Exergen Federal Circuit Affirms Patent Eligibility Of Diagnostic Patent Claims Reciting Laws Of Nature Under Alice
§ 101 and §§ 102/103 prior art are not always the same
- In Exergen v. Kaz, a non-precedential decision, the Federal Circuit affirmed the lower court finding of patent eligibility of a number of diagnostic patent claims reciting laws of nature
- Something is not well-understood, routine, and conventional merely because it is disclosed in a prior art reference. In other words, § 101 and §§ 102/103 prior art are not always the same
- Lower court’s conclusion that patent claim elements were not well-understood, routine, and conventional is a question of fact to which Federal Circuit must give clear error deference
- Claims that applied two previously known but unrelated natural laws or phenomena succeeded by reciting non-preemptive and non-general diagnostic limitations of “moving while (laterally) scanning,” “obtaining a peak temperature reading,” and “obtaining at least three readings per second” in claims directed to detecting arterial temperature beneath the skin
In Exergen Corporation v. Kaz, USA, Inc decided on March 8, 2018, the Federal Circuit affirmed the trial court on § 101 in finding diagnostic patent claims to be patent eligible under Alice. In so deciding, the Federal Circuit explained that the claims recited an unconventional technological solution (combination of two previously known but uncorrelated arteriovenous anastomoses (AVAs) and thermodynamic scientific principles) to a technological problem (unmet need for accurate temperature measurements taken by less intrusive instruments).
Exergen’s 6,292,685 and 7,787,938 patents on appeal are directed to non-invasive methods and devices for accurately determining a person’s deep body temperature by taking measurements of the skin temperature over an artery, preferably, the temporal artery. The patents addressed an unmet need particularly in pediatric medicine for accurate temperature measurements taken by less intrusive instruments than ear thermometers.
The Federal Circuit found that the diagnostic patent claims build on two previously known but unrelated natural laws or phenomena – the absence of arteriovenous anastomoses (AVAs) that would create a relatively constant blood flow in certain arteries close to the skin surface, including the temporal artery, and the principles of thermodynamics embodied by the heat transfer equations disclosed in the patents. While the asserted claims are based on natural phenomena, they do not simply identify some previously unremarked upon natural law, or recite a perfunctory intersection of a couple of previously perceived phenomena; rather, they reveal a novel combination of two previously known but uncorrelated scientific principles.
The Federal Circuit found no evidence in the record that the recited steps of “moving while (laterally) scanning,” “obtaining a peak temperature reading,” and “obtaining at least three readings per second” were “well-understood, routine, or conventionally used to detect arterial temperature beneath the skin before the introduction of Exergen’s patent.” Op. 7, 8.
Albeit a non-precedential decision, the Exergen case is important since it provides guidance on claim recitations that transform a diagnostic process into an inventive application of the formula. Just as the incorporation of a well-known mathematical formula into a claim for a rubber curing process was patent eligible in Diehr, so too the incorporation of a well-known mathematical formula into a claim for noninvasively and accurately detecting human body temperature is patent eligible.
Exergen is important also for clarifying the role of facts in the § 101 determination. There is no question that whether a claim is directed to patentable subject matter is a question of law. Op. 9. However, that legal determination is not made in a vacuum but based on underlying facts. (“whether a claim is directed to patentable subject matter is a question of law based on underlying facts.”) Id.
The Federal Circuit made clear that while questions of law are reviewed de novo, questions of fact are reviewed for clear error. Id. As the Federal Circuit explained “The question of whether a claim element is well understood, routine, and conventional to a skilled artisan in the relevant field is a question of fact and deference must be given to the determination made by the fact finder on this issue.” Op 10. So while performing its de novo review of the § 101 determination, the Federal Circuit gives no deference to the trial court’s assessment of that purely legal question. But questions of fact are reviewed under the clearly erroneous standard so unless the trial court is clearly erroneous in its finding of facts, those findings will not be disturbed on appeal.
Exergen is important finally for distinguishing between § 101 and §§ 102/103 prior art. As the court explained, “[s]omething is not well-understood, routine, and conventional merely because it is disclosed in a prior art reference.” Id. The court observed that “[t]here are many obscure references that nonetheless qualify as prior art.” (citing as an example a single copy of a thesis written in Germany and located in a German university library which is a printed publication for purposes of §§ 102/103 but would not suffice to establish that something is well-understood, routine, and conventional activity previously engaged in by scientists who work in the field.) Id.