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 .
Response to Amendment
The amendment filed on 02/02/2026 has been entered. Claims 1, 3, 7, 14 and 16 have been amended. Claims 1-12 and 14-17 remain pending.
The previously raised objections for Claim 16 are withdrawn because the issues have been properly corrected.
The previously raised 35 U.S.C. 112(f) for Claim 1 is withdrawn because the issue has been properly corrected.
Response to Arguments
On Pages 6-7 of Remarks, Applicant argues that reference Warner does not teach the determination of a real-time skill estimate that indicates a current ability of the current user to perform the current task, and neither Holden, Jones nor Ninomiya rectify the deficiencies of Warner. Examiner respectfully disagrees. The claimed “real-time skill estimate” indicated by “a current ability” (Claim 1, Lines 12-14) is determined based on the claimed “user interaction data” (Claim 1, Line 7). Such user interaction is recited at a high level of generality. Reference Warner discloses one type of user interaction, by which a user approves, delete or adjust a configuration (with specified skill plugins) provided by a digital assistant, and such user interaction would clearly reveal a user’s preference and/or skill. Further, the disclosed “user interaction” by Warner agrees with Application’s disclosure, “The interaction items may comprise one or more interaction items representing respective individual interactions of the user with the system, for example, individual inputs provided by the user …” (Specification, Page 6, Lines 17-19). However, Examiner agrees that other type of user interaction and skill assessment may also agree with the claimed ones, e.g. a reference listed in section of Conclusion, Tepper (US-20140004488-A1), discloses assessing a user’s mechanical proficiency or manual dexterity in performing ultrasound tasks.
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.
Claims 1, 3-5, 8-11 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warner et al (US 20210104317 A1; hereafter Warner).
With regard to Claim 1, Warner discloses an ultrasound system, wherein the ultrasound system is operable by one or more users of the ultrasound system to process ultrasound measurements of a patient (Warner, Para 0037; “FIG. 1 is a block diagram of an example apparatus or system 100 including a digital assistant 110 and a medical equipment 120. The medical equipment 120 can be implemented as an imaging system (e.g., x-ray, MR, CT, ultrasound, …”), the system comprising:
an ultrasound, wherein the ultrasound is operable to perform the ultrasound measurements of the patient (Warner, Para 0037; “The medical equipment 120 can be implemented as an imaging system (e.g., x-ray, MR, CT, ultrasound, …”);
a customizer (Warner, Abstract; “Systems, apparatus, instructions, and methods for configuring and controlling medical equipment using a digital assistant …”) configured to:
obtain user interaction data of one or more interactions of a current user performing a current task at the ultrasound system (Warner, Para 0069; “the configuration of the skill can be displayed via a graphical user interface for user approval, adjustment, deletion, etc. At 830, the skill is approved, deleted, or adjusted based on the input from the user/system.”), wherein the ultrasound system provides user-facing functionality for performing the current task (Warner, Para 0069; “At 820, the digital assistant 110 generates a skill or configuration based on the information from the medical equipment 120. ... At 825, the digital assistant 110 can provide the skill to a user and/or other system for approval.”), wherein the customizer is configured to provide the user-facing functionality at multiple different skill levels that differ in the amount of user guidance and/or automation that is provided (Warner, Para 0069; “The skill saves the equipment type, vendor, version, settings for configurable parameters, etc., in the digital assistant 110, for example. … For example, one or more parameters can be adjusted based on user override, input from another application/system, etc. The adjusted configuration can then be saved as a skill with the digital assistant 110 (e.g., as part of the digital twin 230, as a plugin 570, 572, etc.).”) (Warner, Para 0102; “The similarities and differences can drive a customized configuration and guidance for a particular event/use case.”) (To one of ordinary skill in the field, different configurations for operating a medical equipment would represent user-facing functionality at different difficulty or skill levels);
from the user interaction data, determine a real-time skill estimate of the current user (Warner, Para 0078; “At 965, the user can accept, deny, or modify the proposed action(s) via the user device 620. … At 975, the user response is recorded and processed. Based on the response, at 980, the request is denied and control reverts to the user device 620 or, at 985, the request is granted and updated machine settings are provided to the medical equipment 120. ”. In this disclosure, user reveals his or her skill estimate to the system by accepting, denying or modifying the actions proposed by the digital assistant), wherein the real-time skill estimate indicates a current ability of the current user to perform the current task (Warner, Para 0079; “At 1005, the user device 620 generates a notification to the digital assistant 110 regarding a different version, vendor, etc., of the medical equipment 120. … As such, the user can be unfamiliar with CT scanner B …”. In this disclosed example, the ability of the user to operate scanner B is low);
customize the ultrasound system for performing the current task and provide the user-facing functionality at a skill level corresponding to the real-time skill estimate of the current user (Warner, Para 0079; “As such, the user can be unfamiliar with CT scanner B, and the digital assistant 110 can take the user's preferences, norms, configuration/settings, etc., for CT scanner A and translate/convert them into configuration/settings for CT scanner B using the digital twin 230, plugin 570-572, etc.”. In this disclosure, the regular configuration of scanner A is unfamiliar or difficult for the user, so the user-facing functionality is customized to a configuration (i.e. scanner B) that corresponds to the user’s familiarity or skill level).
With regard to Claim 3, Warner discloses the ultrasound system of claim 1, wherein the ultrasound system is an ultrasound for monitoring system (Warner, Para 0105; “certain examples provide a digital assistant enabled with skills, … skills can include hemodynamic configuration and monitoring …”; Para 0106; “The example skill can automatically … begin capture of patient vitals, capture an ECG baseline, etc.”), wherein the ultrasound for monitoring system further comprises a patient monitor configured to show information based on the performed ultrasound measurements (Warner, Para 0103; “Output can be provided via the example user interface 510 to display information to a user (e.g., settings/configuration information, program options, skills, etc.) …”), and wherein the user performs the current task at the patient monitor or at a bridge device of the ultrasound for monitoring system used for information exchange between the ultrasound and the patient monitor (Warner, Para 0103; “… facilitate feedback and/or other interaction for digital twin 230 model development, medical equipment 120 configuration/operation, etc. FIG. 16 depicts an example implementation of the user device 620 as a smartphone with the graphical user interface 510.”).
With regard to Claim 4, Warner discloses the ultrasound system of claim 1, wherein the user-facing functionality is provided at multiple different skill levels and according to multiple different clinical roles (Warner, Para 0059; “The user database 533 stores information about preferences, profiles, etc., for one or more users associated with the digital assistant 110. The information in the user database 533 can be used by the digital twin 230 to customize the medical equipment 120 for a particular user, for example.”) (Warner, Para 0062; “user identification/authentication, role, privileges/authorization, preferences, history, etc., can be maintained as a user profile 640.”).
With regard to Claim 5, Warner discloses the ultrasound system of claim 1, wherein the customizer is further configured to derive from the user interaction data the current task that the current user is performing (Warner, Para 0063; “a voice command to configure a GE CT scanner can be transformed by the input analyzer 710 into a series of commands and keywords to access a model of the GE CT scanner from the digital twin 230 and/or one or more associated data stores 530 (e.g., the equipment database 531, the user database 533, and the task database 537, etc.) to configure the CT scanner for a particular user, patient, task(s), etc.”).
With regard to Claim 8, Warner discloses the ultrasound system of claim 1, wherein the customizer is configured to determine the real-time skill estimate based on context information about the physical environment in which the ultrasound system is being used (Warner, Para 0098; “the retrieved skill(s) and/or model(s) are adapted based on the combination of skill(s) and/or model(s) along with user preferences, other constraints (e.g., regulatory, usage-based, location-based, etc.), etc., to form a configuration for the event.”) (Warner, Para 0121; “the digital assistant can dynamically configure the medical equipment for the user more precisely for a particular location, …”).
With regard to Claim 9, Warner discloses the ultrasound system of claim 1, wherein the customizer is configured to customize the ultrasound system by, depending on the skill level, providing or not providing a user guidance (Warner, Para 0034; “The digital assistant can also ease use learning on equipment by sharing tips and tricks to new users …”), and/or, depending on the skill level, automating or not automating an operation (Warner, Para 0064; “The input analyzer 710 triggers the skill selector 720 to select, using the command(s)/keyword(s) generated by the input analyzer 710, one or more skills … such as a skill to automate configuration and/or documentation of an interventional catheterization procedure, …”).
With regard to Claim 10, Warner discloses the ultrasound system of claim 1, wherein the customizer comprises a user interface configured to enable the user to override the skill level at which the ultrasound system is customized (Warner, Para 0038; “a user and/or other application, system, device, etc., can approve the modeled output, override the modeled output, adjust the modeled output, etc.”).
With regard to Claim 11, Warner discloses the ultrasound system of claim 1, wherein the ultrasound system is for use in a critical care and/or perioperative environment (Warner, Para 0092; “information is retrieved from the digital twin 230 regarding configuration of a catheter-based ultrasound system for cardiovascular imaging.”).
With regard to Claim 14, Warner discloses a computer-implemented method of customizing an ultrasound system (Warner, Para 0025; “… methods to integrate operation and/or structure of a digital assistant with medical equipment such as … ultrasound …”), wherein the ultrasound system is operable by one or more users of the ultrasound system to process ultrasound measurements of a patient, wherein the ultrasound system comprises an ultrasound operable to perform the ultrasound measurements of the patient (Warner, Para 0037; “The medical equipment 120 can be implemented as an imaging system (e.g., x-ray, MR, CT, ultrasound, …”), wherein the method comprises:
obtaining user interaction data of one or more interactions of a current user performing a current task at the ultrasound system (Warner, Para 0069; “the configuration of the skill can be displayed via a graphical user interface for user approval, adjustment, deletion, etc. At 830, the skill is approved, deleted, or adjusted based on the input from the user/system.”), wherein the ultrasound system provides user-facing functionality for performing the current task (Warner, Para 0069; “At 820, the digital assistant 110 generates a skill or configuration based on the information from the medical equipment 120. ... At 825, the digital assistant 110 can provide the skill to a user and/or other system for approval.”), wherein the method is configured to provide the user-facing functionality at multiple different skill levels that differ in the amount of user guidance and/or automation that is provided (Warner, Para 0069; “The skill saves the equipment type, vendor, version, settings for configurable parameters, etc., in the digital assistant 110, for example. … For example, one or more parameters can be adjusted based on user override, input from another application/system, etc. The adjusted configuration can then be saved as a skill with the digital assistant 110 (e.g., as part of the digital twin 230, as a plugin 570, 572, etc.).”) (Warner, Para 0102; “The similarities and differences can drive a customized configuration and guidance for a particular event/use case.”) (To one of ordinary skill in the field, different configurations for operating a medical equipment would represent user-facing functionality at different difficulty or skill levels);
from the user interaction data, determining a real-time skill estimate of the current user (Warner, Para 0078; “At 965, the user can accept, deny, or modify the proposed action(s) via the user device 620. … At 975, the user response is recorded and processed. Based on the response, at 980, the request is denied and control reverts to the user device 620 or, at 985, the request is granted and updated machine settings are provided to the medical equipment 120. ”. In this disclosure, user reveals his or her skill estimate to the system by accepting, denying or modifying the actions proposed by the digital assistant), wherein the real-time skill estimate indicates a current ability of the current user to perform the current task (Warner, Para 0079; “At 1005, the user device 620 generates a notification to the digital assistant 110 regarding a different version, vendor, etc., of the medical equipment 120. … As such, the user can be unfamiliar with CT scanner B …”. In this disclosed example, the ability of the user to operate scanner B is low); and
customizing the ultrasound system for performing the current task and providing the user-facing functionality at a skill level corresponding to the real-time skill estimate of the current user (Warner, Para 0079; “As such, the user can be unfamiliar with CT scanner B, and the digital assistant 110 can take the user's preferences, norms, configuration/settings, etc., for CT scanner A and translate/convert them into configuration/settings for CT scanner B using the digital twin 230, plugin 570-572, etc.”. In this disclosure, the regular configuration of scanner A is unfamiliar or difficult for the user, so the user-facing functionality is customized to a configuration (i.e. scanner B) that corresponds to the user’s familiarity or skill level).
With regard to Claim 15, Warner discloses a non-transitory computer-readable medium comprising data representing instructions which, when executed by a processor system, cause the processor system to perform the computer-implemented method according to claim 14 (Warner, Para 0109; “the example process(es) can be implemented using coded instructions (e.g., computer and/or machine readable instructions) stored on a non-transitory computer and/or machine readable medium …”).
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.
Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Warner, in view of Holden et al (International Journal of Computer Assisted Radiology and Surgery (2019) 14:1993–2003; hereafter Holden).
With regard to Claim 2, Warner discloses all the limitations of Claim 1 as discussed above. Warner does not clearly and explicitly disclose wherein the customizer is configured to determine the real-time skill estimate independent from any user identification.
Holden in the same field of endeavor discloses wherein the customizer is configured to determine the real-time skill estimate independent from any user identification (Holden, Fig. 1; in determining the skill estimates, only the performance metrics listed in Table 1 are used for skill assessment, without considering any user identification. Further, Holden discloses in Page 1996, Para 2; “As ground-truth assessment, we did not use participants’ level of training. Instead, we recruited three clinical experts to assess participants’ performance via anonymized hand motion videos using a previously validated global rating scale [32, 33].”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Warner, as suggested by Holden, in order to determine skill estimate without considering user identification. One of ordinary skill in the art would have been motivated to make the modification for the benefit of using only the elements or metrics that are relevant to the procedure to be tested (Holden, Page 1996, Para 1; “These metrics were designed based on consultation with clinical experts, and they are intended to cover all relevant aspects of the ultrasound-guided needle insertion tasks.”).
With regard to Claim 7, Warner discloses all the limitations of Claim 1 as discussed above. Warner does not clearly and explicitly disclose wherein the user interaction data comprises multiple interaction items, comprising one or more interaction items representing individual interactions of the user in performing the current task and/or one or more interaction items representing aggregate quantities determined over multiple interactions of the user with the system in performing the current task and/or one or more interaction items representing sensor measurements of the ultrasound system apart from the ultrasound measurements by the ultrasound.
Holden in the same field of endeavor discloses wherein the user interaction data comprises multiple interaction items (Holden, Page 1995, Para 8; “We recorded videos of participants’ hands and tracked the needle and ultrasound probe. Tools were tracked with the Ascension trakStar (Northern Digital Inc.), and data was recorded using the PLUS Toolkit (www.plustoolkit.org) [30] and Perk Tutor (www.perktutor.org) [31].” Table 1 lists all the interaction items used in the study), comprising one or more interaction items representing individual interactions of the user in performing the current task and/or one or more interaction items representing aggregate quantities determined over multiple interactions of the user with the system in performing the current task (Holden, Page 1996, Table 1; “Elapsed time (s)” and “Probe path length (mm)”) and/or one or more interaction items representing sensor measurements (Holden, Page 1996, Para 1; “Tools were tracked with the Ascension trakStar (Northern Digital Inc.) …”) of the ultrasound system apart from the ultrasound measurements by the ultrasound. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Warner, as suggested by Holden, in order to collect data of multiple user interactions including aggregate quantities and/or sensor measurements. One of ordinary skill in the art would have been motivated to make the modification for the benefit of performing a comprehensive skill assessment (Holden, Page 1996, Para 1; “These metrics were designed based on consultation with clinical experts, and they are intended to cover all relevant aspects of the ultrasound-guided needle insertion tasks.”).
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Warner, in view of Jones et al (Academic emergency medicine 2003; 10:1054–1058; hereafter Jones).
With regard to Claim 6, Warner discloses all the limitations of Claim 1 as discussed above. Warner does not clearly and explicitly disclose wherein the current task is part of a current stage of multiple stages of the processing of the ultrasound measurements, wherein the real-time skill estimate is determined for the current stage from interactions of the current user only at the current stage.
Jones in the same field of endeavor discloses wherein the current task is part of a current stage of multiple stages (Jones, Page 1055, Para 3; “the objectives of the goal-directed examination … were defined as correct interpretation of 1) image orientation, 2) anatomy identification, 3) cardiac chamber size grading, 4) ventricular function estimation (visual qualitative assessment of function using gross wall contractions and wall thickening during systole and diastole), and 5) pericardial effusion identification.”) of the processing of the ultrasound measurements, wherein the real-time skill estimate (Jones, Page 1056, Para 1; “the attending EP ultrasound instructor … scored the participant in real time according to correctness of response”) is determined for the current stage from interactions of the current user only at the current stage (Jones, Page 1056, Para 1; “the participants were asked to obtain windows and identify structures”. The two stages include 16 elements, which are separately scored, so each of the two stages has a score at the end of the assessment.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Warner, as suggested by Jone, in order to assess a user’s skill level for each individual stage of ultrasound measurement separately. One of ordinary skill in the art would have been motivated to make the modification for the benefit of assessing the user’s skill in a specific stage or one element or task of the stage so that more training and/or guidance can be provided for the specific stage or task.
With regard to Claim 16, Warner and Jones disclose all the limitations of Claim 6 as discussed above. Warner further discloses comprising using a real-time skill estimate and/or clinical role derived from an earlier stage of the multiple stages (Warner, Para 0062; “user identification/authentication, role, privileges/authorization, preferences, history, etc., can be maintained as a user profile 640. Data base 531-539 information and user profile 640 preferences can be used by the processor 580 of the digital assistant 110 to drive a configuration for the medical equipment 120”).
Claims 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Warner, in view of Ninomiya et al (US 20150182196 A1; hereafter Ninomiya).
With regard to Claim 12, Warner discloses all the limitations of Claim 1 as discussed above. Warner does not clearly and explicitly disclose wherein the ultrasound system is for use outside of a hospital.
Ninomiya in the same field of endeavor discloses wherein the ultrasound system is for use outside of a hospital (Ninomiya, Para 0003; “various types of portable ultrasonic diagnostic apparatus have been developed, being available not only in a laboratory within a hospital, but also in a hospital room or out of hospital.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Warner, as suggested by Ninomiya, in order to use the ultrasound system outside of a hospital. One of ordinary skill in the art would have been motivated to make the modification for the benefit of performing ultrasound examination at locations where traditional imaging instruments are not accessible (Ninomiya, Para 0003; “… enables examination performed at a place where it is difficult to bring a general ultrasound diagnostic apparatus for examination …”).
With regard to Claim 17, Warner and Ninomiya disclose all the limitations of Claim 12 as discussed above, but do not clearly and explicitly disclose wherein the ultrasound system is for use at home, in an ambulance, or at a sports facility.
Ninomiya further discloses wherein the ultrasound system is for use at home, in an ambulance, or at a sports facility (Ninomiya, Para 0003; “This portable ultrasound diagnostic apparatus enables examination performed … within a vehicle, e.g., an ambulance and a visiting car.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Warner and Ninomiya, as further suggested by Ninomiya, in order to use the ultrasound system in an ambulance. One of ordinary skill in the art would have been motivated to make the modification for the benefit of timely performing ultrasound examination for patients in critical status during transportation to hospital.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Tepper (US-20140004488-A1) discloses methods and systems for monitoring and skill assessment of practitioners using an ultrasound system, particularly assessment of a user’s mechanical proficiency or manual dexterity in performing ultrasound tasks.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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