Obviousness and Medical Devices
Patent prosecutors spend a great deal of time pondering the question of whether a particular combination of references ought to render a patent claim obvious. This is true regardless of whether one is involved in patent prosecution, IPRs or litigation.
To understand how obviousness is applied at the USPTO, we examined 21,074 office actions issued between June 14, 2012 and October 13, 2015 in U.S. Classification 600 for "Surgery," and U.S. Classification 623 for Prosthesis. Although medical devices may be classified in classes other than 600 and 623 (e.g., classes 128, 351, 601 and 602), these two particular classes, 600 and 623, are robust and provide a large enough sample to gain insight into the general examination of medical devices.
Not surprisingly, of the 21,074 office actions that were examined, 16,957 office actions (80.46%) received at least one 103 obviousness rejection. By comparison, only 12,267 office actions (58.2%) of the total received a 102 anticipation rejection.
By examining the data even more closely, we can better see the examination patterns, and the outliers become more visible. For example, a handful of applications included seven or more different references being cited in various obviousness combinations.
Readers may recall that in In re Gorman, 933 F.2d 982, the Federal Circuit took up the question of whether the combination of a large number of references “of itself weighs against a holding of obviousness," and refused the argument that the sheer number of references alone can rebut obviousness. The M.P.E.P., relying on In re Gorman, instructs Examiners that "[i]n response to applicant’s argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention" (M.P.E.P. 707.07(f)). Thus, simply pointing out that the Examiner is combining ten references is insufficient to rebut an obviousness rejection. Instead, the applicant must make an some additional argument such as, for example, that the references are not combinable. Relatedly, an overwhelming majority of inter partes review (IPR) petitions rely on a maximum of three-reference combinations in forming obviousness challenges. Thus, while patent examiners are not shy in putting forward a large number of references, patent attorneys acting as petitioners appear to see the flaws of such combinations. In the medical device context in particular, consideration should be given to the principle of operation of devices, and the intended usage when examining the propriety of such rejections. Additional posts may follow to discuss some of the best ways to overcome obviousness rejections.