Source: https://www.ipwatchdog.com/2019/04/14/patent-eligibility-of-medical-diagnostics-inventions-where-are-we-now-and-where-is-there-to-go/id=108263/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Ipwatchdog+%28IPWatchdog.com%29
Timestamp: 2019-04-25 18:20:51+00:00

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Patent Eligibility of Medical Diagnostics Inventions: Where Are We Now, and Where Are We Headed?
In each of the recent Federal Circuit decisions on medical diagnostics inventions, Athena Diagnostics v. Mayo Collaborative Services, 2017-2508, (Fed. Cir. Feb. 6, 2019) (“Athena”) and Cleveland Clinic Found. v. True Health Diagnostics LLC, 2018-1218 (Fed. Cir. April 1, 2019; non-precedential) (“Cleveland Clinic II”), the court affirmed a district court ruling that found a medical diagnostic or a related patent invalid for being directed to ineligible subject matter. Athena and Cleveland Clinic II follow the hard stance taken by the Federal Circuit against medical diagnostics inventions, first in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) (“Ariosa”) and next in Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352, 1361 (Fed. Cir. 2017) (“Cleveland Clinic I”).
In Athena, the patent covered a method for diagnosing a disease in a subpopulation of affected individuals based on the discovery of a correlation between the disease and certain autoantibodies found only in that subpopulation. In Cleveland Clinic I, the patent claims were directed to diagnosing the risk of atherosclerotic cardiovascular disease (CVD) based on the correlation between elevated levels of a protein found in the blood and occurrence of atherosclerotic CVD. In Cleveland Clinic II, the claims were directed to methods of identifying elevated levels of the protein but did not include any recitation of the correlation.
Notably, despite confirming the invalidity of the patent, the panel majority in Athena affirmed that “providing patent protection to novel and non-obvious diagnostic methods would promote the progress of science and useful arts”—the constitutional purpose patents serve. Athena, Majority opinion at 15. Also, the majority agreed with the dissent that “the public interest is poorly served by adding disincentive to the development of new diagnostic methods.” Id. Nonetheless, the majority felt that its hands were tied by Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) (“Mayo”). Id. (stating, “[b]ut, whether or not we as individual judges might agree or not that these claims only recite a natural law…the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature, see 566 U.S. at 77, and “[p]urely ‘conventional or obvious’ ‘[pre]-solution activity’ is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.” (citation omitted).
In Mayo, the U.S. Supreme Court held that a patent directed to a method was invalid as a natural law if the method, in addition to the natural law, involved only well-understood, routine, conventional steps previously engaged in by scientists in the field. The court formulated a two-step test for examining patent eligibility under which step one requires determining whether a claim is directed to a judicial exception, (i.e., a law of nature, a natural phenomenon, or an abstract idea). If so, then step two requires determining whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to something significantly more than the judicial exception.
The Mayo test, expanded in Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), for abstract ideas, and now commonly referred to as the Alice/Mayo test, leads to the dissection of a claim to first extract the judicial exception. The remainder is analyzed for an inventive concept to determine whether the additional elements “transform the nature of the claim” into a patent-eligible application. A claim failing the second step is held patent-ineligible as being directed to the judicial exception. Many medical diagnostics patent claims detect correlations using commonly known techniques and thus are likely to suffer the same fate as the claims in Ariosa and Athena, for example. This problem became widely recognized in the wake of Ariosa where the Federal Circuit, applying the Alice/Mayo analysis, struck down Sequenom’s important innovation for prenatal diagnosis of fetal abnormalities. The court first determined that the claim was directed to a patent ineligible concept and then proceeded to the next step, explaining, “[W]e next consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Ariosa at 1375 (emphasis added).
This compartmentalized approach was criticized by the dissent in Athena, which cited four Supreme Court precedents supporting the proposition that a claim must be analyzed as a whole. These include Mercoid Corp. v. Minneapolis-Honeywell Regulator Co., 320 U.S. 680, 684 (1944), stating, “a patent on a combination is a patent on the assembled or functioning whole, not on the separate parts;” and Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 344 (1961), stating, “if anything is settled in the patent law, it is that the combination patent covers only the totality of the elements in the claim and that no element, separately viewed, is within the grant.” Athena, Dissenting opinion at 4-5.
In this regard, the U.S. Patent and Trademark Office’s 2019 Revised Patent Subject Matter Eligibility Guidance does require considering the claim as a whole in the first step, the “directed to” inquiry step, of the Alice/Mayo test. The guidance addresses eligibility of patent claims that recite an abstract idea. According to the guidance, a claim is not “directed to” a judicial exception, and thus is patent eligible, if the claim as a whole integrates the recited judicial exception into a practical application of that exception. The guidance explains integration as follows: “[a] claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” The guidance seems to require mainly that the claim impose a meaningful limit on the judicial exception. However, the guidance does not have the force of law, and there is no certainty that the Federal Circuit will endorse the guidance.
Further, it is worth noting that the court has required more than a meaningful limit on the judicial exception to avoid full eligibility analysis. For example, in Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, (Fed. Cir. 2016) (“Enfish”), the court, in determining that the claims at issue were not directed to an abstract idea within the meaning of Alice, stated that rather, they were “directed to a specific improvement to the way computers operate…” Enfish at 1336. Also, in McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, (Fed. Cir. 2016) (“McRO”), the court stated that when looked at as a whole, the claim at issue was “directed to a patentable, technological improvement over the existing, manual 3-D animation techniques.” McRO at 1316.
The requirement for an improvement to the technology involved in carrying out the claimed method is a steep hurdle for the eligibility of most medical diagnosis inventions, since the essence of such inventions is applying a newly discovered correlation to deliver a practical benefit—not improving the technology used to provide the diagnosis. In this regard, medical diagnostic inventions are unique. This point was highlighted by the Athena dissent through reference to the amici curiae Five Life Sciences Patent Practitioners’ brief, which stated, “[medical] diagnostic methods . . . are so tightly bound to underlying natural laws and phenomen[a], they are especially susceptible to undue expansion of the eligibility standards…” Athena Dissenting opinion at 13.
Since all patent eligibility determinations have to satisfy the requirements set forth in Mayo, the broad question is whether Mayo can be read with prior Supreme Court patent eligibility cases in a way that medical diagnostics claims can be found eligible. Before exploring answers to this question, however, several post-Mayo Federal Circuit decisions related to patent eligibility of medical diagnostics patents are outlined below.
In Ariosa, the claims were directed to a method for detecting paternally inherited cell-free fetal DNA (cffDNA) in maternal plasma or serum to determine fetal characteristics such as gender. The method was based on the discovery that cffDNA could be found in maternal plasma/serum. The method required amplifying the cffDNA present in the plasma/serum and detecting the paternally inherited cffDNA using known laboratory techniques. Prior art prenatal diagnoses methods were invasive and risky to the mother and to the pregnancy.
The panel majority in Ariosa found that the claimed method started with maternal cffDNA and ended with paternally inherited cffDNA. It reasoned that since the existence of each was a natural phenomenon, the method began and ended with a natural phenomenon and therefore was directed to naturally occurring matter. Because techniques like polymerase chain reaction (PCR) to amplify and detect cffDNA were well-understood, routine, and conventional, the only subject matter new and useful, the majority observed, was the discovery of the presence of cffDNA in maternal plasma/serum.
In Cleveland Clinic I, the patent at issue claimed methods for characterizing the risk of cardiovascular disease in an individual by determining the level of the enzyme myeloperoxidase (MPO) in a bodily sample taken from the individual and comparing that level with the MPO levels in persons not having cardiovascular disease. MPO is released when an artery is damaged or inflamed. Detection of MPO could be performed with known methods. In step one of the Alice/Mayo analysis, the Federal Circuit determined that the claims were directed to multistep methods for observing a law of nature, namely, that MPO correlates with cardiovascular disease. The Court observed that, as in Ariosa, the claimed method started and ended with naturally occurring phenomena with no meaningful non-routine steps in between.
In Rapid Litig. 827 F.3d 1042 (Fed. Cir. 2016), the asserted claims were directed to a method of producing a preparation of hepatocytes that could be frozen and thawed at least two times. Because cryopreservation can damage cells, it was believed that hepatocytes could be frozen only once without losing viability. As such, upon thawing they had to be either used or discarded, which was a significant limitation. The inventors discovered that some fraction of hepatocytes was capable of surviving multiple freeze-thaw cycles. Based on this discovery, they developed an improved process of preserving hepatocytes, which they patented. The district court found the claims ineligible as directed to a law of nature, the law being that hepatocytes are capable of surviving multiple freeze-thaw cycles. The Federal Circuit reversed, determining that the claims were directed to a new and useful laboratory technique for preserving hepatocytes. Unlike Ariosa, the end result was not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles, but a new and useful method of preserving hepatocytes, the court explained.
In Athena, the patent at issue claimed methods of diagnosing neurological disorders such as Myasthenia gravis (MG) by detecting autoantibodies that bind to an epitope of a membrane protein called MuSK. Autoantibody detection could be performed using techniques known in the art. About 80% of patients with MG produce acetylcholine receptor autoantibodies, but the other 20% do not, even though they experience the same MG symptoms. The inventors discovered that many of the 20% of MG patients without acetylcholine receptor autoantibodies instead generate autoantibodies to a protein called MuSK. No disease had previously been associated with MuSK.
Mayo argued that the claims were directed to a natural law—the correlation between naturally-occurring MuSK autoantibodies and MuSK-related neurological diseases like MG. Athena argued the opposite and pointed out that the claims recited innovative, specific, and concrete steps that do not preempt a natural law. The panel majority determined that as in Cleveland Clinic I and Ariosa, the claims were directed to a natural law because the claimed advance was only in the discovery of a natural law, and that the additional recited steps only applied conventional techniques to detect that natural law.
The majority acknowledged that the step one “directed to” inquiry focuses on the claim as a whole but added that the court had frequently considered whether the claimed advance improved upon a technological process or merely an ineligible concept, citing Ariosa, Rapid Litig., and McRO among others. The majority also distinguished the claims in Athena from those in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1133–36 (Fed. Cir. 2018) on the ground that the latter claimed a new treatment based a natural law, not the natural law.
In Cleveland Clinic II, the claims were directed to methods of identifying elevated levels of MPO in blood. Unlike Cleveland Clinic I, the claims recited neither diagnosing the risk for atherosclerotic CVD nor the correlation between elevated levels of MPO and CVD risk. Cleveland Clinic argued in part that the claims were not directed to a natural law because they did not recite or describe any ineligible concept. The argument was based on the USPTO guidance published May 4, 2016 (Example 29) that if a claim does not recite or describe any ineligible concept, it is not directed to natural law. The Federal Circuit rejected this argument, noting that the guidance does not have the force of law.
Turning back to Supreme Court precedents on patent eligibility, despite strongly disagreeing with the majority, the Athena dissent did not view the Mayo decision as generally barring the typical medical diagnostics invention. For example, it stated, “[a]pplying the Mayo/Alice protocol of two-step claim analysis, claims 7–9 of the ’820 patent are patent-eligible under Step 1, for this method of diagnosing Myasthenia Gravis is not a law of nature, but a man-made chemical-biomedical procedure.” Athena Dissenting opinion at 11. Rather, in its view, the panel majority misapplied precedent and misinterpreted 35 U.S.C. 101. Id. at 14. Beyond underscoring that a claim must be considered as a whole (see above), it pointed to statements in Mayo and Alice cautioning against wielding the two-step subject matter eligibility test too heavily: “too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” (Mayo, 566 U.S. at 71); and “[a]t the same time, we tread carefully in construing this exclusionary principle lest it swallow all of patent law.” (Alice, 573 U.S. at 217). Id. at 9.
A contrary position is that Mayo leaves no room for finding medical diagnostics claims patent eligible. As noted above, this appears to be the view of the Athena majority. Such was the view also of the concurrence in Ariosa, which indicated that the problem lay in the manner in which the Mayo court had applied the second part of the patent eligibility test. The concurrence observed that the Mayo court, referring to Diamond v. Diehr 450 U.S. 175 (1981) (Diehr), explained that in Diehr the overall process was patent eligible because of the way the additional steps of the process integrated the equation (the judicial exception) into the process as a whole, yet it discounted the conventional activities recited in the claim in Mayo. Ariosa at 1380.
While disregarding conventional activities might have been warranted in Mayo because there the conventional activities were steps that doctors were already performing (administering the thiopurine drug, measuring metabolite levels, and adjusting dosing based on the metabolite levels), the Supreme Court did not limit its ruling to those particular facts and circumstances, the concurrence observed. Id at 1381. As a result, a conventional activity (e.g., PCR) that had never been carried out for detecting the natural correlation at issue (e.g., detection of cffDNA in Ariosa) but had been been performed in other contexts, could be disregarded without testing if it integrated the natural correlation into the method. This is contrary to Diehr.
Medical diagnostics inventions continue to face strong challenges on the ground of subject matter ineligibility. These inventions are unique in that the practical benefits they provide do not necessarily depend on improvements to the techniques used for detecting the natural correlations on which the inventions are based. According to a 2016 report, about 66% of clinical decisions are based on guidance provided by in vitro diagnostic tests. Ulrich-Peter Rohr, et al., (2016) The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report, 11 PLoS One 11(3): e0149856. Disincentives to the development of new diagnostic tests are therefore not in the public interest. Many strongly believe that resolving the current eligibility impasse would require congressional action. In May of 2018, two major IP groups, Intellectual Property Owners Association (IPO) and American Intellectual Property Law Association (AIPLA) jointly proposed a legislative solution to amend 35 U.S.C. § 101 to clarify the patent eligibility standard and restore the scope of eligibility limited by the Supreme Court’s recent decisions. Currently, lawmakers in both the House and the Senate are engaged in efforts to redefine patent eligibility to bring certainty to what is patentable, especially in the areas of medical diagnostics and computer software. In this regard, they have been collecting stakeholders’ responses to the central question of how narrow or broad section 101 should be in order for it to serve a gatekeeping function. Not everybody is in favor of a narrow reading of this function, however. A broad reading helps defeat patent infringement lawsuits based on subject matter ineligibility and is favored by certain sections of certain industries. Only time will tell if there will be a change to section 101 and how far that change will go.
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That is, if the Common Law rewritten statute is allowed to stand.
And sadly, this answer may not be entirely figurative for real people.
Apart from writing or being lead author of amicus briefs on the Ariosa/Sequenom case and being lead author of the CIPA amicus brief in Athena I have been studying the CAFC decision and the more recent decisions to consider the case for en banc review.
The recent posting by Sherry Knowles represents in my opinion a key initiative and her drawing attention to the Supreme Court decision in Henry Schein v Archer & White is a valuable contribution.
“It will be apparent to any educated person that there is in principle no overlap between the eligible categories in Set A and the ineligible categories in set B. There is no objection of principle against invoking the two-part Mayo test to check whether subject-matter seemingly falls into one of the four eligible categories, but invoking a judicial exception against subject matter that falls as a matter of substance within an eligible category amounts to impermissible judicial legislation, see Antonin Scalia and Bryan A. Garner, Reading Law: The Interpretation of Legal Texts, Thompson/West, 2012, pages 93-100, Omitted-Case Canon.” Kavanaugh J.’s forthright statement in Schein that “We must interpret the Act as written” applies as plainly and directly to 35 USC as it did in that case to the Federal Arbitration Act and supports the proposition set out in my Recognicorp brief.
In order to succeed with this argument, however, it is essential to have claims that can be perceived even by judges without prior technical training or experience in patent law such as Judge Reyna as falling into a relevant eligible category. For example, the narrower claims in Athena directed to the use of radiolabelled MuSK are transformational process claims resulting in a precipitated material (e.g. the 3-component substance autoantibody/125I-MuSK/Sheep IgG which was new to science) that qualifies both as a new composition of matter and as a new manufacture. However, the production of that new substance is only implicit in the relevant claim and it is not recited either by a generic formula or by a specific formula for the product of the exemplified process. It would have been more difficult for the court to have treated the claim dismissively as they did if the relevant claim had positively recited by a generic formula the new substance produced and Athena had been in a position to point to the black-letter law as to the eligibility of new chemical products. Arguments are available to overcome the present problems, but they will be strengthened by carefully drafted and appropriately detailed claims.
On the other side of the pond you have article 53(c) of the EPC, which basically says the same. So at least you are not getting ripped off by the French.
You continue to attempt to use your Venn diagram “logic,” and I continue to be puzzled why you pursue such an obviously weak argument.
Not only is the math simply not correct given the plain meaning of the word “exception,” the cases by the Supreme Court simply do not support your attempt, and further, your view directly leads to a Pandora Box of “a matter of substance” of the claim language (and WHO gets to decide that point), along with an admonition of yours that may well be true, but is used AGAINST the Rule of Law concerning 35 USC 101 (your admonition of “strengthening” only serves as a weak path of excusing the Court for its ultra vires OVERREACH into imposing its policies into statutory law.
On the whole, this “logic” of yours is the absolute weakest point of your reasoning, and yet, time and again you seem to want to emphasize it. What is worse, is that the last several times that you emphasize it, I call you out for the weakness, and each time you disappear, only to come out later as if you had not been called out at all.
Stop with the Internet style “shout down” and the pretending that your position has more merit than it does. Yes, the advice to “write better” may well be good advise – but such does not — cannot — rise to the excuse of one branch of the US government imposing its will where it does not belong.
If the Schein case proves influential in the field of patent law, it is predictable that the debate will shift from the judicial exceptions to the four eligible categories. Given the existing body of case law, a shift is only predictable if a leading case to come before the Federal Circuit or perhaps the Supreme Court relates to subject matter which clearly complies with one of the eligible categories and that fact can be perceived even by a judge without prior education in IP law. And it should be recalled that each of the four categories has its own body of case law as can readily be ascertained by consulting the MPEP.
For example, in the Prometheus case the two features of novelty were the upper and lower limits of the therapeutic window and were pure information not involving the hand of man. For that reason, compliance with the “process” category of Section 101 was somewhat suspect. On the face of the patent specification there was no elegible contribution.
Investpic is interesting and thanks for bringing it to my attention. But I wonder whether this mathematical method falls within the “process” category as defined in existing case law or even falls within the “useful arts” contemplated by the Constitution.
What you have written is, with all due respect, unintelligible.
You double down on the weak “logic” of your Set Theory and give in to the very notion that is at the heart of the current mess of 101 with conflating novelty and statutory category. You (again) invite the Pandora’s Box of “clearly complies” with invitation for a judge to decide “enough” with no actual defining guidelines except for the mentioned conflation on novel items.
“Recalling Case Law” only gets you to the point that THAT case Law has become a Gordian Knot (and your reference to the MPEP belies the fact that the MPEP is not a controlling document FOR case law – I can show you at least half a dozen places in the MPEP that Case Law is badly mangled.
You speak of “eligible contribution” as if eligiblity is not taken on the claim as a whole, but in some type of Jepson differentiation.
You exhibit — all in one post — so much of what is wrong with the current state of 101, and this is in defense of mine calling out your earlier weakness?
Instead of strengthening your position, you have done the opposite, and have now cast serious doubt as to you even grasping what the problem is.
Any practitioner who routinely considers only the exceptions to a statutory section without first considering the substantive provisions of that section places himself or herself in a position where fitness to practice may be seriously questioned. In my understanding that is a matter of black letter law, and is something that anyone who has been through any law school where the Common Law is taught would accept as a matter of course. If that is an implied comment on the current practice in the Federal Circuit, so be it.
Again if you consider the judicial exceptions as outlined by the Supreme Court these do not overlap with the four eligible Section 101 categories. Any fair reader of recent Supreme Court case law would equally pick up this point.
It follows that if subject matter falls within one of the Section 101 categories and should be so held by the USPTO or a court, it CANNOT simultaneously fall within one of the exceptions without that exception being judicially stretched so as to over-ride the will of Congress. That is NOT a difficult proposition, and it is now strongly supported by the holding in Schein.
That MIGHT bring about a useful change in the position of the Federal Circuit by the “Kavanaugh Scissors” in an appropriate case where the previous logic clearly gives rise to an erroneous result and if there is good advocacy to that effect.
There is NOTHING RAMBLING about this, and it is not a defence, merely a possible route to better results for our clients. As a UK subject and an Oxford alumnus, I cannot applaud two CAFC decisions belittling the scientific contributions of that university.
The term “process” is very broad, but Investpic is predicated on the claims being an exception under s101 not falling under s101.
Further, what is a mathematical operation but a method of doing something? There is a consideration that a human mind alone might do this, and at the end of the day if the SOTUS takes cert I suspect Investpic’s software claims will survive but the others may not.
Your statement of “Again if you consider the judicial exceptions as outlined by the Supreme Court these do not overlap with the four eligible Section 101 categories.” is flat out false.
I do not understand how you continue to not comprehend this. This comes from the very nature of the word “exception” and is quite evident in the direct writings of the Court.
If you cannot see this, then the rest of what you have to say is lost.
The problem for you (I believe) is that you are somehow still clinging to the notion that the Supreme Court has acted properly in their writing of patent law TO include their exceptions. You have in the past shown great reluctance to be critical of our highest court, and I can only imagine that some vestibule residual of that (inappropriate) reverence remains. You continue to want to place “blame” solely on the CAFC, when the source of that blame is with the Supreme Court.
Powerful, hard-hitting (as it needs to be) brief B.
This s101 foolishness has to end — now.
Other countries are gobbling up for themselves America’s greatest innovations of the 21st Century.
If we consider bare natural phenomena, mental processes and abstract ideas it would be apparent even to a casual reader that these things do not fall within any of the categories “process”, “apparatus”, “manufacture” or “composition of matter” deemed eligible by 35 USC 101. That is the basis of the two non-intersecting sets concept put forward in previous comments.
However, over-enthusiastic and inadmissible extension of the bare exceptions to disregard “allegedly well-understood, routine and conventional activity previously engaged in by researchers in the field” and hence arriving at a conclusion of ineligibility often produces, in my submission, an inadmissible overlap. The Athena decision, in my opinion, represents a paradigm example of inadmissible extension of a natural principle to exclude what should be an eligible application of that principle clearly falling as a matter of substance into the eligible “process” category.
As an alien [as I used to be reminded whenever entering the US during the 1990’s] I am as you have suggested reluctant to criticise the Justices of the Supreme Court and instead am keen to find rules of law flowing from their decisions that are sufficiently narrow not to create undue damage to the patent system. But in apportioning blame, I would place greater weight on the decisions of the Federal Circuit which has “gold-plated” the decisions of the Supreme Court, disregarded the limited and cautionary language in its decisions and shown a striking disregard both for established principles of patent law and for the relevant technical fact which is too often replaced by science fiction.
So many challenge in the future, but we will do it. because we can. Nice post, thanks.

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