{"id":2043,"date":"2018-05-16T00:25:19","date_gmt":"2018-05-16T04:25:19","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=2043"},"modified":"2018-05-29T10:01:56","modified_gmt":"2018-05-29T14:01:56","slug":"printed-matter-cannot-be-a-patentable-limitation-unless-it-is-functionally-related-to-the-claim-elements","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=2043","title":{"rendered":"Printed Matter Cannot Be a Patentable Limitation Unless it is Functionally Related to the Claim Elements"},"content":{"rendered":"

In Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.<\/a>, [2016-2616, 2016-2656](May 16, 2018), the Federal Circuit affirmed the PTAB decision that claims 1\u20138 and 10\u201311 of U.S. Patent 8,846,112 directed\u00a0to methods of distributing nitric oxide gas cylinders for pharmaceutical applications were unpatentable as obvious, and reversed the decision that claim 9 was not unpatentable.<\/p>\n

In construing the claims, the Board applied the\u00a0printed matter doctrine. The Board interpreted the\u00a0providing information, evaluating, and recommendation\u00a0claim limitations to be either printed matter or purely
\nmental steps not entitled to patentable weight, as those\u00a0limitations lacked a functional relationship to the other\u00a0claim limitations except in claim 9.\u00a0\u00a0With respect to\u00a0claim 9, however, the Board interpreted \u201cin accordance\u00a0with\u201d to mean \u201cbased on, or as a result of\u201d the recommendation\u00a0to discontinue nitric oxide treatment from claim 7,
\nthereby establishing a functional relationship to the\u00a0recommendation limitation.\u00a0\u00a0The Board found that the\u00a0cited prior art collectively taught each limitation of claims\u00a01\u20138 and 10\u201319 that did have patentable weight, and held they were obvious.<\/p>\n

The Federal Circuit began with the printed matter doctrine, applied by the PTAB.\u00a0 The Federal Circuit explained that claim limitations directed to printed matter are not\u00a0entitled to patentable weight unless the printed matter is\u00a0functionally related to the substrate on which the printed
\nmatter is applied.\u00a0 However the printed matter doctrine is not limited to printed materials, and applies if the claims are directed to the content<\/em> of information.<\/p>\n

If a claim limitation is directed to printed matter,\u00a0then the next step is to ascertain whether the printed\u00a0matter is functionally related to its \u201csubstrate.\u201d Printed\u00a0matter that is functionally related to its substrate is given\u00a0patentable weight, while\u00a0where the printed matter is not functionally related to\u00a0the substrate, the printed matter will not distinguish the
\ninvention from the prior art in terms of patentability.\u00a0 In\u00a0in Ngai,<\/em>\u00a0there was no functional relationship between claimed\u00a0instructions and a diagnostic kit, as the instructions \u201cin\u00a0no way depended on the kit, and the kit did not dependon the\u201d instructions. However, Ngai<\/em> distinguished Gulack<\/em>, where
\nthere was a functional relationship between printed digits\u00a0on a circular band because \u201cthe printed matter and the\u00a0circularity of the band were interrelated, so as to produce\u00a0a new product useful for educational and recreational\u00a0mathematical purposes.\u201d<\/p>\n

The Federal Circuit agreed that the Board properly addressed the printed matter\u00a0doctrine during claim construction.\u00a0 The Federal Circuit rejected Mallinckrodt’s argument that the printed matter\/mental steps doctrines only apply to patent eligibility, noted that the printed matter doctrine raises an\u00a0issue where the \u00a7 101 patent-eligibility inquiry and the
\n\u00a7 102 and \u00a7 103 novelty and nonobviousness inquiries\u00a0overlap.\u00a0 The Federal Circuit explained\u00a0because claim limitations\u00a0directed to mental steps may attempt to capture\u00a0informational content, they may be considered printed\u00a0matter lacking patentable weight in an obviousness
\nanalysis. Accordingly, a limitation that merely claims\u00a0information by incorporating that information into a\u00a0mental step will receive patentable weight only if the\u00a0limitation is functionally related to the substrate.<\/p>\n

The Federal Circuit noted that claim 3’s requirement that the medical provider weigh “the potential benefit of treating the [neonatal patient]
\nwith 20 ppm inhaled nitric oxide vs. the potential\u00a0risk that inhaled nitric oxide could cause\u00a0an increase in PCWP” merely\u00a0requires a medical provider to think about the information\u00a0claimed in the providing information limitation of\u00a0claim 1.\u00a0 The Federal Circuit said that\u00a0adding an ineligible mental process to\u00a0ineligible information still leaves the claim limitation\u00a0directed to printed matter. To hold otherwise would make
\nthe printed matter doctrine a dead letter, requiring no\u00a0more than a \u201cthink about it\u201d step to give patentable\u00a0weight to a claim limitation directed to information\u00a0content.<\/p>\n

The Federal Circuit found that the reference to\u00a0\u201cpharmaceutically acceptable\u201d referred to the nature of the nitric acid gas, not the prescribing\u00a0information that may accompany it, and thus there was no functional relationship between\u00a0the\u00a0information and methods of providing and potentially\u00a0administering the drug.\u00a0 Since no other functional relationship was asserted, the Federal Circuit held that the printed matter in claims 1\u20138 and 10\u00a0lacks a functional relationship to its substrate, and thus cannot be the basis of patentability.<\/p>\n

The Federal Circuit then turned to claim 9, which survived the IPR, summarizing it as:\u00a0(1) determining that a neonatal patient has preexisting\u00a0LVD; (2) treating that neonate with nitric oxide, whereupon
\nthe neonate experiences pulmonary edema;\u00a0(3) providing information and a recommendation to the\u00a0medical provider to discontinue nitric oxide treatment for\u00a0a patient with preexisting LVD who experiences a pulmonary\u00a0edema; and (4) \u201cbased on\u201d the\u00a0 recommendation,\u00a0 discontinuing nitric oxide treatment due to the pulmonary\u00a0edema. The Federal Circuit noted that claim\u00a09 requires a medical provider to take a specific\u00a0action, discontinuing treatment, as a result of the\u00a0 recommendation limitation, and agreed that this creates the required functional relationship with the rest of the claim.\u00a0 However the Federal Circuit disagreed with the Board that\u00a0claim 9 as a whole would not have been\u00a0obvious.<\/p>\n

The Federal Circuit found the Board improperly construed claim 9 as requiring the exclusion of persons from the treatment, rather than discontinuing persons from treatment if edema occurs, and thus the prior art teaching of treatment with monitoring\u00a0 made the claimed invention obvious.<\/p>\n","protected":false},"excerpt":{"rendered":"

In Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd., [2016-2616, 2016-2656](May 16, 2018), the Federal Circuit affirmed the PTAB decision that claims 1\u20138 and 10\u201311 of U.S. Patent 8,846,112 directed\u00a0to methods of distributing nitric oxide gas cylinders for pharmaceutical … 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":[12,78,1],"tags":[],"class_list":["post-2043","post","type-post","status-publish","format-standard","hentry","category-obviousness","category-printed-matter","category-uncategorized"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2043","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=2043"}],"version-history":[{"count":4,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2043\/revisions"}],"predecessor-version":[{"id":2047,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/2043\/revisions\/2047"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2043"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2043"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2043"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}