DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Responsive to the communication dated 11/25/2025.
Claims 2 and 12 are cancelled.
Claims 21 and 22 are newly presented.
Claims 1, 3 – 11, 13 - 22 are presented for examination.
Final Action
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Response to Arguments
Claim Rejections - 35 USC § 103
The Applicant has amended the claims and asserts that the amended claims are not made obvious by the cited prior art. In particular, the Applicant asserts that the art of record does not make obvious “displaying a simulated surgical outcome based on the selected surgical rang and the selected surgical tool at the surgical tool selection point on a graphical representation.”
In response the argument is not persuasive. The Applicant is overlooking clear teachings in the art that are taught by figures and paragraphs not considered by the Applicant. See the updated rejection as outlined in the body of the Office action.
The Applicant further asserts that the art of record does not make obvious the limitations in newly presented claims 21 and 22 which recite: “wherein the simulated surgical outcome is a perfusion outcome, and wherein the perfusion outcome is one of minimal perfusion, low perfusion, or moderate perfusion.”
The Examiner notes that Shelton_2021 at par 581 - 582 states:
“The surgical visualization system 5067 of FIG. 65 can receive the user selected transection path 5096 via user interface and assess the user selected transection path 5096… the surgical visualization system can identify that the user selected transection path 5096 interferes with an artery 5080, vein 5082, and bronchus 5084 of the anatomical structure 5069. Accordingly, the display 5093 can depict the anticipated interference and issue a notification to the operating clinician(s). The notification can be visual, audible, haptic, and/or any combination thereof. The display 5093 can additionally highlight a characteristic or a portion of the anatomical structure 5069 affected by the user selected transection path 5096 and/or a portion of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096. For example, the display 5093 of FIG. 66 can highlight a transection portion 5098 of the artery 6080 to represent a blood supply 5100 that would be affected by the user selected transection path 5096. The display 5093 can also highlight a portion 5102 of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096 due to lack of blood or air… additionally… the surgical visualization system 5067 of FIG. 66 can depict… on the display 5093 that would… minimize adverse impacts to the detected characteristics of the anatomical structure 5069. For example… does not interfere with the artery 5080, vein 5082, and bronchus 5084…”
Because, perfusion is the essential delivery of blood that provides oxygen and nutrients for tissue life the above citation would make obvious to those of ordinary skill in the art to simulate (i.e., anticipate) a perfusion outcome.
Further, a review of the specification shows that paragraph 47 discloses minimal, low, and moderate perfusion is illustrated in FIG. 3. A review of FIG. 3 shows symbols for minimal perfusion as a blood drop is a circle with a line through it which according to ISO 7010 means general prohibition or no. This is the common symbol to indicate forbidden or prohibited. The low perfusion symbol is 1 drop, and the moderate perfusion symbol is shown as two drops. The specification does not provide any non-subjective indication (e.g., numerical value) indicating what minimal, low, or moderate means other than what is shown in FIG. 3. Therefore, the support of newly presented claim 21 and 22 such that they are not indefinite must be that “minimal” means none (i.e., zero %) perfusion. Moderate perfusion is illustrated to be on the opposite end of the scale. Accordingly, the opposite end of the scale from zero is 100%. Therefore, moderate perfusion indicates that perfusion is not interfered with. Low perfusion is illustrated in the middle between zero % and 100 %.
Because Shelton_2021 at par 581 – 582 teaches to provide indications of perfusion outcomes of “rendered non-viable” this makes obvious zero perfusion. Also, because Shelton_2021 at par 581 – 582 teaches “does not interfere with the artery…” this makes obvious the opposite of zero perfusion. Accordingly, Shelton_2021 makes obvious a simulated perfusion surgical outcome wherein the perfusion outcome is one of minimal perfusion, low perfusion, or moderate perfusion
End Response to Arguments
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 1, 3, 4, 5, 6, 8, 9, 10, 11, 13, 14, 15, 16, 18, 19, 20, 21, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton_2021 (US 2021/0196425 A1 Filed Dec. 30, 2019) in view of Greer_2010 (US 2010/0198402 A1) in view of Huang_2015 (A thickness Calibration Device is Needed to Determine Staple Height and Avoid Leaks in Laparascopic Sleeve Gastrectomy, OBES SURG (2015)).
Claim 1. Shelton_2021 makes obvious “A device for simulating a surgical activity (par 482: “… in challenging or high-risk procedures, the clinician can utilize pre-operative patient scans to simulate a surgical approach…”; par 356: “… the user can utilize pre-operative patient scans to simulate a surgical approach. The pre-surgical planning simulations can allow a user to follow a particular pre-surgical plan based on training runs…”; par 673: “… a visualization display… advanced visualization features… portions of the visualization display 6620 are simulated…”; EXAMINER NOTE: The above citations teach two types of simulations. The first type are pre-operative simulations that “simulate a surgical approach” and these approaches are “based on training runs.” This teaches a pure simulation of the surgical activity prior to surgery for the purpose of training on/testing outcomes of a proposed surgical plan. The second type of simulation is provided while the actual surgery is occurring. These simulations are provided as part of the visualization display that shows the simulated surgical plan overlayed with the real world surgical scenario.), comprising: A processor (Fig. 2A: 402 Processor) configured to: Present a first graphical representation of a portion of anatomy (Fig. 29: block 4102: “identify an anatomical organ targeted by the surgical procedure”, block 4104: “generate a 3D construct of anatomical organ”); Simulate a path for the surgical activity via a second graphical representation, wherein the simulated path is superimposed over the first graphical representation (Fig. 29: “block 4107: “overplay onto the 3D construct a layout plan of the surgical procedure determined based on the anatomical structures”; par 397: “… overlay landmarks onto the positions 4113, 4117, 4119 on a virtual 3D constructs of stomach 4110…” par 401: “in addition to the landmarks identifying relevant anatomical structures, the visualization system may also overly a procedure layout plan 4135, which can be in the form a recommended treatment path, onto the 3D critical structure… in the form of three resection paths 4136, 4137, 4138…” Fig. 34); determine a plurality of surgical tool selection points associated with selecting a plurality of surgical tools on the simulated path for the surgical activity; display the plurality of surgical tool selection points associated with the selecting the plurality of surgical tools on the simulated path for the surgical activity; (par 322: “… the surgeon(S) can alternate between robotic tools and handheld surgical instruments and/or can use the devices concurrently…”; par 599: “… computer system… can provide 7144 a recommendation based on the comparison between the surgical action and the baseline. In various aspects, the recommendation can be provided preoperatively (e.g., recommending a different mix of surgical devices to perform the procedure)…”
EXAMINER NOTE: these citations indicates that the surgeons utilize a plurality of tools and they make choice from among this plurality of surgical tools and recommendations are made different mixes of surgical devices. Note that recommending different mix of surgical devices makes obvious a plurality of surgical tools.
FIG. 64B: illustrates oncologic recommendation for stapling with recommended cartridge selection of 45 mm blue and 45 mm gold and oncologic and airleaks recommendations for stapling of 45mm blue and 60 mm gold; Par 94: “FIG. 69 is a logic flow diagram of a process for providing dynamic surgical recommendations to users, in accordance with at least one aspect of the present disclosure”
Par 588 - 590: “at least in part by visualizing what is occurring in a surgical procedure via the imaging system 7004, the surgical system 7000 can monitor decision points within the procedure (e.g., device selection, stapler cartridge selection, or order of operating steps)… the various decision points can then be utilized to inform algorithms that balance patient factors, surgeon factors, device utilization, and clinical outcome data to, for example, train machine learning models… once trained, the machine learning models can offer suggestions to users when a statistically significant outcome could be influenced by a decision point during the surgical procedure… in one aspect, the trained machine learning models can be executed by the back-end computer system 7010 and provide recommendations or analysis to the control system 7002… can be configured to analyze the various actions being taken during the surgical procedure, such as the type of surgical instrument selected to perform a given surgical procedure… to provide trends and references… the visualized surgical procedure data can be compared with clinical outcomes resulting during the performance of the procedure… in one implementation, the control system 7002 can be configured to execute various control algorithms, as described in connection with FIG. 2. Including… display information to users…”
EXAMINER NOTE: The above citations teach to have trained algorithms that display suggestions and information to users at decision points about the proper device selections and stapler cartridge selections to achieve surgical outcomes.) Present a surgical(choice/suggestion) and the plurality of surgical tools to select from at a surgical tool selection point of the plurality of surgical tool selection points; (FIG. 64B, FIG. 69; FIG. 33 block 4304: “present parameters of the surgical instrument in accordance with the proposed surgical resection path” FIG. 34 element 4315, 4314 illustrates points where green cartridge is used vs. points where black cartridge is used along the path. FIG. 35 illustrates a plurality of surgical tools (i.e., green and block cartridges) at tool selection points on the path of the surgical activity.); Receive an indication of a selected surgical (choice/selection) (abstract: “… receiving a user selection to manipulate the three-dimensional representation, and updating the three-dimensional representation as displayed on the display screen… according to the received user selection…” par 2: “… a user selection to manipulate the three-dimensional representation…”; par 402: “… the user to enter a size selection and, in response, present a procedure layout plan, which can be in the form of a resection path…” par 406: “… after the surgical stapler is fired, recommendations for new cartridge selection can be presented onto the screen…”; par 577: “… recommended staple type and sizes for the determined margins…”; par 593: “… providing dynamic surgical recommendations to users…”; par 596: “… recommended surgical actions to be performed at each decision point… provide preoperative, intraoperative, or postoperative recommendations to users…”; par 599: “… computer system… can provide 7144 a recommendation based on the comparison between the surgical action and the baseline. In various aspects, the recommendation can be provided preoperatively (e.g., recommending a different mix of surgical devices to perform the procedure)…”) and a selected surgical tool (Par 306: “… checking for errors during the setup of the surgical procedure or during the course of the surgical procedure… situationally aware surgical hub… configured to compare the list of items for the procedure… to a recommended, or anticipated manifest of items and/or devices for the given surgical procedure. If there are any discontinuities between the lists, the surgical hub 2404 can be configured to provide an alert…”; par 307: “… a situationally aware surgical hub 2404 could determine whether the surgeon (or other medical personnel) was making an error… in one exemplification, the surgical hub 2404 can be configured to provide an alert indicating that an unexpected action is being performed or an unexpected device is being utilized at that particular step in the surgical procedure…”; par 350: “… may further alert the current user of the surgical instrument 4600 – using an audible, visual, and/or haptic alerting mechanism…”
; determine a simulated surgical outcome based on the selected surgical (choice/selection) and the selected surgical tool at the surgical tool selection point; and display the simulated surgical outcome based on the selected surgical (choice/selection) and the selected surgical tool at the surgical tool selection point (par 2: “… generating a three-dimensional representation of the surgical site based on the first image and the second image as aligned, displaying the three-dimensional representation on a display screen, receiving a user selection to manipulate the three-dimensional representation, and updating the three-dimensional representation as displayed on the display screen from a first state to a second state according to the received user selection…”; par 402: “… the user to enter a size selection and, in response, present a procedure layout plan, which can be in the form of a resection path…”; FIG. 84 block 6660: “update the POV or state of the 3D representation according to user selection” par 404: “… the visualization system to overlay the resection paths onto the virtual 3D construct…”; par 587: “… in various aspects, a surgical system can be configured to monitor the actions taken by users in performing a surgical procedure and then provide recommendations or alerts when the actions deviate… determined by monitoring or recording the performance of surgical procedures, determining the surgical outcomes associated with the various surgical procedures…”
EXAMINER NOTE: the above citation teach that the user provides selections and then the state of the surgical simulation is updated to a second state. This is an outcome of the surgery. Also, the above citations teach to monitor the actions taken by a user. The actions taken by a user include device choices. In the above citation, recommendations are made based on simulated surgical outcomes.).
While Shelton_2021 clearly teaches a choice/suggestion for surgical staple sizes, Shelton_2021 does not teach a “surgical range” associated with the choice of staples.
While Shelton_2021 teaches to update a graphical representation of the surgical field and also teaches that surgical tool can be hand-held surgical instruments or instruments coupled to robotic arms (par 429, par 320, 334) and the surgeon can alternate between robotic tools and handheld tools or use the tools concurrently (par 322) and the tools can include motors for activating and firing closure, and or articulation (par 335) and such tools can be staplers as illustrated in Figure 36 with interchangeable cartridges (par 205, 387, 405, 406), and while Shelton_2021 illustrates a surgical tool in the user graphical interface representation of the surgical field in Figures 32A, 32C, Shelton_2021 does not clearly illustrate a virtual “surgical tool” generated in, for example, a training simulation mode of software.
Greer_2010; however, clearly illustrates a virtual “surgical tool” generated in a training simulation model of a software device (FIG. 5, 6, 7, 8, 9, 10 illustrates robotic arms used as surgical tools; Figure 12 illustrates a surgical tool in the surgical field).
Shelton_2021 and Greer_2010 are analogous art because they are from the same field of endeavor called surgery. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Shelton_2021 and Greer_2010. The rationale for doing so would have been that Shelton_2021 teaches to have surgical tools including surgical staples with interchangeable cartridges and also teaches to have a robot arm that can be combined with other surgical tools and also teaches to have simulations for making preoperative plans (par 356). Greer_2010 teaches to have robotic arms for performing surgery and teaches to have a software tool for performing training simulations. Therefore, it would have been obvious to combine Shelton_2021 and Greer_2010 for the benefit of improving surgical outcomes by having a simulation that includes the surgical tools such as robotic arms and staplers for surgeons to practice operations and create pre-operative plans to obtain the invention as specified in the claims.
Shelton_2021 and Greer_2010 does not teach “surgical range”.
Huang_2015 however, makes obvious a “surgical range” (introduction: “… bleeding or leaking if the thickness of the stomach is outside the indicated range of the cartridge…”; page 2361 Statistical Analysis… range of appropriate thicknesses… Tables 1 and 2…” page 2363 Table 3. NOTE: Huang_2015 clearly teaches that tissue thickness has a surgical range and associates the selection of staple size (i.e., surgical tools) to the surgical tissue range.).
Shelton_2021 and Huang_2015 are analogous art because they are from the same field of endeavor called surgery. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Shelton_2021 and Huang_2015. The rationale for doing so would have been that Shelton_2021 teaches to have surgical tools including surgical staples with interchangeable cartridges. Huang_2015teaches to interchange cartridges according to a surgical range of the tissue thickness to avoid poor surgical outcomes. Therefore, it would have been obvious to combine Shelton_2021 and Huang_2015for the benefit of improving surgical outcomes by avoiding bleeding and necrosis to obtain the invention as specified in the claims.
Claim 11. The limitations of claim 11 are substantially the same as those of claim 1 and are therefore rejected due to the same reasons as outlined above for claim 1.
Claim 3, 13. Shelton_2021 makes obvious “wherein the simulated surgical outcome is [bleeding and/or non-viable ] outcome (PAR 581 – 582: “…The display 5093 can also highlight a portion 5102 of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096 due to lack of blood or air…”; par 586: “… the amount of bleeding that that occurs… determine which actions are most highly correlated to surgical outcomes (e.g., the amount of bleeding… in order to suggest particular actions at the various decision points associated with the surgical procedure…”) and the plurality of surgical tools is a plurality of staple cartridge types (FIG. 34, 35, FIG. 64B), and wherein the processor is further configured to: determine the simulated outcome ; and display the simulated outcome based on the selected surgical range and the selected surgical tool at the surgical tool selection point” (par 581 – 582: “The surgical visualization system 5067 of FIG. 65 can receive the user selected transection path 5096 via user interface and assess the user selected transection path 5096… the surgical visualization system can identify that the user selected transection path 5096 interferes with an artery 5080, vein 5082, and bronchus 5084 of the anatomical structure 5069. Accordingly, the display 5093 can depict the anticipated interference and issue a notification to the operating clinician(s). The notification can be visual, audible, haptic, and/or any combination thereof. The display 5093 can additionally highlight a characteristic or a portion of the anatomical structure 5069 affected by the user selected transection path 5096 and/or a portion of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096. For example, the display 5093 of FIG. 66 can highlight a transection portion 5098 of the artery 6080 to represent a blood supply 5100 that would be affected by the user selected transection path 5096. The display 5093 can also highlight a portion 5102 of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096 due to lack of blood or air… additionally… the surgical visualization system 5067 of FIG. 66 can depict… on the display 5093 that would… minimize adverse impacts to the detected characteristics of the anatomical structure 5069. For example… does not interfere with the artery 5080, vein 5082, and bronchus 5084…”)
Huang_2015 teaches that improper staple selection may result in necrosis which makes “perfusion” and also that the outcome is “based on the selected surgical range and the selected surgical tool at the surgical selection points” obvious (abstract: “… gastric thickness, a single staple height cannot be used to appose the full range of gastric wall thickness without potentially causing necrosis or poor apposition…”
EXAMINER NOTE: The above citation teaches that multiple staple heights/types are required because a single height cannot because for the full range of tissue thicknesses. This also indicates that the surgical outcome is based upon the plurality of staples used to perform the procedure. Accordingly, this makes obvious that the perfusion outcome is based on the selected surgical range (i.e., staple height/range) and the selected surgical tool used at the various points along the path.
In combination, Shelton_2021 teaches a path, along which, surgical tools/ranges are chosen for stapler and staple cartridges (e.g., type/size/height of staples) and also teaches so simulate the outcome of the path where the outcomes can be non-viable tissue (i.e., necrosis) and also to simulate and recommend paths that do not result in non-viable tissue. Huang_2015 teaches that the necrosis can occur due to improper selection of staples used along the points of the surgical path. Accordingly, it would be obvious to those of ordinary skill in the art that perfusion (i.e., blood and oxygen flow to tissue) is a consequence of staple selection along the path and it would further be obvious to simulate perfusion outcomes as taught by Shelton_2021 in paragraphs 581 – 582 along staple paths for the benefit identifying non-viable outcomes and making recommendations to the surgeon that avoid non-viable outcome due to improper staple selection along the surgical path.).
Claim 4, 14. Huang_2015 makes obvious “wherein the processor is further configured to:
a reinforcement range associated with the selected surgical range; and
Calculate a reinforced surgical range based on the selected surgical range and the reinforcement range, wherein the simulated surgical outcome is determined based on the reinforced surgical range; (page 2365 – 2366: “… if buttressing material is used, its thickness should be accounted for when selecting a staple cartridge. For example, GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement… measures 0.16 mm per side, when using the material, the operating surgeon should adjust the choice of cartridge by adding 0.32 mm to the perceived thickness…”).
Shelton_2021; however, makes obvious to “display” a reinforcement range “and display the calculated reinforcement range” (Par 197: “… the display 146 can include one or more screens or monitors for depicting real, virtual, and/or virtually-augmented images and/or information to one or more users…”; Par 552: “… a characteristic of the anatomical structure can include… a foreign structure in proximity to the subject tissue (e.g., a surgical device, surgical fastener, or clip),… among others. There is an increasing need for surgical visualization systems configured to detect such critical structures, synthesize data associated with the subject tissue, and communicate the synthesized data to the operating clinician(s) in the form of relevant information and/or instructions…”
EXAMINER NOTE: the above citations teach to have displays and present information to one or more users on those displays and further that there is a need to identify foreign structures in proximity to the subject tissue and to synthesize information about these foreign structures and present this information in relevant form. Buttressing material is a foreign object in proximity of the tissue and Huang_2015 explicitly teaches that an operating surgeon should adjust the choice of cartridges (e.g., surgical fasteners) according to its thickness (i.e., calculated reinforcement range). Accordingly, it would have been obvious to those of ordinary skill in the art to synthesize the thickness of the buttress material (i.e., calculated reinforcement range) and display this range to a clinician(s) for the benefit of detecting critical structures and communicating relevant information to a clinician(s) so they can adjust the choice of cartridge required for the surgical procedure.
Claim 5, 15. Shelton_2021 makes obvious “wherein the plurality of surgical tools is a first plurality of surgical tools (par 205: “… the surgical device 102 can be any suitable surgical device such as, for example, a dissector, a stapler, a grasper, a clip applier… end effector…”), the simulated surgical outcome is a first simulated surgical outcome (par 581 – 582: “The surgical visualization system 5067 of FIG. 65 can receive the user selected transection path 5096 via user interface and assess the user selected transection path 5096… the surgical visualization system can identify that the user selected transection path 5096 interferes with an artery 5080, vein 5082, and bronchus 5084 of the anatomical structure 5069. Accordingly, the display 5093 can depict the anticipated interference and issue a notification to the operating clinician(s). The notification can be visual, audible, haptic, and/or any combination thereof. The display 5093 can additionally highlight a characteristic or a portion of the anatomical structure 5069 affected by the user selected transection path 5096 and/or a portion of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096. For example, the display 5093 of FIG. 66 can highlight a transection portion 5098 of the artery 6080 to represent a blood supply 5100 that would be affected by the user selected transection path 5096. The display 5093 can also highlight a portion 5102 of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096 due to lack of blood or air… additionally… the surgical visualization system 5067 of FIG. 66 can depict… on the display 5093 that would… minimize adverse impacts to the detected characteristics of the anatomical structure 5069. For example… does not interfere with the artery 5080, vein 5082, and bronchus 5084…”
EXAMINER NOTE: the above citation indicates a simulated outcome where anatomy is rendered non-viable due to lack of blood or air. This is bad perfusion)
, and the processor (FIG. 2A) is further configured to: present a second plurality of surgical tools to select from at the selected surgical tool selection point (par 353: “… cartridge selection…” par 322: “… it should be noted that surgeons regularly switch back and forth between surgical stapling/cutting instruments and surgical energy (i.e., RF or ultra sonic) instruments depending upon the particular step in the procedure… the surgeon(s) can alternate between… tools”)
In response to receiving the indication of the selected(choice/selection), display a second simulated surgical outcome (par 581 – 582: “The surgical visualization system 5067 of FIG. 65 can receive the user selected transection path 5096 via user interface and assess the user selected transection path 5096… the surgical visualization system can identify that the user selected transection path 5096 interferes with an artery 5080, vein 5082, and bronchus 5084 of the anatomical structure 5069. Accordingly, the display 5093 can depict the anticipated interference and issue a notification to the operating clinician(s). The notification can be visual, audible, haptic, and/or any combination thereof. The display 5093 can additionally highlight a characteristic or a portion of the anatomical structure 5069 affected by the user selected transection path 5096 and/or a portion of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096. For example, the display 5093 of FIG. 66 can highlight a transection portion 5098 of the artery 6080 to represent a blood supply 5100 that would be affected by the user selected transection path 5096. The display 5093 can also highlight a portion 5102 of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096 due to lack of blood or air… additionally… the surgical visualization system 5067 of FIG. 66 can depict… on the display 5093 that would… minimize adverse impacts to the detected characteristics of the anatomical structure 5069. For example… does not interfere with the artery 5080, vein 5082, and bronchus 5084…”
EXAMINER NOTE: the above citation teaches to identify and show the user a second potential surgical outcome where the chosen surgical plan does not kill the anatomical tissue. This is good perfusion.)
associated with the selecting a surgical tool of the second plurality of surgical tools at the surgical tool selection point” (FIG. 34, 35, 64B; par 598: “… determine what preoperative mix of surgical devices are planned for the surgical procedure…”; par 356: “… pre-surgical planning simulations… the pre-surgical planning simulation can allow a user to follow a particular pre-surgical plan…”
EXAMINER NOTE: the path, as illustrated in FIG. 34, 35, 54B is associated with, for example, the selected stapler and various selected staples chosen to be used along the path.).
Receive an indication of a selected surgical tool of the second plurality of surgical tools; and In response to receiving the indication of the selected surgical tool of the second plurality of surgical tools, generate a surgical plan for the plurality of surgical tool selection points on the path of the surgical activity; and display the generated surgical plan” (par 402: “… make adjustments to a proposed resection path on a screen showing the resection path overlaid…”; par 404: “… the visualization system to overlay the resection paths onto the virtual 3D construct…”; par 406: “… the selected resection path – are overlaid onto the virtual 3D construct view and/or the surgical field view…”; par 419: “… present parameters 4314 of the surgical instruments that are selected in accordance with the proposed 4303 surgical resection path 4312… indicative of staple cartridge… based on the proposed 4303 surgical resection path… size… color… cartridge type… length overlaying such parameters onto, or near, the proposed 4303 surgical resection path 4312, as illustrated in FIGS. 34…”; FIG. 64B. EXAMINER NOTES: a resection path is a surgical plan. Figures 34 and 64B clearly illustrate that a stapler is to be used and it illustrates the path and also illustrates that cartridges to be used at different locations along the resection path.).
Huang_2015 makes obvious “surgical range” (introduction: “… bleeding or leaking if the thickness of the stomach is outside the indicated range of the cartridge…”; page 2361 Statistical Analysis… range of appropriate thicknesses… Tables 1 and 2…” page 2363 Table 3. NOTE: Huang_2015 clearly teaches that tissue thickness has a surgical range and associates the selection of staple size (i.e., surgical tools) to the surgical tissue range.).
Claim 6, 16. Shelton_2021 makes obvious “wherein the processor is further configured to: convert the selected surgical tool of the second plurality of surgical tools to a surgical tool of the first plurality of surgical tools at the surgical tool selection point; (par 253: “… the visual overlay correlates to the visualization data representing tissue deformation to changes in clamping force over time. The correlation helps a user confirm proper cartridge selection…” NOTE: cartridge selection converts unselected cartridge to selected cartridge. This also coverts the stapler to one with different staples and therefore has different stapling characteristics.)
Greer_2010 makes obvious “and display the converted surgical tool” (par 49: “… manipulators 100 are shown in an unhighlighted manner on the GUI shown in FIG. 5, signifying that neither has been selected for using in either training/simulation or a procedure using the buttons at the bottom left of the screen…”; par 52: “… shows only one manipulator as a result of the left arm selection, and shows it in a highlighted state…” EXAMINER NOTE: the surgical tool in the above citation is converted from unselected to selected and is shown on a display and the conversion is indicated by, for example, highlighting the converted tool.).
Claim 8, 18. Shelton_2021 makes obvious wherein the surgical activity is a cutting path (FIG. 31: “… surgical resection path for removing a portion of the anatomical organ…”), the plurality of surgical tools is a plurality of staple cartridge types (FIG. 34, 35 Green and Black Cartridges), and the surgical range is a tissue thickness range (par 353: “… tissue thickness… the visual overlay correlates the visualization data… the correlation helps a user confirm proper cartridge selection…” par 420: “… tissue parameters 4315 are tissue thicknesses presented by displaying a cross-section… in various aspects, the staple cartridge utilized by the surgical instrument 4600 can be selected…”), and wherein the processor (FIG. 2A) is further configured to: determine a plurality of surgical tool selection points associated with selecting a plurality of staple cartridge types on the cutting path (FIG. 34, 35); display the plurality of surgical tools selection points associated with selecting the plurality of staple cartridge types on the cutting path (FIG. 34, 35, 64B)
Present the tissue thickness range to select from at a surgical tool selection point of the plurality of surgical tool selection points (par 442: “… propose an arrangement 4317 of two or more staple cartridge sizes (e.g., 45 mm and 60 mm) in accordance with determined tissue thicknesses along at least a portion of the surgical resection path…”);
Receive an indication of a (selection/choice) (par 402: “… in one example, the control circuit prompts the user to enter a size selection and, in response, present a procedure layout plan, which can for a resection path… in yet another example, the control circuit allows the user to make adjustments to a proposed resection path…”)
In response to receiving the indication of the (range/choice) display a simulated surgical outcome associated with selecting a surgical tool of the plurality of surgical tools at the surgical tool selection point (par 356: “… the user can utilize pre-operative patient scans to simulate a surgical approach. The pre-surgical planning simulations can allow a user to follow a particular pre-surgical plan based on training runs…”; Fig. 69 block 7104: “determine outcome associated with the surgical procedure”; par 581 – 582: “The surgical visualization system 5067 of FIG. 65 can receive the user selected transection path 5096 via user interface and assess the user selected transection path 5096… the surgical visualization system can identify that the user selected transection path 5096 interferes with an artery 5080, vein 5082, and bronchus 5084 of the anatomical structure 5069. Accordingly, the display 5093 can depict the anticipated interference and issue a notification to the operating clinician(s). The notification can be visual, audible, haptic, and/or any combination thereof. The display 5093 can additionally highlight a characteristic or a portion of the anatomical structure 5069 affected by the user selected transection path 5096 and/or a portion of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096. For example, the display 5093 of FIG. 66 can highlight a transection portion 5098 of the artery 6080 to represent a blood supply 5100 that would be affected by the user selected transection path 5096. The display 5093 can also highlight a portion 5102 of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096 due to lack of blood or air… additionally… the surgical visualization system 5067 of FIG. 66 can depict… on the display 5093 that would… minimize adverse impacts to the detected characteristics of the anatomical structure 5069. For example… does not interfere with the artery 5080, vein 5082, and bronchus 5084…” EXAMINER NOTE: a transection path is a path through tissue, which has a thickness. The surgical outcome is displayed for the transection path.
par 590: “… surgical outcomes data can further be utilized to refine the various control algorithms… include data associated with interactions between the tissue and the surgical instrument, to improve control algorithms of the device…” NOTE: tissue thickness and the selection of staple cartridge ) Receive an indication of a selected staple cartridge type of the plurality of staple cartridge types; and (par 406: “… recommendations for new cartridge selection can be presented onto the screen…” par 419: “… at least one staple cartridge size, a staple cartridge color, a staple cartridge type, and a staple cartridge length… overlayed such parameters onto, or near, the proposed 4303 surgical resection path 4312, as illustrated in FIGS. 34 and 35) In response to receiving the indication of the selected staple cartridge type of the plurality of staple cartridge types, generate a surgical plan for the plurality of surgical tool selection points on the path of the surgical activity” (par 598: “… determine what preoperative mix of surgical devices are planned for the surgical procedure…”; par 356: “… pre-surgical planning simulations… the pre-surgical planning simulation can allow a user to follow a particular pre-surgical plan…”) and display the generated surgical plan (par 402: “… make adjustments to a proposed resection path on a screen showing the resection path overlaid…”; par 404: “… the visualization system to overlay the resection paths onto the virtual 3D construct…”; par 406: “… the selected resection path – are overlaid onto the virtual 3D construct view and/or the surgical field view…”; par 419: “… present parameters 4314 of the surgical instruments that are selected in accordance with the proposed 4303 surgical resection path 4312… indicative of staple cartridge… based on the proposed 4303 surgical resection path… size… color… cartridge type… length overlaying such parameters onto, or near, the proposed 4303 surgical resection path 4312, as illustrated in FIGS. 34…”; FIG. 64B. EXAMINER NOTES: a resection path is a surgical plan. Figures 34 and 64B clearly illustrate that a stapler is to be used and it illustrates the path and also illustrates that cartridges to be used at different locations along the resection path.).
Huang_2015 makes obvious “selected tissue thickness range” (introduction: “… bleeding or leaking if the thickness of the stomach is outside the indicated range of the cartridge…”; page 2361 Statistical Analysis… range of appropriate thicknesses… Tables 1 and 2…” page 2363 Table 3. NOTE: Huang_2015 clearly teaches that tissue thickness has a surgical range and associates the selection of staple size (i.e., surgical tools) to the surgical tissue range.).
Claim 9, 19. Shelton_2021 makes obvious “wherein the processor if further configured to:
Segment the path into six segments based on the simulated path for the surgical activity via a second graphical representation; Identify a start point and five intersection points between the six segments as the plurality of surgical tool selection points; Receive an indication of a selected surgical tool of the plurality of surgical tools (par 572: “… depicted in linear segments about the anatomical structure 5024, corresponding to the capabilities of an intended surgical instrument. For example, the surgical instrument can be a surgical stapler configured to staple tissue…”; FIG. 35 illustrates a path with 6 segments where each segment is associated with a type of staple to be used for each segment. The first segment is 45 Green, segments 2 – 4 are 60 green, segment 6 is 60 black); And In response to receiving the indication of the selected surgical tool of the plurality of surgical tools, generate a surgical plan for the plurality of surgical tool selection points on the path of the surgical activity” (par 356: “… the user can utilize pre-operative patient scans to simulate a surgical approach. The pre-surgical planning simulations can allow a user to follow a particular pre-surgical plan based on training runs. The control circuit can be configured to correlate fiducial landmarks of the pre-operative cans/simulations…”; par 482: “… in challenging or high-risk procedures, the clinician can utilize pre-operative patient scans to simulate a surgical approach…”); and display the generated surgical plan (par 402: “… make adjustments to a proposed resection path on a screen showing the resection path overlaid…”; par 404: “… the visualization system to overlay the resection paths onto the virtual 3D construct…”; par 406: “… the selected resection path – are overlaid onto the virtual 3D construct view and/or the surgical field view…”; par 419: “… present parameters 4314 of the surgical instruments that are selected in accordance with the proposed 4303 surgical resection path 4312… indicative of staple cartridge… based on the proposed 4303 surgical resection path… size… color… cartridge type… length overlaying such parameters onto, or near, the proposed 4303 surgical resection path 4312, as illustrated in FIGS. 34…”; FIG. 64B. EXAMINER NOTES: a resection path is a surgical plan. Figures 34 and 64B clearly illustrate that a stapler is to be used and it illustrates the path and also illustrates that cartridges to be used at different locations along the resection path.).
Claim 10. 20. Shelton_2021 makes obvious “wherein the processor is further configured to:
Present a graphical user interface configured to enable a user to draw on the fist graphical representation of a portion of anatomy; receive an indication from the user of a drawn path on the first graphical representation of the portion of anatomy; and superimpose the drawn path over the grist graphical representation of the portion of anatomy” (Figure 88: “.. generate a first image of the surgical site… generate a second image of the surgical site that overlaps with the first image… “; par 45: “… resection path overlaid onto the surgical field…”; par 225: “… a system with augmentation image overlays…”; par 227: “… detect the critical structure and provide an image overlay…”).
Claims 21, 22. Shelton_2021 makes obvious “wherein the simulated surgical outcome is a perfusion outcome, and wherein the perfusion outcome is one of minimal perfusion, low perfusion, or moderate perfusion” (par 581 – 582: “The surgical visualization system 5067 of FIG. 65 can receive the user selected transection path 5096 via user interface and assess the user selected transection path 5096… the surgical visualization system can identify that the user selected transection path 5096 interferes with an artery 5080, vein 5082, and bronchus 5084 of the anatomical structure 5069. Accordingly, the display 5093 can depict the anticipated interference and issue a notification to the operating clinician(s). The notification can be visual, audible, haptic, and/or any combination thereof. The display 5093 can additionally highlight a characteristic or a portion of the anatomical structure 5069 affected by the user selected transection path 5096 and/or a portion of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096. For example, the display 5093 of FIG. 66 can highlight a transection portion 5098 of the artery 6080 to represent a blood supply 5100 that would be affected by the user selected transection path 5096. The display 5093 can also highlight a portion 5102 of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096 due to lack of blood or air… additionally… the surgical visualization system 5067 of FIG. 66 can depict… on the display 5093 that would… minimize adverse impacts to the detected characteristics of the anatomical structure 5069. For example… does not interfere with the artery 5080, vein 5082, and bronchus 5084…”
EXAMINER NOTE: Because, perfusion is the essential delivery of blood that provides oxygen and nutrients for tissue life the above citation would make obvious to those of ordinary skill in the art to simulate (i.e., anticipate) a perfusion outcome.
Further, a review of the specification shows that paragraph 47 discloses minimal, low, and moderate perfusion is illustrated in FIG. 3. A review of FIG. 3 shows symbols for minimal perfusion as a blood drop is a circle with a line through it which means general prohibition or no. This is the common symbol to indicate forbidden or prohibited. The low perfusion symbol is 1 drop, and the moderate perfusion symbol is shown as 2 drops. The specification does not provide any non-subjective indication (e.g., numerical value) indicating what minimal, low, or moderate means other than what is shown in FIG. 3. Therefore, the support of newly presented claim 21 and 22 such that they are not indefinite must be that “minimal” means none (i.e., zero ) perfusion. Moderate perfusion is illustrated to be on the opposite end of the scale. Accordingly, the opposite end of the scale from zero is 100. Therefore, moderate perfusion indicates that perfusion is not interfered with. Low perfusion is illustrated in the middle between 0 and 100.
Because Shelton_2021 at par 581 – 582 teaches to provide indications of perfusion outcomes of “rendered non-viable” this makes obvious zero perfusion. Also, because Shelton_2021 at par 581 – 582 teaches “does not interfere with the artery…” this makes obvious the opposite of zero perfusion. Accordingly, Shelton_2021 makes obvious a simulated perfusion surgical outcome wherein the perfusion outcome is one of minimal perfusion, low perfusion, or moderate perfusion).
Claims 7, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton_2021 in view of Greer_2010 in view of Huang_2015 in view of Henderson_2017 (Add a Slider to your chart in Excel, Youtube.com May 1 2017).
Claim 7, 17. Huang_2015 makes obvious wherein the processor is further configured to:
Present a first axis configured to represent the surgical range to select from,
wherein the plurality of surgical tools is presented along a second axis (Table 1 illustrates staple height along the horizontal axis while the staple selection is presented along the vertical axis.)
Shelton_2021 makes obvious “and, based on the selected surgical range selected (par 356: “… the user can utilize pre-operative patient scans to simulate a surgical approach…”; par 482: “… simulate a surgical approach…”; par 401 - 402: “… the layout plan 4135 is in the form of three resection paths… and corresponding outcomes… prompts the user to enter a size selection and, in response, present a procedure layout plan, which can be in the form of a resection path…”; par 476: “… tissue thickness and can therefore influence stapling outcomes…” ; par 581 – 582: “The surgical visualization system 5067 of FIG. 65 can receive the user selected transection path 5096 via user interface and assess the user selected transection path 5096… the surgical visualization system can identify that the user selected transection path 5096 interferes with an artery 5080, vein 5082, and bronchus 5084 of the anatomical structure 5069. Accordingly, the display 5093 can depict the anticipated interference and issue a notification to the operating clinician(s). The notification can be visual, audible, haptic, and/or any combination thereof. The display 5093 can additionally highlight a characteristic or a portion of the anatomical structure 5069 affected by the user selected transection path 5096 and/or a portion of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096. For example, the display 5093 of FIG. 66 can highlight a transection portion 5098 of the artery 6080 to represent a blood supply 5100 that would be affected by the user selected transection path 5096. The display 5093 can also highlight a portion 5102 of the anatomical structure 5069 that can be rendered non-viable by the user selected transection path 5096 due to lack of blood or air… additionally… the surgical visualization system 5067 of FIG. 66 can depict… on the display 5093 that would… minimize adverse impacts to the detected characteristics of the anatomical structure 5069. For example… does not interfere with the artery 5080, vein 5082, and bronchus 5084…”; par 586: “… the surgical outcomes associated with any given decision point in a surgical procedure can be direct and easy to identify…”; FIG. 34, 35 illustrate surgical tool selection points.
EXAMINER NOTES: the above citations teach that to simulate a surgery and during the simulation of the surgery that surgical outcomes associated with any given decision made in the simulation can be easy to identify and teaches an example of a surgical outcome where a decision renders anatomical structures non-viable due to lack of blood and air. This makes obvious to simulate a surgical outcome.
Shelton_2021 and Huang_2015 are analogous art because they are from the same field of endeavor called surgery. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Shelton_2021 and Huang_2015. The rationale for doing so would have been that Shelton_2021 teaches to have surgical tools including surgical staples with interchangeable cartridges. Huang_2015teaches to interchange cartridges according to a surgical range of the tissue thickness to avoid poor surgical outcomes. Therefore, it would have been obvious to combine the simulations and staple paths of Shelton_2021 and the table of Huang_2015 for the benefit of improving surgical outcomes by avoiding bleeding and necrosis to obtain the invention as specified in the claims.
Greer_2010 makes obvious “wherein the indication of the selected surgical range is received via the slider” and selected “via the slider” (par 10: “… user may also deliver inputs through one or more graphical user interfaces (GUIs) using any suitable input device such as… (e.g., buttons, slider bars…”).
Shelton_2021 and Greer_2010 are analogous art because they are from the same field of endeavor called surgery. Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Shelton_2021 and Greer_2010. The rationale for doing so would have been that Shelton_2021 teaches to make a selection of staple cartridges during surgery and Greer_2010 teaches that selection can be made using any appropriate input device including sliders. Therefore, it would have been obvious to combine Shelton_2021 and Greer_2010 for the benefit of having a computer input device for making medical tool selections to obtain the invention as specified in the claims.
Henderson_2017 makes obvious a selection in “the first axis having a slider” and results of selection “presented along a second axis” (page 1 as illustrated in the image at 2:49 of 3.3).
Huang_2015 and Henderson_2017 are analogous art because they are from the same field of endeavor called selecting data from regions having axis (i.e., tables). Before the effective filing date it would have been obvious to a person of ordinary skill in the art to combine Huang_2015 and Henderson_2017.
The rationale for doing so would have been that Huang_2015 teaches to select staple cartridges shown along a first axis according to tissue thickness ranges shown along a second axis to avoid bleeding and necrosis. Henderson_2017 teaches that a slider can be used to make a selection from a table. Therefore; it would have been obvious to combine the slider of Henderson_2017 with staple selection tables of Huang_2015 for the benefit of selection the proper staple to avoid bleeding and necrosis to obtain the invention as specified in the claims.
Conclusion
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/BRIAN S COOK/Primary Examiner, Art Unit 2187