Opinion ID: 4517001
Heading Depth: 3
Heading Rank: 1

Heading: The Claims are Directed to a

Text: Patent-Ineligible Natural Phenomenon The claims are directed to a natural phenomenon because the patent’s claimed advance is the discovery of that natural phenomenon. The Majority disregards well-established precedent for conducting the Alice, step one, “directed to” inquiry by failing to consider the patent’s claimed advance. The Supreme Court first articulated the “directed to” inquiry in Alice, 573 U.S. at 217–218. To make that determination, the Court analyzed whether the claims “involved” patent-ineligible subject matter (there, an abstract idea). Id. at 218–220 (citing Gottschalk v. Benson, 409 U.S. 63, 71–72 (1972), and Bilski v. Kappos, 561 U.S. 593, 599 (2010)). In the three years following Alice, this court addressed numerous § 101 cases without articulating a more definite “directed to” inquiry. Instead, we performed step one of the patent-eligibility inquiry by comparing the claims at issue to the claims held eligible or ineligible in earlier Supreme Court and Federal Circuit cases. See, e.g., In re Smith, 815 F.3d 816, 818 (Fed. Cir. 2016); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1353 (Fed. Cir. 2014). Since 2016, in a string of cases reciting process claims, we began conducting the “directed to” inquiry by asking whether the “claimed advance” of the patent “improves upon a technological process or [is] merely an ineligible concept.” Athena, 915 F.3d at 750 (Lourie, J.); Genetic Techs., 818 F.3d at 1375. To determine a process’s “claimed advance,” we review the claims and the written description. Athena, 915 F.3d at 750. If a written description highlights the discovery of a natural phenomenon—e.g., by describing the natural phenomenon as the only “surprising” or “unexpected” aspect of the invention or that the invention is “based on the Case: 19-1419 Document: 55 Page: 22 Filed: 03/17/2020 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. 7 discovery” of a natural law—the natural phenomenon likely constitutes the claimed advance. See Ariosa, 788 F.3d at 1376; Athena, 915 F.3d at 751; Cleveland Clinic, 859 F.3d at 1360 –61. In Ariosa, we concluded that the claims were directed to a natural phenomenon based in part on the patent’s disclosure that the natural phenomenon was a “surprising and unexpected finding.” 788 F.3d at 1376 (citation and quotation omitted). In Athena, we concluded that the claimed advance was “only in the discovery of a natural law” based in part on the patent’s disclosure that the inventors “surprisingly found” the natural law. 915 F.3d at 751 (citation and quotation omitted). In Cleveland Clinic, we concluded that the claims were directed to a natural law relying, in part, on the patent’s disclosure that “the inventions are ‘based on the discovery’” of the natural law. 859 F.3d at 1360–61 (citation omitted). Here, the claimed advance is the inventors’ “surprising[]” discovery of a natural phenomenon—that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream. See ’751 patent col. 1 ll. 54–61. Like in Ariosa and Athena, the patent’s written description identifies the natural phenomenon as the only “surprising finding.” Id. at col. 1 l. 54–col. 2 l. 6. And the patent explains that the natural phenomenon “forms the basis of the present invention,” like the patent in Cleveland Clinic. Id. at col. 2 ll. 1–6. It is undisputed that the surprising discovery is a natural phenomenon. See Maj. Op. at 3–4, 8. The claimed advance is, therefore, the natural phenomenon. This conclusion is bolstered by the fact that the claimed method steps begin and end with a naturally occurring substance, as in Ariosa. 788 F.3d at 1376. In Ariosa, we found ineligible process claims directed to a method of detecting paternally inherited cff-DNA. Id. The claimed method steps began with a naturally occurring blood sample and ended with cff-DNA, both naturally occurring substances. Case: 19-1419 Document: 55 Page: 23 Filed: 03/17/2020 8 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. Id. The inventors did not create or alter any of the genetic information encoded in the cff-DNA in the claimed method steps. Id. Likewise, the claimed method here begins and ends with a naturally occurring substance. The claimed method begins with extracting a sample of blood plasma or serum from a pregnant mother that consists wholly of various naturally occurring substances, including cff-DNA. ’751 patent col. 7. ll. 58–61. The claimed method separates those naturally occurring substances by size, leaving a “fraction” of the original sample that is predominantly cff-DNA. Id. at col. 7 ll. 63–67, col. 8 ll. 53–55. The claimed method ends with analyzing the components of the “fraction,” which contains cff-DNA. Id. at col. 8 ll. 56–57. The substances present throughout the process are naturally occurring substances, and the claimed method steps do not alter those substances. The claimed method is therefore directed to a natural phenomenon. The Majority fails to identify the claimed advance The Majority’s step one analysis ignores the claimed advance inquiry altogether. Contrary to the Majority’s conclusion, the claims here are not directed to “a patent-eligible method that utilizes [the natural phenomenon].” Maj. Op. at 8–9. Although the Majority states that the claims “are directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA” (id. at 9), the Majority fails to address with specificity the patent’s claimed advance. Instead, the Majority only seems to suggest that the claimed advance is an improvement in “size discriminat[ion]” and “selective[] remov[al]” techniques. See id. at 9–10. The Majority reasons that the inventors used “specific process steps” of “size discriminating and selectively removing DNA fragments that are above a specified size threshold” and that these “concrete process steps . . . exploit [the natural phenomenon] in a method for preparation of a Case: 19-1419 Document: 55 Page: 24 Filed: 03/17/2020 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. 9 mixture enriched in fetal DNA.” Id. at 10–11. But whether the steps are concrete is not the appropriate analysis for determining the claimed advance. Where a written description identifies a technology as well-known or performed using commercially available tools or kits, that technology cannot logically constitute a claimed advance. Ariosa, 788 F.3d at 751; see also Athena, 915 F.3d at 751 (identifying the claimed “immunological assay techniques [as] known per se in the art” and therefore not the claimed advance); Cleveland Clinic, 859 F.3d at 1361 (relying on the patent’s disclosure of “commercially available testing kits” for detecting the natural law). Here, the claimed advance is not an improvement in the underlying DNA-processing technology, as hinted by the Majority. The written description identifies the claimed method steps as well-known or performed using commercially available tools or kits. See ’751 patent col. 2 l. 49–col. 3 l. 18, col. 3 ll. 49–50, col. 3 l. 65–col. 4 l. 13, col. 5 ll. 45–50. For example, the table below highlights the commercially available tools and kits that are identified in the written description as used to perform each claimed method step. Case: 19-1419 Document: 55 Page: 25 Filed: 03/17/2020 10 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. Performance of Claimed Method Steps Commercially Available Claimed Method Step Tool or Kit QIAgen Maxi kit Claim 1(a), “extracting (’751 patent col. 3 ll. 49– DNA” 50) Invitrogen 1% agarose gel (’751 patent col. 3 ll. 66– 67) New England Biolabs 100 Claim 1(b)(i), “size dis- base pair ladder crimination” (id. at col. 4 ll. 4–5) Claim 1(b)(ii), “selec- Lamda Hind III digest tively removing” (’751 patent col. 4 ll. 5–6) QIAEX Gel Extraction kit (id. at col. 4 ll. 10–12) Applied Biosystems (ABI) 7000 Sequence Detection System (’751 patent col. 4 ll. 14– Step (c), “analyzing a ge- 38) netic locus” TaqMan System and TaqMan Minor Groove Binder (id. at col. 4 ll. 19–38) The selection of 300 and 500 base pairs resulted from using commercially available DNA size-markers. See id. at col. 4 ll. 3–9. The claimed DNA-processing technologies do not, therefore, constitute the claimed advance. See Cleveland Clinic, 859 F.3d at 1361. Case: 19-1419 Document: 55 Page: 26 Filed: 03/17/2020 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. 11 The Majority relies on CellzDirect. See Maj. Op. at 12– 13. But CellzDirect is different from this case. In CellzDirect, the inventors created a new and useful cryopreservation technique comprising multiple freeze-thaw cycles. 827 F.3d at 1048. The claimed invention went beyond applying a known laboratory technique to a newly discovered natural phenomenon and, instead, created an entirely new laboratory technique. Id. Unlike CellzDirect, the claimed method steps here are not new nor are the claimed techniques used in a new or unconventional way. The Majority recognizes that the inventors “did not invent centrifugation, chromatography, electrophoresis, or nanotechnology”—the claimed techniques described in the written description. Maj. Op. at 13. The Majority’s remaining reasoning fails The Majority further reasons that the claimed method steps of size discrimination and selective removal “change the composition of the mixture, resulting in a DNA fraction that is different from the naturally-occurring fraction in the mother’s blood.” Id. at 10. On this basis, the Majority concludes that the claimed method in the patent “achieves more than simply observing that fetal DNA is shorter than maternal DNA, or detecting the presence of that phenomenon.” Id. The Majority’s reasoning is shortsighted. A process that merely changes the composition of a sample of naturally occurring substances, without altering the naturally occurring substances themselves, is not patent eligible. See Genetic Techs., 818 F.3d at 1374 (using PCR to amplify genomic DNA in a sample before detecting it); Ariosa, 788 F.3d at 1373 (using PCR to amplify cff-DNA in a sample before detecting it). Here, the claimed method steps of size discrimination and selective removal do not alter the naturally occurring substances in the sample of blood plasma or serum from a pregnant mother. Cf., Myriad, 569 U.S. at 593 (“Myriad’s Case: 19-1419 Document: 55 Page: 27 Filed: 03/17/2020 12 ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”). The Majority attempts to distinguish Myriad, reasoning that the claims at issue in Myriad were not method claims. Maj. Op. at 12 (citing Myriad, 569 U.S. at 595). But I see no principled reason why, under the facts of this case, Myriad should or should not apply simply because this case presents a method claim and not a composition of matter claim. Whether the asserted claims recite a composition of matter or a “method of preparation,” the purpose of § 101 remains the same, to safeguard against claims that monopolize a law of nature, natural phenomenon, or abstract idea. See Alice, 573 U.S. at 216 (“We have described the concern that drives this exclusionary principal as one of pre-emption.”). Because the patent’s claimed advance is the discovery of the natural phenomenon, the claims are directed to a natural phenomenon under the step one inquiry.