Craig Venter - Wikipedia, the free encyclopedia - Sent Using Google Toolbar

Craig Venter - Wikipedia, the free encyclopedia

J. Craig Venter (born John Craig Venter October 14, 1946, Salt Lake City) is an American biologist and businessman.

Contents [hide] 1 Biography 1.1 Human Genome Project 1.2 Current work 2 Mycoplasma laboratorium 3 Further reading 4 See Also 5 References 6 External links

[edit] Biography

He was an ex surfer turned scientist and a Vietnam veteran. He began his academic career at a community college, College of San Mateo (California), after enlisting in the U.S. Navy and serving a tour of duty during the Vietnam War. On returning, he received his bachelor's degree in biochemistry in 1972, and his Ph.D. in physiology and pharmacology in 1975, both from the University of California, San Diego. In San Diego, he married former Ph.D. candidate, Barbara Rae. ^{[1] [2]} After working as a professor at the State University of New York at Buffalo, he joined the National Institutes of Health in 1984. In Buffalo, he divorced Dr. Rae-Venter and married his student, Claire M. Fraser, ^[3] and remained married to Ms. Fraser until 2005. ^[4]

While at NIH, Venter learned of a technique for rapidly identifying all of the mRNAs present in a cell, and began to use it to identify human brain genes. The short cDNA sequence fragments discovered by this method are called expressed sequence tags, or ESTs, a name coined by Anthony Kerlavage at The Institute for Genomic Research . In a controversial court case, Venter tried to patent these gene fragments and lost the case.

[ edit] Human Genome Project

He was the former president and founder of Celera Genomics, which became famous for running a parallel version of the Human Genome Project of its own for commercial purposes, using shotgun sequencing technology in 1999. The aim of the Celera project was to create a database of genomic data that users could subscribe to for a fee. This proved very unpopular in the genetics community and spurred several groups to redouble their efforts to produce the full sequence and release it as open access. DNA from 5 individuals was used by Celera to generate the sequence of the human genome; one of the 5 individuals used in this project was Venter. The Human Genome Project, which was composed of many groups from around the world, rendered the attempt to privatise the process unfeasible. ^[5] Venter was fired by Celera in early 2002 after it became clear that selling genome data would not become profitable and Venter resisted efforts by the company board to change the strategic direction of the company.

Despite their differing motivations, Venter and rival scientist Francis Collins of the National Institute of Health jointly made the announcement of the mapping of the human genome in 2000, along with US President Bill Clinton. ^[6] Venter and Collins thus shared an award for "Biography of the Year" from A&E Network. ^[7]

[edit ] Current work

Venter founded The Institute for Genomic Research (TIGR) in 1992. He is currently the president of the J. Craig Venter Institute, created and funded by TIGR's board (which Venter chairs). In June of 2005, he co-founded Synthetic Genomics, a firm dedicated to using modified microorganisms to produce ethanol and hydrogen as alternative fuels. He used his sloop, Sorcerer II, in the Global Ocean Sampling Expedition to help assess genetic diversity in marine microbial communities. ^[8]

Venter has been the subject of articles in several magazines, notably Wired, ^[9] The Economist, ^[10] Australian science magazine Cosmos ^{[citation needed]} and Atlantic Monthly. ^[11] Additionally, he was featured on The Colbert Report on February 27, 2007.

Venter appeared in the "Evolution" episode of the documentary television series Understanding .

On May 10th, 2007, Venter was awarded an honorary doctorate from Arizona State University. ^[12] He was on the 2007 Time 100 most influential people in the world list made by Time magazine.

On September 4th, 2007, a team led by Craig Venter, published his complete diploid DNA sequence ^[13], unveiling the six-billion-letter genome of a single individual for the first time.

[ edit] Mycoplasma laboratorium

Venter is seeking to patent the first life-form created by man, possibly to be named Mycoplasma laboratorium. ^[14] There is speculation that this bacterium may someday produce fuel. ^[15]

[edit ] Further reading

• Ridley, M Genome, ISBN 0-06-089408-3
• Shreeve, J The Genome War, ISBN 0-375-40629-8
• Spufford, F Backroom Boys, ISBN 0-571-21497-5
• Sulston, J & Ferry, G The Common Thread, ISBN 0-309-08409-1

[edit] See Also

• Craig Venter's Genome

[edit] References

1. ^ http://www.rae-venterlaw.com/who.htm
2. ^ http://www.smh.com.au/news/science/the-god-of-small-things/2007/01/25/1169594430068.html?page=fullpage
3. ^ http://www.smh.com.au/news/science/the-god-of-small-things/2007/01/25/1169594430068.html?page=fullpage
4. ^ High-profile departure ends genome institute's charmed run, M. Wadman, Nature Medicine 13, 518 (2007).
5. ^ Spufford, Francis [2003]. Backroom Boys. Faber.  
6. ^ Jamie Shreeve, " The Blueprint of Life," U.S. News and World Report , 10/31/05, URL accessed 30 January 2007.
7. ^ " Montgomery County, Maryland, Press Releases," December 19, 2000, URL accessed 30 January 2007.
8. ^ Larkman, Kirell. " Yacht for Sale: Suited for Sailing, Surfing, and Seaborne Metagenomics", GenomeWeb.com, GenomeWeb News, September 7 2007. Retrieved on 2007- 09-07.  
9. ^ Shreeve, James. " Craig Venter's Epic Voyage to Redefine the Origin of the Species," Wired, August 2004. Accessed June 7, 2007.
10. ^ "The Journey of the Sorcerer", The Economist, Dec 4, 2004.
11. ^ Douthat, Ross. "The God of Small Things," Atlantic Monthly, Jan/Feb 2007.
12. ^ Aufrett, Sarah. " ASU Celebrates Spring Graduates," ASU Insight, May 11, 2007. Accessed June 7, 2007.
13. ^ Levy S, Sutton G, Ng PC, Feuk L, Halpern AL, et al. (2007). "The Diploid Genome Sequence of an Individual Human". PLoS Biology 5 (10).  
14. ^ http://www.post-gazette.com/pg/05180/530330.stm
15. ^ http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/06/08/nbiofuel108.xml

[edit ] External links

Wikinews has related news:

US scientist says he created first 'artificial life form'

• J. Craig Venter Institute
• Sorcerer II Expedition
• Synthetic Genomics
• The Institute for Genomic Research (TIGR)
• Radio interview on Philosophy Talk
• Cracking the code to life

Patent Docs: Federal Circuit Issues Patent Law Malpractice Decisions - Sent Using Google Toolbar

Patent Docs: Federal Circuit Issues Patent Law Malpractice Decisions

Federal Circuit Issues Patent Law Malpractice Decisions

    By Kevin E. Noonan --

Malpractice is an ugly word.  But patent practitioners may take some comfort in two precedential decisions today from the Federal Circuit, holding that allegations of malpractice in patent prosecution "arise under" patent law and thus provide subject matter jurisdiction in Federal Court under 28 U.S.C. § 1338.

The first of these cases, Air Measurement Tech., Inc. v. Akin Gump Strauss Hauer & Feld, L.L.P., was an appeal from the interlocutory decision of the U.S. District Court for the Western District of Texas denying plaintiffs' motion to remand the case to state court, on the grounds that the court did not have subject matter jurisdiction on the malpractice cause of action for non-diverse parties.  The malpractice claim alleged that counsel "(1) failed to file the initial patent application within the one year 'on sale bar' of 35 U.S.C. § 102(b); (2) failed to disclose two prior patents and other facts during the prosecution of the patent applications; (3) failed to file in a timely fashion the application that resulted in the '771 patent, which contains the broadest claims to the invention; (4) miscalculated the settlement damages in [a] . . . prior litigation; (5) failed to inform AMT of his mistakes despite his fiduciary duty to do so; (6) failed to inform AMT adequately of the existence of the prior litigant's defenses of on sale bar and inequitable conduct; and (7) made misrepresentations to AMT."  As a consequence, AMT claimed it was forced to settle several malpractice lawsuits for much less than the patents would have been worth "but for" counsel's malpractice.  The claim was originally filed in Texas state court, and had been transferred to federal court on defendants' motion, and the court earlier denied plaintiff's motion to remand on the grounds that "in order to prevail, AMT 'must establish that their infringement claims were otherwise valid, but that Hamilton's negligence afforded the patent defendants certain defenses under patent law.'"  Now, the parties had changed their positions, and the court's denial of defendants' motion for remand to state court was the subject of this appeal.

The Federal Circuit affirmed the District Court's denial of defendants' remand motion in an opinion written by Chief Judge Michel and joined by Judges Lourie and Rader; in doing so, the CAFC asserted that this was a question of first impression.  In his analysis, Judge Michel applied the two-part test recited by the Supreme Court in Christianson v. Colt Indus. Operating Corp., 486 U.S. 800 (1988).  According to the Federal Circuit, "Section 1338 jurisdiction extends to any case 'in which a well-pleaded complaint establishes either that federal patent law creates the cause of action or that the plaintiff's right to relief necessarily depends on resolution of a substantial question of federal patent law, in that patent law is a necessary element of one of the well-pleaded claims.'"  Under the Federal Circuit's analysis, the question is whether patent law is a "necessary element" of the plaintiff's malpractice claim.  Reviewing the complaint, the CAFC found that seven allegations of error constituting malpractice concerned patent prosecution or litigation.  Moreover, in order to prevail, the plaintiffs would have to establish that they would have prevailed on the earlier infringement lawsuits "but for" counsel's malpractice.  Thus, the District Court would have to, "hypothetically," adjudicate the infringement claim on the merits.  Thus, patent law comprised a "necessary element" of the malpractice claim.  On this record, the Federal Circuit found that the malpractice claim "arose under" patent law, and thus provided federal question jurisdiction under 28 U.S.C. § 1338.  Accordingly, the CAFC affirmed denial of defendants' removal motion.

In the second of these cases, Immunocept, LLC v. Fulbright & Jaworski LLP, the plaintiff appealed a decision of the U.S. District Court for the Western District of Texas on summary judgment that the malpractice claim was barred by the statute of limitations and the claim for damages was too speculative to be recovered under state law.  The panel raised sua sponte the question of whether jurisdiction over the malpractice claim (which is clearly a state law matter) could be considered as "arising under" patent law when patent prosecution was basis of the claim.  The facts of the case are as follows.  The invention involved large pore hemofiltration ("LPHF") technology for treating a number of diseases and disorders, including sepsis, shock, acute renal failure, multiple organ system failure, and systemic inflammatory response syndrome-related diseases.  Fulbright and Jaworski was retained to prepare the patent application, which was granted as U.S. Patent No. 5,571,418 on November 5, 1996, Immunocept LLC being named assignee of this patent.  Claim 1 of the '418 patent reads as follows:

A method of treating a pathophysiological state caused by a toxic mediator-related disease consisting of hemofiltering blood with a filter, wherein said filter has a molecular weight exclusion limit of 100,000 to 150,000 Daltons and allows for passage of molecules with a molecular weight of about 70,000 Daltons in the presence of whole blood.

Importantly, the transitional phrase "consisting of" was added by amendment during prosecution.  Immunocept hired another attorney to pursue additional applications while Immunocept pursued licensing opportunities.  These efforts were fruitless, however, since the potential licensees assessed the '418 patent claims to provide insufficient protection based on the closed claim language "consisting of."  Immunocept's malpractice claim was based on this limitation of the '418's claims.  However, the District Court found that the claim was time-barred by the Texas statute of limitations and that Immunocept's damages claim was too speculative.

The Federal Circuit affirmed in an opinion written by Chief Judge Michel and joined by Judges Lourie and Rader.  More important to patent practitioners than the Federal Circuit's decision on the substantive question presented was its determination that the malpractice claim was one "arising under" U.S. patent law and thus within its (and federal District Courts') jurisdiction.  The Federal Circuit analyzed federal court jurisdiction under the two-part test enunciated by the Supreme Court in Grable & Sons Metal Prods., Inc. v. Darue Eng'g & Mfg. , 545 U.S. 308 (2005).  As stated by the Federal Circuit, the test requires that "a state-law claim necessarily raise[s] a stated federal issue, actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities."  Id. at 314.  The malpractice claim, a tort, requires under Texas law proof of "proof of duty, breach, causation, and damages."  In this case, the basis for the malpractice claim was solely that the patent attorney improperly narrowed the scope of the '418 claims and thus that the patent was unable to be licensed for value.  Thus, according to the Federal Circuit, claim drafting and the question of claim scope were necessary elements of the cause of action.  Since claim scope defines the scope of patent protection, the court considered it to be "surely" a substantial question of patent law, citing Johnson & Johnston Assocs. v. R.E. Serv. Co. , 285 F.3d 1046 (Fed. Cir. 2002) (en banc).  The panel also cited Air Measurement Techs. in support of their decision.  The Federal Circuit further justified this outcome on the grounds that "[l]itigants will benefit from federal judges who are used to handling these complicated rules [of claim construction]" and that jurisdiction was consistent with Congressional intent to harmonize U.S. patent law when it enacted the Federal Courts Improvement Act of 1982 (Pub. L. No. 97-164, 96 Stat. 25) that established the Federal Circuit.

Air Measurement Tech., Inc. v. Akin Gump Strauss Hauer & Feld, L.L.P. (Fed. Cir. 2007)
Panel: Chief Judge Michel and Circuit Judges Lourie and Rader
Opinion by Chief Judge Michel

Immunocept, LLC v. Fulbright & Jaworski LLP (Fed. Cir. 2007)
Panel: Chief Judge Michel and Circuit Judges Lourie and Rader
Opinion by Chief Judge Michel

Additional information regarding these cases can be found at Patently-O .

Posted at 10:42 PM in Articles & Cases: Miscellaneous | Permalin

Inside College Sports' Biggest Money Machine - WSJ.com - Sent Using Google Toolbar

Inside College Sports' Biggest Money Machine - WSJ.com

Inside College Sports' Biggest Money Machine

What do you get for $109 million a year? Jon Weinbach on Ohio State's record-breaking budget.

By JON WEINBACH
October 19, 2007; Page W1

At $109,382,222 for the current year, Ohio State's athletic budget is the largest in the nation and the biggest in the history of college sports. It allows the school to field 36 varsity teams in everything from baseball and soccer to riflery and synchronized swimming. The school spends about $110,000 on each of its 980 athletes, which is triple the amount the university spends per undergraduate on education.

VIEW FROM THE TOP

 

• BY THE NUMBERS: Athletic budgets of college football's top-10 schools. Interactive Chart

• SMALL SPENDERS: Q&A with the CFO of athletics at No. 2-ranked University of South Florida.

The budget for this academic year allots $65,000 in private jet time, or roughly 11 hours, to men's basketball coach Thad Matta for recruiting trips over 200 miles -- and a further 15 hours of jet time for the coach's personal travel. A just-completed $19.5 million renovation of the football team's practice facility, funded with a large donation from Limited Brands Chief Executive Leslie Wexner, added a players-only entrance, a lounge that has six flat-panel TVs, three videogame systems and a juice bar. "There's always a race to get up there after practice," says Jake Ballard, a sophomore tight end for the football team that enters this weekend ranked No. 1 in the country.

The men's and women's ice-hockey teams train on a $75,000 hockey treadmill that features a lubricated, ice-like surface that tilts at sharp angles and goes as fast as 16 miles per hour. Men's hockey coach John Markell solicited a donor to buy the equipment, which he says has become a key part of players' workouts. It's a machine most college teams -- and even many National Hockey League clubs -- haven't purchased. "We don't have the space or resources for that," says a spokesman for the Anaheim Ducks, last season's Stanley Cup champions.

Here in Columbus, the OSU athletic department is a gold-plated island in a region getting roiled by harsh economic forces. The lavish program is the most vivid example of how college sports have turned into a humongous business and created a parallel universe of high-living in the world of academia. OSU's athletic budget, which has grown 46% in five years, has expanded despite a prolonged downturn in the Ohio economy and several rounds of public-funding cuts to higher education. The state's median household income fell 9.3% between 2000 and 2005, one of the worst declines for any state during that span.

Foreclosures and Poverty

Buckeyes head coach Jim Tressel with Tyler Whaley

Ohio has the nation's highest rates for foreclosures and delinquent mortgages, and during the second quarter of 2007, 22.9% of Ohio homeowners with subprime loans were over 90 days late -- almost twice the national average, according to the Mortgage Bankers Association in Washington, D.C. The state is home to two of the five poorest cities in America -- Cleveland and Cincinnati, both of which had more than 25% of residents living below the poverty line in 2006, according to the U.S. Census Bureau. Ohio has been ravaged by the struggling U.S. auto industry and the forces of globalization. From 2000 to 2006, the state lost about 200,000 manufacturing jobs and added just 40,000 new positions to offset the decline. Companies such as Mr. Coffee, Rubbermaid and Hoover closed plants and shifted production abroad.

From 2002 to 2005, the Ohio Legislature decreased annual support for the state's universities. In response, OSU instituted its highest annual tuition increases in nearly 40 years, boosting rates nearly 60% from 2002 to 2006.

Ohio State was one of just 19 schools to turn a profit on athletics in 2006, according to data collected by the NCAA. OSU says its athletic department is self-sufficient -- it uses sports revenues to pay for its teams and operations. It doesn't draw from the same budget that's used to fund academic departments. How much the athletic department spends is determined by how much it brings in, not by how much the university decides to give it. A 2005 economic-impact study, commissioned by OSU, estimated that the school's sports program pumps over $100 million a year into the local economy, with more than a third coming from Buckeyes fans' spending on hotels, food, parking and shopping.

At right, Ohio State cheerleading

In a sports-mad country, why Columbus? The alma mater of track star Jesse Owens, golfer Jack Nicklaus and basketball Hall of Famer John Havlicek, Ohio State has a long history of passionately supporting its athletes. OSU's teams are the premier sports attraction in Columbus, Ohio's state capital and biggest city, and the school has the largest enrollment in the country, with more than 52,000 students. TV broadcasts of OSU games routinely attract 60% of all local viewers, and in Columbus, the OSU football coach's Sunday-morning chat show gets better ratings than "Meet the Press."

Supporting the program is seen as a civic virtue. Over the past five years, giving to the Buckeye Club has increased an average of 12%. The booster club's membership of nearly 3,700 is up 32% from 2003. In addition to Mr. Wexner, a 1959 OSU graduate, prominent donors include Robert Schottenstein, CEO of M/I Homes Inc., one of the country's largest home builders.

The enormous financial rewards for successful programs have fueled an arms race among schools to build larger, more lavish venues that can ring up millions from luxury suites and sponsors. Over the past five years, schools in the NCAA's top six sports conferences raised more than $3.9 billion for new sports facilities, according to the Chronicle of Higher Education.

At Oklahoma State, oil and hedge-fund mogul T. Boone Pickens gave $30 million to renovate the football stadium, and put his name on it. He has also committed $165 million more to build an "athletics village" on campus. Nike founder Phil Knight recently donated $100 million to Oregon's athletic department, which plans to use the money as a safety net to cover potential operating losses. The department still plans to ask for public funds to build a $200 million basketball arena.

Other big spenders include the University of Texas-Austin, which has the nation's second largest sports budget at $107.6 million, although it fields 16 fewer teams than Ohio State. Last year, the Longhorns' athletic department paid $152,585 for nutritional supplements like Gatorade and PowerBars.

Preserving 'Opportunities'

The football and men's basketball programs at OSU are the only sports there that turn a profit -- and their revenues support teams other universities have eliminated for lack of funding. "We never want to get into the business of taking opportunities away from students," says Gene Smith, OSU's athletic director.

Ohio State's synchronized swimming team

Ohio State's varsity synchronized swimming team competes in a two-year-old, $20 million facility, nicknamed the "Taj Mahal," that features seven bodies of water and two whirlpools for athletes to relax in during competitions. A multimillion-dollar renovation of the school's "Scarlet" golf course, completed last year and overseen by Mr. Nicklaus, added a short-game practice area and enlarged the course to over 7,400 yards.

OSU's pistol team maintains a supply of about 30 firearms for the team's 11 members, and all shooters receive an array of free Nike gear, including polo shirts, a jacket and shoes. "We're a good-looking team," says James Sweeney, OSU's pistol coach since 1999. This year, for the first time ever, OSU's rifle and pistol teams received scholarship money to recruit top competitors.

At other schools, there is a more Darwinian approach to smaller sports. Last year, Rutgers cited budget shortfalls for its decision to cancel six sports, including swimming, men's tennis and fencing. But the athletic department still gave assistant football coaches a sizable raise, completed a $12.5 million renovation of football's training complex, and is in the midst of a stadium renovation that will add nearly 10,000 seats.

At Ohio State, "nonrevenue" sports such as men's lacrosse and women's track don't have to worry about earning their funding. Excluding football and basketball, OSU's other 34 teams generate about $1.5 million in revenue. Last year, for example, expenses for the women's hockey team totaled a little over $1.2 million while the sport brought in just $1,642, all of it from arena concessions. Many sports, including rifle, pistol, and women's fencing, don't contribute any revenue at all. "I'm sure my scholarship is possible because of the football team," says Lindsay Quintiliani, a sophomore goalie on the field hockey team.

Hockey-team winger John Dingle trains on a specialized treadmill

Last season, Ohio State's football program generated about $57 million in revenue. The sum included a $4.75 million payment from the NCAA for advancing to the national championship game and $31.65 million in ticket sales from home games at Ohio State's 105,000-seat stadium. Team expenses, which include nearly $2 million for meals and travel, as well as debt payments to cover stadium renovations, subtracted about $21 million. Still, football supplied nearly $36 million in profit to the athletic department's coffers. The University of Florida, which beat OSU for the national championship in January, made about $34 million on football last year.)

OSU's men's basketball team, which moved into a new, 19,500-seat arena in 1998, advanced to last year's national championship game and turned a record $9 million profit.

A significant chunk of the athletic department's budget is spent in ways that benefit the school's general fund. This year, the athletic department will spend $12 million on scholarships or "Grant-in-Aid" to pay for athletes' tuitions. A few years ago, the department contributed $5 million to help fund renovations to the campus's main library. OSU's sports program is also among the few that pays for all maintenance, security and operating costs at its facilities. (The utilities bill at the football stadium last year: $731,309.) In addition, the athletic department transfers about $1.7 million to the school's academic-support center to pay for tutors and "life skills" workshops for athletes. "I think we're paying somebody $25 an hour to tutor physics," says Mr. Smith.

Last year, the issue of swelling athletic-department budgets was taken up in Washington by the House Ways and Means Committee and the Senate Finance Committee. In a strongly worded letter to NCAA President Myles Brand, former Ways and Means Committee Chairman Bill Thomas criticized "highly paid coaches with no academic duties," and wrote that Division I football and men's basketball "more closely resemble professional sports than amateur sports."

Judy Bunting oversees OSU's 46 cheerleaders and four student mascots. Her team gets about $169,000 from the athletic department, and supplements it with interest income from a special endowment established by a donor a few years go. "We probably have more scholarship money than most," says Ms. Bunting. In contrast to the spirit squads at Notre Dame and UCLA, OSU's cheerleaders get seats on the football's team's chartered jets. "That's a big plus," she says. "We used to drive vans and fly commercial."

Write to Jon Weinbach at jonathan.weinbach@wsj.com

PLI - Patent Blog - Sent Using Google Toolbar

PLI - Patent Blog

Unequal Treatment Under Rules for Those Similarly Situated

19 October 2007

 

By Gene Quinn, Patent Attorney & PLI Blog Editor

---

While the comment below asks "what if" the temporary flagging and removal from an examiner's docket caused problems that could affect  one applicant who has a similar or overlapping technology, while not affecting the other.  While this certainly could be a problem, what if competitor 1 receives a first office action on the merits before November 1, 2007, thereby not needing to comply with the new claims and Examination Support Document rules, and the other competitor does not receive such an action before November 1, 2007? 

It seems to me that this would a situation where similarly situated persons are being treated differently under the law.  I refuse to believe that a different filing date by a few days or administrative delay could legitimately be argued to make the applicants not similarly situationed.   This would certainly raises fairness issues and maybe even constitutional questions associated with equal protection.  I won't say that this is an equal protection problem for certain, Constitutional Law was a long time ago and since then I have quite willingly limited my knowledge of the Constitution to the Intellectual Property Clause, the Bill of Rights, and in the repeal of prohibition, but that one is a different story, for another time.

What follows below comes straight from an Anonymous poster to this blog.  I wanted to make sure to highlight this comment with its own post because  I think it very well illustrates the arbitrary and capricious aspects of these new rules.  Everyone is going to be affected by these new rules!  I think the trouble with getting any kind of grass roots movement here is that no one will know for sure whether they have received the short end of the stick until well after the November 1, 2007 effective date.  That should not mean that you sit this round out.  It should mean that we all have a clear and vested interest that can be easily understood and articulated.

Michigan forms biotech caucus - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News - Sent Using Google Toolbar

Michigan forms biotech caucus - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

Michigan forms biotech caucus

October 19, 2007

By Maureen Martino

Tags Michigan   Economic development   biotechnology   Biotech news   biotech news  

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In cooperation with MichBio--Michigan's life sciences association--a group of Michigan legislators are forming a biotechnology legislative caucus in an effort to get state's political leaders to take the industry more seriously. They hope the caucus will give the industry a way to communicate more effectively with politicians. While Michigan's biotech industry isn't as robust as say, California's or Boston's, the state has made great strides in recent years to attract drug developers.

James Greenwood, president and CEO of BIO, said that Michigan has a promising future in biotech and that it should continue investing in the industry whether or not its profitable right now. "The reason that Michigan should invest in life sciences is because it is undoubtedly where the future is going," Greenwood said. "There is nothing people value more than the health and the health of their loved ones. People will pay for that. Society will pay for that."

- read this report for more

Related Article:
Pfizer pares down Ann Arbor campus. Report

Patent Docs: Will Compliance with the New Rules Be Enforced by the Patent Office through the Office of Enrollment and Discipline? - Sent Using Google Toolbar

Patent Docs: Will Compliance with the New Rules Be Enforced by the Patent Office through the Office of Enrollment and Discipline?

Will Compliance with the New Rules Be Enforced by the Patent Office through the Office of Enrollment and Discipline?

    By Kevin E. Noonan --

The Patent Office has met the enemy, and it is the patent bar.  This has been evident since the original Notice of Proposed Rulemaking with regard to the continuation and claims limitations rules, where the Office blamed the bar for the proliferation of continuation applications and alleged prolixity of claiming.  According to the Office, patent attorneys are routinely guilty of incompetence, malfeasance, or misfeasance in representing their clients before the Office, and many if not all of the current Patent Office administration's management problems would be solved if the bar would join the Office in a partnership to improve patent pendency and quality (to paraphrase the upbeat portion of Commissioner Doll's stump speech).  Unfortunately for the bar, "partnering" means just following orders, a definition typical of the current administration's views.

Just in case the bar hasn't appreciated the message, the Office sent Harry Moatz (at left), Director of the Office of Enrollment and Discipline (OED), to reinforce the message at a recent Intellectual Property Owners (IPO) meeting in New York.  In only the second slide of his presentation, Mr. Moatz reminds us that the Office has the capacity to discipline registered practitioners who do not "comply with the regulations promulgated under [the Office's rulemaking authority]."  In particular, this applies to the new rules published on August 21st and going into effect on November 1st.  Specifically, the OED is "considering" attorney conduct with regard to the duty to make a reasonable inquiry and the obligation to avoid submitting papers "for improper purpose or delay."  The Office will be monitoring compliance to detect any violations of these duties, as well as attorney "incompetence or neglect."

Mr. Moatz cited 37 C.F.R. § 10.18(b) as requiring that an attorney fulfill a duty to make an inquiry "reasonable under the circumstances" to avoid submitting papers for an "improper purpose" or delay.  This duty, as understood by the Office, includes an affirmative duty that an attorney read every paper submitted to the Office.  While on its face not an unreasonable requirement, in practice this duty applies to each and every prior art reference submitted in compliance with Rule 56.  Mr. Moatz affirmatively stated that this rule applied to each paper submitted to the Office regardless of its source, and that the paper must be read "in its entirety."  (This raises an interesting dilemma if a foreign patent office cites a reference that is not relevant to U.S. prosecution, such as a reference that is not prior art in the U.S. due to the one-year grace period.  If an attorney submits this reference in an Information Disclosure Statement, is it for an "improper purpose"?)  Moreover, while imposing the requirement that an attorney review a reference for its materiality, the need to perform this analysis does not excuse delay in submitting the reference; this requirement certainly appears to set up a classic Catch-22 situation.

A close reading of the rule indicates that this does not appear to be its purpose:  37 C.F.R. § 10.18(b)(1) states that submitting a paper certifies that any statement made therein does not "cover up" a material fact "by any trick, scheme or device," and 37 C.F.R. § 10.18(b)(2) imposes a duty to make reasonable inquiry that the paper is not filed for any "improper purpose."  The Office is interpreting these requirements to have the same attributes as Rule 11 of the Federal Rules of Civil Procedure, without any apparent justification (and in view of the differences between ex parte prosecution and inter partes litigation, without any logical underpinnings).  The Office clearly intends to apply these rules to require a prefiling inquiry, although the Office concedes that time constraints might demand that an application be filed before completion of the reasonable inquiry, resulting in a duty to file documents or amendments to comply.  Of course, this requirement may be in conflict with the well-established principle that an applicant (or his or her counsel) is under no obligation to perform a prefiling search (which could qualify as a "reasonable inquiry").

Mr. Moatz provided a number of examples of conduct that might run afoul of the Office's ethical rules.  These include:

• filing a reference material to patentability "buried among a large number of cumulative references, where the buried reference anticipates one or more claims;" under these circumstances there cannot have been a "reasonable inquiry";
• filing an application with claims that are anticipated by at least one publication authored by one of the inventors;
• adding an "undue" number of claims with multiple dependent claims (where the fact that multiple dependencies can involve "thousands of claims" appears to be sufficient to establish that there could have been no reasonable inquiry); and
• filing a paper without the required fee, due to insufficient funds or stopped payment.

There are certainly ways in which the Office could apply these rules reasonably to stem actual abuses; however, the timing of this message from the Office does not suggest that reasonableness will be the watchword.

Mr. Moatz's presentation also contained a discussion of inequitable conduct.  Again, the presentation emphasized an attorney's continuing duty to make a reasonable inquiry.  The presentation cited Brasseler, U.S.A. LLP v. Styker Sales Corp., 267 F.3d 1370 (Fed. Cir. 2001) in this regard, a case where the CAFC characterized attorney conduct as constituting a "studied refusal to timely investigate" and failure to disclose material information.  This requirement is illustrated by the following scenario:

• A first practitioner advises applicant that prior art is material to patentability of the claimed invention and must be disclosed to the USPTO.
• The applicant refuses to follow this course of action and discharges the first practitioner.
• The applicant engages a second practitioner without telling the second practitioner of the potentially damaging prior art.
• Under § 10.85(b), the first practitioner would be required to disclose this situation to the Office.

(see Practice Before the Patent and Trademark Office, Final Rule 50, FR 5158, 5165 (Feb 8, 1985)).  While not unreasonable on its face, this example raises questions about the extent to which the first practitioner "knows" the applicant has filed the application without disclosing the "potentially damaging" prior art.  Is mere publication of an application enough, or does the rule require actual knowledge?  Does the duty of reasonable inquiry apply in this instance as well, where the first practitioner does not represent the applicant and is not involved in (and may have no reason to know about) filing or prosecution of the improper filing by the second practitioner?  The presentation does not make this clear, and application of the rule is thus fraught with undefined interpretations of the meaning of the "reasonable inquiry" requirement.

There is a perverse beauty to Mr. Moatz's message.  The Office is not proposing any new rules; indeed, Mr. Moatz reminded his listeners that these rules were promulgated in 1997.  This warning from the Office merely threatens to apply the existing rules of conduct to force compliance inter alia with the new procedural rules.  The possibility exists that these rules of conduct will be applied fairly and that discipline will be applied only to those practitioners who affirmatively break the Office's ethical rules or practice fraudulently in violation of their duties.  However, the timing and emphasis of Mr. Moatz's presentation suggests otherwise.  Under these circumstances, the only thing that is certain is that the members of the patent bar have been warned.

For additional information regarding specific provisions of the New Rules, please see:

Predictive Biosciences: A Small Startup With a Big Pedigree is Out to Personalize Cancer Care | Xconomy - Sent Using Google Toolbar

Predictive Biosciences: A Small Startup With a Big Pedigree is Out to Personalize Cancer Care | Xconomy

Predictive Biosciences: A Small Startup With a Big Pedigree is Out to Personalize Cancer Care

Malorye Allison 10/19/07

It's got advisors like Bob Langer and Judah Folkman, a particularly innovative strategy, and more than 15 years of research behind it. But Lexington, MA-based Predictive Biosciences is starting out by trying to be as small as it possibly can be.

With just $10 million in initial financing, and that all tied to strict milestones, the diagnostic startup "is operating on a staffing model of less than a dozen employees," said Eugene Chiu, the firm's co-founder and VP of business development. Chiu was speaking at Genomic Health Strategies' Personalized Medicine meeting last week, where he, Predictive co-founder Marsha Moses, and venture capitalist Michael Greeley served on a panel that detailed the genesis of this little company, its strategy, and why they have such high hopes for it. It was a cozy little meeting with lots of insiders, more like a think tank in some ways. The presentation on Predictive was meant to show one model for a personalized medicine company. (Predictive plays in the personalized medicine space in the sense that its tests could facilitate more individualized treatment of cancer.)

To be more specific, Predictive Biosciences is developing tests to detect cancer from urine samples, thereby sparing patients the usual diagnostic discomforts. The company, which was founded in 2006, grew out of work that Moses did as a post-doc in Langer's MIT lab in 1989-90 studying what makes cancers grow and spread. (Langer, an Xconomist, is a member of Predictive's board.) Moses and Bruce Zetter, another co-founder, now both have labs at Children's Hospital Boston within the vascular biology program, which Folkman, a member of Predictive's scientific advisory board, directs. Today, Moses also leads the Urinary Proteomics Initiative at Children's Hospital. There, she's helped to build "the largest urine bank in the world," she said.

Having all that pee on hand and all those years of research under their belts has helped the Predictive team identify a new set of biomarkers, or telltale molecules, that are shed into the urine by a range of cancers, including biggies like breast and colon tumors. And while most screening tools for cancer are pretty poor—they raise a lot of false alarms, miss many cancers, and often generate a lot of confusion—Predictive is working on using the biomarkers it has discovered to produce tests that yield "actionable results," according to Chiu.

Predictive's first target market is cancer survivors. After being treated for cancer, people typically undergo a series of painful procedures, such as biopsies or invasive exams, to see if they are cancer-free. Bladder cancer patients, for example, "have 13 to 15 cystoscopies over five years. One every three months at first," Chiu said. A cystoscopy is a really uncomfortable procedure where a tube has to be slipped into the bladder.

Using Predictive Biosciences' tests, doctors could ostensibly weed out the patients who really need those cystoscopies from those who don't, thereby "personalizing" their follow up. Once the test for bladder cancer is validated, the company hopes to go on to develop tests to predict recurrence of breast, colon, and other cancers. Eventually, such tests could also be used for screening healthy patients. Predictive is aiming to get its first product to market within two years. The company is also designing clinical management tools to help doctors plan follow-up for patients depending on test results.

All in all, Predictive has novel idea and has put a lot of work behind it. So why so much fiscal caution?

Well, many investors see diagnostics as a perennially low-margin business that cannot reap anything close to the rewards seen with pharmaceutical ventures. "Everyone was trying to talk us out of investing in a diagnostics company," said Greeley, a general partner at IDG Ventures, one of the two firms that put up the initial capital for Predictive. Highland Capital is Predictive's other investor.

Greeley and his colleagues saw another angle to it. For one thing, "We think 'value pricing' is on the horizon," he said. In other words, as health-care costs continue to skyrocket, a growing number of pundits think diagnostics will become more important as a way to cut costs, enabling diagnostics companies, paradoxically, to garner higher prices. Still, the VCs admit they are uncertain about how big the market will really be. A lot depends on how many tests Predictive can churn out.

In a hotbed of entrepreneurial activity like Boston, the decision to form the company may actually seem overdue, but Moses points to a convergence of factors that finally pushed her into start-up mode. "There was growing interest in biomarkers," she said, and there's been huge improvements in the company's technology platform, called proteomics. These tools can now accurately analyze samples to detect even tiny levels of proteins, including the biomarkers in which Predictive is interested.

Predictive's approach has also gotten a vote of confidence of sorts from the public. "Every time our papers come out in the press," says Moses, "we are inundated with unsolicited urine samples from people who 'get it.'"

Patent Docs: DNA Non-obviousness under Ex parte Kubin (It Gets Worse) - Sent Using Google Toolbar

Patent Docs: DNA Non-obviousness under Ex parte Kubin (It Gets Worse)

DNA Non-obviousness under Ex parte Kubin (It Gets Worse)

    By Kevin E. Noonan --

Last week, the U.S. Patent and Trademark Office promulgated its long-awaited guidelines for Examiners in making obviousness determinations in view of the U.S. Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc. (see "Patent Office Issues Examination Guidelines Regarding Obviousness after KSR").

As part of these guidelines, the Office provided various rationales available to Examiners to fulfill KSR's requirement that the factfinder provide a reasoned basis for an obviousness determination.  One such rationale dealt with the "obvious to try" issue, as discussed by the Supreme Court in KSR:

When there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

The guidelines with regard to the "obvious to try" standard are set forth in Rationale E:

(E) ''Obvious to try'' - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;

(1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;

(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;

(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and

(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

Citing KSR, the Notice requires for this rationale that an Examiner articulate facts supporting the conclusion that ''a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."

The issue for biotechnology arises in Example 3 illustrating how an Examiner should apply this rationale; that Examiner relates to the Board's decision in Ex parte Kubin (see Patent Docs post on this case):

Example 3:  The claimed invention in Ex parte Kubin, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007), was an isolated nucleic acid molecule.  The claim stated that the nucleic acid encoded a particular polypeptide.  The encoded polypeptide was identified in the claim by its partially specified sequence, and by its ability to bind to a specified protein.

A prior art patent to Valiante taught the polypeptide encoded by the claimed nucleic acid, but did not disclose either the sequence of the polypeptide, or the claimed isolated nucleic acid molecule.  However, Valiante did disclose that by employing conventional methods, such as those disclosed by a prior art laboratory manual by Sambrook, the sequence of the polypeptide could be determined, and the nucleic acid molecule could be isolated.  In view of Valiante's  disclosure of the polypeptide, and of routine prior art methods for sequencing the polypeptide and isolating the nucleic acid molecule, the Board found that a person of ordinary skill in the art would have had a reasonable expectation that a nucleic acid molecule within the claimed scope could have been successfully obtained.

Relying on In re Deuel, Appellant argued that it was improper for the Office to use the polypeptide of the Valiante patent together with the methods described in Sambrook to reject a claim drawn to a specific nucleic acid molecule without providing a reference showing or suggesting a structurally similar nucleic acid molecule.  Citing KSR, the Board stated that ''when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.''  The Board noted that the problem facing those in the art was to isolate a specific nucleic acid, and there were a limited number of methods available to do so.  The Board concluded that the skilled artisan would have had reason to try these methods with the reasonable expectation that at least one would be successful.  Thus, isolating the specific nucleic acid molecule claimed was ''the product not of innovation but of ordinary skill and common sense.''

This is nothing more, and nothing less, than a per se obviousness standard.  According to the guidelines, the existence of an isolated polypeptide in the prior art, without more, renders obvious a claim to a nucleic acid encoding the polypeptide.  Note that the guidelines do not require that even a partial amino acid sequence of the prior art polypeptide be known, nor does it require that a cell or tissue source of the protein be known, to raise a prima facie obviousness determination against a nucleic acid claim.  To put this in context, human blood clotting Factor VIII, which causes Hemophilia A, was "isolated" from fractionated blood components many years before the gene encoding the protein was isolated.  During that time, the cells producing the protein were not known; it has since been found to be produced by vascular endothelial cells.  Despite this inherent uncertainty, according to the Patent Office (no doubt having been "constantly advised by the patent examiners, who are highly skilled in this art, that cloning procedures are routine in the art"), the nucleic acid encoding Factor VIII would be prima facie obvious in view of the mere existence of a purified preparation of the protein in the art.  This rationale goes even further than the Board in Deuel, since there, the Board's obviousness decision was based on "the examiners urg[ing] that when the sequence of a protein is placed into the public domain, the gene is also placed into the public domain because of the routine nature of cloning techniques."  Here, even this requirement has been dropped.

This result is not required by KSR, and is in fact contrary to it.  The Court did not abrogate In re Deuel in the KSR decision, and the portion of KSR dealing with the "obvious to try" standard is consistent with Federal Circuit precedent, including Deuel:

It is true that this court and its predecessors have repeatedly emphasized that "obvious to try" is not the standard under §103.  However, the meaning of this maxim is sometimes lost.  Any invention that would in fact have been obvious under §103 would also have been, in a sense, obvious to try.  The question is: when is an invention that was obvious to try nevertheless nonobvious?

The admonition that "obvious to try" is not the standard under § 103 has been directed mainly at two kinds of error.  In some cases, what would have been "obvious to try" would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.  In others, what was "obvious to try" was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.

Obviousness does not require absolute predictability of success.  Indeed, for many inventions that seem quite obvious, there is no absolute predictability of success until the invention is reduced to practice.  There is always at least a possibility of unexpected results, that would then provide an objective basis for showing that the invention, although apparently obvious, was in law nonobvious.  For obviousness under § 103, all that is required is a reasonable expectation of success.

In re O'Farrell (Fed. Cir. 1988) (citations omitted).  Neither of these situations apply per se to isolating a nucleic acid that encodes a known protein.

The guidelines are not even consistent with the Board's decision in Kubin.  There, the Board cited several factual distinctions between the obviousness issue presented by Kubin and the facts in Deuel, including:

1.  In Kubin, a cell "unambiguously" (see below) expressing the gene was known; in Deuel, a protein that the prior art taught was expressed in brain was cloned from placenta.

2.  In Kubin, the nucleotide and amino acid sequence of the mouse ortholog of human NAIL was known; in Deuel, the prior art disclosed three different brain-specific proteins and a partial amino-terminal amino acid sequence thereof.

3.  In Kubin, the art provided an isolated preparation of the cognate protein and a monoclonal antibody that binds to the protein; in Deuel, the art disclosed isolated preparations of three different brain-specific proteins but no antibodies.

4.  In Kubin, the art provided a monoclonal antibody specific for the gene product of the desired cDNA and thus providing a specific probe; in Deuel, the probes were a plurality of degenerate oligonucleotides prepared from the partial amino-terminal amino acid sequences.

5.  In Kubin, the art has developed expression cloning technology and provided an antibody probe specific for the gene product of the desired clone; in Deuel, the absence of a specific antibody precluded use of expression cloning technology.

None of these factual issues are mentioned or required to be considered under the guidelines.

On the law, the Board conflated (and the guidelines set in stone) the issues of the obviousness of a composition of matter and the obviousness of producing it.  This is the same mistake that the Board made in Deuel :

The PTO's focus on known methods for potentially isolating the claimed DNA molecules is also misplaced because the claims at issue define compounds, not methods.  See In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993).  In Bell, the PTO asserted a rejection based upon the combination of a primary reference disclosing a protein (and its complete amino acid sequence) with a secondary reference describing a general method of gene cloning.  We reversed the rejection, holding in part that "the PTO's focus on Bell's method is misplaced.  Bell does not claim a method.  Bell claims compositions, and the issue is the obviousness of the claimed compositions, not of the method by which they are made."  Id.

We today reaffirm the principle, stated in Bell, that the existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious, in the absence of other prior art that suggests the claimed DNAs.  . . .  There must, however, still be prior art that suggests the claimed compound in order for a prima facie case of obviousness to be made out; as we have already indicated, that prior art was lacking here with respect to claims 5 and 7.  Thus, even if, as the examiner stated, the existence of general cloning techniques, coupled with knowledge of a protein's structure, might have provided motivation to prepare a cDNA or made it obvious to prepare a cDNA, that does not necessarily make obvious a particular claimed cDNA. "Obvious to try" has long been held not to constitute obviousness.  In re O'Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1680-81 (Fed. Cir. 1988).  A general incentive does not make obvious a particular result, nor does the existence of techniques by which those efforts can be carried out.  Thus, Maniatis's teachings, even in combination with Bohlen, fail to suggest the claimed invention.

The differences in the underlying technological sophistication in the art noted by the Board in Kubin could, under the appropriate circumstances,  render obvious a nucleic acid encoding, for example, a highly-conserved sequence where the art disclosed closely-related species orthologs, the cell or tissue of  origin was reliably known, and specific reagents, such as monoclonal antibodies to the protein, were readily available.  None of these factors are required under the Office's KSR rationale to permit an Examiner to assert a prima facie case of obviousness against a nucleic acid claim.  Perhaps the Office is merely reflecting the current trend to pass as much of the examination burden as possible onto applicants, and expects that in instances where there are facts contrary to Kubin or the guidelines, applicants will provide sufficient rebuttal evidence to overcome the prima facie case.  This procedural avenue, however, does not address the analytical mistake of equating obviousness of the method of making with the obviousness of the thing made.  And by promulgating a per se rule of obviousness it is the Office, not the Federal Circuit, that runs directly afoul of Supreme Court precedent.

Unless Kubin has filed an appeal with a district court or the Federal Circuit, the only way that this guideline will be overturned will be after it has been improperly applied, appealed, affirmed by the Board, and then sent to the Federal Circuit for review.  Even then, the facts of that case will need to be sufficient for the CAFC to properly consider the issue.  It would be easier, and better for American innovation (in biotechnology, where the U.S. remains a leader) if the Office would be more preoccupied with allowing than rejecting patents.  On recent evidence, at least with regard to nucleic acid claiming, the Patent Office appears more interested in settling scores with the Federal Circuit.

Posted at 10:52 PM in Commentary, Patent