Recently, in a notably unremarked decision, the Board reversed the Examiner, effectively canceling all of the claims to pluripotent human embryonic stem cells (ES) in Thomson (U.S. Pat. No. 7029913): The Foundation for Taxpayer & Consumer Rights v. Patent of Wisconsin Alumni Research Foundation (WARF), App. No. 2010-001854 (April 28 2010). The Examiner had reversed his original rejections on the basis that there would not have been a reasonable expectation of success that the mouse techniques disclosed in the prior art for producing mourse stem cells would work to yield stable cultures of humna stem cells. The Board reversed the Examiner.
The re-entry of an anticipation rejection based on Williams et al. (US 5166065) deserves a law review article, but it is the obviousness rejection that got my goat (or my murine species, to be more exact). While the Fed. Cir. has recently been reasonably temperate in its application of the somewhat fuzzy KSR standards to chemical composition claims, The Board latched onto one of the most poorly-reasoned early post-KSR decisions, Bayer v. Barr, 575 F.3d 1341 (Fed. Cir. 2009).
In the WARF reexamination, it was established that the art was using two basic techniques to try to isolate animal and human ES. One involving physically disassembling blasocysts (or very early-stage embryos) to get at the inner stem cells, and one involved using antibodies to remove the outer cell layers. Neither technique had been successfully used to produce human ES. In fact they had only worked in rodents (mice, rats, guinea pigs) and perhaps, in pigs. At least ten references were of record to this effect, and were quoted from by the Board. WARF had argued and the Examiner had found that there was no reasonable expectation of success that these techniques would lead to human ES. So what made the claimed cultured human ES obvious?
The Board relied on Bayer to find that “while a requirement that there be a ‘reasonable expectation of success’ …may be one useful standard in assessing the obviousness of an invention, it is not the only standard to be applied when [resolving the obviousness question]…..The Supreme Court has held that an invention may be proved obvious by showing that a combination of elements was ‘obvious to try.’…. A solution which had been known to work when applied to one system might, in some circumstances, be obvious to try in another. If the solution succeeded, the invention likely would have been obvious too persons of ordinary skill in the art…..[WARF] has not established that the protocol followed by Dr. Thomson necessitated him to ‘try all possibilities in a field unreduced by direction,’ but rather the evidence….points to significant guideposts that would have led the skilled worker in the right direction to successful isolation of human ES.”
But wait a minute. Those “significant guideposts” had only directed the art to mouse, rat and guinea pig stem cells (and maybe, pig), not even to dog, or horse, or cow. This reasoning is like saying, “Well there were signs to the base camp at 15000′ so the person of ordinary skill in mountaineering would have been successful in reaching the summit of Everest.” This is using the fact of the pioneer’s success against him/her, essentially as part of the prior art. In effect, the Board is saying, “Even if there was no reasonable expectation of success based on the prior art, the facts that there were techniques that were obvious to try AND that human ES were isolated using these techniques makes the invention unpatentably obvious.” As the Board concluded:
“Because it would have been obvious to have tried the known mouse protocols on human embryos [ed.: of course], and because such protocols would have resulted in human ES, we conclude that the claimed human ES would have been obvious to persons of ordinary skill in the art.”
This is an obviousness standard lifted from its context in KSR, a simple mechanical case, and dropped into a much more uncertain art area. I think what the Supreme Court could have said more clearly was that if the routes to try are available to the art and, if they are tried, the outcome of performing them is manifest (e.g., would be clear to the art worker), then the invention is obvious. The “guideposts alone” standard of KSR and Bayer has no real legal foundation in KSR, was applied improperly in Bayer, and endorses hindsight reconstruction. The Fed. Cir. should clearly disavow this “verdict now, trial later” standard as soon as possible.
On September 1st, the Office of Patent Legal Administration (I didn’t know there was one) issued 17 pages in the Fed. Reg. (Vol. 75, 53643) updating its obviousness guidelines. (A copy of the guidelines is found at the end of this post.) The Update is mostly a meaty analysis of 22 post-KSR Fed. Cir. decisions, 12 of which are in the pharma/biotech area and nine of which deal with the principles of “structural obviousness.” The Guidelines state that apart from using the TSM test as a rationale “to support an obviousness determination,” the 2007 KSR Guidelines identified six other rationales that can also be used: (1) Combining prior art elements according to known methods to yield predictable results; (2) simple substitution of one known element for another to obtain predictable results; (3) use of a known technique to improve similar devices, methods, or products in the same way; (4) applying a known technique to a known device, method or product ready for improvement to yield predictable results; (5) “obvious to try”; and (6) known work in one field of endeavor may prompt variation of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to POSA.