Recently, Seth Waxman and his team filed a wonderful certiorari petition in the Athena Diagnostics v. Mayo Collaborative Serv. case, which we will discuss in a forthcoming post.  Using quotations from the various combinations of Federal Circuit judges in the eight (!) opinions concurring and dissenting from refusal to grant rehearing en banc, the petition paints an accurate picture of a Court struggling to properly apply Supreme Court and its own precedent with regard to claims to reagents and methods for medical diagnostics, and failing (i.e., none of the diagnostic claims brought before the Court have passed eligibility muster).

Lest anyone think this situation exists only for medical diagnostics-related claims, consideration of today's decision in American Axle & Mfg. v. Neapco Holdings LLC will quickly dispel any such illusion.  In this case, American Axle sued Neapco Holdings for infringing claims of U.S. Patent No. 7,774,911, directed to methods for manufacturing driveline propeller shafts that "attenuate[e] . . . vibrations transmitted through the shaft assembly."  Claims 1 and 22 are representative according to the majority in the Federal Circuit's opinion; Judge Moore dissented, even as to this characterization:

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 configured 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.

22.  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 a mass and a stiffness of at least one liner, and
    inserting the at least one liner into the shaft member;
    wherein the at least one liner is a tuned resistive absorber for attenuating shell mode vibrations and
    wherein the at least one liner is a tuned reactive absorber for attenuating bending mode vibrations.

The District Court granted summary judgment that these claims, and all other asserted claims, were invalid under Section 101 for being directed to a natural law (at least Hooke's law and "friction damping") and did nothing more than instruct the skilled worker to "apply" that law, in contravention of the patent eligibility requirements for satisfying Section 101 set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc.  The District Court's basis for arriving at this conclusion was that the '911 specification did not provide a "particular means of how to craft the liner and propshaft in order to do so".  American Axle appealed.

The Federal Circuit affirmed, in an opinion by Judge Dyk joined by Judge Taranto; Judge Moore filed what can charitably called a vociferous dissent.  The majority set out its understanding of the invention and the basis for the District Court's decision to invalidate.  According to the opinion, the way propshafts in automotive drivetrains are constructed can in their use cause three modes of vibration:  bending, torsion, and shell modes, specifically, taken from the '911 patent specification:

Bending mode vibration is a phenomenon wherein energy is transmitted longitudinally along the shaft and causes the shaft to bend at one or more locations.  Torsion mode vibration is a phenomenon wherein energy is transmitted tangentially through the shaft and causes the shaft to twist.  Shell mode vibration is a phenomenon wherein a standing wave is transmitted circumferentially about the shaft and causes the cross-section of the shaft to deflect or bend along one or more axes.

Each of these vibration modes has a different frequency, according to the majority.  An important component of the majority's analysis (contradicted in Judge Moore's dissent) is that the prior art addressed the vibration problem using liners, defined in the opinion as "hollow tubes made of a fibrous material (like cardboard) with outer resilient members that 'frictionally engage the inner diameter of the [propshaft].'"  These liners also vibrate, so careful matching of propshaft and liner can result in damping the vibration of the propshaft, and this matching can be "tuned" by varying "certain variables" of the liner.  According to the majority, "[i]t was known in the prior art to alter the mass and stiffness of liners to alter their frequencies to produce dampening.  Indeed, this was sufficiently well known that prior art patents disclosed the use of particular materials to achieve dampening."

Turning to specifics, the majority identify two relevant types of attenuation of these vibrations:  resistive attenuation ("a vibration attenuation means that deforms as vibration energy is transmitted through it . . . so that the vibration attenuation means absorbs . . . the vibration energy ") and reactive attenuation ("a mechanism that can oscillate in opposition to the vibration energy [of the propshaft] to thereby 'cancel out' a portion of the vibration energy").  The '911 specification (according to the majority) discloses that the prior art contained means and methods for attenuating each of the three propshaft vibration modes, but were limited insofar as they could not attenuate two vibration modes simultaneously; the specification identified a "need in the art" to dampen shell mode and bending mode vibrations simultaneously (which American Axle contended below and at the Federal Circuit comprised the "inventive concept" required by Supreme Court precedent to make their claim patent eligible).  While recognizing these assertions, in the majority's view the '911 specification does not disclose how to achieve these goals (this being the basis for finding the claims were not patent eligible).

The majority set forth the now well-worn recitation of the two-step test for patent eligibility announced in Mayo and further clarified in Alice Corp. Pty. Ltd. v. CLS Bank International.  First, a court asks if the claim is "direct to" a law of nature, natural phenomenon, or abstract idea.  If it is, then the court must ascertain whether the claims recite an "inventive concept" that is not merely activities that are routine, conventional and well-understood and that provide "something more" than the law of nature itself and an instruction to "apply" the law.  Seemingly anticipating the reaction that the opinion would engender, the majority asserts that "[t]here is no legal principle that a claim to a method of manufacturing cannot be directed to a natural law, nor are there any cases saying so."  The majority believe that the '911 specification establishes that "most aspects of the '911 patent were well known in the art," meaning in context that the vibration "problem" addressed by the claimed methods, methods for attenuating resistive and reactive vibration with liners and other things, and that selection of frequencies needed for such attenuation are obtained by an application of Hooke's law (which the majority believes to have been undisputed according to select portions of testimony from both parties' witnesses).

The majority opinion gets to the analytical basis for its decision when it says that "the patent claims do not describe a specific method for applying Hooke's law in this context.  They simply state that the liner should be tuned to dampen certain vibrations."  This in their view "essentially amounts to the sort of directive prohibited by the Supreme Court in Mayo—i.e. 'simply stat[ing] a law of nature while adding the words ''apply it.''"  The majority rejected testimony to the contrary (to the effect that axle liner tuning is not simply an application of Hooke's law) saying "[t]he problem with AAM's argument is that the solution to these desired results is not claimed in the patent.  We have repeatedly held that features that are not claimed are irrelevant as to step 1 or step 2 of the Mayo/Alice analysis," citing Alice; Synopsis, Inc. v. Mentor Graphics Corp.; and Ariosa Diagnostics, Inc. v. Sequenom, Inc., in support of this legal principle.  According to the majority, "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 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."  And such "trial and error" methods of identifying appropriate damping frequencies were also well known in the art, according to the majority who cite the '911 specification for support.  And further:

This case might well be significantly different, if, for example, specific FEA [finite element analysis] 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 majority then cites Supreme Court and Federal Circuit case law for the principle that ""[a] patent is not good for an effect, or the result of a certain process, as that would prohibit all other persons from making the same thing by any means whatsoever," Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–75 (1853), and particularly Parker v. Flook (although apparently conflating or equating the rationale enunciated regarding the ineligibility of an abstract idea with their analysis of inventions based on laws of nature); the opinion then contrasted that situation with the patent-eligible invention in Diamond v. Diehr (not surprisingly, to the extent these decisions can be reconciled).  The majority reiterated its basis for finding ineligibility, that there is no "physical structure or steps for achieving the claimed result of damping two different types of vibrations" and that the "focus of the claimed advance here is simply the concept of achieving that result, by whatever structures or steps happen to work."  (If this language reminds anyone of the Court's reasoning in University of Rochester v. G.D. Searle, note Judge Moore's dissenting opinion that follows.)  And the majority provoked Judge Moore's analytical ire in its assessment of the second step of the Alice/Mayo test to these claims, where the majority states 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."

Judge Moore's full-throated dissent is based on her belief that "[t]he majority's decision expands § 101 well beyond its statutory gate-keeping function and the role of this appellate court well beyond its authority."  She characterized the majority's analysis as merely "parrot[ing]" the Alice/Mayo test and reducing the test to the single question of whether a claim is directed to a law of nature.  Judge Moore states that she is "deeply troubled by the majority's disregard for the second part of the Alice/Mayo test, its fact finding on appeal and its repeated misrepresentation of the record, in each instance to the patentee's detriment" under circumstances (appeal of summary judgment) where the proper standard is to give the non-movant (here, the patentee) the benefit of any evidentiary ambiguities.  As the majority recognized, Judge Moore's primary concern is that invalidity, if it is to lie against these claims, must be based on Section 112(a) for lack of enablement, not Section 101, saying "[w]e 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" (an argument the majority easily rejected under Justice Breyer's similar jurisprudential disdain for any section of the Patent Statute other than Section 101 in Mayo).  The Judge was equally critical of the majority's failure to identify which natural law the claims were directed to, stating that "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 believes there is sufficient disclosure of an "inventive concept" for the claims to pass Section 101 muster even if they are directed to a not completely defined (by the court) natural law.  In her view there are many inventive concepts disclosed in the '911 specification, and there exists at least sufficient questions of fact regarding this aspect as to preclude summary judgment.  (It should be remembered that Judge O'Malley recently called into question the propriety of another opinion by Judge Dyk, In re BRCA1– and BRCA2– Based Hereditary Cancer Test Patent Litig., where the question was whether the district court properly denied Myriad Genetics' motion for preliminary injunction and instead invalidated all claims at issue; see "Roche Molecular Systems v. Cepheid").  Here, Judge Moore enumerates a half dozen such novel uses for liners that constitute in her view an "inventive concept" (and a finding of unconventionality) sufficient to overcome Neapco Holdings' patent eligibility challenge under Section 101.  When addressing the citations to the '911 specification used by the majority to support its conclusion that the claims did not satisfy the "inventive concept" (and unconventionality) prong of the Alice/Mayo test Judge Moore is blunt:  "These statements are false."  The Judge's reading of the very same specification identifies ample instances where the patentee distinguished the invention from what was known in the art ("More than a dozen times in the briefs and during oral argument the patentee argued that the use of liners to attenuate bending mode vibration was one of its inventive concepts.").  The Judge even cites to an instance during oral argument when American Axle's counsel corrected a member of the majority when he asserted the conventionality of using liners for the claimed purpose, and that "[e]ven Neapco acknowledged that the patent states that liners had not been used to attenuate bending mode vibrations." Judge Moore characterizes these conclusions by the majority as de novo "fact-finding," including application of the disclosure of a patent (U.S. Patent No. 3,075,406) "never introduced as evidence in this case or cited by either party" to support its (erroneous, in Judge Moore's view) conclusions.  "Moreover," Judge Moore states, "a disclosure in a single patent does not establish that the use of liners to attenuate bending mode vibration was "well-understood, routine, conventional activity" as required by the Supreme Court," and the majority's statement that "the inventive concept 'makes no difference to the section 101 analysis'" is "an outright rejection of the second step of the Alice/Mayo test."  Judge Moore asserts that the majority's explanation that "Section 101 is concerned with whether the claims at issue recite a natural law, not whether the specification has adequately described how to make and use the concretely claimed structures and steps" is "just plain wrong" as a statement of the law.

In Judge Moore's view, "[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," and the Judge cites almost a dozen statements from the majority opinion in support of this conclusion.  For Judge Moore, that deficiency is one falling properly under the scope of Section 112, not Section 101 of the statute.  (Seemingly somewhat tongue in cheek, Judge Moore recites the majority's statement that if the specification had disclosed computer-based methods for determining vibration dampening frequencies it might have satisfied Section 101, and then states "[s]urely, this is the first time adding software to a claim would make it eligible.")  Judge Moore further notes that:

The majority acknowledges that there is a very specific example given in the patent with precise dimensions, weights, lengths, materials, positioning, etc.  Whether this disclosure combined with the knowledge of a skilled artisan would permit that skilled artisan to tune a liner to a given propshaft in order to reduce bending mode vibrations without undue experimentation is exactly and precisely the enablement test pursuant to § 112.  A patentee's failure to enable his invention renders the claims invalid under § 112, it does not, however, render the claims ineligible under § 101.

and:

To be clear, according to the majority, even if these claims are enabled, they are still ineligible because the claims themselves didn't teach how.  This is now the law of § 101.  The hydra has grown another head.

And finally:

The majority holds that [the '911 claims] are directed to some unarticulated number of possible natural laws apparently smushed together and thus ineligible under § 101.  The majority concludes that the inventive concepts "make no difference."  Section 101 simply should not be this sweeping and this manipulatable.  It should not be used to invalidate claims under standards identical to those clearly articulated in other statutory sections, but not argued by the parties.  It should not subsume § 112.  It should not convert traditional questions of fact (like undue experimentation) into legal ones.  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.

Anyone having read the Court's decision not to grant rehearing en banc in Athena Diagnostics v. Mayo Collaborative Serv. should be well aware of the fractious nature of the Section 101 inquiry among the Federal Circuit judges, and the desperate need for the Supreme Court to clarify the patent eligibility standard it recited (murkily) in its Mayo and Alice decisions.  Even if in agreement with Judge Moore, it is not difficult to see how the majority arrived at its conclusions, and how easy it is to apply Section 101 in a "sweeping and manipulatable" way.  When a specialized appellate court, created by Congress to harmonize and clarify U.S. patent law, can find a method of manufacturing a propshaft for an automobile to be ineligible under Section 101 as a natural law, it is clear that the Court, and as a consequence the rest of us, has clearly lost its way.

American Axle & Mfg. v. Neapco Holdings LLC (Fed. Cir. 2019)
Panel: Circuit Judges Dyk, Moore, and Taranto
Opinion by Circuit Judge Dyk; dissenting opinion by Circuit Judge Moore