OMG WordPress BBQ!
This weekend, thousands of WordPress users and developers are among the people attending the South by Southwest (SxSW) Interactive conference in Austin, TX. To celebrate this, we’re throwing a WordPress BBQ at SxSW tomorrow so that there’s a place for us all to get together.
If you’re a WordPress fan attending SxSW (or you just happen to be in Austin), please join us for lunch after 12pm* tomorrow, Sunday March 14. We’re getting the BBQ from Rudy’s and the red velvet cake from Central Market. Yum! Come, eat, talk about the cool things you’re doing with WordPress, let us know what we can do better, gossip about Mark Jaquith’s new hairstyle, whatever. Think of it like a WordCamp without presentations. I’ll be there, lead developers Mark Jaquith and Ryan Boren will be there, core contributors will be there, plugin and theme developers will be there, and basically all the most intelligent and attractive people from SxSW will be there. You should be, too!
Location: Conjunctured coworking space, 1309 East 7th St., Austin, TX 78702. From the convention center, walk up to 7th Street, hang a right, and walk until you get to #1309. If you’re tired of walking, taking a cab is a decent option. Note that this is on the other side of I-35 from the convention center.
View WordPress BBQ at SxSW in a larger map
* We’ll keep serving until we run out of food, so probably until around 2 or 3? We’ll have a hundred pounds of bbq meat, a bunch of sides, and dozens of gallons of iced tea, so come hungry.
Trillium Expands Immunology Pipeline And Enters Stem Cell Field Through In-licensing Of Two New Programs
Trillium Therapeutics Inc...Diabetes Experts Call For Early, Integrated Treatment Approach To Help Prevent Complications And Improve Patient Outcomes
Results from a new online survey of more than 300 practicing endocrinologists and family medicine physicians1 show that a large majority of physicians (83 percent)1 indicated that using a team of specialists early in the course of type 2 diabetes (T2D) treatment can help prevent serious T2D-related complications...FDA Approves Five-Day Dosing Regimen For Dacogen(R) (decitabine) For Injection, Offering A New Outpatient Dosing Option For Myelodysplastic Syndromes
Eisai Inc announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells...FDA Approves Five-Day Dosing Regimen For Dacogen(R) (decitabine) For Injection, Offering A New Outpatient Dosing Option For Myelodysplastic Syndromes
Eisai Inc announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells...TaiGen Announces Nemonoxacin (TG-873870) Once-A-Day Oral Dosing In Diabetic Foot Infection Met Primary Endpoints
TaiGen Biotechnology Co., Ltd. announced the Phase II trial of nemonoxacin (TG-873870) in Diabetic Foot Infection (DFI) with once-a-day dosing met the primary endpoints and showed promising clinical efficacy and good tolerability. Nemonoxacin is a novel non-fluorinated quinolone that has a broad spectrum of activity against gram-positive and gram-negative bacteria and atypical pathogens...TaiGen Announces Nemonoxacin (TG-873870) Once-A-Day Oral Dosing In Diabetic Foot Infection Met Primary Endpoints
TaiGen Biotechnology Co., Ltd. announced the Phase II trial of nemonoxacin (TG-873870) in Diabetic Foot Infection (DFI) with once-a-day dosing met the primary endpoints and showed promising clinical efficacy and good tolerability. Nemonoxacin is a novel non-fluorinated quinolone that has a broad spectrum of activity against gram-positive and gram-negative bacteria and atypical pathogens...A Novel Mechanism Of Drug Delivery – PEGylated Dendrimers
Monash Institute of Pharmaceutical Science (MIPS) researchers, in collaboration with the biotechnology company Starpharma Holdings Ltd (ASX:SPL) have developed a new method to deliver medications that may benefit thousands of patients with particular types of cancer, HIV and lymphatic conditions world-wide...Regulatory Affairs Workload At Drug Development Firms Has Increased Dramatically, According To Tufts Center For The Study Of Drug Development
A growing volume of global drug development and commercialization activity during the past decade has dramatically increased the workload for regulatory affairs professionals at pharmaceutical and biotech companies, according to a study recently completed by the Tufts Center for the Study of Drug Development...PhRMA Spends $6.3 Lobbying In Fourth Quarter, Slight Increase From Year Before
The Pharmaceutical Research and Manufacturers of America spent $6.3 million lobbying Congress and other government arms on health care in the fourth quarter of 2009, The Associated Press reports. PhRMA "spent just 2 percent more than the $6.17 million it paid out for lobbying in the year-ago period. The group's members include drug giants Pfizer Inc., Merck & Co...Access Pharmaceuticals Reports Significant Oral Bioavailability Of Cobalamin(TM) Oral Insulin In Additional Studies
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced that it has received reports of significant bioavailability of orally delivered insulin in two independently-conducted animal studies. The studies, which confirm earlier findings, were performed as part of on-going work with commercial collaborators that are evaluating Access' Cobalamin™ Oral Drug Delivery Technology...CBio Secures Another Clinical Trial Milestone
Australian drug development company CBio Limited (ASX: CBZ) announced the achievement of a clinical trial milestone under its option agreement with global pharmaceutical leader Novo Nordisk A/S. The agreement relates to the development of XToll, the potential new-generation drug therapy which could provide safer and more effective treatment of autoimmune diseases such as rheumatoid arthritis (RA)...Newly-Published Study Reinforces Role Of Antiepileptic Drug Vimpat(R) (lacosamide) (C-V) As An Add-on Treatment That Significantly Reduces Epilepsy
UCB announced that the antiepileptic drug (AED) Vimpat® (lacosamide) (C-V) demonstrated significantly fewer partial-onset seizures versus placebo in adults living with epilepsy, according to a Phase III clinical study published online in Epilepsia. This study was one of three that supported the approval of Vimpat by the U.S...AstraZeneca Comments On FDA Joint Advisory Committee Meeting On Post-Marketing Safety Studies For The Use Of LABAs In Asthma
On March 10-11, 2010, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) -- including the Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees -- discussed the design of post-marketing safety studies for long-acting beta-agonist (LABA)-containing products in the U.S., including SYMBICORT® (budesonide/formoterol fumarate dihydrate)...BIO Asks Congress To Support Deployment Of Biotech Chemical Platforms To Create Green Jobs
Federal tax policies should incentivize commercial deployment of advanced industrial biotechnologies, which can create jobs, reduce reliance on petroleum, and achieve greenhouse gas reductions...Tougher Action To Support Medicines Supply, UK
A package of tough new actions to ensure that NHS patients can get the medicines they need was agreed at a summit to discuss concerns about current difficulties with the supply of medicines, hosted by Health Secretary Andy Burnham and Health Minister Mike O'Brien yesterday...Firefox Personas, WordPress-style
We recommend open source software whenever we can, and the Firefox browser from Mozilla is one of our favorites. Firefox 3.6 recently came out with persona support, allowing users to skin their browsers with favorite designs and brands. WordPress users everywhere seem to love the W symbol (at WordCamps it shows up on everything from t-shirts to iPhone skins), so it was only natural that WordPress personas would come along.
To kick it off, designer Chad Pugh created two WordPress personas based on the WordPress brand: “Vintage Press” and “Inkwell.” These two designs are a great way to show the WordPress love, even if you’re only showing it to yourself. 
 |
The “Vintage Press” Persona is inspired by the style of old-fashioned printing presses and the mechanics of working with type. This persona might appeal to WordPress developers and users who appreciate the way things work under the hood. |
| “Inkwell” is more of a palimpsest* & watercolor hybrid that might appeal to the artists among us. Music, script and spills of color combine… |  |
Okay, I’m starting to feel like an art critic so I’ll stop there. Check out the WordPress personas for Firefox and decide for yourselves.
* I never thought I would have occasion to use the word “palimpsest” in a dev blog post. Never.
Patent On Lysine-Producing Bacterium Killed For Lack of Best Mode
Earlier, the International Trade Commission (ITC) ruled that the importation and sale of certain lysine feed products did not violate section 337 of the Tariff Act of 1930 as amended, 19 U.S.C. § 1337. The Commission found that (1) the asserted claims of Ajinomoto’s U.S. Patents 5,827,698 and 6,040,160 are invalid under 35 U.S.C. § 112 for failure to comply with the best mode requirement and (2) the ’698 patent is unenforceable due to inequitable conduct. The U.S. Court of Appeals for the Federal Circuit agreed. Ajinomoto v. ITC (09-1081).
The ’698 and ’160 patents relate to improved methods of producing L-lysine (“lysine”) by cultivating Escherichia bacteria that have been genetically engineered to produce and accumulate greater quantities of lysine than naturally occurring (or wild- type) bacterial strains. Lysine is an essential amino acid, which means that most animals cannot synthesize it but must obtain it directly from their diets. Consequently, feed producers and farmers regularly add lysine as a necessary dietary supplement to low-protein grass feed for livestock. To supply lysine, the industry employs microorganisms such as Escherichia coli that can synthesize lysine from a carbon source (e.g., a sugar such as glucose) through a well- known biosynthetic pathway.
The patents involved in this case alter two mechanisms that contribute to E. coli’s limited lysine production. The first mechanism, known as “feedback inhibition,” is triggered by lysine itself. Specifically, when sufficient lysine is present to meet the organism’s needs, lysine inhibits its own production by inhibiting the activity of certain of its biosynthetic enzymes. At the same time, E. coli also employ enzymes, called lysine decarboxylases, which break down any extra lysine produced into a non-nutritious byproduct. Both mechanisms—feedback inhibition and lysine degradation—keep E. coli from accumulating excess lysine.
Scientists at Ajinomoto disrupted the lysine degradation limitation imposed on lysine production by engineering an E. coli with a mutant lysine decarboxylase gene. Specifically, the ’698 patent, entitled “Lysine Decarboxylase Gene and Method of Producing L-Lysine,” discloses the identification of the lysine decarboxylase gene ldc and the creation of an E. coli strain with mutations in ldc that reduce or eliminate lysine decarboxlyase activity. Asserted claim 15 of the ’698 patent covers a method of producing lysine by cultivating E. coli with mutant ldc and collecting the accumulated lysine:
A method for producing L-lysine, comprising: cultivating an isolated microorganism belonging to the genus Escherichia, wherein the microorganism contains a [mutant lysine decarboxylase] in a liquid medium, thereby producing the L-lysine and accumulating the L-lysine in the liquid medium, and collecting the L-lysine produced and accumulated in step (a), wherein the microorganism belongs to the species Escherichia coli.
The’160 patent, entitled “Method of Producing L-Lysine by Fermentation,” discloses the creation of an E. coli strain with at least one of two mutations in dapA, the gene encoding the biosynthetic enzyme dihydrodipicolinate synthase (“DDPS”). The mutations release DDPS from the feedback inhibition imposed by excess lysine, and result in an E. coli strain that produces greater amounts of lysine than wild-type strains. Asserted claim 15 of the ’160 patent covers a method of producing lysine by cultivating E. coli that contain mutant dapA and collecting the accumulated lysine:
A method of producing L-lysine, comprising: cultivating a bacterium belonging [to] the genus Escherichia which is transformed with a DNA coding for a dihydrodipicolinate synthase originating from a bacterium belonging to the genus Escherichia and having mutation to desensitize feedback inhibition of L-lysine, wherein the mutation is selected from the group consisting of [a mutation to replace the alanine residue at the 81st position and/or a mutation to replace the histidine residue at the 118th position] in a suitable culture medium, producing and accumulating L- lysine in the culture thereof, and collecting L-lysine from the culture.
Both patents disclose certain E. coli host strains for practicing the claimed inventions. The ’698 patent describes a two-step process of producing a mutant ldc host strain. In contrast to the disclosure in the specification, it is undisputed that the actual strain used by the inventors had two additional genetic alterations made to it before the addition of mutant ldc. The inventors identified this strain as WC80.
Similarly, the ’160 patent discloses two host strains, B-399 and W3110(tyrA), into which the inventors introduced mutant dapA. Yet, before filing the Japanese application from which the ’160 patent claims priority, the inventors characterized a different strain, AE-70, as their best lysine producer.
After Ajinomoto filed a complaint at the ITC, the Administrative Law Judge (ALJ) found that the asserted claims were invalid for multiple violations of the best mode requirement of 35 U.S.C. § 112, first paragraph, and that both patents were unenforceable for inequitable conduct because of those best mode violations.
The ALJ concluded that the inventors had violated the best mode requirement by (1) concealing their preferred and only host strain, WC80-1 96S, via a misrepresentation of the steps actually performed to create a mutant ldc host strain; (2) concealing sucrose as their preferred carbon source, which materially affects achieving the claimed invention; and (3) submitting data associated with fictitious host strains in support of the best mode. Similarly, with regard to claim 15 of the ’160 patent, the ALJ concluded that the inventors had violated the best mode requirement by (1) concealing their preferred host strain, AE-70, and (2) submitting fictitious data in support of the best mode.
Section 112 of the Patent Act provides that the patent specification “shall set forth the best mode contemplated by the inventor of carrying out his invention.” Known as the best mode requirement, it comprises part of the quid pro quo of the patent grant, prohibiting inventors from receiving the benefit of the right to exclude while at the same time concealing from the public preferred embodiments of their inventions. To satisfy the best mode requirement, an inventor must disclose the preferred embodiment of his invention as well as preferences that materially affect the properties of the invention.
Determining compliance with the best mode requirement is a two-prong inquiry. First, the court must determine whether, at the time the patent application was filed, the inventor possessed a best mode of practicing the claimed invention. Second, if the inventor has a subjective preference for one mode over all others, the court must then determine whether the inventor “concealed” the preferred mode from the public.
The Federal Circuit held:
By defining the invention to include the host strains, we do not read the Commission’s decision as requiring the disclosure of any and all preferences related to the production of lysine, as Ajinomoto claims. The Commission simply defined the scope of the claimed invention to include “cultivating a bacterium” as recited by the asserted claims. Also, the Commission did not, as Ajinomoto asserts, require the disclosure of all subject matter having to do with the claim term “bacterium.” The Commission simply required the disclosure of the preferred and, for the ’698 patent, only bacterial strain that the inventors used to practice the claimed invention.
…
[W]e disagree with Ajinomoto’s interpretation of the Commission’s opinion and the law. First, the Commission’s opinion did not, as Ajinomoto contends, find that the inventors concealed the method of creating the host strain into which they later introduced an ldc mutation. Rather, the Commission found that the inventors concealed the identity of the preferred host strain, and specifically that other genetic alterations, including a lysC variant and sucrose utilization genes, had been introduced (by whatever method) into the only host strain used to practice the claimed invention. Cf. Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1347 (Fed. Cir. 2000) (finding no best mode violation when one of skill in the art would know that the identified preferred host strain contained another genetic alteration).
Second, the best mode requirement cannot be satisfied by the deposit of a non- preferred strain. It is undisputed that the host strain deposited by Ajinomoto lacked the sucrose utilization genes and thus was not the host strain into which the inventors inserted an ldc mutation. Furthermore, while the deposited strain contained the lysC variant, the specification contains no disclosure of that fact, and one of skill in the art would not know that the strain had such an alteration. As such, the deposit failed to enable one of skill in the art to practice the inventors’ preferred embodiment and thus concealed the best mode.
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Small Business Patent Data Collection Act of 2010
Sen. Mary Landrieu (D-LA) is Chairwoman of the Senate Small Business Committee. Sen. Landrieu has introduced The Small Business Patent Data Collection Act of 2010 after concerns about how the Senate patent reform bill will impact small businesses. Small businesses represent 99.7 percent of all employers, employing 1/2 of the U.S. labor force.
The bill directs the Small Business Administration’s Office of Advocacy to conduct a study in consultation with the U.S. PTO to analyze how changes to the current system will impact the ability of small businesses to obtain patents, whether the change would create barriers, and how it will impact the costs and benefits to small businesses overall.
S. 3089
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. STUDY AND REPORT OF PATENT LAW CHANGES.
(a) Definitions.—In this section—
- the term “Chief Counsel” means the Chief Counsel for Advocacy of the Small Business Administration; and
- the term “small business concern” has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).
(b) Study.—
- IN GENERAL.—The Chief Counsel, in consultation with the Director of the United States Patent and Trademark Office, shall conduct a study of the effects of changing from a first-to-invent to a first-to-file invention priority system under patent law under title 35 of the United States Code.
- AREAS OF STUDY.—The study conducted under paragraph (1) shall include examination of the effects of changing from a first-to-invent to a first-to-file invention priority system, including examining—
(A) how the change would affect the ability of small business concerns to obtain patents;
(B) whether the change would create or exacerbate any disadvantage for applicants for patents that are small business concerns relative to applicants for patents that are not small business concerns; and
(C) the costs and benefits to small business concerns of the change.
(c) Report.—Not later than 18 months after the date of enactment of this Act, the Chief Counsel shall submit to the Committee on Small Business and Entrepreneurship and the Committee on the Judiciary of the Senate and the Committee on Small Business and the Committee on the Judiciary of the House of Representatives a report regarding the results of the study under subsection (b).
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Yahoo! Submits Document to FDA Social Media Docket and Status of Submissions
Is FDA still listening about social media and medical products?
The deadline has passed (February 28), but a new submission was posted - this time from Yahoo! to the FDA's Social Media Docket that was set up in the wake of the November Part 15 meeting related to the use of the Internet and social media in medical product promotion. In fact, however, it is about social media use at all, not just for promotion, but for education - the fact that the title never reflected that might reveal a biased mindset on the part of the FDA, but that is neither here nor there for now.
The Yahoo! submission quoted back to FDA some of the usual statistics and some I had not heard before including:
- 91 million Americans use the Internet to access health information at over 1700 sites (had not heard that one);
- 78% of Americans suffering from a medical condition who are online visit a health-related website to learn about their condition and 56% of caregivers do the same;
- And quoting Manhattan Research, the number of Americans researching prescription drugs online has doubled since 2005 to 102 million people.
They then provided some insights into their own internal research on Internet use as it relates to prescription drugs.
"Over half of online Americans are on prescription medication with a fifth having done some research regarding some prescription drug medication. Patients are learning about new prescription drugs through a plethora of sources - both online and offline. However, online searches were the second most popular way these consumers obtained prescription drug information at 28%, compared with 44% who learned about the drug from their doctor and 24% who learned about a drug from a pharmacist. Search is a clearly common and mainstream way for consumers to obtain drug information and the online space is becoming a key driver in how consumers are learning and researching about medication."
You may be wondering why there are still documents appearing in the docket despite the fact that the docket was closed on February 28. So was I, so I asked Dr. Jean Ah-Kang, Special Assistant to DDMAC's Tom Abrams. You may recall that it was my March 2009 podcast with her that began the public dialog with FDA on the issue of social media. Here is what she said today about the status of submissions and the late entry by Yahoo!
"The Yahoo! submission was submitted prior to the deadline and just posted yesterday due to some technical issues... The docket is technically closed, and people will not be able to submit electronic comments on regulations.gov since that is no longer an option (the "Submit" function is not available through our docket). However if someone is still very interested in submitting comments, please ask them to contact me directly - thanks!
She also indicated that the Division of Dockets Management reviews each submission prior to posting for all dockets, which means that there is a lag time between the time of submission and posting. Electronic submissions will go through more quickly than hard copy.
Dr. Kang's email address is Jean-Ah.Kang@fda.hhs.gov
And one hopes that in the future, FDA ditches Regulations.gov. It is cumbersome. It is not user-friendly. And, it is not timely.
