ISC Patent On Making Human Stem Cells Advances Cloning Technology

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alt=”” width=”150″ height=”150″ />Apart from being praised as an ethical work-around to the problems of destroying early-stage human embryos—often about to be discarded as surplusage by fertility clinics — to obtain human pluripotent stem cells, Revazova et al. (U.S. Pat. No. 7732202 – copy at end of post) got relatively little attention from the IP community. I predict that the relatively benign reception that this patent got will change as various groups begin to sort through the claims and 138 columns of disclosure. Dolly, the cloned ewe, was made by removing the nucleus from an oocyte, or unfertilized ovum, of one breed of sheep, and replacing it with nuclear material from an adult donor cell taken from a different breed of sheep. The renucleated oocyte was induced to divide by an electrical pulse, and reimplanted in a surrogate mother, that eventually gave birth to Dolly, who looked just like the sheep that donated the nuclear material. The donor sheep had successfully been cloned. Today you can clone Fluffy, your favorite cat or, if the USDA would allow it, eat a burger made from beef from a cloned herd of steers. In 1998, Tompson et al. at the University of Wisconsin, claimed human embryonic stem cells obtained by disassembling blastocysts, or very early stage fertilized eggs. In 83 JPTOS 830 (Nov. 2001), I wrote:

“The debate about reproductive or therapeutic cloning of individuals has become interlocked with the ethical controversy that has accompanied a new area of science broadly termed “stem cell technology.” This area of research is based on the discovery that cells of the early mammalian embryo, including those from the blastocyst, can be cultured in vitro so as to proliferate indefinitely in an undifferentiated state. More importantly, the cells are pluripotent, in that they can be induced by various cytokines to form derivatives of all three embryonic germ layers. These “[embryonic] stem cells” (ES) have enormous potential for both drug discovery and direct therapeutic applications….Combined with cloning techniques, the use of ES theoretically permits an individual to clone him/herself in early embryonic form in order to obtain and differentiate stem cells into tissue that could be used for an autologous transplant, …or even to create synthetic organs.”

The ‘202 patent is assigned to International Stem Cell Corporation, Oceanside, CA and entitled “Oxygen Tension for the Parthenogenic Activation of Human Oocytes for the Production of Human Embryonic Stem Cells.” An abbreviated version of claim 1 follows:

1. A method of producing human stem cells comprising:

a) parthenogenetically activating a human oocyte, wherein activating comprises; i) contacting the oocyte with an ionophore at high oxygen tension and ii)contacting the oocyte with a serine-threonine kinase inhibitor under low oxygen tension;

b) cultivating the activated oocyte…until blastocyst formation;

c) transferring the blastocyst to a layer of feeder cells, and cuilturing [it];

d) mechanically isolating an inner cell mass (ICM) from trophectoderm of the blastocyst; and

e) culturing cells of the ICM…thereby producing human stem cells.

Parthenogenic activation means causing the oocyte to begin dividing without fertilization by human sperm. Note that the claim does not use the term “embryonic stem cells.” It all sounds pretty benign until you get to step d), where the ICM is mechanically isolated from the blastocyst, e.g., the blastocyst is disassembled. This is the trigger point for many opponents of stem cell research.

Well here’s another one, from column 1, lines 55-60 of the patent:

“Parthenogenic activation of mammalian oocytes may be used as an alternative to fertilization by sperm/[or nuclear transfer, as in “Dolly”] to prepare oocytes for embryonic stem cell generation. Parthenogenic activation is the production of embryonic cells, with or without eventual development into an adult, from a female gamete in the absence of any contribution from a male gamete.”

In other words, what if ICM (or anyone following the teachings of the patent) replaces step (d) above with “implanting the blastocyst into a surrogate female; and (e) allowing the blastocyst to form an embyo and develop to term”? Now you have cloned the female donor of the “human oocyte” of step (a), without the need to remove the nucleus of the oocyte and replace it with a donor nucleus (from a male or second female). Why destroy a (potential) life when you can replicate one? Incidently, human reproductive cloning is not illegal in the United States, although President Clinton instituted a ban of Federal funding for human cloning experiments shortly after the birth of Dolly was announced. Our wait for the arrival of a cloned human child may not be a long one.

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Apart from being praised as an ethical work-around to the problems of destroying early-stage human embryos—often about to be discarded as surplusage by fertility clinics — to obtain human pluripotent stem cells, Revazova et al. (U.S. Pat. No. 7732202 – copy at end of post) got relatively little attention from the IP community. I predict that the relatively benign reception that this patent got will change as various groups begin to sort through the claims and 138 columns of disclosure. Dolly, the cloned ewe, was made by removing the nucleus from an oocyte, or unfertilized ovum, of one breed of sheep, and replacing it with nuclear material from an adult donor cell taken from a different breed of sheep. The renucleated oocyte was induced to divide by an electrical pulse, and reimplanted in a surrogate mother, that eventually gave birth to Dolly, who looked just like the sheep that donated the nuclear material. The donor sheep had successfully been cloned. Today you can clone Fluffy, your favorite cat or, if the USDA would allow it, eat a burger made from beef from a cloned herd of steers. In 1998, Tompson et al. at the University of Wisconsin, claimed human embryonic stem cells obtained by disassembling blastocysts, or very early stage fertilized eggs. In 83 JPTOS 830 (Nov. 2001), I wrote:
“The debate about reproductive or therapeutic cloning of individuals has become interlocked with the ethical controversy that has accompanied a new area of science broadly termed “stem cell technology.” This area of research is based on the discovery that cells of the early mammalian embryo, including those from the blastocyst, can be cultured in vitro so as to proliferate indefinitely in an undifferentiated state. More importantly, the cells are pluripotent, in that they can be induced by various cytokines to form derivatives of all three embryonic germ layers. These “[embryonic] stem cells” (ES) have enormous potential for both drug discovery and direct therapeutic applications….Combined with cloning techniques, the use of ES theoretically permits an individual to clone him/herself in early embryonic form in order to obtain and differentiate stem cells into tissue that could be used for an autologous transplant, …or even to create synthetic organs.”

The ‘202 patent is assigned to International Stem Cell Corporation, Oceanside, CA and entitled “Oxygen Tension for the Parthenogenic Activation of Human Oocytes for the Production of Human Embryonic Stem Cells.” An abbreviated version of claim 1 follows:
1. A method of producing human stem cells comprising:
a) parthenogenetically activating a human oocyte, wherein activating comprises; i) contacting the oocyte with an ionophore at high oxygen tension and ii)contacting the oocyte with a serine-threonine kinase inhibitor under low oxygen tension;
b) cultivating the activated oocyte…until blastocyst formation;
c) transferring the blastocyst to a layer of feeder cells, and cuilturing [it];
d) mechanically isolating an inner cell mass (ICM) from trophectoderm of the blastocyst; and
e) culturing cells of the ICM…thereby producing human stem cells.
Parthenogenic activation means causing the oocyte to begin dividing without fertilization by human sperm. Note that the claim does not use the term “embryonic stem cells.” It all sounds pretty benign until you get to step d), where the ICM is mechanically isolated from the blastocyst, e.g., the blastocyst is disassembled. This is the trigger point for many opponents of stem cell research.
Well here’s another one, from column 1, lines 55-60 of the patent:
“Parthenogenic activation of mammalian oocytes may be used as an alternative to fertilization by sperm/[or nuclear transfer, as in “Dolly”] to prepare oocytes for embryonic stem cell generation. Parthenogenic activation is the production of embryonic cells, with or without eventual development into an adult, from a female gamete in the absence of any contribution from a male gamete.”
In other words, what if ICM (or anyone following the teachings of the patent) replaces step (d) above with “implanting the blastocyst into a surrogate female; and (e) allowing the blastocyst to form an embyo and develop to term”? Now you have cloned the female donor of the “human oocyte” of step (a), without the need to remove the nucleus of the oocyte and replace it with a donor nucleus (from a male or second female). Why destroy a (potential) life when you can replicate one? Incidently, human reproductive cloning is not illegal in the United States, although President Clinton instituted a ban of Federal funding for human cloning experiments shortly after the birth of Dolly was announced. Our wait for the arrival of a cloned human child may not be a long one.
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