Monday, February 27, 2006

What "60 Minutes" didn't tell you on Feb. 26, 2006

"60 Minutes" talked about embryonic stem cells on February 26, 2006, including a dicussion of work by Hans Keirstead. They didn't mention the patent applications of Keirstead or where the stem cell lines came from.

--> Oligodendrocytes derived from human embryonic stem cells for remyelination and treatment of spinal cord injury
Keirstead, Hans S., 20050101014 (May 12, 2005)
Application 10/661105 (filed Sept 12, 2003)


35. A differentiated cell population as part of a system for generating glial cells, wherein at least .about.80% of cells in the differentiated cell population are oligodendrocyte precursors having the following characteristics: they are progeny of primate pluripotent stem (pPS) cells; they stain with antibody specific for NG2 proteoglycan; and they are negative for the neuronal marker NeuN; and wherein the system further comprises the line of pPS cells from which the differentiated cells were produced.

[0001] This application is a continuation of PCT application serial no. PCT/GB2003/003021, filed Jul. 10, 2003 (Atty Docket No. IRVN-009WO, entitled "Oligodendrocytes Derived from Human Embryonic Stem Cells fro Remyelination and Treatment of Spinal Cord Injury," which application was filed in English and designating the United States, which application is a continuation-in-part of U.S. application Ser. No. 10/406,817, filed Apr. 4, 2003, which application claims the benefit of U.S. provisional application Ser. No. 60/395,382, filed Jul. 11, 2002. [Giving this application pre-Hwang priority.]

Oligodendrocytes derived from human embryonic stem cells for remyelination and treatment of spinal cord injury
20040009593 (Jan. 15, 2004)
This invention provides populations of neural cells bearing markers of glial cells, such as oligodendrocytes and their precursors. The populations are generated by differentiating pluripotent stem cells such as human embryonic stem cells under conditions that promote enrichment of cells with the desired phenotype or functional capability. Various combinations of differentiation factors and mitogens can be used to produce cell populations that are over 95% homogeneous in morphological appearance, and the _expression of oligodendrocyte markers such as GalC. The cells are capable of forming myelin sheaths, and can be used therapeutically improve function of the central nervous system.

App 10/406817 filed April 4, 2003

******

from Transplant Immunology, Volume 15, Issue 2 , December 2005, Pages 131-142:


Pre-differentiation of hESCs increases the likelihood that the transplant population will survive and maintain their desired phenotype in the host, and decreases the likelihood of teratoma formation. These cells can be driven to yield a high purity population of a desired lineage for a specific cell replacement strategy reducing the influence of environmental signals on the transplant population. Although hESCs may be ideally suited for transplant-mediated remyelination, the environment of human demyelinating pathologies is not. The complex, reactive, and multifocal nature of human demyelinating diseases present significant challenges that must be overcome before cellular replacement strategies become a clinical reality. The more immediately approachable demyelinating pathologies will be those that present relatively fewer environmental challenges, such as spinal cord injury.


from The Journal of Neuroscience, May 11, 2005, 25(19):4694-4705:

Here, we show that transplantation of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells (OPCs) into adult rat spinal cord injuries enhances remyelination and promotes improvement of motor function. OPCs were injected 7 d or 10 months after injury. In both cases, transplanted cells survived, redistributed over short distances, and differentiated into oligodendrocytes. Animals that received OPCs 7 d after injury exhibited enhanced remyelination and substantially improved locomotor ability. In contrast, when OPCs were transplanted 10 months after injury, there was no enhanced remyelination or locomotor recovery. These studies document the feasibility of predifferentiating hESCs into functional OPCs and demonstrate their therapeutic potential at early time points after spinal cord injury.

The H7 and H7-enhanced green fluorescent protein (eGFP) hESC lines at passage 32 and the human fibroblast (hFb) line at passage 48 were obtained from Geron (Menlo Park, CA).


Nonetheless, we cannot rule out the possibility that locomotor improvement may have resulted from an uncharacterized effect of the transplant, such as neurotrophin-induced axonal sprouting (Lu et al., 2003 ).

**FOLLOWUP**

There is an issue about the video shown by "60 Minutes" on February 26, 2006. From
the website of the Reeve-Irvine Center:

Reeve-Irvine Research Center researcher Hans Keirstead was featured in a segment of "60 Minutes" that aired Sunday, Feb. 26. The segment explored Keirstead's efforts to develop a stem cell therapy for spinal cord injury.


The segment featured live video footage of rats; this video was not provided by UCI and is not of Dr. Keirstead's work. The animation featured in the piece - developed and provided by UCI - accurately represented Dr. Keirstead's work.


The Reeve-Irvine Research Center is dedicated to finding treatments for Spinal Cord Injury. We are a research center and currently do not see patients, have a rehabilitation program or run any clinical trials using stem cell or other technologies. Please visit the pages of this web site to learn more about our research programs.

Koreans who exposed Hwang now victims?

Donald Kennedy of Science said that he faces a recurring question: in analysing the
peer-review reports of Hwang's papers, has he seen anything that should've raised a
red flag earlier? ''I have to say, I have not, but my colleagues may,'' he said.
Kennedy also claimed that he had not heard rumours that the young Korean
scientists who helped reveal Hwang's deceit were being victimised. ''And if I had I
wouldn't tell you,'' he said.


from "Science a test for society," The Australian, p. 25, February 25, 2006.

Saturday, February 25, 2006

Purdue v. Endo: the changing faces of inequitable conduct

Christopher Cotropia wrote about the 2005 case Purdue v. Endo in the Jan. 2006 issue of JPTOS (88 JPTOS 46). Unfortunately on February 1, 2006, that decision was vacated and replaced by 2006 U.S. App. LEXIS 2887.

From the Cotropia article:

Purdue Pharma L.P. v. Endo Pharmaceuticals
Inc., 410 F.3d 690 (Fed. Cir. 2005)

A unanimous Federal Circuit panel in Purdue Pharma L.P. v. Endo
Pharmaceuticals, Inc. found statements made by an applicant to be material for purposes
of inequitable conduct when the statements (a) where used to distinguish
his invention over the prior art and (b) implied experimental results that
had been obtained when actually such statements were based on only the
inventor's insight.

(...)

Purdue is a significant case because, due to the early
nature of patent disclosures, inventors rarely have scientifically, fully
established every aspect of their invention. So statements such as those that
appear in the written description in Purdue are not uncommon. These statements alone,
however, are not what the court focuses on to find materiality. It is the
reliance on these statements to overcome a rejection. Therefore, Purdue is a
reminder to the patent prosecutor to communicate with the inventor or inventors
throughout the prosecution process and make sure, when relying on something such as
unexpected results, that there truly are results upon which to base that argument.

Did Schatten use fake Hwang data to help get NIH grant?

The Pittsburgh Tribune Review writes on February 26, 2006: The shiner the University of Pittsburgh received from its association with fraudulent stem-cell research in South Korea is balanced by another black eye. Reproductive biologist Gerald Schatten, who was lead author on an article describing the now-discredited "breakthrough," used the research to help win a $16.1 million federal grant last year for more stem-cell work at Pitt. And there is every indication the National Institutes of Health and the university will not stand in his way. Giving the benefit of the doubt owed, there is no evidence available to us that Mr. Schatten knew the data were false when he applied for the grant.

The Korea Times said :

Two other researchers are working with Schatten on the project: Peter Donovan at the University of California, Irvine, and Roger Pedersen at Cambridge in England.

As the five-year grant is based on the false cloning experiments, which Schatten co-authored, the university officials should consider whether he remains eligible to lead research projects and receive grants, Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, was quoted as saying.

When applying for the grant, Schatten's team is also said to have referred to Hwang's research in creating stem cells and the "exceptional international collaborations" between the labs of the two countries.

Park Jong-hyuk, former researcher at Mizmedi Hospital in Seoul, was also named as a key person on the grant. Park is currently under a prosecutors' investigation in Korea. Park Eul-soon, another researcher who is with the school, is also listed as a predoctoral trainee.

Hwang also voiced his support for Schatten's work, referring to their "intensively involved" collaboration, the newspaper reported, quoting a letter forwarded to the NIH.

It is unclear whether the NIH will withdraw the grant due to Schatten's involvement in the falsified research.

"NIH is in contact with the University of Pittsburgh as part of the oversight that occurs in connection with any and all grants awarded by the NIH," spokesman Don Ralbovsky was quoted as saying.

The South Korean prosecution has tried to question Schatten over his role in fabricating the research. The U.S. scientist recently told the prosecution he will cooperate in their probe through e-mail, and prosecutors who mailed their questions last week are waiting for responses from him.

An investigation by the University of Pittsburgh said earlier that Schatten "did not deliberately fabricate data himself," though he committed "a serious failure that facilitated the publication" of the paper by Hwang.

On the USPTO's proposed limitations on continuing application practice

As pointed out in IPT in Nov. 2005, RCE's are now the most prominent type of "continuing" application, although they were not considered in data of Lemley and Moore in the Boston University Law Review ("Ending Abuse...")

Of the issue of patent application backlog, it's hard to believe that continuing applications are the direct source of application backlog, since the fraction of continuing applications has been relatively constant for some time (ca. 25% of all applications). Further, one notes that it is probably easier for an examiner to handle ANY continuing application (whether RCE, div, con, cip) than to start on an entirely new application. Thus, a rule that would foreclose 100 continuing applications would not open up an amount of time which could be used to handle 100 new applications.

Nevertheless restricting continuing application practice is SOMETHING that the USPTO can do to free up some time. In the presence of repeated failure by Congress to end fee diversion, the USPTO is engaging in a bit of self-help. It won't be enough to stem the backlog, but it might make a dent. The PTO's position is out of self-interest, not through acceptance of the validity of the article by Lemley and Moore.

Comments on the USPTO proposal on continuations:

from 271blog:

On 4 Jan 06

There are two primary reasons. First, current continuation practice allows applicants to file unlimited continuations off of a single disclosure. As a result, the USPTO can never finally reject, or even allow, an application for patent. And when applicants file long strings of continuations from allowed applications, the effect of this is akin to the "submarine patents" of bygone days - defendants can feasibly be sued multiple times off of the same disclosure, and crafty applicants can tweak continuation claims to ensnare unsuspecting companies. Recent research conducted by legal scholars Mark Lemley and Kimberly Moore found that, while continuations are filed in 23% of all patent applications, patents based on continuation applications represent 52% of all litigated patents.

The second reason is that continuation applications unnecessarily eat up USPTO resources. The Office claims that 30% of examiner time is spent reviewing continuation applications. Furthermore, the Office issued over 289,000 first Office actions on the merits in fiscal year 2005. According to the Office, "had there been no continued examination filings, the Office could have issued an action for every new application received in 2005 and reduced the backlog by issuing actions in 35,000 older cases. Instead, the Office's backlog grew because of the large number of continued examination filings." While the USPTO appreciates the necessity of filing continuations to further prosecution, the Office has statistically concluded that the "marginal" benefits provided by second or subsequent continuations are outweighed by the burden placed on the USPTO.


end 4 Jan 06

begin 21 Feb 06

During February's [2006] Town Hall Meeting in Chicago, the USPTO was putting forth arguments in support of the continuation restriction proposal. One of the main reasons for restricting continuations was that the purported excess of continuation applications was overwhelming patent examiners, thus slowing production.

Most practitioners rightfully questioned the extent to which continuation applications delay overall examination. The USPTO has been touting the hiring of 1,000 examiners over the coming year as evidence that the USPTO is tackling the pendency problem. Also, the encouragement of electronic filing and other initiatives are being promoted additional tools for reducing the amount of time applications wallow in the Office.

So it was somewhat surprising that, during the Town Hall Meeting, the USPTO claimed that the hiring of additional examiners would not solve production problems, and that restricting continuations was necessary as a result. In fact, the USPTO made a pretty strong point of this, as shown by one of the Power-Point slides provided at the meeting:

[We Can Not Hire Our Way Out!]

end 4 Feb 06

One comment--> Rather, it seemed apparent that the real reason for restricting continuations was to restrict applicants’ ability to use a continuation application to address competitors’ efforts to design around. They apparently believe that practice is inappropriate. In other words, at least for the continuation rules, they seem to be using the backlog as merely a smokescreen for a substantive change in law/policy.



from promotetheprogress:

To make matters worse, the proposed rule would apply to applications filed on or after the effective date of the rule, if adopted. What does that mean? In essence, beginning on the effective date of the rule, any application that is a third or subsequent application in a chain must be accompanied by a petition providing justification for its existence. Oh, and another thing...the standard for the justification you must provide...it's perfectly undefined.

Now you can really worry.

If adopted as proposed, the new rule would force all companies that make use of legitimate continuation practice to review their entire portfolio of pending applications and determine which continuations should be filed before the effective date of the rule. This would result in great expense and administrative burden and would likely translate into a massive surge in filings during the weeks, days, and months before the effective date of the rule. If a company elects to avoid the time and expense of reviewing the portfolio and filing continuations, it will risk losing the ability to seek protection because the burden that must be satisfied under the proposed "justify your existence" petition is not known.

So, for corporate counsel, the proposed rule creates a largely unpredictable expense and a tremendous fear of the unknown.

Now you can really, really worry.

What should you do?

First, understand the proposed rule and its potential effect on your patent application filing strategy. Biotech, pharma, and medical device companies should pay particular heed. You can view and/or download the Federal Register Notice of the proposed rule here.

Second...contact your intellectual property trade association of choice and get involved with its coordinated effort on the issue.

Third, consider filing comments on the proposed rule. Written comments can be sent by e-mail to AB93Comments@uspto.gov and must be received on or before May 3, 2006.




[IPBiz post 1285]

Friday, February 24, 2006

The term "gifted amateur"

"The Avengers" was a BBC television series of the 1960s, starring, most famously, Diana Rigg and (throughout) Patrick MacNee. The two played elegantly effective secret agents: MacNee's character, John Steed, a professional in service to the Crown; Riggs', Emma Peel, a "gifted amateur" (fortunately, she had her own money).

The introduction to the early shows: Extraordinary crimes against the people and the State have to be avenged by agents extraordinary. Two such people are John Steed, top professional, and his partner Emma Peel, talented amateur -- otherwise known as the Avengers."

The mirage of internet commentary; problems with the prior art of the future?

On IPBiz in December 2005, I posted some comments on an article by Jacquie McNish, "Misadventures in the wacky world of patent law; Firms as diverse as eBay, RIM find themselves at the wrong end of a quirky system," which appeared in the Toronto Globe and Mail. The article was available on the internet, and I wrote a letter to the Globe and Mail pointing out some problems with article (e.g., litigation was not stalled in US courts because we are a first to invent country). The Globe didn't publish my letter.

About a week or so later, on December 25, 2005, the Detroit News republished the McNish article. I sent in my same comments, and the Detroit News placed my letter (Wacky Patents or Wacky Reporting?) on their internet site, although someone else had already criticized the McNish article.

Two months later, the original McNish article cannot be directly accessed on the Globe and Mail site, although it can be accessed on on the Detroit News site. The critical comments are gone.

Look at this general fact pattern in an abstracted analysis of knowledge of one of ordinary skill. At this point in time, one could point to the "truth" of the McNish article, on the basis that no one criticized it. Of course, it was criticized, but that was removed from the internet, so, for all practical purposes, it didn't happen. This sort of thing becomes a working embodiment of Orwell's 1984.

Also, look at this in terms of the comments within Delaware's Doe v. Cahill. Contrary to the assumptions therein, one could not respond to the "untruths" on the initial website. One could not reach the same audience. However, one could respond on a secondary website, which had run the same material. But, at the end of the day, the "untruths" remained, but the response was removed.

Forbes on Blackberry future

Forbes brings up the possibility of action by RIM shareholders against RIM. Apart from a design-around to protect RIM's future, one still has the prospects of treble damages arising from RIM's past infringement. The re-exams don't change that.


Complicating RIM's prospects is the likelihood that even if it can get a good settlement, the company will be hit with lawsuits from shareholders angry that it spent so much time and money to fight NTP's claim.

Plenty of BlackBerry users remain faithful to RIM--and to their favorite gadget. "We are not worried about service being shut down," says Beth Perlman , CIO of Constellation Energy Group and another BlackBerry fan. "We have spoken to executives at RIM and feel comfortable that they have proven work-arounds."

Of course, that doesn't mean they won't jump ship if they have to. "We have been testing [Microsoft's] Windows mobile devices for some time," says Perlman. "We have these devices ready for executives should the need arise. So we're prepared either way."

The coming skirmish on the IP frontier

Looks like availability of old sites on the internet archive wayback machine has thinned out a lot.

Not much left of IPT.



"A tale of conflicting models: the coming skirmish on the IP frontier
from Intellectual Property Today, 2001.

**UPDATE on Oct. 10, 2006**

from the just-n-examiner blog:

I also have seen some talk about the fact that the Internet Archive, better known as the Wayback Machine, contains a disclaimer regarding the accuracy of the contents of its database:

"You understand and agree that the Archive makes no warranty or representation regarding the accuracy, currency, completeness, reliability, or usefulness of the content in the Collections, that the Site or the Collections will meet your requirements, that access to the Collections will be uninterrupted, timely, secure, or error free, or that defects, if any, will be corrected. We make no warranty of any kind, either express or implied."

Once again, the discussion was about whether the Wayback Machine can be relied upon for prior art to be used by examiners in rejecting the claims of a patent application. And once again, I'd say that you need to consider the material for what it's worth. In the case of the Wayback Machine, however, I think I'm pretty safe in saying that the material is somewhat more reliable/credible than that from the average Wikipedia entry.

Since the Wayback Machine gathers its data through the use of automated robots, the only way (that I know of) for the data to be unreliable is either that their software is buggy (which doesn't strike me as extremely likely) or their database is getting hacked (which also strikes me as unlikely). If the web content in the Wayback Machine's database gets corrupted, then it doesn't seem to me as if it would be useful as prior art, since it likely wouldn't even load and display. If the database is getting hacked, then you've got to ask yourself why. Better yet, it seems extremely unlikely that someone would rewrite old web pages in such a way that would make it useful to an examiner, unless you can convince me that some competitor of the assignee of the application under examination is doing it. Talk about unlikely.

I just can't see a simple disclaimer as grounds for excluding the contents of the Wayback Machine as a source of prior art for examiners. If it ever does happen, though, then you can look forward to more pretty obvious Internet patents to issue, what with the speed at which Internet companies (and their web pages) evolve and/or go out of business. Without the Wayback Machine, examiners would have a much harder time trying to establish what actually existed on the Internet in the past.


Comments:

If I were an examiner, I'd have no issues with citing the wayback machine. If someone challenges the prior art, chances are good that I can find the people behind the website. Without divulging anything, I can get an affidavit that the site was actually available as of the cited date. I realize that examiners don't usually go to this kind of trouble, but it's a nice threat to have. On the other side, what do you expect to accomplish by raising the challenge if the PTO will bring back verification?

(..)

Um, examiners don't have enough time to go around trying to find the author of a website and get them to file an affidavit in order to prove something was written on their website as of such and such a date. Attorneys know no examiner has the time/ability to do and thus they would take that as an extremely empty threat. Attorneys can hunt down affidavits because they have a whole legal staff helping them find what they need, examiners on the other hand are normally left in the area of "if you can't get it yourself, well, too bad."

IPBiz says: cross-reference these comments to what Quillen and Webster said in QWIII about my not citing OETD paper in my Kent-JIP paper. When I finally tracked down the European folks who "wrote" the paper, they were clueless about "when" the paper was written or appeared on the net. An affidavit? LOL. I like dreamin.

Blackberry judge: In plain words, the case should have been settled

Judge James R. Spencer: “In plain words, the case should have been settled, but it hasn’t so I have to deal with that reality. ” The judge also objected to RIM’s argument that the future of the economy and of civilization would be impacted in the event of a BlackBerry shutdown. [from Red Herring]

Thursday, February 23, 2006

Opportunities for intellectual property in China

Over 90 percent of Chinese companies have no patent application experience, and only 0.03 percent of Chinese companies have their own intellectual property rights (IPR).

[IPBiz post 1279]

Wednesday, February 22, 2006

On February 22, the U.S. Patent and Trademark Office issued a final rejection of claims of one of five patents owned by NTP and involved in the NTP/RIM litigation, which is a step in a long process that Research In Motion Ltd. hopes will allow it to keep operating its U.S. BlackBerry service.

NTP, a closely held patent holding company, has previously won a district court verdict against RIM for infringement of claims of its patents.

On February 24, the presiding judge in the case, U.S. District Court Judge James Spencer, will hold a hearing to consider NTP's request to go forward with an injunction that would shut down most sales of RIM's BlackBerry wireless e-mail device and service in the United States.

RIM said on February 22 that the latest decision and previous rejections have been based on "multiple grounds" and "are expected to withstand all future appeals" by NTP. However, the issue here is one of timing. NTP can appeal rejections in a re-examination first to the BPAI and second to the CAFC as a matter of right. If Judge Spencer grants a permanent injunction before the re-exam procedure is over, then RIM is going to have trouble no matter what the ultimate fate of the re-examination procedure turns out to be. This possibility may be perceived as unjust to some, but it is a possible avenue for the litigation to take.

See also CNN money





[IPBiz post 1278]

Tuesday, February 21, 2006

Tim Wu's --Weapons of Business Destruction-- dull stupidity?

Paragraph one includes a discussion of NTP v. RIM as the tech world's very own Dr. Strangelove. NTP, a one-man Virginia firm, armed with nothing but patents, currently threatens to bring down BlackBerry and with it the sanity of millions of e-mail addicts.

The total inappropriatness of Wu's image is captured in Strangelove's line: Of course, the whole point of a Doomsday Machine is lost, if you *keep* it a *secret*! Why didn't you tell the world, EH? NTP and Campana TOLD THE WORLD of the invention by placing it in a patent.

Thus, when Wu continues: It is telling that the dilemmas created by software patents today are routinely compared to those created by nuclear arms, with patent trolls playing the role of the nuclear madman. one wonders where the relationship to Dr. Strangelove is. In Dr. Strangelove, the Americans doubted the technology of the Doomsday Machine: Mr. President, if I may speak freely, the Russkie talks big, but frankly, we think he's short of know how. I mean, you just can't expect a bunch of ignorant peons to understand a machine like some of our boys. And that's not meant as an insult, Mr. Ambassador, I mean, you take your average Russkie, we all know how much guts he's got. Hell, lookit look at all them them Nazis killed off and they still wouldn't quit.

Strangelove, Muffley, Turgidson and the rest were reacting to something that had been kept secret, and about which there was uncertainty. Not exactly the situation of RIM as to NTP's patents, which were all written down.

Wu does include the mandatory soundbyte suggesting PTO incompetence: On Nov. 1, 2005, the PTO issued Boris Volfson of Huntington, Ind., Patent 6,960,975 for his invention of an antigravity space vehicle (according to the application, "the spacetime curvature imbalance … provides for the space vehicle's propulsion"). This is a replacement for the more typical allusion to Smucker's patent covering a crustless, sealed peanut butter and jelly sandwich.

In this, Campana et al's patents (here attributed to the lawyer "David" Stout) fit right in: Arguably his patents should never have been granted; the idea of "wireless e-mail" is just too obvious to merit patent.

Even the Federal Circuit is demonized: Over time, that court changed course on software and other questionable areas of patent, transforming the system from one that was highly conservative to one that's much more liberal. The result was a rush for software and other patents that began in the 1990s and continues today.

Wu confuses innovation with invention, the area of concern of the PTO: And NTP got their chance when RIM did what NTP never did: They actually developed and made popular a wireless e-mail product, the now ubiquitous BlackBerry. As University of Chicago professor Douglas Lichtman puts it, "The original inventor maybe invented, but he didn't actually bring the idea into the world." The Patent Office simply is not concerned with whether or not the inventor commercialized the invention. Wu doesn't mention the business deals and partnerships of NTP.

To Wu, the only good thing about trolls like NTP is that they have inspired patent reform: About the best that might be said of trolls like NTP is that they've inspired a serious patent-reform debate. A growing crowd—including major firms like Amazon, IBM, Intel, Yahoo!, and Microsoft, and academics like Mark Lemley, Douglas Lichtman, Bhaven Sampat, Arti Rai, and others—now advocate some form of major patent reform. They want to fix the PTO to ensure that only the best, truly novel inventions get a patent, and they want to change aspects of patent procedure that currently make harassing litigation too easy. Ex-FCC-chairman Reed Hundt, for example, proposes reducing the number of patents by 90 percent and handing over a lot more money to those overworked patent examiners. The link under the word "advocate" is to Lemley et al's proposal on gold plating patent applications, something that did not come up in the FTC and NAS discussions. Further, patent reform started with an academic discussion, manifested in the FTC and NAS papers, and only gathered traction when various companies tried to use patent reform to advance their own interests. When these interests collided, in the area of permanent injunctions, patent reform 2005 was over. Wu does not mention that the Eolas patent survived re-examination without amendment, or the questionable nature of eBay's re-exam on the MercExchange patent giving rise to the permanent injunction issue. Perhaps all trolls are not created equal?

Wu concludes: In this debate it must be remembered that the regime of easy patenting of software is not natural law but an experiment—a judicial flight of fancy in an area of difficult economic policy. To remain healthy, the U.S. legal system should experiment, but it also needs to recognize when its experiments have failed. Both Congress and the Supreme Court have a chance to do something about the problem this year. The rise of the patent trolls is, in this sense, telling us something—that it may be time to end a system that is doing no one any favors.

Of course, neither the Supreme Court or Congress are scheduled to address software patents per se this year. Other issues are on tap.

ConFold v. Polaris: NDAs in CA7

A case taking a hard line on nondisclosure agreements (NDAs) is ConFold, Inc. v. Polaris, Inc., 2006 U.S. App. LEXIS 513 (CA7 Jan. 10, 2006) (Posner J.).

Indian patent trap awaiting Cipla and Ranbaxy over Tamiflu?

Of the discussion below, one recalls that it is Gilead, not Roche, that holds the various patents on Tamiflu. Roche Holdings is the licensee of the patent(s). One recalls that not too long ago Roche alleged that competitors would not be able to get up to speed quickly on Tamiflu synthesis. (Recall also the various false statements by Alec van Gelder.)

In the wake of the avian flu outbreak, domestic drug companies Cipla and Ranbaxy have offered to produce generic versions of Roche’s Tamiflu. While both companies are confident that there are no patent issues involved, a section of the industry is concerned that this could turn into a test of the country’s new patent laws.

Tamiflu — generic name oseltamivir — is one of the two drugs effective in treating influenza caused by the H5N1 strain in humans. But the drug is under patent globally. Though it has not been granted a product patent in India, the new set of laws make it eligible for one.

“As a matter of caution, India should have invoked the compulsory licensing clause in the patent law to allow domestic companies to make oseltamivir without having to worry about legal repercussions,” DG Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), said. In fact, the IPA, a body of leading domestic firms, had submitted a memorandum to the government in October last year suggesting the move.


Recall an earlier post on IPBiz mentioning Indians referring to a Roche application.

Judge Spencer rejects hearing proposed by DOJ

Judge James Spencer of ED Va, overseeing the patent infringement case against the maker of the BlackBerry portable e-mail device, on Feb. 21 rejected a request by the U.S. Justice Department to hold additional proceedings on how to exempt government users from a potential shutdown of BlackBerry service.

The judge turned down a request by the Justice Department to hold a separate hearing to delve into the department's concerns about the potential shutdown, according to an order posted on the court's Web site. [Reuters]

We should have a further decision in three days.

[IPBiz post 1274]

Cert granted in MedImmune v. Genentech on Feb. 21

IPFrontline correctly called the day of cert decision in MedImmune:

Also at Friday's (Feb. 17) conference, the Court is scheduled to consider certiorari in MedImmune, Inc. v. Genentech, Inc., S.Ct. No. 05-608; and MedImmune, Inc. v. Centocor, Inc., S.Ct. No. 05-656. In both cases, plaintiff-petitioner relies upon Lear, Inc. v. Adkins, 395 U.S. 653 (1969), to challenge validity of patents as an unhappy licensee. Unlike Lear, however, the plaintiff-petitioner continues to pay royalties under the patent license, a distinction which led to dismissals in both cases. A decision on certiorari is expected February 21, 2006.

The following AP report is a little hazy on the law (and some facts), but does introduce other factors present in the case.

from AP:

The U.S. Supreme Court agreed Feb. 21 to hear a case on whether drug-maker MedImmune Inc. has the right to sue rival Genentech Inc. over a lucrative drug patent.
MedImmune claims San Francisco-based Genentech and British biotechnology firm Celltech R&D Ltd. improperly schemed to obtain a patent on antibody technology, allegedly in violation of antitrust laws. MedImmune wants the patent invalidated.
Several companies use manufactured antibodies as the basis of new drugs. In return, the companies pay Genentech licensing fees under patents held by the drug maker known as "Cabilly" after inventor Shmuel Cabilly. That includes MedImmune, which uses antibody technology for the childhood respiratory drug Synagis that topped $1 billion in worldwide sales last year.
Genentech obtained a Cabilly patent in 1989 that was set to expire in 2006. In 2001, it acquired a second patent through negotiations with Celltech, which had a similar antibody patent. The second Cabilly patent runs through 2018.
MedImmune filed an antitrust lawsuit in Los Angeles in 2003, claiming Celltech and Genentech colluded over the second patent. But federal district and appeals courts rejected MedImmune's claims, saying it did not have a right to file suit under federal law.
In October, however, the U.S. Patent and Trademark office rejected the second Cabilly patent but agreed to re-examine its decision, which could be a lengthy process.

The MedImmune case was not on Wegner's "top 10" Supreme Court Patent Cases, as updated on Nov. 29, 2005.

Comments on stem cells from AAAS meeting

A year ago, Hwang Woo Suk was a conquering hero at the Seattle meeting. Now, quotes are of a different nature.

"Regardless of all the strife in this field and our complaining incessantly about our national policy and some recent events that cast a shadow on this work, there is a great deal of excitement," said Dr. John Gearhart of Johns Hopkins University in Baltimore.

"I am still excited about this. It is robust ... it is vibrant," Gearhart told a news conference after a symposium on stem cell research at a meeting of the American Association for the Advancement of Science in St. Louis.

As they met, the independent National Academy of Sciences said it was setting up a new committee to provide updated guidelines on how best to ethically conduct human embryonic stem cell research.

Dr. Lawrence Goldstein of the University of California San Diego and Howard Hughes Medical Institute said researchers will be working on the use of cloning technology to make stem cells -- valued because they would perfectly match the patient and perfectly model an individual's disease.

"I am personally optimistic that with enough skilled people working on this problem in the United States and other countries it is workable," Goldstein told the news conference.

Goldstein said there is no reason to believe humans cannot be cloned, as sheep, dogs, cats, mice and other animals have been. "While it is possible that humans somehow will pose unusual difficulties, I don't think it is likely," he said.

The bigger problem, Goldstein said, is a lack of human eggs to work with. Therapeutic cloning or nuclear transfer is done by hollowing out an egg cell and inserting the nucleus of a cell from the animal, or the tissue, to be cloned.

SNU to be audited over Hwang-gate

The Korean Board of Audit and Inspection (BAI) said Feb. 21, 2006 that it would inspect Seoul National University (SNU) for the first time over the school's use of research and development funds coming from the government.

The state auditor has decided to launch a probe into SNU as a series of incidents, including the now-retracted stem cell research project led by Hwang Woo-suk, have revealed misappropriations of research money by some of the school's faculty members.

The BAI plans to begin looking into how the SNU has appropriated R&D funds it got from the government, and announce the results of its probe in May.

The audit will also cover numerous state agencies and other academic institutions that received government research money.


Hwang violated SNU regulations requiring that research funds from outside should be received by the college first and then distributed to individual projects.

He was found to have accepted some 5.1 billion won from companies and foundations that was deposited directly into his account.

The Christian Science Monitor asks: why lie?

The Christian Science Monitor looks at the procedure of submission of a manuscript to a journal, but doesn't comment much on what happens afterwards, such as when the journal does not investigate pending patent applications or accusations that the work is wrong or fraudulent. Thus, there is no comment about what happens to the "rubbish" known to have been published.

The Monitor posits that Hwang-gate may have been the biggest scientific fiasco since the supposed discovery of cold fusion in 1989, carefully skipping over the work of Jan-Hendrik Schon of Bell Labs, which wasted millions of dollars of federal research funds.

As to "why lie," Schon and Hwang may have been counting on "real science" catching up to their "science fiction" before their fiction was recognized as such. In that world, the true enabler would be counted only as the second person on the scene.

As to traction from the current Hwang issue, one notes that the American Chemical Society did essentially nothing after the Schon matter, although the American Physical Society did tighten rules on co-author responsibility. Patents were not a big issue in the Schon matter, because Bell Labs withdrew them immediately after the Beasley report. Patents are going to be a big thing in Hwang-gate. Schatten is not withdrawing his application, and Hwang's may not be withdrawn either. Stay tuned for a turbulent ride.

from the Monitor on 21 Feb. 06:

Why lie? Fraudsters sometimes yield to the temptation to exaggerate their results to gain the eye of editors at top scientific journals. Acceptance for publication can boost careers and win fresh funding for future projects.

Editors of scientific journals are in the midst of soul-searching, asking what they can do to reduce such transgressions. "Even the very best journals have published rubbish they wish they'd never published at all," says Richard Smith, former editor of BMJ (British Medical Journal), in the current issue of The Scientist.

Editors of prominent journals receive thousands of submissions and have neither the time nor funds to duplicate experiments or investigate articles with the thoroughness of a detective or a courtroom prosecutor. The time-honored process of peer review, in which potential articles are sent to experts in the given field for secret vetting, is itself under fire.

So what can be done?

Fortunately, scientists aren't scam artists who disappear and reemerge with another identity. Their conclusions eventually will be tested by others. If the results can't be duplicated, their research loses credibility, and they ultimately face ostracism.

Computer programs are beginning to be used to check if data contains suspect patterns or an image has been altered. All the authors of a paper should reveal exactly what their role has been and accept responsibility for the findings. Peer reviewers should reveal if they have any conflicts of interest.

In addition, courses on ethics and integrity in research should be given higher prominence in college science programs and at research firms. (A recent study found that half of today's US college students admit to serious cheating on written assignments.)

The British government is introducing a code of scientific ethics next month that will call on scientists to act with "rigor, respect, and responsibility" and to present findings honestly and accurately.

It's important for citizens to feel that scientists have made their highest motive the quest for knowledge and the advancement of the public good - not fame or personal gain.

What's the true story on patent invalidity determinations?

On March 15, 2005, IPBiz discussed Lunney's findings that patent invalidity determinations were down.

In a recent article (46 IDEA 1), Abbott and Michel of the FTC report 58% of (contested) patents were invalidated in 2003, citing to U Houston PatStats
(http://www.patstats.org/2003.html).

What's the correct story on the trend in patent invalidity at the courts?

The article also talked about injunctions, and cited to Richardson v. Suzuki (not MercExchange v. eBay). The law on permanent injunctions is the same in the two cases, despite allegations that the eBay case enunciated something new.

The article had an interesting typo: A patentee must exercise its property right -- it's right to exclude -- in a manner that is consistent with the laws.

The article also cited Continental Paper for "Patents are property."

Two articles on IP coursework in law school appear in IDEA

See 46 IDEA 143 and 46 IDEA 165.

Of footnote 134 in the Deka article (46 IDEA at 161-162), I note that, more than 10 years ago, I was able to take at the University of Chicago Law School: trademark law, copyright law, patent law, and art law, and a great course on technology from Rochelle Dreyfuss.

The Port article states: Clearly, American legal academia has "discovered" IP.

Now, when will they be able to write about it intelligently?

Is there a gulf between legal academics and the Federal Circuit?

John R. Thomas suggests there might be a gulf between law professors and the Court of Appeals for the Federal Circuit in an article-- Academics and the Federal Circuit: Is There a Gulf and How Do We Bridge It?, 15 Fed Cir B J 315 (2005).

Thomas cites to a previous paper by Craig Nard which had noted that copyright and trademark opinions of CA2 and CA9 are four times more likely to cite a law review than is the an opinion of the CAFC in a patent case. [Nard, 39 Hous. L. Rev. 667 (2002)]

Thomas also cites to the text "not based on occasional journal articles", which appears in Enzo, 323 F3d 956, 974 (CAFC 2002).

There is also mention of "junk law" and "patent law remained something of a backwater."

One notes that Federal Circuit Bar Journal, which now brings us the thoughts of Professor Thomas, previously brought us the (now-discredited) "97% patent grant rate" work of Quillen and Webster. A defense of the later "85% patent grant rate" which appeared in the Boston University Law Review completely misquoted work of Clarke which appeared in JPTOS. The plethora of legal articles on "written description" were like a plague of locusts, with about the same intellectual content. Maybe there is a reason for the perceived gulf?

**
Another discussion of legal academics and RIM/NTP appears at
robhyndman.com

More articles on stem cell funding and Woo Suk Hwang

I have new articles available on

Problems loom in state-funded stem cell programs and on


How did Woo Suk Hwang trick the scientific world about stem cells?




Note also my 6,000 word piece: LESSONS TO BE LEARNED FROM THE HWANG MATTER: ANALYZING INNOVATION THE RIGHT WAY, to be published in the Journal of the Patent & Trademark Office Society in March 2006.

Monday, February 20, 2006

Chinese Netac company sues American PNY

The Chinese flash memory company Netac has brought a suit for patent infringement against the American company PNY in the Eastern District of Texas.

Netac has two issued US patents. The more recent is US 6,829,672, issued December 7, 2004. The first claim of the '327 is:

An electronic flash memory external storage method, comprising the steps of:

establishing data exchange channel between a data processing system and a portable external storage device based on USB or IEEE1394 bus upon plug said portable external storage device into said USB or IEEE 1394 bus interface of said data processing system;

acquiring a DC power supply from said data processing system for said external storage device through said USB or IEEE1394 bus upon plug said portable external storage device into said USB or IEEE 1394 bus interface;

configuring a flash memory storage module built-in said external storage device, wherein the data storage structure of the flash memory storage module is arranged on a block basis;

directly accessing data or information in the said flash memory storage module based on USB or IEEE1394 bus standard through said established data exchange channel by implementing and processing the data access operation requests issued by users, wherein said data processing system assigning and displaying a device symbol for said external storage device and processing the operation request in magnetic disk operation format issued from users upon plug said external storage device into said USB or IEEE 1394 interface of said data processing system.

There is a claim of priority to Nov 14, 1999. No US patents cite the '672 patent.


The other patent is US 6,795,327, issued Sept. 21, 2004.

The first claim of the '327 patent states:

A semiconductor storage method supporting multi-interface, comprising steps:

(a) setting up a semiconductor storage device in which is installed a semiconductor storage medium module (10), a controller module (20) to control said semiconductor storage device, and an interface module (40) which supports at least two interfaces of different standards, wherein said interfaces of different standards include serial or parallel or wireless communication interfaces; physically, said modules can exist independently or they can be combined into one or two modules;

(b) connecting said storage device, through said interfaces of different standards, to at least one data processing system which has the corresponding standard interface;

(c) establishing information exchange channel between said storage device and said data processing system based upon said serial or parallel or wireless communication interfaces;

(d) said storage device exchanges data through said exchange channel with said data processing system and stores data from said data processing system into said semiconductor storage medium module (10); said data processing system can retrieve required data from said semiconductor storage device.

The underlying application was filed September 30, 2002, and claims priority to two Chinese applications.


To date, the '327 patent has been cited by ONE US patent, 6,842,794 (to Inventec).

RadioShack CEO, David Edmondson, resigns over false resume

David Edmondson, CEO of RadioShack, resigned Monday, February 20 [a federal and market holiday] following questions about his resume's accuracy.

Edmondson had claimed that he received degrees in theology and psychology from Pacific Coast Baptist College in California, which moved in 1998 to Oklahoma and renamed itself Heartland Baptist Bible College.

The school's registrar told the Ft. Worth Star-Telegram that records showed Edmondson completed only two semesters and that the school never offered degrees in psychology. The school official declined to comment to The Associated Press.

Edmondson had worked for RadioShack for 11 years.

Notre Dame's WNDU on plagiarism: forgetting the past?

WNDU quotes Brother Tim Erdel, an Associate Professor of Religion and Philosophy at Bethel College: "Senior professors at Harvard have been dismissed on similar allegations in the past. In an academic setting, that's about the worse crime a person can commit."

The whole point of recent plagiarism episodes at Harvard was that senior professors were NOT dismissed (or seriously reprimanded) for acts of plagiarism which would have landed students in a great deal of trouble. Although plagiarism in an academic setting sounds bad, nothing really happens when it occurs. Brother Erdel needs to study recent history, and even perhaps to look at the Supreme Court's Dastar decision.

As noted elsewhere on IPBiz, worse than plagiarism is the publication of false statements which go uncorrected. If you believe what you read in the Stanford Law Review, Gary Boone is the inventor of the integrated circuit. But don't try that one with people who have heard of Noyce and Kilby.

Note discussion in IPBiz from April 2005 on plagiarism at Harvard.

**Of the story actually being discussed by WNDU

Joseph Bottom wrote on First Things:



Fr. Richard McBrien—the Notre Dame theology professor and long-time lefty Catholic columnist—is being tagged with the charge of plagiarism. The Boston Herald has picked up the story, which involves its Beantown competitor, the Boston Globe, and seems to run like this:


On December 11, 2005 the Globe ran a column by Eileen McNamara about the Catholic Charities’ dinner on December 9 that was headlined by Boston’s pro-abortion mayor, Thomas Menino. On January 6, The Tidings ran a column by Richard McBrien about, um, the Catholic Charities’ dinner on December 9 that was headlined by Boston’s pro-abortion mayor, Thomas Menino.


The blogger Diogenes notes:


Here’s a snippet from the original McNamara column: “They are a tiny band of antiabortion zealots….These folks do not just miss the Latin Mass; they miss Cardinal Bernard Law….There’s Bill Cotter, pining for the good old days when Law would allow Operation Rescue to use Catholic churches as staging areas for illegal blockades of abortion clinics.”


Now from Father McBrien’s column, which wasn’t quite so original: “These ultra-conservative activists, for whom abortion is the only moral and political issue that counts, not only miss the Latin Mass but also the former archbishop of Boston, Cardinal Bernard Law, who allowed Operation Rescue, a militant anti-abortion organization, to use Catholic churches as staging areas of illegal blockades of abortion clinics.”

The Herald reports that McBrien has denied the charge: “‘Plagiarism is when you steal someone’s ideas,’ said the 69-year-old priest, who taught at Boston College in the 1970s and whose column once ran in the Boston Pilot. ‘I was using the (Globe’s) facts (because) I’m not a reporter; I wasn’t at Menino’s talk.’ McBrien added that his critics ‘are not concerned about plagiarism, it’s that they disagree strongly with the point of the column.’ The January piece did attribute one sentence to the Globe.”


The facts that McBrien got from the Globe are curiously wrong. For instance, the dinner was not at the Seaport Hotel but the Harbor Hotel (a point the Globe later corrected). More significantly, Cardinal Law actually prohibited rather than allowed Operation Rescue to use the parish churches. Is it too much to ask a Catholic commentator to have better facts about Catholicism than the Boston Globe?


Apparently so. Still, I think Fr. McBrien is innocent of the charge of plagiarism. There’s no doubt that he was writing in the wake of Eileen McNamara, which is typically a sign of tiredness in a columnist: an indication that the man’s story ideas are running thin. But he did actually mention the Globe, and the weaker newspaper columnists have always fed off the chum left from the bigger sharks’ attacks. Within the ethics (so to speak) of the profession, that’s not plagiarism. So Richard McBrien behaves no better than other columnists in the bottom tier of American newspapers. Why is this news?

EFS at the PTO coming on March 17, 2006

The official release date for EFS-Web to the general public is March 17, 2006, which is three weeks from tomorrow.

Information on EFS by clicking here

Schatten's enhanced positioning for pending patent applications

The AP report below specifically mentions Schatten's enhanced positioning for pending patent applications. At the time the AP report was written, Schatten's 20060037086 (based on appl. 11/003006) was not yet public, but his earlier application (10/821,200) was public. The journal Science knew the authors of the 2005 paper by Hwang, Schatten, et al., had a patent interest, but did not investigate this interest, or inform the Science readership of the interest.


RAMESH SANTANAM (AP):

The University of Pittsburgh panel concluded Schatten "likely did not intentionally falsify or fabricate experimental data" and there is no evidence he knew of misconduct reported to have occurred in Hwang's group in South Korea.


But in a harshly worded report, the panel said Schatten joined forces with Hwang to help a colleague he admired and to help himself through "enhancement of his scientific reputation, improved opportunities for additional research funding, enhanced positioning for pending patent applications, and considerable personal financial benefit."

The panel was critical of Schatten's behavior, pointing out he accepted $40,000 in honoraria from Hwang within a 15-month span, including $10,000 in cash while attending a press conference after the 2005 paper was published.


The panel recommended the university implement suitable corrective or disciplinary actions.

Dudas talks about 600,000 application backlog at USPTO

At a speech at University of North Carolina-Charlotte [UNCC] on Friday, Feb. 17, Jon Dudas noted that the United States Patent Office [USPTO] has a backlog of about 600,000 applications; it often takes more than two years to process an application. Application fees are $1,000, although small businesses can qualify for a lower charge. Dudas noted that hiring 1,000 additional examiners annually over the next five years will reduce the backlog of patent applications.

Patently O had noted that the backlog in one class [275] was 19,181 for fiscal year 2004. A commenter on Patently O stated on 6 Jan 06:

The PTO also alleges that the increase in continuations poses a burden on the office and precludes examiners from acting on new cases, thereby contributing to the backlog. But I've researched issued patents back to 1970, and the average percentage of continuations filed (for patented cases anyways) was about 27.5%, and it has not changed that much. Moreoever, the backlog only exists in 2 technologies - software and electronics, which is not surprising to most patent practitioners - and the PTO has not provided any evidence that more continuations are filed in these technologies. The PTO faces backlogs like this whenever there is a new technology. In the 1950's and 1960's it was polymers, in the 1980's and 1990's it was biotechnology, and now its software. The backlog has nothing to do with continuation applications (interestingly, the Fed. Reg. notes that 2nd generation continuations only account for 3.7% of filings for continuations, and 3.1% for RCEs - so how does that contribute to the backlog, and how does elimination of these continuations get rid of the backlog?). New technologies with little prior art are harder to examine, and always create a backlog that takes the PTO 5-10 years to remove.

Returning to Dudas' comments on hiring, the issue is not simply hiring, because the USPTO has a severe attrition rate.

The Charlotte Observer noted that Dudas cited a 2001 report that ranked UNCC first in the nation in the number of patent applications and start-up companies, second in innovations, and third in the number of patents issued per $10 million in research expenses. The report was by the Association of University Technology Managers. Dudas called the university a "model" in promoting innovation in health care technology.



[IPBiz post 1260]

Ferring v. Barr. Split on inequitable conduct at CAFC.

In Ferring v. Barr, 2006 U.S. App. LEXIS 3554, Judge Newman wrote:

"Inequitable conduct" in patent practice means misconduct by the
patent applicant in dealings with the patent examiner, whereby the applicant
or its attorney is found to have engaged in practices intended to deceive or
mislead the examiner into granting the patent. It is a serious charge, and the
effect is that an otherwise valid and invariably valuable [*40] patent is
rendered unenforceable, for the charge arises only as a defense to patent
infringement.

Today my colleagues on this panel not only ignore Kingsdown and
restore a casually subjective standard, they also impose a positive inference of
wrongdoing, replacing the need for evidence with a "should have known"
standard of materiality, from which deceptive intent is inferred, even in the
total absence of evidence.
Thus the panel majority infers material
misrepresentation, infers malevolent intent, presumes inequitable conduct, and wipes out a valuable property right, all on summary judgment, on the theory that the
inventor "should have known" that something might be deemed material. The panel
majority, steeped in adverse inferences, holds that good faith is irrelevant and
presumes bad faith. Thus the court resurrects the plague of the past, ignoring
the Kingsdown requirements of clear and convincing evidence of a
misrepresentation or omission material to patentability, made intentionally and for the
purpose of deception. I respectfully, but urgently, dissent.


***
At issue is conflict-of-interest by an affiant/declarant.

The affiant's or declarant's interest is a factor which may be considered, but the affidavit or declaration cannot be disregarded solely for that reason." As appellants concede, we have previously held that a declarant's prior relationships with the patent applicant may be material, and that failure to disclose such relationships to the examiner may constitute inequitable conduct. Refac Int'l, Ltd. v. Lotus Dev. Corp., 81 F.3d 1576, 1581-82 (Fed. Cir. 1996); Paragon, 984 F.2d at 1191-92.

Inequitable conduct in Cargill/Dow patent fight

In 2003 Cargill had filed a lawsuit in federal district court in Portland, Oregon, claiming that Dow's Natreon canola cooking oil infringes on claims of four patents issued to Cargill. Cargill marketed a product: Clear Valley high oleic canola oils.

The court ruled that Dow infringed on claims of two of the four patents, ordering Dow to pay Cargill $2 million in damages.

But a post-trial motion by Dow alleged that Cargill had not submitted all relevant testing data to the US Patent Office, which resulted in the district court declaring the patents unenforceable in the US.

“The ruling is mystifying,” said Cargill president Greg Page. “Cargill submitted all the relevant data derived from the most highly reliable testing technology and procedures available. We had valid reasons for believing the un-submitted data – the results of some less precise tests on frost-damaged or immature seed samples – was inaccurate and unreliable compared with the reams of other testing data we submitted.”

“The District Court applied incorrect legal standards and made clearly erroneous findings of fact on both the relevance of the un-submitted data and Cargill's intent in not submitting it,” added Ron Dudley, head of Cargill Specialty Canola Oils. “We strongly believe the ruling is contrary to the law and will be overturned.”

On its side, Dow AgroSciences claimed that “Cargill was clearly in possession of testing data that demonstrated its oils were neither novel nor otherwise patentable.”

As the debate continues, a process expected to last about a year, Cargill said it will continue providing its high stability Clear Valley canola oils to its customers.

High oleic oils, which claim to provide good cooking stability and shelf life while eliminating unhealthy trans fatty acids, have enjoyed good demand since the nation's Food and Drug Administration (FDA) has required all food products to label their trans fat content.

Could Science have done more about Hwang's 2005 paper?

In the submission of the 2005 paper to Science, Hwang Woo Suk checked a box to designate that a patent was "anticipated, applied for, or held," but inexplicably the journal Science did not make any further inquiries prior to publishing the [now-retracted] paper. When there was a later discussion about inconsistencies within photographs, Science explained that the problems were with later-submitted higher resolution photographs, when in fact there were problems with the photographs, as submitted, which could have been identified by diligent inspection. Further, several scientists have questioned whether there was enough time between January 2006 (when the new Korean rules on egg donation were implemented, and allegedly followed by Hwang) and March 2006 (when the paper was submitted) to allow for the creation and analysis of 11 patient specific stem cell lines.

Alan Boyle writes in "Stem cell debate looks beyond scandal":

Donald Kennedy, Science's editor-in-chief, was sympathetic: "This is really a twin tragedy —both for the people who were misled over there [in South Korea] and for the people who were misled here. ... I'll certainly join in any ritual apology."

Science launched two investigations of the practices that led to the publication of the fraudulent papers. Kennedy told MSNBC.com that both probes — one by five of the journal's editors, the other by an independent panel — should be ready for review by the AAAS board in mid- to late April. (AAAS is a content provider for MSNBC.com.)

Kennedy said he is often asked whether he could see anything in retrospect that Science could have done to detect the fraud before publication. "I cannot, but my colleagues may," he said.

From IPBiz on January 14, 2006:

In the conflict-of-interest statement supplied to Science for the 2005 paper, Hwang replied on behalf of all authors and checked a box to designate that a patent was "anticipated, applied for, or held," according to Editor-in-Chief Donald Kennedy. He did not supply requested details about the patent, Kennedy said.

"At this point, we do not know whether the patent is awarded or expected, and whether it is Dr. Hwang's or one of the other authors,'" Kennedy said in an e-mail response to questions. "Our retrospective review of our procedures that we will be conducting shortly will include an evaluation of our conflict-of-interest policies."


IPBiz note: Schatten's published application 20040268422 was publicly available on December 30, 2004, and the status of said application could have been determined at the time of the submission of the Science manuscript through public PAIR. Published application 20060037086 became available on February 16, 2006. Of Hwang, in addition to telling Science that he had submitted patent applications, Hwang had told a reporter for the New York Times that he had submitted PCT applications. Thus, apart from not following up on what it was told, Science could have independently investigated the presence of applications, both in the name of Schatten and of Hwang. As an aside, it is not clear what Hwang knew of Schatten's applications, and when he might have learned it.

Sunday, February 19, 2006

Schatten to cooperate with Korean prosecutors via email

Korea Times, 19 Feb. 06: Schatten recently told Korean prosecutors that he will cooperate in their probe on Hwang through e-mail. Prosecutors who mailed their questions to Schatten last week are expecting a response from the U.S. scientist by the end of this week.

Prosecutors will question a list including former Mizmedi Hospital researcher Kim Sun-jong, who co-wrote the 2005 Science paper, Hanyang University professor Yoon Hyun-soo, also a co-author of the 2005 paper, and Lee Yang-han, an official at the state-run National Institute of Scientific Investigation, who conducted the DNA test for the stem cell samples described in the 2005 paper.

from the Pittsburgh Post-Gazette :

Lawyers for University of Pittsburgh researcher Gerald Schatten told South Korean prosecutors on Feb. 17 that he would respond to their e-mailed questions regarding a discredited report on cloned embryonic stem cells, according to Korean press reports.

Dr. Schatten was a co-author with Hwang Woo-suk of Seoul National University of a 2005 article in the journal Science that claimed to have created 11 patient-specific embryonic stem cell lines from cloned embryos. An investigation by the Seoul university last month concluded that all 11 stem cell lines were fakes.

Two weeks ago, press reports indicated South Korean prosecutors had e-mailed a list of questions to Dr. Schatten, director of the Pittsburgh Development Center at Magee-Womens Research Institute. Though he did receive a list of questions, University of Pittsburgh Medical Center spokeswoman Jane Duffield said "they weren't official" and it wasn't clear who sent them.

His attorney has since contacted the prosecutors and assured them that Dr. Schatten will respond to their questions once he has an official copy of the list, she said.

Dr. Schatten has not publicly commented on the matter since he asked Science editors in December to retract the disputed paper.

The decision to respond to questions came a day after prosecutors said a former colleague of Dr. Hwang told them that Dr. Schatten was aware of contamination that had destroyed four of the 11 claimed stem cell lines, yet had pressed to publish the paper nonetheless.

The Yonhap news agency said that the allegation by veterinarian Kang Sung-keun suggests that Dr. Schatten was directly involved in the fraud.

"I heard conversations exchanged between Hwang and Gerald Schatten when they met at an overseas academic meeting right after the stem-cell contamination occurred," Dr. Kang reportedly told prosecutors. He quoted Dr. Schatten as saying, "Let's publish the paper since the stem cell line numbers four to seven have been made," despite the contamination of those cell lines.

The account does not differ markedly from a report last week by a University of Pittsburgh investigatory panel, which concluded that Dr. Schatten was not involved in faking data and had not committed scientific misconduct.

The panel was critical of Dr. Schatten, however, for a number of shortcomings in preparing the report, including the issue of the contaminated stem cell lines.

"We feel that he did not exercise a sufficiently critical perspective as a scientist," the panel said in a summary report. For example, "he reported that he was told by Dr. Hwang in the middle of January 2005 that some contamination of the cells had occurred. Dr. Schatten's reaction was apparently to accept Dr. Hwang's assurance that this problem was a minor nuisance."

There is also an article from Scientic American :

At worst, says Alan Colman of ES Cell International in Singapore, "[the Hwang fraud] may cause a tainting of the whole field" if the public confuses the tiny corner of research spearheaded by the Koreans with mainstream work on embryonic stem cells harvested from preestablished lines. [IPBiz note: if this is the mainstream work, then are not the states, like California, wasting their money?] That work, the only kind funded by the U.S. government, is not as scientifically or ethically precarious because it does not demand new human eggs. ESC research opponent Andrew Fergusson, president of the Center for Bioethics and Human Dignity, corroborates that outcome, predicting that this debacle will "make the average American less likely to support stem cell research" when financial investments, ethical tightrope walking and lack of scientific proof are taken into account. Such a reversal would be disastrous for U.S. researchers, who rely on the public's enthusiasm--translated into private donations and state-sponsored legislation--rather than federal dollars for support.


But at best the scandal has only "set back the clock" on therapeutic cloning, so that "the field is wide open," says Evan Snyder of the Burnham Institute in La Jolla, Calif., who will continue to pursue research similar to that of the Koreans. Tailored stem cell colonies are considered a crucial way "to study pathology in a petri dish, so you can make all kind of advances that are hard to predict otherwise," explains Douglas Melton, co-director of the Harvard Stem Cell Institute; he says that the obstacles to succeeding where Hwang failed are principally technical, not biological, and that the money being poured into the work is still money well spent.


Whether funding sources will agree remains to be seen. Moreno points out that "the effect won't be as great as might have been the case a year ago," because four states--California, Connecticut, Illinois and New Jersey--have already made a financial commitment to embryonic stem cell work. (Still, New Jersey recently tabled its 2005 stem cell measure.) As for institutional backing, opines bioethicist Arthur Caplan of the University of Pennsylvania, "patient advocacy isn't budging"--certainly a positive note for the embattled science.

Beyond the future of research, the bigger issue may be how the scientific community will address the apparent lack of safeguards against misconduct. Defenders note that Hwang's faulty science would have been caught eventually, when the experiments defied replication by other, independent parties. And in terms of ethical responsibility, they point to the National Academy of Sciences's guidelines, published voluntarily seven months before Hwang's fraud, and to the fact that it was caught by other scientists, as evidence of the community's self-correcting nature. [IPBiz note: The fraud was alleged by Hwang's co-workers, speaking anonymously to third parties. The fraud was NOT caught by Hwang's scientific peers. Note the results with Jan-Hendrik Schon was the same. Insiders blew the whistle. Scientists who complained to journals about problems with Schon's work were ignored!!]

Yet the peer-review process--required to publish papers in scientific journals--is not designed to expose outright wrongdoing, even the staunchest advocates have to admit. They agree that had whistle-blowers not come forward, Hwang's falsified data and unethical means of egg procurement might have gone unnoticed. And this revelation, in turn, has recast the spotlight on missing legislation at home and abroad.

"It's become the Wild West out there, with each state doing what it pleases," says Steven Teitelbaum of Washington University in St. Louis, who has lobbied for changes in the Bush administration policy. "We have nothing that assures the research will be done ethically--laws should be passed on this." Others, including Caplan, believe that international treaties will be necessary to head off concerns over egg sales. One danger is that without oversight, nations may pull away from the international stem cell exchange and cooperative research altogether. "If there are differences in standards, countries could turn isolationist," Colman says.

That slowdown is certain to occur in at least one arena. After seeing how Gerald Schatten of the University of Pittsburgh, a senior co-author who purportedly played a minor role in Hwang's experiments, was carried along in the downward spiral, Moreno says, "people will think twice about collaborating." Potential co-authors of the future may painstakingly assess a project before consenting to give their names--and journals may be pressed to monitor more carefully the contributions of all involved. As for scientific relations with South Korea specifically, Snyder reports that "some of our philanthropic support sent a message: essentially, 'Don't work with the Koreans.' They have no problems with the field, but the Koreans are radioactive now."

Gillette, Schick to settle razor blade wars?

"The vast majority of the differences between the two companies have been settled and we look forward to remaining vigorous competitors in the marketplace, and not in the courtroom," Gillette spokesman Eric Kraus said Feb. 17.

Gillette Co. and Schick Wilkinson-Sword had been waging a legal battle since Schick started its Quattro four-blade razor in August 2003, with one more blade than Gillette’s three-bladed Mach3 razor.

Waters to pay Agilent $6.1 million to settle patent dispute

Waters Corp., a maker of instruments used by chemical researchers, said Feb. 17 it reached an approximately $6.1 million settlement with Agilent Technologies Deutschland GmbH to resolve its patent suit.

Stephanie Stoughton on RIM, NTP and the Blackberry saga

James R. Spencer, a no-nonsense U.S. district judge widely respected in the legal community, now finds himself in the unusual position of weighing an injunction against RIM even as the U.S. Patent and Trademark Office is expected to finally rescind NTP's patents. [The scheduled date for decision is February 24, 2006]

“These patents are ... guaranteed to go in the garbage,” James Balsillie, co-chief executive of Canada's RIM, said in December. “At the end of the day, our position is real simple: Let the system work.” [IPBiz note: Even if the USPTO finally rejected all claims of all patents, NTP would have two levels of review, first before the Board (BPAI) and then at the Court of Appeals for the Federal Circuit (CAFC)].

Unfortunately for Balsillie, the system doesn't necessarily work in a timely fashion. Spencer has signaled that he is unwilling to delay his proceedings while awaiting final word from the patent office, which lags far behind the court system. A case that could change the practice of granting injunctions in patent cases, eBay Inc. v. MercExchange, will be taken up by the Supreme Court, but no decision is expected until the spring at the earliest. Spencer, meanwhile, has scheduled a hearing for Feb. 24 on the injunction and damages. [IPBiz note: In theory, Spencer could delay the impact of the injunction until eBay v. MercExchange is decided. It's not clear that the issues in the eBay will help RIM. For one thing, NTP, unlike MercExchange, is in the commercial arena, so that the Continental Paper issue, even if decided adversely to MercExchange (which is doubtful in any event) would not impact NTP. Further, the "public interest" component of injunctions in the eBay case is less of a factor in eBay/MercExchange case than it is in NTP/RIM, where the saga of Sept. 11 gets better traction than does an auction network.]

Because patent infringement cases don't often rise to this level of importance and even fewer make it this far in the courts, it's hard to tell how Spencer will rule. An injunction he once issued on a sediment-control device, for instance, interested few people outside the construction industry. RIM v. NTP, on the other hand, could affect many of the more than 3 million BlackBerry users in the United States. [IPBiz note: until recently, patent injunctions were not a big deal. An injunction only issues after the patent is found valid and infringement established. Generally, most people would understand that an injunction should issue at that point.]

“His bottom line is that he wants this case off his docket,” said Susan Dadio, a patent attorney in Alexandria, Va. “And if the two sides can't reach a settlement or resolve this, he will not be afraid to act himself.”

Arlington, Va.-based NTP was co-founded by the late Thomas Campana Jr., an engineer who in 1990 created a system to send e-mails between computers and wireless devices. He is survived by his wife, who owns a large stake in NTP.

The BlackBerry hit the market in the late 1990s, becoming popular with lawyers, consultants and others who wanted to check e-mails away from their office and home computers.

In 2001, NTP filed suit. A year later, a federal jury in Richmond agreed that RIM had infringed on NTP's patents. The jury awarded the small firm 5.7 percent of U.S. BlackBerry sales, a rate that Spencer later increased to 8.55 percent.

Spencer issued an injunction in 2003 but held off on its enforcement during RIM's appeals. Those efforts largely failed and the case returned to his court last year.

Government and emergency workers would be exempted from any BlackBerry blackout, but the Justice Department has asked Spencer to hold off on an injunction until the details can be sorted out.

If granted, that delay would also permit corporate and individual BlackBerry users to switch to other devices or to download new software that RIM claims would work around NTP's patents.

RIM executives say the new software will prevent any service disruptions, but they have released few details. Some analysts are questioning the viability of the workaround and whether it might inconvenience users or degrade service.

The unanswered questions in the case have led thousands of companies to contact consultants in recent weeks for advice on alternative technologies, though few have actually made the switch.

At United Parcel Service Inc., as many as 3,000 managers, executives and technical support employees use BlackBerries. In the worst-case scenario, the company would switch those users over to Palm Treo handhelds, which are used by other employees, said Donna Barrett, a UPS spokeswoman.

David Johnson, infrastructure technology director for Grant Thornton LLP, said the Chicago-based accounting firm has been moving away from BlackBerries to a variety of devices supporting Microsoft Corp.'s Windows Mobile operating system.

That move has been due to personal preferences rather than the RIM litigation, but now the firm has asked two wireless providers to be prepared to supply backup devices for some of its 550 remaining BlackBerry users.

Even so, Johnson hopes RIM and NTP will work out their differences.

“If they want to kill each other and put each other out of business, all they're going to do is drive people to Windows Mobile faster,” Johnson said. “This is stupid is as stupid does.”

Analysts and others say both sides should settle. RIM would be able to avoid the headaches of the injunction and focus more on its business, especially with Microsoft posing a greater threat.

And NTP, they say, would fare better with a fat settlement (perhaps beyond the $250 million RIM has deposited in escrow) while continuing to reap royalties from licensing agreements with RIM competitors Nokia Corp., Good Technology Inc. and Visto Corp.

Those companies have only small pieces of the wireless e-mail market dominated by RIM. And eventually, some analysts say, the patent office would catch up to NTP, eliminating its leverage.

“Their days of milking these patents are nearing their end,” Gartner analyst Ken Dulaney said, referring to NTP. “If they are indeed worried about the poor widow Campana, they should take the money.”

(Stephanie Stoughton, from signsonsandiego.com)



[IPBiz post 1253]

Catholic church to enforce its copyrights

The demand by the Vatican to respect copyright on the pontiff's writings and pay for their use has triggered hot debate: Should an institution which exists to spread the word of God be putting a price on papal writ?

Unthinkable, say some authors. Not so, counters the Vatican; the authors are being paid for their efforts, so why not the church?

While the question is pondered, the new papacy is shaping up as a publisher's dream. Benedict's first encyclical, "God is Love," is a best-seller.

Among those raising questions about copyright is Vittorio Messori, an Italian Catholic writer who co-authored Pope John Paul II's best-selling "Crossing the Threshold of Hope," as well as a book with Cardinal Joseph Ratzinger, now Pope Benedict.

Messori predicted in an interview with the Turin daily La Stampa that the campaign will "terrorize" publishers and writers.

(...)
LEV says news organizations can quote from the pope's speeches, encyclicals and other writings without charge. They can also publish full texts for free provided they cite Vatican copyright, it says, but if a text is published separately, as Tornielli did in a book, payment is due.

LEV's Bucciarelli, in a telephone interview, said enforcing copyright helps ensure that the pope's writings are correctly reproduced.



[from FRANCES D'EMILIO, Associated Press Writer]

The involvement of journal editors in legal cases: Vioxx

Although the journal Science accepted Hwang's 2005 manuscript in a matter of weeks, without presenting objections (even though Hwang did not even have any data on patient specific cell lines), the saga of Merck's submission on Vioxx to the New England Journal of Medicine seems a bit more complicated. You have probably heard of the dangers of the -- track changes -- feature of Microsoft's Word wordprocessor (among other places discussed on IPBiz); the Vioxx case illustrates how dangerous this feature can be to the submitter of the digital version of a Word document. The Vioxx case also may foreshadow a new era in which editors of journals who publish problematic articles can expect to be hauled into court.

Merck prevailed in this particular federal jury trial. Is the journal editor ready to participate in future trials?

Forbes: On Feb. 17, 2006, a jury of five men and three women agreed that Vioxx did not cause the 2001 heart attack death of Richard "Dicky" Irvin, a 53-year-old manager of a St. Augustine, Fla.-based seafood distributor. The case was brought by his widow, Evelyn Irvin Plunkett. The case, which had previously ended in a hung jury in a Houston court, was heard by Judge Eldon Fallon in the U.S. District Court of the Easter District of Louisiana in New Orleans.

"This is a satisfying jury verdict for Merck," said Kenneth C. Frazier, senior vice president and general counsel of Merck in a prepared statement. "Juries in federal and state courts have now rejected unfounded theories about short-term use of Vioxx, and have decided the company acted responsibly in properly disclosing data to the FDA and the medical community."

Plaintiffs' lawyers said they would continue to press on with other cases. Beasley Allen's Andy Birchfield, who represented the Irvin family, said in a statement, "Unfortunately, the testimony by Dr. Gregory Curfman, editor of The New England Journal of Medicine, Dr. Eric Topol, and others was apparently not enough to convince the jury that Vioxx caused the death of Dicky Irvin." He added, "We are determined to go forward on behalf of other victims of Vioxx. Merck intends to fight each and every Vioxx lawsuit and so do we."

from AP on Feb. 10, 2006: The New England Journal of Medicine demanded changes before publishing results of the study that led Merck and Co. to pull the painkiller Vioxx from the market, and one of its top editors disputes the way the drugmaker is using it as a pillar of its legal defense in liability suits.

According to a court deposition of Executive Editor Gregory Curfman, the respected medical journal initially didn't accept the draft of the manuscript because it advanced the idea that Vioxx use was safe for up to 18 months. Curfman said he contested that claim.

Such editor-author discussions are commonplace, but this disagreement goes to the heart of Merck's defense: The company contends that a doubling of risks for heart attacks and strokes didn't show up until after 18 months among users of the pain medication, and that once those findings became known, the drug was immediately pulled from the market in September 2004.


from "in the pipeline" on Jan. 23, 2006:

Tuesday and Wednesday of this week are the days when Merck's attorneys are scheduled to question Dr. Gregory Curfman of the New England Journal of Medicine and another unnamed staffer. The journal's handling of the published Vioxx data (the VIGOR study) looks as if it could be a key part of the next trial, which will be in lawsuit-friendly Rio Grande City, Texas, with jury selection beginning this week. Note that the late plaintiff had taken Vioxx for all of seventeen days.

The Jan. 23 post references a Dec. 13 post:

Why did the New England Journal of Medicine come out with their "expression of concern" last Friday?

Then the first Federal case starts up, and the journal's editor is brought in to give a deposition. And now the editorial staff springs into action, rushing out an unprecedented comment on a paper from their own journal that manages to publish on a Friday afternoon. All of a sudden, somehow, things couldn't wait.

Could it be that the plaintiff's attorneys, while questioning Gregory Curfman, mentioned that there could be more targets for litigation than just Merck? You run a prestigious journal there. . .probably influenced a lot of physicians to prescribe Vioxx, eh? Didn't see anything odd in the cardiovascular data, you say? Why, that's nearly a tort right there. . . I don't like to think that this is what happened. But it's not impossible, either. The journal's actions look like those of an organization that fears the legal discovery process. And why would you fear that, unless you fear that you'll be sued?

from "in the pipeline" on Dec. 9, 2005:

You don't see many articles in the medical literature titled "Expression of Concern". But that's how yesterday's release from the New England Journal of Medicine starts out (PDF).

The editors are expressing their concern over the published VIGOR trial data from 2000. It turns out that some time ago, the journal's editors had found a disk which had been part of the submission of the paper, and it contained earlier versions of the manscript. These had a blank table for cardiovascular events, and in what looks like another example of the wonders of the "track editing changes" function, it appeared that the table had been deleted by Merck two days before the final version. The journal wasn't sure what to make of this, and kept quiet (for four years) until their editor, Dr. Gregory Curfman, went through a deposition during this latest trial. He then saw a complete version of the earlier manuscript, which seemed to show more adverse cardiovascular data than appears in the final published version. (Forbes is all over this story; check that link for the full details).

One comment-->
I think it is irresponsible for NEJM to come out with this. I would regard pre-press communications between journals and authors to be confidential, unless subpeoned. This SERIOUSLY undermines my faith in NEJM's ethics.

A different comment-->
There are any number of changes that a manuscript could go through prior to submission for any number of reasons. I've been known to put "fake" data into a manuscript in progress just as a placeholder to work out formatting, for example. Or to write in throw-away notes for sections I don't want to work on right away, such as "discuss BS paper by Smith et al. and why it's wrong". All of which could be greatly misconstrued by someone--especially someone with an agenda.

A different comment -->
I think it's perfectly legit to go delving into the documents you've been sent, particularly if questions of malfeasance are on the table. The Jan-Hendrik Schon scandal was definitively proven through such means. [IPBiz note: Huh?] I don't think the NEJM can be faulted for this. But...

[IPBiz note: Both the Schon and Hwang frauds were uncovered through the actions of INSIDERS contacting THIRD PARTIES.]

A different comment -->
In my view, the original NEJM article does everything possible to downplay the cardiovascular risk of Vioxx, short of lying. There's no table of cardiovascular risk data, only discussion in the text. Results are reported as reductions in MI due to Naproxen, not increases due to Vioxx. There's speculation that the results are due to the cardioprotective effects of Naproxen (unsupported at the time, and since debunked -- Naproxen may be somewhat cardioprotective, but not nearly enough to explain a 400% difference in MIs). Finally, there's the implication that the problem isn't Vioxx, it's that patients weren't taking aspirin. But aspirin isn't remotely protective enough to offset a 400% increase in risk. So, I'm not surprised that the NEJM editors feel like they've been misled.










[IPBiz post 1251]

Saturday, February 18, 2006

Another trademark war in Princeton?

Princeton University is going after the $539 billion "Princeton Portfolio Research & Management" fund because of confusion over the name "Princeton." Princeton's endowment is termed the Princeton University Investment Company.

There is an allegation that Robert Doll (related to the fund) said that the name "Princeton" "had positive connotations given the prestige of the university."

The article also alluded to the previous controversy over the name College of New Jersey. What is now Princeton was called The College of New Jersey from 1746 to 1896.

from NJBiz, Feb. 13, 2006, page 5.


On a more upbeat New Jersey note, information on the Duke Estate on Route 206 is available at www.princtoninfo.com/200602/60201c01.html.

[IPBiz post 1250]

Some points on Benjamin Franklin, the lightning rod, and kites

The first disclosure of the use of the lightning rod may have been in a letter by Franklin to the Royal Society in 1752, which letter was more directed to the use of the kite.

The Pennylvania Gazette of Oct. 19, 1752 mentioned the kite and also referred to Poor Richard's Almanack, which discussed the utility of the lightning rod.

Although there is discussion of widespread adoption of lightning rods, one notes that on July 2, 1768 (when a building at Harvard was destroyed by fire generated by lightning), there were no lightning rods at Harvard. In 1769, St. Paul's Cathedral in London attached a lightning rod, as did St. Mark's in Venic in 1775. Franklin may have installed a rod on his own home in Sept. 1752. Even though Franklin did not apply for a patent on the lightning rod, and thus the rod was free to all, adoption did not occur until after a patent lifetime from discovery.

Franklin had sent letters to the Royal Society PRIOR TO 1752: May 25, 1747, July 28, 1747, Dec. 14, 1749 (date of reading), and on July 29, 1750 (which proposed the sentry box experiment). Franklin had little luck at the Royal Society because of opposition by William Watson.

The performance of the sentry box experiment on May 10, 1752 in Marly, France launched Franklin. Tucker in his book points to the underlying political issue:

If you approach an institution with new electrical ideas, you don't go to its leading electrical authority. You go to the most powerful enemy of the leading electrical authority. [p. 122 of Tucker]

In execution, Tucker notes that Franklin arranged for Collinson to give a copy of Franklin's text on the sentry box to Buffon, an enemy of Watson, the leading electrical authority at the time.

This political reality is of relevance to the proposal of "peer review" of patent applications, made by, among others, Rebecca Eisenberg.

Of the invention by Franklin, Tucker states:


The tale of this invention, like that of a number of other inventions, is a document of hesitations, late adoptions, feuds, and, on occasions, unnerving lapses. Franklin himself wasn't that clear at first about what he had invented. At the start, he imagined that the lightning rod might drain away electricity from the clouds and prevent lightning strike. In 1752, Thomas Dalibard had claimed that a hundred lightning rods guarding Paris would disarm the thunderclouds of their bolts. (...) The lightning device was a prophylactic. [p. 188]

[Text from Tom Tucker, Benjamin Franklin and his Electric Kite Hoax, Public Affairs, 2003.]

Schatten cites Simerly paper in IDS on 27 Jan 06 in both parent and cip cases

In an interesting development in Hwang-gate, the patent attorney for Gerald Schatten/UPittsburgh/(Magee Womens?) filed an IDS docketed on January 27, 2006 in BOTH the parent and cip cases citing Simerly, Science Direct Dev. Biology, 276, 237-252 (2004). This text came out on Dec. 15, 2004, and includes the statement:

Protocol improvements include the following: enucleation just prior to metaphase-II arrest; extrusion rather than extraction of the meiotic spindle-chromosome complex (SCC); nuclear transfer by electrofusion with simultaneous cytoplast activation; and sequential media.

The interplay between the patent applications of Gerald Schatten and Woo Suk Hwang is destined to become very amusing. Among other things, the PTO and the courts will have to determine whether journal articles which have been retracted [as in the case of Hwang's 2004 and 2005 papers in the journal Science] are available for all they teach, or have become nullities. Separately, the fate of Hwang's patent applications seems up in the air, with SNU possibly seeking withdrawal although Hwang is not wishing withdrawal.

The cip case of Schatten seems to have a new title: "Chimeric Embryo Assays and Methods of Use." The preliminary amendment of November 4, 2005, which canceled claims 56-214 does suggest that these claims might be filed in later cases.

An IDS was filed in the cip case on 3/22/05 and includes numerous references, including Wilmut, 385 Nature 810 (1997) [The Dolly the Sheep paper]

For more on Schatten's cip, see
http://ipbiz.blogspot.com/2006/02/schattens-cip-application-published-on.html

As an aside, there is an IDS in the cip case on 2/28/05 which belongs to an entirely different case, that of Mark Farabee, Methods of Treating Subterranean Formations, filed 1-11-05.

Thursday, February 16, 2006

Kang Sung-geun states Schatten involved in Hwang-gate fraud

from english.chosun: Prosecutors say circumstantial evidence suggests that the disgraced cloning scientist Hwang Woo-suk's former collaborator Prof. Gerald Schatten was from the beginning involved in the faking of stem cell research. They said the University of Pittsburgh academic co-wrote a now discredited paper on patient-specific stem cells published last year although he knew that stem cell lines supposedly documented in the paper had become contaminated. The charge contradicts the U.S. university's own investigation, which cleared Schatten of any deliberate distortions.
Seoul Central District Prosecutors Office quoted a witness as saying Hwang told Schatten when they met at a seminar overseas in January last year that stem cells nos. 4 to 7 supposedly produced from cloned embryos had become contaminated. They said Schatten urged Hwang to go ahead with publication regardless since the stem cells had clearly been produced. The testimony came from Prof. Kang Sung-geun of Seoul National University, who attended the seminar with Hwang.

Prosecutors have e-mailed Schatten, who late last year publicly broke with Hwang, a 130-point questionnaire, asking among other things if he was aware of the stem cell contamination at the SNU lab, if he suggested publishing the paper despite it, and why he severed ties with Hwang.