Electronic Medical Records: Not Eligible

Ex parte Naeymi-Rad (PTAB 2018)

Clever Clinical Objects, Inc. (IMO) has an appealing business enterprise of capturing, standardizing, and simplifying clinical documentation used in 3,500 hospitals and by 450,000 doctors.  This method is vital for both of those procedure and payment — all in an natural environment the place mistakes can direct to dying and individual bankruptcy.  In the U.S., businesses have put in billions of pounds on developing electronic clinical report systems — however major troubles remain.

IMO’s CEO Frank Naeymi-Rad together with 11 other folks are mentioned as inventors of the company’s pending Software No. 13/622,934 – lately turned down on eligibility grounds.  The statements are directed to a software program procedure for “implementing a controlled vocabulary” within just a longitudinal clinical report.   The examiner last but not least turned down all 14 statements for on eligibility grounds (withdrawing the obviousness rejection) — concluding that the statements are directed to the abstract idea of “providing healthcare by making and processing clinical data.”

On appeal, the PTAB sided with the examiner – holding that – at a higher level of abstraction, the statements “can be characterized as accumulating, storing, and arranging … and transmitting information.”   Although the examiner acknowledges that the statements are novel and non-clear, the PTAB still located no inventive principle.

Whilst the second action in the Mayo/Alice framework is termed as a research for an “inventive principle,” the investigation is not an evaluation of novelty or non-obviousness.

On this stage, the PTAB quoted Diamond v. Diehr:

The ‘novelty’ of any aspect or actions in a method, or even of the method by itself, is of no relevance in figuring out regardless of whether the issue make a difference of a assert falls within just the Segment 101 categories of potentially patentable issue make a difference.

Relatively than focusing on novelty as the “inventive concept” language suggests, the PTAB indicated its second action aim is a research for a little something “sufficient to guarantee that the patent in observe quantities to drastically far more than a patent on the [ineligible concept] itself” quoting Alice/Mayo.  A person method that is effective for patentees is to present that their creation is an enhancement of laptop performance.  Right here, having said that, the PTAB ruled that the statements merely use laptop technology — “generic elements … employed in a regular fashion.”

IMO argued (via its lawyer Richard Beem) that the addition of affected individual-by-affected individual controlled vocabulary was a vital function that permitted the longitudinal clinical data possible simply because it permitted for relational storage — decreasing memory and growing speed.  I anticipate an appeal to the Federal Circuit on these (and other) details.

I listing assert 1 underneath:

1. A system of applying a controlled vocabulary in a longitudinal electronic clinical report, comprising:

making a very first instance of a plurality of information objects through a very first encounter, mentioned plurality of information objects comprising information features even more comprising a very first instance identifier and temporal identifiers

linking a information item in mentioned very first instance to a summarization reference with a pointer, the place the plurality of information objects and the summarization reference are linked as element of a directed graph information framework

creating an additional instance of a plurality of information objects through a afterwards encounter, mentioned additional instance of a plurality of information objects comprising information features even more comprising an additional instance identifier and temporal identifier

furnishing continuity for mentioned plurality of information objects of mentioned very first instance in excess of time[, wherein said providing step comprises tracking a relationship between said data object of said first instance and a data object of said additional instance]

capturing mentioned controlled vocabulary making use of a laptop by forming a listing of clinical phrases and listing of involved descriptions

creating a listing of codes interior to mentioned controlled vocabulary[, wherein said controlled vocabulary maps to at least one of a reference terminology or an administrative terminology]

storing mentioned codes, mentioned clinical phrases, and mentioned descriptions making use of a laptop in a structure acceptable for use in the longitudinal electronic clinical report and

tagging features within just a domain within just the longitudinal clinical report with mentioned controlled vocabulary[.]

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