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PerkinElmer v. Interna Ltd.

Representative Claim(s)

1. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome, the method comprising the steps of:

measuring the level of at least one screening marker from a first trimester of pregnancy by:

(i) assaying a sample …; and/or

(ii) measuring at least one first ultrasound screening marker from an ultrasound scan …;

measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:

(i) assaying a sample …; and/or

(ii) measuring at least one second ultrasound screening marker from an ultrasound scan …; and

determining the risk of Down’s syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies.

20. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome, the method comprising the steps of:

measuring the level of at least one first screening marker from a first trimester of pregnancy by:

(i) assaying a sample …; and/or

(ii) measuring at least one first ultrasound screening marker from an ultrasound scan …;
determining a first risk estimate of Down’s syndrome by comparing the measured level of the at least one first screening marker level from the first trimester of pregnancy with observed relative frequency distributions of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies;

comparing the first risk estimate with a predetermined cut-off level to initially classify the pregnant woman as screen-positive or screen-negative based on the comparison;

and if the pregnant woman is initially classified as screen-negative; measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:

(i) assaying a sample …; and/or

(ii) measuring at least one second ultrasound screening marker from an ultrasound scan…
and determining the risk of Down’s syndrome by comparing the measured level of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from second trimester of pregnancy with observed relative frequency distributions of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies.

Posture:

Appeal from decision of the District Court.  The District Court determined that claims were drawn to patent-eligible subject matter under 35 U.S.C. § 101, but held that the asserted claims were anticipated and obvious.

 

Exception Categories: Law of Nature, Abstract Idea

“Here, Intema claims analytical methods to determine the risk of fetal Down’s syndrome… The claims… recite the mental process of comparing data to determine a risk level: data are gathered in the first trimester of pregnancy; data are gathered in the second trimester of pregnancy; those data are compared to known statistical information. No action beyond the comparison is required.”

“Intema also claims a law of nature: the relationship between screening marker levels and the risk of fetal Down’s syndrome… Since Intema’s claims recite mental processes and natural laws, we must decide if Intema added enough to the statements of ineligible subject matter to direct the claims, not to the ineligible concepts themselves, but to applications of those concepts. We think not.”

Significantly More: No

The court first assessed whether the individual measuring and determining steps were sufficient to make the claims patent-eligible.  Finding that the patent directs users to measure screening markers “through whatever known method they wish,” the court held that such measuring steps were well-understood, routine, and conventional.  The court also found the determining step to be insufficient to make the claims patent-eligible, holding that the step merely required a comparison to well-understood, conventional statistical information.

The court also found that the combination of the measuring step and the determining step were not enough to move the claims over the threshold of patent eligibility.  “As the Court in Mayo reasoned, anyone who wants to use this mental step or natural law must follow the claimed process. Mayo, 132 S.Ct. at 1298. And, as in Mayo, there is no requirement that a doctor act on the calculated risk.  There is at most ‘a suggestion’ that the doctor take the mental determination into account when assessing the patient.”