Exergen Corp. v. Kaz USA, Inc. – A Crack in the Patent Eligibility of Diagnostic Claims?

In Exergen Corp. v. Kaz USA, Inc., Appeal No. 2016-2315, 2016-2341 (Fed. Cir., March 8, 2018) (Non-precedential). A panel of Moore, Bryson and Hughes (Hughes dissenting), upheld a district court decision, following trial, that claims to a method of measuring core body temperature by employing multiple readings of the skin temperature of the subject over an artery and then calculating the body “core temperature” using a “newly calculated coefficient” [not in the claims] were patent eligible under s. 101. I think this is the first time that a diagnostic technique was found patent-eligible under s. 101.

The new MPEP guidelines have a difficult time in providing examination standards for patent-eligible processes that involve laws of nature, only citing CellzDirect and Tilghman v Proctor, an 1881 decision, for examples of claims describing natural processes that were found to not be directed to natural phenomenon. See MPEP, 2106.04(B))  Continue reading

Posted in Alice, Claim Construction, Section 101 | Leave a comment

A Vibration Dampener Fails Mayo/Alice Test in D. Delaware – Is the Decision as Shaky as it Seems?

This is a guest post from Gregory Stark, a Principal of Schwegman Lundberg & Woessner.

Stack of legal filesThe Vibration Dampener decision is not as bad as the headline might suggest, the claims are very broad method of manufacturing claims.  Accordingly, the claims are not specifically directed at the device, but rather how the device is manufactured.  As illustrated by the claim below, the vast majority of the claim language is functional with little to no specifics about the structure of the device.

  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.

It will be interesting to see if this decision is appealed, the claim language highlighted above will likely be a point of contention-as it at least attempts to move away from purely functional language (but still fails to recite any structure).

One aspect of the decision that seems troubling is how the decision characterizes the claims as an “application” of Hooke’s law (not claiming Hooke’s law, but an application of it).  The Court likely intends this to mean that the claims cover nothing more than a Law of Nature, but their language is ripe for future abuse.  The decision does go on to elaborate that the claims do not recite any particular method to design or construct the liners to obtain the claimed results (which is the real problem with the claims).

In my view, these are not good claims for an appeal, as the claim language is lacking in specifics regarding the structure of the liners with all elements relying on functional language alone to characterize the invention.

Nonetheless, this is not a good development for the mechanical arts in the area of 101.

Posted in Claim Construction, Section 101 | 1 Comment

Cleveland Clinic – Time to Purport an Inventive Concept in a Diagnostic Invention?

Inventive StepAs an introduction to this topic, please reread my post of July 5, 2017 about The Cleveland Clinic v. True Health Diagnostics, subtitled “Time to Redefine ‘Inventive Concept'”? The claim were directed to diagnosing the presence of cardiovascular disease (CAD) by measuring the blood level of the MPO enzyme in a patient and comparing it to the level  in a control subject diagnosed as not having the disease. The panel found that the method failed to pass Step 2 of the Alice/Mayo test. I wrote:

“The part of the decision that set off some legal alarm bells, at least for me, was the panel’s trivializing the techniques used to establish he controls and the relationship between the MPOP level in a patient vs. the control level in a patient population not having CAD. The panel wrote:

‘[T]he claims instruct that MPO levels be detected or determined using any of these known techniques. The claims of the testing patent also contain a comparing step where MPO levels are compared to statistically derived control or predetermined values. Here too, the Cleveland Clinic does not purport to drive new statistical methods to arrive at the predetermined or control levels of MPO that would indicate a patient’s risk of [CAD].’”

In a talk I recently gave on the dire fate of diagnostic methods in the hands of the courts and PTAB, I argued that, in view of the columns of selection criteria and statistical analysis required to carry out the claimed diagnosis, that Cleveland Clinic might have “purported” more than they did about the inventive concept(s) required to reach the diagnostic conclusion.

I am not claiming any influence over the able litigators at Jones Day, but this is the central approach that they took in the Petition for Cert. that they filed on January 16, 2008:

“[T]he Federal Circuit ignored a crucial point: while the patents employed conventional techniques, the inventors adapted those techniques for an entirely new purpose not known in the prior art, and, in fact, taught away from by the prior art. …[the Federal Circuit] ignored the inventor’s important and previously unknown discovery that those techniques could be adapted in a new way to provide medically-relevant data that was predictive of the risk of CVD….This case raises the issue whether the discovery of a new application of known techniques resulting in a novel and non-obvious method for diagnosing the risk of heart disease is patent eligible subject matter under Section 101.”

Since 2014, the walls have been closing in on diagnostic methods. Ariosa adapted the PTO’s implicit finding that the discovery of the significance of a naturally occurring correlation could not provide the inventive concept required by the Mayo/Alice test. At the end of the Mayo decision, Judge Breyer rejected the Government’s argument that “virtually any step beyond a statement of a law of nature itself should transform an unpatentable law of nature into a potentially patentable invention [under 101].”

The question remaining is what sort of additional steps – if any – should be recognized as accomplishing the transformation. Cleveland Clinic is trying to get the Supreme Court to answer this question for diagnostic tests. Since the question of the patent-eligibility of diagnostic tests was raised (and ducked) in Mayo, Cleveland Clinic may have a better than zero chance of saving patents in this increasingly important area of personalized medicine.

Posted in Section 101 | 1 Comment

Do You Really Want to File for Pharma Patent Protection in Canada, India or Ecuador?

IPO Letter Reports Weaknesses in IP Protection Around the World

In a 27 page letter dated February 8, 2018 and sent to Sue Chang at the Office of the U.S. Trade Representative, the Executive Director of IPO, Mark Lauroesch, extensively summarizes the flaws in IP protection in a number of countries, including Argentina, China, Mexico, Brazil, India and South Africa, including some you might not expect to be on such a list, such as Australia and Canada. There is a particular emphasis on the ability to effectively claim pharmaceuticals and to keep and enforce such patents if issued. Continue reading

Posted in Govt Policy/PTO Policy, Int'l Practice and Policy, Non-U.S. Practice | Tagged , , | 1 Comment