Category Archives: Medical
Anastomosis for treating COPD; Rox Medical, Inc.; U.S. Pat. No. 8,016,782
U.S. Patent No. 8,016,782, issued on September 9, 2011 to Rox Medical, Inc. of San Clemente, CA, discloses a method for providing oxygenated blood to venous circulation.
Chronic obstructive pulmonary disease (COPD), encompassing chronic bronchitis and emphysema, is a common form of lung disease. While smoking is the leading cause of COPD, it can also be caused by exposure to certain gases or fumes, exposure to heavy amounts of secondhand smoke and pollution, and frequent use of cooking fire without adequate ventilation. There is not a cure to COPD, but according to the ’782 patent, the present standard of care is oxygen therapy, by which the patient supplements their breathing with extra oxygen (e.g., from a pressurized gas cylinder). Such sources of oxygen can be cumbersome, and the ’782 patent discloses a method for providing oxygenated blood to the patient’s venous system by creating an end-to-side anastomosis between the a source of the patient’s oxygenated arterial blood (e.g., artery, aorta, left chamber of the heart) and the patient’s Inferior Vena Cava or Superior Vena Cava.
According to its website, Rox Medical is “an early phase medical device company” that has developed a device that “creates a passage between an artery and a vein in the pelvic region which redirects oxygen rich blood back to the lungs of severe COPD patients.” The company’s “Anastomotic Coupler System (ACS)” is currently undergoing clinical trials, and is not currently available in the U.S.
To directly infringe a patented method (under 35 U.S.C. 271(a)), an entity must perform all the steps of the patented method, and for claim drafting strategy, it is important to consider who is actually expected to be performing these various steps. Ideally, if a patentee plans to use its patent to protect its market, the company would prefer to do so by suing its competitors for direct infringement. For example, a claim to a method of making a particular device would be expected to be infringed by competitors making a device similar or identical to the patentee’s device. Also, because it is generally easier to prove direct infringement of claims directed to a device, and such claims are expected to be infringed by a company’s competitors, device claims are preferable for a robust patent portfolio, particularly for medical device companies.
However, the claims of the patent may not be written in a way that the competitor is the entity performing all the steps of the patented method. For example, for methods of using the product, the claims might be written so that the steps are instead performed by the patentee’s customers or potential customers. To assert such a claim, the patentee would have to sue these customers, which is generally not a palatable option.
There are other theories of infringement that can be used to sue competitors using such claims. For inducement of infringement (under 35 U.S.C. 271(b)), a competitor must be shown to have actively induced another entity (e.g., the customer) to directly infringe a patent. For contributory infringement (under 35 U.S.C. 271(c)), the competitor must be shown to have offered to sell, sold, or imported a component that is especially made or adapted for infringing use and that is not suitable for substantial noninfringing use. These other versions of infringement necessarily require that some entity directly infringe the patent. They also include other facts that must be proven beyond the requirements of direct infringement, so they are generally less desirable to assert than direct infringement.
The claims of the ’782 patent are all directed to “a method of providing oxygenated blood to the venous circulation of a patient,” and all of the steps of this method are potentially performed by hospitals and surgeons, presumably Rox Medical’s customers. To sue its competitors for inducement of infringement or contributory infringement, Rox Medical would have to show that direct infringement of the ’782 patent occurred (e.g., by the hospital or surgeon) and that the competitors satisfied the other conditions for these forms of infringement.
According to the USPTO database, Rox Medical has three other U.S. patents, only one of which has device claims that might be directly infringed by a competitor. The company also has other pending U.S. patent applications, hopefully for the company, for pursuing additional claims that would be directly infringed by the company’s competitors.
Stem cell growth medium, California Stem Cell, Inc.; U.S. Pat. No. 7,977,096
U.S Patent No. 7,977,096, issued on July 12, 2011 to California Stem Cell, Inc. of Irvine, CA, discloses a growth medium for stem cells.
Stem cells are unspecified cells that are capable of dividing and renewing themselves over long periods of time. In addition, stem cells can undergo differentiation whereby they are used by an adult organism to generate replacement cells for the specialized cells of heart, lung, nerve, and other tissues lost through normal wear and tear, injury, or disease (such specialized cells do not normally reproduce themselves). During development of the organism, embryonic stem cells undergo differentiation to serve as the basis for the organism’s specialized tissues.
Stem cells are seen as having significant promise in the treatment of numerous maladies due to their unique regenerative abilities. According to the ’096 patent, growth of stem cells is typically performed in a base medium supplemented with serum or serum replacement. Such a media formulation is intended to be sufficient to sustain conditions for cell survival or proliferation for a desired period of time without the differentiation that converts the stem cells into cells of specialized tissue. The ’096 patent describes a media formulation for culturing human embryonic stem cells without substantial differentiation.
According to its website, California Stem Cell, Inc. (CSC) is a privately held company, founded in 2005, “to catalyze the efficient development of human therapies based on human embryonic stem cells” by producing and supplying human stem cell lines using processes that are “scalable, efficient and highly reproducible … at a fraction of the cost of conventional cells manufacturing.” The website includes numerous videos of CSC’s Board Chairman, Dr. Hans Keirstead, describing the importance of various milestones in the development of stem-cell-based therapies.
Last year, CSC submitted an Investigational New Drug application to the Food and Drug Administration (FDA) for approval of a Phase I clinical study for a stem-cell-based therapy of spinal muscular atrophy (SMA), and the company is working on providing additional animal study results to the FDA to further ensure safety.
The ’096 patent is CSC’s first U.S. patent, according to the USPTO database.
Expandable rods to treat scoliosis; Ellipse Technologies, Inc.; U.S. Pat. No. 7,955,357
U.S. Patent No. 7,955,357, issued on June 7, 2011 to Ellipse Technologies, Inc. of Irvine, CA, discloses a system that uses expandable rods that are implanted in a patient’s back to provide a controlled force over an extended period of time to counter a scoliotic curve of the spine.
According to the ’357 patent, if adolescent or idiopathic scoliosis is caused by tight ligament fibers (ligamentum flavum) running along the spine, then it should be treatable using mechanical stretching. The ’357 patent discloses an expandable rod that is implantable “under the skin and attached to selected portions fo the scoliotic curve of the spine at opposing ends of the rod.” The rod can be incrementally lengthened to produce a controlled force tending to stretch the ligamentum flavum of the spine over an extended period of time to allow the spine to straighten.
According to the company’s website, Ellipse Technologies’ initial product, the MAGEC™ (MAGnetic Expansion Control) system uses “novel motion-preserving, minimally invasive technology that, through communication with an external magnetic field, can be dynamically adjusted in an outpatient setting via remote control by a medical professional to correct spinal deformities.” By using an implant that can be adjusted non-invasively, the MAGEC™ system (pronounced “magik” according to a company video) is designed to avoid multiple surgical procedures that the child patient would otherwise have to endure.
In a recent press release, the company announced that its MAGEC™ system has been approved for use in Europe, but is not yet available in the U.S. The company has recently closed its Series C private equity financing event, raising $17.6 million.
The ’357 patent is the first of three U.S. patents issued to Ellipse Technologies so far in 2011. The company also has numerous U.S. patent applications still pending, according the USPTO database.
Visual Prosthesis; Second Sight Medical Products, Inc.; U.S. Pat. No. 8,000,000
U.S. Patent No. 8,000,000 has been issued today by the USPTO to Second Sight Medical Products, Inc. of Sylmar, CA. While Second Sight is not an Orange County company, I thought readers of this blog would be interested in this patent at least for its milestone patent number.
According to the ’000 patent, the prosthesis combines an implantable retinal stimulator and a video camera in a wearable visor. The system also includes a video processing unit that converts the video image to a stimulation pattern and an external coil that transmits the stimulation pattern to the implant. If valid telemetry data is not received from the implant, the system stops stimulating the wearer’s retina.
According to the company’s website, its “Argus™ II” prosthesis system “elicit[s] visual perception in blind subjects with severe to profound retinitis pigmentosa.” According to a recent article in the MIT Technology Review, the “Argus™ II” system has been approved for clinical use in Europe, and the company is collaborating with the National Institutes of Health (NIH) in clinical trials in the U.S. and is pursuing approval from the US Food and Drug Administration. A YouTube™ video shows how the system works.
The system works for people with retinitis pigmentosa (RP), by bypassing the damaged photoreceptors and stimulating the retina’s remaining cells, which the patient “can learn to interpret as visual patterns.” To me, the system sounds reminiscent to cochlear implants which provide people who have lost hearing due to certain conditions the ability to hear again. My mom has benefited greatly from her cochlear implants, and hopefully Second Sight’s device can provide similar benefits for patients with RP.
Since the invention was made with support from a NIH grant, the U.S. government has certain rights to the invention. According to the USPTO database, Second Sight owns about 90 U.S. patents, and the ’000 patent is the company’s 23rd U.S. patent received so far in 2011.
The USPTO has noted this milestone patent in a press release, and it provides a brief history and description of the other members of the “million”-aire patent club.
Nanoparticles for drug delivery; GP Medical, Inc.; U.S. Pat. No. 7,879,312
U.S. Patent No. 7,879,312, issued on February 1, 2011 to GP Medical, Inc. of Newport Beach, CA and National Tsing Hua University (NTHU) of Hsinchu, Taiwan, discloses a nanoparticle composition for protein drug delivery.
According to the ’312 patent, the oral route is the most convenient way to administer pharmaceutically active peptides and proteins. However, hydrophillic drugs such as peptides and proteins do not diffuse easily into the bloodstream through the intestinal epithelium. In addition, the acidic environment of the stomach can degrade such drugs taken orally. The ’312 patent discloses a nanoparticle composition that utilizes a shell of chitosan, a non-toxic and soft-tissue compatible molecule that enhances diffusion across mucosal epithelia, combined with γ-poly-glutamic acid (γ-PGA) and loaded with the drug to be administered, such as insulin.
The ’312 patent is one of four U.S. patents issued to GP Medical and NTHU on February 1, 2011 (the others are U.S. Pat. Nos. 7,879,313, 7,879,361, and 7,879,819). In addition, seven other U.S. patents have been granted to GP Medical and NTHU in the previous month or so. All ten of these patents are continuation or continuation-in-part applications which claim priority through a string of earlier patents to U.S. Pat. No. 7,265,090, filed on January 4, 2005.
GP Medical appears to be a patent holding company of Nanomega Medical Corp. of Lake Forest, CA (Nanomega’s website touts the ’312 patent and the other patents as its own, without mentioning GP Medical). According to its website, Nanomega seeks to “develop orally administered insulin nanoparticles for less invasive and painless diabetes management” based on “5 years of groundbreaking research work by Hsing-Wen Sung Ph.D. and his team of researchers in Taiwan.”
Besides Dr. Sung, the co-inventors of the ’312 patent also include Dr. Hoshen (“Roger”) Tu, the founder of Nanomega. Dr. Tu is a prolific OC inventor, listed on over 180 U.S. patents that have been assigned to various SoCal biomedical companies over the years, such as Irvine Biomedical, Inc., Polymerex Medical Corp., Glaukos Corp., 3F Therapeutics, Inc., QuantumCor, Inc., and Maxwell Sensors, Inc.
Plasmid DNA Isolation; Zymo Research Corp.; US Pat. No. 7,858,363
U.S. Patent No. 7,858,363, issued on December 28, 2009 to Zymo Research Corp. of Orange, CA, discloses a device for filtering as part of a DNA analysis.
Plasmids are DNA molecules, separate from chromosomal DNA, that occur in bacteria and can be used in epigenetics, the study of inhereted changes beyond changes in the underlying DNA sequence. Isolation of plasmids by “alkaline lysis” is a standard procedure in biology research laboratories, but according to the ’363 patent, it can be difficult to apply on a large scale due to the need to remove cell debris, salts, and other contaminants. The ’363 patent discloses a lysate filtration device that includes filtering media that “allows the plasmid DNA to be captured on the DNA-binding matrix follow[ing] a single centrifugation step.”
According to its website, Zymo Research seeks “to develop and provide the most comprehensive set of research tools for DNA methylation analysis and epigenetics research available today.” Their spin columns are touted as “efficiently remov[ing] contaminants during the purification process” and “ensur[ing] rapid and complete filtration of solutions through the column matrix.”
Zymo Research has also received U.S. Pat. No. 7,867,751 on January 11, 2011 for a plasmid isolation device. According to the USPTO database, Zymo Research owns two other US patents, including one US design patent.
Handwashing monitor; Cognetive Systems Inc.; U.S. Pat. No. 7,855,651
U.S. Patent No. 7,855,651, issued on December 21, 2010 to Cognetive Systems Inc. of Irvine, CA, discloses a computer system for remotely monitoring soap dispensers to document the frequency and interval of hand washing practices by a group of individuals.
According to the ’651 patent, there are numerous studies demonstrating that effective hand hygiene is the best way to guard against disease transmission. For example, “70% of the outbreaks [of food borne illnesses] originate in the food service sector” and “40% of these are the result of poor hand washing and cross contamination.” Various industries, such as the health care, food preparation and services, and the hotel and travel industries, are interested in monitoring the compliance of their workers to proper hand hygiene processes.
The ’651 patent discloses a system which can analyze the monitored hand hygiene behavior of many individuals using many dispensers of soap or hand sanitizer in distributed locations. Each dispenser is equipped with a wireless communication device that broadcasts information regarding usage of the dispensers (e.g., number of dispensing events, as well as the time and identification of the dispenser) to a central host database. The system allows the computer user to access the raw hygiene data and to perform a desired analysis to determine the performance or compliance rate of the group as a whole.
According to its website, Cognetive Systems is a privately held company that designs and develops wireless sensor networking platforms for specific applications. For hand hygiene applications, the company markets the Intelligent Hygiene™ wireless system that ”measures and reports the hand hygiene performance for an entire group or team” by collecting data wirelessly and automatically. According to the USPTO database, the ’651 patent is Cognetive System’s third U.S. patent.
The ’651 patent is a continuation-in-part (CIP) application claiming priority to an earlier-filed and subsequently abandoned patent application. Such CIP applications usually include all the information from the earlier application, as well as additional information that can be used to support one or more of the claims of the CIP application. The claims of the CIP application that rely on the new information for support have a priority date as of the filing date of the CIP application, while any claims of the CIP application that can be fully supported by the first application have a priority date as of the filing date of the first application.
For the ’651 patent, the USPTO rejected the claim of the first application as being unpatentable. Rather than presenting arguments or claim amendments to the USPTO in response, Cognetive Systems abandoned the first application and filed a second application (the one that resulted in the ’651 patent) in December 2009 with additional information. This additional information discussed that the conventional methodology for gathering raw data was viewed by the workers being monitored as being overly intrusive. It also discussed how the system disclosed by the ’651 patent, by aggregating the data of the workers as a group, can allieve such concerns.
Presumably, the second application was filed because the additional information was viewed as being supportive of one or more of these new claims. Happily for Cognetive Systems, these new claims were deemed allowable by the USPTO in the first office action in August 2010, resulting in the December 2010 issuance of the ’651 patent. According to the USPTO database, the company has filed a continuation application to pursue additional claims.
Immediate immunization; Altermune Technologies, LLC; U.S. Pat. No. 7,850,975
U.S. Patent No. 7,850,975, issued on December 14, 2010 to Altermune Technologies, LLC of Corona del Mar, CA, discloses a method of immediately immunizing a human or animal against a specific pathogen.
Conventional active immunization of a subject involves exposing the subject to a specific immunogen or antigen (related to the pathogen to be immunized against) in order to provoke the subject’s immune system to respond by producing antibodies to counter the pathogen. As described by the ’975 patent, it can take weeks to months for the immune response to occur, and maintaining the immune response sometimes requires that a booster shot of the antigen be given weeks or months after the initial injection. As a result, conventional immunization is not useful for immediate treatment.
The ’975 patent discloses a method for immediately immunizing a subject against a specific pathogen using a “immunity linker molecule” that has (i) a first binding site that binds to an antibody produced by a previous immunization, and (ii) a second binding site that binds to the target pathogen. According to the ’975 patent, once a subject has already been immunized against one antigen, the subject “can be immediately immunized against a chosen antigen simply by administering … the immunity linker molecule with the appropriate second binding site.” I picture the process as the “immunity linker molecule” serving as an adapter that fits onto the existing antibody so that it can bind with a different pathogen. Such an immediate immunization would be helpful in various contexts, as described by the ’975 patent, for example, soldiers can be pre-immunized against a first molecule, and then if exposed to a second pathogenic molecule (e.g., anthrax), the appropriate immunity linker molecule can be administered, thereby immediately protecting the soldiers against the second pathogen.
I’m no stranger to inventors making fantastic claims regarding their inventions. As a patent attorney with a Ph.D. in physics, I’ve had my share of initial meetings with inventors that have purportedly found a way around one or more of the laws of thermodynamics (there usually isn’t a second meeting). But as amazing as the claims of the ’975 patent are, they may warrant the benefit of the doubt, because the sole inventor of the ’975 patent is Kary Mullis, co-winner of the 1993 Nobel Prize in Chemistry. Dr. Mullis was awarded the Nobel Prize for his development of the polymerase chain reaction (PCR) technique, now used in medical and biological research on DNA, as well as in forensic science and other fields in which genetic identification is performed. Dr. Mullis has a reputation for expressing non-conventional ideas in other fields, such as climate change, AIDS, and astrology. With regard to immunology and Altermune (the company that owns the ’975 patent), he states that the company represents:
a distinct change in direction for the medical treatment of microbial infections, metabolic disorders, cancer, any number of problems where surgical procedures are too crude, present chemical interventions are losing out to resistant strains, and yet some kind of molecular intervention is necessary and still makes sense.
The ’975 patent has had a long history at the USPTO. In 1999, Dr. Mullis filed a U.S. provisional application describing the invention, and followed up with filing a PCT application in 2000 which entered the national phase in the U.S. in 2002. After three office actions by the USPTO (which included rejections based on insufficient disclosure; see my earlier discussion of such “enablement” rejections), Altermune filed a U.S. continuation application in 2006. Five office actions later, Altermune received a Notice of Allowance in 2010. In the meantime, two continuation-in-part applications were issued to Altermune as U.S. Pat. No. 7,422,746 and U.S. Pat. No. 7,645,743 covering similar inventions. According to the USPTO database, Altermune owns three U.S. patents: the ’975, ’746, and ’743 patents.
Electrosurgical device for the eye; Neomedix Corp.; U.S. Pat. No. 7,842,034
U.S. Patent No. 7,842,034, issued on November 30, 2010 to Neomedix Corp. of Tustin, CA, discloses a device for cutting or coagulating tissue within the eye.
According to the ’034 patent, vision can be adversely affected by the formation of an epiretinal membrane (ERM) within the eye, since contraction of the ERM can cause wrinkles, puckers, or other distortions of the retina. ERMs are generally treated by removal using electrosurgery (application of high-frequency electric current to cut or coagulate tissue). The ’034 patent discloses an electrosurgical device which is touted as making this procedure easier by avoiding “undesirable tugging or traction on the retina with potential tearing, bleeding, or even local detachment of the retina.”
According to its website, Neomedix develops and commercializes medical devices. The company currently markets devices for treating glaucoma by removal of portions of the trabecular meshwork which governs the drainage of aqueous humor, the fluid in the eye. The increased intraocular pressure of glaucoma can be caused by decreased flow of the fluid from the eye, and the Trabectome® procedure of Neomedix is intended to increase this fluid flow.
According to the USPTO database, the ’034 patent is Neomedix’s fourth U.S. patent.
Bioreactor for testing drug toxicity; HepaHope, Inc.; U.S. Pat. No. 7,829,325
U.S. Patent No. 7,829,325, issued on November 9, 2010 to HepaHope, Inc. of Irvine, CA, discloses a bioreactor for use in drug development.
According to the ’325 patent, liver damage is a great concern in evaluating potential new drugs, and conventional toxicity tests utilizing small animals or cell cultures have various disadvantages. The system disclosed by the ’325 patent is a bioreactor which contains slices of liver tissue (either human or animal, e.g., pig) that are exposed to a medium and the drug being evaluated. The toxicity of the drug can be measured by observing the effectiveness of the slices to metabolize a compound in the presence of the drug. Such a system is touted by the ’325 patent as providing “improved efficiency, viability, and functionality for use in drug development.”
According to its website, HepaHope was founded in 1999 and has targeted the artificial liver replacement market, the oncology testing market, and the drug development market for its bioartificial liver technology. Its website explains that HepaHope’s HepaPheresis™ System is ”an extracorporeal toxin management system that assists a patient’s liver by selectively removing toxins from the bloodstream” which the company has submitted to the FDA as a prerequisite to human clinical trials. In addition, HepaHope describes its BioTester™ system as “a drug screening testing system developed for the pharmaceutical industry to provide a better alternative to in vivo or in vitro studies” which provides “a more efficient, accurate, and cost-effective in vitro testing system — one capable of further reducing the need for expensive and out-of-favor animal testing.”
According to the USPTO database, besides the ’325 patent, HepaHope owns four other U.S. patents, including one U.S. design patent.
Vacuum-actuated syringe; SafeShot Technologies, LLC; U.S. Pat. No. 7,806,858
U.S. Patent No. 7,806,858, issued on October 5, 2010 to SafeShot Technologies, LLC of Mission Viejo, CA, discloses a safety syringe that uses vacuum pressure to retract the needle.
To prevent accidental needle pricks after being used, a safety syringe pulls back its needle into the syringe body after use. The ’858 patent discloses a safety syringe that utilizes vacuum pressure to retract the needle. As the plunger of the syringe is pressed down during injection, an air-tight volume within an outer shell increases in size, thereby creating a reduced pressure within the volume. When the plunger is fully compressed, it engages the needle, and upon release of the compressing force on the plunger, the vacuum pulls the plunger and the needle back into the syringe’s body.
According to its website, SafeShot Technologies markets the Epiphany™ safety syringe which “uses patented vacuum technology that offers a competitive advantage with fewer parts and ease of production” as compared to conventional spring-based safety syringes. Earlier this year, the company launched a “No More Pricks” campaign to heighten awareness of the issue of needlestick injuries to healthcare workers.
One of the co-inventors of the ’858 patent, Rex Bare, is on the Board of Directors of SafeShot, and is a co-founder and President of Omnica Corp., an Irvine company specializing in medical device design, product engineering, and product development. Omnica has an impressive list of clients and projects. Its website states that “your I.P. continues to belong to you,” a promise that was kept with regard to the ’858 patent, which was first assigned to Omnica, and later assigned to SafeShot.
According to the USPTO database, SafeShot owns three U.S. patents, including the ’858 patent.
Enhancing receptor functioning in synapses; Cortex Pharmaceuticals, Inc.; U.S. Pat. No. 7,799,913
U.S. Patent No. 7,799,913, issued on September 21, 2010 to Cortex Pharmaceuticals, Inc. of Irvine, CA, discloses a drug for treating various neurological conditions that are accompanied by memory impairment.
According to the ’913 patent, AMPA receptors of the neurons in the brain are involved with a host of cognitive processes, and various maladies (e.g., Parkinson’s disease, schizophrenia, and affective or mood disorders) are associated with impairment of these cognitive processes. The ’913 patent discloses a compound that enhances AMPA receptor functioning, and that can be used to treat these maladies, as well as to facilitate memory encoding.
According to its website, Cortex Pharmaceuticals “is focused on the discovery and clinical development of AMPAKINE® molecules” and its business plan “focuses on out-licensing internally developed AMPAKINE compounds for the very large CNS diseases such as ADHD, Alzheimer’s and Parkinson’s disease, while retaining the small indications and orphan diseases for internal development.” The company sold its rights to certain AMPAKINE compounds for use in the field of respiratory depression to Valeant Pharmaceuticals International.
The company also states that it has 200 issued patents or allowed patent applications in the U.S. and offshore. A check of the USPTO website finds nine U.S. patents assigned to Cortex Pharmaceuticals, including the ’913 patent.
Detecting thyroid dysfunction in dogs; Hemopet; U.S. Pat. No. 7,794,954
U.S. Patent No. 7,794,954, issued on September 14, 2010 to Hemopet of Garden Grove, CA, discloses a non-radioisotopic method of detecting canine T4AA in a blood sample.
According to the ’954 patent, autoimmune thyroid disease is one of the most common endocrine disorders of humans and domestic animals. In particular, thyroid dysfunction caused by autoimmune thyroiditis, leading to hypothyroidism, is the most common endocrine disorder of dogs. The disease is detected by testing blood samples for elevated levels of autoantibodies directed against thyroid hormones. However, existing techniques using radioimmunoassay (RIA) to perform these tests use toxic radioisotope materials, are labor-intensive, and must be performed by skilled technologists. The method disclosed by the ’954 patent is a non-radioisotopic technique using chemiluminescence assay (CLA) or electroluminescence assay (ELA) for detecting T3AA and T4AA thyroid autoantibodies in a sample that is safe, easy to perform, and has increased efficiency.
According to its website, Hemopet established the first non-profit national animal blood bank, and operates a world-renowned rescue program for greyhounds. Hemopet is a 501(c)(3) charitable organization.
In addition, Hemopet developed Hemolife, “the only pet diagnostic health laboratory for individualized diagnoses that consider age, sex, breed type and activity of the animal.” Hemolife is described as using “novel, ‘green’ non-RIA technology never offered before in veterinary medicine (patent pending).” The organization owns eight issued U.S. patents, two of which issued in 2010, including the ’954 patent.
Compound for treating epilepsy; Valeant Pharmaceuticals; U.S. Pat. No. 7,786,146
U.S. Patent No. 7,786,146, issued on August 31, 2010 to Valeant Pharmaceuticals International of Aliso Viejo, CA, discloses chemical compounds that serve as potassium channel modulators for treating epileptic seizures.
According to the ’164 patent, about 3% of people suffer from epilepsy, and about 30% of these people do not respond to currently available treatments. One drug, retigabine (or ezogabine) (N-(2-amino-4-(4-flourobezylamino) phenyl carbamic acid, ethyl ester], has shown promise in treating a broad range of seizure disorders, such as epilepsy, presumably by modulating the transport of potassium ions across the neuron’s membrane. This realization has been motivation to find additional potassium channel modulators. Some of the compounds disclosed by the ’164 patent are purported to be potassium channel modulators which “display a 40- to 400-fold improvement over retigabine.”
According to its website, Valeant Pharmaceuticals is a multinational specialty pharmaceutical company with specializations in developing treatments in neurology and dermatology, and had $830.5 million in revenues in 2009. Valeant’s neurology pipeline includes retigabine, which “has been evaluated in two large Phase III trials conducted in patients with refractory epilepsy receiving treatment with up to three antiepileptic drugs,” and is the subject of a exclusive worldwide collaboration agreement between Valeant and GlaxoSmithKline. According to a recent press release, the FDA has recently extended the goal date for its regulatory review of ezogabine by three months to November 30, 2010.
Beyond treatment of epileptic seizures, retigabine is also being evaluated for treating “post-herpetic neuralgia (PHN), a painful and common complication of shingles.” According to the company’s 2009 annual report, Valeant has a number of patents and pending patent applications covering various forms of retigabine, and the ’164 patent appears to be the result of Valeant’s efforts to find still more effective drugs.
Device for intracranial access; InnerSpace Medical, Inc.; U.S. Pat. No. 7,780,679
U.S. Patent No. 7,780,679, issued on August 24, 2010 to InnerSpace Medical, Inc. of Tustin, CA, discloses a device for preparing and accessing holes in a patient’s skull.
The technical challenges and high stakes involved in brain surgery make it probably the most-frequently cited of difficult endeavors (with rocket science and nuclear physics running a close second and third). For example, drilling a hole in the patient’s skull and accessing the patient’s brain through this hole is a complex process. To avoid traumatizing the brain by the drill plunging deeper than the skull’s thickness, a hand drill is typically used with the surgeon repeatedly adjusting a drill stop to allow incremental forward motion until the surgeon senses that the drill tip has passed through the skull. In addition, the surgeon must swab and rinse the drill site to remove the drilled bone material from the hole. Once the hole is created, the surgeon typically extends a catheter through the hole to enter a ventricle of the brain for drainage. If a tissue-monitoring or intracranial pressure (ICP) probe is to be used, a second hole is drilled into the skull. The ’679 patent discloses a device designed to make this process significantly easier for the surgeon by (i) stopping the drill bit as soon as it extends through the skull without the surgeon relying on sensing when this occurs, (ii) collecting bone material as it is produced by the drilling, (iii) directing the catheter in a simple manner, (iv) providing more radial holes for drainage, and (v) allowing placement of a ICP or tissue-monitoring probe through the same hole occupied by the catheter.
According to its website, InnerSpace Medical “has created and marketed a unique combination of patented technologies” for treating traumatic brain injury (TBI). For example, the company’s Hummingbird™ series of neurosurgery access/drainage devices provide “access through a single twist-drill hole” for ventricular drainage and intracranial pressure monitoring. Earlier this summer, the company recently had a unique product-placement opportunity in a story line on ABC’s soap opera “All My Children,” in which InnerSpace’s Hummingbird™ Synergy device was used to treat Ryan Lavery’s brain aneurysm.
The ’679 patent almost didn’t issue because the issue fee was not paid before the April 13, 2010 deadline set by the USPTO. As I described in an earlier blogpost, a Notice of Allowance from the USPTO sets a three-month deadline for paying the issue fee, and failure to pay before the deadline can result in abandonment of the patent application. Apparently, InnerSpace’s patent attorneys realized the error and paid the issue fee two weeks late on April 27, 2010, along with a petition to revive the patent application that asserted that the entire delay in payment was “unintentional.” The USPTO granted the petition, accepted the late payment, and issued the patent.
According to the USPTO database, InnerSpace Medical has three issued U.S. patents, two of which were issued in 2010 (including the ’679 patent).
Machining dental instruments; Ormco Corp.; U.S. Pat. No. 7,779,542
U.S. Patent No. 7,779,542, issued on August 24, 2010 to Ormco Corp. of Orange, CA, discloses a method of machining superelastic dental instruments.
During an endodontic root canal procedure, the nerve is removed from the tooth’s root canal, which then is filled with a rubber-like substance and sealed up. The tools used to perform such procedures include a helical flute having a spiral structure to clean out and shape the root canal. These helical flutes have previously been fabricated out of thin carbon steel or stainless steel rods that have been simultaneously grinded and twisted to form the spiral structure. More recently, superelastic materials (e.g., NiTi alloys) have been used since their flexibility provides benefits over the relatively stiff steel materials used previously. However, helical flutes made from these materials tend to lose their spiral structure by returning to their original shape after the release of an applied force (see my previous blogpost where such behavior of NiTi shape-memory alloys is a feature, not a bug). The ’542 patent discloses a method of machining these superelastic materials to make dental instruments that are flexible and highly resistant to torsional breakage.
According to its website, Ormco has been providing high quality, innovative orthodontic products for more than 45 years. Through SybronEndo, a division of Ormco Corp., the company markets a line of “twisted files” which “combine three proprietary processes to deliver unsurpassed strength and flexibility.” The company’s website has a series of videos and podcasts that demonstrate the properties of these endodontic instruments that utilize “R-phase” nickel-titanium alloy having “a crystalline structural modification that maximizes flexibility and increases resistance to breakage.”
According to the USPTO database, the ’542 patent is the third U.S. patent issued to Ormco Corp. so far in 2010, and the company received four U.S. patents in 2009 and five U.S. patents in 2008.
Removing thimerosal from medications; MGP Biotechnologies, LLC; U.S. Pat. No. 7,767,872
U.S. Patent No. 7,767,872, issued on August 3, 2010 to MGP Biotechnologies, LLC of Irvine, CA, discloses a device to remove thimerosal from medications using purified metallothionein protein.
Thimerosal is a mercury-containing organic compound that has been widely used as a preservative in vaccines. However, despite their usefulness, concerns regarding the theoretical neurotoxicity of such compounds have spurred efforts to reduce or eliminate thimerosal from vaccines. The ’872 patent discloses a system and method for removing thimerosal from medications at the time of administration of these medications to the patient.
MGP is an early-stage biotechnology company. According to a company presentation, its technology is based on the affinity of metallothionein proteins to bind to heavy metal atoms for use in medical treatments, water remediation, environmental cleanup, and recovery of precious metals. MGP’s initial target market is to develop “a point-of-use syringe filter for removal of the mercury-based preservative thimerosal from flu vaccine.”
Because of a missed deadline for paying the issue fee, the ’872 patent almost did not get issued. In December 2009, the USPTO mailed out a Notice of Allowance that set March 4, 2010 as the deadline for paying the issue fee. When that date passed without MGP making the required payment, the application became abandoned. MGP was able to successfully petition the USPTO to revive the application by making the proper payment and stating that “the entire delay … was unintentional.”
According to the USPTO database, MGP has four issued U.S. patents, including the ’872 patent, and two pending U.S. patent applications.
RFID Tags for Syringes; Codan US Corp.; U.S. Pat. No. 7,760,099
U.S. Patent No. 7,760,099, issued on July 20, 2010 to Codan US Corp. of Santa Ana, CA, discloses an RF verification system for drug delivery systems.
According to the ’099 patent, the potential for mix-ups of medications in health-care facilities such as hospitals is increasing exponentially, and written labels or bar codes have various flaws, including smudging, tearing, and separating and becoming lost from the associated container. The ’099 patent discloses a radio-frequency identification (RFID) tag that affixes to a medical container (e.g., a syringe) and that identifies the drugs in the container. Besides identifying the drug, the information provided by the device can include other information such as patient ID, physician ID, and method, route, frequency of administration. Since the information is accessed using radio waves, the medical container can be tracked throughout the hospital by an automated system.
Codan US is a subsidiary of a German corporation, Codan Medizinische Geräte GmbH & Co KG, with 1,700 employees worldwide. According to a slideshow on the Codan website, the company originated in Denmark in 1959 marketing disposable medical devices, “a revolutionary concept at the time.” The company’s Santa Ana facility, responsible for the assembly, packaging, and sterilization of products for the North American market, has its own mission statement to provide ”Infusion Therapy made Clean, Safe and Simple.” The company apparently is supportive of technical innovations coming out of the Santa Ana facility, as evidenced by the ’099 patent.
According to the USPTO database, besides the ’099 patent, Codan US owns one other U.S. patent, U.S. Design Patent No. D542,406 for an “Oral Syringe Adapter,” and three pending U.S. patent applications.
Treatment of tumors using implanted radiation sources; Cianna Medical, Inc.; U.S. Pat. No. 7,736,292
U.S. Patent No. 7,736,292, issued on June 15, 2010 to Cianna Medical, Inc. of Aliso Viejo, CA, discloses a device and method for treating breast cancer or prostate cancer using radiation sources implanted in the body (brachytherapy).
In low-dose rate (LDR) brachytherapy, multiple radiation sources or “seeds” (e.g., each about the size of a grain of rice) are implanted via needles within or near a tumor and/or surrounding tissue that may contain cancerous cells to deliver a measured and localized dose of radiation for extended periods of time. The lower radioactivity of LDR seeds provides benefits as compared to high-dose rate (HDR) brachytherapy, including less stringent safety procedures for healthcare workers, less damage of normal tissue during treatment, and fewer visits by the patient to the healthcare facility. However, there are potential drawbacks of LDR brachytherapy, such as the implanted seeds are generally not removable or repositionable, can move or migrate within the body, and need to be manipulated individually at the time of implantation, which can be a time-consuming process. The ’292 patent discloses a method and apparatus that prevents or substantially limits movement of the LDR seeds, allows removal of the seeds after treatment, and uses pre-arranged seed packages to facilitate implantation.
According to its website, Cianna Medical is “a women’s health company dedicated to the innovative treatment of early-stage breast cancer.” The website includes alot of information on Cianna’s SAVI® applicator for targeting radiation “to sculpt dose away from the skin and chest wall without sacrificing overall treatment coverage.” The SAVI® applicator appears to be compatible with some of aspects of the technology disclosed by the ’292 patent.
According to the USPTO database, Cianna has two issued U.S. patents, including the ’292 patent, and four pending U.S. patent applications. However, Cianna likely has other intellectual property protection besides these two U.S. patents. For example, a March 2009 press release by Cianna touted U.S. Patent Nos. 7,497,819 and 7,497,820 as being “directly related to its SAVI multi-catheter brachytherapy device for the treatment of breast cancer.” Yet these two patents were issued to Theragenics Corp., not Cianna. Presumably, Cianna obtained a license to these two patents from Theragenics, a hypothesis supported by the fact that Theragenics’ 2009 Annual Report states that in May 2008, the company “entered into an exclusive license agreement for the rights to certain intellectual property related to an expandable brachytherapy delivery system developed by us.” The report did not identify Cianna as the licensee, but gave some information regarding the license including the minimum annual royalties.
TechAmerica OC’s “High-Tech Innovation” Awards and Finalists; Clarient
On June 2, 2010, I attended the 17th Annual High-Tech Innovation Awards presented by TechAmerica OC. A number of my firm’s clients were finalists for awards in the various categories, and I was happy to see that a few of them picked up awards in areas including medical technology and “green” technology.
I had the pleasure of sitting at a table with Ronnie Andrews, CEO of Clarient, Inc. of Aliso Viejo, CA, and a few members of his team. Clarient develops innovative cancer diagnostic technologies, and was a finalist in the medical technology category. From our conversation, it was clear that they see patent protection as an important part of Clarinet’s success, and that they are on top of the latest developments in patent law as they relate to Clarient’s business.
According the USPTO database, Clarient’s most recent U.S. patent issued in March 2010 as U.S. Pat. No. 7,678,581 for a method of ”Correlating chemical and spatial data within pathology samples.”
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