Update by David M. Longo, Ph.D.
On August 29, 2022, the Federal Circuit released a modified version* of its precedential opinion in Best Medical Int’l, Inc. v. Elekta, Inc. There were several issues in the appeal, though this summary focuses on the dispute as to the requisite “level of ordinary skill in the art” as part of the obviousness analysis.
The claims at issue in Best Medical’s U.S. Patent No. 6,393,096 are directed to an improved method of radiation therapy that computes an optimized arrangement for a radiation beam to maximize the irradiation of a tumor while minimizing the irradiation of surrounding tissue.
The ’096 patent was subject to two Inter Partes Review (IPR) petitions and parallel ex parte reexamination proceedings. The Patent Trial and Appeal Board (the Board) issued final written decisions in the IPRs, finding that Elekta demonstrated that certain claims of the ’096 patent were unpatentable as obvious over two prior art references. In finding that the claims were obvious, the Board found that the person of ordinary skill in the art would have had some formal computer programming experience. In the IPRs, Elekta’s expert met this criterion, but Best Medical’s expert did not. The Board ultimately held that the claims were obvious. Best Medical appealed to the Federal Circuit.
The Federal Circuit noted that Best Medical and Elekta had not presented much evidence to the Board regarding the various factors that can aid in finding the suitable level of skill in the art. These factors include: “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” (Slip op., p. 10, internal citation omitted.) The Federal Circuit also noted that while the Board was faced with “competing expert testimony and little supporting evidence from either party” (Slip op., p. 11), it still sought to determine whether the person of ordinary skill in the art would have had experience with computer programming.
The Federal Circuit concluded that the Board “was not unreasonable in concluding that a skilled artisan would have had formal computer programming experience” (Slip op., p. 12), based on the Board’s review of the entire trial record including the patent’s disclosure as a whole. In doing so, the Federal Circuit also noted that “the Board recognized (and it is undisputed) that the claimed invention is implemented on a computer.” (Id.)
The Federal Circuit rejected Best Medical’s opposing arguments. Best Medical had counter argued that the patent disclosure had used the word “program” in the sense of data entry and not in the sense of coding. The Federal Circuit noted that the Board had already considered and rejected this evidence. Even so, the Federal Circuit pointed out that it was reviewing the Board’s finding (as to the level of ordinary skill in the art) for substantial evidence. According to the Federal Circuit, “[o]n such a review, we do not reweigh the evidence but rather ask whether there is “evidence that a reasonable mind might accept as adequate to support a conclusion.”” (Id., internal citation omitted.) On this standard of review, the Federal Circuit approved the Board’s finding that the level of ordinary skill in the art included some formal programming experience.
In view of this level of ordinary skill in the art, the Federal Circuit also found that substantial evidence supported the Board’s other findings as to the obviousness of the claims at issue, and found no error in the Board’s claim construction. Accordingly, the Federal Circuit affirmed the Board’s conclusion that the claims at issue were obvious.
*The opinion was originally released on August 26th. The modified version of the opinion released on August 29th corrected several minor formatting and typographical issues on p. 11 of the slip opinion (the footnote markers for footnotes 4-7 were not shown in superscript on p. 11 at lines 2, 7, 11, and 13, and a comma was replaced with a period after the word “embodiment” on p. 14 at line 15).