Saturday, December 31, 2005

New data confirms Snuppy is a clone

from the Korea Times:

A Korean institute Wednesday, Dec. 27, said that its DNA tests proved Prof. Hwang Woo-suk at Seoul National University (SNU) had successfully cloned a dog.

HumanPass Wednesday confirmed fingerprinting traces of Snuppy, Hwang's canine clone, matched those of its somatic cell donor, an Afghan hound named Tai, while they demonstrated disparate mitochondrial genotypes. Snuppy was cast under suspicion following revelations that the Korean scientist had fabricated his stem cell research.

"This is an indisputable piece of evidence that Snuppy is a clone. I am sure of the results because I myself watched as Hwang's team extract blood samples from the two dogs," HumanPass chief executive Rhee Seung-jae said.

Rhee said that he started the tests this Monday at the request of Hwang and staged the same experiments three times to ensure the credibility of the result.

"When I informed Hwang of the result today (Wednesday), he said it is the natural outcome. He seemed to have confidence in the dog clone," Lee said.

Park Se-pill, head of Seoul-based fertility clinic Maria Biotech, said the tests can silence Hwang's critics who have suggested the dog might be a twin created from a split embryo rather than a clone.

"With this, Hwang demonstrated his team's technical prowess in cloning. It brightens the prospects that his team retains the source technologies for stem cell research," Park said.

After an investigative panel at SNU found last week that Hwang's team fabricated data for his purported exploit of making 11 tailor-made stem cells, his other works such as Snuppy were all cast under suspicion.

Prof. Kong Il-keun at Suncheon University who cloned six cats last summer concurs with Park but the embryologist expressed his regret since Hwang asked for the tests while the SNU team is reviewing the authenticity of Snuppy.

Friday, December 30, 2005

NTP gets 30 day extension in re-exam

The Wall Street Journal has reported that NTP Inc has won a 30-day extension from the US Patent and Trademark Office.

The US district court in ED Va is set to consider imposing an injunction against RIM which might amount to a US ban on Blackberry at a hearing after Feb 1. RIM said it has developed 'workaround' technology to bypass a possible injunction.

A patent-office spokesman said the office is re-examining NTP's case and will issue a decision within six to 10 weeks.

Hwang's cell lines no longer exist

Dec. 29, 2005 -- South Korean laboratories used by scientist Hwang Woo Suk no longer have any stem cells created from patients' tissues, the result of the researcher's landmark May 2005 paper, the Seoul National University said.

``The patient-matching stem cells no longer exist,'' Roe Jung Hye, dean of research of affairs at the university, said in an e-mailed statement. The university has been conducting a probe on Hwang and his research since Dec. 16, including genetic tests on stem cells being stored at the laboratories. (from Bloomberg)

Furthermore, there is uncertainty as to whether Hwang possessed the technology to perform the experiments:

``There is disagreement among the investigative body on whether Hwang had the technology to begin with,'' Roe said. The university will likely announce the final results of its investigation some time next month, she said.

Furthermore, it now appears that Hwang possessed only two cell lines at the time his article was submitted to Science (March 15, 2005):

Only two of Hwang's 11 claimed stem-cell lines existed when he submitted his 2005 paper to the journal, Science, the university said on Dec. 23.

The stem cells in storage at Hwang's laboratories at the university were all derived from the fertility clinic MizMedi's blastocysts, which were generated by in vitro fertilization. Hwang's stem cells should have been found to be nuclear transferred embryonic stem cells from patients' skin cells.

Thursday, December 29, 2005

Referees of science papers check whether a report's conclusions follow from data

A question both Science and Nature have considered is that of whether their editors and reviewers should have caught the errors in Dr. Hwang's papers before publication. But as in past cases of fraud, the journals' editors and other scientists assert that their system depends basically on trust and that reviewers can check only whether a report's conclusions follow from the data presented.

from NICHOLAS WADE, NYTimes, Dec. 25, 2005 as reproduced in the Lakeland, FL Ledger.

As I pointed out in Intellectual Property Today in June 2005, some patent reformers, such as Rebecca Eisenberg in 19 Berkeley Law Tech J. 885 (2004) have advocated the use of referees in the review of patent applications. In 2004, Eisenberg did not mention referee flaws in the Jan-Hendrik Schon incident two years earlier. Now, in 2005, we have an even bigger issue with refereeing by Science and Nature in the Hwang matter. As is evident by the superficial review of the June 17 Hwang paper [the absence of photographs to document all 11 cell lines, the suspicious nuclear DNA profiles, the absence of mitochondrial DNA profiles, the issues with oocyte donors], the reviewers basically accepted on faith what was presented and did not look for inconsistencies. Further, after more explicit identification of problems developed, Science denied problems. For example, on December 6, Science referred to a mere mix-up of photos of the 11 cell lines, even though about 10 days later, even Hwang admitted he had only 8 cell lines at the time of submission to Science (March 15, 2005). If Science thought on March 15 that there was evidence for 11 cell lines, when in fact only 8 existed, there are some major problems. Contrary to what Eisenberg suggests, the review procedure at Science is not one that the USPTO ought to be emulating.

Other problems with Eisenberg's proposed plan were pointed out in the June 2005 article, Patent Reform 2005: Can You Hear Me, Major Tom? The brief of the 24 law professors in KSR v. Teleflex is flawed.

Other points from the Wade article:

In addition, the main premise of Dr. Hwang's article, that he could perform human cloning very efficiently, with just a few human eggs, was untrue. The committee said he used far more eggs than he reported.

The panel is also reviewing Dr. Hwang's 2004 claim in which he was apparently the first to clone human cells. If that also proves false, the goal of therapeutic cloning - repairing patients' cells with their own tissues - may be considerably further off than it seemed a few months ago.

How did Dr. Hwang manage to rise so quickly in the scientific firmament and convince so many leading experts that his work was sound?

Three ingredients of his ascent were attracting generous support from the South Korean government, compartmentalizing his laboratory so that few others had any overall view of what was going on and reporting plausible advances that scientists abroad felt they, too, might have achieved if they had access to as many human eggs as Dr. Hwang obtained.

In addition, Dr. Hwang invited well-known American researchers to be co-authors on his articles, which he may have hoped would make his findings more acceptable to leading journals like Science and Nature. He even invited Dr. Gerald Schatten, a stem cell expert at the University of Pittsburgh, to be the lead author on the June 2005 report although Dr. Schatten had done none of the experiments. But Dr. Donald Kennedy, the editor of Science, said the inclusion of American co-authors "certainly did not affect us."

The starting point of Dr. Hwang's rise to fame was his skill in making the South Korean system work for him. The government had invested about $65 million in his research before the collapse came, and the Ministry of Science and Technology had acclaimed him as an "Outstanding Korean Scientist."

The Health and Welfare Ministry promised to provide $15 million next year to set up a World Stem Cell Hub in which Dr. Hwang's technicians would have cloned human cells for scientific customers abroad.

An indication of Dr. Hwang's good connections to the government was the inclusion of Dr. Park Ky Young as a co-author of his 2004 report on human cloning. A botanist by training, Dr. Park may not have contributed much scientifically to the task of cloning of human cells. She is, however, the science adviser to Roh Moo Hyun, the president of South Korea.

The frequent American visitors to Dr. Hwang's growing operation were impressed at the scale and skill of his operation and how he divided his scientists into task forces that specialized in each step of the cloning process. But this compartmentalization may have meant that not all of his co-workers knew what was going on. Few seem to have seen the colonies of embryonic cells Dr. Hwang said he had cloned from patients.

Outside of South Korea, the debacle has left a bitter taste with scientists who trusted Dr. Hwang's work. "It's a sad business," said Dr. Kennedy, the Science editor. "We don't feel like it's our best day."

Science and Nature, two leading journals that compete with each other in publishing striking scientific advances, accepted reports from Dr. Hwang. But Science is now reviewing the accuracy of articles of 2004 and 2005 in which Dr. Hwang said he had cloned human cells, and Nature is re-examining his claim to have cloned a dog, which he named Snuppy.

"We are investigating the Snuppy paper and will review whether we and referees acted appropriately, and whether standards should change," said Dr. Philip Campbell, the editor of Nature.

A question both journals have considered is that of whether their editors and reviewers should have caught the errors in Dr. Hwang's papers before publication. But as in past cases of fraud, the journals' editors and other scientists assert that their system depends basically on trust and that reviewers can check only whether a report's conclusions follow from the data presented.

"Peer review is not set up to test for fraud," Dr. Campbell said. "It is set up to provide expert assessment of the scientific credibility and reliability of what scientists report, taking the report itself in good faith."

Dr. Kennedy noted that journals often published articles that were later shown to be innocently in error. "The public needs to understand that the journals and peer review are not perfect," he said.

Reviewers can, however, recommend that the author provide more data if they are dissatisfied on any point. Science's reviewers asked Dr. Hwang to furnish DNA fingerprints showing that each of his embryonic cell colonies had the same DNA fingerprint as the patient from whom they were said to be derived. Dr. Hwang sent in pairs of fingerprints, some of which had the identical background noise, suggesting the same print was being presented twice. But this anomaly was noticed only later by Dr. Hwang's critics.

Nature's reviewers did not ask Dr. Hwang to provide evidence that would have proved Snuppy was cloned from another dog. Dr. Campbell said that Nature, as part of its investigation of the article, would consider whether its standards of proof should be changed in the future.

Dr. Hwang's failure may have repercussions on the standing of South Korean science.

"Clearly the scientific credibility of Korean investigators has been compromised," said Dr. John Gearhart, a stem cell expert at Johns Hopkins University and a member of Science's board of reviewers. He referred to the fact that duplicate and misidentified photos had turned up in articles by other South Korean authors besides Dr. Hwang.

Dr. Kennedy said, "You cannot avoid a sense of taint from an experience like this." He added, however, that many leading American universities had had at least one case of scientific fraud.

It was also South Koreans who took the lead in detecting Dr. Hwang's falsifications. Dr. Zach Hall, president of the California Institute of Regenerative Medicine, noted that young South Korean scientists had brought to light many problems with Dr. Hwang's papers in Web site postings, and that Seoul National University seemed to be conducting a vigorous inquiry.

The ultimate test of a scientific claim is whether other laboratories independently confirm it. Some scientists have argued that even if Dr. Hwang's errors had remained undetected by the scientific journals and their readers, his work would have fallen under suspicion if no one could repeat it. However, if other scientists had succeeded in cloning human cells before any challenge had emerged to Dr. Hwang's work, it is not so clear that he would have been exposed.

"If the procedure works indeed and other labs would have repeated it, the credit would have gone to Hwang," said Dr. Rudolf Jaenisch of the Whitehead Institute in Cambridge, Mass.

The people best situated to detect scientific problems are those inside the laboratory who see the raw data being generated and have some practical reason for suspicion. As in many other cases of scientific fraud this was true of Dr. Hwang's, too.

It was a whistle-blower in Dr. Hwang's lab who informed the South Korean television network MBC of problems in his work, and that led South Korean journalists to begin to investigate.

But for the whistle-blower, Dr. Hwang might well be continuing his meteoric career on the wings of his reports in Science and Nature.

The fraud passed right through the hands of the referees.

Remaing two cell lines of Hwang declared fake by SNU panel

A panel from Seoul National University [SNU] investigating the human SCNT work of Hwang Woo-suk said last week at least nine of the 11 patient-specific stem cell lines reported this year in the journal Science [Vol. 308, p. 1777, June 17, 2005] were fabricated. On Thursday, December 29, the panel said the remaining two cell lines were also faked. The panel did not evaluate charges by Hwang that some of the cell lines had been switched. [AP]

The AP report of December 29 also noted:

"The panel couldn't find stem cells that match patients' DNA regarding the 2005 paper and it believes that Hwang's team doesn't have scientific data to prove that (such stem cells) were made," Roe Jung-hye, the university's dean of research affairs, told reporters.

The latest revelations are a setback for research into stem cells, master cells that can grow into any body tissue.

Creating patient-specific stem cells would be a breakthrough because they would not be rejected by patients' individual immune systems. Scientists hope to someday use such cells to cure Alzheimer's, diabetes and paralysis.

"The bottom line is that it's a major disaster to our whole field because the expectations were so high and now we are back to square one," said Joseph Itskovitz, a stem cell researcher and director of the department of obstetrics and gynecology at Rambam Medical Center in Haifa, Israel.

Hwang's whereabouts were unknown and he could not immediately be reached for comment. A mobile phone number he gave to journalists has been changed.

Hwang bolted to international fame last year when he published an article in Science claiming that he had created the world's first cloned human embryo and extracted stem cells from it. This year, he and his research team published an article in the journal Nature claiming they had produced the world's first cloned dog, an Afghan hound named Snuppy.

Those breakthroughs — which are now also under suspicion — catapulted the veterinarian, dubbed "The Pride of Korea," into the role of national hero. The government responded with pledges of massive financial support.

But trouble began for Hwang last month when he admitted, after more than a year of denial, that he had used eggs donated by lab workers, in violation of ethics guidelines. He also acknowledged that some of the eggs he used were bought. He had claimed that all the eggs were donated. [See for example footnotes 8 and 32 of the June 17, 2005 paper, which footnotes appear on page 1783 of Volume 308 of Science, which footnotes comprise false statements.]

Then this month, a former colleague [Sung Il Roh, the second listed author on the June 17, 2005 paper] alleged that at least nine of the stem cell lines that Hwang said he had created through cloning were faked. He did not elaborate on the charge, but the accusation sparked an investigation by Hwang's university.

Last Friday [Dec. 23], after the university's disclosure that at least nine stem cell lines were faked, Hwang, 53, apologized for the fabrication and stepped down as professor at the university.

Biotech shares on the Seoul stock market took another hit Thursday after declining on the university's initial report. Medipost Co., which develops therapies using stem cells from umbilical cord blood, fell 7.1 percent. Innocell Corp., which specializes in cell therapies, plunged 10.6 percent.

Despite Hwang's fall from grace, some were not ready to give up the dreams that his claims inspired.[Please note also the statements by followers of Jan-Hendrik Schon of the inspiration they received from the [fraudulent] work of Jan-Hendrik Schon, posted elsewhere on IPBiz. See]

"Our confidence in Hwang remains unchanged," said Jung Jin-owan, 40, secretary general of the Korea Spinal Cord Injury Association.

"As we didn't hear directly from Hwang about the result, we would like to believe that he created patient-specific stem cells," added Jung, who was paralyzed from the waist down in a 1987 traffic accident.

The South Korean government, which last week strongly suggested it would stop supporting Hwang, reacted cautiously.

"We don't have an official position over today's report as Seoul National University's investigation is still under way," said Nam Sang-mun, a spokesman for the Science and Technology Ministry.

Hwang filed a complaint with prosecutors last Friday that some of the stem cell lines his team created were replaced by those made at Seoul's Mizmedi Hospital, which had collaborated with his research team.

Roe said while the university's investigation found that some of Hwang's purported stem cell lines originated from Mizmedi, probing any possible switch is beyond the scope of the panel.

Prosecutors said last week they are waiting for the university investigation to be completed before launching their own investigation.

Wednesday, December 28, 2005

Two Hwang co-authors back up claim of considerable advances in cloning

from english.chosun:

Two scientists who closely worked with disgraced cloning expert Hwang Woo-suk on Wednesday, Dec. 28, 2005 suggested Hwang has in fact made considerable advances in cloning somatic cells and stem cell technology, lending support to Hwang's insistence that source technology for cloning patient-specific stem cells exists. Dr. Kim Min-kyu, a Seoul National University veterinarian who was on the team that created what may be the world's first dog cloned from adult somatic cells, said both cloning of the dog and of embryos required the same technique substituting the nucleus of an egg with that of a somatic cell. Kim also said embryonic stem cells from dogs have survived in the lab for 60 weeks.

An issue with Snuppy is that, while the nuclear DNA fingerprint comparison between Snuppy and the genetic parent was reported, the mitochondrial DNA fingerprint (which would be different between Snuppy and the genetic parent, but the same as to the embryo donor) was not reported. This omission, which did not concern the referees of Nature, would not rule out that Snuppy was a twin, not a clone.

The article also mentioned:

The panel said it will answer whether Hwang's stem cells genetically match patients' somatic cells, and how a sum of US$50,000 that has been subject to speculation was used. It will also brief reporters on progress of its investigation into the veracity of a 2004 article by Hwang on cloning somatic cells and of the cloning of the dog Snuppy. It will also clarify why it postponed the announcement of its final report until next month.

One hitch in the investigation was that the panel commissioned additional DNA testing on Snuppy. It first entrusted the test to a human DNA testing institute, but differences in technique made it advisable to send the dog's blood samples to one specializing in animals, it said.

Meanwhile, Yoon on Wednesday, Dec. 28, also dismissed rumors that Kim Seon-jong, a former Hwang team member now working at the University of Pittsburgh, attempted suicide after telling TV reporters he fabricated research results at Hwang's behest. Yoon confirmed reports that he gave Kim $20,000 during a recent visit to the U.S. but denied the money was intended as a sweetener. Rather, it was a contribution to Kim's hospital expenses after he was admitted for stress, Yoon said. He also confirmed that core team member Prof. Ahn Cu-rie of SNU gave Kim another $10,000. Meanwhile, customs caught Kim with the money when he recently returned to Korea. By law, sums over $10,000 brought into the country must be declared.

Hmmm, doesn't the University of Pittsburgh give medical coverage to its staff, such as Kim Seon-jong? Or is this like the old days of San Filippo and Rutgers University?

[Post 1102]

Tuesday, December 27, 2005

Google a patent infringement defendant?

from Mike at TechDirt

Gary Price, over at the Search Engine Watch site, is breaking the news that Google is being sued for patent infringement concerning the Google Talk IM/VoIP client. Price points to a very thorough look at RTI, the company doing the suing, by Rich Tehrani. The company tries to position itself as not being a patent troll -- but again, they do seem to be suing companies who are innovating in areas that RTI isn't doing anything. The two (one and two) patents at issue are focused on "least cost routing," basically figuring out the cheapest way to make a phone call and selecting that route. You can make a very reasonable argument that this is a non-trivial matter -- but is it so difficult that it's somehow non-obvious to those skilled in telephony? Either way, it's still unclear how Google is infringing on either patent, as it doesn't appear that Google Talk connects to the traditional (PSTN) phone system these days. So, how are they violating patents concerning least cost routing on the telephone network when they never touch the telephone network? It's quite likely that Google Talk will eventually interconnect with the PSTN, but it seems like this patent suit might be a bit premature.

More on NTP/RIM; MercExchange/eBay

Of the idea RIM’s case with NTP is different, not only does it affect the nerds and geeks, but the everyday 3 million American Blackberry users, remember that patent infringement cases circa 1910 over the Selden patent for cars affected lots of everyday users. Nothing new here...

Of the positions -->

Against the patentee, from BlackBerry Cool: RIM’s Case The Catalyst For Patent Reform:

Over the past few years, there’s been a lot of talk about how broken down the patent system is, examples like Amazon patenting a “1-click” checkout or ActiveBuddy who successfully patented instant messaging in 2002. Both of these patents had something called “prior art” which means they should have not been granted because the technology has already been readily available. [OK, how come BN (Barnes&Noble) LOST its case?] Anyone that used ICQ during its popularity would tell you that, but somehow it went unnoticed at the patent office.

Now we’re not against the idea of a patent, an inventor should get rewarded for their hard work. However the NTP case is different and you can say that for many other technology patents. Many of these technology patents are the equivalent of a “land grab”, just file something very crude and broad and hopefully it gets approved by the USPTO. That’s the case with NTP, a company that was founded to exploit the patent system. This Virginia-based company has no employees other than co-founder Donald Stout who happens to be a patent-infringement lawyer or any real products. It has never tried to build a real business or product out of its patents, hell they don’t even have a website. In the patent world, these companies are called “patent trolls” and they are becoming more prominent, 3,000 multi-million lawsuits were filed, double the amount that was filed 15 years ago.

You may say to yourself, what a bunch of crooks but what they are doing is completely legal. These companies depend on the broken down patent system, a department that is under funded and under staffed. When the USPTO actually puts some time and resources in to investigating a patent they become sensible. And now we come full circle with the RIM/NTP case, under enormous media pressure and most likely political, the USPTO had made the NTP patents priority, re-examining them and invalidating 3 out of 5, and most likely the other 2 very soon.[All claims have been rejected in non-final Office Actions] However it may be all for nothing, Judge Spencer has went on record that he wants to get the case over with as soon as possible and it’s not sure if he’s going to allow new evidence.

Unfortunately the worst case scenario of a Blackberry blackout would probably be the tipping point for patent system reform but RIM will never allow that. So ironically, RIM would probably have to settle with NTP on the patents they infringed on which were later decided invalid patents.

For the patentee, Richard Epstein:

Typically, popular sentiment sides with David when he does battle with Goliath. But not when MercExchange (as David) must lock horns with Ebay (as Goliath). Their struggle is now before the United States Supreme Court, as ME tries grimly to hang on to an injunction stopping Ebay from making a wilful infringing use of ME’s patent technology to run its own fix-priced auctions. EBay thinks that the trial judge should use sound discretion to decide whether to grant that injunction or simply to require the payment of a royalty set by the court. The traditional rule routinely grants the injunction.

Ebay has a lot of supporters in clarion call for wide discretion. Patti Waldmeir’s FT column is sympathetic to Ebay. A distinguished group of 35 law professors took up Ebay’s cause in urging the Court to undertake its broad review.
The Supreme Court should reaffirm the traditional view. The impulse for the fresh look at doctrine lies in the evident (but hardly novel) holdout potential that strong patent rights give to a prior inventor. The concrete fear is that greedy holdouts will be able to shut down valuable devices that incorporate multiple patented technologies, such as those ubiquitous Blackberrys. Better, we’re told, to preserve the status quo by ordering the wrongdoer to pay the inventor a fair royalty, with no holdout potential.

That argument is not wrong in isolation. But it is fatally incomplete. Start with the particulars of this case. Ebay did not commit inadvertent infringement, because it was unaware that ME’s patent covered its pricing tools. Quite the opposite, Ebay had wilfully infringed the patent when it and ME came to a bargaining impasse over royalty terms.

Now the plot thickens. Just as we don’t like some holdouts after the fact, we also don’t like firms that take the law into their own hands by consciously deciding that it is cheaper to infringe than to purchase. Yet once the use of the injunction is relaxed at the back end of a transaction, then every firm can circumvent the law, hoping to profit from its own wrong. A veritable deluge of infringements can descend on ME, until endless litigation saps its incentive to innovate. Both Ms Waldmeir and the amicus professors never discuss wilful infringement, but work from an unstated and incorrect assumption that patent infringements won’t multiply like rabbits if injunctions aren’t routinely granted. Yet what’s to prevent Ebay from building a whole network out of infringing elements?

The problem is not new to the law, for the identical problem has arises in land encroachment cases. Suppose one landowner builds a large office structure located six inches on the land of the neighbour. After the fact, it looks as though ripping down the building is a huge social waste. Yet most courts will routinely order that destruction for any wilful encroachment. It’s important to force potential encroachers to enter into voluntary transactions to obviate the deluge of lawsuits if hapless owners get only trifling damages for repeated invasions. The holdout problem is only one form of abuse. Deliberate infringement is the far greater risk.

The same logic carries over to patents. It is wrong to insist that injunctions have to be denied in patent cases to spur innovation. Innovation depends on the work of multiple inventors through the entire technology chain, not just those at the back end. Why make it less attractive for ME to innovate to help out Ebay? Nor should it make the slightest difference that ME chooses to operate solely through licenses, rather than using its patented technology to fabricate its own equipment. No one strips a landowner of all protection if he decides to lease it out instead of building on it himself. We will get efficient make-or-license decisions in the patent context, as elsewhere, only if keep legal protection constant regardless of how the patent holder chooses to exploit its invention.

A strong tradition in all IP areas has rightly granted injunctions for wilful infringement except in rare circumstances. Once the remedy is up for grabs, courts will have to work their way through endless fact patterns, with the unhappy consequence of increasing costs and reduce the predictability. The strong injunction has worked so well on a systematic level, that not one judge on the specialised patent court, the Federal Circuit, saw fit to re-examine the basic rule. There might come a time for a fresh look if some innocent infringement threatens to shut down a complex operation which otherwise has scrupulously used only licensed technologies. But that inquiry is not needed when Ebay has only its own wilful misconduct to blame for the mess it created for itself.

Lawrence B. Ebert Your comment is awaiting moderation.
December 27th, 2005 23:36 1Any idea that patent infringement affecting “everyday users” is a new thing is wrong. Think back to automobile buyers at the time of Henry Ford and the Selden patent, with ads like “Don’t buy a lawsuit.” And, in the copyright area, we have the RIAA and the Grokster decision.

Of the text –under enormous media pressure and most likely political, the USPTO had made the NTP patents priority, re-examining them and invalidating 3 out of 5, and most likely the other 2 very soon.– the re-examinations were initiated by RIM, and the initial results in non-final Office Actions are claim rejections. (information on IPBiz, including There are rejections under 112, 102, and 103.

However, recall that in the re-examination of the Eolas/Berkeley patent, there were two sets of USPTO rejections, both of which were overcome by the patentee, in large part through declarations made by university professors at Princeton and Michigan. And remember the Amazon one-click patent was never invalidated.

[Post 1100]

Mark Frankel on science fraud: unconvincing

Of the text below, "We have a history of dealing with these kinds of matters, and we have gotten better at it," said Mark Frankel of the American Association for the Advancement of Science, which owns the journal Science, one recalls that the scandal involving Jan-Hendrik Schon of Bell Labs does not suggest that Americans or the journal Science did a good job in dealing with scientific fraud.

Currently, research is largely self-policed through a patchwork of safeguards designed to make sure studies are ethical and conducted well. Universities, hospitals and other research centres have internal review boards that approve studies before they are begun and monitor their conduct. Scientists then submit their findings to journals, which ask experts in the field to review them.

Some experts said the system of checks and balances might not be as stringent in countries such as South Korea. "We have a history of dealing with these kinds of matters, and we have gotten better at it," said Mark Frankel of the American Association for the Advancement of Science, which owns the journal Science , which published the disputed work. "The Koreans are at a very nascent stage of dealing with these kinds of things."

The increasing complexity of science made it more difficult for fraud to be detected, Mr Boese said. "As science becomes more specialised, it becomes harder for scientists to check each other, which makes it easier to get away with fraud," he said.

At the same time, the proliferation of scientific journals and the advent of the internet have put pressure on the journals to publish papers more quickly, some say.

"People use press coverage as a way to judge the value of research," said Monica Bradford, the executive editor of Science. "They want to know did it get in the papers - not whether it really expands our knowledge."

An attempt at hush money to Kim Seon-jong in Hwang-gate?

UPI: SEOUL, Dec. 27 (UPI) -- Two members of a stem-cell research team allegedly gave $30,000 to a former member of the group to retract comments about fabricating research data.

Professors Ahn Cu-rie and Yoon Hyun-soo, both of Seoul National University, allegedly gave the money to Kim Seon-jong during a trip this month to the University of Pittsburgh, where he had been working since he left the South Korean research team, the Chosun Ilbo newspaper reported Tuesday.

University officials say research by Professor Hwang Woo-suk was fabricated. Hwang said he would resign from the university but did not admit his work, involving the creation of stem-cell lines, was faked, the BBC reported.

Hwang, in research published in May in the journal Science, claimed South Korean scientists were able to clone human embryos that included DNA that matched genetic materials from 11 patients.

Officials claim Ahn and Yoon gave Kim thousands of dollars to retract statements regarding the research. Kim returned the funds to Seoul National University when he returned to South Korea, the newspaper said.

of books about Hwang

Hwang Woo-suk accuses Kim Sun-jong of substituting stem cell samples

Hwang has filed a case against his research associate Kim Sun-jong, alleging that Kim replaced not only the two cells (the two of the eleven reported in Science, which at this time might not be fake) but also some others with the stem cells created by MizMedi Infertility Clinic with the artificially produced embryos.

The Korea Times reported on Dec. 25:

With the return of a key member in Professor Hwang Woo-suk's controversial stem cell research from the University of Pittsburgh Saturday night, people's concerns are focused on whether Hwang really created at least two patient-specific stem cells, regarded as his last line of defense. But it is generally accepted that Kim Sun-jong, a researcher at the MizMedi Hospital, will fail to resolve the issue because it seems the two cells no longer exist.

The latest suspicion over the authenticity of the two cells was raised by Hwang himself on Thursday [Dec. 22] when he filed a suit against Kim with the prosecution, claiming that Kim replaced not only the two cells but also some others with the stem cells created by MizMedi with the artificially produced embryos. Hwang sued his research member a day before an investigative committee of Seoul National University made public its interim report, confirming that Hwang fabricated the data in his paper published in the U.S.-based journal Science in May. As already known, nine of the 11 stem cells in the paper which Hwang said were produced from the embryos cloned with the body cells of the 11 patients were fabricated with the two others. Weeks before his arrival, Kim, an expert on cultivating stem cells, confessed to his manipulation of the pictures of the nine bogus cells on Hwang's order.

Hwang's accusation of his research partner the day before the SNU panel revealed the report on its investigation of his false paper induces many people to distrust his claim that he discovered that the two cells were also replaced with two stem cells made at MizMedi, a fertility clinic in Seoul. They speculate that the results of DNA tests of the two cells, which the SNU committee said will be revealed in a few days, may compel Hwang to accuse his team member in order to cover up another bombshell hoax that he created the controversial cells.

As Kim protested, it is regarded as impossible for Kim to replace Hwang's stem cells with those made at MizMedi in light of the tight supervision of his activities by Hwang's research team. Even though Kim claimed that he actually cultivated some patient-specific stem cells, there is the possibility that they might be those provided by MizMedi. The reason is that Kim only took part in cultivating stem cells, which Hwang said were made from the cloned embryos.

As Hwang already indicated that the two cells at issue no longer exist, it is certain that the SNU investigation team will be unable to discover the true nature of his experiments which once amazed the world, but now stun it with the disclosure of their fabrication. It is sincerely hoped that Hwang will tell the truth of his stem cell research as his last service as a scientist to put an end to people's confusion over his work.

The title of the paper in Science, published in paper form on June 17, 2005, is "Patient-Specific Embryonic Stem Cells Derived from Human SCNT Blastocysts."

Monday, December 26, 2005

NYTimes finally mentions on Dec. 25 role of MBC in Hwang-gate

From Nicholas Wade, Clone Scientist Relied on Peers and Korean Pride, NYT, Dec. 25:

Dr. Philip Campbell, the editor of Nature: "We are investigating the Snuppy paper [by Hwang] and will review whether we and referees acted appropriately, and whether standards should change."

Science is now reviewing the accuracy of articles of 2004 and 2005 in which Dr. Hwang said he had cloned human cells.

A question both journals have considered is that of whether their editors and reviewers should have caught the errors in Dr. Hwang's papers before publication. But as in past cases of fraud, the journals' editors and other scientists assert that their system depends basically on trust and that reviewers can check only whether a report's conclusions follow from the data presented. [Yes, but there were inconsistencies/missing information that were apparent on the surface.]

Nature's reviewers did not ask Dr. Hwang to provide evidence that would have proved Snuppy was cloned from another dog. [Note: that is, for the profiles of the mitochondrial DNA] Dr. Campbell said that Nature, as part of its investigation of the article, would consider whether its standards of proof should be changed in the future.

If other scientists had succeeded in cloning human cells before any challenge had emerged to Dr. Hwang's work, it is not so clear that he would have been exposed. [This type of thinking can even be used to resurrect old frauds, such as Jan-Hendrik Schon. Thus, if someone does it later, somebody is going to say "Schon was right" or "I was inspired by Schon."]

***Finally, the NY Times mentions MBC (PD Notebook):

It was a whistle-blower in Dr. Hwang's lab who informed the South Korean television network MBC of problems in his work, and that led South Korean journalists to begin to investigate.

But for the whistle-blower, Dr. Hwang might well be continuing his meteoric career on the wings of his reports in Science and Nature.

[Wade might have mentioned the demise of PD Notebook on MBC.]

Merely fyi, see
Stem Cell Project Scandal Is Disturbing but Hardly an Uncommon Occurrence

Separately, from AP

- A University of Pittsburgh researcher wanted the school to provide $200,000 to help fund stem cell research with a South Korean scientist whose work is now being questioned, but the proposal never got off the ground, the university said Wednesday.
Pitt's Dr. Gerald Schatten wanted the money to collaborate with now-embattled researcher Hwang Woo-suk, but it "never was funded. It never went anywhere," university spokeswoman Jane Duffield said Wednesday.

Ranbaxy's arguments about Lipitor fail at D. Delaware

The really "big deal" in the Pfizer v. Ranbaxy case, 2005 U.S. Dist. LEXIS 33393, was an argument by Ranbaxy that Pfizer had not claimed atrovastatin calcium, the active ingredient in Lipitor, in U.S. Patent No. 5,273,995. This hypertechnical argument concerning 35 USC 112 P4 did not get much traction with Judge Joseph J. Farnan Jr., although it did produce some discussion about disagreements among judges of the CAFC about 35 USC 112 P1. Ranbaxy had a weak 112 P1 argument about claims of US 4,681,893, which also went nowhere.

[Note the relevance of the later Energizer, Everyready vs. ITC case, wherein the CAFC rejected a similar hypertechnical argument over 112 P2. Don't bet on Ranbaxy in the appeal.]

On the '893 patent-->

Some text on written description:

the Federal Circuit also acknowledged in Lilly its holding in Utter v. Hiraga, 845 F.2d 993, 998-999 (Fed. Cir. 1988), that "[a]
specification may, within the meaning of § 112 P1, contain a written
description of a broadly claimed invention without describing all species that claim encompasses."

In this case, the written description of the '893 patent is a generic formula which the patent specification expressly indicates includes all
trans-enantiomers. Ranbaxy acknowledges that one skilled in the art would know how to resolve racemates into their constituent enantiomers, and therefore, the Court concludes that the generic formula description contained in the '893 patent is sufficient to satisfy the written description requirement, regardless of whether the specific
isomeric compounds are individually described in the patent.

Of the relevance of foreign prosecutions to US litigations:

However, the Federal Circuit has recognized that "'the varying legal and procedural requirements for obtaining patent protection in foreign countries might render consideration of certain types of representations inappropriate' for consideration in a claim construction analysis of a United States counterpart." TI Group Auto. Sys. (N. Am.), Inc. v. VDO N. Am., L.L.C., 375 F.3d 1126, 1136 (Fed. Cir. 2004) (citations omitted).

Of estoppel from a later-prosecuted patent:

In a similar vein, Ranbaxy contends that Pfizer is precluded from
pursuing its proposed claim construction of the '893 patent based on statements made by Warner-Lambert during the prosecution of the '995 patent. However, the Federal Circuit has repeatedly held that arguments from a later, unrelated patent prosecution cannot be used to interpret and/or limit an earlier, unrelated and already issued patent. n3 Integra Lifesciences 1, Ltd. v. Merck KGaA, 331 F.3d 860, 868 (Fed. Cir. 2003), cert. granted on other grounds, 125 S. Ct. 823

On the '995 patent-->

The claim construction issue pertained to claim 6 of the '995 patent.

6. The hemicalcium salt of the compound of claim 2.

The parties' claim construction dispute regarding claim 6 is whether
claim 6 can be construed to cover the salt atorvastatin calcium. Ranbaxy
contends that claim 6 cannot be construed to cover the salt, because claim 6 depends on claim 2 and claim 2 narrows the subject matter of claim 1 from atorvastatin acid or atorvastatin lactone, or harmaceutically acceptable salts thereof to the single
compound, atorvastatin acid.
Ranbaxy argues that because claim 2 does not encompass salts, dependent claim 6 cannot cover the salt atorvastatin calcium. According to Ranbaxy, a reading of claim 6 to include the salt would render the patent invalid under Section 112, paragraph 4.

The Court finds the language of claim 6 to be unambiguous to the
extent that claim 6 is meant to claim the salt, atrovastatin calcium.

Despite this standard use of chemical nomenclature and the fact that
the meaning of claim 6 is clear to those skilled in the art, Ranbaxy
contends that the Court should not interpret claim 6 to refer to atorvastatin calcium, because such an interpretation would render the claim invalid for failure to adhere to the drafting requirements for dependent claims set forth in Section 112. Pursuant to Section 112, paragraph 4, "a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation
of the subject matter claimed."

Darrell L. Olson was on-board for Ranbaxy along with Jay R. Deshmukh, Esquire and George E. Heibel of Ranbaxy.

The Wicker patent case, confusing issues of prior art?

Taking the following AP story at face value, the text In September, company lawyers determined that the U.S. Patent and Trademark Office had in effect overruled the 1995 court decision three years later when it granted a more thorough patent application he had written with his sons' help. suggests that the USPTO approved broader claims after a court had invalidated narrower claims over prior art. The USPTO does not have the authority to overrule a court decision on patent claim validity.

***by Ben Dobbin of AP-->

While testing a fine-line engraving method, Ralph Wicker befriended Patrick White, a print shop owner who put the latest color copier models at his disposal. Shortly before securing a patent in 1991, Ralph presented his work to Secret Service officials, who urged him not to tell anyone, his sons say.

But the Treasury stopped taking his calls, his sons say, then unveiled a technique it called "concentric fine-line printing."

In a 1995 lawsuit, Ralph accused the Treasury Department of pirating his patented method of incorporating fine-line engravings in its new $100 bill. He rejected a $3million settlement offer.

Although finding that "the United States in fact was infringing" upon his 1991 and 1993 patents, the U.S. Court of Federal Claims determined two earlier European patents invalidated parts [?] of his invention.

Ralph died in 1997 of liver cancer. In 1999, Tom and David Wicker received word that the European Patent Office had decided their late father's work was a technological leap over "prior art" patents in Britain in 1968 and Germany in 1986 that had tripped up the lawsuit in Washington.

In 2002, the brothers transformed their expanding portfolio of patents into Document Security Systems Inc., a publicly traded company headed by White. Tom Wicker was given 1 million shares; the stock recently surged above $13. The Rochester-based company employs 21 people and generates $2 million in anti-piracy products sales.

Tom Wicker has secured patents of his own to tackle forgeries. The technology embeds hidden images that become visible when documents, photos, movies or compact discs are copied.

Ralph Wicker's fine-line method appears today in all U.S. bank notes and has been inserted into at least 75 currencies, the Wickers say. Their first in a potentially long line of patent-infringement targets is the euro.

In September, company lawyers determined that the U.S. Patent and Trademark Office had in effect overruled the 1995 court decision three years later when it granted a more thorough patent application he had written with his sons' help.

The upshot: The Wickers hope to negotiate a multimillion-dollar payoff with the Treasury. A Bureau of Engraving and Printing spokeswoman declined comment.

Need to look into this matter in more detail, later...


Final Holding of invalidity: A final holding of claim invalidity or unenforceability (after all appeals) is controlling on the Patent Office. In such cases, a substantial new question of patentability would not be present as to the claims held invalid or unenforceable. See Ethicon v. Quigg, 849 F.2d 1422, 7 USPQ2d 1152 (Fed. Cir. 1988). Where all claims are affected, the reexamination will be vacated by the TC Director. A non-final holding of claim invalidity or unenforceability, however, will not be controlling on the question of whether a substantial new question of patentability is present.
[See also 35 U.S.C. 311 ]

Separately, this could have some relevance to the patent quality debate.

Don Ho, stem cells, and VesCell therapy

from Israeli insider:

In May, 2005, a team of cardiac surgeons led by Dr. Kit Arom, a renowned cardiac surgeon worldwide at Bangkok's Heart Hospital, and Dr. Amit Patel of the University of Pittsburgh operated on Jeanine Lewis in Thailand, and she became the first patient in the world to have stem cells that had been harvested using TheraVitae's Israeli-developed VesCell therapy implanted directly into her heart.

"I'm not ready to run a marathon," she recently wrote on her website. "But I feel like I did before I was pregnant. That they could take something from your own body and use it to heal you, there's nothing more natural than that."

Earlier this month, Hawaiian music legend Don Ho also underwent the VesCell treatment. He has now returned home to Honolulu.

"He is continuing his rest and recuperation at an undisclosed location," the Hawaiian crooner's publicist, Donna Jung, said Monday. "We're delighted to say that his health is improving dramatically."

The 75-year-old Ho, known for his signature tune, "Tiny Bubbles," underwent a new treatment on Dec. 6, 2005 that hasn't been approved in the United States. It involves multiplying stem cells taken from his blood and injecting them into his heart in hopes of strengthening the organ.

He was among the first patients selected for the VesCell adult stem cell therapy.

The experimental procedure was developed by TheraVitae Co., which has offices in Thailand and laboratories in Israel, where Ho's stem cells were sent to be multiplied. The surgery costs roughly $30,000.

Ho, who has entertained Hawaiian tourists for more than four decades, has suffered from heart problems for about a year. He had a pacemaker implanted a few months ago.

In August, he was admitted to a hospital with shortness of breath. He was treated for an abnormal heart rhythm and released after three days. He soon returned to his Waikiki show on a reduced schedule.

As a coincidence in time, on Dec. 6, 2005 the journal Science was suggesting there was nothing wrong with the paper of Dr. Hwang of SNU and Dr. Schretten of the University of Pittsburgh, titled "Patient-Specific Embryonic Stem Cells Derived from Human SCNT Blastocysts."

Transfers of nuclear material from one entity into the cell of another entity create changes in the mitochondrial DNA (mtDNA) as to the first entity, and are regulated by the FDA.

Report with DNA results on Hwang's cells delayed till Jan. 10, 2006

from English.chosun: A Seoul National University panel investigating stem cell research by embattled cloning scientist Hwang Woo-suk will delay its feverishly anticipated final report until Jan. 10, fueling speculation that independent institutes tasked with DNA analysis of two stem cells created by Hwang have produced conflicting results. The panel last week concluded that the two stem cells were all that existed of 11 patient-tailored stem cells Hwang claimed to have created in a project written up in the magazine Science this year. The DNA tests were to determine whether these two at least really were cloned from patients' somatic cells.

Note the panel has concluded that 9 of the 11 cell lines that appeared in the journal Science were fabrications. No conclusion has been reached on the remaining two at this time. Note also that Hwang alleged junior researcher Kim Sun-jong swapped cloned patient-specific stem cells created by the team with normally fertilized stem cells from outside.

from hankooki:

Some Korean media reported earlier on Dec. 26, 2005 that the panel already has judged that the two stem-cell lines in question are not cloned. However, the panel denied the report, saying that it was just a private opinion of one of its members.

Prosecutors also said it will not intervene in the case as long as the panel is still making up its mind.

"We will start working on the case when the university's panel cannot make any more progress in its investigation and asks us to help," prosecutor Hwang Hee-chul of Seoul Central District Prosecutor's Office told reporters. "It won't be helpful in finding the truth if the prosecution takes charge now."

Prosecutors, however, reportedly already put travel bans on 10 people involved in the case, including Prof. Hwang, Roh Sung-il, chief of Mizmedi hospital who supplied human eggs for the research, and researcher Kim Sun-jong who is believed to have played a main role in fabricating the research data.

Kim flew back to Seoul on Saturday night from the United States and was questioned by the university early Sunday morning. According to the panel, Kim volunteered to come to the panel as he wanted to refute accusations against him, and is willing to comply if the prosecution summons him.

Kim has been accused by Hwang of swapping the stem cells used in the research. He is also believed to have been involved in fabricating the data of the two stem cells to make it look as if there were 11.

Prof. Hwang filed a petition with the Seoul Central District Prosecutor's Office on Thursday [Dec. 22], asking the prosecution to investigate whether his collaborators at Mizmedi, including Kim, tampered with the data on stem cells in a plot against him.

Sunday, December 25, 2005

Hwang problem simply a photo mixup: flashback to New York Times, Dec. 7

An example of a Times story that didn't quite pan out:

An error in a prominent article about an advance in stem cell research arose because the authors supplied the wrong set of replacement photos and not because of anything that would undermine the article's conclusions, the editors of Science, the journal that published the article, said yesterday [Dec. 6].

In the article, Dr. Hwang Woo Suk, a researcher at Seoul National University in South Korea, reported that he had established embryonic stem cell lines from 11 patients, the first step toward the long-heralded goal of repairing patients with their own tissues. But questions arose about the research after his American co-author, Dr. Gerald P. Schatten of the University of Pittsburgh, publicly severed relations last month over the issue of whether the human eggs used in the experiment had been paid for.

A new problem arose on Monday [Dec. 5], when Dr. Hwang informed Science that several of the 11 photos in his published report of June 17 were duplicates, even though each was meant to show a different human cell colony. If supporting photographic evidence were lacking, it could have raised doubts as to whether the researchers had really established 11 cell lines. [Note: Hwang was responding to an internet post which raised the issue he identified to Science. There were other issues raised in the internet which Huang did not identify to Science and which Science did not independently evaluate.]

But after a review of the journal's files, the editors say they have concluded that the original manuscript contained 11 different photos and that the set with the erroneous duplicates was sent by the authors after Science had requested higher-resolution photos.
[Note: on Friday, Dec. 16, 2005, Hwang admitted that at the time of manuscript submission (March 15, 2005) he possessed only eight cell lines. In a nationally televised news conference, the Seoul National University scientist admitted there were only eight stem cell lines when he submitted the paper for review, but that his team later created three more. He added that tests on his stem cell lines will prove his team "has the source technology to produce them." Thus, the editors of Science have some explaining to do about the significance of the "11 different photos."]

All the photos were prepared in Seoul and sent to Dr. Schatten in Pittsburgh, who forwarded them to Science. It is not yet clear if the mix-up occurred in Seoul or in Pittsburgh. where Dr. Schatten copied the photos, said Jane Duffield, a spokeswoman at Pittsburgh. Though all the research was done in Seoul, Dr. Schatten's role was to correct the English and serve as a consultant, she said.

Dr. Donald Kennedy, the editor of Science, said in yesterday's statement that he had no reason to believe that the erroneous photos cast doubt on the article's scientific findings. [by this time, both internet posts had occurred and "PD Notebook" had interviewed a number of researchers, including Koreans then working for Dr. Schatten.]

[by Nicholas Wade, Dec. 7, 2005]

Note that even the abstract of the Hwang paper clearly states: "Eleven hESC lines were established by somatic cell nuclear transfer (SNT) of skin cells from patients with disease or injury into donated oocytes."

It takes more than patents for innovation to occur

An article by Tom Still correctly differentiates the act of "getting a patent" from the result of effecting change ("innovating") and suggests the state of Wisconsin needs to get more active in the latter. Perhaps some intellectual property professors should take note.

From Still's article:

Why aren’t more stem cell companies taking root in Wisconsin? There may be several reasons:

• Virtually all of the people involved in stem cell science in Wisconsin are proud “lab rats,” meaning they would prefer to remain on the research side and not engage in the uncertainties of the marketplace. They’re not business people and they’re smart enough to admit it. But their discoveries need to get into the hands of experienced business executives (now the case with Thomson’s CDI) so their discoveries can be pulled into the marketplace. Cezar is an exception to the Wisconsin rule; she’s as interested in market applications as she is in the core research.

• Some states and nations have a more aggressive culture when it comes to commercializing science. Wisconsin is a leader in producing patents, but fairly mediocre when it comes to turning those inventions into companies, jobs and profits. California is an example of both: Voters there have authorized up to $3 billion over 10 years to invest in stem cell research and commercialization. While lawsuits have slowed California’s public investment, private investment there has been strong.

• Wisconsin politicians have sent some discouraging signals. Legislative efforts to enact research controls that go beyond federal limits haven’t succeeded, but scientists and investors worry about what will happen if there’s a new governor in the Capitol’s East Wing. Governor Jim Doyle has already vetoed one bill that threatened stem-cell research and vows to keep doing so. But he must stand for re-election in 2006. Cezar, for one, says she would leave Wisconsin if the Legislature enacted bans on stem-cell research.

Wisconsin is fortunate be where scientists began unlocking the secrets of human embryonic stem cells. The world is catching up, however, and is now running ahead when it comes to exploring commercial opportunities. Letting others beat us to the punch on stem cell commerce would be like giving away Stephen Babcock’s milk butterfat test in 1890 or failing to follow up on Harry Steenbock’s Vitamin D discoveries in the 1920s. Wisconsin capitalized on major academic breakthroughs in the past; it should do so again.


Around the world, Cezar noted, there are about 70 companies doing significant stem-cell research in an effort to move discoveries to market. Those companies are engaged in drug discovery, in examining specific therapies, and in basic research about how cells work.A number of clinical studies are beginning or soon will begin in areas ranging from spinal cord injuries to chronic diseases.

Geron has recently announced plans to move from working with animal embryonic stem cells to tests on human embryonic stem cells.

Saturday, December 24, 2005

Issues of peer review; co-authorship

Of the Hwang matter, I saw a post on peer review which is of relevance to proposals by Rebecca Eisenberg and others for peer review of patent applications. The post included the words:

Another flaw lies in the peer review system for scientific publication. In the real world, peer review is a misnomer and can be more appropriately renamed "buddy review" i.e. if you have lots of good buddies in high places, you are more likely to get your manuscripts published. Journal editorial boards have often been likened to college fraternities. If you are in the club, the path will be a lot smoother for you.

Of the issue of peer review, the Hwang paper published in Science on June 17, 2005 (online version available May 19), was received on March 15 and accepted May 12. The gap between receipt and acceptance is shorter than average, suggesting that review was relatively quick. On the face of the paper, some issues could have been raised about the DNA profiles, but apparently were not. For example, the traces for several cell lines appear to be identical to the traces from the respective patients, raising an issue of copying similar to the fraud involving Jan-Hendrik Schon. There is also an issue of duplicated images beyond the scope initially admitted to Science by Hwang.

These sort of things could have been caught by the reviewers, but were not, neither in the case of Hwang nor in the earlier case of Schon. Whether this is the fault of a buddy system of review, wishful thinking by the editors and reviewers, or simply a lack of attention to detail by the reviewers remains to be seen. Certainly, research in an area can build up a constituency, wherein it is to the advantage of all constituents that favorable results appear in high profile journals such as Science and Nature, and more research dollars become available to all constituents. Separately, once journals publish the work of one research group in an area (earlier work by Hwang appeared in Science, 303, 1669 (2004)), they themselves can become stakeholders.

Hwang is the first listed author and Schatten is the last, although only the names Hwang and Schatten bear asterisks and email addresses for contact.

According to a report in Forbes, based on information from Roh Sung-Il, ONLY Hwang and Schatten wrote and saw the manuscript prior to publication.

The anonymous post on the "PD Notebook" board happened within days after the appearance of the online version, and may have originated with one of the other 23 co-authors. Schatten's contact with Science about withdrawal of his name happened after the "PD Notebook"/MBC reporters contacted some of the Koreans in Pittsburgh.

The insistence on Science of an agreement among all authors for RETRACTION is problematic if there were no agreement among all authors as to SUBMISSION. In the case of US patent applications, prosecution cannot begin until all inventors sign a declaration, which includes, among other things, a statement of knowledge of the submitted application. Furthermore, in the earlier case of Schon, it is less than clear that Schon agreed to retraction of his papers in Science, including the one about a superconducting material based on oxidized buckminsterfullene (aka buckyball).

See also comments on

***More on peer review

of law journals see (which list does not seem to include the Journal of Law & Economics)

of Hwang, a link to a note from the BBC (also published on IPBiz):

Rejections of claims in re-exam of NTP patents.

The re-examination of the NTP patents is an ex parte re-examination proceeding under 37 CFR 1.550(f). In re-exam 90/006675, claims 1-89 and 183-200 were rejected in a non-final Office Action on December 15, 2005. There are rejections under 112, 102, 103 and for double-patenting.

35 USC 307:

(a) In a reexamination proceeding under this chapter, when the time for appeal has expired or any appeal proceeding has terminated, the Director will issue and publish a certificate canceling any claim of the patent finally determined to be unpatentable, confirming any claim of the patent determined to be patentable, and incorporating in the patent any proposed amended or new claim determined to be patentable.

See also 37 CFR 1.570. MPEP 2288

The issuance of a final Court decision (in a civil action arising in whole or in part under 28 U.S.C. 1338) upholding validity during an inter partes reexamination, where the person who filed the request was a party to the litigation, will have the effect that the Office will discontinue examination of all claims affected by the holding of validity. If the provisions of 37 CFR 1.907(b) apply such that all of the claims in the reexamination proceeding cannot be maintained, the order to reexamine is vacated by the TC Director, and reexamination is terminated. If the provisions of 37 CFR 1.907(b) apply to some of the claims, but not all of the claims in the proceeding; those claims to which 37 CFR 1.907(b) applies will not be treated. The examiner's action will point out the claims not treated, and the reason why those claims cannot be maintained in the reexamination under 37 CFR 1.907(b). Action will be given on the remaining claims. Note that the provisions of 37 CFR 1.907(b) cannot be waived since they track the statute, 35 U.S.C. 317.

Friday, December 23, 2005

The scope of fallout from the Hwang fraud?

Paul Elias (AP) wrote on December 23: Scientists fretted Friday that a spectacular cloning fraud that hid in plain sight has set back legitimate stem cell work around the world. Workers in the cloning area feel "public confidence in their work had been weakened by a sham branded by experts as the most visible case of scientific fraud they could recall." Hmm, no one ever talks about Jan-Hendrik Schon anymore. How quickly they forget.

Of the refereeing pass-through and general acceptance since May: Scientists also struggled to explain how they didn't earlier catch the charismatic South Korean veterinarian's claim in a Science paper published in May that he cloned 11 human embryos to produce stem cells. One contemplates the fate of "PD Notebook" of the television network MBC that pushed the early allegations of fraud to the view of the public. Also of refereeing: "That's a difficult one," said Keith Campbell, the University of Nottingham researcher who helped clone Dolly the sheep in 1997. "Scientists are asked to referee a lot of papers and to a certain extent we have to believe each other as to the validity of the data."

The AP story quotes Dr. Robert Lanza: "It's a stain on the honor and integrity of the whole field. It has sent a lot of scientists on a wild goose chase and down false paths." These are exactly the same issues raised after the revelation about Jan-Hendrik Schon. Same old, same old....

An issue in the results is that to create DNA results for the article in Science, Hwang's team split cells from one patient into two test tubes for analysis - rather than actually match cloned cells to a patient's original cells.

Another issue is in the number of eggs used to create the cells: Hwang's article this year in Science was separately viewed as significant for his efficiency in cloning the stem-cell lines, saying just 185 human eggs were used to create custom-made embryonic stem cells for the 11 patients. But Roe Jung-hye said the investigation "found that there have been a lot more eggs used than were reported," although the exact number was being determined.

In light of the findings suggesting fraud, the SNU panel said it now would investigate Hwang's other landmark research, including a 2004 Science article on the world's first cloned human embryos and an August 2005 paper in the journal Nature on the cloned dog Snuppy.

One notes that there are outstanding DNA tests to address other issues in Hwang's research. New DNA test results expected within days will address

--> whether Hwang ever cloned stem cells as he claimed in a landmark research paper (ie, tests on the remaining two cell lines)
--> whether Hwang created the world's first cloned human embryo and
--> whether Hwang created the only cloned dog as he asserted in research that kindled worldwide optimism of revolutionary cures for diseases.

See the December 23 article in Forbes.

Hwang work intentionally fabricated

Roe Jung-hye, head of the Seoul National University's research office, said the data of Hwang on patient-matched cells was "intentionally fabricated, not an accidental error". He added: "It is difficult for Professor Hwang to avoid taking major responsibility." A leading American bioethicist, Laurie Zoloth, from Northwestern University, called the development "a heartbreaking turn for science and Korea".

Hwang led the team that claimed to have created Snuppy, (Seoul National University puppy). The Afghan hound, now eight months old, gained worldwide fame, with Time magazine calling him "the most amazing invention" of 2005. There are now questions being asked about Snuppy, so Time may have to re-think its invention analysis.

Hwang Woo-suk resigns his professorship

AP reports: South Korean researcher Hwang Woo-suk resigned from his position as a professor on December 23, 2005 after his university said he had fabricated the results of at least nine of 11 stem-cell lines that he claimed to have created.

"I sincerely apologize to the people for creating a shock and disappointment," Hwang told reporters as he was leaving his office at Seoul National University. "As a symbol of apology, I step down as professor of Seoul National University."

The charges of Mizmedi Infertility Clinic head (Mr. Roh Sung Il) who had said nine of the 11 stem cell lines were fake (and the veracity of the other two was questionable) seem to have been validated. Mr. Roh had also indicated that, of the authors of the May 2005 paper in Science, only Professors Hwang and Gerald P. Schatten (University of Pittsburgh) had written the paper (or even seen the paper prior to publication). Apart from the apparently bad refereeing, the journal Science has something to answer for in its acceptance and retraction policy as to co-authors.

Thursday, December 22, 2005

75% of drugs in FDA Orange Book have generic counterparts

As of June 2005, there were 11,167 drugs listed in the FDA's
Orange Book, and about 8,400 had generic counterparts.

Brian Williams on NBC on Dec. 21 had another lament about confusion over Medicare Part D. It would seem that a database correlating the 40-60 plans with the (less than or equal to) 11,000 drugs could solve this "problem" pretty quickly.

Staggering fraud at UMDMJ in New Jersey

Keeping with the theme of fraud in academics, the Newark Star-Ledger ran a story "Staggering Fraud Likely at UMDMJ. Codey: Probe could find scandal tops tens of millions." US Attorney Christopher Christie is investigating.

The cost in wasted federal research monies allocated in following up the fraudulent research of Jan-Hendrik Schon has also been estimated (at least) in the tens of millions. Stem cell researchers are currently worried about the possible fallout from the allegations about the research of Professor Woo Suk Hwang. This work inspired a global ramp-up in stem cell efforts. If the Hwang work proves to be false, much of that money may have been wasted.

***from Professor David Rebovich

In the meantime, given UMDNJ's problems one has to wonder what will happen to the support in the legislature and from Codey and Corzine for a stem cell research institute. UMDNJ was supposed to play a central role in this research and receive public funds and attract private money to help make New Jersey a leader in this emerging field. Given its legal and financial woes, will UMDNJ lose some of its top researchers, frighten away potential private partners and investors, and make lawmakers leery about involving the University in anything so major until the federal investigation is complete?

***Separately on Jan. 5, 2006:

Dead for this legislative session, Assembly Speaker-designate Joseph Roberts said Wednesday he expects an altered version of the now-tabled stem cell research initiative to be resurrected in coming months.

Roberts, D-5 of Camden, made the statement one day after he and current Assembly Speaker Albio Sires said they would not post the $350 million stem cell research initiative by the end of the lame duck legislative session on Monday.

Patents and the prisoner's dilemma

Ghosh writes: While the commonly accepted notion is that patent law protects against various forms of the commons problem as
described by the prisoner's dilemma, a more apt description is that
patent law resolves the problem of what game theorists call the "assurance game." I show how the assurance game better captures the economics, politics, and practices that patent law responds to.

To Ghosh, the analysis is a prisoner's dilemma between inventor and copyer. Ghosh does not evaluate the benefit to the public of public disclosure.

Of the "assurance game":
The main reason that the assurance game serves as a better
description of the underlying problem for patent law is that individuals can assure each other not to imitate. The assurance is called trade secret law. As a hybrid of tort, contract, and property law, trade secret law allows individuals to enter into private arrangements that limit imitation. The existence of such private arrangements calls into question the assumption that imitation is a dominant choice for individuals. If imitation is not a dominant choice, then the prisoner
's dilemma is not an appropriate description of the world. Of course,
that does not mean the assurance game is a perfect description either. The argument, however, is that we should consider alternatives to the prisoner's dilemma and the assurance game is one alternative.

from 18 Can. J.L. & Juris. 307 (2005)

Lemley on patenting nanotechnology

Mark A. Lemley has a recent paper "Patenting Nanotechnology" that appears in 58 Stan. L. Rev. 601 (Nov. 2005).

He finds the area significant:

First, this is almost the first new field in a century in which the basic ideas are being patented at the outset. [Query: what about transistors, among other things?]

A second factor distinguishing nanotechnology is its unique cross-industry structure. Unlike other new industries, in which the
patentees are largely actual or at least potential participants in the
market, a significant number of nanotechnology patentees will own rights not just in the industry in which they participate, but in other industries as well.

Finally, a large number of the basic nanotechnology patents have been
issued to universities, which have become far more active in patenting in the last twenty-five years.
[i.e., post Bayh-Dole]

One does find mention of the transistor:
AT&T did obtain basic patents on the transistor, an important component of later computers, n27 but licensed them broadly at low royalty rates under an antitrust consent decree that also precluded it from entering the market for transistors itself. n28 [Query: Wasn't AT&T/Bell Labs having meetings disclosing transistor technology to third parties and licensing said technology BEFORE any consent decree?]

Lemley's footnote 27: Circuit Element Utilizing Semiconductive Material, U.S. Patent No. 2,569,347 (filed June 26, 1948). Lemley's footnote 28: United States v. AT&T, 552 F. Supp. 131, 136 (D.D.C. 1982). For this argument, see Robert P. Merges & Richard R. Nelson, On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 839, 896 (1990); Sabety, 1 Nanotechnology L. & Bus. 262, at 269.

Of the integrated circuit [IC]:
But because two different inventors working independently developed the integrated circuit at about the same time (1971), the patents were put into interference. Gary Boone was ultimately declared the winner, but not until 1999, twenty-eight years after the first patent application was filed. n49 [Gary Boone the inventor of the IC????]

Lemley's footnote 49: Gary W. Boone first filed a patent application disclosing an integrated circuit on July 19, 1971. See U.S. Patent No. H1970 (filed July 19, 1971). Interference No. 102,598 was declared on March 27, 1991, and the Board of Patent Appeals and Interferences (BPAI) finally reconsidered its earlier decision of priority on May 10, 1996. See Hyatt v. Boone, 146 F.3d 1348, 1351 n.1 (Fed. Cir. 1998). An opinion in the last appeal of the BPAI's decision awarding priority to Boone was issued on August 26, 1998. See id.

Those inhabiting a universe different from Lemley's might recall two fellows by the names of Kilby and Noyce. They had a patent interference that was decided by the CCPA years ago. One of the fellows even won a Nobel Prize.

Lemley's conclusion: The sum of all these stories is rather remarkable: for one reason or another, the basic building blocks of what might be called the enabling technologies of the twentieth century - including the computer, software, the Internet, and biotechnology - all ended up in the public domain. Whether through a policy decision, a personal belief, shortsightedness, government regulation, or invalidation of the patent, no one ended up owning the core building blocks of these technologies during their formative years.
[Gee, TI and Fairchild made a bundle licensing the IC patent. And Bell Labs did get royalties, hardly the equivalent of "public domain."]

Lemley's conclusion: Nanotechnology patents bear watching. They have characteristics that may well make them fundamentally different than patents in any other industry in the last eighty years.


How could Stanford's Lemley have made such an awful error about the invention of the integrated circuit?

Of "historians" at Stanford and Berkeley

In a footnote, Wineburg notes that even professional historians do poorly outside their research specialization. In a 1991 study, Wineburg found that when historians trained at Stanford, Berkeley and Harvard answered questions from a leading high school textbook, they scored a mere 35 percent,­ in some cases lower than a comparison group of high school students taking Advanced Placement U.S. History. "Technology may have changed since 1917, but the capacity of the human mind to retain information has not," he writes.

PD Notebook, the tv show that exposed Hwang, is gonzo

In a November 21 article, A Korean TV Show Reports, and the Network Cancels It, the New York Times got around to the involvement of MBC in the scandal involving Hwang Woo Suk.

According to the article, it was an anonymous post on a confidential Internet bulletin board maintained by ''PD Notebook,'' South Korea's leading investigative news show that got the ball rolling on an investigation into Hwang's research. [In passing, I note the case John Doe No. 1 v. Cahill, 2005 Del. LEXIS 381 about anonymous internet posts] According to the PD Notebook post, Dr. Hwang faked some of the human stem cell cloning data that had been published days earlier in Science [May 2005; to avoid some confusion that has appeared on the internet, I note that online version of the article appeared on 19 May 2005, 7 days after acceptance. The paper version of the article appeared on 17 June 2005 in Volume 308 of Science, at pages 1777-1783].

The show, PD Notebook, did one story on Hwang, and was going to do another, when a flap developed about coercive techniques used in interviews. And now PD Notebook is gone. On Saturday afternoon [Dec. 17] Choi Seung Ho, the ''PD Notebook'' executive producer sat unsmiling in his newsroom, dressed in black and blue, dragging occasionally on a menthol cigarette. Protesters had picketed his network, MBC. Death threats and photos of family members of his reporting team had been posted on the Internet. All 12 advertisers had fled the program. After 15 successful years of ''PD Notebook,'' MBC has pulled the plug.

from JAMES BROOKE, NY Times, 21 Dec. 2005, Section C; Column 1; Business/Financial Desk; MEDIA; Pg. 5

In an article in the Dec. 16, 2005 issue of Science (Vol. 310 at pp. 1748-1749), there is a mention of a DIFFERENT internet post, specifically one on the Biological Research Information Center [BRIC] website. This post was on or about December 5, 2005, and thus was much after the post on "PD Notebook" site. Shortly after the post on the BRIC site (ie, a span of hours), Dr. Hwang emailed the journal Science about problems with duplicate images in the May 2005 paper.

The Dec. 16 Science article has a quote from Alan Colman: "I'd still like to believe this is a case of sloppy presentation but good science."

Prophetically, material provided to Science by Korean sources was anonymous because the Koreans feared a backlash against what are perceived to be attacks on Hwang. In light of the fate of MBC's PD Notebook, this fear was reasonable.

Separately, although the Science article mentions possible problems with the images of the nuclear DNA fingerprints, it does not mention the issue of mitochondrial DNA.

One notes that, in the timetable of Hwang, results on the five remaining specimens should be available next week (ie after Christmas and before New Year's). At that point, we'll get some idea about the sloppy presentation/good science conjecture.

Tuesday, December 20, 2005

Patent litigation in China: a Christmas Less Bright?

In "A Christmas Less Bright," [Trenton Times, 18 Dec. 2005, pp. A1, A6], Mark Perkiss details a horror story of patent litigation in the Chinese courts.

The US company Fiber Optic Designs [David Allen, Jim Bruno) had developed "Forever Bright" Christmas lights, utilizing LED lights, which light string could be powered by standard electrical outlets. Allen got a US patent on the circuitry.

Fiber Optics contracted with a first, then a second Chinese manufacturer. Because of demand, they contacted a third. The third company got a Chinese patent on the design of the lanterns in the light string. The third company sued Forever Bright and the two other Chinese manufacturers for patent infringement.

To show prior invention, Fiber Optics submitted a copy of the Trenton Times from December 2001. The copy had to be notarized by a notary public. In turn, a state judge had to affirm the status of the notary. In turn, a state agency had to affirm the status of the state judge. In turn, the US State Department had to affirm the status of the state agency. Then, the State Department had to submit all of the above the Chinese embassy. This process cost $50,000.

In an article "Patent Litigation in Chinese Courts," [Intellectual Property Today, pp. 21-23, November 2005], Bai, Wang, and Cheng state merely that "A notary public is often used to authenticate evidence," without delving into the full scope of the requirements.

Experts Sabrina Safrin and Andrew Mertha opined on what Fiber Optics could have done differently. Individually, I think the first lesson is that non-disclosure agreements are not of great value, certainly not in China, and not even especially valuable in the US. The second lesson is that getting a patent application on file is what counts. Here, Fiber Optics filed nothing in China. Had they filed, it would probably have been on the circuitry, but in filing they could have disclosed everything about the product, including what appeared in the Trenton Times. The cost of filing would have been less than what they ultimately paid.



[Merges} explains that a crucial, but often-overlooked, role of patents and other (intellectual) property is to facilitate contracting. Specifically, companies that disclose or share their technology with others often do much better if they file patent applications prior to disclosure, instead of relying strictly on nondisclosure agreements or other purely contractual forms of protection.

The point being one gets IP protection first and then does a nondisclosure agreement. Having only a nondisclosure agreement is a big mistake.

Sunday, December 18, 2005

PTO gives NTP only 30 days to respond to OA in re-exam

the USPTO said in a Dec. 14 letter:

-->"Given the district court's concerns that the office has delayed the proceedings and the outstanding public interest in ensuring that these proceedings are acted upon with special dispatch, the office has assigned a dedicated examining team to handle all of the co-pending proceedings."

The patent office was responding to a request by NTP to give it more time to respond to actions by the agency. The patent office shortened the normal 60-day response time to 30 days. The agency, in rejecting NTP's request, said the 30 days was all that was required by law. <--

The patent office, in initial Office Actions in re-exam of the five patents, rejected claims of all five patents. The PTO has indicated it expects its next step to be a final rejection.

Even a final rejection of claims by the USPTO would not end the re-examination procedure. NTP can appeal to BPAI within the patent office, and, in the event of an unfavorable BPAI decision, seek review before the CAFC, the appeals court that previously upheld part of the finding of infringement.

NTP co-founder Don Stout, who also is a patent lawyer, said in a Dec. 14 interview that part of the appeal will center on the patent office's decision not to follow the Federal Circuit's interpretation of key wording in the patent. The patent office responded, in the Dec. 14 letter, that it has different standards by law. Generally, the USPTO interprets the scope of claims broadly, which can lead to invalidity in terms of close prior art. [see earlier post on IPBiz about Yamamoto.

In addition to the patent office review, Research In Motion has filed a petition asking the U.S. Supreme Court to review the case, arguing that the Federal Circuit improperly expanded the scope of U.S. patent law by ruling that a system based in Canada could infringe a U.S. patent. In that decision, reported earlier on IPBiz, the CAFC distinguished between a claim to a system and a claim to a method, with the current issue over the CAFC interpretation of a claim to a method.

NYTimes: Scandal rocks the journal Science?

On Dec. 18, Gina Kolata wrote: The publication of that paper [on cloning from Hwang], celebrated by Science with great fanfare on May 19, has now turned into a debacle. And the mood in Science's editorial offices on the 10th floor of a gray marble office building in Washington has gone from elation to distress and exhaustion. Although Kolata mentions other controversies at Science, there is no mention of the scandal involving the publication by Science of fraudulent papers by Jan-Hendrik Schon working for Bell Labs.

Kolata gives a timeline for events in the Hwang paper:

For Science, the chain of events began on Tuesday, March 15, when the manuscript arrived by e-mail. It was clearly a high-profile paper, and its lead author, Hwang Woo Suk of Seoul National University, was known at the journal.

He had published a previous paper in Science, on Feb. 12, 2004, announcing that he had, with great difficulty, cloned a human embryo and extracted stem cells.

Still, Science put this latest paper from Dr. Hwang's lab through the same process it put the nearly 12,000 other papers received this year, Ms. Bradford said.

Papers are sent to one or two outside experts on the journal's board of reviewing editors who advise on whether they are appropriate for Science magazine. Seventy percent of submitted papers are rejected. The others are sent to at least two additional scientists for in-depth review.

The reviewers comment on the paper and also assess its quality, checking off boxes ranging from "reject" to "publish without delay." About 25 percent of those reviewed end up being published. But the reviewers are not the science police, Ms. Bradford and outside scientists emphasized.

"We work on the assumption that the data are real," Ms. Bradford said. "The question is, Do the data support the conclusions?"

On May 12, after having passed scrutiny by three outside reviewers, Dr. Hwang's paper was accepted for publication, faster than the journal's average time from submission to acceptance, which is about three months.

When the paper appeared May 19, it met with enormous acclaim. Dr. Hwang traveled the world lecturing on his work and scientists trekked to South Korea to visit the lab and see how the feat was accomplished.

The first hints that something might not be right came in November. By Dec. 9, Ms. Bradford and her colleagues - Katrina L. Kelner, the deputy editor, who has an office next door; another editor, working from another city, whom Ms. Bradford would not identify; and the editor in chief, Donald Kennedy, who is at Stanford - were trying to get some answers. [Note: Kolata does not mention the issues of the one presentation on Korean television, and the issue of coercion by the Korean tv interviewers as to Korean researchers working for Prof. Schatten in Pittsburgh.]

As the weeks passed, Dr. Hwang, was hospitalized for stress but insisted that his group had really cloned human embryos and created 11 lines of stem cells, as his paper reported. But one of his co-authors, Dr. Roh Sung Il, said the data were fraudulent. [Note: Kolata does not mention the issue that only 8 cell lines existed at the time of the submission of the manuscript to Science.]

One question was whether photographs, described in the paper as being stem cells derived from cloned human embryos, were frauds. Dr. Roh said they were actually from a large computer file of stem cells and not derived from cloning experiments.

Of the photograph issue, Kolata wrote:

"We sent a series of questions to the authors," Ms. Bradford said. "How did this high resolution image get put together? Look at all your images. Go through your data. The same with the DNA fingerprinting: go through your data. What are your answers?"

But despite repeated calls and e-mail messages to South Korea, Ms. Bradford said Thursday, "We haven't gotten any answers yet."

Kolata does not mention the issue that a photograph of one cell line was used to depict more than one cell line.

Kolata discusses retraction issues, including those with with Pittsburgh researcher and co-author Schatten:

Dr. Kennedy said in news conference by telephone on Friday [Dec. 16]afternoon, "As of now we can't reach any conclusions with respect to misconduct issues." He also said that as of now the journal's editors did not know the exact reasons that Dr. Schatten and Dr. Hwang asked that the paper be withdrawn.

If the paper is withdrawn, Dr. Kennedy said, "There will have to be a retraction statement, and it will have to contain more than we now know about the authors' reasons for retracting it."

He added, "I can't state chapter and verse, but it is more than we have gotten now."

Of the need to obtain the permission of co-authors to retract, Kolata notes:
Ms. Bradford said that despite quite a bit of effort, she and her colleagues had been unable to get even e-mail addresses for all of the authors.
One wonders why Science did not obtain contact information for the co-authors prior to publication. Kolata does not mention the issue raised by co-author Roh that ONLY Hwang and Schatten saw the paper prior to submission to Science. One wonders how the co-authors can give permission to retract something they never saw (and thus could not have reasonably given permission to publish in the first place). Does the submission procedure to Science require the editors of Science to verify co-authors have seen the paper? At least at the USPTO, the Patent Office requires all named inventors to sign a declaration prior to the beginning of patent prosecution.

Of co-authors, Kolata quotes Laurie Zoloth, an ethicist at Northwestern University:

"What we do not understand is how one person could have hoaxed all 24 of the collaborators on the papers - all of whom seemed eager to claim the work as 'our' work at the time," Dr. Zoloth said. "Did we see only what we yearned to see?"

The actual information indicates BOTH Hwang AND Schatten were involved in the writing of the paper. Zoloth seems unaware that co-author Roh complained about not seeing the manuscript before publication.

The Houston Chronicle reproduced the Gina Kolata article within
the Chronicle on December 18.

Saturday, December 17, 2005

Seoul National University investigation of cloning issue to conclude in one or two weeks

South Korea National University will step up an investigation into charges made against Professor Hwang after allegations that key parts of a landmark paper were fabricated. The university's dean of research affairs, Roe Jung-hye, told reporters the review team would send Professor Hwang's team a questionnaire on Dec. 19 and a conclusion could be reached in one or two weeks. After an emergency meeting chaired by South Korean Prime Minister Lee Hae-chan, the South Korean Government said it would wait for an internal probe by Seoul National University. "Seoul National University will probe doubts raised about (Hwang's) 2005 thesis first and, if the doubts are confirmed, will replicate experiments," a university statement said, referring to a study, published in May, on tailor-made human stem cells.

The Korea Times alluded to television reports in a discussion of co-author Schatten of the University of Pittsburgh:

Schatten fully supported Hwang's bombshell experiments until recently, despite the growing doubts about it both at home and abroad triggered by an MBC TV's investigative report. The American scholar stunned Hwang and stirred the global science community as well early last month when he announced his decision to sever his 20-month collaboration with Hwang, citing the Korean celebrity's ethical lapses in securing human egg cells. He claimed that Hwang used ova donated by at least one of the members of his research team, in contravention of the 1964 Helsinki Declaration forbidding a scientist from coercing his or her subordinate to provide materials used in a research project.

The ado was touched off following MBC's decision to withhold its report on the matter for violating journalistic ethics on collecting information from two researchers now deployed to the University of Pittsburgh. At Schatten's request, the American school is investigating Hwang's work, with its probe focused on the pictures of the stem cells placed in Science.

From an earlier Korea Times report:

We were 100 percent confident of out tailor-made stem cells in the face of challenges from MBC (a local TV network that raised doubts on Hwang's research). So we provided five stem cells and somatic cells of patients to MBC.

Our staff even took a flight to get a somatic cell because one of the five patients was a foreigner.

Due to worries over the credibility of MBC-initiated tests, we carried out in-house trials that revealed Nov. 18 that their DNA fingerprint traces were different from those printed in Science.

Back then, we could not suspect a possibility that they were from Mizmedi so we checked out any probability that DNA peak value can change due to long-time culturing.

Many specialists participated in the trial but they failed to find any relevant paper. Since we heard of the allegations that our stem cell lines came from Mizmedi, we turned to address that possibility.

After sending data to one of former Mizmedi researchers, we learned the stem cells were actually made in Mizmedi. We double-checked it through a second-round trial.

Authentication of Stem Cells

Our team is thawing five frozen stem cell lines to authenticate our performance. I think their DNA fingerprints will be learned within 10 days.

Who is Responsible?

We staged an in-house probe late last month on how our tailor-made stem cells were replaced with those of Mizmedi.

Presumably, the stem cells were changed in their nascent stage with those of Mizmedi because a total of six related researchers do not have any doubts as to the authenticity of stem cells.

Subsequently, we could not exclude above-mentioned possibility. The fact adds suspicions that genders of somatic cell contributors correspond with those of Mizmedi stem cells.

In addition, most of the stem cell lines were turned to stem cells of which the existence and DNA characteristics were not disclosed.

Based on this reasoning, we suspect someone who had access both to our lab and Mizmedi is responsible. To confirm this, we will request the police to investigate this case.

As the leader of our research team I sincerely apologize for causing all these controversies both at home and abroad.

But we still need to confirm the veracity of five stem cells and that the 2004 stem cells really exist.

I beg people's pardon once again for allowing critical flaws in revealing our scientific breakthroughs even though we retain source technologies.

--> Of MBC, Gulf Times reported:

Hwang on November 24 offered to resign from his official posts and apologised for covering up the fact that two of his junior researchers had donated their own eggs for his breakthrough research in violation of accepted ethics.
The scandal snowballed afterwards, with Seoul-based broadcaster MBC airing a programme alleging ethical breaches and preparing another which questions the authenticity of his research.

MBC yesterday [Dec. 11] decided to suspend the broadcasting of its second report and apologised for using coercion to obtain information critical of the pioneer.

-->The Korea Times reported on the MBC apology and on the coercion involved.

Kim Song-jong on the incident:

"MBC producers visited me on Oct. 20 and insisted Hwang's research is all fake and his two papers published by Science will be canceled. They even said Hwang will be arrested," said Kim Son-jong, a feeder cell expert who is now at the University of Pittsburgh.

"Then they said a police investigation would start in the United States and urged me to reveal everything I know saying that doing so would protect me from the probe," he added.

Asking Hwang to carry out a second round of tests to clear away all suspicions, MBC producer Han Hak-soo said last week that he got a crucial confession in Pittsburgh, but Kim flatly rebuffed that.

"They continued to claim that there are no (patient-specific human embryonic stem) cells so I made it clear that there are. After double-checking it from Seoul, I called Han and confirmed it again," Kim said.

Kim contended MBC duped him and his two Korean colleagues at the University of Pittsburgh into accepting the interview, believing the TV network was making a documentary.

"MBC even did not let us know that the broadcaster recorded the interview. After knowing that, I asked it not to air the interview, but it refused the request," Kim said.

MBC reiterated the TV station would reveal everything on the air tomorrow night on its program "PD Notebook."

Kim and two other researchers are now under professor Gerald Schatten at the University of Pittsburgh, who pulled out of the 20-month-old partnership with Hwang last out of ethical concerns.

Kim said he reported all the contents of the interview with MBC to Schatten and that event appears to be the major cause for Schatten to sever ties with Hwang.

***from an article in English

Top scientists, academics and Internet users were united in anger after revelations on the YTN news channel that MBC's "PD Diary" crew used threats and hidden cameras in their quest to dig up dirt on Prof. Hwang Woo-suk's research.

Kim Woo-ryong, a professor of journalism at Hankuk University of Foreign Studies said, "In the process of gathering information, if MBC used coercive techniques or in any way camouflaged their identity, this would be a serious breach of press ethics." He went on to say, "If in their investigation, MBC threatened to discredit the team or claimed that Hwang would be arrested or misrepresented the facts, it could legally constitute defamation."

Lee Young-soon, of Seoul National University's College of Veterinary Medicine, said, "MBC was making threats during its investigation of the science in the matter when it was never qualified to investigate it in the first place." Lee added, "If 'PD Diary' with absolutely no scientific background, tried to verify the scientific research, it would become laughing stock of the scientific world. With 'PD Diary' completely discredited, it would now be desirable for national agencies to step in."