[author: Kevin E. Noonan]
In an otherwise unremarkable case of a PTO rejection based on anticipation, Judges Dyk and Lourie engaged in an interesting colloquy on the proper interpretation of what constitutes inherent anticipation, in In re Montgomery. The case involved claims to methods for "treating or preventing" stroke, using "renin-angiotensin system (RAS)" inhibitors, specifically ramipril. The claims at issue included the following:
42. A method for the treatment or prevention of stroke or its recurrence, wherein said method comprises administering, to a patient diagnosed as in need of such treatment or prevention, an inhibitor of the rennin-angiotensin system, said inhibitor having a ClogP of greater than about 1.
43. The method as claimed in claim 42, wherein the inhibitor of the rennin-angiotensin system comprises at least one inhibitor of angiotensin-converting enzyme.
45. The method as claimed in claim 43, wherein the inhibitor of angiotensin-converting enzyme comprises ramipril.
(Emphasis in original)
The claims were rejected based on any of four prior art references:
• AIRE (The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators, Effect of Ramipril on Mortality and Morbidity of Survivors of Acute Myocardial Infarction with Clinical Evidence of Heart Failure, 342 Lancet 821 (1993));
• Frampton (James E. Frampton & David H. Peters, Ramipril: An Updated Review of Its Therapeutic Use in Essential Hypertension and Heart Failure, 49 Drugs 440 (1995) (abstract));
• HOPE (The HOPE Study Investigators, The HOPE (Heart Outcomes Prevention Evaluation) Study: The Design of a Large, Simple Randomized Trial of an Angiotensin- Converting Enzyme Inhibitor (Ramipril) and Vitamin E in Patients at High Risk of Cardiovascular Events, 12 Can. J. Cardiology 127 (1996)); or
• Gohlke (Peter Gohlke et al., Angiotensin-Converting Enzyme Inhibition Improves Cardiac Function, 23 Hypertension 411 (1994)) as evidenced by Richer (C. Richer et al., Antihypertensive Drugs in the Stroke-Prone Spontaneously Hypertensive Rat, 19 Clinical & Experimental Hypertension 925 (1997) (abstract), available here.
The Examiner, and the Board, found that each of these references taught administration of ramipril to individuals at risk for stroke (the Court's opinion noting that the limitation that the RAS inhibitor had "a ClogP of greater than about 1" was inherently a property of ramipril).
Specifically, the Board made the factual determinations that "[h]ypertension is a known risk for stroke" and that the cited references described studies showing treatment of patients with hypertension with ramipril (although at least in the AIRE study the results were not statistically significant). The HOPE study was described as involving the combination of ramipril and Vitamin E "in the prevention of myocardial infarction, stroke, or cardiovascular death." (The HOPE study showed statistically significant reduction in stroke risk, but not until after Montgomery's priority date.) The Gohlke reference showed "the effects of . . . ramipril on functional and biochemical cardiac parameters in stroke-prone spontaneously hypertensive rats," which found that the treatment "improves cardiac function even at low doses," where Richer established that "[t]he stroke-prone spontaneously hypertensive rat . . . is an experimental model that has been widely used to investigate the potential preventive effects vs stroke and mortality of numerous antihypertensive agents." The Board construed the claims as having two elements: "(1) 'to administer an inhibitor of the rennin-angiotensin system,' and (2) 'the patient population receiving the inhibitor . . . encompasses patients diagnosed as required stroke treatment or prevention.'" The Board held that each reference provided these elements and hence anticipated the claims.
The Federal Circuit opinion noted that the Board did not rule "directly" on the question of whether the claims contained a requirement that the method be effective at...
