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 Amendment
The amendment filed on 10/22/2025 has been entered. Claims 1-13, 15, and 17-21 remain pending, claims 1-10 are withdrawn.
Response to Arguments
Applicant's arguments filed on 10/22/2025 have been fully considered but they are not persuasive or are moot.
Applicant argues on pages 11-15 that the previously cited art does not disclose the newly added limitations to the claims related to vibration frequency at 125-175 Hz. The Examiner respectfully disagrees. In the new grounds of rejection necessitate by amendment Stulen discloses an overlapping range of frequencies (Stulen, Para 96; "A suitable vibrational frequency range may be about 20 Hz to 32 kHz and a well-suited vibrational frequency range may be about 30-10 kHz."). Accordingly, this argument is not persuasive.
Applicant argues on pages 12-13 that there is no motivation to modify Von Allmen with Stulen. The Examiner respectfully disagrees. A motivation to combine was provided in the previous rejection and the rejection below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-13, 15, 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Von Allmen et al. (US20170188990, hereafter Von Allmen) in view of Stulen (US20140005667, hereafter Stulen).
Regarding claim 11, Von Allmen discloses a method for automatically inserting a penetrating member into tissue or a body cavity(Von Allmen, Para 112; “The needle assembly 30 illustratively includes a syringe 76 and a needle 78.”) (Von Allmen, Para 9; "introduces a needle tip into a target lesion or vessel autonomously thus improving the success rate and reducing the time, cost and experience necessary to achieve vascular access.") (Von Allmen, Para 54; “With reference initially to FIG. 1, an illustrative image guided autonomous needle insertion system 10”) (Von Allmen, Para 81; “The shortest path to the target vein 60 will ensure that most of the needle 78 is located inside the tissue”), the method comprising:
providing a device having a detector and an extension actuator (Von Allmen, “Para 87; “Illustratively, the system 10: 1) incorporates an appropriate ultrasound imaging probe 26 with the mechanical guidance mechanism to provide consistent registration of the ultrasound image with the coordinates of the robotic guidance, 2) includes interface software to transfer the information from the targeting imaging to the guidance system, and 3) defines an optimal human machine interface 22.”) (Von Allmen, Para 149; “The target position is sent to the path planner 36 which searches for the optimal needle trajectory and sends the information to the control unit. First, the control unit sets the dispenser to the pre-defined insertion angle. Then the linear motor 104 is activated and the needle 78 inserted. As the motor 84 of the dispenser and control unit 16 rotates the needle 78 toward the target vein 60, the needle target 456 moves toward the borders 452 and 454 as shown in FIG. 31. FIG. 32 shows the needle target 456 aligned with the borders 452 and 454, where the cross-hair 458 is positioned within the inner border 452 of the target vein 60.”);
determining a target site within the tissue or the body cavity for the penetrating member to be inserted; obtaining imaging data of the target site with the detector (Von Allmen, Para 84; “The position is found by either the operator setting the target manually with the joystick 56 or by confirming the vein or organ detection provided by the image processor 34.”);
determining targeting information of at least an insertion distance for the penetrating member to reach the determined target site based on the image data (Von Allmen, Para 84; “Once the position is confirmed by the operator, the coordinates of the target vein 60 relative to the ultrasound probe 26 are extracted from the ultrasound image 33.”) (Von Allmen, Para 77 Table; showing a calculated penetration parameter z);
providing operative instructions of an insertion speed and distance to the extension actuator based on the target information (Von Allmen, Para 57; “The path planner 36 searches for an optimal trajectory of the needle assembly 30, follows execution (e.g., movement of the needle assembly 30), and provides real time adaptation if necessary.”) (Von Allmen, Para 77 Table; showing calculated x, y, z parameters, insertion speed, rotation angle, and showing a calculated penetration parameter z) (Von Allmen, Para 76; “The path or trajectory of the needle 78 is estimated by the path planner 36 which sends the required path coordinates and speed.”); and
activating the extension actuator to initiate insertion of the penetrating member into the tissue or the body cavity according to the operative instructions (Von Allmen, Para 57; “The path planner 36 searches for an optimal trajectory of the needle assembly 30, follows execution (e.g., movement of the needle assembly 30), and provides real time adaptation if necessary.”) (Von Allmen, Para 149; “The target position is sent to the path planner 36 which searches for the optimal needle trajectory and sends the information to the control unit. First, the control unit sets the dispenser to the pre-defined insertion angle. Then the linear motor 104 is activated and the needle 78 inserted. As the motor 84 of the dispenser and control unit 16 rotates the needle 78 toward the target vein 60, the needle target 456 moves toward the borders 452 and 454 as shown in FIG. 31. FIG. 32 shows the needle target 456 aligned with the borders 452 and 454, where the cross-hair 458 is positioned within the inner border 452 of the target vein 60.”).
Von Allmen does not disclose providing the device a vibrational actuator; providing operative instructions of vibrational parameters to the vibrational actuator based on the targeting information; activating the vibration actuator to initiate vibration according to the operative instructions; detecting a vibrational load on the vibrational actuator and an insertion load on the extension actuator; comparing the detected vibrational load to a predetermined vibrational value and the detected insertion load to a predetermined extension value; and adjusting the insertion speed of the extension actuator when the detected vibrational load deviates from the predetermined vibrational value and adjusting the vibration of the vibrational actuator when the detected insertion load deviates from the predetermined extension value.
In an analogous automatic surgical instrument field of endeavor Stulen discloses providing a device a vibrational actuator (Stulen, Para 170; “the control logic 726 may provide a control signal to the motor control logic 712 to adjust the speed of the motor 714. As another example, the control logic 726 may be coupled to a generator to control an ultrasonic or radiofrequency signal generated by the generator and applied to the electrosurgical end effector 722”) (Stulen, Para 71; “In ultrasonic operation mode, the electrical signal supplied to the acoustic assembly may cause the distal end of the end effector 18, to vibrate longitudinally in the range of, for example, approximately 20 kHz to 250 kHz. According to various embodiments, the blade 22 may vibrate in the range of about 54 kHz to 56 kHz, for example, at about 55.5 kHz. In other embodiments, the blade 22 may vibrate at other frequencies including, for example, about 31 kHz or about 80 kHz. The excursion of the vibrations at the blade can be controlled by, for example, controlling the amplitude of the electrical signal applied to the transducer assembly of the acoustic assembly by the generator 20”);
providing operative instructions of vibrational parameters to the vibrational actuator based on the targeting information; activating the vibration actuator to initiate vibration according to the operative instructions (Stulen, Para 181; “By modulating the drive control signal 716, the control logic 726 may ensure proper treatment of the target tissue 707 by increasing or decreasing the speed of the blade 724 to allow a longer or shorter application of energy to the target tissue 707”), wherein vibration is produced at a frequency of 125-175 Hz (Stulen, Para 96; "A suitable vibrational frequency range may be about 20 Hz to 32 kHz and a well-suited vibrational frequency range may be about 30-10 kHz. A suitable operational");
detecting a vibrational load (first feedback signal 710) on the vibrational actuator (Stulen, Para 179; “The feedback signal 710 may be used to calculate the rate of change of impedance of the target tissue 707 during the treatment process. […] the feedback signal 710 […] indicative of one or more characteristics of the electrosurgical end effector 722 […] The feedback signal 710 provides a measurement of the one or more characteristics to the control logic 726, which may then calculate the impedance at the site of the target tissue 707.”) and an insertion load (second feedback signal 710’) on the extension actuator (Stulen, Para 180; “a second feedback signal 710′ may be provided by the motor control logic 712 to the control logic 726. The motor 714 may be configured to provide a signal indicating load on the motor 714 during movement of the blade 724”) (Stulen, Para 168; “The blade 724 may be driven by a motor 714. The motor 714 is connected to a motor control logic 712, which may vary the speed of the motor 714 [...] the blade 724 is advanced by the motor 714”);
comparing the detected vibrational load to a predetermined vibrational value and the detected insertion load to a predetermined extension value (Stulen, Para 178-180; “The change in impedance, either gradual or sudden, may be monitored by the control logic 726 which may modulate one or more electrosurgical signals to maintain the rate of change of impedance at a predetermined level or within a predetermined range. The term modulation is intended to cover any suitable form of signal modulation, such as, for example, amplitude modulation, frequency modulation, phase modulation, or any combination thereof without limitation. […] ”); and
adjusting the insertion speed of the extension actuator when the detected vibrational load deviates from the predetermined vibrational value (Stulen, Para 181; “the electrosurgical instrument 700 may be configured to control the movement speed of the blade 724 in response to the first and second feedback signals 710, 710', alone or in combination”); and adjusting the vibration of the vibrational actuator when the detected insertion load deviates from the predetermined extension value (Stulen, Para 59; “The electrosurgical signal may be modified by the control logic to maintain a rate of increase of impedance of the target tissue at a predetermined rate or within a predetermined range”) (Stulen, Para 180; “The motor 714 may be configured to provide a signal indicating load on the motor 714 during movement of the blade 724. [...] The motor control circuit 712 may monitor the load on the motor 714 and generate the second feedback signal 710' indicative of the load. The second feedback signal 710' may be applied to the control logic 726 which may alter one or more electrosurgical signals 708 in response to the second feedback signal 710' generated by the motor control logic 712”) (Stulen, Para 175; “control logic 726 may maintain a rate of increase of the impedance by varying the speed of the motor 714. The control logic 726 may provide a control signal to the motor control logic 712. The motor control logic 712 may vary the output signal to the motor 714 to increase or decrease the longitudinal speed of the blade 724 to ensure proper cutting and sealing of the target tissue 707. The motor control logic 712 may be any suitable motor controller, such as, for example, an adjustable-speed driver or an intelligent motor controller. An adjustable-speed driver is a control circuit that may vary the output voltage or current to the motor resulting in the motor running at faster or slower speeds, proportional to the voltage. An intelligent motor controller is a logic circuit which may control the voltage, current, or other output to the motor to increase or decrease the longitudinal speed”) (Stulen, Para 185; “At time ‘B,’ the blade speed 816 is increased in response to a decrease in the impedance of the target tissue 707 indicated by the change in the tissue impedance feedback signal”) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen to include providing a device a vibrational actuator; providing operative instructions of vibrational parameters to the vibrational actuator based on the targeting information; activating the vibration actuator to initiate vibration according to the operative instructions, wherein vibration is produced at a frequency of 125-175 Hz; detecting a vibrational load on the vibrational actuator and an insertion load on the extension actuator; comparing the detected vibrational load to a predetermined vibrational value and the detected insertion load to a predetermined extension value; and adjusting the insertion speed of the extension actuator when the detected vibrational load deviates from the predetermined vibrational value and adjusting the vibration of the vibrational actuator when the detected insertion load deviates from the predetermined extension value in order to maintain the appropriate parameters as needed for treatment of the tissue in a more efficient, accurate, and easy way as taught by Stulen (Stulen, Para 7-16).
Regarding claim 12, Von Allmen as modified by Stulen above discloses all of the limitations of claim 11 as discussed above.
Von Allmen does not clearly and explicitly disclose wherein adjusting the insertion speed further comprises one of: (a) decreasing the insertion speed when the detected vibrational load on the vibrational actuator increases above the predetermined vibration value, and (b) increasing the insertion speed when the detected vibrational load on the vibrational actuator decreases below the predetermined vibrational value.
However, Stulen further discloses wherein adjusting an insertion speed further comprises one of: (a) decreasing the insertion speed when a detected vibrational load on the vibrational actuator increases above a predetermined vibrational value, and (b) increasing the insertion speed when the detected vibrational load on the vibrational actuator decreases below the predetermined vibration value (Stulen, Para 175; “he control logic 726 may maintain a rate of increase of the impedance by varying the speed of the motor 714. The control logic 726 may provide a control signal to the motor control logic 712. The motor control logic 712 may vary the output signal to the motor 714 to increase or decrease the longitudinal speed of the blade 724 to ensure proper cutting and sealing of the target tissue 707. The motor control logic 712 may be any suitable motor controller, such as, for example, an adjustable-speed driver or an intelligent motor controller. An adjustable-speed driver is a control circuit that may vary the output voltage or current to the motor resulting in the motor running at faster or slower speeds, proportional to the voltage. An intelligent motor controller is a logic circuit which may control the voltage, current, or other output to the motor to increase or decrease the longitudinal speed”) (Stulen, Para 185; “At time ‘B,’ the blade speed 816 is increased in response to a decrease in the impedance of the target tissue 707 indicated by the change in the tissue impedance feedback signal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen as modified by Stulen above wherein adjusting the insertion speed further comprises one of: (a) decreasing the insertion speed when the detected vibrational load on the vibrational actuator increases above the predetermined vibration value, and (b) increasing the insertion speed when the detected vibrational load on the vibrational actuator decreases below the predetermined vibrational value in order to maintain the appropriate parameters as needed for treatment of the tissue as taught by Stulen (Stulen, Para 11-16).
Regarding claim 13, Von Allmen as modified by Stulen above discloses all of the limitations of claim 12 as discussed above.
Von Allmen does not clearly and explicitly disclose wherein the predetermined vibrational value is at least one of a percentage amount of amplitude and a percentage amount of power consumption of the vibrational actuator.
However, Stulen further discloses wherein a predetermined vibrational value is at least one of a percentage amount of amplitude and a percentage amount of power consumption of a vibrational actuator (Stulen, Para 181; “the electrosurgical instrument 700 may be configured to control the movement speed of the blade 724 in response to the first and second feedback signals 710, 710′, alone or in combination. For example, the control logic 726 may modulate a drive control signal 716 applied to the motor control logic 712 to adjust the speed of the motor 714. The drive control signal 716 may be modulated in any suitable manner. For example, the voltage and/or current of the drive control signal 716 may be modulated. In various embodiments, modulation may be based on amplitude, frequency, phase, or any combination thereof, based on voltage and current measurements”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen as modified by Stulen above wherein the predetermined vibrational value is at least one of a percentage amount of amplitude and a percentage amount of power consumption of the vibrational actuator in order to maintain the appropriate parameters as needed for treatment of the tissue as taught by Stulen (Stulen, Para 11-16).
Regarding claim 15, Von Allmen as modified by Stulen above discloses all of the limitations of claim 11 as discussed above.
Von Allmen does not clearly and explicitly disclose wherein adjusting the vibration further comprises one of: (a) increasing one of power, amplitude and frequency of the vibrational actuator when the detected insertion load on the extension actuator decreases below the predetermined extension value, and (b) decreasing one of the power, amplitude and frequency of the vibrational actuator when the detected insertion load on the extension actuator increases above the predetermined extension value.
However, Stulen further discloses wherein adjusting vibration further comprises one of: (a) increasing one of power, amplitude and frequency of an vibrational actuator when a detected insertion load on an extension actuator decreases below a predetermined extension value, and (b) decreasing one of the power, amplitude and frequency of the vibrational actuator when the detected insertion load on the extension actuator increases above the predetermined extension value (Stulen, Para 185; “As shown in the illustrated embodiment, the electrosurgical energy signal 808 is modulated over the time period from ‘B’ to ‘C’ to increase or decrease the pulse width or pulse time of the applied electrosurgical energy signal 808 to maintain the rate of change of the tissue 707 impedance at a predetermined rate”) (Stulen, Para 175; “control logic 726 may maintain a rate of increase of the impedance by varying the speed of the motor 714. The control logic 726 may provide a control signal to the motor control logic 712. The motor control logic 712 may vary the output signal to the motor 714 to increase or decrease the longitudinal speed of the blade 724 to ensure proper cutting and sealing of the target tissue 707. The motor control logic 712 may be any suitable motor controller, such as, for example, an adjustable-speed driver or an intelligent motor controller. An adjustable-speed driver is a control circuit that may vary the output voltage or current to the motor resulting in the motor running at faster or slower speeds, proportional to the voltage. An intelligent motor controller is a logic circuit which may control the voltage, current, or other output to the motor to increase or decrease the longitudinal speed”) (Stulen, Para 70; “a second feedback loop in the control system 25 maintains the electrical current supplied to the acoustic assembly at a pre-selected constant level in order to achieve substantially constant excursion at the end effector 18 of the acoustic assembly”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen as modified by Stulen above discloses all of the limitations of claim 11 as discussed above wherein adjusting the vibration further comprises one of: (a) increasing one of power, amplitude and frequency of the vibrational actuator when the detected insertion load on the extension actuator decreases below the predetermined extension value, and (b) decreasing one of the power, amplitude and frequency of the vibrational actuator when the detected insertion load on the extension actuator increases above the predetermined extension value in order to maintain the appropriate parameters as needed for treatment of the tissue as taught by Stulen (Stulen, Para 11-16).
Regarding claim 17, Von Allmen as modified by Stulen above discloses all of the limitations of claim 11 as discussed above.
Von Allmen does not clearly and explicitly disclose monitoring the vibrational load on the vibrational actuator and the insertion load on the extension actuator by iterative detection, and wherein comparing the detected vibrational and insertion loads to the predetermined vibrational and extension values respectively occurs with each iterative detection
However, Stulen further discloses monitoring a vibrational load on a vibrational actuator and an insertion load on an extension actuator by iterative detection, and wherein comparing a detected vibrational and insertion loads to predetermined vibrational and extension values respectively occurs with each iterative detection (Stulen, Para 174-185; describing that the monitoring is done using feedback loops, which a person having ordinary skill in the art would understand to be iterative).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen as modified by Stulen above to include monitoring the vibrational load on the vibrational actuator and the insertion load on the extension actuator by iterative detection, and wherein comparing the detected vibrational and insertion loads to the predetermined vibrational and extension values respectively occurs with each iterative detection
Regarding claim 21, Von Allmen discloses a method for advancing a vibrating penetrating member into tissue or a body cavity (Von Allmen, Para 112; “The needle assembly 30 illustratively includes a syringe 76 and a needle 78.”) (Von Allmen, Para 9; "introduces a needle tip into a target lesion or vessel autonomously thus improving the success rate and reducing the time, cost and experience necessary to achieve vascular access.") (Von Allmen, Para 54; “With reference initially to FIG. 1, an illustrative image guided autonomous needle insertion system 10”) (Von Allmen, Para 81; “The shortest path to the target vein 60 will ensure that most of the needle 78 is located inside the tissue”), the method comprising:
determining a target site within the tissue or the body cavity for the penetrating member to be advanced into; obtaining data representative of the target site within the tissue or the body cavity (Von Allmen, Para 84; “The position is found by either the operator setting the target manually with the joystick 56 or by confirming the vein or organ detection provided by the image processor 34.”);
calculating a distance between a distal end of the penetrating member to the target site within the tissue or the body cavity (Von Allmen, Para 84; “Once the position is confirmed by the operator, the coordinates of the target vein 60 relative to the ultrasound probe 26 are extracted from the ultrasound image 33.”) (Von Allmen, Para 77 Table; showing a calculated penetration parameter z);
distally advancing the penetrating member to the target site within the tissue or the body cavity (Von Allmen, Para 57; “The path planner 36 searches for an optimal trajectory of the needle assembly 30, follows execution (e.g., movement of the needle assembly 30), and provides real time adaptation if necessary.”) (Von Allmen, Para 77 Table; showing calculated x, y, z parameters, insertion speed, rotation angle, and showing a calculated penetration parameter z) (Von Allmen, Para 76; “The path or trajectory of the needle 78 is estimated by the path planner 36 which sends the required path coordinates and speed.”) (Von Allmen, Para 149; “The target position is sent to the path planner 36 which searches for the optimal needle trajectory and sends the information to the control unit. First, the control unit sets the dispenser to the pre-defined insertion angle. Then the linear motor 104 is activated and the needle 78 inserted. As the motor 84 of the dispenser and control unit 16 rotates the needle 78 toward the target vein 60, the needle target 456 moves toward the borders 452 and 454 as shown in FIG. 31. FIG. 32 shows the needle target 456 aligned with the borders 452 and 454, where the cross-hair 458 is positioned within the inner border 452 of the target vein 60.”).
Von Allmen does not disclose vibrating the penetrating member at a frequency of 125-175 Hz; detecting a vibrational load on a vibrational actuator being used to vibrate the penetrating member while the penetrating member is distally advancing to the target site; detecting an insertion load on an extension actuator being used to distally advance the penetrating member to the target site; comparing the detected vibrational load to a predetermined vibrational value and the detected insertion load to a predetermined extension value; and adjusting an insertion speed of the extension actuator when the detected vibrational load deviates from the predetermined vibrational value and adjusting the vibration of the vibrational actuator when the detected insertion load deviates from the predetermined extension value.
In an analogous automatic surgical instrument field of endeavor Stulen discloses vibrating a penetrating member (Stulen, Para 170; “the control logic 726 may provide a control signal to the motor control logic 712 to adjust the speed of the motor 714. As another example, the control logic 726 may be coupled to a generator to control an ultrasonic or radiofrequency signal generated by the generator and applied to the electrosurgical end effector 722”) (Stulen, Para 71; “In ultrasonic operation mode, the electrical signal supplied to the acoustic assembly may cause the distal end of the end effector 18, to vibrate longitudinally in the range of, for example, approximately 20 kHz to 250 kHz. According to various embodiments, the blade 22 may vibrate in the range of about 54 kHz to 56 kHz, for example, at about 55.5 kHz. In other embodiments, the blade 22 may vibrate at other frequencies including, for example, about 31 kHz or about 80 kHz. The excursion of the vibrations at the blade can be controlled by, for example, controlling the amplitude of the electrical signal applied to the transducer assembly of the acoustic assembly by the generator 20”) (Stulen, Para 181; “By modulating the drive control signal 716, the control logic 726 may ensure proper treatment of the target tissue 707 by increasing or decreasing the speed of the blade 724 to allow a longer or shorter application of energy to the target tissue 707”) at a frequency of 125-175 Hz (Stulen, Para 96; "A suitable vibrational frequency range may be about 20 Hz to 32 kHz and a well-suited vibrational frequency range may be about 30-10 kHz. A suitable operational");
detecting a vibrational load (first feedback signal 710) on a vibrational actuator being used to vibrate the penetrating member while the penetrating member is distally advancing to the target site (Stulen, Para 179; “The feedback signal 710 may be used to calculate the rate of change of impedance of the target tissue 707 during the treatment process. […] the feedback signal 710 […] indicative of one or more characteristics of the electrosurgical end effector 722 […] The feedback signal 710 provides a measurement of the one or more characteristics to the control logic 726, which may then calculate the impedance at the site of the target tissue 707.”) and an insertion load (second feedback signal 710’) on the extension actuator being used to distally advance the penetrating member to the target site (Stulen, Para 180; “a second feedback signal 710′ may be provided by the motor control logic 712 to the control logic 726. The motor 714 may be configured to provide a signal indicating load on the motor 714 during movement of the blade 724”) (Stulen, Para 168; “The blade 724 may be driven by a motor 714. The motor 714 is connected to a motor control logic 712, which may vary the speed of the motor 714 [...] the blade 724 is advanced by the motor 714”);
comparing the detected vibrational load to a predetermined vibrational value and the detected insertion load to a predetermined extension value (Stulen, Para 178-180; “The change in impedance, either gradual or sudden, may be monitored by the control logic 726 which may modulate one or more electrosurgical signals to maintain the rate of change of impedance at a predetermined level or within a predetermined range. The term modulation is intended to cover any suitable form of signal modulation, such as, for example, amplitude modulation, frequency modulation, phase modulation, or any combination thereof without limitation. […] ”); and
adjusting an insertion speed of the extension actuator when the detected vibrational load deviates from the predetermined vibrational value (Stulen, Para 181; “the electrosurgical instrument 700 may be configured to control the movement speed of the blade 724 in response to the first and second feedback signals 710, 710', alone or in combination”); and adjusting a vibration of the vibrational actuator when the detected insertion load deviates from the predetermined extension value (Stulen, Para 59; “The electrosurgical signal may be modified by the control logic to maintain a rate of increase of impedance of the target tissue at a predetermined rate or within a predetermined range”) (Stulen, Para 180; “The motor 714 may be configured to provide a signal indicating load on the motor 714 during movement of the blade 724. [...] The motor control circuit 712 may monitor the load on the motor 714 and generate the second feedback signal 710' indicative of the load. The second feedback signal 710' may be applied to the control logic 726 which may alter one or more electrosurgical signals 708 in response to the second feedback signal 710' generated by the motor control logic 712”) (Stulen, Para 175; “control logic 726 may maintain a rate of increase of the impedance by varying the speed of the motor 714. The control logic 726 may provide a control signal to the motor control logic 712. The motor control logic 712 may vary the output signal to the motor 714 to increase or decrease the longitudinal speed of the blade 724 to ensure proper cutting and sealing of the target tissue 707. The motor control logic 712 may be any suitable motor controller, such as, for example, an adjustable-speed driver or an intelligent motor controller. An adjustable-speed driver is a control circuit that may vary the output voltage or current to the motor resulting in the motor running at faster or slower speeds, proportional to the voltage. An intelligent motor controller is a logic circuit which may control the voltage, current, or other output to the motor to increase or decrease the longitudinal speed”) (Stulen, Para 185; “At time ‘B,’ the blade speed 816 is increased in response to a decrease in the impedance of the target tissue 707 indicated by the change in the tissue impedance feedback signal”) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen to include vibrating the penetrating member at a frequency of 125-175 Hz; detecting a vibrational load on a vibrational actuator being used to vibrate the penetrating member while the penetrating member is distally advancing to the target site; detecting an insertion load on an extension actuator being used to distally advance the penetrating member to the target site; comparing the detected vibrational load to a predetermined vibrational value and the detected insertion load to a predetermined extension value; and adjusting an insertion speed of the extension actuator when the detected vibrational load deviates from the predetermined vibrational value and adjusting the vibration of the vibrational actuator when the detected insertion load deviates from the predetermined extension value in order to maintain the appropriate parameters as needed for treatment of the tissue in a more efficient, accurate, and easy way as taught by Stulen (Stulen, Para 7-16).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Von Allmen and Stulen as applied to claim 11 above, and further in view of Bouvier et al. (US20080031413, hereafter Bouvier).
Regarding claim 18, Von Allmen as modified by Stulen above discloses all of the limitations of claim 11 as discussed above.
Von Allmen as modified by Stulen above further discloses stopping the insertion of the penetrating member when the penetrating member traverses the insertion distance to reach the determined target site (Von Allmen, Para 84; “Once the position is confirmed by the operator, the coordinates of the target vein 60 relative to the ultrasound probe 26 are extracted from the ultrasound image 33.”) (Von Allmen, Para 77 Table; showing a calculated penetration parameter z) (Von Allmen, Para 57; “The path planner 36 searches for an optimal trajectory of the needle assembly 30, follows execution (e.g., movement of the needle assembly 30), and provides real time adaptation if necessary.”) (Von Allmen, Para 149; “The target position is sent to the path planner 36 which searches for the optimal needle trajectory and sends the information to the control unit. First, the control unit sets the dispenser to the pre-defined insertion angle. Then the linear motor 104 is activated and the needle 78 inserted. As the motor 84 of the dispenser and control unit 16 rotates the needle 78 toward the target vein 60, the needle target 456 moves toward the borders 452 and 454 as shown in FIG. 31. FIG. 32 shows the needle target 456 aligned with the borders 452 and 454, where the cross-hair 458 is positioned within the inner border 452 of the target vein 60.”).
Von Allmen is interpreted as disclosing this limitation in the claim because a person having ordinary skill in the art would understand that to have a needle arrive the target point the actuators would have stopped to prevent the needle from bypassing the target point hence the penetration distance z discussed in Von Allmen.
Von Allmen does not clearly and explicitly disclose stopping insertion of the penetrating member when detecting contact with a surface of the tissue by a component of the device other than the penetrating member.
In an analogous automatically moving medical device field of endeavor Bouvier discloses stopping a device when detecting unwanted contact with a surface of the tissue by a component of a device (Bouvier, Para 12; “This anti-collision system stops the motion of the moving parts of the apparatus in the event of contact with the real patient.”) (Bouvier, Para 131; “The images thus obtained are interpreted by the specialist practitioner in order to perform a diagnosis or as an aid in the performance of surgical operations”, In Bouvier the movement is stopped when the x-ray machine hits the patient but not when a device meant to contact the patient for surgery, such as a knife contacts the patient)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen as modified by Stulen above to include stopping insertion of the penetrating member when detecting contact with a surface of the tissue or the body cavity by a component of the device other than the penetrating member in order to reduce risk of injury to the patient as taught by Bouvier (Bouvier, Para 12-19).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Von Allmen and Stulen as applied to claim 11 above, and further in view of Ransbury et al. (US20140221968, hereafter Ransbury).
Regarding claim 19, Von Allmen as modified by Stulen above discloses all of the limitations of claim 11 as discussed above.
Von Allmen as modified by Stulen above does not disclose inserting a guidewire through the penetrating member once the determined target site is reached.
In an analogous surgical device field of endeavor Ransbury discloses inserting a guidewire through a penetrating member once a target site is reached (Ransbury, Para 12; “The physician feeds the guidewire through the opening of the needle and then pulls the needle out of the patient over the wire, leaving it in place for the insertion of an introducer sheath or central line for indefinite vascular access”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen as modified by Stulen above to include inserting a guidewire through the penetrating member once the target site is reached in order to allow for indefinite access to the determined target site as needed by the physician as taught by Ransbury (Ransbury, Para 12).
Regarding claim 20, Von Allmen as modified by Stulen above discloses all of the limitations of claim 11 as discussed above.
Von Allmen as modified by Stulen above does not disclose disconnecting the penetrating member from the device.
In an analogous surgical device field of endeavor Ransbury discloses disconnecting a penetrating member (Ransbury, Para 12; “The physician feeds the guidewire through the opening of the needle and then pulls the needle out of the patient over the wire, leaving it in place for the insertion of an introducer sheath or central line for indefinite vascular access”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Von Allmen as modified by Stulen above to include disconnecting the penetrating member from the device in order to allow for indefinite access to the target site as needed as taught by Ransbury (Ransbury, Para 12).
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 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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/JOHN D LI/Primary Examiner, Art Unit 3798