I agree with you about the other stuff, and I find I generally disagree with AI, but re:
"By the way, AI, you did say we "absolutely should" "allow people to patent methods of thinking about newly discovered scientific facts" in your Oct 29, 2009 at 03:06 PM comment, did you not?"

Maybe AI edited the post(although I didn't think that was enabled), or maybe you need a break from staring at the computer screen, cause what's coming up for me is:

MM: "That doesn't mean we should allow people to patent methods of thinking about newly discovered scientific facts."

But we absolutely should, and are legally required to allow patents on novel, non obvious applications of newly discovered scientific facts.

Posted by: Actual Inventor | Oct 29, 2009 at 03:06 PM

Posted by: anon | Oct 29, 2009 at 09:19 PM

______________

MIchael L. Slonecker wrote: Mr. Mooney:
Is there a reason beyond your "view of your subject matter mastery" that compels you to constantly mock others who are apparently trying, with obvious sincerity, to present comments that they believe may contribute to the ongoing discussion? Might I suggest you add the words "respect" and "collegiality" to your dictionary? They go a long way towards engendering useful and informative discussions, one of the primary reasons underlying why Mr. Crouch even created this blog?
Posted by: MIchael L. Slonecker | Oct 30, 2009 at 12:52 PM
_____________

[Actual Inventor]

6 wrote: "Lol WUT?"

I corrected the grammatical errors. Now, a challenge for you.

If you can, how about demonstrating your IQ and legal analysis skills by invalidating the current Supreme Court test for patentable subject matter I have outlined below.

You must cite case law, statute, and/or the constitution as the basis for your arguments.

No "LOL" or third grade humor, or paper tiger bravado. Just show what you can do with your intellect and the law.
______

How the Preemption analysis is applied according to The Supreme Court of the United States.

STEP ONE: Read the claims as a whole.


Diehr says: “In determining the eligibility of respondents’ claimed process for patent protection under §101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The “novelty” of any element or steps in a process, or even of the <450 U.S. 189> process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter.12
_____

STEP TWO: Ask, if the claims when considered as a whole preempt a scientific principle or phenomenon of nature?


Diehr says: “We recognize, of course, that when a claim recites a mathematical formula (or scientific principle or phenomenon of nature), an inquiry must be made into whether the claim is seeking patent protection for that formula in the abstract.”
CAUTION! Do not mistake this as a pass to dissect claims into unpatentable subject matter. Diehr also says: “Similarly, in Parker v. Flook,supra,we stated, “A process is not unpatentable simply because it contains a law of nature or a mathematical algorithm.” 437 U.S.,at 590, 198 USPQ at 197 .”
__

STEP THREE: Ask, if the claims when considered as a whole are an application of scientific or technological facts.

Diehr says: It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection. See, e.g., Funk Bros. Seed <450 U.S. 188> Co. v. Kalo Co., 333 U.S. 127, 76 USPQ 280 (1948);Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923); Cochrane v. Deener,94 U.S. 780 (1876); O’Reilly v. Morse,15 How. 62 (1853); andLe Roy v. Tatham, 14 How. 156 (1852).

[Hans Blix]

Actual Inventor, you are focusing on Diehr, but the claims at issue in this case, as Mayo's petition points out, are more like Benson and Flook than Diehr. Did Diehr expressly overrule Benson and Flook?

[Noise above Law]

Hans,

It seems that you implying that AI has misapplied case law. Assuming for the moment that you are correct, does that make his challenge any less worthwhile? Do you think the answer to the challenge would be meaningless? Do you have an answer to his challenge?

The question presented in the petition you reference clearly deals with preemption, and clearly invokes Diehr (p16-17). Are you saying that Diehr does NOT apply? While I am not sure that whether Diehr expressly overruled Benson or Flook is of that great import to AI's challenge, the hint to 6 to base his non-sophmoric response may be too subtle for him to pick up (he also has a difficult time actually constructing legal arguments as witnessed by his failure for the 112 paragraph 1 challenge, where he couldn't even use the tools or the reference cites correctly).

The petition itself is interesting in that it says in essence that MOT should be reversed (it is not sufficient to cover preemption, thus not THE clue to patentability - although its treatment of "a" versus "the" at pages 19-20 is a rather thinly "the court was wrong" conclusive statement). The petition highlights the rigidity of the CAFC brightline rule. It seems that Prometheus took the court's lead and merely echoed the Bilski holding. How could that court do anything else after what it said in Bilski? To do otherwise would be tantamount to admitting that Bilski was wrongly decided.

However, basing a cornerstone of your petition on dicta from a minority party (from a proceeding, no less - not a full and final case hearing), seems to rely overly on that "persuasiveness", which the court they are in front of has already dismissed as "not the rule of law". I did not read through the arguemtns related to Labcorp.

This will be interesting to see how the courts handle this.

[Malcolm Mooney]

anonymous : "the content of the movies has no substantial functional affect on the comparing function"

As 6 pointed out upthread, this is incorrect. The choice of a baseline is critical to the claimed invention.

1. A method for optimizing a selection of movies, comprising:
(1) breathing, wherein said breathing delivers oxygen to the brain to facilitate neuronal firing; and
(2) determining a most preferred movie, wherein said determining involves ranking the anticipated enjoyment from watching a plurality of movies to the anticipated enjoyment from watching RINGMASTER.

Patentable under 101?

AI: "
Diehr says: “We recognize, of course, that when a claim recites a mathematical formula (or scientific principle or phenomenon of nature), an inquiry must be made into whether the claim is seeking patent protection for that formula in the abstract.”

It's not difficult to argue that this is exactly what Prometheus' claims are doing, whether you "take it as a whole" or "dissect it". There is no transformation effected by the claimed methods that is relevant to the invention's alleged utility. Instead, the claim attempts to capture the practioner's thoughts about the results of a test. It is therefore a quintessential example of a claim that amounts to "patent protection for the scientific principle in the abstract."

I've already provided examples of how Prometheus' alleged invention should have been claimed to avoid this problem, and I've explained why this problem issue is non-trivial.

I've also acknowledged that there may be other ways (e.g., anonymous "descriptive matter doctrine") to skin this cat, noting that (1) those ways have their own failings (e.g., they don't address the obvious 101 issues raised by my RINGMASTER hypo) and (2) I have yet to hear an argument for the neutering of 101 that isn't rooted in a hypocritical and self-serving wish by the proponent to preserve his/her rights to claim concepts and discoveries outright.

If you want an example of a "bright line rule" that needs to be tanked, look no further than Diehr's "strict" prohibition against looking behind the curtain to determine whether a claim has a 101 problem. It makes no sense, logically or from a policy standpoint, to allow limitations to be read out of claims for 102 and 103 purposes but to mandate that all limitations must be considered for 101 purposes. Then again, this assumes that the Diehrbots are correct in their (apparently) ultra-"strict" interpretation of Diehr. I'm not convinced at all that this is the case (on the contrary, I think any court, including the Supremes, is happy to ignore limitations for 101 purposes depending on the nature of those limitations).

[anonymous]

"As 6 pointed out upthread, this is incorrect. The choice of a baseline is critical to the claimed invention."

But the baseline (RINGMASTER) is non-functional copyrightable expression that is not functionally (cause and effect) linked to anything else. Accordingly, the antipated enjoyment value for RINGMASTER input is just treated as a generic enjoyment value input for 102/103. You still have the critical numerical baseline, but you ignore that it came from RINGMASTER because it's non-functional.

[anonymous]

contrast that with the Diehr numerical value, which represented a temperature, which was functional because the temperature was functionally tied to the rubber curing process.

[lee rahn]

As is frequently the case, I believe the claim would have covered patentable subject without restricting the scope of protectioin if it had stated that the administered dose IS increased when the level of 6-thioguanine is less than about 230 pmol per 8108 red blood cells and the administered dose IS decreased when the level of 6-thioguanine is more than about 400 pmol per 8108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8108 red blood cells.

[Malcolm Mooney]

anonymous: "But the baseline (RINGMASTER) is non-functional copyrightable expression that is not functionally (cause and effect) linked to anything else."

I'm sorry, anon, but the baseline is functionally linked to the determination step. You can say that it isn't but that doesn't change the fact that it is.

Again, I'm left wondering: why not just admit that this claim is invalid under 101? Why the desperate (and frankly incomprehensible) attempts to find it invalid under another provision?

[Malcolm Mooney]

anon: "contrast that with the Diehr numerical value, which represented a temperature, which was functional because the temperature was functionally tied to the rubber curing process."

There is no contrast. RINGMASTER is functionally tied to the determination step and without it there can be no optimization.