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 .
This Office Action is in response to the amendments dated May 21, 2026.
Claims 1-3, 5, 7, 9-20, and 39-40 are pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-2, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Connolly et al. (US PGPUB 2019/0000568 – “Connolly”).
Regarding Claim 1, Rohl discloses:
A non-transitory, computer-readable medium storing instructions thereon that, when executed by one or more processors of a computing system, cause the computing system to perform operations (Rohl FIG. 9, processing device 650; Rohl paragraph [0049], “processing device 650 may comprise a central processing unit and include or be coupled to a non-volatile storage device configured to execute at least a force monitoring process wherein the forces exerted upon control cables are monitored and displayed at a graphic user interface (GUI) 655”) comprising:
moving a distal end portion of the flexible elongate device (Rohl FIG. 1, distal end 135 of flexible catheter 130; Rohl paragraph [0032], “control cables 370 may be coupled to a controller (not shown) configured to apply a drive force or other load, torque, compression or tension to the plurality of cables (either individually or in combination) to control a distal task at the distal end 305 of the shaft.”) to a plurality of distal tip positions by actuating a plurality of control elements (Rohl FIG. 3A, control cables 370) coupled to the distal end portion of the flexible elongate device, wherein the flexible elongate device is configured to be inserted within an anatomic region of a patient (Rohl FIG. 1, showing flexible catheter 130 inserted into a human heart 100), wherein the plurality of distal tip positions includes at least two different distal tip positions (Rohl FIG. 5A, first position of distal end 571 of catheter 570; Rohl FIG. 5B, second position of distal end 571 of catheter 570); and
recording a plurality of measured tensions in the plurality of control elements (Rohl FIG. 11, step 810; Rohl paragraph [0054], “At step 810, the controller measures and stores the received drive cable forces”) while tension is applied to maintain each of the plurality of the distal tip positions (Rohl paragraph [0033], “the measured force may be communicated to and/or sampled by a controller (not shown) coupled to the catheter 300 and used to control a drive force administered to the drive cables 370.”);
determining a correction factor that is based, at least in part, on the plurality of measured tensions (Rohl FIG. 5A, cables 575 and sensors 581, 582; Rohl paragraph [0043], “once the working position is identified, the relative forces upon the cables may be measured by sensors 581, 582 saved as baseline forces associated with a ‘zero’ position of the catheter”); and
steering the flexible elongate device (Rohl paragraph [0011], “The system includes a controller configured to apply one or more drive forces to the plurality of cables to minimize the one or more variances. In various embodiments, the controller comprises one or more of a joystick, a tablet, a trackball, a keyboard, or a touchpad”) by applying the correction factor to a plurality of preload tensions actuating the plurality of control elements (Rohl paragraph [0042], “the catheter disclosed herein is referred to as a ‘zero force’ catheter configured to monitor received forces during use and apply compensating drive forces to maintain a position of a distal end of the catheter to reduce deflections caused by internal and external forces acting upon the catheter during use”).
Rohl does not explicitly disclose calibrating a flexible elongated device based on previous movement of a distal end of the flexible elongated device.
Connolly is analogous art in the field of controlling movement of a flexible elongate device that teaches calibrating a flexible elongated device (Connolly FIG. 2B, shaft 126 having an articulatable region 128; Connolly FIG. 5, drive mechanism 500 having pull wires 556) based on previous movement of a distal end (Connolly FIG. 2B, distal end 132 of shaft 126) of the flexible elongated device (Connolly paragraph [0094], “any change in the tensioning of any of the pull wires 556 can be detected and measured. The drive mechanism 500 can be calibrated such that the strain measured in the strain gauges 554 can be correlated to…the position of the distal end 132”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the movement of the distal end portion of the flexible elongate device, the measured tensions of the control elements, and the correction factor thereof disclosed by Rohl to calibrate the device, as taught by Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a flexible elongate device that is calibrated to detect changes in the position of the distal end of the flexible elongate device (Connolly paragraph [0094], “drive mechanism 500 can be calibrated such that the strain measured in the strain gauges 554 can be correlated to… the position of the distal end 132…Any change in the position of the distal end 132 can thus be detected and/or measured”).
Regarding Claim 2, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl further discloses the plurality of preload tensions are maintained at unequal loads (Rohl FIG. 11, step 820; Rohl paragraph [0054], “At step 820 the controller automatically identifies adjustments for one or more drive forces that would reduce the variances in forces experienced by the control cables.”).
Regarding Claim 10, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl further discloses creating a calibration matrix specifying each of the plurality of measured tensions correlated with a corresponding distal tip position of the plurality of distal tip positions (Rohl FIG. [0039], “tension of distal UP cable 506…modifies the tension of distal DOWN cable 507 to thereby affect the position of the distal end 510 of the catheter 505”. Examiner interprets this process as a one-dimensional calibration matrix for moving the distal tip position of the insertion portion.).
Regarding Claim 14, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl further discloses wherein the plurality of distal tip positions includes a zero tip position (Rohl FIG. 3A, showing distal end 305 of shaft 320 in a zero tip (i.e., axial) position; Examiner notes that paragraph [0083] of the present specification states that the “zero tip position” may be used to refer to “any position from which calibration may start”.).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Connolly et al. (US PGPUB 2019/0000568 – “Connolly”) and Hata et al. (US PGPUB 2015/0088161 – “Hata”).
Regarding Claim 3, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl in view of Connolly does not explicitly teach wherein the plurality of preload tensions are minimum tensions.
Hata is analogous art in the field of endoscope control that teaches wherein the plurality of preload tensions are minimum tensions (Hata paragraph [0117], control tendon “tension has pre-tensioning value to avoid a slack of a tendon”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the use of Hata’s pre-tensioning for avoiding tendon/control cable slack with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscopic device having more responsive control at a beginning of an endoscopic operation.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Connolly et al. (US PGPUB 2019/0000568 – “Connolly”) and Tang et al. (US PGPUB 2021/0213628 – “Tang”).
Regarding Claim 5, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl in view of Connolly does not explicitly teach determining a condition of the flexible elongate device, wherein the correction factor is based at least in part on the condition of the flexible elongate device, wherein the condition of the flexible elongate device is at least one of an age of the flexible elongate device, a number of uses of the flexible elongate device, a number of cleanings of the flexible elongate device, or a number of sterilizations of the flexible elongate device.
Tang is analogous art in the field of endoscope control that teaches determining a condition of the flexible elongate device (Tang FIG. 3, block 640; Tang paragraph [0049], “The step 640 may include a behavioral model of the insertion tube and cable system. The model may represent the behavior of the cable and insertion tube under various levels of tension.”), wherein the correction factor is based at least in part on the condition of the flexible elongate device (Tang paragraph [0049], “a step 640 of adjusting the drive setting… step 640 may include a behavioral model of the insertion tube and cable system. The model may represent the behavior of the cable and insertion tube under various levels of tension. The model may also take into account age or extreme usage of the steering mechanism”), wherein the condition of the flexible elongate device is at least one of an age of the flexible elongate device (Tang paragraph [0049], “The model may also take into account age or extreme usage of the steering mechanism”), a number of uses of the flexible elongate device, a number of cleanings of the flexible elongate device, or a number of sterilizations of the flexible elongate device..
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Tang’s method of adjusting/correcting a tension/drive setting for steering cables in a borescope/endoscope with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a borescope/endoscope having adjustable tension on control cables using a model that is at least partially based on the condition of the steering mechanism (see paragraph [0049] of Tang).
Claims 7 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Connolly et al. (US PGPUB 2019/0000568 – “Connolly”) and Darisse et al. (US PGPUB 2018/0228557 – “Darisse”).
Regarding Claim 7, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl further discloses determining a tool is inserted through a lumen of the flexible elongate device (Rohl FIG. 2B, showing implant component 230 tool inserted through a lumen of catheter 210), and
determining a type of the tool (Rohl FIG. 2A, implant component 230).
Rohl in view of Connolly does not explicitly teach determining the tool affects the asymmetric load condition.
Darisse is analogous art in the field of flexible tube control that teaches determining the tool (Darisse FIG. 52, introduction device 480 having a side tool tube 143b inserted into side flexible tube 144) affects an asymmetric load condition (Darisse paragraph [0999], “introduction device 480 may include multiple coaxial tubes including tool tube 143a, 143b which slidingly receives, or otherwise communicates with, flexible tube 144…tool tube 143a, 143b is more rigid than flexible tube 144 such that flexible tube 144 flexes and tool tube 143a, 143b remains relatively rigid when a tool shaft or other filamentous device that has been inserted into flexible tube 144, has a load applied to it”. Examiner interprets this description as describing an asymmetric load condition created when a tool shaft is inserted into the side flexible tube 144.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the use of Darisse’s stiff side tool channel with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscopic device capable of accommodating treatment tools in a peripheral channel, in order to reserve usage of a main lumen in the endoscope for other purposes (e.g., suction).
Regarding Claim 39, Rohl in view of Connolly teaches the features of Claim 1, as described above.
As described above in the rejection of Claim 1, Rohl in view of Connolly teaches applying a correction factor to the preload tensions when calibrating the flexible elongate device. More broadly, and as described above in the rejection of Claim 1, Connolly calibrates the device using a variety of characteristics of the device, such as movement of the distal end portion of the flexible elongate device and measured tensions of the control elements.
However, Rohl in view of Connolly does not explicitly teach compensating for an asymmetric load at the distal end portion of the flexible elongate device when applying the correction factor.
Darisse is analogous art in the field of lumen control that teaches an asymmetric load at the distal end portion of the flexible elongate device (Darisse FIG. 52, introduction device 480; Darisse paragraph [0999], “introduction device 480 may include multiple coaxial tubes including tool tube 143a, 143b which slidingly receives, or otherwise communicates with, flexible tube 144…tool tube 143a, 143b is more rigid than flexible tube 144 such that flexible tube 144 flexes and tool tube 143a, 143b remains relatively rigid when a tool shaft or other filamentous device that has been inserted into flexible tube 144, has a load applied to it”. Examiner interprets this description as describing an asymmetric load condition created at the distal end of the side flexible tube 144 when a tool tube is inserted into the side flexible tube 144.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate Darisse’s asymmetrical load at the distal end portion of the flexible elongate device into the correction factor taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these
prior art elements according to known methods to yield the predictable result of a method that recognizes the impact of asymmetrical side channels on the calibration state of the main lumen 480 (see Darisse FIG. 52).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Connolly et al. (US PGPUB 2019/0000568 – “Connolly”), Darisse et al. (US PGPUB 2018/0228557 – “Darisse”), and Morimoto (US PGPUB 2016/0089125 – “Morimoto”).
Regarding Claim 9, Rohl in view of Connolly and Darisse teaches the features of Claim 7, as described above.
Rohl in view of Connolly and Darisse does not explicitly teach determining a condition of the tool, wherein the correction factor is based at least in part on the condition of the tool.
Morimoto is analogous art in the field of instrument control that teaches determining a condition of the tool (Morimoto paragraph [0123], “the bending stiffness of the tool treatment led out from the distal end part 34 through a treatment tool insertion channel is large (in a case where the treatment tool is difficult to bend); Examiner interprets the condition of the tool as being stiff), wherein the correction factor is based at least in part on the condition of the tool.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Morimoto’s stiff treatment tool in the method taught by Rohl in view of Connolly and Darisse. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that utilizes a treatment tool that is resistant to outside bending/deformation forces.
Claims 11-13 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Connolly et al. (US PGPUB 2019/0000568 – “Connolly”) and Donhowe et al. (US PGPUB 2018/0235709 – “Donhowe”).
Regarding Claim 11, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl in view of Connolly does not explicitly teach creating a plurality of curves correlating each of the plurality of measured tensions with a corresponding distal tip position of the plurality of distal tip positions.
Donhowe is analogous art in the field of insertion instrument control that teaches creating a plurality of curves correlating each of the plurality of measured tensions with a corresponding distal tip position of the plurality of distal tip positions (Donhowe FIG. 2A, medical instrument 226, having a flexible catheter body 216 with shape sensors 222 and creating curved portions of distal end 218; Donhowe paragraph [0054], “medical instrument 226 may house cables, linkages, or other actuation controls (not shown) that extend between the proximal and distal ends of the instrument to controllably bend the distal end of the instrument”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Donhowe’s steerable insertion portion with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having a six-axis steerable insertion portion of the endoscope.
Regarding Claim 12, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl in view of Connolly does not explicitly teach wherein the plurality of distal tip positions includes a first position and a second position, wherein the second position is in an opposite bending direction from the first position.
Donhowe is analogous art in the field of insertion instrument control that teaches wherein the plurality of distal tip positions includes a first position and a second position, wherein the second position is in an opposite bending direction from the first position (Donhowe FIG. 2A, medical instrument 226, having a flexible catheter body 216 with shape sensors 222 and creating opposing curved portions of distal end 218).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Donhowe’s steerable insertion portion with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having a six-axis steerable insertion portion of the endoscope.
Regarding Claim 13, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl in view of Connolly does not explicitly teach wherein the plurality of distal tip positions includes a first position and a second position, wherein the first position is in a yaw direction and the second position is in a pitch direction.
Donhowe is analogous art in the field of insertion instrument control that teaches wherein the plurality of distal tip positions includes a first position and a second position, wherein the first position is in a yaw direction and the second position is in a pitch direction (Donhowe FIG. 6A, distal tip 618 of catheter 610; Donhowe paragraph [0076], “control signals may cause actuation of control members extending within the surgical instrument to move the distal tip 618 in a range of movements including yaw, pitch, and roll.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Donhowe’s steerable insertion portion with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having a six-axis steerable insertion portion of the endoscope.
Regarding Claim 17, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl in view of Connolly does not explicitly teach wherein the plurality of distal tip positions are each a commanded distal tip position.
Donhowe is analogous art in the field of insertion instrument control that teaches wherein the plurality of distal tip positions are each a commanded distal tip position (Donhowe FIG. 2A showing a plurality of commanded distal tip positions 219 of distal end 218 of flexible catheter body 216, which is controlled by control system 112 shown in Donhowe FIG. 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Donhowe’s steerable insertion portion with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having a six-axis steerable insertion portion of the endoscope.
Regarding Claim 18, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl in view of Connolly does not explicitly teach wherein the plurality of distal tip positions are determined based on data from a sensor coupled to the distal end portion of the flexible elongate device.
Donhowe is analogous art in the field of insertion instrument control that teaches wherein the plurality of distal tip positions are determined based on data from a sensor coupled to the distal end portion of the flexible elongate device (Donhowe FIG. 2A, medical instrument 226, having a flexible catheter body 216 with shape sensors 222 and creating curved portions of distal end 218; Donhowe paragraph [0054], “medical instrument 226 may house cables, linkages, or other actuation controls (not shown) that extend between the proximal and distal ends of the instrument to controllably bend the distal end of the instrument”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Donhowe’s steerable insertion portion with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having a six-axis steerable insertion portion of the endoscope.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Connolly et al. (US PGPUB 2019/0000568 – “Connolly”) and Romo et al. (US PGPUB 2016/0184032 – “Romo”).
Regarding Claim 15, Rohl in view of Connolly teaches the features of Claim 1, as described above.
Rohl in view of Connolly does not explicitly teach wherein moving the distal end portion of the flexible elongate device includes moving the distal end portion to the plurality of distal tip positions at a plurality of different velocities.
Romo is analogous art in the field of insertion instrument movement control that teaches wherein moving the distal end portion of the flexible elongate device includes moving the distal end portion to the plurality of distal tip positions at a plurality of different velocities (Romo FIG. 17B, robotic catheter 1704; Romo paragraph [0189], “Robotic catheter 1704 may comprise a shaft 1709 with a distal tip and proximal end. A tool base 1710 for receiving the control signals and drive from IDM 1703 may be coupled to the proximal end of the shaft 1709. Through the signals received by the tool base 1710, the shaft 1709 of robotic catheter 1704 may be controlled, manipulated, and directed based on the angular motion transmitted via output shafts 1705, 1706, 1707, and 1708”; Romo paragraph [0262], “a 3-axis MEMS-based sensor chip with an accelerometer may be coupled near the tip of the catheter, on the same printed circuit board as the digital camera. The accelerometer measures the linear acceleration along the three different axes to calculate the velocity and direction of the catheter tip.“; Examiner interprets these passages as teaching the accelerometer is capable of measuring different velocities at different directions of movement of the catheter tip.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Romo’s method of measuring tip movement with the method taught by Rohl in view of Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method capable of identifying/measuring tip movement velocity in order to avoid excessive tip velocities that could injure a patient’s lumen.
Regarding Claim 16, Rohl in view of Connolly and Romo teaches the features of Claim 15, as described above.
Romo further teaches wherein calibrating the flexible elongate device further comprises recording the plurality of different velocities (Romo FIG. 4A, module 402; Romo paragraph [0135], “Each…module may comprise an independent drive system, which may include a motor. They may contain…memory chips that record their calibration and application related information. A system calibration check may be required after a new mechanism is connected to the robot arm. In some embodiments, a module may control an associated sheath, catheter leader, or flexible endoscope.”
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Romo’s method of recording endoscopic positions with the method of Claim 15 as taught by Rohl in view Connolly and Romo. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that can self-calibrate during future usages (see paragraphs [0135] and [0203] of Romo).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Donhowe et al. (US PGPUB 2018/0235709 – “Donhowe”) in view of Weitzner et al. (US PGPUB 2019/0167950 – “Weitzner”), Rohl et al. (US PGPUB 2020/0384243 – “Rohl”), and Connolly et al. (US PGPUB 2019/0000568 – “Connolly”).
Regarding Claim 19, Donhowe discloses:
A medical instrument system (Donhowe FIG. 1, teleoperational assembly 102) comprising:
a plurality of actuators (Donhowe paragraph [0035], “teleoperational assembly 102 includes plurality of actuators or motors that drive inputs on the medical instrument system 104 in response to commands from the control system (e.g., a control system 112).”);
a medical instrument (Donhowe FIG. 2A, medical instrument system 200) comprising:
a flexible body (Donhowe FIG. 2A, elongated flexible catheter body 216) having a distal end portion (Donhowe FIG. 2A, distal end 218),
a plurality of lumens along the flexible body (Donhowe paragraph [0055, “one or more lumens, through which medical instruments can be deployed and used at a target surgical location, are defined in the walls of the flexible body 216”), and
a plurality of control elements, each control element coupling the distal end portion to an actuator of the plurality of actuators such that the plurality of actuators is operable to apply tension to the plurality of control elements to move the distal end portion (Donhowe paragraph [0035], “teleoperational assembly 102 includes plurality of actuators or motors that drive inputs on the medical instrument system 104 in response to commands from the control system (e.g., a control system 112).).
Donhowe does not explicitly disclose wherein the plurality of lumens includes at least one lumen associated with an asymmetric load.
Weitzner is analogous art in the field of insertion instrument control that teaches wherein the plurality of lumens includes at least one lumen associated with an asymmetric load (Weitzner FIG. 2, support beam 1160 within unlabeled lumen inside multi-lumen catheter 1110; Weitzner paragraph [0070], “The stabilizing or rigidifying structure may be independently and/or selectively actuated into or out of the lumen of the support beam 1160 by movement of a stiffening actuator on and/or in the handle housing 1130 to change the rigidity and/or stiffness of the support beam 1160.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine use of Weitzner’s adjustably rigid offset beam/lumen with the system disclosed by Donhowe. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an insertion portion having an offset rigidity beam, in order to leave other axial areas unoccupied for use by other instruments/lumen.
Donhowe in view of Weitzner does not explicitly teach:
a control system operably connected to the plurality of actuators, the control system being configured to execute operations comprising:
moving the distal end portion of the medical instrument to a plurality of distal tip positions by actuating the plurality of control elements, wherein the plurality of distal tip positions includes at least two different distal tip positions;
recording a plurality of measured tensions in the plurality of control elements while tension is applied to maintain each of the plurality of distal tip positions, wherein the correction factor is determined/based, at least in part, on the plurality of measured tensions; and
steering the medical instrument by applying the correction factor to a plurality of preload tensions actuating the plurality of control elements.
Rohl teaches:
a control system (Rohl FIG. 3A, control cables 370 on catheter 300; Rohl paragraph [0032], “control cables 370 may be coupled to a controller (not shown) configured to apply a drive force or other load, torque, compression or tension to the plurality of cables (either individually or in combination) to control a distal task at the distal end 305 of the shaft“) operably connected to the plurality of actuators (Rohl FIG. 4, motors 520, 530), the control system being configured to execute operations for determining a correction factor comprising: moving the distal end portion of the medical instrument to a plurality of distal tip positions by actuating the plurality of control elements (Rohl paragraph [0032], “control cables 370 may be coupled to a controller (not shown) configured to apply a drive force or other load, torque, compression or tension to the plurality of cables (either individually or in combination) to control a distal task at the distal end 305 of the shaft“), wherein the plurality of distal tip positions includes at least two different distal tip positions (Rohl FIG. 5A, first position of distal end 571 of catheter 570; Rohl FIG. 5B, second position of distal end 571 of catheter 570);
recording a plurality of measured tensions in the plurality of control elements (Rohl FIG. 11, step 810; Rohl paragraph [0054], “At step 810, the controller measures and stores the received drive cable forces”) while tension is applied to maintain each of the plurality of the distal tip positions (Rohl paragraph [0033], “the measured force may be communicated to and/or sampled by a controller (not shown) coupled to the catheter 300 and used to control a drive force administered to the drive cables 370.”), wherein the correction factor is determined/based, at least in part, on the plurality of measured tensions (Rohl FIG. 5A, cables 575 and sensors 581, 582; Rohl paragraph [0043], “once the working position is identified, the relative forces upon the cables may be measured by sensors 581, 582 saved as baseline forces associated with a ‘zero’ position of the catheter”); and
steering the flexible elongate device (Rohl paragraph [0011], “The system includes a controller configured to apply one or more drive forces to the plurality of cables to minimize the one or more variances. In various embodiments, the controller comprises one or more of a joystick, a tablet, a trackball, a keyboard, or a touchpad”) by applying the correction factor to a plurality of preload tensions actuating the plurality of control elements (Rohl paragraph [0042], “the catheter disclosed herein is referred to as a ‘zero force’ catheter configured to monitor received forces during use and apply compensating drive forces to maintain a position of a distal end of the catheter to reduce deflections caused by internal and external forces acting upon the catheter during use”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Rohl’s control system that performs the moving, recording, and steering processes described above with the system taught by Donhowe in view of Weitzner. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that is able to maintain tension in controls cables for a particular positioning of a catheter (see Rohl FIG. 10.)
Donhowe in view of Weitzner and Rohl does not explicitly teach calibrating a flexible elongated device based on previous movement of a distal end of the flexible elongated device.
Connolly is analogous art in the field of controlling movement of a flexible elongate device that teaches calibrating a flexible elongated device (Connolly FIG. 2B, shaft 126 having an articulatable region 128; Connolly FIG. 5, drive mechanism 500 having pull wires 556) based on previous movement of a distal end (Connolly FIG. 2B, distal end 132 of shaft 126) of the flexible elongated device (Connolly paragraph [0094], “any change in the tensioning of any of the pull wires 556 can be detected and measured. The drive mechanism 500 can be calibrated such that the strain measured in the strain gauges 554 can be correlated to…the position of the distal end 132”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the movement of the distal end portion of the flexible elongate device, the measured tensions of the control elements, and the correction factor thereof taught by Rohl to calibrate the device, as taught by Donhowe in view of Weitzner and Rohl. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a flexible elongate device that is calibrated to detect changes in the position of the distal end of the flexible elongate device (Connolly paragraph [0094], “drive mechanism 500 can be calibrated such that the strain measured in the strain gauges 554 can be correlated to… the position of the distal end 132…Any change in the position of the distal end 132 can thus be detected and/or measured”).
Regarding Claim 20, Donhowe in view of Weitzner, Rohl, and Connolly teaches the features of Claim 19, as described above.
Rohl further teaches the plurality of preload tensions are maintained at unequal loads (Rohl FIG. 11, step 820; Rohl paragraph [0054], “At step 820 the controller automatically identifies adjustments for one or more drive forces that would reduce the variances in forces experienced by the control cables.”).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Donhowe et al. (US PGPUB 2018/0235709 – “Donhowe”) in view of Weitzner et al. (US PGPUB 2019/0167950 – “Weitzner”), Rohl et al. (US PGPUB 2020/0384243 – “Rohl”), Connolly et al. (US PGPUB 2019/0000568 – “Connolly”), and Darisse et al. (US PGPUB 2018/0228557 – “Darisse”).
Regarding Claim 40, Donhowe in view of Weitzner, Rohl, and Connolly teaches the features of Claim 19, as described above.
As described above in the rejection of Claim 19, Donhowe in view of Weitzner, Rohl, and Connolly, particularly Rohl in view of Connolly, teaches applying a correction factor to the preload tensions when calibrating the flexible elongate device. More broadly, and as described above in the rejection of Claim 19, Connolly calibrates the device using a variety of characteristics of the device, such as movement of the distal end portion of the flexible elongate device and measured tensions of the control elements.
However, Donhowe in view of Weitzner, Rohl, and Connolly does not explicitly teach the correction factor being further based on an asymmetric load at the distal end portion of the medical instrument.
Darisse is analogous art in the field of lumen control that teaches an asymmetric load at the distal end portion of the medical instrument (Darisse FIG. 52, introduction device 480; Darisse paragraph [0999], “introduction device 480 may include multiple coaxial tubes including tool tube 143a, 143b which slidingly receives, or otherwise communicates with, flexible tube 144…tool tube 143a, 143b is more rigid than flexible tube 144 such that flexible tube 144 flexes and tool tube 143a, 143b remains relatively rigid when a tool shaft or other filamentous device that has been inserted into flexible tube 144, has a load applied to it”. Examiner interprets this description as describing an asymmetric load condition created at the distal end of the side flexible tube 144 when a tool tube is inserted into the side flexible tube 144.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate Darisse’s asymmetrical load at the distal end portion of the flexible elongate device into the correction factor taught by Donhowe in view of Weitzner, Rohl, and Connolly. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical instrument system that recognizes the impact of asymmetrical side channels on the calibration state of the main lumen 480 (see Darisse FIG. 52).
Response to Arguments
Applicant’s arguments, see page 7, filed May 21, 2026, with respect to the rejection of Claims 5 and 7-8 under 35 U.S.C. 112(b) have been fully considered and are persuasive in view of the amendments to Claims 1 and 7 and the rejection of Claim 8. The rejection of Claims 5 and 7-8 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see pages 7-14, filed May 21, 2026, with respect to the rejection(s) of Claims 1-3, 5, 7; and 9-20 under 35 U.S.C. 102/103 have been fully considered and are persuasive. Therefore, the rejection of Claims 1-3, 5, 7; and 9-20 under 35 U.S.C. 102/103 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Connolly et al. (US PGPUB 2019/0000568 – “Connolly”). All of Applicant’s arguments are directed to the newly-added feature to independent Claims 1 and 19 of “calibrating a flexible elongate device”. This feature is taught a combination of previously-cited prior art and Connolly, as described in the rejections herein. No other arguments are presented by Applicant.
As such, the rejection of Claims 1-3, 5, 7, and 9-20 under 35 U.S.C. 103 are maintained, as well as the rejection of new Claims 39-40 under 35 U.S.C. 103.
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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan 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.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
6/26/26
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