Applying Bilski to Biotechnology and the Life Sciences

By Professor Christopher M. Holman (University of Missouri at Kansas City School of Law and author of Holman’s Biotech IP Blog)

The Bilski majority characterizes its machine-transformation test as "the governing test for determining patent eligibility of a process under section 101." Under this test, a claim is patent-eligible if (and as applied in Bilski apparently only if): (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." As explained by the Court, the test serves as a proxy for assessing the more fundamental concern – ensuring that the claim does not seek to impermissibly "preempt the use of a fundamental principle." This might make sense in the context of so-called business method patents, where the fundamental principle implicated is typically characterized as an abstract idea or mental process. But it is unclear to what extent this test will prove applicable to patent claims arising out of the life sciences, where patentable subject matter challenges more often allege preemption of a natural phenomena or law of nature, rather than an abstract idea or mental process.

For example, although Bilski states that a process claim is "surely" patent-eligible under section 101 if it complies with the machine-transformation test, this cannot be literally correct with respect to a naturally occurring biological process. Photosynthesis transforms carbon dioxide and water into sugar, and in Bilski the Court specifically points to chemical reactions as the sort of physical transformation that will render a process patentable, but a claim directed to photosynthesis would clearly violate Supreme Court precedent which bars the patenting of natural phenomena.

Bilski acknowledge that the machine-transformation test might require refinement or augmentation in the future, and I think this refinement will likely be necessary when the court addresses patentable subject matter challenges based on allegations that a patent claim preempts a biological natural phenomenon. Three such cases are currently on appeal to the Federal Circuit – Ariad v. Lilly, Classen v. Biogen, and Prometheus v. Mayo. Nevertheless, since for the time being the machine-transformation test is apparently the governing test, it is worth considering how the claims at issue in these case, and some other controversial biotechnology patent claims, might fare under this approach.

Ariad’s claims essentially recite methods of altering the activity of a regulatory protein (NF-kB) in a cell, which would seem to satisfy the transformation prong of the test. This outcome would be consistent with the District Court’s determination that the claims comply with section 101, albeit for an entirely different reason. But Lilly argues (reasonably I think) that the claims wholly preempt the use of a natural biological phenomenon, and since Bilski acknowledges that the machine-transformation test is really just a proxy for weeding out patent claims that preempt "fundamental principles," this argument might prevail even though the claim does recite a physical transformation.

The claims at issue in Classen, on the other hand, are directed to methods for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in treatment groups subjected to different vaccination schedules. Determining an immunization schedule does not appear to satisfy either prong of the machine-transformation test. The claims do include an additional step of immunizing patients, but under Bilski this step would likely be classified as "insignificant extra-solution activity." For example, the majority particularly points to data collection steps as insufficient to render patentable a claim that is essentially directed to a process of analyzing the data. Notably, the majority strongly suggests that the inclusion of a data-gathering step in the claim at issue in LabCorp v. Metabolite is insufficient to confer patentability on that claim, the essence of which is directed to the non-tranformative step of observing a correlation between homocysteine and vitamin B levels in a body fluid. In this regard, Bilksi appears to be consistent with the approach suggested by Justice Breyer in his dissent from the Supreme Court’s decision not to decide LabCorp.

Similarly, the claims at issue in Prometheus essentially target observing the level of a drug metabolite in a patient, and based on that observation recognizing that an adjustment in dosage may be required. The claims recite the administration of the drug to a patient and determining the level of metabolite in the patient’s body, but under Bilski these might well be treated as an insignificant extra solution data-gathering steps, analogous to the assay step in the claim challenged in LabCorp. If we disregard these steps, the claims would appear to fail machine-transformation test.

Note that at the core, the reason the claims in Prometheus and Classen might fail the machine-transformation test has little to do with any underlying natural phenomenon, but rather because they preempt an abstract idea/mental process without tying that process to a specific machine or apparatus. In contrast, the challenge to Ariad’s claims is fundamentally different, being based on preemption of a natural phenomenon rather than preemption of an abstract idea that could be implemented mentally without the use of a machine. In my view, the machine-transformation test just does not work for claims such as Ariad’s.

Some of the most controversial biotechnology patents are so-called human gene patents, particularly those relating to genetic diagnostic testing. For example, Myriad has been widely criticized for its perceived aggressive enforcement of patents relating to the BRCA breast cancer genes. Some of these patents broadly claim methods of identifying mutations, with no apparent extra-solution step that transforms a particular article or is tied to a particular machine or apparatus. For example, U.S. Patent No. 5,753,441 claims a "method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene . . . with germline sequences of wild-type BRCA1 gene . . ., wherein a difference in the sequence of the BRCA1 gene . . . of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

Similarly, U.S. Patent No. 6,432,644 claims "a method for diagnosing the presence of a polymorphism in human KCNE1 . . . wherein said method is performed by means which identify the presence of said polymorphism . . .."

Arguably, these sorts of claims are merely directed to "comparing" naturally occurring genetic sequences, or "diagnosing" the presence of natural mutations, and lack the significant extra-solution step necessary for patent-eligibility under Bilski.

Finally, note that Bilski in effect treats the patentable subject matter doctrine as a mechanism for policing claim scope, a role more commonly associated with the enablement and written description requirements. For example, the majority points to its earlier decision in Abele as an example where a broad claim is invalid for encompassing patent-ineligible subject matter, but an appropriately narrowed dependent claim complies with Section 101. Similarly, genetic diagnostic testing claims might be fine if limited to a specific test or tests, but patent-ineligible if drafted so broadly as to effectively encompass any method for observing a genetic variation.

59 thoughts on “Applying Bilski to Biotechnology and the Life Sciences

  1. “Finally, note that Bilski in effect treats the patentable subject matter doctrine as a mechanism for policing claim scope, ”

    Actually this makes a *lot* of sense. Since “bad subject matter” is invariably linked to *overbroad* patents. This is a good trend and will probably straighten out the ‘subject matter’ restrictions a lot.

    Your subject matter has to be *narrow enough*. Your claims must not cover laws of nature, purely mental processes, entirely abstract ideas, etc. — these are simply a long list of things which can render your claim scope *too broad* to be granted.

    This is a fairly coherent and straightforward way of looking at subject matter restrictions.

  2. Natural phenomena should be considered *PRIOR ART*. Anything which exists in nature is *not an invention*, it’s been anticipated. You shouldn’t be able to patent a chemical which you knew occurred in humans, and this applies to naturally occurring genes.

    So this is really quite easy to deal with.

  3. PHD “I also disagree that the communication of a diagnosis from physician to patient is what the patentee seeks to prevent. The patentee WANTS the physician to communicate a diagnosis to the patient, but he wants to prevent others from performing the physically transformative step of contacting a patient’s biological sample with a reagent that allows the detection of what’s being measured and that reads on his claims”

    If that’s what the patentee wants, then the patentee needs to invent a new assay and patent it. Otherwise, he’s left with preventing the communication step.

    But in reality the patentee wants to make money. I suggest sticking with reality and staying out of the silly hypothetical swamp embodied by the last paragraph of your comment.

    Lastly, I don’t know how we got onto talking about “restricting use of a law of nature.” The issue (or one of them — see my comment in the Bilski/Metabolite thread) is the pre-emption of all non-trivial applications of an otherwise unpatentable idea, i.e., claims that could be used to harass people who are arguably thinking about a correlation discovered by the patentee.

  4. Erez “A “communicating step” allows you to sue medical personnel rather than the Pharma company making the knock-off diagnostic kit.”

    What about sueing the Pharma company for inducement?

  5. Malcolm,

    “Second, I would like to know WHY you think that communicating a diagnosis is “nothing more than a post-solution” activity when, in fact, it is primarily that act, i.e., diagnosing a patient’s disease, that the patentee seeks to prevent others from practicing by filing the patent.”

    Because communicating does not “transform” anything “to a different state or thing.” A contacting (or binding or adding or separating) step does. Following a contacting step, the biological sample containing whatever is being measured now contains e.g., an antibody-antigen conjugate, a primer-extended nucleic acid, one or more of the biological components immobilized on a solid support…whatever the contacting reagent is.

    By your reasoning, Bilski’s claim could be amended to patentable subject matter by adding step (d)”communicating the management of the consumption risk costs to the commodity provider.” I don’t think so.

    I also disagree that the communication of a diagnosis from physician to patient is what the patentee seeks to prevent. The patentee WANTS the physician to communicate a diagnosis to the patient, but he wants to prevent others from performing the physically transformative step of contacting a patient’s biological sample with a reagent that allows the detection of what’s being measured and that reads on his claims, leading others to be able to take purely mental step of diagnosing based on his othewise closely-held and newly-discovered law of nature, or more accurately, he wants the others to buy his reagent or pay him a royalty to make and/or use it.

    But for the FDA, the inventor could run the test himself without ever telling anyone how he’s doing it, and without ever disclosing the underlying unpatentable discovery, and then deliver the diagnosis to the physician or patient himself as a product. The market would decide whether he should continue selling his product and what it’s worth to physicians, patients and researchers alike. There would be no issue of restricting use of a law of nature because no one but the inventor would know what the law was until someone else discovered it.

  6. communicating a diagnosis is more than a post-solution” activity IMO. (It looks like I might agree with Malcolm.)

  7. Max you disappoint.
    The invention we are discussing is exactly what Malcolm is saying: A diagnosis based on using a well-known assay to ascertain a concentration of a metabolite in a blood sample, where the novelty is interpreting a specific concentration as indicative of a disease.

    It is in the public interest that someone will validate an assay (which is tedious, technical and very expensive) and develop kits for doing the assay in order to recoup the costs.

    To call a patent directed to such an invention junk is not very nice. I, for one, was not clever or skilled enough to discover such a diagnosis or to develop a useful kit, or even to convince investors to fund people who were clever enough.

    Malcolm, at 2:01 you said you do not want to give patents for “purely mental discoveries”. This might be a reasonable dogma, but what price (in numbers deaths) should society pay to preserve this dogma? As a PhD in Life Sciences you know that there are a limited number of well-known assays all of which are obvious to try once a correlation is known.

    The valuable claims you suggest at 12:12 and 5:01 are not valuable. A “communicating step” allows you to sue medical personnel rather than the Pharma company making the knock-off diagnostic kit.

  8. “I stand by my statement that a “contacting” step or another physical or machine step is required”

    Why? Bilski does not require that for patentability.

    “regardless of whether it is required by Examiners, your communicating step is nothing more than “post-solution” activity that will not save an unpatentable method that lacks physical transformation or machine step.”

    First, I never said that Examiner would require a communicating step. Read my comment carefully.

    Second, I would like to know WHY you think that communicating a diagnosis is “nothing more than a post-solution” activity when, in fact, it is primarily that act, i.e., diagnosing a patient’s disease, that the patentee seeks to prevent others from practicing by filing the patent. That is where most of the “non-research tool” value of the “discovery” lies, is it not?

  9. Max Drei,

    No, I don’t think a registration system would solve the problem. Having trained examiners that know how to read an entire specification and claims, understand what they have read technically, communicate in English, and apply the MPEP consistently, would.

    Thinking that rejection of the maximum number of patent applications possible (perhaps all) is an indicia of “quality”, is not.

    A count system that rewards uncecked, flagrant misuse of the phrase “the Examiner has consider Applicant’s arguments but has not found them persuasive” when no argument has in fact, been considered is not.

    A count system that permits no more time to examine inventions to complex, potentially life-saving therapies than to “Toy vehicle with a detachably attachable wheel” (US Patent No. 7,445,539) is not.

    A patent system that favors and/or can be bought by, one industry over another, is not.

    A patent system that refuses to examine more than one polynucleotide or amino acid sequence in an application to methods that clearly require multiple sequences for operability simply because they have not invested in adequate resources to perform the search, is not.

    Taining VCs is not the province of the patent system, but if I had my way, I’d train them to appreciate the value of a well-protected trade secret.

    Malcolm,

    I stand by my statement that a “contacting” step or another physical or machine step is required and further submit that regardless of whether it is required by Examiners, your communicating step is nothing more than “post-solution” activity that will not save an unpatentable method that lacks physical transformation or machine step.

  10. PHD “think your point about no “step of diagnosing a patient” is overly stated considering the “thereby clause” taken together with the preamble, which I consider clearly limiting.”

    My friend, there is no “overly stating” of anything. There is no step of diagnosing anything in the claim you presented. The step is missing. Most Examiners will tell you to add the step in if presented with a claim like that.

    “Nevertheless, I would like to hear your view of a valuable claim that does not give up vast amounts of scope based on similar facts.”

    I’ve told you: add the communicating step. Or maybe a recording step, although that is a bit more dubious for the reasons I described upthread.

    “Would you be satisified if the preamble stated “A method of detecting condition X in a subject… thereby detecting condition X”?

    It doesn’t matter what would satisfy me. Again: I’m assuming we’re talking about the interesting case where we have an old assay and a new diagnosis. A claim with the structure you propose fails because it presents the diagnosis as a mental step inherent to the observation of the assay results.

  11. “I don’t think communicating it to anyone adds anything to the claim.”

    Let’s be clear: we’re talking about the diagnostic claim that utilizes an old assay, right? Not the less interesting scenario where it’s a new assay (because in that case, just claim your new assay and be done with it).

    In the case where it’s an old assay, I’ve already explained why the communicating step is significant. If you think it’s not significant, then explain why you think so.

    “What if your potential customer/infringer simply wants to determine the market value of a treatment for condition X and obtains annonymous samples from patients? Shouldn’t s/he be required to pay my client a royalty?”

    You lost me there. Try to keep it simple. Complicated hypotheticals are a waste of time.

  12. MaxDrei,

    My pal Ockham would say – “The Office should do a better job with the laws they have and not release junk patents.”

    Registration only –> all patents junk
    pre-1978 Uk –> all patents junk
    be-ribboned issue certificates –> really fool no-one.

    Investors want what the Office is supposed to provide: that presumption of validity of a granted patent.

  13. Thanks for that explanation of funding, Mr Deeper. So, would it be a good idea for the USA to move to a “registration only” patent system, or maybe a pre-1978 UK “Novelty examination but not non-obviousness” to resuscitate funding through the valley of death by giving start-ups lots of cheap but impressively be-ribboned issue certificates that they can lay down in front of potential investors. Or should resources instead be invested in educating investors, before they invest in holders of junk patents?

  14. Malcolm,

    I don’t think your method of counting eyelashes would be allowed by the PTO today or for the past 3-5 years unless it was tied to an instrument (read machine) — or perhaps if you physically plucked them out one by one — which is all I stated from the beginning.

    I think your point about no “step of diagnosing a patient” is overly stated considering the “thereby clause” taken together with the preamble, which I consider clearly limiting.

    Nevertheless, I would like to hear your view of a valuable claim that does not give up vast amounts of scope based on similar facts. Would you be satisified if the preamble stated “A method of detecting condition X in a subject… thereby detecting condition X”?

    I don’t think communicating it to anyone adds anything to the claim. What if your potential customer/infringer simply wants to determine the market value of a treatment for condition X and obtains annonymous samples from patients? Shouldn’t s/he be required to pay my client a royalty?

    Erez Gur – I’m with you. My clients are struggling to overcome the “valley of death” in funding and will never do so unless they can get patent protection for their inventions. The worst case scenario is if medical diagnostic and other biotech/pharma inventions are driven out by this nonsense and valuable advances are never commercialized. What benefit will it be to anyone if nobody takes the risk to put that kit on the market? Is the physician of tomorrow expected to be able to observe a biomarker using his super-sensitive ultra-x-ray vision? He can think about it and talk about it all he wants, but unless the kit is out there he’ll never be able to use that correlation to help any real world patients.

  15. “You are correct about the thin ice, but is this a desirable result?”

    Well, I think it is certainly NOT desirable to grant people patents that can be reasonably alleged to cover activities that are purely mental, or that effectively pre-empt all uses of a scientific discovery by scientists. So in that sense, I don’t have a huge problem with the changes. Valuable claims can be drafted that do not give up vast amounts of scope.

    As is typically the case with this rapidly evolving area of law, the unfortunate part is the claims of folks who weren’t thinking far enough ahead or were simply cookie cutting who find themselves holding a bag of doodoo when the music stops. Has the CAFC ever issued a holding on 101, obviousness, enablement, whatever, that was not to applied retroactively?

  16. PHD “Either Y or Z is novel and non-obvious”

    In that case, we’re out of LabCorp territory. Totally different issues.

    “but the physical contact is still required.”

    What if the newly discovered correlation requires only viewing something with the naked eye, say, the number of eyelashes in the right half of the right eye correlates with disease Z? Do I still need “physical contact” to get a patent? Assume nobody has counted eyelashes in that region before.

    “The “wherein” clause in conjunction with a limitation that Y actually does bind gets over enablement issues.”

    You might think so but in fact it adds nothing to the enablement of your claim because your claim does not recite a step of diagnosing a patient. The only thing that needs to be enabled in your claim is “detecting” because that is the only method step that your claim requires.

    The wherein clause in this case might help you overcome a utility rejection, but you probably wouldn’t get a utility rejection in that case.

    All I’m saying is: your claim is on very thin ice. You should know that. Your client should know that. And your client’s competitors should know that.

  17. Malcom Mooney – Either Y or Z is novel and non-obvious, but the physical contact is still required

    The “wherein” clause in conjunction with a limitation that Y actually does bind gets over enablement issues. It’s possible to write claims that account for both postive and negative results, but these are much more complicated to write and prosecute, and why bother since the method is only going to practiced if it does at least sometimes detect Z/ thereby condition X. The negative results may not infringe the claim, but who cares.

  18. Piled higher “A method for diagnosing condition X comprising contacting a biological sample with a reagent Y that binds to/reacts with/detects Z; detecting bound Y, wherein binding of Y indicates the presence of Z and the presence of Z indicates condition X, thereby diagnosing condition X.”

    Unless your reagent Y is a new, non-obvious reagent, this claim is DOA. The “wherein” clause adds nothing except to recite information that is unpatentable under LabCorp.

    You’ve been warned.

  19. There is no invention or discovery that is inherently patentable or inherently not patentable. The US chooses to give patents for ideas in fields that they want to encourage.

    For public, economic and moral reasons, the US should want to encourage medical diagnosis.

    An inventor who discovers a correlation between a marker and a disease does not want to prevent a doctor from thinking or talking about the result of an assay for the marker.

    Also, the inventor neither wants nor deserves a monopoly on the method of treatment resulting from the assay results, as Malcolm suggests.

    The marketable product which should be subject to a monopoly is an assay kit, whatever its technology.

    A claim such as “a method of determining X by determining X” sounds silly, but if everyone understands that the patent monopoly is practically limited to an assay kit, the desired public policy goal is achieved.

  20. From the outside looking into the biotech arts, it’s an interesting place to draw the line between (1) mere discussion and (2) communication of a diagnosis to patient.

    I’ll trust that its common and accepted, but I can’t help but wonder whether Supreme Court justices — similarly without experience in the biotech arts — will or will not think that the first person to observe a natural phenomenon can have the exclusive right to a method that adds a common observation technique and a generic diagnosis step (i.e., vocalization of a diagnosis to a patient).

    In the end, the question is what bundle of rights related to a “natural phenomenon” must remain in the public domain under 101. Since the term “natural phenomenon” isn’t found in 101, we’re really at the mercy of courts to decide this issue. I hope that, whatever the courts do, they don’t obliterate the incentives to do medical research by drastically affecting their ability to recoup their investments.

  21. Not sure any of this is really new to the PTO. We’ve for years been getting rejections for diagnostic method claims that don’t recite a “contacting” or similar step, e.g. A method for diagnosing condition X comprising contacting a biological sample with a reagent Y that binds to/reacts with/detects Z; detecting bound Y, wherein binding of Y indicates the presence of Z and the presence of Z indicates condition X, thereby diagnosing condition X.
    Dependent claim – wherein reagent Y is a polynucleotide primer.
    Dep. claim – wherein measuring bound Y comprises PCR…

    The contacting step is the “transformation”

    Also get dinged for claims that read on non-results – ie if the method is for diagnosing condition X and you don’t detect any Y, then you don’t have condition X and you can’t diagnose it (many variations of this rejection scenario).

    Guess we just get all the “hard” examiners…

    In the case of the Ariad patent, contacting or some other similar step would also typically be required to satisfy most examiners we deal with. That claim recites “reducing NF-kappaB activity” Reducing NF-KB can happen without anyone doing anything, so this claim reads on nature. If the claim recited “contacting the cell with a compound, wherein said contacting reduces NF-KB activity in the cell” that would be a different story.

  22. Oh, speaking of last words, yours will additionally include “Paper or plastic? THOSE DURNED SOFTWARE PATENTS, GET OFF MY LAWN” ~ you grumpy little freak.

  23. Well if you can make the long climb from your cardboard box in the subway to sitting on the Federal Circuit, which statistics on social mobility strongly suggest against, Rader will have the last word. Your last words will be, “paper or plastic?”

  24. SF “whether the first person to discover natural phenomenon should, under 101, be able to prevent others from observing, thinking about and talking about the same observation to any degree.”

    exclude observing the phenomenon – no
    exclude thinking about the phenomenon – no
    exclude talking about the phenomenon – no
    exclude communicating a diagnosis to a patient -yes, with the caveat that the diagnosis be based on the observation and probably should include the communication of the underlying observation as well as the diagnosis and, even better, treatment of the patient

    “To me, adding vocalization or a well-known observation technique is no more substantial than adding a general purpose computer to an algorithm.”

    Well, I agree with you, but I’m not proposing that adding a mere “vocalization” suffices. I think also that the discovery of a new marker or set of markers that greatly improves the ease and accuracy of a diagnosis bears little or no resemblance to the ancient and trivial fact that a computer can crunch numbers faster than a dude with a pencil and paper.

  25. “Unfortunately for both you and Rader, life expectancy statistics strongly suggest that I will have the last word.”

    Unfortunately for nearly everyone reading this, I will have the last word.

  26. Well, I don’t mean to imply that public health is driving my issue. It’s more of whether the first person to discover natural phenomenon should, under 101, be able to prevent others from observing, thinking about and talking about the same observation to any degree.

    When there is nothing substantial about the observation step (just using a well-known technique) or the diagnosis step (just using the well-known technique of vocalization), I am troubled by allowing that to be in 101. To me, adding vocalization or a well-known observation technique is no more substantial than adding a general purpose computer to an algorithm.

  27. SF “To keep a natural phenomenon in the public domain, however, I would think you would want people to be able to observe it, think about it and talk about it. Or is it sufficient to allow people to observe, think and talk about it, but not diagnose?”

    The question seems to answer itself, doesn’t it? If there are significant non-trivial ways to exploit the phenomenon without infringing the claim (or its broadest reasonable interpretation), then the claim does not pre-empt the phenomenon. End of analysis.

    Beyond that, we perhaps are getting into a different discussion, i.e., whether certain methods relating to public health should be patentable. But I don’t think Breyer’s dissent in LabCorp was about “policy” but just another expression of classic 101 jurisprudence.

  28. “Hopefully Rader will have the last word. You certainly won’t.”

    Unfortunately for both you and Rader, life expectancy statistics strongly suggest that I will have the last word.

  29. “you’re wrong about Bilski”

    No, Mooney, like just about everything else you post, you’re wrong about Bilski too. You’re a hack and a poseur. I only say “just about” because even a stopped clock is “right” twice a day.

    The Federal Circuit clearly teed Bilski up nicely for clarification of the long standing tension between Diehr and Benson as Rader masterfully noted. Hopefully Rader will have the last word. You certainly won’t.

  30. I’m not sure why we would want people to be able to freely observe a natural phenomenon using a well-known observation technique and then think about it, but not talk about it (whether with a patient as part of a diagnosis or with a colleague). In other words, I don’t see how the fundamental principle line can be drawn between thinking about a natural phenomenon that was observed and talking about it.

    To be sure, you can draw a line between thinking and talking/diagnosing. And claiming talking/diagnosis surely doesn’t preempt all uses because you can still think about it.

    To keep a natural phenomenon in the public domain, however, I would think you would want people to be able to observe it, think about it and talk about it. Or is it sufficient to allow people to observe, think and talk about it, but not diagnose?

  31. “Preventing others from communicating a result or diagnosis or recommended course of treatment preempts almost as much as preventing others from thinking of it.”

    You keep moving the goalpost. Communicating a result? That’s plainly different from communicating a diagnosis to a patient or recommending a treatment to a patient.

    Second, just because you say something is so does not make it so. Preventing others from communicating a diagnosis does not preempt “almost as much” as preventing others from thinking of “it” (whatever “it” happens to be). In the latter instance, you do effectively preempt the idea because every skilled scientist in the field, as well as non-scientists and even patients themselves, can be reasonably accused of thinking about “it” when he/she/they look at the results of a suitable assay.

    But only a select few people in the field are going to be prevented from infringing a claim that requires communicating a diagnosis to a patient. Again, there’s no pre-emption. Please drop the argument or start explaining how you get to “about as much” with some concrete examples.

    As I already noted, EVERY CLAIM pre-empts all uses of some narrowly defined “fundamental principle” in a particular context, where that context often is generally described in the preamble. That is not the “pre-emption” problem that Breyer is referring to in LabCorp. That “pre-emption” problem occurs only with extraordinarily broad claims that recite either purely mental (or computer processed) steps *or* OLD active steps and a purely mental step(s) of recognizing a result in the OLD active step.

    A reminder lest we forget: just because a lot of attorneys/agents wrote claims a certain way and “got away with it” for a long period of does not mean that those claims were ever solidly patentable and valid claims.

  32. I think SF made my earlier preemption point much better than I had; though I tried, I just got too wordy.

    Preventing others from communicating a result or diagnosis or recommended course of treatment preempts almost as much as preventing others from thinking of it. Will a CAFC that just issued Bilski really let a claim stop doctors from talking to their patients? Will Breyer let such a decision stand?

    Thank you SF. And with that, back to work…

  33. “So can you preempt the ability to discuss an natural phenomenon when that phenomenon was observed using a well-known method of observing?”

    I think a claim to a method of discussing a natural phenomenon would go down for lack of a non-trivial utility.

  34. “I am talking about a step of COMMUNICATING a diagnosis to a patient.”

    So can you preempt the ability to discuss an natural phenomenon when that phenomenon was observed using a well-known method of observing?

  35. “Not to beat a dead horse, but I fear Bilski has barred ALL doors and MUST be overturned. Thankfully the CAFC has a ready opportunity in Prometheus.”

    Thankfully, you’re wrong about Bilski and you’re wrong about Prometheus. Prometheus is even worse than Bilski, reciting only two active steps: administering a drug (old in the art, if I’m not mistaken) and “determining” an effect of the drug (a mental step). As in LabCorp, the claim evidently covers merely thinking about a result of an old method. Hence the claim is pure crap. Easy.

  36. bruinjack: “The diagnosis IS folate-deficiency.”

    I trust that is not your argument and I also suggest that you not substitute a false equivalency for the actual facts. Communicating a diagnosis based on X is different from not communicating a diagnosis based on X.

    A claim similar to that in LabCorp that ADDITIONALLY expressly requires a step of communicating a diagnosis of folate-deficiency from an assay result that, prior to the discovery of the inventor, would NOT have led to the recited communication is neither pre-emptive of the discovered correlation (i.e., the “fundamental principle”) nor obvious. Thus, it’s patentable.

    “I think Breyer would not accept parsing the diagnosis from the correlation; they are one and the same.”

    Please read my comments carefully. I am not talking about inserting a step of “diagnosing”. Unless expressly defined otherwise, that is a metnal step. I am talking about a step of COMMUNICATING a diagnosis to a patient. That step does not pre-empt a fundamental principle, as a matter of objective fact.

    “[Bilski's] reasoning has made clear that effective pre-emption of all applications of [the correlation between homocysteine levels and folate deficiency] even just within the area of [diagnostics or personalized medicine] is impermissible.”

    How about it? It’s crap. Where did you come up with this? Every method claim pre-empts “all applications” within “an area.” So what?

  37. The diagnosis IS folate-deficiency. I think Breyer would not accept parsing the diagnosis from the correlation; they are one and the same. “Prescribing” a particular treatment is is also unhelpful as it is old and, under Bilski, probably an insignificant extra-solution activity (when looking at the prescription of folate supplements, who cares whether the test determined the deficiency by directly measuring folate levels or by measuring homocysteine levels?).

    Remember that field of use limitations are unhelpful under Bilski because the claim will often still preempt the fundamental principle: “And while Applicants argue that the scope of this pre-emption is limited to hedging as applied in the area of consumable commodities, the Supreme Court’s reasoning has made clear that effective pre-emption of all applications of hedging even just within the area of consumable commodities is impermissible. See Diehr, 450 U.S. at 191-92 (holding that field-of-use limitations are insufficient to impart patent-eligibility to otherwise unpatentable claims drawn to fundamental principles).”

    How about this: “[Bilski's] reasoning has made clear that effective pre-emption of all applications of [the correlation between homocysteine levels and folate deficiency] even just within the area of [diagnostics or personalized medicine] is impermissible.”

    Not to beat a dead horse, but I fear Bilski has barred ALL doors and MUST be overturned. Thankfully the CAFC has a ready opportunity in Prometheus.

  38. “I still question whether the claim in LabCorp would have passed muster for Breyer had it recited reporting a folate deficiency rather than the mere data-gathering of assaying homocysteine levels. Still “preempting a natural phenomenon.”

    There are infinite ways that a scientist can use the correlation discovery other than communicating a diagnosis to a patient. So where is the pre-emption of the principle? The answer is that there is no pre-emption in that case.

    “E.g., transforming electron scattering data from an electron microscope into a visual display. Wouldn’t you agree this is qualitatively different?”

    I think a new method of achieving that transformation should be patentable, providing it was properly claimed.

  39. Malcolm:

    I agree that the facts (claims) of this case are atrocious and that the real test will come from Prometheus (though I don’t think those claims recite reporting and so that type of claim will not be tested). Good analysis. However, I still question whether the claim in LabCorp would have passed muster for Breyer had it recited reporting a folate deficiency rather than the mere data-gathering of assaying homocysteine levels. Still “preempting a natural phenomenon.” Don’t get me wrong, I’m still trying it and hoping against hope!

    I think the data transformation in Abele is qualitatively different from the data transformation in reporting a physiological association. At the very least, Abele did not claim the dreaded natural phenomenon (see Breyer’s LabCorp dissent). A scenario that would be closer to Abele would be a new way of quantitating gene expression (i.e., transforming raw data into refine data that is intelligible to humans). E.g., transforming electron scattering data from an electron microscope into a visual display. Wouldn’t you agree this is qualitatively different?

    As for reading too much into the dicta, you are also right to some extent. Limiting to the facts is always available as an escape valve. However, think of these two things: first, the CAFC clearly intended this decision to be far-reaching and widely applicable (en banc, exhaustive “pre-decision” discussion of precedent, etc.); second, Bilski specifically discusses diagnostic claims in citing In re Grams.

  40. “I really don’t see how a reporting claim preempts the fundamental principle any less than an assaying claim.”

    I’m referring to the common case, i.e., the LabCorp facts, where the assay is old in the art. The invention is premised on the discovery of a correlation between a disease state and one or more markers that are measurable by any of dozens of old assays. Specifically, the invention is a method of communicating a disease diagnosis to a patient (or to another co-worker) based on information obtained elsewhere (e.g., from an assay performed by a third party).

    I agree that limiting the claim to a particular assay results in less “preemption” compared to a claim without the assay limitation. But if the assay is old it gets you nowhere with respect to the LabCorp problem because the claim now covers a method of doing an old assay and thinking about the result. That’s dead under 101/103 and me and my buddy Justice Breyer think that’s a good result for everyone.

    I also agree that the untested question is whether this communication is “significant post-solution activity.” I’ve argued above why it should be the case. If you aren’t persuaded, then I think the only course is to include the additional step (maybe in a dependent claim) of “treating the patient based on the diagnosis”. But I caution against relying solely on such a limitation in the absence of a communication step because you are again risking capturing infringers with the claim who are practicing OLD methods of treating the disease (the only difference being that you, the patentee, will argue that the treatment was “based” on the patentee’s discovery). That claim is dead upon assertion.

    Another question to ponder is whether merely “recording” the diagnosis (without communicating it) is sufficiently “significant”. That is a closer question than a communicating step, I believe, because other than modifying the surface on which the information is recorded, it accomplishes nothing absent its presentation to a third party.

  41. Some good questions here.

    “Are you arguing that the doctor verbalizing the correlation constitutes a “transformation” of data under Bilski?”

    I’m not arguing. I’m stating it is a fact. Because it is a fact. The communication of the information is a transformation, just as “displaying X-ray info on a monitor” is a transformation.

    “It certainly doesn’t involve any particular machine.”

    In my hypothetical claim where the steps are
    “ascertaining a level of marker X” and “communicating a diagnosis of Y based on said level”, I agree: there is no machine necessarily involved. At the same time, the CAFC can’t possibly be saying that only claims that recite machines are patentable. Reciting an old assay as an early or intermediate step in my hypothetical method adds nothing to *the invention*.

    I think we need to be careful about applying the dicta in Bilski too broadly. Bilski’s alleged “invention” was a claim drafting horrorshow of zero value to the public. Anytime the CAFC wants to limit Bilski to its facts, it can do so and nobody will complain.

  42. I really don’t see how a reporting claim preempts the fundamental principle any less than an assaying claim. Of course, Bilski SAYS preemption is merely a signal of a claim failing to abide by the machine-transformation test…

    Again, Bilski has barred all the exits.

  43. Monsanto would be happy about activist patent attorneys who want to change the law rather than to abide it. Bilski blues for the those who make profit with the patent system. And if it wasn’t about profit the patent profession would qualify as a true religion which believes that you can turn government granted monopolies into wealth creation. Works for the attorneys… So let’s have a wider scope of patent law and lower the bar so that more hungry patent attorneys get their fair share.

  44. Ideally in a Paymentech world you would tailor separate claims to capture each conceivable party: reference labs and/or doctors for direct infringement and pharma or anyone else for inducement (hence the requirement to catch the doctors).

    But Malcolm’s comment about suing providers just shows more of the far-reaching and likely unintended consequences of Bilski: a physical transformation is required and I think the best (though not a good) candidate for this is the assaying step. I really question the communicating or reporting step (though I admit we include such claims in our applications).

  45. “In order to capture the doctor’s activity, you really don’t want your claim to recite the “assay”. You want the claim to recite a step of “ascertaining the level of marker Y”, “correlating the level of marker Y with disease X” and “reporting or recording the diagnosis.”

    [...]

    “Here’s the deal: if you’ve got only the communication step in your claims, then you’re going to end up having to sue providers (or maybe hospitals for inducing). That will make everybody think that you suck. If you’ve got a step of communication and a step of treating a diagnosed patient in the claims, then you’ve got a shot at sueing the pharmaceutical company for inducing (e.g., via the drug labeling). Then only the big pharma lobbyists will think you suck.”

    This is the Paymentech split/joint infringement issue (i.e., often no single party assays and reports) we’ve been trying to avoid in our claims for a while. I suppose I can accept reporting as a “physical step” (it certainly can’t be done entirely in the doctor’s mind… yet). But you still need a transformation. Are you arguing that the doctor verbalizing the correlation constitutes a “transformation” of data under Bilski? It certainly doesn’t involve any particular machine. Though I would welcome such a conclusion by the CAFC, I doubt it.

    Once again, I think Bilski has blocked all the exits. Look at the language regarding the transformation being central to the purpose of the claimed method. This is bad enough in isolation, but then consider that this quote practically introduces Abele. There the claimed method was a way of transforming raw data representing a physical structure into a visual display. When both are read in conjunction, I worry about whether Abele is really the single ray of hope I thought it was. Thus verbalizing a result either is not a transformation or is not the kind envisioned by the CAFC as sufficient to make the claim patent-eligible.

  46. “Bilski the Court specifically points to chemical reactions as the sort of physical transformation that will render a process patentable, but a claim directed to photosynthesis would clearly violate Supreme Court precedent which bars the patenting of natural phenomena.”

    I think the answer is easy… photosynthesis would be patentable if it were novel and non-obvious. If someone invents a way to perform photosynthesis in a way that has never been done, they deserve a patent.

    Remember, passing the machine-or-transformation test doesn’t mean you get a patent. It just means that you advance to the next stage of examination.

  47. “I personally see no inherent 101 or 112 problem with the specific claim to “A method of diagnosing syndrome Y comprising (1) PCR amplifying a target nucleic acid with primers of SEQ ID NOs: A and B, (2) sequencing the PCR product using a primer of SEQ ID NO: C, wherein the presence of a C at position 47 of the PCR product is associated with syndrome Y and the presence of a G at position 47 of the PCR product is not associated with syndrome Y”

    There is no step of actually “diagnosing” anything in your claim. It’s basically a method of sequencing a region of DNA with some *specifically recited primers*. The qualifying language about the “associations” is an inherent property of the genome being analzyed and adds nothing.

    If it’s not obvious (a very big if), it should be patentable. But very few people are interested in such patents.

  48. Malcolm,

    I think the issue of “determining” in a biotech method depends. It depends on two factors. First, the BRCA claim you cited (and maybe the others as well) likely was issued because the gene sequence and function of BRCA1 was determined before the human genome project. Therefore, there was no specific prior art (under the Fed. Cir. previous TSM test) which would suggest analyzing that particular region of the genome. Whether the generic idea to analyze the entire genome to identify differences would be obvious under KSR may be different, but without some “reason” or some “predictability”, a new gene sequence will likely survive 103. Of course, with Fisher, such a claim will not survive 101 unless the Applicant knows what to do with the gene, but in the case of BRCA, the breast cancer association pretty clearly satisfies 101. Finally, 112, first written description could be used by Examiners after about 1999-2000 to address these sorts of claims, but the BRCA1 patent issued in 1998, prior to the real availability of 112, first for Examiners. (Examiners were whipsawed with 112 first in the 1999-2000 period, reopening and writing, then withdrawing, and finally reopening and rewriting the rejections, depending upon policy that day).

    A generic claim like these would likely not issue without some specific association with disease or treatment (if it comes out of the proper art units). However, I personally see no inherent 101 or 112 problem with the specific claim to “A method of diagnosing syndrome Y comprising (1) PCR amplifying a target nucleic acid with primers of SEQ ID NOs: A and B, (2) sequencing the PCR product using a primer of SEQ ID NO: C, wherein the presence of a C at position 47 of the PCR product is associated with syndrome Y and the presence of a G at position 47 of the PCR product is not associated with syndrome Y”

    (There always might be prior art).

  49. “I agree with the comments above that the assay step is significant to the claimed invention”

    I’m not sure if you are referring to my comments are not, but the “significant extra-solution step” I was referring to is not the assay. It’s the *communication* of the interpretation of an assay’s results to a third party. The assay is old. The interpretation of the assay results is the “discovery” but as a “discovery” it is unpatentable. The transformation of the unpatentable discovery into a patentable method is the *communication” of the results.

    Yes, this is LabCorp. again. You can not obtain a patent that prevents people from performing old assays and *thinking* about the results in a way that they would not have prior to the patentee’s discovery. But, with a method patent, you can exclude others from performing a series of steps comprising old assays AND the peformance of *new actions* that they would not have performed prior to the patentee’s discovery.

    The closer question here is the case where a doctor, without instructing anyone to perform any assay, is provided only with *raw data* about, e.g., a significant level of a serum marker Y in a patient’s blood, perhaps by phone, and then, based on the doctor’s knowledge of the link (that he obtained from reading the patent specification), the doctor reports to the patient that the patient is “at risk of Disease X because of the high level of the serum marker”. In order to capture the doctor’s activity, you really don’t want your claim to recite the “assay”. You want the claim to recite a step of “ascertaining the level of marker Y”, “correlating the level of marker Y with disease X” and “reporting or recording the diagnosis.”

    For years prior to Bilski, the PTO in grownup art units was pushing back on claims that recited steps of “determining” or “ascertaining.”

    Here’s the deal: if you’ve got only the communication step in your claims, then you’re going to end up having to sue providers (or maybe hospitals for inducing). That will make everybody think that you suck. If you’ve got a step of communication and a step of treating a diagnosed patient in the claims, then you’ve got a shot at sueing the pharmaceutical company for inducing (e.g., via the drug labeling). Then only the big pharma lobbyists will think you suck.

  50. “Similarly, genetic diagnostic testing claims might be fine if limited to a specific test or tests, but patent-ineligible if drafted so broadly as to effectively encompass any method for observing a genetic variation.”

    Here’s the problem: often the mutation or, even more prevalent these days, the association is the ONLY novel part of the claim. The assay techniques are ancient. Under the above analysis what would stop the patentee from preempting the abstract idea by splitting the invention into 20 different independent claims each requiring a specific assaying technique?

    I agree with the comments above that the assay step is significant to the claimed invention (i.e., without it how could one implement the correlation in any given patient’s case?). But this is Bilski’s problem: did anyone catch that the “transformation must be central to the purpose of the claimed process”? When you combine this with statements about data-gathering, the outlook is pretty bleak.

    I think the better question is which “natural phenomena” should be off-limits and which should not. Photosynthesis… off-limits. Increased expression of Gene X associated with improved response to Drug Y… have at it. Protein X catalyzes the conversion of compound Y to compound Z… off-limits. Method of inhibiting the production of compound Z by administering a composition that inhibits the enzymatic function of Protein X… have at it (subject to written description and enablement limits). In other words, overturn Morse.

  51. “unusual unlitigated patents ”

    Non-sequitur. What patents referred to upthread do you find “unusual”?

  52. Sorry, I should have said “fully litigated to a final formal opinion of the Fed. Cir.” rather than “unlitigated” because (especially considering that Courts reversal rate) that is what I meant.

  53. Picking examples of unusual unlitigated patents issued by the USPTO to pick on as examples of where patent law is, or is going, is an old media tactic that is particularly intellectually dishonest – no more valid than citing unusual decisions of small town “justices of the peace” as relevant legal authority. With millions of patent application claims a year to be examined in only a few available hours by a single examiner, mostly young non-lawyers, obviously some issued patents will contain claims that bear no realistic relation to what kind of claims would survive competent judicial scrutiny.

  54. “Similarly, genetic diagnostic testing claims might be fine if limited to a specific test or tests, but patent-ineligible if drafted so broadly as to effectively encompass any method for observing a genetic variation.”

    Survey: is there anyone here who doesn’t think that is a good thing?

    “U.S. Patent No. 6,432,644 claims “a method for diagnosing the presence of a polymorphism in human KCNE1 . . . wherein said method is performed by means which identify the presence of said polymorphism . . ..”

    That’s a crap claim and its true crappiness will be ascertainable the moment that the patentee attempts to assert it against someone who happens to detect the presence of the polymorphism by practicing an old technique in the art. The tip-off is the phrase, “diagnosing the presence”. That is a claim written by a moe-ran trying to be oh-so-clever.

    “5,753,441 claims a “method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene . . . with germline sequences of wild-type BRCA1 gene . . ., wherein a difference in the sequence of the BRCA1 gene . . . of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.”

    Again, unless the ellipses add something of substance: that’s crap. Screening genes is old. Detecting differences in genes is old. The idea that there are polymorphisms in genomes is old. You can’t exclude people from doing old stuff merely by discovering something “specific” in one corner of the genome. The step that is missing here is **reporting or recording** a diagnosis of a disease state based on the observed difference. Another possible way to get around the 101/103 issues is to recite a *specific* nucleotide probe or set of probes that will be used to determine the existence of a polymorphism, and it should provide unexpectedly good results (i.e., the wild-type sequence wouldn’t suffice).

    “The claims at issue in Classen, on the other hand, are directed to methods for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in treatment groups subjected to different vaccination schedules. Determining an immunization schedule does not appear to satisfy either prong of the machine-transformation test. The claims do include an additional step of immunizing patients, but under Bilski this step would likely be classified as “insignificant extra-solution activity.”

    Why do you believe that immunization step is “insignificant”? Wouldn’t the “significance” of the “extra-solution activity” be determined by comparing the inherent utility of the claim WITH the recited “extra-solution activity” versus the inherent utility of the method WITHOUT the recited “extra-solution activity”? If so, it becomes readily apparent that reporting or recording an observed diagnosis or (going further) acting upon a diagnosis and treating a patient accordingly is unquestionably significant compared to merely “observing” some data.

  55. “…Bilski acknowledges that the machine-transformation test is really just a proxy for weeding out patent claims that preempt ‘fundamental principles,’…”

    I thought Bilski (incomprehensibly in my mind) said it was the other way around: “[P]re-emption is merely an indication that a claim seeks to cover a fundamental principle itself rather than only a specific application of that principle. [...] In contrast, a claim that is tied to a particular machine or brings about a particular transformation of a particular article does not pre-empt all uses of a fundamental principle in any field but rather is limited to a particular use, a specific application. Therefore, it is not drawn to the principle in the abstract.”

    This discussion really seems to spin Benson around (“The Supreme Court, however, has enunciated a definitive test to determine whether a process claim is tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself. A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing. See Benson, 409 U.S. at 70.”) and I think it is way off from a policy perspective.

  56. This is another Halloween scare story about patent law [popular among academic legal writers and other media these days]. Obviously if a claim is really broad enough to read on a previously occurring phenomena or material, natural or otherwise, it is going be be invalid under 35 USC 102, etc., so whether or not In re Bilski’s 101-only “test[s]” cover it or not is irrelevant.

  57. “Ariad’s claims essentially recite methods of altering the activity of a regulatory protein (NF-kB) in a cell, which would seem to satisfy the transformation prong of the test. This outcome would be consistent with the District Court’s determination that the claims comply with section 101, albeit for an entirely different reason. But Lilly argues (reasonably I think) that the claims wholly preempt the use of a natural biological phenomenon, and since Bilski acknowledges that the machine-transformation test is really just a proxy for weeding out patent claims that preempt “fundamental principles,” this argument might prevail even though the claim does recite a physical transformation. ”

    Of course that will work out, if it actually does. If there are other applications of that natural phenom that are unclaimed then it will fail. I’m not going to be the one to analyze that today tho.

    Nice song btw.

  58. Jus’ last week
    Everything was fine
    We knew where we stood
    Thought we knew the line
    Now all of our claims
    Are in disarray
    Machines’n’transformations
    Dat’s the new way
    But what does it mean?
    Nobody knows
    What can do?
    Man, this just blows!
    I got the Bilski blues
    I got the Bilski blues real bad

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