DETAILED ACTION
Remarks
This final office action is in response to the amendments filled on 09/25/2025. Claims 1, 13, 16 and 20 are amended. Claims 1-20 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 .
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) 1, 2, 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and further in view of US 2016/0235492 (“Morard”).
Regarding claim 1 (and similarly claim 20), Hufford discloses a robotic surgical system (see at least fig 1), comprising:
a control console configured to generate a set of actuation instructions (see at least fig 1, where 12 is control console. See also [0010]);
a robotic arm in communication with the control console, the robotic arm being configured to receive the set of actuation instructions generated by the control console, the robotic arm being configured to actuate based on the set of actuation instructions (see at least [0010-12] and fig 1, where 11a, 11b and 11c are robotic arms); and
an instrument configured to selectively attach to the robotic arm such that the robotic arm is configured to actuate the instrument based on the set of actuation instructions (see at least [0009] and fig 1, where 9a, 9b and 9c are surgical instruments attached with robotic arms)
the control console being configured to calculate an external zone of operation for the robotic arm based on patient tracking data (see at least [0016], where 29 is interpreted as external zone of operation. See also fig 1, where robotic arm is positioned above the abdomen of the patient. See also [0026] and [0027]), the patient tracking data indicating a position of at least one external anatomical structure of the patient (see at least [0025], where camera is used for positioning surgical instrument within the patient),
the control console being configured to calculate an instrument zone of operation for at least a portion of the instrument based on at least one of the following:
anatomical data received by the control console (see at least [0029], where the robot arm is controlled based on internal organ/anatomical data. One instrument is grasping the exterior of the uterus. The exterior of the uterus is the zone of operation for the instrument), or
instrument data received by the control console.
Hufford does not disclose the following limitation:
the control console is configured to restrict a location of at least a portion of the robotic arm to be confined within the external zone of operation.
However, Morard discloses a system wherein the control console is configured to restrict a location of at least a portion of the robotic arm to be confined within the external zone of operation (see at least [0012], where “constraining and/or maintaining, by the processor, an orientation of the surgical instrument guide along the planned trajectory as the surgical instrument guide is moved (e.g., by a surgeon; e.g., by a surgeon physically touching a portion of the robotic arm and/or end effector) through an incision to (e.g., adjacent or near) a surface of the vertebra.”; see also [0044], where “maintain a position of the surgical instrument guide as a k-wire (e.g., flexible k-wire) is inserted into the hole in the vertebrae”; see also fig 8, where robotic arm is inserted into a human body by restricting a location confined within the external zone of operation.).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Atarot to incorporate the teachings of Morard by including the above feature for reducing tissue damage during surgical procedure by placing the surgical tool on a defined location and by restricting the movement outside of the defined location.
Regarding claim 2, Hufford further discloses a system the instrument comprising a uterine manipulator, the uterine manipulator comprising a colpotomy cup (see at least [0025], where “The surgical system may be a multi-arm system, with one arm supporting an organ manipulator such as a uterine manipulator”; see also abstract, where “an organ manipulation device such as a uterine manipulator with a colpotomy cup is positionable on a first robotic manipulator”).
Regarding claim 15, Hufford further discloses a system the instrument comprising a shaft, the shaft comprising a proximal linear portion and a distal curved portion (see at least fig 2 and fig 3).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and in view of US 2016/0235492 (“Morard”), as applied to claim 2 above, and further in view of US 2021/0282836 (“Prior”).
Regarding claim 3, Hufford in view of Morard does not disclose claim 3. However, Prior discloses a system wherein the instrument data comprising a size of the colpotomy cup (see at least [0057], where “a size of a diameter of colpotomy cup 730 can be actively adjusted as desired.”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard to incorporate the teachings of Prior by including the above feature for reducing risk of ureteral injury during surgical procedure.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and in view of US 2016/0235492 (“Morard”), as applied to claim 2 above, and further in view of US 2023/0144183 (“Simi”).
Regarding claim 4, Hufford further discloses a system wherein the uterine manipulator comprising an elongated shaft having a distal tip (see at least fig 5A, where the manipulator has elongated shaft and distal tip).
Hufford in view of Morard does not disclose the following limitation:
the instrument data comprising a size of the distal tip of the elongated shaft.
However, Simi discloses a system wherein the instrument data comprising a size of the distal tip of the elongated shaft (see at least [0071], [0088] and [0093]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard to incorporate the teachings of Simi by including the above feature for reducing risk of ureteral injury during surgical procedure.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and in view of US 2016/0235492 (“Morard”), as applied to claim 2 above, and further in view of US 2023/0200816 (“Tsinteris”).
Regarding claim 5, Hufford in view of Morard does not disclose claim 5. However, Prior discloses a system wherein the anatomical data comprising a size of a vaginal canal (see at least [0096], where “the physician can select an appropriately sized cutting head 64 to suit the size of the vaginal cavity VC of the patient P.”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard to incorporate the teachings of Tsinteris by including the above feature for reducing risk of ureteral injury during surgical procedure.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and in view of US 2016/0235492 (“Morard”), as applied to claim 2 above, and in view of US 2023/0200816 (“Tsinteris”), as applied to claim 5 above, and further in view of US 6,544,041 (“Damadian”).
Regarding claim 6, Hufford in view of Morard Tsinteris does not disclose claim 6. However, Damadian discloses a system wherein the control console being configured to receive the anatomical data manually (see at least col 4, lines 37-43, where “the mannequin can be fabricated to provide the desired internal structure and the sizes and shapes of internal organs can be provided…by providing computer data representing the sizes and shapes of the organs manually or from the computer system used to fabricate the mannequin.”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard Tsinteris to incorporate the teachings of Damadian by including the above feature for increasing precision during surgical procedure.
Claim(s) 7, 8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and in view of US 2016/0235492 (“Morard”), as applied to claim 1 above, and further in view of US 2022/0202508 (“Hiranandani”).
Regarding claim 7, Hufford in view of Morard does not disclose claim 7. However, Hiranandani discloses a system wherein the control console being configured to update the instrument zone of operation based on feedback data (see at least [0024], where “these sensors may provide information to a processor (which may be included in surgical robot 104, controller 102, or another device) which uses a feedback loop to continually adjust the location, force, etc. applied by surgical robot 104. In some embodiments, sensors in the arms 106 of surgical robot 104 may be used to determine the position of the arms 106 relative to organs and other anatomical features.”; location is interpreted as zone of operation).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard to incorporate the teachings of Hiranandani by including the above feature for reducing tissue damage and increasing precision during surgical procedure.
Regarding claim 8, Hiranandani further discloses a system wherein the instrument comprising at least one force sensor configured to generate the feedback data (see at least [0024], where “image/optical sensors (e.g., camera 108), pressure sensors (stress, strain, etc.) and the like are all used to control the surgical robot 104 and to ensure accurate motions and applications of pressure.”).
Regarding claim 12, Hufford in view of Morard does not disclose claim 12. However, Hiranandani further discloses a system wherein comprising a visual tracking system in communication with the control console (see at least [0017]), the visual tracking system being configured to track the position of the at least one external anatomical structure of the patient (see at least [0022] and [0024]). Same motivation of claim 7 applies.
Claim(s) 9, 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and in view of US 2016/0235492 (“Morard”), as applied to claim 1 above, and further in view of US 2022/0015840 (“Scheib”).
Regarding claim 9, Hufford in view of Morard does not disclose claim 9. However, Scheib discloses a system wherein the instrument comprising a memory configured to upload the instrument data to the control console wirelessly (see at least [0103], where “the controller can be coupled (e.g., communicatively, electronically, electrically, wirelessly and/or mechanically) with an instrument such that manipulation of the controller causes a corresponding manipulation of the instrument e.g., via master slave control.”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard to incorporate the teachings of Scheib by including the above feature for increasing precision of surgical robot control.
Regarding claim 11, Hufford further discloses a system wherein the control console comprising (see at least fig 1, where control console is shown).
Hufford in view of Morard does not disclose the following limitation:
the control console comprising a control tower.
However, Scheib further discloses a system wherein the control console comprising a control tower (per submitted specification, designated sensor is working as control tower, see at least [0071] of submitted specification. see Scheib at least [0054], where “The tower 112 may also include support equipment for sensors deployed throughout the robotic system 100.”). Same motivation of claim 7 applies.
Regarding claim 14, Hufford in view of Morard does not disclose claim 14. However, Scheib further discloses a system wherein the robotic arm comprising a tool driver configured to longitudinally actuate the instrument (see at least fig 1, where 108 is instrument driver. see also [0120], where “The robotic surgical system may also include a mobile instrument driver comprising an instrument driver carriage translatable along a longitudinal base and operable to drive one or more functions of a mobile surgical tool.”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard to incorporate the teachings of Scheib by including the above feature for increasing precision of surgical robot control while minimizing surgeon fatigue.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and in view of US 2016/0235492 (“Morard”), as applied to claim 1 above, and further in view of US 6,120,433 (“Mizuno”).
Regarding claim 10, Hufford in view of Morard does not disclose claim 10. However, Mizuno discloses a system wherein the instrument comprising a switch configured to interact with the robotic arm in order to generate the instrument data (see at least col 7, lines 28-32, where “The foot switch interface section 11g receives the information generated by operating the foot switch unit 12. The section 11g is a circuit which has the structure illustrated in FIG. 3. With reference to FIG. 3, it will be explained how the section 11g operates.”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard to incorporate the teachings of Mizuno by including the above feature for controlling data generation by using switch.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0080767 (“Hufford”), and in view of US 2016/0235492 (“Morard”), as applied to claim 1 above, and view of US 2022/0202508 (“Hiranandani”), as applied to claim 12 above, and further in view of US 2024/0252179 (“Bell”).
Regarding claim 13, Hufford further discloses a system wherein the visual tracking system being configured to: track the position of the at least one external anatomical structure of the patient (see at least [0009], where camera is tracking operating field.).
Hufford in view of Morard Hiranandani does not disclose the following limitations:
spatially locate at least two fiducial bodies the at least one external anatomical structure of the patient and thereby track the position of the at least one external anatomical structure of the patient, and
communicate fiducial location data to the control console to thereby provide at least a portion of the patient tracking data.
However, Bell discloses a system wherein the visual tracking system being configured to:
spatially locate at least two fiducial bodies the at least one external anatomical structure of the patient and thereby track the position of the at least one external anatomical structure of the patient (see at least [0079], where “The optical tracking system 402 in this example includes a plurality of markers or fiducials 406A-D that allow the surgical computer 150 or other navigation or tracking device within the CASS 100 to determine the position and orientation of the patient anatomy 404.”), and
communicate fiducial location data to the control console to thereby provide at least a portion of the patient tracking data (see at least fig 5).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Hufford in view of Morard Hiranandani to incorporate the teachings of Bell by including the above feature for improving precision and reducing damage of tissue.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0141597 (“Atarot”), and further in view of US 2023/0149114 (“Boese”).
Regarding claim 16, Atarot discloses a method of defining a zone of operation and limiting movement of at least a portion of an instrument within the zone of operation while the instrument is attached to a robotic arm (see at least [0049], where “control system…at least one predetermined set of operative instructions is via a predetermined set of rules, said at least one predetermined set of rules comprising at least one rule selected from a group consisting of…no fly zone rule… restricted movement rule, preferred volume zone rule…said allowed movement being permitted by said controller and said restricted movement being denied by said controller according to said predetermined set of rules.”; preferred volume zone is interpreted as zone of operation restricted movement rule is interpreted as limiting movement of an instrument within the zone. see also fig 1a, where 65 is a robotic arm with end-effector. See also [0057]), the method comprising:
receiving a set of data associated with (see at least [0073], where “said tool-dependent allowed and restricted movement rule comprises a communicable database; said communicable database is configured to store predetermined characteristics of at least one of said at least one surgical tool; said tool-dependent allowed and restricted movement rule is configured to determine said allowed movement and said restricted movement according to said predetermined characteristics; such that said allowed movement is a movement of said endoscope which tracks said at least one of said at least one surgical tool having said predetermined characteristics; said predetermined characteristics of said surgical tool being selected from a group consisting of: physical dimensions, structure, weight, sharpness, and any combination thereof”);
calculating the zone of operation utilizing the set of data (see at least [0119], where “tool dependent allowed and restricted rule”);
receiving instructions which instruct the robotic arm to actuate the portion of the instrument out of the zone of operation (see at least [0284], where movement is allowed when the tool is outside the no-fly zone which is preferred operation zone. see also [0056-58]); and
filtering the received instructions such that the portion of the instrument remains within the zone of operation (see at least [0284], “the no-fly zone rule is configured to define a restricted zone into which no tool…is permitted to enter…the no-fly zone rule is configured to determine a restricted movement if the movement is within the no-fly zone and an allowed movement if the movement is outside the no-fly zone”; see also fig 2).
Atarot does not disclose the following limitation:
receiving a set of data associated with at least one dimension of anatomy which the instrument is to be inserted into.
However, Boese discloses a method wherein receiving a set of data associated with at least one dimension of anatomy which the instrument is to be inserted into (see at least [0259], where “the implant planning system may receive information from the scaled 2D images (e.g., one or more dimensions of the patient anatomy) as an additional input in the prediction model.”; see also [0267] and [0103]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Atarot to incorporate the teachings of Boese by including the above feature for reducing risk of injury during surgical procedure by placing the accurately sized instrument based on the dimension of the anatomy.
Regarding claim 17, Atarot further discloses a method wherein filtering the received instructions comprising ignoring the received instructions such that the instrument does not acuate in response to the received instructions (see at least [0385], where “the system prevents movement 350, but does not command movement (340); in such embodiments, the tool (310) will remain close to the liver (320).”; see also [0412] and [0423]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0141597 (“Atarot”), and in view of US 2023/0149114 (“Boese”), as applied to claim 16 above, and US 2023/0016940 (“Lang”).
Regarding claim 18, Atarot in view of Boese does not disclose claim 18. However, Lang discloses a method wherein filtering the received instructions comprising modifying the received instructions such that the instrument is actuated toward a boundary of the zone of operation (see at least [0041] and [1051]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Atarot in view of Boese to incorporate the teachings of Lang by including the above feature for avoiding unnecessary tissue damage by setting boundary of operation zone.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0141597 (“Atarot”), and in view of US 2023/0149114 (“Boese”), as applied to claim 16 above, and US 2023/0080767 (“Hufford”).
Regarding claim 19, Atarot in view of Boese does not disclose claim 19. However, Hufford further discloses a method wherein the instrument comprising a uterine manipulator, calculating the zone of operation comprising utilizing anatomical data regarding a uterus (see at least [0025], where “The surgical system may be a multi-arm system, with one arm supporting an organ manipulator such as a uterine manipulator”; see also abstract, where “an organ manipulation device such as a uterine manipulator with a colpotomy cup is positionable on a first robotic manipulator”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Atarot in view of Boese to incorporate the teachings of Hufford by including the above feature for providing precise frequently performed surgical procedure e.g., uterus removal.
Response to Arguments
Applicant’s arguments with respect to claim 1-20 have been considered but are moot because the arguments do not apply to the new combination used in the current rejection that is due to the newly added claim amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/SOHANA TANJU KHAYER/ Primary Examiner, Art Unit 3657