DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
1. Applicant's arguments filed 03/27/2026 have been fully considered but they are not persuasive.
The Applicant argues that neither Balicki nor Jaworek teach there being autonomous control of the system, wherein in the autonomous mode of operation, dynamic adjustment of the end effector position is based on sensor feedback and is limited to end effector positions within a pre-defined region within the body cavity. The Examiner respectfully disagrees. The art of Balicki is used to teach a medical device system that wherein the robotic system includes a mode of operation operable to dynamically adjust the end effector position within the patient using the first robotic arm to substantially maintain a target direction and magnitude of forces or torques applied by the end effector (See Par. 0047 and claims 7-9). While Balicki teaches that this operation and control can be done manually, they do not teach where a medical device system can have autonomous control over the positioning of an end effector. Jaworek is relied on instead to teach this. Jaworek teaches that there is a stop sensor that can adjust the position of the end effector within the tissue automatically and can continue to send feedback, thus showing that it is known in medical device systems to have autonomous control over an end effector positioning. The Examiner reiterates that the Jaworek reference is only being used to show that autonomous modes are known/common in similar surgical robots (in general). The combination/modification presented in the below U.S.C. 103 is automating the control algorithm explicitly taught by the primary, i.e. maintaining the force and direction.
The Examiner notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. Further, per the MPEP 2144.04, “The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art”
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.
2. Claim(s) 1-4 and 8 is/are rejected under 35 U.S.C. 103 as being obvious over Balicki (US 20160361125 A1) in view of Jaworek (US 20170007255 A1).
In regards to claim 1, Balicki discloses a medical robotic system (Abstract) comprising:
at least a first robotic arm configured to support a surgical instrument having an end effector (Abstract and Par. 0021 disclose a robotic arm that can hold a surgical instrument. Par. 0043 teaches the instrument has an end effector),
a sensor positioned to determine a magnitude of force or torque applied to tissue of a patient using the instrument (Par. 0019 teaches the arm having a force sensor [114]);
wherein the robotic system includes a mode of operation operable to dynamically adjust the end effector position within the patient using the first robotic arm to substantially maintain a target direction and magnitude of forces or torques applied by the end effector (Par. 0047 teaches a cooperative control algorithm that can guide the arm. Claim 7-9 teach that the control system can also control the forces applied. Claim 7-9 further teach that the force sensor compares the applied force to a pre-determined value in order to maintain that value and makes corrections if it exceeds this value, i.e. it maintains direction and force).
Balicki does not disclose wherein the system is programmed to operate in an autonomous mode, wherein in the autonomous mode of operation, dynamic adjustment of the end effector position is based on sensor feedback and is limited to end effector positions within a pre-defined region within the body cavity.
However, in the same field of endeavor, Jaworek teaches a robotic instrument system that comprises an end effector (Abstract, Par. 0183 and 0327) wherein the system comprises a sensor that can provide feedback to stop or control the movement of the effector, all of this being done automatically via the control system (i.e. not manually by the user), (Par. 0316 and 0327) in order to prevent damage to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Balicki and modified them by having the system operate in an autonomous mode, as taught and suggested by Jaworek, in order to keep the end effector in the aligned position.
In regards to claims 2 and 3, the combined teachings of Balicki and Jaworek teach the system of claim 1, further including at least one input device operable to set the target direction and magnitude and wherein the input device includes a user control input operable to command robotic motion of the robotic arm to position the end effector in contact with tissue and to apply a force or torque to the tissue at a first magnitude and in a first direction, and to instruct the system to set the target direction and target magnitude at the actual magnitude and actual direction (Par. 0061 of Balicki teaches giving user input for the direction and the force/torque).
In regards to claim 4, the combined teachings of Balicki and Jaworek teach the system of claim 2, wherein the first robotic arm includes a manual mode in which the end effector is manually moveable by the hand of a user to position the end effector in contact with tissue and to apply an actual force or torque to the tissue at an actual magnitude, and wherein the system includes a surgeon input operable to instruct the system to set the target magnitude at the actual magnitude (Par. 0043 of Balicki discloses a user can hold and control the end-effector manually).
In regards to claim 8, the combined teachings of Balicki and Jaworek teach the system of claim 1, where the movement allowed by the robotic arm when operating in the mode of operation is bound by operational limits that are controlled by the surgeon (Par. 0034 of Balicki teaches limiting the arms applied forces and movement).
3. Claim(s) 5-7 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balicki and Jaworek in view of Hourtash (US 20140276954 A1)
In regards to claims 5 and 7, the combined teachings of Balicki and Jaworek teach the system of claim 1, where the system includes a user input and a mode of operation for controlling the robotic arm/end effector’s applied force or torque as well as its positions (Par. 0034 and 0061 of Balicki). However, Balicki nor Jaworek disclose where in the is a second robotic arm or wherein at least two or more arms are enabled with the mode of operation, each arm being used to retract tissue, either along a common axis of force or along different axes of force.
On the other hand, in the same field of endeavor, Hourtash teaches a robotic assembly for moving an end effector (Abstract) wherein there are two or more robotic arms with their own controllers/inputs (Par. 0006) and wherein the arms are used to retract tissue (Par. 0043 teaches manipulating tissue with the instruments) in order to move additional surgical instruments, or the like.
Therefore, it would have been obvious to one having ordinary skill in the art to have taken the teachings of Balicki and Jaworek and modified them by having the system comprise two arms that can perform tissue resection, as taught and suggested by Hourtash, in order to move additional surgical instruments, or the like
In regards to claim 6, the combined teachings of Balicki, Jaworek, and Hourtash as applied to claim 5 discloses the system of claim 5, wherein in the mode of operation movement of the second effector mirrors movement of the first end effector relative to a defined plane (Par. 0021 of Hourtash teaches the processor/control can determine the movements of the arms).
In regards to claim 9, Balicki discloses a surgical robotic system (Abstract), comprising:
robotic arm configured for robotic positioning of surgical instruments, respectively, in a body cavity, (Abstract and Par. 0021 disclose a robotic arm that can hold a surgical instrument) the robotic system configured to measure or receive as input direction and value of forces and/or torques applied by an end effector of each surgical instrument in contact with tissue using input from at least one sensor on the corresponding arm (Par. 0019 teaches the arm having a force sensor [114]);
at least one surgeon input device for receiving surgeon input, the robotic system configured to control the first robotic arm based on the surgeon input to apply a first force and/or torque to tissue using the first surgical instrument (Par. 0061 teaches giving user input for the direction and the force/torque);
wherein the system is operable in a force modulation mode in which the robotic system controls the robotic arm to apply a force to the tissue using the surgical instruments, the system configured to determine the direction and magnitude of the second force and/or torque to be applied based on the direction and magnitude of the first force and/or torque (Par. 0047 teaches a cooperative control algorithm that can guide the arm. Claim 7-9 teach that the control system can also control the forces applied).
Balicki does not disclose where in the is a second robotic arm. On the other hand, in the same field of endeavor, Hourtash teaches a robotic assembly for moving an end effector (Abstract) wherein there are two or more robotic arms with their own controllers/inputs (Par. 0006) in order to move additional surgical instruments, or the like.
Therefore, it would have been obvious to one having ordinary skill in the art to have taken the teachings of Balicki and modified them by having the system comprise two arms that can perform tissue resection, as taught and suggested by Hourtash, in order to move additional surgical instruments, or the like.
Balicki and Hourtash do not disclose wherein the system is programmed to operate in an autonomous mode, wherein in the autonomous mode of operation, dynamic adjustment of the end effector position is based on sensor feedback and is limited to end effector positions within a pre-defined region within the body cavity.
However, in the same field of endeavor, Jaworek teaches a robotic instrument system that comprises an end effector (Abstract, Par. 0183 and 0327) wherein the system comprises a sensor that can provide feedback to stop or control the movement of the effector, all of this being done automatically via the control system (i.e. not manually by the user), (Par. 0316 and 0327) in order to prevent damage to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Balicki and Hortash and modified them by having the system operate in an autonomous mode, as taught and suggested by Jaworek, in order to keep the end effector in the aligned position.
In regards to claim 10, the combined teachings of Balicki, Jaworek, and Hourtash as applied to claim 9 discloses the system of claim 9, further including a third robotic arm configured for robotic positioning of a third surgical instrument based on surgeon input using the at least one surgeon input device (Par. 0006 of Hourtash teaches there can be multiple robotic arms).
In regards to claim 11, the combined teachings of Balicki, Jaworek, and Hourtash as applied to claim 9 discloses the system of claim 10, wherein system includes first and second surgeon input devices, the robotic system configured to control the first robotic arm based on surgeon input using the first surgeon input device, and to control the third robotic arm based on surgeon input using the second surgeon input device (Par. 0006 of Hourtash teaches two or more robotic arms with their own controllers/inputs).
4. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balicki, Jaworek, and Hourtash and in further view of Wang (US 20210121258 A1)
In regards to claim 12, the combined teachings of Balicki, Jaworek, and Hourtash as applied to claim 9 discloses the system of claim 11 except for wherein the first and second surgical instruments are traction instruments and the third surgical instrument is an instrument for cutting, separating, or dissecting tissue.
However, in the same field of endeavor, Wang teaches a surgical robotic system (Abstract) wherein there are several robotic arms (Par. 0005) that hold various surgical instruments for traction and cutting (Par. 0004 and 0060) in order to perform particular surgical procedures.
Therefore, it would have been obvious to one having ordinary skill in the art to have taken the teachings of Balicki, Jaworek, and Hourtash and modified them by having the system comprise surgical instruments for traction and cutting, as taught and suggested by Wang, in order to perform particular surgical procedures.
Conclusion
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.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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