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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12 and 18-20) in the reply filed on 12 August 2026 is acknowledged. Claims 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 August 2026.
Benefit
The application filed 24 January 2025 claims benefit to US Provisional 63/626,221 filed 29 January 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 January 2025, 10 June 2026, and 12 August 2026, have been considered by the examiner. Signed copies are attached.
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.
Claims 1-7, 10-12, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Couture et al US 20220015770 (20 January 2022).
Regarding independent claim 1, Couture teaches a surgical system (integrated robotic surgery system 10; ¶15) comprising:
a tourniquet system (tourniquet system 50; ¶15) including a cuff (FIGs 1, 2, cuff 51; ¶27) configured to perform occlusion of a limb of a patient during a surgical procedure (FIG 2, cuff 51 encircling a patient’s thigh at a location proximal to the surgical site of a knee; ¶27);
a visualization system (FIGs 1, 2, tracking system; ¶¶15, 20) including one or more cameras (camera 60; ¶¶20, 47) configured to provide a field of view that includes a surgical site at the limb of the patient (¶47); and
a controller (tourniquet control module 55; ¶32) electronically coupled to the tourniquet system (50, ¶32),
wherein the controller (55; ¶¶32-33) is configured to determine a presence or an absence of bleeding (via blood flow monitoring module 55A (¶33) and cuff 51 (¶27)), at the surgical site based upon data from the visualization system (using image segmentation, ¶33), and
control the tourniquet system to increase or decrease of a pressure of the cuff in response to such determination (blood flow monitoring module 55A, and cuff pressure controller 52 control the pressure in cuff 51 using a proportional loop or PID loop system; ¶33).
Couture does not expressly teach that the controller (tourniquet control module 55; ¶32) is electronically coupled to the visualization system (tracking system; ¶32) and the tourniquet system (50, ¶32).
However, Couture teaches that “integrated robotic surgery system 10 may be used with or may further include a tracking system” (¶20), including “tracking camera 60” (¶15). Couture also teaches that robotic control module 25 can receive data from the encoders or from the tracking device (¶21). Couture also teaches that the tracking device may involve optical tracking or may perform image acquisition, range imaging, depth imaging, and utilize other tracking modalities (¶20).
Tracking camera 60 is taught as being able to track robot arm 20 and/or cuff(s) 51 (FIGs 1, 2; ¶47). Cuff 51 is taught as being able to sense variation in blood penetration or blood flow in the portion of the limb encircled by cuff 51 (¶27). Couture also teaches “tracking techniques combining optical tracking and ultrasound tracking may be used” (¶48).
Additionally, Couture teaches that “blood flow monitoring module 55A uses image segmentation to fit a cross-sectional shape representative of the artery that can be assisted by the operator via a visual display of the artery from ultrasound imaging on the interface 12” (¶33). Couture teaches that interface 12 comprises multiple systems and subsystems to produces images on monitors or screens or augmented reality (¶12). Couture teaches that robot controller module 25 may be operated by processor 15 and that robot controller module 25 provides a display on interface 12 (¶22). Tourniquet system 50 is taught as having a tourniquet control module 55, which may be operated by processor unit 15 (¶32). Tourniquet control module 55 is taught as displaying a GUI (graphical user interface) for interface 12 to display information to the user and permit the user to control the operation of the tourniquet system 50 (¶36).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the interconnected system and subsystem components Couture given that Couture, as a whole, teaches and suggests the interconnectedness of the subsystems, including their electronic coupling through controllers and processors, as part of the overall integrated robotic surgery system 10. Paragraph 15 of Couture expressly teaches the integration structure of robotic surgery system 10 and the subsystems, including tourniquet system 50, along with the further inclusion of a tracking system including a tracking camera (¶15). The teachings of integrated system and multiple subsystems of Couture provide a teaching, suggestion, or motivation to one of ordinary skill in the art, to combine the teachings with a reasonable expectation of success. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Couture teaches the multiple subsystems individually and occasionally teaches some of the connecting links, but not necessarily in a single embodiment or figure, such that a person of ordinary skill in the art would need to understand the linked connections and the intermediate components as part of the larger whole-integrated system, as taught by Couture at ¶15. One of ordinary skill in the art would be motivated to select among the various subsystems of Couture depending on the integrated subsystem components of interest. One would have a reasonable expectation of success in selecting from the finite embodiments taught by Couture that are best suited for the particular end-use case based on the particular subsystem of interest.
Regarding claim 2, Couture teaches the surgical system of claim 1, as set forth above, for the reasons set forth above, wherein the tourniquet system (50) includes at least one sensor (FIG 2; blood transducer 53; ¶¶29, 30, 35) configured to sense an arterial blood pressure at the limb of the patient (¶¶29, 30), and wherein the controller is configured to control the tourniquet system to increase or decrease the pressure of the cuff in response to data from the at least one sensor in addition to the data from the visualization system (FIG 3, ¶¶32, 33, 48).
Regarding claim 3, Couture teaches the 3 surgical system of claim 1, as set forth above, for the reasons set forth above, wherein the visualization system (FIGs 1, 2, tracking system; ¶¶15, 20); is coupled to and integrated in an arthroscopic device configured for use during the surgical procedure (FIGs 2, 4; ¶¶10, 25).
Regarding claim 4, Couture teaches the surgical system of claim 1, as set forth above, for the reasons set forth above, wherein, if the presence of bleeding is determined (¶35),
the controller (55) is configured to increase the pressure of the cuff (¶32) and
the controller (55) is configured to redetermine based upon second data from the visualization system (“tracking techniques combining optical tracking and ultrasound tracking may be used”, ¶48), gathered after an elapsed period of time (FIG 3, intervals or continuous; ¶40), the presence or the absence of bleeding at the surgical site (includes using photoplethysmography, ¶35).
Couture does not expressly teach a range of pressure of the cuff increases by between 10% and 25%, inclusive.
However, Couture expressly teaches “using the size, the blood flow monitoring module 55A may calculate blood flow, blood flow=(artery area)*(blood speed), to use blood flow as an alternative to speed to adjust tourniquet pressure and that blood flow monitoring module 55A integrates values of blood flow over time to get a normalized blood flow value. The normalized blood flow value, or other values such as normalized velocity, nominal velocity, systolic velocity, as calculated by the blood flow monitoring module 55A, may be used to loop back to the tourniquet 51 to apply a pressure correction via the cuff pressure controller 52 in order to reduce or increase compression” (¶33).
Additionally, the claimed the range of pressure that the cuff is increased or decreased is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that lengths can be optimized depending on the end effect desired for the use case. This is shown by FIG 3 of Couture and expressly discussed at ¶33. One of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range based on the individual patient anatomy and the fluctuations in the blood pressure and blood flow values as monitored by the tourniquet control module as set forth at ¶¶32-35 of Couture.
The range of pressure increase at the cuff can be optimized by a person of ordinary skill in the art without undue experimentation based on the actual fluctuation as a differential from normal blood flow value as determined by the tourniquet controller as taught by Couture at ¶¶32-35). As such, adjusting the pressure around normal blood flow in order to adjust tourniquet pressure would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 5, Couture teaches the surgical system of claim 1, as set forth above, for the reasons set forth above, wherein, if the absence of bleeding is determined (¶35), the controller (55) is configured to decrease the pressure of the cuff (¶32) and
the controller (55) is configured to redetermine based upon second data from the visualization system (“tracking techniques combining optical tracking and ultrasound tracking may be used”, ¶48), gathered after an elapsed period of time (FIG 3, intervals or continuous; ¶40), the presence or the absence of bleeding at the surgical site (includes using photoplethysmography, ¶35).
Couture does not expressly teach a range of pressure of the cuff decreases by between 10% and 25%, inclusive.
However, Couture expressly teaches “using the size, the blood flow monitoring module 55A may calculate blood flow, blood flow=(artery area)*(blood speed), to use blood flow as an alternative to speed to adjust tourniquet pressure and that blood flow monitoring module 55A integrates values of blood flow over time to get a normalized blood flow value. The normalized blood flow value, or other values such as normalized velocity, nominal velocity, systolic velocity, as calculated by the blood flow monitoring module 55A, may be used to loop back to the tourniquet 51 to apply a pressure correction via the cuff pressure controller 52 in order to reduce or increase compression” (¶33).
Accordingly, the claimed the range of pressure where the cuff is increased or decreased is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that lengths can be optimized depending on the end effect desired for the use case. This is shown by FIG 3 of Couture and expressly discussed at ¶33. One of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range based on the individual patient anatomy and the fluctuations in the blood pressure and blood flow values as monitored by the tourniquet control module as set forth at ¶¶32-35 of Couture.
The range of pressure increase at the cuff can be optimized by a person of ordinary skill in the art without undue experimentation based on the actual fluctuation as a differential from normal blood flow value as determined by the tourniquet controller as taught by Couture at ¶¶32-35). As such, adjusting the pressure around normal blood flow in order to adjust tourniquet pressure would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 6, Couture teaches the surgical system of claim 1, as set forth above, for the reasons set forth above, for the reasons set forth above, wherein the controller determines the presence or absence of bleeding (¶35) based as a percent of red color pixels (Doppler ultrasonography, ¶31) at the surgical site and a rate of change of the red color pixels (“blood flow characteristics imaged on a color scale on interface 12”; ¶33).
Couture does not expressly teach a percent of red color pixels at the surgical site or a rate of change.
However, Couture teaches “blood flow characteristics imaged on a color scale on interface 12” (¶33) and using blood transducer 53 employs photoplethysmography, and produces a signal indicative of arterial blood penetrating past the cuff 51. Couture teaches Doppler ultrasonography at ¶31. Couture also teaches that “the blood pressure monitoring module 55B processes the signals from the blood transducer 53 to indicate blood penetration. The blood pressure monitoring module 55B may be configured to automatically determine the limb occlusion pressure (LOP) at a time prior to the commencement of surgery when blood penetration past the cuff 51 is permitted and will not interfere with the surgical operation” (¶35).
Accordingly, the percentage of red color pixels or rate of change is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that Couture teaches the monitoring modules as detecting and processing signals that correspond to bleeding, broadly encompassing blood penetration of an area that is otherwise under limb occlusion pressure (LOP), and that such signals can be optimized depending on the end effect desired for the use case. This is shown by FIG 3 of Couture and expressly discussed at ¶¶33 and 35. One of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed percent of red color pixels and rate of change based on the individual patient anatomy and the fluctuations in the blood pressure and blood flow values as monitored by the tourniquet control module as set forth at ¶¶32-35 of Couture.
The range of pressure increase at the cuff can be optimized by a person of ordinary skill in the art without undue experimentation based on the actual fluctuation as a differential from normal blood flow value as determined by the tourniquet controller as taught by Couture at ¶¶32-35). As such, adjusting the pressure around normal blood flow in order to adjust tourniquet pressure would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 7, Couture teaches the surgical system of claim 1, as set forth above, for the reasons set forth above, further comprising:
a flow inducing device configured to provide an irrigating fluid to a surgical site (FIG 1, fluid waste management system 30 comprising wound irrigation, ¶25); and
a negative pressure source configured to induce flow to remove the irrigating fluid from the surgical site (FIG 1, fluid waste management system 30 comprising wound vacuum cleaning and/or irrigation, ¶25);
wherein the controller (55; ¶¶32-33) is configured to selectively control the flow inducing device and the negative pressure source to increase or decrease irrigating fluid at the surgical site based upon the determined presence or absence of bleeding at the surgical site (¶25).
Regarding claim 10, Couture teaches the 10 surgical system of claim 9, as set forth above, for the reasons set forth above, further comprising a machine learning engine (¶52) and wherein the controller is configured to train the machine learning engine using the related prior surgical procedures,
including the at least one result or action taken by the controller and at least one corresponding outcome (¶53).
Regarding claim 11, Couture teaches the 11 surgical system of claim 1, as set forth above, for the reasons set forth above, wherein the surgical procedure comprises one of a minimally invasive sports medicine procedure or a joint replacement procedure (FIG 4, knee joint, hip joint, shoulder, ¶10).
Regarding claim 12, Couture teaches the 12 surgical system of claim 1, as set forth above, for the reasons set forth above, wherein the one or more cameras (60) are configured for sensing at an infrared wavelength range (¶48),
wherein using the data sensed by the one or more cameras (¶48), the controller is configured to identify (¶48) at least one of: a change in temperature of the surgical site or the presence of bleeding ( “blood transducer 53 employs photoplethysmorgraphy and produces a signal indicative of arterial blood penetrating past the cuff”; ¶35).
Regarding independent claim 18, Couture teaches a surgical system (integrated robotic surgery system 10; ¶15) comprising:
a tourniquet system (tourniquet system 50; ¶15) including a cuff (FIGs 1, 2, cuff 51; ¶27) configured to perform occlusion of a limb of a patient during a surgical procedure (FIG 2, cuff 51 encircling a patient’s thigh at a location proximal to the surgical site of a knee; ¶27);
a flow inducing device configured to provide an irrigating fluid to a surgical site at the limb of the patient (FIG 1, fluid waste management system 30 comprising wound irrigation, ¶25); and
a negative pressure source configured to induce flow to remove the irrigating fluid from the surgical site (FIG 1, fluid waste management system 30 comprising wound vacuum cleaning and/or irrigation, ¶25);
a visualization system (FIGs 1, 2, tracking system; ¶¶15, 20) including one or more cameras (camera 60; ¶¶20, 47) configured to provide a field of view that includes a surgical site at the limb of the patient (¶47); and
a controller (tourniquet control module 55; ¶32) electronically coupled to the tourniquet system (50, ¶32),
wherein the controller (55; ¶¶32-33) is configured to determine a presence or an absence of bleeding (via blood flow monitoring module 55A (¶33) and cuff 51 (¶27)), at the surgical site based upon data from the visualization system (using image segmentation, ¶33), and
control at least one of: the tourniquet system to increase or decrease of a pressure of the cuff in response to such determination (FIG 3, blood flow monitoring module 55A, and cuff pressure controller 52 control the pressure in cuff 51 using a proportional loop or PID loop system; ¶33) or from the surgical site in response to such determination (FIG 3; ¶33).
Couture does not expressly teach that the controller (tourniquet control module 55; ¶32) is electronically coupled to the visualization system (tracking system; ¶32) and the tourniquet system (50, ¶32).
However, Couture teaches that “integrated robotic surgery system 10 may be used with or may further include a tracking system” (¶20), including “tracking camera 60” (¶15). Couture also teaches that robotic control module 25 can receive data from the encoders or from the tracking device (¶21). Couture also teaches that the tracking device may involve optical tracking or may perform image acquisition, range imaging, depth imaging, and utilize other tracking modalities (¶20).
Tracking camera 60 is taught as being able to track robot arm 20 and/or cuff(s) 51 (FIGs 1, 2; ¶47). Cuff 51 is taught as being able to sense variation in blood penetration or blood flow in the portion of the limb encircled by cuff 51 (¶27). Couture also teaches “tracking techniques combining optical tracking and ultrasound tracking may be used” (¶48).
Additionally, Couture teaches that “blood flow monitoring module 55A uses image segmentation to fit a cross-sectional shape representative of the artery that can be assisted by the operator via a visual display of the artery from ultrasound imaging on the interface 12” (¶33). Couture teaches that interface 12 comprises multiple systems and subsystems to produces images on monitors or screens or augmented reality (¶12). Couture teaches that robot controller module 25 may be operated by processor 15 and that robot controller module 25 provides a display on interface 12 (¶22). Tourniquet system 50 is taught as having a tourniquet control module 55, which may be operated by processor unit 15 (¶32). Tourniquet control module 55 is taught as displaying a GUI (graphical user interface) for interface 12 to display information to the user and permit the user to control the operation of the tourniquet system 50 (¶36).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the interconnected system and subsystem components Couture given that Couture, as a whole, teaches and suggests the interconnectedness of the subsystems, including their electronic coupling through controllers and processors, as part of the overall integrated robotic surgery system 10. Paragraph 15 of Couture expressly teaches the integration structure of robotic surgery system 10 and the subsystems, including tourniquet system 50, along with the further inclusion of a tracking system including a tracking camera (¶15). The teachings of integrated system and multiple subsystems of Couture provide a teaching, suggestion, or motivation to one of ordinary skill in the art, to combine the teachings with a reasonable expectation of success. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Couture teaches the multiple subsystems individually and occasionally teaches some of the connecting links, but not necessarily in a single embodiment or figure, such that a person of ordinary skill in the art would need to understand the linked connections and the intermediate components as part of the larger whole-integrated system, as taught by Couture at ¶15. One of ordinary skill in the art would be motivated to select among the various subsystems of Couture depending on the integrated subsystem components of interest. One would have a reasonable expectation of success in selecting from the finite embodiments taught by Couture that are best suited for the particular end-use case based on the particular subsystem of interest.
Regarding claim 20, Couture teaches the surgical system of claim 19, as set forth above, for the reasons set forth above, wherein the one or more cameras (60) are configured for sensing at an infrared wavelength range (¶48),
wherein using the data sensed by the one or more cameras (¶48), the controller is configured to identify (¶48) at least one of: a change in temperature of the surgical site or the presence of bleeding ( “blood transducer 53 employs photoplethysmorgraphy and produces a signal indicative of arterial blood penetrating past the cuff”; ¶35).
wherein the tourniquet system (50) includes at least one sensor (FIG 2; blood transducer 53; ¶¶29, 30, 35) configured to sense an arterial blood pressure at the limb of the patient (¶¶29, 30), and
wherein the controller is configured to control the tourniquet system to increase or decrease the pressure of the cuff in response to data from the at least one sensor in addition to the data from the visualization system (FIG 3, ¶¶32, 33, 48).
Claims 8, 9, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Couture et al US 20220015770 (20 January 2022) in view of Squilla et al., US 20090182577 (16 July 2009).
Regarding claim 8, Couture teaches the surgical system of claim 7, as set forth above, for the reason set forth above.
Couture does not expressly teach wherein the controller is configured to: collect and record the data from the visualization system during at least a portion of the surgical procedure; query a database to retrieve information about related prior surgical procedures, the information including at least one result or next action taken after the data from the visualization system was provided to the controller; determine, based upon the information, a next action including at least one of: implementing a change of the pressure of the cuff of the tourniquet system and implementing an addition or removal of the irrigating fluid from the surgical site; implement the next action; and collect further data from at least the visualization system as to results from the next action.
However, Couture teaches implementing a change of the pressure of the cuff of the tourniquet system (FIG 3; ¶¶32-35) and implementing an addition or removal of the irrigating fluid from the surgical site (¶25).
Squilla teaches an automated information management healthcare facility workflow process with surgery-specific preferences 30 (FIGs 1, 3). The healthcare workflow process (FIG 1) is taught as encompassing patient photos and other information “content” related to a medical or surgical procedure (¶17). Content collected within the operating room is taught as including live video, radiological images, and photographs (¶19). FIG 2 illustrates modular information management system 10 that includes the collection, organization, and display of content (¶24). Squilla teaches that system 10 includes controller 12 connected to one or more storage devices 14, one or more content collection devices 16, one or more operator interfaces 18, one or more display devices 24, one or more remote receivers/senders 22 via one or more connection lines 28 (¶25). Content collection devices 16 are configured to retrievably store and/or archive captured content from videos and still images (¶29) and the stored content can be transferred from the content collection devices 16 to the storage device 14 and/or controller 12 during the collection phase of FIG 1 (¶29). Content collection devices 16 can locally store still images and/or videos and can be configured to later upload the substantially live content to the storage device 14 and/or the controller 12 (¶31).
Squilla teaches that the desired content is established (predetermined) at step 30 (FIG 3). Checklists that include all of the heterogeneous content needed (predetermined) are taught as being able to be verified within the “Collection Phase” (FIG 3; ¶41). If no new content is required, the checklist can be determined to be complete and the collected content saved (¶41). The workflow then proceeds to the “Organize Phase” (FIG 4, ¶49). Once those steps have been completed for each selected input in a key phase of a surgical sequence, the associated functionality of that sequence can be saved and the user may proceed to the next phase, the Display Phase (FIG 5; ¶¶50-51).
Squilla teaches universal functionality icons 96 comprising tools configured to access images captured during a surgical procedure (FIGs 6-8, ¶54). Rule set 118 is taught as “governing at least one of the collection phase (FIG. 3), organize phase (FIG. 4), and display phase (FIG. 5) of an exemplary healthcare facility workflow process” and can be based on at least one of many decision factors 120 (FIG 9, ¶69). Decision factors 120 are include doctor-specific preferences 124 comprising the organization of the surgical sequence phases, priority levels, display locations, content desired or requested and determinations regarding content collected and relevancy (FIG 9, ¶72). Content characteristics 122 can include specialist-indicated relevancy determinations which can be utilized as a factor in creating rule set 118 (¶69). Rule set 118 can be utilized to assist in automatically processing a plurality of content (¶77). Hierarchies can be applied to content types including live video and still images (¶84). An automated healthcare facility workflow process can be utilized to suggest to the user a preferred/optimized display layout displaying the plurality of content associated with a surgical procedure (¶84). FIG 9 shows steps by which the content can be organized by automatically associating content-specific functionality with each content of the plurality of content, which can be based on decision factors 120 (¶87).
Accordingly, Squilla teaches controllers (¶26) configured to collect and record the data from the visualization system during at least a portion of the surgical procedure (FIGs 1, 3, 6-8, 9, workflow processes); query a database to retrieve information about related prior surgical procedures (FIG 9, hierarchical organized content characteristics 122, surgical sequence (as doctor-specific preferences) 124, or specialty/surgical sequence preferences 126, or institution characteristics 128, or medical payer requirements for documentation 129), the information including at least one result or next action taken after the data from the visualization system was provided to the controller (FIG 9, by rule set 118);
determine, based upon the information (content collection 102/132; ¶70, 84), a next action (FIG 9, organized phase 134), including at least one of:
implementing a change of the pressure of the cuff of the tourniquet system and implementing an addition or removal of the irrigating fluid from the surgical site (FIG 9, by rule set 118);
implement the next action (FIG 9, rule set 118; claims 1, 9, 12); and
collect further data from at least the visualization system as to results from the next action (FIG 9, by rule set 118).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Couture and Squilla given that the prior art included each element claimed, although not necessarily in a single reference. Couture and Squilla teach in the same field of endeavor comprising integrated robotic surgical systems comprising processors, memory, and imaging systems for capturing information about surgical procedures.
Although, Couture discloses the claimed a surgical system) comprising a tourniquet system including a cuff configured to perform occlusion of a limb of a patient during a surgical procedure, a visualization system including one or more cameras configured to provide a field of view that includes a surgical site at the limb of the patient and a controller electronically coupled to the tourniquet system wherein the controller is configured to determine a presence or an absence of bleeding and at the surgical site based upon data from the visualization system and
control the tourniquet system to increase or decrease of a pressure of the cuff in response to such determination, Couture does not expressly teach wherein the controller is configured to collect and record the data from the visualization system during at least a portion of the surgical procedure; query a database to retrieve information about related prior surgical procedures, the information including at least one result or next action taken after the data from the visualization system was provided to the controller; determine, based upon the information, a next action including at least one of: implementing a change of the pressure of the cuff of the tourniquet system and implementing an addition or removal of the irrigating fluid from the surgical site; implement the next action; and collect further data from at least the visualization system as to results from the next action.
Squilla specifically addresses the claimed plurality of data/information-related tasks or subtasks (FIGs 1, 3, 6-8, 9, workflow processes) includes tasks or subtasks (FIG 9) designated (FIG 9, rule set 118) as ones for which photo documentation (content collection 102/132; still images ¶¶70, 84) is to be captured upon completion thereof (FIG 9, organized phase 134), and wherein said predetermined surgical step is a task or subtask so designated (FIG 9, rule set 118; claims 1, 9, 12).
Couture teaches integrated robotic surgical systems such that a person of ordinary skill in the art, seeking to utilize Couture’s hardware systems and subsystems in a surgical/medical workflow architecture for medical record collection, data analytics, and determining and integrating surgical plans and predetermined steps in a surgical plan, based on data or imaging or other information, including that based on the imaging data captured during surgical procedures would reasonably consult Squilla’s medical record and surgical workflow documentation solution. Squilla uses algorithmic determinations and analytics that can be readily incorporated alongside Couture’s integrated surgical system (same one or more processors, instructions stored in at least one memory executable by the at least one processor, and tracking systems/visualization systems, and camera(s) positionable to capture image data of a surgical treatment site), using known methods without redesigning Couture’s core integrated system architecture. Additionally, a person of ordinary skill in the art seeking to utilize Couture’s integrated systems and subsystems could readily incorporate Squilla’s automated healthcare facility workflow processes, including a rules set (FIG 9, 118) that can be assigned and determined by any or all of the decision factors 120 (FIG 9) which can then automatically process content (collect, organize, and display/save/archive/collaborate) in order to automate the image capturing process of multiple individuals and groups in one workflow system. One of ordinary skill in the art would be motivated to add Squilla’s automated solution because it is modular, encompasses automatic processing of a plurality of content from a heterogenous content sources automating the workflow based on a rule set comprising hierarchical organization which encompasses still images that are displayed, saved, and archived.
Because the references address the same engineering problem (documenting surgical imaging using at least one processor, at least one memory, and a camera positionable to capture real-time image data of a surgical treatment site) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding software functions based on tracked motions including tool movement patterns or sequential surgical procedure steps, documenting that the predetermined surgical step has been completed and automatically extracting a still image (frame) from the real-time image data captured at a time of completion of a surgical step and storing the still images (frames) in the at least one memory in a medical record in association with the predetermined surgical step, where the steps are part of a healthcare facility workflow process that is automated and designed to utilize a rules-based platform for plural content from heterogeneous content sources), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings because they all work together as demonstrated by Squilla.
Additionally, one of ordinary skill in the art recognizes that computer-implemented processes are results-effective variables which can be optimized when using a general computer. The system encompasses both hardware and software. One of ordinary skill in the art would have had a reasonable expectation of success to modify software with workflow processes based on the modified rejections provided below in response to Applicant’s arguments and amendments. Such processes can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings of the references as set forth below. The references themselves provide the teaching, suggestion, and motivation for computer-implemented workflow processes in a healthcare setting where modifications thereof would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 9, Couture teaches the surgical system of claim 1, as set forth above, for the reasons set forth above.
Couture does not expressly teach wherein the controller is configured to: collect and record the data from the visualization system during at least portion of the surgical procedure; query a database to retrieve information about related prior surgical procedures, the information including at least one result or next action taken after the data from the visualization system was provided to the controller; determine, based upon the information, a change of the pressure of the cuff of the tourniquet system; implement the change; and collect further data from at least the visualization system and redetermine the presence or absence of bleeding as a result of the change.
However, Couture teaches implementing a change of the pressure of the cuff of the tourniquet system (FIG 3; ¶¶32-35). Couture also expressly teaches that the controller (55) is configured to redetermine based upon second data from the visualization system (“tracking techniques combining optical tracking and ultrasound tracking may be used”, ¶48), gathered after an elapsed period of time (FIG 3, intervals or continuous; ¶40), the presence or the absence of bleeding at the surgical site (includes using photoplethysmography, ¶35).
Squilla teaches an automated information management healthcare facility workflow process with surgery-specific preferences 30 (FIGs 1, 3). The healthcare workflow process (FIG 1) is taught as encompassing patient photos and other information “content” related to a medical or surgical procedure (¶17). Content collected within the operating room is taught as including live video, radiological images, and photographs (¶19). FIG 2 illustrates modular information management system 10 that includes the collection, organization, and display of content (¶24). Squilla teaches that system 10 includes controller 12 connected to one or more storage devices 14, one or more content collection devices 16, one or more operator interfaces 18, one or more display devices 24, one or more remote receivers/senders 22 via one or more connection lines 28 (¶25). Content collection devices 16 are configured to retrievably store and/or archive captured content from videos and still images (¶29) and the stored content can be transferred from the content collection devices 16 to the storage device 14 and/or controller 12 during the collection phase of FIG 1 (¶29). Content collection devices 16 can locally store still images and/or videos and can be configured to later upload the substantially live content to the storage device 14 and/or the controller 12 (¶31).
Squilla teaches that the desired content is established (predetermined) at step 30 (FIG 3). Checklists that include all of the heterogeneous content needed (predetermined) are taught as being able to be verified within the “Collection Phase” (FIG 3; ¶41). If no new content is required, the checklist can be determined to be complete and the collected content saved (¶41). The workflow then proceeds to the “Organize Phase” (FIG 4, ¶49). Once those steps have been completed for each selected input in a key phase of a surgical sequence, the associated functionality of that sequence can be saved and the user may proceed to the next phase, the Display Phase (FIG 5; ¶¶50-51).
Squilla teaches universal functionality icons 96 comprising tools configured to access images captured during a surgical procedure (FIGs 6-8, ¶54). Rule set 118 is taught as “governing at least one of the collection phase (FIG. 3), organize phase (FIG. 4), and display phase (FIG. 5) of an exemplary healthcare facility workflow process” and can be based on at least one of many decision factors 120 (FIG 9, ¶69). Decision factors 120 are include doctor-specific preferences 124 comprising the organization of the surgical sequence phases, priority levels, display locations, content desired or requested and determinations regarding content collected and relevancy (FIG 9, ¶72). Content characteristics 122 can include specialist-indicated relevancy determinations which can be utilized as a factor in creating rule set 118 (¶69). Rule set 118 can be utilized to assist in automatically processing a plurality of content (¶77). Hierarchies can be applied to content types including live video and still images (¶84). An automated healthcare facility workflow process can be utilized to suggest to the user a preferred/optimized display layout displaying the plurality of content associated with a surgical procedure (¶84). FIG 9 shows steps by which the content can be organized by automatically associating content-specific functionality with each content of the plurality of content, which can be based on decision factors 120 (¶87).
Accordingly, Squilla teaches controllers (¶26) configured to collect and record the data from the visualization system during at least a portion of the surgical procedure (FIGs 1, 3, 6-8, 9, workflow processes); query a database to retrieve information about related prior surgical procedures (FIG 9, hierarchical organized content characteristics 122, surgical sequence (as doctor-specific preferences) 124, or specialty/surgical sequence preferences 126, or institution characteristics 128, or medical payer requirements for documentation 129), the information including at least one result or next action taken after the data from the visualization system was provided to the controller (FIG 9, by rule set 118);
determine, based upon the information (content collection 102/132; ¶70, 84), a next action (FIG 9, organized phase 134), including at least one of:
implementing a change of the pressure of the cuff of the tourniquet system and implementing an addition or removal of the irrigating fluid from the surgical site (FIG 9, by rule set 118);
implement the next action (FIG 9, rule set 118; claims 1, 9, 12); and
collect further data from at least the visualization system as to results from the next action (FIG 9, by rule set 118).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Couture and Squilla given that the prior art included each element claimed, although not necessarily in a single reference. Couture and Squilla teach in the same field of endeavor comprising integrated robotic surgical systems comprising processors, memory, and imaging systems for capturing information about surgical procedures.
Although, Couture discloses the claimed a surgical system comprising a tourniquet system including a cuff configured to perform occlusion of a limb of a patient during a surgical procedure, a visualization system including one or more cameras configured to provide a field of view that includes a surgical site at the limb of the patient and a controller electronically coupled to the tourniquet system wherein the controller is configured to determine a presence or an absence of bleeding and at the surgical site based upon data from the visualization system and
control the tourniquet system to increase or decrease of a pressure of the cuff in response to such determination, Couture does not expressly teach wherein the controller is configured to: collect and record the data from the visualization system during at least portion of the surgical procedure; query a database to retrieve information about related prior surgical procedures, the information including at least one result or next action taken after the data from the visualization system was provided to the controller; determine, based upon the information, a change of the pressure of the cuff of the tourniquet system; implement the change; and collect further data from at least the visualization system and redetermine the presence or absence of bleeding as a result of the change.
Squilla specifically addresses the claimed plurality of data/information-related tasks or subtasks (FIGs 1, 3, 6-8, 9, workflow processes) includes tasks or subtasks (FIG 9) designated (FIG 9, rule set 118) as ones for which photo documentation (content collection 102/132; still images ¶¶70, 84) is to be captured upon completion thereof (FIG 9, organized phase 134), and wherein said predetermined surgical step is a task or subtask so designated (FIG 9, rule set 118; claims 1, 9, 12).
Couture teaches integrated robotic surgical systems such that a person of ordinary skill in the art, seeking to utilize Couture’s hardware systems and subsystems in a surgical/medical workflow architecture for medical record collection, data analytics, and determining and integrating surgical plans and predetermined steps in a surgical plan, based on data or imaging or other information, including that based on the imaging data captured during surgical procedures would reasonably consult Squilla’s medical record and surgical workflow documentation solution. Squilla uses algorithmic determinations and analytics that can be readily incorporated alongside Couture’s integrated surgical system (same one or more processors, instructions stored in at least one memory executable by the at least one processor, and tracking systems/visualization systems, and camera(s) positionable to capture image data of a surgical treatment site), using known methods without redesigning Couture’s core integrated system architecture. Additionally, a person of ordinary skill in the art seeking to utilize Couture’s integrated systems and subsystems could readily incorporate Squilla’s automated healthcare facility workflow processes, including a rules set (FIG 9, 118) that can be assigned and determined by any or all of the decision factors 120 (FIG 9) which can then automatically process content (collect, organize, and display/save/archive/collaborate) in order to automate the image capturing process of multiple individuals and groups in one workflow system. One of ordinary skill in the art would be motivated to add Squilla’s automated solution because it is modular, encompasses automatic processing of a plurality of content from a heterogenous content sources automating the workflow based on a rule set comprising hierarchical organization which encompasses still images that are displayed, saved, and archived.
Because the references address the same engineering problem (documenting surgical imaging using at least one processor, at least one memory, and a camera positionable to capture real-time image data of a surgical treatment site) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding software functions based on tracked motions including tool movement patterns or sequential surgical procedure steps, documenting that the predetermined surgical step has been completed and automatically extracting a still image (frame) from the real-time image data captured at a time of completion of a surgical step and storing the still images (frames) in the at least one memory in a medical record in association with the predetermined surgical step, where the steps are part of a healthcare facility workflow process that is automated and designed to utilize a rules-based platform for plural content from heterogeneous content sources), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings because they all work together as demonstrated by Squilla.
Additionally, one of ordinary skill in the art recognizes that computer-implemented processes are results-effective variables which can be optimized when using a general computer. The system encompasses both hardware and software. One of ordinary skill in the art would have had a reasonable expectation of success to modify software with workflow processes based on the modified rejections provided below in response to Applicant’s arguments and amendments. Such processes can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings of the references as set forth below. The references themselves provide the teaching, suggestion, and motivation for computer-implemented workflow processes in a healthcare setting where modifications thereof would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 19, Couture teaches the surgical system of claim 18, as set forth above, for the reasons set forth above.
Couture does not teach querying a database to retrieve information about related prior surgical procedures, the information including at least one result or next action taken after the data from the visualization system was provided to the controller; determine, based upon the information, a next action including at least one of: implementing a change of the pressure of the cuff of the tourniquet system and implementing an addition or removal of the irrigating fluid from the surgical site; implement the next action; and collect further data from at least the visualization system as to results from the next action.
However, Couture expressly teaches implementing a change of the pressure of the cuff of the tourniquet system (FIG 3; ¶32-35) and implementing an addition or removal of the irrigating fluid from the surgical site (¶25); implement the next action (¶35); and collect further data from at least the visualization system as to results from the next action (¶35).
Squilla teaches an automated information management healthcare facility workflow process with surgery-specific preferences 30 (FIGs 1, 3). The healthcare workflow process (FIG 1) is taught as encompassing patient photos and other information “content” related to a medical or surgical procedure (¶17). Content collected within the operating room is taught as including live video, radiological images, and photographs (¶19). FIG 2 illustrates modular information management system 10 that includes the collection, organization, and display of content (¶24). Squilla teaches that system 10 includes controller 12 connected to one or more storage devices 14, one or more content collection devices 16, one or more operator interfaces 18, one or more display devices 24, one or more remote receivers/senders 22 via one or more connection lines 28 (¶25). Content collection devices 16 are configured to retrievably store and/or archive captured content from videos and still images (¶29) and the stored content can be transferred from the content collection devices 16 to the storage device 14 and/or controller 12 during the collection phase of FIG 1 (¶29). Content collection devices 16 can locally store still images and/or videos and can be configured to later upload the substantially live content to the storage device 14 and/or the controller 12 (¶31).
Squilla teaches that the desired content is established (predetermined) at step 30 (FIG 3). Checklists that include all of the heterogeneous content needed (predetermined) are taught as being able to be verified within the “Collection Phase” (FIG 3; ¶41). If no new content is required, the checklist can be determined to be complete and the collected content saved (¶41). The workflow then proceeds to the “Organize Phase” (FIG 4, ¶49). Once those steps have been completed for each selected input in a key phase of a surgical sequence, the associated functionality of that sequence can be saved and the user may proceed to the next phase, the Display Phase (FIG 5; ¶¶50-51).
Squilla teaches universal functionality icons 96 comprising tools configured to access images captured during a surgical procedure (FIGs 6-8, ¶54). Rule set 118 is taught as “governing at least one of the collection phase (FIG. 3), organize phase (FIG. 4), and display phase (FIG. 5) of an exemplary healthcare facility workflow process” and can be based on at least one of many decision factors 120 (FIG 9, ¶69). Decision factors 120 are include doctor-specific preferences 124 comprising the organization of the surgical sequence phases, priority levels, display locations, content desired or requested and determinations regarding content collected and relevancy (FIG 9, ¶72). Content characteristics 122 can include specialist-indicated relevancy determinations which can be utilized as a factor in creating rule set 118 (¶69). Rule set 118 can be utilized to assist in automatically processing a plurality of content (¶77). Hierarchies can be applied to content types including live video and still images (¶84). An automated healthcare facility workflow process can be utilized to suggest to the user a preferred/optimized display layout displaying the plurality of content associated with a surgical procedure (¶84). FIG 9 shows steps by which the content can be organized by automatically associating content-specific functionality with each content of the plurality of content, which can be based on decision factors 120 (¶87).
Accordingly Squilla specifically teaches querying a database (FIGs 1, 3, 6-8, 9, workflow processes) to retrieve information about related prior surgical procedures (FIG 9, hierarchical organized content characteristics 122, surgical sequence (as doctor-specific preferences) 124, or specialty/surgical sequence preferences 126, or institution characteristics 128, or medical payer requirements for documentation 129), he information including at least one result or next action taken after the data from the visualization system was provided to the controller (FIG 9, by rule set 118); determine, based upon the information (content collection 102/132; ¶70, 84), a next action (FIG 9, organized phase 134), including at least one of: implementing a change of the pressure of the cuff of the tourniquet system and implementing an addition or removal of the irrigating fluid from the surgical site (FIG 9, by rule set 118); implement the next action (FIG 9, rule set 118; claims 1, 9, 12); and collect further data from at least the visualization system as to results from the next action (FIG 9, by rule set 118).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Couture and Squilla given that the prior art included each element claimed, although not necessarily in a single reference. Couture and Squilla teach in the same field of endeavor comprising integrated robotic surgical systems comprising processors, memory, and imaging systems for capturing information about surgical procedures.
Although, Couture discloses the claimed a surgical system) comprising a tourniquet system including a cuff configured to perform occlusion of a limb of a patient during a surgical procedure, a visualization system including one or more cameras configured to provide a field of view that includes a surgical site at the limb of the patient and a controller electronically coupled to the tourniquet system wherein the controller is configured to determine a presence or an absence of bleeding and at the surgical site based upon data from the visualization system and
control the tourniquet system to increase or decrease of a pressure of the cuff in response to such determination, Couture does not expressly teach querying a database to retrieve information about related prior surgical procedures, the information including at least one result or next action taken after the data from the visualization system was provided to the controller; determine, based upon the information, a next action including at least one of: implementing a change of the pressure of the cuff of the tourniquet system and implementing an addition or removal of the irrigating fluid from the surgical site; implement the next action; and collect further data from at least the visualization system as to results from the next action.
Squilla specifically addresses the claimed plurality of data/information-related tasks or subtasks (FIGs 1, 3, 6-8, 9, workflow processes) includes tasks or subtasks (FIG 9) designated (FIG 9, rule set 118) as ones for which photo documentation (content collection 102/132; still images ¶¶70, 84) is to be captured upon completion thereof (FIG 9, organized phase 134), and wherein said predetermined surgical step is a task or subtask so designated (FIG 9, rule set 118; claims 1, 9, 12).
Couture teaches integrated robotic surgical systems such that a person of ordinary skill in the art, seeking to utilize Couture’s hardware systems and subsystems in a surgical/medical workflow architecture for medical record collection, data analytics, and determining and integrating surgical plans and predetermined steps in a surgical plan, based on data or imaging or other information, including that based on the imaging data captured during surgical procedures would reasonably consult Squilla’s medical record and surgical workflow documentation solution. Squilla uses algorithmic determinations and analytics that can be readily incorporated alongside Couture’s integrated surgical system (same one or more processors, instructions stored in at least one memory executable by the at least one processor, and tracking systems/visualization systems, and camera(s) positionable to capture image data of a surgical treatment site), using known methods without redesigning Couture’s core integrated system architecture. Additionally, a person of ordinary skill in the art seeking to utilize Couture’s integrated systems and subsystems could readily incorporate Squilla’s automated healthcare facility workflow processes, including a rules set (FIG 9, 118) that can be assigned and determined by any or all of the decision factors 120 (FIG 9) which can then automatically process content (collect, organize, and display/save/archive/collaborate) in order to automate the image capturing process of multiple individuals and groups in one workflow system. One of ordinary skill in the art would be motivated to add Squilla’s automated solution because it is modular, encompasses automatic processing of a plurality of content from a heterogenous content sources automating the workflow based on a rule set comprising hierarchical organization which encompasses still images that are displayed, saved, and archived.
Because the references address the same engineering problem (documenting surgical imaging using at least one processor, at least one memory, and a camera positionable to capture real-time image data of a surgical treatment site) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding software functions based on tracked motions including tool movement patterns or sequential surgical procedure steps, documenting that the predetermined surgical step has been completed and automatically extracting a still image (frame) from the real-time image data captured at a time of completion of a surgical step and storing the still images (frames) in the at least one memory in a medical record in association with the predetermined surgical step, where the steps are part of a healthcare facility workflow process that is automated and designed to utilize a rules-based platform for plural content from heterogeneous content sources), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings because they all work together as demonstrated by Squilla.
Additionally, one of ordinary skill in the art recognizes that computer-implemented processes are results-effective variables which can be optimized when using a general computer. The system encompasses both hardware and software. One of ordinary skill in the art would have had a reasonable expectation of success to modify software with workflow processes based on the modified rejections provided below in response to Applicant’s arguments and amendments. Such processes can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings of the references as set forth below. The references themselves provide the teaching, suggestion, and motivation for computer-implemented workflow processes in a healthcare setting where modifications thereof would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Robinson et al., US 20210145299 (20 May 2021) teaches methods and apparatuses for central venous pressure measurement status.
Fitz et al., US 20220047278 (17 February 2022) teaches patient selectable joint arthroplasty devices and surgical tools.
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/CHERIE M POLAND/Examiner, Art Unit 3771
