The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 8, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection.
As argued on page 8 of the remarks: (i) ”the classifying amendment requiring that the second parameter defines (rather than ‘is related to’) the curvature makes it unambiguous that the control scheme relies on shape rather than distal portion position/orientation”, and (ii) “Connolly fails to disclose a control of an articulation ‘to change the articulation.’ Instead, Connelly discloses a locking of the distal end at its target position.”
With regard to (i) above, it is noted that the previous rejection of the claims over Connolly relied upon an electromagnetic (EM) tracking system for the one or more sensors to sense a first parameter and, therefore utilized the data from this tracking system for determining the second parameter. However, the new rejection below discusses a different aspect of Connolly for this reason, specifically the use of strain gauges (see rejections below).
With regard to (ii) above, while the examiner agrees that Connolly teaches to “lock” the distal end at a certain position, this “locking” is done by modifying the tension in the pull wires. With this “lock” being used by Connolly, the distal end (or articulable portion) would deflect from its current/previous position. Therefore, the “locking” described by Connolly, in fact, requires “control [of] the one or more actuators to change the articulation of the articulable portion based at least in part on the determined second parameter”, because again, if this control was not actuated then the articulable portion would deflect naturally. Therefore, keeping it in its current/previous position actually requires changing the natural deflection. This function by Connolly is specifically relevant to the claimed invention, as this is exactly what is claimed in the second option of claim 13, which depends from claim 1 (i.e., “the control of the actuators causes at least one of … a decrease in a bend angle of the one or more portions of articulable portion.”).
For at least these reasons, the rejections that follow are applicable.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-6, 13-14, 16 and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Connolly et al. (US Patent Pub. No. 2019/0000568).
Regarding claim 1, Connolly discloses instrument insertion compensation (see Title) which aims to solve the challenge where “with existing flexible instruments for surgical purposes is that advancing or extending an insertable instrument through the working channel of the flexible instrument can cause deflection of the flexible instrument such that its distal end is moved from a target position. As the result of such deflection, the distal end of the flexible instrument can be misaligned with the tissue site” (see paragraph 6). As such, Connolley teaches a medical system comprising:
an elongated body including a channel extending through the elongated body, wherein the elongated body includes an articulable portion extending along at least a portion of a length of the elongated body (“FIG. 1 illustrates an embodiment of a robotic system 100 configured to facilitate performing medical procedure(s) at a distance, such as within a lumen of a patient. The system 100 may comprise flexible instruments, such as a sheath 120 and a leader 130 through which an insertable instrument 140 can be inserted” - see paragraph 43-44 and Figure 1; also paragraph 45 discusses that “The distal end 122 can be guided through the lumen of the patient by articulating the articulable region 128 (e.g., via the use of one more pull wires”));
one or more actuators operatively coupled to the articulable portion of the elongated body by one or more flexible tethers, wherein the one or more actuators are configured to apply a tension to the one or more flexible tethers to articulate the articulable portion of the elongated body (“[T]he leader 130 and the sheath 120 are each coupled to a separate drive mechanism 154, 164, with each drive mechanism coupled to the distal end of a robotic arm 150, 160” -see paragraph 43, also see paragraph 50-51 which uses the word actuators when discussing the first and second robot; “The drive mechanism 154 can be configured to manipulate the positioning of the sheath 120… As described further below with reference to FIG. 5, the drive mechanism 154 can also be configured to manipulate the tensioning of pull wires to articulate the articulable region 128” - see paragraph 49);
one or more sensors configured to sense a first parameter related to a shape of the articulable portion of the elongated body (see strain gauges discussed in paragraphs 93-94, where “any change in the tensioning of any of the pull wires 556 can be detected and measured” by the strain gauges, and this measured strain “can be correlated to a position of the leader 130, such as the position of the distal end 132 and/or the deflection angle 116 of the articulable region 128”, which therefore teaches that the strain relates to a shape; and
a processor operatively coupled with the one or more actuators and the one or more sensors, wherein the processor is configured to:
determine a second parameter that defines related to a curvature of one or more portions of the articulable portion based at least in part on the sensed first parameter (see paragraphs 93-94, where “any change in the tensioning of any of the pull wires 556 can be detected and measured” by the strain gauges, and this measured strain “can be correlated to a position of the leader 130, such as … the deflection angle 116 of the articulable region 128”); and
during relative movement between the channel of the elongated body and a tool disposed in the channel, control the one or more actuators to change the articulation of the articulable portion based at least in part on the determined second parameter (see paragraph 95, which teaches that the use of these stain gauges and their measurements can be used to determine/measure “deflection of the leader 130, such as by the insertion of an insertable instrument 140 within a working channel 139 or through an articulable region 138 of the leader 130”; additionally, paragraph 83 teaches that “The pull wires 556 can control the articulation angle 116 and direction of the articulable region 138. Once the distal end 132 of the leader 130 is at the target position 118, in some embodiments, the pull wires 556 can be locked in place to maintain the distal end in a desired position or orientation, for example, corresponding to the target position 118 described above with reference to FIG. 2B. Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased.” These quotes from paragraphs 83 and 120 teach that during insertion of an instrument 140 through the working channel of the leader 130, control signals may be sent to the actuators that control the pull wires to “lock” the distal end 132 at its target/desired position, since “Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased”).
Regarding claim 3, it is noted that paragraph 120 states that “block 820 may involve detecting, based on a data signal from at least one sensor, a position change of the distal end 132 of the leader 130 from the initial position, e.g., in response to insertion of an insertable instrument 140 into a working channel 139 of the leader 130. Any of the above-described tracking systems for monitoring the position of the distal end 132 can be used to detect the deflection of the distal end 132. The controller can receive data indicating a deflection from the tension sensing system. For example, … the tension sensing system 500 can relay data from the strain sensors 554 indicating a change in the articulation angle 116 of the articulable region 138 to the controller.”
Regarding claim 4, it is re-iterated that paragraph 83 teaches that “The pull wires 556 can control the articulation angle 116 and direction of the articulable region 138. Once the distal end 132 of the leader 130 is at the target position 118, in some embodiments, the pull wires 556 can be locked in place to maintain the distal end in a desired position or orientation, for example, corresponding to the target position 118 described above with reference to FIG. 2B. Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased.” As shown in Figure 2B, this example illustrates that the initial position 118 has been deflected to position 119. Therefore, the “locking” of the distal end that would be used to correct this deflection would result in the decreasing the deflected angle 116a to the original angle 116, thereby reading on claim 4.
Regarding claim 5, it is noted that the “locking” of the distal end results in the system “returning” the articulable portion to a commanded bend angle when the tool is fully inserted or removed from the elongated body, as claimed, since the locking of the distal end keeps the distal end at a specific position before, during and after the instrument is inserted/removed.
Regarding claim 6, Connolly teaches that “the one or more processors are configured to execute the instructions to cause the system to: determine an articulation angle of the articulable region of the shaft; and generate the at least one control signal further based on the articulation angle” (see paragraph 150, emphasis added).
Regarding claim 13, it is re-iterated that the quotes from paragraphs 83 and 120 discussed in the rejection of claim 1 teach that during insertion of an instrument 140 through the working channel of the leader 130, control signals may be sent to the actuators that control the pull wires to “lock” the distal end 132 at its target/desired position, since “Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased” (see paragraph 83). Also, paragraph 83 teaches that “The pull wires 556 can control the articulation angle 116 and direction of the articulable region 138. Once the distal end 132 of the leader 130 is at the target position 118, in some embodiments, the pull wires 556 can be locked in place to maintain the distal end in a desired position or orientation, for example, corresponding to the target position 118 described above with reference to FIG. 2B. Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased.” As shown in Figure 2B, this example illustrates that the initial position 118 has been deflected to positions 119. Therefore, the “locking” of the distal end that would be used to correct this deflection would result in the decreasing the deflected angle 116a to the original angle 116, thereby reading on “a decrease in the bend angle of the one or more portions of articulable portion.”
Regarding claims 14 and 21, Connolly teaches within paragraph 119 that an initial position of a distal end 132 of leader 130 may be detected by the electrical strain gauges, and in paragraph 120, “At block 820, the system 100 can detect, based on a data signal from at least one sensor, a position change (e.g., deflection) of the distal end of the shaft in response to insertion of a second instrument into the working channel of the first instrument. For example, block 820 may involve detecting, based on a data signal from at least one sensor, a position change of the distal end 132 of the leader 130 from the initial position, e.g., in response to insertion of an insertable instrument 140 into a working channel 139 of the leader 130. Any of the above-described tracking systems for monitoring the position of the distal end 132 can be used to detect the deflection of the distal end 132.” Paragraphs 93-94 teach that “any change in the tensioning of any of the pull wires 556 can be detected and measured” by strain gauges, and this measured strain “can be correlated to a position of the leader 130, such as … the deflection angle 116 of the articulable region 128”, which teaches is “determining a parameters that defines a curvature of one or more portions of the articulable portion of an elongate body including a channel extending through the elongated body”. Also, this quote from paragraph 120 teaches that this detection is “in response to insertion of a second instrument into the working channel of the first instrument. For example, block 820 may involve detecting, based on a data signal from at least one sensor, a position change of the distal end 132 of the leader 130 from the initial position, e.g., in response to insertion of an insertable instrument 140 into a working channel 139 of the leader 130”, which teaches that it was determined that there was a relative movement between a tool disposed in the channel and the channel has occurred, as claimed. Finally, paragraph 83 teaches that “The pull wires 556 can control the articulation angle 116 and direction of the articulable region 138. Once the distal end 132 of the leader 130 is at the target position 118, in some embodiments, the pull wires 556 can be locked in place to maintain the distal end in a desired position or orientation, for example, corresponding to the target position 118 described above with reference to FIG. 2B. Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased.” These quotes from paragraphs 83 and 120 teach that during insertion of an instrument 140 through the working channel of the leader 130, control signals may be sent to the actuators that control the pull wires to “lock” the distal end 132 at its target/desired position, since “Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased” (see paragraph 83). This reads on the “during the determined presence of the relative movement, controlling articulation of the articulable portion based at least in part on the determined parameter.
Regarding claim 16, it is re-iterated that paragraph 83 teaches that “The pull wires 556 can control the articulation angle 116 and direction of the articulable region 138. Once the distal end 132 of the leader 130 is at the target position 118, in some embodiments, the pull wires 556 can be locked in place to maintain the distal end in a desired position or orientation, for example, corresponding to the target position 118 described above with reference to FIG. 2B. Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased.” As shown in Figure 2B, this example illustrates that the initial position 118 has been deflected to positions 119. Therefore, the “locking” of the distal end that would be used to correct this deflection would result in the decreasing the deflected angle 116a to the original angle 116, thereby reading on claim 4. It is also noted that the “locking” of the distal end results in the system “returning” the articulable portion to a commanded bend angle when the tool is fully inserted through the elongated body, as claimed, since the locking of the distal end keeps the distal end at a specific position before, during and after the instrument is inserted/removed. Additionally, as the instrument is withdrawn or removed from the leader, the system would relieve the added tension on the pull wires in order to keep the distal end 132 “locked” at the target position. As such, this reads on the limitations of claim 16.
Regarding claim 22, it is re-iterated that paragraph 83 teaches that “The pull wires 556 can control the articulation angle 116 and direction of the articulable region 138. Once the distal end 132 of the leader 130 is at the target position 118, in some embodiments, the pull wires 556 can be locked in place to maintain the distal end in a desired position or orientation, for example, corresponding to the target position 118 described above with reference to FIG. 2B. Locking the pull wires may involve increasing the tension on the pull wires 556 such that the force needed to move the leader 130 is increased.” As shown in Figure 2B, this example illustrates that the initial position 118 has been deflected to position 119. Therefore, the “locking” of the distal end that would be used to correct this deflection would result in the decreasing the deflected angle 116a to the original angle 116. In other words, the device of Connolly is brought into its desired position (i.e., position 118 in Figure 2B), which is the commanded articulation angle of the articulable portion. Then, a tool is inserted through a channel in the device, which causes the articulable portion to deflect to position 119 of Figure 2B, which is still the commanded articulation angle of the articulable portion. The system of Connolly then controls the actuators based on measurement by the strain gauges to decrease the articulation angle from 116a back to 116. This reads on claim 22.
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 7-10, 12, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Connolly in view of Au (US Patent Pub. No. 2017/0281287).
Connolly is described above with regard to claims 1 and 16. While Connolly teaches to determine the angle of deflection (see numeral 115 in Figure 2B) and/or the bend angle (see numerals 116 and 116a in Figure 2B), it does not explicitly teach the radius of curvature.
Regarding claims 7 and 17, Au discloses a system with guides and tools of different flexibility (see Title). As illustrated in Figure 1, “Catheter 110 may be a flexible guide tube having at least one tool lumen for guiding of a tool… Catheter 110 may particularly be a steerable device, e.g., having an actuated distal section 112 capable of controlling the pitch and yaw of a distal tip 114 of catheter 110. Distal section 112 may, for example, be controlled by pulling on cables or tendons” (see paragraph 17). Control Logic 240 (see Figure 2) includes shape analysis module 243 which “can be used to analyze shape data 249… For example, when a user desires to insert a tool such as a biopsy needle along the deployed shape of catheter 210, shape analysis module 243 can use shape data 249 and possibly data regarding the tool to identify any bend in catheter 210 that is too sharp for the tool to traverse” (see paragraph 35). More specifically related to claim 6, it is noted that Figures 5A-5C illustrate an example in which the distal end of the elongate guide tube creates too sharp of a bend (as determined by the control system), and causes the guide tube to retract as shown in Figure 5B to allow tool to be inserted to the distal end of the guide tube (see Figure 5C) prior to the bend. “A sharp bend, for example, may be a section of catheter 210 that extends for more than a specific distance or angle and has a radius of curvature that is less than the minimum permitted bend radius. For example, shape analysis module 243 may determine a radius of curvature at each of a series of points associated with the shape data and compare each determined radius of curvature to a minimum permitted radius of curvature for the specific tool” (see paragraph 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to determine the radius of curvature, as explicitly stated and taught by Au, within the system and methods of Connolly as a functional equivalent or alternative to the deflection or bend angle, as such a modification amounts to substitution of known equivalents for determining an angle of an articulable portion of an elongate body to yield predictable results (KSR v. Teleflex).
Regarding claims 8, Au teaches that “shape analysis module 243 may determine a radius of curvature at each of a series of points associated with the shape data and compare each determined radius of curvature to a minimum permitted radius of curvature for the specific tool” (see paragraph 38).
Regarding claim 9, Au teaches that “shape analysis module 243 may identify the locations of any bends in the target configuration of the guide tube that are too sharp for a desired tool to traverse without application of an insertion force deemed to be too large. A sharp bend, for example, may be a section of catheter 210 that extends for more than a specific distance or angle and has a radius of curvature that is less than the minimum permitted bend radius… The minimum permitted bend radius may be selected according to the tool being inserted and may depend on, for example, the coefficient of friction between the tool and guide tube, the stiffness and length of a critical section of the tool, the stiffness of the guide tube, the stiffness tissue supporting the guide tube, and other factors. Alternatively, an ‘empirical table’ may be developed that indicates whether a section of guide tube is problematic” (see paragraph 38). This all teaches that a minimum radius is determined by the system of Au.
Regarding claim 10, Au teaches “shape analysis module 243 may identify the locations of any bends in the target configuration of the guide tube that are too sharp for a desired tool to traverse without application of an insertion force deemed to be too large. A sharp bend, for example, may be a section of catheter 210 that extends for more than a specific distance or angle and has a radius of curvature that is less than the minimum permitted bend radius” (see paragraph 38). This passage teaches that a radius of curvature is determined and compared to a minimum permitted bend radius, or threshold radius of curvature as claimed. With regard to the processor controlling the actuators, Au teaches that “control logic 240 on its own initiative may engage retract module 244, which automatically generates actuation signals for actuators 222 and 232 from shape data 249” (see last sentence of paragraph 40), and paragraph 45 states that “Automated navigation for retraction and return during a biopsy procedure can be based on recorded shape data”.
Regarding claim 12, while Connolly does not explicitly refer to the strain gauges as “shape sensors”, it is obvious that the teachings in paragraphs 93-94 teaches a determination of a shape/bend (i.e., “any change in the tensioning of any of the pull wires 556 can be detected and measured” by the strain gauges, and this measured strain “can be correlated to a position of the leader 130, such as … the deflection angle 116 of the articulable region 128”). However, the incorporation of Au illustrates that the use of optical fibers with fiber Bragg gratings to similarly determine a bend in an elongate body/catheter is explicitly “a shape sensor” (i.e., “In the implementation of FIG. 2, a fiber optic shape sensor 264 may extend along the entire length or a distal portion of catheter 210, so that shape measurement module 242 can use measurements of the interference of light transmitted on optical fiber, determine the shape of at least a portion of catheter 210” – see paragraph 34).
Regarding claim 19, Au teaches that “shape analysis module 243 may identify the locations of any bends in the target configuration of the guide tube that are too sharp for a desired tool to traverse without application of an insertion force deemed to be too large. A sharp bend, for example, may be a section of catheter 210 that extends for more than a specific distance or angle and has a radius of curvature that is less than the minimum permitted bend radius… The minimum permitted bend radius may be selected according to the tool being inserted and may depend on, for example, the coefficient of friction between the tool and guide tube, the stiffness and length of a critical section of the tool, the stiffness of the guide tube, the stiffness tissue supporting the guide tube, and other factors. Alternatively, an ‘empirical table’ may be developed that indicates whether a section of guide tube is problematic” (see paragraph 38). This all teaches that a minimum radius is determined by the system of Au.
Regarding claim 20, Au teaches “shape analysis module 243 may identify the locations of any bends in the target configuration of the guide tube that are too sharp for a desired tool to traverse without application of an insertion force deemed to be too large. A sharp bend, for example, may be a section of catheter 210 that extends for more than a specific distance or angle and has a radius of curvature that is less than the minimum permitted bend radius” (see paragraph 38). This passage teaches that a radius of curvature is determined and compared to a minimum permitted bend radius, or threshold radius of curvature as claimed. With regard to the processor controlling the actuators, Au teaches that “control logic 240 on its own initiative may engage retract module 244, which automatically generates actuation signals for actuators 222 and 232 from shape data 249” (see last sentence of paragraph 40), and paragraph 45 states that “Automated navigation for retraction and return during a biopsy procedure can be based on recorded shape data”.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Connolly in view of Au as applied to claim 17 above, and further in view of Walker et al. (US Patent Pub. No. 2017/0151027).
Connolly in combination with Au is described above with regard to claim 17. While Au teaches that “shape analysis module 243 may determine a radius of curvature at each of a series of points associated with the shape data and compare each determined radius of curvature to a minimum permitted radius of curvature for the specific tool” (see paragraph 38), Au does not explicitly teach that the radius of curvature of one or more portions of the articulable portion are averaged.
Walker teaches a robot-assisted driving system and methods (see Title). In paragraph 132 and with description of Figure 14, Walker teaches that an articulation angle may be calculated based on an average of multiple shape information for a local area (see how Figure 14 illustrates an inner member having multiple bends which are averaged to determine a command for the outer member). Note that paragraph 132 also states in the last a sentence “In another embodiment, the curvature of the articulation section is determined from averaging the curvature across portions of the virtual instrument.”
It would have been obvious to one of ordinary skill in the art at the time of the invention to average shape information for a local area to determine an overall radius of curvature for that area, as taught by Walker, and to utilize that technique within the system and methods of Connolly as combined with Au because each individual point along the length of the elongate device (e.g., a point at each millimeter) may have a different radius of curvature, and each such point would not be useful in navigation of the overall system. By averaging sections of the radius along defined lengths of the device, the system would optimize navigation by minimizing unnecessary directional changes and creating a smoother path.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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