19 Sep Patent examiner made two legal errors in stem cell patent decision, consumer advocates claim
Santa Monica, Calif. – In a brief filed with the U.S. Patent Office’s board of appeals and interferences, consumer watchdog groups have cited two legal errors allegedly made by a patent examiner in confirming a Wisconsin Alumni Research Foundation patent on human embryonic stem cells.
The groups that filed the briefs, Consumer Watchdog and the Public Patent Foundation, have asked that WARF’s claims on patent 913 be rejected.
According to the two groups, the patent examiner’s mistakes led him to make incorrect conclusions about the patentability of the stem cell research.
The groups claims the examiner erroneously applied too high a standard for reasonable expectation of success, and he applied too high a standard for obviousness.
Janet Kelly, communications director for WARF, said the foundation has no comment, other than to say it will await a decision by the patent office.
An obvious claim?
Throughout the patent reexamination, the two consumer groups have argued that the creation of human embryonic stem cell lines was obvious in the light of work that had been done in other species, and therefore was not patentable.
The patent in question, known as patent 913, is being re-examined under rules that provide for an appeal to the patent office’s board of appeals and interferences. According to WARF, this patent covers development of a replicating in vitro cell culture of human embryonic stem cells that are derived from a pre-implantation embryo.
In a step that official concluded the re-examination of patents 780 and 806, the Patent and Trademark Office issued reexamination certificates for the two patents, which date back to the 1995 and 1998 discoveries of the isolation and culture of primate and human embryonic stem cells made at the University of Wisconsin-Madison. The ruling on these two patents was not appealable, and their claims are enforceable.
Consumer Watchdog, formerly known as the Foundation for Taxpayer and Consumer Rights, and the Public Patent Foundation first challenged all three WARF stem cell patents -780, 806 and 913 – in July 2006. Initially, the PTO rejected WARF’s claims associated with the patents, but after WARF mounted a defense, the patent claims were narrowed but upheld.
The original 913 patent covered all embryonic stem cells no matter how they are derived. While the amended ruling permitted the patent, it narrowed the claim only to stems cells derived from pre-implantation embryos.
In their most recent appeal brief on 913, the consumer groups argued the following:
“In this reexamination, the Examiner made two critical legal errors that led him to make incorrect conclusions regarding the patentability of the instant claims. First, the Examiner required the expectation of success to be an absolute certainty in order for it be considered `reasonable.’ This is too high a standard and conflicts with binding precedent.
“Second, the Examiner concluded that since human embryonic stem cell cultures as claimed had not existed before, they were not obvious. This effectively eviscerated the non-obviousness requirement by collapsing it into the Examiner’s anticipation inquiry. This standard is too high and conflicts with binding precedent.”