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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 2, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 is rejected for claiming “a condition of the flexible elongate device” in line 3. The term “a condition of the flexible elongate device” is not defined in the specification. Paragraph [0098] of the present specification provides examples of information that describes a condition of a flexible elongate device (e.g., age, number of uses, number of cleanings, number of sterilizations, etc.). However, these examples are non-limiting (“e.g.”), and do not define the term “a condition of the flexible elongate device”. As such, the phrase “a type of the type” is indefinite since “the boundaries of the protected subject matter are not clearly delineated and the scope is unclear”. MPEP 2173.04
See also Examiner’s response to Applicant’s arguments in the “Response to Arguments” section below.
Examiner notes that dependent Claim 6 overcomes this 112(b) rejection for Claim 6, but not Claim 5 itself.
Appropriate correction by Applicant is required.
For purposes of examination, Examiner interprets the phrase “a condition of the flexible elongate device” as any descriptor of the flexible elongate device (e.g., single-use, make, model, weight, etc.).
Claim 7 is rejected for claiming “a type of the tool” in line 4. The claim and specification do not define “a type of the tool”, nor does the specification provide examples of different tool types. More specifically, the “type” of tool is never defined, nor are examples of different “types” of tools ever provided in the present patent application. As such, the phrase “a type of the type” is indefinite since “the boundaries of the protected subject matter are not clearly delineated and the scope is unclear”. MPEP 2173.04
See also Examiner’s response to Applicant’s arguments in the “Response to Arguments” section below.
Claim 8 is also rejected for depending on Claim 7 and for further claiming “the type of the tool”.
Appropriate correction by Applicant is required.
For purposes of examination, Examiner interprets “a type of the tool” as a tool type of any type of tool.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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. 102(1)(2) as being anticipated by Rohl et al. (US PGPUB 2020/0384243 – “Rohl”).
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:
receiving a signal to move a distal end portion of a 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.”);
storing 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”).
Regarding Claim 2, Rohl discloses 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 discloses the features of Claim 1, as described above.
Rohl further disclosed 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 discloses 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 Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Hata et al. (US PGPUB 2015/0088161 – “Hata”).
Regarding Claim 3, Rohl discloses the features of Claim 1, as described above.
Rohl does not explicitly disclose wherein the plurality of preload tensions are minimum tensions.
Hata 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 disclosed by 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 an endoscopic device having more responsive control at a beginning of an endoscopic operation.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Tang et al. (US PGPUB 2021/0213628 – “Tang”).
Regarding Claim 5, Rohl discloses the features of Claim 1, as described above.
Rohl does not explicitly disclose 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.
Tang 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”).
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 disclosed by 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 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).
Regarding Claim 6, Rohl in view of Tang teaches the features of Claim 5, as described above.
Tang further teaches 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Darisse et al. (US PGPUB 2018/0228557 – “Darisse”).
Regarding Claim 7, Rohl discloses 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 does not explicitly disclose determining the tool affects the asymmetric load condition.
Darisse further 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 disclosed by 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 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).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) in view of Darisse et al. (US PGPUB 2018/0228557 – “Darisse”) and Morimoto (US PGPUB 2016/0089125 – “Morimoto”).
Regarding Claim 8, Rohl in view of Darisse teaches the features of Claim 7, as described above.
Rohl in view of Darisse do not explicitly teach wherein the correction factor is based, at least in part, on the type of the tool.
Morimoto teaches wherein the correction factor is based, at least in part, on the type of the tool (Morimoto FIG. 1, distal end part 34 of insertion part 10; 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)”).
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 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.
Regarding Claim 9, Rohl in view of Darisse and Morimoto teach the features of Claim 8, as described above.
Morimoto further 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.
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 Donhowe et al. (US PGPUB 2018/0235709 – “Donhowe”).
Regarding Claim 11, Rohl discloses the features of Claim 1, as described above.
Rohl does not explicitly disclose 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 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 disclosed by 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 an endoscope having a six-axis steerable insertion portion of the endoscope.
Regarding Claim 12, Rohl discloses the features of Claim 1, as described above.
Rohl does not explicitly disclose 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 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 disclosed by 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 an endoscope having a six-axis steerable insertion portion of the endoscope.
Regarding Claim 13, Rohl discloses the features of Claim 1, as described above.
Rohl does not explicitly disclose 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 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 disclosed by 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 an endoscope having a six-axis steerable insertion portion of the endoscope.
Regarding Claim 17, Rohl discloses the features of Claim 1, as described above.
Rohl does not explicitly disclose wherein the plurality of distal tip positions are each a commanded distal tip position.
Donhowe 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 disclosed by 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 an endoscope having a six-axis steerable insertion portion of the endoscope.
Regarding Claim 18, Rohl discloses the features of Claim 1, as described above.
Rohl does not explicitly disclose 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 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 disclosed by 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 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 Romo et al. (US PGPUB 2016/0184032 – “Romo”).
Regarding Claim 15, Rohl discloses the features of Claim 1, as described above.
Rohl does not explicitly disclose wherein receiving the signal to move 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 teaches wherein receiving the signal to move 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 disclosed by 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 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 Romo teaches the features of Claim 15, as described above.
Romo further teaches wherein the operations further comprise 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 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”) and Rohl et al. (US PGPUB 2020/0384243 – “Rohl”).
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 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 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, 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 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 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.)
Regarding Claim 20, Donhowe in view of Weitzner and Rohl 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.”).
Response to Arguments
Applicant's arguments on pages 6-8, filed March 2, 2026, with respect to the rejection of Claim 5 under 35 U.S.C. 112(b), based on claiming the element “a condition of the flexible elongate device”, have been fully considered but they are not persuasive.
Examiner agrees that MPEP 2173.02 requires claims to be read in light of the specification, and not that limitations of the specification can/should be read into the claims. Furthermore, Examiner appreciates Applicant’s highlighting sections of MPEP 2173.04 to clarify Applicant’s position that broad claims are not necessarily indefinite. However, Examiner notes that MPEP 2173.04 also states:
A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim).
In other words, a claim can be broad provided that the scope (i.e., the extent of the area or subject matter that something deals with or to which it is relevant) is clear. Claim 5, when read in light of the specification, does not identify the scope of “a condition of the flexible elongate device”. As such, the claim is indefinite since the scope of the element is unclear, and a potential infringer would not be put on notice as to what a patent would cover.
Therefore, the rejection of Claim 5 under 35 U.S.C. 112(b) is maintained.
Applicant's arguments on pages 8-9, filed March 2, 2026, with respect to the rejection of Claim 7 under 35 U.S.C.112(b), for using the phrase “a type of the tool”, have been fully considered but they are not persuasive.
Applicant first makes a similar argument based on MPEP 2173.02 that Examiner refutes above in the response to the rejection of Claim 5 under 35 U.S.C. 112(b). That is, Claim 7, when read in light of the specification, does not identify the scope of “a type of the tool”. As such, the claim is indefinite since the scope of the element is unclear, and a potential infringer would not be put on notice as to what a patent would cover.
On page 9, Applicant further cites MPEP 2173.02 for support for Applicant’s position that “a type of the tool” is clear. As cited by Applicant, MPEP 2173.02 states that whether the claim meets the threshold requirements of clarity and precision set forth in the statute. The statute 35 U.S.C. 112(b) requires “particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention”. Since the claim and/or specification do not define what the term “type” means when describing a tool, Examiner refers to a dictionary (Dictionary.com, https://web.archive.org/web/20190717222648/https://www.dictionary.com/browse/type), which defines “type” as:
(1) a number of things or persons sharing a particular characteristic, or set of characteristics, that causes them to be regarded as a group, more or less precisely defined or designated; class; category; or
(2) a thing or person regarded as a member of a class or category; kind; sort.
These definitions, when read in view of the claim language and/or in light of the specification, do not provide the requisite level of definiteness required to satisfy MPEP 2173.02. That is, definition (1) says that a “type” is a number of things that share a particular characteristic, but the definition and/or the present claim and/or the present specification do not define what these shared characteristics are. Therefore, it is unclear if the shared characteristics are shape, size, color, weight, age, construction materials, etc. Definition (2) provides no clarity, since it only defines “type” as a thing regarded as a member of a class or category. This definition and/or the present claim and/or the present specification do not define what class or category is used to define the “type of tool”. As such, the claim is indefinite since the scope of the element is unclear, and a potential infringer would not be put on notice as to what a patent would cover.
Therefore, the rejection of Claim 5 under 35 U.S.C. 112(b) is maintained.
Applicant’s arguments, see pages 9-13, filed March 2, 2026, with respect to the rejection(s) of Claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, in view of the present amendments, is made in view of Rohl et al. (US PGPUB 2020/0384243 – “Rohl”) under 35 U.S.C. 102(a)(2). Therefore, the arguments directed towards Darisse et al. (US PGPUB 2018/0228557 – “Darisse”) in the rejection of Claim 1 under 35 U.S.C. 103 are moot.
As such, the rejection of Claims 1-2, 10, and 14 under 35 U.S.C. 102(a)(2), as well as the rejections of Claims 3-9, 11-13, and 15-18 under 35 U.S.C. 103 are maintained for reasons presented in the rejection of Claim 1 under 35 U.S.C. 102 above.
Applicant’s arguments, see pages 13-14, filed March 2, 2026, with respect to the rejection(s) of Claim 19 under 35 U.S.C. 103 have been fully considered and are persuasive, including the arguments directed towards Darisse et al. (US PGPUB 2018/0228557 – “Darisse”). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is now made under 35 U.S.C. 103 based on Donhowe et al. (US PGPUB 2018/0235709 – “Donhowe”) in view of Weitzner et al. (US PGPUB 2019/0167950 – “Weitzner”) and Rohl et al. (US PGPUB 2020/0384243 – “Rohl”), without Darisse, as described above in the rejection of Claim 19 under 35 U.S.C. 103.
As such, the rejection of Claims 19-20 under 35 U.S.C. 103 are maintained.
Finally, Examiner points out that the “zero force” catheter disclosed in Rohl does not mean that there is zero tension/force on the control cables. Rather, Rohl teaches “zeroing” a controller (e.g., a joystick) to compensate for pre-tension applied to control wires. See Rohl FIGs. 5A/5B, 9, and 10, and relevant written descriptions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure includes:
Blumenkranz (US PGPUB 2014/0257333 – “Blumenkranz”), which teaches in Blumenkranz FIG. 13b and Blumenkranz paragraph [0098] pre-loading tension in control wires in drive components 756a, 756b by the use of torsion springs 762, 764.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/21/2026