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 .
Status of the Claims
The office action is in response to the claims filed on December 19, 2024, for the application filed on December 19, 2024, which is a U.S. National Stage of International Application No. PCT/EP2023/066143 filed June 15, 2023, which claims priority to Provisional Application No. 63/356,515 filed on June 29, 2022. Claims 1 – 23 are currently pending and have been examined as discussed below.
Claim Objections
Claims 2, 14, and 18 are objected to because of the following informalities: the term “one or more criterion; and” in line 4 of claim 2 should be replaced with “one or more criterion; ”; the term “that information” in line 6 of claim 14 should be replaced with “complexity prediction statistics”; and the term “on the determine complexity” in line 3 of claim 18 should be replaced with “on the complexity”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1 – 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Examiners should determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance with the flowchart in MPEP 2016(III).
Eligibility Step 1:
Under Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim as a whole falls within one of the statutory categories of invention (i.e., a process, machine, manufacture, or composition of matter). See MPEP 2106.03. In the instant application, claims 1 – 4 are directed to a system (i.e., a machine); claims 5 – 22 are directed to a non-transitory, computer-readable storage medium (i.e., an article of manufacture); and claim 23 is directed to a computer-implemented method (i.e., a process).
While each one of claims 1 – 23 appears to fall within one or more statutory categories of invention, the Office has determined that the full eligibility analysis is required because there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself. The eligibility of each claim is not self-evident at least because each claim as a whole did not appear to clearly improve a technology or computer functionality. To the contrary, each claim as a whole appeared to merely apply one or more judicial exceptions on a computer.
Accordingly, it has been determined that each one of claims 1 – 23 as a whole falls within one or more statutory categories under Step 1, and the Office proceeds with the full eligibility analysis (the Alice/Mayo test described in MPEP 2106(III)) as discussed below.
Eligibility Step 2A, Prong One:
Under Step 2A, Prong One of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim is directed to one or more of the judicial exceptions (i.e., an abstract idea, law of nature, or natural phenomenon). See MPEP 2106.04(II)(A)(1). After evaluation, it has been determined that claims 1 – 23 are directed to judicial exceptions because claims 1 – 23 recite an abstract idea. (The Office will not determine that a claim is not directed to a judicial exception under Step 2A, Prong One for the mere reason that claim further recites one or more additional elements beyond the judicial exception.)
Independent claims 1, 5, and 23 are determined to be directed to a judicial exception including abstract ideas (i.e., mental process). Representative claim 1 recites the mental process identified in bold as:
A system for optimizing medical imaging examinations, the system comprising:
one or more processors configured to access one or more data streams of an imaging bay including at least (i) a screen mirroring data stream comprising content presented on a controller display and (ii) a communication pathway connecting the imaging bay and at least some of the one or more processors;
a complexity scoring module executed by the one or more processors and configured to assess a complexity of an upcoming medical imaging examination identified by a scheduler by:
acquiring data related to the upcoming medical imaging examination, the data comprising one or more of time taken to complete preparation and scanning activities associated with the upcoming medical imaging examination, whether contrast is used, what type of contrast is used, body part to be imaged, patient demographics, idle time between sequences, likelihood of repeated or additional imaging sequences, or image quality; and
determining the complexity of the upcoming medical imaging examination based on a weighted combination of a plurality of complexity scores respectively derived from the acquired data; and
an alerting module configured to output an alert indicative of the determined complexity of the upcoming medical imaging examination.
Claim 1 recites the combination of limitations identified as “optimizing medical imaging examinations,” “assess a complexity of an upcoming medical imaging examination identified by a scheduler,” and “determining the complexity of the upcoming medical imaging examination based on a weighted combination of a plurality of complexity scores respectively derived from the acquired data.” A broadest reasonable interpretation of this combination amounts to determining a complexity of an upcoming medical imaging examination. This activity may be practically performed in the human mind using observation, evaluation, judgment, and opinion, and thus represents an abstract idea falling in the “mental process” grouping.. With the exception of generic computer-implemented steps, there is nothing in each of claims 1, 5, and 23 themselves that forecloses them from being performed by a human, mentally or with tools such as pen and paper. Thus, this activity is an abstract idea in the "mental process" grouping.
Accordingly, claims 1, 5, and 23 are recite judicial exceptions under Step 2A, Prong One.
Dependent claims 2 – 4 and 6 – 22 are directed to one or more judicial exceptions (i.e., abstract idea exceptions) under Step 2A, Prong One of the full eligibility analysis as follows:
Regarding claims 2 – 4 and 6 – 22, each combination of limitations identified in bold as “determining the complexity of the upcoming one or more imaging examinations includes: partitioning data related to historical imaging examinations into one or more classes based on one or more criterion; [and] generating performance statistics for the partitioned historical imaging examinations in each class; partitioning data related one or more current imaging examinations into one or more classes based on the one or more criterion; applying the generated performance statistics for the partitioned historical imaging examinations to the one or more current imaging examinations in a common class; and determining the complexity of the one or more current imaging examinations based on the generated performance statistics” in claims 2 and 9, “generate a prediction of one or more factors contributing to the determined complexity of the upcoming imaging examinations” in claims 3 and 12, “indicating that an upcoming imaging exaction will be complex” in claims 4, 15, and 17, “the acquired data includes one or more of a modality of the medical imaging device an imaged anatomy, and specific imaging sequences specified in an imaging examination card” in claim 6, “the acquired data further includes one or more of information on historical imaging examinations such as total length, time for each imaging examination phase, contrast agent delivery, patient unloading, and idle time” in claim 7, “the acquired data is acquired from one or more data sources including HL7 messages, an examination order placed by a referring physician, an examination card, a patient electronic medical record, and imaging technician education and experience records” in claim 8, “the one or more criterion include examination type, modality, imaging sequences, patient characteristics, an imaging technologist performing the examination, or a technician's class segmented by experience” in claim 10, “the performance statistics include one or more of average total examination time, average time for each phase, average idle time between successive phases, average number of rescans, average number of consultations with a remote expert, and average obtained image quality” in claim 11, “determine required data to determine the complexity that is missing; and assign an average data value for the missing required data” in claim 13, “generate complexity prediction statistics for coarser examination types that omit that information” in claim 14, “receive feedback from the LO on the determine complexity at an end of the imaging examination” in claim 16, “receive feedback from the RE on the determine complexity at an end of the imaging examination” in claim 18, “the alert is output prior to beginning upcoming imaging examinations” in claim 19, “determining the complexity based on one or more patient characteristics” in claim 20, “determining the complexity based on data related to a local operator (LO) performing the medical imaging examination” in claim 21, and “updating a scheduler comprising a schedule of medical imaging examinations based on a determined complexity for each imaging examination on the schedule” in claim 22 defines the activity of determining a complexity of an upcoming medical imaging examination. These activities may be practically performed in the human mind using observation, evaluation, judgment, and opinion, and thus represents an abstract idea falling in the “mental process” grouping.. With the exception of generic computer-implemented steps, there is nothing in each of claims 2 – 4 and 6 – 22 themselves that forecloses them from being performed by a human, mentally or with tools such as pen and paper.
Accordingly, claims 2 – 4 and 6 – 22 are recite judicial exceptions under Step 2A, Prong One.
Eligibility Step 2A, Prong Two:
Claims 1, 5, and 23 recite additional limitations beyond the judicial exceptions. Representative claim 1 recites the additional limitations identified in bold as:
A system for optimizing medical imaging examinations, the system comprising:
one or more processors configured to access one or more data streams of an imaging bay including at least (i) a screen mirroring data stream comprising content presented on a controller display and (ii) a communication pathway connecting the imaging bay and at least some of the one or more processors;
a complexity scoring module executed by the one or more processors and configured to assess a complexity of an upcoming medical imaging examination identified by a scheduler by:
acquiring data related to the upcoming medical imaging examination, the data comprising one or more of time taken to complete preparation and scanning activities associated with the upcoming medical imaging examination, whether contrast is used, what type of contrast is used, body part to be imaged, patient demographics, idle time between sequences, likelihood of repeated or additional imaging sequences, or image quality; and
determining the complexity of the upcoming medical imaging examination based on a weighted combination of a plurality of complexity scores respectively derived from the acquired data; and
an alerting module configured to output an alert indicative of the determined complexity of the upcoming medical imaging examination.
Claim 1 recites the additional limitations identified in bold as “a system,” “one or more processors configured to access one or more data streams of an imaging bay including at least (i) a screen mirroring data stream comprising content presented on a controller display and (ii) a communication pathway connecting the imaging bay and at least some of the one or more processors,” “a complexity scoring module executed by the one or more processors,” “acquiring data related to the upcoming medical imaging examination, the data comprising one or more of time taken to complete preparation and scanning activities associated with the upcoming medical imaging examination, whether contrast is used, what type of contrast is used, body part to be imaged, patient demographics, idle time between sequences, likelihood of repeated or additional imaging sequences, or image quality,” and “an alerting module configured to output an alert indicative of the determined complexity of the upcoming medical imaging examination.” Each of these elements is an additional limitation beyond the judicial exception (i.e., the mental process of determining a complexity of an upcoming medical imaging examination). At best, looking at the combination of all additional elements and the judicial exception, the claim as a whole amounts to a general purpose computer (i.e., having one or more processors, a complexity scoring module, and an alerting module) used for necessary data gathering (i.e., accessing one or more data streams of an imaging bay, e.g., a screen mirroring data stream and a communication pathway, and acquiring data related to the upcoming medical imaging examination) and data outputting (i.e., outputting an alert indicative of the determined complexity of the upcoming medical imaging examination).
MPEP 2106.05(a) states: “In determining patent eligibility, examiners should consider whether the claim ‘purport(s) to improve the functioning of the computer itself’ or ‘any other technology or technical field.’… [A]n improvement in the abstract idea itself is not an improvement in technology.” Furthermore, MPEP 2106.05(a)(II) states: “Merely adding generic computer components to perform the method is not sufficient.” In the instant application, claim 1 as a whole does not improve the functioning of the processors, the complexity scoring module, and the alerting module; nor does the claim as a whole improve any other technology or technical field. The processors, the screen mirroring data stream, the controller display, the communication pathway, the complexity scoring module, and the alerting module are general purpose computer components added post-hoc to the abstract idea of determining a complexity of an upcoming medical imaging examination. The claim as a whole improves exclusively upon the abstract idea itself by using conventional and generic computer technology to merely automate the manual process of determining a complexity of an upcoming medical imaging examination. See MPEP 2106.05(a). The claim as a whole represents mere instructions to apply the abstract idea to conventional and generic computer technology recited at a high level of generality. See MPEP 2106.05(f). Regarding the consideration under MPEP 2106.05(g), the limitations of “accessing one or more data streams of an imaging bay including at least (i) a screen mirroring data stream comprising content presented on a controller display and (ii) a communication pathway connecting the imaging bay and at least some of the one or more processors,” “acquiring data related to the upcoming medical imaging examination” (i.e., pre-solution activity of necessary data gathering) and “output an alert indicative of the determined complexity of the upcoming medical imaging examination” (i.e., post-solution activity of data outputting) are determined to add no more than insignificant extra-solution activities to the judicial exception. The claim as a whole represents the primary process (i.e., determining a complexity of an upcoming medical imaging examination) to which the extra-solution activities are incidental. Regarding the consideration under MPEP 2106.05(h), the additional limitations, individually or in combination, also amount to merely indicating a field of use or technological environment in which to apply the judicial exception. In the instant application, the additional limitations (i.e., the processors, the screen mirroring data stream, the controller display, the communication pathway, the complexity scoring module, and the alerting module) do no more than link the abstract idea (i.e., determining a complexity of an upcoming medical imaging examination) to a computer environment. Thus, the additional limitations fail to add an inventive concept to the claims.
Accordingly, in view of these considerations, the Office has determined that each one of claims 1, 5, and 23 as a whole does not integrate the abstract idea exception into a practical application under Step 2A, Prong Two, and thus each claim as a whole is directed to a judicial exception under Step 2A.
Dependent claims 2 – 4 and 6 – 22 present additional information in tandem with further details regarding elements and the abstract idea from an associated one of independent claims 1, 5, and 23 and are therefore directed to an abstract idea for similar reasons as given Under Step 2A, Prong One above. Claims 2 – 3, 6 – 14, and 20 – 22 do not recite any additional limitations beyond the abstract idea of determining a complexity of an upcoming medical imaging examination. Claims 4 and 15 – 19 further recite additional limitations, and these additional limitations fail to integrate the abstract idea into a practical application under Step 2A, Prong Two as follows:
Claims 4 and 15 – 19 recite the additional limitations identified in bold as “wherein outputting an alert indicative of the determined complexity of the upcoming imaging examinations includes: outputting the alert indicating that an upcoming imaging exaction will be complex on an electronic processing device operable by a local operator performing the upcoming imaging examination” in claim 4, “outputting an alert indicative of the determined complexity of the upcoming imaging examinations includes: outputting the alert indicating that an upcoming imaging exaction will be complex on an electronic processing device operable by a local operator performing the upcoming imaging examination” in claim 15, “the instructions further cause the one or more processors to: receive feedback from the LO on the determine complexity at an end of the imaging examination” in claim 16, “outputting an alert indicative of the determined complexity of the upcoming imaging examinations includes: outputting the alert indicating that an upcoming imaging exaction will be complex on a remote electronic processing device operable by a remote expert (RE) monitoring the upcoming imaging examination” in claim 17, “the instructions further cause the one or more processors to: receive feedback from the RE on the determine complexity at an end of the imaging examination” in claim 18, and “the alert is output prior to beginning upcoming imaging examinations” in claim 19. Regarding the consideration under MPEP 2106.05(g), the Office has determined that each one of claims 4 and 15 – 19 as a whole fails to add more than insignificant extra-solution activities to the judicial exception. Each one of claims 4 and 15 – 19 as a whole represents the well-known pre-solution activity of necessary data gathering because each claim as a whole is incidental to the primary process of determining a complexity of an upcoming medical imaging examination. Each one of claims 4 and 15 – 19 as a whole represents the well-known post-solution activity of data outputting (i.e., outputting the alert indicating that an upcoming imaging exaction will be complex) because each claim as a whole is incidental to the primary process of determining a complexity of the upcoming medical imaging examination. The broadest reasonable interpretation of each one of claims 4 and 15 – 19 as a whole does not add meaningful limitation to the process of determining a complexity of the upcoming medical imaging examination. Regarding the consideration under MPEP 2106.05(h), the additional limitations, individually or in combination, also amount to merely indicating a computer field in which to apply the judicial exception. Thus, the additional limitations fail to add an inventive concept to the claims.
Accordingly, the Office has determined that each one of claims 2 – 4 and 6 – 22 as a whole does not integrate the abstract idea exception into a practical application under Step 2A, Prong Two, and thus each claim as a whole is directed to a judicial exception under Step 2A.
Eligibility Step 2B:
Regarding independent claims 1, 5, and 23, the Office carries over its identification of the additional elements (and combinations thereof) from Step 2A, Prong Two so as to apply the same additional elements in Step 2B. See MPEP 2106.05(II). The Office further carries over its conclusions from the considerations discussed in MPEP 2106.05(a) through (c), (e) through (h) in Step 2A, Prong Two so as to apply the same considerations in Step 2B.
Under Step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the claim provides an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements 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, each claim as a whole does not provide an improvement to technology or technical field under MPEP 2106.05(a). The additional limitations amount to mere instructions to apply an abstract idea under MPEP 2106.05(f) and/or necessary data gathering and/or outputting under MPEP 2106.05(g). Each claim as a whole recites an electronic processing device and/or non-transitory computer readable medium at a high level of generality, with their functions claimed in a merely generic manner such that each claim as a whole represents the well‐understood, routine, and conventional functions of the electronic processing device and/or non-transitory computer readable medium for automatically determining a complexity of an upcoming medical imaging examination. Evidence that automated chart review process is a well‐understood, routine, and conventional function is provided by Sethumadhavan (U.S. Pub. No. 2015/0142473 A1).
Furthermore, looking at the limitations individually or as any ordered combination adds nothing that is not already present when looking at each claim as a whole. There is no indication that the individual elements or combinations of elements amount to an inventive concept.
Therefore, claims 1, 5, and 23 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Regarding claims 2 – 4 and 6 – 22, the Office carries over its determination from Step 2A, Prong Two that claims 2 – 3, 6 – 14, and 20 – 22 do not further recite additional limitations beyond the judicial exception (i.e., the abstract idea of determining a complexity of an upcoming medical imaging examination) so as to apply the same determination in Step 2B. See MPEP 2106.05(II). The Office further carries over its conclusions from the considerations discussed in MPEP 2106.05(a) through (c), (e) through (h) in Step 2A, Prong Two so as to apply the same considerations in Step 2B. The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. Claims 4 and 15 – 19 do not recite any additional limitations beyond the abstract idea of determining a complexity of an upcoming medical imaging examination. Claims 4 and 15 – 19 further recite additional limitations, and these additional limitations do not amount to significantly more than the judicial exception under Step 2B as follows:
Each claim as a whole does not provide an improvement to technology or technical field under MPEP 2106.05(a), but rather only improves the abstract idea itself. Each claim as a whole amounts to mere instructions to apply the abstract idea to generic computer components (i.e., the non-transitory computer readable medium and the electronic processing device) under MPEP 2106.05(f). The limitations of “wherein outputting an alert indicative of the determined complexity of the upcoming imaging examinations includes: outputting the alert indicating that an upcoming imaging exaction will be complex on an electronic processing device operable by a local operator performing the upcoming imaging examination” in claim 4, “outputting an alert indicative of the determined complexity of the upcoming imaging examinations includes: outputting the alert indicating that an upcoming imaging exaction will be complex on an electronic processing device operable by a local operator performing the upcoming imaging examination” in claim 15, “the instructions further cause the one or more processors to: receive feedback from the LO on the determine complexity at an end of the imaging examination” in claim 16, “outputting an alert indicative of the determined complexity of the upcoming imaging examinations includes: outputting the alert indicating that an upcoming imaging exaction will be complex on a remote electronic processing device operable by a remote expert (RE) monitoring the upcoming imaging examination” in claim 17, “the instructions further cause the one or more processors to: receive feedback from the RE on the determine complexity at an end of the imaging examination” in claim 18, and “the alert is output prior to beginning upcoming imaging examinations” in claim 19 merely represent data outputting incidental to the primary process of the claim as a whole (i.e., determining a complexity of an upcoming medical imaging examination) and thus those limitations are merely nominal or tangential additions to the associated claims under MPEP 2106.05(g). Each claim as a whole recites the non-transitory computer readable medium and/or the electronic processing device at a high level of generality, with their functions claimed in a merely generic manner such that each claim as a whole represents the well‐understood, routine, and conventional functions of the non-transitory computer readable medium and/or the electronic processing device for automatically determining a complexity of an upcoming medical imaging examination. Evidence that automated chart review process is a well‐understood, routine, and conventional function is provided by Sethumadhavan (U.S. Pub. No. 2015/0142473 A1).
Therefore, claims 2 – 4 and 6 – 22 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 10 and 23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Starobinets (U.S. Pub. No. 2021/0158946 A1) in view of Reiner (U.S. Pub. No. 2008/0312963 A1).
Regarding independent claims 1, 5, and 23, Starobinets teaches the limitations of representative claim 1 identified in bold as:
A system for optimizing medical imaging examinations (Paragraphs [0025] and [0032] of Starobinets. In the instant application, the broadest reasonable interpretation of “a system for optimizing medical imaging examinations” reads on the system in Starobinets (Paragraphs [0025] and [0032]) for performing independent assessment of the accuracy and/or appropriateness of the contrast injector settings, and for providing an alert of any detected potentially erroneous injector settings prior to commencement of the contrast-enhanced (portion of the) imaging examination.), the system comprising:
one or more processors configured to access one or more data streams of an imaging bay including at least (i) a screen mirroring data stream comprising content presented on a controller display and (ii) a communication pathway connecting the imaging bay and at least some of the one or more processors (Paragraphs [0035] – [0040] of Starobinets. In the instant application, the broadest reasonable interpretation of “one or more processors configured to access one or more data streams of an imaging bay including at least (i) a screen mirroring data stream comprising content presented on a controller display and (ii) a communication pathway connecting the imaging bay and at least some of the one or more processors” reads on the medical imaging device controller in Starobinets (Paragraphs [0035] – [0040]) configured to access the video stream of a portion of the medical imaging bay. The contrast injector includes the dedicated physical injector display, and the content of the display is captured in the video stream. Additionally, a screen mirroring data stream is sent from the imaging device controller to the remote workstation. The video stream is sent to the remote workstation via the communication link, i.e., a natural language communication pathway for verbal and/or textual communication between the local operator and the remote operator.);
a complexity scoring module executed by the one or more processors and configured to assess a complexity of an upcoming medical imaging examination identified by a scheduler by:
acquiring data related to the upcoming medical imaging examination, the data comprising one or more of time taken to complete preparation and scanning activities associated with the upcoming medical imaging examination, whether contrast is used, what type of contrast is used, body part to be imaged, patient demographics, idle time between sequences, likelihood of repeated or additional imaging sequences, or image quality; and
determining the complexity of the upcoming medical imaging examination based on a weighted combination of a plurality of complexity scores respectively derived from the acquired data; and
an alerting module configured to output an alert indicative of the determined complexity of the upcoming medical imaging examination.
Starobinets does not appear to explicitly disclose, but Reiner teaches the limitation identified in bold as “a complexity scoring module executed by the one or more processors and configured to assess a complexity of an upcoming medical imaging examination identified by a scheduler by” (Paragraphs [0011] – [0015], [0054], and [0085] – [0087] of Reiner. The broadest reasonable interpretation of “a complexity scoring module executed by the one or more processors and configured to assess a complexity of an upcoming medical imaging examination” reads on the processor in Reiner (Paragraphs [0011] – [0015], [0054], and [0085] – [0087]) configured to determine a Productivity Workflow Index (PWI) from a pooled set of data and/or from calculated individual PWI scores.).
Starobinets does not appear to explicitly disclose, but Zakutny teaches the limitation identified in bold as “a complexity scoring module executed by the one or more processors and configured to assess a complexity of an upcoming medical imaging examination identified by a scheduler by” (Paragraphs [0011] – [0015], [0054], and [0085] – [0087] of Reiner. The broadest reasonable interpretation of “a complexity scoring module executed by the one or more processors and configured to assess a complexity of an upcoming medical imaging examination” reads on the exam/procedure schedules in Zakutny (Paragraph [0052]).).
Starobinets does not appear to explicitly disclose, but Reiner teaches the limitation identified in bold as “acquiring data related to the upcoming medical imaging examination, the data comprising one or more of time taken to complete preparation and scanning activities associated with the upcoming medical imaging examination, whether contrast is used, what type of contrast is used, body part to be imaged, patient demographics, idle time between sequences, likelihood of repeated or additional imaging sequences, or image quality” (Paragraphs [0011] – [0015], [0085] – [0087], and [0143] – [0147] of Reiner. The broadest reasonable interpretation of “acquiring data related to the upcoming medical imaging examination, the data comprising one or more of time taken to complete preparation and scanning activities associated with the upcoming medical imaging examination, whether contrast is used, what type of contrast is used, body part to be imaged, patient demographics, idle time between sequences, likelihood of repeated or additional imaging sequences, or image quality” reads on the activity in Reiner (Paragraphs [0011] – [0015], [0085] – [0087], and [0143] – [0147]) of obtaining or pooling data, regarding human computer actions and workflow-related variables, from other sources that have been recorded on at least one accessible database, e.g., PACS, RIS, EMR, Imaging Modality, CPOE, Electronic Auditing Tool, and QA Scorecards. Variables within a Medical Imaging workflow may include imaging modality, anatomic region being imaged, contrast administration, image processing/reconstructions, patient profile, patient physical characteristics (e.g. size), correlating imaging data, correlating clinical data (lab, pathology, testing), medical history, clinical indication, image quality, and decision support.).
Starobinets does not appear to explicitly disclose, but Reiner teaches the limitation identified in bold as “determining the complexity of the upcoming medical imaging examination based on a weighted combination of a plurality of complexity scores respectively derived from the acquired data” (Paragraphs [0011] – [0015], [0085] – [0087], and [0143] – [0147] of Reiner. The broadest reasonable interpretation of “determining the complexity of the upcoming medical imaging examination based on a weighted combination of a plurality of complexity scores respectively derived from the acquired data” reads on the activity in Reiner (Paragraphs [0011] – [0015], [0085] – [0087], and [0143] – [0147]) of determining Productivity Workflow Index (PWI) scores by assigning weighted values to the pooled data regarding human computer actions by a user and workflow-related variables from an electronic database.).
Starobinets does not appear to explicitly disclose, but Reiner teaches the limitation identified in bold as “an alerting module configured to output an alert indicative of the determined complexity of the upcoming medical imaging examination” (Paragraphs [0218] – [0222] of Reiner. The broadest reasonable interpretation of “an alerting module configured to output an alert indicative of the determined complexity of the upcoming medical imaging examination” reads on the automated workflow distribution model in Reiner (Paragraphs [0218] – [0222]) for searching and cross-referencing PWI exam-specific databases with the radiologist-specific PWI databases, with PWI scores being derived and analyzed to accomplish the goal of achieving the optimal and most efficient match (based on the available pool of radiologists).).
Therefore, it would have been obvious to one of ordinary skill in the art of computer-aided diagnosis systems at the time of filing to modify the system and method of Starobinets to: include a complexity scoring module executed by the one or more processors and configured to assess a complexity of an upcoming medical imaging examination identified by a scheduler by: acquiring data related to the upcoming medical imaging examination, the data comprising one or more of time taken to complete preparation and scanning activities associated with the upcoming medical imaging examination, whether contrast is used, what type of contrast is used, body part to be imaged, patient demographics, idle time between sequences, likelihood of repeated or additional imaging sequences, or image quality; and determining the complexity of the upcoming medical imaging examination based on a weighted combination of a plurality of complexity scores respectively derived from the acquired data; and an alerting module configured to output an alert indicative of the determined complexity of the upcoming medical imaging examination, as taught by Reiner (Paragraphs [0011] – [0015], [0085] – [0087], [0143] – [0147], and [0218] – [0222]), in order to provide more accurate and reliable productivity measurement tools for complex workflow processes (Paragraph [0010] of Reiner).
Regarding claims 2 and 9, Starobinets as modified by Reiner and applied to an associated one of claims 1 and 5 teaches the limitations of representative claim 2 identified in bold as:
“wherein determining the complexity of the upcoming one or more imaging examinations includes:” (Paragraphs [0011] – [0015], [0085] – [0087], and [0143] – [0147] of Reiner. The broadest reasonable interpretation of “determining the complexity of the upcoming one or more imaging examinations includes” reads on the activity in Reiner (Paragraphs [0011] – [0015], [0085] – [0087], and [0143] – [0147]) of determining Productivity Workflow Index (PWI) scores by assigning weighted values to the pooled data regarding human computer actions by a user and workflow-related variables from an electronic database.);
“partitioning data related to historical imaging examinations into one or more classes based on one or more criterion; and” (Paragraphs [0085] – [0087], [0109], [0111], and [0348] of Reiner. In the instant application, the broadest reasonable interpretation of “partitioning data related to historical imaging examinations into one or more classes based on one or more criterion” reads on the activity in Reiner (Paragraphs [0085] – [0087], [0109], [0111], and [0348]) of presenting an automated PWI score based on historical data specific the task and the individual end-user’s profile.);
“generating performance statistics for the partitioned historical imaging examinations in each class” (Paragraphs [0085] – [0087], [0109], [0111], and [0348] of Reiner. In the instant application, the broadest reasonable interpretation of “generating performance statistics for the partitioned historical imaging examinations in each class” reads on the activity in Reiner (Paragraphs [0085] – [0087], [0109], [0111], and [0348]) of providing the end-user with reference values of the anticipated task complexity and time requirements, with the reference values providing comparable PWI scores for other end-users performing the same task.);
“partitioning data related one or more current imaging examinations into one or more classes based on the one or more criterion” (Paragraphs [0349] – [0350] of Reiner. In the instant application, the broadest reasonable interpretation of “partitioning data related one or more current imaging examinations into one or more classes based on the one or more criterion” reads on the activity in Reiner (Paragraphs [0349] – [0350]) of calculating the actual PWI score at the end of task completion.);
“applying the generated performance statistics for the partitioned historical imaging examinations to the one or more current imaging examinations in a common class” (Paragraphs [0085] – [0087], [0109], [0111], and [0348] – [0350] of Reiner. In the instant application, the broadest reasonable interpretation of “applying the generated performance statistics for the partitioned historical imaging examinations to the one or more current imaging examinations in a common class” reads on the activity in Reiner (Paragraphs [0085] – [0087], [0109], [0111], and [0348] – [0350]) of comparing the reference values (i.e., comparable PWI scores for other end-users performing the same task) to the actual PWI score.); and
“determining the complexity of the one or more current imaging examinations based on the generated performance statistics” (Paragraphs [0085] – [0087], [0109], [0111], and [0348] – [0350] of Reiner. In the instant application, the broadest reasonable interpretation of “applying the generated performance statistics for the partitioned historical imaging examinations to the one or more current imaging examinations in a common class” reads on the activity in Reiner (Paragraphs [0085] – [0087], [0109], [0111], and [0348] – [0350]) of calculating the actual PWI score at the end of task completion.).
Regarding claim 3, Starobinets as modified by Reiner and applied to claim 1 teaches the limitations identified in bold as “the complexity scoring module is further configured to: generate a prediction of one or more factors contributing to the determined complexity of the upcoming imaging examinations” (Paragraphs [0087] – [0135] of Reiner. In the instant application, the broadest reasonable interpretation of “the complexity scoring module is further configured to: generate a prediction of one or more factors contributing to the determined complexity of the upcoming imaging examinations” reads on the factors in Reiner (Paragraphs [0087] – [0135]) taken into account with respect to each workflow-related variable pooled with human computer actions to determine Productivity Workflow Index.).
Regarding claims 4, Starobinets as modified by Reiner and applied to claim 1 teaches the limitation identified in bold as “outputting an alert indicative of the determined complexity of the upcoming imaging examinations includes: outputting the alert indicating that an upcoming imaging exaction will be complex on an electronic processing device operable by a local operator performing the upcoming imaging examination” (Paragraph [0183] of Reiner. In the instant application, the broadest reasonable interpretation of “outputting an alert indicative of the determined complexity of the upcoming imaging examinations includes: outputting the alert indicating that an upcoming imaging exaction will be complex on an electronic processing device operable by a local operator performing the upcoming imaging examination” reads on the activity in Reiner (Paragraph [0183]) of providing, on a computer queried by an operator, a measure of exam complexity and time requirements.).
Regarding claim 6, Starobinets as modified by Reiner and applied to an associated one of claims Reiner teaches the limitation identified in bold as “the acquired data includes one or more of a modality of the medical imaging device, an imaged anatomy, and specific imaging sequences specified in an imaging examination card” (Paragraphs [0085] – [0087] and [0116] of Reiner. In the instant application, the broadest reasonable interpretation of “the acquired data includes one or more of a modality of the medical imaging device an imaged anatomy, and specific imaging sequences specified in an imaging examination card” reads on the acquisition device (modality, e.g. CT scanner) in Reiner (Paragraphs [0085] – [0087] and [0116]) as an example of a type of factor that may be taken into account with respect to each workflow related variables in a Medical Imaging workflow, where the PWI score is determined from pooling data regarding human computer actions by a user and workflow-related variables.).
Regarding claim 7, Starobinets as modified by Reiner and applied to claim 6 teaches the limitation identified in bold as “the acquired data further includes one or more of information on historical imaging examinations [such as] total length, time for each imaging examination phase, contrast agent delivery, patient unloading, and idle time” (Paragraphs [0111] and [0127] of Reiner. In the instant application, the broadest reasonable interpretation of “the acquired data further includes one or more of information on historical imaging examinations such as total length, time for each imaging examination phase, contrast agent delivery, patient unloading, and idle time” reads on the workflow related variables in Reiner (Paragraphs [0111] and [0127]) including historical imaging exams and contrast administration.).
Regarding claim 8, Starobinets as modified by Reiner and applied to claim 5 teaches the limitation identified in bold as “the acquired data is acquired from one or more data sources including HL7 messages, an examination order placed by a referring physician, an examination card, a patient electronic medical record, and imaging technician education and experience records” (Paragraph [0052] of Starobinets. Paragraphs [0137], [0162], and [0185] of Reiner. In the instant application, the broadest reasonable interpretation of “the acquired data is acquired from one or more data sources including HL7 messages, an examination order placed by a referring physician, an examination card, a patient electronic medical record, and imaging technician education and experience records” reads on the examination order in Staribonets (Paragraph [0052]) and the card, the patient electric medical record, and the radiologist’s technical, clinical, and educational factors in Reiner (Paragraphs [0137], [0162], and [0185]).).
Regarding claim 10, Starobinets as modified by Reiner and applied to claim 9 teaches the limitation identified in bold as “the one or more criterion include examination type, modality, imaging sequences, patient characteristics, an imaging technologist performing the examination, or a technician's class segmented by experience” (Paragraphs [0085] – [0087] and [0222] of Reiner. In the instant application, the broadest reasonable interpretation of “the one or more criterion include examination type, modality, imaging sequences, patient characteristics, an imaging technologist performing the examination, or a technician's class segmented by experience” reads on factors in Reiner (Paragraphs [0085] – [0087] and [0222]) taken into account with workflow related variables, with the factors including acquisition device (modality, e.g. CT scanner), number of sequences, patient profile, and clinical, technologist, and patient-specific differences.).
Claims 11 – 12 are rejected under 35 U.S.C. 103(a) as being unpatentable over Starobinets as modified by Reiner and applied to claim 9, and further in view of Zaktuny (U.S. Pub. No. 2023/0290491 A1).
Regarding claim 11, Starobinets as modified by Reiner and applied to claim 9 does not appear to explicitly disclose, but Zaktuny teaches the limitations identified in bold as “the performance statistics include one or more of average total examination time, average time for each phase, average idle time between successive phases, average number of rescans, average number of consultations with a remote expert, and average obtained image quality” (Paragraphs [0030] – [0032] of Zaktuny. In the instant application, the broadest reasonable interpretation of “the performance statistics include one or more of average total examination time, average time for each phase, average idle time between successive phases, average number of rescans, average number of consultations with a remote expert, and average obtained image quality” reads on the average time needed to perform the corresponding exam/procedure in Zaktuny (Paragraphs [0030] – [0032]).).
Therefore, it would have been obvious to one of ordinary skill in the art of computer-aided diagnosis systems at the time of filing to modify the system and method of Starobinets as modified by Reiner, such that the performance statistics include one or more of average total examination time, average time for each phase, average idle time between successive phases, average number of rescans, average number of consultations with a remote expert, and average obtained image quality, as taught by Zaktuny (Paragraphs [0030] – [0032]), in order to accurately reflect the level and complexity of work performed by the technologist in imaging exams/procedures (Paragraph [0003] of Zaktuny).
Regarding claim 12, Starobinets as modified by Reiner and Zaktuny and applied to claim 11 teaches the limitation identified in bold as “generating a prediction of one or more factors contributing to the determined complexity of the upcoming imaging examinations” (Paragraphs [0087] – [0135] of Reiner. In the instant application, the broadest reasonable interpretation of “generating a prediction of one or more factors contributing to the determined complexity of the upcoming imaging examinations” reads on the factors in Reiner (Paragraphs [0087] – [0135]) taken into account with respect to each workflow-related variable pooled with human computer actions to determine Productivity Workflow Index.).
Subject Matter Allowable Over the Prior Art
The following is a statement of reasons for the indication of allowable subject matter: none of the cited art appears to explicitly disclose the limitations of “determine required data to determine the complexity that is missing; and assign an average data value for the missing required data” in claim 13. Claims 14 – 22 depend directly or indirectly from claim 13 and include the subject matter of claim 13.
Claims 13 – 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/V.C.I./Examiner, Art Unit 3686
/DEVIN C HEIN/Examiner, Art Unit 3686