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
Response to Arguments
In the remarks on pages 7-8, the applicant argues that the prior art Au fails to teach the amendments to the claims. While a majority of the amendment to the independent claim 1 relates to the previously claimed subject matter of claim 2, it is noted that the amendments of “to change the articulation of the articulable portion” is new and not previously presented in claim 2. This is not taught by Au because the interpretation taken in the previous rejection of claim 2 related to actuation of insertion/removal of the elongate body, rather than to articulation of the body. As such, the scope of claim 1 has changed as compared to previous claim 2. New prior art is provided below based on this change.
Regarding the amendments to claim 14, it is noted that “determining that a relative movement… is occurring” differs from the previous recitations of claim 15, which recited “determining if a relative movement… is occurring”, since this now requires the specific requirement of determining the movement is happening, as opposed to the alternative of whether or not there is, or there is not, movement. The newly applied prior art to Connolly better addresses these changed limitations, and is used below in the following rejections.
Regarding claim 21, it is noted that the amendments to this independent claim were not present in any dependent claims of claim 21, and therefore these amendments change the scope. The new rejections below address these changes.
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, 12-14, 16 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Connolly et al. (US Patent Pub. No. 2019/0000568).
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).
“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, 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”)). The sheath 120 and leader 130 together, or the leader alone, reads on lines 2-4 of claim 1 (i.e., the “an elongated body…” portion of claim 1).
“[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), which reads on the “one or more actuators” portion of claim 1 (see lines 5-8).
Paragraph 9 describes a multitude of different types of sensors that may be used with the system of Connolly, which includes EM sensors, whereas paragraph 70 teaches a multitude of other types of tracking systems. “[T]racking system can detect whether the distal end 132 has been navigated by the system 100 into the target position 118, whether the distal end 132 has been deflected from the target position 118, and/or the magnitude of the deflection from the target position 118” (see paragraph 66). “In addition to navigation, the camera can be used to detect deflection of the distal end 132 and/or to measure the magnitude of such deflections” (see paragraph 71), which reads on “one or more sensors configured to sense a first parameters [i.e., EM signals or any of the other tracking system types] related to a shape of the articulable portion of the elongated body (see lines 9-10 of claim 1).
Additionally, Connolly teaches “each of the tracking systems can include or otherwise be in communication with a controller such as, for example, the command center 700 discussed below with reference to FIG. 7. The controller can include a processor communicatively coupled with a computer readable medium with instructions stored thereon for generating a control signal to the robotic system 100 for compensating for the measured or detected deflection of the distal end 132 from the target position 118 using the data from any of the tracking systems” (see paragraph 66), which reads on “a processor operatively coupled with the one or more actuators and the one or more sensors” as recited in line 11 of claim 1.
Connolly also teaches within paragraph 119 that an initial position of a distal end 132 of leader 130 may be detected by the tracking system, 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.” This teaches that first parameters (i.e., tracking signals’ EM signals initial and a second, subsequent signal) are used to determine a new (second) parameter, for example a changed position or deflection of the distal end 132 (see paragraph 120). This deflection is “related to a curvature of one or more portions of the articulable portion based at least on the sensed first parameter”, as claimed in lines 12-14 of claim 1. 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.” 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).
Regarding claim 3, it is noted that “The distal portion of the leader 130 can further comprise tracking sensors for use in conjunction with one or more tracking systems or sensor modalities for locating a position of the distal end 132 of the leader 130” (see paragraph 65) and “In some embodiments, such as in the robotic system 100 in which the insertable instrument 140 is inserted manually through the working channel 139 of the leader 130, the EM sensor 482 can be used in conjunction with the EM tracking system 480 to track the progress of the distal end 142 of the insertable instrument 140 through the leader 130” (see paragraph 80). Therefore, the tracking system can track distal ends of both the leader 132 and the insertable instrument 142, and can “track the progress of the distal end 142 of the insertable instrument 140 through the leader 130” (see paragraph 80). Therefore, the tracking system is configured to determine if the relative movement of the tool and the channel is occurring.
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 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.
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 12, it is noted that Connolly teaches “Using the readings from EM sensor 484, display modules can display the EM sensor's relative position within a pre-generated three-dimensional model for review by the operator” (see paragraph 75). In paragraph 65, Connolly states that US App. No. 15/268238, which is Mintz (US Patent Pub. No. 2017/0084027) is incorporated herein by reference in its entirety. As shown in Figures 8E and 8F, the tracking system, when tracked over time, provides shape information which relates to the shape of the insertable sheath and leader. Therefore, the tracking system of Connolly reads on “wherein the one or more sensors includes a shape sensor”; i.e., sensor(s) that can determine a shape of the device.
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 tracking system, 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.” This teaches determining a parameter, for example a changed position or deflection of the distal end 132 (see paragraph 120), which is “related to 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.
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, 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 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
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 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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