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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE10 2024 204 665.5, filed on 05/21/2024.
Status of Claims
This Office Action is responsive to the claims filed on 07/23/2026. Claims 1, 6, 10, 11, and 17-19 have been amended. Claim 20 is newly presented. Claims 1-20 are presently pending in this application.
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.
Claims 1-4, 10, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fitterer (US 20210338064 A1) in view of Miller (US 20230071306 A1).
Regarding claim 1, Fitterer teaches a system for moving a medical object (Paragraph [0012]; a system for delivery of an elongate shaft along a path to a target; Paragraph [0060]; a steerable apparatus 100 (which may be a therapeutic, diagnostic, or imaging medical instrument, such as a ureteroscope)), the system comprising:
a processing unit (Paragraph [0122]; a system for delivery of an elongate shaft along a path to a target can comprise a processor; Fig. 16 control system);
a movement apparatus (Paragraph [0136]; system 1600 generally includes a manipulator assembly 1602 to manipulate a medical instrument); and
a capturing unit (Paragraph [0140]; system 1600 may further include… tracking systems; the tracking system can be coupled to the sensor system),
wherein the processing unit is configured to receive a preprocedural dataset (Paragraph [0150]; control system may implement one or more EM sensor, fiber optic sensors, and/or other sensors to register and display a medical implement together with preoperatively recorded surgical images) that has a representation of a hollow organ of an examination object (Paragraph [0123]; a pre-operative model of anatomy can be rendered from pre-operative imaging data (e.g. CT data); Paragraph [0055]; navigating and performing medical procedures within a patient's urinary tract; Paragraph [0117]; kidney through an anatomical orifice, such as a subject's ureter, as illustrated in FIG. 12),
wherein a predefined section of the medical object (Paragraph [0061]; shown in FIG. 1A, the elongated shaft 110 of the apparatus 100 has a distal end portion 110a,) is arranged in the hollow organ of the examination object in an operating state of the system (Paragraph [0117]; During operation…may assist or enable advancing the steerable apparatuses through a subject's anatomy, especially within an organ, as disclosed herein; as illustrated in FIG. 12, the apparatus is navigated through a large chamber. If the target stone to be accessed is at a location in the lower portion of the kidney),
wherein the capturing unit is configured to capture an instantaneous positioning of the predefined section of the medical object (Paragraph [0145]; Medical instrument system 1700 further includes tracking system 1730 for determining the position, orientation, speed, velocity, pose, and/or shape of distal end 1719 and/or of one or more segments 1724 along flexible body 1716.; Paragraph [0147]; information from tracking system 1730 may be sent… to provide the operator with real-time position information),
wherein the processing unit is configured to identify a curvature of the hollow organ at the instantaneous positioning of the predefined section using the preprocedural dataset (Paragraph [0123]; the method 1400 includes detection of a departure (veering away) from travel along the inner curve of a bend in the anatomy…shape sensors can be used to detect a departure of measured shape of the apparatus along the bend with determined radius of curvature of the bend as determined in pre-operative or intra-operative images; Fig. 14, step 1410),
wherein the processing unit is configured to provide the movement apparatus with a control specification for movement of the medical object based on the curvature of the hollow organ (Paragraph [0123]; When the apparatus begins to veer away from the inner curve within the bend, the advancement of the apparatus can be stopped, and the apparatus can be positioned at the bend; Fig. 14, steps 1430 and 1460),
wherein the control specification has a specification relating to the manipulation of the predefined section (Paragraph [0124]; the rigidizable element, in a relaxed state, may be positioned so that a distal end of the rigidizable element is at or near a distal end of the apparatus, or at an intermediate position along the length of the apparatus then both the rigidizable element and apparatus are advanced simultaneously to the bend), and
wherein the movement apparatus is configured to move the medical object in accordance with the control specification and manipulate the predefined section (Paragraph [0136]; As shown in FIG. 16, the system 1600 generally includes a manipulator assembly 1602 to manipulate a medical instrument 1604 while performing various procedures on a patient P.; Paragraph [0137]; In this regard, the manipulator assembly 1602 may include a plurality of actuators or motors that drive inputs on the medical instrument 1604 in response to commands from a control system 1612).
Fitterer does not explicitly teach the manipulation comprises a deforming of the predefined section and the movement apparatus is configured to move the medical object to deform the predefined section.
Miller, however, teaches a system (Paragraph [0198]; the instructions for advancing the medical device) for moving a medical object (Paragraph [0042]; Medical instrument system 100 includes an elongate device 102, Fig. 1), the system comprising:
wherein the processing unit is configured to provide the movement apparatus with a control specification for movement of the medical object (Paragraph [0096]; In some embodiments, the direction of contact between the device 1002 and a body wall may be detected and automatically corrected, for example, to move the device 1002 in a direction away from the contact (e.g., by moving the device 1002 a distance apart from the contact)) based on the curvature of the hollow organ (Paragraph [0114]; Selective control of the elongate device 1002 may then be provided based on the device 1002 insertion depth corresponding to the curvatures of the body spaces.),
wherein the control specification has a specification relating to a manipulation of the predefined section (Paragraph [0116]; the elongate device 1002 may include multiple bending sections 1040 to provide selective stiffening), the manipulation comprising a deforming of the predefined section (Paragraph [0105]; aspects of the present disclosure provide navigation and control of a computer-assisted teleoperated treatment device… Additionally or alternatively, portions of the treatment device may be stiffened or rigidized), and
wherein the movement apparatus is configured to move the medical object in accordance with the control specification (Paragraph [0086]; The manipulator assembly 802 may be teleoperated with at least partial computer assistance, manually operated, or operated as a hybrid computer) and deform the predefined section (Paragraph [0114]; . For example, one or more stiffening mechanisms may include a plurality of control wires or cables (e.g., optionally nitinol wires) embedded in a wall of the flexible body 1016, as described above. The plurality of wires may be selectively engaged or articulated to maintain a pose).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Fitterer to have included deforming of the predefined section and the movement apparatus is configured to move the medical object to deform the predefined section as taught by Miller because it would have allowed changing or adjusting the bend radius to match the bend of the organ to allow the medical device to be advanced through the organ without contacting or injuring the organ (Paragraph [0115]-[0116]).
Regarding claim 2, together Fitterer and Miller teach all of the limitations of claim 1 as noted above.
Fitterer further teaches the capturing unit has a medical imaging device (Paragraph [0145]; Tracking system 1730 may use data or information from a sensor system… including one or more sensors and/or imaging devices) configured to record intraprocedural image data of the examination object (Paragraph [0123]; the departure from the threshold distance can be determined using endoluminal imaging, such as ultrasound or OCT probes integrated with or carried by the apparatus, to measure a real time distance of the apparatus to a tissue wall, e.g. the tissue wall at the inner curve), and
wherein the capturing unit is configured to identify the instantaneous positioning of the predefined section using the intraprocedural image data (Paragraph [0149]; indicate an actual location within the patient anatomy where the medical instrument has been positioned. Such a virtual navigational marker may be dynamically referenced with registered preoperative or concurrent images or models; Paragraph [0138]; the system 1600 may include a sensor system 1608 with one or more sub-systems for receiving information about the instruments coupled to the instrument manipulator… Such sub-systems may include a… a visualization system for capturing images from the distal portion of the medical instrument 1604).
Regarding claim 3, together Fitterer and Miller teach all of the limitations of claim 1 as noted above.
Fitterer further teaches the movement of the medical object comprises a translation (Paragraph [0123]; When the apparatus begins to veer away from the inner curve within the bend, the… the apparatus can be positioned at the bend; Fig. 14, steps 1430 and 1460; Paragraph [0124]; the rigidizable element can be initially disposed within the apparatus and advanced together with the apparatus as it is positioned at the bend).
Regarding claim 4, together Fitterer and Miller teach all of the limitations of claim 1 as noted above.
Fitterer further teaches the processing unit is further configured to:
capture an item of planning information that specifies a target positioning for the predefined section on the hollow organ or in the hollow organ (Paragraph [0130]; detecting the target using live intra-operative imaging (e.g. fluoroscopy, CT, external ultrasound), tracking of the apparatus using localization sensors registered to a pre-operative model); and
provide the control specification additionally based on the target positioning (Paragraph [0130]; If the selectively rigidizable apparatus has reached the target location, the method 1400 is complete. If the selectively rigidizable apparatus has reached the target location and another bend is disposed between the bend and the target location, the method 1400 includes repeating steps 1410 to 1490 until the apparatus is positioned at the target).
Regarding claim 10, Fitterer teaches a method (Paragraph [0012]; a system for delivery of an elongate shaft along a path to a target; Paragraph [0055]; and methods of the present technology can be used for various image-guided medical procedures, such as medical procedures) for providing a control specification (Paragraph [01400]; Method 1400 provides for an incremental method to navigate an apparatus to a target within anatomy that includes at least one bend), the method comprising:
receiving a preprocedural dataset (Paragraph [0150]; control system may implement one or more EM sensor, fiber optic sensors, and/or other sensors to register and display a medical implement together with preoperatively recorded surgical images) having a representation of a hollow organ of an examination object (Paragraph [0123]; a pre-operative model of anatomy can be rendered from pre-operative imaging data (e.g. CT data); Paragraph [0055]; navigating and performing medical procedures within a patient's urinary tract; Paragraph [0117]; kidney through an anatomical orifice, such as a subject's ureter, as illustrated in FIG. 12);
receiving an item of positioning information (Paragraph [0145]; Medical instrument system 1700 further includes tracking system 1730 for determining the position, orientation, speed, velocity, pose, and/or shape of distal end 1719 and/or of one or more segments 1724 along flexible body 1716.; Paragraph [0147]; information from tracking system 1730 may be sent… to provide the operator with real-time position information) relating to a positioning of a predefined section of a medical object (Paragraph [0061]; shown in FIG. 1A, the elongated shaft 110 of the apparatus 100 has a distal end portion 110a,) in the hollow organ of the examination object (Paragraph [0117]; During operation…may assist or enable advancing the steerable apparatuses through a subject's anatomy, especially within an organ, as disclosed herein; as illustrated in FIG. 12, the apparatus is navigated through a large chamber. If the target stone to be accessed is at a location in the lower portion of the kidney);
identifying a curvature of the hollow organ at the positioning of the predefined section using the preprocedural dataset and the item of positioning information (Paragraph [0123]; the method 1400 includes detection of a departure (veering away) from travel along the inner curve of a bend in the anatomy…shape sensors can be used to detect a departure of measured shape of the apparatus along the bend with determined radius of curvature of the bend as determined in pre-operative or intra-operative images; Fig. 14, step 1410); and
providing the control specification based on the curvature of the hollow organ (Paragraph [0123]; When the apparatus begins to veer away from the inner curve within the bend, the advancement of the apparatus can be stopped, and the apparatus can be positioned at the bend; Fig. 14, steps 1430 and 1460), wherein the control specification has a specification relating to a manipulation of the predefined section (Paragraph [0124]; the rigidizable element, in a relaxed state, may be positioned so that a distal end of the rigidizable element is at or near a distal end of the apparatus, or at an intermediate position along the length of the apparatus then both the rigidizable element and apparatus are advanced simultaneously to the bend).
Fitterer does not explicitly teach the manipulation of the predefined section comprises a deforming of the predefined section.
Miller, however, teaches a system (Paragraph [0198]; the instructions for advancing the medical device) for moving a medical object (Paragraph [0042]; Medical instrument system 100 includes an elongate device 102, Fig. 1), the system comprising:
wherein the processing unit is configured to provide the movement apparatus with a control specification for movement of the medical object (Paragraph [0096]; In some embodiments, the direction of contact between the device 1002 and a body wall may be detected and automatically corrected, for example, to move the device 1002 in a direction away from the contact (e.g., by moving the device 1002 a distance apart from the contact)) based on the curvature of the hollow organ (Paragraph [0114]; Selective control of the elongate device 1002 may then be provided based on the device 1002 insertion depth corresponding to the curvatures of the body spaces.),
wherein the control specification has a specification relating to a manipulation of the predefined section (Paragraph [0116]; the elongate device 1002 may include multiple bending sections 1040 to provide selective stiffening), the manipulation comprising a deforming of the predefined section (Paragraph [0105]; aspects of the present disclosure provide navigation and control of a computer-assisted teleoperated treatment device… Additionally or alternatively, portions of the treatment device may be stiffened or rigidized), and
wherein the movement apparatus is configured to move the medical object in accordance with the control specification (Paragraph [0086]; The manipulator assembly 802 may be teleoperated with at least partial computer assistance, manually operated, or operated as a hybrid computer) and deform the predefined section (Paragraph [0114]; . For example, one or more stiffening mechanisms may include a plurality of control wires or cables (e.g., optionally nitinol wires) embedded in a wall of the flexible body 1016, as described above. The plurality of wires may be selectively engaged or articulated to maintain a pose).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Fitterer to have included the manipulation of the predefined section comprises a deforming of the predefined section as taught by Miller because it would have allowed changing or adjusting the bend radius to match the bend of the organ to allow the medical device to be advanced through the organ without contacting or injuring the organ (Paragraph [0115]-[0116]).
Regarding claim 15, together Fitterer and Miller teach all of the limitations of claim 10 as noted above.
Fitterer further teaches an item of planning information is captured that specifies a target positioning for the predefined section on the hollow organ or in the hollow organ (Paragraph [0130]; detecting the target using live intra-operative imaging (e.g. fluoroscopy, CT, external ultrasound), tracking of the apparatus using localization sensors registered to a pre-operative model), and
wherein the control specification is provided additionally based on the target positioning Paragraph [0130]; If the selectively rigidizable apparatus has reached the target location, the method 1400 is complete. If the selectively rigidizable apparatus has reached the target location and another bend is disposed between the bend and the target location, the method 1400 includes repeating steps 1410 to 1490 until the apparatus is positioned at the target).
Regarding claim 17, Fitterer teaches a non-transitory computer-readable medium (Paragraph [0159]; non-transitory machine-readable medium or media) comprising computer program product (Paragraph [0012]; a system for delivery of an elongate shaft along a path to a target; Paragraph [0060]; a steerable apparatus 100 (which may be a therapeutic, diagnostic, or imaging medical instrument, such as a ureteroscope); Paragraph [0159]) having a computer program (Paragraph [0159]; having instructions recorded thereon for execution by a processor or computer) configured to be loaded directly into a memory (Paragraph [0159]; non-transitory machine-readable medium or media) of a processing unit (Paragraph [0122]; a system for delivery of an elongate shaft along a path to a target can comprise a processor; Fig. 16 control system), wherein the computer program, when executed by the processing unit (Paragraph [0159]; recorded thereon for execution by a processor or computer. The set of instructions can include various commands that instruct the computer or processor to perform specific operations such as the methods and processes of the various embodiments described herein), is configured to:
receive a preprocedural dataset (Paragraph [0150]; control system may implement one or more EM sensor, fiber optic sensors, and/or other sensors to register and display a medical implement together with preoperatively recorded surgical images) having a representation of a hollow organ of an examination object (Paragraph [0123]; a pre-operative model of anatomy can be rendered from pre-operative imaging data (e.g. CT data); Paragraph [0055]; navigating and performing medical procedures within a patient's urinary tract; Paragraph [0117]; kidney through an anatomical orifice, such as a subject's ureter, as illustrated in FIG. 12);
receive an item of positioning information (Paragraph [0145]; Medical instrument system 1700 further includes tracking system 1730 for determining the position, orientation, speed, velocity, pose, and/or shape of distal end 1719 and/or of one or more segments 1724 along flexible body 1716.; Paragraph [0147]; information from tracking system 1730 may be sent… to provide the operator with real-time position information) relating to a positioning of a predefined section of a medical object (Paragraph [0061]; shown in FIG. 1A, the elongated shaft 110 of the apparatus 100 has a distal end portion 110a,) in the hollow organ of the examination object (Paragraph [0117]; During operation…may assist or enable advancing the steerable apparatuses through a subject's anatomy, especially within an organ, as disclosed herein; as illustrated in FIG. 12, the apparatus is navigated through a large chamber. If the target stone to be accessed is at a location in the lower portion of the kidney);
identify a curvature of the hollow organ at the positioning of the predefined section using the preprocedural dataset and the item of positioning information (Paragraph [0123]; the method 1400 includes detection of a departure (veering away) from travel along the inner curve of a bend in the anatomy…shape sensors can be used to detect a departure of measured shape of the apparatus along the bend with determined radius of curvature of the bend as determined in pre-operative or intra-operative images; Fig. 14, step 1410); and
provide the control specification based on the curvature of the hollow organ (Paragraph [0123]; When the apparatus begins to veer away from the inner curve within the bend, the advancement of the apparatus can be stopped, and the apparatus can be positioned at the bend; Fig. 14, steps 1430 and 1460), wherein the control specification has a specification relating to a manipulation of the predefined section (Paragraph [0124]; the rigidizable element, in a relaxed state, may be positioned so that a distal end of the rigidizable element is at or near a distal end of the apparatus, or at an intermediate position along the length of the apparatus then both the rigidizable element and apparatus are advanced simultaneously to the bend).
Fitterer does not explicitly teach the manipulation of the predefined section comprises a deforming of the predefined section.
Miller, however, teaches a system (Paragraph [0198]; the instructions for advancing the medical device) for moving a medical object (Paragraph [0042]; Medical instrument system 100 includes an elongate device 102, Fig. 1), the system comprising:
wherein the processing unit is configured to provide the movement apparatus with a control specification for movement of the medical object (Paragraph [0096]; In some embodiments, the direction of contact between the device 1002 and a body wall may be detected and automatically corrected, for example, to move the device 1002 in a direction away from the contact (e.g., by moving the device 1002 a distance apart from the contact)) based on the curvature of the hollow organ (Paragraph [0114]; Selective control of the elongate device 1002 may then be provided based on the device 1002 insertion depth corresponding to the curvatures of the body spaces.),
wherein the control specification has a specification relating to a manipulation of the predefined section (Paragraph [0116]; the elongate device 1002 may include multiple bending sections 1040 to provide selective stiffening), the manipulation comprising a deforming of the predefined section (Paragraph [0105]; aspects of the present disclosure provide navigation and control of a computer-assisted teleoperated treatment device… Additionally or alternatively, portions of the treatment device may be stiffened or rigidized), and
wherein the movement apparatus is configured to move the medical object in accordance with the control specification (Paragraph [0086]; The manipulator assembly 802 may be teleoperated with at least partial computer assistance, manually operated, or operated as a hybrid computer) and deform the predefined section (Paragraph [0114]; . For example, one or more stiffening mechanisms may include a plurality of control wires or cables (e.g., optionally nitinol wires) embedded in a wall of the flexible body 1016, as described above. The plurality of wires may be selectively engaged or articulated to maintain a pose).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the computer-readable medium of Fitterer to have included the manipulation of the predefined section comprises a deforming of the predefined section as taught by Miller because it would have allowed changing or adjusting the bend radius to match the bend of the organ to allow the medical device to be advanced through the organ without contacting or injuring the organ (Paragraph [0115]-[0116]).
Regarding claim 20, together Fitterer and Miller teach all of the limitations of claim 1 as noted above.
Fitterer does not explicitly teach the deforming of the predefined section is a length-preserving deforming of the predefined section.
Miller, however, teaches deforming of the predefined section is a length-preserving deforming of the predefined section (Paragraph [0114]; The plurality of wires may be selectively engaged or articulated to maintain a pose; The articulating to bend the sections is considered to be a length-preserving deformation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Fitterer in view of Miller to have included a length-preserving deforming of the predefined section as taught by Miller because it would have allowed the medical device to form and maintain a shape that would allow the object to pass through curvatures of the body (Paragraph [0114]).
Claims 5-7, 11, 12, 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fitterer in view of Miller as applied to claims 4, 1, 10, and 17 above, respectively, and further in view of Huang (US 20230149102 A1).
Regarding claim 5, together Fitterer and Miller teach all of the limitations of claim 4 as noted above.
Fitterer does not explicitly teach the processing unit is further configured to:
identify a planned direction of movement of the predefined section using the item of planning information;
identify a narrowing of the hollow organ along the planned direction of movement using the preprocedural dataset; and
provide the control specification such that the predefined section is configured to move past the narrowing inside a lumen of the hollow organ in accordance with the control specification.
Huang, however, teaches the processing unit is further configured to:
identify a planned direction of movement of the predefined section (Paragraph [0040]; d a first moving direction at the first position a is an extending direction of the AC. Then, a second position C is determined in the first motion direction, and the second position C is connected with the planning path 301 to obtain a shortest connecting line BC, wherein a point B is an intersection point of the shortest connecting line BC and the planning path 301, Fig. 3) using the item of planning information (Paragraph [0040]; the 301 is the planning path, 302 is the blood vessel, 303 is the terminal point, and 304 is the guide wire.);
identify a narrowing of the hollow organ along the planned direction of movement using the preprocedural dataset (Paragraph [0046]; the intra-operative image is analyzed to determine the vessel branch and curve condition and the vessel width in front of the advancing of the medical interventional device; whether the width of the blood vessel exceeds the third threshold is continuously judged (step S404) and if the width of the blood vessel exceeds the third threshold, the width of the blood vessel is narrow, Fig. 4); and
provide the control specification such that the predefined section is configured to move past the narrowing inside a lumen of the hollow organ in accordance with the control specification (Paragraph [0046]; so that an automatic navigation instruction for reducing the advanceing speed is also generated (step S405) to enable the medical interventional device to execute the automatic operation at a safe speed, and the safety of the operation is ensured, Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Fitterer in view of Miller such that the processing unit is further configured to: identify a planned direction of movement of the predefined section using the item of planning information; identify a narrowing of the hollow organ along the planned direction of movement using the preprocedural dataset; and provide the control specification such that the predefined section is configured to move past the narrowing inside a lumen of the hollow organ in accordance with the control specification as taught by Huang because it would have allowed different speed modes can be selected and different strategies are given for different blood vessel conditions and thereby improve the operation efficiency and safety of the operation (Paragraph [0046]).
Regarding claim 6, together Fitterer and Miller teaches all of the limitations of claim 1 as noted above.
Fitterer does not explicitly teach the deforming of the predefined section comprises a directional curving of the predefined section.
Huang, however, teaches the manipulation of the predefined section comprises a directional curving of the predefined section (Paragraph [0054]; the system calculates how to control the slave-end mechanism 102 to act, and the concrete expression may include calculating the rotation direction, rotation angle, rotation speed, etc. of each motor, and these control information are used as navigation instructions, sending the navigation instructions to the slave-end mechanism 102 of the robot).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Fitterer in view of Miller such that the deforming of the predefined section comprises a directional curving of the predefined section as taught by Huang because it would have allowed the automatic navigation instruction to proceed on the confirmed planning path, thereby ensuring the instrument advances toward the target area (Paragraph [0054]).
Regarding claim 7, together Fitterer, Miller, and Huang teaches all of the limitations of claim 6 as noted above.
Fitterer further teaches comparing the curvature of the hollow organ at the positioning of the predefined section with a first threshold value (Paragraph [0123]; detection of a departure (veering away) from travel along the inner curve of a bend in the anatomy; measuring the movement of the apparatus and determining when the apparatus has departed from the bend by a threshold amount).
Fitterer does not explicitly teach providing the control specification such that the control specification specifies a curvature for the predefined section that is larger with respect to the curvature of the hollow organ when the curvature of the hollow organ overshoots the first threshold value;
and/or wherein the curvature of the hollow organ at the positioning of the predefined section is compared with a second threshold value and the control specification is provided such that the control specification specifies: (i) a curvature for the predefined section that is smaller with respect to the curvature of the hollow organ, or (ii) no additional curvature, when the curvature of the hollow organ undershoots the second threshold value,
wherein the second threshold value is less than or equal to the first threshold value.
Huang, however further teaches comparing the curvature of the hollow organ at the positioning of the predefined section with a first threshold value (Paragraph [0046]; analyzed to determine the vessel branch and curve condition and the vessel width in front of the advancing of the medical interventional device, and if the number of the vessel branches in front exceeds a first threshold, or the curvature is greater than a second threshold) and providing the control specification such that the control specification specifies a curvature for the predefined section that is larger with respect to the curvature of the hollow organ when the curvature of the hollow organ overshoots the first threshold value (Paragraph [0041]-[0043]; , directly advancing the head of the guide wire to the second position indicated by the automatic navigation instruction of the advancing distance by the user, or directly rotating the guide wire by the first threshold angle and then continuously advancing, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Fitterer in view of Miller and Huang to include providing the control specification such that the control specification specifies a curvature for the predefined section that is larger with respect to the curvature of the hollow organ when the curvature of the hollow organ overshoots the first threshold value as taught by Huang because it would have reduced the possibility of the advancing instrument creating a hazard leading to vascular rupture, thereby allowing the medical interventional device can execute the automatic operation in a more accurate and safe mode through the cooperative control (Paragraphs [0042]-[0043]).
Regarding claim 11, together Fitterer and Miller teach all of the limitations of claim 10 as noted above.
Fitterer does not explicitly teach the deforming of the predefined section comprises a directional curving of the predefined section.
Huang, however, teaches the deforming of the predefined section comprises a directional curving of the predefined section (Paragraph [0054]; the system calculates how to control the slave-end mechanism 102 to act, and the concrete expression may include calculating the rotation direction, rotation angle, rotation speed, etc. of each motor, and these control information are used as navigation instructions, sending the navigation instructions to the slave-end mechanism 102 of the robot).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Fitterer in view of Miller such that the deforming of the predefined section comprises a directional curving of the predefined section as taught by Huang because it would have allowed the automatic navigation instruction to proceed on the confirmed planning path, thereby ensuring the instrument advances toward the target area (Paragraph [0054]).
Regarding claim 12, together Fitterer, Miller, and Huang teach all of the limitations of claim 12 as noted above.
Fitterer further teaches comparing the curvature of the hollow organ at the positioning of the predefined section with a first threshold value (Paragraph [0123]; detection of a departure (veering away) from travel along the inner curve of a bend in the anatomy; measuring the movement of the apparatus and determining when the apparatus has departed from the bend by a threshold amount).
Fitterer does not explicitly teach providing the control specification such that the control specification specifies a curvature for the predefined section that is larger with respect to the curvature of the hollow organ when the curvature of the hollow organ overshoots the first threshold value;
and/or wherein the curvature of the hollow organ at the positioning of the predefined section is compared with a second threshold value and the control specification is provided such that the control specification specifies: (i) a curvature for the predefined section that is smaller with respect to the curvature of the hollow organ, or (ii) no additional curvature, when the curvature of the hollow organ undershoots the second threshold value,
wherein the second threshold value is less than or equal to the first threshold value.
Huang, however further teaches comparing the curvature of the hollow organ at the positioning of the predefined section with a first threshold value (Paragraph [0046]; analyzed to determine the vessel branch and curve condition and the vessel width in front of the advancing of the medical interventional device, and if the number of the vessel branches in front exceeds a first threshold, or the curvature is greater than a second threshold) and providing the control specification such that the control specification specifies a curvature for the predefined section that is larger with respect to the curvature of the hollow organ when the curvature of the hollow organ overshoots the first threshold value (Paragraph [0041]-[0043]; , directly advancing the head of the guide wire to the second position indicated by the automatic navigation instruction of the advancing distance by the user, or directly rotating the guide wire by the first threshold angle and then continuously advancing, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Fitterer in view of Miller and Huang to include providing the control specification such that the control specification specifies a curvature for the predefined section that is larger with respect to the curvature of the hollow organ when the curvature of the hollow organ overshoots the first threshold value as taught by Huang because it would have reduced the possibility of the advancing instrument creating a hazard leading to vascular rupture, thereby allowing the medical interventional device can execute the automatic operation in a more accurate and safe mode through the cooperative control (Paragraphs [0042]-[0043]).
Regarding claim 16, together Fitterer and Miller teach all of the limitations of claim 15 as noted above.
Fitterer does not explicitly teach a planned direction of movement of the predefined section is identified using the item of planning information,
wherein a narrowing of the hollow organ along the planned direction of movement of the predefined section is identified using the preprocedural dataset, and
wherein the control specification is provided such that the predefined section is moved past the narrowing inside a lumen of the hollow organ in accordance with the control specification.
Huang, however, teaches identifying a planned direction of movement of the predefined section (Paragraph [0040]; d a first moving direction at the first position a is an extending direction of the AC. Then, a second position C is determined in the first motion direction, and the second position C is connected with the planning path 301 to obtain a shortest connecting line BC, wherein a point B is an intersection point of the shortest connecting line BC and the planning path 301, Fig. 3) using the item of planning information (Paragraph [0040]; the 301 is the planning path, 302 is the blood vessel, 303 is the terminal point, and 304 is the guide wire.);
identify a narrowing of the hollow organ along the planned direction of movement using the preprocedural dataset (Paragraph [0046]; the intra-operative image is analyzed to determine the vessel branch and curve condition and the vessel width in front of the advancing of the medical interventional device; whether the width of the blood vessel exceeds the third threshold is continuously judged (step S404) and if the width of the blood vessel exceeds the third threshold, the width of the blood vessel is narrow, Fig. 4); and
provide the control specification such that the predefined section is configured to move past the narrowing inside a lumen of the hollow organ in accordance with the control specification (Paragraph [0046]; so that an automatic navigation instruction for reducing the advanceing speed is also generated (step S405) to enable the medical interventional device to execute the automatic operation at a safe speed, and the safety of the operation is ensured, Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Fitterer in view of Miller to including identifying a planned direction of movement of the predefined section using the item of planning information; identify a narrowing of the hollow organ along the planned direction of movement using the preprocedural dataset; and provide the control specification such that the predefined section is configured to move past the narrowing inside a lumen of the hollow organ in accordance with the control specification as taught by Huang because it would have allowed different speed modes can be selected and different strategies are given for different blood vessel conditions and thereby improve the operation efficiency and safety of the operation (Paragraph [0046]).
Regarding claim 18, Fitterer teaches all of the limitations of claim 1 as noted above.
Fitterer does not explicitly teach the deforming of the predefined section comprises a curving of the predefined section, and the curving is a bending and/or bowing of the predefined section along one or more directions.
Miller, however, further teaches the curving is a bending and/or bowing of the predefined section along one or more directions (Paragraph [0096]; the device tip may be programmed to become more or less compliant (e.g. automatically varying tension in pull wires used to articulate the device in bending; Paragraph [0118]; all of the controlled articulation is provided in the lead flexible catheter; Re-centering may then be applied as described above. For example, proximal capacitive sensing and orientation and alignment cues from an inclinometer may be used to help automatically conform to one or more of the desired curves of the G1 tract; Paragraph [0097]; Paragraph [0097]; expected shape of the device may be compared with a measured shape to determine that the device is making contact with tissue. Based on a pre-determined threshold differential between expected and measured shape, the device may be automatically repositioned or automatically made less compliant until the differential is reduced to an acceptable amount; Paragraph [0039]; the term “shape” refers to a set of poses, positions, or orientations measured along an object).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Fitterer such that the curving is a bending and/or bowing of the predefined section along one or more directions as taught by Miller because it would have allowed have allowed the medical device to form and maintain a shape that would allow the object to pass through curvatures of the body (Paragraph [0114]).
Fitterer does not explicitly teach the deforming of the predefined section comprises a curving of the predefined section.
Huang, however, teaches the manipulation of the predefined section comprises a directional curving of the predefined section (Paragraph [0054]; the system calculates how to control the slave-end mechanism 102 to act, and the concrete expression may include calculating the rotation direction, rotation angle, rotation speed, etc. of each motor, and these control information are used as navigation instructions, sending the navigation instructions to the slave-end mechanism 102 of the robot).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Fitterer such that the manipulation of the predefined section comprises a curving of the predefined section as taught by Huang because it would have allowed the automatic navigation instruction to proceed on the confirmed planning path, thereby ensuring the instrument advances toward the target area (Paragraph [0054]).
Regarding claim 19, together Fitterer and Miller teach all of the limitations of claim 10 as noted above.
Fitterer does not explicitly teach the deforming of the predefined section comprises a curving of the predefined section, and wherein the curving is a bending and/or bowing of the predefined section along one or more directions.
Miller, however, further teaches the curving is a bending and/or bowing of the predefined section along one or more directions (Paragraph [0096]; the device tip may be programmed to become more or less compliant (e.g. automatically varying tension in pull wires used to articulate the device in bending; Paragraph [0118]; all of the controlled articulation is provided in the lead flexible catheter; Re-centering may then be applied as described above. For example, proximal capacitive sensing and orientation and alignment cues from an inclinometer may be used to help automatically conform to one or more of the desired curves of the G1 tract; Paragraph [0097]; Paragraph [0097]; expected shape of the device may be compared with a measured shape to determine that the device is making contact with tissue. Based on a pre-determined threshold differential between expected and measured shape, the device may be automatically repositioned or automatically made less compliant until the differential is reduced to an acceptable amount; Paragraph [0039]; the term “shape” refers to a set of poses, positions, or orientations measured along an object).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Fitterer such that the curving is a bending and/or bowing of the predefined section along one or more directions as taught by Miller because it would have allowed have allowed the medical device to form and maintain a shape that would allow the object to pass through curvatures of the body (Paragraph [0114]).
Fitterer does not explicitly teach the deforming of the predefined section comprises a curving of the predefined section.
Huang, however, teaches the manipulation of the predefined section comprises a directional curving of the predefined section (Paragraph [0054]; the system calculates how to control the slave-end mechanism 102 to act, and the concrete expression may include calculating the rotation direction, rotation angle, rotation speed, etc. of each motor, and these control information are used as navigation instructions, sending the navigation instructions to the slave-end mechanism 102 of the robot).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Fitterer such that the manipulation of the predefined section comprises a curving of the predefined section as taught by Huang because it would have allowed the automatic navigation instruction to proceed on the confirmed planning path, thereby ensuring the instrument advances toward the target area (Paragraph [0054]).
Claims 8 are rejected under 35 U.S.C. 103 as being unpatentable over Fitterer in view of Miller and Huang as applied to claims 7 and 12 above, respectively, and further in view of Graetzel (US 20190246882 A1).
Regarding claim 8, together Fitterer in view of Miller and Huang teach all of the limitations of claim 7 as noted above.
Fitterer does not explicitly teach identifying a diameter of the hollow organ at the positioning of the predefined section using the preprocedural dataset;
compare the diameter with a third threshold value; and
provide the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value.
Graetzel, however, teaches identifying a diameter of the hollow organ (Paragraph [1805]; processor identifies a portion of the luminal network along the path having a shape… a diameter of the luminal network) at the positioning of the predefined section using the preprocedural dataset (Paragraph [0096]; Techniques such as center-line geometry may be determined and approximated from the CT images to develop a three-dimensional volume of the patient's anatomy, referred to as preoperative model data 91);
compare the diameter with a third threshold value (Paragraph [0191]; a diameter of the luminal network that is less than a threshold value; Paragraph [0196]; to identify a location along the path at which a diameter of a lumen in the luminal network is within a threshold range of a diameter of the outer body); and
provide the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value (Paragraph [0191]; a diameter of the luminal network that is less than a threshold value; the processor causes, on at least a portion of a set of feedback devices, a parking indication at a position corresponding to the identified portion with respect to the model; Paragraph [0194]; system may be further configured to receive an outer body park instruction to park the outer body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Fitterer in view of Miller and Huang to have included identifying a diameter of the hollow organ at the positioning of the predefined section using the preprocedural dataset; comparing the diameter with a third threshold value; and providing the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value as taught by Graetzel because it would have allowed parking the instrument at a point where the luminal network narrows to a point at which it may be difficult to further advance the outer body (Paragraph [0196]), thereby preventing damage and increasing the safety of the operation.
Regarding claim 13, together Fitterer in view of Miller and Huang teach all of the limitations of claim 12 as noted above.
Fitterer does not explicitly teach a diameter of the hollow organ is identified using the preprocedural dataset at the positioning of the predefined section,
wherein the diameter is compared with a third threshold value, and wherein the control specification is provided such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value.
Graetzel, however, teaches identifying a diameter of the hollow organ (Paragraph [1805]; processor identifies a portion of the luminal network along the path having a shape… a diameter of the luminal network) at the positioning of the predefined section using the preprocedural dataset (Paragraph [0096]; Techniques such as center-line geometry may be determined and approximated from the CT images to develop a three-dimensional volume of the patient's anatomy, referred to as preoperative model data 91);
compare the diameter with a third threshold value (Paragraph [0191]; a diameter of the luminal network that is less than a threshold value; Paragraph [0196]; to identify a location along the path at which a diameter of a lumen in the luminal network is within a threshold range of a diameter of the outer body); and
provide the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value (Paragraph [0191]; a diameter of the luminal network that is less than a threshold value; the processor causes, on at least a portion of a set of feedback devices, a parking indication at a position corresponding to the identified portion with respect to the model; Paragraph [0194]; system may be further configured to receive an outer body park instruction to park the outer body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Fitterer in view of Miller and Huang to have included identifying a diameter of the hollow organ at the positioning of the predefined section using the preprocedural dataset; comparing the diameter with a third threshold value; and providing the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value as taught by Graetzel because it would have allowed parking the instrument at a point where the luminal network narrows to a point at which it may be difficult to further advance the outer body (Paragraph [0196]), thereby preventing damage and increasing the safety of the operation.
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fitterer in view of Miller as applied to claims 1 and 10 above, respectively, and further in view of Graetzel (US 20190246882 A1).
Regarding claim 9, together Fitterer and Miller teach all of the limitations of claim 1 as noted above.
Fitterer does not explicitly teach identifying a diameter of the hollow organ at the positioning of the predefined section using the preprocedural dataset;
compare the diameter with a threshold value; and
provide the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the threshold value.
Graetzel, however, teaches identifying a diameter of the hollow organ (Paragraph [1805]; processor identifies a portion of the luminal network along the path having a shape… a diameter of the luminal network) at the positioning of the predefined section using the preprocedural dataset (Paragraph [0096]; Techniques such as center-line geometry may be determined and approximated from the CT images to develop a three-dimensional volume of the patient's anatomy, referred to as preoperative model data 91);
compare the diameter with a third threshold value (Paragraph [0191]; a diameter of the luminal network that is less than a threshold value; Paragraph [0196]; to identify a location along the path at which a diameter of a lumen in the luminal network is within a threshold range of a diameter of the outer body); and
provide the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value (Paragraph [0191]; a diameter of the luminal network that is less than a threshold value; the processor causes, on at least a portion of a set of feedback devices, a parking indication at a position corresponding to the identified portion with respect to the model; Paragraph [0194]; system may be further configured to receive an outer body park instruction to park the outer body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Fitterer in view of Miller to have included identifying a diameter of the hollow organ at the positioning of the predefined section using the preprocedural dataset; comparing the diameter with a third threshold value; and providing the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value as taught by Graetzel because it would have allowed parking the instrument at a point where the luminal network narrows to a point at which it may be difficult to further advance the outer body (Paragraph [0196]), thereby preventing damage and increasing the safety of the operation.
Regarding claim 14, together Fitterer and Miller teach all of the limitations of claim 10 as noted above.
Fitterer does not explicitly teach a diameter of the hollow organ is identified using the preprocedural dataset at the positioning of the predefined section,
wherein the diameter is compared with a threshold value, and
wherein the control specification is provided such that no additional curvature is specified for the predefined section when the diameter undershoots the threshold value.
Graetzel, however, teaches identifying a diameter of the hollow organ (Paragraph [1805]; processor identifies a portion of the luminal network along the path having a shape… a diameter of the luminal network) at the positioning of the predefined section using the preprocedural dataset (Paragraph [0096]; Techniques such as center-line geometry may be determined and approximated from the CT images to develop a three-dimensional volume of the patient's anatomy, referred to as preoperative model data 91);
compare the diameter with a third threshold value (Paragraph [0191]; a diameter of the luminal network that is less than a threshold value; Paragraph [0196]; to identify a location along the path at which a diameter of a lumen in the luminal network is within a threshold range of a diameter of the outer body); and
provide the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value (Paragraph [0191]; a diameter of the luminal network that is less than a threshold value; the processor causes, on at least a portion of a set of feedback devices, a parking indication at a position corresponding to the identified portion with respect to the model; Paragraph [0194]; system may be further configured to receive an outer body park instruction to park the outer body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Fitterer in view of Miller to have included identifying a diameter of the hollow organ at the positioning of the predefined section using the preprocedural dataset; comparing the diameter with a third threshold value; and providing the control specification such that no additional curvature is specified for the predefined section when the diameter undershoots the third threshold value as taught by Graetzel because it would have allowed parking the instrument at a point where the luminal network narrows to a point at which it may be difficult to further advance the outer body (Paragraph [0196]), thereby preventing damage and increasing the safety of the operation.
Response to Arguments
Claim Rejections under – 35 U.S.C. § 101
Examiner acknowledges the amendments to claim 17 and withdraws all previous rejections under 35 USC 101.
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 102 and 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
10/8/26
Prosecution Insights