Supreme Court Enunciates New Indefiniteness Standard

Patently BIOtech

The Supreme Court has once again reversed a decision by the Federal Circuit, in this case involving the proper standard for finding claims indefinite. The case, Nautilus, Inc. v. Biosig Instruments, Inc., overturned the Federal Circuit’s “insolubly ambiguous” test and substituted its own “reasonable certainty” test.  The Court left intentionally unclear the precise ways in which their new test will differ from the Federal Circuit’s abrogated test, leaving it to the lower court to decide in the first instance whether the claims are indefinite using the Court’s new test.

The claims at issue in U.S. Patent No. 5,337,753 encompassed exercise equipment components that enabled the user to detect her heart rate during exercise using sensors placed in such a way that the signals from skeletal muscles in motion (the electromyogram or EMG) don’t interfere with or mask signals from the heart (the electrocardiogram or ECG)  The claimed invention takes advantage of the difference in polarity between the right hand and the left hand exhibited by the ECG absent in EMG signals, wherein the ECG is detected by eliminating EMG signals based on this polarity difference. The claim term at issue related to the relative placement of electrodes, specifically that they are “mounted . . . in spaced relationship with each other.  Biosig’s interpretation was that the phrase meant the difference in spacing between the electrodes in each electrode pair, while Nautilus contended that the term meant a spacing “greater than the width of each electrode.” The District Court construed the term to mean that there was a “defined relationship” between the electrodes on the sensor for one hand that was the same as the defined relationship between the electrodes on the other hand, and based on this construction granted summary judgment of invalidity to Nautilus because the term “did not tell [the court] or anyone what precisely the space should be,” or “even supply ‘any parameters’ for determining the appropriate spacing.” The Federal Circuit reversed, based on the panel’s determination that the claim term was not insolubly ambiguous because intrinsic evidence surrounding the claim term contained “certain inherent parameters of the claimed apparatus, which to a skilled artisan may be sufficient to understand the metes and bounds of ‘spaced relationship.’”

The Supreme Court vacated this judgment and remanded to the Federal Circuit, in a unanimous opinion written by Justice Ginsberg. The Justice recited as undisputed that:

• “First, definiteness is to be evaluated from the perspective of someone skilled in the relevant art;”

• “Second, in assessing definiteness, claims are to be read in light of the patent’s specification and prosecution history,”

• “Third, “[d]efiniteness is measured from the viewpoint of a person skilled in [the] art at the time the patent was filed.”).

The Court discerned that the statutory section “entails a ‘delicate balance,’” wherein “[o]n the one hand, the definiteness requirement must take into account the inherent limitations of language,” while on the other hand “a patent must be precise enough to afford clear notice of what is claimed, thereby ” ‘appris[ing] the public of what is still open to them.’” The considerations involved in the “inherent limitations of language” include that there is a “modicum of uncertainty” that is necessary to encourage innovation in view of the target audience of the patent claim, which are “‘not addressed to lawyers, or even to the public generally,’ but rather to those skilled in the relevant art.” Nevertheless, this inherent ambiguity cannot become so great that it creates a “zone of uncertainty” around the patent claims, which would discourage innovation without any benefit to the public says the Court. And the Court also apparently was persuaded that “patent applicants face powerful incentives to inject ambiguity into their claims” unless countervailing disincentives (in the form of being put at risk of being invalidated) are in place.

The Court enunciated its new standard by saying that “a patent’s claims, viewed in light of the specification and prosecution history, [must] inform those skilled in the art about the scope of the invention with reasonable certainty.” The Court’s justification for adopting this test, over the Federal Circuit’s “insolubly ambiguous” test, is that the Federal Circuit’s test would “breed lower court confusion,” and that claim terms must be unambiguous at the time the patent is granted to a person skilled in the art and “not [to] a court viewing matters post hoc.” The Court asserted that the consequence of upholding the “insolubly ambiguous” test would be to ‘diminish the definiteness requirement’s public-notice function and foster the innovation-discouraging “zone of uncertainty.”  It remains to be seen whether in practice there is any difference in the extent to which patent claims are held to be indefinite, depending on how the Federal Circuit and lower courts implement this new test.

Kevin Noonan is a Partner at McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies, from startups to Fortune 100 companies, on a myriad of issues, as well as several universities in both patenting and licensing to outside investors. He has filed amicus briefs to district courts, the Federal Circuit and the Supreme Court involving patent issues relevant to biotechnology. Kevin is a founding author of the Patent Docs weblog where he writes frequently, and was recently named Chicago’s Biotechnology “Lawyer of the Year” by Best Lawyers in America 2013 and 2014. In 2010, Kevin was interviewed on 60 Minutes about gene patenting.

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