DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Claim 1 recites:
A radiology system comprising:
a Picture Archiving and Communication System (PACS) database storing examination reports;
a user interface (UI); and
at least one electronic processor programmed to:
receive, during a reading session in which a user is logged into the UI, a selection of one or more medical imaging examinations from the PACS database;
present, at a first time point and via the UI, the selected one or more medical imaging examinations from the PACS database, including displaying one or more clinical images of the selected one or more medical imaging examinations;
receive, via the UI, one or more examination reports regarding the presented one or more medical imaging examinations, wherein the one or more examination reports contain clinical findings prepared by the user;
file, at a second time point later than the first time point, the received one or more examination report, comprising uploading the received one or more examination report to the PACS database; and
perform a tracking including:
(i) generating, by an artificial intelligence (AI) algorithm of a computer aided diagnostic (CAD) process running as a background process during the reading sessions, computer-generated AI clinical findings based on the one or more clinical images of the presented one or more medical imaging examinations, the computer-generated AI clinical findings corresponding to the clinical findings contained in the one or more examination reports;
(ii) computing concurrence scores quantifying concurrence between the clinical findings contained in the examination reports and the corresponding computer-generated AI clinical findings for the presented medical imaging examinations which are generated by the computer aided diagnostic (CAD) process running as the background process during the reading sessions; and
(iii) determining reading times for the presented medical imaging examinations wherein the reading time for each presented medical imaging examination is a time interval between the first time point and the second time point; and
generate at least one time-dependent user performance metric for the user based on the computed concurrence scores and/or the determined reading times.
Step 1:
The claim as a whole falls within at least one statutory category, i.e. a process, machine, manufacture, or composition of matter.
Step 2A Prong One:
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Certain methods of organizing human activity” because the steps are directed towards a technique of managing physician performance, i.e. managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). MPEP 2106.04(a)(2)(II)
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Mental processes”.
But for a generic computer recited with a high level of generality in a post hoc manner to implement the abstract idea, the steps may be performed in the human mind either mentally or with pen and paper.
Accordingly, these limitations have been found to be directed towards concepts performed in the human mind (including an observation, evaluation, judgment, opinion). MPEP 2106.04(a)(2)(III)
The different categories of abstract ideas are being considered together as one single abstract idea. MPEP 2106.04(II)(B)
Dependent claim(s) recite(s) additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim(s) 2-3, 5-6, 8-10, 12-13 reciting limitations further defining the abstract idea, which may be performed in the mind but for recitation of generic computer components, and/or may be a method of managing relationship or interactions between people).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites the following additional element(s), if any:
a Picture Archiving and Communication System (PACS) database storing examination reports;
a user interface (UI); and
at least one electronic processor programmed to:
receive, during a reading session in which a user is logged into the UI, a selection of one or more medical imaging examinations from the PACS database;
present, at a first time point and via the UI, the selected one or more medical imaging examinations from the PACS database, including displaying one or more clinical images of the selected one or more medical imaging examinations;
receive, via the UI, one or more examination reports regarding the presented one or more medical imaging examinations, wherein the one or more examination reports contain clinical findings prepared by the user;
file, at a second time point later than the first time point, the received one or more examination report, comprising uploading the received one or more examination report to the PACS database; and
by an artificial intelligence (AI) algorithm of a computer aided diagnostic (CAD) process running as a background process during the reading sessions.
The additional element(s) do(es) not integrate the abstract idea into a practical application, other than the abstract idea per se.
Regarding the electronic processor, the Specification as originally filed on 09 March 2020 in parent application 62986881 (hereafter referred to as “the Provisional Specification”) discloses a generic microprocessors, as well as other types of generic processors (Figure 1, see also page 7-8 paragraph 0035-0036).
Similarly, the AI has been invoked in a generic manner to implement the abstract idea.
Accordingly, this limitation amount(s) to mere instructions to apply an exception (invoking computers as a tool to perform the abstract idea). MPEP 2106.05(f))
Regarding the PACS database, UI, and the steps of presenting data via a UI, receiving data therefrom, and storing the received data, these steps merely add(s) insignificant extra-solution activity to the abstract idea (mere data gathering, insignificant application). MPEP 2106.05(g))
Dependent claim(s) recite(s) additional subject matter which amount to limitation(s) consistent with the additional element(s) in the independent claims (such as claim(s) claim 7 reciting an AI CAD, additional limitation(s) which amount(s) to invoking computers as a tool to perform the abstract idea; claim(s) 4, 11 reciting presenting data, such as via the UI, claim 12 reciting generating an alert, additional limitation(s) which add(s) insignificant extra-solution activity to the abstract idea).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, the additional elements do not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Accordingly, the claim recites an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use.
The additional elements, as discussed above and incorporated herein, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use, as discussed above and incorporated herein.
Mere instructions to apply an exception, insignificant extra-solution activity, and linking to a particular technological environment using a generic computer component cannot provide an inventive concept.
Regarding the step of presenting data via a UI, this limitation amount(s) to element(s) that have been recognized as well-understood, routine, and conventional (WURC) activity in particular fields. Accordingly, Nye (20190164285) discloses exemplary GUIs (Figure 13, page 13 paragraph 0132).
Regarding the steps of receiving data, this limitation amount(s) to element(s) that have been recognized as WURC activity in particular fields (e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)).
Regarding the steps of storing data in a PACS database, this limitation amount(s) to element(s) that have been recognized as WURC activity in particular fields (e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv)). Additionally, Ouyang (20120289858) discloses PACS storage in a manner that would be WURC in the pertinent arts (page 8-9 paragraph 0143).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claim(s) 4, 11 reciting presenting data, Nye discloses exemplary GUIs (Figure 13, page 13 paragraph 0132) in a manner that would be WURC in the pertinent arts; claim 12 reciting generating an alert, Nye discloses generating alerts in a manner that would be WURC (page 3 paragraph 0044)). MPEP 2106.05(d)(II)(ii))
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
The claim is not patent eligible.
Claim(s) 14-20 recite(s) substantially similar limitations as those of claim(s) 1, 3, 5-6, 12-13 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Subject Matter Free of Prior Art
Claim(s) 1-20 distinguish(es) over the prior art for the following reasons.
The following is a statement of reasons for the subject matter free of prior art:
Claim 1: the primary reason for the indication of subject matter free of prior art is the inclusion of the following limitations in the combination as recited in the abstract concept and not found in the closest available prior art of record:
present, at a first time point and via the UI, the selected one or more medical imaging examinations from the PACS database, including displaying one or more clinical images of the selected one or more medical imaging examinations;
receive, via the UI, one or more examination reports regarding the presented one or more medical imaging examinations, wherein the one or more examination reports contain clinical findings prepared by the user;
file, at a second time point later than the first time point, the received one or more examination report, comprising uploading the received one or more examination report to the PACS database; and
perform a tracking including:
(i) generating, by an artificial intelligence (AI) algorithm of a computer aided diagnostic (CAD) process running as a background process during the reading sessions, computer-generated AI clinical findings based on the one or more clinical images of the presented one or more medical imaging examinations, the computer-generated AI clinical findings corresponding to the clinical findings contained in the one or more examination reports;
(ii) computing concurrence scores quantifying concurrence between the clinical findings contained in the examination reports and the corresponding computer-generated AI clinical findings for the presented medical imaging examinations which are generated by the computer aided diagnostic (CAD) process running as the background process during the reading sessions; and
(iii) determining reading times for the presented medical imaging examinations wherein the reading time for each presented medical imaging examination is a time interval between the first time point and the second time point; and
generate at least one time-dependent user performance metric for the user based on the computed concurrence scores and/or the determined reading times.
The closest available prior art of record are as follows:
Bedi (WO2011121457, previously provided by Applicant on 06 September 2022) discloses a turnaround time being used to rate the radiologist (page 12-13 paragraph 15), but does not fairly disclose or suggest generating a time-dependent user performance metric as claimed.
Based on the evidence presented above, none of the closest available prior art of record fairly discloses or suggests the claimed invention. For this reason, claim 1 would be found to be subject matter free of prior art.
Claim(s) 2-13: this/these claim(s) would also be found to be subject matter free of prior art for at least the same rationale as applied to parent claim 1 above, and incorporated herein.
Claim(s) 14-20: this/these claim(s) would also be found to be subject matter free of prior art for substantially similar rationale as applied to claim(s) 1-13 above, and incorporated herein.
Response to Arguments
In the Remarks filed on 06 July 2026, Applicant makes numerous arguments. Examiner will address these arguments in the order presented.
On page 10-12 Applicant argues that the claims are not directed towards Certain Methods of Organizing Human Activity.
In making this argument, Applicant makes certain assertions about how the Office previously generalized the feature of using AI as being directed towards an abstract idea.
Examiner respectfully submits that the feature of using AI has not been previously recited, and therefore the Office has not had opportunity to consider this limitation.
Accordingly, Applicant’s assertion on page 11 regarding the AI limitations are not supportable by the current record. See the section above for the Office’s proper consideration of the newly presented limitations.
Regarding the argued limitations, see the section above for proper disposition of the abstract idea and resulting additional elements (the AI feature has been found to be directed towards a generic computer, and not as an abstract idea as argued by Applicant).
Beyond the improper characterization by Applicant, this argument does not even state why the argued limitations cannot be properly considered to be directed towards Certain Methods of Organizing Human Activity. Instead, Applicant merely provides a conclusory statement that this holding would be improper and unreasonably broad under the Alice/Mayo two-part framework without providing any reasoned statement for supporting such conclusion.
On page 13 Applicant makes similar arguments regarding Mental Processes.
Similar rationale applies, as addressed above, and incorporated herein.
Namely, newly presented limitations are addressed in the section above, and that the highlighted portions are directed towards the mental processes; Applicant provides no reasoned statement why they would not be practically performed in the human mind either mentally or with pen and paper.
On page 14-17 Applicant argues that certain limitations provide technical improvement.
While Applicant’s arguments have been carefully considered, Examiner respectfully disagrees because the Specification, when read as a whole by one of ordinary skill in the art, would lead one of ordinary skill in the art to conclude that Applicant’s invention is directed towards a comparison process between a human radiologist and an AI diagnostic, and not the AI diagnostic itself.
As such, at best the AI has been invoked as providing a benchmarking tool against which a human radiologist may be compared. Instead, the invention is directed towards scoring how a human radiologist fares when compared against an AI tool. This is not a technical improvement; it is an improvement in the abstract idea of managing human productivity (i.e. not a recognized technology or related field).
Furthermore, the additional elements merely invokes generic computers and insignificant extrasolution activities of receiving and displaying data, as discussed above and incorporated herein.
On page 17 Applicant argues again that the claims provide AI CAD.
As addressed above, there is simply no nexus between benchmarking a human radiologist against an AI diagnostic tool. The claim does not recite how any concurrency is used to improve AI CAD.
While Applicant’s arguments have been carefully considered, they are not found persuasive for this reason.
Accordingly, Applicant’s arguments have not been found persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reiner (8249892) discloses tracking a radiologist’s interpretation time (column 13 line 47-60) in a manner similar to those disclosed in the instant pending Specification as originally filed.
Ketchel (20200334727) discloses tracking physician percentage time being active (page 31 paragraph 0257) in a manner similar to those disclosed in the instant pending Specification as originally filed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/T.N.N./ Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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