Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC

United States Court of Appeals, Federal Circuit

July 3, 2019


          Appeal from the United States District Court for the District of Massachusetts in No. 1:15-cv-40075-IT, Judge Indira Talwani.

          Adam Gahtan, Fenwick & West, New York, NY, filed a petition for rehearing en banc for plaintiffs-appellants. Also represented by Eric M. Majchrzak, Vanessa Park-Thompson; Andrew Joseph Kabat, Emmett J. McMahon, Robins Kaplan LLP, Minneapolis, MN; Dimitrios T. Drivas, White & Case LLP, New York, NY.

          Jonathan Elliot Singer, Fish & Richardson, PC, San Diego, CA, filed a response to the petition for defendants-appellees. Also represented by John Cameron Adkisson, Elizabeth M. Flanagan, Phillip Goter, Deanna Jean Reichel, Minneapolis, MN.

          Melissa A. Brand, Biotechnology Innovation Organization, Washington, DC, for amici curiae Biotechnology Innovation Organization, CropLife International, Pharmaceutical Research and Manufacturers of America, Wisconsin Alumni Research Foundation. Also represented by Hansjorg Sauer. Amicus curiae Biotechnology Innovation Organization also represented by Brian Paul Barrett, Eli Lilly and Company, Indianapolis, IN. Amicus curiae Pharmaceutical Research and Manufacturers of America also represented by David Evan Korn, Pharmaceutical Research and Manufacturers Association of America, Washington, DC.

          Matthew James Dowd, Dowd Scheffel PLLC, Washington, DC, for amici curiae Richard A. Epstein, Christopher Michael Holman, Adam Mossoff, Kristen J. Osenga, Michael Risch, Ted M. Sichelman, Brenda M. Simon. Also represented by Robert James Scheffel.

          Sherry M. Knowles, Knowles Intellectual Property Strategies, LLC, Atlanta, GA, for amici curiae Freenome Holdings Inc., Achillion Pharmaceuticals, Inc. Also represented by Meredith Martin Addy, AddyHart P.C., Atlanta, GA.

          Before Prost, Chief Judge, Newman, Lourie, Dyk, Moore, O'Malley, Reyna, Wallach, Taranto, Chen, Hughes, and Stoll, Circuit Judges.



          PER CURIAM.

         A petition for rehearing en banc was filed by appellants Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V. A response to the petition was invited by the court and filed by appellees Mayo Collaborative Services, LLC and Mayo Clinic. Several motions for leave to file amici curiae briefs were filed and granted by the court. The petition for rehearing, response, and amici curiae briefs were first referred to the panel that heard the appeal, and thereafter, to the circuit judges who are in regular active service. A poll was requested, taken, and failed.

         Upon consideration thereof, It Is Ordered That:

         1) The petition for panel rehearing is denied.

         2) The petition for rehearing en banc is denied.

         3) The mandate of the court will issue on July 10, 2019.

          Lourie, Circuit Judge, with whom Reyna and Chen, Circuit Judges, join, concurring in the denial of the petition for rehearing en banc.

         I concur in the court's decision not to rehear this case en banc. In my view, we can accomplish little in doing so, as we are bound by the Supreme Court's decision in Mayo. Some of us have already expressed our concerns over current precedent. E.g., Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 753 n.4 (Fed. Cir. 2019); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1284 (Fed. Cir. 2015) (Lourie, J., concurring in the denial of rehearing en banc); id. at 1287 (Dyk, J., concurring in the denial of rehearing en banc).

         If I could write on a clean slate, I would write as an exception to patent eligibility, as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma, Boyle's Law, Maxwell's Equations, etc. I would not exclude uses or detection of natural laws. The laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable.

         But we do not write here on a clean slate; we are bound by Supreme Court precedent. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the claims at issue were held by the Court to be directed to the relationship between the concentration of metabolites in the blood and the likelihood that a drug dose will be ineffective, which it referred to as a law of nature. 566 U.S. 66, 74-75, 77 (2012). The other steps-administering a drug and detecting the level of a specific metabolite-added only "[p]urely 'conventional or obvious' '[pre]-solution activity'" that was "not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law." Id. at 79 (second alteration in original) (quoting Parker v. Flook, 437 U.S. 584, 590 (1978)); see Bilski v. Kappos, 561 U.S. 593, 610-11 (2010) ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by attempting to limit the use of the formula to a particular technological environment' or adding 'insignificant postsolution activity.'" (quoting Diamond v. Diehr, 450 U.S. 175, 191-92 (1981))); Flook, 437 U.S. at 590 ("The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance."). Because the claims recited only what the Court called a natural law together with well-understood, conventional activity, the Court concluded the claims were ineligible under § 101. Mayo, 566 U.S. at 73, 79-80.

         In applying Mayo, we have accordingly held claims focused on detecting new and useful natural laws with conventional steps to be ineligible. E.g., Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352, 1363 (Fed. Cir. 2017), cert. denied, 138 S.Ct. 2621 (2018); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1378 (Fed. Cir. 2015), cert. denied, 136 S.Ct. 2511 (2016). In Cleveland Clinic, the claims recited a specific assay to detect the protein MPO, the enzyme-linked immunosorbent assay. 859 F.3d at 1357-58, 1362. Ariosa similarly involved a specific technique to amplify and detect DNA, the polymerase chain reaction. 788 F.3d at 1377. But in both cases, the patents' specifications described these techniques as well-understood and conventional. Cleveland Clinic, 859 F.3d at 1355; Ariosa, 788 F.3d at 1377. We concluded that using these routine assays to detect new natural phenomena did not transform the claims into patent eligible applications. Cleveland Clinic, 859 F.3d at 1362- 63; Ariosa, 788 F.3d at 1376-77.

         In contrast, new method of treatment patents do not fall prey to Mayo's prohibition. E.g., Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 1136 (Fed. Cir. 2018). Nor have unconventional arrangements of known laboratory techniques, even if directed to a natural law. Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1051 (Fed. Cir. 2016). But this case involves neither scenario. Athena's claims recite observing a natural law using a radioimmunoassay that the specification describes as "standard" and "known per se in the art." U.S. Patent 7, 267, 820 col. 3 ll. 33-37, col. 4 ll. 10-12. The claims do not recite a new method of treatment or an unconventional combination of steps to detect the natural law. The only unconventional aspect is the inventors' discovery of what the Supreme Court would call the natural law-the correlation between MuSK autoantibodies and the neurological disorder myasthenia gravis-but we cannot premise eligibility solely on the natural law's novelty. Mayo, 566 U.S. at 73 (concluding that "the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field" (emphasis added)); Flook, 437 U.S. at 591-92 ("[T]he novelty of the mathematical algorithm is not a determining factor at all" and "is treated as though it were a familiar part of the prior art."). Under Supreme Court precedent, I do not believe that specific yet purely conventional detection steps impart eligibility to a claim that otherwise only sets forth what the Court has held is a natural law. That is the situation presented in Ariosa, Cleveland Clinic, and now Athena. Accordingly, as long as the Court's precedent stands, the only possible solution lies in the pens of claim drafters or legislators. We are neither.

         Amici and others have complained that our eligibility precedent is confused. However, our cases are consistent. They have distinguished between new method of treatment claims and unconventional laboratory techniques, on the one hand, and, on the other hand, diagnostic methods that consist of routine steps to observe the operation of a natural law, a clear line. Beyond that, I do not see a way clear to distinguish Mayo in a useful, principled, fashion. Software is another matter, but such patents are not before us here.

         I therefore concur in the decision of the court not to take this case en banc because I do not believe we can convincingly distinguish Mayo in this case.

          Hughes, Circuit Judge, with whom Prost, Chief Judge, and Taranto, Circuit Judge, join, concurring in the denial of the petition for rehearing en banc.

         The multiple concurring and dissenting opinions regarding the denial of en banc rehearing in this case are illustrative of how fraught the issue of § 101 eligibility, especially as applied to medical diagnostics patents, is. I agree that the language in Mayo, as later reinforced in Alice, forecloses this court from adopting an approach or reaching a result different from the panel majority's. I also agree, however, that the bottom line for diagnostics patents is problematic. But this is not a problem that we can solve. As an inferior appellate court, we are bound by the Supreme Court.

         I, for one, would welcome further explication of eligibility standards in the area of diagnostics patents. Such standards could permit patenting of essential life saving inventions based on natural laws while providing a reasonable and measured way to differentiate between overly broad patents claiming natural laws and truly worthy specific applications. Such an explication might come from the Supreme Court. Or it might come from Congress, with its distinctive role in making the factual and policy determinations relevant to setting the proper balance of innovation incentives under patent law.

          Dyk, Circuit Judge, with whom Hughes, Circuit Judge, joins, and with whom Chen, Circuit Judge, joins as to Parts IV, V, and VI, concurring in the denial of the petition for rehearing en banc.


         In the realm of abstract ideas, the Mayo/Alice framework has successfully screened out claims that few would contend should be patent eligible, for example, those that merely apply well-known business methods and other processes using computers or the Internet.[1] The Mayo/Alice framework has thus proven to be both valuable and effective at invalidating overly broad, non-inventive claims that would effectively "grant a monopoly over an abstract idea." Alice Corp. v. CLS Bank Int'l, 573 U.S. 208, 216 (2014) (quoting Bilski v. Kappos, 561 U.S. 593, 611-612 (2010)). As the Supreme Court has recognized, the concern with such patents is that they would "'inhibit further discovery by improperly tying up the future use of' these buildings blocks of human ingenuity." Id. (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 85 (2012)). At the same time, our § 101 precedent has allowed room for claims that do more than recite conventional applications of abstract concepts.[2]


         Despite assertions to the contrary, the doctrines of novelty under § 102, obviousness under § 103, and enablement and written description under § 112 cannot adequately guard against the dangers of overclaiming. In Mayo, the Supreme Court rejected the argument that "other statutory provisions"-specifically §§ 102, 103, and 112-could adequately "perform th[e] screening function" served by § 101. 566 U.S. at 89. Although the Court recognized that the § 101 patent eligibility inquiry "might sometimes overlap" with considerations of novelty and non-obviousness under §§ 102 and 103, it concluded that "to shift the patent-eligibility inquiry entirely to these later sections risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do." Id. at 90. Those sections and § 112 do not adequately address "the risk that a patent on the [natural] law would significantly impede future innovation." Id. at 90-91; see also Mark Lemley et al., Life After Bilski, 63 Stan. L. Rev. 1315, 1329-32 (2011) (outlining differences between §§ 101 and 112). Nor do these other provisions typically allow early stage resolution of the "threshold" issue of patent eligibility, Bilski, 561 U.S. at 602, necessary to avoid the costs of lengthy litigation. Thus, § 101 serves an important purpose not served by these other provisions in the Patent Act.

         A simple example in the area of diagnostic patents illustrates this point. If the first person to identify the relationship between a genetic abnormality and a disease had sought a broad patent on a method of searching for genetic abnormalities and determining their relationship to disease, the claims would have been neither anticipated nor obvious. Nor is it likely that they would they have been invalid for lack of enablement (since a representative species was disclosed) or written description (the overall conception being in the mind of the inventor). The only barrier to such broad patent claiming is § 101.

         In fact, one of the diagnostic patents that we have held unpatentable under § 101 had exactly that problem of over-breadth. In In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014), we held that genetic testing claims were directed to the "patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations" of the gene. Id. at 763. We noted the breadth of the claims, explaining that they "are not restricted by the purpose of the comparison or the alteration being detected," nor "limited to the detection of risk of breast or ovarian cancer." Id. at 763-64. Indeed, the claims encompassed "comparisons for purposes other than detection of cancer." Id.; see also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373-74, 1378 (Fed. Cir. 2015) (invalidating claims to methods of detecting cffDNA in maternal serum or plasma that encompassed any diagnosis of any disease). What was claimed was a broad concept, and we therefore held the claims ineligible under § 101, though the claims may well have survived challenge under §§ 102, 103, and 112.


         The problem with § 101 arises not in implementing the abstract idea approach of Alice, but rather in implementing the natural law approach of Mayo. Although Mayo's framework is sound overall, I share the concerns expressed by my dissenting colleagues that the Mayo test for patent eligibility should leave room for sufficiently specific diagnostic patents. But it is the Supreme Court, not this court, that must reconsider the breadth of Mayo.

         Although the Supreme Court's decision in Mayo did not make all diagnostic claims patent ineligible, as we previously held in Ariosa, 788 F.3d at 1376-77, Mayo left no room for us to find typical diagnostic claims patent eligible, absent some inventive concept at Mayo step two. The panel here correctly concluded that Mayo controls.

         The inventors of U.S. Patent 7, 267, 820 ("the '820 patent") discovered that myasthenia gravis ("MG"), a neurological disorder, can be diagnosed by detecting the presence of MuSK autoantibodies in bodily fluid. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 747 (Fed. Cir. 2019). At Mayo step one, the claims are directed to a natural law: "the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid" and certain neurological diseases like MG. Id. at 750. This is similar to the correlation between "concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm," which the Supreme Court held "sets forth a natural law" in Mayo, 566 U.S. at 77.

         So too as in Mayo, at step two, the additional steps of the claims here, though "set forth with some specificity," Athena, 915 F.3d at 752, "only require standard techniques to be applied in a standard way" and thus do not supply the requisite inventive concept, id. at 753. The specification explains that "[t]he actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known per se in the art." Id. at 753-54 (alteration in original). Similarly, in Mayo, adding steps "to determine the level of the relevant metabolites in the blood" was held "not sufficient to transform an unpatentable law of nature into a patent-eligible application" because those steps were "well known in the art." 566 U.S. at 79. Therefore, the panel here correctly held that under the Mayo framework, the claims are not patent eligible under § 101. Athena, 915 F.3d at 746, 756. And the Supreme Court has instructed us to follow its precedent until the Court itself chooses to expressly overrule it.[3]


         It is nonetheless appropriate to point out that there is tension between Mayo and the Supreme Court's later decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and that the holding of Mayo may be overbroad. The language of § 101 does cover "discover[ies]," 35 U.S.C. § 101, and there is no doubt that determining the relationship between specific genetic abnormalities and specific diseases constitutes an important discovery with proven utility. There is much to be said for the patentability of claims to such discoveries, if not drafted overbroadly. And Myriad suggests that such discoveries may be patent eligible. There, the patent applicant discovered a previously unknown natural phenomenon: the location and sequence of the BRCA1 and BRCA2 genes and their connection to cancer. Myriad, 569 U.S. at 582-83. Although the Court held ineligible the claims to naturally occurring DNA sequences, it suggested that "new applications of knowledge about the BRCA1 and BRCA2 genes" could be eligible and referred to various "unchallenged claims" discussed in Judge Bryson's concurrence to our court's decision below. Id. at 596 (emphasis in original) (citing Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, Inc., 689 F.3d 1303, 1349 (Fed. Cir. 2012) (Bryson, J. concurring)). One of these "unchallenged claims" was claim 21 of Myriad's U.S. Patent No. 5, 753, 441, which covered a method of detecting (using conventional methods) any of several specific mutations in the BRCA1 gene, newly discovered by the patent applicant and shown to increase a person's risk of developing particular cancers (a far narrower claim than the claims held unpatentable in BRCA1- & BRCA2).

         By suggesting that such a claim could be patent eligible, Myriad thus recognized that an inventive concept can sometimes come from the discovery of an unknown natural phenomenon and its application for a diagnostic purpose. This appears to be in tension with Mayo. Under Mayo, a natural phenomenon itself, no matter how narrow and specific, cannot supply the requisite "inventive concept." See Mayo, 566 U.S. at 77-78, 88-89.

         Thus, it would be desirable for the Supreme Court to refine the Mayo framework to allow for sufficiently specific diagnostic patent claims with proven utility. In the life sciences, development of new diagnostic methods is often based on researching complex biological systems. The inventive concepts in this area may lie primarily in the application of a natural law.


         At the same time, Mayo's central concern was both important and consistent with the Patent Act. There is a substantial risk that overbroad claims involving natural laws may "preempt the use of a natural law" and thus "inhibit further discovery by improperly tying up the future use of laws of nature." Id. at 72, 85. In other words, there is a risk that granting overbroad patents could reward a mere concept rather than the work subsequently done by the actual inventor. The risks associated with such overbreadth are shown by the examples discussed earlier.

         In my view, the Mayo framework should be refined in limited respects. First, at step one of Mayo, the natural law cannot be claimed as such. See Gottschalk v. Benson, 409 U.S. 63, 67 (1972). As Mayo noted, "Einstein could not patent his celebrated law that E=mc2." 566 U.S. at 71 (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); see also Parker v. Flook, 437 U.S. 584, 591 (1978). Nor could a patent claimant "simply recite a law of nature and then add the instruction 'apply the law, '" such as if Einstein had claimed "a process consisting of simply telling linear accelerator operators to refer to the law." Mayo, 566 U.S. at 78. Where the natural law itself is so broadly claimed, there is no reason to address step 2 (the inventive concept). The claims are simply ineligible.

         At the same time, "all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas." Id. at 71. Thus, a sufficiently specific "application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." Id. (emphasis in original) (quoting Diamond v. Diehr, 450 U.S. 175, 187 (1981)).

         For there to be a patent eligible application of a natural law, there must be a "discover[y]," 35 U.S.C. § 101, and the claims must recite a specific application of that "discovery" with established utility. Otherwise, the natural law may be entirely preempted, even as to those aspects where the patent claimant has done no more than claim a broad conception. Requiring a specific application mitigates against the risk of granting patents too early-that is, before the patent applicant has devised a specific application of the natural law-and thereby prevents monopolization of the "basic tools of scientific and technological work." Mayo, 566 U.S. at 71 (quoting Benson, 409 U.S. at 67); Brenner v. Manson, 383 U.S. 519, 534-35 (1966) (noting that before a claimed invention is sufficiently "refined and developed," granting a patent "may confer power to block off whole areas of scientific development"); see generally Lemley, supra, at 1337-38 (arguing for a focus on claim scope under § 101 and noting that overly broad claims "make later improvements more costly or even impossible").

         The Supreme Court's opinion in O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1854), the foundation of the Court's jurisprudence on patent eligibility, appears to make this very distinction. There, the Court allowed Morse's narrower claims, which were tied specifically to his discovery: the telegraph. See id. at 112.[4] The Court reasoned that Morse "discover[ed] a method by which intelligible marks or signs may be printed at a distance" and that "for the [particular] method or process thus discovered, he is entitled to a patent." Id. at 117. But the Court held unpatentable Morse's claim to all "marking or printing [of] intelligible characters, signs, or letters, at any distances" via electric currents, because "the claim is too broad, and not warranted by law." Id. at 112-13. As in Mayo, the Court was particularly concerned about preempting use of the natural phenomenon: "For aught that we now know some future inventor, in the onward march of science, may discover a [different] mode of writing or printing at a distance by means of the electric or galvanic current . . . . But yet if it is covered by this patent the inventor could not use it, nor the public have the benefit of it without the permission of this patentee." Id. at 113.

         More recent opinions of the Supreme Court are also consistent with a focus on claims that sweep too broadly. In Benson, the Court observed that the claims were "so abstract and sweeping as to cover both known and unknown uses of" the mathematical formula at issue, and so held the claims ineligible. 409 U.S. at 67-68. Similarly, in Flook, the claims to "a formula for computing an updated alarm limit" could "cover a broad range of potential uses" and were also held ineligible. 437 U.S. at 586. By contrast, in Diehr, the Court held eligible claims that used a well-known mathematical equation in a process of curing synthetic rubber. 450 U.S. at 191-92. The patent claimants did "not seek to pre-empt the use of th[e] equation," but rather sought "only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process" for curing rubber. Id. at 187. Thus, the Supreme Court's precedents support a requirement of specific application as part of the patent eligibility inquiry as to natural laws.

         To ensure against overbroad claims, the scope of the § 101 natural law exception is necessarily informed by the utility requirement of § 101. The utility requirement has its origins in the constitutional grant of Congressional authority, which contemplated that the "discoveries" entitled to patents would be limited to those of proven utility. See U.S. Const. art. I, § 8, cl. 8; Sean M. O'Connor, The Overlooked French Influence on the Intellectual Property Clause, 82 U. Chi. L. Rev. 733, 792-93 (2015). And the statutory requirement of utility has been held by the Supreme Court to require that the claimed invention have established utility, not merely the prospect of future utility. Brenner, 383 U.S. at 534-36. In Brenner, the Supreme Court held that a patent claiming an allegedly novel process for making certain known steroids was ineligible for lack of utility. Id. The Court reasoned that without a showing of utility, "the metes and bounds of th[e] monopoly are not capable of precise delineation," and "[s]uch a patent may confer power to block off whole areas of scientific development, without compensating benefit to the public." Id. at 534. "Unless and until a process is refined and developed to this point- where specific benefit exists in currently available form- there is insufficient justification for permitting an applicant to engross what may prove to be a broad field." Id. at 534-35. It follows that the scope of patents involving the application of natural laws should not extend beyond established utility, and that claims that extend further are not patent eligible. Under this approach, because of their breadth, the claims in Mayo would not be eligible at step one. See Mayo, 566 U.S. at 87 (explaining that the claim steps were "set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways").

         However, if the claim is sufficiently tied to a specific and useful application of a natural law at Mayo step one, that application itself should serve as the necessary inventive concept at Mayo step two. Yet at step two, the application must be more than determining the precise correlation of a known relationship using prior art processes, as was the case in Mayo itself. In Mayo, "scientists already understood that the levels in a patient's blood of certain metabolites, including [those involved in the claims] were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective." Id. at 73-74. And "scientists routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds." Id. at 79. "But those in the field did not know the precise correlations between metabolite levels and likely harm or ineffectiveness." Id. at 74. Thus, Mayo's claims only involved determining the precise correlations of a law of nature that was already well known. The asserted application of the natural law was therefore no more than determining "the precise correlations between metabolite levels and likely harm or ineffectiveness" of a drug dosage and thus was patent ineligible.

         Requiring specific and useful application for the entire scope of the claim at Mayo step one, and more than determining precise correlations of a known natural law using prior art processes at Mayo step two, would ensure that the claims truly recite an "inventive application" of the natural law that should be eligible under § 101. This approach would help ensure that the reward of a patent goes to those who have actually done the work to develop a specific application of a natural law, not those who are the first to the patent office with broad, conceptual claims lacking proven utility in many applications.


         Finally, this case may involve claims that could be patent eligible under this suggested approach. First, claims 7-9 do not claim the natural law itself-the relationship between MuSK autoantibodies and MG, a rare neurological disorder-but rather claim specific methods of diagnosing neurological disorders like MG by detecting MuSK autoantibodies. See Athena, 915 F.3d at 747.[5] Second, unlike in Mayo, this case involves a "discovery" of the relationship, not mere determination of the precise correlations of a known natural law using prior art processes. As the panel noted, "[p]rior to the[] discovery [by the named inventors], no disease had been associated with MuSK." Id.

         Because at least some of the claims here recite specific applications of the newly discovered law of nature with proven utility, this case could provide the Supreme Court with the opportunity to refine the Mayo framework as to diagnostic patents.

          Chen, Circuit Judge, concurring with denial of the petition for rehearing en banc.

         "Congress plainly contemplated that the patent laws would be given wide scope." Bilski v. Kappos, 561 U.S. 593, 601 (2010) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980)). As the Court observed, "Congress took this permissive approach to patent eligibility to ensure that 'ingenuity should receive a liberal encouragement.'" Id. Consistent with that mandate, the Court in Diamond v. Diehr, 450 U.S. 175 (1981) adopted a relatively narrow and more administrable version of the judicial exceptions to the statutory text of 35 U.S.C. § 101 compared to what the Court articulated three years earlier in Parker v. Flook, 437 U.S. 584 (1978). Under Diehr's "claim as a whole" principle, which does not divide the claim into new versus old elements, Athena's claims, particularly claims 7 and 9, likely would have been found to be directed to a patent-eligible process comprising a set of technical, transformative steps to test a patient for a particular medical condition. But in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), the Court set forth an inventive concept/point of novelty framework, which is a more far-reaching, aggressive version of the judicial exceptions to the statute and is largely incompatible with Diehr's core rationale. At the same time, nothing in Mayo suggests that it sought to repudiate Diehr's analysis. While I believe our court would benefit from the Supreme Court's guidance as to whether it intended to override central tenets of Diehr, Mayo's reasoning is clear and we are bound by it. Because that analysis requires the affirmance of the district court's decision to invalidate Athena's claims, I concur with this court's decision to deny the petition for rehearing en banc.

         I. Flook AND Diehr

         In Flook, the Court articulated the notion that something else beyond an algorithm or law of nature recited in a claim must provide the key "inventive concept" to make a claim patent-eligible. 437 U.S. at 594. There, the claims recited a formula for computing an updated alarm limit, a number that signals the presence of an abnormal temperature, pressure, and flow rate combination indicating inefficiency or perhaps danger during catalytic conversion processes. Id. at 585. While the Court recognized that "a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm," id. at 590, it also declared that "the discovery of such a phenomenon cannot support a patent unless there is some other inventive concept in its application." Id. at 594. Because the recited field of use of catalytic conversion of hydrocarbons was "well known," and the formula received no credit in the analysis, the Court concluded that Flook's claim "contains no patentable invention." Id. The Court indicated that it had considered the claim "as a whole," but it did so by reviewing the claim on an element-by-element basis in search of something new and inventive, discounting the formula as "assumed to be within the prior art." Id. In so doing, the Court found no novel "inventive concept" in the claim. Id.

         The Court advanced a very different analytic approach for the judicial exceptions in Diamond v. Diehr, 450 U.S. 175 (1981), one that is difficult to reconcile with much of Flook's reasoning. The Court held patent-eligible under § 101 a claim for a process of constantly measuring the temperature inside a molding press to determine when to remove a cured rubber product. Id. at 192-93. The relationship between temperature and cure relied on a known mathematical equation, but the Court found that, when the overall patent claim was considered as a whole, the respondents did "not seek to patent a mathematical formula," but instead "[sought] protection for a process of curing synthetic rubber." Id. at 187. Rejecting a point of novelty inquiry for § 101, the Court stated: "The 'novelty' of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Id. at 188-89; id. at 193 n.15 ("The fact that one or more of the steps in [a claimed] process may not, in isolation, be novel or independently eligible for patent protection is irrelevant to the question of whether the claims as a whole recite subject matter eligible for patent protection under § 101.") (emphasis in original); see also id. at 190 ("The question therefore of whether a particular invention is novel is 'wholly apart from whether the invention falls into a category of statutory subject matter.'" (quoting In re Bergy, 596 F.2d 952, 961 (C.C.P.A. 1979))).

         Furthermore, Bilski recognized the interplay between Diehr and Flook, pointing out that Diehr "established a limitation on the principles articulated in [Gottschalk v.] Benson and Flook" in that "Diehr emphasized the need to consider the invention as a whole, rather than 'dissect[ing] the claims into old and new elements . . . in the analysis.'" Bilski, 561 U.S. at 611 (quoting Diehr, 450 U.S. at 188). Thus, as recently as Bilski, the Court understood Diehr as requiring consideration of the claim as a whole, including any mathematical formula or scientific principle, in the § 101 inquiry, and as rejecting any dissection of the claim in search of novel or unconventional components.

         Aside from reaffirming the result in Flook, the Diehr Court addressed Flook's takeaway meaning at two different points in the opinion. First, Diehr observed: "Our recent holdings in Gottschalk v. Benson, supra, and Parker v. Flook, supra, both of which are computer-related, stand for no more than [the] long-established principles" that "[e]xcluded from such patent protection are laws of nature, natural phenomena, and abstract ideas." 450 U.S. at 185 (citing Flook and other cases describing the judicial exceptions, e.g., "[a] principle[] in the abstract . . . cannot be patented."). Second, Diehr explained the defect in the Flook claim in the following way: "A mathematical formula does not suddenly become patentable subject matter simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use . . . . All the application provided was a 'formula for computing an updated alarm limit.'" Id. at 192 n.14 (quoting Flook, 437 U.S. at 586). The Diehr Court thus regarded the Flook claim as merely reciting a formula that would be applicable in an industrial process, but not reciting an industrial process itself.[1] Aside from these two points, Diehr did not restate any other principles expressed in Flook.

         That Diehr established a limitation on Flook and rejected the point of novelty/inventive concept approach to patent eligibility is underscored by the protests within the Diehr dissent. See Diehr, 450 U.S. at 204-16. "Proper analysis," in the dissent's view, "must start with an understanding of what the inventor claims to have discovered- or phrased somewhat differently-what he considers his inventive concept to be." Id. at 212. Because the claim had "no other inventive concept" other than the addition of a mathematical algorithm to the otherwise conventional claimed process for curing rubber, the dissent would have found the Diehr claim ineligible. Id. at 213-14. The Diehr majority responded: "In order for the dissent to reach its conclusion it is necessary for it to read out of respondents' patent application all the steps in the claimed process which it determined were not novel or 'inventive.' That is not the purpose of the § 101 inquiry and conflicts with the proposition recited above that a claimed invention may be entitled to patent protection even though some or all of its elements are not 'novel.'" Id. at 193 n.15.

         Given Diehr's evident disagreement with Flook's analysis, Diehr, as the later opinion, was widely understood to be the guiding, settled precedent on § 101 for three decades. See, e.g., Arrhythmia Research Tech., Inc. v. Corazo-nix Corp., 958 F.2d 1053, 1057 n.4 (Fed. Cir. 1992) ("Although commentators have differed in their interpretations of Benson, Flook, and Diehr, it appears to be generally agreed that these decisions represent evolving views of the Court, and that the reasoning in Diehr not only elaborated on, but in part superseded, that of Benson and Flook.") (citing R.L. Gable & J.B. Leaheey, The Strength of Patent Protection for Computer Products, 17 Rutgers Computer & Tech. L.J. 87 (1991); D. Chisum, The Patentability of Algorithms, 47 U. Pitt. L. Rev. 959 (1986)); see also Edward W. Roush, Jr., Patent Law-Patentable Subject Matter-Manufacturing Process Which Includes Use of Mathematical Formula and Computer Program Constitutes Patentable Subject Matter, 13 St. Mary's L.J. 420, 428-29 (1981) ("The Diehr Court's holding is entirely consistent with title 35, section 101 subject matter standards. Although both the majority and dissent acknowledged that Diehr presented a section 101 statutory subject matter question, the dissent improperly injected considerations of section 102 novelty into its analysis. The majority in Flook employed the same rationale.").

         II. Mayo AND Alice

         Three decades after Diehr, Mayo provided a framework for the judicial exceptions that strongly tracked the reasoning of Flook and the Diehr dissent. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). The claims in Mayo were for a method of optimizing the treatment of an immune-mediated gastrointestinal disorder comprising two physical steps: (1) administering a synthetic drug to a patient, and (2) determining the concentration level of certain metabolic byproducts in the patient's bloodstream. The claims also included two "wherein" clauses, reciting that the measured level indicates whether the patient has received a safe and effective dose. Id. at 74-75. The Court found that the "wherein" clauses incorporate a law of nature: the relationship between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm. Id. at 78. Because the two physical steps were well-known in the prior art, the Mayo Court characterized these claims as adding to that law of nature nothing more than "well-understood, routine, conventional activity." Id. at 73, 79-80.

         Citing primarily to Flook, as well as Bilski, the Court stated that its prior decisions "insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself." Id. at 72-73. Because, in the Court's view, "the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field," the claims lacked any inventive concept. Id. at 73. Moreover, the Court did not share the concerns Diehr expressed as to preserving a doctrinal distinction between §§ 101 and 102; instead, the Court noted: "We recognize that, in evaluating the significance of additional steps [beyond the law of nature] the § 101 patent eligibility inquiry and, say, the § 102 novelty inquiry might sometimes overlap." Id. at 90. Mayo's rationale thus follows the point of novelty/inventive concept reasoning of Flook and the Diehr dissent.

         As such, Mayo is in considerable tension with Diehr's instruction to consider claims "as a whole" and Diehr's disapproval of dissecting claims into elements and ignoring non-novel elements in the § 101 analysis. 450 U.S. at 188. The Mayo Court indicated that it considered the claimed steps "as an ordered combination," but it excluded the law of nature from that review and concluded that the "ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately." 566 U.S. at 79. In other words, after setting aside the law of nature, "any additional steps consist[ed] of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add[ed] nothing significant beyond the sum of their parts taken separately." Id. at 79-80. The Court found support for this understanding of the judicial exceptions in Flook, observing that, for the Flook claim, the steps of monitoring a catalytic conversion process "were all 'well known,' to the point where, putting the formula to the side, there was no 'inventive concept' in the claimed application of the formula." Id. at 82. That type of "ordered combination" review ("putting the formula to the side"), however, is fundamentally different from Diehr's "claim as whole" principle, which does not carve out the judicial exception from the patent eligibility inquiry, nor does it dismiss elements that lack novelty.[2] See Diehr, 450 U.S. at 188-93.

         In Alice, the Court reaffirmed this reversion to Flook, reiterating that, if the claims at issue are directed to laws of nature, natural phenomena, or abstract ideas, then we must ask "what else is there in the claims before us?" And in doing so, we must "consider the elements of each claim individually and 'as an ordered combination' to determine whether the additional elements 'transform the nature of the claim' into a patent-eligible application." Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208, 217 (2014) (quoting Mayo, 566 U.S. at 78-79) (emphases added). As in Mayo, Alice described the second step of this analysis "as a search for an 'inventive concept'" that discounts the law of nature or abstract idea from that inquiry. Id. (quoting Mayo, 566 U.S. at 72-73); see also id. at 221 ("A claim that recites an abstract idea must include 'additional features' to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" (quoting Mayo, 566 U.S. at 77)).[3]

         When it comes to applying the judicial exceptions, it bears noting that the Mayo analytical approach is considerably harder to apply consistently than the Diehr framework, and more aggressive in its reach. Consider the claim in Mayo. If that claim had recited just the single step of administering a synthetic drug to a patient, that single-step claim would be patent-eligible, but lack novelty under § 102. And if that claim added a second step for determining the subsequent level of a non-naturally occurring metabolite in a patient, that claim also would pass muster under § 101, but lack novelty. But when the claim further recites a relationship between a metabolite level and its efficacy in a patient, that claim suddenly would be invalid under § 101 for violating the law of nature exception. In other words, steps 1 and 2 now get pushed aside and declared insignificant, and the last step is designated as the "focus" of the claim, i.e., the heart of the invention. The notion that adding claim language can convert an otherwise patent-eligible claim into a patent-ineligible claim is counterintuitive and a very difficult thing to explain to 8, 000 patent examiners.[4] Moreover, the process of determining what the claim is "really about" when the claim is viewed in pieces, rather than as a whole, can be highly subjective and impressionistic. This approach puts courts and examiners in the position of assigning value judgments to individual limitations, designating some as "significant" and others as "insignificant," and hoping everyone else reaches the same conclusion as to whether the claim contains a truly meritorious inventive contribution as opposed to a judicial exception embellished with insignificant window dressing. And all this just to resolve the threshold question of whether an invention is eligible for the patent system.

         As written, Mayo requires a patent claim to have an inventive concept apart from the recitation of a natural law. That requirement has consequences that go beyond the facts of Mayo and is certainly clear enough that we are obliged to follow it. But, as explained above, Mayo's framework is in tension on its face with Diehr, which was equally clear in requiring that a patent claim be considered as a whole, without putting aside any natural law or otherwise dissecting a claim into new versus old elements. Moreover, nothing in Mayo suggests that it sought to repudiate anything in Diehr; it instead suggests that it sought to maintain continuity with the Court's prior cases in this area. As for Flook, the Court in Bilski acknowledged that Diehr had "established a limitation" on Flook by "emphasiz[ing] the need to consider the invention as a whole, rather than 'dis-sect[ing] the claims into old and new elements . . . in the analysis.'" Bilski, 561 U.S. at 611 (quoting Diehr, 450 U.S. at 188). Importantly, Mayo does not say that it nullified this key "limitation" expressed in Diehr. Furthermore, as Judge Dyk points out in his concurrence, the Court's opinion in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), which issued after Mayo, could be read as potentially maintaining an open door for diagnostic claims such as Athena's, because they may be regarded as applications of knowledge of discovered natural laws. See Dyk Concurrence at 7. Myriad thus could suggest that Mayo should not go as far as its language indicates.

         Through it all, there is a serious question today in patent law as to what extent Diehr remains good law in light of Mayo. We are not in a position to resolve that question, but the Supreme Court can. Resolution of the present confusion is important because if Mayo in fact overruled the principles in Diehr (as reiterated in Bilski), then that would be a significant incursion on the settled expectations that had existed for 30 years since Diehr. Relying on the Diehr framework, the Patent Office examined and granted many patents for medical diagnostic methods, establishing settled expectations in those granted property rights, and prompted companies and research institutions to organize their conduct and choices accordingly. Many of these diagnostic claims, including the ones at issue here, do not hold up well against Mayo's more searching, claim dissection scrutiny.

         III. Athena's Claims

         Judge Newman, Judge Moore, the petitioner, and the amici raise several valid concerns. But I believe the reasoning underlying recent Supreme Court decisions compels us to affirm the district court's invalidity determination here. While Diehr long established that we must evaluate "the claim as a whole" for § 101 purposes, that principle has been considerably undermined, for we've been recently instructed to ask for claims such as Athena's, "do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?" Mayo, 566 U.S. at 77 (emphases in original). Moreover, "[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." Id. at 79.

         It appears to me that, per Mayo, because the association of an antibody and a medical disorder is deemed to be a law of nature rather than an application of a law of nature, detecting that law of nature, by using data gathering steps or devices that can be said to be basic, conventional, or obvious, fails § 101. This is in contrast to examples, such as Diehr and Neilson, in which, as characterized by Mayo, the claimed inventions included unconventional steps beyond reliance on an abstract scientific principle. Mayo, 566 U.S. at 80-81, 83-84. In other words, the Supreme Court has made clear that detecting a law of nature (without more than conventional steps for accessing the law of nature) does not qualify as a patent-eligible application of a law of nature.

         Here, the inventors of Athena's U.S. Patent No. 7, 267, 820 discovered an association between the disorder myasthenia gravis and the presence of muscle specific ty-rosine kinase (MuSK) ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.