USPTO grants PubPat re-exam request on WARF / Thomson stem cell patents
In a letter mailed on 9/29/06 (examiner signature on 8/22/06) the USPTO has granted the request of PubPat / FTCR for re-exam of the '780 (and other patents). IPBiz previously outlined the obviousness arguments in the re-exam request.
The USPTO has determined that a substantial question of patentability is raised as to claims in the '780 in view of four different references.
IPBiz notes that the USPTO misidentified WARF's Thomson patent as the "Thomason" patent on the fourth page of the letter (6th overall page). Not much proofreading by the USPTO here.
The Piedrahita 1990 reference was found to raise a substantial question of patentability. See page five of the letter (7th overall page). The Piedrahita 1990 reference had been applied in the parent case, but was not applied as to this application. The USPTO also noted that the Piedrahita 1990 reference was applied in a new light in the re-exam request.
The grant of a re-exam request is distinct from a determination that any claim is invalid over the cited prior art. The USPTO determination of whether any claim is invalid is yet to occur.
***
The Wisconsin Technology Network stated:
WARF, armed with a $1.5 billion endowment, has said it is prepared to take on any legal challenges to its stem cell patents. Following the PTO decision, Beth Donley, executive director of the WiCell Research Insitute, a subsidiary of WARF, said the decision was not unexpected.
"The patent office grants more than 90 percent of the requests for reexamination, so this decision does not come as a surprise," Donley said in a statement. "WARF believes the Thomson patents are valid and will affirm the validity of the patents."
While patent reviews have taken anywhere from one year to 10 years to complete, Simpson said that in 70 percent of requested third-party reviews, the patents either have been overturned or narrowed.
Of Simpson's comment, IPBiz notes that re-examinations are about CLAIMS. Re-exams in which ALL claims are invalidated are not common. Re-exams in which SOME claims are narrowed are more common. In the director-ordered re-exam of the controversial Eolas/Berkeley patent, NO CLAIMS were altered.
The Wisconsin Technology Network also noted:
To receive a patent, something must be new, useful, and non-obvious. In challenging the WARF patent, the Public Patent Foundation submitted what it said was unseen "art" or evidence that the previous work of other scientists made the derivation of human embryonic stem cells "obvious and therefore unpatentable." [IPBiz notes that the re-exam request raised issues of both anticipation and obviousness.]
The Network also noted:
Dr. Jeanne Loring, a stem cell scientist at the Burnham Institute for Medical Research, said the real discovery of embryonic stem cells was made in 1981 by scientists Martin Evans, Matt Kaufman, and Gail Martin.
Loring filed a 30-page statement in support of the challenge.
Loring's declaration provided no basis to initiate the re-examination. A declaration is not a basis to establish a substantial question of patentability.
***Comment posted to californiastemcellreport.blogspot:
Of the comments in the Sacramento Bee:
In a break with academic tradition that has stirred controversy, the foundation has required university researchers to negotiate licenses to do virtually any sort of embryonic stem cell research. In addition, it generally negotiates "reach-through" royalty rights, giving it the right to claim a share of the proceeds from cures developed through the research.
The actions of WARF about licensing seem to be directed to non-profit (e.g., university) bodies who are affiliated with for-profit entities. WARF does not seem to be after entities who are totally non-profit, and research activities of such entities would likely be insulated from infringement through 35 USC 271(e)(1).
As a result, the Patent Office's decision could have financial implications for California taxpayers, who will be funding $3 billion in embryonic stem cell research in the next decade -- if voter-approved Proposition 71 survives its ongoing legal challenges.
About 70 percent of patents that are accepted for re-examination by the Patent Office are ultimately altered or thrown out, according to agency figures. It usually takes between two and 10 years for the office to issue a final decision, according to Dan Ravicher, executive director of the Public Patent Foundation.
Re-examination itself should be concluded much closer to the "two year" point than the "ten year" point. In the face of an unfavorable decision, WARF would have the right of judicial review, which would add additional time.
It is also possible that litigation could move in tandem with re-examination. In the case of the Eolas/Berkeley patent, Eolas survived re-examination at the USPTO without any claim amendment, but is still engaged in a litigation.
Separately, note that it is claims, not patents, which are investigated in a re-exam. The majority (88%) of patents involved in re-examination survive with (some) valid claims.
[http://ipbiz.blogspot.com/2006/10/uspto-grants-pubpat-re-exam-request-on.html]
**
The AP report on the topic contained the text:
The patent office is acting in response to challenges brought by two groups who contend the patents should never have been issued because other researchers paved the way for the breakthroughs in Wisconsin.
Patent claims are not invalidated because earlier researchers paved the way for later researchers. PubPat's anticipation argument for human embryonic stem cells is based on a prior reference which is not enabled as to human embryonic stem cells. To look in a different area, the work of Galileo (and others) may have paved the way for the Wright Brothers, but no one achieved three dimensional flight control before the Wright Brothers, or taught how three dimensional flight control could be achieved. PubPat's obviousness argument is based on the assertion: recipe for mouse embryonic stem cells renders obvious recipe for human embryonic stem cells. If this were true, it probably would not have taken 15 years between mouse and human.
The USPTO has determined that a substantial question of patentability is raised as to claims in the '780 in view of four different references.
IPBiz notes that the USPTO misidentified WARF's Thomson patent as the "Thomason" patent on the fourth page of the letter (6th overall page). Not much proofreading by the USPTO here.
The Piedrahita 1990 reference was found to raise a substantial question of patentability. See page five of the letter (7th overall page). The Piedrahita 1990 reference had been applied in the parent case, but was not applied as to this application. The USPTO also noted that the Piedrahita 1990 reference was applied in a new light in the re-exam request.
The grant of a re-exam request is distinct from a determination that any claim is invalid over the cited prior art. The USPTO determination of whether any claim is invalid is yet to occur.
***
The Wisconsin Technology Network stated:
WARF, armed with a $1.5 billion endowment, has said it is prepared to take on any legal challenges to its stem cell patents. Following the PTO decision, Beth Donley, executive director of the WiCell Research Insitute, a subsidiary of WARF, said the decision was not unexpected.
"The patent office grants more than 90 percent of the requests for reexamination, so this decision does not come as a surprise," Donley said in a statement. "WARF believes the Thomson patents are valid and will affirm the validity of the patents."
While patent reviews have taken anywhere from one year to 10 years to complete, Simpson said that in 70 percent of requested third-party reviews, the patents either have been overturned or narrowed.
Of Simpson's comment, IPBiz notes that re-examinations are about CLAIMS. Re-exams in which ALL claims are invalidated are not common. Re-exams in which SOME claims are narrowed are more common. In the director-ordered re-exam of the controversial Eolas/Berkeley patent, NO CLAIMS were altered.
The Wisconsin Technology Network also noted:
To receive a patent, something must be new, useful, and non-obvious. In challenging the WARF patent, the Public Patent Foundation submitted what it said was unseen "art" or evidence that the previous work of other scientists made the derivation of human embryonic stem cells "obvious and therefore unpatentable." [IPBiz notes that the re-exam request raised issues of both anticipation and obviousness.]
The Network also noted:
Dr. Jeanne Loring, a stem cell scientist at the Burnham Institute for Medical Research, said the real discovery of embryonic stem cells was made in 1981 by scientists Martin Evans, Matt Kaufman, and Gail Martin.
Loring filed a 30-page statement in support of the challenge.
Loring's declaration provided no basis to initiate the re-examination. A declaration is not a basis to establish a substantial question of patentability.
***Comment posted to californiastemcellreport.blogspot:
Of the comments in the Sacramento Bee:
In a break with academic tradition that has stirred controversy, the foundation has required university researchers to negotiate licenses to do virtually any sort of embryonic stem cell research. In addition, it generally negotiates "reach-through" royalty rights, giving it the right to claim a share of the proceeds from cures developed through the research.
The actions of WARF about licensing seem to be directed to non-profit (e.g., university) bodies who are affiliated with for-profit entities. WARF does not seem to be after entities who are totally non-profit, and research activities of such entities would likely be insulated from infringement through 35 USC 271(e)(1).
As a result, the Patent Office's decision could have financial implications for California taxpayers, who will be funding $3 billion in embryonic stem cell research in the next decade -- if voter-approved Proposition 71 survives its ongoing legal challenges.
About 70 percent of patents that are accepted for re-examination by the Patent Office are ultimately altered or thrown out, according to agency figures. It usually takes between two and 10 years for the office to issue a final decision, according to Dan Ravicher, executive director of the Public Patent Foundation.
Re-examination itself should be concluded much closer to the "two year" point than the "ten year" point. In the face of an unfavorable decision, WARF would have the right of judicial review, which would add additional time.
It is also possible that litigation could move in tandem with re-examination. In the case of the Eolas/Berkeley patent, Eolas survived re-examination at the USPTO without any claim amendment, but is still engaged in a litigation.
Separately, note that it is claims, not patents, which are investigated in a re-exam. The majority (88%) of patents involved in re-examination survive with (some) valid claims.
[http://ipbiz.blogspot.com/2006/10/uspto-grants-pubpat-re-exam-request-on.html]
**
The AP report on the topic contained the text:
The patent office is acting in response to challenges brought by two groups who contend the patents should never have been issued because other researchers paved the way for the breakthroughs in Wisconsin.
Patent claims are not invalidated because earlier researchers paved the way for later researchers. PubPat's anticipation argument for human embryonic stem cells is based on a prior reference which is not enabled as to human embryonic stem cells. To look in a different area, the work of Galileo (and others) may have paved the way for the Wright Brothers, but no one achieved three dimensional flight control before the Wright Brothers, or taught how three dimensional flight control could be achieved. PubPat's obviousness argument is based on the assertion: recipe for mouse embryonic stem cells renders obvious recipe for human embryonic stem cells. If this were true, it probably would not have taken 15 years between mouse and human.
posted by Lawrence B. Ebert at 4:35 PM
1 Comments:
David Wahlberg published an interview with Professor Thomson which included the text:
DW: California has started a $3 billion stem-cell research initiative. Other states, including Connecticut and New Jersey, are also contributing state money to this research. Is Wisconsin still a leader in this field? Is the state in danger of losing its prominence?
JT: [Audio] We're already losing people. The person from WiCell (Ren-He Xu) moved to Connecticut to assume a lab directorship to get access to that state money. The first person to actually show hematopoietic differentiation from human ES cells in my lab (Dan Kaufman) took a faculty position in Minnesota instead of Wisconsin. I suspect that pattern will continue. Nonetheless at the moment we are the leaders in this field. If you look at the total number of publications of this institution versus, say, Harvard, for example, we're way ahead of them. But other people are starting to outspend us. California is only one. Harvard has a program to get $100 million for their stem-cell institute as do some other institutes.
(...)
DW: Are there any specific obstacles you're concerned about that could be brought into play in Wisconsin? For example, are you concerned that Mark Green says he would want to ban therapeutic cloning?
JT: [Audio] Mostly I'm concerned about perception. We have major competitors out there, and the state is not currently investing in this research. They hope to make some buildings, and that's very nice, and that's very positive. If they go beyond that and make it sound restrictive here, it's going to be really hard to recruit people to the state of Wisconsin. It's hard already just because of the dollars. But if you make it even worse, it's going to be very, very difficult to get talent to come here. At the end of the day, the talent is more important than the dollars. The dollars follow the talent. But if you can't get them here somehow, it's a problem.
(...)
DW: Is the United States still leading in stem-cell research, or have other countries taken over?
JT: I'd still say the highest quality publications have come out of the United States. Britain has had very liberal legislation, and they're finally kind of kicking in. But their research dollars aren't as high as here.
But it's going to be California against the rest of the world with that amount of money. On a per capita basis, we'd have to be investing about $50 million a year to be equal to California. We're not doing that.
DW: What about places like Singapore?
JT: Yeah, I think Singapore might ultimately make important contributions. But they haven't done a whole lot yet. Certainly they've published some things, but most of the significant research has been dominated by the United States. There's exceptions to that. It's not absolute.
Certainly Britain's making a lot more, and Israel's published a lot and Singapore has published. But I would think that ten years from now, if the dollars flow as they're currently set, California will be the dominant researcher in this area.
DW: Your lab recently announced the creation of the first stem-cell lines known not to contain animal products, which could make them safer for use in humans. What's the latest on this development?
JT: There's no real change. The Bush compromise doesn't allow federal funding for that, although we do have some private funding to actually allow the derivation. All this nice equipment we have around us is intermingled with private and federal funding. We haven't done a lot with those cell lines. They're in the freezer now.
We did that as a proof of principle. It shows that it can be done. We would like to be able to expand those efforts. But given the realities of federal funding, we probably won't be doing a lot of research on those cell lines for a while.
DW: What else are you focusing on at your lab and at your company, Cellular Dynamics?
JT: They're very separate things. Within my lab, I'm interested in the basic biology of these cells. There's something very special about why one cell can give rise to everything else and most cells can't do that. It's called pluripotency. I'm very interested in how that's regulated and how that works. If you really understand that, then this reprogramming thing that Dolly does might become possible.
In one way or another my lab is either studying this basic concept of pluripotency or how the cells decide to become something else or sustain themselves - self-renewal versus differentiation - and that balance and how that balance works. We've kind of stepped back from some of the practical issues to look at this somewhat more basic biology issue. We continue to collaborate with some of the MDs on campus that have particular lineages of therapy with importance. But I didn't want to get so spread thin. I decided, this is the thing I think is kind of cool, and we'll concentrate on that.
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