California group turns up heat on WARF stem cell patents

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Wisconsin Technology Network

Santa Monica, CA — The Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation have filed our formal comments with the U.S. Patent and Trademark Office supporting its rejection of human embryonic stem cell patent claims asserted by the Wisconsin Alumni Research Foundation because the claimed advances are obvious in the light of previous stem cell research.

Our case against WARF was bolstered by statements from four internationally known stem cell scientists: Dr. Douglas Melton of Harvard University, Dr. Alan Trounson of Monash University in Australia, Dr. Chad Cowan of Harvard University, and Dr. Jeanne Loring of the Burnham Institute for Medical Research. They agreed with the PTO’s earlier finding that the work done by Dr. James Thomson does not deserve a patent.

In papers filed recently, we said that although WARF has narrowed its claims and made several arguments in its response to the PTO, “none of the Patent Owners’ arguments have sufficient merit to overcome the rejections.”

“I very much believe Dr. Thomson deserves the scientific and public recognition he has received,” Melton’s declaration said. “However, he deserves that recognition because he undertook the arduous and timely task of getting fresh and high quality embryos to use as starting material for his work, and sufficient funding for such research, not because he did anything that was inventive.

“His perseverance and commitment deserve recognition and accolades. But I believe that had any other stem cell scientist been given the same starting material and financial support, they could have made the same accomplishment, because the science required to isolate and maintain human embryonic stem cells was obvious.”

Narrowed claims:

WARF holds three stem cell patents, numbers 780, 806, and 913, based on work done by Thomson. The PTO granted the requests for re-examination and in March rejected all the claims of all three patents. WARF had the opportunity to respond to all three rejections. The rules applicable to the 913 case under a so-called “inter partes” re-examination allow the challengers to comment on WARF‘s response in that proceeding.

The two earlier patents are undergoing “ex parte” re-examination and those rules do not allow formal comment from us. Nonetheless, the points we make in the 913 case are relevant to the other two.

WARF narrowed its claims in its response to the PTO finding, seeking to patent only stem cells derived from “pre-implantation embryos.” This means that stem cells derived by other methods — such as therapeutic cloning — may not be covered. In January, WARF eased its licensing requirements on stem cells, a move many observers believed was an effort to blunt widespread criticism of its aggressive patent policy from the stem cell research community.

While the challenge has already improved the situation for researchers, the patents are still not justified. In the 913 case, the patent examiner cited five grounds for rejecting WARF‘s claim, basing the decision on earlier publications and patents by Robertson, Piedrahita, Williams, and Hogan. (Read the PTO decision here).

In our formal comments, we agreed with the examiner and rebutted WARF‘s arguments making these five essential points:

WARF incorrectly argues that a skilled stem cell scientist would not have used teachings relating to mouse, sheep, and pig embryonic stem cells to derive human embryonic stem cells. To argue that what such scientists knew about embryonic stem cells of other mammals was not relevant to human embryonic stem cells is simply ludicrous.

– Despite WARF‘s assertions, not a single scientist in the field tried and failed to achieve Thomson’s accomplishment. Comparisons made by WARF to the work of others are misleading because the others did not have the access to the materials they needed.

WARF attempts to read the cited publications and patents too narrowly and does not take into account all the suggestions and motivations actually included in the documents.

– The recent Supreme Court decision in KSR International v. Teleflex in the doctrine of the law of obviousness supports and strengthens the examiner’s rejection of WARF‘s claims.

– Simply because a scientific accomplishment is important does not necessarily mean that it was an advance worthy of patenting.

Of mice and humans:

In his declaration, Dr. Trounson speaks about the relevance of isolating mouse embryonic stem cells to isolating human embryonic stem cells: “In January, 1995, it was obvious to me and others in the art of ES cell derivation that the process taught by Robertson ’83 and Robertson ’87 for isolating mouse stem ES cells could be used to isolate human ES cells. The motivation to do so came at least from the general understanding in the field of the applicability of mouse studies to human research.”

Dr. Cowan’s and Dr. Loring’s declarations agree that the patent’s claims were obvious and apparent to anyone working in the field at the time. Read the scientists’ statements and judge yourself:

Dr. Melton’s declaration.

Dr. Trounson’s declaration.

Dr. Cowan’s declaration.

Dr. Loring’s declaration.

Commendable, not patentable:

Certainly Dr. Thomson is a valued researcher in the stem cell scientific community. His work was impressive, and contributed greatly to the field, but any unbiased observer will conclude that what Dr. Thomson did was not patentable.

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