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 .
DETAILED ACTION
This action is in reference to the communication filed on 18 NOV 2025.
Amendments to claims 1, 13, 15, 16 have been entered and considered.
Claims 1-20 are present and have been examined.
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 1-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-20 the independent claim(s) 1, 13, 16 recite(s) a method and systems, each of which is a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-20 the independent claim(s) (claims 1, 13, 16) is/are directed, in part, to:
Claim 1:
A method for monitoring a medical intervention taking place in an operating room or an examination room, or a medical examination on a patient by medical personnel, the method comprising:
Acquiring,
Evaluating
when the stress, the negative emotions, or the stress and the negative emotions are recognized, determining at least one cause of the stress, the negative emotions, or the stress and the negative emotions using the
triggering, measures, such that the determined at least one cause is remediated, the stress is reduced, the negative emotions of the at least one individual are reduced, or any combination thereof.
Claim 13: (representative of claim 16 as well)
A system for monitoring a medical intervention taking place in an operating room or an examination room, or a medical examination on a patient by medical personnel, the system comprising:
acquire
evaluate the
determine at least one cause of the stress, the negative emotions, or the stress and the negative emotions; and
trigger measures, such that the determined at least one cause is remediated, the stress is reduced, the negative emotions of the at least one individual is reduced, or any combination thereof.
These claims are found to be directed to a mental process, in that the claims ensconce concepts performed in the human mind including observation, evaluation, judgment, and opinion functions. Receiving a plurality of types of data (i.e. optical, acoustic, haptic, etc.), and using that data to evaluate a state of stress, determine a cause of that stress, and trigger measures to reduce or mitigate the stress/emotions, are all examples of observation, judgment, and opinion functions of a human. If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, then it/they falls/ fall into the “mental processes” category.
The claims also ensconce concepts including managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Receiving information about medical personnel, and evaluating the information to trigger measures to reduce stress or negative emotions is a management of personal behavior of people – the medical personnel being monitored in the medical environment. If a claim limitation under its broadest reasonable interpretation covers managing personal behavior or relationships then it falls within the “method of organizing human activity” grouping of abstract idea(s)
Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional element – an “acoustic sensor” common to all independent claims, as well as receiving additional “digital data” as in claim 1, with claims 1, 13, 16 recently amended to include a processor. Examiner finds the sensor data being sent/received is at best sending and receiving the data, regardless of type, which is analogous to adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g). Examiner finds no improvement to the functioning of the computer/processor, or any other technology or technical field in the sensors or processor(s) as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e). With particular regard to the newly amended “processor” in claims 1, 13, 16, Examiner finds these elements recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h).
Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as: an “acoustic sensor” common to all independent claims, as well as receiving additional “digital data” as in claim 1, with claims 1, 13, 16 recently amended to recite a processor. When considered individually, the “sensor” claim elements only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification at:
[0028] In a first act 20, voice recordings of at least one individual 13 among the medical personnel are acquired by an acoustic sensor during the corresponding intervention or the examination. The acoustic sensor may, for example, be formed by one microphone 3 or a plurality of microphones. The microphone 3 may be arranged in the operating room 8 in which the intervention is taking place or the individual 13 carries the microphone 3.
[0034] In order to determine the cause(s), use may be made of the sensor data from the acoustic sensor (e.g., voice recordings from the microphones 3), and the spoken language contained therein may be analyzed (e.g., natural language processing (NLP); also with the aid of particular keywords). In addition, other optical, acoustic, haptic, digital, and/or other data acquired during the intervention or the examination that allows a conclusion to be drawn as regards the cause may be used to determine the cause.
[0035] A plurality of sources may be used for the data: other sensors or data acquisition units (e.g., microphones, cameras 4, haptic sensors, acceleration sensors, capacitive sensors, etc.); system data from the X-ray device, the robot system, or other devices (e.g., data about the operational sequence of the intervention, programs and parameters used, or error messages); medical imaging acquisitions of the patient (e.g., acquisitions acquired by the X-ray device) and evaluations of the acquisitions; inputs by the individual 13 or another individual among the medical personnel; eye tracking data for the individual 13; vital parameters of the patient 5 (e.g., EKG data, blood pressure or oxygen saturation, increased flow in external ventricle drainage, etc.); vital parameters of the individual 13; error messages of the system or individual devices; functional data and error messages of objects or devices (e.g., if an object does not behave as predicted, such as a stent does not open as predicted) or a collision has occurred, with/without damage to the device; temporal, spatial, or functional deviations from normal operational processes, sequences, and normal behavior of objects or individuals; time information (e.g., about the duration of steps of the intervention); and/or other information about the intervention or the examination. A request may also be issued to the individual to make an input (e.g., a question may be asked and the answer/input evaluated). The sensor data or other data may be transmitted by wireless or wired data transmission connections (e.g., WLAN, Bluetooth, etc.; dashed lines).
[0042] The monitoring system 1 also has an operating unit for the operation of the system by the at least one individual 13 among the medical personnel. This may, for example, be a PC with an input unit 18 and a monitor 24, or else a smart device or a joystick. The operating unit may be arranged in the operating room 8 or outside the operating room 8 or remotely. Further operating units (e.g., also by voice input) or display units 9 may be present in the operating room 8.
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. The invention relies upon the sensor(s) as claimed operating in a known manner. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a sensor “sends” data for determination purposes, and the PC is interpreted to contain the “processors” as amended. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2-12, 14-15, 17-20:
Dependent claims 2, 5-11 do not recite any additional abstract ideas or additional non-abstract elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as types of interventions, and types of patterns identified for the different negative emotions. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Dependent claims 3, 4, 12, 17-20 do not recite any additional abstract ideas, but do at least nominally recite additional elements.
Claims 3, 4, nominally recite further information about the sensor, however, for the reasons noted above these elements are not found to cause a finding of a practical application and/or significantly more.
Dependent claim 12, 20 recite the use of a remote connection, however sending and receiving data is generally found to be insignificant extra solution activity as referenced above, and as such is not found to constitute a finding of a practical application. Further, discussion of the remote connection is addressed in the relevant portions of the specification cited above with regard to a lack of significantly more.
Dependent claims 17, 18 recite the use of an imaging device, as well as wherein the imaging device is an x-ray device. These are both found to be recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h). No improvement to the functioning of the computer or any other technology or technical field in the imaging elements as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e). With regard to significantly more, Examiner references [027, 035] of the specification, which clarifies the use of the machinery in functional terms only, i.e. existing technology applied to the abstract idea. At [012] “The medical intervention may also involve 2D or 3D image acquisition by a medical device (e.g., an imaging device such as an X-ray device, CT, MR, ultrasound, etc.). This includes all medical examinations or interventions (e.g., also those with sequences consisting of multiple steps). Also included are interventions with remotely connected individuals among the medical personnel.” – i.e. the type of imaging technology is not specific to the invention whatsoever. As such no finding of significantly more is made.
Dependent claim 15 nominally recites the use of a trained algorithm. In the interest of compact prosecution Examiner notes that the algorithm falls under a mathematical process - i.e. mathematical relationships, formulas, equations, and/or calculations. If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationships, formulas, equations, and/or calculations, then it/they falls/ fall into the “mathematical processes” category. Examiner finds nothing additional for consideration as a practical application and/or significantly more.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14, 16-18, 20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Reiner (US 20130311190 A1).
In reference to claim 1, 13, 16:
Reiner teaches: A method (as in claim 1), and system (as in claims 13) and complete medical system (as in claim 16) for monitoring a medical intervention taking place in an operating room or an examination room, or a medical examination on a patient by medical personnel (at least [fig 1 and related text, as well as 078, 081, 088] Examples of types of imaging procedures a patient would have in a medical setting, performed by the radiologist), the method comprising:
Acquiring, by a processor, sensor data from at least one acoustic sensor, of at least one individual among the medical personnel during the medical intervention or the medical examination (at least [045] “…voice recognition systems, speakers, microphones” see also [085-088] “voice stress analysis” is used in conjunction with the system for the given user, i.e. Dr. Jones in [0083]);
Evaluating, by the processor, the sensor data from the at least one acoustic sensor as regards recognition of stress, negative emotions, or the stress and the negative emotions of the at least one individual (at least [fig 2B, 2C and related text] “the program 110 correlates this baseline stress modulator score with the user-specific historical stress profile to identify changes above or below baseline.” “these real-time stress scores are continuously updated by the program 110 and presented to the end-user based upon his/her pre-defined preferences for data presentation.” At [0148] “In step 219, in the event that the continuous stress scores (based upon speech analysis) exceed a pre-defined threshold as detected by the program 110, then an automated prompt is sent by the program 110 via electronic means, to alert the end-user of the elevated stress scores along with intervention options.”);
when the stress, the negative emotions, or the stress and the negative emotions are recognized, determining by the processor at least one cause of the stress, the negative emotions, or the stress and the negative emotions using the sensor data, further optical data, further acoustic data, further haptic data, further digital data, other data acquired during the intervention or the examination, or any combination thereof (at least [0078] “This stress inflection point is also dynamic and changes in accordance with the stress/performance metrics of individual tasks. As an example, a radiologist may exhibit higher performance measures for different exam types (e.g., CT angiography of the chest vs. magnetic resonance imaging (MRI) of the knee) at comparable stress levels, and therefore have different stress inflection points for each of these exam types. At the same time, the same radiologist may have different performance measures (at comparable stress levels) for the same exam type (e.g., chest CT angiography) but two different clinical indications (e.g., evaluate pulmonary embolism vs. thoracic aorta aneurysm). A final example might include the same radiologist, same exam type (e.g., chest CT angiography), and same clinical indication (e.g., pulmonary embolus). When using two different technologies (e.g., CAD programs) in performing interpretation, the same radiologist may have different performance metrics and/or stress level measurements; thereby creating two different stress inflection points.“ i.e. the type of procedure/test may cause different levels of stress in a given professional, and at [090] “ In addition to analyzing uncertainty through speech analysis, a number of supporting technologies can be incorporated into implementation to improve performance. Two examples of these supporting technologies include uncertainty detection through linguistic and visual (eye-tracking) analyses…For visual analysis of uncertainty, eye tracking technology (one of stress measurement systems 42) can be used to identify visual uncertainty which can take a number of different forms including increased dwell time and backtracking of eye movements over a single point of interest, and its data analyzed by the program 110.” – i.e. eye movements are used to supplement the stress determination noticed in the voice analysis); and
triggering, by the processor, measures, such that the determined at least one cause is remediated, the stress is reduced, the negative emotions of the at least one individual are reduced, or any combination thereof (at least [095] “If however, analysis of the stress and outcomes data by the program 110 does show a correlation (i.e., increased stress is associated with adverse outcomes), then positive outcomes can be effected by the program 110 identifying, communicating, and acting upon these transient increased stress levels at the point of care. Examples of potential intervention strategies instituted by the program 110 when the radiologist interpreting the medical imaging exams experiences a high level of stress in a specific task, could include the following: [0096] 1. Activation of computerized decision-support technologies (e.g., computer-aided diagnosis software). [0097] 2. Recommendation for a consultation or second opinion from a colleague. [0098] 3. Deferral of the case to another radiologist. [0099] 4. Bookmark of the case for subsequent quality assurance (QA) analysis and peer review. [0100] 5. Automated search by the program 110, of the patient's electronic medical record (EMR) for additional clinical/imaging data to assist in the interpretation process.” – i.e. alternatives to improve outcomes based on the stressor(s) of a given professional; see also [0103-0106] “As an example, one end-user may elect to continue performing all tasks despite feedback of elevated stress levels, whereas another individual end-user may elect to modify his/her workflow or temporarily stop working until stress levels return to baseline or more acceptable levels.“ at [0111] “While the specific parameters for determining when these QA triggers would be initiated can be customized by the program 110 in accordance with individual preferences, the ultimate functionality and accountability of the present invention would remain consistent. Whenever an individual end-user continues to operate in a manner considered to be unacceptable (based upon a comparison analysis by the program 110 with the predetermined stress inflection data), an automated alert would be sent by the program 110 to the end-user, using electronic means, with the recommendation to temporarily cease or modify workflow.”).
In reference to claim 2:
Reiner further teaches: wherein the monitoring of the medical intervention takes place with at least one medical device, at least one medical object, or a combination thereof (at least [0151] “In the example of the radiologist interpreting a medical imaging exam (e.g., MRI of brain), an electronic time-stamp is recorded which identifies the specific action in which the elevated stress measure is recorded. For this example, the specific action recorded by the program 110 could consist of the specific image, annotation, and/or recorded text associated with the elevated stress measure. The combined stress data related to uncertainty is recorded in the corresponding speech analysis database 113 by the program 110, for future review and analysis, specific to the individual end-user, task performed, data reviewed, and outcomes.” – MRI metadata is recorded regarding the procedure itself).
In reference to claim 3:
Reiner further teaches: wherein the acquired sensor data is in the form of voice recordings (at least [0109, 110, 045] voice recognition, see also [fig 2A and related text] for discussion of user specific profiling of language, i.e. Recordings.)
In reference to claim 4:
Reiner further teaches: wherein the sensor data is acquired in the form of spoken language, and wherein the evaluating of the sensor data in the form of the spoken language is performed using at least one algorithm from machine learning, a database, or a combination thereof (at least [036, 062] “The ability of the program 110 to correlate real-time (i.e., contemporaneous) analysis of speech with a data rich and comprehensive personalized speech profile baseline stored in the database 113,” and at [093] “The ability of the program 110 to correlate uncertainty and outcomes data could potentially provide insights into the clinical significance of uncertainty and need for intervention. As an example, if quality assurance (QA) analysis of an individual radiologist's information stored in the database 113, by the program 110, shows a specific and reproducible stress (or language) uncertainty pattern associated with higher than expected QA discrepancies, voice stress pattern could be prospectively analyzed so that the program 110 will identify "high risk" reports (or individual findings) associated with inaccurate diagnoses. The ultimate goal would be the creation of a context and user-specific database 113 by the program 110 which could identify specific voice stress and language patterns associated with poor outcomes data.”).
In reference to claim 5:
Reiner further teaches: wherein the at least one cause of the stress, the emotions, or the stress and the emotions is determined using sensor data from further sensors, system data from medical devices or other devices, medical imaging acquisitions of the patient, inputs by the individual, camera recordings of the intervention or of the medical examination, eye tracking data for the individual, vital parameters of the individual, the patient, or the individual and the patient, functional data of objects or devices, other information about the intervention or the medical examination, or any combination thereof (at least [0078] “This stress inflection point is also dynamic and changes in accordance with the stress/performance metrics of individual tasks. As an example, a radiologist may exhibit higher performance measures for different exam types (e.g., CT angiography of the chest vs. magnetic resonance imaging (MRI) of the knee) at comparable stress levels, and therefore have different stress inflection points for each of these exam types. At the same time, the same radiologist may have different performance measures (at comparable stress levels) for the same exam type (e.g., chest CT angiography) but two different clinical indications (e.g., evaluate pulmonary embolism vs. thoracic aorta aneurysm). A final example might include the same radiologist, same exam type (e.g., chest CT angiography), and same clinical indication (e.g., pulmonary embolus). When using two different technologies (e.g., CAD programs) in performing interpretation, the same radiologist may have different performance metrics and/or stress level measurements; thereby creating two different stress inflection points.“ i.e. the type of procedure/test may cause different levels of stress in a given professional, and at [090] “ In addition to analyzing uncertainty through speech analysis, a number of supporting technologies can be incorporated into implementation to improve performance. Two examples of these supporting technologies include uncertainty detection through linguistic and visual (eye-tracking) analyses…For visual analysis of uncertainty, eye tracking technology (one of stress measurement systems 42) can be used to identify visual uncertainty which can take a number of different forms including increased dwell time and backtracking of eye movements over a single point of interest, and its data analyzed by the program 110.” – i.e. eye movements are used to supplement the stress determination noticed in the voice analysis).
In reference to claim 6:
Reiner further teaches: wherein the at least one determined cause of the stress, the negative emotions, or the stress and the negative emotions comprises: problems with the at least one medical device;
problems with the medical object;
problems with the medical intervention or the medical examination;
a conflict with another individual among the medical personnel; or any combination thereof (at least [0078] “As an example, a radiologist may exhibit higher performance measures for different exam types (e.g., CT angiography of the chest vs. magnetic resonance imaging (MRI) of the knee) at comparable stress levels, and therefore have different stress inflection points for each of these exam types. At the same time, the same radiologist may have different performance measures (at comparable stress levels) for the same exam type (e.g., chest CT angiography) but two different clinical indications (e.g., evaluate pulmonary embolism vs. thoracic aorta aneurysm). A final example might include the same radiologist, same exam type (e.g., chest CT angiography), and same clinical indication (e.g., pulmonary embolus). When using two different technologies (e.g., CAD programs) in performing interpretation, the same radiologist may have different performance metrics and/or stress level measurements; thereby creating two different stress inflection points.” At [0081] “An example of an actual increase in task complexity can be illustrated in the course of a radiologist tasked with serial interpretation of medical imaging exams. When he/she transitions from a relatively simple and straightforward exam (e.g., chest radiograph for detection of pneumonia) to a more complex and data-intensive exam (e.g., MRI for re-evaluation of brain tumor following radiation therapy), one would routinely expect to observe a transient increase in measured stress levels, in accordance with the interval change in task complexity.” – i.e. problems with the type of procedure itself).
In reference to claim 7:
Reiner further teaches: wherein the at least one determined cause of the stress, the negative emotions, or the stress and the negative emotions comprises problems with the at least one medical device, the problems with the at least one medical device including operational problems, errors that occur, collisions, or any combination thereof (at least [0078] “As an example, a radiologist may exhibit higher performance measures for different exam types (e.g., CT angiography of the chest vs. magnetic resonance imaging (MRI) of the knee) at comparable stress levels, and therefore have different stress inflection points for each of these exam types. At the same time, the same radiologist may have different performance measures (at comparable stress levels) for the same exam type (e.g., chest CT angiography) but two different clinical indications (e.g., evaluate pulmonary embolism vs. thoracic aorta aneurysm). A final example might include the same radiologist, same exam type (e.g., chest CT angiography), and same clinical indication (e.g., pulmonary embolus). When using two different technologies (e.g., CAD programs) in performing interpretation, the same radiologist may have different performance metrics and/or stress level measurements; thereby creating two different stress inflection points.” At [0081] “An example of an actual increase in task complexity can be illustrated in the course of a radiologist tasked with serial interpretation of medical imaging exams. When he/she transitions from a relatively simple and straightforward exam (e.g., chest radiograph for detection of pneumonia) to a more complex and data-intensive exam (e.g., MRI for re-evaluation of brain tumor following radiation therapy), one would routinely expect to observe a transient increase in measured stress levels, in accordance with the interval change in task complexity.” – i.e. operational problems with the type of procedure itself).
In reference to claim 8:
Reiner further teaches: wherein the at least one determined cause of the stress, the negative emotions, or the stress and the negative emotions comprises problems with the medical intervention or the medical examination, the problems with the medical intervention or the medical examination including errors, medical emergencies, unscheduled events that occur, or any combination thereof (at least [088-089, 093] “As an example, if quality assurance (QA) analysis of an individual radiologist's information stored in the database 113, by the program 110, shows a specific and reproducible stress (or language) uncertainty pattern associated with higher than expected QA discrepancies, then this user-specific voice stress pattern could be prospectively analyzed so that the program 110 will identify "high risk" reports (or individual findings) associated with inaccurate diagnoses.” – i.e. error on the part of the clinician; see also [0104] “In the case of the brain MRI for stroke, the radiologist's historical outcomes data for stroke interpretation on brain MRI reports a diagnostic accuracy of 92% (for 112 prior cases). In the case of memory loss evaluation of brain MRI, the reported diagnostic accuracy is 99% (for 36 cases). When provided with this context and user-specific outcomes data by the program 110, the radiologist realizes that the uncertainty associated with the stroke case takes on greater importance than the uncertainty associated with the memory loss case, based upon his/her own historical outcomes data. As a result, the radiologist may elect to accept the memory loss report "as is" and not require additional intervention. For the stroke case with poorer outcomes results, the same radiologist may elect to seek out a second opinion from a colleague before finalizing the report.”)
In reference to claim 9:
Reiner further teaches: wherein triggering measures comprises triggering measures dependent on the at least one determined cause of the stress, the negative emotions, or the stress and the negative emotions (at least [0104-0108] “In the case of the brain MRI for stroke, the radiologist's historical outcomes data for stroke interpretation on brain MRI reports a diagnostic accuracy of 92% (for 112 prior cases). In the case of memory loss evaluation of brain MRI, the reported diagnostic accuracy is 99% (for 36 cases). When provided with this context and user-specific outcomes data by the program 110, the radiologist realizes that the uncertainty associated with the stroke case takes on greater importance than the uncertainty associated with the memory loss case, based upon his/her own historical outcomes data. As a result, the radiologist may elect to accept the memory loss report "as is" and not require additional intervention. For the stroke case with poorer outcomes results, the same radiologist may elect to seek out a second opinion from a colleague before finalizing the report. This shows the ability of the program 110 to support cross-analysis of the stress and outcomes databases 113 to determine the most effective course of action with the stress data being presented by the program 110 to the user.” “Alternatively, the department or institution in which the end-user is employed may elect to have pre-defined rules which govern work under increased stress levels. These rules can be fixed for all end-users by the program 110, or can be modified by the program 110 in accordance with the specific task complexity and end-user performance metrics.”)
In reference to claim 10:
Reiner further teaches: wherein triggering measures comprises triggering measures, such that the determined at least one cause is remediated, and
wherein the measures include at least one instance of:
operational support with the at least one medical device, the at least one
medical object, or the at least one medical device and the at least one medical object;
automatic assistance; automatic troubleshooting; collision management; automatic assistance with steps of the medical intervention or of the medical examination (at least [061, 095-0100, 0104] automatic deferral or support of an additional colleague);
a query to the at least one individual thereof (at least [093-0100, 0102-0107, 0111] “Whenever an individual end-user continues to operate in a manner considered to be unacceptable (based upon a comparison analysis by the program 110 with the predetermined stress inflection data), an automated alert would be sent by the program 110 to the end-user, using electronic means, with the recommendation to temporarily cease or modify workflow.” – alerts are sent to the individual experiencing the higher than normal stress event);
or any combination thereof.
In reference to claim 11:
Reiner as cited teaches the above limitations. The limitation wherein the operational support is referenced further limits a limitation claimed in the alternative. As such, Reiner teaches/makes obvious the claimed limitation.
In reference to claim 12:
Reiner further teaches: wherein one or more individuals of the at least one individual among the medical personnel is taking part in the medical intervention or the medical examination using a remote connection (at least [023] remote access to the system, at [097, 0104] second opinion from a colleague using the remote system.)
In reference to claim 14:
Reiner further teaches: at least one operating unit configured for operation of the system by the at least one individual among the medical personnel (at least [fig 1 and related text] Client 101, RIS 30, see also [005]. At fig 2A and related text, the process begins with an end user, i.e. radiologist, logging into the system).
In reference to claim 17:
Reiner further teaches a medical device in the form of an imaging device (at least [fig 1 and related text] “The system 100 is designed to interface with existing information systems such as a Hospital Information System (HIS) 10, a Radiology Information System (RIS) 20, an acquisition or radiographic device 21, and/or other information systems that may access a computed radiography (CR) cassette or direct radiography (DR) system… According to one embodiment, bi-directional communication between the system 100 of the present invention and the information systems, such as the HIS 10, RIS 20, radiographic device, CR/DR plate reader 22, and PACS 30, etc., may be enabled to allow the system 100 to retrieve and/or provide information from/to these systems.”)
In reference to claim 18:
Reiner further teaches: wherein the imaging device comprises an X-ray device (at least [fig 1 and related text] “The system 100 is designed to interface with existing information systems such as a Hospital Information System (HIS) 10, a Radiology Information System (RIS) 20, an acquisition or radiographic device 21, and/or other information systems that may access a computed radiography (CR) cassette or direct radiography (DR) system… According to one embodiment, bi-directional communication between the system 100 of the present invention and the information systems, such as the HIS 10, RIS 20, radiographic device, CR/DR plate reader 22, and PACS 30, etc., may be enabled to allow the system 100 to retrieve and/or provide information from/to these systems.” “…the image display device 102 may clearly, easily and accurately display images, such as x-rays, and/or other images”).
In reference to claim 20:
Reiner further teaches: wherein one or more individuals of the at least one individual among the medical personnel is taking part in the medical intervention or the medical examination using a remote connection (at least [023] remote access to the system, at [097, 0104] second opinion from a colleague using the remote system.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 15, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al (US 20220101999 A1, hereinafter Bonutti).
In reference to claim 15:
Reiner as cited teaches all the limitations above. While Reiner teaches the evaluation/determination as claimed, and while one of ordinary skill in the art could likely infer that given the database involved machine learning was likely used, it does not specifically disclose a trained machine learning algorithm. Bonutti however does teach: at least one trained algorithm for machine learning (at least [032, 036] a trained CNN is used to determine that the appropriate procedure was followed during a surgical procedure, and at [030] “ For example, if the healthcare provider failed to request certain diagnostic testing or as certain questions during a patient visit based on the patient's verbal symptoms and/or diagnostic results, the system 100 may generate information in that regard during the visit for the provider to correct any omissions or mistakes. The system 100 could constantly update based on outcomes to ensure evolve the algorithm.”). Reiner and Bonutti are analogous as both disclose ensuring patient safety during a surgical procedure. As discussed above, one of ordinary skill in the art would have found the use of trained machine learning algorithms to be obvious to include within the database searching of Reiner, as it would have improved the efficiency of the searching/matching/suggestion process in Reiner, and therefore would have improved the patient’s safety and overall experience with an often scary or intimidating medical procedure.
In reference to claim 19:
Reiner as cited teaches all the limitations above, as well as teaching a plurality of imaging techniques, including imaging for hollow organs (see i.e. [078] for lung imaging). While one of ordinary skill in the art could infer the use of a tool such as an endoscope would be within the range of imaging suggested by Reiner, Examiner notes that Bonutti teaches: a robot based navigation of a medical object through a hollow organ of the patient (at least [044] “As an example, the one or more cameras 150, 154 may be positioned on the endoscope 140 or robot 156 for assisted surgery or other instrument or device that is insertable into the patient's body to obtain video of the target tissue.” At [026] “In addition to or alternatively, the software 122 may be configured to recognize other critical aspects of the recorded surgery (or recognize commands given by the surgeon or other person) that it is programmed to recognize, using visual data and/or audio data… In addition to or alternatively, the software 122 may be configured to recognize other critical aspects of the recorded surgery (or recognize commands given by the surgeon or other person) that it is programmed to recognize, using visual data and/or audio data. For example, a critical aspect may be visual data of the tissue to be operated on (“target tissue”) before surgery is performed on the tissue for purposes of diagnosis, for example. Thus, the software 122 may be configured to recognize the target tissue when the surgeon has visualized the target tissue before the surgery has started. This video could come from cameras 110 mounted in the room, an endoscope 140, or any camera (e.g., camera 144 mounted on a light 146; camera 150 mounted on surgeon (such as head or visor) or other healthcare practitioner; or camera 154 mounted on a surgical robot 156) used during the surgical procedure. “ Bonutti and Reiner are analogous as both disclose several means of assisted imaging of a patient during or prior to a procedure/diagnosis, including several overlapping technologies. As such, it would have been obvious to one of ordinary skill to simply substitute the endoscope or robotic capabilities of Bonutti with the plurality of imaging techniques taught by Reiner in order to provide a more comprehensive patient imaging experience.
Relevant Prior Art
The following references are not relied upon, but are believed to be relevant to the claim(s).
US 20190050984, to Blendinger, discloses a speech control management system for use by clinicians during a variety of procedures.
US 20110041077, also to Reiner, discloses using speech patterns to recognize profiles/preferences of the clinicians in a medical setting.
Response to Arguments
Applicant’s remarks as filed on 18 NOV 2025 have been fully considered.
Applicant’s amendments to claims 13, 15, 16 have negated the interpretation under 112f and the subsequent rejection under 35 USC 112a/b.
Applicant’s remarks regarding the rejection under 35 USC 101 begin on page 9 of the response. Applicant references the amendments made. Examiner does not find the amendments sufficient to overcome the rejection.
Applicant begins a discussion of the prior art on page 10 of the remarks. Examiner respectfully disagrees with Applicant’s conclusions regarding the prior art rejection – as noted in the rejection, Examiner provided citations indicating that a type of procedure or equipment could be the cause or source of increased stress. If Applicant seeks a more narrow interpretation, Applicant is encouraged to amend the claims to reflect that. Examiner respectfully notes that Bonutti was not cited for the limitations in question.
Applicant also discusses the remediation limitation on page 11. Examiner notes that the claim allows for “any combination” of remediation, reduction, etc., and automatically suggesting them. Examiner respectfully submits that if Applicant seeks a specific remediation beyond the ones suggested by the reference, Applicant is encouraged to amend the claimed limitations to reflect that. The “potential intervention” is triggered in the sending of a recommendation, and the stress levels are monitored going forward to determine if a reduction occurred. Examiner respectfully disagrees – a positive outcome in Reiner is clearly linked to a reduction in the detected stress level(s). Stress levels are, as noted in Reiner, tied to particular procedures. Again, Examiner respectfully notes Bonutti is not cited to teach the limitations in question and as such this line of reasoning isn’t persuasive.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687