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 .
Claim Rejections - 35 USC § 112
Claims 50 and 58 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 50 recites “wherein a first portion of the resilient force member is coupled to the moveable member, and wherein the first portion of the resilient force member is configured to contact a first elastic component coupled to a part of the sensor different from the moveable member, and wherein the resilient force comprises a mechanical resistance force between the first portion of the resilient force member and the first elastic component.” The term “elastic component” lacks definitiveness, as it is unclear if the elastic component is required (i.e. positively recited) by the claimed language. The claim requires more specificity as to whether the elastic component is required to be in contact with the resilient force member or merely a component that is able to (or can be configured to) be in contact with the resilient force member.
Moreover, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 50 recites the broad recitation stating “wherein a first portion of the resilient force member is coupled to the moveable member, and wherein the first portion of the resilient force member is configured to contact a first elastic component coupled to a part of the sensor different from the moveable member, and wherein the resilient force comprises a mechanical resistance force between the first portion of the resilient force member and the first elastic component”, and the claim also recites “in particular (i) wherein the first portion of the resilient force member and the first elastic component are arranged such that the first portion of the resilient force member and the first elastic component bias the moveable member towards the first position”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Furthermore, claim 58 recites “wherein the sensor is configured to determine that the moveable member is in the first position and/or the second position based on the characteristic detectable by the magnetic field measurement unit when the moveable member is in the first position and/or second position” and the claim also recites “in particular wherein the sensor is configured to determine a magnitude of the resilient force based on the characteristic detectable by the magnetic field measurement unit when the moveable member is in the second position”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 41, 46-50, and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0375682 A1 to Kincaid et al. (hereinafter “Kincaid”).
Regarding claim 41, Kincaid teaches:
A sensor for an endovascular robotic system (see abstract- first sentence, para 0002, and para 0011 - “ a sensor (221, 231) configured to measure an amount strain or an amount of displacement of the control wire (110) ”),
wherein the sensor comprises:
a moveable member/moving carriage (see para [0059] – “In FIG. 4, a first control wire 110a of the steerable instrument 100 is directly connected at its proximal end thereof to a corresponding first motor 311 via a moving carriage 341, and a second control wire 110b is directly connected at is proximal end to a second motor 312 via a moving carriage 342.”),
moveable between a first position and a second position (actively controlled mode vs. passively controlled mode – see abstract: “ In one embodiment, the steerable instrument includes an elongate body (100), a control wire (110) arranged in a channel (104) of the elongate body and displaceable along the channel to bend the elongate body;
and a controller (320) to selectively control drive forces applied to the control wire (110) under an actively controlled mode and a passively controlled mode”, para [0018], para [0065], para [0093], fig. 4, fig. 5A-5B, and fig. 10B),
a resilient force member/magnetic base plate (see para [0063] – “In FIG. 5A, the actuator or motor is implemented as a drive unit 1300 composed of a mover or motor carriage 1330 and a stator composed of a magnetic base plate 1360, and a top plate or guide 1310. ”) coupled to or integral to the moveable member/moving carriage (see fig. 5A and the sentence as stated from para [0063] above),
wherein the resilient force member/magnetic base plate is configured to provide a resilient force (see fig. 5B – 1340, para [0063]- last three sentences, and para [0065]), when the moveable member/moving carriage is in the second position, to bias the moveable member/moving carriage towards the first position (from one position to the other/position of lesser force – see para [0064]-[0065]),
and a detection unit/position sensor configured to detect a change in position of the moveable member/moving carriage from the first position to the second position and/or the second position to the first position (See para [0058] and para [0063] – “A position sensor 1331 monitors the linear movement of the motor carriage 1330, and outputs a signal Xi indicative of an amount of displacement of the motor carriage 1330 (moving carriage))”.
Regarding claim 46, Kincaid as modified teaches:
The sensor as claimed in claim 41, wherein the resilient force (see fig. 5B-1340 and para [0065] – last three sentences) is a continuous resilient force/continuous force(s) (see para [0012]-emphasis on the following sentence: “ According to various aspects of the present disclosure, a steerable medical device is significantly improved by providing an actively-controlled passive bending mode whereby, (1) forces in the control wires are brought to zero when maximum flexibility is needed in the steerable instrument; (2) forces and displacements of the control wires can be continually monitored regardless of the control mode employed”),
and wherein the continuous resilient force/continuous force is configured to change continuously as the moveable member moves between the first position and the second position and/or between the second position and the first position (between passive and/or active control mode – see para [0012] and para [0065]).
Regarding claim 47, Kincaid as modified teaches:
The sensor as claimed in claim 41, wherein the resilient force member/magnetic base plate comprises a plurality of magnets (see para [0063] - first sentence and last sentence, and annotated fig. 5B below),
wherein a first magnet (N magnet in fig. 5B below) of the plurality of magnets is coupled to the moveable member/carriage (see figs. 5A-5B, 1330 and 1360 and para 0063), and wherein a second magnet of the plurality of magnets (the S magnet) is coupled to a part of the sensor different from the moveable member/carriage, and wherein the resilient force comprises a magnetic force between the first magnet and the second magnet (the permanent magnets (N,S)- see figs. 5A-5B and para 0063-0065)
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Regarding claim 48, Kincaid as modified teaches:
The sensor as claimed in claim 47, wherein the plurality of magnets (see annotated fig. 5B above) are arranged such that, in a pair of magnets, the magnets repel or attract each other, and wherein the pair of magnets biases the moveable member towards the first position/direction of lesser forces (see figs. 5A-5B, para [0063] – first and last sentence, and para [0064]-[0065]).
Regarding claim 49, Kincaid as modified teaches:
The sensor as claimed in claim 47, wherein the moveable member is moveable in two degrees of freedom (see figs. 5A-5B and para [0063]-[0065]) – the moveable member/carriage is moveable along the horizontal and vertical direction, due to the motion from Z=0 to Z=max in the horizontal direction and due to the “floating” effect of the carriage in the air bearing due to the pre-loaded pressure and vacuum zones),
wherein a first plurality of the plurality of magnets is configured to provide a change in a first directional resilient force/inductive force in relation to a first degree of freedom as the moveable member/carriage is moved between the first position and the second position and/or between the second position and the first position,
and
wherein a second plurality of the plurality of magnets is configured to provide a change in a second directional resilient force in relation to a second degree of freedom as the moveable member is moved between the first position and the second position and/or between the second position and the first position (see annotated figs. 5A-5B below and para 0063-0065)- the movement along the horizontal and vertical direction moves the carriage in four positions.
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Regarding claim 50, Kincaid as modified teaches:
The sensor as claimed in claim 41, wherein a first portion of the resilient force member/magnetic base plate is coupled to the moveable member/carriage (see figs. 5A-5B and para [0063]-[0064]),
and
wherein the first portion or part of the resilient force member/magnetic base plate is configured to contact (or capable of contacting) a first elastic/flexible component (or wire) coupled to a part of the sensor different from the moveable member (See fig. 1B- 110, 210, and 310, annotated fig. 5A, para [0037]-[0038], and para [0063]-[0065]),
and wherein the resilient force/inductive force comprises a mechanical resistance force between the first portion of the resilient force member/base plate and the first elastic/flexible component (or wire - see para [0063]-[0065]),
in particular
(i) wherein the first portion of the resilient force member/base plate and the first elastic component/wire are arranged such that the first portion of the resilient force member/base plate and the first elastic component/wire bias the moveable member towards the first position/direction of lesser forces (see para [0063]- last three sentences, and para [0064]-[0065]),
and/or
(ii) wherein the moveable member is moveable in two degrees of freedom and wherein the first portion of the resilient force member and the first elastic component are configured to provide a change in a first directional resilient force in relation to a first degree of freedom as the moveable member is moved between the first position and the second position and/or between the second position and the first position,
and wherein a second portion of the resilient force member and a second elastic component are configured to provide a change in a second directional resilient force in relation to a second degree of freedom as the moveable member is moved between the first position and the second position and/or between the second position and the first position.
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Regarding claim 52, Kincaid as modified teaches:
The sensor as claimed in claim 41, further comprising an air bearing (see figs. 5A-5B and para [0063]-[0065]), wherein a third portion/part of the moveable member/base plate is arranged at least partially in the air bearing (see fig. 5B and para [0063]-[0065]),
and wherein the air bearing is configured to allow the moveable member/base plate to move in a substantially frictionless manner (para [0061] and para [0063]-[0065]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 42-45 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid in view of US 12,064,109 B2 to Shelton, IV et al. (Hereinafter “Shelton”).
Regarding claim 42, Kincaid teaches the sensor as claimed in claim 41, but does not disclose
wherein the detection unit comprises an optical unit comprising a light source for emitting light and
a light sensor for detecting the light emitted by the light source,
wherein a first portion of the moveable member is arranged, in the first and/or second position of the moveable member, in an optical path of the emitted light between the light source and the light sensor for at least partially blocking, by the first portion of the moveable member, the emitted light travelling on the optical path between the light source and the light sensor, and
wherein a first amount of the emitted light which is blockable by the first portion of the moveable member in the optical path between the light source and the light sensor is different between the moveable member being in the first position and the moveable member being in the second position, respectively.
However, Shelton teaches a surgical instrument configured with a drive component positioned within the shaft and a control circuit with a motor control program configured to drive a drive component (see abstract, lines 1-5). The system (figs. 7A-7B) contains a detection unit/sensing system (see fig. 7A, 1330) comprising an optical unit, which comprises a light source/light emitter for emitting light (see fig. 7A, 1331 and col. 35-36: “The sensing system 1330 comprises a plurality of light emitters 1331 oriented perpendicular to or at least substantially perpendicular to the actuation member 1320 and mounted to the hollow shaft 1310, a plurality of windows 1321 defined in the actuation member 1320 configured to allow light to pass through the actuation member 1320 and a plurality of light sensors, or receivers, 1333 configured to detect light emitted by the light emitters 1331 and mounted to the hollow shaft 1310.”),
wherein a first portion of the moveable member/actuation member is arranged, in the first and/or second position of the moveable member/actuation member, in an optical path of the emitted light between the light source/light emitter and the light sensor for at least partially blocking, by the first portion/part of the moveable member/actuation member, the emitted light travelling on the optical path between the light source and the light sensor (see fig. 7A, 1320 and 1333, and col. 36, lines 6-18 – the translation of the moveable member/actuation member will effectively partially block the emitted light when in motion, causing the change in light presence detected by the windows and the light sensors),
and
wherein a first amount of the emitted light which is blockable by the first portion/part of the moveable member/actuator member in the optical path between the light source/light emitter and the light sensor is different between the moveable member/actuation member being in the first position and the moveable member/actuation member being in the second position, respectively (see col. 36, lines 19-37 (emphasis on the following statement): “ In at least one instance, the detection of light presence, alone, is used to determine the position of the actuation member 1320. In at least one instance, the detection of light intensity is used to determine the position of the actuation member 1320. Light intensity can be varied by arranging the plurality of windows 1321 in specific patterns where some patterns allow a first amount of light to pass through and other patterns allow a second amount of light to pass through which is different than the first amount of light.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton to arrive at the claimed invention. Such modification would improve the system by providing an accurate location and movement of the actuation member/moveable member during the procedure, ultimately allowing for a more reliability of the movement of the device in the presence of bodily fluids or debris when performing a medical procedure.
Regarding claim 43, Kincaid as modified teaches:
The sensor as claimed in claim 42, wherein the system comprises an LED configured to provide status of the surgical instrument (such as if the surgical instrument is in normal operations or abnormal operations – see para [0033]), and wherein the strain-gauge sensors (configured to detect/measure the compressive or tensile forces exerted on the control wire 110) can be optical based (see para [0057]), but does not explicitly disclose wherein,
the sensor is configured to determine that the moveable member is in the first position and/or the second position based on a second amount of the emitted light, sensed by the light sensor, not blockable by the first portion of the moveable member in the optical path between the light source and the light sensor when the moveable member is in the first position and/or second position .
However, Shelton teaches wherein the sensor is configured to determine that the moveable member/actuation member is in the first position and/or the second position based on a second amount of the emitted light, sensed by the light sensor, not blockable by the first portion of the moveable member/actuation member in the optical path (sensed by the windows) between the light source/light emitter and the light sensor when the moveable member/actuation member is in the first position and/or second position (see col. 36, lines 6-36 – the light sensors in a first and/or second position contain light sensors (1333) configured to detect an amount of light through the windows in specific patterns, therefore the light sensors detect light not blockable by the first portion of the moveable member in the optical path between the light emitter and light sensor when the actuation member is in the first and/or second position).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton to arrive at the claimed invention. Such modification would improve the system by providing an accurate location and movement of the actuation member/moveable member during the procedure, ultimately allowing for more reliability when evaluating the movement of the device in the presence of bodily fluids or debris when performing a medical/surgical procedure.
Regarding claim 44, Kincaid as modified teaches:
The sensor as claimed in claim 43, wherein a force sensor is used to detect the compressive or tensile force exerted on the control wire (see para [0057]-[0058], and para [0076]), and wherein the magnitude of resilient force (through the resilient force member/magnetic base plate) is measured based on the position sensor/detection unit (see fig. 5A-1331, para [0063] – “In FIG. 5A, the actuator or motor is implemented as a drive unit 1300 composed of a mover or motor carriage 1330 and a stator composed of a magnetic base plate 1360, and a top plate or guide 1310. ”, see fig. 5B – 1340, para [0051], para [0058], para [0063]- last three sentences, and para [0065]),
but does not disclose wherein the sensor is configured to determine a resilient force based on the second amount of the emitted light sensed by the light sensor.
However, Shelton teaches wherein the sensor is configured to determine that the moveable member/actuation member (also referred to as a firing member) is in the first position and/or the second position based on a second amount of the emitted light, sensed by the light sensor, not blockable by the first portion of the moveable member/actuation member in the optical path (sensed by the windows) between the light source/light emitter and the light sensor when the moveable member/actuation member is in the first position and/or second position (see col. 36, lines 6-36 – the light sensors in a first and/or second position contain light sensors (1333) configured to detect an amount of light through the windows in specific patterns, therefore the light sensors detect light not blockable by the first portion of the moveable member in the optical path between the light emitter and light sensor when the actuation member is in the first and/or second position). Furthermore, following the moment of the actuation member, the control signal can monitor the signal to determine the exact position of the actuation member/firing member.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of force and detection/position system of Kincaid with the light detection system of Shelton to arrive at the claimed invention. Such modification would improve the system by allowing the system to seamlessly switch control modes of the surgical device and providing an accurate location and movement of the actuation member/moveable member during the procedure, ultimately allowing for more reliability when evaluating the movement of the device in the presence of bodily fluids or debris when performing a medical/surgical procedure.
Regarding claim 45, Kincaid as modified teaches:
The sensor as claimed in claim 42, but does not explicitly disclose wherein the sensor is configured to determine that the moveable member is in a first transition between the first position and the second position and/or a second transition between the second position and the first position based on a change of a said amount of the emitted light not blockable by the first portion of the moveable member in the optical path between the light source and the light sensor.
However, Shelton teaches wherein the sensor is configured to determine that the moveable member/actuation member is in a first transition between first position and the second position and/or a second transition between the second position and the first position based on a change of a said amount of the emitted light not blockable by the first portion of the moveable member/ actuation member (dictated by the amount of light change caused by the windows 1321) in the optical path between the light source and the light sensor. (see col. 36, lines 6-36: “The light sensors in a first and/or second position contain light sensors (1333) configured to detect an amount of light through the windows in specific patterns, therefore the light sensors detect light not blockable by the first portion of the moveable member in the optical path between the light emitter and light sensor when the actuation member is in the first and/or second position….. Light intensity can be varied by arranging the plurality of windows 1321 in specific patterns where some patterns allow a first amount of light to pass through and other patterns allow a second amount of light to pass through which is different than the first amount of light).
Since the actuation member/movable member (also referred to as a firing member) continuously moves linearly in order for the actuation member to be positioned in the proximal-most and distal-most position longitudinally along the shaft, the sensor is configured to sense the moveable member/actuation member in a first and/or second transition between the first and/or second position based on the change of light not blockable by the actuation member in the optical path until it reaches the distal-most and proximal-most position.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton to arrive at the claimed invention. Such modification would improve the system by providing an accurate location and movement of the actuation member/moveable member during the procedure, ultimately allowing for more reliability when evaluating the movement of the device in the presence of bodily fluids or debris when performing a medical/surgical procedure.
Regarding claim 59, Kincaid as modified teaches:
A sensor for an endovascular robotic system, wherein the sensor comprises:
a moveable member/carriage moveable between a first position and a second position (see abstract), but does not disclose wherein,
and an optical unit comprising a light source for emitting light and a light sensor for detecting the light emitted by the light source, wherein a portion of the moveable member is arranged, in the first and/or second position of the moveable member, in an optical path of the emitted light between the light source and the light sensor for at least partially blocking, by the portion of the moveable member, the emitted light travelling on the optical path between the light source and the light sensor, and wherein a first amount of the emitted light which is blockable by the portion of the moveable member in the optical path between the light source and the light sensor is different between the moveable member being in the first position and the moveable member being in the second position, respectively, and
wherein the light sensor is configured to determine that the moveable member is in the first position and/or the second position based on a second amount of the emitted light, sensed by the light sensor, not blockable by the portion of the moveable member in the optical path when the moveable member is in the first position and/or second position.
However, Shelton teaches a surgical instrument configured with a drive component positioned within the shaft and a control circuit with a motor control program configured to drive a drive component (see abstract, lines 1-5). The system (figs. 7A-7B) contains a detection unit/sensing system (see fig. 7A, 1330) comprising an optical unit, which comprises a light source/light emitter for emitting light (see fig. 7A, 1331 and col. 35-36: “The sensing system 1330 comprises a plurality of light emitters 1331 oriented perpendicular to or at least substantially perpendicular to the actuation member 1320 and mounted to the hollow shaft 1310, a plurality of windows 1321 defined in the actuation member 1320 configured to allow light to pass through the actuation member 1320 and a plurality of light sensors, or receivers, 1333 configured to detect light emitted by the light emitters 1331 and mounted to the hollow shaft 1310.”),
wherein a first portion of the moveable member/actuation member is arranged, in the first and/or second position of the moveable member/actuation member, in an optical path of the emitted light between the light source/light emitter and the light sensor for at least partially blocking, by the first portion/part of the moveable member/actuation member, the emitted light travelling on the optical path between the light source and the light sensor (see fig. 7A, 1320 and 1333, and col. 36, lines 6-18 – the translation of the moveable member/actuation member will effectively partially block the emitted light when in motion, causing the change in light presence detected by the windows and the light sensors),
and
wherein a first amount of the emitted light which is blockable by the first portion/part of the moveable member/actuator member in the optical path between the light source/light emitter and the light sensor is different between the moveable member/actuation member being in the first position and the moveable member/actuation member being in the second position, respectively (see col. 36, lines 19-37 (emphasis on the following statement): “ In at least one instance, the detection of light presence, alone, is used to determine the position of the actuation member 1320. In at least one instance, the detection of light intensity is used to determine the position of the actuation member 1320. Light intensity can be varied by arranging the plurality of windows 1321 in specific patterns where some patterns allow a first amount of light to pass through and other patterns allow a second amount of light to pass through which is different than the first amount of light.”), and wherein, the sensor is configured to determine that the moveable member/actuation member is in the first position and/or the second position based on a second amount of the emitted light, sensed by the light sensor, not blockable by the first portion of the moveable member/actuation member in the optical path (sensed by the windows) between the light source/light emitter and the light sensor when the moveable member/actuation member is in the first position and/or second position (see col. 36, lines 6-36 – the light sensors in a first and/or second position contain light sensors (1333) configured to detect an amount of light through the windows in specific patterns, therefore the light sensors detect light not blockable by the first portion of the moveable member in the optical path between the light emitter and light sensor when the actuation member is in the first and/or second position).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton to arrive at the claimed invention. Such modification would improve the system by providing an accurate location and movement of the actuation member/moveable member during the procedure, ultimately allowing for more reliability when evaluating the movement of the device in the presence of bodily fluids or debris when performing a medical/surgical procedure.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Kincaid in view Shelton, and further in view of US 2020/0237191 A1 to Penny et al. (hereinafter “Penny”).
Regarding claim 51, Kincaid as modified teaches:
The sensor as claimed in claim 41 containing a movable member/base plate (fig. 5A-5B, 1360), but does not explicitly disclose wherein a second portion/part of the moveable member/base plate is arranged within an oscillation dampening pool, wherein the oscillation dampening pool is configured to provide oscillation dampening to the moveable member.
However, Penny teaches a endoscopy apparatus containing an elongated member, an insertion shaft, and a surgical tool (see abstract). The system (figs. 2 and 12) teach wherein a portion/part of the moveable member/connector is arranged within (coupled to) an oscillation dampening pool/fluid, wherein the oscillation dampening pool is configured to provide oscillation dampening to the moveable member/connector (see fig. 12, 1216 and 1222, para [0146]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base plate of Kincaid with the dampening system of Penny to arrive at the claimed invention . Such modification would improve the system by dampening unwanted oscillations of the moveable member, ultimately providing more reliability of the movement intended when operating the device.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Kincaid in view of US 2018/0214218 A1 to Overmyer et al. (Hereinafter Overmyer).
Regarding claim 53, Kincaid as modified teaches:
The sensor as claimed in claim 41, but does not teach further comprising a zero positioning unit, wherein the zero positioning unit comprises a positioning sensor, a positioning flag, and an indicator configured to indicate that the sensor is in a zero position, wherein the moveable member does not encounter a net force in the zero position.
However, Overmyer teaches methods and devices for measuring the rotational position of an elongated shaft for surgical tools (see abstract). The system (figs. 4-5) teaches where the system comprises a zero positioning unit, wherein the zero positioning unit comprises a positioning sensor, a positioning flag/stop, and an indicator configured to indicate that the sensor is in a zero position (see figs. 4-5, para [0032]-[0034]), wherein the moveable member (see annotated figs. 4-5 below) does not encounter a net force in the zero position (unrotated position of the shaft/moveable member – see annotated figs. 4-5 below, para [0008], para [0029], and para [0032]-[0034]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the teachings of Overmyer to arrive at the claimed invention. Such modification would improve the system by ensuring the moveable member is in an unbiased or resting position prior to switching between a first and/or second position, ultimately preventing an injury from occurring to the patient during the surgical procedure.
Claims 54 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid in view of Shelton, and Further in view of WO 2021/151502 A1 to Baltrunas et al. (hereinafter “Baltrunas”).
Regarding claim 54, Kincaid as modified teaches:
The sensor as claimed in claim 41, wherein the moveable member/ carriage is coupled to or comprises a first endovascular robotic instrument (see abstract, lines 1-5 and para [0002]), but does not explicitly disclose wherein,
the detection unit comprises an optical unit comprising a light source for emitting light and a light sensor for detecting the light emitted by the light source, wherein a first portion of the moveable member is arranged, in the first and/or second position of the moveable member, in an optical path of the emitted light between the light source and the light sensor for at least partially blocking, by the first portion of the moveable member, the emitted light travelling on the optical path between the light source and the light sensor, wherein a first amount of the emitted light which is blockable by the first portion of the moveable member in the optical path between the light source and the light sensor is different between the moveable member being in the first position and the moveable member being in the second position, respectively,
and,
wherein the sensor is configured to transmit data relating to sensed light stemming from the light source to a receiver, but does not
and wherein the external receiver is comprised in a second endovascular robotic instrument controllable based on the received data.
However, Shelton teaches a surgical instrument configured with a drive component positioned within the shaft and a control circuit with a motor control program configured to drive a drive component (see abstract, lines 1-5). The system (figs. 7A-7B) contains a detection unit/sensing system (see fig. 7A, 1330) comprising an optical unit, which comprises a light source/light emitter for emitting light (see fig. 7A, 1331 and col. 35-36: “The sensing system 1330 comprises a plurality of light emitters 1331 oriented perpendicular to or at least substantially perpendicular to the actuation member 1320 and mounted to the hollow shaft 1310, a plurality of windows 1321 defined in the actuation member 1320 configured to allow light to pass through the actuation member 1320 and a plurality of light sensors, or receivers, 1333 configured to detect light emitted by the light emitters 1331 and mounted to the hollow shaft 1310.”),
wherein a first portion of the moveable member/actuation member is arranged, in the first and/or second position of the moveable member/actuation member, in an optical path of the emitted light between the light source/light emitter and the light sensor for at least partially blocking, by the first portion/part of the moveable member/actuation member, the emitted light travelling on the optical path between the light source and the light sensor (see fig. 7A, 1320 and 1333, and col. 36, lines 6-18 – the translation of the moveable member/actuation member will effectively partially block the emitted light when in motion, causing the change in light presence detected by the windows and the light sensors),
and
wherein a first amount of the emitted light which is blockable by the first portion/part of the moveable member/actuator member in the optical path between the light source/light emitter and the light sensor is different between the moveable member/actuation member being in the first position and the moveable member/actuation member being in the second position, respectively (see col. 36, lines 19-37 (emphasis on the following statement): “ In at least one instance, the detection of light presence, alone, is used to determine the position of the actuation member 1320. In at least one instance, the detection of light intensity is used to determine the position of the actuation member 1320. Light intensity can be varied by arranging the plurality of windows 1321 in specific patterns where some patterns allow a first amount of light to pass through and other patterns allow a second amount of light to pass through which is different than the first amount of light.”), wherein the sensor is configured to transmit data relating to sensed light stemming from the light source to a receiver (see col. 35, lines 57-67 and col. 36, lines 1-5), but Kincaid nor Shelton disclose
wherein the external receiver is comprised in a second endovascular robotic instrument controllable based on the received data.
However, Baltrunas teaches an endovascular robotic system comprising two endovascular robotic instruments coupled together (see abstract). The system (fig. 3) teaches wherein an external receiver/transceiver is comprised in a second endovascular robotic instrument controllable based on the received data from the first robotic instrument (see page 4 lines 6-10, page 5, lines 20-28, page 15, lines 21-26).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton and the system of Baltrunas to arrive at the claimed invention. Such modification would improve the system by providing more precise control of the surgical robotic instruments when performing the surgical procedure, ultimately preserving patient safety when performing the surgical procedure.
Regarding claim 56, Kincaid as modified teaches:
The sensor as claimed in claim 54, wherein the moveable member/ carriage is coupled to or comprises a first robotic instrument (see abstract, fig. 1B, figs. 5A-5B, and para [0002]), but does not disclose wherein:
the second endovascular robotic instrument is identical or substantially identical to the first endovascular robotic instrument , and/or
(ii) wherein a function of the second endovascular robotic instrument is identical to a function of the first endovascular robotic instrument.
However, Baltrunas teaches wherein:
the second endovascular robotic instrument is identical or substantially identical to the first endovascular robotic instrument (see annotated fig. 3 below and page 14, lines 32-37).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton and the system of Baltrunas to arrive at the claimed invention. Such modification would improve the system by providing more precise control of the surgical robotic instruments when performing the surgical procedure, ultimately preserving patient safety when performing the surgical procedure.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Kincaid in view of Shelton, and Baltrunas, and further in view of US 2021/0196269 A1 to Shelton, IV et al. (hereinafter “Shelton’269”).
Regarding claim 55, Kincaid as modified teaches:
The sensor as claimed in claim 54, but does not explicitly disclose wherein the sensor comprises an external receiver, further comprising a slip ring,
wherein the slip ring is configured to allow for substantially continuous transmission of data corresponding to the sensed light to the external receiver.
Shelton’269 teaches a surgical instrument comprising a sensing circuit used to control the system in response to data transmitted from the sensing circuit (see abstract). The system (figs. 1-2, fig. 7A-7B, and fig. 28) teaches wherein the sensor comprises a receiver (see para [0550] and para [0639]), further comprising a slip ring/slip rings (see annotated figs. 59-61 below and para [0669]-[0670]),
wherein the slip ring is configured to allow for substantially continuous transmission of data corresponding to the sensed light to the receiver (see para [0004], para [0010]-[0011], para [0537]-[0539], para [0550]-[0554], para [0668]-[0670], and para [0948]). The slip ring allows for continuous transmission of data to determine the proper orientation of the shaft assembly relative to the attachment interface, which is connected to the optical system in figs. 7A-7B, which use the optical waveguide, light emitters, and receivers to determine the position of the actuation member/firing member located in the shaft assembly.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton’269 to arrive at the claimed invention. Such modification would improve the system by providing more precise control of the surgical robotic instruments when performing the surgical procedure, ultimately preserving patient safety when performing the surgical procedure.
Claims 57-58 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid in view of Shelton’269.
Regarding claim 57, Kincaid as modified teaches:
The sensor as claimed in claim 41, wherein one or more strain sensor can be hall effect based sensors that can be used to switch the device from passive control mode to active control mode (see para [0057]), but does not explicitly disclose wherein:
the detection unit comprises a magnetic field measurement unit configured to detect a change in a magnetic field,
wherein in the first and/or second position of the moveable member, a characteristic of the magnetic field is detectable by the magnetic field measurement unit,
and wherein the characteristic of the magnetic field detectable by the magnetic field measurement unit is a first value when the moveable member is in the first position and a second value when the moveable member is in the second position,
wherein the first value is different from the second value.
However, Shelton’269 teaches wherein,
the detection unit/sensing system (see fig. 8, 1430 and para [0555]) comprises a magnetic field measurement unit/ hall effect sensor(s) (see fig. 8, 1431 and 1433, and para [0555]) configured to detect a change in a magnetic field (see para [0555]),
wherein in the first and/or second position of the moveable member/actuation member, a characteristic (such as a disturbance or voltage value) of the magnetic field is detectable by the magnetic field measurement unit/hall effect sensors (see figs. 8-12, para [0014] and para [0555]-[0557]),
and wherein the characteristic/disturbance of the magnetic field detectable by the magnetic field measurement unit/hall effect sensors is a first value (greater disturbance reading when the magnet 1435 is closer to hall effect sensor 1431 and vice versa for hall effect sensor 1433) when the moveable member is in the first position and a second value (disturbance reading) when the moveable member/actuation member is in the second position, wherein the first value is different from the second value (see para [0556]-[0057]). If the magnet is closer to first hall effect sensor (1431), the disturbance value may be higher than the disturbance value of the second hall effect sensor, and based off the voltage reading of one or more of the sensors, a determination of the actuation member’s position is determined. If one or both of these values are above the expected value reading, the control system can modify or correct the motion of the actuation member.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton’269 to arrive at the claimed invention. Such modification would improve the system by providing more precise control of the surgical robotic instruments when performing the surgical procedure, ultimately preserving patient safety when performing the surgical procedure.
Regarding claim 58, Kincaid as modified teaches:
The sensor as claimed in claim 57, wherein the sensor is configured to determine that the moveable member is in the first position and/or the second position (abstract), but does not explicitly disclose wherein,
wherein the sensor is configured to determine that the moveable member is in the first position and/or the second position based on the characteristic detectable by the magnetic field measurement unit when the moveable member is in the first position and/or second position,
in particular wherein the sensor is configured to
determine a magnitude of the resilient force based on the characteristic detectable by the magnetic field measurement unit when the moveable member is in the second position;
and/or wherein the sensor is configured to determine that the moveable member is in a first transition between the first position and the second position and/or a second transition between the second position and the first position based on a change of the characteristic detectable by the magnetic field measurement unit;
and/or wherein the magnetic field measurement unit is configured to transmit data about the detected characteristic to a microcontroller coupled to the magnetic field measurement unit, in particular wherein the magnetic field measurement unit comprises a first magnet;
and/or wherein the magnetic field measurement unit comprises a Hall effect sensor, in particular further comprising a second magnet coupled to the moveable member, and wherein the characteristic detectable by the magnetic field measurement unit is based on a magnetic field interaction between the first magnet and the second magnet.
However, Shelton’269 teaches wherein, the detection unit/sensing system (see fig. 8, 1430 and para [0555]) comprises a magnetic field measurement unit (see fig. 8, 1431 and 1433, and para [0555]) configured to detect a change in a magnetic field (see para [0555]), wherein the sensor is configured to determine that the moveable member/actuation member is in the first position and/or the second position (or multiple positions – see para [0555]-[0557]) based on the characteristic/disturbance detectable by the magnetic field measurement unit/hall sensor(s) when the moveable member/actuation is in a first position and/or second position (see para [0555]-[0557]- If the magnet is closer to first hall effect sensor (1431), the disturbance value may be high than the disturbance value of the second hall effect sensor, and based off the voltage reading of one or more of the sensors, a determination of the actuation member’s position is determined. If one or both of these values are above the expected value reading, the control system can modify or correct the motion of the actuation member), in particular wherein the magnetic field measurement unit/ is configured to:
transmit data about the detected characteristic (disturbance) to a microcontroller/control system coupled to the magnetic field measurement unit/hall effect sensors, in particular wherein the magnetic field measurement unit/hall effect sensor(s) comprises a first magnet (see fig. 8, 1435 and para [0555]-[0557]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton’269 to arrive at the claimed invention. Such modification would improve the system by providing more precise control of the surgical robotic instruments when performing the surgical procedure, ultimately preserving patient safety when performing the surgical procedure.
Regarding claim 60, Kincaid as modified teaches:
A sensor for an endovascular robotic system (see abstract- first sentence, para 0002, and para 0011 - “ a sensor (221, 231) configured to measure an amount strain or an amount of displacement of the control wire (110) ”),
wherein the sensor comprises:
a moveable member/moving carriage (see para [0059] – “In FIG. 4, a first control wire 110a of the steerable instrument 100 is directly connected at its proximal end thereof to a corresponding first motor 311 via a moving carriage 341, and a second control wire 110b is directly connected at is proximal end to a second motor 312 via a moving carriage 342.”),
moveable between a first position and a second position (actively controlled mode vs. passively controlled mode – see abstract: “ In one embodiment, the steerable instrument includes an elongate body (100), a control wire (110) arranged in a channel (104) of the elongate body and displaceable along the channel to bend the elongate body;
and a controller (320) to selectively control drive forces applied to the control wire (110) under an actively controlled mode and a passively controlled mode”, para [0018], para [0065], para [0093], fig. 4, fig. 5A-5B, and fig. 10B), but does not explicitly disclose wherein a magnetic field measurement unit comprising a first magnet, wherein the magnetic field measurement unit is configured to detect a change in a magnetic field, wherein in the first and/or second position of the moveable member, a characteristic of the magnetic field is detectable by the magnetic field measurement unit, wherein the characteristic of the magnetic field detectable by the magnetic field measurement unit is a first value when the moveable member is in the first position and a second value when the moveable member is in the second position, wherein the first value is different from the second value, and wherein the sensor is configured to determine that the moveable member is in the first position and/or the second position based on the characteristic detectable by the magnetic field measurement unit when the moveable member is in the first position and/or second position.
However, Shelton’269 teaches wherein, the detection unit/sensing system (see fig. 8, 1430 and para [0555]) comprises a magnetic field measurement unit (see fig. 8, 1431 and 1433, and para [0555]) configured to detect a change in a magnetic field (see para [0555]), wherein a magnetic field measurement unit comprising a first magnet (see fig. 8, 1435 and para [0555])
wherein in the first and/or second position of the moveable member/actuation member, a characteristic (such as a disturbance or voltage value) of the magnetic field is detectable by the magnetic field measurement unit/hall effect sensors (see figs. 8-12, para [0014] and para [0555]-[0557]),
and wherein the characteristic/disturbance of the magnetic field detectable by the magnetic field measurement unit/hall effect sensors is a first value (greater disturbance reading when the magnet 1435 is closer to hall effect sensor 1431 and vice versa for hall effect sensor 1433) when the moveable member is in the first position and a second value (disturbance reading) when the moveable member/actuation member is in the second position, wherein the first value is different from the second value (see para [0556]-[0057]). If the magnet is closer to first hall effect sensor (1431), the disturbance value may be higher than the disturbance value of the second hall effect sensor, and based off the voltage reading of one or more of the sensors, a determination of the actuation member’s position is determined. If one or both of these values are above the expected value reading, the control system can modify or correct the motion of the actuation member.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kincaid with the light detection system of Shelton’269 to arrive at the claimed invention. Such modification would improve the system by providing more precise control of the surgical robotic instruments when performing the surgical procedure, ultimately preserving patient safety when performing the surgical procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gafford et al. (US 2017/0360279 A1) teaches a light-intensity force sensor configured to be coupled to the distal end of an endoscopic to provide haptic feedback to the user (see abstract).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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