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
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, noting that the claims have been amended to include additional limitations.
Claim Objections
Claim 72 is objected to because of the following informalities: in line 9, “the locally control loop” should read “the locally closed control loop” for consistency with line 8 of the claim. Appropriate correction is required.
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) 55-63, 65-66 and 72-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanof et al. (US 2003/0097060) in view of Simaan et al. (US 2013/0090763) and Harris (US 2012/0190981). Yanof discloses a medical puncture system comprising a controllable manipulator (200) configured to support a puncture device (needle 210; fig. 2), the puncture device configured to create a puncture through patient tissue and into an internal patient cavity to enable an end effector of a medical tool to be inserted through the puncture into the cavity (note: the prior art manipulator must only be capable of supporting a puncture device that enables an end effector of a medical tool to be inserted through the puncture since this is a recitation of intended use and the medical tool is not positively recited as part of the claimed medical puncture system), wherein the controllable manipulator comprises one or more joints ([0034]), the one or more joints disposed between links of the controllable manipulator supporting the puncture device, enabling movement of the links relative to one another resulting in an updating of a kinematic configuration of the controllable manipulator supporting the puncture device ([0034]), a sensor (230; fig. 3), a drive system (drive signal and robot controller 700; fig. 6 and abstract) configured to drive the one or more joints of the controllable manipulator and a controller (800/400; fig. 6) operably coupled to the sensor and the drive system, the controller configurated to: when the puncture device is supported by the controllable manipulator, operate the drive system based on at least one signal generated by the sensor as the puncture device is moved through the patient tissue into the cavity, to cause the controllable manipulator to guide creation of the puncture by the puncture device, the at least one signal being indicative of motion of the puncture device from a first layer of the patient tissue to a second layer of the patient tissue, or indicative of the motion of the puncture device from the patient tissue into the cavity (see [0052]). The controllable manipulator of Yanof is configured to support a medical tool insertable into the cavity through the puncture created by the puncture device, and the controller is configured to, when the medical tool is supported by the manipulator, operate the drive system to cause the controllable manipulator to control movement of the medical tool. It is noted that the medical tool is not positively recited as part of the medical puncture system. Because the puncture device (biopsy needle 210; see fig. 2) of Yanof can be retracted from the patient via the controllable manipulator after forming the puncture, thereafter removed from the gripper (220) of the manipulator, and a medical tool can be coupled to the gripper of the manipulator and inserted into the cavity by the manipulator along the same path as the puncture device followed, it meets this functional recitation (see [0035], noting gripper 220 has opposing portions 222a, 222b which are selectively advanced toward or away from one another to selectively hold and release needle or other instrument positioned between holding members 224).
Yanof does not expressly disclose that the sensor is configured to generate signals indicative of a parameter sensed at a joint of the one or more joints, and instead discloses that the sensor is placed on a distal element of the controllable manipulator.
Simaan discloses another controllable manipulator configured to support a surgical device, the manipulator comprising one or more joints disposed between links (e.g., 270,272,274; fig. 13; [0005]-[0006], [0078]) of the manipulator and enabling movement of the links relative to each other resulting in an updating of kinematic configuration of the manipulator. Simaan discloses a sensor configured to generate signals indicative of a parameter (e.g., actuation force or displacement of joint) sensed at a joint of the one or more joints of the manipulator (fig. 14; [0091]). Simaan discloses that the force at the distal end of the robot can be calculated based on the sensor feedback even though there is no sensor directly measuring the force at the distal end of the robot (see fig. 14; [0005]). By calculating the force at the distal end of the robot via sensors placed at joints of the robot, the robotic manipulator may be made smaller, cheaper, and designed without the constrains of placing a sensor at the distal end of the robot to make the force measurements (see [0005], [0039]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Yanof to include a sensor configured to generate signals indicative of a parameter sensed at a joint of the one or more joints of the manipulator of Yanof as taught by Simaan, such that the robotic manipulator may be made smaller, cheaper, and designed without the constrains of placing a sensor at the distal end of the robot to make the force measurements.
Yanof also fails to disclose that the controller is operably coupled to the sensor and drive system to close a control loop between the drive system and the sensor such that the drive system, based on at least one signal generated by the sensor as the puncture device is autonomously moved through the patient tissue by the controller to cause the manipulator to autonomously create the puncture by the puncture device.
Harris discloses another puncture system including a controllable manipulator (robot arm 1) configured to support a puncture device (41), a sensor (91/213) configured to generate signals indicative of force ([0085]; [0110]), a drive system (93; fig. 20) configured to drive the manipulator, and a controller (90) operably coupled to the sensor and the drive system to close a local control loop between the drive system and the sensor ([0084]), the controller configured to, when the puncture device is supported by the controllable manipulator, operate the drive system based on at least one signal generated by the sensor as the puncture device is autonomously moved through patient tissue by the controller to cause the controllable manipulator to autonomously create the puncture by the puncture device (see abstract and [0084]-[0086]). Harris teaches that autonomous insertion of a puncture device is advantageous for a number of reasons including minimizing the number of unsuccessful insertion attempts and lessening the dependence on skilled technicians and nurses in busy hospital environments ([0035]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Yanof to operably couple the controller to the sensor and drive system to close a control loop between the drive system and the sensor such that the drive system, based on at least one signal generated by the sensor as the puncture device is moved autonomously through the patient tissue by the controller to cause the manipulator to autonomously create the puncture by the puncture device, in view of the teachings of Harris in order to allow for precise and substantially error free operation of the system while autonomously completing insertion of the puncture device into the patient ([0086]).
Regarding claim 56, Yanof discloses an indicator system (display; see abstract) operable by the controller to produce human-perceptible feedback (video monitor that shows virtual image of instrument) based on the signal in combination with patient information, in particular, data representing an image of the patient tissue and the cavity (“pre-procedure image” in abstract; see fig. 4).
Regarding claim 57, the patient information includes a thickness of the patient tissue (in the form of an image of patient tissue; see for example fig. 4).
Regarding claim 58, the parameter sensed at the joint is a force applied to the joint as taught by Simaan ([0005], [0091]; fig. 8,14 of Simaan).
Regarding claim 59, the at least one signal comprises a first signal indicative of the motion of the puncture device from the first layer of patient tissue to the second layer of patient tissue (change in force on sensor, which may be an increase or decrease depending on types of tissue; [0051]), and a second signal indicative of the puncture device being in the cavity (e.g., signal indicating very large drop in force on sensor as puncture device enters cavity)
Regarding claim 60, the controller is configured to cooperate to operate the drive system based on the at least one signal to cause the controllable manipulator to autonomously create the puncture by operating the drive system to inhibit movement of the puncture device in response to the at least one signal ([0051] of Yanof, [0084]-[0086] of Harris).
Regarding claims 61 and 62, operating the drive system to inhibit movement of the puncture device comprises inhibiting a range of motion of the puncturing device (i.e., the range of motion past the point where the device senses that the puncturing device encounters bone or the point where myocardium wall is punctured as discussed in par. [0051] of Yanof), and inhibiting translational movement of the puncture device to within a distance of an initial position of the puncture device (i.e., movement from initial position of puncture device (against skin) is inhibited to distance that corresponds to depth of anatomy or tissue of concern since threshold force may be set to halt advancement of needle before anatomy or tissue of concern is damaged as per par. [0051] of Yanof).
Regarding claim 66, the at least one signal is at least one first signal (e.g., sensor feedback when needle is in one type of tissue), and the puncture system further comprises a sensor system comprising the sensor, the sensor system configured to generate a second signal indicative of a location of the puncture device relative to the patient tissue along an insertion axis of the puncture device (e.g., sensor feedback when needle enters different type of tissue, or contacts bone: [0051] of Yanof).
Regarding claim 63, in addition to replacing the distal end sensor of Yanof with a joint sensor as taught by Simaan, it would also have been obvious to add a joint sensor as taught by Simaan to the device of Yanof such that it has both a distal end sensor (as disclosed by Yanof) and a joint sensor (as taught by Simaan) for the predictable result of providing redundant sensors that can be used to detect discrepancies or indicate problems with one of the sensors, or supplement feedback from the other sensor. This second sensor (strain gauge sensor 230 disclosed by Yanof; see abstract) is a force sensor configured to generate a signal in response to a force on the puncture device.
Regarding claim 65, the controller is configured to operate the drive system to cause the manipulator to control movement of the medical tool when the medical tool is supported by the manipulator by operating the drive system to cause the manipulator to control movement of an end effector (e.g., translational movement of end effector via movement of entire medical tool) of the medical tool in the cavity when the end effector is inserted through a port device in the puncture forming an access port to the cavity, wherein the port device is inserted into the puncture after the puncture device creates the puncture. It is noted that this is a recitation of intended use and the medical tool and port device are not positively recited as part of the puncture system. Thus, the prior art must only be capable of carrying out these functional limitations in order to meet the functional limitations. Because the controller of Yanof operates the drive system to cause the manipulator to control movement of the tool held by the manipulator, and the puncture device can be removed from the manipulator and replaced with a medical tool having an end effector, which is thereafter advanced along the same trajectory through a port placed in the puncture, it meets this recitation of intended use.
Claim 67-68 and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanof in view of Simaan and Harris as applied to claim 55 above and further in view of Kubota (US 4,299,230). Yanof in view of Simaan and Harris discloses the invention substantially as stated above except for a plurality of electrode sensors arranged to contact distinct portions of the patient tissue as the puncture device is moved through the patient tissue into the cavity.
Kubota discloses another puncture system, wherein the system includes a sensor system comprising a plurality of electrode sensors (41, 42, 43…fig. 11; noting each pressure sensor may take form of fig. 10, which includes an electrode) configured to generate at least one second signal, wherein the plurality of electrode sensors are arranged to contact distinct portions of the patient tissue as the puncture device is moved through the patient tissue into the cavity (fig. 11; col. 4, ll. 9-48). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Whitman to include a plurality of electrode sensors arranged along a length of the puncture device as taught by Kubota in order to provide additional depth feedback of the puncture device to the controller, thereby further minimizing unintentional tissue damage.
Regarding claim 68, the electrode sensors are positioned along the insertion axis of the puncture device and spaced apart from one another (consider sensors 41 and 43 of Kubota).
Regarding claim 70, the plurality of electrode sensors comprises at least three electrode sensors and the at last one second signal comprises at least three second signals (E1, E2, E3), and each of the at least three electrode sensors is configured to generate a corresponding signal of the at least three second signals (see fig. 11)
Claim 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanof in view of Simaan, Harris, and Kubota as applied to claim 67 and further in view of Lum et al. (US 2002/0042594). Yanof in view of Simaan, Harris, and Kubota discloses a plurality of electrodes sensors that form a matrix of electrodes to generate the at least one second signal indicative of a property sensed along the insertion axis (see fig. 11 of Kubota), but does not expressly disclose that the signal is indicative of an impedance map along the insertion axis.
Lum discloses that penetration depth of a puncture device can be determined by monitoring impedance which varies with penetration depth due to the impedance differences between layers of tissue ([0006]-[0008]). Lum disclose that an electrode sensor placed on the puncture device can be used to sense impedance ([0023]). It would have been obvious to one of ordinary skill in the art to have modified the sensors of Yanof as modified by Kubota to comprise impedance sensors in view of Lum’s teachings because such a modification can be considered a substitution of one type of sensor for determining penetration depth for another wherein the results are predictable and one skilled in the art would have a reasonable expectation of success. Since Yanof in view of Simaan, Kubota and Lum includes a plurality of electrode sensors disposed along the length of the puncture device as taught by Kubota, the sensors sensing impedance as taught by Lum, the at least one second signal provided by the plurality of electrode sensors is indicative of an impedance map along the insertion axis of the puncture device.
Claim 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanof in view of Simaan and Harris as applied to claim 55 above and further in view of Nezhat (US 2004/0049127). Yanof in view of Simaan and Harris discloses the invention substantially as stated above except for a stabilizing device as claimed.
Nezhat teaches a stabilizing device (12/16) to apply a stabilizing force to a region of tissue that is to be punctured by a puncture device (14). The stabilizing device comprises a suction device (12/16) operable to apply traction to the region of tissue ([0059], [0060]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Yanof to include a stabling device comprising a suction device as taught by Nezhat in order to draw tissue away from vulnerable underlying structures ([0004]), thereby further minimizing unintended perforation of the vulnerable underlying structures by the puncture device.
Claims 72-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanof in view of Simaan, Harris, and Stoianovici et al. (US 2002/0111634). Regarding claim 72, Yanof discloses a method of operating a controllable manipulator (200; fig. 2) configured to support a puncture device (210; fig. 2), wherein the controllable manipulator (200) comprises one or more joints disposed between links of the controllable manipulator that enable movement of the links relative to one another resulting in an updating of a kinematic configuration of the controllable manipulator supporting the puncture device ([0034]), the method comprising detecting, based on at least one signal generated by a sensor (230) of the manipulator, a parameter associated with motion of a puncture device supported by the manipulator through the patient tissue into an internal patient cavity or from a first layer of the patient tissue to a second layer of the patient tissue, and causing the manipulator, based on the detected motion, to guide insertion of the puncture device ([0036], [0049], [0051]; note also trajectory shown in fig. 4). The puncture device is considered configured to create a puncture through patient tissue and into an internal cavity to enable an end effector of a medical tool to be inserted through the puncture into the cavity since it can penetrate through tissue to form a track into which another medical tool may be inserted and thus meets this recitation of intended use. Yanof does not expressly disclose that the sensor is configured to sense the parameter at a joint of the one or more joints.
Simaan discloses another controllable manipulator configured to support a surgical device, the manipulator comprising one or more joints disposed between links of the manipulator and enabling movement of the links relative to each other resulting in an updating of kinematic configuration of the manipulator ([0005]-[0006]). Simaan discloses a sensor configured to generate signals indicative of a parameter (e.g., actuation force or displacement of joint) sensed at a joint of the one or more joints of the manipulator (fig. 14; [0091]). Simaan discloses that the force at the distal end of the robot can be calculated based on the sensor feedback even though there is no sensor directly measuring the force at the distal end of the robot (see fig. 14; [0005]). By calculating the force at the distal end of the robot via sensors placed at joints of the robot, the robotic manipulator may be made smaller, cheaper, and designed without the constrains of placing a sensor at the distal end of the robot to make the force measurements (see [0005], [0039]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Yanof to include a sensor configured to generate signals indicative of a parameter sensed at a joint of the one or more joints of the manipulator of Yanof as taught by Simaan, such that the robotic manipulator may be made smaller, cheaper, and designed without the constrains of placing a sensor at the distal end of the robot to make the force measurements.
Yanof also fails to expressly disclose a locally closed control loop between the drive system of the controllable manipulator and the sensor, the locally closed control loop configured to autonomously move the puncture device through patient tissue, and operating the drive system to cause the manipulator, based on feedback from the sensor, to autonomously create the puncture.
Harris discloses another puncture system including a controllable manipulator (robot arm 1) configured to support a puncture device (41), a sensor (91/213) configured to generate signals indicative of force ([0085]; [0110]), a drive system (93; fig. 20) configured to drive the manipulator, and a controller (90) operably coupled to the sensor and the drive system to close a local control loop between the drive system and the sensor ([0084]), the controller configured to, when the puncture device is supported by the controllable manipulator, operate the drive system based on at least one signal generated by the sensor to cause the controllable manipulator to autonomously create the puncture by the puncture device (see [0084]-[0086]). Harris teaches that autonomous insertion of a puncture device is advantageous for a number of reasons including minimizing the number of unsuccessful insertion attempts and lessening the dependence on skilled technicians and nurses in busy hospital environments ([0035]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Yanof to couple the controller to the sensor and drive system to form a locally closed control loop between the drive system and the sensor, and to operate the drive system to cause the controllable manipulator, based on sensor feedback, to autonomously create the puncture by the puncture device, in view of the teachings of Harris in order to allow for precise and substantially error free operation of the system while autonomously completing insertion of the puncture device into the patient ([0086]).
Although the manipulator of Yanof is clearly capable of releasing the puncture device (biopsy needle) and holding another medical tool to control movement of the medical tool in the same manner as movement of the biopsy needle, Yanof does not expressly disclose a method that includes holding, in addition to the claimed puncture device, another medical tool with the controllable manipulator and causing the controllable manipulator to control movement of the medical tool when the medical tool is supported by the controllable manipulator and is inserted through the puncture.
Stoianovici discloses another controllable manipulator (160; fig. 1) that controls movement of a puncture device (first biopsy needle 50). Stoianovici discloses removing the puncture device from the controllable manipulator and replacing it with a sterilized medical tool (second biopsy needle) ([0056]). It would have been obvious to one of ordinary skill in the art to have modified the prior art method of Yanof to include releasing the puncture device and thereafter holding a medical tool in the form of a second biopsy needle with the controllable manipulator and causing the controllable manipulator to control movement of the medical tool when the medical tool is supported by the controllable manipulator in view of Stoianovici’s teaching that it is known to remove and replace a first puncture device being held by a manipulator with a sterilized second puncture device of the same or different size for the predictable result of allowing an additional biopsy to be taken, and one skilled in the art would have understood that the manipulator is then used to control movement of the medical tool (second biopsy needle) in the same manner as the puncture device. Regarding control of movement of the medical tool “while it is inserted through the puncture”, one skilled in the art would have found it obvious to place the second biopsy needle in the puncture formed by the puncture device (i.e., first biopsy needle) since it may be desirable to take an additional biopsy from the same target tissue (e.g., when insufficient tissue is removed via the first biopsy needle, or when multiple samples are needed for multiple tests), and inserting a second biopsy needle through the same puncture and along the same tissue track formed by the puncture device (first biopsy needle) would minimize the amount of tissue damage experienced by the patient as recognized by one of ordinary skill in the art.
Regarding claims 73 and 74, causing the controllable manipulator of Yanof as modified by Harris and Simaan to autonomously create the puncture comprises, inhibiting a range of motion of the puncturing device (i.e., inhibits motion past the point where the device senses that the puncturing device encounters bone or the point where myocardium wall is punctured as discussed in par. [0051] of Yanof, which is carried out autonomously in view of Harris; see also [0113], [0152], [0158] of Harris), and inhibiting translational motion of the puncture device to within a distance of an initial position of the puncture device (i.e., movement from initial position of puncture device (against skin) is inhibited to distance that corresponds to depth of anatomy or tissue of concern since threshold force may be set to halt advancement of needle before anatomy or tissue of concern is damaged as per par. [0051] of Yanof).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims (55), (56,57), 58, 59, 60, 61, 62, 63, 65, 72, 73, and 74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1), (5), 8, 10, 12, 13, 14, 17, 19, 27, 28, and 30, respectively, of U.S. Patent No. 11,534,079 in view of Simaan (US 2013/0090763) and Harris. Claims (1), (5), 8, 10, 12, 13, 14, 17, 19, 27, 28, and 30 of ‘079 claim the invention of instant claims (55,64), (56,57), 58, 59, 60, 61, 62, 63, 65, 72, 73, and 74, respectively, except for the one or more joints being disposed between links of the controllable manipulator enabling movement of the links relative to one another resulting in an updating of a kinematic configuration of the controllable manipulator, the sensor configured to generate signals indicative of a parameter sensed at a joint of the one or more joints.
Simaan discloses another controllable manipulator configured to support a surgical device, the manipulator comprising one or more joints disposed between links (e.g., 270,272,274; fig. 13; see also [0006]) of the manipulator and enabling movement of the links relative to each other resulting in an updating of kinematic configuration of the manipulator. Simaan discloses a sensor configured to generate signals indicative of a parameter (e.g., actuation force or displacement of joint) sensed at a joint of the one or more joints of the manipulator (fig. 14). Simaan discloses that the force at the distal end of the robot can be calculated based on the sensor feedback even though there is no sensor directly measuring the force at the distal end of the robot (see fig. 14; [0005]). By calculating the force at the distal end of the robot via sensors placed at joints of the robot, the robotic manipulator may be made smaller, cheaper, and designed without the constrains of placing a sensor at the distal end of the robot to make the force measurements (see [0005], [0039]).
It would have been obvious to one of ordinary skill in the art to have modified the claimed device of claims 1, 5, 8, 10, 12- 14, 17, 19, 27, 28, and 30 of ‘079 to include the one or more joints disposed between links of the manipulator, the joints enabling movement of the links relative to one another resulting in an updating of the kinematic configuration of the manipulator, and to configure the sensor to generate signals indicative of a parameter sensed at a joint of the one or more joints as taught by Simaan, such that the robotic manipulator is able to carry out complex movements as is known in the art, and the robot may be made smaller, cheaper, and designed without the constrains of placing a sensor at the distal end of the robot to make the force measurements. It would also have been obvious to control movement of the medical tool while it is inserted into the puncture since one skilled in the art would have recognized the advantages associated with introducing the medical tool into the patient’s body via the already formed puncture, namely minimizing tissue damage.
Claims (1), (5), 8, 10, 12, 13, 14, 17, 19, 27, 28, and 30 of ‘079 also fail to claim that the controller is operably coupled to the sensor and drive system to close a control loop between the drive system and the sensor such that the drive system, based on at least one signal generated by the sensor as the puncture device is autonomously moved through the patient tissue by the controller to cause the manipulator to autonomously create the puncture by the puncture device.
Harris discloses another puncture system including a controllable manipulator (robot arm 1) configured to support a puncture device (41), a sensor (91/213) configured to generate signals indicative of force ([0085]; [0110]), a drive system (93; fig. 20) configured to drive the manipulator, and a controller (90) operably coupled to the sensor and the drive system to close a local control loop between the drive system and the sensor ([0084]), the controller configured to, when the puncture device is supported by the controllable manipulator, operate the drive system based on at least one signal generated by the sensor as the puncture device is autonomously moved through patient tissue by the controller to cause the controllable manipulator to autonomously create the puncture by the puncture device (see abstract and [0084]-[0086]). Harris teaches that autonomous insertion of a puncture device is advantageous for a number of reasons including minimizing the number of unsuccessful insertion attempts and lessening the dependence on skilled technicians and nurses in busy hospital environments ([0035]). It would have been obvious to one of ordinary skill in the art to have modified the claimed device of claims 1, 5, 8, 10, 12- 14, 17, 19, 27, 28, and 30 of ‘079 to operably couple the controller to the sensor and drive system to close a control loop between the drive system and the sensor such that the drive system, based on at least one signal generated by the sensor as the puncture device is moved autonomously through the patient tissue by the controller to cause the manipulator to autonomously create the puncture by the puncture device, in view of the teachings of Harris in order to allow for precise and substantially error free operation of the system while autonomously completing insertion of the puncture device into the patient ([0086]).
Claim 66-68 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,534,079 in view of Simaan and Harris as applied to instant claim 55 above, and further in view of Kubota (US 4,299,230). Claim 1 of ‘079 as modified in view of Simaan and Harris claims the invention of instant claims 66-68 and 70 except for the following which is taught by Kubota. Kubota discloses another puncture system, wherein the system includes a sensor system comprising a plurality of electrode sensors (41, 42, 43…fig. 11; noting each pressure sensor may take form of fig. 10, which includes an electrode) configured to generate at least one second signal indicative of a location of the puncture device relative to the patient tissue along an insertion axis of the puncture device, wherein the plurality of electrode sensors are arranged to contact distinct portions of the patient tissue as the puncture device is moved through the patient tissue into the cavity (fig. 11; col. 4, ll. 9-48). It would have been obvious to one of ordinary skill in the art to have modified the invention of claim 1 of ‘079 to include a plurality of electrode sensors arranged along a length of the puncture device configured to generate at least one second signal as taught by Kubota in order to provide additional depth feedback of the puncture device to the controller, thereby further minimizing unintentional tissue damage.
Regarding claim 68, the electrode sensors are positioned along the insertion axis of the puncture device and spaced apart from one another as taught by Kubota (consider sensors 41 and 43 of Kubota).
Regarding claim 70, the plurality of electrode sensors comprises at least three electrode sensors and the at last one second signal comprises at least three second signals (E1, E2, E3), and each of the at least three electrode sensors is configured to generate a corresponding signal of the at least three second signals as taught by Kubota (see fig. 11)
Claim 69 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,534,079 in view of in view of Simaan, Harris, and Kubota as applied to instant claim 67 above and further in view of Lum et al. (US 2002/0042594). Claim 1 of ‘079 as modified by Simaan, Harris, and Kubota discloses a plurality of electrodes sensors that form a matrix of electrodes to generate the at least one second signal indicative of a property sensed along the insertion axis (see fig. 11 of Kubota), but does not expressly disclose that the signal is indicative of an impedance map along the insertion axis.
Lum discloses that penetration depth of a puncture device can be determined by monitoring impedance which varies with penetration depth due to the impedance differences between layers of tissue ([0006]-[0008]). Lum disclose that an electrode sensor placed on the puncture device can be used to sense impedance ([0023]). It would have been obvious to one of ordinary skill in the art to have modified the sensors of the invention of claim 1 of ‘079 as modified by Kubota to comprise impedance sensors in view of Lum’s teachings because such a modification can be considered a substitution of one type of sensor for determining penetration depth for another wherein the results are predictable and one skilled in the art would have a reasonable expectation of success. Since the invention of claim 1 of ‘079 as modified by Lum and Kubota includes a plurality of electrode sensors disposed along the length of the puncture device as taught by Kubota, the sensors sensing impedance as taught by Lum, the at least one second signal provided by the plurality of electrode sensors is indicative of an impedance map along the insertion axis of the puncture device.
Claim 71 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,534,079 in view of Simaan and Harris as applied to instant claim 55 above and further in view of Nezhat (US 2004/0049127). Claim 1 of ‘079 as modified by Simaan and Harris claims the invention of claim 71 substantially except for a stabilizing device as claimed. Nezhat teaches a stabilizing device (12/16) to apply a stabilizing force to a region of tissue that is to be punctured by a puncture device (14). The stabilizing device comprises a suction device (12/16) operable to apply traction to the region of tissue ([0059], [0060]). It would have been obvious to one of ordinary skill in the art to have modified the invention of claim 1 of ‘079 to include a stabling device comprising a suction device as taught by Nezhat in order to draw tissue away from vulnerable underlying structures ([0004]), thereby further minimizing unintended perforation of the vulnerable underlying structures by the puncture device.
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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KSH 5/13/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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