Patent claims directed to a method for using screening markers to determine the risk of Down's syndrome are invalid under 35 U.S.C. § 101, the Federal Circuit has held. In Perkinelmer, Inc. v. Intema Ltd., No. 2011-1577 (Fed. Cir. Nov. 20, 2012), the Federal Circuit reversed a lower court's holding that claims of U.S. Patent No. 6,573,103 were valid under Section 101. Thus, the Federal Circuit did not address the District Court's holding that the asserted claims of the '103 patent were invalid as anticipated or obvious under 35 U.S.C. §§ 102 and 103.
The claims of the ’103 patent recited assaying samples, during both the first and second trimesters of pregnancy, from a woman to obtain a biochemical marker as well as making measurements from ultrasounds to obtain ultrasound screening markers. The risk of Down's syndrome was then determined “by comparing the measured levels of” the screening markers “with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.” Claim 1 of the ’103 patent is reproduced at the end of this post.
The District Court had “held that the claims cover patent-eligible subject matter because, even though they recite an ineligible algorithm, they focus on a data-gathering method.” Further, the District Court thought that the machine-or-transformation test confirmed its holding because assaying involved a “transformation,” and measuring used an ultrasound machine.
As one might guess, the very first case cited in the Court's legal analysis was the 2012 Supreme Court decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc., for the proposition that “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.” Claims that recite patent-ineligible concepts such as natural laws, according to the Mayo Court, are patentable only if they “contain other elements or a combination of elements, sometimes referred to as an ’inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.”
Here, the patent owner argued that “the claims are directed to a specific medical test, not to an abstract method.” The patent owner further argued that assaying involved a chemical transformation, and that “the measurement of an ultrasound scan involves the transformation of data into a visual depiction.”
The Federal Circuit rejected these arguments, stating that the claims of the ’103 patent failed the “inventive concept” requirement set forth by the Supreme Court in Mayo. Citing Mayo and Parker v. Flook, 437 U.S. 584 (1978), the Court explained that “conventional pre-solution activity” cannot make a claim patentable. The claimed relationship between screening markers and the risk of Down's syndrome was a law of nature. “Measuring” and “determining” steps were insufficient to make the claims patent-eligible. Further, “[l]ooking to the claims as a whole, the steps in combination do not make the ineligible mental step and natural law patent-eligible.”
Finally, even if the claims passed the machine-or-transformation test, they would have been unpatentable. However, the claims failed the MOT test. The assaying step need not involve a transformation if science later develops a totally different method of assaying that does not require a transformation. The ultrasound measuring step at most transformed ultrasound scan data into data relating to the risk of Down's syndrome, and did not require any visual depiction or transformation. In short, “the data-gathering steps are conventional and obvious extra-solution activity that cannot save the claims.”
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 obtained from the pregnant woman at said first trimester of pregnancy for at least one first biochemical screening marker; and/or
(ii) measuring at least one first ultrasound screening marker from an ultrasound scan taken at said first trimester of pregnancy;
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 obtained from the pregnant woman at said second trimester of pregnancy for at least one second biochemical screening marker; and/or
(ii) measuring at least one second ultrasound screening marker from an ultrasound scan taken at said second trimester of pregnancy; 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.