By Donald Zuhn —
Last month, Consumer
Watchdog filed its opening brief in an appeal of a Board decision affirming the
patentability of U.S. Patent No. 7,029,913,
arguing that the claims of the '913 patent are invalid because they cover
ineligible subject matter and were anticipated and obvious. The appeal arises from an inter partes reexamination of the '913
patent that Consumer Watchdog, which describes itself as a not-for-profit
public charity dedicated to providing a voice for taxpayers and consumers in
special interest-dominated public discourse, government and politics, filed
in 2006. The '913 patent, which is
assigned to the Wisconsin Alumni Research Foundation (WARF), has three
claims. According to the Consumer
Watchdog brief, independent claim 1 (as amended by WARF during the
reexamination) recites:
1. (Amended) 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, and (iv) are inhibited from differentiation when
cultured on a fibroblast feeder layer.
After the Patent Office
granted Consumer Watchdog's request for an inter
partes reexamination (Control No. 95/000,154), the Examiner determined that
the pending claims were allowable, and Consumer Watchdog appealed to the
Board. The Board reversed, designating
four news grounds of rejection (one anticipation rejection and three different
obviousness rejections), and WARF responded by filing a request to reopen
prosecution along with an amendment and a declaration. The Examiner determined that the claims were
patentable over the Board's rejections, and the Board affirmed. Consumer Watchdog's appeal to the Federal
Circuit followed.
In addition to arguing that
the '913 patent is invalid as anticipated or obvious in view of the references on which the Board based its new grounds of rejection, Consumer
Watchdog also argues that the claims of the '913 patent are invalid under §
101. In particular, the brief states:
As a threshold
matter, the claims of the '913 patent are invalid under 35 U.S.C. § 101 for
claiming subject matter that is not patent eligible. Specifically, the claimed hES [human
embryonic stem] cell culture falls within the "product of nature"
exception to statutory subject matter.
It is within the Court's discretion to address this issue despite the fact
that the Board failed to address it below, and is especially appropriate in
light of the recent Supreme Court ruling on Section 101 in Ass'n. for Molecular Pathology v. Myriad Genetics, Inc.. 2013 U.S.
LEXIS 4540 (June 13, 2013).
Noting that "[t]he
Supreme Court restated [in June] that discovery and isolation of a product that
occurs in nature does not render that product patent eligible under Section 101,"
the brief attempts to draw analogies between its appeal and the Myriad case. For example, the brief states that "[a]s
in AMP, the '913 patent's claims are
drawn to neither a method of preparation nor a scientific application of the
claimed composition." The brief
also suggests that:
The '913 patent's
requirement that the claimed culture of cells be in vitro is analogous to the
claim limitation in AMP that the DNA be "isolated." But here there is not even a chemical change
between ES cells in an in vivo embryo and ES cells in an vitro culture as there
is between human DNA in vivo and isolated DNA in vitro.
The brief also notes that
"[t]he '913 patent does not in any way distinguish the claimed ES cells
from those that exist in nature," adding that "if the claimed ES cells
were not the same as natural ES cells, the claimed invention would offer very little
benefit for medical research." As the brief argues, "WARF did not create or alter the properties
inherent in stem cells any more than Myriad created or altered the genetic
information encoded in the DNA it claimed."
Although "[t]he Board never
considered whether the claims to hES cells are patent eligible subject
matter," the brief contends that "the Court may still consider whether
the claims here are invalid under Section 101 because, 'a court may consider an
issue antecedent to . . . and ultimately dispositive of the dispute before it,
even an issue the parties fail to identify and brief,'" citing U.S. Nat'l Bank v. Indep. Ins. Agents,
508 U.S. 439, 447 (1993). With respect to the issue of patent eligibility, the brief states that "[c]onsideration of the 101 question is especially
appropriate in light of the fact that the Supreme Court's recent AMP decision came after the Board's
decision here."
WARF now has until August
12 to file its opening brief in the appeal.

Leave a reply to Moocow Cancel reply