By Kevin Emerson Collins, Associate Professor of Law, Indiana University Maurer School of Law—Bloomington [BIO][Articles][PDF Version of this Post]
Background: The Machine-or-Transformation Test of Bilski
Last fall, the Federal Circuit articulated the “machine-or-transformation” test for patent eligibility in its landmark case In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc). It held that a method is eligible for patent protection only if it is either (a) limited to a “particular machine” or (b) responsible for transforming a “particular article” into a different state or thing. Id. at 954. Additionally, in a classic example of language that adds judicial wiggle room, the machine or transformation that satisfies either of these prongs “must impose meaningful limits on the claim’s scope,” it “must be central to the purpose of the claimed process,” and it must not be part of “insignificant extra-solution activity” or a “mere data-gathering step.” Id. at 961–62 (emphases added).
The Supreme Court has accepted certiorari in Bilski, but the impending Supreme Court opinion has not stopped the Federal Circuit from issuing what is perhaps its most important case to date applying the machine-or-transformation test: Prometheus Laboratories, Inc. v. Mayo Collaborative Services. There have been two distinct types of claims that have taken center stage in recent debates over the section 101 doctrine of patent eligibility: “business methods” and what I will call “determine-and-infer methods.” The claim at issue in Bilski describes a classic business method. In contrast, Prometheus involves a determine-and-infer method. The Federal Circuit’s opinion in Prometheus opens a new window into the import of the machine-or-transformation test. Regardless of one’s views of the soundness of Federal Circuit’s reasoning in Prometheus, herein lies one of the opinion’s greatest virtues. By issuing Prometheus before the Court’s oral arguments in Bilski, the Federal Circuit has helped to clarify the stakes of the Court’s decision to sanction, reformulate, or reject the machine-or-transformation test.
Determine-and-Infer Claims and Prometheus
Employed most frequently today in the medical arts, determine-and-infer claims follow a standard template. They initially recite prior-art steps that identify or measure a real-world phenomenon (the “determining” step), and they conclude with a newly invented mental step in which the identifier infers useful information about a distinct real-world phenomenon from the measured phenomenon (the “inferring” step). The Supreme Court’s truncated proceedings in Laboratory Corp. v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006), involved a determine-and-infer claim: (a) determine the amount of one chemical in a bodily fluid and (b) infer information about the amount of another chemical in the bodily fluid. The claim in Prometheus follows this template, too, adding only a slight twist. It includes as a limitation an initial step that creates the phenomenon that is subsequently measured: (a) administer a drug to a patient, (b) determine the concentration of the drug’s metabolite in the patient’s body, and (c) infer information about the optimality of the amount of the drug administered to the patient. Prometheus, slip. op. at 3. (Some of the Prometheus claims, however, lack the administering step and are classic determine-and-infer claims. Id. at 16.) Determine-and-infer claims are nonobvious advances over the prior art because the inventor discovers a previously unknown relationship or correlation among real-world phenomena and employs that relationship as a premise in the act of logical reasoning that constitutes the mental inference.[2] The patent applicant in Laboratory Corp. discovered the relationship between chemical A and chemical B in bodily fluids and invented the mental process of inferring information about the unmeasured chemical B from the measurement of chemical A. The patent applicant in Prometheus discovered the relationship between the concentration of a drug’s metabolite in a patient and the optimality of the dose of the drug that the patient is currently taking.
In Prometheus, the Federal Circuit upheld the claims at issue as patent eligible subject matter under the transformation prong of Bilksi‘s machine-or-transformation test. While acknowledging that the inference step was a mental step that did not affect a transformation, id. at 19, it concluded that both the administering and determining steps were steps that transformed articles into different states or things. The administering step transforms “the human body,” and the determining step manipulates the “bodily sample” taken to measure the metabolite because the metabolite “levels cannot be determined by mere inspection” but must rather be physically manipulated through a process such as high pressure liquid chromatography. Id. at 14–17. Furthermore, the Federal Circuit asserted—as it had to in order to support its finding of patent eligibility—that the transformations in the administering and determining steps were central to the purpose of the claims and thus were not mere data-gathering steps. Id. at 18–19, 20–21.
The Irrelevance of Intangibility
There is no rational reason to use the tangibility of the transformation affected by the determining steps in a determine-and-infer claim as a peg on which to hang patent eligibility. There are, of course, administrative difficulties entailed in distinguishing patent-eligible transformations of articles from worldly changes that are insufficient to amount to patent-eligible transformations. Does simply drawing blood count as a transformative process, in and of itself? Reasoning by analogy, is the breaking of a chair a transformation, but not the shuffling of chairs from one room to another? The point to be made here is that the transformation of an article is dependent on the level of generality at which one defines the relevant “article.” Rooms are physically transformed by the shuffling of chairs, but the individual chairs may appear not to be. Bodies and circulatory systems are physically transformed by the drawing of blood (they have less mass after the procedure than they did before), but the individual blood cells may appear not to be.[3]
Yet, however daunting the task may initially seem, the difficulty inherent in line-drawing is not a reason in and of itself categorically to avoid drawing lines. Sometimes the lines are important, and the cost of line-drawing is often an acceptable cost that is outweighed by the benefit of having the line in place. In the context of determine-and-infer claims, the crux of the issue is that the line between tangible and intangible determining steps is not important. The intangibility of the determining steps is irrelevant to the policy concerns that underlie the doctrine of patent eligibility. To underline this fact, consider two determine-and-infer claims in which the determining step is accomplished through different technologies. One determining step requires cell membranes to be broken and chemical reactions to alter molecules, whereas the other simply requires the analysis of the spectrum of the light that a blood sample absorbs. Why should the former claim be patent eligible, but not the latter?
The Real Stakes
What is actually at stake in the debate over the patent eligibility of determine-and-infer claims is the nature of the property rights that can result from the invention of an act of logical, human reasoning. As explained above, “inferring” steps are acts of human reasoning that are enabled by the inventor’s disclosure in the specification of a previously unknown factual relationship among real-world phenomena. There is a widespread consensus that inferring steps in isolation are not eligible for patent protection: the act of thinking about the information disclosed in the specification per se is not patent eligible. See, e.g., Bilski at 965 (nothing that the “application of [only] human intelligence to the solution of problems” is not patentable subject matter). However, when newly invented inferring steps are combined with prior-art, extra-mental steps to create determine-and-infer claims, the consensus disappears, and the controversial issue addressed in Prometheus appears.
To be clear, the issue is not an easy one. There are weighty concerns on each side. The proponents of determine-and-infer claims argue that the incentives generated by these claims will speed up the development of personalized medicine, and that patent incentives will be insufficient in their absence. Incentive arguments lie at the heart of the justification of the patent regime, and they should not be lightly tossed aside. On the other side, however, is inter alia a concern about the dynamic costs of patents that privatize “the basic tools of technological and scientific work.” Gottschalk v. Benson, 409 U.S. 64, 67 (1972). The determine-and-infer claims in Metabolite and Prometheus arguably describe methods consumed by the end-users of medical advances: they describe methods through which doctors can diagnose sick patients or increase the safety and efficacy of patients’ drug regimens. However, the determine-and-infer claim establishes a template that can readily be used to generate property rights in most, if not all, basic scientific advances. For example, assume that a researcher discovers that a particular mutation in a gene leads to a malformed protein that in turn leads to an increase in the likelihood of a particular type of cancer. Following the determine-and-infer template, the researcher could claim a right to exclude others from (a) determining whether a cell contains either the genetic mutation or the malformed protein and (b) correlating the presence of the mutation/malformation to an increased likelihood of cancer. This claim—which may be just as useful, novel, and nonobvious as the Prometheus claim—effectively privatizes future research involving the metabolic pathway through which the genetic mutation leads to an increased likelihood of cancer. Furthermore, the determining step is just as transformative as the determining step in Prometheus.
The Patent-Eligibility of Human Inference
There are basically three rational approaches to the doctrine that governs the patent eligibility of determine-and-infer claims. First, determine-and-infer claims could be categorically eligible for patent protection. Perhaps the incentives are sorely needed, and perhaps the concerns about dynamic costs will be mitigated by under-enforcement of patent rights in academic laboratories.
Second, determine-and-infer claims could be categorically ineligible for patent protection if, when such claims are considered as a class, the balancing of costs and benefits tilts strongly in the other direction. The Federal Circuit, however, has shown no interest in this approach as a doctrinal matter. It would require a rule that resembles the now-defunct mental steps doctrine and that prohibits the patenting of any claim in which the advance over the prior art resides in an act of human cognition enabled by the information disclosed in the patent specification. The Federal Circuit has repeatedly insisted that the Supreme Court’s articulation in Diamond v. Diehr of a “claim as a whole” approach to patent eligibility for “laws of nature, natural phenomena, and abstract ideas” also governs the patent eligibility of mental processes. See, e.g., Bilski, 545 at 958. This interpretation of Diehr rules out an approach modeled on the mental steps doctrine that inquires whether an act of human cognition is the claim’s point of novelty. If determine-and-infer claims are to be categorically ineligible for patent protection, it looks like the Supreme Court will need to cabin the Federal Circuit’s interpretation of Diehr. Given that the Supreme Court has not yet addressed a claim that literally encompasses an act of human cognition, however, a clarification that the claim as a whole approach to patent eligibility was never meant to apply to mental processes is a reasonable possibility in either Bilski or a future case.
Third, determine-and-infer claims could be screened on a case-by-case basis to sort the wheat from the chaff. To address the “basic tools” concern, one possibility is that claims could be differentiated on the basis of whether they are used principally by end-users or by the practioners of basic science. However, this is a delicate, policy-intensive undertaking without many clear-cut factual distinctions onto which courts and PTO examiners can grasp. If one is concerned about line drawing, this would seem to be one of the most difficult lines to draw, and one would likely find the categorical treatments of determine-and-infer claims considered above to be preferable.
Yet, in the end, this policy-intensive line may be precisely the line that the Federal Circuit has set itself up to police—in a behind-the-rhetoric manner, of course—with its Prometheus decision. Assume that the Federal Circuit concludes that the vast majority of determining steps transform articles into different states or things. Or, more modestly, assume that most determining steps can be re-drafted to encompass only processes that transform articles into different states or things without an economically meaningful loss of scope. If this assumption holds, then the patentability of determine-and-infer claims will hinge on whether the administering and determining steps are central to the purpose of the claims (i.e., are not mere data-gathering steps). The discussion of the centrality of the administering and determining steps is the least-satisfying line of reasoning in the Federal Circuit’s Prometheus opinion. It simply asserts that these steps “are part of the treatment protocol.” Id. at 18-19. This characterization of the claims provides no basis to distinguish Prometheus from past cases in which claims to mental processes were held to be ineligible for patent protection because they recited mental steps in combination with mere data-gathering determining steps. Id. (attempting to distinguish In re Grams). It is tautological to argue that data-gathering steps are part of the overall claimed method. The reasoning must be result-driven: the administering and determining steps are central to the purpose of the claim because the panel believed that claims to methods for optimizing the treatment of patients should be eligible for patent protection. One of the most persuasive reasons for viewing the Prometheus claim as patent eligible is that it describes a method that is most commonly performed to directly benefit the identifiable end-users of health care, namely individual patients. Inversely, perhaps future courts will be more likely to identify the determining steps as mere data-gathering steps when the claims are likely to be employed in basic scientific research. In other words, perhaps it will be the distinction between claims that are treatment protocols and those that are research protocols that guides whether determine-and-infer claims are eligible for patent protection under the machine-or-transformation test. If this is the end result, there might be something to applaud. However, if this is the case, the Federal Circuit should openly admit the irrelevance of intangibility.
[1] Cite as Kevin E. Collins, An Initial Comment on Prometheus: The Irrelevance of Intangibility, Patently-O, https://patentlyo.com/patent/2009/09/an-initial-comment-on-prometheus-the-irrelevance-of-intangibility-1.html (September 17, 2009).
[2] For an in-depth analysis of a determine-and-infer claim, see Kevin Emerson Collins, Propertizing Thought, 60 S.M.U. L. Rev. 317, 323–42 (2007).
[3] The author discusses this concept—namely the importance of the level of generality at which a conceptual thing-type is framed—in much greater depth in Kevin Emerson Collins, The Reach of Literal Claim Scope into After-Arising Technology: On Thing Construction and the Meaning of Meaning, 41 Conn. L. Rev. 493, 514–36 (2008) (explaining how “thing construction” is important when determining the reach of an enabled claim into after-arising technology).
1. the high-pressure liquid chromatography assay is not proprietary and is widely used in Europe.
2. TGN thresholds at 235 pmol/8x10e8 RBCs have been established in 1990 (lennard) and 1995 (cuffari)
3. the patent was filed in 1997
there is definitvely something wrong here…
“Determine-and-infer claims are…”
unpatentable under 101.
They are scientific *discoveries* and as such categorically excluded from patentability.
I am really tired of the joke which the patent system has become. It appears to exist solely to enrich patent lawyers, and it is quite unconstitutional.
Good morning Malcolm. I’m sorry that I made you sad yesterday evening, with my deliberately provocative comment about the theory that you are a PTO Exr, writing that it seemed “plausible”. But I think that comment falls short of a stoopit conclusion, don’t you.
By reacting with distain, you aren’t doing anything to reduce the plausibility of the theory. If you really were an Exr, that’s exactly what you would do, no? The plot thickens.
Isn’t this all such fun? Light relief from arguing patent law.
And keep on commenting on patent law please. (All the more so if you really are a PTO Exr). I value your contributions far more than many of those that purport to come from “learned” counsel.
Malcolm, I think I did answer JV’s question. I would not mix Section 112, p. 1 and Section 101 and I specified how to do it.
As to the MPEP, you guys (examiners) are bound by it, I am not.
As to the case law, both you and I are bound by Supreme Court case law and in banc Fed. Cir. or CCPA case law, but little else, as the Fed. Cir. has a habit of developing conflicting lines of authority among panels. But, when the whole issue is at the Supreme Court, we are all free to argue about best practices.
Further, I hardly think any court would mandate the office enter a 101 rejection where the issue really is 112. But, a lot of these issue arise from the courts where defense lawyers choose the best defense for their clients. If the issue is best framed in 101, that is where they will go.
“Can there be any more damming evidence that Malcolm is not a member of the patent bar?”
IDK, this quote from Examiner Mooney is pretty convincing evidence that he’s an examiner
——————————————-
Now the troll is talking to its sockpuppet? LOL.
Instead of jumping to stoopit conclusions, Encyclopedia Brown, why not just ask some biotech prosecutors how they feel about the EST utility issue? Like I said, most of them (including me) have no problem with it. I have no idea why holding that view would cause a person to think I’m a patent examiner unless of course that person was a m0rAn.
And, yes, MD — today that includes you. Sad.
You didn’t answer JV’s question, Ned. I also note (again) that the MPEP rules and case law for evaluating utility under 101 are at odds with your puritanical approach to the statute.
Just Visiting, “There is no distinction between written description requirement that a claim conclude at a useful endpoint, and a utility requirement under 101 that only includes the recited elements of a claim. Don’t 101 and 112 have to be applied to all claims? How does your interpretation of 112 avoid contaminating every regime that MM’d version of 101 would contaminate.”
Obviously, I disagree. I think the utility requirement should focus primarily if not solely on the disclosure. If the claims do not correspond to a disclosed utility, do not include an essential step, or claim more than what is enabled, they have at least Section 112, p. 1, problems and probably also prior art problems.
“Under these circumstances, the claim should include the change in dosage step as a necessary claim element under Section 112, p. 1”
There is no distinction between written description requirement that a claim conclude at a useful endpoint, and a utility requirement under 101 that only includes the recited elements of a claim. Don’t 101 and 112 have to be applied to all claims? How does your interpretation of 112 avoid contaminating every regime that MM’d version of 101 would contaminate.
If the claims were not method claims, nobody would challenge the fact that some precursor to a useful device or thing [1] was not itself useful by making the claims recite the end point. I’m sure you routinely draft device claims that wouldn’t hold up to the scrutiny you advocate here.
[1] except ESTs 🙂
Malcolm, et al., if the claimed invention has a utility unsupported in the specification, I think the problem is, at a minimum, a Section 112, p. 1, problem. (Your yield improvement example, where the claim apparently has nothing to do with the disclosed utility.) If the claimed invention does not include a necessary step to support the disclosed utility, the problem again is at least as Section 112, p. 1, problem. (If the disclosed utility is a method of treatment, the claim should have the change in dosage step.) It is my view that addressing these issues under Section 101, even if possible, should not be the preferred rejection as it so conflates issues as to potentially contaminate one or the other regimes with bad law. Such was Judge Rich’s objection to Flook – it infected Section 101 analysis with novelty considerations.
With respect to the test and infer cases, if the test itself is new, then it should not matter that the dosage change step be claimed. However, it appears from these cases that the test itself is old, and that it is utility of the particular information derived from the (old) test which is new. Under these circumstances, the claim should include the change in dosage step as a necessary claim element under Section 112, p. 1.
What this means, of course and as a corollary, that merely thinking about the significance of the test results cannot substitute for a required step. But I still the the proper rejection is under Section 112, p. 1. (I would also reject the under Section 102 as anticipated.) I would not venture into utility at all, because the disclosed utility clearly is patentable under Section 101. It is just that the claim itself does not correspond to the disclosed utility.
ag: “I just don’t see what’s so outlandish about expecting a claim’s limitations and utility to be consistent. If the original method was for determining information required (i.e. “more or less of something”, which is my understanding of the implication of the infer step) to properly determine an appropriate dose of the medicine, why not say so? If its a method for actually treating the patient with an appropriate dose, then why stop before that step?”
The answer, of course, is that the scope of the claim is narrower if you do that. This is why many applicants freak out on 101, particularly those applicants (1) whose “inventions” are in fact “discoveries” about the natural world that they would like to own; and (2) whose “inventions” are algorithms or methods of thinking expressed as a series of intangible transformations on a computer. These two classes of inventions are, generally speaking, the thinnest of any alleged inventive contributions that exist. You or I or anyone with half a brain could file a 100 “determine and infer” or “computerized method of recommending a cursor shape” provisional applications tomorrow if we wished and they would be no more or less “inventive” than the garbage flooding the system now.
But ask these applicants to step up their game and you’ll get some shouting and a possibly a few tears but little else. Even in places outside of Texas.
Why not just claim “a material that undergoes a change in shape when exposed to electrical current comprising…”?
What is the point of reciting limitations in the preamble that I don’t intend to have patentable weight.
“I just don’t see what’s so outlandish about expecting a claim’s limitations and utility to be consistent.”
It’s not outlandish, but the expectation is not current law.
The current law is that by disclosing a use (not the boat anchor stuff) for the material in my specification, USC 101 allows me to claim the material without limitation to use.
Bah, I missed “device” cause I was reading too fast. No, not the device, just a utility it lives up to.
Perhaps. But are you suggesting that a product claim to such a an invention must recite the end use device?
Must it? Legally, I really don’t know. Practically, I don’t know why not.
Why not just claim “a material that undergoes a change in shape when exposed to electrical current comprising…”? If your claim then recites such a material, who would object to such a claim meeting its established utility? Alternatively, if your claim does not recite such a material, is it wrong to object to it not achieving its supposed utility?
I just don’t see what’s so outlandish about expecting a claim’s limitations and utility to be consistent. If the original method was for determining information required (i.e. “more or less of something”, which is my understanding of the implication of the infer step) to properly determine an appropriate dose of the medicine, why not say so? If its a method for actually treating the patient with an appropriate dose, then why stop before that step?
With regards to application/context vs utility, I do agree that establishing that in the specification should be sufficient. If I’ve made a better wheel, I would claim a wheel, and say in the spec that it can be used in a car. I wouldn’t claim the car though, that’s not the invention.
“then isn’t their utility going to be enhancing/allowing the operation of that device?”
Perhaps. But are you suggesting that a product claim to such a an invention must recite the end use device?
Suppose I invent a material that undergoes a change in shape when exposed to electrical current. Must I recite in my claims an actual application of the material or is it enough to disclose some uses in my specification?
“The problem is that many inventions that are components of a useful device or apparatus wouldn’t meet the utility requirement as you misstate it. ”
If these inventions are components of a more complicated device, then isn’t their utility going to be enhancing/allowing the operation of that device? Many inventions are only useful in the context of a more complicated device, but that doesn’t mean that their utility is that entire device, but rather the function they perform that enables the device as a whole to work, or to work better.
If the method is for obtaining more gold, then there should be a step that allows it to obtain more gold. If the method is for determining how much gold there is to obtain, that too is useful, but it is not the same stated utility as a method for obtaining more gold.
What’s wrong with actually stating the utility of the invention instead of the downstream benefits you hope your invention may provide?
“Given the facts I’ve presented, why in the world would you object to killing this claim under 101, as lacking utility? 101 exists.”
The problem is that many inventions that are components of a useful device or apparatus wouldn’t meet the utility requirement as you misstate it. There are other 101 tools to apply to the claims at issue here, so why not use them?
Ah-ha. Seems very plausible, I must say.
But that means that, after all, he’s not Dennis. Doesn’t a certain accuser (who was so certain of it at the time) now owe an apology to the estimable Professor Crouch?
“Can there be any more damming evidence that Malcolm is not a member of the patent bar?”
IDK, this quote from Examiner Mooney is pretty convincing evidence that he’s an examiner:
“Incorrect. I agree with the decision that ESTs should not be patentable, as do many (if not the overwhelming majority) of my peers, and I don’t particularly mind the reasoning. I would just like to see that reasoning applied consistently, across the board.”
So Malcolm and an “overwhelming majority” of his peers, aka, his art unit buddies, agree that something is not patentable under 101. Is anybody surprised?
Ned: “assaying the amount of gold in the rocks is useful in improving yield because a determination of the amount of gold in the rocks is necessary to determine yield in the first place.”
You’re shifting the sands a bit here. I’m not claiming a method for **determining** whether the yield of gold from rocks has in fact improved or not relative to a previous attempt to obtain gold from rocks. I’m claiming a method of improving the yield of gold from rocks, period. My invention works to improve the yield of extracted gold (I say for the purposes of my hypothetical) whether or not you are aware of the previous yield, or whether or not you measure the yield of extracted gold before or after. As you know, you don’t necessarily need to extract the gold from the rocks to determine how much gold is in the rock (but let’s assume that some transformation of the rock is required).
Are you beginning to see the utility problem with my claim? I can explain the problem quite simply: the claimed method does not achieve what is promised. And it’s not because it’s “overbroad.” It’s because it fails to recite the steps necessary to achieve what is promised. Given the facts I’ve presented, why in the world would you object to killing this claim under 101, as lacking utility? 101 exists. Use it.
“Using a barometer to measure the height of building by dropping it and timing its descent to the pavement is the kind of “general” utility that any physical object has.”
That’s incorrect. There are an infinite number of objects without the particular properties that make a barometer useful for that purpose. In fact, there’s no doubt that certain barometers would not be useful for that purpose. And you think my approach to the utility requirement under 101 is unsound? 😉
Malcolm: Your hypothetical specific that digging up rocks and knowledge of the amount of gold in the rock was both known and and known to be insufficient (for profitable operations, I presume). Therefor, your hypothetical claim was entirely old. But certainly, assaying the amount of gold in the rocks is useful in improving yield because a determination of the amount of gold in the rocks is necessary to determine yield in the first place. For example, the entire “improved” process could be
1) digging rocks;
2) determining the amount of gold in the rocks;
3) if the amount is less that x, use process “a” to extract the gold; and
4) if the amound is greater than x, use process “b.”
Now, I would argue that at least one of the last two steps would have to be present for novelty purposes if the first two were old. But that does not mean that if the first two steps are not useful if they are new. If no one had ever, heretofore, dug for rocks and determined the amount of gold in them for any purpose, all one would have to have is some disclosed specific utility for patentability purposes.
Malcolm further asked, “I’d also be curious to know whether it is your opinion that a claimed method has utility as long as ANY step in the claim can be argued to be useful to somebody.”
No. Using a barometer to measure the height of building by dropping it and timing its descent to the pavement is the kind of “general” utility that any physical object has.
As to your last point, I agree. But the utility of the tagged genes should not have been the issue.
Ned: “Malcolm, regarding your hypo, the claimed subject matter is both clearly useful and clearly old.”
Finish the thought, Ned. What is the “utility” in my hypothetical claim that is so “clear” in your opinion? Try to keep in mind the preamble of the claim and the specification. I presented them to you for a reason. Also, please refer to the MPEP for guidance on how one determines whether something is useful.
I’d also be curious to know whether it is your opinion that a claimed method has utility as long as ANY step in the claim can be argued to be useful to somebody.
“The genes tagged had no presently known use”
That’s plainly false, of course. Perhaps you meant to say that they had no credible, subtantial utility sufficient to meet the requirements under 101?
Malcolm, regarding your hypo, the claimed subject matter is both clearly useful and clearly old. Let’s change the facts just a bit: assume the method of determining comprises a specific novel method for determining the level of gold in the rocks. Would it make any difference to the utility requirement that the claim did not additionally add mining or not mining in response to the level? But, these essentially are the fact in Flook. The Supremes seemed to require that additional step.
In the EST tag case, the tags had a clear use — researching the use of the specific corn gene fragments. The genes tagged had no presently known use, but they clearly had a use of some sort. The tags were helpful, and thus useful, in this research.
Ned: “I was talking about the Mayo case. What we think we know about that case is that everything is old except the adjustment of the dosage depending on the test results. So I suggested that if the claim does not include that step, the real issue is anticipation.”
Well, the claim does not recite any step of adjusting anything. I have no idea why you think that makes the issue of “anticipation” any more “real” than the issue of a lack of utility.
Let’s imagine an application that talks about improving the yield of gold obtained from a gold mine. The application talks abou how people have been digging up gold for years but the amount of gold in the rocks is low so that an improved method is needed. Claim 1 recites : “A method of increasing the yield of gold extracted from mined rocks, comprising (a) digging up a plurality of rocks; and (b) determining the amount of gold in the rocks.”
What in heck is the problem with objecting to that claim under 101? I understand that there are other ways of rejecting the claim, but so what?
Troll: “And now according to the math of another examiner, I am happily at 101% of comments assailing the likes of 6 and Malcolm. I’m aiming for at least 110%.”
Sounds like a total meltdown. Good luck!
Breadcrumbs: “Ned, isn’t 101 a threshold issue?”
Should be, but it is seems highly related in peoples minds to novelty. Take a look at my previous posts, including the one just above. Note the contrast between the case were the sole novelty is in the dosage adjustment and the case where the novelty is (also) in the lab blood test itself. In the first case, the claim has to include the adjustment of dosage, otherwise it is anticipated by the prior art. If the second case, I would argue, that it is not necessary to claim the adjustment of dosage because the test itself is novel.
Both these considerations involve Section 102 considerations, not Section 101.
Which brings me back to the vice of Flook. There the invention was the improved algorithm for updating the alarm limits. There was disclosed utility. That should have ended the Section 101 analysis. However, the Supremes totally reversed the analysis by deeming the invention, the algorithm, to be part of the prior art. With such a premise, the result in Flook was both predictable and completely wrong.
Malcolm said: “Not necessarily your fault, Ned, but you completely lost me with that last comment. Which claim are we talking about? The actual determine-and-infer claim at issue in the case, or the “fixed claim” I proposed in my 7:15 pm post to address the 101 issue?”
Malcolm, I believe I was talking about the Mayo case. What we think we know about that case is that everything is old except the adjustment of the dosage depending on the test results. So I suggested that if the claim does not include that step, the real issue is anticipation.
In contrast, if the test itself is novel and claimed, and the test has disclosed utility in a treatment method, I do not believe that one has to actually claim the adjustment in dosage for section 101 purposes.
And now according to the math of another examiner, I am happily at 101% of comments assailing the likes of 6 and Malcolm.
I’m aiming for at least 110%.
curious,
In relation to Malcolm’s often stated “Whether it dies under 101 or 102 or 103 … is not terribly interesting”:
Can there be any more damming evidence that Malcolm is not a member of the patent bar?
No one would take such cavalier atitude to such basic underpinnings, yet Malcolm proudly brandishes this as part of his shield of persistent ignorance.
“One doesn’t even have to get into section 101.”
Ned, isn’t 101 a threshold issue?
Not necessarily your fault, Ned, but you completely lost me with that last comment. Which claim are we talking about? The actual determine-and-infer claim at issue in the case, or the “fixed claim” I proposed in my 7:15 pm post to address the 101 issue?
Malcolm, there is a problem unless one links the test result back into the treatment. The problem is lack of novelty. Everything up to and including the test for metabolites itself is old and old in that combination it would seem. The claim is anticipated. One doesn’t even have to get into section 101.
Imagine a lab that has been conducting blood tests for the concerned metabolites for years. Even if the blood samples came from a doctor practicing the entire method, and even if they reported the results back to the doctor, all they would be doing would be practicing the prior art. The only possible direct infringer under these circumstances would be the doctor who adjusted the dosage depending upon the results of the test.
But the case is quite different if the method of testing were the invention. Here, it would be quite irrelevant whether the claim additionally called for the doctor to actually do anything with the test results as the method of treatment itself is not the invention.
What I see in these test and infer claims is an attempt to shift liability for infringement for new methods of treatment to a lab which is itself doing nothing new. This really is not or should not be a section 101 issue — or should it?
Ned: “Malcolm, in Mayo, the use of the drug to treat the disease was old. The test for metabolites was old. What was allegedly new was testing for metabolites of the drug made by the body and changing the drug dosage depending on the number.”
Agreed. But, for the thousandth time, there is no step of “changing the drug dosage” in the claim.
“Now, just how much of the details of the process must be put into the claim so as to link the claim to the disclosed utility?”
That’s easy: a single step of actually administering a second lower dose to the subject. That would actually effect a useful transformation that is central to the purpose of the claim.
Is it a valid claim? I have my doubts but at least we’d get beyond the 101 issue.
Note also that the “wherein” clause that includes some garbage about what the determination “means is absolutely irrelevant here. And it shouldn’t be relevant to determining the validity of the method in view of the prior art. You can’t claim thoughts, and you can’t distinguish a method from a prior art method based on what someone is thinking while they are practicing the method.
“Whether it dies under 101 or 102 or 103 … is not terribly interesting”
Most patent attorneys would find it very interesting and useful to their practices.
“Incorrect. I agree with the decision that ESTs should not be patentable, as do many (if not the overwhelming majority) of my peers, and I don’t particularly mind the reasoning.”
I know that’s what you’d like to claim, and the way you’d like to frame the issue MM. I’m framing it for people not seeing it from your jaundiced point of view. They need to understand what caused you to take the view on 101 which you are currently taking if they’re going to talk to you. Bottom line is, you want to see that reasoning applied across the board.
Never the less, they’re not going to put that standard into practice across the board.
“I would just like to see that reasoning applied consistently, across the board.”
Exactly, but it won’t be.
I had more to say to Ned, but he appears to simply sidestep the very issue he brought up. That of the “new number”. And then he brings up other issues. I have no desire to discuss the entirety of vague “methods of producing a number” patents. Claim by claim basis is how we approach these things.
Malcolm, in Mayo, the use of the drug to treat the disease was old. The test for metabolites was old. What was allegedly new was testing for metabolites of the drug made by the body and changing the drug dosage depending on the number. That clearly was and is useful. But even if everything in such a claim were old, the it would still be useful, but unpatentable for lack of novelty.
Now, just how much of the details of the process must be put into the claim so as to link the claim to the disclosed utility? That is the real question here.
It is axiomatic that one does have have to put all details of a useful machine into a claim in order to patent an improvement. I could claim a screw have a certain material for use in a high performance engine. I am sure such a claim is patentable even if a screw with that material in isolation and completely out of context has no specific utility.
So just how many steps of a method claim do you have to claim in order for the claim elements to be associated only with the disclosed utility. I think the answer should depend on the context.
Turning to Beauregard claims, how can we justify patenting such claims but not to the software claimed as a computer process or a programmed machine? The hypocrisy of it all appalls me.
As to ESTs, I just read the case to understand better your point. I think Radar had the better argument, but clearly that case was about whether the disclosed utility was specific. There is no doubt here that the method of treatment disclosed in Mayo is specifically useful.
Ned: “Your objection is that the number is not physical. But it does have utility.”
My objection is that the utility of a “number” does not make the number itself patentable, nor does it make thinking about the number patentable and that is all that this claim appears to do.
Once again, as I understand it, there is no dispute that “determining” 6-TG levels in a patient pre-dates Prometheus application. Therefore, determining those levels is not “the invention”. The “invention” is something else. The “invention” can’t be thinking about the levels and what they “mean”, because everyone agrees that you can’t claim a thought under 101.
Whatever the invention actually is, then, all we really know is that it wasn’t claimed. So kill it. Whether it dies under 101 or 102 or 103 (after appropriately ignoring the mental hoohaw after the wherein clause) is not terribly interesting, as long as it’s dead because promoting the issuance of these sorts of claims is a ruinous proposition for everyone involved (except for patent attorneys and lowlife exploiters/trolls).
Your typical software crap has even less going for it, of course, because it merely takes the unpatentable thinking step and puts in on a computer. As of this moment, that practice is deemed sufficiently creative to justify a patent but for the life of me I have no idea why.
Name a method of doing anything. Think of a bunch of ways it can be done. Turn some of the ways into a “score” or “value” that has a stoopit name that you make up on the spot. Write a Beauregard claim. You’re done. Why are we using the patent system to promote this crap? The answer is that certain patent attorneys want it that way and if they don’t get their way we know what they will do: they will cry.
If there was any doubt about this before, surely there can be no doubt about it now.
6. Thanks for your thoughtful response. As you might guess, I am not trying to define what the current law is, but what it should be given that the whole subject is now before the Supreme Court. I think the Supremes should reconsider their precedent and not just decide whether the Fed. Cir.’s Bilski test is exclusive or not.
As to particular numbers, the patent is not on the number, but on the process of producing the number. The resulting number has particular utility which is disclosed, but only in context of the claimed process. I am not suggesting that patents issue on numbers out of context.
Regarding the issue of determining utility, injecting novelty into the analysis can produce absurd results. Consider again the screwdriver. It clearly is useful. But it is also old. But surely one cannot say that a screwdriver is useless because it is old.
Flook introduced the novelty analysis into the determination of patentable subject matter. More than that, it dissected new features from old. I think Flook is wrong; but, unfortunately, it remains the law.
“MM’s bottom line issue however is that the sequence tags got bad treatment and now he has a jaundiced view of 101 as a whole.”
Incorrect. I agree with the decision that ESTs should not be patentable, as do many (if not the overwhelming majority) of my peers, and I don’t particularly mind the reasoning. I would just like to see that reasoning applied consistently, across the board.
Just remember that jobs were lost and companies were hurt by the decision and yet it happened and our patent system is better for it.
“One should, I suggest, look at a claim as if everything were new for “utility” purposes.”
That is kind of dumb even if that is where the lawl is today.
“But the result was a better molded product.”
Then claim the better molded product and get on with life instead of insisting upon claiming an old method where you simply used a new “algorithm” to do something old. I note that the real issue isn’t the usage of the algorithm in the claim, the real issue is that the applicant doesn’t want to describe in the proper “method step” manner what is new about his process because the claim using the algorithm is deemed by him to be more valuable and he thinks the courts should let him get away with distinguishing his claim thus.
“In the present cases, the utility is in the improved treatment of a patient, where the only thing new is the particular drug administered and the particular test.”
Actually from what I hear the particular drug was old as well.
“But if the software calculates a new number that does have disclosed utility, that should be sufficient.”
Could you give me an example of a new number? 1, 2, 3? I’m pretty sure that all numbers are pretty much old.
Also, I see you just posted again, I don’t think that a “price” is necessarily new. I assume the term “price” covers the number 1.00$. That isn’t a new number. Does the alarm limit in Flook cover then number 1? I believe that his objection is that the number is not new. Or in the case of the instant claim under discussion in the thread, that the wherein’s where all inherent to the old process.
MM’s bottom line issue however is that the sequence tags got bad treatment and now he has a jaundiced view of 101 as a whole. I don’t blame him, it was wrong for the court to make a special utility exception for those sequence tags if they wanted to properly follow precedent. If they are going to make that exception then they should change the lawl to something approximating what he is saying it is. Even though he is mistaken and that is not the current lawl.
Malcolm,
–the “price” in State Street Bank was a new number. It had disclosed utility.
— the alarm limit in Flook was a new number. It had disclosed utility.
— the test results in both Mayo and Metabolite are new numbers. They both have disclosed utility.
— the binary number in Benson was useful as it had a one-to-one relationship with the BCD number at the input.
I could go on and on and on.
Your objection is that the number is not physical. But it does have utility.
Consider the screwdriver. It has many uses. All that is required is that the specification disclose one.
But you would argue, the screwdriver is physical. I would agree. But its physicality has nothing whatsoever to do with utility. I hope you now begin to see my point.
“if the software calculates a new number that does have disclosed utility, that should be sufficient.”
I think that you should read what you wrote and consider how completely insane it sounds.
Malcolm, you really like to parse claims between new and old elements in your Section 101 analysis — just like the Supremes did in Flook. But I agree with Judge Rich on this issue. Importing novelty considerations into the analysis is flawed, seriously flawed.
One should, I suggest, look at a claim as if everything were new for “utility” purposes.
Take Diehr, for example. Everything in that claim was old except for the algorithm. But the result was a better molded product. Now, that utility was not stated in the claim, but in the specification. In the present cases, the utility is in the improved treatment of a patient, where the only thing new is the particular drug administered and the particular test.
As to software, I agree that utility of software is not a given if there is no use for the software disclosed. But if the software calculates a new number that does have disclosed utility, that should be sufficient. But that would mean that Flook, at a minimum, was wrongly decided.
We haven’t even gotten into whether business methods should be declared useful within the meaning of Section 101. But I am sure they are useful in fact, which means the Supremes will have to announce a categorical exclusion if they are to properly decide Bilski.
Ned: “In Flook, the claim calculated an updated alarm limit from which all sorts of useful acts could be inferred. But the Supremes found this claim unpatenable.”
They were right.
“I have no problem with utility in this case so long as the claim is reasonably tied to a method of treatment of a patient. The lab may only produce a useful signal from the blood, but I think that is (or should be) enough.”
Signals aren’t patentable. And the invention here is a method for optimizing treatment. The claimed method does not optimize treatment. Although I’ve been waiting for someone to point out the contrary, the steps recited in the claimed method are, in fact, old and pre-date the filing date.
The only “new” feature in the claim is the information about a correlation between an old lab result and a “need for treatment”. That correlation, however, is merely an abstraction, a thought, a fact, that has been unambiguously and irrevocably donated to the public by the applicant.
Now, a new physical step following the previous two steps (both of which were old, in the order practiced) might actually result in a substantial, credible utility. For example, a step of administering a SECOND lower dose, within a particular time period following the determining step. That would be getting somewhere. Now an actual method would be claimed, instead of an end-around attempt to claim a fact. Bear in mind, there may still be serious 102 and 103 and/or 112 issues to deal with. But at least we can all agree that we are looking at an invention that accomplishes more than simply causing a doctor or a lab technician to think about something.
“software is useful per se”
Nothing is “useful per se”, as far as the law of utility is concerned. That was made very clear when, e.g., expressed sequence tags were declared unpatentable as lacking utility.
Hagbard, my hypos were just examples of how to redraft the claims to selectively focus the infringement on the doctor or the lab. It really had nothing to do with the utility issue per se.
The problem the claims currently have is that it has acts both of the doctor and of the lab, which in the real world can be and often times are two independent entities. In order to infringe a claim, you have to have one actor. There is no such thing as joint infringement.
The Fed. Cir. has in recent cases suggested this is just a claim drafting issue so as to confine all the acts in one party. I was just illustrating how to do this.
Back to utility for a moment, I have no problem with utility in this case so long as the claim is reasonably tied to a method of treatment of a patient. The lab may only produce a useful signal from the blood, but I think that is (or should be) enough.
Which gets us back to Flook and Diehr. In Flook, the claim calculated an updated alarm limit from which all sorts of useful acts could be inferred. But the Supremes found this claim unpatenable. Next it held under very similar facts that opening a mold was enough tip the balance in favor of patentability.
Now the differences between Flook and Diehr are clear, one was pure software (no weight to the data gathering steps) and the other included a physical act. But, as we should all know by now, software is useful per se. It does not “withdraw” from mankind useful tools that are available to all, but adds mightily to those tools and to the welfare of mankind.
Flook (as well as Benson) were wrongly decided and the Supreme Court needs to reverse them.
Ned:
“3) Lab informs doctor that dosage will have to be increased or decreased depending on the level of certain metabolites.”
But that’s not what the claim says. It just says:
wherein the level of 6-thioguanine less than about 230 pmol per 8x10EXP8 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 8x10EXP8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
Those aren’t method steps at all. They’re just conclusions with no actions. The only method steps in the claim are (a) administering a drug providing 6-thioguanine and (b) determining a level of 6-thioguanine.
Now, I know that the opinion says that the claim satisfies M-or-T because there is transformation (implicit) in step (a), but where’s the utility? It’s in your step 3, which isn’t in the claim.
How about:
indicating a need to increase the amount of said drug subsequently administered to said subject when the level of 6-thioguanine less than about 230 pmol per 8x10EXP8 red blood cells or
indicating a need to increase the amount of said drug subsequently administered to said subject when the level of 6-thioguanine greater than about 400 pmol per 8x10EXP8 red blood cells
You then, at least arguably, have a “useful” method. Should it still have to rely on the supposed “transformation in step (a)?
Interesting article, but I think it misses the most significant point, which is the M-O-T test was satisfied inherently, not expressly. In other words, the claim recited no transformation whatsoever, but one skilled in the art would know that someone to whom a drug is administered experiences a transformation. The article seems to be cabinned to the topic of the determine-and-infer claims.
Has it suddenly become popular to use “cabin” as a verb? It seems to have become a fad word among academics. (Not to imply that it isn’t proper English. The definition is “to confine; enclose tightly; cramp.”)
Malcolm, what was the vice Flook was trying to prevent? The utility of the alarm limits were described. The claim did not preempt any pure mathematics or law of nature. The claim was not seeking to patent an abstract principle. the subject matter was technological. All Flook did was violate the principle that a method must transform something physical in order to be patentable subject matter. But, beyond this meager objection, I see no vice in the Flook claim.
Tell me about Flook, Malcolm. Then we can discuss your question in the previous post.
“Now, if the additional step of actually doing something rather than just inferring it seems artificial, I agree. ”
What seems “artificial” about “actually doing something” in a method claim?
Leaving out the step but pretending that the claim actually achieves what it purports to achieve seems more “artificial” to me.
Hagbard, A1 and B1 are like Flook and A2 and B2 are like Diehr.
Now, if the additional step of actually doing something rather than just inferring it seems artificial, I agree. But consider what really is going on here: a shift of infringers.
Claim 1,
1) Doctor administers drug,
2) Doctor draws blood;
3) Doctor increases or decreases dosage of drug depending upon level of certain metabolites.
Doctor is the infringer. Lab and its test is not specific to claim.
2) Lab test blood sample drawn from a patient administered drug; and
3) Lab informs doctor that dosage will have to be increased or decreased depending on the level of certain metabolites.
Lab is the infringer.
There is no real difference in utility, IMHO. There is a difference in who’s the infringer.
Assuming that example A would fail 102/3 but example B would pass 102/3, and that A2 and B2 would pass 101, do A1 and B1 pass 101?
Example A
Pour a cup of coffee
Take a sip
A1 Wherein the coffee being painfully hot indicates a need to blow on it.
OR
A2 If the coffee is painfully hot, blow on it.
Example B
Engage gizmo with whangdoodle
Measure parameter X of gizmo
B1 Wherein parameter X exceeding value Y indicates a need to downwardly adjust parameter Z of whangdoodle.
OR
B2 If parameter X exceeds value Y, downwardly adjust parameter Z of whangdoodle.
“Obviously if you “discover” a new washing machine, you can patent it. ”
Unless you’re in the maytag store.
And unless the washing machine was running wild on the open plain.
Yes, AI, that’s why I put “discoveries” in quotes. Obviously if you “discover” a new washing machine, you can patent it. But if you discover a new fact, you can’t patent the new fact. You can keep the fact secret and exploit the new fact, or you can claim a method or apparatus that exploits the new fact. But the claim can’t prevent people from thinking about the fact.
MM Wrote: “Except that you can’t patent “discoveries”
You are wrong. Under the 1952 Patent Act, Section 35 U.S.C. § 101, provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof,” may obtain a patent on the invention or discovery.
“he mere existence of “a utility” is not enough to pass 101. It needs to be a credible, substantial utility that achieves what the claim and invention description promise. ”
MM can you cite the case law and or statute that says this? Because It appears you not familiar with the law concerning 101 and useful process. In which case I strongly suggest you read posted by: curious | Sep 18, 2009 at 09:06 PM.
Section 101 of the Patent Act of 1952, 35 U.S.C. § 101, provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof,” may obtain a patent on the invention or discovery. The threshold of utility is not high: An invention is “useful” under section 101 if it is capable of providing some identifiable benefit. See Brenner v. Manson, 383 U.S. 519, 534, 86 S.Ct. 1033, 16 L.Ed.2d 69 (1966); Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F.2d 1555, 1571 (Fed.Cir.1992) (“To violate § 101 the claimed device must be totally incapable of achieving a useful result”); Fuller v. Berger, 120 F. 274, 275 (7th Cir.1903) (test for utility is whether invention “is incapable of serving any beneficial end”).
6. I agree. The only invention is the improved treatment. The lab test is conventional. What it important is what is tested and what is done with the test results.
Which means, the claims are trying to rope in via direct infringement the lab, where it might be better to go after a lab under an inducement theory.
Previous comment should have read “…is NOT, in and of itself, fatal…”.
And just to be clear, the fact that an invention has as its purpose to create thoughts in another person is fatal in and of itself (at least, I’m not arguing that it should be now — who knows what may come later?). This isn’t at all like Juicy Whip v. Orange Bang. In that case, there were novel steps and/or apparatuses that effected the change.
Here the change is effected by the patentee’s dissemination of knowledge.
Think about it.
6: “Looks like it to me.”
LOL. I assume your Office Actions are a bit less succinct.
“But it does deliver a utility.”
My friend, the mere existence of “a utility” is not enough to pass 101. It needs to be a credible, substantial utility that achieves what the claim and invention description promise. My nucleic acid that I just randomly created has utility as an additive to be sprinkled on mice to feed my pet alligator. And it will recognize and “determine” a complementary sequence somewhere. But that’s not enough to pass 101.
The invention here is a method for optimizing therapy. But the steps do not achieve that. Nothing new happens whatsoever except that a subset of people who have read the patent (or who have read this blog, or who have read an article on the subject) will have a thought different than people who have not read the patent (or this blog, or an article on the subject).
That’s a substantial utility? Changing the thoughts of a person who has read the patent?
Seems trivial to me. And not statutory subject matter.
If this issue is presented to the Supreme Court in a forthright matter, the Supremes are going to beat these garbage claims into dust.
don’t perpetual motion machine claims have to be accompanied by working prototypes?
“In light of the written description in this case, the claim clearly fails to deliver the promised utility.”
But it does deliver a utility. And that’s a problem for your “no utility” argument.
“Is that statutory subject matter?”
Looks like it to me.
Sorry MM it just isn’t going to fly.
6 “Remember, when looking for utility you don’t only look to the distinguishing features of the claim for utility, you look to the entire claim.”
I had a longer comment on this subject which was somehow disappeared. Suffice it to say that your MPEP is quite clear that 101 determinations can be made at any time during examination and that not only the claim but the written description should be consulted. In light of the written description in this case, the claim clearly fails to deliver the promised utility.
Let me repeat: there is no law requiring that 101 determinations be made without reference to the specification. The rules indicate that the opposite is true.
Would a claim to “A method of operating a machine perpetually without input of energy, comprising cooking a hot dog while operating the machine, wherein the increasing temperature of said hot dog indicates increased likelihood that the operator will copulate with the mate of his or her choice.”
Is that statutory subject matter? It has a transformation step. And everyone loves the idea so that’s a “reason” it should be statutory.
Flook found unpatentable the updating of an alarm limit (calculated from measurements), from which one of ordinary skill might “infer” to run like hell; while Diehr, under the same facts held patentable opening the mold after the calculation.
Solely from the above, I would suggest that measurement and infer claims would be more like Flook than Diehr and to not constitute patentable subject matter. The data gathering is not truly transformative, IMHO, and is or should be irrelevant to the patentability question as suggested by Professor Collins.
But the Collins artile is striking by italicizing, it its opening paragraph, the wiggle words in the legal test: “Meaninful,” “central,” “insigficant,” and “mere.” This demonstrates that we do not have a real legal test, but a “totality of cirmunstances” mish-mash that the Supremes “condemned” in recent patent cases. They really need to go back to the drawing board and give us a very simple to understand and to apply bright line test.
I don’t think that “the incentives generated by these claims” is a relevant consideration or factor.
“MM you of all people should be arguing that sticking a needle in someone’s arm HAS UTILITY. And so far as I understand it, this claim has that encompassed within step 1. Utility is thus assured.
Remember, when looking for utility you don’t only look to the distinguishing features of the claim for utility, you look to the entire claim.”
Examiner 6 absolutely schooled Examiner Mooney!!!!!!!
I love it.
Maybe Examiner Mooney should be sent back to the PTA for some refresher courses.
“Right, so the claim as drafted obviously has no utility,”
MM you of all people should be arguing that sticking a needle in someone’s arm has utility. And so far as I understand it, this claim has that encompassed within step 1. Utility is thus assured.
Remember, when looking for utility you don’t only look to the distinguishing features of the claim for utility, you look to the entire claim.
Curious, I dont’ know man. They claim a genus recitation (administering) of sticking someone in the arm with a needle as step 1 as far as I can see and that suffices for 101 so far as I can tell. Furthermore, the court is interpreting the “determining” step as doing some labwork or something. So that helps as well. I just can’t see a 101 issue here.
“They claim a genus recitation (administering) of sticking someone in the arm with a needle as step 1 as far as I can see and that suffices for 101 so far as I can tell. Furthermore, the court is interpreting the “determining” step as doing some labwork or something. So that helps as well. I just can’t see a 101 issue here.”
I agree
“Right, so the claim as drafted obviously has no utility,”
MM you of all people should be arguing that sticking a needle in someone’s arm HAS UTILITY. And so far as I understand it, this claim has that encompassed within step 1. Utility is thus assured.
Remember, when looking for utility you don’t only look to the distinguishing features of the claim for utility, you look to the entire claim.
Curious, I dont’ know man. They claim a genus recitation (administering) of sticking someone in the arm with a needle as step 1 as far as I can see and that suffices for 101 so far as I can tell. Furthermore, the court is interpreting the “determining” step as doing some labwork or something. So that helps as well. I just can’t see a 101 issue here.
On the other hand, 6, the administering and/or determining steps bring the claim within the ambit of 101, imho.
“My opinion is that the two “wherein clauses” in the Prometheus claim do not further limit either of the two method steps nor do they introduce a new method steps and therefore they should be accorded no patentability significance for 102 and 103.”
FTW
“Patent examiners should be deciding whether or not a claim can be enforced as part of their examination duties?”
Uh, no. But they should be examining claims for patentability under 101. And that should require more than just looking to see whether the word “method” or “composition” is somewhere in the claim.
“My opinion is that the two “wherein clauses” in the Prometheus claim do not further limit either of the two method steps nor do they introduce a new method steps and therefore they should be accorded no patentability significance for 102 and 103.”
Right, so the claim as drafted obviously has no utility, therefore unpatentable under 101. Easy.
My opinion is that the two “wherein clauses” in the Prometheus claim do not further limit either of the two method steps nor do they introduce a new method steps and therefore they should be accorded no patentability significance for 102 and 103.
Patent examiners should be deciding whether or not a claim can be enforced as part of their examination duties?
“I don’t believe that the claim as interpreted by the FC can be enforced against a physician performing a mental step”
Then how can it be enforced?
If it can’t be enforced, then why should the PTO waste its time examining it? Why should the number of poorly drafted unenforceable uninfringeable claims such as this one be encouraged, at a time of ballooning filings and a massive PTO backlog?
“I’m not particular bothered that the mental step is the final step, at least for the purpose of determining compliance with 101.”
Okay, so you’re not bothered. Lots of people aren’t bothered by Beauregard claims, either, or pure business method claims. But it doesn’t mean that software or thoughts should be statutory subject matter and it doesn’t mean that a claim that results in nothing but cause a person to think an unpatentable thought should be deemed sufficient under 101. Shall we take a poll of everyone in the country and see what they think about whether claims to thinking a thought about some data should be protected for 20 years by a patent?
MM says:
“you can’t patent “discoveries”
The problem with statements like this is that despite being correct, they don’t really convey anything that would help sort out the patentable from the unpatentable. Does this particular claim patent an principle? I don’t find that to be such an easily answered question.
“That’s why when a claim states a method for optimizing therapy and it’s final step does not optimize the therapy..”
IMO this is just form over substance stuff that shouldn’t decide the ultimate issue of patentability any more than does writing method claims in Beauregard format does. I don’t believe that minor tweaks to the preamble ought to make any difference, and I’m not particular bothered that the mental step is the final step, at least for the purpose of determining compliance with 101.
The form of the claim is related more to what infringers the claim is going to catch rather than to what activity is being protected. I don’t believe that the claim as interpreted by the FC can be enforced against a physician performing a mental step, and from a policy stand point, I don’t see anything to be gained by making the claim invalid under 101 in addition to being uninfringed and/or unenenforceable.
When reading through some of the Benson/Flook/Diehr case law, I saw that one of the policy issues revolved around the difficulty that PTO has with examining claims drawn to software. That same policy issue might affect the Bilksi result, but as Prof Collins points out (and hats off to KEC for a very thought provoking article and to DC for brining it) I simply don’t see that particular policy issue here.
I’m going to stop commenting now that MM and 6 are agreeing with me.
JV “Thus the fact a discovery has been published but cannot be used should not, without more, be a convincing argument against patentability.”
Except that you can’t patent “discoveries” and you can’t patent abstract ideas (i.e., thoughts). You can patent processes and you can patent compositions of matter, provided they have a substantial utility.
“the level of abstraction at which the natural principle is expressed determines whether a claim states an unprotectable principle or a patentable application of the unprotectable principle.”
True enough. That’s why when a claim states a method for optimizing therapy and it’s final step does not optimize the therapy but rather just recites a thought that one might have about a result, it’s not patentable subject matter.
No pretzels here.
BHodges: “I take this to mean that the fact that the significance of the measured levels has been unambiguously placed in the public domain, I first question that it is in the public domain, i.e., free for the public to make use of in any way.”
Well, this is the crux of the issue, as far as I’m concerned, and it’s also the clearest argument for eliminating protection of claims like Prometheus claims that prevent people from making inferences, correlating data, or drawing conclusions.
As you are well aware, you can’t patent a fact. If we take the inventors words at face value, then it is a fact that a low level of 6-TG in certain patients “indicates a need” for increasing the dose in those patients. To the extent the fact is disclosed in the specification, it is donated to the public. How can it not be, unless you are advocating (which you must do, to be consistent) that one should be able to patent thoughts?
“That discovery clearly has real world value when applied as claimed”
You keep saying that but you’re incorrect. You’re making a utility argument. Following the steps set forth in the claims achieves NOTHING new except changing a thought in the mind of a person looking at the data results. Is that a substantial utility, in this context? I don’t think so. Changing a thought in someone’s mind doesn’t help the patient. The utility is in the optimization of the treatment requiring additional steps that, unfortunately, are not recited in the claims we are discussing. Additional steps could have been recited. I would have had no difficulty drafting claims with such steps, and in fact have been doing so for years.
Bob: “And consider, the valuable test (valuable both to the test seller and to patients) might not have been developed unless patent protection was available”
You’re going off the rails now, Bob. First of all, the “test” itself was not claimed. Is there a novel kit here that I’m missing? Was determing the level of metabolites of BME following administration actually a new method? If so, then what is the point of the “wherein” clause?
The claim purports to be a method for optimizing treatment. The treatment was old and nobody is disputing that. Are you saying, Bob, that without patents on thoughts and abstractions (i.e., facts and “discoveries”) that hospitals and researchers won’t try to optimize treatments? I suggest to you that the opposite is more likely.
I also second Mike’s response upthread.
By the way, can someone please confirm that the point of novelty in this claim *is* the inference to be drawn from the data? I haven’t seen any suggestion that administering BME to a patient with IBD and detecting BME metabolite levels in the patient is, by itself, new. Assuming it is NOT new, can someone tell me why Mayo would be inducing infringement if it simply provided the testing kit to doctors tomorrow and told them to “use their best judgment in treating patients based on the results”? In my view, there is no way to do that without effectively arguing that the claim is a patent on a human thought.
“However, not every valuable discovery is patentable…”
I think this misses the point. An application of matrix math to MRI data to produce blips on a CRT to enable diagnosing some malady may be protectable despite the fact that the underlying math itself is not. Thus the fact a discover has been published but cannot be used should not, without more, be a convincing argument against patentability. Is the problem here that it is simply too easy to apply the knowledge?
The law *does* require that the claimed invention must not preempt all possible application of a natural phenomenon. But preemption requires a policy based subjective determination. Namely, the level of abstraction at which the natural principle is expressed determines whether a claim states an unprotectable principle or a patentable application of the unprotectable principle.
The MOT test isn’t supposed to be be a per se bar on patentability for processes. If it were, how could it be justifiable to apply the test to non process claims?
Rather MOT is supposed to help us put claims drawn to principles in the trash while allowing claims for applications of principles. In cases where there are other means of making this call, the MOT test should be irrelevant.
These debates / discussions keep moving further and further away from the original three items listed by the US Supreme Court:
1) Abstract ideas
2) Laws of Nature
3) Natural phenomenon
Part of the problem may be because the SCT got #2 wrong. Actually #2 is a species of the genus defined by #1. And #3 has little to do with #1.
So then the Bilski panel goes off and tries to see something “fundamental” in #1-#3. There is nothing “fundamental”. #1 and #3 are not the same thing.
To top things off, we get professors trying to blindly feel around the elephant by seeing “tangibilitys” and infer/determine dichotomies in the whole mess.
Bottom line is that Mother Nature does not divide herself into tangibles versus intangibles. It’s all one; just like matter and energy (e=mc^2) are all part of a same multidimensional phenomenon. It’s we human who fool ourselves by thinking that Nature divides into subspecialities. Law professors who never studied modern physics simply don’t get it. They fool themselves into believing they see new truths in the infer/determine territory. There’s no there over there.