{"id":2723,"date":"2020-03-17T16:51:39","date_gmt":"2020-03-17T20:51:39","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2723"},"modified":"2020-03-21T12:56:59","modified_gmt":"2020-03-21T16:56:59","slug":"an-improved-step-in-a-diagnostic-method-is-patentable-subject-matter","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2723","title":{"rendered":"An Improved Step in a Diagnostic Method is Patentable Subject Matter"},"content":{"rendered":"\n

In Illumina, Inc., v. Ariosa Diagnostics, Inc.<\/a>, [2019-1419] (March 17, 2020) the Federal Circuit reversed the district court\u2019s determination that claims of U.S. Patent Nos. 9,580,751 and 9,738,931 were invalid under 35 U.S.C. \u00a7 101 as directed to an ineligible natural phenomenon. <\/p>\n\n\n\n

Illumina\u2019s related U.S. Patent 6,258,540, which claimed a method for detecting the small fraction of paternally inherited cell-free fetal DNA in the plasma and serum of a pregnant woman, were famously held invalid under 35 U.S.C. \u00a7 101 back in 2015 because they were directed to \u201cmatter that is naturally occurring\u201d\u2014i.e.<\/em>, the natural phenomenon that cell-free fetal DNA exists in maternal blood.\u00a0 The \u2018751 and \u2018931 patents presently at issue were based upon the \u201csurprising\u201d discovery that the majority of the circulatory extracellular fetal DNA has a relatively small size of approximately 500 base pairs or less, which meant that fetal DNA could be amplified by separating extracellular DNA fragments which are smaller than approximately 500 base pairs. <\/p>\n\n\n\n

The Federal Circuit noted that this was not a diagnostic invention, or a treatment invention, but a method of preparation invention, and applied the two step Alice\/Mayo<\/em> test.\u00a0 At Step 1, the Federal Circuit said it was undisputed that the inventors of the \u2019751 and \u2019931 patents discovered a natural phenomenon. But at step one of the Alice<\/em>\/Mayo <\/em>test, \u201cit is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is \u2018directed to.\u2019\u201d \u00a0\u00a0After noting the parties difficulty in identifying the natural phenomenon involved, the Federal Circuit identified the natural phenomenon: that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother\u2019s bloodstream. Turning to the crucial question of whether the claims are \u201cdirected to\u201d that natural phenomenon, the Federal Circuit concluded that the claims are not <\/em>directed to that natural phenomenon but rather to a patent-eligible method that utilizes it.<\/p>\n\n\n\n

The Federal Circuit explained the claims in this case are directed to methods for pre-paring a fraction of cell-free DNA that is enriched in fetal DNA. The methods include specific process steps\u2014size dis-criminating and selectively removing DNA fragments that are above a specified size threshold\u2014to increase the relative amount of fetal DNA as compared to maternal DNA in the sample.\u00a0 These process steps change the composition of the mixture, resulting in a DNA fraction that is different from the naturally-occurring fraction in the mother\u2019s blood. Thus, the process achieves more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon.<\/p>\n\n\n\n

Roche insisted that the claims in this case are no more eligible than the claims at issue in Ariosa<\/em>, but the Federal Circuit disagreed, noting that in Ariosa<\/em>, the relevant independent claims were directed to a method \u201cfor detecting a paternally inherited nucleic acid\u201d or a method \u201cfor performing a prenatal diagnosis,\u201d and the only operative steps in the claims were \u201camplifying\u201d (i.e., <\/em>making more of) the cell-free fetal DNA and then \u201cdetecting [it],\u201d \u201csubjecting [it] . . . to a test,\u201d or \u201cperforming nucleic acid analysis on [it] to detect [it].\u201d The claims were ineligible because, like the invalid diagnostic claims at issue in Mayo<\/em>, Athena<\/em>, and Cleveland Clinic<\/em>, they were directed to detecting a natural phenomenon. <\/p>\n\n\n\n

This case shows the importance of how the invention is characterized to the 101 analysis <\/p>\n","protected":false},"excerpt":{"rendered":"

In Illumina, Inc., v. Ariosa Diagnostics, Inc., [2019-1419] (March 17, 2020) the Federal Circuit reversed the district court\u2019s determination that claims of U.S. Patent Nos. 9,580,751 and 9,738,931 were invalid under 35 U.S.C. \u00a7 101 as directed to an ineligible … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15],"tags":[],"class_list":["post-2723","post","type-post","status-publish","format-standard","hentry","category-15"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2723","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2723"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2723\/revisions"}],"predecessor-version":[{"id":2724,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2723\/revisions\/2724"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2723"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2723"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2723"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}