person of ordinary skill in the art/POSITA Archives

Back to the Future: Expert Can Be Skilled Artisan Based on Later-Acquired Knowledge

The US Court of Appeals for the Federal Circuit clarified that a technical expert does not need to have been a person of ordinary skill in the art (POSITA) at the time of the invention. Instead, they may rely on later-acquired knowledge to offer testimony from the vantage point of a skilled artisan at the time of the invention. Osseo Imaging, LLC v. Planmeca USA Inc., Case No. 23-1627 (Fed. Cir. Sept. 4, 2024) (Dyk, Clevenger, Stoll, JJ.)

Osseo owns patents related to orthopedic imaging systems that use X-ray beam techniques to create tomographic and/or densitometric models of a scanned object. The alleged invention date of the patents was 1999. Osseo sued Planmeca for infringement of dental imaging systems that generate and display 3D models to a user.

At trial, the jury was instructed to determine the requisite level of ordinary skill and was told that a POSITA would have a bachelor’s degree in electrical or computer engineering, plus three to five years’ experience working in a diagnostic imaging environment that uses the techniques described in the asserted patents. During cross-examination, Planmeca sought to demonstrate that Osseo’s technical expert did not have the requisite experience in 1999, the alleged date of invention. The jury returned a verdict that Planmeca infringed the asserted patents.

After trial, Planmeca moved for judgment as a matter of law (JMOL), arguing that Osseo’s expert’s testimony should be disregarded because he was not a POSITA at the time of the patents’ alleged date of invention in 1999. The district court denied the motion as legally incorrect. Planmeca appealed.

Planmeca argued that the district court erred in denying JMOL because although Osseo’s expert became a POSITA eight to 10 years after the time of the invention, he was not so skilled at the time of the invention, and thus the verdict could not be supported by his testimony. The Federal Circuit reiterated that “[to] offer expert testimony from the perspective of a skilled artisan in a patent case – like for claim construction, validity, or infringement – a witness must at least have ordinary skill in the art.” The Court rejected Planmeca’s argument to add a timing requirement that the expert must have possessed the requisite ordinary skill in the art at the time of the invention. Instead, the expert must be qualified to offer testimony from the vantage point of a skilled artisan.

The Federal Circuit explained that it made little sense to add a timing requirement because an expert could acquire the necessary skill level later and develop an understanding of what a POSITA knew at the time of the invention. The Court noted that the fact that the expert was not a POSITA at the time of the invention may well be used during cross-examination to undermine the credibility of the expert but also noted that an expert could avoid such potential damage by explaining how they gained the perspective of a POSITA at the time of the invention.

Accordingly, the Federal Circuit affirmed [...]

Continue Reading

Apply That Formulation: Presumption of Obviousness Based on Overlapping Ranges

The US Court of Appeals for the Federal Circuit found a method of treatment claims pertaining to topical formulations to be obvious, applying the presumption of obviousness of overlapping ranges theory. Almirall, LLC v. Amneal Pharmaceuticals LLC & Amneal Pharmaceuticals of New York, LLC, Case No. 020-2331 (Fed. Cir. Mar. 14, 2022) (Lourie, Chen, Cunningham, JJ.)

Almirall’s patent generally claims methods of treating acne or rosacea with formulations containing certain concentrations or concentration ranges of dapsone and acryloyldimethyl taurate (a type of thickening agent known as A/SA). The claims also contain a negative claim limitation of “wherein the topical composition does not comprise adapalene.”

In a final written decision, the Patent Trial & Appeal Board (Board) relied on three main references in its finding that the challenged claims would have been obvious. One reference (Garrett) disclosed dapsone formulations with a different type of thickening agent (Carbopol®). Garrett did not disclose any formulations that contained adapalene. Another reference (Nadau-Fourcade) described formulations containing exemplary types of thickeners, including both Carbopol® and A/SA agents. The last reference (Bonacucina) disclosed dispersions containing sodium acryloyldimethyl taurate that can be used for topical administration. All three references disclosed formulations with thickening agents within the claimed ranges.

The Board applied a presumption of obviousness based on the overlapping ranges of the thickening agents and ultimately concluded that it would have been obvious to a person of ordinary skill in the art (POISTA) to substitute the A/SA agents taught in either Nadau-Fourcade or Bonacucina for the Carbopol® agent disclosed in Garrett. The Board found that the claimed range of thickening agents overlapped with Garrett, Nadau-Fourcade and Bonacucina. The Board also relied on an expert presented by Amneal who testified that a POSITA would have appreciated that the different gelling agents are interchangeable to find a reasonable expectation of success in terms of a rationale for combing the prior art.

Almirall appealed, contending that the Board erred in presuming obviousness based on the overlapping ranges found in the prior art references. Almirall argued that the presumption of obviousness only applies when a single reference discloses all the claimed ranges, whereas the Board relied on different references to create the presumption (Garrett with either Nadau-Fourcade or Bonacucina). Citing the evidence showing the interchangeability of the two different types of thickeners, the Federal Circuit found that the Board did not err in applying the presumption, citing to its 2018 case of E.I. du Pont de Nemours & Co. v. Synvina: “[t]he point of our overlapping range cases is that, in the absence of evidence indicating that there is something special or critical about the claimed range, an overlap suffices to show that the claimed range was disclosed in—and therefore obvious in light of—the prior art.” The Court also noted that this case did not turn on the presumption, since the combination of prior art was simply involved the substitution of one known thickening agent for another as there was no evidence to challenge the substitutability.

The Federal Circuit [...]

Continue Reading