Patent-Eligibility Of hESC Challenged

Now that the U.S. Supreme Court has determined that isolated, naturally-occurring genes are not patent-eligible (see, Ass'n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013))("Myriad"), Consumer Watchdog ("CW", formerly known as The Foundation for Taxpayer and Consumer Rights, a self-described public charity dedicated to provide a voice for taxpayers and consumers) has asked the Federal Circuit to apply the holding of Myriad to in vitro cultured, human embryonic stem cell cultures and deem them patent-ineligible for failing to satisfy 35 U.S.C. § 101. Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. 2013).

Reexamination of U.S. Patent No. 7,029,913

CW's challenge is contained in an appeal from a Decision of the USPTO's Board of Patent Appeals ("Board") in inter partes reexamination No. 95/000,154, which confirmed the patentability of claims 1-3 of U.S. Patent No. 7,029,913 (the '913 Patent) entitled "Primate Embryonic Stem Cells". The '913 Patent issued on April 18, 2006 naming Dr. James A. Thomson of the University of Wisconsin as the sole inventor. The '913 Patent is assigned to Appellee Wisconsin Alumni Research Foundation ("WARF").

In the reexamination proceeding itself, Appellant CW only challenged the novelty and non-obviousness of the claims. The Board determined that the claims were novel because the cited prior art neither disclosed nor enabled using feeder cells to isolate human embryonic stem cells ("hESCs"). The Board also determined that the evidence of record supported a finding of non-obviousness because one of skill in the art would not have known how to identify and select hESCs during the stem cell derivation process.

After reexamination, claim 1 of the '913 Patent, the broadest and only independent claim recites:

1. A replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo, wherein the stem cells (i) will proliferate in an in vitro culture for over one year in an undifferentiated state without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.

Patent-Eligibility of hESCs

CW did not challenge the...