Federal Circuit Evaluates Patentability of "Providing Information" Claim Limitation
In re Kao (decided 5/13/11)By: Y. Jenny Chen
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What This Means to You
- When relying on a step of "providing dosage information" to establish patentability of a medical treatment claim over prior art, consider:
- Including a "functional relationship" between the dosage information and the administration step in the claimed treatment, and
- If applicable, providing evidence that a secondary consideration bears a connection to the "providing information" step.
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Overview
In a recent decision (In re Kao), the Federal Circuit reaffirmed the “functional relationship” test in determining whether an applicant can rely on a step of “providing dosage information” in a medical treatment claim to establish patentability.
Case Background
Endo Pharmaceuticals, Inc. was the assignee of a patent application covering a medical treatment that involved a step of “providing dosage information.” The application was rejected by the US Patent and Trademark Office (“PTO”) for reasons of obviousness over the prior art, and the rejection was appealed to the PTO’s Board of Patent Appeals and Interferences (“Board”) which affirmed the rejections.
Endo appealed the Board’s decisions to the Federal Circuit, and the Federal Circuit affirmed.
Decision Analysis
Endo argued that the claimed medical treatment was patentable over the cited art because it required providing information about a correlation between renal conditions and drug bioavailability, which is not taught or suggested in the cited art.
The Federal Circuit disagreed. Following a line of precedent decisions, the court appliedits “functional relationship” test to determine whether the “providing information” step was sufficient to render the claimed treatment patentable.
The court found the claim at issue did not require adjusting drug dosage based on a patient’s renal conditions; nor did it even reference the actual condition of the patient’s renal system. In view of these findings, the Federal Circuit concluded that the step of “providing dosage information” bore no patentability weight because there was no functional relationship between the information-providing step and the administration step in the claimed treatment.
In light of Endo’s evidence of secondary consideration, the Federal Circuit concluded that it is not sufficient to rebut the obviousness rejection as there is no evidence showing that the secondary considerations are attributable to the information-providing step in the claimed treatment.
Takeaway
For claims that rely on a “providing information” step to get around prior art, it is important to set forth in the claims a functional relationship between the “providing information” step and another active step recited in the claims.
