A Diagnostics & Imaging Week

Applied Biosystems (ABI, Foster City, California) an Applera (Norwalk, Connecticut) business, and Agilent Technologies (Santa Clara, California) reported that they have entered into a settlement resolving patent infringement lawsuits originally filed by Applera against Stratagene (La Jolla, California) (acquired by Agilent in 2007), alleging infringement of Applera’s real-time thermal cycler instrument patents. The lawsuits resulted in injunctions in Germany and the Netherlands and were pending in the U.S. and France.

In connection with the settlement, Agilent has entered into an agreement with Applera to license certain Applera technology relating to Agilent’s real-time thermal cycler instrument business in research-related fields and excluding the field of human in vitro diagnostics. The two companies also reported that Agilent has entered into another agreement with Applera to license certain Applera technology relating to Agilent’s PCR and real-time enzymes and kits.

Financial terms of the settlement and related license agreements were not disclosed. The agreements resolve all pending disputes between Applera and Stratagene.

Thermal cyclers are the main instruments for performing polymerase chain reactions (PCR). In real-time PCR, the amplified DNA is detected during, rather than at the end of, the PCR process, a feature that facilitates greater accuracy in important applications, including gene expression quantitation and genotyping.

Agilent Technologies is focused on communications, electronics, life sciences and chemical analysis.

The Applied Biosystems group develops instrument-based systems, consumables, software, and services.

In other patent news:

• Florida Atlantic University (FAU; Boca Raton) received the patent “Promoting Cardiac Cell Differentiation,” based on an invention which induces and restores cardiac muscle function.

The invention was discovered by FAU researcher and vice president for research, Larry F. Lemanski PhD. and his postdoctoral fellow, Chi Zhang PhD. Their research has focused on understanding the mechanisms that regulate myocardial cell differentiation and myofibrillogenesis, the process by which proteins in the heart are changed into heart muscle cells in the developing heart. From their findings, these researchers hope to repair myocardial deficiencies in the heart, caused by either congenital heart defects or heart attacks.

Lemanski, Zhang and colleagues at FAU have been looking at the cellular, molecular and genetic signals that affect heart cell differentiation and regulation of the synthesis of contractile proteins within cardiac muscle cells that allows cells to contract. Identifying the biological factors that induce this differentiation would be a major step forward in the development of therapies.

“When an individual has a heart attack with a significant region of the heart muscle damaged, recovery to pre-heart attack levels are rarely achieved,” said Lemanski. “Strategies to regenerate damaged cardiac tissue could be significant in the treatment of cardiovascular disease.”

Adult heart muscle cells lack the ability to regenerate following injury because of terminal differentiation. The number of heart cells is determined at birth and once damaged cannot repair themselves. Furthermore, many congenital abnormalities are thought to be caused by improper signaling between cells and tissues as a result of abnormal genes.

Observing cardiac mutant salamanders, the researchers identified a major protein that was deficient in these axolotl hearts which prevented the organization of myofibrils (contractile machinery) and the ability to beat. Using these findings, they were able to show that this mutant defect could be rescued by treatment with specific and unique RNA (ribonucleic acid) derived from the gut of normal animal model embryos. They cloned the gene for this specific RNA, synthesizing a “bioactive” RNA that is capable of rescuing mutant hearts by promoting the development and differentiation of contractile cardiac muscle cells from non-contractile, pre-cardiac, non-muscle cells.

Lemanski termed this discovery as “myofibrillogenesis inducing RNA” (MIR). Additional studies have shown that humans have a similar, most likely identical, mechanism as the axolotls, for the formation of functional contracting heart muscle cells. It may also be possible to produce new functional cardiac muscle tissue in areas of human hearts that require these cells and tissues for restoration of normal function.

• Power3 Medical Products, (The Woodlands, Texas) has filed two Utility Patent Applications with the U.S. Patent and Trademark Office for a number of the company’s blood serum protein biomarkers, part of Power3’s biomarker panel for early detection and differential diagnosis of Parkinson’s disease.

“The specificity for early diagnosis of Parkinson’s disease is very important for early treatment,” said Ira Goldknopf, director of proteomics for Power3 Medical. “The biomarkers involved in these patent applications have demonstrated unique specificities for Parkinson’s disease. When used in combination with other Parkinson’s biomarkers in our diagnostic panel, they increase the accuracy of diagnostic specificity to distinguish Parkinson’s patients from other similar neurological disorders.”