Recite Mental Steps

One very significant issue in claiming new uses for old compounds or devices is that the new use might have been inherent in the old use. For example, in the Broccoli case , the Federal Circuit addressed claims directed to treating disease by selecting and eating sprouts from cruciferous vegetables having especially high levels of advantageous compounds. The Court held that the claims were invalid on the rationale that people had eaten such sprouts for centuries, and it was inherent in the prior art that people were treating cancer (unknowingly) by selecting and eating such sprouts. One possible way around that rationale may well be to expressly recite a mental step of "appreciating" or "recognizing." For example, an applicant could claim "A method of treating a cancer comprising: recognizing that cruciferous sprouts <<under certain conditions>> contain <<an especially high level of some compound>>; and ingesting the sprouts for the purpose of treating the cancer".

U.S. 6063772 successfully uses this very strategy.

1. A method of treating a disease responsive to ribavirin, comprising:

recognizing progression of the disease as being mediated at least in part by Th1 lymphocytes;

recognizing ribavirin as being effective to promote a Th1 response and suppress a Th2 response when administered in a dosage range below which both Th1 and Th2 responses are suppressed; and

administering ribavirin to a patient having the disease within the dosage range.

U.S. 4683195 employs a similar mental step strategy, but instead of reciting "recognizing", the claims use the term "suspected of containing".

1. A process for detecting the presence or absence of at least one specific nuclei acid sequence in a sample containing a nucleic acid or mixture of nucleic acids, or distinguishing between two different sequences in said sample, wherein the sample is suspected of containing said sequence or sequences, which process comprises….

U.S. 6541267 employs yet another similar strategy, this time relying on the mental step of "correlating".

1. A method of determining oxidative stress in a subject, comprising:

correlating a presence of an aldehyde in urine of a subject with an oxidative stress in the subject;

providing a test reagent comprising a pH regulator, a reducing agent, and an aldehyde-reactive chromogen, wherein the reducing agent includes at least one of a sulfur atom and a phosphor atom;

combining the test reagent with the urine to produce an aldehyde-modified chromogen; and

correlating a color of the aldehyde-modified chromogen with the oxidative stress.

Whether this strategy will be upheld against challenges is unclear. In Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings , the Federal Circuit upheld "correlating" language in claim 13 of U.S. patent 4940658 against challenges to indefiniteness, sufficiency of written description, enablement, anticipation, and obviousness.

13. A method for detecting a deficiency of cobalamin or folate in warm- blooded animals comprising the steps of:

assaying a body fluid for an elevated level of total homocysteine; and

correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

The Court further found that physicians directly infringed the patents by ordering the assays and correlating the results, and that LabCorp indirectly induced infringement by providing the assays. On appeal LabCorp challenges validity of the claim as reciting nothing more than a scientific principle or law of nature, i.e., "no actual invention beyond the scientific discovery it recites". Of course, the Supreme Court may yet reverse the Federal Circuit as to patentability of the subject matter. But if so that Court would be running against very longstanding practice. As of January 2006, the USPTO database lists 11,717 recent (since 1976) patents that include the term "correlating" in the claims, 10,106 patents that include the term "recognizing" in the claims, and 1,349 patents that include the term "suspected of containing" in the claims.