Wednesday, April 04, 2007

PubPat/FTCR use overreaching reference to invalidate WARF patents

There is an irony in the use by PubPat and FTCR of the Williams patent reference (US 5,166,065)against WARF's patents. PubPat and FTCR asserted that WARF claimed too broadly. For example, John M. Simpson, FTCR's stem cell project director, has held that the patents were overly broad and never should have been granted.

The first claim of US US 5,166,065 recites: A method for the isolation of embryonic stem (ES) cells from mammalian embryos in vitro which method comprises deriving and maintaining said embryos in culture medium containing an effective amount of recombinant leukaemia inhibitory factor (LIF) for a time and under conditions sufficient for the development of said ES cells.

Although US 5,166,065 did not define "mammalian," one of ordinary skill would consider humans to be mammals. The '065 patent never disclosed a method for the isolation of embryonic stem (ES) cells from human embryos, but its claim would encompass humans. Thus, the claim of the '065 overreaches into an area which was never actually done by Williams et al. This does remind one of Curtiss and the Wright Brothers. Curtiss used the Langley machine as prior art against the Wrights, even though the Langley machine never flew (and did not have three-dimensional control either). Whether now, or 100 years ago, prior art that didn't work shouldn't render invalid claims of someone who was first to accomplish something.

The USPTO is citing the specification of the '065. The specification is even more expansive:

Accordingly, a first aspect of the present invention relates to a method for the isolation of embryonic stem (ES) cells from animal embryos in vitro which method comprises deriving ES cells from said embryos in culture medium, said culture medium containing an effective amount of leukaemia inhibitory factor (LIF), for a time and under conditions sufficient for the development of said ES cells. The embryos used may be isolated from animals including, but not limited to, humans and a number of other animal species such as birds (e.g. chickens), mice, sheep, pigs, cattle, goats and fish.

The observant reader will note that the '065 keeps talking about LIF. Thus, this method requires something (LIF) that isn't mentioned in the Thomson claims. Apart from the fact that the method didn't work for human stem cells, it required something not found in the Thomson claims.

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