[For purposes of anticipation under 35 U.S.C. § 102(b),] a result is only inherent if it inevitably flows from the prior art disclosure.
On May 8, 2012, in In re Montgomery, the U.S. Court of Appeals for the Federal Circuit (Lourie, Dyk,* Prost) affirmed the USPTO Board of Patent Appeals and Interferences decision upholding the patent examiner's rejection of U.S. patent application Serial No. 11/118,824, which related to renin-angiotensin system (RAS) inhibitors, as anticipated. The Federal Circuit stated:
"Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo." "During examination, 'claims . . . are to be given their broadest reasonable interpretation consistent with the specification, and . . . claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art.'" The broadest reasonable interpretation, like claim construction in the infringement context, is a question of law that we review de novo. "The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence." A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation. A reference may anticipate inherently if a claim limitation that is not expressly disclosed "is necessarily present, or inherent, in the single anticipating reference." The inherent result must inevitably result from the disclosed steps; "[i]nherency . . . may not be established by probabilities or possibilities."
The contested elements of claim 45 are the administration of ramipril (1) "to a patient diagnosed as in need of [stroke] treatment or prevention," (2) where such administration is "for the treatment or prevention of stroke or its recurrence." We thus determine de novo the broadest reasonable interpretation of each of these requirements. Because we conclude that HOPE [prior art reference] discloses both requirements, we need not address Montgomery's arguments concerning [the other prior art references,] AIRE, Frampton, and Gohlke.
We first examine the requirement that the administration be "to a patient diagnosed as in need of [stroke] treatment or prevention." Montgomery does not contest that the patients in HOPE satisfy this claim requirement. HOPE explicitly disclosed the administration of ramipril to patients "at high risk for cardiovascular events such as myocardial infarction and stroke," and the eligibility criteria included patients with previous stroke. We see no error in the Board's uncontested conclusion that HOPE discloses the administration of ramipril to patients diagnosed as in need of stroke treatment or prevention.
We next turn to the preamble requirement that the method be "for the treatment or prevention of stroke or its recurrence." The Board did not rule directly on whether the broadest reasonable interpretation of the claims required that the treatment or prevention be effective or whether it was sufficient that the administration be designed to treat or prevent stroke. But in resting the decision on inherency, the Board appeared to assume that the patent included an efficacy requirement. We are skeptical that a proper interpretation of the claims would include an efficacy requirement. . . . We need not resolve this question, however, for we agree with the Board that even if the claim includes an efficacy requirement, efficacy is inherent in carrying out the claim steps. We agree with the dissent that a result is only inherent if it inevitably flows from the prior art disclosure, but there is no question here that treating stroke-prone patients with ramipril does in fact inevitably treat or prevent stroke. And Montgomery does not dispute that ramipril is in fact effective at preventing or treating stroke, which is the entire premise of his patent. We have repeatedly held that "[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent . . ." HOPE discloses a protocol for the administration of ramipril to stroke-prone patients, and administering ramipril to stroke-prone patients inevitably treats or prevents stroke. Thus, HOPE inherently anticipates the claims at issue.
However, Montgomery urges that inherent anticipation requires that the claimed method have been actually performed, and that HOPE does not disclose actual performance of the method. This is not correct; HOPE reveals the actual administration of ramipril for treatment or prevention of stroke. In any event, even if HOPE merely proposed the administration of ramipril for treatment or prevention of stroke (without actually doing so), it would still anticipate.
To be sure, as the dissent points out, "[a]n invitation to investigate is not an inherent disclosure." But HOPE's protocol for the administration of ramipril is far from an abstract theory -- it is an advanced stage of testing designed to secure regulatory approval. HOPE was designed to obtain data for submission to regulatory agencies on the effect of ramipril on cardiovascular diseases including stroke based on substantial evidence that ramipril improved cardiovascular health, including by treating stroke risk factors such as hypertension. It is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials. In all relevant respects, HOPE is identical to the patent itself, which does not disclose actual results from the administration of ramipril for these purposes. Montgomery conceded at oral argument that HOPE's authors could have obtained the patent claims at issue based on the HOPE reference so it cannot be that this reference fails to anticipate. We thus affirm the rejection of claims 42, 43 and 45 of the '824 application as anticipated by HOPE. Because we affirm the Board's decision on this ground, we need not reach the issue of whether the claims are anticipated by the other prior art considered by the Board.