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.