In Illumina, Inc., v. Ariosa Diagnostics, Inc., [2019-1419] (March 17, 2020) the Federal Circuit reversed the district court’s determination that claims of U.S. Patent Nos. 9,580,751 and 9,738,931 were invalid under 35 U.S.C. § 101 as directed to an ineligible natural phenomenon.

Illumina’s related U.S. Patent 6,258,540, which claimed a method for detecting the small fraction of paternally inherited cell-free fetal DNA in the plasma and serum of a pregnant woman, were famously held invalid under 35 U.S.C. § 101 back in 2015 because they were directed to “matter that is naturally occurring”—i.e., the natural phenomenon that cell-free fetal DNA exists in maternal blood.  The ‘751 and ‘931 patents presently at issue were based upon the “surprising” discovery that the majority of the circulatory extracellular fetal DNA has a relatively small size of approximately 500 base pairs or less, which meant that fetal DNA could be amplified by separating extracellular DNA fragments which are smaller than approximately 500 base pairs.

The Federal Circuit noted that this was not a diagnostic invention, or a treatment invention, but a method of preparation invention, and applied the two step Alice/Mayo test.  At Step 1, the Federal Circuit said it was undisputed that the inventors of the ’751 and ’931 patents discovered a natural phenomenon. But at step one of the Alice/Mayo test, “it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’”   After noting the parties difficulty in identifying the natural phenomenon involved, the Federal Circuit identified the natural phenomenon: that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream. Turning to the crucial question of whether the claims are “directed to” that natural phenomenon, the Federal Circuit concluded that the claims are not directed to that natural phenomenon but rather to a patent-eligible method that utilizes it.

The Federal Circuit explained the claims in this case are directed to methods for pre-paring a fraction of cell-free DNA that is enriched in fetal DNA. The methods include specific process steps—size dis-criminating and selectively removing DNA fragments that are above a specified size threshold—to increase the relative amount of fetal DNA as compared to maternal DNA in the sample.  These process steps change the composition of the mixture, resulting in a DNA fraction that is different from the naturally-occurring fraction in the mother’s blood. Thus, the process achieves more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon.

Roche insisted that the claims in this case are no more eligible than the claims at issue in Ariosa, but the Federal Circuit disagreed, noting that in Ariosa, the relevant independent claims were directed to a method “for detecting a paternally inherited nucleic acid” or a method “for performing a prenatal diagnosis,” and the only operative steps in the claims were “amplifying” (i.e., making more of) the cell-free fetal DNA and then “detecting [it],” “subjecting [it] . . . to a test,” or “performing nucleic acid analysis on [it] to detect [it].” The claims were ineligible because, like the invalid diagnostic claims at issue in Mayo, Athena, and Cleveland Clinic, they were directed to detecting a natural phenomenon.

This case shows the importance of how the invention is characterized to the 101 analysis

In Customedia Technologies, LLC v. Dish Network Corporation, [2018-2239, 2019-1000] (March 6, 2020), the Federal Circuit affirmed the PTAB’s determination that U.S. Patent Nos. 8,719,090 and 9,053,494 on comprehensive data management and processing systems were ineligible under 35 U.S.C. §101.

The Federal Circuit followed the Supreme Court’s two-step framework for determining patent-eligibility under §101. At Step 1, the Federal Circuit found that the claims at issue here were directed to the abstract idea of using a computer to deliver targeted advertising to a user, not to an improvement in the functioning of a computer.  The Federal Circuit explained that to be a patent-eligible improvement to computer functionality, it requires the claims to be directed to an improvement in the functionality of the computer or network platform itself. Improving a user’s experience while using a computer application is not, without more, sufficient to render the claims directed to an improvement in computer functionality. In sum, software can make non-abstract improvements to computer technology just as hardware improvements can.  But to be directed to a patent-eligible improvement to computer functionality, the claims must be directed to an improvement to the functionality of the computer or network platform itself.

At step two, the Federal Circuit agreed with the Board that the elements of the claims, considered individually and as an ordered combination, fail to recite an inventive concept. The Federal Circuit noted that aside from the abstract idea of delivering targeted advertising, the claims recite only generic computer components, including a programmable receiver unit, a storage device, a remote server and a processor.  Such generic and functional hardware is insufficient to render eligible claims directed to an abstract idea.  The invocation of already-available computers that are not themselves plausibly asserted to be an advance amounts to a recitation of what is well-understood, routine, and conventional.

In American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, [2018-1763] (October 3, 2019), the Federal Circuit affirmed summary judgment that the asserted claims of U.S. Patent No. 7,774,911 on a method for manufacturing driveline propeller shafts designed to attenuate vibrations transmitted through a shaft assembly were ineligible under §101.

1. A method for manufacturing a shaft assembly of a driveline system, the driveline system further including a first driveline component and a second driveline component, the shaft assembly being adapted to transmit torque between the first driveline component and the second driveline component, the method comprising:
providing a hollow shaft member;
tuning at least one liner to attenuate at least two types of vibration transmitted through the shaft member; and
positioning the at least one liner within the shaft member such that the at least one liner is configured to damp shell mode vibrations in the shaft member by an amount that is greater than or equal to about 2%, and the at least one liner is also con-figured to damp bending mode vibrations in the shaft member, the at least one liner being tuned to within about ±20% of a bending mode natural frequency of the shaft assembly as installed in the driveline system.

Two types of attenuation were involved — resistive attenuation and reactive attenuation. Resistive attenuation of vibration employs something that deforms as vibration energy is transmitted through it absorbing the vibration energy. Reactive attenuation of vibration refers to a mechanism that can oscillate in opposition to the vibration energy to thereby ‘cancel out a portion of the vibration energy.

The analysis of § 101 follows the Supreme Court’s two-step test established in Mayo and Alice, asking first whether the claims are directed to a law of nature, natural phenomenon, or abstract idea, and second whether the claims embody some “inventive concept”—i.e., whether the claims contain “an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.

The claims are directed to tuning liners—i.e., controlling a mass and stiffness of at least one liner to configure the liner to match the relevant frequency or frequencies. It was known that vibrations could be damped by resistive attenuation and that bending mode vibrations could be damped by reactive attenuation. the selection of frequencies for the liners to damp the vibrations of the propshaft at least in part involves an application of Hooke’s law. The problem, the Federal Circuit found, was that the solution to these desired results is not claimed in the patent.

The elements of the method here that AAM argues take the patent outside the realm of ineligible subject matter i.e., the mechanisms for achieving the desired result—are not actually claimed in the claims. The Federal Circuit noted that “the patent specification recites only a nonexclusive list of variables that can be altered to change the frequencies exhibited by a liner and a solitary example of a tuned liner (though not the process by which that liner was tuned).” “Most significantly,” the Federal Circuit said, the claims do not instruct how the variables would need to be changed to produce the multiple frequencies required to achieve a dual-damping result, or to tune a liner to dampen bending mode vibrations.

The Federal Circuit said that this case might well be significantly different, if, for example, specific models were included in the claims. But, the claims’ general instruction to tune a liner amounts to no more than a directive to use one’s knowledge of Hooke’s law, and possibly other natural laws, to engage in an ad hoc trial-and-error process of changing the characteristics of a liner until a desired result is achieved. The Federal Circuit said that this claiming of a natural law runs headlong into the very problem repeatedly identified by the Supreme Court in its cases shaping eligibility analysis.

Citing Parker v. Flook, the Federal Circuit said “if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is nonstatutory.” In contrast, the Federal Circuit noted that in Diamond v. Diehr, the claims recited other steps apparently adding to the formula something that in terms of patent law’s objectives had significance—they transformed the process into an inventive application of the formula.

The Federal Circuit concluded that the claims here simply instruct the reader to tune the liner—a process that, as explained above, merely amounts to an application of a natural law (Hooke’s law) to a complex system without the benefit of instructions on how to do so. The focus of the claimed advance here is simply the concept of achieving that result, by whatever structures or steps happen to work. Thus the subject matter of the claims was not patent eligible.

Judge Moore dissented, observing that “[t]he majority opinion parrots the Alice/Mayo two-part test, but reduces it to a single inquiry: If the claims are directed to a law of nature (even if the court cannot articulate the precise law of nature) then the claims are ineligible and all evidence of non-conventionality will be disregarded or just plain ignored.” Judge Moore quoted the majority that “it makes no difference to the section 101 analysis whether the use of liners to attenuate bending mode vibration was known in the prior art,” saying that this disregarded the second part of the Mayo test.

Judge Moore argues that the majority’s concern with the claims at issue had “nothing to do with a natural law and its preemption and everything to do with concern that the claims are not enabled.” Respectfully, there is a clear and explicit statutory section for enablement, § 112. We cannot convert § 101 into a panacea for every concern we have over an invention’s patentability, especially where the patent statute expressly addresses the other conditions of patentability and where the defendant has not challenged them.”

Judge Moore was also concerned that the natural law two which the claims were supposedly directed, was never identified, saying “Section 101 is monstrous enough, it cannot be that now you need not even identify the precise natural law which the claims are purportedly directed to.”

Judge Moore also took exception to the majority’s rejection of the inventive concepts asserted by the patentee, first as inaccurate (a fact finding made by the majority on appeal and contrary to all the evidence of record) and second as irrelevant. Judge Moore said that “[u]ltimately, the majority says the inventive concept “makes no difference to the section 101 analysis” — a statement she takes to be an outright rejection of the second step of the Alice/Mayo test.

Judge Moore concludes that “[t]he majority’s true concern with these claims is not that they are directed to Hooke’s Law (because this is clearly a much more complex system not limited to varying mass and stiffness), but rather the patentee has not claimed precisely how to tune a liner to dampen both bending and shell mode vibrations.” Thus the issue was really not one of eligibility, but rather one of enablement. She said: “[a] patentee’s failure to enable his invention renders the claims invalid under § 112, it does not, however, render the claims ineligible under § 101.

Judge Moore finishes: “The majority’s validity goulash is troubling and inconsistent with the patent statute and precedent. The majority worries about result-oriented claiming; I am worried about result-oriented judicial action. I dissent.”

In Mymail, Ltd. v. Oovoo, LLC, [2018-1758, 2018-1759] (August 16, 2019), the Federal Circuit vacated and remanded judgment on the pleadings, the district court erred by declining to resolve the parties’ claim construction dispute before adjudging patent eligibility.

The district court found U.S. Patent Nos. 8,275,863 and 9,021,070 were directed to patent ineligible subject matter under 35 U.S.C. § 101. The district court concluded that the MyMail patent claims are directed to an abstract idea because they “fall within the category of gathering and processing information” and “recite a process comprised of transmitting data, analyzing data, and generating a response to transmitted data.” At Alice step two, the district court concluded that the claims fail to provide an inventive concept sufficient to save the claims.

The Federal Circuit said that Patent eligibility may be determined on a Rule 12(c) motion, but only when there are no factual allegations that, if taken as true, prevent resolving the eligibility question as a matter of law. The Federal Circuit said that determining patent eligibility requires a full under-standing of the basic character of the claimed subject matter. As a result, if the parties raise a claim construction dispute at the Rule 12(c) stage, the district court must either adopt the non-moving party’s constructions or resolve the dispute to whatever extent is needed to conduct the § 101 analysis.

Before the district court, the parties disputed the construction of “toolbar,” a claim term present in the claims of both MyMail patents. MyMail directed the district court to a construction of “toolbar” rendered in another case involving the MyMail patents. The Federal Circuit noted that the district court never addressed the parties’ claim construction dispute. Nor did the district court construe “toolbar” or adopt MyMail’s proposed construction of “toolbar” for purposes of deciding ooVoo’s and IAC’s Rule 12(c) motions.

The Federal Circuit concluded that the district court erred by failing to address the parties’ claim construction dispute before concluding, on a Rule 12(c) motion, that the MyMail patents are directed to patent-ineligible sub-ject matter under § 101, and vacated and remanded for further proceedings consistent with this opinion.

In Trading Technologies International, Inc. v. IBG LLC, [2017-2257] (April 18, 2019), the Federal Circuit affirmed the determination of the Board that the challenged claims in U.S. Patent Nos. 7,533,056, 7,212,999, and 7,904,374 in meet the criteria to be eligible for CBM review and the claims are ineligible under 35 U.S.C. § 101. The Board additionally held that the claims of the ’056 patent would have been obvious.

With respect to the ‘999 patent, the Board determined that the claims were directed to “the abstract idea of graphing (or displaying) bids and offers to assist a trader to make an order.” The Federal Circuit agreed, noting it has treated collecting information, including when limited to particular content (which does not change its character as information), as within the realm of abstract ideas. The Federal Circuit also agreed that placing an order based on displayed market information is a fundamental economic practice, and the fact that the claims add a degree of particularity as to how an order is placed does not change the analysis. The Federal Circuit said that the fact that this is a “computer-based method” did not not render the claims non-abstract, the specification indicating that the claimed GUI is displayed on any computing device. The collection, organization, and display of two sets of information on a generic display device is abstract. At step II, the Federal Circuit agreed with the Board that the claims do not contain an inventive concept, either individually or as an ordered combination.

With respect to the ‘056 Patent, the Board found the claims were directed to the abstract idea of graphing (or displaying) bids and offers to assist a trader to make an order. The Federal Circuit found no meaningful difference between ‘056 patents and the ‘999 patent. At Step II, the Board held the elements, both individually and as an ordered combination, do not recite an inventive concept. The Federal Circuit rejected the argument that the invention improves computer functionality, noting that the invention helps the trader process information more quickly, but this is not an improvement to computer functionality.

With respect to the ‘374 patent, the Board held that the claims of the ’374 pa-tent were directed to the abstract idea of receiving user input to send a trade order. This may be because the claims were drafted too broadly. The Board noted that while the claims require “displaying . . . graphical locations along an axis” they did not require the graphical locations to display the price levels that are mapped to them. At Step II, the Board held the elements of the claims, individually or as an ordered combination, do not add an inventive concept. The Board noted that the specification discloses that the invention can be implemented “on any existing or future terminal or device” and describes the programming as insignificant. The Federal Circuit agreed, adding that the claims do not solve any purported technological problem.

When the Federal Circuit concedes that even meritorious inventions are sometimes patent ineligible, one can start to believe that overcoming Section 101 is hopeless. However Trading Technologies teaches a few things: (1) Make sure that the technical details actually make it into the claims; (2) Identify a technological problem that is solved; and (3) Avoid sweeping statements that the invention can be implemented conventional equipment. Good luck.

In Chargepoint, Inc. v. Semaconnect, Inc., [2018-1739] (March 28, 2019), the Federal Circuit affirmed the 12(b)(6) dismissal of a claim of infringement of U.S. Patent Nos. 8,138,715; 8,432,131, 8,450,967, and 7,956,570 because the claims charging stations for electric vehicles were ineligible for patenting.

ChargePoint contended that its inventors created improved charging stations that address the various needs inherent in electric vehicle charging by creating networked charging stations.

At step one of the Mayo/Alice inquiry, the court must first determine whether the claims at issue are directed to a patent-ineligible concept. Because at some level, all inventions embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas, it is not enough to merely identify a patent-ineligible concept underlying the claim; the court must determine whether that patent-ineligible concept is what the claim is “directed to.”

With respect to claims 1 and 2 of the ‘715 patent, the Federal Circuit found that looking at the problem identified in the patent, as well as the way the patent describes the invention, the specification suggests that the invention of the patent is nothing more than the abstract idea of communication over a network for interacting with a device, applied to the context of electric vehicle charging stations. In short, the inventors here had the good idea to add networking capabilities to existing charging stations to facilitate various business interactions, but that is where they stopped, and that is all they patented. The Federal Circuit thus concluded that the claims were directed to an abstract idea.

With respect to claims 1 and 8 of the ‘131 patent. The Federal Circuit noted that claim 1 of the ‘131 patent was similar to claim 1 of the ‘715 patent. ChargePoint argued that the electricity flow is modified based on demand response principles, but the Federal Circuit found that this does nothing to make this claim directed to something other than the abstract idea. The Court noted that demand response is itself an abstract concept—a familiar business choice to alter terms of dealing to help match supply and demand. The Federal Circuit said that adding one abstract idea to another abstract idea does not render the claim non-abstract. Thus the Federal Circuit concluded that claims were also directed to the abstract idea of communicating over a network.

Claims 1 and 2 of the ‘967 patent are method claims that are similar to the apparatus claims the Federal Circuit had already analyzed. ChargePoint focused its arguments on the ability to modify an electric vehicle charging station’s operation based on a demand response business policy, but the Federal Circuit pointed out that the patent never discusses any technical details regarding how to modify electricity flow, and the fact that any modifications are made in response to a demand response policy merely adds one abstract concept to another. The Federal Circuit concluded that We thus conclude that claims 1 and 2 of the ʼ967 patent are directed to the abstract idea of communicating over a network.

Lastly, with respect to claims 31 and 32 of the ‘570 patent, while the Federal Circuit noted that these claims were in a different form than claim 1 of the ʼ715 patent, it found the analysis of that claim applicable. The Federal Circuit said that the only improvement alleged is use of the concept of network communication to interact with the particular devices. This remains the focus of these two claims, thus making both directed to an abstract idea.

The Federal Circuit concluded that while the eight claims on appeal vary in some respects, they are all directed to the abstract idea of communicating over a network for device interaction. The Court said that communication over a network for that purpose has been and continues to be a “building block of the modern economy.”

At Step II of the Alice inquiry, the Federal Circuit noted that the alleged “inventive concept” that solves problems identified in the field is that the charging stations are network-controlled. But network control is the abstract idea itself, and a claimed invention’s use of the ineligible concept to which it is directed cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept. The Federal Circuit analyzed the asserted technical improvements of each claim, but concluded that they were insufficient to make the claimed inventions not abstract.

In Endo Pharmaceuticals Inc., v. Teva Pharmaceuticals USA, Inc., [ 2017-1240, 2017-1455, 2017-1887](March 28, 2019), the Federal Circuit reversed the district court’s determination that the claims of U.S. Patent No. 8,808,737 ineligible under 35 U.S.C. § 101.

The ’737 patent, entitled “Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment” covers a method of using oxymorphone to treat pain in patients with impaired kidney function. The method adjusted the level of oxymorphone administered based upon the severity of the renal impairment.

The magistrate judge first analyzed step 1 of the Alice/Mayo test, reasoning that the claims are directed to the natural law that the bioavailability of oxymorphone is increased in people with severe renal impairment. The district court adopted the magistrate judge’s recommendation, finding the patent claims ineligible.

At step one of the Alice/Mayo, the Federal Circuit said “it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’” Applying this law, the Federal Circuit concluded that the asserted claims are not directed to patent-ineligible subject matter. On the contrary, the Federal Circuit found that the claims were directed to a patent-eligible method of using oxymorphone or a pharmaceutically acceptable salt thereof to treat pain in a renally impaired patient. This conclusion was supported by the claim language itself and confirmed by the specification, the claims, the abstract, patent title, and summary of the invention all describe the invention as a “method of treating pain” in patients with renal impairment.

The claims at issue here are legally indistinguishable from the representative claim in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd, 887 F.3d 1117 (Fed. Cir. 2018). Both claims recite a method for treating a patient. The Vanda patent claims recite the steps of carrying out a dosage regimen based on the results of genetic testing, while in the instant case the claims similarly recite the steps of carrying out a dosage regimen, though the steps are based on the results of kidney function testing. Additionally, the claims in both cases require specific treatment steps.

The Federal Circuit distinguished Mayo in part because the claims as a whole were not directed to the application of a drug to treat a particular disease. The Federal Circuit noted that the inventor here recognized the relationship between oxymorphone and patients with renal impairment, but that is not what he claimed. Rather, he claimed an application of that relationship—specifically, a method of treatment including specific steps to adjust or lower the oxymorphone dose for patients with renal impairment. The claims are thus directed to more than just reciting the natural relationship.

The Federal Circuit concluded that the ’737 patent claims are like those in Vanda. They are eligible because they are “directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” Finding “[o]ur precedent leaves no room for a different outcome.”

In Natural Alternatives International, Inc. v. Creative Compounds, LLC, [2018-1295](March 15, 2019), the Federal Circuit reversed and remanded judgment on the pleadings that the asserted claims of U.S. Patent Nos. 5,965,596, 7,825,084, 7,504,376, 8,993,610, 8,470,865, and RE45,947
relating to dietary supplements containing beta-alanine, are not patent eligible.

The district purported accepted Natural Alternatives’ proposed claim constructions, in finding that the subject matter ineligible. However, the Federal Circuit found that the proposed claim constructions, we hold that the complaint’s factual allegations, together with all reasonable inferences, plausibly establish the eligibility of the representative claims. While the Method Claims have similarities to the claims found ineligible in Mayo, as they utilize an underlying natural law, this is not sufficient to establish that they are directed to that law. Under Natural Alternatives’ constructions, the Method Claims require specific steps be taken in order to bring about a change in a subject, altering the subject’s natural state.

The Federal Circuit said that like the claims in Vanda, the Method Claims contain specific elements that clearly establish they are doing more than simply reciting a natural law. Like the Vanda claims, which specify a patient population to be treated, the Method Claims specify particular results to be obtained by practicing the method. The Federal Circuit also noted that while beta-alanine may exist in nature, Natural Alternatives has argued that the quantities being administered do not, and that the claimed consumption greatly exceeds natural levels.

The Federal Circuit concluded that the Method Claims at issue are treatment claims. They cover using a natural product in unnatural quantities to alter a patient’s natural state, to treat a patient with specific dosages outlined in the patents. The Federal Circuit held that the Method Claims are not directed to ineligible subject matter.

The Federal Circuit further noted that at step two, factual impediments exist to resolving the case at this stage.

As to the product claims, the Federal Circuit noted that although beta-alanine is a natural product, the Product Claims are not directed to beta-alanine. The Federal Circuit said that a claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and “the potential for significant utility.” At this stage in the litigation, the Federal Circuit found that it has been sufficiently alleged that these characteristics provide significant utility, as the claimed dosage forms can be used to increase athletic performance in a way that naturally occurring beta-alanine cannot. Accordingly, neither claim is directed to ineligible subject matter.

In University of Florida Research Foundation, Inc., v. General Electric Company, [2018-1284] (February 26, 2019), the Federal Circuit affirmed the determination that the claims of U.S. Patent No. 7,062,251 are directed to ineligible subject matter under 35 U.S.C. § 101.

At the outset, the Federal Circuit determined that the University of Florida Research Foundation waived its sovereign immunity claims by suing General Electric in the first place.

The ’251 patent describes a method and system for integrating physiologic data from at least one bedside machine. At Alice step one, the district court determined the claims are directed to the abstract idea of “collecting, analyzing, manipulating, and displaying data.” At Alice step two, the district court found that the claims did not recite an inventive concept.

The Federal Circuit agreed that the claims were ineligible, noting the ’251 patent seeks to automate “pen and paper methodologies” to conserve human resources and minimize errors. The Federal Circuit said that it was a quintessential “do it on a computer” patent: it acknowledges that data from bedside machines was previously collected, analyzed, manipulated, and displayed manually, and it simply proposes doing so with a computer. We have held such claims are directed to abstract ideas.

The Federal Circuit noted that the fact that the automation can “result in life altering consequences,” is laudable, but it does not render it any less abstract. The Federal Circuit noted that neither the ’251 patent, nor its claims, explains how the drivers do the conversion that UFRF points to. The drivers are described in purely functional terms: they “facilitate data exchanges,” “convert received data streams to a format independent of any particular bedside machine,” “translate the data stream,” “interpret data streams,” “facilitate communications with the bedside machine,” and “interpret [discrete] segments” in a “data stream for the machine.” The Federal Circuit said that the ’251 patent “fails to provide any technical details for the tangible components, . . . instead predominately describ[ing] the system and methods in purely functional terms.” The Federal Circuit concluded that at Alice step one that representative claim 1 is directed to the abstract idea of “collecting, analyzing, manipulating, and displaying data,” and observing the claims fare no better at Alice step two.

In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, [2017-2508] (February 6, 2019), the Federal Circuit affirmed the district court’s holding that claims 6–9 of U.S. Patent 7,267,820 (the “’820 patent”) are invalid under
35 U.S.C. § 101 and dismissing Athena’s complaint under Rule 12(b)(6).

The inventors discovered the association between MuSK autoantibodies
and Myasthenia gravis, and in the ’820 patent disclosed and claimed methods of diagnosing neurological isorders such as MG by detecting autoantibodies that bind to a MuSK epitope.

The Federal Circuit agreed that the claims were directed to a natural law, specifically, the correlation between the presence of naturally-occurring
MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG. The Federal Circuit said “This correlation
exists in nature apart from any human action. There can
thus be no dispute that it is an ineligible natural law.”

The Federal Circuit concluded that 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 apply conventional techniques to detect that natural law. This finding was bolstered by the truthful but unfortunate statements in the specification 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.”

The Federal Circuit said: “The claims here are directed to a natural law because they recite only the natural law together with standard techniques
for observing it. That the routine steps are set forth with some specificity is not enough to change that conclusion.”

Finally, the Federal Circuit rejected Athena’s argument that the claims were patentable because they required labeling MuSK with a manmade
substance, finding that the use of a man-made molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law.

At step II of the aptly named Mayo test, the Federal Circuit found that the steps of the claims not drawn to ineligible subject matter, whether viewed individually or as an ordered combination, only required standard
techniques to be applied in a standard way. This was bolstered by the specification’s description of the steps as “conventional techniques.” The Federal Circuit refused to hold that performing standard techniques in a standard way to observe a newly discovered natural law provides an inventive concept.