Prometheus v. Mayo: En Banc Petition on Patentability of Medical Methods

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)(on petition en banc)

by Dennis Crouch

In the wake of the Supreme Court ruling in Bilski v. Kappos, Mayo has petitioned the Court of Appeals for the Federal Circuit to sit en banc to re-hear its statutory subject matter challenge to the Prometheus  patents. (U.S. Patents 6,355,623 and 6,680,302).

The Prometheus Claims are directed toward an iterative approach of dosing an active drug ingredient (6-thioguanine).  Most of the claims are centered around three ordered-steps of:

  1. administering a dose of the drug to the subject;
  2. determining the amount of the drug in the subject’s blood; and
  3. re-calibrating the drug dosage.

A broader claim (claim 46 of the ‘632 patent) does not require the administering step of claim 1 above.

In its 2006 decision, The district court held the Prometheus patents invalid under Section 101 — holding that the claims preempt all practical uses of a natural phenomenon.  On appeal, the Federal Circuit reversed that decision — that the claims satisfied the Machine-or-Transformation test. Namely, the Federal Circuit panel held that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.”

The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined. Because the claimed methods meet the transformation prong under Bilski, we do not consider whether they also meet the machine prong. . . . [C]laims to methods of treatment . . . are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition. . . .

[T]he determining step, which is present in each of the asserted claims, is also transformative and central to the claimed methods. Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection. Some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or other modification of the substances to be measured, is necessary to extract the metabolites from a bodily sample and determine their concentration.

Preemption: The original appellate panel addressed preemption issue somewhat indirectly — holding that the claims could not preempt a fundamental principle because they passed the machine-or-transformation test: “Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.”

Following its Bilski decision, the Supreme Court vacated the Federal Circuit’s Prometheus holding and remanded for further proceedings. 

Not Concentric: Some have described the Supreme Court’s Bilski v. Kappos holding as situated somewhere between the broad State Street decision and the narrow machine-or-transformation test. (See Joe Mullin’s article quoting Mark Lemley as saying “Now we're halfway in between.”).  However, Supreme Court’s vacatur in Prometheus suggests that there are cases that would have been patentable under the strict machine-or-transformation test but that are no longer patentable.  (Otherwise, the court could have simply denied Mayo’s petition for a writ of certiorari as it did in Fergusun.

Roadmap: The machine-or-transformation test offers a clue to the existence of Section 101 qualifying subject matter. However, Prometheus may well present a situation where the claims satisfy MoT, but fail because of their preemptive nature. In its brief, Mayo argues that the three-justice opinion dissenting from the dismissal (DIG) provides a “roadmap” for this case.

95 thoughts on “Prometheus v. Mayo: En Banc Petition on Patentability of Medical Methods

  1. 90

    Has there been a decision in King v. Eon? That was one of the lamest “inventions” ever, regardless of any of the 101 issues.

  2. 88

    Malcolm, do you agree with the Federal Circuit that the metabolization of a drug by the body is a transformation with in the MOT test?

    I the only transformation in a method was the “metabolization” of a drug, I’d say that there was a lack of utility under 101.

    An eligible transformation is the transformation of diseased tissue to healthy tissue effected BY the drug.

    The problem in this case that the only transformation in the *claimed* method is an old transformation (in fact, even that trivial transformation is deleted from some of the claims). What was conceived by the inventors in Prometheus is, unfortunately, claimed only conceptually (“a need is indicated”).

    The claims at issue in Prometheus are, in fact, more abstract than those in Bilski. By a long shot. The “transformation” alluded by the Federal Circuit in their pathetic attempt to find the claim eligible is just a red herring.

  3. 87

    As to NWPA talking about turles idk 2xu te ef he’s referring to.

    “Now people are learning to build machines that process information like we do.”

    An abacus processed information “like we do”, in so far as that canard holds true for a computer. Ropes with knots tied in them did before that. Machines to assist in doing mathematics and displaying the results are nothing new. What is your point?

    So, NWPA, let me ask you, do you process information by the operation of transistors?

  4. 86

    “Obviously 6, you are wrong based on the given PHOSITA source of the definition I done stole.”

    PHOSITA cannot change reality pingerdoodle. Sorry mate.

    Also, I note that my prior response must not have posted. Thus, you will apparently be without its considerable wisdom.

  5. 85

    computer programs are not a “component”.

    Obviously 6, you are wrong based on the given PHOSITA source of the definition I done stole.

    Kinda crumbles your pathetic (lack of) understanding. Every. Single. Time.

  6. 84

    Does anyone know the common sense reason why the word “glue” is both a noun and a verb?

  7. 83

    Malcolm, do you agree with the Federal Circuit that the metabolization of a drug by the body is a transformation with in the MOT test?

  8. 82

    MM>>My prediction is they get it right this time >>and tank the claims.
    >>They won’t make the mistake again

    OK. Well, that is a prediction. Thank you. What will be the holding?

  9. 81

    rusty MM >>But those computer programs are

    Rusty MM, you have no clue what one of ordinary skill in the art needs described to be able practice a computer implemented invention.

  10. 80

    >>Note that even back in my Iron Age, we had >>machines that can do what people can do, like >>make yarn, bail grass, and plow a field. There >>is nothing special about your “Information >>Age” machines.

    Do you understand rust brain that the difference is that in your iron age the machines did what people did physically. Now people are learning to build machines that process information like we do. Sheesh. Thus, rust brain, data structures are structure. Transforming information is a transformation. But, I know, to you it is turtles all the way.

  11. 79

    >>Look, if you can point to some structure in >>your limitation then you’re fine. “data >>structures” are by definition a relationship >>RATHER than structure.

    6, It’s turtles all the way isn’t?

    Rust brain.

  12. 78

    “Walls” by itself is a word. “Walls” by itself is an abstraction. It is the relationship of the abstract word “Walls” to something else that makes the abstract into the particular.

  13. 76

    “Walls ”

    Walls are structure. The relationship it has is irrelevant to this concern.

    Look, if you can point to some structure in your limitation then you’re fine. “data structures” are by definition a relationship RATHER than structure.

    ” That’s an effective admission that there is no “particular machine” at all but just a general purpose computer with some dreamed up functionality, the sort of vague conceptual baloney that any clown can concoct while he’s paying his NetFlix bill.”

    No kidding, what would have been nice would have been for Netflix to end this ridiculous sht in the courts using that guy’s application. Not that the guy isn’t a nice guy or whatever, but it’d be just dessert. I note that they already might do wonders for getting $$$ back, they’re a real class act.

  14. 75

    They may incidentally have that relationship but that isn’t going to make that relationship be the structure.

    6, you LOL yourself. Walls holding up a roof is not structure?

    Malcolm,

    You say mundane – yet look around you. The standard of living increase evident in this information age belies just how “mundane” the results be.

    You want mundane? drop off the face of the earth in some backwater country that dont have these modern conveniences.

    As to the descriptions in specifications – you be wrong. They be needed to be described only to the level of PHOSITA. That power done cut two ways Chuckles. Ya see the issue you can’t handle is that there are many levels of abstraction, and the actual functional level in certain arts just be different than in other arts. Working examples and deposits are hardly required anywheres!

    You need to get over your anti-software mindset.

  15. 74

    Well, 6, MM, & sods, what is your prediction for the outcome?

    My prediction is they get it right this time and tank the claims.

    Neither the Fed Cir’s Bilksi decision nor the Supreme’s decision was needed to decide this case correctly the first time. The CAFC didn’t even apply its own test correctly.

    They won’t make the mistake again. And Prometheus will appeal and the Supremes will deny cert.

  16. 73

    ping Both statements quoted above miss the point of this fantastic synergy the mundane result released when the ubiquitous general purpose computer is transformed into a “particular computer programmed to apply the otherwise abstract method…..

    Fixed.

    Descriptive material can be characterized as either “functional descriptive material” or “nonfunctional descriptive material.” In this context, “functional descriptive material” consists of data structures and computer programs which impart functionality when employed as a computer component.

    But those computer programs are almost never described in the specification of your typical bullshirt computer-implemented invention application, much less recited in the claims. Instead, they are referred to abstractly without a single working example provided or deposited. There is *nothing* described in the typical application which would “impart functionality” to any computer. The excuse is that “anyone can do the programming.” That’s nice. That’s an effective admission that there is no “particular machine” at all but just a general purpose computer with some dreamed up functionality, the sort of vague conceptual baloney that any clown can concoct while he’s paying his NetFlix bill.

  17. 72

    Predictions:

    They will hold the processes of the body to metabolize drugs is a phenomena of nature and not a transformation; otherwise phenomena of nature could be patentable.

    Measuring a phenomena of nature coupled with using the measurement to do something useful with the information is neither abstract nor a monopolization of the phenomena of nature.

    The claims that simply measure the phenomena of nature, without more, do not recite patentable subject matter.

  18. 71

    “functional relationship could be structure?”

    Hmmm, no. A structure is a structure, not a relationship. Likewise a relationship is a relationship, not a structure.

    Next time you talk to your wife or girlfriend be sure to inquire how your structure is between you two. I’m sure she’ll respond that your structure is great and you’ll be married for another 20 years.

    “Welcome to the information age which is building machines that do things that people can do.”

    We were acquainted quite awhile back, and lo and behold, all of those “machines that are built to do things that people can do” still have structure and are still liable to be distinguished by such in in patent law.

    Note that even back in my Iron Age, we had machines that can do what people can do, like make yarn, bail grass, and plow a field. There is nothing special about your “Information Age” machines.

    I’ll not be party to your doublespeaking in order to distinguish your claims improperly.

    “And stop calling people tards. Makes you sound like you are 10 years old with rust.”

    K, tard.

    “And if it helps 6, ya might think of an office building having a structure of iron beams “having a physical or logical relationship among iron elements designed to support building functions (such as holding up a roof).”

    They may incidentally have that relationship but that isn’t going to make that relationship be the structure.

    Facts is facts boys, I’d trounce you idi ots any day of the week. You people who are of ordinary brain-washing in that art do not change reality and never will. All that is required is for someone who knows what they’re talking about to come in and speak it how it actually is and your pathetic understanding crumbles. Every. Single. Time.

  19. 70

    Wouldn’t that be Iron brainless 6?

    And if it helps 6, ya might think of an office building having a structure of iron beams “having a physical or logical relationship among iron elements designed to support building functions (such as holding up a roof).

    Try seeing this from a perspective of someone having ordinary skill in the art.

  20. 69

    >>Hmmm, so a “data structure” isn’t really >>a “structure”, it is a “relationship”? Pretty >>much just shot yourself in the foot there >>quinny boy.

    Iron brain 6, do you think that a functional relationship could be structure? Welcome to the information age which is building machines that do things that people can do.

    And stop calling people tards. Makes you sound like you are 10 years old with rust.

  21. 67

    Ping, you are a re tard, just like quinny, neither structure or functional language has anything to do with “data structure”, and computer programs are not a “component”. You’ve simply mangled the definitions of the words to suit your ends.

    “(The definition of “data structure” is “a physical or logical relationship among data elements, designed to support specific data manipulation functions.” The New IEEE Standard Dictionary of Electrical and Electronics Terms 308 (5th ed. 1993).)”

    Hmmm, so a “data structure” isn’t really a “structure”, it is a “relationship”? Pretty much just shot yourself in the foot there quinny boy.

  22. 66

    “Well, 6, MM, & sods, what is your prediction for the outcome? ”

    That depends on many things. Will Rader step down for this decision like he was asked to for the Myriad one?

    Bottom line it will come down to those that want to uphold the law, and those who don’t understand the law.

    My prediction will be, as of right now, assuming bad arguments from both sides, if Rader stays in, he will lead way for his side of “decide based on feeeeeeeeeeeeelllllllllings, ooooo whoa whoa feeeeeeeeeeeeeeeellllllllllllllinnnnnnnnnnngs”. If however, Rader is not present due to his outright admission that he doesn’t believe the law to be applicable, and that he’d rather decide on his feeeeeeeeeeelings, then the claim will be invalidated.

    But ask me again after I’ve seen how well the parties argue in their briefs and possibly at oral arguments. It will all boil down to one thing, will Mayo correctly tell the court which abstract idea is being preempt and state why such is so? Even if Rader stays in, Mayo will win in that event.

  23. 65

    the only rule we can extrapolate from the case is that a general purpose computer does not particularize an otherwise abstract method.

    and Malcolm’s (always carefully worded):

    wherein a computer does the observing

    Sure – on its face the general purpose computer is an abstraction fairly limited to do much of anything with one great big difference – it can by synergized! Both statements quoted above miss the point of this fantastic synergy released when the ubiquitous general purpose computer is transformed into a “particular computer programmed to apply the otherwise abstract method.

    To top it off, let me steal, um borrow, something from Quinny’s website as to such claims being differentiated in structure:

    Descriptive material can be characterized as either “functional descriptive material” or “nonfunctional descriptive material.” In this context, “functional descriptive material” consists of data structures and computer programs which impart functionality when employed as a computer component. (The definition of “data structure” is “a physical or logical relationship among data elements, designed to support specific data manipulation functions.” The New IEEE Standard Dictionary of Electrical and Electronics Terms 308 (5th ed. 1993).) “Nonfunctional descriptive material” includes but is not limited to music, literary works and a compilation or mere arrangement of data.

  24. 64

    Well, 6, MM, & sods, what is your prediction for the outcome?

    You have such a great record at predicting outcomes. Perhaps that is because you have no idea what you are talking about.

  25. 63

    Note that sticking a limitation “wherein a computer does the observing” also should not save the claim.

    A claim to an improved mailable package comprising a computer that calculates the time from the removal of the letter from the mailbox to the time of opening of the letter would be 101 eligible, I think. But it’s an obvious invention, of course, and no claim should be granted.

  26. 62

    Is the transformation here any less ‘obvious’?”

    sigh

    Please stop conflating 103 with 101.

    TINLA, I put the term in quotes because I wanted to make it clear I wasn’t referring to 103. The point is: whether the old transforming step in the claimed method is administering a life-saving drug or simply putting a letter into a mailbox, the problem with the *invention* is the same. There is no patentable subject matter in the invention as claimed. There is an old step and there is a thought or an observation made about a result of the old step.

    101 FAIL.

  27. 61

    “Is it? Nobody bothered to tell the Supreme Court. They seemed to think the claim was for use in a general purpose computer.”

    It is, they come in various shapes and sizes and, gasp, guess what, can have different hardware inside! Shift registers are nice, and can speed up some calculations by a lot, but they are by no means required.

    Nevertheless, we can infer what you say. That notwithstanding, we can also infer what I have said.

    The only use for the algorithm in Benson was using shift registers for the claimed process. That is to say, by claiming the process he claimed, which was a rather specific process, he got all of the useful things that the algorithm could be used to do. Save pencil and paper calculating perhaps. That is practically wholly preempting the use of the algorithm.

    “Whether they were right or wrong about the facts, the only rule we can extrapolate from the case is that a general purpose computer does not particularize an otherwise abstract method.”

    The “rule” which they explicitly recited was different from that. Maybe you can think hard and remember it.

    What you recite is one principle we can infer.

    Another is what I recited above that you took issue with, instead preferring your “particular machine” rhetoric rather than something that will be persuasive no matter the situation or argument against it.

  28. 60

    “Problem is fixed.”

    No sooner do I declare the slow lod times resolved than they reappear. That one just took a minute and twenty seconds.

  29. 59

    You do know that it is possible to make a general purpose computer without shift registers right?

    Is it? Nobody bothered to tell the Supreme Court. They seemed to think the claim was for use in a general purpose computer.

    Whether they were right or wrong about the facts, the only rule we can extrapolate from the case is that a general purpose computer does not particularize an otherwise abstract method.

  30. 58

    “No, what happened in Benson is that a general purpose computer doesn’t particularize anything at all. That leaves you with a claim to the bare method “performed somehow”, which in Benson was nothing but math”

    You do know that it is possible to make a general purpose computer without shift registers right?

  31. 57

    “Is the transformation here any less ‘obvious’?”

    sigh

    Please stop conflating 103 with 101. I don’t think I can take it anymore.

    At least pretend for a while to stop doing it and maybe say something else, like, “is the transformation here any less ‘abstract?'” I mena that, would actually get close to the proper inquiry regarding whether it is a particular transformation, versus if the transformation as recited is itself a generalized abstraction (i.e., the mere idea of administering a drug or displaying a result, as opposed to a particular way of doing those things).

  32. 56

    “It looks like the main page gets hung up trying to load the Prep & Pros and Pre-Bilski surveys, which appear to no longer exist. The problem should go away as soon as those articles get bumped to page 2, but perhaps some editing is in order to make the front page more user-friendly in the meantime.”

    Problem is fixed.

  33. 55

    Just like what happened in Benson.

    No, what happened in Benson is that a general purpose computer doesn’t particularize anything at all. That leaves you with a claim to the bare method “performed somehow”, which in Benson was nothing but math.

  34. 54

    IANAE:

    “If a machine or a transformation is particular enough, then by construction it does not preempt use of the principle with any other machine or transformation.”

    If the principle is only useful with ONE machine or transformation and that is claimed then is the principle wholly preempt?

    Yes. It is. Just like what happened in Benson.

  35. 53

    IANAE That’s clearly patentable subject matter, since making the shampoo necessarily involves a transformation.

    LOL. IANAE gets it.

  36. 52

    I just want to let you know that the main page now has an extremely long load time. I am assuming it is due to the addition of your photo. The wait for that part of the page to load is very long.

    The individual articles also have his photo, and they load fine. With all due respect to Dennis, I don’t think the problem is people hammering the servers to get a look at his face.

    It looks like the main page gets hung up trying to load the Prep & Pros and Pre-Bilski surveys, which appear to no longer exist. The problem should go away as soon as those articles get bumped to page 2, but perhaps some editing is in order to make the front page more user-friendly in the meantime.

  37. 50

    Malcolm: delivering a shampoo sample-containing letter to a mailbox by inserting the letter into the mailbox;

    That’s clearly patentable subject matter, since making the shampoo necessarily involves a transformation.

    Malcolm: Or do people prefer a bright line rule: an old method with an abstraction/mental step tacked on (e.g., a “realization”) is per se obvious.

    Oh Diehr, anything but that, please.

  38. 49

    Did you know that r e d p u m p s trips the word filter?

    Don’t point your anger at me Malcolm, go directly to RWA to get your possessions back.

    As to non sequitur, throwing a completely new claim at the stunningly simple and painfully obvious transforma – oops, conversion of a drug ingested and operative in a subject – yeah, that’s preety clear.

  39. 46

    Nice non sequitur Sunshine.

    How is this a non-sequitur?

    Oh wait — you think that optimizing receipt claim is a patentable invention, don’t you?

  40. 44

    I think they may have gone for the obvious that the drug conversion is a transformation.

    A method of optimizing receipt of shampoo samples contained in letters, comprising:

    delivering a shampoo sample-containing letter to a mailbox by inserting the letter into the mailbox;

    determining when the letter was opened, wherein if the letter was opened in less than 22 hours and 30 minutes, a reduction in the number of “urgent: read me” stickers on subsequent letters is indicated; and wherein if the letter is opened in more than 22 hours and 30 minutes, an increase in the number of “urgent: read me” stickers on subsequent letters is indicated.

    Is the transformation here any less “obvious”? It’s certainly equally irrelevant to a proper 101 analysis.

    Or do people prefer a bright line rule: an old method with an abstraction/mental step tacked on (e.g., a “realization”) is per se obvious.

    I thought bright line rules were the worst thing ever.

  41. 43

    Awww Ping, you’re so cute. My little Pingy-Wingy. I didn’t know there was a way where a person could reach into their own cells and manually direct the metabolism of a drug that has been administered to them. Darn. I guess I won’t be able to get a patent on that.

  42. 42

    What I don’t understand is how/why the Federal Circuit bent over backwards to find the claims eligible under 101 in the first place.

    Um lets see – transformation -> start with drug, drug is converted (transformed), proceed to other steps…

    I think they may have gone for the obvious that the drug conversion is a transformation.

    Just a wild guess.

  43. 41

    If a drug is metabolized in the brain, does that make the transformation nothing more than a series of mental steps? ;)

    No, it’s a series of physical steps performed by the brain, which makes it non-statutory as telekinesis.

    Malcolm: What I don’t understand is how/why the Federal Circuit bent over backwards to find the claims eligible under 101 in the first place.

    They fell in love with the spec, probably. Someone came in with a grandiose proclamation that they had a way to save a bunch of lives, and the court said “okay, anything you claim is fine I guess”. That’s clearly what happened in Arrhythmia, if you read the opinions.

  44. 40

    The Feds held the natural body process of converting a drug into a metabolite to be a “transformation,” placing the subject matter of the claim with the ambit of patentable subject matter without more. I think at least four of the Supremes disagreed. Thus the remand.

    No, I understand the remand. What I don’t understand is how/why the Federal Circuit bent over backwards to find the claims eligible under 101 in the first place.

  45. 39

    If a drug is metabolized in the brain, does that make the transformation nothing more than a series of mental steps? ;)

  46. 38

    Malcolm, I think you and I agree on the ultimate holding on one, but I also think you fail to appreciate why the Supremes vacated and remanded. The Feds held the natural body process of converting a drug into a metabolite to be a “transformation,” placing the subject matter of the claim with the ambit of patentable subject matter without more. I think at least four of the Supremes disagreed. Thus the remand.

    Of course there are secondary issues of whether measuring a natural phenomenon is a transformation. I think not. One must do something with the measurement — and that appears to be your ultimate position as well, just stopping at the measurement is not sufficient.

  47. 37

    to the extent “mere inspection” comprises eyeballing (in the context of a determine+correlating claim), you run into the problem of creating literal infringers who have done nothing but (1) learn the underlying the facts about the correlation and (2) happened to be looking in the wrong place at the wrong time.

    Yes, but you create the same problem when the “transformation” is old and well-known, or implicit/automatic/metabolic. What if ABO blood type had a newly-discovered correlation with some specific disorder? Why should an old, routine, transformative blood test plus the lab tech’s knowledge infringe a new patent?

    In Diehr, the result of the calculation changed how the machine was operated to carry out the transformation. That’s how MOT distinguishes between an abstract calculation and a real-world application.

    Rather, a “need” is “indicated.”

    The need isn’t positively recited in the claim, nor is changing the dose. It simply says that a particular level of 6-TG “indicates a need”, which is passive and isn’t really a limitation at all. It does nothing more than recite what the 6-TG level means to a person. The only steps in the claimed method are (a) administering and then (b) determining a level. Not even so much as a post-solution output of an alarm limit.

    101 fail indeed.

  48. 36

    Just as a reminder, please take a look at claim 1 of the ‘623:

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

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

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

    wherein the level of 6-thioguanine less than about 230 pmol per 8×10^8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

    wherein the level of 6-thioguanine greater than about 400 pmol per 8×10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    Note that there is no administration step in this claim either. Rather, a “need” is “indicated.” That “need” could be indicated by something else, of course (e.g., patient doesn’t seem to be responding well). But if you happen to measure the level of 6-TG, it evidently does not matter why you changed the dose. You still infringe, not because of what you did or thought, but because of what the “data indicated”.

    Pretty screwed up. 101 FAIL.

  49. 35

    I just want to let you know that the main page now has an extremely long load time. I am assuming it is due to the addition of your photo. The wait for that part of the page to load is very long.

    Anyone else notice how the eyes seem to follow you around the room?

  50. 34

    Malcolm: Which brings me to a broader question: from a policy standpoint, what is the distinction between a determination made by “mere inspection” and one that requires a trivial, unpatentable transformation of matter (e.g., removal of blood and analysis thereof according to old well-known techniques).

    IANAE Unless the particular transformation itself is the point of novelty, I don’t see any legal or policy reason to distinguish between “performing [routine test] on said patient’s blood” and “determining based on a color of said patient’s skin” as a step in a diagnostic method. It’s just pre-solution data gathering.

    I think you alluded to the policy reason upthread in one of your other comments: to the extent “mere inspection” comprises eyeballing (in the context of a determine+correlating claim), you run into the problem of creating literal infringers who have done nothing but (1) learn the underlying the facts about the correlation and (2) happened to be looking in the wrong place at the wrong time.

    I continue to find it fascinating that the patent teabuggers are not at all alarmed by this.

  51. 33

    Mr. Nonobvious,

    How could this possibly be non-obvious? People do this several times a day for years, if you count candy bars/blood glucose as a drug. Drug companies must do this routinely in testing to determine proper dosage and determine pharmacokinetics. Seems like a bad case to use to set new law.

    The issue regarding whether the limitation that recites the particular transformation or particular machine is an old one. The 1981 SCOTUS case Diehr said that you cannot dissect out the old part for the 101 analysis, but the CAFC panel in Classen did exactly that, followed by Mayo v Prometheus, in which the CAFC panel decided not to do that. SCOTUS granted cert in both cases, immediately vacated the decisions below, and then remanded them for consideration in view of Bilski v Kappos. If both cases are heard En Banc, my prediction is that the CAFC will find the claims in both cases to pass 101 for reciting a particular transformation, even though the transformation is not the new part.

  52. 32

    Dennis,

    I just want to let you know that the main page now has an extremely long load time. I am assuming it is due to the addition of your photo. The wait for that part of the page to load is very long.

  53. 31

    because the curing of rubber upon application of heat is just as much a natural phenomenon.

    Man’s tool box is filled with things found in nature or made by man from things found ini nature – there is no other way. The tool box can be electrons, protons and neutrons at one abstraction level, or it can be bits and pieces of molecules at another abstraction level, or it can be gears, pins and levers at yet another abstraction level.

    Let’s play nice now.

  54. 30

    Hmmm – interesting question

    More broadly, what about any transformation that occurs naturally as a consequence of discretionary human action?

    Can everyone agree:

    Phenomenon is singular, phenomena are plural.

  55. 29

    The natural phenomena of a body process in converting a drug into a metabolite cannot be a transformation under the MOT as a matter of law?

    I’m hesitant to agree to that exact statement, because the curing of rubber upon application of heat is just as much a natural phenomenon.

    However, I would agree that it’s not an MOT-qualifying transformation because you can’t meaningfully recite it as a step in the method. The infringer isn’t really performing that step.

    I’m willing to accept administering a particular medication as a qualifying machine or transformation, I guess, but not if the actual invention is simply observing the result. The administering should be controlled in some way by the abstract observation of the natural correlation between some specific test data and the need for more medication.

  56. 28

    Can everyone agree:

    The natural phenomena of a body process in converting a drug into a metabolite cannot be a transformation under the MOT as a matter of law?

  57. 27

    1) using 6-TG to treat an immune-mediated GI disorder is old (I assume that the additional step would be administering some amount of 6-TG),

    All the actual steps in Diehr were old.

    2) nobody would want a claim with the extra conditional treatment step (physicians are immune from infringement with respect to medical treatment methods, and they aren’t the ones doing the actual testing).

    Who is infringing without the treatment step? Nobody is actually doing anything at all. Will we make it an infringement for lab techs to notice things? See the top of page 4 of the petition. “Because [Dr. el-Azhary] had seen those levels and not erased her mind, however, Prometheus accused her of infringement without her having to do anything with her natural and unavoidable mental recognition.”

  58. 26

    OK IAENE. I’m not completely up to speed on “diamondy-shape” things in patent applications, so I guess I’ll defer to you. Doesn’t really matter because 1) using 6-TG to treat an immune-mediated GI disorder is old (I assume that the additional step would be administering some amount of 6-TG), and 2) nobody would want a claim with the extra conditional treatment step (physicians are immune from infringement with respect to medical treatment methods, and they aren’t the ones doing the actual testing).

  59. 25

    Malcolm: Which brings me to a broader question: from a policy standpoint, what is the distinction between a determination made by “mere inspection” and one that requires a trivial, unpatentable transformation of matter (e.g., removal of blood and analysis thereof according to old well-known techniques).

    Unless the particular transformation itself is the point of novelty, I don’t see any legal or policy reason to distinguish between “performing [routine test] on said patient’s blood” and “determining based on a color of said patient’s skin” as a step in a diagnostic method. It’s just pre-solution data gathering.

    6: ““Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.””

    That might be non sequitur of the year for the CAFC.

    If that’s a non sequitur, it can only be so as a matter of law. The Supreme Court’s statement that there’s any wiggle room at all between MOT and section 101 is based purely on hope and speculation. Let’s not forget that they were deciding a case that was abstract and failed MOT. If a machine or a transformation is particular enough, then by construction it does not preempt use of the principle with any other machine or transformation.

    PharmaPatents: Does the MOT require the M or T to be novel per se?

    No, that would be inconsistent with Diehr. The M or the T simply have to meaningfully limit the scope of the claim to a particular application, rather than abstract math. In other words, the novel element has to have some nontrivial relationship to the M or the T.

    Hans Blix: The problem with that kind of claim is the “if then” problem (e.g., IF level of 6-thioguanine is X, THEN the treatment is A, and IF level of 6-thioguanine is other than X, THEN the treatment is other than A). Isn’t that indefinite?

    Conditional steps aren’t indefinite, if the condition is well defined. They’re the diamondy-shaped ones in the flowchart. By the time you get to that step, you have enough information to know exactly how to carry out that step.

    Would you prefer a “while” condition to an “if/then” condition? Diehr essentially claims maintaining the press in a closed position until a condition occurs, which is the same as opening the press if the condition occurs. You’d have no problem at all practicing that claim or knowing whether you infringe it. A claim of periodically administering a drug until a patient’s metabolite level exceeds a threshold would be analogous to Diehr.

  60. 24

    “This is a pretty weak point to make in an otherwise impressive en banc petition.”

    Andrew,

    There are other “weak points” in this petition:

    1. Reliance upon Breyer’s LabCorp dissent. Only 2 other Justices signed onto that dissent, and those Justices don’t include Scalia. Whether Scalia’s signing onto Breyer’s concurrence in Bilski v. Kappos evidences agreement with Breyer’s view in this LabCorp dissent isn’t clear, anymore so than exactly what Scalia disagreed with in Parts II B-2 and C-2 of the Court’s opinion in Bilski v. Kappos (other than Scalia doesn’t believe “business methods” should be patent-eligible).

    2. Any reliance upon Steven’s concurrence (actually a partial dissent) in Bilski v. Kappos. What Steven’s says, especially in part V of his concurrence, is so much disingenuous sophistry in the extreme. In fact, Steven’s concurrence completely misrepresents what 35 USC 273 says about the patent-eligibility of “business methods” as evidenced by the “black and white” Congressional intent for enacting 35 USC 273: “The bill [35 USC 273] protects the [business method] patent owner by providing that the establishment of the defense by such an inventor or entrepreneur does not invalidate the patent.” Contrary to what Steven’s concurrence suggests, 35 USC 273 isn’t a “red herring.” Accordingly, I would completely discount any reliance by Mayo’s petition upon Steven’s concurrence.

  61. 23

    Let me summarize, from Breyer’s point of view.

    1. The natural phenomena of a body process in converting a drug into a metabolite cannot be a transformation under the MOT as a matter of law.

    2. The measurement of a natural phenomena cannot be a transformation under the MOT as a matter of law.

    3. The adjustment of a drug treatment regime of a disease in response to such a measurement is a physical act that may qualify as being the use of the natural phenomena in an otherwise patentable process.

    4. Claims that do not require the adjustment step do not have any legally qualifying MOT.

  62. 22

    A retired nuclear inspector said:

    “Oh well, it was a good run while it lasted.”

    The run will continue while any opportunity is presented.

    Some might wonder whether the new invention economy based on fanciful and “clever” semantic twists will really provide the advancement of the public’s interest and benefit.

    It may be more to the point to wonder whether the Federal Circuit experiment has failed.

  63. 21

    The key claim at issue in this case, as Breyer stated in his dissent of the dismissal of LabCorp. v. Metabolite, isn’t even “at the boundary” of being valid. Same thing for Classen v. Biogen, and for the mutation screening claims in AMP v. USPTO. No matter what one says, the claims seek to prohibit the recognition or observation of natural phenomena which, although newly discovered (newly discovered at the time of filing, that is), are still just natural phenomena.

    Some have suggested that if the claim in Prometheus included an additional treatment step, such treatment step being dictated by how much 6-thioguanine was detected, then the claim would hold up. I’m not sure about that. The problem with that kind of claim is the “if then” problem (e.g., IF level of 6-thioguanine is X, THEN the treatment is A, and IF level of 6-thioguanine is other than X, THEN the treatment is other than A). Isn’t that indefinite?

    Some have also suggested that the claim might be saved by adding a step that consists of “communicating” the results of the test to the patient. But if the mode of communication is old, then the claim is still dead, right?

    Oh well, it was a good run while it lasted.

  64. 20

    “Yep that indeed was the official notice getting the boot.”

    He did kind of take a bad official notice, but if you read carefully, I believe he simply didn’t take official notice of enough.

    What’s funny is that the spurned, or insufficient, official notice then is simply replaced by common sense in the new grounds of rejection it looks like. LOL. Gj attorney.

  65. 19

    coach handbags, you seem to be claiming the natural phenomenon of the specialness of each moment. True, you are limiting your claims to minutes, hours and days, but collectively this amounts to a claim on the whole ball of wax.

    I suggest amending your claims to novel, non-obvious methods of enjoying particular human experiences. Maybe there is a particular combination of Merlot and bossa nova that would really improve my life. I’d pay a reasonable royalty if you’ve got something there.

  66. 17

    Check that out for some good laughs regarding the new MoT at the board and official notice to boot.

    Just like 6 to point out a piece of travesty (at least it tries to do more than just MoT), particularly pointing out the only thing the examiner lost on (taking official notice). Yep that indeed was the official notice getting the boot.

  67. 16

    How could this possibly be non-obvious? People do this several times a day for years, if you count candy bars/blood glucose as a drug. Drug companies must do this routinely in testing to determine proper dosage and determine pharmacokinetics. Seems like a bad case to use to set new law.

  68. 15

    link to des.uspto.gov

    Check that out for some good laughs regarding the new MoT at the board and official notice to boot.

    Easy there MM, dam man, I thought your questions were rhetorical to make a point.

    “from a policy standpoint, what is the distinction between a determination made by “mere inspection” and one that requires a trivial, unpatentable transformation of matter (e.g., removal of blood and analysis thereof according to old well-known techniques). ”

    Probably none, they’re both probably post-solution activity or abstractions themselves. I don’t give a dam what incidental transformation takes place in a given determining step (especially if we’re relying on the spec etc. to tell us it takes place), “determining” is an abstraction, specifically, an abstract idea. If they want to say, in their claim, determining by scanning electron microscopy etc. in their claim then maybe we could have this discussion.

    Other than that man, f I don’t know. I haven’t thought that out all that much and I don’t have all day, I have a lot on my plate, and a new decision to read through and lol @.

    And remember, I think your questions are kind of irrelevant to me, I couldn’t give a sht less about MoT. And neither should you. It is for lols, “wankers” and tards and you know it. Srs men get down with whether or not an abstract idea is preempt or not. Even more srs men would decide if the relevant claim belongs to the Useful Arts, but alas, we sent a claim that didn’t depend solely upon this distinction to the USSC, and will have to wait for another go round in a few decades to get that sorted, frakin judicial restraint.

    Btw, great call on the utility req for the 2nd example. I may well use that. I’m not so sure about the abstraction part, but it was what I was previously considering. I can’t make up my mind.

  69. 14

    PharmaPatents Isn’t patentability evaluated as a whole, rather than on a line-by-line basis?

    No, for the reasons I’ve given above. You can’t do an end-around 101 by adding an essentially non-limiting step or device.

  70. 13

    A method of making a bicycle, the method comprising:
    providing a frame
    providing a seat.

    101 pass/fail?

    No transformation. FAIL.

    A method of making a bicycle, the method comprising:
    positioning a frame
    positioning a seat.

    Manually positioning old objects in a non-limiting fashion not a substantial utility under 101. FAIL. Also so vague and general as to constitute an abstraction. FAIL.

    And thanks for answering my questions, 6, you lazy $#%$%.

  71. 12

    Yes, people with claims similar to Prometheus thought they were safe after Bilksi, until the remand came out.

    See my article at:
    link to pharmapatentsblog.com

    Does the MOT require the M or T to be novel per se? If not, how can it matter that the “transformation” is performed by known methods? If so, how can all those business method patents that recite the use of a “computer” to comply with MOT actually be patentable? Isn’t patentability evaluated as a whole, rather than on a line-by-line basis?

    The panel opinion addressed the “data gathering” issue and determined that the steps at issue, while useful for obtaining data, also were essential to the methods, and so could support patent-eligibility. We’ll see what happens on remand.

    I agree that the Prometheus/Classen/Myriad case present an interesting trio that could have a major impact.

  72. 11

    Mayo asserts that “it is unlikely that any efficiency would be gained by having this case considered in the first instance by the panel, because the original panel cannot be reconstituted….” (CJ Michel retired and a USDJ sitting by designation was on the original panel).

    This is a pretty weak point to make in an otherwise impressive en banc petition. So what if that’s true? En banc review is about the exceptional importance of the case and/or resolving conflicts in the CAFC’s jurisprudence. It’s not about judicial efficiency.

  73. 10

    I have a work related question for you guys, and maybe some of you can help me out.

    The claim is:

    A method of making a bicycle, the method comprising:
    providing a frame
    providing a seat.

    101 pass/fail? Why or why not? Be as specific as you can please.

    Likewise for:

    A method of making a bicycle, the method comprising:
    positioning a frame
    positioning a seat.

  74. 9

    ““Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.””

    That might be non sequitur of the year for the CAFC.

    “However, Supreme Court’s vacatur in Prometheus suggests that there are cases that would have been patentable under the strict machine-or-transformation test but that are no longer patentable. ”

    I try to tell people this but they don’t seem to understand. It is as if they were (and some still are) so focused on MoT (and its ability to destroy their claims) they lost the forest for the trees.

  75. 8

    Mayhaps “trvial” harkens to the sam saw about breathing life into a claim:

    If a claim is dead without it, it ain’t trivial.

  76. 7

    IANAE It’s a fancy way of saying “output the result of the calculation in the form of a single binary bit”.

    Perhaps, but note that even a “determining” step that involves a transformation can be “self-outputting.” In other words, the determination may be construed to require a composition of matter to be transformed, but obtaining the value/result/determiniation from that transformation step can be achieved by “mere inspection” without any “outputting” or “displaying” steps.

    Which brings me to a broader question: from a policy standpoint, what is the distinction between a determination made by “mere inspection” and one that requires a trivial, unpatentable transformation of matter (e.g., removal of blood and analysis thereof according to old well-known techniques). If you had to use a magnifying glass to make the determination, is that still “mere” inspection? What if you had a take a month long course to learn how to do the inspection according to the ancient (but uniquely useful) method? What if the inspection itself takes 2 hours of expert looking according to the ancient (but uniquely useful) method? Still “mere” inspection?

  77. 6

    the invention is necessarily an abstraction (e.g., “determined value indicates that an individual should get more medication;” “determined value indicates that a person will enjoy the movie”, etc.).

    “determined value indicates abnormal conditions in catalytic conversion process”…

    It’s a fancy way of saying “output the result of the calculation in the form of a single binary bit”.

  78. 5

    I don’t think there will ever be a claim that passes MOT and is invalid for preempting an abstract idea. Ever.

    Posted by: IANAE | Jul 26, 2010 at 01:52 PM

    cf:

    Prometheus may well present a situation where the claims satisfy MoT, but fail because of their preemptive nature

    Yummy words.

  79. 4

    If the determining step transforms something, it should be particularized, e.g. “determining the levels of 6-TG or 6-MPP by performing the steps of …”. Because, really, the claim doesn’t exclude determining the levels by mere inspection, should someone someday figure out a way to do that.

    That’s another issue, IANAE. If the only physical transformation effected by the claim is an old one, then the claim is ineligible under 101 because the invention is necessarily an abstraction (e.g., “determined value indicates that an individual should get more medication;” “determined value indicates that a person will enjoy the movie”, etc.).

  80. 3

    The transformation being used to shoehorn claim 1 into 101 eligibility according to this argument is not an outcome effected by the invention as whole,

    Exactly. If the determining step transforms something, it should be particularized, e.g. “determining the levels of 6-TG or 6-MPP by performing the steps of …”. Because, really, the claim doesn’t exclude determining the levels by mere inspection, should someone someday figure out a way to do that.

  81. 2

    Fed Circuit [T]he determining step, which is present in each of the asserted claims, is also transformative and central to the claimed methods. Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection.

    The transformation being used to shoehorn claim 1 into 101 eligibility according to this argument is not an outcome effected by the invention as whole, but an insignificant side effect of one of the method steps, not unlike “energy consumption” or “breathing”.

    According to the same logic, one could argue that reference to a computer or a person in a method claim “necessarily involves” a transformation because both the person and the computer necessarily involved a transformation from, e.g., a zygote or a collection of component parts.

  82. 1

    Dennis,

    Besides Prometheus, there’s also Classen (an mind-boggling brief opinion that says nothing about why the MoT test was applicable), as well as AMP v. USPTO. I see this trio of cases as making (or potentially breaking) the patent-eligibility of comparative/correlative diagnostic methods.

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