496 F. App'x 65
Fed. Cir.2012Background
- Intema appeals a district court grant of summary judgment to PerkinElmer on patent-eligibility under 35 U.S.C. § 101 for the ’103 patent.
- The district court held the claims focus on data gathering and satisfy the machine-or-transformation test, rendering them patent-eligible.
- The district court construed claims 1 and 20 as directed to determining Down’s syndrome risk by comparing marker distributions from first and second trimesters.
- The district court found the claims recite a patent-eligible application despite alleged ineligible abstract mental steps and a natural law.
- This court reviews only the § 101 eligibility issue and reverses the district court’s position on eligibility.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether claims 1 and 20 are patent-eligible under § 101. | Intema: claims are specific medical tests, not abstract concepts. | PerkinElmer: claims recite an ineligible algorithm and fail the machine-or-transformation test. | No; claims are ineligible under § 101. |
| Do the steps of measuring and determining render the claims patentable applications of natural laws/mental processes? | Intema: measuring transforms data; two-marker approach applies a medical test. | PerkinElmer: steps are merely conventional data gathering; not transformative enough. | No; steps constitute conventional activity and fail the inventiveness requirement. |
| Does the machine-or-transformation test save the claims? | Intema: data gathering and measured markers transform samples or data into useful outputs. | PerkinElmer: transformation is not sufficiently tied to a machine or tangible output. | No; the test does not rescue the claims; they do not produce a patentable transformation. |
| How does Myriad influence the analysis of these process claims? | Intema: Myriad supports non-mental-process patentable applications. | PerkinElmer: Myriad favors identifying abstract mental steps; no patentable subject matter here. | Precedent from Mayo and Myriad supports ineligibility; the claims fail § 101. |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 140 (U.S. 2012) (laws of nature not patentable; inventive concept required)
- Association for Molecular Pathology v. PTO, 689 F.3d 1303 (Fed. Cir. 2012) (Myriad; mental steps as ineligible when not tied to application)
- Diehr, Diamond v. Diehr, 450 U.S. 175 (U.S. Supreme Court 1981) (inventive concept in context of a transformative process)
- Gottschalk v. Benson, 409 U.S. 63 (U.S. Supreme Court 1972) (mental processes not patentable)
- In re Abele, 684 F.2d 902 (C.C.P.A. 1982) (transformation of data as an improving claimed process, but distinguishable)
- In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (data gathering steps not alone ensuring statutory subject matter)
- Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) (distinguishes patent-eligible applications from abstract principles)
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (Supreme Court 2012) (emphasizes inventive concept; pre-solution activity insufficient)
- Myriad Genetics, Inc. v. Ass’n for Molecular Pathology, 689 F.3d 1303 (Fed. Cir. 2012) (claims reciting abstract mental steps lacking patentable application)