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Mallindrockt v. Praxair

Representative Claim(s)

‘741 – 1. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, the method comprising:

(a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment;

(b) determining that a first patient of the plurality does not have left ventricular dysfunction;

(c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide;

(d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and

(e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.

Posture:

Bench Trial

Exception Categories: Law of Nature, Natural Phenomenon

“Plaintiffs’ expert, Dr. Rosenthal, and Defendants’ expert, Dr. Lawson, agreed that iNO’s effect on a neonate with LVD was a matter of human physiology. Specifically, administering iNO to neonates or children with LVD may cause pulmonary edema because iNO causes the pulmonary vessels to relax. That relaxation leads to increased blood flow, causing increased pulmonary capillary wedge pressure, and, possibly, pulmonary edema. According to Dr. Lawson’s credible and convincing testimony, the ‘standard observation‘ that a dysfunctional ventricle, in combination with increased blood flow, could cause a backup of venous blood, and, in turn, edema, is a law of nature taught to first year medical students.”

“Here, just like in Mayo, some of the claimed steps require human action. Nonetheless, the core of the alleged invention is the increased risk of pulmonary-capillary wedge pressure that develops when administering iNO to term or near-term patients with both hypoxic respiratory failure and left-ventricular dysfunction. …That ‘invention’ is really a patient populations’ natural physiological response to 20 ppm of inhaled nitric oxide treatment. While man discovered the adverse physiological response that occurs when some patients receive iNO, such a discovery does not amount to innovation. The question before the court, therefore, is whether the claimed method does more than simply describe the natural phenomenon. In turning to that question, the court must tread cautiously, making sure that the method claim does more than ‘recite the law of nature and [ ] add the instruction ‘‘apply the law.’’

Significantly More: No

“The last step of claim 1’s method directs physicians to exclude a patient with LVD from treatment with iNO, based on the determination that, given the patient’s LVD, he is at an increased risk of increased PCWP leading to pulmonary edema when treated with iNO. It is really this last step, Plaintiff’s argue, that makes the method-at-issue worthy of patent protection. According to Plaintiffs, ‘[n]one of the clinical trials (other than the revised INOT22 protocol) excluded neonates or children with LVD from iNO therapy prior to the critical date, underscoring that the methods involve a new use for iNO.’ But, as the Supreme Court and the Federal Circuit have previously recognized, ‘even valuable contributions [to science] can fall short of statutory patentable subject matter.’ ”

“The ‘excluding’ step is really no different than the ‘wherein’ clauses of the patent at issue in Mayo. In Mayo, after administering a drug and determining ‘the level of 6–thioguanine in said subject,’ the person practicing the patent was advised of the following: if the level of 6-thioguanine was ‘less than about 230 pmol per 8×108 red blood cells,’ that ‘indicate[d] a need to increase the amount of said drug subsequently administered.’ [citation omitted] Here, just as in Mayo, the applicationstep of the claimed method simply tells the relevant audience about the natural phenomenon and directs that audience to take that phenomenon into account when treating patients. The natural phenomenon is that some patients with preexisting LVD have a negative reaction to treatment. Plaintiffs cannot seriously contend that it is a new practice to exclude certain patients from treatment with a drug when those patients are at an increased risk of experiencing negative side effects from the drug. In fact, the HF’s patents inventor testimony would contradict any such contention.”

“Dr. Baldassarre stated that it was his ‘observation’ in the INTO22 study that led to the          ‘invention’ claimed in the HF patents. The purpose of the invention, according to Dr. Baldassarre, was to notify physicians ‘to look for a specific circumstance which might indicate that [a] child was at a higher risk of a serious adverse event.’ Simply excluding children or neonates from iNO treatment based on that specific circumstance is no different than stating the law of nature and adding the words ‘apply it.’ While it may not have been routine to exclude neonates with LVD from treatment with iNO before the INOT22 study, that does not make the last step of claim 1 inventive. Terminating treatment for patients experiencing adverse reactions to it was known in the art. Tacking that step on to a study’s observation of an adverse event associated with a specific defect does not make the claim patent-eligible.”

“The court comes to the same conclusion when considering the method as a whole. Contrary to Plaintiff’s assertion, the HF claims are not directed to a new way to use an existing drug. Instead, the claims are directed to a conventional response to the discovery of a serious adverse event. The method offers no innovation or improvement over the prior art outside of the novel realization that patients with LVD should not receive iNO treatment because their bodies respond to that treatment in a way that increases their risk of pulmonary edema. While that realization may be valuable, it is not worthy of patent protection.”