Diagnostic Testing in the Wake of Bilski v. Kappos

It has long been anticipated that the Bilski v. Kappos decision, though based on business method claims, would have implications that reached far beyond the business method world. Indeed, Justice Kennedy acknowledged that the M-or-T test would create uncertainty for new technologies of the Information Age, including, among other types of technologies, diagnostic medical testing techniques. (Bilski, Slip Op., p. 9.) The removal of the machine-or-transformation test as the sole test is good news for the biotech industry, particularly in the field of personalized medicine.

In the wake of the Supreme Court’s decision in Bilski on June 28, on June 29 the Supreme Court acted in two cases related to the patent-eligibility of diagnostic testing and methods of treatment – Mayo Collaborative Svcs., et al. v. Prometheus Laboratories and Classen Immunotherapies, Inc. v. Biogen Idec, et al. In both cases, petitions for certiorari were granted, immediately followed by a decision vacating the judgment below and remanding the case to the Court of Appeals for the Federal Circuit for further consideration in light of Bilski.

This article explores Prometheus and Classen in further detail. We first revisit relevant Federal Circuit history prior to these decisions. We then discuss the specific facts of each case, and conclude with how the Supreme Court’s Bilski decision is likely to affect the Federal Circuit’s actions on remand.

Diagnostic Testing To-Date

The patent-eligibility of diagnostic testing was first addressed by the Federal Circuit in In re Grams, 888 F.2d 835 (Fed. Cir. 1989). A representative claim from Grams follows:

A method of diagnosing an abnormal condition in an individual, the individual being characterized by a plurality of correlated parameters of a set of such parameters that is representative of the individual’s condition, the parameters comprising data resulting from a plurality of clinical laboratory tests which measure the levels of chemical and biological constituents of the individaul [sic] and each parameter having a reference range of values, the method comprising

performing said plurality of clinical laboratory tests on the individual to measure the values of the set of parameters;

producing from the set of measured parameter values and the reference ranges of values a first quantity representative of the condition of the individual;

comparing the first quantity to a first predetermined value to determine whether the individual’s condition is abnormal;

upon determining from said comparing that the individual’s condition is abnormal, successively testing a plurality of different combinations of the constituents of the individual by eliminating parameters from the set to form subsets corresponding to said combinations, producing for each subset a second quantity, and comparing said second quantity with a second predetermined value to detect a non-significant deviation from a normal condition; and

identifying as a result of said testing a complementary subset of parameters corresponding to a combination of constituents responsible for the abnormal condition, said complementary subset comprising the parameters eliminated from the set so as to produce a subset having said non-significant deviation from a normal condition.

This claim was held unpatentable as being directed to non-statutory subject matter. Although the first step in the claimed method involved performing clinical tests on an individual, the remaining steps were deemed to represent a mathematical algorithm. Since the novelty of the invention centered around the algorithm, the clinical test “to measure the values of the set of parameters” was interpreted as a data-gathering step ancillary to the main invention. Since mathematical algorithms are not considered patent-eligible subject matter, the rejection was upheld.

The Grams decision was made well before the recent activity related to Bilski. More recent than Grams, however, were the Federal Circuit’s decisions in Classen Immunotherapies, Inc. v. Biogen Idec, 304 Fed. Appx. 866 (Fed. Cir. 2008), and Prometheus Laboratories, Inc. v. Mayo Collaborative Svcs, 581 F.3d 1336 (Fed. Cir. 2009).

A representative claim from Classen follows:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises:

immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and

comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

In a very brief, non-precedential opinion, the Federal Circuit found that this claim did not meet the qualifications set forth by its then-exclusive machine-or-transformation (M-or-T) test, and was therefore not patent-eligible. The M-or-T test provided that 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.” In re Bilski, 545 F.3d 943, 954, aff’d, 561 U.S. ___ (2010). Unfortunately, the Classen opinion did not provide the specific reasoning for why this test was not met. Some speculation can be made, however, based on the Federal Circuit’s opinion in Prometheus.

A representative claim from Prometheus recites:

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

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

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

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Unlike in Grams and Classen, the Federal Circuit in Prometheus found that this claim satisfied its then-exclusive machine-or-transformation (M-or-T) test, and was patent-eligible. Although the Prometheus claim appears to be very similar in form to the Classen claim, the Federal Circuit approved of the Prometheus claims by stating, “[t]he asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” Prometheus, 581 F.3d at 1346. In their decision, the Federal Circuit distinguished the Prometheus claims from the claims in Grams. As mentioned above, the Grams claims were determined to be centered on the mathematical algorithm, such that the arguably transformative step of performing a clinical test to obtain data was ancillary. To the contrary, the Federal Circuit decided that the determining step in the Prometheus claims was the central feature of the invention, and required a transformation of the body and/or of collected blood in order to be completed. As such, the determining step was not ancillary to the invention, and contributed to satisfying the M-or-T test.

The Bilski Effect

On June 28, 2010, the Supreme Court issued its decision in Bilski v. Kappos. The Bilski decision had three primary holdings: (1) the underlying claim in Bilski was directed to an abstract idea, and therefore was not patent-eligible; (2) business methods cannot be categorically excluded from patent-eligibility; and (3) the M-or-T test is not the exclusive test to determine patent-eligibility. Bilski, No. 08-964, slip op. at 6-11 and 15-16. The very next day, the Supreme Court granted cert in both Classen and Prometheus. The Federal Circuit’s decisions in both cases were immediately vacated, and the cases were remanded for reconsideration based on the Supreme Court’s opinion in Bilski. (Order list for June 29, 2010, 561 U.S. __ (2010).)

Now that the Supreme Court has vacated and remanded both the Classen and Prometheus decisions, the Federal Circuit must revisit these issues. For Prometheus, the decision may be simpler, because the claims were already held to meet the machine-or-transformation test. Although the Supreme Court’s Bilski decision held that the M-or-T test was not the only test by which patent-eligibility can be determined, the Supreme Court seemed to have agreement from all nine Justices that the machine-or-transformation test was still a useful tool and valid option. See, e.g., Bilski, slip. op. at 2 of J. Breyer’s concurrence. Although a claim that does not meet the M-or-T test may still be patent-eligible under other theories, one can presume that the M-or-T test is still a “safe harbor” for claims that meet its provisions. The Federal Circuit’s re-visitation of Prometheus will be the first opportunity for this presumption to be tested.

The future for Classen is a bit more uncertain. The Bilski opinion noted that the M-or-T test would create uncertainty for, among other types of claims, diagnostic medical testing techniques. Bilski, slip op. at 9. Since the Federal Circuit in Classen used the M-or-T test to find the claims non-statutory, it is possible that its decision on remand could be reversed, since the M-or-T test is no longer the exclusive test. On the other hand, the Federal Circuit may take the completely opposite approach and declare that the Classen claims are directed to non-statutory subject matter even without considering the M-or-T test.

Much of the uncertainty in Classen comes because the Federal Circuit gave no insight whatsoever into its rationale for dismissing the Classen claims. However, the Supreme Court’s denial of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories Inc., 126 S. Ct. 2921 (2006), may have underscored the Federal Circuit’s original Classen decision. Although cert was denied in LabCorp, Justices Breyer, Stevens, and Souter filed a hefty dissent, detailing reasons why they would have found the following claim patent-ineligible:

A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:

assaying a body fluid for an elevated level of total homocysteine; and

correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

The Federal Circuit had originally found the claim to be patent-eligible. Indeed, the patentee (Metabolite) argued that this claim was patent-eligible because it required a transformation of matter. Specifically, the patentee argued that the blood was altered during the assay for determining the homocysteine level. The dissenting Justices on the Supreme Court disagreed, saying that the claim did not describe a process for transforming blood. Rather, the Justices likened the claim to (1) obtaining test results and (2) thinking about them, and equated the correlation to a natural phenomenon.

If anything certain can be gleaned from the Supreme Court’s opinion in Bilksi, it is that there are still three types of subject matter that are excluded from patent-eligibility: laws of nature, natural phenomena, and abstract ideas. Bilski, slip op. at 5. If the Federal Circuit follows the logic from the LabCorp dissent, it could again declare the Classen claims patent-ineligible as being directed to a natural phenomenon. Such a decision would not be contrary to the Supreme Court’s opinion in Bilski, as it would be relying on the long-established exclusion of natural phenomena from patent-eligibility.

Interestingly, Footnote 3 of the Federal Circuit’s opinion in Prometheus discussed the LabCorp dissent, noting that the dissent was not controlling law. It is also worth noting that both Justices Breyer and Stevens, who dissented from the LabCorp dismissal, were again not in the majority for the Bilski decision.

With the remand of Prometheus and Classen, we hopefully will learn the Federal Circuit’s rationale behind distinguishing the two claim sets. In any event, the Federal Circuit will have its first chance to put diagnostic techniques to the test – without being limited to a machine-or-transformation analysis.

The Author

Eric Steffe & Michelle Holoubek

Eric Steffe & Michelle Holoubek

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 14 Comments comments.

  1. patent leather July 2, 2010 3:15 pm

    What’s funny is the Supreme Court slapped the Federal Circuit for the “useful, concrete, tangible result” test (between both concurrences that’s a 5 justice majority) and also slapped the Federal Circuit for holding that the MoT is the only test. But then the Supreme Court appears to give license to the Fed Circuit to still develop the law. Thus, logic dictates the paradoxical situation the Fed Circuit is in now:

    1) in order for the Fed Circuit to not be reversed by the Supreme Court, they need to hold something is patentable and not state any particular test or tests are the only tests;
    2) by holding something unpatentable (that is not easy to reject as an “abstract idea”), the Fed Circuit would be implying they have exhausted all of their tests, thereby holding that the MoT plus any new test(s) they have developed are the only tests. This scenario has a good chance of being reversed by the Supreme Court, because they don’t find statutory support for any absolute test.

    Therefore, hopefully the Fed Circuit would find patentable subject matter in both Classen and Prometheus and the Supreme Court would not have to get involved. Even with Stevens out, they still seem like a dangerous bunch.

  2. EG July 3, 2010 8:16 am

    Eric and Michelle,

    Very nice laying out of the potential impact of Bilski on the Prometheus and Classen cases. I too see the tension between these cases which I view as inreconcilable (the no/minimal opinion in Classes is a “joke” and I’ve said so in the article I posted on this blog in discussing Prometheus).

    Also, what happened in Bilski is surely to have impact on Myriad’s method claims which were invalidated by Judge Sweet in AMP v. USPTO based essentially on the MoT test and which is currently on appeal. I just hope the Federal Circuit doesn’t “turn tail” in view of how SCOTUS has currently handled Bilski, Prometheus and Classen and run in a direction that does damage to patent-eligibility of medical diagnostic claims. We’lll just have to wait a see on that.

    Anyway, again, nice job.

  3. step back July 4, 2010 7:46 am

    Eric and Michelle,

    One notable word that appears a few times in the SCt B.v.K decision is the word “explains” as attached to what the Bilski claims do (they explain, they describe).

    The Justices seem to have gotten hung up on the mere-provider of non-substantive information theory as in the case of the horse whisperer and the antitrust law lecturer.

    Well medical diagnostics falls into that pigeon hole.

    There are some ignorable input-gathering steps (clinical tests) which are then followed by the “true invention”, namely, the computation and the providing of the information (the diagnosis). As Justice Sotomayor indicated during orals, that is merely non-substantive exchange of “information” –no different that what the Bilski claims do according to the BvK majority , explaining in the abstract, the concept of hedging.

  4. breadcrumbs July 4, 2010 11:03 am

    step back,

    Does the computation step, which you label as part of the “true invention”, involve any transformation?

    Also, where is the line drawn between reading the claims as a whole and dis-assembling the claims into types of steps? Is the labeling of “true invention” steps in the eye of the beholder, or is part of the invention the weaving of old steps together – “the work of someone, with whom no one of these ideas was original, combines all together, and produces what is justly called a new invention.” ?

  5. step back July 4, 2010 12:26 pm


    What is confusing about the SCt BvK majority opinion is they say they are reading the claim as a whole and yet they don’t. They say one thing and do another.

    I am of course hoping that you caught my sense of sarcasm within the electron stream when I put “true invention” in quotes. Personally I do not believe such an approach is viable if we are going to be a nation of laws rather than of men and their whims. Who is going to say what constitutes the “true invention” and how are they methodically and objectively going to do so? It’s nonsense.

    If you ask me personally, “computation” always involves transformation. Energy is always going to be converted/ transformed into high entropy waste heat during performance of the computation.

    Of course, if you talk to an English or Poli Sci trained judge, they are not going to grok that kind of stuff. Thermodynamics is outside their world model.

    If you yourself are the medical care recipient (the patient) and the data that is being massaged by the “computer” so as to arrive at your diagnosis is of a life or death kind, you are not going to be thinking that the output “data” (diagnosis) is mere “abstraction”. It’s going to be all too real and consequential for you (and for your doctor).

    It is only the ivory tower judges sitting comfortably on their philosopher stone thrones and puffing on their existential pipes (pipes which are not pipes) who can see the “abstraction” of it all being cast as a shadow on the wall of their Plato’s cave. 😉

  6. breadcrumbs July 4, 2010 1:57 pm

    The scary thing is, I understand every word that you are saying.

  7. New Here July 5, 2010 11:20 am

    -step back-
    I am of course hoping that you caught my sense of sarcasm within the electron stream when I put “true invention” in quotes. Personally I do not believe such an approach is viable if we are going to be a nation of laws rather than of men and their whims. Who is going to say what constitutes the “true invention” and how are they methodically and objectively going to do so? It’s nonsense.

    Just wish to take from here, not change context or meaning:

    For many years the PTO relied upon for evidence of prior – existing art, only that within PTO
    walls. And examinations of applications produced a result, another more serious problem;
    it fuels patent litigation today.

    The basis of that litigation points to how faulty the system has become. Some patent application
    is granted a patent because no prior – existing art challenge to it could be found within PTO walls.
    This very approach, creates without intent, a “blind-spot” for everyone the patent could potentially impact.

    Without some knowledge, of knowledge existing in many forms beyond the PTO, patents have been
    and continue to be granted in what is my conclusion – opinion; a closed world of its own.

    For some reason I have the idea the SCOTUS understands this better then I do, without them pointing
    to a target. It is this understanding that I see within it, that great care must be taken
    going forward from Bilski.

    Any Law(s) passed re of Bilski, that guide the direction back-over the SCOTUS with just another case
    of the same anytime soon, that was Bilski – or more; the Court of the remaining seven / eight,
    I would guess, aren’t going to be nice! I could see software patents being in grave danger !.

    The patent world, my opinion, will not prevent the return to the SCOTUS, taking what has been written
    as the fall-out of Bilski. I will guess that this matter will be before the Court again inside the next
    two years with a result that will end software patents… if not more.

  8. step back July 5, 2010 1:25 pm

    New Here,

    Clearly you are not a law practitioner –no offense intended; honestly.
    If you truly are interested in understanding better, you have an awful plenitude to learn and as they say, Rome was not built in a single day.

    The short answer is that the B.v.K case is strictly a section 101 issue and not a 102, 103 or 112 issue.

    To learn more you should Google (and wiki) 35 USC 102, 35 USC 103, 35 USC 112 an US Patent Law.

    God will learning 😉

  9. New Here July 5, 2010 5:59 pm

    @step back

    “Clearly you are not a law practitioner –no offense intended; honestly.
    If you truly are interested in understanding better, you have an awful plenitude to learn and as they say, Rome was not built in a single day.”

    Thank you for your reply, and I have read over some parts of the Law on this matter the best I can understand it. I try not to go “too heavy” with talking about it, because I’m not a law practitioner as I have stated a number of times… no offense intended or taken; honestly !

    The idea to make my last post here you reply to, came from your clear point about “true invention”.

  10. step back July 6, 2010 3:31 am

    New Here,

    Just to clarify what I was talking about because I did not spell it out, 35 USC begins with:

    “Whoever invents or discovers any …”

    The question centers on the verb phrase, “invents or discovers”. Does that refer to an invented thing (i.e. process) as defined by the written claim taken in whole or does it refer to some other thing; to what the judges deem to be the underlying “true invention” stripped of some crafty words that a skilled patent attorney/agent may have added during preparation or prosecution of the application.

    IIRC, the B.v.K. majority says somewhere that they are reading the claim as a whole. However they never address the claims in detail with each being read as a whole. Instead they say each claim “is” an abstraction. That is very vague and can be read in all sorts of ways.

  11. step back July 6, 2010 3:32 am

    I meant to say 35 USC “101” begins with.

  12. Blind Dogma July 6, 2010 7:31 am

    The Bilski case is a poor primer for 101 jurisprudence to the uninitiated.

    There simply is no cognizable analysis of why the claims in question are abstract. There is no process of figuring out the process.

    Stevens is correct in stating that the majority lacks this (actually it is all nine justices who lack this and none, including Stevens that did anything helpful about it).

    It is too bad that Stevens spent all of his considerable time and energy trying to outlaw business methods (a futile effort given the plainly written law of section 273) based on his ideology and spent no time helping the court figure out a workable test for deducing the proper level of abstract.

  13. step back July 6, 2010 12:18 pm


    The Universe must be out of balance. I wholly concur with your comment @ 12.

    The BvK opinion is wholly divorced from the actual words of the Bilski claims and wholly divorced from the actual words of 35 USC 101. In other words, the BvK decision is itself a multi-faceted abstraction of an alleged abstraction (by each and every one of the 9 Justices).

    You would have thought the 9 Justices were embarrassed enough by the failure of so-called ordinary-creativity and “common sense as well as “market forces” to provide a working Toyota brake pedal system (see their logic re the KSR v. Teleflex accelerator pedal system) that they would know better than to again indulge in a shallow brushing over of a major patent law issue. Luckily for them, the lay public is not tuned in to the peculiarities of esoteric patent law and thus can’t see the emperor marches nakedly in horns and trumpets parade.

    Besides, the public has enough to chew on over the Citizens United decision and the declaration by the fab 9 that a corporation has a heart that beats and a larynx that bleeds and therefore deserves “protection” under the 1st Amendment because, obviously, that’s what the Founding Framers were thinking when they inked the original scripture.

  14. step back July 6, 2010 12:19 pm

    in “a” horns and trumpet

    (Gene, this web site badly needs a Comment Preview button)