Friday, February 13, 2009

A correlation step is an element for anticipation purposes (BPAI)

Ex parte FLORIAN KRONENBERG (BPAI)
Appeal 2008-4087
Application 10/485,039
Technology Center 1600
Decided: February 13, 2009

The claims below were ultimately found to be anticipated and obvious based upon other references than the one I describe below but I have seen a rejection in a case I am working on where the correlation or diagnosing step is ignored when determining whether something is anticipated. The definiteness issue is also helpful because it slaps the Examiner for making an illogical argument.

19. A method of diagnosing early stage renal impairment in humans, comprising:
measuring an amount of apoA-IV in a plasma sample or a serum sample of a human;
comparing the measured amount of apoA-IV with a reference value; and
diagnosing early stage renal impairment based on the comparison of the measured amount of apoA-IV with the reference value.

50. A method of diagnosing coronary heart disease in humans who suffer from renal impairment comprising:
measuring the amount of apoA-IV in a plasma sample or a serum sample of a human;
comparing the measured amount of apoA-IV with a reference value; and
diagnosing coronary heart disease in humans who suffer from renal impairment based on the comparison of the measured amount of apoA-IV with the reference value.

The Examiner alleged that claims 19 and 50 were indefinite because "the interrelationships of the steps are not clear because it is not clear in what or for what diagnosing is being made or how diagnosing is “based on” the comparison. There are no limitations found in the claims limiting the human (patient) population, defining “early stage” from any other renal impairment, or other, condition wherein a patient has an elevated apoA-IV level, or even setting forth that the diagnosis is for the condition in the human providing the sample."

The Board reversed finding when read in light of the specification the terms were clear. In part, the Board stated: "We disagree with the Examiner’s finding that “it is not clear in which humans or human, or in what manner, one is to diagnose the condition with the measurement comparison”"…"That manner of diagnosis in either of claim 19 or claim 50 would be any manner that would measure the amount of apoA-IV in a plasma or serum sample of a human."


The Examiner also rejected a kit claim as being indefinite because it included a calibration curve. The Examiner found that “[c]laim 49 provides no further limitation of the components of the kit. The curve, essentially printed matter, merely relates to the intended use for the components of the kit” The Board reversed holding: A person of ordinary skill in this art understands what is meant by the term “calibration curve.” Further, we know of no prohibition against the inclusion of language relating to the intended use of article of manufacture (e.g., a kit). Accordingly, the term is not indefinite even if it represents printed matter and relates to the intended use of the kit’s components.

The Examiner also rejected the claims as anticipated. The Examiner found a reference that disclosed the measuring steps but did not include the diagnosing step and because there is nothing "other than a mental step setting forth an intended result, or a characterization of the results, from the active measuring and comparing steps." the claim was anticipated. The Board reversed and agreed with the Appellant finding that the reference did not disclose the diagnosing step. The Board stated, "There is no evidence on this record that [the reference] correlated apoA-IV levels to early stage renal impairment or coronary heart disease in humans who suffer from renal impairment is diagnosed. The fact that [the reference] teaches an ELISA for detecting apoA-IV is not sufficient to anticipate Appellant’s method claims."

Case can be found here