ThermoGenesis Corp. and the International Netcord Foundation have announced that the United States Patent and Trademark Office (PTO) issued two new office actions rejecting all of the claims of PharmaStem Therapeutics Inc.'s U.S. Patent No. 5,192,553 and U.S. Patent No. 6,569,427 as unpatentable over prior art.
Recently, the PTO issued initial office actions rejecting all the claims of PharmaStem Patent Nos. 5,004,681 and 6,461,645.
These patents relate to the collection, cryopreservation and storage of hematopoietic stem cell - containing umbilical cord blood.
ThermoGenesis and Netcord have supported these re-examinations based on their conviction that the patents' claims are not distinct over "prior art", including the publication of several medical journal articles describing the same and similar techniques and observations predating by several years the filing date of the original applications.
According to the recently issued re-examination order from the PTO, critical references have "evidenced that it was well known in the art at the time of effective filing date of the earliest PharmaStem patents '553 and '681, that stem and progenitor cells are present in umbilical cord blood cells, and could be cryopreserved for future stem cell transplantation".
Previously, ThermoGenesis and Netcord opposed PharmaStem patent claims in Europe, and on April 7, 2003 the European Patent Office ("EPO") confirmed the revocation of PharmaStem's European patent on cryopreserved cord blood compositions and uses thereof by dismissing PharmaStem's appeal of an earlier ruling of the EPO, which had previously revoked all 68 claims of the European patent.
The decision of the EPO is final and is not subject to appeal and applies throughout Europe.
In a joint statement, Philip Coelho, Chairman and CEO of ThermoGenesis, and Peter Wernet, M.D., President of Netcord and Director of the Jose Carreras Cord Blood Bank at the University of Dusseldorf commented, "We strongly doubt the validity of the claims contained in the PharmaStem patents, given the existing prior art."
"The methods and observations reported in these patents were well known and the possibility of using cord blood for bone marrow and immune system reconstitution had been suggested several times in the medical literature."
"Furthermore, it is our opinion that this ruling by the U.S. PTO invalidating these patent claims will enhance the ability of stem cell banks and other research organizations to increase the inventory of life-saving cord blood grafts and offer life-saving treatments to patients, as well as conduct breakthrough research."
"We consider these abilities to be vital to a rapidly evolving field of medicine which will likely have a dramatic impact on the direction of healthcare innovation."