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
Status of Claims
The present Office Action is pursuant to Applicant’s communication on 09-29-2025; current application filed on 09-29-2025, continuation of 18/037,976, filed as application No. PCT/US2021/060900 on Nov. 26,2021, now Pat. 12,451,239.
Examiner’s Note
The rejections below group claims that may not be identical, but whose language and scope are so substantively similar as to lend themselves to grouping, in the interests of clarity and conciseness.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10-15-2025, 12-19, 2025, have been acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The evaluation of claims 1-20 under 35 U.S.C. § 101 follows the established Alice/Mayo two-step framework analysis, beginning with an assessment of the independent claims before addressing the dependent limitations.
Step One of the analysis determines whether the claims are directed to a judicial exception, such as an abstract idea, law of nature, or natural phenomenon. The Claims recite subject matter within a statutory category are within the four statutory categories. However, it will be shown in the following steps, that claims 1-20 is/are nonetheless unpatentable under 35 U.S.C. 101.
Independent claims 1, 12, and 16 recite generating metric values from surgical data, processing those metrics through a machine learning model to produce a skill score, mapping that score against a reference set, identifying deviations, and determining recommendations or feedback. This core functionality is directed to the abstract idea of data gathering, mathematical analysis, and mental processes of comparing performance metrics to establish a baseline and generate advisory output. The specification confirms this analytical nature by describing how the system analyzes "objective performance indicators (OPIs), quantitative metrics generated from surgical data" to assess operator skills. Because the claims essentially automate the collection, statistical comparison, and recommendation generation based on performance data, they fall squarely within the abstract idea grouping of mathematical concepts and mental processes. The broadest reasonable interpretation of these steps includes “Mental Processes” and “Organizing Human Activity” because these steps can practically be performed by the human mind or with pen and paper.
Proceeding to Step 2A, the analysis examines whether the additional elements integrate the judicial exception into a practical application. The independent claims merely recite generic computing infrastructure, such as "one or more processors, coupled to memory" or a "non-transitory computer-readable medium”, to perform the data processing steps. The specification describes these components in standard terms, noting that "The computing system 2100 may include an interconnect 2105, connecting several components, such as, e.g., one or more processors 2110, one or more memory components 2115”. Applying a generic computer to execute data analysis and display results does not improve the functioning of the computer itself, nor does it apply the abstract idea in a meaningful way beyond conventional automation. The surgical environment serves merely as a field of use, as the system simply processes "surgical data received for a surgical procedure" without introducing any technical improvement to surgical instrumentation or robotic control mechanisms.
At Step 2B, the inquiry focuses on whether the claims contain an inventive concept that amounts to significantly more than the judicial exception. The additional elements recited are well-understood, routine, and conventional activities in the field of data processing and machine learning. The specification details standard analytical techniques, such as training models using "expert and nonexpert [users]" and employing conventional algorithms to classify performance. Furthermore, the presentation of results through a graphical interface is a routine display function, with the specification noting that "an overlay may include an icon, e.g., a pie chart shown in icon 1320e, indicating the surgeon's score for the portion of the surgery depicted”. These elements merely instruct the practitioner to apply the abstract idea on a conventional computer and present the output via standard display techniques, which fails to provide an inventive concept sufficient to overcome the § 101 rejection.
The dependent claims, spanning claims 2-11, 13-15, and 17-20, do not alter this conclusion because they merely add further limitations that are either abstract or conventional. For example, claim 2 limits the recommendation to "reducing energy activation of a surgical instrument”, while claim 6 specifies computing values "overlapping time windows across successive data segments”. These limitations simply define specific types of feedback or standard signal processing techniques like temporal windowing, which are well-known in the art. Similarly, claims 13 and 17 recite overlaying indicators on video footage, and claim 5 defines a deviation as a score falling below a threshold, all of which represent routine data comparison and display operations. None of these dependent claims introduce additional elements that would integrate the abstract idea into a practical application or provide an inventive concept under Step 2A and Step 2B.
Consequently, claims 1-20 are rejected under 35 U.S.C. § 101 because they are directed to the abstract idea of data collection, mathematical comparison, and performance recommendation generation without reciting additional elements that integrate the exception into a practical application or amount to significantly more than conventional computer implementation. The claims rely entirely on generic processing hardware and standard analytical routines to automate a mental process of skill assessment, which remains ineligible for patent protection under current judicial precedent.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claim(s) 1-20 is/are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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 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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolf (US 10,943,682) in view of Wang1.
Regarding claim(s) 1, 12, 16, Wolf discloses: A surgical system, A non-transitory computer-readable medium comprising instructions configured to cause a surgical system to perform a method, comprising:
one or more processors, coupled to memory, configured to [“The instructions executed by at least one processor may, for example, be pre-loaded into a memory integrated with or embedded into the controller or may be stored in a separate memory. [9:41-10:3]”]:
Wolf does not explicitly disclose as disclosed by Wang:
generate, based at least on surgical data received for a surgical procedure performed using the surgical system, a plurality of metric values comprising a plurality of objective performance indicator (OPI) values for the surgical procedure; [“summary features [without a priori dependence on engineered features], such as movement time …, path length …, motion jerk …, and curvature …, are widely used and have shown to have high correlations with surgical skills. [Page 1960, Fig 1, Fig 2]”]
generate a score for a skill of a user at least in part by providing one or more metric values of the plurality of metric values as input to a machine learning model trained for the skill; [“A deep convolutional neural network is implemented to map multivariate time series data of the motion kinematics to individual skill levels. [Page 1959]”]
map the score to a reference set of scores corresponding to a plurality of skill levels for the surgical procedure; [“output is the predicted labels representing corresponding expertise levels of trainees, which can be one-hot encoded as y ∈ {1: 'Novice', 2: 'Intermediate', 3: 'Expert'}. [Page 1961]”
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Wolf, including mechanism(s) [a]-[c] as taught by Wang. One of ordinary skill would have been so motivated to employ said mechanism(s), which extracts kinematic/metric features, feeds them into a trained CNN to generate skill scores, maps those scores to predefined expert/novice levels facilitating classification and training needs of surgical professionals. [Pages 1959-1970]
Wolf discloses:
identify, based on a comparison of the score of the user to the reference set of scores, an OPI deviation for the user; [“comparing the accessed frames with the recommended sequence of events to identify an indication of a deviation between the specific surgical procedure and the recommended sequence of events for the surgical procedure [153:37-60]”] and
determine, based at least on the OPI deviation, a recommendation of an action to take by the user with respect to using the surgical system2 3. [“outputting a recommendation to a user to undertake the specific action [166:48-168:21]” including “outputting [displaying] a notification [recommendation/feedback] based on a determination that the indication of actual contact force exceeds the selected contact force threshold [175:55-67]”]
Regarding claim(s) 2, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wolf disclosing: wherein the surgical system provides recommendation to the user of the action of reducing energy activation of a surgical instrument while using the surgical system. [“outputting a notification [a recommendation] based on a determination that the indication of actual contact force [corresponding to energy] exceeds the selected contact force threshold [175:55-67]”]
Regarding claim(s) 3, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wolf disclosing: wherein the surgical system provides recommendation to the user of the action of applying energy using a surgical instrument more frequently in shorter time periods while using the surgical system. [“outputting a recommendation to a user to undertake the specific action... based on the determined existence of a decision making junction and an accessed correlation [223:45-67]” associated with “outputting a notification based on a determination that the indication of actual contact force exceeds the selected contact force threshold [and associated with] an “elapsed time [175:55-67]”]
Regarding claim(s) 4, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wolf disclosing: wherein the surgical system provides the recommendation to the user of the action of increasing a frequency or speed of adjusting a camera of the surgical system. [“the control application may be configured to coordinate the position and zoom of various cameras [associated with camera adjustments to position, zoom, and tracking frequency based on real-time surgical events] during a surgical procedure [90:6-10] ... direct camera 115 to track a surgical instrument, to direct camera 121 to location 127 [14:51-15:17]”]
Regarding claim(s) 5, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wolf disclosing: wherein identifying an OPI deviation comprises determining that the score falls below a threshold of the reference set of scores. [“determining, based on the received image data associated with the second event, a change in the predicted outcome, causing the predicted outcome to drop below a threshold [184:1-20]” wherein sets of scores are associated with a numerical scale corresponding to “skill levels [48:19-49:19]”]
Regarding claim(s) 6, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wang disclosing wherein
generating the plurality of objective performance indicator (OPI) comprises computing OPI values over overlapping time windows across successive data segments of the surgical procedure; [“we carried out a label-preserving cropping with a sliding window, where the motion sub-sequences were extracted using crops, i.e., sliding a fixed-size window within the trial... window size W=60 and a step size L=30 [Page 1964]”] and
providing the feedback comprises overlaying, on a video of the procedure, an indicator that varies over time in accordance with the score for each time window. [“we carried out a label-preserving cropping with a sliding window, where the motion sub-sequences were extracted using crops, i.e., sliding a fixed-size window within the trial... window size W=60 and a step size L=30 [Page 1964]”]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Wolf, including mechanism(s) [a]-[b] as taught by Wang. One of ordinary skill would have been so motivated to employ said mechanism(s), which extracts kinematic/metric features, feeds them into a trained CNN to generate skill scores, maps those scores to predefined expert/novice levels facilitating classification and training needs of surgical professionals, combining sliding-window temporal analysis (overlapping crops) with real-time video overlay timelines that dynamically update indicators based on computed scores. [Pages 1959-1970]
Regarding [a]-[b], Wolf discloses providing an overlay; [“overlaying on the at least one video outputted for display a surgical timeline, wherein the surgical timeline includes markers identifying at least one of a surgical phase, an intraoperative surgical event, and a decision making junction [210:48-67]”]
Regarding claim(s) 7, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wang disclosing [a]: wherein identifying an OPI deviation comprises comparing the score to distributions of expert and nonexpert values in the reference set of scores. [“The dataset contains recordings from eight surgeons with varying robotic surgical experience... self-proclaimed skill labels based on practice hours with expert reporting greater than 100h, intermediate between 10 and 100h, and novice reporting less than 10 h of total surgical robotic operation time [Page 1963]”]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Wolf, including mechanism(s) [a] as taught by Wang. One of ordinary skill would have been so motivated to employ said mechanism(s), which extracts kinematic/metric features, feeds them into a trained CNN to generate skill scores, maps those scores to predefined expert/novice levels facilitating classification and training needs of surgical professionals, building a reference population stratified by expert vs. non-expert (novice/intermediate) distributions to benchmark and identify deviations in user performance. [Pages 1959-1970]
Regarding claim(s) 8, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wang disclosing [a]: wherein the reference set of scores comprises surgical data annotated as being associated with expert and nonexpert users. [“ground-truth skill labels are acquired from expert ratings [Page 1961] ... self-proclaimed skill levels and GRS-based skill levels as the ground-truth labels for each surgical trial [Page 1963]”]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Wolf, including mechanism(s) [a] as taught by Wang. One of ordinary skill would have been so motivated to employ said mechanism(s), which extracts kinematic/metric features, feeds them into a trained CNN to generate skill scores, maps those scores to predefined expert/novice levels facilitating classification and training needs of surgical professionals, building a reference population stratified by expert vs. non-expert (novice/intermediate) distributions to benchmark and identify deviations in user performance, associated with a reference set explicitly annotated with expert-derived ratings (GRS) and self-reported experience levels to train and validate the skill assessment model. [Pages 1959-1970]
Regarding claim(s) 9, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wolf disclosing: further comprising identifying a data structure comprising a mapping of each of the plurality of OPIs to at least one skill of a plurality of skills and selecting, from the data structure comprising the mapping, one or more OPIs of the plurality of OPIs based at least on the skill from the plurality of skills. [“accessing at least one data structure including image-related data characterizing surgical procedures [155:40-49] ... accessing, in the at least one data structure, a correlation between an outcome and a specific action taken at the decision making junction [166:35-41]”]
Regarding claim(s) 10, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wang disclosing [a]: wherein mapping the score to the reference set of scores comprises ordering the reference set of scores into an order of decreasing magnitude and determining a position of the score within the order. [“output is the predicted labels representing corresponding expertise levels of trainees, which can be one-hot encoded as y ∈ {1: 'Novice', 2: 'Intermediate', 3: 'Expert'}. [Page 1961]”]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Wolf, including mechanism(s) [a] as taught by Wang. One of ordinary skill would have been so motivated to employ said mechanism(s), which extracts kinematic/metric features, feeds them into a trained CNN to generate skill scores, maps those scores to predefined expert/novice levels facilitating classification and training needs of surgical professionals, building a reference population stratified by expert vs. non-expert (novice/intermediate) distributions to benchmark and identify deviations in user performance, associated with a reference set explicitly annotated with expert-derived ratings (GRS) and self-reported experience levels to train and validate the skill assessment model. [Pages 1959-1970]
Regarding claim(s) 11, Wolf-Wang as a combination discloses: The surgical system of claim 1, Wang disclosing [a]: wherein mapping the score to the reference set comprises generating a mapping between the score to one or more skill levels of users based upon a reference population of users and skill levels. [“The objective cost function for training the network is defined as a multinomial cross-entropy cost... output is the predicted labels representing corresponding expertise levels of trainees [Page 1961]”]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Wolf, including mechanism(s) [a] as taught by Wang. One of ordinary skill would have been so motivated to employ said mechanism(s), which extracts kinematic/metric features, feeds them into a trained CNN to generate skill scores, maps those scores to predefined expert/novice levels facilitating classification and training needs of surgical professionals, building a reference population stratified by expert vs. non-expert (novice/intermediate) distributions to benchmark and identify deviations in user performance, associated with a reference set explicitly annotated with expert-derived ratings (GRS) and self-reported experience levels to train and validate the skill assessment model. [Pages 1959-1970]
Regarding claim(s) 13, Wolf-Wang as a combination discloses: The system of claim 12, Wolf disclosing: wherein providing the feedback comprises overlaying an indicator upon a video of the procedure and varying the indicator over time in accordance with the score. [“overlaying on the at least one video outputted for display a surgical timeline, wherein the surgical timeline includes markers identifying at least one of a surgical phase, an intraoperative surgical event, and a decision making junction [210:49-211:67]”]
Regarding claim(s) 14, Wolf-Wang as a combination discloses: The system of claim 12, Wang disclosing [a]: wherein providing the feedback comprises presenting the score as one of a plurality of scores generated over a course of at least a portion of the surgical procedure. [“per-window assessment... higher average accuracy can be found with an increase in sliding-window size [Page 1965]”]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Wolf, including mechanism(s) [a] as taught by Wang. One of ordinary skill would have been so motivated to employ said mechanism(s), which extracts kinematic/metric features, feeds them into a trained CNN to generate skill scores, maps those scores to predefined expert/novice levels facilitating classification and training needs of surgical professionals, combining sliding-window temporal analysis (overlapping crops) with real-time video overlay timelines that dynamically update indicators based on computed scores. [Pages 1959-1970]
Regarding claim(s) 15, Wolf-Wang as a combination discloses: The system of claim 12, Wolf disclosing: wherein providing the feedback comprises associating the score with corresponding data segment timestamps of video of the surgical procedure. [“associating a time marker with the at least one phase; and wherein the derived image-based information includes the time marker associated with the at least one phase [Claim 5]”]
Regarding claim(s) 17, Wolf-Wang as a combination discloses: The non-transitory computer-readable medium of claim 16, Wolf disclosing: comprising instructions configured to cause the surgical system to provide the feedback as an overlay upon a video of the surgical procedure, the overlay indicating the score for a portion of the surgical procedure and varying over the course of the video. [“overlaying on the at least one video outputted for display a surgical timeline [19:1-45]”]
Regarding claim(s) 18, Wolf-Wang as a combination discloses: The non-transitory computer-readable medium of claim 16, Wolf disclosing: comprising instructions configured to cause the surgical system to provide the feedback as a recommendation that the user reduce energy activation of surgical instruments during the surgical procedure. [“outputting a notification [feedback] based on a determination that the indication of actual contact force exceeds the selected contact force threshold [175:55-67]”]
Regarding claim(s) 19, Wolf-Wang as a combination discloses: The non-transitory computer-readable medium of claim 16, Wolf disclosing: comprising instructions configured to cause the surgical system to provide the feedback as a recommendation that the user activate surgical instruments more frequently in shorter time periods while using the surgical system. [“outputting a recommendation [feedback] to a user to undertake the specific action... based on the determined existence of a decision making junction [223:60-67]”]
Regarding claim(s) 20, Wolf-Wang as a combination discloses: The non-transitory computer-readable medium of claim 16, Wolf disclosing: comprising instructions configured to cause the surgical system to provide the feedback as a recommendation that the user increase a frequency or speed of adjusting a camera of the surgical system. [“the control application may be configured to coordinate the position and zoom of various cameras during a surgical procedure [90:1-16]”]
Conclusion
The prior art made of record4 and NOT relied upon is considered pertinent to applicant's disclosure:
Nowlin (US 2019/0282312):
A teleoperated surgical system is provided comprising: a first robotic surgical instrument; an image capture; a user display; a user input command device coupled to receive user input commands to control movement of the first robotic surgical instrument; and a movement controller coupled to scale a rate of movement of the first robotic surgical instrument, based at least in part upon a surgical skill level at using the first robotic surgical instrument of the user providing the received user input commands, from a rate of movement indicated by the user input commands received at the user input command device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL EZEWOKO whose telephone number is 571 272 7850. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached on 571 270 5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-7850.
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/MICHAEL I EZEWOKO/Primary Examiner, Art Unit 3682
1 Form 892: Non-Patent Literature
2 display, based at least on the OPI deviation, a graphical user interface to provide feedback to the user with respect to use of the surgical system
3 determining, based at least on the OPI deviation, feedback for the user with respect to using the surgical system
4Please see Form 892 for complete listing
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