Federal Circuit: Hardening the Line on Method-of-Treatment Claims

by Dennis Crouch

This case focuses on patents covering the opioid drug oxymorphone that Endo sells as Opana ER.  In 2017, the FDA requested that (reformulated) Opana ER be removed from the  market in response to the high risk of its illicit use.  Endo had previously pulled Opana ER from the market in 2012 and then re-launched in a “non-crushable form.”  However, that form continued to be abused (including by liquefying and injecting). In response to a new FDA request, Endo again removed the reformulated version from the market. The appeal here is focused on one a subset of the patents covering Opana — a fight between Endo and generic manufacturers who want to start distributing the drug once again. 

Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2019)

Endo’s patents at issue on appeal claim a personalized method-of-treatment that has three distinct steps:

  1. “Providing” the drug (5 to 80 mg of oxymorphone in a controlled release matrix);
  2. “Measuring” the patient’s creatine clearance rate; and
  3. “Administering” the drug with dosage calculated based upon the patient’s creatine clearance rate (using a particular formula).

The inventors here were concerned about renal impairment experienced by some folks taking oxymorphone.  In their research, they discovered that some folks clear the drug faster (and have fewer kidney problems). The inventors here used the metabolite creatine as an easier to measure proxy for measuring drug clearance (creatine clearance rate) since it comes out in the urine.

These discoveries in hand, the inventors came up with the scheme of giving lower dosages of oxymorphone to individuals with lower clearance rates.

The district court reviewed the claims and found them invalid — holding that the claims were effectively directed to a law of nature.  On appeal, the Federal Circuit has reversed and reinstated the patent’s validity.  This decision here is the next in a series of decisions creating a hard rule that method-of-treatment claims are patent eligible. See Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018) and Natural Alternatives International v. Creative Compounds, LLC, 2019 WL 1216226 (Fed. Cir. Mar. 15, 2019).  Here, the court writes:

[T]he asserted claims are not directed to patent-ineligible subject matter. On the contrary, the claims are directed to a patent-eligible method of using oxymorphone … to treat pain in a renally impaired patient. . . .

The claims at issue here are legally indistinguishable from the representative claim in Vanda. Both claims recite a method for treating a patient.

The key precedent here is Mayo v. Prometheus (2012). As in Vanda and Natural Alternatives, the Federal Circuit has characterized Mayo as directed only to a method of optimizing a treatment plan — rather than being a treatment itself.   The claims at issue in Mayo require administering a particular drug for treatment of a GI disorder. However, the Federal Circuit explained away that aspect of the claim:

Although the representative claim in Mayo  recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease. Furthermore, the administering step in Mayo is distinguishable from the administering step in the [Endo] patent because the administering step in Mayo is the first step in the method that simply describes giving the drug to a patient with a certain disorder. By contrast, the administering step in the ’737 patent is the step that describes giving a specific dose of the drug based on the results of kidney function testing.

The district court had rejected the clams — agreeing with its magistrat judge that “[t]he administering step merely instructs physicians to dispense oxymorphone for the treatment of pain in a well-know[n] manner, while utilizing the natural law to manage the dosage.”

= = = = =

Question for those of you doing software – What is your equivalent of a “method-of-treatment” claim.

96 thoughts on “Federal Circuit: Hardening the Line on Method-of-Treatment Claims

  1. 13

    Stuck in the filter is a real nice mini-treatise on five types of “personalized” “treatment” claims which raise eligibility issues of varying degrees.

    1. 13.1

      Cleveland Clinic Foundation case is non-precedential but relatively well written (it doesn’t completely obscure the relevant case law but applies it).

      Also shoots down one of the PTO guideline examples which never made sense in view of CAFC case law.

      Congrats to the CAFC panel in Cleveland for following precedent and making that precedent more clear (in contrast to Endo which mucks it up in silly ways).

      1. 13.1.1

        The Clinic case has a “tinge” of interest in that the claim set is from a continuation of an earlier case that was bounced on 101, but has claims “benefitting” from the hindsight of Office published examples of what would be considered patent-eligible (including an Office-published example of an eligible claim mapping to a claim in the current case):

        Finally, Cleveland Clinic argues that the district court failed to give the appropriate deference to subject matter eligibility guidance published by the PTO2, as required by Skidmore v. Swift & Co., 323 U.S. 134 (1944).

        While we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.”[sic]***

        And

        Finally, to the extent Cleveland Clinic argues that the district court should have deferred to the examiner’s decision to allow the asserted claims, we have consistently held that any such deference is incorporated into the presumption of patent validity under 35 U.S.C. § 282, see Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346, 1357 (Fed. Cir. 2013), which the district court recognized.

        *** The joke here by the Court is (and should be) self-evident in that the latest Office guidance explicitly notes that the courts have NOT been “mindful of the need for consistent application of our case law” BECAUSE that very case law is a Gordian Knot of Inconsistency.

        1. 13.1.1.1

          that very case law is a Gordian Knot of Inconsistency

          Not so bad, really, once you appreciate the fundamental principles. Then you learn which cases are ultimately going to fall by the wayside and into oblivion (McRo) and which ones are ultimately going to be permanently cemented into the system (Ariosa).

          I guarantee you this much: there is never going to be a “method of treatment” loophole in 101. And I think the CAFC knows this, too. We can question their motives in trying to pretend otherwise, of course.

          1. 13.1.1.1.1

            LOL – you are doing that “there are no inconsistencies if you ignore half the cases” thingie again.

            I guarantee you this much: there is never going to be a “method of treatment” loophole in 101.

            Have you seen the Senate 101 change “guidelines”?

            I guess “loophole” would not be the correct term for the express freeway under consideration.

            1. 13.1.1.1.1.1

              I’m not “ignoring” the inconsistencies. I’m just not throwing a childish temper tantrum and flipping out while screeching “I CANT UNDERSTAN THIS STUFF OMG NOTHING IS ELIGERBIL” like you and your cohorts do around the lock.

              That’s because I am a very experienced patent attorney and I understand the legal system and the patent system and how the various parts relate to each other. Maybe you should clam up for a while and try to learn instead of kicking up dust and humping your nearest know-nothing patent maximalist. Just a thought.

              [shrugs]

              1. 13.1.1.1.1.1.1

                You do realize why the score board is broken as reflected by the Gordian Knot, right?

                Your “Because I Am So Good” does not reflect the broken system, and the fact that you think that it does shows just how far off base your self-assessment is.

                Clamming up won’t fix the broken score board.

                I don’t kick up dust – showing the incongruencies is the opposite of kicking up dust.

                humping your nearest know-nothing patent

                wtf?

                1. You do realize why the score board is broken as reflected by the Gordian Knot, right?

                  Stay off d r u gs, people, or you’ll end up like this miser@ble nertcase.

  2. 12

    It would be nice to know that Supreme Court agreed with this decision.

    However, the truth is if they disagree, I would rather that they keep their opinion to themselves, as who know how much more of mess they will create, particularly in the software area.

    1. 12.1

      Given the amounts of money related to pharmaceutical and “health supplement” patents, more cert petitions seem likely from Fed. Cir. decisions arguing distinctions from Mayo on this basis of method-of-treatment or adding dispensing changes to method-of-diagnosis claims.

      1. 12.1.1

        Given the amounts of money related to pharmaceutical and “health supplement” patents,

        B-b-but that’s a “good” form of grift, because “objective physical structure” or some such thing.

        1. 12.1.1.1

          on cue, LAW 360 today includes this tidbit:

          The Federal Trade Commission has urged the Third Circuit to revive parts of an antitrust action against AbbVie Inc. and an affiliate, even after winning a $448 million penalty against the drugmakers, saying their illegal profits from alleged sham patent litigation were nearly triple that amount.

          B-b-b-but “computing innovation” is what Malcolm 0bsesses over…

  3. 11

    Partial kudos to the panel on the Court of Appeals for this one. They arrived at the correct conclusion and with the correct reasoning; however, they were too soft on Mayo by giving any crediblity to the faulty reasoning therein as regards eligibility. We need congress and judges to recognize and verbalize the problems with the reasoning in Mayo, Myriad, and Alice and then to take action through legislature and improved jurisprudence with cogent and proper reasoning. Good job on getting this one right Judges Andrews, Wallach, Clevenger and Stoll. Good job Endo and counsel on moving the case along to proper conclusion.

    1. 11.1

      What was the “faulty reasoning” in Mayo?

      Also, which member of Congress believes that doctors should be found liable for infringing patents when they carry out a prior art data gathering step and think about the result?

      Serious questions for “Rick Mayos”.

  4. 10

    Let’s put this back into the Pharma world and focus on the extent of the “Laws of Nature” keep out zone:

    Question for those of you doing any Pharma – How is any equivalent of a “body metabolite” claim NOT merely taking a Law of Nature and just saying “Apply it”….?

    ALL Pharma claims must rely on the natural law of a body processing something in order to achieve the necessary utility of the claim.

    If one is going to be consistent with the “anti-functional result” “Gist” of the Court, how does any Pharma patent not perish? (Keeping in mind that mere “scrivining” may not ‘save’ what is really going on)

    1. 10.1

      What exactly is a “body metabolite” claim? Give us an example.

      101 is not a problem for most of us in chem/bio. Never was. Mayo was a great decision and it’s never going to be overturned.

      1. 10.1.1

        They all recite a law of nature (e.g., chemical X kills cancer cells) and say “apply it.”

        Abstract Idea, fundamental building block, take your pick.

    2. 10.2

      Most pharma patents “don’t perish” because most of them are not defective under 101. If you have a compelling argument as to why a particular class of claim reciting a non-obvious structure or a nonobvious physical transformation should fail under 101 then by all means make that argument. You haven’t made one yet. All you are doing now is waving your arms around, stating a silly conclusion, and asking people to help fix your mind. Why would we bother?

      1. 10.2.1

        So another “count filter” item is stuck in count purgatory…

        compelling argument as to why a particular class of claim reciting a non-obvious structure or a nonobvious physical transformation should fail under 101

        Let’s unscramble your dissembling a bit, shall we Malcolm?

        First, it appears that YOU are not taking heed of your own celebrated “Ends-driven” Supreme Court scriviners who rejected what you are attempting here with the thinly veiled Machine or Transformation effect.

        Second, as has long been noted, that very same (strictly only a) clue (and not a test) was deemed by your own celebrated “Ends-driven” Supreme Court scriviners to be neither necessary nor sufficient.

        My pointing this out (again) is NOT “waiving my arms around.” The conclusion — as silly as it may be — is not MY conclusion; it is the Court’s conclusion.

        I am asking NO ONE to “fix my mind.” I AM asking you to approach the situation with just a little bit of inte11ectual honesty. Something that seems beyond your capability.

        1. 10.2.1.1

          If you are afraid or incapable of answering the question I asked, Bildo, then just say so. We can all see right through your p@ thetic mewling and projecting.

          1. 10.2.1.1.1

            If you are afraid or incapable of answering the question I asked,

            LOL – wow, that’s a candidate for the Accuse Others Meme Application of the year.

            We can all see right through your p@ thetic mewling and projecting.

            ..and a nice runner up.

            Maybe instead you might want to engage as I suggest…

            1. 10.2.1.1.1.1

              One more time for the world, Bildo:

              If you have a compelling argument as to why a particular class of claim reciting a non-obvious structure or a nonobvious physical transformation should fail under 101 then by all means make that argument.

              Go ahead. Make everyone’s day. If you can’t do this, then all your screeching and whining is just evidence of some personal mental issues that we can’t solve for you here.

              1. 10.2.1.1.1.1.1

                One more time: why don’t YOU stop with your Accuse Others Meme and engage in the points already put to you?

                You merely repeating the canard that I have pointed out IS a canard won’t change that into not being a canard.

                Your “stand-by” of “mental illness” is a vapid and mindless ad hominem. Try being on point instead.

              2. 10.2.1.1.1.1.2

                engage in the points

                You didn’t make any “points”, Bildo. I’m asking you to make one, and then I’ll respond.

                Acting like a derpshert and spouting off nonsense isn’t a “point.”

                Now please G F Y and polish Big Jeans’ buttons like a good little lapd0g. You excel at that. It’s a good fit for you.

                1. That’s a whole bunch of nothing Malcolm — other than your usual 0bsess10n with Quinn, and your clench tight your eyes in order to not see a point that you won’t (can’t) respond to any sense of being inte11ectually honest.

                  In other words: Malcolm being Malcolm.

  5. 9

    The key difference here is that after the test method is performed the dose is adjusted, involving the hand of man and therefore bringing the claimed subject-matter as a matter of substance into the eligible category.

    As to the Athena decision mentioned in the Court’s opinion, see the CIPA brief downloadable from link to patentlyo.com. There is a diagram in that brief with a dividing line showing what occurs in nature and what are laboratory procedure steps. Athena is a precedential Federal Circuit decision firmly based on science-fiction.

    1. 9.1

      Paul,

      Your “matter of substance” is a Pandora’s box, and only invites the “Legislators from the Bench” to insert themselves into the position that our Congress has designated for the patentee.

    2. 9.2

      The “hand of man” is not the “key” difference, Paul Cole. The hand of man was involved in Prometheus claims, too. The key difference is the relationship of the “hand of man” steps in the claim to those in the prior art. Inserting mental steps into a prior art therapy method is the fastest way to tank your claim under 101.

      Failing to grasp this is going to cost d u m b patent attorneys and their clients a lot of money.

    3. 9.3

      Paul,

      Thanks for re-providing the link to the brief.

      I could not help but notice that BOTH the new USPTO eligibility protocol and the recent precedential case of SRI International reinforce your point at page 7 (emphasis added):

      The district court’s attention was misdirected to these statements of purpose or result and away from the recited combination of structural steps on which the method is truly directed or focused. Thus, at page 7 of its decision, the district court misapplied Electric Power Group., LLC v. Alstom S.A., 830 F.3d. 1350 (Fed. Cir. 2016) and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016). The true focus of claims 7-9 is not on any natural occurrence but rather on the recited non-naturally occurring materials and the recited sequence of process steps

      and at page 8:

      The passage correctly explains that standard techniques existed for iodination of proteins in general. It does not imply that iodination of MuSK or deletion fragments thereof was well-understood, routine, conventional activity already engaged in by the scientific community.
      (standard techniques do NOT make such as applied to any specific item to put the technique with the item into being a conventional thing – such confuses particularity with type of action; a refrain OFTEN deliberately dissembled with computing known as the House fallacy).

      I would slightly amend your statement bridging pages 8-9 to a more universal format of:

      If [insert any qualifying entities of items made by the hand of man, including those reflecting the exceptions to the judicial doctrine of printed matter], a method that employs them as part of an ordered combination of steps cannot logically be treated as ineligible subject matter.

      And let’s just reflect that Malcolm AGAIN seeks to confuse and conflate prior art into the eligibility equation. The Ends do not justify the Means.

  6. 8

    About time the CAFC starting reining in Mayo. A few years late, but this is certainly an improvement.

    If Teva wants to knock out this patent, let it do so on grounds of anticipation, obviousness or lack of written description/enablement.

    1. 8.1

      There is no doubt that the CAFC could cabin the 101 decisions by the SCOTUS if they wanted to.

      1. 8.1.1

        NW – think of the psychological thought experiment of Firehose training of simians in a cage.

        The “could” you propose may well be true, but also as a matter of reality, may well be more (much more) likely than not to be NOT the path taken.

        There are NO Judge Rich’s on the bench with the chops and knowledge to effectively push back against the Royal Nine.

        1. 8.1.1.1

          >>There are NO Judge Rich’s on the bench with the chops and knowledge to effectively push back against the Royal Nine.

          Nope. Obama appointed a bunch of people that are anti-patent and the reset are totally ignorant of science or are getting pretty old. Moore was considered anti-patent when appointed.

          Newman is very old.

          There aren’t really any keepers on the CAFC. I’d dissolve and restart with the justification that Obama allowed SV to select the judges.

  7. 7

    “Question for those of you doing software – What is your equivalent of a “method-of-treatment” claim.”

    Computer processing which sounds impressive.

    1. 7.1

      LOL

      That’s definitely how certain panels on the CAFC see it. It’s the “neato!” test for the eligibility of logic, sometimes known as the “This is way better than the computer Judge Moore was able to purchase from Radio Shack when she was in law school.”

      1. 7.1.1

        …and somehow 35 USC 101 (and any improvement thereof) is not applicable to computing machines?

        Oh that’s right – you refuse to be inte11ectually honest about the design choice of “wares” for computing machines as well as the exceptions to the judicial doctrine of printed matter…

      2. 7.1.2

        It is also weird the way MM tries to demean information processing by looking at its lowest levels of processing, i.e., all it does it add, substract, and multiply.

        But anyone that is trained in modern science knows of emergence and that we are no more than these lowest level operations as well.

        What bothers me and I find disturbing is the way the anti-patent people play to the scientific ignorance of the judges and that SV paid Obama to appoint a carload full of judges without science backgrounds.

    2. 7.2

      Just strange that you think that machines that perform information processing that takes time, space, and energy are somehow inferior to other inventions. Particularly weird given that the one thing modern humans value more than anything else is their ability to process information with their brains.

      Also odd is that the proper perspective on the relationship between human “thinking” and machine “information processing” is rarely given or understood.

      Also, you can pretty much count yourself among the scientifically illiterate if you don’t agree with this post.

      1. 7.2.1

        Also odd is that the proper perspective on the relationship between human “thinking” and machine “information processing” is rarely given or understood.

        Worse – it is purposefully dissembled, conflated and confused. “Means” are obscured and critical thinking as to those Means is scoffed at — as long as (and ONLY as long as) the desired Ends have been obtained.

        One word captures the point that you present:

        Anthropomorphication

      2. 7.2.2

        the proper perspective on the relationship between human “thinking” and machine “information processing” is rarely given or understood.

        Please tell everyone in clear terms what you believe is the “proper” perspective on the relationship between (1) instructing a person about how to react to input data X; and (2) instructing a computer how to react to input data X.

        I would suggest starting with a very simple example. For example, imagine that your job is to write instructions for a person. The instructions are “When you see X, remember when you saw it.” How does the process of writing those instructions relate to the process of instructing an instructable computer to store the time at which input data X occurs? What’s the “proper” perspective on that “relationship”?

        I look forward to your deeply nuanced and philosophically serious answer. Likewise, I look forward to your super serious answer explaining why virtually nobody believes that the former process is eligible for patenting but a tiny loudmouthed fraction of patent attorneys insists that the latter must be eligible for patenting. You’ve thought about this a lot, I’m sure. I really can’t wait.

        I’m sure Dennis is right there with us.

        1. 7.2.2.1

          I would suggest starting with a very simple example.

          You mean like a Simple Set Theory explication of the exceptions to the judicial doctrine of written matter?

          I really can’t wait.

          Great. You don’t have to.

          Soooo “super serious”

        2. 7.2.2.2

          One is a person MM. One is a machine.

          The person and machine are different.

          Read Deener.

  8. 6

    “Question for those of you doing software – What is your equivalent of a “method-of-treatment” claim.”

    Not a perfect analogy (and not a legal one), but software which does diagnostics and analysis of, for example, systems and the environment of a real world airplane flying through the air, if claimed only to a point serves “merely” to gather information (loosely analogous to mere diagnosis of a human being as such… assuming no implicit purpose for the diagnosis, it could be malevolent, academic, or intended for benevolent reasons).

    Now software which incorporates the diagnostics and the information it “gathers” to determine what to do with the various bits of the plane, to actually do those things to the various bits of the plane to make it fly, keep it in the air… is loosely analogous to incorporating human diagnosis and the information gathered in order to determine what courses of action can be taken to improve the health of that human, and to actually take those actions which are “medical treatment”.

    Diagnosis could conceivably be used to do the opposite, in a case of one using information for malevolent purposes, or in the case of a pure academic who cares nothing about what actually happens to the person, merely keeps records and statistics regarding the humans he’s diagnosed… that would be software which measures everything about the plane… but does nothing to prevent it from crashing.

    1. 6.1

      Firstly, Anon2, you aren’t directly addressing the question which concerns the eligibility of certain categories of claims based on exactly what is recited in the claims (not magic words, but bona fide limitations).

      Secondly, as for this:

      software which incorporates the diagnostics and the information it “gathers” to determine what to do with the various bits of the plane, to actually do those things to the various bits of the plane to make it fly, keep it in the air… is loosely analogous to incorporating human diagnosis and the information gathered in order to determine what courses of action can be taken to improve the health of that human, and to actually take those actions which are “medical treatment”.

      But, again, consider a claim to:

      A computer for improving pilotless flight of a plane, wherein said plane comprises at least one sensor and at least two wings, wherein said wings comprise flaps operably connected to said computer;

      and wherein said computer receives data about wind velocity and direction collected by said at least one sensor;

      and wherein based on said data or a number calculated from said data, said processor automatically adjusts flaps on said wing to minimize the likelihood that said plane will crash.

      That’s nothing more than taking logic (ineligible) and tacking it onto prior art (or obvious variations of it). The question is: what would need to be added to such a claim to make the claim eligible for patenting?

      My view would be that some non-obvious objective physical structure of some aspect of the plane needs to be added, or possibly a description of a particular non-obvious flap movement described in objective (not functional, result oriented) terms. For an apparatus claim, the latter limitation is probably not appropriate or the most desirable.

      But the claim I wrote should be deemed ineligible (and invalid, too). And I don’t think there’s any functional description of logic that could be added to the claim to make it eligible. Does this mean I want planes to crash out of the sky? Of course not. We’re having a discussion about subject matter eligibility in our utility patent system. There is no evidence and you’ll never be able to find any evidence that the lack of such claims is going to lead to worse auto-piloting programs. There is definitely evidence, on the other hand, that if you open wide the gates to patenting functionally claimed logic in every context than the social costs of using computers for their intended purpose is going to skyrocket, and those costs will be pushed onto consumers and programmers who will be forced to navigate through a bottomless thicket of … logic and information, mostly drafted using the most obscure terminology that can be scrivened. Who benefits from that? Primarily a small segment of patent attorneys and an even microscopically smaller group of already wealthy con artists and tr 0 ll types.

      Remember: it was only a few years ago that an especially vociferous patent maximalist was shut down while trying to claim “improved” databases where the “improvement” was the information content of the database. What was the content? Diagnostic medical information. Surprise, surprise.

      1. 6.1.1

        …”objective physical structure

        and YET AGAIN, the canard of attempting to turn an optional claim format into something that is not optional….

      2. 6.1.2

        16. A method, comprising:
        receiving a value for an aircraft movement limit, wherein the aircraft movement limit is associated with a manned aircraft and includes a position limit;
        automatically setting the aircraft movement limit to the value, wherein the value is associated with a body of water;
        receiving a pilot instruction; and
        generating a control signal for the aircraft using the pilot instruction and the aircraft movement limit, wherein the control signal constrains the aircraft to stay above the body of water.

        link to patents.google.com

        1. 6.1.2.1

          What’s your point, Les?

          The PTO grants reams of ineligible and invalid patents every week. Increasingly more of them lately, in fact.

          1. 6.1.2.1.1

            Says you.

      3. 6.1.3

        1. A method comprising:
        calculating, using a processor, a thrust resolver angle based on a flight condition of an aircraft during a vertical height change maneuver of the aircraft; and
        overriding throttle movement of a throttle lever from moving past at least one of the thrust resolver angle or a range defined by the thrust resolver angle to maintain the aircraft in a preferred flight mode.

        link to patents.google.com

    2. 6.2

      Schrödinger’s cat very much cares about your “just ascertaining” notion.

      1. 6.2.1

        Schrödinger was wrong about mere perception causing reality to collapse the cat from quantum indeterminacy into physical reality… he should have known only forceful enough wishful thinking can directly affect reality (and move mountains) in such ways.

        1. 6.2.1.1

          Schrödinger was wrong about…

          Really?

          Well, you will have to excuse me if I do not simply take your word at that.

          (As to your follow on sentence, that’s a bit of a non sequitur to actual observational collapse, now isn’t it? )

  9. 5

    Dennis –

    I’m not sure what you are looking for here: “Question for those of you doing software – What is your equivalent of a “method-of-treatment” claim.”

    But I think the claims in Diamond v. Diehr are at least close to analogous. They call for doing something (heating was it?), measured something (temperature was it?) and determine if the dose of something (heat?) was sufficient and if so, ended the treatment (opened the oven door).

  10. 4

    The laziness and sloppiness of the CAFC is boundless. Where does responsibility lie? With the clerks? Or with the attorneys who argue these cases? Let’s just take this one paragraph and look at the various assertions.

    Although the representative claim in Mayo recited administering a thiopurine drug to a patient …

    Indeed. The initial treatment of a patient by 6-TG was required by Prometheus’ claim. The key point, however, is that both the initial treatment step AND the step of measuring metabolite levels subsequent to that treatment step were both in the prior art (and in that order in the prior art).

    … the claim as a whole was not directed to the application of a drug to treat a particular disease.

    This is very silly and it obscures the important issues behind some conclusory and wishy-washy language that (at least as it’s used here) appears very “subjective”. Prometheus’ claim “as a whole” was directed to the application of a drug to treat a particular disease. People are treated in Prometheus’ claim, after all! The important point which is lost in the CAFC’s lazy language is that the mere fact that people are treated in a recite step in the claim is not determinative of eligibility. And we know this last statement is true because of the Supreme Court’s essential and necessary holding in Mayo: the claims are ineligible.

    Furthermore, the administering step in Mayo is distinguishable from the administering step in the [Endo] patent because the administering step in Mayo is the first step in the method that simply describes giving the drug to a patient with a certain disorder.

    Good grief, people! Whether the administering step is first or last is not the determinative issue. The determinative issue is whether the physically transformative steps (including structural characteristics of the dosage form and the administered amounts) that are recited in the claim are in the prior art. As long as the dosage being administered is in the prior art, Prometheus’ claims would have been just as ineligible if they recited the step of “use [this previously undisclosed correlation] to determine a dosage level” before the dose was administered. If anyone reading this doesn’t understand why this is the case, please, please, please just ask me and I will break it down using very easy to understand examples. The bottom line is that you can’t protect information (or a process of thinking about information) using a patent claim, and the recitation of a prior art context (e.g., administering a dose taught in the prior art) doesn’t address the ineligibility issue.

    By contrast, the administering step in the ’737 patent is the step that describes giving a specific dose of the drug based on the results of kidney function testing.

    Again, (and without getting into the particular facts of this case) the administration of specific dosages alone will not cure the eligibility issue that arises from the recitation of a logic step if administration of the same drug (in the same dosage form) is in the prior art. That is because of the unacceptable risk that doctors who are treating patients exactly as they were treating them in the prior art will suddenly become infringers because they are aware of a medical fact about their patients (or any other fact, for that matter).

    And before someone pipes up stating that “oh, that’s just being paranoid” or “how do you prove it”, please educate yourselves about the facts in Prometheus v. Mayo, and specifically Prometheus’ theory of infringement. Prometheus was very clear that nothing needed to be changed relative to the prior art in order to infringe their claim except that a doctor needed to consider Prometheus’ disclosed correlation and “make a determination” based on the correlation. In other words, the risk is real. Some incredibly greedy players in the patent system went way way down the road and smashed face first into the Constitution and the First Amendment. That’s what Prometheus v. Mayo was about.

    1. 4.1

      Mouthing “First Amendment” again while confusing and conflating prior art…

    2. 4.2

      Better duck. Here comes that pendulum again.

  11. 3

    The Endo patent claims:

    1. measuring the clearance rate
    2. based on that measurement, modifying the amount of the drug administered

    The Mayo patent claimed:

    1. administering the drug
    2. measuring metabolites
    3. based on that measurement, modifying the amount of the drug subsequently administered

    It’s clear that the patent in Mayo claims a subsequent treatment of the disease, not just a single administration of the drug in order to measure metabolite levels for its own sake.

    I don’t see how there is a principled distinction here at all. The Endo court claims:

    Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease

    The claims in Mayo all begin with “A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder”, which the specification defines as IBD including Crohn’s and ulcerative colitis. That’s pretty particular.

    By contrast, the patent in Endo isn’t directed to the treatment of a particular disease, just “providing pain relief”. The specification itself regards pain as a symptom, not a disease. I don’t see a meaningful distinction here, and if anything it cuts the other way than the court is trying to argue.

    The Endo court continues:

    Furthermore, the administering step in Mayo is distinguishable from the administering step in the [Endo] patent because the administering step in Mayo is the first step in the method that simply describes giving the drug to a patient with a certain disorder

    But since the method in Mayo involved measuring drug metabolites, the first step was necessarily administering the drug! And the patent then goes on claim subsequent administration of the drug, which seems an awful lot like a method of treatment to me.

    The only reason administration is not the first step in the Endo patent is because the Endo patent uses creatine clearance as a proxy. If the method had been to measure opioid clearance directly then it would be virtually the same as the patent in Mayo.

    1. 3.1

      JDaily: It’s clear that the patent in Mayo claims a subsequent treatment of the disease, not just a single administration of the drug in order to measure metabolite levels for its own sake.

      This mythology is false and it’s been debunked a 9,999 times already. Stop spreading the mythology. Those who spread the mythology are those creating the confusion.

      For the ten thousandth time: PROMETHEUS ADMITTED ON THE RECORD THAT THEIR CLAIM WAS INFRINGED WITHOUT ANY SUBSEQUENT TREATMENT STEP. The final step in their claim was simply to “make a determination” about whether and how to change the dose. That fact is the primary reason the case went all the way to the Supreme Court (the issue was similar to the facts in the LabCorp v. Metabolite case which the Supremes did not take, but which led to Breyer’s insightful and now very famous dissenting view on the refusal to take cert). It’s also the reason why it was a 9-0 decision that will never, ever be overturned.

      1. 3.1.1

        Prometheus admitted on the record that their claim was infringed without any subsequent treatment step

        Citation, please? I reviewed the Petitioner’s Brief, Reply Brief, and the Respondent’s brief and I can find no support for this statement. Indeed, I find support to the contrary. In its Supreme Court brief, Prometheus argues states:

        Infringement occurs only when thiopurines are administered to a patient suffering from an autoimmune disorder, blood or tissue samples are extracted, specified metabolites’ levels are measured using sophisticated scientific instruments, and the doctor is warned (by a comparison of those measurements with the indicated correlations) of a possible need to adjust subsequent dosages for better treatment.

        Brief for Respondent 33.

        It is not possible to be “warned…of a possible need to adjust subsequent dosages” if there is no contemplation of a subsequent dose. Moreover, in practice, no one would ever order such a test if there was no intention to administer the drug in the future. It makes neither logical nor practical sense.

        The final step in their claim was simply to “make a determination” about whether and how to change the dose.

        Making a determination about whether or how to change the dose only makes sense (and indeed is only possible) if another dose is contemplated. It is possible that the results of the test would be such that administration of the drug would be discontinued entirely (and the specification contemplates that), but the test would only be ordered in the first place if subsequent doses were intended. Why would a doctor ever order this test if there was no intention to administer the drug again in the future?

        1. 3.1.1.1

          James Daily, struggling with the basics: the test would only be ordered in the first place if subsequent doses were intended.

          Except immediately prior to this, and in the SAME SENTENCE (?!), you wrote:

          It is possible that the results of the test would be such that administration of the drug would be discontinued entirely (and the specification contemplates that)

          Please. Just … stop … digging.

        2. 3.1.1.2

          James Daily: Citation, please? I reviewed the Petitioner’s Brief, Reply Brief, and the Respondent’s brief and I can find no support for this statement [that Prometheus admitted on the record that their claim was infringed without any subsequent treatment step.

          The admission appears at least in the Petition for En Banc Rehearing by the Federal Circuit after Bilski was issued. See page 3:

          Prometheus’ claims, broadly interpreted at Prometheus’ urging, cover a process of recognizing naturally-occurring correlations between levels of certain chemicals in a patient’s blood and the patient’s health. The claims contain no requirement that any action be taken with respect to the correlations; in other words, a doctor infringes the claims without using the correlations in any way with respect to the patient’s treatment. [See, e.g., A12538-40; ~29.1′ As Prometheus’ own expert testified, merely seeing a document with test results causes infringement even if a doctor “crumples it up, throws it away, reads it, acts on it, doesn’t act on it, any assumptions you want to come up with.” [A13557-58;A13805-06.1]

          I’ve been pointing out this fact relentlessly here for almost TEN YEARS. At some point the failure of certain patent attorneys to acknowledge this fact (kind of important) seems less like incompetence and more like intellectual dishonesty. That point passed about five years ago at least. If you don’t know about this already, you are willfully ign0rant or your law school IP professor really really let you down.

          1. 3.1.1.2.1

            The Federal Circuit has a nasty habit of misstating things (no doubt, learned from the Supremes due to the Firehose Effect).

            This is STILL not on point to the party making the statement.

            1. 3.1.1.2.1.1

              This is STILL not on point

              Thank you for proving once again that the intellectual dishonesty and willful ignorance of the patent maximalists is boundless. Given everything else we know about this case and why cert was taken, including Prometheus’ own description of their claims (posted just a few comments upthread by James), what possible reason would there be to question what was written except to reveal yourself as some kind of denialist for tr 0lling’s sake?

              Oh wait — maybe Prometheus’ expert was an imposter planted by Mayo … and the real expert was kidnapped! I can’t prove otherwise so, oh well, I guess it’s all just stuff people made up because they “h@te patents”. Or something. Meanwhile, you and James will be here shortly to assure everyone that you are hunting down the “real expert”. Then we’ll really be impressed! I can’t wait. This level of seriousness is rarely reached.

              1. 3.1.1.2.1.1.1

                proving once again that the intellectual dishonesty and willful ignorance of the anti- patentists is boundless.

                Fixed that for you (given your propensity for Accuse Others).

                I am NOT being any kind of “denialist,” as you are the one that made a statement, was questioned about that statement (with an objective point showing the opposite of your statement), and then YOU launched into all sorts of spin doing everything EXCEPT what was asked of you.

                You could have simply provided a simple and direct answer to the question asked of you, but you chose differently.

                Notably, you still have not given that simple and direct answer.

    2. 3.2

      JD I don’t see how there is a principled distinction here at all.

      Well, you can be forgiven for this much at least because, as I wrote in Comment 4, the CAFC’s description of its reasoning is abhorrent and is only going to result in painful lessons for those patent attorneys who lack the intelligence to understand what is going on.

      And this stuff isn’t even terribly difficult, for cripesake.

      1. 3.2.1

        …but there are no contradictions in the Common Law law writing being done by the courts, right?

        The score from the scoreboard is perfectly fine — as long as it reflects the Ends that you agree with. Never mind actually discussing the Means of the Judicial Branch rewriting the direct words of Congress, eh?

  12. 2

    Question for those of you doing software – What is your equivalent of a “method-of-treatment” claim.

    I would assume it is the EPG of receive, analyze, display: Receive kidney test results, analyze according to the natural law, display the dosage that should be used to treat.

    1. 2.1

      Your (over) reliance on EPG has been put out to pasture.

    2. 2.2

      I wonder if Dennis is looking for the software equivalent of a claim that is unambiguously eligible because (following the CAFC’s reasoning in this case) the claim “as a whole” is directed to something that the CAFC has declared unambiguously eligible?

      If that is D’s request, the “software equivalent” at present would be claim that, “as a whole” is “directed to” a method of improving the computational functioning of a computer (as opposed to merely applying existing computational functionality in a particular context). That sort of claim, of course, if well-drafted, would be devoid of both descriptions of the content of data as well as abstractions such as “authentic”, “secure”, etc.

      1. 2.2.1

        See the Grand Hall experiment.

        Most ALL software objectively improves a computing machine.

        1. 2.2.1.1

          Most ALL software objectively improves a computing machine.

          ROTFLMAO

          In fact, most software objectively just causes my objective computer running an objective operating system along with an objective set of other programs to objectively crash. Only very well written software “improves” the computer and even that stuff doesn’t improve the computing functionality of the computer. It just harnesses the existing data processing functionality in a context defined by the abstract meanings that humans have laid on top of the data that is being processed.

          Thankfully you’re a very serious person so none of this nuance and tech-y stuff will be lost on you.

          1. 2.2.1.1.1

            I noticed that you avoided actually addressing the Grand Hall experiment.

            Try again.

            1. 2.2.1.1.1.1

              you avoided actually addressing the Grand Hall experiment.

              I also avoided reciting the declaration of independence backwards, along with a whole lot of other stuff that is not relevant to the issue being discussed. Somehow you missed that while you were kicking up dust.

              1. 2.2.1.1.1.1.1

                The Grand Hall experiment is precisely relevant.

                And it is THAT relevance that you are avoiding actually discussing the merits of the item that reveal (yet again) that you are engaging your number one meme of Accuse Others.

                That, and you are still running away. You are an inte11ectual cow@rd.

                1. The Grand Hall experiment is precisely relevant.

                  Please tell everyone exactly what is the specific assertion I made is being rebutted by the so-called “Grand Hall experiment”. Copy the assertion I made verbatim so there is no question about it and don’t even try to leave out any express qualifications to that assertion that I may have included when I made the assertion.

                  Then tell everyone exactly how the results of this so-called “Grand Hall experiment” rebut that assertion.

                  Go ahead. Otherwise kindly stifle yourself.

                2. Instead of wanting someone else to do something (yet again), why don’t YOU actually engage in the points (long) put to you?

                  For all else of your rambling, I reject your Br’er Rabbit invitation to “repeat what you stated.”

      2. 2.2.2

        as opposed to merely applying existing computational functionality

        See the Big Box of Protons, Neutrons and Electrons.

  13. 1

    Question for those of you doing software – What is your equivalent of a “method-of-treatment” claim.

    “Just apply it.”

    1. 1.1

      Wrong. There is clearly no software equivalent for the administration of a composition of matter to a specific individual.

    2. 1.2

      Too bad the claim didn’t say: “apply an ‘effective amount’ ” that would have really highlighted the bias against software and business method patents.

      1. 1.2.1

        Too bad the claim didn’t say: “apply an ‘effective amount’ ” that would have really highlighted the bias against software and business method patents.

        What “bias” are you talking about? And how would the recitation of the phrase “effective amount” in a method of treatment claim “highlight” this alleged “bias”?

        You realize, of course, that when most practitioners use the phrase “effective amount” the term is almost always bounded (by definition in the specification, usually) by some objective physical characteristic (mass, for instance), or there will be some reasonable clarity as to what that effective amount is to a skilled artisan. If that doesn’t exist, the claims are invalid and are very often rejected.

        There’s a big difference between some fuzz at the margins of an objectively determinable physical characteristic (like mass), on one hand, and a purely functional description with zero determinable relationship to any objective structure on the other hand (which is the case for software patents). In case you find this confusing, consider the following:

        0010100101010010010101010010010010011110
        10101010111010100011010010010101010010011

        One of those series of bits describes a kind of cake. The other describes a famous actor’s mustache. Let’s wait for a software “expert” to come by and tell us which is which, along with his reasoned explanation.

        1. 1.2.1.1

          Please feel free to abstain from using ANY of these “software-related” items in the real world because you feel that they “don’t work.”

          Also, since you are so enamored with trying to confuse cake and moustaches, please feel free to wipe out the hard drives of all of your computing devices and reformat each of them with a Britney Spears CD.

          We ALL would enjoy that, and your posts here would achieve their highest level of sense.

          1. 1.2.1.1.1

            Please feel free to abstain from using ANY of these “software-related” items in the real world because you feel that they “don’t work.”

            Please feel free to address what I actually wrote and not a ridiculous strawman.

            Nobody is arguing that software “doesn’t work”.

            please feel free to wipe out the hard drives of all of your computing devices and reformat each of them with a Britney Spears CD

            Please feel free to disclose at least one bug-free working example of code on a relevant operating system in your specification, and please feel free to recite the essential parts of that code in your claim.

            Oh but wait! That’s too difficult for you. Boo hoo hoo. Well, kiss those j u n k y claims to computer-implemented functionality goodbye then. Nobody needs them anyway except for the Silly Con Valley Boys and their “angels”, and nobody needs those people either except for the worst patent attorneys who ever walked the planet. Good riddance.

            1. 1.2.1.1.1.1

              Please recognize that a patent application is not an engineering document (that’s kind of important for that “tech-y thing” comment of your to not blow up in your own face)

              1. 1.2.1.1.1.1.1

                a patent application is not an engineering document

                This kind of non-responsive, self-serving conclusory statement is just an example of your tr 0 lling, B i l do, and your eagerness to change the topic and kick up dust at every opportunity. Because the last thing you want to do is discuss the issues and the facts. You perform very weakly at the former, and the latter undercut you at every turn.

                The fact is that valid, eligible patents in the grown-up arts are indeed “engineering documents” and necessarily include all kinds of details about the structures and physical transformations that distinguish the claimed inventions from the structures/transformations in the prior art (now go ahead and play rhetorical games with that term rather than just admit what everybody already knows).

                [shrugs]

                1. LOL – I give you a fact in simple and direct English and you call it “non-responsive, self-serving conclusory statement

                  I am not the one doing any type of changing the topic or kicking up dust.

                  Highlighting YOUR inanity is very much on point here. Your Accuse Others of “issues and facts” f001s no one.

        2. 1.2.1.2

          —You realize, of course, that when most practitioners use the phrase “effective amount” the term is almost always bounded (by definition in the specification, usually) by some objective physical characteristic (mass, for instance), or there will be some reasonable clarity as to what that effective amount is to a skilled artisan. If that doesn’t exist, the claims are invalid and are very often rejected.—
          —————————————————————————–

          You are correct that “effective amount” is a nonce term and should therefore be limited as a means plus function term.

          1. 1.2.1.2.1

            You are correct that “effective amount” is a nonce term

            It’s not a “nonce term” if it’s not the novel feature of the claim, if its bounds are defined in the specification, and/or if ranges (i.e., the objectively physically measurable values and the effect itself) are ascertainable to skilled artisans. Fuzz at the margins is not “nonce.”

            Note again: this is very different from the case where we are talking about a subjective effect (“aesthetically pleasing”) at the point of novelty, or a black box (“processor”) without objectively discernable art-distinguishing structure that is responsible for a claimed function.

            1. 1.2.1.2.1.1

              It’s not a “nonce term” if it’s not the novel feature of the claim,

              That’s not how the law works, son.

            2. 1.2.1.2.1.2

              —It’s not a “nonce term” if it’s not the novel feature of the claim,—
              ————————————————————————-
              Got any authority for that, Chief?

              Meanwhile, MPEP §2181 says:

              Accordingly, examiners will apply 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph to a claim limitation if it meets the following 3-prong analysis:
              (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
              (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
              (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.

          2. 1.2.1.2.2

            Your example of bias seems to amount to “they get avoid MPF with no structure where we have to recite a ubiquitous token of structure to avoid MPF.”

            I think you’re probably right, but a pox on both your houses none the less.

            1. 1.2.1.2.2.1

              The “effective amount” language is never at the point of novelty and it’s never structurally unbounded in the way that a “module” at the point of novelty is structurally unbounded. In a normal drug admin claim, there is always a composition with objective physical structure being administered and there is always a reasonably ascertainable amount being administered. So the idea that there is “no structure” is bizarrely wrong.

              A pox on you, as the Silver Apples once sang.

              1. 1.2.1.2.2.1.1

                Please point to me where in 35 USC 112 this “point of novelty” thing is that you are going on about.

                And please make sure that you are accounting for the actual words of Congress in the Act of 1952.

                1. Funny how most the attorneys here seem to interpret the 1952 act in the way that aligns with their financial interests.

                2. Or not.

                  But hey, when you have nothing else Ben, why not throw out their a depricating remark as if there were no state ethics codes for attorneys.

                  Maybe, just maybe, you should spend your energy on the issues instead of merely trying to diminish the other side when you are out of points to make.

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