DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Note Regarding Change in Examiner
It is noted that the foregoing application has been assigned to a different Examiner than that with whom Applicant had been communicating previously. Despite this change, every effort has been made to maintain continuity with the substance of prosecution thus far.
Response to Arguments
Applicant's arguments filed 4/7/2025 regarding the rejection of Independent Claim 1 under 35 USC 103 as being unpatentable over US 2017/0100197 A1 to Zubiate et al. (“Zubiate”) in view of US 2017/0340396 A1 to Romo et al. (“Romo”) have been fully considered but they are not persuasive.
Claim 1 has been amended to recited “reducing a service loop formed by the flexible shaft…” and “transitioning to driving insertion … based at least in part on reducing the service loop formed by the flexible shaft.” Claim 1 previously recited “reducing slack in the flexible shaft,” and “transitioning to driving insertion … based at least in part on the reduced slack in the flexible shaft.” Applicant argues that this language differentiates Claim 1 from the combination of Zubiate and Romo. This argument is not persuasive.
As noted by Applicant, Para. [0149] of the Present Specification prescribes a special definition for the term “service loop,” stating “a service loop can refer to a length of the shaft of the instrument between an instrument base (from which the shaft extends) and the drive device that is longer than the distance between the instrument base and the drive device.” However, there are indefiniteness issues involving the limitations “reducing a service loop formed by the flexible shaft…” and “transitioning to driving insertion … based at least in part on reducing the service loop formed by the flexible shaft.” To summarize those issues (which are explained in depth below at the rejection of Claim 1 under 35 USC 112(b)) as they pertain to Applicant’s arguments, it is not clear from the phrasing of Claim 1 that “reducing a service loop” means “shortening or contracting the service loop” (see Present Specification at Para. [0165]), which interpretation Applicant’s arguments rely upon.
The Examiner notes that were Claim 1 amended to resolve the herein-cited indefiniteness issues such that the substance of Para. [0165] (i.e., “…during insertion, the slack in the service loop 226 can be taken up (shortening or contracting the service loop 226). During retraction, the service loop 226 can be generated (increasing in length or expanding).”), Applicant’s arguments would very likely be persuasive.
The Examiner notes that such clarification could further serve to differentiate Zubiate’s “flexible shaft” from that of Claim 1.
Para. [0149] of the Present Specification continues to state that “[t]he service loop can thus provide slack between the instrument base and the drive device.” The term “reducing a service loop…” thus equates to “reducing slack” as previously recited. Zubiate teaches reducing slack. The rejection is maintained.
Applicant’s arguments regarding the rejection of Independent Claims 9 and 15 under 35 USC 103 are similar to Applicant’s arguments regarding Claim 1. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above with respect to Claim 1. The Examiner notes that the suggestions made with respect to Claim 1 apply similarly to Claims 9 and 15.
Applicant’s arguments regarding the rejection of dependent Claims 3-8, 10-14, 16-19 and 21-22 are based on Applicant’s arguments regarding Independent Claims 1, 9 and 15. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above.
Applicant’s arguments with respect to the objection to Claim 15 for minor informalities have been fully considered and are persuasive. The Examiner agrees that the amendments to Claim 15 are sufficient to resolve the cited indefiniteness issues.
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 1, 9 and 15, and Claims 3-8, 10-14, 16-19 and 21-22 by dependency, 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.
Regarding Independent Claim 1, Claim 1 recites “reducing a service loop formed by the flexible shaft between the first robotic component and the second robotic component responsive to detecting that the distal tip of the flexible shaft is positioned beyond the distal tip of the access sheath; and transitioning to driving insertion of the flexible shaft of the medical instrument at a second rate that is slower than the first rate based at least in part on reducing the service loop formed by the flexible shaft.”
The limitation “based at least in part on reducing the service loop formed by the flexible shaft” is a dangling modifier. As a matter of grammar, it is unclear which claim element the limitation is intended to modify. For example, the limitation “based at least in part on reducing the service loop formed by the flexible shaft” could modify the claim element “transitioning to driving…” (e.g., the transitioning is done “based at least in part on reducing the service loop…”), the claim element “a second rate that is slower than the first rate” (i.e., the second rate is slower than the first rate “based at least in part on reducing the service loop…”), or something else.
For purposes of this Office Action, the above limitation is being interpreted to mean that the transitioning is done “based at least in part on reducing the service loop….”
This issue could be resolved by altering the placement of the modifier “based at least in part on reducing the service loop formed by the flexible shaft” such that its subject is clear (e.g., “transitioning, based at least in part on reducing the service loop formed by the flexible shaft, to driving insertion of the flexible shaft of the medical instrument at a second rate that is slower than the first rate”).
It is unclear what is contemplated by the term “reducing a service loop formed by the flexible shaft.”
The Present Specification sets forth a special definition for the term “service loop” at Para. [0149], stating “a service loop can refer to a length of the shaft of the instrument between an instrument base (from which the shaft extends) and the drive device that is longer than the distance between the instrument base and the drive device.” Substituting the special definition word-for-word, Claim 1 requires “reducing a length of the shaft of the instrument between an instrument base (from which the shaft extends) and the drive device that is longer than the distance between the instrument base and the drive device.”
It is not clear whether the term “service loop” in Claim 1 is intended to reference a numerical length (i.e., a numerical length of the portion of the shaft that is “between an instrument base … and the drive device that is longer than the distance between the instrument base and the drive device”) or a physical subsection of the shaft (i.e., the physical subsection of the shaft that is “between an instrument base … and the drive device that is longer than the distance between the instrument base and the drive device”).
For purposes of this Office action, the limitation “reducing a service loop formed by the flexible shaft” is being interpreted to reference a physical subsection of the shaft.
This interpretation is supported by the subsequent usage of the term “service loop” in the recitation “transitioning to driving insertion of the flexible shaft of the medical instrument at a second rate that is slower than the first rate based at least in part on reducing the service loop formed by the flexible shaft,” which would not make sense if a numerical length were intended to be reduced. That said, similar issue exists with respect to the term “reducing the service loop” as used in the limitation “transitioning to driving….”
The Examiner notes that this distinction is significant: “reducing” a physical subsection of a shaft is far broader than “reducing” a numerical length of that subsection.
Regarding Independent Claims 9 and 15, Claims 9 and 15 recite similar limitations to that of Claim 1, and are indefinite for the same reasons.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-9, 12-15, 18-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Zubiate et al. (US 2017/0100197 A1) (hereinafter “Zubiate”) in view of Romo et al. (US 2017/0340396 A1 cited previously) (hereinafter “Romo”). The rejection is maintained.
Regarding Independent Claim 1, Zubiate teaches:
A method for a robotic medical procedure (“articulating probe assemblies, systems and methods incorporating the same, and systems and methods for performing a surgical procedure” (Zubiate, par. [0043])).
drive insertion of a flexible shaft of a medical instrument with a drive device at a first rate during a first insertion period when a distal tip of the flexible shaft is positioned within an access sheath inserted into a patient (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], the probe is a flexible shaft of a medical instrument, the carriage drive segment is the drive device, and the introducer is the access sheath.).
detecting that the distal tip of the flexible shaft is positioned beyond a distal tip of the access sheath “A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], it is implied that there is detection of when the probe 400 exits the introducer 480, so as to change control of probe movement from rapidly advancing to fine motion control.).
reducing a service loop formed by the flexible shaft responsive to detecting that the distal tip of the flexible shaft is positioned beyond the distal tip of the access sheath; and transitioning to driving insertion of the flexible shaft of the medical instrument at a second rate that is slower than the first rate based at least in part on reducing the service loop formed by the flexible shaft (“The method of FIG. 27 actively manages a cable payout offset that is applied to the two or more (e.g. three) outer mechanism 440 tensioning cables such that 1) when steering “quickly” (as determined by a velocity or acceleration assessment, such as when beginning or in the middle of a steering maneuver, and/or by assessing the amount of steering called for by the user (e.g. the offset of the HID from the neutral position)), the outer links 441 are loosely tensioned with a larger cable payout offset, and 2) when steering “slowly” (e.g. at the end of a steering maneuver, and/or when the offset of the HID from the neutral position is small or minimal), the outer links 441 are more tightly tensioned with a smaller cable payout offset. Thus, the method of FIG. 27 provides for the constant monitoring of the steering input from the user and, in response to steering motion values generated from the monitoring, smoothly varies the tension of one or more cables to anticipate the end of a steering move by tightening the tensioning cables as the steering command slows. Once the steering command ends (i.e. the user is no longer directing the probe to steer via the HID or other input mechanism), articulating probe 400 is already in a partially locked state—because the cables are tensioned thus reducing the additional tension that is required to fully lock articulating probe 400 (e.g. reducing unwanted motion caused by applying tension to cables). The method of FIG. 27 can smoothly ramp cable payout from low to high tension based on the assessment performed in step 2702 (e.g. slower payout when less aggressive steering detected)” (Zubiate, par. [0433]).)
However, Zubiate does not expressly teach:
controlling a first robotic component to drive insertion; the first robotic component being coupled to the drive device and a second robotic component being coupled to a base of the medical instrument; detecting that the distal tip of the flexible shaft is positioned beyond a distal tip of the access sheath based on a position of the second robotic component relative to a position of the first robotic component; and a flexible shaft between the first robotic component and the second robotic component.
Romo teaches methods for moving or manipulating robotic arms (Romo, Abstract). Field of the present application pertains to medical devices (Romo, par. [0003]). Romo is analogous art.
Romo teaches:
controlling a first robotic component to drive insertion, the first robotic component being coupled to the drive device and a second robotic component being coupled to a base of the medical instrument; and a flexible shaft between the first robotic component and the second robotic component (In Fig. 37D, catheter 3701 is mounted to tool base 3709 of mechanical arm 3702, and the active drive mechanism 3713 is mounted on mechanical arm 3704. Active drive mechanism 3713 controls insertion of catheter 3701 through the use of motorized rollers (Romo, par. [0305]).).
detecting the position of the distal tip of the flexible shaft is based on a position of the second robotic component relative to a position of the first robotic component (See Fig. 2A of Romo. Proximal end 222 of leader 212 is mounted to tool base 208 of second arm 204, and tool base 206 (which can provide mechanical actuation (e.g., motor driven axels) (Romo, par. [0124])) is mounted to first arm 202. Here, robotic arms are arranged to form a “virtual rail” (Romo, par. [0121]) and can move leader 212 deeper into the patient. Detection of arm positions can occur by using registration targets (Romo, par. [0131]). Based on the positioning of the arms, the positioning of the distal end 220 of the leader 212 can be deduced.).
It would have been obvious to one of ordinary skill in the art to include the catheter and active drive mechanism supported by robotic arms of Romo in the invention of Zubiate in order to “support intuitive control and management of flexible and/or steerable elongate devices, such as steerable catheters, that are suitable for use during minimally invasive medical techniques” (Romo, par. [0004]).
Regarding Claim 3, Zubiate in view of Romo teaches the invention of claim 1.
Zuibiate further teaches:
further comprising: driving retraction of the flexible shaft of the medical instrument with the drive device at a third rate during a first retraction period wherein the distal tip of the flexible shaft is positioned beyond the distal tip of the access sheath; and automatically transitioning to driving retraction of the flexible shaft of the medical instrument with the drive device at a fourth rate that is faster than the third rate during a second retraction period when the distal tip of the flexible shaft is positioned within the access sheath, (“In an embodiment, three of the bobbins 316a are configured to control the outer links, such as to steer, feed cable for articulating probe 400 advancement, retract cable for probe 400 retraction, transition probe 400 from a limp to a rigid state (e.g. to lock), and to transition probe 400 from a rigid to a limp state (e.g., to become flexible)” (Zubiate, par. [0289]). Based on par. [0289], Zubiate can perform probe retraction.
Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0289] and [0292], during the retraction, probe 400 initially moves in a controlled fine motion, but once it has been detected that the probe has entered introducer 480, the probe 400 rapidly moves.
“The steering module 150 comprises an integrator 151 and a steering processor 152 for executing some or all processes or computations of a steering procedure” (Zubiate, par. [0407]). Based on par. [0407], probe steering can be an automated procedure.).
Regarding Claim 4, Zubiate in view of Romo teaches the invention of claim 1.
Zuibiate further teaches:
wherein automatically transitioning to driving retraction of the flexible shaft of the medical instrument with the drive device at the fourth rate comprises detecting when the distal tip of the flexible shaft is positioned within the access sheath
Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0289] and [0292], during the retraction, probe 400 initially moves in a controlled fine motion, but once it has been detected that the probe has entered introducer 480, the probe 400 rapidly moves.
“The steering module 150 comprises an integrator 151 and a steering processor 152 for executing some or all processes or computations of a steering procedure” (Zubiate, par. [0407]). Based on par. [0407], probe steering can be an automated procedure.).
Regarding claim 5, Zubiate in view of Romo teaches the invention of claim 1, as set forth above.
Romo further teaches:
mounting the base of the medical instrument on the second robotic component (In Fig. 37D of Romo, catheter 3701 is mounted to tool base 3709 of mechanical arm 3702);
mounting the drive device on the first robotic component (In Fig. 37D of Romo, the active drive mechanism 3713 is mounted on mechanical arm 3704); and
engaging the flexible shaft of the medical instrument with the drive device (In Fig. 37D, the active drive mechanism provides “active drive support” to the catheter 3701 (Romo, par. [0305]).
Regarding claim 6, Zubiate in view of Romo teaches the invention of claim 5, as set forth above.
Romo further teaches:
wherein engaging the flexible shaft of the medical instrument with the drive device comprises engaging opposing rollers of the drive device with the flexible shaft (In Fig. 37D, “mechanical arms provide active drive support through the use of motorized rollers at the flange points of the arms” (Romo, par. [0305]).).
Regarding claim 7, Zubiate in view of Romo teaches the invention of claim 6, as set forth above.
Romo and further teaches:
wherein engaging the flexible shaft of the medical instrument with the drive device further comprises inserting the flexible shaft into a channel on an upper surface of the drive device (In Fig. 37D of Romo, the catheter 3701 is led between the rollers of the active drive mechanism 3713).
Regarding claim 8, Zubiate in view of Romo teaches the invention of claim 5.
Romo and further teaches:
moving the base towards the drive device with the second robotic component during insertion (In Fig. 37D of Romo, the mechanical arm 3702 leads the catheter 3701 towards mechanical arm 3704 which has the active drive mechanism 3713 mounted to it.); and
moving the base away from the drive device with the second robotic component during retraction (In Fig. 37D of Romo, the mechanical arm 3702 pulls the catheter 3701 away from mechanical arm 3704 which has the active drive mechanism 3713 mounted to it.).
Regarding Independent Claim 9, Zubiate teaches:
a robotic medical system (“articulating probe assemblies, systems and methods incorporating the same, and systems and methods for performing a surgical procedure” (Zubiate, par. [0043])).
a drive device comprising a pair of rollers configured to engage a shaft of a medical instrument (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends” (Zubiate, par. [0292]). Based on par. [0292], the probe is a shaft of a medical instrument and the carriage drive segment is the drive device.
“In some embodiments, the mating capstans 216b and gears 316b can comprise carriage drive capstan/gear pairs for driving the inner link and outer link carriages 315a, 325b, respectively, of probe 400, which in turn advance and/or retract inner links and outer links of an inner link mechanism 420 and outer link mechanism 440, respectively” (Zubiate, par. [0349]). Based on par. [0349], carriage drive capstan(s) pair is the pair of rollers.).
a processor (“FIG. 23 is a block diagram of a steering system 153, in accordance with the present inventive concepts. The steering system 153 includes an HID 122 and a steering module 150” (Zubiate, par. [0405]).).
operate the rollers to drive insertion of the shaft at a first rate during a first insertion period when a distal tip of the shaft is positioned within an access sheath inserted into a patient (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], the introducer is the access sheath.).
detecting that the distal tip of the shaft is positioned beyond a distal tip of the access sheath “A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], it is implied that there is detection of when the probe 400 exits the introducer 480, so as to change control of probe movement from rapidly advancing to fine motion control.).
reduce a service loop formed by the shaft responsive to detecting that the distal tip of the shaft is positioned beyond the distal tip of the access sheath; and drive insertion of the shaft at a second rate that is slower than the first rate based at least in part on reducing the service loop formed by in the shaft (“The method of FIG. 27 actively manages a cable payout offset that is applied to the two or more (e.g. three) outer mechanism 440 tensioning cables such that 1) when steering “quickly” (as determined by a velocity or acceleration assessment, such as when beginning or in the middle of a steering maneuver, and/or by assessing the amount of steering called for by the user (e.g. the offset of the HID from the neutral position)), the outer links 441 are loosely tensioned with a larger cable payout offset, and 2) when steering “slowly” (e.g. at the end of a steering maneuver, and/or when the offset of the HID from the neutral position is small or minimal), the outer links 441 are more tightly tensioned with a smaller cable payout offset. Thus, the method of FIG. 27 provides for the constant monitoring of the steering input from the user and, in response to steering motion values generated from the monitoring, smoothly varies the tension of one or more cables to anticipate the end of a steering move by tightening the tensioning cables as the steering command slows. Once the steering command ends (i.e. the user is no longer directing the probe to steer via the HID or other input mechanism), articulating probe 400 is already in a partially locked state—because the cables are tensioned thus reducing the additional tension that is required to fully lock articulating probe 400 (e.g. reducing unwanted motion caused by applying tension to cables). The method of FIG. 27 can smoothly ramp cable payout from low to high tension based on the assessment performed in step 2702 (e.g. slower payout when less aggressive steering detected)” (Zubiate, par. [0433]).)
However, Zubiate does not expressly teach:
a first robotic component being coupled to the drive device and configured to control the drive device; a second robotic component being coupled to a base of the medical instrument; detect that the distal tip of the shaft is positioned beyond a distal tip of the access sheath based on a position of the second robotic component relative to a position of the first robotic component; and a shaft between the first robotic component and the second robotic component.
Romo teaches systems for moving or manipulating robotic arms (Romo, Abstract). Field of the present application pertains to medical devices (Romo, par. [0003]). Romo is analogous art.
Romo teaches:
a first robotic component coupled to the drive device and configured to control the drive device (Mechanical arm 3704 is coupled to active drive mechanism 3713. Arm 3704 controls where mechanism 3713 is positioned during a medical procedure (Romo, par. [0305]).).
a second robotic component coupled to a base of the medical instrument (Mechanical arm 3702 is coupled to tool base 3709 of catheter 3701 (Romo, par. [0301]).)
shaft between the first robotic component and the second robotic component (In Fig. 37D, catheter 3701 is mounted to tool base 3709 of mechanical arm 3702, and the active drive mechanism 3713 is mounted on mechanical arm 3704. Active drive mechanism 3713 controls insertion of catheter 3701 through the use of motorized rollers (Romo, par. [0305]).).
detect that the distal tip of the shaft is positioned beyond a distal tip of the access sheath based on a position of the second robotic component relative to a position of the first robotic component (See Fig. 2A of Romo. Proximal end 222 of leader 212 is mounted to tool base 208 of second arm 204, and tool base 206 (which can provide mechanical actuation (e.g., motor driven axels) (Romo, par. [0124])) is mounted to first arm 202. Here, robotic arms are arranged to form a “virtual rail” (Romo, par. [0121]) and can move leader 212 deeper into the patient. Detection of arm positions can occur by using registration targets (Romo, par. [0131]). Based on the positioning of the arms, the positioning of the distal end 220 of the leader 212 can be deduced.).
It would have been obvious to one of ordinary skill in the art to include the catheter and active drive mechanism supported by robotic arms of Romo in the invention of Zubiate in order to “support intuitive control and management of flexible and/or steerable elongate devices, such as steerable catheters, that are suitable for use during minimally invasive medical techniques” (Romo, par. [0004]).
Regarding claim 12, Zubiate in view of Romo teaches the invention of claim 9.
Zubiate further teaches:
wherein the processor is further configured to: operate the rollers to drive retraction of the shaft of the medical instrument at a third rate during a first retraction period when the distal tip of the shaft is positioned beyond the distal tip of the access sheath; and operate the rollers to drive retraction of the shaft of the medical instrument at a fourth rate that is faster than the third rate during a second retraction period when the distal tip of the shaft is positioned within the access sheath; (“In an embodiment, three of the bobbins 316a are configured to control the outer links, such as to steer, feed cable for articulating probe 400 advancement, retract cable for probe 400 retraction, transition probe 400 from a limp to a rigid state (e.g. to lock), and to transition probe 400 from a rigid to a limp state (e.g., to become flexible)” (Zubiate, par. [0289]). Based on par. [0289], Zubiate can perform probe retraction.
Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0289] and [0292], during the retraction, probe 400 initially moves in a controlled fine motion, but once it has been detected that the probe has entered introducer 480, the probe 400 rapidly moves.).
Regarding claim 13, Zubiate in view of Romo teaches the invention of claim 9, as set forth above.
Romo additionally teaches:
and further teaches further comprising: wherein the first robotic component is a first robotic arm (In Fig. 37D, mechanical arm 3704) and the second robotic component is a second robotic arm (In Fig. 37D, mechanical arm 3702).
Regarding claim 14, Zubiate in view of Romo teaches the invention of claim 13, as set forth above.
Romo additionally teaches:
and teaches further comprising: the second robotic arm is configured to move the base of the medical instrument towards the drive device during insertion (In Fig. 37D of Romo, the mechanical arm 3702 can lead the catheter 3701 towards mechanical arm 3704, which has the active drive mechanism 3713 mounted to it.); and the first robotic arm is configured to move the base of the medical instrument away from the drive device during retraction (In Fig. 37D of Romo, the mechanical arm 3704, which has the active drive mechanism 3713 mounted to it, can pull away from tool base 3709 of the catheter 3701.).
Regarding Independent Claim 15, Zubiate teaches:
a robotic medical system (“articulating probe assemblies, systems and methods incorporating the same, and systems and methods for performing a surgical procedure” (Zubiate, par. [0043])).
an elongated flexible access sheath (“The introducer 480 can be constructed and arranged to slidingly receive an articulating probe such as the articulating probe 400, and support, stabilize, and/or guide the articulating probe to a region of interest. The region of interest may be a lumen of a body of a patient (P), such as a cavity at the patient's head (H), e.g., a nose or mouth, or an opening formed by an incision” (Zubiate, par. [0275]). Based on par. [0275], the introducer can accommodate different orifice configurations of a patient.).
a medical instrument comprising an elongated flexible shaft configured to be received in a drive device (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], the probe is an elongated flexible shaft of a medical instrument and the carriage drive segment is the drive device.).
a processor (“FIG. 23 is a block diagram of a steering system 153, in accordance with the present inventive concepts. The steering system 153 includes an HID 122 and a steering module 150” (Zubiate, par. [0405]).).
drive insertion of the elongated flexible shaft with the drive device at a first rate during a first insertion period when a distal tip of the elongated flexible shaft is positioned within the elongated flexible access sheath (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]).).
detect that the distal tip of the elongate flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath “A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], it is implied that there is detection of when the probe 400 exits the introducer 480, so as to change control of probe movement from rapidly advancing to fine motion control.).
reduce a service loop formed by the elongated flexible shaft responsive to detecting that the distal tip of the elongated flexible shaft is positioned beyond the distal tip of the elongated flexible access sheath; and transition to driving insertion of the shaft at a second rate that is slower than the first rate based at least in part on reducing service loop formed by in the elongated flexible shaft (“The method of FIG. 27 actively manages a cable payout offset that is applied to the two or more (e.g. three) outer mechanism 440 tensioning cables such that 1) when steering “quickly” (as determined by a velocity or acceleration assessment, such as when beginning or in the middle of a steering maneuver, and/or by assessing the amount of steering called for by the user (e.g. the offset of the HID from the neutral position)), the outer links 441 are loosely tensioned with a larger cable payout offset, and 2) when steering “slowly” (e.g. at the end of a steering maneuver, and/or when the offset of the HID from the neutral position is small or minimal), the outer links 441 are more tightly tensioned with a smaller cable payout offset. Thus, the method of FIG. 27 provides for the constant monitoring of the steering input from the user and, in response to steering motion values generated from the monitoring, smoothly varies the tension of one or more cables to anticipate the end of a steering move by tightening the tensioning cables as the steering command slows. Once the steering command ends (i.e. the user is no longer directing the probe to steer via the HID or other input mechanism), articulating probe 400 is already in a partially locked state—because the cables are tensioned thus reducing the additional tension that is required to fully lock articulating probe 400 (e.g. reducing unwanted motion caused by applying tension to cables). The method of FIG. 27 can smoothly ramp cable payout from low to high tension based on the assessment performed in step 2702 (e.g. slower payout when less aggressive steering detected)” (Zubiate, par. [0433]).).
However, Zubiate does not expressly teach:
a drive device that is coupled to a first robotic component, the medical instrument further comprising an instrument handle configured to couple to a second robotic component; detect that the distal tip of the elongated flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath based on a position of the second robotic component relative to a position of the first robotic component; and the elongated flexible shaft between the first robotic component and the second robotic component.
Romo teaches systems for moving or manipulating robotic arms (Romo, Abstract). Field of the present application pertains to medical devices (Romo, par. [0003]). Romo is analogous art.
Romo teaches:
a medical instrument comprising an elongated flexible shaft configured to be received in a drive device that is coupled to a first robotic component (In Fig. 37D, catheter 3701 is received by active drive mechanism 3713, which is coupled to mechanical arm 3704 (Romo, par. [0305]).).
the medical instrument further comprising an instrument handle configured to couple to a second robotic component (Mechanical arm 3702 is coupled to tool base 3709 of catheter 3701 (Romo, par. [0301]).).
a shaft between the first robotic component and the second robotic component (In Fig. 37D, catheter 3701 is mounted to tool base 3709 of mechanical arm 3702, and the active drive mechanism 3713 is mounted on mechanical arm 3704. Active drive mechanism 3713 controls insertion of catheter 3701 through the use of motorized rollers (Romo, par. [0305]).).
detect that the distal tip of the elongated flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath based on a position of the second robotic component relative to a position of the first robotic component (See Fig. 2A of Romo. Proximal end 222 of leader 212 is mounted to tool base 208 of second arm 204, and tool base 206 (which can provide mechanical actuation (e.g., motor driven axels) (Romo, par. [0124])) is mounted to first arm 202. Here, robotic arms are arranged to form a “virtual rail” (Romo, par. [0121]) and can move leader 212 deeper into the patient. Detection of arm positions can occur by using registration targets (Romo, par. [0131]). Based on the positioning of the arms, the positioning of the distal end 220 of the leader 212 can be deduced.).
It would have been obvious to one of ordinary skill in the art to include the catheter and active drive mechanism supported by robotic arms of Romo in the invention of Zubiate in order to “support intuitive control and management of flexible and/or steerable elongate devices, such as steerable catheters, that are suitable for use during minimally invasive medical techniques” (Romo, par. [0004]).
Regarding Claim 18, Zubiate in view of Romo teaches the invention of claim 15.
Zubiate further teaches:
wherein the processor is further configured to: drive retraction of the elongated flexible shaft of the medical instrument at a third rate during a first retraction period when the distal tip of the elongated flexible shaft is positioned beyond the distal tip of the elongated flexible access sheath; and transition to driving retraction of the elongated flexible shaft of the medical instrument at a fourth rate that is faster than the third rate during a second retraction period when the distal tip of the elongated flexible shaft is positioned within the elongated flexible access sheath(“In an embodiment, three of the bobbins 316a are configured to control the outer links, such as to steer, feed cable for articulating probe 400 advancement, retract cable for probe 400 retraction, transition probe 400 from a limp to a rigid state (e.g. to lock), and to transition probe 400 from a rigid to a limp state (e.g., to become flexible)” (Zubiate, par. [0289]). Based on par. [0289], Zubiate can perform probe retraction.
Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0289] and [0292], during the retraction, probe 400 initially moves in a controlled fine motion, but once it has been detected that the probe has entered introducer 480, the probe 400 rapidly moves.).
Regarding claim 19, Zubiate in view of Romo teaches the invention of claim 15.
Romo further teaches:
move an instrument handle of the medical instrument towards the drive device during insertion (In Fig. 37D of Romo, the mechanical arm 3702 leads the catheter 3701 towards mechanical arm 3704 which has the active drive mechanism 3713 mounted to it.);
and move the instrument handle away from the drive device during retraction. (In Fig. 37D of Romo, the mechanical arm 3702 pulls the catheter 3701 away from mechanical arm 3704 which has the active drive mechanism 3713 mounted to it.).
Regarding claim 22, Zubiate in view of Romo teaches the invention of claim 1, as set forth above.
Romo further teaches:
wherein the detecting that the distal tip of the flexible shaft is positioned beyond the distal tip of the access sheath is based on driver data associated with driving the drive device (See Fig. 17A of Romo. The instrument device manipulator (IDM) 1703 uses angular motion transmitted via output shafts in order to control the robotic catheter 1704 (Romo, par. [0188]).)
Claims 10-11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zubiate (US 20170100197 A1) in view of Romo (US 2017/0340396 A1), as applied to claims 9 and 15, and further in view of Diolaiti (US 2009/0326552 A1 cited previously). The rejection is maintained.
Regarding claims 10-11 and 16-17, Zubiate in view of Romo teaches the invention of claims 9 and 15, but does not expressly teach lines 3-4 of claim 10, line 3 of claim 11, lines 3-4 of claim 16, and lines 3-4 of claim 17.
Diolaiti discloses a method for manipulating a medical robotic system in par. [0006] - [0008]. Diolaiti further teaches
wherein the processor is configured to detect that the distal tip of the shaft is positioned beyond a distal tip of the access sheath based on geometric information indicating at least one of a length of the shaft;
wherein the processor is configured to detect that the distal tip of the shaft is positioned beyond a distal tip of the access sheath based on image information obtained with the medical instrument
wherein the processor is configured to detect that the distal tip of the elongated flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath based on geometric information associated with the elongated flexible access sheath and the elongated flexible shaft,
wherein the processor is configured to detect that the distal tip of the elongated flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath based on image information obtained with the medical instrument
(“[D]etermining a length that the tip of the articulatable instrument extends beyond the distal end of the entry guide” (Diolaiti, claim 7), and “determine lengths that distal tips of the plurality of articulatable instruments extend beyond the distal end of the entry guide” (Diolaiti, claim 25). Furthermore, in applying the method [of Fig. 8], images of the articulatable instrument tip and entry guide tip reference are collected by camera 211 (Diolaiti, par. [0068]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the device component position detection of Diolaiti in the invention of Zubiate, as modified thus far, in order to properly guide instruments and maneuver them about a work site within a patient (Diolaiti, par. [0004]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Zubiate (US 20170100197 A1) in view of Romo (US 2017/0340396 A1), as applied to claim 1 above, and further in view of Shelton IV et al. (US 2020/0405403 A1 filed 06/27/2019 and cited previously) (hereinafter “Shelton IV”). The rejection is maintained.
Regarding claim 21, Zubiate in view of Romo teaches the invention of claim 1, as set forth above, but does not expressly teach lines 2-5 of claim 21.
Shelton IV teaches a method of using a surgical modular robotic assembly (Shelton IV, Abstract). Shelton IV further teaches further comprising: using kinematics data to determine a distance between a distal end of the first robotic component and a distal end of the second robotic component; and determining the position of the second robotic component relative to the first robotic component based on the distance (“Based on the position or proximity signals, the base unit control circuit can determine the pose of each robotic arm, including the position and orientation of each arm, as well as the positional relationships between various arms such as a distance between a first robotic arm and a second robotic arm of the robotic arms 9002a-9002e” (Shelton IV, par. [0873]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the distance between a first robotic arm and second robotic arm of Shelton IV in the invention of Zubiate, as modified thus far, in order to “aggregate data to compile a more complete view of the surgical site and/or the surgical procedure in order to determine the best possible course of action” (Shelton IV, par. [0464]).
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.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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