DETAILED ACTION
Remarks
This non-final office action is in response to the CON application filled on 09/23/2024. Claims 1-20 are canceled. Claims 21-40 are pending and examined below.
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 .
Priority
Acknowledgment is made of applicant’s claim for benefit of CON application 17/965,244 filled on 10/13/2022 which is an issued pat. No. 12,137,991. Application 17/965,244 was a CON of application no 15/940,690 filled on 03/29/2018, now abandoned. Application 17/965,244 claims domestic benefit of provisional application No. 62/649,307, filed on Mar. 28, 2018, provisional application No. 62/611,341, filed on Dec. 28, 2017, provisional application No. 62/611,340, filed on Dec. 28, 2017, provisional application No. 62/611,339, filed on Dec. 28, 2017.
Information Disclosure Statement
As of date of this action, IDS filled has been annotated and considered.
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.
Claim(s) 21, 23-25, 29, 31, 33, 34 and 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0038981 (“Kilroy”), and in view of US 2012/0021684 (“Schultz”), and in view of US 2016/0157717 (“Gaster”), and further in view of US 2013/0191513 (“Kamen”).
Regarding claim 21 (and similarly claim 36), Kilroy discloses a surgical system (see fig 2, where 100 is a surgical system), comprising:
a robotic tool (see fig 2, where 300/200 are robotic tools or surgical arms; see also [0131]);
a robot control system (see fig 2, where 605 is control system for 300/200; see also [0128], where “With continued reference to FIG. 2, the hyperdexterous surgical system 100 can include a user interface subsystem 605. The user interface sub-system 605 can include an input device (e.g., controller 514).”), comprising:
a control console (see fig 2, where 514 is controller for 300/200; controller corresponds to control console. see also [0123], [0128] and [0129]); and
a control unit comprising a robot processor in signal communication with said control console and said robotic tool, wherein said robot processor is configured to receive input signals from said control console and transmit control signals to said robotic tool (see [0122], where “The hyperdexterous surgical system 100 includes a control system and displays 600, 702 which provide the operator with visual cues that aid the surgeon in controlling the operation of the one or more hyperdexterous surgical tools 300 and the manual tools 350.”; see also [0130], where “The display 600 allows the operator 1 to perform many functions including pairing a hyperdexterous surgical tool 300 with an input device 500 so that the operator 1 can operate the paired hyperdexterous surgical tool 300 with the input device 500.”; see also [0263] and [0258]; see also fig 37, where control console (514) is wirelessly connected with the surgical tools. See also fig 40, where manual tool and surgical tools are controlled by wireless controller.);
a handheld surgical instrument comprising a sensor (see fig 2, where 350 are manual tools; see also [0255], where “The control system 400 can lock one or more hyperdexterous surgical tools 300 to a single tool (e.g., a hyperdexterous surgical tool 300 or a manual tool 350).”; see also [0262]); and
a surgical hub comprising (see fig 34, where control system of a surgical system is shown and 702 is a display; see also fig 36 and 40 where screenshot of displays is shown.), wherein said surgical hub processor is in signal communication with said robot processor by way of a (see fig 34, where robotic tool, 300 is associated/connected with control system, 400 and display, 702 by solid arrow. see also [0263], where “The display 600 may show the associations (e.g., pairings) between the input devices 500 and the controlled objects, such as the one or more hyperdexterous surgical arms 200 and/or the one or more hyperdexterous surgical tools 300.”; see also [0264]) and in signal communication with said surgical instrument (see fig 34, where manual tool, 350 is associated/connected with control system, 400 and display, 702 by solid arrow. Surgical hub (display) is connecting handheld device (manual tool). In signal communication is interpreted as connecting manual tool with the display. See also [0122], where “The hyperdexterous surgical system 100 includes a control system and displays 600, 702 which provide the operator with visual cues that aid the surgeon in controlling the operation of the one or more hyperdexterous surgical tools 300 and the manual tools 350.”; see also [0131]. Kilroy teaches connecting/pairing/linking manual/handheld device with display. Display shows the images of manual tool.), and wherein said surgical hub is configured to detect said handheld surgical instrument (see fig 36, where operator selects a controllable object icon which causes the device to be paired/connected with and control the selected controllable object. See also [0265], where “For example, one controller 514, labeled Wireless Controller 1, may control one controllable object, labeled Tool 3. One controller 514, labeled Wireless Controller 2, may control one controllable object, labeled Tool 4.”) and represent data from said handheld surgical instrument and from said robot control system tool on said display (see [0131], where “The display 702 can display information about the one or more hyperdexterous surgical arms 200, the one or more hyperdexterous surgical tools 300, the patient, or any other information that may be relevant to the surgeon or surgical team. The display 702 can show images as seen by a camera 304 (shown schematically in FIG. 35) or other visualization devices, such as images of the hyperdexterous surgical tools 300 that are held by the hyperdexterous surgical arms 200, or images of a manual tool 350 held by the operator (e.g., surgeon).”).
Kilroy discloses a surgical system that comprises a display and configured to display surgical arms and manual tools by communicating/pairing with the surgical arms and the manual tools. Kilroy does not disclose different communication protocols to communicate with different tools/devices e.g. surgical arms and manual tools.
Kilroy does not disclose the following limitations:
a handheld surgical instrument comprising a surgical instrument processor;
a surgical hub comprising a surgical hub processor; and
signal communication…by way of a first communication protocol and in signal communication…by way of a second communication protocol different than the first communication protocol.
However, Schultz discloses a method of communications with different appliances via a device, wherein the device with display, 100 is communicating/controlling various appliances, 300s and the appliances are not connected with each other. And appliances are different e.g. car, washer etc. So, it is obvious that 100 is using one protocol to communicate with car and another protocol to communicate with washer (see fig 1, where 100 corresponds to hub and 300’s are various appliances. See also [0051], where “Fig. 1 discloses a remote-control system comprising one or more controllers 100 that communicate using a protocol means 2000, 2100, 2200, 2300, 2400, 2500 carried via wireless communications link 200, with one or more devices 300 which according to the teachings of the present invention are self-describing.”; see also [0110]).
Kilroy discloses a surgical system that include a control system for identifying via communication and displaying the status of the robotic tool and manual tool status (see citation above). Schultz discloses a system that communicates with various appliances product by various manufacturer (see citation above). So, it would be obvious to incorporate various communication protocols disclosed by Schultz into control system disclosed by Kilroy for communicating and controlling the surgical tools and the handheld surgical instrument separately.
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kilroy to incorporate the teachings of Schultz by including the above feature, signal communication…by way of a first communication protocol and in signal communication…by way of a second communication protocol different than the first communication protocol, for providing surgeons a wide variety of available instruments during surgical procedure and displaying the status of all kinds of surgical tools (e.g. manual, robotic) developed by different manufacturer.
Kilroy in view of Schultz does not disclose the following limitations:
a handheld surgical instrument comprising a surgical instrument processor; and
a surgical hub comprising a surgical hub processor.
However, Gaster discloses a handheld surgical instrument comprising a surgical instrument processor (see fig 2, where wearable device includes a microcontroller. See also [0042], where “A processor in the wearable device (e.g., microcontroller 110) … may execute one or more algorithms integrated into software on the remote device and/or wearable electronic device.”; see also fig 1B, where 100 is interpreted as handheld device.).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kilroy in view of Schultz to incorporate the teachings of Gaster by including the above feature for sending and receiving information directly from central controller.
Kilroy in view of Schultz does not disclose the following limitation:
a surgical hub comprising a surgical hub processor.
However, Kamen discloses a surgical hub comprising a surgical hub processor (see [0032], where “The hub includes an operating system (which may be embodied as a processor executing software) and a sandbox component (which may be embodied as a processor executing software). The operating system component is configured to access at least one of a hardware resource of the hub and a software resource of the hub.”).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kilroy in view of Schultz and Gaster to incorporate the teachings of Kamen by including the above feature for increasing efficiency during surgical procedure by utilizing available resources and minimizing downtime.
Regarding claim 23 (and similarly 37), Kilroy further discloses a surgical system wherein said handheld surgical instrument is configured to be controlled independent of said robot control system (see [0112], where “FIG. 1A shows the interaction continuum of the hyperdexterous surgical system. The right end of the continuum illustrates physical interactions between the body of the surgeon and the body of the patient. The far-right end of the continuum includes the surgeon moving tissue by hand. The use of a manual tool such as a scalpel is less physically interactive than moving tissue by hand.”; see also claim 5, where “the manual tool are operated independently of each other”; [0309]; manual tools of the surgical system is independent, do not need any additional control system and controlled independently by pressing with fingers (e.g. scalpel).).
Regarding claim 24 (and similarly claim 38), Kilroy further discloses a system wherein said surgical hub is configured to display a location of said handheld surgical instrument relative to the robotic tool on said display (see [0321], where “the control system 400 and/or the visualization components perform real-time 3D reconstruction of the environment both internal and external to the patient 2.”; see also [0122], where “The hyperdexterous surgical system 100 includes a control system and displays 600, 702 which provide the operator with visual cues that aid the surgeon in controlling the operation of the one or more hyperdexterous surgical tools 300 and the manual tools 350.”; see [0135], where “FIGS. 2 and 4 show embodiments of the hyperdexterous surgical arm 200 mounted to a fixture. The various components allow the hyperdexterous surgical arm 200 to be positioned relative to the patient 2.”; see also [0335]; Kilroy discloses a system wherein the current context of surgical apparatus including robotic arms and manual tools are displayed and surgeon is performing the surgery by looking the display screen.).
Regarding claim 25 (and similarly claim 34 and 39), Kilroy further discloses a system wherein said surgical hub is configured to display an operating status of said handheld surgical instrument on said display (see fig 45, where a display image showing the operating status of surgical procedure. That also include manual tools. See also [0115], where “The operator 1 may refer to a display 702 which provides images of the surgery.”; see also [122], where “The hyperdexterous surgical system 100 includes a control system and displays 600, 702 which provide the operator with visual cues that aid the surgeon in controlling the operation of the one or more hyperdexterous surgical tools 300 and the manual tools 350.”; see also fig 40, [0116] and [0321]).
Regarding claim 29, Kilroy in view of Schultz does not disclose claim 29. However, Gaster further discloses a system wherein said surgical hub is configured to send information to said handheld surgical instrument (see [0036], where “the remote device may send a signal to the wearable device to display medical condition findings automatically or semi-automatically determined by the remote device.”; see also fig 1B, where 100 is interpreted as handheld device and 130 is interpreted as hub/remote device.).
Regarding claim 31, Kilroy further discloses a surgical system (see fig 2, where 100 is a surgical system), comprising:
a robotic tool (see fig 2, where 300/200 are robotic tools or surgical arms; see also [0131]);
a robot control system (see fig 2, where 605 is control system for 300/200; see also [0128], where “With continued reference to FIG. 2, the hyperdexterous surgical system 100 can include a user interface subsystem 605. The user interface sub-system 605 can include an input device (e.g., controller 514).”), comprising:
a control console (see fig 2, where 514 is controller for 300/200; controller corresponds to control console. see also [0123], [0128] and [0129]); and
a control unit comprising a robot processor in signal communication with said control console and said robotic tool, wherein said robot processor is configured to receive input signals from said control console and transmit control signals to said robotic tool (see [0122], [0130], [0263], [0258], fig 37 and fig 40);
a handheld surgical instrument configured to operate in plurality of operating states (see [0117], where “the operator 1 can insert the manual tool 350 into a trocar 302 (shown in FIG. 2) supported by the hyperdexterous surgical arm 200. The trocar 302, with the manual tool 350 inserted therein, may be manipulated by hand. The third scenario may be useful when it may be difficult to maneuver the manual tool 350 only with the hands.”), wherein said handheld surgical instrument comprising a sensor (see fig 2, where 350 are manual tools; see also [0255] and [0262]); and
a surgical hub comprising (see fig 34, where control system of a surgical system is shown and 702 is a display; see also fig 36 and 40 where screenshots of displays are shown.), wherein said surgical hub processor is in signal communication with said robot processor by way of a (see fig 34, where robotic tool, 300 is associated/connected with control system, 400 and display, 702 by solid arrow. see also [0263] and [0264]) and in signal communication with said handheld surgical instrument processor by way of a (see fig 34, where manual tool, 350 is associated/connected with control system, 400 and display, 702 by solid arrow. Surgical hub (display) is connecting handheld device (manual tool). In signal communication is interpreted as connecting manual tool with the display. See also [0122] and [0131]. Kilroy teaches connecting/pairing/linking manual/handheld device with display. Display shows the images of manual tool.), and wherein said surgical hub is configured to detect an activated operating state of said handheld surgical instrument (see fig 36, where operator selects a controllable object icon which causes the device to be paired/connected with and control the selected controllable object. See also [0265]) and represent said active operating state on said display along with data from the robot control system (see [0131], where “The display 702 can display information about the one or more hyperdexterous surgical arms 200, the one or more hyperdexterous surgical tools 300, the patient, or any other information that may be relevant to the surgeon or surgical team. The display 702 can show images as seen by a camera 304 (shown schematically in FIG. 35) or other visualization devices, such as images of the hyperdexterous surgical tools 300 that are held by the hyperdexterous surgical arms 200, or images of a manual tool 350 held by the operator (e.g., surgeon).”).
Kilroy discloses a surgical system that comprises a display and configured to display surgical arms and manual tools by communicating/pairing with the surgical arms and the manual tools. Kilroy does not disclose different communication protocols to communicate with different tools/devices e.g. surgical arms and manual tools.
Kilroy does not disclose the following limitations:
a handheld surgical instrument comprises a surgical instrument processor;
a surgical hub comprising a surgical hub processor; and
signal communication…by way of a first communication protocol and in signal communication … by way of a second communication protocol different than the first communication protocol.
However, Schultz further discloses a method of communications with different appliances via a device, wherein the device with display, 100 is communicating/controlling various appliances, 300s and the appliances are not connected with each other. And appliances are different e.g. car, washer etc. So, it is obvious that 100 is using one protocol to communicate with car and another protocol to communicate with washer (see fig 1, where 100 corresponds to hub and 300’s are various appliances. See also [0051] and [0110]).
Kilroy discloses a surgical system that include a control system for identifying via communication and displaying the status of the robotic tool and manual tool status (see citation above). Schultz discloses a system that communicates with various appliances product by various manufacturer (see citation above). So, it would be obvious to incorporate various communication protocols disclosed by Schultz into control system disclosed by Kilroy for communicating and controlling the surgical tools and the handheld surgical instrument separately. Same motivation of claim 21 applies.
Kilroy in view of Schultz does not disclose the following limitations:
a surgical hub comprising a surgical hub processor; and
a handheld surgical instrument comprises a surgical instrument processor.
However, Gaster further discloses a handheld surgical instrument comprises a surgical instrument processor (see fig 2, where wearable device includes a microcontroller. See also [0042]; see also fig 1B, where 100 is interpreted as handheld device.). Same motivation of claim 21 applies.
Kilroy in view of Schultz does not disclose the following limitation:
a surgical hub comprising a surgical hub processor.
However, Kamen further discloses a surgical hub comprising a surgical hub processor (see [0032]). Same motivation of claim 21 applies.
Regarding claim 33, Kilroy further discloses a surgical system wherein said surgical hub is configured to display an orientation of said handheld surgical instrument tool on said display (see [0105], [0122] and [0262]).
Claim(s) 22 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0038981 (“Kilroy”), and in view of US 2012/0021684 (“Schultz”), and in view of US 2016/0157717 (“Gaster”), and in view of US 2013/0191513 (“Kamen”), as applied to claim 21 and 31 above, and further in view of US 9,937,014 (“Bowling”).
Regarding claim 22 (and similarly claim 32), Kilroy in view of Schultz, Gaster and Kamen does not disclose claim 22. However, Bowling discloses a system wherein said handheld surgical instrument comprises a motorized, autonomous surgical instrument (see col 1, lines 64-65, where “The surgical tool autonomously moves along the path in the at least one acceptable orientation.”; see also col 8, lines 5-7, where “The surgical tool 16 is placed in the at least one acceptable orientation 65 when the surgical tool 16 autonomously moves along the path 60.”; Motor is inherently present for autonomous movement.).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kilroy in view of Schultz, Gaster and Kamen to incorporate the teachings of Bowling by including the above feature for preventing movement of the surgical tool into the altered orientation.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0038981 (“Kilroy”), and in view of US 2012/0021684 (“Schultz”), and in view of US 2016/0157717 (“Gaster”), and in view of US 2013/0191513 (“Kamen”), as applied to claim 21 above, and further in view of US 2005/0277913 (“McCary”).
Regarding claim 26, Kilroy in view of Schultz, Gaster and Kamen does not disclose claim 26. However, McCary discloses a surgical system wherein said display comprises a heads-up display (see abstract, where “A heads-up display 12 is connected to each of the surgery-viewing device 10 and the surgical console 74 for displaying at least one of the surgical parameters to a user through the surgery-viewing device 10.”; see also [0012]).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kilroy in view of Schultz, Gaster and Kamen to incorporate the teachings of McCary by including the above feature for allowing the surgeon to be aware of critical surgical parameters while not diverting his gaze or attention away from the surgery site.
Claim(s) 27, 28, 35 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0038981 (“Kilroy”), and in view of US 2012/0021684 (“Schultz”), and in view of US 2016/0157717 (“Gaster”), and in view of US 2013/0191513 (“Kamen”), as applied to claim 21, 31 and 36 above, and further in view of US 9,129,054 (“Nawana”).
Regarding claim 27 (and similarly claim 35 and 40), Kilroy in view of Schultz, Gaster and Kamen does not disclose claim 27. However, Nawana discloses a surgical planning method wherein said surgical hub comprises a situational awareness module configured to recommend a surgical function based on the detection of said handheld surgical instrument relative to a position of said robotic tool (see abstract, where “The system can provide recommendations regarding diagnosis, non-surgical treatment, surgical treatment,”; see also col 9, lines 55-58, where “the operation module can identify an instrument to be used in the actual performance of the selected invasive procedure and provide an indication of a position of the instrument in an instrument tray”; see also col 44, lines 29-31, where “a display screen 66 located at a position easily seen from all or nearly all positions within the OR by a surgeon 68 and medical support personnel 70.”; see also col 46, lines 45-48, where “The data board 83 can include a flat surface that can be tracked for position by the camera 84, and can have selected images displayed on the surface thereof.”; see also col 54, lines 37-42, where “(e.g., the equipment tracking module 230, discussed further below) can be configured to determine an amount of time is takes to position each instrument, register ( e.g., identify and log) the instruments as being present, and/ or to track movement of the registered instruments. The instrument movement can be tracked”; see also col 59, lines 29-33).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kilroy in view of Schultz, Gaster and Kamen to incorporate the teachings of Nawana by including the above feature for the accurate and effective surgical procedure.
Regarding claim 28, Kilroy in view of Schultz, Gaster and Kamen does not disclose claim 28. However, Nawana further discloses a system wherein said surgical hub is configured to detect an electro-magnetic field emitted by said handheld surgical instrument (see col 61, lines 40-53).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kilroy in view of Schultz, Gaster and Kamen to incorporate the teachings of Nawana by including the above feature for automatically tracking the patient positioning, so that complexity of patient processing, reduce chances of surgical instruments being advanced into a patient at an unsafe and/or undesired trajectory can be prevented and the access to surgical site can be improved so that accuracy in diagnosis and effectiveness of treatment can be improved.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0038981 (“Kilroy”), and in view of US 2012/0021684 (“Schultz”), and in view of US 2016/0157717 (“Gaster”), and in view of US 2013/0191513 (“Kamen”), as applied to claim 21 above, and further in view of US 2008/0281301 (“DeBoer”).
Regarding claim 30, Kilroy in view of Schultz, Gaster and Kamen does not disclose claim 30. However, DeBoer discloses a surgical system wherein the handheld surgical instrument is not identifiable by said robot control system (see [0019], where “the present invention is directed to a personal surgical center comprising a portable computer unit in wireless communication with at least one of a plurality of handheld instruments…automatically identifying at least one of the plurality of handheld instruments; wirelessly receiving operation status of the identified handheld instruments; monitoring changes in the operation status of the identified handheld instruments; and displaying the operation status on a display.”; see also [0075], where “In step 1008, the software identifies the instrumentations (e.g. handheld instruments and independent surgical centers) that are active in the surgery room, and generates a list of such instrumentations for monitoring.”; Software that runs independently on a computer (not connected with the robotic tool) identify the handheld instrument. The robot control system is not identifying the handheld instrument.).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kilroy in view of Schultz, Gaster and Kamen to incorporate the teachings of DeBoer by including the above feature for avoiding any confusion during detection by detecting handheld instrument separately (independently) from robotic tool.
Conclusion
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/SOHANA TANJU KHAYER/Primary Examiner, Art Unit 3657