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GlaxoSmithKline, USPTO, Intellectual Property Office of Australia, CG Therapeutics, University of Washington, ImmuneRegen BioSciences, University of Medicine and Dentistry of New Jersey,, Stevens Proof of Concept, Stevens Institute of

Court Rules for GlaxoSmithKline in USPTO Rulemaking Case
The US District for the Eastern District of Virginia has granted summary judgment to GlaxoSmithKline and Tafas, ruling in support of GSK’s challenge to final rules issued by the US Patent and Trademark Office in August, the pharma giant said this week.
GSK said that the court essentially decided that the proposed rules are substantive in nature, and that the PTO has exceeded its rulemaking authority under the law.
In August, the USPTO published new rules in the Federal Register that it said were designed to improve patent quality and improve the effectiveness and efficiency of patent examination.
Under the proposed rules, patent applicants would have been able to file two new continuing applications and one request for continued examination as a matter of right.
In addition, each patent application would have been allowed to contain no more than 25 separate claims, with no more than five of them independent, without any additional effort on the part of the applicant.
Beyond these thresholds, the rules would have required applicants to show why an additional continuation is necessary or to provide supplementary information relevant to the claimed invention to present additional claims.
Current rules allow applicants to file an unlimited number of continuing applications, requests for continued examination, and claims.
In October, GSK filed a complaint against the USPTO with the US Federal Court for the Eastern District of Virginia to challenge the published rules, claiming that the changes would irreparably harm the firm because of the large number of patents it has in continuation or pending. An inventor named Triantafyllos Tafas, who founded medical imaging firm Ikonisys, sued the USPTO in August for similar reasons, and the court consolidated the two complaints.
Specifically, GSK’s complaint sought a “preliminary injunction staying the implementation of the final rules until the resolution of the lawsuit, a permanent injunction against the implementation of the final rules, a declaratory judgment that the final rules are contrary to law, and a request that the final rules be vacated,” according to court documents.
In November, The US District Court for the Eastern District of Virginia sided with GlaxoSmithKline in its suit against the US Patent and Trademark Office, temporarily barring the agency from enacting a set of recently proposed changes in US patent rules (see BTW, 11/5/2007).
Regarding the court’s final decision this week, GSK said in a statement that it is “pleased that the court has considered our arguments and decided that the PTO lacks the necessary authority to implement the proposed rule changes. This is a judgment in support of innovation across all industries. It reaffirms that all who want to patent their inventions in the United States will be allowed to seek protection on the full scope of their discoveries.”

USPTO, Aussie Patent Office Collaborate to Speed Patent Issuance
The US Patent and Trademark Office and the Intellectual Property Office of Australia this week said that they will launch a trial cooperative initiative called the Patent Prosecution Highway this month.
The initiative will take advantage of fast-track patent examination procedures already available in both offices to allow applicants in both countries to obtain corresponding patents faster and more efficiently, USPTO said.
It will also permit each office to benefit from work previously done by the other office, in turn reducing examination workload and improving patent quality, USPTO said.
The trial program is set for one year, and is designed to gauge the interest of applicants and determine if the program improves quality and efficiency and reduces the workload in each office.
The pilot project with Australia builds on a similar program initiated with the Japan Patent Office, which was made permanent in January. The USPTO said that pendency to first action was substantially reduced in many cases relative to normal pendency in the particular technology area.

CG Therapeutics, University of Washington to Jointly Develop mAbs
CG Therapeutics said this week that it has entered into an agreement with the University of Washington to jointly develop monoclonal antibodies.
CG is commercializing CG201, a vaccine that produces antibodies that neutralize hCG, a hormone produced by tumor cells to speed their growth. The joint program will develop human mAbs against hCG that can be used with the CG201 vaccine to provide comprehensive cancer treatments, CG said.
UW researchers Karl Eric and Ingegerd Hellstrom will head the research program.
Financial details of the agreement were not disclosed.

UMDNJ to Test ImmuneRegen Compound in Stimulating Stem Cell Activity
ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, said this week that it has signed a material transfer agreement with the University of Medicine and Dentistry of New Jersey.
Under the agreement, ImmuneRegen will ship its drug candidate Homspera to UMDNJ stem cell researcher Pranela Rameshwar, who will test the compound’s effect in stimulating stem cell activity of human bone marrow.
Specifically, Rameshwar will lead the examination of Homspera’s effects on human adult bone marrow stem cells and its potential ability to stimulate hematopoiesis and strengthen the immune system. Rameshwar is also a member of Homspera’s scientific advisory board. Launches New Free Stem Cell Patent Database this week said that it has launched a redesigned free database covering US issued patents related to stem cells.
The website provides summaries and analyses for more than 1,200 patents chosen by experts in the field to be relevant to stem cell commercialization and development, said.
The company, based in Toronto, launched a beta version of the site in November 2006.

Medical Device Developed by Stevens Institute Students, NYU Prof Wins 510(k) Clearance
A hand-held biomedical device manufactured by Stevens Proof of Concept and developed jointly by students at Stevens Institute of Technology and Norman Marcus, a New York University physician and professor, has received 510(k) clearance from the US Food and Drug Administration.
The device began as a Stevens undergraduate senior design team project in 2004. In 2005, SPOC was formed by Helena Wisniewski, vice president of university research and enterprise development at Stevens; Marcus; and three senior-year biomedical engineering students at Stevens to commercialize the device.
In April 2007, a quasi-public Connecticut-based tech-transfer firm Connecticut Innovations made a $500,000 seed-stage investment in SPOC to support commercialization of the device (see BTW, 4/9/2007).
The point-of-care device is designed to pinpoint specific myofascial trigger points causing pain. SPOC said that approximately 100 million people in the US suffer from chronic pain and approximately 80 percent of Americans suffer from some form of pain in their lifetime.

The Scan

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.

Researchers Reprogram Plant Roots With Synthetic Genetic Circuit Strategy

Root gene expression was altered with the help of genetic circuits built around a series of synthetic transcriptional regulators in the Nicotiana benthamiana plant in a Science paper.

Infectious Disease Tracking Study Compares Genome Sequencing Approaches

Researchers in BMC Genomics see advantages for capture-based Illumina sequencing and amplicon-based sequencing on the Nanopore instrument, depending on the situation or samples available.

LINE-1 Linked to Premature Aging Conditions

Researchers report in Science Translational Medicine that the accumulation of LINE-1 RNA contributes to premature aging conditions and that symptoms can be improved by targeting them.