This 2008 pre-Bilski decision is of interest since the Board purportedly applied the Diamond v Diehr “standard” – “[t}ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines” (450 U.S. at 184) – that the Federal Circuit adopted as the rule by which to judge whether or not a process or method claim is patentable subject matter. The Board applied this much-criticized test to affirm the Examiner’s ruling that a claim to a method to provide LASIK corrective surgery that was patient-customized was not patentable subject matter under section 101. Here is some of the relevant language from the decision:
“The claimed invention deals with a methodology for improving refractive opthlamic treatment. The steps of claim 120 include (a) obtaining a first measurement of a cornea; (b) determining a first ablation specification based on this first measurement; (c) obtaining perturbation data from the cornea to obtain biodynamic response data; (d) correlating…Steps (a), (c) and (d) are actions that can be characterized as data gathering steps. Steps (b), (e) and (f) are actions that can be characterized as mental steps in forming an individualized ablation specification….The claim does not include any recitation of a particular machine used to implement the claimed steps. The steps could be performed entirely by a human being with no machine involvement whatsoever.” (Appeal No. 2008-1355 July 15, 2008)
Oh really! I’d like to see that (actually it would be to gruesome to watch). Step (c) of claim 120 actually reads “obtaining non-tissue removing perturbation data from the cornea.” In rebutting a section 112 rejection, appellants argued (and the Board did not dispute) that the non-tissue removing perturbation is accomplished by making an incision in the cornea to form a corneal flap (“cutting the corneal flap”), which is then put back into place after the measurements are taken. At the least, this is a transformation of matter (corneal tissue) with a machine adapted to do this delicate procedure (e.g., a very sharp knife called a microketratome). I would (not) like to see this procedure carried out “with no machine involvement whatsoever.”
In fact, in their later obviousness analysis, the Board appears to recognize that perturbing is cutting: “Further it is unclear what the Appellants deem constitutes a surgical procedure. For example, it appears to us as though the step of perturbing the cornea entails a surgical procedure on the eye. The claims do not recite any other steps that include another surgical procedure on the eye.”
Well, how many surgical procedures on the eye are required to transform the article into different state? Finally, I hope that Ohio State University, the owner of the application, was aware that claims to “medical activities,” just like this one, while impliedly patentable subject matter under section 101, may be infringed without any liability for damages, at least by doctors and their employers. See 35 USC 287(c)(1). This section was added to the patent statutes in 1996 after one eye doctor got a patent on a method of performing cataract surgery and sued a competitor who was using the same technique. But that’s another story.
I want to thank Michael D. Stein of Woodcock Washburn for bringing this decision to my attention. We will be presenting an AIPLA Webinar on the evolution of patentable subject matter on September 2, 2009. Keep an eye out for us.